text:
Influence of radiation treatment on pharmaceuticals and adjuvants: A literature study. Pt. 9. Supplement
International Nuclear Information System (INIS)
Sterilization of medical aid articles (e.g. catheters, one-way syringes) with ionizing radiation is a successful practice in many countries. During recent years, the results from numerous experiments of radiosterillization of pharmaceuticals and adjuvants have likewise been published. Experience has shown that radiation treatment, in many cases, is leading to transformations of the irradiated substances. In the present part IX of the bibliographic study on the influence of radiation treatment on pharmaceuticals and adjuvants the results of experiments on ca. 80 substances from 36 different sources have been evaluated. In all parts of the study results of about 560 experiments on 360 substances from 176 different sources are present. (orig.)
Sterilization of pharmaceutical ingredients, adjuvants and packaging materials by gamma radiation
International Nuclear Information System (INIS)
Different antibiotics, pharmaceutical ingredients, adjuvants and packaging materials were treated with gamma radiation of 0.5-2.8x106 rad using 60Co source. The effect of 2.5-2.8x106 rad on antibiotics, carbohydrates, citiric acid is a discoloration in some degree. The change of colour was accompanied by a decrease of activity of oxytetracycline hydrochloride and tobramycin sulphate, a decrease of viscosity of starch, and an increase of the reducing rate of saccharose and lactose. The sterility of substances contaminated by 103 organisms per gram was obtained by a dose of 0.5x106 rad. There was no discoloration and no changes were observed in the examined parameter of these materials. The examined aluminium, rubber and plastic packaging materials suffered no changes. (author)
The influence of radiation treatment on pharmaceuticals and adjuvants. A literature study. Pt. 8
International Nuclear Information System (INIS)
The 8th last volume is a summary and review of results from 467 experimental irradiations of 311 substances (based on 134 different sources) discussed in the previous seven volumes. This report is initially introducing a review list of the substances examined in the previous seven volumes. Further data are given on primary literature source. An alphabetical listing of standardized descriptions used in this report is furthermore presented. A list of substances per substance group and a list of substances per reference source are both added. In the results from individual substance groups, a so-called text evaluation is first providing a general review of results from the respective substance group prior to discussing the individual substances. In the summarizing list of each substance group, data are tabulated in reference to irradiation conditions, examining methods and substance decay. The subsequent excerpt from the summarizing list of the respective substance group is compiling the results. All results are compiled in comparison to the decay from irradiation in form of solid substance or aqueous solution; and likewise the effects from a sodiumpyrosulphide additive on the decay of aqueous solutions in comparison to solutions without additives. This is followed by a comparison of decay from radiosterilization and heat sterilization. The report is concluded by a summary of results from investigations on the toxicity of irradiated pharmaceuticals. (orig./MG)
Pharmaceutical Economics begins with an investigation of the structure of the industry and its three main components: the research firms which produce innovative products; the generic drug industry and its expanding role; and the biotech industry, which is regarded as the future for pharmaceuticals. Further sections discuss topics including demand and incentives, pricing and regulation.
[Influenza vaccine and adjuvant].
Nakayama, Tetsuo
Adjuvant is originated from the Latin word "adjuvare" which means "help" in English to enhance the immunological responses when given together with antigens. The beginning of adjuvant was mineral oil which enhanced the immune response when it was given with inactivated Salmonella typhimurium. Aluminium salt was used to precipitate diphtheria toxoid and increased level of antibody response was demonstrated when administered with alum-precipitated antigens. Since 1930, aluminium salt has been used as DTaP (diphtheria-tetanus-acellular pertussis vaccine) adjuvant. Many candidates were tested for adjuvant activity but only aluminum salt is allowed to use for human vaccines. New adjuvant MF59, oil-in-water emulsion type, was developed for influenza vaccine for elderly (Fluad) and series of AS adjuvant are used for hepatitis B, pandemic flue, and human papiloma virus vaccines. Oil-adjuvanted influenza pandemic vaccines induced higher antibody response than alum-adjuvanted vaccine with higher incidence of adverse events, especially for local reactions. Alum-adjuvanted whole virion inactivated H5N1 vaccine was developed in Japan, and it induced relatively well immune responses in adults. When it applied for children, febrile reaction was noted in approximately 60% of the subjects, with higher antibodies. Recent investigation on innate immunity demonstrates that adjuvant activity is initiated from the stimulation on innate immunity and/or inflammasome, resulting in cytokine induction and antigen uptake by monocytes and macrophages. The probable reason for high incidence of febrile reaction should be investigated to develop a safe and effective influenza vaccine. PMID:22129866
Institute of Scientific and Technical Information of China (English)
@@ When shares of Shanghai Pharmaceutical(Group)Co.Ltd.(Shanghai Pharma)resumed normal transactions on March9,2010,the biggest listed pharmaceutical company on China's stock market was born.By the time the closing bell rang at the end of the trading day,the market value of Shanghai Pharma had reached 32.28 billion yuan($4.73 billion).
Directory of Open Access Journals (Sweden)
Belozersky V. I.
Full Text Available A concept of adjuvants and their story of creation ischaracterized in the article. They're presented thevarious types of non-specific stimulators of immunesysteme, thier excipients and classification. They'redescribed basic properties of adjuvant systems, their significant advantages and disadvantages. Particular attention is paid to the numerous antigen delivery systems, including alive vectors, nanoparticles, bacterial toxins, etc. They're considered non-specific stimulators mechanisms of action on immune system and theirinteraction with antigens. They're given examples of different adjuvants in licensed vaccines use.
Belozersky V. I; Zhdamarova L.A.; Yelyseyeva I. V; Babych Ye. M.; Isaenko Ye. Yu.; Kolpak S. A
A concept of adjuvants and their story of creation ischaracterized in the article. They're presented thevarious types of non-specific stimulators of immunesysteme, thier excipients and classification. They'redescribed basic properties of adjuvant systems, their significant advantages and disadvantages. Particular attention is paid to the numerous antigen delivery systems, including alive vectors, nanoparticles, bacterial toxins, etc. They're considered non-specific stimulators mechanisms of a...
ERM immersion vaccination and adjuvants
DEFF Research Database (Denmark)
Skov, J.; Chettri, J. K.; Jaafar, R. M.;
Two candidate adjuvants were tested with a commercial ERM dip vaccine (AquaVac™ Relera, MSD Animal Health) for rainbow trout in an experimental design compatible with common vaccination practices at farm level, i.e. immersion of fish in vaccine (±adjuvant) for 30 s. The adjuvants were the...
Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)
International Nuclear Information System (INIS)
The microbiological quality of many raw materials used in the manufacture of pharmaceuticals and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed. (author)
Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)
Ražem, D.; Katušin-Ražem, B.; Starčević, M.; Galeković, B.
The microbiological quality of many raw materials used in the manufacture of pharmaceutical and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed.
Adjuvant Treatment for Ampullary Cancer
Richard Kim; John Chabot; Muhammad Wasif Saif
Ampullary cancer is an uncommon tumor and tends to have a better prognosis than pancreatic cancer. However, one half of patients will die from recurrent disease suggesting the need for effective adjuvant therapy. Currently, there is lack of randomized trials to guide the use of adjuvant therapy in ampullary cancer. At the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting, the largest trial (Abstract #4006) evaluating adjuvant treatment of ampullary cancer was presented.
Adjuvant Treatment for Ampullary Cancer
Directory of Open Access Journals (Sweden)
Richard Kim
Full Text Available Ampullary cancer is an uncommon tumor and tends to have a better prognosis than pancreatic cancer. However, one half of patients will die from recurrent disease suggesting the need for effective adjuvant therapy. Currently, there is lack of randomized trials to guide the use of adjuvant therapy in ampullary cancer. At the 2011 American Society of Clinical Oncology (ASCO Annual Meeting, the largest trial (Abstract #4006 evaluating adjuvant treatment of ampullary cancer was presented.
Ursem, Carling; Van Loon, Katherine; Venook, Alan
In 2015, ramucirumab and TAS-102 became the 10th and 11th drugs approved by the Food and Drug administration for the treatment of patients with colorectal cancer, not counting leucovorin, and yet only 3 agents, 5-fluorouracil, capecitabine, and oxaliplatin, have proven benefit in adjuvant treatment. In fact, there have been no additions (and 1 subtraction levamisole) to our arsenal of therapies for patients with stages II and III colon cancer for more than a decade. How did we get here? Are we stuck? And how do we move forward? PMID:27341598
GMK (Progenics Pharmaceuticals).
Knutson, Keith L
Progenics Pharmaceuticals is developing GMK vaccine (a ganglioside conjugate vaccine coupled to keyhole limpet hemocyanin and formulated with the adjuvant QS-21), licensed from the Memorial Sloan-Kettering Cancer Center, for the potential treatment of melanoma and other cancers [194258], [325284]. It was previously under co-development with Bristol-Myers Squibb, but in May 2001, all rights to the GMK vaccine were returned to Progenics [409168]. It was the first of a new class of ganglioside conjugate vaccine evaluated by Progenics [194258]. GMK vaccination induces antibodies against GM2 ganglioside capable of specifically killing melanoma cells. Melanoma patients with antibodies against GM2 ganglioside have significantly improved disease-free and overall survival compared to antibody-negative subjects. The vaccine is undergoing two phase III trials, the first comparing GMK to high-dose IFNalpha in melanoma patients with more serious disease and at a high risk of relapse, and the second, in collaboration with the European Organization for Research and Treatment of Cancer, comparing GMK (14 doses of GMK over three years) to no treatment other than close monitoring of malignant melanoma patients at immediate risk of relapse [409168]. In February 1999, Lehman Brothers predicted that the vaccine had a 50% probability of reaching market, with an estimated first launch date in 2002. The analysts predicted potential peak sales in 2008 of $150 million in the US and $100 million in the rest of the world at that time [319225]. In January 2000, Lehman Brothers expected that an NDA filing would take place in 2002, with possible launch of the vaccine in 2003. In addition, Lehman Brothers estimated potential peak sales at $500 million [357788]. In August 2000, Punk, Ziegel & Company predicted that Progenics Pharmaceuticals will become sustainably profitable in 2003 following the launch of GMK and PRO-542 in 2002 [390063]. In July 2001, Ladenburg Thalmann predicted a $257 million
Adjuvant therapies for colorectal cancer
Institute of Scientific and Technical Information of China (English)
The management of colon and rectal cancer has changed dramatically over the last 25 years. The use of adjuvant therapies has become standard practice in locally advanced (stage Ⅲ and selected stage Ⅱ) colorectal cancer. Improved surgical techniques, chemotherapeutics and radiotherapy are resulting in higher cure rates and the development of agents targeting proliferative and angiogenic pathways offer further promise. Here we explore risk factors for local and distant recurrence after resection of colon and rectal cancer, and the role of adjuvant treatments. Discussion will focus on the evidence base for adjuvant therapies utilised in colorectal cancer, and the treatment of sub-groups such as the elderly and stage Ⅱ disease. The role of adjuvant radiotherapy in rectal cancer in reduction of recurrence will be explored and the role and optimal methods for surveillance post-curative resection with or without adjuvant therapy will also be addressed.
Innate immunity and adjuvants.
Akira, Shizuo
Innate immunity was for a long time considered to be non-specific because the major function of this system is to digest pathogens and present antigens to the cells involved in acquired immunity. However, recent studies have shown that innate immunity is not non-specific, but is instead sufficiently specific to discriminate self from pathogens through evolutionarily conserved receptors, designated Toll-like receptors (TLRs). Indeed, innate immunity has a crucial role in early host defence against invading pathogens. Furthermore, TLRs were found to act as adjuvant receptors that create a bridge between innate and adaptive immunity, and to have important roles in the induction of adaptive immunity. This paradigm shift is now changing our thinking on the pathogenesis and treatment of infectious, immune and allergic diseases, as well as cancers. Besides TLRs, recent findings have revealed the presence of a cytosolic detector system for invading pathogens. I will review the mechanisms of pathogen recognition by TLRs and cytoplasmic receptors, and then discuss the roles of these receptors in the development of adaptive immunity in response to viral infection. PMID:21893536
Radiation sterilization of pharmaceuticals
International Nuclear Information System (INIS)
Ionizing radiation for sterilization of medical products has been widely used throughout the world, but application of pharmaceuticals has not yet gain popularity due their complex nature. Radiation sterilization especially gamma radiation is a promising method for those pharmaceuticals which are sensitive to heat and ethylene oxide. This article compare various methods of sterilization and their shortcomings, radiation sterilization and its advantages over conventional methods, various radiation sources, effect of gamma irradiation on solid and aqueous pharmaceuticals and the methods of evaluation of irradiated products. Different pharmaceuticals approved for radiation treatment in different parts of the world and pharmaceuticals and radiopharmaceutical kits sterilized in Pakistan have also been described. (author)
Adjuvant Therapy of Pancreatic Cancer
Directory of Open Access Journals (Sweden)
Chakra P Chaulagain
Full Text Available There is no clear consensus on what type of adjuvant therapy should be used for patients with pancreatic cancer. Chemoradiation is the favored treatment modality by many in the United States while gemcitabine based chemotherapy is favored in Europe. Both of these approaches have been shown by large prospective, randomized trials to improve disease free intervals and in some studies overall survival. This year at the American Society of Clinical Oncology (ASCO Gastrointestinal Cancer Symposium, the randomized phase III study presented by Uesaka et al. from Japan (Abstract #145 represents a newer paradigm of oral adjuvant S-1 chemotherapy in place of the traditional standard of care intravenous gemcitabine in terms of prolonging patients' survival. Another study by Fan et al. (Abstract #269 examined the value of targeted therapy using erlotinib with adjuvant chemoradiation and chemotherapy. We present the summary of these two studies and discuss the potential impact on our clinical practice on this highly lethal cancer.
Adjuvant chemotherapy and cancer cure
International Nuclear Information System (INIS)
The use of chemotherapy as an adjuvant to surgery and/or radiotherapy is well founded in experimental tumor systems and appears to be effective in patients in some circumstances. It is clear from both clinical and experimental studies that (1) the dose is important, (2) the earlier chemotherapy is started after primary therapy the better, and (3) combination chemotherapy may be more effective than single-agent treatment. The better the estimation of risk of recurrence, the better the assessment of the risk-benefit ratio with adjuvant therapy. Salvage therapy as well as relative risk of recurrence are considerations in the choice of patients to be treated. Finally, some evidence is presented to indicate that alkylating agents may not be necessary in combination regimens for adjuvant therapy if effective antimetabolite combinations are available
Muramyl dipeptide-induced adjuvant arthritis.
Nagao, S.; Tanaka, A.
Muramyl dipeptide, N-acetylmuramyl-L-alanyl-D-isoglutamine, induced adjuvant arthritis in WKA rats when injected in a water-in-oil emulsion prepared with Freund incomplete adjuvant (Difco), but not when emulsified with Drackeol and Arlacel A.
Biological and Pharmaceutical Nanomaterials
Kumar, Challa S. S. R.
This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.
A Review and Prospect on Herbicide Adjuvants
Institute of Scientific and Technical Information of China (English)
The history, present status and future prospects of adjuvants application in herbicides were briefly reviewed. Adjuvants can be separated into two groups, activator adjuvants and utility adjuvants. The former directly enhances the efficacy of a herbicide through increasement of herbicide absorption, spreading, cuticular penetration, rainfastness and retention enhancement, and photodegradation of the herbicide can also be decreased. And the latter is utilized for improving application characteristics, behaviors and physical properties of herbicides and reducing or minimizing unwanted side effects on application.
Adjuvant therapy in pancreatic cancer
Institute of Scientific and Technical Information of China (English)
Paula Ghaneh; John Slavin; Robert Sutton; Mark Hartley; John P Neoptolemos
The outlook for patients with pancreatic cancer has been grim. There have been major advances in the surgical treatment of pancreatic csncer, leading to a drsmatic reduction in post-operative mortality from the development of high volume specialized centres. This stimulated the study of adjuvant and neoadjuvant treatments in pancreatic cancer including chemoradiotherapy and chemotherapy. Initial protocols have been based on the original but rather small GITSG study first reported in 1985. There have been two large European trials totalling over 600 patients (EORTC and ESPAC-1) that do not support the use of chemoradiation as adjuvant therapy. A second major finding from the ESPAC-1 trial (541 patients randomized) was some but not conclusive evidence for a survival benefit associated with chemotherapy. A third major finding from the ESPAC-1 trial was that the quality of life was not affected by the use of adjuvant treatments compared to surgery alone.The ESPAC-3 trial aims to assess the definitive use of adjuvant chemotherapy in a randomized controlled trial of 990 patients.
Wisdom Pharmaceutical Co., Ltd.
Institute of Scientific and Technical Information of China (English)
@@ Wisdom Pharmaceutical Co., Ltd. (Wisdom) headquartered in Haimen, Nantong, Jiangsu Province, China, is specialized in providing highly efficient production processes of active pharmaceutical ingredients (API) and intermediates. Currently, Wisdom is in the process of expanding GMP (Good Manufacturing Practice) capabilities, which is expected to be approved by the authorities before the end of September 2003.
FDA pharmaceutical quality oversight.
Yu, Lawrence X; Woodcock, Janet
The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale. PMID:26027494
Improving vaccine delivery using novel adjuvant systems.
Pichichero, Michael E
Adjuvants have been common additions to vaccines to help facilitate vaccine delivery. With advancements in vaccine technology, several adjuvants which activate immune specific responses have emerged. Available data show these adjuvants elicit important immune responses in both healthy and immunocompromised populations, as well as the elderly. Guidelines for the use and licensure of vaccine adjuvants remain under discussion. However, there is a greater understanding of the innate and adaptive immune response, and the realization of the need for immune specific adjuvants appears to be growing. This is a focused review of four adjuvants currently in clinical trial development: ASO4, ASO2A, CPG 7907, and GM-CSF. The vaccines including these adjuvants are highly relevant today, and are expected to reduce the disease burden of cervical cancer, hepatitis B and malaria. PMID:18398303
Adjuvant Therapy of Pancreatic Cancer
Chakra P Chaulagain; Muhammad Wasif Saif; Goodman, Martin D.; John Ng
There is no clear consensus on what type of adjuvant therapy should be used for patients with pancreatic cancer. Chemoradiation is the favored treatment modality by many in the United States while gemcitabine based chemotherapy is favored in Europe. Both of these approaches have been shown by large prospective, randomized trials to improve disease free intervals and in some studies overall survival. This year at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposiu...
Comparison of immunogenicity of Aluminum salts as adjuvant for recombinant Hepatitis-B vaccine
Directory of Open Access Journals (Sweden)
Fazeli MR
Full Text Available Background: Aluminum salts are common adjuvants in human and animal vaccine preparations. The two adjuvants aluminum phosphate and aluminum hydroxide show acceptable immunoadjuvant properties with many antigens. These two salts have different physicochemical characteristics that make each one suitable for certain antigens. The surface antigen of Hepatitis B (HBsAg has several antigenic epitopes that bind to aluminum adjuvants by a ligand exchange mechanism. Although HBV vaccines using an aluminum hydroxide adjuvant are available, higher antigenicity is needed for the subgroup of people who do not respond sufficiently to the currently available vaccines. Methods: A solution of recombinant HBsAg for making different formulations of vaccines with aluminum phosphate (Adju-Phos® and aluminum hydroxide (Alhydrogel® adjuvants was obtained from Darupakhsh Pharmaceutical Company. The total protein content, antigenicity, and purity of HBsAg solution were determined using BCA, ELISA, and SDS-PAGE methods, respectively. The different formulations were prepared in the lab and administered i.p. to two test groups of Balb/C mice and a third test group received the Engerix vaccine, which is currently available on the market and uses an aluminum hydroxide adjuvant. The control group of animals received the solution without antigen. After 28 days, heart blood samples were collected and serum was separated to determine the antibody titer against HBsAg using an ELISA kit. Results: This study shows that the vaccine formulated with aluminum phosphate exerted more immunogenicity than both the aluminum hydroxide laboratory formulation and the Engerix vaccines. Conclusion: Although the results of our study indicate higher immunogenic properties of the vaccine formulated with the aluminum phosphate adjuvant, complementary experiments are needed to further evaluate the biological properties with respect to effectiveness, adverse effects, product stability and finally
Energy Technology Data Exchange (ETDEWEB)
This Energy Consumption Guide shows the results of a survey of the UK Pharmaceutical Industry undertaken in 1992 in conjunction with the Association of the British Pharmaceutical Industry (ABPI). The survey was questionnaire based and the companies who replied represent approximately 20% of the energy consumption of the pharmaceutical industry as a whole. The questionnaire also included questions about the uptake of various energy saving measures, and the results of the analysis of these questions are presented in the guide. An action plan is presented which gives a number of ideas for energy saving measures suitable for application in the pharmaceutical industry. A potential for energy saving of 10 PJ per year costing Pound 34 million per year is indicated by comparing the performance of more efficient companies with others. (author)
Pharmaceutical Industry Develops Steadily
Institute of Scientific and Technical Information of China (English)
@@ With the development of the economy, the growth of the total population, the growing proportion of older citizens, and the increasing awareness of people's health care,the pharmaceutical market in China has seen a sustained and rapid expansion.
The regulation of Pharmaceutical Excipients
Vikrant Saluja; Bhupinder Singh Sekhon
Pharmaceutical excipients are vital components of drug formulations and are generally considered pharmacologically inert. Control of excipient manufacturing and distribution is now considered a key priority by regulatory authorities and pharmaceutical manufacturers, because adulteration of pharmaceutical excipients has resulted in adverse effects in patients. Furthermore, with the emergence of novel excipients and delivery systems, better quality and supply control of pharmaceutical excipient...
Systemic adjuvant therapies in renal cell carcinoma
Sebastiano Buti; Melissa Bersanelli; Maddalena Donini; Andrea Ardizzoni
Renal cell carcinoma (RCC) is one of the ten most frequent solid tumors worldwide. Recent innovations in the treatment of metastatic disease have led to new therapeutic approaches being investigated in the adjuvant setting. Observation is the only current standard of care after radical nephrectomy, although there is evidence of efficacy of adjuvant use of vaccine among all the strategies used. This article aims to collect published experiences with systemic adjuvant approaches in RCC and to d...
Should pharmaceutical costs be curbed?
Brekke, Kurt R.; Dalen, Dag Morten; STRØM, Steinar
Pharmaceuticals account for almost a fifth of total health spending in OECD-countries. Both pharmaceutical innovations and the aging of the population explain the increasing importance of pharmaceuticals in health care. Due to the importance of patent protection and insurance coverage, pharmaceutical markets are subjected to economic regulation – both on the supply-side and the demand-side. In this paper, we briefly review the Nordic pharmaceutical market, before explaining ...
Novel Adjuvants and Immunomodulators for Veterinary Vaccines
DEFF Research Database (Denmark)
Heegaard, Peter M. H.; Fang, Yongxiang; Jungersen, Gregers
Adjuvants are crucial for efficacy of vaccines, especially subunit and recombinant vaccines. Rational vaccine design, including knowledge-based and molecularly defined adjuvants tailored for directing and potentiating specific types of host immune responses towards the antigens included in the va...
Conceptualizing Pharmaceutical Plants
DEFF Research Database (Denmark)
Larsen, Bent Dalgaard; Jensen, Klaes Ladeby; Gjøl, Mikkel
In the conceptual design phase of pharmaceutical plants as much as 80%-90% of the total cost of a project is committed. It is therefore essential that the chosen concept is viable. In this design process configuration and 3D models can help validate the decisions made. Designing 3D models is a...... complex task and requires skilled users. We demonstrate that a simple 2D/3D configuration tool can support conceptualizing of pharmaceutical plants. Present paper reports on preliminary results from a full scale implementation project at a Danish engineering company....
Adjuvants: Classification, Modus Operandi, and Licensing
Apostólico, Juliana de Souza
Vaccination is one of the most efficient strategies for the prevention of infectious diseases. Although safer, subunit vaccines are poorly immunogenic and for this reason the use of adjuvants is strongly recommended. Since their discovery in the beginning of the 20th century, adjuvants have been used to improve immune responses that ultimately lead to protection against disease. The choice of the adjuvant is of utmost importance as it can stimulate protective immunity. Their mechanisms of action have now been revealed. Our increasing understanding of the immune system, and of correlates of protection, is helping in the development of new vaccine formulations for global infections. Nevertheless, few adjuvants are licensed for human vaccines and several formulations are now being evaluated in clinical trials. In this review, we briefly describe the most well known adjuvants used in experimental and clinical settings based on their main mechanisms of action and also highlight the requirements for licensing new vaccine formulations.
Smith, Paul F
GW Pharmaceuticals is developing GW-1000 (Sativex), a narrow ratio delta9-tetrahydrocannabinol:cannabidiol product for the potential treatment of multiple sclerosis, spinal cord injury, neurogenic pain and peripheral neuropathy. In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada. PMID:15298072
Regulation of Pharmaceutical Prices
DEFF Research Database (Denmark)
Kaiser, Ulrich; Mendez, Susan J.; Rønde, Thomas
On April 1, 2005, Denmark changed the way references prices, a main determinant of reimbursements for pharmaceutical purchases, are calculated. The previous reference prices, which were based on average EU prices, were substituted to minimum domestic prices. Novel to the literature, we estimate the...
The Effectiveness of Pharmaceutical Marketing
Kappe, E.R.
textabstractPharmaceutical marketing effectiveness comprises the measurement of marketing efforts of pharmaceutical firms towards doctors and patients. These firms spend billions of dollars yearly to promote their prescription drugs. This dissertation provides empirical analyses and methods to contribute to several substantial problems on pharmaceutical marketing effectiveness. Using unique data in every essay, it studies the role of the firm, sales rep and doctor in pharmaceutical marketing....
Glucocorticosteroids: as Adjuvant Therapy for Bacterial Infections
Directory of Open Access Journals (Sweden)
Full Text Available Glucocorticoids (GCs, synthetic analogues of the natural steroid hormones, are well known for their antiinflammatory and immunosuppressive properties in the periphery. They are widely and successfully used in the treatment of autoimmune diseases, chronic inflammation, and transplant rejection. Nowadays, GCs are claimed to have a beneficial role being as adjunct therapy in various infections. Different studies have been conducted to investigate their use as adjuvant therapy for different bacterial infection. This review, therefore, summarizes various bacterial infections for which glucocorticoids are reported to be used as adjuvant therapy, strategies for administration of glucocorticoids, and challenges of using glucocorticoids as adjuvant therapy.
Pharmaceutical Public-Private Partnerships
DEFF Research Database (Denmark)
Bagley, Constance; Tvarnø, Christina D.
This article provides a game theory and law-and-management analysis of for- profit pharmaceutical public-private partnerships, a complex type of legal arrangement in the highly regulated pharmaceutical industry. A pharmaceutical public-private partnership (PPPP) agreement is a legally binding...... contract be- tween a private pharmaceutical enterprise and a public research university (or a private university conducting publicly funded research) to support research leading to new commercial pharmaceutical and biologic products. The key purpose of this article is to provide a theoretical explanation...
EU pharmaceutical expenditure forecast
Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher
Background and Objectives With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States' pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Method In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012–2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. Results According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (−€9,367 million), France
Influence of radiation treatment on pharmaceuticals. A study of the relevant literature
International Nuclear Information System (INIS)
The present communication provides a quick overview of the behaviour of individual substances when treated with ionizing radiation while making reference to the respective original literature. The choosen form of an encyclopaedia enables the user to find information at a glance. It is based on parts I - XII of our review of literature on the influence of radiation treatment on pharmaceutical products and adjuvants/excipients we started in 1978. (orig.)
Pharmaceutical market in Serbia
Directory of Open Access Journals (Sweden)
Veselin Tima Dickov
Full Text Available Marketing concept formed around the focus on the consumers, their needs, wants and demands, evolves in the case of pharmaceutical into a care of the complex interest of constituents generating demand on this market and #8211; pres scribers whose role is to select therapies, pharmacists who dispense drugs within a specialized distribution channel to the final consumer -patient, alongside the payers and #8211; the state and or insurance companies refund a part of or total costs of the pharmaceutical product. A special challenge that the subject raises is the existence of controversy generated from two sources. Marketing controversy stems from criticism leveled at the effectiveness and efficiency of marketing activities and the debatable ethical code of conduct. [J Intercult Ethnopharmacol 2012; 1(1.000: 44-51
Objective: To review the risk in pharmaceutical industries and the risk management process and tools. There is risk always in anything we do. All the industries on this globe perform actions that involve risks; risk is only dangerous when there is no anticipation to manage it. Risks if assessed and controlled properly will benefit the industries against the fall and makes stronger. Risk should not be assessed as bad, but should assess as an opportunity for making things resilient by proper ma...
Pharmaceutical market in Serbia
Veselin Tima Dickov
Marketing concept formed around the focus on the consumers, their needs, wants and demands, evolves in the case of pharmaceutical into a care of the complex interest of constituents generating demand on this market and #8211; pres scribers whose role is to select therapies, pharmacists who dispense drugs within a specialized distribution channel to the final consumer -patient, alongside the payers and #8211; the state and or insurance companies refund a part of or total costs of the pharmac...
Adjuvant Bisphosphonates for Postmenopausal Breast Cancer
A summary of a meta-analysis of randomized trials of bisphosphonates as adjuvant therapy for women with early-stage breast cancer that shows the drugs can reduce the rate of disease recurrence in bone.
Trade, TRIPS, and pharmaceuticals.
Smith, Richard D; Correa, Carlos; Oh, Cecilia
The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus. PMID:19167054
Adjuvant interferon treatment for melanoma.
Agarwala, S S; Kirkwood, J M
After decades of research, the adjuvant therapy of patients with melanoma has recently shown significant survival and relapse-free interval benefit for the intravenous and subcutaneous administration of maximally tolerable dosages of recombinant IFN alpha 2b in a trial conducted by the ECOG (E1684). Despite the toxicity of this therapy, retrospective analyses of its impact upon quality-of-life using Q-TWiST methods and cost-efficacy analyses all argue for the benefit and utility of this intervention, especially for node-positive patients with resectable melanoma at highest risk of relapse. A confirmatory trial has been completed and will mature in the spring of 1998. The impact of lower dosages of IFN, apparent transiently during and for a period of time following treatment has not been sustained with longer follow-up in a number of trials. Current approaches in Europe and North America focus upon refinement of dose and duration of treatment with IFN and their potential interactions with, and comparison with, active specific immunotherapy with vaccines. A recently emerging area of research is the patient with stage IIA melanoma and the potential role of an abbreviated high-dose regimen of IFN alpha in this patient subset. PMID:9759581
Review: Adjuvant effects of saponins on animal immune responses
Institute of Scientific and Technical Information of China (English)
RAJPUT Zahid Iqbal; HU Song-hua; XIAO Chen-wen; ARIJO Abdullah G.
Vaccines require optimal adjuvants including immunopotentiator and delivery systems to offer long term protection from infectious diseases in animals and man. Initially it was believed that adjuvants are responsible for promoting strong and sustainable antibody responses. Now it has been shown that adjuvants influence the isotype and avidity of antibody and also affect the properties of cell-mediated immunity. Mostly oil emulsions, lipopolysaccharides, polymers, saponins, liposomes, cytokines,ISCOMs (immunostimulating complexes), Freund's complete adjuvant, Freund's incomplete adjuvant, alums, bacterial toxins etc.,are common adjuvants under investigation. Saponin based adjuvants have the ability to stimulate the cell mediated immune system as well as to enhance antibody production and have the advantage that only a low dose is needed for adjuvant activity. In the present study the importance of adjuvants, their role and the effect of saponin in immune system is reviewed.
Pharmaceutical industry in strategic development
World pharmaceutical industry has been changing profoundly as it has been steadily concentrating and consolidating in the last decade. According to our survey, we may underline the intensive marketing management represents an extremely important operational and even strategic function for proper business performance and long-term strategic orientation for the world pharmaceutical companies. We may even conclude that intensive consolidation of world pharmaceutical industry is a market driven a...
Pharmaceuticals labelled with stable isotopes
International Nuclear Information System (INIS)
The relatively new field of pharmaceuticals labelled with stable isotopes is reviewed. Scientific, juridical, and ethical questions are discussed concerning the application of these pharmaceuticals in human medicine. 13C, 15N, and 2H are the stable isotopes mainly utilized in metabolic function tests. Methodical contributions are given to the application of 2H, 13C, and 15N pharmaceuticals showing new aspects and different states of development in the field under discussion. (author)
China's Chemical Pharmaceutical Industry Rebounding
Institute of Scientific and Technical Information of China (English)
@@ After reorganization in 2006, China's chemical pharmaceutical industry began to pick up in 2007. According to the China Pharmaceutical Industry Association,China's chemical pharmaceutical industry achieved sales revenues of RMB202.5 billion in the first eight months this year, a growth of 24.6% - 5.6 percentage points faster than January to May this year. The net profit was RMB17.4 billion, an increase of 50.8% over the same period of 2006.
Marketing Communication in Pharmaceutical Industry
Jirků, Jitka
Thesis - Marketing Communications in Pharmaceutical Industry - consists of two parts - theoretical and practical. The theoretical part presents the various attributes of marketing communication, together with the marketing mix. In detail, the work will focus on the 4P - product, price, distribution and marketing communication. Each of these attributes will be related to the specific environment of the pharmaceutical industry. In this section we outline the history of the pharmaceutical indust...
Electrochemical biosensors in pharmaceutical analysis
Eric de Souza Gil; Giselle Rodrigues de Melo
Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, fo...
Bolaamphiphiles: A Pharmaceutical Review
Fariya, Mayur; Jain, Ankitkumar; Dhawan, Vivek; Shah, Sanket; Nagarsenker, Mangal S.
The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery. PMID:25671179
Beyond antigens and adjuvants: formulating future vaccines.
Moyer, Tyson J; Zmolek, Andrew C; Irvine, Darrell J
The need to optimize vaccine potency while minimizing toxicity in healthy recipients has motivated studies of the formulation of vaccines to control how, when, and where antigens and adjuvants encounter immune cells and other cells/tissues following administration. An effective subunit vaccine must traffic to lymph nodes (LNs), activate both the innate and adaptive arms of the immune system, and persist for a sufficient time to promote a mature immune response. Here, we review approaches to tailor these three aspects of vaccine function through optimized formulations. Traditional vaccine adjuvants activate innate immune cells, promote cell-mediated transport of antigen to lymphoid tissues, and promote antigen retention in LNs. Recent studies using nanoparticles and other lymphatic-targeting strategies suggest that direct targeting of antigens and adjuvant compounds to LNs can also enhance vaccine potency without sacrificing safety. The use of formulations to regulate biodistribution and promote antigen and inflammatory cue co-uptake in immune cells may be important for next-generation molecular adjuvants. Finally, strategies to program vaccine kinetics through novel formulation and delivery strategies provide another means to enhance immune responses independent of the choice of adjuvant. These technologies offer the prospect of enhanced efficacy while maintaining high safety profiles necessary for successful vaccines. PMID:26928033
Synthetic Self-Adjuvanting Glycopeptide Cancer Vaccines
Payne, Richard; McDonald, David; Byrne, Scott
Due to changes in glycosyltransferase expression during tumorigenesis, the glycoproteins of cancer cells often carry highly truncated carbohydrate chains compared to those on healthy cells. These glycans are known as tumor-associated carbohydrate antigens, and are prime targets for use in vaccines for the prevention and treatment of cancer. Herein, we review the state-of-the-art in targeting the immune system towards tumor-associated glycopeptide antigens via synthetic self adjuvanting vaccines, in which the antigenic and adjuvanting moieties of the vaccines are present in the same molecule. The majority of the self-adjuvanting glycopeptide cancer vaccines reported to date employ antigens from mucin 1, a protein which is highly over-expressed and aberrantly glycosylated in many forms of cancer. The adjuvants used in these vaccines predominantly include lipopeptide- or lipoamino acid-based TLR2 agonists, although studies investigating stimulation of TLR9 and TLR4 are also discussed. Most of these adjuvants are highly lipophilic, and, upon conjugation to antigenic peptides, provide amphiphilic vaccine molecules. The amphiphilic nature of these vaccine constructs can lead to the formation of higher-order structures by vaccines in solution, which are likely to be important for their efficacy in vivo.
Systemic adjuvant therapies in renal cell carcinoma.
Buti, Sebastiano; Bersanelli, Melissa; Donini, Maddalena; Ardizzoni, Andrea
Renal cell carcinoma (RCC) is one of the ten most frequent solid tumors worldwide. Recent innovations in the treatment of metastatic disease have led to new therapeutic approaches being investigated in the adjuvant setting. Observation is the only current standard of care after radical nephrectomy, although there is evidence of efficacy of adjuvant use of vaccine among all the strategies used. This article aims to collect published experiences with systemic adjuvant approaches in RCC and to describe the results of past and ongoing phase III clinical trials in this field. We explored all the systemic treatments, including chemotherapy, immunotherapy and targeted drugs while alternative approaches have also been described. Appropriate selection of patients who would benefit from adjuvant therapies remains a crucial dilemma. Although the international guidelines do not actually recommend any adjuvant treatment after radical surgery for RCC, no conclusions have yet been drawn pending the results of the promising ongoing clinical trials with the target therapies. The significant changes that these new drugs have made on advanced disease outcome could represent the key to innovation in terms of preventing recurrence, delaying relapse and prolonging survival after radical surgery for RCC. PMID:25992216
Systemic adjuvant therapies in renal cell carcinoma
Directory of Open Access Journals (Sweden)
Sebastiano Buti
Full Text Available Renal cell carcinoma (RCC is one of the ten most frequent solid tumors worldwide. Recent innovations in the treatment of metastatic disease have led to new therapeutic approaches being investigated in the adjuvant setting. Observation is the only current standard of care after radical nephrectomy, although there is evidence of efficacy of adjuvant use of vaccine among all the strategies used. This article aims to collect published experiences with systemic adjuvant approaches in RCC and to describe the results of past and ongoing phase III clinical trials in this field. We explored all the systemic treatments, including chemotherapy, immunotherapy and targeted drugs while alternative approaches have also been described. Appropriate selection of patients who would benefit from adjuvant therapies remains a crucial dilemma. Although the international guidelines do not actually recommend any adjuvant treatment after radical surgery for RCC, no conclusions have yet been drawn pending the results of the promising ongoing clinical trials with the target therapies. The significant changes that these new drugs have made on advanced disease outcome could represent the key to innovation in terms of preventing recurrence, delaying relapse and prolonging survival after radical surgery for RCC.
Does lipophilicity per se induce adjuvant effects?
DEFF Research Database (Denmark)
Hansen, Jitka Stilund; Larsen, Søren Thor; Poulsen, Lars K.;
) or on lung function parameters. Thus, MP did not possess irritant or inflammatory properties, which may be a precursive stimulus for adjuvant effects. Second, mice were exposed to aerosols of MP, 6 or 323 mg/m3, for 1 h followed by a 20-min low-dose ovalbumin (OVA) inhalation. OVA only and OVA + Al......Anthopogenically introduced substances and pollutants are suspected to promote sensitization and development of allergic airway diseases, that is, acting as adjuvants. Lipophilicity may serve as an immunological warning signal, promoting adjuvant effects. Whether the lipophilicity of an inhaled...... compound induces immunomodulatory effects was investigated in a murine inhalation model with the highly lipophilic methyl palmitate (MP) as model substance. First, studies of acute effects following a 1-h exposure of up to 348 mg/m3 MP showed no effects on cell composition in bronchoalveolar lavage (BAL...
Mycophenolate mofetil as adjuvant in pemphigus vulgaris
Directory of Open Access Journals (Sweden)
Sarma Nilendu
Full Text Available Pemphigus vulgaris (PV is a life threatening autoimmune blistering disease of skin and mucous membranes. Advent of systemic steroids has greatly reduced the mortality rate. However, steroids and adjuvant immunosuppressive therapy are nowadays frequent contributory agents of morbidity and mortality of PV. Mycophenolate mofetil (MMF has been reported to be an effective adjuvant to systemic steroids. It helps in increasing the immunosuppressive effect and minimizing the toxicities by steroid sparing effect. However, its efficacy in refractory cases of PV is not well documented. The lowest possible dose with satisfactory therapeutic efficacy and least side effects is known. We used MMF 1 g/day and systemic steroids in 3 Indian patients with pemphigus vulgaris who were resistant to systemic steroid monotherapy or combination treatment with azathioprine. In our experience, MMF offers an effective adjuvant with minimal side-effects in the treatment of resistant PV.
PSE in Pharmaceutical Process Development
DEFF Research Database (Denmark)
Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John
The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper will discuss the use of Process Systems Engineering (PSE) methods in pharmaceutical process development, and searches for answers to questions such as: Which PSE...
Pharmaceutical Marketing - Time for Change
Buckley, Joan
This paper reviews current marketing practices in the pharmaceutical sector, and their impact on consumer and doctor behaviour. It identifies negative impacts which include misleading advertising, disease mongering and escalating costs. It argues the need to move from industry self-regulation to an independently monitored code of practice for pharmaceutical marketing.
The argument for pharmaceutical policy
DEFF Research Database (Denmark)
Traulsen, Janine Morgall; Almarsdóttir, Anna Birna
Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of...
[Adjuvant chemotherapy of adults soft tissue sarcomas].
Bui-Nguyen, B; Italiano, A; Delva, F; Toulmond, M
The main progress in the management of soft tissue sarcomas have been obtained in the field of local control. Although the main evolutive, vital, risk of these diseases is metastatic dissemination, efficacy of adjuvant chemotherapy remains a controversial issue. Thus, adjuvant chemotherapy cannot be considered as a standard for any situation. The last results of clinical trials, meta-analysis and population studies are presented and discussed in this article. New therapeutic strategies are to be developed to prevent metastases in soft tissue sarcomas. This needs a better understanding of the biology of those tumors, of metastases risk factors and of the determinants of systemic therapies efficacy in these tumors. PMID:20547481
21 CFR 582.99 - Adjuvants for pesticide chemicals.
... § 582.99 Adjuvants for pesticide chemicals. Adjuvants, identified and used in accordance with 40 CFR 180.1001(c) and (d), which are added to pesticide use dilutions by a grower or applicator prior to... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Adjuvants for pesticide chemicals. 582.99...
21 CFR 182.99 - Adjuvants for pesticide chemicals.
....99 Adjuvants for pesticide chemicals. Adjuvants, identified and used in accordance with 40 CFR 180.1001 (c) and (d), which are added to pesticide use dilutions by a grower or applicator prior to... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Adjuvants for pesticide chemicals. 182.99...
Effectiveness of spray adjuvants on reduction of spray drift
Numerous drift reduction adjuvants and spray deposition aids are available to applicators of crop production and protection chemicals. Performance of many of the newly introduced drift control adjuvants has not been well documented for aerial application. Five new drift control adjuvants were sele...
Advax-Adjuvanted Recombinant Protective Antigen Provides Protection against Inhalational Anthrax That Is Further Enhanced by Addition of Murabutide Adjuvant
Feinen, Brandon; Petrovsky, Nikolai; Verma, Anita; Tod J Merkel
Subunit vaccines against anthrax based on recombinant protective antigen (PA) potentially offer more consistent and less reactogenic anthrax vaccines but require adjuvants to achieve optimal immunogenicity. This study sought to determine in a murine model of pulmonary anthrax infection whether the polysaccharide adjuvant Advax or the innate immune adjuvant murabutide alone or together could enhance PA immunogenicity by comparison to an alum adjuvant. A single immunization with PA plus Advax a...
Norman, P
OSI-774 (formerly CP-358774), a quinazoline derivative, is an orally active epidermal growth factor receptor (EGFR) inhibitor which was originally under joint development by Pfizer and OSI Pharmaceuticals (formerly Oncogene Science) for the potential treatment of cancer (eg, ovarian, non-small cell lung cancer (NSCLC) and head and neck). It is being evaluated in phase II trials [304305], [372201]. On 8 January 2001, OSI announced that it had signed an agreement with Roche and Genentech for the global co-development and marketing of OSI-774. The agreement with Genentech covers the United States, that with Roche the rest of the world [395371], [395526]. In June 2000, OSI gained all development and marketing rights for OSI-774 following Pfizer's merger with Warner-Lambert [371439]. In September 2000, Pfizer transferred the IND dossierfor OSI-774 to OSI ahead of the timeline agreed in the June 2000 development and marketing rights agreement [383786]. The phase II trials will assess OSI-774 both as a single agent and in combination with existing chemotherapy regimens [347783]. Phase III trials are expected to be initiated in 2001 [347783]. In October 2000, Lehman Brothers predicted that OSI-774 would move into pivotal trials in thefirst half of 2001 and that the drug would be launched in 2003. The analysts also estimated worldwide sales of US $66 million, $285 million and $461 million in 2003, 2004 and 2005, respectively, and peak sales in excess of US $500 million [395189]. PMID:11816847
Spilker, B
This article describes several types of risk encountered in drug discovery, development and marketing, as well as the overall business risks in the pharmaceutical industry. Discovery risk refers to the risk companies face if they are partly or totally dependent on discovering new drugs; many avenues are presented for companies to pursue in order to decrease discovery risk. Development risk is defined as the risk that drug discoveries that enter development will not reach the market and become commercially viable drugs. To decrease development risk, it is possible to pursue one or more of the approaches presented. Significant marketing risks for a company include that the sales forecasts will not be met, the positioning of a drug may not be correct or optimal and the sales force is not performing adequately. At the corporate level there are numerous major risks involved in pursuing the specific mission, objectives, strategies and tactics of the overall company as well as those in the functional areas. Many aspects of the company's business can be adjusted or changed to decrease corporate risk. Selected issues concerning risk include venture capital funds, the appetite for risk within a company and the influence of senior and middle level managers' personalities on risk. PMID:15616620
Directory of Open Access Journals (Sweden)
Юрий Владимирович Тарасов
Full Text Available Pharmaceutical products market is one of the most saturated consumers' markets. Characteristic features of it are: high competition, fierce struggle for the customer, specific technologies of promotion. In conditions of globalization and increase in competition both in world pharmaceutical market and in the market of medicines and goods of medical purpose in Russia modern marketing techniques of promotion of the products to the end consumers are the key tools for strengthening market positions – both of producers of pharmaceutical goods and their suppliers, distributors, big whole-sale companies. Among main tools of promotion are: advertising, public relations, stimulation of sales on the market of medicines, personal sales, computer technologies. The article describes different technologies of promotion of medicines: indoor-advertising, hot lines, pharmaceutical exhibitions, packing. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-1
Recognizing misleading pharmaceutical marketing online.
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. PMID:24986349
New generation adjuvants--from empiricism to rational design.
O'Hagan, Derek T; Fox, Christopher B
Adjuvants are an essential component of modern vaccine development. Despite many decades of development, only a few types of adjuvants are currently included in vaccines approved for human use. In order to better understand the reasons that development of some adjuvants succeeded while many others failed, we discuss some of the common attributes of successful first generation adjuvants. Next, we evaluate current trends in the development of second generation adjuvants, including the potential advantages of rationally designed synthetic immune potentiators appropriately formulated. Finally, we discuss desirable attributes of next generation adjuvants. Throughout, we emphasize that the importance of formulation and analytical characterization in all aspects of vaccine adjuvant development is often underappreciated. We highlight the formulation factors that must be evaluated in order to optimize interactions between vaccine antigens, immune potentiators, and particulate formulations, and the resulting effects on safety, biological activity, manufacturability, and stability. PMID:26022561
Marketing strategy of Pharmaceutical Company
Kremlová, Tereza
The diploma thesis "Marketing strategy of pharmaceutical company" examines the subject of original and generic drugs in the pharmaceutical industry which many firms face with. This process of patent acquisition has many stages and testing phases, when are verified the effectiveness, the quality of product and side effects and only if provided with maximally positive results, the drug can obtain the patent protection. Unfortunately, this right is time limited and when the patent expires, the g...
Abhijjeet Welankiwar; Shrikant Saudagar; Jitendra kumar; Ashwini barabde
Stability testing is a key aspect while formulating any pharmaceutical product. The photostability studies are conducted with main objective that appropriate light exposure does not leads to unacceptable changes in dosage form. Photo degradation leads to changes in Physical appearance as well as chemical composition of dosage form. The objective of the present study is to describe the approaches for the photostability studies on pharmaceutical Products. Also this review deals with the factors...
Aripiprazole (Otsuka Pharmaceutical Co).
Ozdemir, Vural; Fourie, Jeanne; Ozdener, Fatih
Otsuka Pharmaceuticals in collaboration with Bristol-Myers Squibb is developing aripiprazole, a dual dopamine autoreceptor agonist and postsynaptic D2 receptor antagonist, for the potential treatment of psychoses including schizophrenia [281327], [340364]. A regulatory filing for schizophrenia in the US was submitted at the end of 2001 [340364]. The compound entered phase III trials in Japan in 1995 [192966]. Although presynaptic dopamine autoreceptor agonists may be efficacious in the treatment of schizophrenia, they may also potentially increase the risk for exacerbation of psychosis through stimulation of postsynaptic dopaminergic receptors [245791], [350478], [350479]. However, earlier neuropharmacology studies have shown that aripiprazole can act as a presynaptic D2 agonist while displaying an antagonistic effect at the postsynaptic D2 receptors [281327], [337126], [350479], [424587], [424588]. In animal models, aripiprazole inhibits the apomorphine-induced stereotypy, without causing catalepsy [281327], [337126]. Moreover, in contrast to classical antipsychotics that produce disabling movement disorders, aripiprazole does not cause an upregulation of D2 receptors or an increase in expression of the c-fos mRNA in the striatum, in agreement with the low risk for extrapyramidal side effects (EPS) during aripiprazole treatment [245781], [262096], [350481], [350483]. Collectively, aripiprazole is an important atypical antipsychotic candidate with a favorable safety profile. Moreover, the mechanism of action of aripiprazole differentiates it from both typical and atypical antipsychotics and hence, may provide important leads for pharmacotherapy of schizophrenia and other psychotic disorders. In January 2000, Lehman Brothers predicted peak sales of aripiprazole could reach US $500 million [357788]. In February 2001, Credit Suisse First Boston predicted sales of US $403 million in 2005 [399484]. PMID:12054061
The adjuvancy of silicones: dependency on compartmentalization.
Klykken, P C; White, K L
Studies have been conducted in mice (B6C3F1) and rats (Sprague Dawley, Fischer 344) to investigate the adjuvancy potential of silicone mammary gel and the low molecular weight silicone fluid, octamethylcyclotetrasiloxane (D4). Dependent on the experimental conditions employed, a divergent data profile emerges. If the antigen (bovine serum albumin, BSA) is emulsified with either the gel or the D4 prior to intramuscular immunization, an amplified anti-BSA IgG antibody response, as measured by multipoint ELISA methodology, is noted over the 8 week measurement period. In parallel studies, a variety of non-silicone personal care ingredients (lanolin, white mineral oil, isopropyl palmitate) were also capable of amplifying this humoral response relative to the non-adjuvant phosphate buffered saline control. These observations are consistent with the empirical knowledge that hydrophobic substances tend to augment immune responses. However, under conditions in which the antigen is not blended with the silicone prior to immunization, normal immune responses are noted. In short (10 day) and long (180 day) term gel implant studies, the optimal IgM and IgG antibody responses, as determined in the antibody forming cell assay, were equivalent between the gel implanted and control animals. Moreover, under similar exposure conditions, no adjuvancy was noted in the three Host Resistance models (B16F10 Melanoma, Listeria monocytogenes, and Streptococcus pneumoniae) tested. Antibody forming cell studies conducted after 28 days of oral or inhalation exposure to D4 have also yielded responses similar to the non-silicone exposed vehicle controls. Collectively, these data suggest that in the absence of premixing the antigen with the silicone test material, there does not appear to be any silicone induced adjuvant response. PMID:8565549
Adjuvant and neoadjuvant treatment in pancreatic cancer
Institute of Scientific and Technical Information of China (English)
Marta Herreros-Villanueva; Elizabeth Hijona; Angel Cosme; Luis Bujanda
Pancreatic adenocarcinoma is one of the most aggressive human malignancies,ranking 4th among causes for cancer-related death in the Western world including the United States.Surgical resection offers the only chance of cure,but only 15 to 20 percent of cases are potentially resectable at presentation.Different studies demonstrate and confirm that advanced pancreatic cancer is among the most complex cancers to treat and that these tumors are relatively resistant to chemotherapy and radiotherapy.Currently there is no consensus around the world on what constitutes "standard"adjuvant therapy for pancreatic cancer.This controversy derives from several studies,each fraught with its own limitations.Standards of care also vary somewhat with regard to geography and economy,for instance chemo-radiotherapy followed by chemotherapy or vice versa is considered the optimal therapy in North America while chemotherapy alone is the current standard in Europe.Regardless of the efforts in adjuvant and neoadjuvant improved therapy,the major goal to combat pancreatic cancer is to find diagnostic markers,identifying the disease in a pre-metastatic stage and making a curative treatment accessible to more patients.In this review,authors examined the different therapy options for advanced pancreatic patients in recent years and the future directions in adjuvant and neoadjuvant treatments for these patients.
Impact of adjuvant chemotherapy for gliomatosis cerebri
International Nuclear Information System (INIS)
Gliomatosis cerebri (GC) is characterized by a diffuse infiltration of tumor cells throughout CNS, however, few details are available about the chemotherapeutic effect on GC. The aim of this study was to investigate its clinical course and to determine the efficacy of chemotherapy for GC. Between Jan. 1999 and Dec. 2004, 37 GC patients were diagnosed by biopsy and treated with radiotherapy in a single institution. To determine the efficacy of chemotherapy for GC, we retrospectively reviewed their clinical courses. The study cohort was divided into 2 groups, those with and without receiving post-radiotherapy adjuvant chemotherapy such as temozolomide or nitrosourea-based chemotherapy. Nineteen patients with adjuvant chemotherapy were assigned to the chemotreatment group and 18 with radiotherapy alone were assigned to the control group. Mean survival for chemotreatment group and control group were 24.2 and 13.1 months, respectively (p = 0.045). Time to progression for these groups were 16.0 and 6.0 months, respectively (p = 0.007). Overall review of the clinical course of patients with GC provided that early appearance of new contrast-enhancing lesions within 6 months from the initial diagnosis and higher histological grade were closely associated with poor survival (p < 0.001 and p = 0.008). Adjuvant chemotherapy following radiotherapy could prolong the survival in patients with GC. In addition, newly developed contrast-enhanced lesions on the follow-up MR images indicate the progression of GC
Chitosan as an adjuvant for poliovaccine.
Ghendon, Y; Markushin, S; Akopova, I; Koptiaeva, I; Krivtsov, G
The use of inactivated poliomyelitis vaccine is very important for eradicating poliomyelitis. However, this vaccine is not available readily in underdeveloped countries due to the high cost. Adjuvants can improve the immunogenicity of a vaccine and reduce the antigen dose required for vaccination, thus lowering the cost of the vaccine. Chitosan glutamate solution and a chitosan sulfate micro/nanoparticle suspension were tested as adjuvants for Imovax-inactivated poliovaccine and for inactivated monovalent poliovirus type 1, 2, and 3 vaccines obtained by inactivation of the attenuated Sabin poliovirus strains. Inactivated vaccines admixed with either chitosan glutamate or chitosan sulfate micro/nanoparticles and administered to mice showed significantly enhanced immunogenicity to poliovirus type 1, 2, and 3 strains compared to the respective vaccines administered without chitosan. Chitosan preparations increased the immunogenicity of 1:2 and 1:4 diluted inactivated Sabin strain preparations in mice 8- to 16-fold, so that the neutralizing antibody titers after vaccination with adjuvanted diluted vaccine were equal to those obtained after vaccination with undiluted vaccine administered without chitosan. Neutralizing antibodies could be detected in sera of rats vaccinated with undiluted, 1:10, and 1:100 diluted Imovax vaccine admixed with chitosan sulfate micro/nanoparticles, although in the control group, vaccination only with the undiluted vaccine resulted in antibody production. These results show that the chitosan glutamate solution and chitosan sulfate micro/nanoparticle suspension can significantly improve the immunogenicity of various poliovaccines, and reduce the effective antigen dose. PMID:21412793
The Pharmaceutical Industry Beamline of Pharmaceutical Consortium for Protein Structure Analysis
Nishijima, K
The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)
The Pharmaceutical Industry Beamline of Pharmaceutical Consortium for Protein Structure Analysis
International Nuclear Information System (INIS)
The Pharmaceutical Industry Beamline was constructed by the Pharmaceutical Consortium for Protein Structure Analysis which was established in April 2001. The consortium is composed of 22 pharmaceutical companies affiliating with the Japan Pharmaceutical Manufacturers Association. The beamline is the first exclusive on that is owned by pharmaceutical enterprises at SPring-8. The specification and equipments of the Pharmaceutical Industry Beamline is almost same as that of RIKEN Structural Genomics Beamline I and II. (author)
Chemistry in the Pharmaceutical Industry
Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind
This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.
Reprivatizing pharmaceutical supplies in Africa.
Turshen, M
Perhaps no part of the health system is as imperiled by neoliberal economic reforms as the public drug sector. The national bill for pharmaceuticals can claim one-third of a developing country's annual health budget. This article describes the essential drugs program created by WHO in the 1980s to protect financially reduced ministries of health from the high prices charged by multinational pharmaceutical companies. It describes the backlash from the World Bank and UNICEF, which launched the Bamako Initiative and other community financing schemes and revolving drug plans in which individuals, families or community groups buy drugs above the wholesale purchase price; clinics use the proceeds to maintain drug supplies and subsidize other health services. When this plan failed, the Bank proposed outright privatization of drug purchase and supply, returning power to the multinational suppliers. The article ends with a consideration of patents and the new intellectual property rights as they pertain to pharmaceutical production in Africa. PMID:11469153
Adjuvant Therapy of Colon Cancer: Current Status and Future Developments
Morse, Michael A.
Options for the adjuvant therapy of resected stage III colon cancer have expanded beyond the previously well-accepted standard of 5-fluorouracil (5-FU) combined with leucovorin. The Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) study confirmed that capecitabine (Xeloda) is at least as effective and is less toxic than a bolus 5-FU and leucovorin regimen for patients with stage III colon cancer. This study, in addition to National Surgical Adjuvant Breast and Bowel Project (NSABP) C-06, which...
Pharmaceuticals Outsourcing Industry: China Strategies for Indian Pharmaceutical Companies
Institute of Scientific and Technical Information of China (English)
Amruth Das
@@ Since last 5 years both India and China, have made rapid strides in the space of pharmaceutical outsourcing.Indian companies, with the largest number of US-FDA approved manufacturing plants outside the USA,has the potential to be a global leader in the outsourcing market.
[Recent advance in adjuvant therapy for breast cancer].
Shimizu, Chikako; Watanabe, Toru
Adjuvant systemic therapy has contributed to a significant improvement of disease-free and overall survival in addition to surgery and irradiation to the local disease. The adjuvant therapy to a patient is determined integrating the information on estimated risk of recurrence, benefit and harm of the therapy and the patient's value. In this review, the state of the art of adjuvant therapy is discussed from several aspects, such as interpretation and evaluation of risk, the best available evidences on adjuvant systemic therapy, the future direction of primary therapy for breast cancer, and patient-oriented decision making. PMID:12506467
Modern Vaccines/Adjuvants Formulation Session 6: Vaccine & Adjuvant Formulation & Production 15-17 May 2013, Lausanne, Switzerland
Fox, Christopher B.
The Modern Vaccines/Adjuvants Formulation meeting aims to fill a critical gap in current vaccine development efforts by bringing together formulation scientists and immunologists to emphasize the importance of rational formulation design in order to optimize vaccine and adjuvant bioactivity, safety, and manufacturability. Session 6 on Vaccine and Adjuvant Formulation and Production provided three examples of this theme, with speakers emphasizing the need for extensive physicochemical characte...
CpG ODN and ISCOMATRIX Adjuvant: A Synergistic Adjuvant Combination Inducing Strong T-Cell IFN-γ Responses
Michael J. McCluskie; Weeratna, Risini D.; Evans, Dana M.; Shawn Makinen; Debbie Drane; Heather L. Davis
For the induction of robust humoral and cellular immune responses, a strong rationale exists to use vaccine-adjuvant combinations possessing both immune modulatory and enhanced delivery capabilities. Herein, we evaluated the combination of 2 different adjuvants, a TLR9 agonist, composed of synthetic oligodeoxynucleotides (ODN) containing immunostimulatory CpG motifs (CpG), and ISCOMATRIX adjuvant (ISCOMATRIX), composed of saponin, phospholipid, and cholesterol, which possesses both immunostim...
The Global Pharmaceutical Industry, 2004
Bernardo Batiz-Lazo; k Sarah Holland
This teaching case looks at the development of the ethical pharmaceutical industry. The various forces affecting the discovery, development, production, distribution and marketing of prescription drugs are discussed in terms of their origins and recent developments. Readers are then invited to consider trends for the future.
Electron microscopy of pharmaceutical systems.
Klang, Victoria; Valenta, Claudia; Matsko, Nadejda B
During the last decades, the focus of research in pharmaceutical technology has steadily shifted towards the development and optimisation of nano-scale drug delivery systems. As a result, electron microscopic methods are increasingly employed for the characterisation of pharmaceutical systems such as nanoparticles and microparticles, nanoemulsions, microemulsions, solid lipid nanoparticles, different types of vesicles, nanofibres and many more. Knowledge of the basic properties of these systems is essential for an adequate microscopic analysis. Classical transmission and scanning electron microscopic techniques frequently have to be adapted for an accurate analysis of formulation morphology, especially in case of hydrated colloidal systems. Specific techniques such as environmental scanning microscopy or cryo preparation are required for their investigation. Analytical electron microscopic techniques such as electron energy-loss spectroscopy or energy-dispersive X-ray spectroscopy are additional assets to determine the elemental composition of the systems, but are not yet standard tools in pharmaceutical research. This review provides an overview of pharmaceutical systems of interest in current research and strategies for their successful electron microscopic analysis. Advantages and limitations of the different methodological approaches are discussed and recent findings of interest are presented. PMID:22921788
Pharmaceutical care in smoking cessation.
Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando
As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779
Pharmaceutical crystallization with nanocellulose organogels.
Ruiz-Palomero, Celia; Kennedy, Stuart R; Soriano, M Laura; Jones, Christopher D; Valcárcel, Miguel; Steed, Jonathan W
Carboxylated nanocellulose forms organogels at 0.3 wt% in the presence of a cationic surfactant. The resulting gels can be used as novel crystallization media for pharmaceutical solid form control, resulting in isolation a new sulfapyridine solvate, morphology modification and crystallization of an octadecylammonium salt of sulfamethoxazole. PMID:27168091
Pharmaceutical crystallization with nanocellulose organogels.
Ruiz-Palomero, Celia; Kennedy, Stuart R.; Soriano, M. Laura; Jones, Christopher D.; Valcárcel, Miguel; Steed, Jonathan W
Carboxylated nanocellulose forms organogels at 0.3 wt% in the presence of a cationic surfactant. The resulting gels can be used as novel crystallization media for pharmaceutical solid form control, resulting in isolation a new sulfapyridine solvate, morphology modification and crystallization of an octadecylammonium salt of sulfamethoxazole.
НАСАКІНА, Світлана Вікторівна
The article deals with the functioning of ergonyms in pharmaceuticals advertising texts. The purpose of the article is the analysis of the ergonyms functioning in pharmaceuticals advertising texts. The tasks are defining the specifics of the ergonyms functioning in pharmaceuticals advertising texts and creating an ergonyms classification on the material under study. There were found similarities in the pharmaceuticals advertising texts in the Ukrainian, Bulgarian and Russian languages. The ar...
Strategic analysis of the world pharmaceutical industry
Kesič, Dragan
The world pharmaceutical industry has been changing profoundly in the last decade. Intensive globalization, increased competitiveness and the fight for global market shares create new challenges for pharmaceutical companies. Fast globalization definitively reinforces the consolidation of the world pharmaceutical industry. Alliancing in forms of mergers and acquisitions prevail more and more as a strategic orientation for the world pharmaceutical companies. By alliancing, they tend to create s...
Pharmaceutical care in smoking cessation
Directory of Open Access Journals (Sweden)
Marín Armero A
Full Text Available Alicia Marín Armero,1 Miguel A Calleja Hernandez,2 Sabina Perez-Vicente,3 Fernando Martinez-Martinez4 1Community Pharmacy, Murcia, Spain; 2Hospital Pharmacy, University Hospital Virgen de las Nieves, Granada, Spain; 3Result Evaluation Unit, Institute of Biomedicine, Sevilla, Spain; 4Research Unit in Pharmaceutical Care, University of Granada, Granada, Spain Abstract: As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. Keywords: community pharmacy, health campaign, tobacco cessation, nicotine replacement therapy
Adjuvant chemotherapy for soft tissue sarcoma.
Casali, Paolo G
Adjuvant chemotherapy is not standard treatment in soft tissue sarcoma (STS). However, when the risk of relapse is high, it is an option for shared decision making with the patient in conditions of uncertainty. This is because available evidence is conflicting, even if several randomized clinical trials have been performed for 4 decades and also have been pooled into meta-analyses. Indeed, available meta-analyses point to a benefit in the 5% to 10% range in terms of survival and distant relapse rate. Some local benefit also was suggested by some trials. Placing chemotherapy in the preoperative setting may help gain a local advantage in terms of the quality of surgical margins or decreased sequelae. This may be done within a personalized approach according to the clinical presentation. Attempts to personalize treatment on the basis of the variegated pathology and molecular biology of STS subgroups are ongoing as well, according to what is done in the medical treatment of advanced STS. Thus, decision making for adjuvant and neoadjuvant indications deserves personalization in clinical research and in clinical practice, taking profit from all multidisciplinary clinical skills available at a sarcoma reference center, though with a degree of subjectivity because of the limitations of available evidence. PMID:25993233
Mucosal adjuvants to improve wildlife rabies vaccination.
Fry, Tricia; Van Dalen, Kaci; Hurley, Jerome; Nash, Paul
RABORAL V-RG(®)a is a recombinant vaccine used in oral rabies vaccination (ORV) programs for wildlife in the United States. Vaccination rates for raccoons are substantially lower than vaccination rates for gray foxes and coyotes. Research suggests that the low viscosity of the oral vaccine may preclude animals from receiving an effective dose when biting into the vaccine bait delivery system. We evaluated the possibility of using two benign compounds, chitosan and N,N,N-trimethylated chitosan (TMC), to increase the viscosity of the vaccine and potentially act as adjuvants to improve the immune response in raccoons (Procyon lotor). Forty mildly sedated raccoons were orally vaccinated via needleless syringe with either RABORAL V-RG (n = 12), chitosan+RABORAL V-RG (n = 12), TMC+ RABORAL V-RG (n = 12), or no vaccine (n = 4), on day 0 and again on day 90. We collected sera every 2-4 wk for 4 mo and evaluated rabies virus-neutralizing antibodies (rVNA). Raccoons were considered responders if rVNA titers were ≥ 0.1 IU/mL. Eleven of 12 raccoons vaccinated with TMC+RABORAL V-RG responded after one dose of vaccine, as did eight of 12 vaccinated with RABORAL V-RG, and three of 12 vaccinated with chitosan+ RABORAL V-RG. Our results suggest that the inclusion of an adjuvant, such as TMC, could increase vaccine efficacy to aid in controlling rabies virus spread in wildlife reservoirs. PMID:23060506
Neoadjuvant and Adjuvant Chemotherapy of Cervical Cancer.
Mallmann, Peter; Mallmann, Christoph
Neoadjuvant chemotherapy is indicated in patients who can tolerate the side effects of a chemotherapy and with preoperative presentation of one of the following clinical risk situations: bulky disease with a maximal tumor diameter of > 4 cm, suspicious lymph nodes in magnetic resonance imaging (MRI), computed tomography (CT) scan or endosonography, histopathologically confirmed lymph node metastasis, or histopathologically documented risk factors such as G3 and L1V1. A neoadjuvant chemotherapy followed by surgery should be performed with cisplatin at a dosage of > 25 mg/m2 per week and an application interval of < 14 days. The previously published data suggests an improved rate of complete resection and reduced incidences of positive lymph nodes and parametric infiltration. Accordingly, the percentage of patients in need for adjuvant radiochemotherapy after operation can be significantly reduced. Some studies demonstrated a prolongation of progression-free and overall survival. Following the previously published studies, adjuvant chemotherapy after operation or after radiochemotherapy has no significant effect on the overall survival and, following the current guidelines, should be avoided. PMID:27614740
Adjuvant Bidirectional Chemotherapy Using an Intraperitoneal Port
Directory of Open Access Journals (Sweden)
Paul H. Sugarbaker
Full Text Available Cytoreductive surgery (CRS and hyperthermic intraperitoneal chemotherapy (HIPEC have been established as treatment options for patients with peritoneal metastases or peritoneal mesothelioma. However, this novel treatment strategy remains associated with a large percentage of local-regional treatment failures. These treatment failures are attributed to the inadequacy of HIPEC to maintain a surgical complete response. Management strategies to supplement CRS and HIPEC are indicated. A simplified approach to the intraoperative placement of an intraperitoneal port for adjuvant bidirectional chemotherapy (ABC was devised. Four different chemotherapy treatment plans were utilized depending upon the primary site of the malignancy. Thirty-one consecutive patients with an intraoperative placement of the intraperitoneal port were available for study. The incidence of adverse events that caused an early discontinuation of the bidirectional chemotherapy occurred in 75% of the 8 patients who had an incomplete cytoreduction and in 0% of patients who had a complete cytoreduction. All of the patients who had complete cytoreduction completed at least 5 of the scheduled 6 bidirectional chemotherapy treatments. Adjuvant bidirectional chemotherapy is possible following a major cytoreductive surgical procedure using a simplified method of intraoperative intraperitoneal port placement.
Phytotherapeutic and naturopathic adjuvant therapies in otorhinolaryngology
Ciuman, Raphael Richard
Phytotherapeutic pharmaceuticals and herbal medicinal products with its roots in classical phytotherapeutic medicine have a well-established role in otolaryngological therapy, especially for diseases of the upper airways and acute and chronic infections. A thorough selection and application could mean huge benefit for the patient, in particular in cases with contraindications, chemo- and antibiotic resistance or patient request. Besides, it might spare other medications. Phytotherapeutic phar...
Vaxjo: A Web-Based Vaccine Adjuvant Database and Its Application for Analysis of Vaccine Adjuvants and Their Uses in Vaccine Development
Samantha Sayers; Guerlain Ulysse; Zuoshuang Xiang; Yongqun He
Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bi...
Vaccine Adjuvants: from 1920 to 2015 and Beyond.
Pasquale, Alberta Di; Preiss, Scott; Silva, Fernanda Tavares Da; Garçon, Nathalie
The concept of stimulating the body's immune response is the basis underlying vaccination. Vaccines act by initiating the innate immune response and activating antigen presenting cells (APCs), thereby inducing a protective adaptive immune response to a pathogen antigen. Adjuvants are substances added to vaccines to enhance the immunogenicity of highly purified antigens that have insufficient immunostimulatory capabilities, and have been used in human vaccines for more than 90 years. While early adjuvants (aluminum, oil-in-water emulsions) were used empirically, rapidly increasing knowledge on how the immune system interacts with pathogens means that there is increased understanding of the role of adjuvants and how the formulation of modern vaccines can be better tailored towards the desired clinical benefit. Continuing safety evaluation of licensed vaccines containing adjuvants/adjuvant systems suggests that their individual benefit-risk profile remains favorable. Adjuvants contribute to the initiation of the innate immune response induced by antigens; exemplified by inflammatory responses at the injection site, with mostly localized and short-lived effects. Activated effectors (such as APCs) then move to draining lymph nodes where they direct the type, magnitude and quality of the adaptive immune response. Thus, the right match of antigens and adjuvants can potentiate downstream adaptive immune responses, enabling the development of new efficacious vaccines. Many infectious diseases of worldwide significance are not currently preventable by vaccination. Adjuvants are the most advanced new technology in the search for new vaccines against challenging pathogens and for vulnerable populations that respond poorly to traditional vaccines. PMID:26343190
Spray characteristics affected by physical properties of adjuvants
Four drift adjuvants, Array, In-Place, Vector and Control, were tested and physical properties and spray spectrum parameters measured. Array had the highest conductivity, indicating a good potential for the electrostatic charging, and the highest shear viscosity. All adjuvants had very similar neut...
Protein antigen adsorption to the DDA/TDB liposomal adjuvant
DEFF Research Database (Denmark)
Hamborg, Mette; Jorgensen, Lene; Bojsen, Anders Riber; Christensen, Dennis; Foged, Camilla
Understanding the nature of adjuvant-antigen interactions is important for the future design of efficient and safe subunit vaccines, but remains an analytical challenge. We studied the interactions between three model protein antigens and the clinically tested cationic liposomal adjuvant composed...
In vitro interactions between macrophages and aluminum-containing adjuvants.
Rimaniol, Anne-Cécile; Gras, Gabriel; Clayette, Pascal
Intramuscular administration of aluminum-adjuvanted vaccines induces an infiltration of aluminum-containing macrophages between muscle fibers. In vitro stimulation of human monocyte-derived macrophages with aluminum hydroxide (AlOOH) induces similar intracellular crystalline inclusions as well as phenotypical and functional modifications. We compared in this study the ability of other adjuvants to exert similar changes in macrophages in vitro. All mineral salts, i.e. aluminic (AlOOH, AlPO(4)) and non-aluminic mineral adjuvants (CaPO(4), FePO(4)) but not emulsion were able to increase macrophages capacity to potentiate autologous memory T lymphocyte proliferation, while only aluminic adjuvants induced CD83 expression and increased CD86 on macrophages. All together, this suggests that aluminic and non-aluminic adjuvants exerted their immunoactivities by distinct mechanisms on macrophages. PMID:17689842
Adjuvants in micro- to nanoscale: current state and future direction.
Gupta, Ankur; Das, Soumen; Schanen, Brian; Seal, Sudipta
Adjuvants have been used in vaccines for over 70 years to promote long-lived and sterilizing immunity. Since then, various adjuvant systems were developed by combining nanotechnology with natural and/or synthetic immunomodulatory molecules. These systems are biocompatible, immunogenic, and possess higher antigen carrying capacity. This article showcases advancements made in the adjuvant systems formulations, their synthesis routes, and the improvement of these adjuvants have brought in response to combat against ongoing global health threats such as malaria, hepatitis C, universal influenza, and human immunodeficiency virus. This review also highlights the interaction of adjuvants with the delivery of antigens to cells and unfolds mechanism of actions. In addition, this review discusses the physicochemical factors responsible for the efficient interaction of nanoadjuvants with antigen receptors to develop more effective, less reactogenic, and multifunctional systems for the next generation vaccines. PMID:26053286
Immune adjuvant activity of the olive, soybean and corn oils
Directory of Open Access Journals (Sweden)
Ana Claudia Marinho da Silva
Full Text Available In the last half of the century, a large amount of substances has been used as immune adjuvant. The immune adjuvant effect of olive, soybean and corn oils in Swiss mice immunized with ovalbumin (OVA plus aluminum hydroxide or emulsified in Marcol, soybean, olive or corn oils was evaluated through the OVA-specific antibodies determined by ELISA and Passive Cutaneous Anaphylaxis. In this work the comparison of the intensity of the immune response was established by the Bayesian analysis. The adjuvant effect of the vegetable oils was shown to be more effective than aluminium hydroxide. Regarding to OVA-specific IgE synthesis, olive oil had the slowest adjuvant effect of the three vegetable oils. Accordingly, olive oil was the most convenient among the vegetable oils to be used as immune adjuvant, since it stimulated a higher production of OVA-specific Ig and lower levels of anti-OVA IgE.
Vaxjo: A Web-Based Vaccine Adjuvant Database and Its Application for Analysis of Vaccine Adjuvants and Their Uses in Vaccine Development
Directory of Open Access Journals (Sweden)
Samantha Sayers
Full Text Available Vaccine adjuvants are compounds that enhance host immune responses to co-administered antigens in vaccines. Vaxjo is a web-based central database and analysis system that curates, stores, and analyzes vaccine adjuvants and their usages in vaccine development. Basic information of a vaccine adjuvant stored in Vaxjo includes adjuvant name, components, structure, appearance, storage, preparation, function, safety, and vaccines that use this adjuvant. Reliable references are curated and cited. Bioinformatics scripts are developed and used to link vaccine adjuvants to different adjuvanted vaccines stored in the general VIOLIN vaccine database. Presently, 103 vaccine adjuvants have been curated in Vaxjo. Among these adjuvants, 98 have been used in 384 vaccines stored in VIOLIN against over 81 pathogens, cancers, or allergies. All these vaccine adjuvants are categorized and analyzed based on adjuvant types, pathogens used, and vaccine types. As a use case study of vaccine adjuvants in infectious disease vaccines, the adjuvants used in Brucella vaccines are specifically analyzed. A user-friendly web query and visualization interface is developed for interactive vaccine adjuvant search. To support data exchange, the information of vaccine adjuvants is stored in the Vaccine Ontology (VO in the Web Ontology Language (OWL format.
Pharmaceutical films made from the waste material from the preparation of propolis extracts: development and characterization
Directory of Open Access Journals (Sweden)
Lucas de Alcântara Sica de Toledo
Full Text Available abstract This study investigated the development and characterized the physicochemical properties of films obtained from by-products (BP from the preparation of propolis extracts. Films were produced in the presence and absence of a polymeric adjuvant (gelatin or ethylcellulose and propylene glycol by a solvent casting method. Density, surface topography by scanning electron microscopy, mechanical properties (folding endurance, tensile strength and percentage elongation, water vapour permeability (WVP, moisture uptake capacity, thermogravimetry, differential scanning calorimetry and Fourier transform infrared spectroscopy (FTIR were determined. The films were a transparent, light greenish-yellow colour, with a uniform surface, and were flexible and easy to handle. The thickness and density of the preparations indicated that the compounds were homogeneously dispersed throughout the film. Mechanical properties were influenced by the film composition; films containing gelatin were more resistant to stress, while those containing ethylcellulose were more flexible. Increasing the adjuvant concentration decreased the elasticity and the rupture resistance, but increased the moisture uptake capacity and WVP of the formulations. BP was thermally stable as were the films. FTIR tests suggested interactions between BP and the adjuvants. This work could contribute to the utilization of BP to prepare films for food and pharmaceutical uses
Modern Vaccines/Adjuvants Formulation Session 6: Vaccine &Adjuvant Formulation & Production 15-17 May 2013, Lausanne, Switzerland.
Fox, Christopher B
The Modern Vaccines/Adjuvants Formulation meeting aims to fill a critical gap in current vaccine development efforts by bringing together formulation scientists and immunologists to emphasize the importance of rational formulation design in order to optimize vaccine and adjuvant bioactivity, safety, and manufacturability. Session 6 on Vaccine and Adjuvant Formulation and Production provided three examples of this theme, with speakers emphasizing the need for extensive physicochemical characterization of adjuvant-antigen interactions, the rational formulation design of a CD8+ T cell-inducing adjuvant based on immunological principles, and the development and production of a rabies vaccine by a developing country manufacturer. Throughout the session, the practical importance of sound formulation and manufacturing design accompanied by analytical characterization was highlighted. PMID:23787558
Pharmaceutical microparticle engineering with electrospraying
DEFF Research Database (Denmark)
Bohr, Adam; Wan, Feng; Kristensen, Jakob;
Microparticles of Celecoxib, dispersed in a matrix of poly(lactic-co-glycolic acid) (PLGA), were prepared by electrospraying using different solvent mixtures to investigate the influence upon particle formation and the resulting particle characteristics. Mixtures consisting of a good solvent, ace...... demonstrated by the increasingly higher drug release rates. The results demonstrate the importance of solvent composition in particle preparation and indicate potential for exploiting this dependence to improve pharmaceutical particle design and performance....
International research networks in pharmaceuticals
DEFF Research Database (Denmark)
Cantner, Uwe; Rake, Bastian
Knowledge production and scientific research have become increasingly more collaborative and international, particularly in pharmaceuticals. We analyze this tendency in general and tie formation in international research networks on the country level in particular. Based on a unique dataset...... over time. Using network regression techniques to analyze the network dynamics our results indicate that accumulative advantages based on connectedness and multi-connectivity are positively related to changes in the countries' collaboration intensity whereas various indicators on similarity between...
Are pharmaceutics really going supercritical?
Pasquali, Irene; Bettini, Ruggero
The present work focuses on some applications of supercritical fluids in the pharmaceutical field, provides a critical review of the most recent advances and aims to give a vision on the future of this technology. In particular, processes such as particle and crystal engineering, formation of cyclodextrin complexes, coating, foaming and tissue engineering, extrusion, production of liposomes, formulation of biotechnological compounds, sterilization and solvent removal are described and discussed. PMID:18597957
Pharmaceutical cocrystals: walking the talk.
Bolla, Geetha; Nangia, Ashwini
Pharmaceutical cocrystals belong to a sub-class of cocrystals wherein one of the components is a drug molecule (or an active pharmaceutical ingredient, API) and the second is a benign food or drug grade additive (generally regarded as safe, GRAS). The two components are hydrogen-bonded in a fixed stoichiometric ratio in the crystal lattice. In the past decade, pharmaceutical cocrystals have demonstrated significant promise in their ability to modify the physicochemical and pharmacokinetic properties of drug substances, such as the solubility and dissolution rate, bioavailability, particle morphology and size, tableting and compaction, melting point, physical form, biochemical and hydration stability, and permeability. In this feature review, we highlight some prominent examples of drug cocrystals which exhibit variable hardness/softness and elasticity/plasticity depending on coformer selection, improvement of solubility and permeability in the same cocrystal, increase of the melting point for solid formulation, enhanced color performance, photostability and hydration stability, and a longer half-life. Cocrystals of flavanoids and polyphenols can make improved pharmaceuticals and also extend to the larger class of nutraceuticals. The application of crystal engineering to assemble ternary cocrystals expands this field to drug-drug cocrystals which may be useful in multi-drug resistance, mitigating side effects of drugs, or attenuating/enhancing drug action synergistically by rational selection. The advent of new techniques for structural characterization beyond the standard X-ray diffraction will provide a better understanding of drug phases which are at the borderline of crystalline-amorphous nature and even newer opportunities in the future. PMID:27278109
Examining pharmaceuticals using terahertz spectroscopy
Sulovská, Kateřina; Křesálek, Vojtěch
Pharmaceutical trafficking is common issue in countries where they are under stricter dispensing regime with monitoring of users. Most commonly smuggled pharmaceuticals include trade names Paralen Plus, Modafen, Clarinase repetabs, Aspirin complex, etc. These are transported mainly from Eastern Europe (e.g. Poland, Ukraine, Russia) to countries like Czech Republic, which is said to have one of the highest number of methamphetamine producers in Europe. The aim of this paper is to describe the possibility of terahertz spectroscopy utilization as an examining tool to distinguish between pharmaceuticals containing pseudoephedrine compounds and those without it. Selected medicaments for experimental part contain as an active ingredient pseudoephedrine hydrochloride or pseudoephedrine sulphate. Results show a possibility to find a pseudoephedrine compound spectra in samples according to previously computed and experimentally found ones, and point out that spectra of same brand names pills may vary according to their expiration date, batch, and amount of absorbed water vapours from ambience. Mislead spectrum also occurs during experimental work in a sample without chosen active ingredient, which shows persistent minor inconveniences of terahertz spectroscopy. All measurement were done on the TPS Spectra 3000 instrument.
Understanding pharmaceutical quality by design.
Yu, Lawrence X; Amidon, Gregory; Khan, Mansoor A; Hoag, Stephen W; Polli, James; Raju, G K; Woodcock, Janet
This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review. PMID:24854893
[E-commerce of pharmaceuticals].
Shani, Segev
The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications. PMID:12803063
Ranitidine as adjuvant treatment in colorectal cancer
DEFF Research Database (Denmark)
Nielsen, Hans Jørgen; Christensen, Ib Jarle; Moesgaard, F;
BACKGROUND: Results from short-term studies of histamine type 2 (H2) receptor antagonists on survival of patients with solid tumours are debatable. In this study the efficacy of the H2-receptor antagonist ranitidine on long-term survival of patients with colorectal cancer was evaluated. METHODS...... by oral ranitidine 150 mg or placebo twice daily for 5 years. Adjuvant cytotoxic or radiation therapy was not given. An observer-blinded interim analysis performed after 40 months showed that there was no effect of ranitidine on overall survival, and the study was discontinued in accordance with the...... postoperative infectious complications (n = 170; HR 0.6 (95 per cent c.i. 0.4 to 0.9), P = 0.01). In multivariate analysis of patients who had a curative resection, including Dukes' stage, age, gender, tumour location, blood transfusion, postoperative infectious complications and treatment, ranitidine still had...
Quadrantectomy and adjuvant radiotherapy for breast cancer
International Nuclear Information System (INIS)
The conservative treatment of early breast cancer always requires irradiation of residual mammary tissue. The preliminary results obtained in 45 early breast cancer patients, who received quadrantectomy plus axillary dissection, followed by radiation of residual breast are reported. Radiation was performed by the two opposed field technique. In some cases the residual breast tissue was compressed using a special accessory provided with the Theratron 780. In addition to the tumor dose of 50 GY, 10 GY boots was added to the surgical scar using 7 MeV electrons. The 6 patients with positive axillary nodes received 6 courses of adjuvant chemotherapy (CMF) after radiotherapy. All patients are currently alive and free of disease. The 64% (29 patients) were followed up for at least 5 years, and 36% (16 patients) for at least 3 years. Only 2 cases of local recurrence were encountered (4,4%). The esthetic result was satisfactory in all cases. No side effects due to treatment were noted
Adjuvant radiation for vulvar carcinoma: improved local control
International Nuclear Information System (INIS)
Purpose: Local recurrence is a significant problem following primary surgery for advanced vulva carcinoma. The objectives of this study were to evaluate the impact of adjuvant vulvar radiation on local control in high risk patients and the impact of local recurrence on overall survival. Methods and Materials: From 1980-1994, 62 patients with invasive vulva carcinoma and either positive or close (less 8 mm) margins of excision were retrospectively studied. Thirty-one patients were treated with adjuvant radiation therapy to the vulva and 31 patients were observed after surgery. Kaplan-Meier estimates and the Cox proportional hazard regression model were used to evaluate the effect of adjuvant radiation therapy on local recurrence and overall survival. Independent prognostic factors for local recurrence and survival were also assessed. Results: Local recurrence occurred in 58% of observed patients and 16% in patients treated with adjuvant radiation therapy. Adjuvant radiation therapy significantly reduced local recurrence rates in both the close margin and positive margin groups (p = 0.036, p = 0.0048). On both univariate and multivariate analysis adjuvant radiation and margins of excision were significant prognostic predictors for local control. Significant determinants of actuarial survival included International Federation of Gynecologists and Obstetricians (FIGO) stage, percentage of pathologically positive inguinal nodes and margins of excision. The positive margin observed group had a significantly poorer actuarial 5 year survival than the other groups (p = 0.0016) and adjuvant radiation significantly improved survival for this group. The 2 year actuarial survival after developing local recurrence was 25%. Local recurrence was a significant predictor for death from vulva carcinoma (risk ratio 3.54). Conclusion: Local recurrence is a common occurrence in high risk patients. In this study adjuvant radiation therapy significantly reduced local recurrence rates and
Adjuvant Strategies for Resectable Pancreatic Cancer: Have We Made Progress?
Directory of Open Access Journals (Sweden)
Suzanne Russo
Full Text Available Substantial controversy remains regarding the optimal adjuvant treatment for patients with resectable pancreatic adenocarcinoma. Despite improvements in radiation techniques, systemic therapies, and incorporation of targeted agents, the 5-year survival rates for early stage patients remains less than 25% and the optimal adjuvant treatment approach remains unclear. Here we summarize the data presented at the 2012 American Society of Clinical Oncology (ASCO Gastrointestinal Cancers Symposium regarding controversial issues surrounding the role, timing, and selection of patients for adjuvant chemoradiation strategies following curative resection for pancreatic adenocarcinoma. (Abstracts #301, #333, and #206.
CpG ODN and ISCOMATRIX Adjuvant: A Synergistic Adjuvant Combination Inducing Strong T-Cell IFN-γ Responses
Directory of Open Access Journals (Sweden)
Michael J. McCluskie
Full Text Available For the induction of robust humoral and cellular immune responses, a strong rationale exists to use vaccine-adjuvant combinations possessing both immune modulatory and enhanced delivery capabilities. Herein, we evaluated the combination of 2 different adjuvants, a TLR9 agonist, composed of synthetic oligodeoxynucleotides (ODN containing immunostimulatory CpG motifs (CpG, and ISCOMATRIX adjuvant (ISCOMATRIX, composed of saponin, phospholipid, and cholesterol, which possesses both immunostimulatory and delivery properties. While both individual adjuvants have been shown effective in numerous preclinical and clinical studies, it is likely that for optimal adjuvant activity a combined adjuvant approach will be necessary. Herein, using three different antigens, namely, hepatitis B surface antigen (HBsAg, ovalbumin (OVA, and influenza A haemagglutinin antigen (HA, we show in mice that some adjuvant effects of CpG and ISCOMATRIX are further enhanced if they are used in combination. In particular, with all three antigens, IFN-γ levels were greatly increased with the CpG/ISCOMATRIX combination. The ability of the CpG/ISCOMATRIX combination to induce antitumor responses when administered with OVA following administration to mice of a highly metastatic OVA-secreting tumor cell line (B16-OVA melanoma was also demonstrated. Thus the CpG/ISCOMATRIX combination may prove to be a valuable tool in the development of novel or improved vaccines.
Introduction: Institutional corruption and the pharmaceutical policy.
Rodwin, Marc A
Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. PMID:24088143
Adjuvant chemotherapy in early breast cancer.
Ejlertsen, Bent
these CMF regimens has not been compared within the context of a randomised trial. Shifting from the 77B's classic CMF regimen to the 82B four-weekly IV regimen or the 89B three-weekly IV regimen was associated with a 30% increased risk of a DFS event in a multivariate analysis of a population-based cohort study. Furthermore, the four-weekly regimen used in 82B was associated with a 40% increase in mortality. The strengths of the design include identical selection criteria, uniform and prospective registration of treatment, tumour and patient characteristics. Caution is still required due to the non-experimental design of the comparison. Another finding was a substantial difference in the risk of amenorrhoea; and while 15% of patients aged 40 or younger in 77B had regular menses throughout chemotherapy, the corresponding percentage was 37 in 82B and 47 in 89B. The DBCG in collaboration with a Swedish and a Dutch centre participating in the DBCG trial 89B compared CMF with ovarian ablation in premenopausal high-risk breast cancer patients with ER-positive tumours. No significant differences were found in DFS or OS in the preplanned analysis, suggesting that the benefits of CMF may, at least in part, be explained by ovarian suppression in premenopausal patients with ER-positive tumours. However, these results are not clinically useful by themselves as other chemotherapy regimens have been more efficacious, and knowledge is still lacking regarding the benefits from adding ovarian suppression to chemotherapy plus tamoxifen. The results from the DBCG 77B and 82C are in accordance with other large adjuvant trials and the EBCTCG meta-analyses. The benefits obtained with any individual anticancer drug are largely determined by the cancer (somatic) genome; and by being a molecular target of anthracyclines, TOP2A aberrations could obviously be associated with cancer drug benefits. In the DBCG 89D, a significant heterogeneity was observed between a beneficial effect on DFS and OS
Bioremediation Kinetics of Pharmaceutical Industrial Effluent
Šabić, M.; Vuković Domanovac, M.; Findrik Blažević, Z.; Meštrović, E.
In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public's enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmente...
Strategic Management of Innovations at Pharmaceutical Enterprises
Honcharova Svіtlana Yu.; Honcharov Andrіy B.
The article is devoted to theoretical and practical issues of the use of the concept of strategic management of innovations at pharmaceutical enterprises. It studies main barriers, which restrict development of Ukrainian pharmaceutical enterprises. It analyses the state and tendencies of development of innovation activity of pharmaceutical enterprises and studies foreign experience of innovation activity. It marks out specific features of strategic management of innovation development in phar...
Vulnerabilities to misinformation in online pharmaceutical marketing
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on...
Supply Chain Management in Zhendong Pharmaceutical Company
Li, Yan
Medicines are special commodity related to people's lives and health, therefore, pharmaceutical distribution is an industry affecting the national economy and the people's livelihood. With health care reform, changeable pharmaceutical policy and fiercely increasing competition in the medical industry, pharmaceutical distribution companies should improve their level of logistics operations and reduce overall logistics management costs in order to gain a leading position in the competition. In ...
Nanotechnology tools in pharmaceutical R&D
Kumar, Challa S. S. R.
Nanotechnology is a new approach to problem solving and can be considered as a collection of tools and ideas which can be applied in pharmaceutical industry. Application of nanotechnology tools in pharmaceutical R&D is likely to result in moving the industry from 'blockbuster drug' model to 'personalized medicine'. There are compelling applications in pharmaceutical industry where inexpensive nanotechnology tools can be utilized. The review explores the possibility of categorizing various nan...
Pharmaceutical Market(ing): Theory and Reality
Stevan Vasiljev; Darko Pantelic
The pharmaceutical market represents one of the most dynamic and controversial markets. Its specific features are rooted in the specific nature of its products and in the complex interests of the main constituents of market demand. Finding ways to improve marketing practice in the pharmaceutical sector lie in understanding marketing theory and best practice logic and comparing it with on-going everyday practice. Sensitive circumstances of using pharmaceuticals, their potential for abuse and h...
Pharmaceutical Policy regarding Generic Drugs in Belgium
Steven Simoens; Kristien De Bruyn; Marc Bogaert; Gert Laekeman
Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to discuss Belgian pharmaceutical policy regarding generic drugs and to analyse how the Belgian dru...
Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers
Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...
Launch Decisions of Pharmaceutical Companies
Abdülkadir Civan; Michael Maloney
This paper models the launch decision of pharmaceutical companies in regard to new drugs and country markets. New drugs are launched with a delay or not launched at all in many countries. Considering that many of these new drugs would have created health benefits to the patients, there seems to be welfare loss. We use market characteristics to explain this phenomenon. We show that most of the estimated launch with a delay and no-launch decision is due to observable market characteristics. The...
Radiological assessment of pharmaceutical clays
International Nuclear Information System (INIS)
The suitability for pharmaceutical and cosmetic application of fourteen clay samples, eight raw and six commercialized samples, from Minas Gerais and Sao Paulo states, Brazil, were evaluated and their mineralogy, chemical and radiological composition were determined. Results indicated that the samples are composed mainly of quartz, kaolinite and feldspar, enriched in Al2O3 and TiO2, Cd, Cs, Sb, Se, Th, and U and depleted in SiO2, MgO, P2O5, and Ca. Concentrations found are unlikely to present any harm in topical applications, and all the radiological parameters were below the global average or the established limits. (author)
Directory of Open Access Journals (Sweden)
Lahkar Sunita
Full Text Available Pulmonary drug delivery system is found to have a wide range of application in the treatment of illness as well as in the research field due to its beneficial effect over the other dosage form. It is used not only in treatment of illness of asthma and chronic obstructive pulmonary disease (COPD but also finds its application in the treatment of diseases like diabetes, angina pectoris. This review article deals with an overview of one of the pulmonary drug delivery system called pharmaceutical aerosols.
Entrepreneurial patent management in pharmaceutical startups.
Holgersson, Marcus; Phan, Tai; Hedner, Thomas
Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. PMID:26948802
Cognitive function after adjuvant treatment for early breast cancer
DEFF Research Database (Denmark)
Debess, Jeanne; Riis, Jens Østergaard; Engebjerg, Malene Cramer;
start of adjuvant treatment and after 6 months by neuropsychological tests and questionnaires to evaluate cognitive function, quality of life and psychological distress. Neuropsychological tests did not reveal any differences in cognitive function between breast cancer patients after chemotherapy and......The purpose of this study was to examine cognitive function in patients with early breast cancer before and after adjuvant chemotherapy or 6 months of tamoxifen. We performed a population-based study in the county of North Jutland, Denmark, including 120 women aged <60 years who received adjuvant...... chemotherapy with seven cycles of cyclophosphamide, epirubicin and fluoruracil or adjuvant tamoxifen for 6 months for early breast cancer from 2004 to 2006. They were compared with an aged-matched group of 208 women without previous cancer selected randomly from the same population. Data were collected before...
Progress in Researches on the Pharmaceutical Mechanism and Clinical Application of Ginkgo Biloba Extract on Various Kinds of Diseases
Institute of Scientific and Technical Information of China (English)
WANG Guo-xia; CAO Fu-liang; CHEN Jun
Progress made over the pharmaceutical mechanism and clinical application of Ginkgo BiIoba extract (GBE) on various kinds of diseases were reviewed in this paper. The effective elements contained in GBE are mainly kinds of Ginkgo flavonoid and Ginkgolide, which have marked protective effects on cardio-cerebral vascular and central nerve systems. In clinical practice, it is applied mostly in treatment of cardio-cerebral vascular diseases. Also it shows apparent effects in the treatment processes of some other diseases as an adjuvant, and therefore, has been gradually accepted by the medical circle in the world, proving to be a medicine of wide prospect in development and application.
Advances in aluminum hydroxide-based adjuvant research and its mechanism
He, Peng; Zou, Yening; Hu, Zhongyu
In the past few decades, hundreds of materials have been tried as adjuvant; however, only aluminum-based adjuvants continue to be used widely in the world. Aluminum hydroxide, aluminum phosphate and alum constitute the main forms of aluminum used as adjuvants. Among these, aluminum hydroxide is the most commonly used chemical as adjuvant. In spite of its wide spread use, surprisingly, the mechanism of how aluminum hydroxide-based adjuvants exert their beneficial effects is still not fully und...
Learning impairment in honey bees caused by agricultural spray adjuvants.
Directory of Open Access Journals (Sweden)
Timothy J Ciarlo
Full Text Available BACKGROUND: Spray adjuvants are often applied to crops in conjunction with agricultural pesticides in order to boost the efficacy of the active ingredient(s. The adjuvants themselves are largely assumed to be biologically inert and are therefore subject to minimal scrutiny and toxicological testing by regulatory agencies. Honey bees are exposed to a wide array of pesticides as they conduct normal foraging operations, meaning that they are likely exposed to spray adjuvants as well. It was previously unknown whether these agrochemicals have any deleterious effects on honey bee behavior. METHODOLOGY/PRINCIPAL FINDINGS: An improved, automated version of the proboscis extension reflex (PER assay with a high degree of trial-to-trial reproducibility was used to measure the olfactory learning ability of honey bees treated orally with sublethal doses of the most widely used spray adjuvants on almonds in the Central Valley of California. Three different adjuvant classes (nonionic surfactants, crop oil concentrates, and organosilicone surfactants were investigated in this study. Learning was impaired after ingestion of 20 µg organosilicone surfactant, indicating harmful effects on honey bees caused by agrochemicals previously believed to be innocuous. Organosilicones were more active than the nonionic adjuvants, while the crop oil concentrates were inactive. Ingestion was required for the tested adjuvant to have an effect on learning, as exposure via antennal contact only induced no level of impairment. CONCLUSIONS/SIGNIFICANCE: A decrease in percent conditioned response after ingestion of organosilicone surfactants has been demonstrated here for the first time. Olfactory learning is important for foraging honey bees because it allows them to exploit the most productive floral resources in an area at any given time. Impairment of this learning ability may have serious implications for foraging efficiency at the colony level, as well as potentially many
Experimental study on Cervi Cornu on Adjuvant Arthritis in rats
Ji-Won, Shin; Jai-Young, Park; Hee-Soo,Park
Objective: To investigate effects of Cervi Cornu on Adjuvant Athritis in rats, the edema inhibit rate, the anaJgesic effects, the number of WBC, RA facter, Platelet, the quantity of CRP, total protein, albumin and globuline in the blood serum were measured in the arthritis part. Results: The results obtained as fonows ; 1. After arthritis of Sprague dawley(SD) rats was induced by injecting Freund's complete adjuvant for 2 weeks, any treatment was not for Control group, acupunctured for Tr...
Second malignancies after breast cancer: The impact of adjuvant therapy
Dong, Chunhui; Chen, Ling
Second malignant neoplasms (SMNs) are potentially life-threatening late sequelae of the adjuvant therapy for breast cancer (BC). The increased risk of SMNs is associated with adjuvant chemotherapy (development of secondary acute myeloid leukemia and myelodysplastic syndrome) and hormonal therapy (risk of uterine cancer secondary to tamoxifen treatment). Previous studies have demonstrated an increased risk of SMNs associated with alkylating agents, topoisomerase-II inhibitors, granulocyte-stim...
Engineering of an Inhalable DDA/TDB Liposomal Adjuvant
DEFF Research Database (Denmark)
Ingvarsson, Pall Thor; Yang, Mingshi; Mulvad, Helle;
The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB).......The purpose of this study was to identify and optimize spray drying parameters of importance for the design of an inhalable powder formulation of a cationic liposomal adjuvant composed of dimethyldioctadecylammonium (DDA) bromide and trehalose-6,6'-dibehenate (TDB)....
Patient adherence to aromatase inhibitor treatment in the adjuvant setting
Verma, S.; Madarnas, Y.; Sehdev, S.; Martin, G; Bajcar, J.
Improvements in adjuvant systemic therapy and detection of early disease have resulted in a decline of breast cancer death rates across all patient age groups in Canada. Non-adherence to adjuvant hormonal therapy in the setting of early breast cancer may significantly affect patient outcome. Factors associated with medication adherence are complex and may be patient-related, therapy-related, and health care provider–related. To date, there is a gap in the literature concerning a comprehensive...
Directory of Open Access Journals (Sweden)
N. M. Sergeeva
Full Text Available Strategy of pharmaceutical goods (PG promotion is a working out of methods of goods realization stimulation. To make PG promotion maximum effective, and to receive a sufficient result for pharmaceutical organization (PO it is necessary to conduct marketing studies (MS, to work out a marketing plan for PG promotion and to offer marketing strategies for goods promotion. To resolve these problems we have formed a concept of marketing promotion of PG system for one of big retail PO of Kursk and Kursk oblast (code name "A". With this purpose we have identified a problem of PG promotion organization, studied an influence of external and internal environment on the PO "A" activity, determined strong and weak sides of PO activity. We have systematized the results in SWOT-analysis, and formed the strategies of PO for the improvement of work efficiency on the market. On the basis of the results received we have worked out the recommendations for the marketing strategies of PG promotion for the certain PO.
Enzymatic biodegradation of pharmaceutical wastewater
Energy Technology Data Exchange (ETDEWEB)
Uwadiae, S.E.; Yerima, Y.; Azik, R.U. [Department of Chemical Engineering, Igbinedion University, Okada, P.M.B. 0006, Benin City, Edo State (Nigeria)
The present effort is an attempt to reduce pollution caused by the discharge of untreated wastewater (effluents) to the environment by using a low cost method. The effluent was bio-remediated using yeast and amylase as the active agents. The greater the decomposable matters present in an effluent, the greater the oxygen demand; the greater the Biological Oxygen Demand (BOD) and Chemical Oxygen Demand(COD) values, the less Dissolved Oxygen(DO) values. 10g of yeast and amylase were added to 1000ml each of pharmaceutical effluent. 150 ml of the effluent (from the yeast and amylase) dosed was withdrawn weekly for analysis alongside with the effluent without enzymes for turbidity, DO, BOD and COD. After a period of six weeks the effluent dosed with yeast gave the highest performance followed by that dosed with amylase. The result shows that as time increases, the amount of oxygen demand reduces while the dissolved oxygen content of the effluent increases. This indicates that the yeast enzyme was able to aid remediation of the pharmaceutical effluent.
Enzymatic biodegradation of pharmaceutical wastewater
Directory of Open Access Journals (Sweden)
Uwadiae S. E, Yerima Y, Azike R.U
Full Text Available The present effort is an attempt to reduce pollution caused by the discharge of untreated wastewater (effluents to the environment by using a low cost method. The effluent was bio-remediated using yeast and amylase as the active agents. The greater the decomposable matters present in an effluent, the greater the oxygen demand; the greater the Biological Oxygen Demand (BOD and Chemical Oxygen Demand(COD values, the less Dissolved Oxygen(DO values. 10g of yeast and amylase were added to 1000ml each of pharmaceutical effluent. 150 ml of the effluent (from the yeast and amylase dosed was withdrawn weekly for analysis alongside with the effluent without enzymes for turbidity, DO, BOD and COD. After a period of six weeks the effluent dosed with yeast gave the highest performance followed by that dosed with amylase. The result shows that as time increases, the amount of oxygen demand reduces while the dissolved oxygen content of the effluent increases. This indicates that the yeast enzyme was able to aid remediation of the pharmaceutical effluent.
Pharmaceutical Industry Oriented Homogeneous Catalysis
Institute of Scientific and Technical Information of China (English)
Zhang Xumu
Chiral therapeutics already makes up over one-third of pharmaceutical drugs currently sold worldwide. This is a growing industry with global chiral drug sales for 2002 increasing by 12%to $160 billion (Technology Catalysts International) of a total drug market of $410bn. The increasing demand to produce enantiomerically pure pharmaceuticals, agrochemicals, flavors, and other fine chemicals has advanced the field of asymmetric catalytic technologies.We aim to become a high value technology provider and partner in the chiral therapeutics industry by offering proprietary catalysts, novel building blocks, and collaborative synthetic solutions. In decade, we have developed a set of novel chiral homogeneous phosphorus ligands such as Binaphane, Me-KetalPhos, TangPhos, f-Binaphane, Me-f-KetalPhos, C4TunePhos and Binapine,which we called Chiral Ligand ToolKit. Complementing the ToolKit, (R, S, S, R)-DIOP*, T-Phos,o-BIPHEP, o-BINAPO and FAP were added recently[1].These ligands can be applied to a broad variety of drug structural features by asymmetric hydrogenation of dehydroamino acid derivatives, enamides, unsatisfied acids and esters, ketones,beta ketoesters, imines and cyclic imines. And ligand FAP had been apllied succefully in allylic alkylation and [3+2] cycloaddition.
Adjuvant therapy for ampullary carcinomas: The Mayo Clinic experience
International Nuclear Information System (INIS)
Purpose: To determine the effects of adjuvant radiotherapy and chemotherapy for carcinoma of the ampulla of Vater. Methods and Materials: We retrospectively reviewed the records of 125 patients who underwent definitive surgery for carcinomas involving the ampulla of Vater between April 1977 and February 2005 and who survived more than 50 days after surgery. Twenty-nine of the patients also received adjuvant radiotherapy (median dose, 50.4 Gy in 28 fractions) with concurrent 5-fluorouracil chemotherapy. Adverse prognostic factors were investigated, and overall survival (OS) and local and distant failure were estimated. Results: Adverse prognostic factors for decreased OS by univariate analysis included lymph node (LN) involvement, locally advanced tumors (T3/T4), and poor histologic grade. By multivariate analysis, positive LN status (p = 0.02) alone was associated with decreased OS. The addition of adjuvant radiotherapy and chemotherapy improved OS for patients with positive LN (p = 0.01). Median survival for positive LN patients receiving adjuvant therapy was 3.4 years, vs. 1.6 years for those with surgery alone. Conclusions: The addition of adjuvant radiotherapy and 5-fluorouracil chemotherapy may improve OS in patients with LN involvement. The effect of adjuvant therapy on outcomes for patients with poor histologic grade or T3/T4 tumors without LN involvement could not be assessed
Chitosan-based mucosal adjuvants: Sunrise on the ocean.
Xia, Yufei; Fan, Qingze; Hao, Dongxia; Wu, Jie; Ma, Guanghui; Su, Zhiguo
Mucosal vaccination, which is shown to elicit systemic and mucosal immune responses, serves as a non-invasive and convenient alternative to parenteral administration, with stronger capability in combatting diseases at the site of entry. The exploration of potent mucosal adjuvants is emerging as a significant area, based on the continued necessity to amplify the immune responses to a wide array of antigens that are poorly immunogenic at the mucosal sites. As one of the inspirations from the ocean, chitosan-based mucosal adjuvants have been developed with unique advantages, such as, ability of mucosal adhesion, distinct trait of opening the junctions to allow the paracellular transport of antigen, good tolerability and biocompatibility, which guaranteed the great potential in capitalizing on their application in human clinical trials. In this review, the state of art of chitosan and its derivatives as mucosal adjuvants, including thermo-sensitive chitosan system as mucosal adjuvant that were newly developed by author's group, was described, as well as the clinical application perspective. After a brief introduction of mucosal adjuvants, chitosan and its derivatives as robust immune potentiator were discussed in detail and depth, in regard to the metabolism, safety profile, mode of actions and preclinical and clinical applications, which may shed light on the massive clinical application of chitosan as mucosal adjuvant. PMID:26271831
Synthetic biology advances for pharmaceutical production
Breitling, Rainer; Takano, Eriko
Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems.
Pharmaceutical Marketing: Transactional Or Relational Exchange?
Rod, M.; Paliwoda, S
The objectives of this paper are to bring together two very topical issues in marketing - pharmaceutical promotion and the movement to a more relationship-based orientation in marketing as well as to address the question of how relationship marketing will affect the marketing of pharmaceuticals to healthcare practitioners.
Sterilization of pharmaceuticals by gamma ray
International Nuclear Information System (INIS)
This paper shows the possibility of sterilization of certain pharmaceuticals and materials involved by gamma radiation from cobalt-60 and cesium-137 sources, and illustrates the importance of gamma ray sterilization compared with other sterilization methods. The paper also reviews some pharmaceuticals and materials involved, which proved the possibility of gamma ray sterilization. (author)
Do pharmaceutical representatives misuse their drug samples?
Tong, K. L.; Lien, C. Y.
OBJECTIVE: To determine the extent to which pharmaceutical representatives misuse their samples. DESIGN: Voluntary questionnaire survey. SETTING: A family practice office. PARTICIPANTS: Pharmaceutical representatives visiting the office during a 3-month period. MAIN OUTCOME MEASURES: Number of surveyed representatives who self-medicated, provided samples of prescription drugs to nonphysicians, or exchanged drugs with other representatives; classes of prescription drugs most commonly used; and...
Pharmaceutic Crisis:Why the Industry Despairs
Institute of Scientific and Technical Information of China (English)
China's pharmaceutical industry isn't feeling warm and fuzzy, but it's not unlike the giant panda "We are now struggling for survival," said Niu Zhengqian, Chief Advisor at the China Center for Pharmacoeconomics and Outcomes Research, whose feeling is shared by many who are engaged with the pharmaceutical
Role of neurologists in the pharmaceutical industry.
Peroutka, S J
Important advances in the field of clinical neuropharmacology have created an increasing demand by the pharmaceutical industry for neurologists. As recently as a decade ago, neurologists were relatively rare in the pharmaceutical industry. I describe the roles played by industrial neurologists and review both the opportunities and risks in this career path.
Drivers of peak sales for pharmaceutical brands
Fischer, Marc; Leeflang, Peter S. H.; Verhoef, Peter C.
Peak sales are an important metric in the pharmaceutical industry. Specifically, managers are focused on the height-of-peak-sales and the time required achieving peak sales. We analyze how order of entry and quality affect the level of peak sales and the time-to-peak-sales of pharmaceutical brands.
Integrating systems Approaches into Pharmaceutical Sciences
DEFF Research Database (Denmark)
Westerhoff, H.V.; Mosekilde, Erik; Noe, C. R.;
During the first week of December 2007, the European Federation for Pharmaceutical Sciences (EUFEPS) and BioSim, the major European Network of Excellence on Systems Biology, held a challenging conference on the use of mathematical models in the drug development process. More precisely, the purpose...... of the conference was to promote the 'Integration of Systems Approaches into Pharmaceutical Sciences' in view of optimising the development of new effective drugs. And a challenge this is, considering both the high attrition rates in the pharmaceutical industry and the failure of finding definitive...... drug solutions for many of the diseases that plague mankind today. The conference was co-sponsored by the American College of Clinical Pharmacology, the European Center for Pharmaceutical Medicine, and the Swiss Society of Pharmaceutical Sciences and, besides representatives from the European...
The changing environment for US pharmaceuticals.
Meyer, P R
Health reform is currently the predominant health policy issue in the US. It carries profound implications for the pharmaceutical field, including the possibility of price controls that could stifle pharmaceutical research. While policy makers are contemplating alternative approaches to reform, the marketplace for pharmaceuticals has changed dramatically. For example, price increases have lessened, price discounting has increased, and new drugs are typically launched at prices lower than those of the leading product in the therapeutic class. These changes are driven in part by the growth of managed care. Further evidence of change in the industry is the number of job reductions announced and the decline in market valuation of pharmaceutical companies. Policy makers need to take the changed marketplace into consideration as they proceed with health reform, to avoid layering additional policy impediments on top of an increasingly harsh and unforgiving market. Such an approach could seriously compromise incentives for pharmaceutical research. PMID:10155590
Pharmaceutical counterfeiting and the RFID technology intervention.
Coustasse, Alberto; Arvidson, Cody; Rutsohn, Phil
Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of the counterfeit drug problem. Recommendations for how the pharmaceutical industry may sooner adopt the RFID model are made. PMID:20582850
Actual Problems and Prospects of the Pharmaceutical Market
Galymzhan Talassov; Gulnar Abdrakhmanova
This article describes the production of basic pharmaceutical products, the share of domestic production in the domestic market, the main capital of the pharmaceutical industry of the Republic of Kazakhstan, the volume of gross value added (GVA) of the pharmaceutical industry, labor productivity in the pharmaceutical industry, pharmaceutical industry exports for the period from 2008 to 2013, as well as the existing main problems of the pharmaceutical industry.
Developing a pharmaceutical purchasing strategy.
Hynniman, C E
The process commonly used by group purchasing organizations to contract for multisource pharmaceuticals and a strategic approach for the director of pharmacy in working with the purchasing group and the P & T Committee is described. The pharmacist should be knowledgeable concerning the group's contract commitment requirements, product specifications, terms and conditions and procedures for vendor selection, product award, contract implementation, and performance monitoring. To ensure results that meet the needs of the medical staff, it is important that the P & T Committee actively participate. The P & T Committee should understand the reasons for selecting a particular purchasing group, understand the necessary steps in obtaining the most favorable economic advantage, review products with potential brand interchange concerns, recommend product specifications, and reaffirm formulary procedures regarding the principle of current consent. PMID:10171225
Choice and Design of Adjuvants for Parenteral and Mucosal Vaccines
Directory of Open Access Journals (Sweden)
Huub F. J. Savelkoul
Full Text Available The existence of pathogens that escape recognition by specific vaccines, the need to improve existing vaccines and the increased availability of therapeutic (non-infectious disease vaccines necessitate the rational development of novel vaccine concepts based on the induction of protective cell-mediated immune responses. For naive T-cell activation, several signals resulting from innate and adaptive interactions need to be integrated, and adjuvants may interfere with some or all of these signals. Adjuvants, for example, are used to promote the immunogenicity of antigens in vaccines, by inducing a pro-inflammatory environment that enables the recruitment and promotion of the infiltration of phagocytic cells, particularly antigen-presenting cells (APC, to the injection site. Adjuvants can enhance antigen presentation, induce cytokine expression, activate APC and modulate more downstream adaptive immune reactions (vaccine delivery systems, facilitating immune Signal 1. In addition, adjuvants can act as immunopotentiators (facilitating Signals 2 and 3 exhibiting immune stimulatory effects during antigen presentation by inducing the expression of co-stimulatory molecules on APC. Together, these signals determine the strength of activation of specific T-cells, thereby also influencing the quality of the downstream T helper cytokine profiles and the differentiation of antigen-specific T helper populations (Signal 3. New adjuvants should also target specific (innate immune cells in order to facilitate proper activation of downstream adaptive immune responses and homing (Signal 4. It is desirable that these adjuvants should be able to exert such responses in the context of mucosal administered vaccines. This review focuses on the understanding of the potential working mechanisms of the most well-known classes of adjuvants to be used effectively in vaccines.
F. I. Belyalov
Relationships of pharmaceutical industry with medical science and practice are analyzed. The influence of pharmaceutical industry on clinical trials, journal publications, governmental organizations, physicians and researchers is discussed.
Role of Adjuvant Chemoradiotherapy for Resected Extrahepatic Biliary Tract Cancer
International Nuclear Information System (INIS)
Purpose: To evaluate the effect of adjuvant chemoradiotherapy (CRT) on locoregional control (LRC), disease-free survival (DFS), and overall survival (OS) for patients with extrahepatic biliary tract cancer treated with curative resection. Methods and Materials: The study involved 168 patients with extrahepatic biliary tract cancer undergoing curative resection between August 2001 and April 2009. Of the 168 patients, 115 received adjuvant CRT (CRT group) and 53 did not (no-CRT group). Gender, age, tumor size, histologic differentiation, pre- and postoperative carbohydrate antigen 19-9 level, resection margin, vascular invasion, perineural invasion, T stage, N stage, overall stage, and the use of adjuvant CRT were analyzed to identify the prognostic factors associated with LRC, DFS, and OS. Results: For all patients, the 5-year LRC, DFS, and OS rate was 54.8%, 30.6%, and 33.9%, respectively. On univariate analysis, the 5-year LRC, DFS, and OS rates in the CRT group were significantly better than those in the no-CRT group (58.5% vs. 44.4%, p = .007; 32.1% vs. 26.1%, p = .041; 36.5% vs. 28.2%, p = .049, respectively). Multivariate analysis revealed that adjuvant CRT was a significant independent prognostic factor for LRC, DFS, and OS (p < .05). Conclusion: Our results have suggested that adjuvant CRT helps achieve LRC and, consequently, improves DFS and OS in patients with extrahepatic biliary tract cancer.
Novel adjuvants & delivery vehicles for vaccines development: a road ahead.
Mohan, Teena; Verma, Priyanka; Rao, D Nageswara
The pure recombinant and synthetic antigens used in modern day vaccines are generally less immunogenic than older style live/attenuated and killed whole organism vaccines. One can improve the quality of vaccine production by incorporating immunomodulators or adjuvants with modified delivery vehicles viz. liposomes, immune stimulating complexes (ISCOMs), micro/nanospheres apart from alum, being used as gold standard. Adjuvants are used to augment the effect of a vaccine by stimulating the immune system to respond to the vaccine, more vigorously, and thus providing increased immunity to a particular disease. Adjuvants accomplish this task by mimicking specific sets of evolutionary conserved molecules which include lipopolysaccharides (LPS), components of bacterial cell wall, endocytosed nucleic acids such as dsRNA, ssDNA and unmethylated CpG dinucleotide containing DNA. This review provides information on various vaccine adjuvants and delivery vehicles being developed to date. From literature, it seems that the humoral immune responses have been observed for most adjuvants and delivery platforms while viral-vector, ISCOMs and Montanides have shown cytotoxic T-cell response in the clinical trials. MF59 and MPL® have elicited Th1 responses, and virus-like particles (VLPs), non-degradable nanoparticle and liposomes have also generated cellular immunity. Such vaccine components have also been evaluated for alternative routes of administration with clinical success reported for intranasal delivery of viral-vectors and proteosomes and oral delivery of VLP vaccines. PMID:24434331
Who benefits most from adjuvant interferon treatment for melanoma?
Gogas, Helen; Abali, Huseyin; Ascierto, Paolo A; Demidov, Lev; Pehamberger, Hubert; Robert, Caroline; Schachter, Jacob; Eggermont, Alexander M M; Hauschild, Axel; Espinosa, Enrique
Metastatic melanoma has a poor prognosis; the median survival for patients with stage IV melanoma ranges from 8 to 18 months after diagnosis. Interferon-α provides significant improvement in disease-free survival at the cost of poor tolerability. Identifying patients who benefit the most may improve the cost:benefit ratio. In addition, no data exist for the role of adjuvant therapy in noncutaneous melanoma. Molecular profiles may help to identify patients who benefit the most from adjuvant interferon therapy. In this review, the American Joint Commission on Cancer 2009 staging criteria and emerging biomarker data to guide adjuvant treatment decisions will be discussed. Several criteria to guide selection of patients are discussed in detail. These include Breslow thickness, number of positive lymph nodes, whether or not the primary lesion has ulcerated, immunologic markers, and cytokine profiles. Substantial progress has been made in deciding which patients benefit from interferon-α adjuvant therapy. Interferon-α is the only agent currently approved for the adjuvant treatment of this deadly disease, despite its side effect profile. More effective drugs with better tolerability are needed. PMID:24176884
Vulnerabilities to misinformation in online pharmaceutical marketing.
De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J
Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527
Strategic Management of Innovations at Pharmaceutical Enterprises
Directory of Open Access Journals (Sweden)
Honcharova Svіtlana Yu.
Full Text Available The article is devoted to theoretical and practical issues of the use of the concept of strategic management of innovations at pharmaceutical enterprises. It studies main barriers, which restrict development of Ukrainian pharmaceutical enterprises. It analyses the state and tendencies of development of innovation activity of pharmaceutical enterprises and studies foreign experience of innovation activity. It marks out specific features of strategic management of innovation development in pharmaceutical industry. It specifies the role and advantages of methods of strategic analysis in the system of management of a pharmaceutical enterprise. It considers the essence of "innovation development" and "innovation model of development" notions and analyses their organisational and legal provision. It justifies strategic tasks of the pharmaceutical filed to focus on in order to achieve a breakthrough when building an innovation model of economic development. The article proves that the most important factors that ensure growth of efficiency of pharmaceutical production are: wide application of the concept of strategic management and creation of innovations.
Operational Aspects of Continuous Pharmaceutical Production
DEFF Research Database (Denmark)
Mitic, Aleksandar
Introduction of the Process Analytical Technolo gy (PAT) Initiative, the Quality by Design (QbD) approach and the Continuous Improvement (CI) methodology/philosophy is considered as a huge milestone in the modern pharmaceutical indust ry. The above concepts, when applied to a pharmaceutical...... strategy by using microwave irradiation resulted in significant improvements. The third example process includes the small-s cale production of (2-Bromophenyl)(phenyl)sulfane. This important API intermediate is receiving si gnificant attention in the pharmaceutical industry due to the fact that there are...
Metrology in Pharmaceutical Industry - A Case Study
Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.
Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area.
Radiation sterilization of pharmaceuticals and biomedical products
International Nuclear Information System (INIS)
Sterilization of pharmaceuticals by radiation is accompanied by chemical degradation which must be eliminated or minimised if the method is to be successfully applied. In order to devise ways in which the pharmaceutical can be protected it is necessary to know the yield and nature of the decomposition products, the mechanisms by which degradation occurs, and the rate constants for the reactions involved. We have obtained such data for a variety of pharmaceutical compounds, viz. vitamin B12, benzyl penicillin, sulphonamides, indoles, heparin, alginates and phenylmercurics, both in the solid state and in aqueous solution. The scope and limitations of radiation sterilization are discussed in the light of these results. (author)
Postoperative adjuvant chemotherapy in rectal cancer operated for cure
DEFF Research Database (Denmark)
Petersen, Sune Høirup; Harling, Henrik; Kirkeby, Lene Tschemerinsky;
Colorectal cancer is one of the most common types of cancer in the Western world. Apart from surgery - which remains the mainstay of treatment for resectable primary tumours - postoperative (i.e., adjuvant) chemotherapy with 5-fluorouracil (5-FU) based regimens is now the standard treatment...... in Dukes´ C (TNM stage III) colon tumours i.e. tumours with metastases in the regional lymph nodes but no distant metastases. In contrast, the evidence for recommendations of adjuvant therapy in rectal cancer is sparse. In Europe it is generally acknowledged that locally advanced rectal tumours receive...... preoperative (i.e., neoadjuvant) downstaging by radiotherapy (or chemoradiotion), whereas in the US postoperative chemoradiotion is considered the treatment of choice in all Dukes´ C rectal cancers. Overall, no universal consensus exists on the adjuvant treatment of surgically resectable rectal carcinoma...
Old and new adjuvants for hepatitis B vaccines.
Leroux-Roels, Geert
The safety and immunogenicity profiles of currently available recombinant hepatitis B vaccines are excellent. However, it remains a real challenge to induce protective immunity in the target groups that respond poorly or not at all to conventional vaccines. Ideally, a hepatitis B vaccine can be developed that conveys lifelong protection against infection rapidly after the injection of a single dose. Although this goal is far from being reached, important improvements have been made. Novel vaccine adjuvants have been developed that enhance the immunogenicity of recombinant hepatitis B vaccines while maintaining a good safety profile. The different adjuvants and adjuvant systems that are discussed herein have all been thoroughly evaluated in clinical trials and some have reached or are close to reach the market. PMID:25523196
The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy.
Ahmed, S Sohail; Montomoli, Emanuele; Pasini, Franco Laghi; Steinman, Lawrence
Despite the very high benefit-to-risk ratio of vaccines, the fear of negative side effects has discouraged many people from getting vaccinated, resulting in the reemergence of previously controlled diseases such as measles, pertussis and diphtheria. This fear has been amplified more recently by multiple epidemiologic studies that confirmed the link of an AS03-adjuvanted pandemic influenza vaccine (Pandemrix, GlaxoSmithKline Biologicals, Germany) used in Europe during the 2009 H1N1 influenza pandemic [A(H1N1) pdm09] with the development of narcolepsy, a chronic sleep disorder, in children and adolescents. However, public misperceptions of what adjuvants are and why they are used in vaccines has created in some individuals a closed "black box" attitude towards all vaccines. The focus of this review article is to revisit this "black box" using the example of narcolepsy associated with the European AS03-adjuvanted pandemic influenza vaccine. PMID:27228647
Development of CpG ODN Based Vaccine Adjuvant Formulations.
Gursel, Mayda; Gursel, Ihsan
Development of effective vaccine mediated immune responses relies on the use of vaccine adjuvants capable of enhancing and directing the adaptive immune response to the antigen. When used as vaccine adjuvants, type I interferon inducing agents can elicit potent effector/memory T cell responses and humoral immunity. Distinct sequences of single stranded synthetic oligodeoxynucleotides containing unmethylated cytosine-phosphate-guanine oligodeoxynucleotide motifs (CpG ODN) can generate type I interferon production via a TLR9-MyD88-IRF7-mediated signaling pathway. Here, we describe two different methods of preparing CpG ODN-based vaccine adjuvant formulations that can induce a robust IFNα response from human peripheral blood mononuclear cells. PMID:27076306
Adjuvant treatment and outcomes of stage III endometrial carcinoma
International Nuclear Information System (INIS)
Surgery with staging using FIGO (1988) classification is accepted management for stage III endometrial carcinoma. The delivery of adjuvant therapy is controversial and tends to be individualised. Retrospective review of stage III endometrial carcinoma patients who underwent radical surgery at the Royal Adelaide and Queen Elizabeth Hospitals from 1984 to 2003 was carried out. Medical records were reviewed for details of patient characteristics, surgery, histopathology, adjuvant therapy and recurrence/survival. Sixty-six patients with a median age of 69 (37-97), had a median follow-up of 26 months (1-188 ). For all stage III patients, the actuarial 5-year disease-free and overall survivals were 50 and 43% respectively. Thirty-five patients received pelvic +/- paraaortic radiotherapy, 5 whole abdominal radiotherapy, 14 vaginal brachytherapy boost, 10 chemotherapy and 13 adjuvant hormones. Forty-six percent of patients recurred in a median time of 13 months (0-95). For these patients, the sites of first recurrence were pelvis in 27%, pelvis and abdomen in 23%, abdomen alone in 13%, distant alone in 27%, distant and abdominal in 7% and all three sites in 3%. On univariate analysis disease-free survival was impacted by; age, grade, parametrial involvement, number of extrauterine sites, lymphovascular invasion, adjuvant radiotherapy to the pelvis alone and postoperative macroscopic residual disease. Lymphovascular invasion, post-operative residual disease and adjuvant pelvic radiotherapy remained significant on multivariate analysis. These outcomes for stage III endometrial carcinoma are comparable to the current literature. Ongoing research is required to establish the most appropriate adjuvant therapy in these high risk patients
Does Adjuvant Radiotherapy Suppress Liver Regeneration After Partial Hepatectomy?
International Nuclear Information System (INIS)
Purpose: To analyze the influence of the adjuvant radiotherapy (RT) on the liver regeneration and liver function after partial hepatectomy (PH). Methods and Materials: Thirty-four patients who underwent PH for biliary tract cancer between October 2003 and July 2005 were reviewed. Hemihepatectomy was performed in 14 patients and less extensive surgery in 20. Of the patients, 19 patients had no adjuvant therapy (non-RT group) and 15 underwent adjuvant RT by a three-dimensional conformal technique (RT group). Radiation dose range was 40 to 50 Gy (median, 40 Gy). Liver volume on computed tomography and the results of liver function tests at 1, 4, 12, 24, and 52 weeks after PH were compared between the RT and non-RT groups. Results: The preoperative characteristics were identical for both groups. During the interval between Weeks 4 and 12 when adjuvant RT was delivered in the RT group, the increase in liver volume was significantly smaller in the RT group than non-RT group (22.9 ± 38.3cm3 and 81.5 ± 75.6cm3, respectively, p = 0.007). However, the final liver volume measured at 1 year after PH did not differ between the two groups (p = 0.878). Liver function tests were comparable for both groups. The resection extent and original liver volume was independent factors for final liver volume measured at 1 year after PH. Conclusions: In this study, adjuvant RT delayed the liver regeneration process after PH, but the volume difference between the two study groups became nonsignificant after 1 year. Adjuvant RT had no additional adverse effect on liver function after PH.
The European Pharmaceutical Industry in a Global Economy: what drives EU exports of pharmaceuticals?
Ludivine Blanc
The pharmaceutical industry is one of the most competitive sectors in the European Union. With its substantial investments in research and development, this industry represents a key asset for the European economy and a major source of growth and employment. However, despite the importance of the pharmaceutical sector for the European Union, few researchers have attempted to assess the determinants of the EU exports of pharmaceuticals. This paper aims at filling the aforementioned gap by exam...
Compulsory licenses for pharmaceuticals: an inconvenient truth?
Thambisetty, Sivaramjani
LSE's Sivaramjani Thambisetty discusses the legal and strategic implications for the pharmaceutical industry of the Indian decision to uphold the grant of the first compulsory license on a patented drug.
Information flow in the pharmaceutical supply chain.
Yousefi, Nazila; Alibabaei, Ahmad
Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401
Radiation processing of pharmaceutics and cosmetics
International Nuclear Information System (INIS)
State of the art in the field of radiation processing for sterilization and pasteurization of pharmaceuticals and cosmetics has been presented. The advantages and disadvantages of radiation methods have been discussed. 7 refs, 2 tabs
Pharmaceutical marketing research and the prescribing physician.
Greene, Jeremy A
Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue. PMID:17502635
Paying for On-Patent Pharmaceuticals
Goldfield, Norbert
In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298
Directory of Open Access Journals (Sweden)
Kaur Harbir
Full Text Available Pharmaceutical oral solid dosage forms have been used widely for decades mainly due to their convenience of administration and their suitability for delivery for delivery of drugs for systemic effects. The most commonly used pharmaceutical solid dosage forms today include granules, pellets, tablets and capsules. The tablets and capsules can be made directly from powders or from granules pellets, or from film-coated multiple units. Tablets are now the most popular dosage form, accounting for some 70% of all ethical pharmaceutical preparations produced.Tablets may be defined as solid pharmaceutical dosage forms containing drug substances with or without suitable diluents and prepared by either compression or molding methods. Hence, tablets can be broadly classified as compressed tablets and molded tablets. Compressed tablets can be further classified as directly compressible tablets, chewable tablets and tablet triturates.
Pharmaceutical manufacturers generate a variety of wastes during manufacturing, maintenance, and housekeeping operations which can be reduced or minimized through source reductIon and recycling. he typical waste streams are spent fermentation broths, process liquors, solvents, eq...
Immuno-analysis for pharmaceutical industry
International Nuclear Information System (INIS)
Immunological measurements involve an antigen-antibody reaction most often quantified by the addition of a tracer (tritium or iodine 125, enzymes or fluorescent and luminescent compounds). Principles and applications of these measurements in pharmaceutical industry are given
Agreements at the Pharmaceutical/University Interface.
Ku, Katherine
Specific agreements that arise at the interface between universities and pharmaceutical companies are described including sponsored research agreements, license agreements, clinical study agreements, material transfer agreements, and patient consent forms with respect to commercialization rights. (Author/MLW)
Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
Škrabanja, Vida; Zajc, Natalija; Gojak, Urška; Vrečer, Franc
The present invention relates to a pharmaceutical formulation comprising aliskiren or a pharmaceutically acceptable salt thereof as the active ingredient, wherein the pharmaceutical formulation is present in a solid dosage form suitable for oral administration based on a granulate obtained by a hot-melt and solvent-free granulation process, and to a process for manufacturing a pharmaceutical formulation.
Pharmaceutical care education in Kuwait: pharmacy students' perspectives
Katoue MG; Awad AI; Schwinghammer TL; Kombian SB
Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients' quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students' attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance...
Pharmaceutical drug detailing in primary care: extent and methods
DEFF Research Database (Denmark)
Schramm, Jesper
The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's.......The dimension and methods of pharmaceutical marketing towards 47 danish general practitioners is described. Conclusions: Pharmaceutical drug detailing possesses a huge potential to influence the prescription pattern of GP's....
THz spectroscopy: An emerging technology for pharmaceutical development and pharmaceutical Process Analytical Technology (PAT) applications
Wu, Huiquan; Khan, Mansoor
As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.
Wastewaters: occurrence of pharmaceutical substances and genotoxicity
Tauxe Würsch, Annick; Tarradellas, Joseph
The major pathways of human pharmaceuticals into the environment are from their use by individuals either at home or under medical supervision in hospitals, and to a lesser extent by the disposal of unwanted or out of date drugs. The administered pharmaceuticals will be excreted as the parent compound, metabolite or conjugate and will be transported to sewage treatment works. In sewage treatment, the compound may be degraded or partially degraded, adsorbed to sludge if lipophilic, be ...
Wastewaters: occurrence of pharmaceutical substances and genotoxicity
Tauxe Würsch, Annick
The major pathways of human pharmaceuticals into the environment are from their use by individuals either at home or under medical supervision in hospitals, and to a lesser extent by the disposal of unwanted or out of date drugs. The administered pharmaceuticals will be excreted as the parent compound, metabolite or conjugate and will be transported to sewage treatment works. In sewage treatment, the compound may be degraded or partially degraded, adsorbed to sludge if lipophilic, be d...
Evolution of Plant-Made Pharmaceuticals
Thomas, David R; Penney, Claire A.; Majumder, Amrita; Walmsley, Amanda M.
The science and policy of pharmaceuticals produced and/or delivered by plants has evolved over the past twenty-one years from a backyard remedy to regulated, purified products. After seemingly frozen at Phase I human clinical trials with six orally delivered plant-made vaccines not progressing past this stage over seven years, plant-made pharmaceuticals have made a breakthrough with several purified plant-based products advancing to Phase II trials and beyond. Though fraught with the usual di...
Raman spectroscopy in pharmaceutical product design
DEFF Research Database (Denmark)
Paudel, Amrit; Raijada, Dhara; Rantanen, Jukka
molecular-based drug discovery, design of innovative drug delivery systems and quality control of finished products. This review presents concise accounts of various conventional and emerging Raman instrumentations including associated hyphenated tools of pharmaceutical interest. Moreover, relevant...... application cases of Raman spectroscopy in early and late phase pharmaceutical development, process analysis and micro-structural analysis of drug delivery systems are introduced. Finally, potential areas of future advancement and application of Raman spectroscopic techniques are discussed....
Defining Relevant Product Markets for Pharmaceuticals
Mihaescu, Oana; Rudholm, Niklas
To identify the relevant product markets for Swedish pharmaceuticals, a spatial econometrics approach is employed. First, we calculate Moran's Is for different market definitions and then we use a spatial Durbin model to determine the effect of price changes on quantity sold off own and competing products. As expected, the results show that competition is strongest between close substitutes; however, the relevant product markets for Swedish pharmaceuticals extend beyond close substitutes down...
The men behind the eponymous pharmaceuticals companies
Khalid Al Aboud; Daifullah Al Aboud
There are different sources of names in medical field. Similarly, the names given to pharmaceuticals companies are derived from different things. Selecting a good name is not always easy. In fact, there are now professional companies to help finding proper names for medical organizations and medications [1]. These were of help in naming pharmaceutical companies. For instance; "Zeneca" was an invented name created by the branding consultancy Interbrand. Interbrand had been instructed to find a...
Paying for On-Patent Pharmaceuticals
Fuller, Richard L.; Goldfield, Norbert
In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets...
Methods for the comparative evaluation of pharmaceuticals
Busse, Reinhard; Velasco-Garrido, Marcial; Zentner, Annette
Political background: As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IGWiG) was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement. The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bun...
Evaluating Innovation and Moral Hazard in Pharmaceuticals
Paris Cleanthous
This paper formulates an empirical methodology that evaluates pharmaceutical innovation in the American antidepressant market by quantifying patient welfare benefits from innovation. While evaluating pharmaceutical innovation in antidepressants, I uncover and address the moral hazard issue that arises due to the existence of prescription drug insurance coverage. A combination of market-level data, drug and patient characteristics are used to estimate demand for all antidepressants between 198...
'Linkage' pharmaceutical evergreening in Canada and Australia
Faunce, Thomas A; Lexchin, Joel
'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong...
Kaur Harbir
Pharmaceutical oral solid dosage forms have been used widely for decades mainly due to their convenience of administration and their suitability for delivery for delivery of drugs for systemic effects. The most commonly used pharmaceutical solid dosage forms today include granules, pellets, tablets and capsules. The tablets and capsules can be made directly from powders or from granules pellets, or from film-coated multiple units. Tablets are now the most popular dosage form, accounting for s...
Ethics in the international marketing of pharmaceuticals
Torvund, Sondre Lislegard
The pharmaceutical industry offers valuable products that may positively affect the lives and well–being of people. The industry has been criticized for enormous profits, which some often link to unethical decisions. This paper will concern the international marketing of pharmaceutical products, and factors such as prices, patents, government and regulation, information asymmetry, as well as how cultural differences may lead to certain challenges. Corruption is a part of unethical acts, and i...
Pharmaceutical supply chain risks: a systematic review
Jaberidoost, Mona; Nikfar, Shekoufeh; Abdollahiasl, Akbar; Dinarvand, Rassoul
Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this stu...
Innovation strategies of Mexican pharmaceutical firms
José Luis Solleiro; Roberto E. López Martínez; Gabriela Sánchez; Yissel Inurrueta; Ana L. Sánchez; Antonia Terán; Jorge I. Castillo
Mexican pharmaceutical market is the most important in Latin America and a significant number of global firms have different business activities in this country: production, licensing of patents, alliances with Mexican firms, distribution facilities or partnerships, etc. In terms of innovation, global pharmaceutical industry has passed through structural changes mainly of technological and institutional nature. These changes have been influential along the whole value chain and have triggered...
Future Perspectives of Pharmaceutical Research and Development
Shein-Chung Chow; Fuyu Song
As more and more innovative drug products (e.g., chemical drug and biological drug products) are going off patent protection, the development of generics/biosimilars products have become the center of attention of many pharmaceutical companies. In addition, as new drug research and development has reached the bottle-neck, the pharmaceutical industry begin to focus on the search for new or alternative medicines such as traditional Chinese medicine that can treat critical and/or life-threatenin...
A Simple Model of Pharmaceutical Price Dynamics
Bhattacharya, Jayanta; Vogt, William B.
Branded pharmaceutical firms use price and promotional strategy to manage public knowledge about their drugs. We propose a dynamic theory of pharmaceutical pricing and conduct an exploratory empirical analysis inspired by the theory. Our theory predicts a pattern of increasing prices and decreasing promotional activities over a drug's life cycle. Prices are kept low and advertising levels high early in the life cycle in order to build public knowledge about the drug. As knowledge grows, price...
A Study on Summer Pharmaceutical Industrial Training
Saurbh; Aarti Garg; Rajat Choudhary
Practical exposure of industrial operation, set up and management is very crucial part in learning and to be skilled for competitive and global demand in pharmaceutical industry. To fulfill these objectives industrial training is mandatory for the award of B. Pharm. Degree. Being a student who wants to mark in industrial field, the best place to gain practical understanding of production is to do summer training in the production department of Pharmaceutical Industry which can be regarded as ...
Anticompetitive Marketing in a Pharmaceutical Switching Context
Domeij, Bengt
The article deals with the intersection between competition law rules on abuse of a dominant position and switching strategies employed by pharmaceutical originator companies. Switching is also known as ever-greening, product hopping or product life cycle strategies. It is one of the most topical issues in the patent-antitrust intersection today and consists in launching a slightly modified, second generation pharmaceutical, 1-2 years before the patent exclusivity expires for a first generati...
Radiation effects on pharmaceuticals and related materials
International Nuclear Information System (INIS)
Radiation sterilization is the method of choice for many medical supplies and devices. However, because of the ionizing nature of gamma radiation, one must consider the effect of such radiation on the physical and chemical properties and on the biological behaviour of pharmaceutical and related materials before the feasibility of radiation sterilization for such products is established. The results of such feasibility studies can lead to an appropriate decision on the suitability of radiation sterilization for a particular pharmaceutical. (author)
Consumer Loyalty in the Swedish Pharmaceuticals Market
Granlund, David; Rudholm, Niklas
This paper reports on a study of the prescribing physician's influence on consumers' choice between medically equivalent pharmaceuticals. The study was performed using a dataset of 666,000 observations in which consumers were asked whether they were prepared to pay the price difference in order to obtain the prescribed pharmaceutical instead of the cheapest available substitute. The main results support the hypothesis that prescribing physicians have an impact on consumers' choice between med...
Potential bias in ophthalmic pharmaceutical clinical trials
Paul Varner
Paul VarnerJohn J Pershing Veterans' Administration Medical Center, Poplar Bluff, Missouri, USAAbstract: To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data an...
Rejection of pharmaceuticals by forward osmosis membranes.
Jin, Xue; Shan, Junhong; Wang, Can; Wei, Jing; Tang, Chuyang Y
Rejection of four pharmaceutical compounds, carbamazepine, diclofenac, ibuprofen and naproxen, by forward osmosis (FO) membranes was investigated in this study. For the first time, the rejection efficiency of the pharmaceutical compounds was compared between commercial cellulose triacetate (CTA) based membranes and thin film composite (TFC) polyamide based membranes. The rejection behavior was related to membrane interfacial properties, physicochemical characteristics of the pharmaceutical molecules and feed solution pH. TFC polyamide membranes exhibited excellent overall performance, with high water flux, excellent pH stability and great rejection of all pharmaceuticals investigated (>94%). For commercial CTA based FO membranes, hydrophobic interaction between the compounds and membranes exhibited strong influence on their rejection under acidic conditions. The pharmaceuticals rejection was well correlated to their hydrophobicity (log D). Under alkaline conditions, both electrostatic repulsion and size exclusion contributed to the removal of deprotonated molecules. The pharmaceuticals rejection by CTA-HW membrane at pH 8 followed the order: diclofenac (99%)>carbamazepine (95%)>ibuprofen (93%) ≈ naproxen (93%). These results can be important for FO membrane synthesis, modification and their application in water purification. PMID:22640821
The importance of adjuvant formulation in the development of a TB vaccine
Baldwin, Susan L.; Bertholet, Sylvie; Reese, Valerie A.; Ching, Lance K; Reed, Steven G.; Coler, Rhea N.
An effective protein based vaccine for tuberculosis (TB) will require a safe and effective adjuvant. There are few adjuvants in approved human vaccines, including Alum and the oil-in-water (o/w) based emulsions MF59 (Novartis Vaccines and Diagnostics), AS03 and AS04 (GlaxoSmith Kline Biologics, GSK) AF03 (Sanofi), and liposomes (Crucell). When used with pure, defined proteins, both Alum and emulsion adjuvants are effective at inducing primarily humoral responses. One of the newest adjuvants i...
A new rabies vaccine with an experimental adjuvant for domestic animals
Süli Judit; Beníšek Z.; Ondrejková Ana; Ondrejka R.; Prokeš M.
The authors had developed a new experimental adjuvant based on squalene and its efficacy was tested on target domestic animals - cats and dogs by means of different rabies vaccines. In this experiment the authors compared the immune response on the rabies vaccine without adjuvant and with aluminium adjuvant or experimental squalene adjuvant, respectively. The level of rabies antibodies was determined by rapid fluorescence focus inhibition test on days 14, 3...
Directory of Open Access Journals (Sweden)
Юрий Владимирович Тарасов
Full Text Available The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which must be considered while developing policy of promotion of pharmaceutical products.The analysis is made of modern state of Russian pharmaceutical industry, its place in world pharmaceutical market. It is found that development of pharmaceutical market is directly influenced by the reform of pharmaceutical industry initiated by the Government of our country in 2008. Characteristic of current stage of market development is more strict conditions in marketing sphere and promotion of drugs. DOI: http://dx.doi.org/10.12731/2218-7405-2013-12-2
Adjuvants and delivery systems in veterinary vaccinology: current state and future developments
DEFF Research Database (Denmark)
Heegaard, Peter M. H.; Dedieu, Laurence; Johnson, Nicholas;
Modern adjuvants should induce strong and balanced immune responses, and it is often desirable to induce specific types of immunity. As an example, efficient Th1-immunity-inducing adjuvants are highly in demand. Such adjuvants promote good cell-mediated immunity against subunit vaccines that have...
Ecotoxicological assessment using six pharmaceuticals commonly found in wastewaters
Taipale, Paula; Ursin, Sisko
Pharmaceutical residues in wastewaters are relatively new concern in environment protection. The usage of pharmaceuticals has increased a lot and their impact on the environment is unknown. Low levels of pharmaceuticals have been detected in many countries in sewage treatment plant effluents, surface waters, seawaters, groundwater and some drinking waters. Pharmaceutically-active compounds until recently have not been studied however even small residues of pharmaceuticals can have an effect o...
Strengthen the Supervision over Pharmaceuticals via Modern Automatic Identification
Institute of Scientific and Technical Information of China (English)
Fake pharmaceuticals inflicts severely upon people(?)~-s health through its circulation in markets.To strengthen the supervision of the pharmaceutical market,China is improving and is perfecting its national coding system in the field of pharmaceuticals. Bar-code tag and IC tag are available to the coding system.This paper summarizes the significance of IC tag to the supervision of pharmaceuticals and gives us a strategically general prospect of pharmaceutical supervision.
Юрий Владимирович Тарасов
The articles addresses key notions and elements of marketing of pharmaceutical companies. Key stages and particularities of formation of pharmaceutical marketing are considered. It is proved that in general pharmaceutical market is developing under general marketing rules, however while developing strategy of promotion of pharmaceutical products specific features of the industry must be taken into consideration. The authors describes specific features of modern pharmaceutical market, which mu...
Taxanes in adjuvant and neoadjuvant therapy for breast cancer
S. V. Limareva
Taxanes (paclitaxel and docetaxel) are currently considered to be basic cytostatics in the treatment of all breast cancer (BC) stages. The results of conducted and ongoing clinical trials suggest that incorporation of taxanes into adjuvant and neoadjuvant chemotherapy regimens enhances the efficiency of treatment for operable BC and show it necessary to apply an individual approach depending on prognostic and predictive factors.
Controversies in the Adjuvant Treatment of Pancreatic Adenocarcinoma
Directory of Open Access Journals (Sweden)
Muhammad Wasif Saif
Full Text Available There is no universally accepted standard approach to treat patients with pancreatic cancer in the adjuvant setting. This controversy derives from several studies, each fraught with its own limitations. Standards of care also vary depending on which side of the Atlantic you are on: chemo-radiotherapy followed by chemotherapy is considered the optimal therapy in North America (GITSG, RTOG while chemotherapy alone is the current standard in Europe (ESPAC-1, CONKO. Whether gemcitabine is superior to 5-FU remains to be learnt from the ESPAC-3 study currently on-going in Europe. A number of important questions have yet to be fully addressed: • What is the absolute value of radiotherapy in this setting? • How should radiotherapy be delivered, if at all? • What should be the time to deliver of either or both therapeutic modalities in the adjuvant setting? • Are there any patients who can benefit from the combined modality? • What is the most appropriate chemotherapeutic agent(s to administer in the adjuvant setting? • Is there any role of integrating the novel/targeted agents, albeit the negative studies in the metastatic setting? • What are the new developments (such as vaccines, pancreas cancer stem cells, etc. in this area? The author summarizes the evolution of adjuvant therapy for resected pancreatic cancer and highlights the controversies that originate from several studies, each fraught with its own limitations.
Organic weed control with vinegar: Application volumes and adjuvants
Preliminary results have indicated that vinegar has potential as an organic herbicide, but further research is needed to increase our understanding of the relationship between acetic acid concentrations, application volumes, adjuvants, weed species, and weed maturity on effectiveness of vinegar to c...
Adjuvant chemotherapy compliance is not superior after thoracoscopic lobectomy
DEFF Research Database (Denmark)
Licht, Peter B; Schytte, Tine; Jakobsen, Erik
BACKGROUND: It is generally assumed that patient compliance with adjuvant chemotherapy is superior after video-assisted thoracoscopic surgery compared with open lobectomy for non-small cell lung cancer (NSCLC). The level of evidence for this assumption, however, is limited to single-institution, ......BACKGROUND: It is generally assumed that patient compliance with adjuvant chemotherapy is superior after video-assisted thoracoscopic surgery compared with open lobectomy for non-small cell lung cancer (NSCLC). The level of evidence for this assumption, however, is limited to single...... histopathology. A clinical oncologist, who was blinded to the surgical approach, reviewed all medical oncology charts for types of adjuvant chemotherapy, reasons for not initiating or stopping treatment, number of cycles delivered, and time interval from surgery to initial chemotherapy. RESULTS: During a 6-year...... adjuvant chemotherapy and 121 (38.7%) completed all four cycles. Ordinal logistic regression revealed that chemotherapy compliance (none, partial, and full chemotherapy) was significantly reduced by the patient's age (p<0.001) and comorbidity index (p=0.003) but increased with N2 status (p=0.02). No...
Evaluation of adjuvant effects of fucoidan for improving vaccine efficacy.
Kim, Su-Yeon; Joo, Hong-Gu
Fucoidan is a sulfated polysaccharide derived from brown seaweed, including Fucus vesiculosus. This compound is known to have immunostimulatory effects on various types of immune cells including macrophages and dendritic cells. A recent study described the application of fucoidan as a vaccine adjuvant. Vaccination is regarded as the most efficient prophylactic method for preventing harmful or epidemic diseases. To increase vaccine efficacy, effective adjuvants are needed. In the present study, we determined whether fucoidan can function as an adjuvant using vaccine antigens. Flow cytometric analysis revealed that fucoidan increases the expression of the activation markers major histocompatibility complex class II, cluster of differentiation (CD)25, and CD69 in spleen cells. In combination with Bordetella bronchiseptica antigen, fucoidan increased the viability and tumor necrosis factor-α production of spleen cells. Furthermore, fucoidan increased the in vivo production of antigen-specific antibodies in mice inoculated with Mycoplasma hyopneumoniae antigen. Overall, this study has provided valuable information about the use of fucoidan as a vaccine adjuvant. PMID:25549218
Liposomal preparations of muramyl glycopeptides as immunomodulators and adjuvants
Czech Academy of Sciences Publication Activity Database
Turánek, J.; Ledvina, Miroslav; Kašná, A.; Vacek, A.; Hříbalová, V.; Krejčí, J.; Miller, A. D.
Roč. 24, S2 (2006), S90-S91. ISSN 0264-410X R&D Projects: GA MZe(CZ) QF3115 Institutional research plan: CEZ:AV0Z40550506 Keywords : liposoma * adjuvant * muramyl glycopeptides Subject RIV: CC - Organic Chemistry Impact factor: 3.159, year: 2006
Tailorable Trimethyl chitosans as adjuvant for intranasal immunization
Verheul, R.J.
Tailorable Trimethyl Chitosans as Adjuvant for Intranasal Immunization Active vaccination has proven to be the most (cost) effective tool in the fight against infectious diseases. Nowadays, most vaccines are administered via parenteral injection. However, the risk of contaminated needles and need fo
Water and stability of pharmaceutical solids
Shalaev, Evgenyi
Solid pharmaceuticals are multi-component systems consisting of an active pharmaceutical ingredient (API) and inactive ingredients (excipients). Excipients may include inorganic salts (e.g., NaCl), carbohydrates (e.g., lactose), and polymers, to name a few, whereas APIs range from relatively simple molecules (e.g., aspirin) to proteins and olygonucleotides. Pharmaceutical solids could exist either as single-phase or heterophase systems. They also may have different extent of order, such as highly ordered crystalline phases, amorphous solids that are thermodynamically unstable but might be kinetically stable under the time frame of observation, and crystalline mesophases including liquid crystals. With all this diversity, there are common features for such systems, and two of them will be discussed in the presentation. (i) Requirements for chemical stability of pharmaceuticals are very strict. A very limited (e.g., less than 0.1%) extent of conversion is allowed in these materials over the shelf life, i.e., during several years of storage at ambient and (sometimes) not fully controlled (e.g., a medicine cabinet in one's bathroom) conditions. (ii) All pharmaceutical solids contain some water, although its amount and physical state are highly variable and may change during manufacturing and shelf life. There are many challenging questions and issues associated with the ``Water and stability of pharmaceutical solids'' subject; some of them will be considered in the presentation: (i) What are the features of chemical reactivity of crystalline vs disordered systems? (ii) What is the role of water in solid state chemical reactivity of amorphous solids, e.g., water as plasticizer vs reactant vs reaction media? (iii) How homogeneous are pharmaceutical amorphous solid solutions, e.g., carbohydrate-water systems? (iv) What is the optimal water content? With water being the most common destabilizing factor, is ``the drier - the better'' always the case?
An Investment Opportunity China's Pharmaceutical Industry: TIANJIN JINHUI PHARMACEUTICAL CO, LTD
Institute of Scientific and Technical Information of China (English)
Xianping; Liu
@@ People say, pharmaceutical is an eternal industry "facing the Sun" in the world market. In 1970, the total revenue pharmaceutical industry was only ($)2.17 Billion, which was raised greatly to ($)41.10 Billion in 2002 and increased further by 7% annually, reaching ($)500 Billion in 2005.
Role of Adjuvant Chemoradiotherapy for Ampulla of Vater Cancer
International Nuclear Information System (INIS)
Purpose: To evaluate the role of adjuvant chemoradiotherapy for ampulla of Vater cancer. Methods and Materials: Between January 1991 and December 2002, 118 patients with ampulla of Vater cancer underwent en bloc resection. Forty-one patients received adjuvant chemoradiotherapy [RT(+) group], and 77 did not [RT(-) group]. Postoperative radiotherapy was delivered to the tumor bed and regional lymph nodes, for a total dose of up to 40 Gy delivered in 2-Gy fractions, with a planned 2-week rest period halfway through the treatment period. Intravenous 5-fluorouracil (500 mg/m2/day) was given on Days 1 to 3 of each split course. The median follow-up was 65 months. Results: The 5-year overall survival rate in the RT(-) and RT(+) groups was 66.9% and 52.8%, respectively (p = 0.2225). The 5-year locoregional relapse-free survival rate in the RT(-) and RT(+) groups was 79.9% and 80.2%, respectively (p = 0.9582). When age, type of operation, T stage, N stage, histologic differentiation, and the use of adjuvant chemoradiotherapy were incorporated into the Cox proportional hazard model, there was an improvement in the locoregional relapse-free survival rate (p = 0.0050) and a trend toward a longer overall survival (p = 0.0762) associated with the use of adjuvant chemoradiotherapy. Improved overall survival (p = 0.0235) and locoregional relapse-free survival (p = 0.0095) were also evident in patients with nodal metastasis. In contrast, enhanced locoregional control (p = 0.0319) did not result in longer survival in patients with locally advanced disease (p = 0.4544). Conclusions: Adjuvant chemoradiotherapy may enhance locoregional control and overall survival in patients with ampulla of Vater cancer after curative resection, especially in those with nodal involvement.
Adjuvant and salvage irradiation following radical prostatectomy for prostate cancer
International Nuclear Information System (INIS)
Purpose: We performed a retrospective analysis to assess the durability of benefit derived from irradiation after prostatectomy for pT3N0 disease, and the possibility of cure. Methods and Materials: We studied 88 patients who were irradiated after prostatectomy and had available prostate specific antigen (PSA) data, no known nodal or metastatic disease, no hormonal treatment, and follow-up of at least 12 months from surgery. Forty patients received adjuvant therapy for a high risk of local failure with undetectable PSA. Forty-eight patients received salvage therapy for elevated PSA levels. Mean follow up was 44 months from date of surgery and 31 months from irradiation. Biochemical failure was strictly defined as a confirmed rise in PSA of > 10%, or as the ability to detect a previously undetectable PSA value. Results: After salvage irradiation, 69% of patients attained an undetectable PSA. Eighty-eight percent of adjuvant patients were biochemically and clinically free of disease (bNED) at 3 years from prostatectomy. Sixty-eight percent of those receiving salvage irradiation were bNED 3 years after surgery. On univariate analysis, treatment group (adjuvant or salvage), pre-operative PSA, and the status of seminal vesicles were significant prognostic factors. The extent of PSA elevation in the salvage group was also significant. We did not demonstrate a significant difference between those salvage patients referred for persistently elevated PSA as compared to those with a late rise in PSA. On multivariate analysis, the only significant predictor of outcome was treatment group, with adjuvant irradiation having better outcome than salvage. Conclusion: More than two-thirds of this group of patients remain biochemically disease free at 3 years following irradiation, attesting to a number of potential cures. For patients with stage pT3N0 prostate cancer following radical prostatectomy, our data support the use of either routine postoperative adjuvant irradiation or
Lubricants in Pharmaceutical Solid Dosage Forms
Directory of Open Access Journals (Sweden)
Jinjiang Li
Full Text Available Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. Then, the application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of its hydration state (anhydrate, monohydrate, dihydrate, and trihydrate and its powder characteristics on lubrication efficiency, as well as product and process performance is summarized. In addition, the impact of lubrication on the dynamics of compaction/compression processes and on the mechanical properties of compacts/tablets is presented. Furthermore, the online monitoring of magnesium stearate in a blending process is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical ingredient (API with magnesium stearate and its reactive impurities is reviewed with examples from the literature illustrating the various reaction mechanisms involved.
Selected aspects of europeization of pharmaceutical law.
Zimmermann, Agnieszka; Wengler, Lubomira; Pawłowski, Leszek
As one of its aspects, the process of European integration has an influence on the legal orders of the Member States, which is often referred to in the literature as the europeization of law. Upon Poland's accession to the structures of the European Union, there have also been radical changes to the Polish legal system. According to the concept of the sources of law in the Polish Constitution and to the judicial decisions of the European Court of Justice, Community law now takes priority over national law, even over acts of parliament. Pharmaceutical law represents one of the areas where the harmonization process has been taking place. It shapes the principles and the manner according to which medicinal products are approved for marketing, the conditions of clinical trials, as well as the conditions of drug manufacture and advertisement. It also determines the rules of trading in medicinal products, the running of pharmaceutical wholesalers and pharmacies, as well as the duties and rights of the Pharmaceutical Inspectorate. This paper provides a summary of research on the impact of Community law on Polish pharmaceutical law, i.e. on the europeization process, and on the consequences of this process for the Polish pharmaceutical market and for research and development. PMID:20369799
Evaluation of several adjuvants in avian influenza vaccine to chickens and ducks
Directory of Open Access Journals (Sweden)
Li Hong T
Full Text Available Abstract The effects of three different adjuvants, mineral oil, Montanide™ ISA 70M VG, and Montanide™ ISA 206 VG, were evaluated on reverse genetics H5N3 avian influenza virus cell cultured vaccine. The immune results of SPF chickens after challenging with highly pathogenic avian influenza (HPAI virus demonstrated that mineral oil adjuvant group and 70M adjuvant group provided 100% protection efficiency, but 206 adjuvant group provided only 40%. Statistical analysis indicated that the protection effects of mineral oil adjuvant group and the 70M adjuvant showed no significant difference to each other, but with significant difference to 206 adjuvant group. All three groups could induce high titres of antibody after immunizing SPF ducks, but there was no significant difference among them. The immunization effect of 70M adjuvant group on SPF chickens were the best and showed significant difference compared with optimized 70Mi Montanide™ eight series adjuvants groups. These results suggest that 70M adjuvant could be a novel adjuvant for preparing avian influenza vaccine.
Effect of different adjuvant formulations on the immunogenicity and protective effect of a live Mycoplasma hyopneumoniae vaccine after intramuscular inoculation.
Xiong, Qiyan; Wei, Yanna; Xie, Haidong; Feng, Zhixin; Gan, Yuan; Wang, Chunlai; Liu, Maojun; Bai, Fangfang; Xie, Fang; Shao, Guoqing
Mycoplasma hyopneumoniae (M. hyopneumoniae) vaccine strain 168 is an intrapulmonically injected attenuated live vaccine that is available in the Chinese market. The aim of this study was to develop suitable adjuvants for this live vaccine to provide effective protection after intramuscular inoculation. Several adjuvant components were screened to assess their toxicity for the live vaccine, and various adjuvant formulations were then designed and prepared. Vaccines supplemented with these adjuvants were used to immunize mice intramuscularly to assess the capacity of the adjuvants to induce a specific immune response. The screened formulations were then evaluated in pigs. Seven of the eight adjuvant components did not affect the viability of the live vaccine, and seven different adjuvant formulations were then designed. In mice, the ISCOM-matrix adjuvant and the levamisole-chitosan mixture adjuvant significantly enhanced serum IgG responses against M. hyopneumoniae, while lymphocyte proliferation was enhanced by the ISCOM-matrix adjuvant, the carbomer-astragalus polysaccharide mixture adjuvant and an oil-in-water emulsion adjuvant. These four adjuvants were evaluated in pigs. Enhancement of specific lymphocyte proliferation responses was observed in the groups vaccinated with the ISCOM-matrix adjuvant and the carbomer-astragalus polysaccharide mixture adjuvant. Significant enhancement of serum IgG antibody production was observed before challenge in pigs vaccinated with the carbomer-astragalus polysaccharide mixture adjuvant and the levamisole-chitosan mixture adjuvant, while after challenge, all of the animals that received vaccines containing adjuvants had higher antibody concentrations against M. hyopneumoniae than unvaccinated animals. Animals inoculated with a vaccine containing the ISCOM-matrix adjuvant (median score 3.57) or the carbomer-astragalus polysaccharide mixture adjuvant (median score 5.28) had reduced lesion scores compared to unvaccinated animals
Pharmaceutical policy and the pharmacy profession
DEFF Research Database (Denmark)
Traulsen, Janine Marie; Almarsdóttir, Anna Birna
In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy...... and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy...... in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession's position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental...
Pharmaceutical policy and the lay public
DEFF Research Database (Denmark)
Traulsen, Janine Marie; Almarsdóttir, Anna Birna
Almost every national and supranational health policy document accords high importance to the need to listen to and 'empower' patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient...... organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry....... The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay...
The economics of pharmaceutical supply in Tanzania.
Yudkin, J S
This paper analyzes the patterns of purchasing, distribution, and utilization of pharmaceuticals currently found in Tanzania, an underdeveloped country in Africa. Like other nations in the Third World, Tanzania offers the prospect of a rapidly expanding market for the multinational pharmaceutical industry. However, this market has been to a large extent developed by the intense promotional activities of the drug companies themselves. In addition to normal marketing methods, these companies indulge in techniques which would be neither acceptable nor legal in developed countries. As a result, expensive proprietary drugs are overpurchased and overprescribed, mainly in the large urban hospitals, with consequent deprivation of other health care facilities, particularly those for the rural peasants who form the majority of the population. The activities of the multinational pharmaceutical companies in the Third World are therefore an important component in the continuing underdevelopment of health in these nations. PMID:7419314
The men behind the eponymous pharmaceuticals companies
Directory of Open Access Journals (Sweden)
Khalid Al Aboud
Full Text Available There are different sources of names in medical field. Similarly, the names given to pharmaceuticals companies are derived from different things. Selecting a good name is not always easy. In fact, there are now professional companies to help finding proper names for medical organizations and medications [1]. These were of help in naming pharmaceutical companies. For instance; "Zeneca" was an invented name created by the branding consultancy Interbrand. Interbrand had been instructed to find a name which began with a letter from either the top or bottom of the alphabet and was phonetically memorable, of no more than three syllables and did not have an offensive meaning in any language. However, using the names of the founders (eponyms is a common type of naming pharmaceuticals companies.
Pharmaceutical strategy and innovation: an academics perspective.
Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K
The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences. PMID:17458911
Thermal properties of food and pharmaceutical powders
Abiad, Mohamad Ghassan
Foods and pharmaceuticals are complex systems usually exposed to various environmental conditions during processing and thus storage, stability, functionality and quality are key attributes that deserve careful attention. The quality and stability of foods and pharmaceuticals are mainly affected by environmental conditions such as temperature, humidity, time, and processing conditions (e.g. shear, pressure) under which they may undergo physical and/or chemical transformations. Glass transition as well as other thermal properties is a key to understand how external conditions affect physical changes of such materials. Development of new materials and understanding the physico-chemical behavior of existing ones require a scientific foundation that translates into safe and high quality foods, improved quality of pharmaceuticals and nutraceuticals with lower risk to patients and functional efficacy of polymers used in food and medicinal products. This research provides an overview of the glass transition and other thermal properties and introduces novel methods developed to characterize such properties.
On radiation treatment of pharmaceutical products
International Nuclear Information System (INIS)
The progress made in the GDR over the past decade in the field of radiosterilization of products of the medical industry, has naturally raised the question of radiosterilization in pharmaceutics. However, because of the diversity and complicated nature of pharmaceutical products and, consequently, longer periods of time required for preliminary studies, their radiosterilization has not yet been applied on an industrial scale, in contrast to the situation in the medical industry. The studies carried out so far have been mainly concerned with ascertaining the permissibility and effectiveness of radiosterilization of individual products under particular conditions rather than with laying down a broad theoretical basis. Accordingly, the present paper does not describe results of special studies but presents a brief rewiev of some studies on radiation treatment of pharmaceutical products undertaken in the GDR. (author)
Terahertz study on porosity and mass fraction of active pharmaceutical ingredient of pharmaceutical tablets.
Bawuah, Prince; Tan, Nicholas; Tweneboah, Samuel Nana A; Ervasti, Tuomas; Axel Zeitler, J; Ketolainen, Jarkko; Peiponen, Kai-Erik
In this study, terahertz time-domain spectroscopic (THz-TDS) technique has been used to ascertain the change in the optical properties, as a function of changing porosity and mass fraction of active pharmaceutical ingredient (API), of training sets of pharmaceutical tablets. Four training sets of pharmaceutical tablets were compressed with microcrystalline cellulose (MCC) excipient and indomethacin API by varying either the porosity, height, and API mass fraction or all three tablet parameters. It was observed, as far as we know, for the first time, that the THz time-domain and frequency-domain effective refractive index, as well as, the frequency-domain effective absorption coefficient both show linear correlations with the porosity and API mass fraction for training sets of real pharmaceutical tablets. We suggest that, the observed linear correlations can be useful in basic research and quality inspection of pharmaceutical tablets. Additionally, we propose a novel optical strain parameter, based on THz measurement, which yields information on the conventional strain parameter of a tablet as well as on the change of fill fraction of solid material during compression of porous pharmaceutical tablets. We suggest that the THz measurement and proposed method of data analysis, in addition to providing an efficient tool for basic research of porous media, can serve as one of the novel quality by design (QbD) implementation techniques to predict critical quality attributes (CQA) such as porosity, API mass fraction and strain of flat-faced pharmaceutical tablets before production. PMID:27288937
The uncertainty budget in pharmaceutical industry
DEFF Research Database (Denmark)
Heydorn, Kaj
Measurements in a pharmaceutical industry are usually carried out to ascertain the quality of a product or the control of a process; in either case the measurement result serves to demonstrate that the value of the measurand is within specified limits. No method is without bias, and no result is...... uncertainty, exactly as described in GUM [2]. Pharmaceutical industry has therefore over the last 5 years shown increasing interest in accreditation according to ISO 17025 [3], and today uncertainty budgets are being developed for all so-called critical measurements. The uncertainty of results obtained by...
Diagnostic and therapeutic radio pharmaceutical capsules
International Nuclear Information System (INIS)
An improved pharmaceutical radioactive capsule consisting of a non-toxic, water soluble material adapted to being ingested and rapidly disintegrating on contact with fluids of the gastro-intestinal tract is described. Each capsule is provided with filler material supporting a pharmaceutically useful radioactive compound absorbable from the gastro-intestinal tract. The capsule is preferably of gelatin, methyl cellulose or polyvinyl alcohol and the filler is a polyethylene glycol. The radioactive compound may be iodine e.g. sodium radioiodide I-131 or 123. The capsule may also contain a reducing agent e.g. sodium thiosulphate, sulphite, or bisulphite. (author)
Professiology and Education of Pharmaceutical Industry Specialists
Directory of Open Access Journals (Sweden)
Starostenkova T.A.
Full Text Available The article investigates the pharmaceutical industry professions. In this field, new professions has emerged, and the functions of the traditional ones has changed. Changed are also the content of activities and the level of responsibility of specialists. All this requires improved employees training. Scientific basis for the professional standards, educational standards and educational programs are different job analysis. The author substantiates the need for job description research for different specializations in pharmacy, as well as the feasibility of combining efforts of professiologists and representatives of educational institutions to address the actual problem of training for pharmaceutical industry professionals.
Globalization of pharmaceutical industry brings opportunities
Institute of Scientific and Technical Information of China (English)
Pharmaceutical industry has been experiencing a difficult time over the last few years. Despite record high investment on R&D,the overall productivity reached a historic low level. The growth rate of pharmaceutical industry based on total sales hit a low of 9% in 2002, a sharp decline from double-digit growth rates in late 1990s. A shortage of good new drugs in the pipeline, the imminent patent expirations on blockbuster drugs, and fierce competitions from generic drugs are major challenges.
Radiostability of pharmaceuticals under different irradiation conditions
International Nuclear Information System (INIS)
In this paper, the products studied are cefazolin, glucagon and dobutamine HCl. The radioresistance of pharmaceuticals may depend on the conditions of irradiation. The best is to irradiate the drugs in solid state and the chemical transformations can be reduced also by lowering the temperature of the liquid. In solid state, the dose rate has no influence on the decomposition for the selected molecules and it should be noted that drug excipients selected for bioavailability reasons are not always radioprotectors. These results are important from a technical point of view in pharmaceutical industry
O. V. Sokolova; L. I. Lavrentyeva; K. S. Alekseyeva
Pharmacy organizations are an element of regional pharmaceutical market infrastructure formation. They have different character and activity type, organizational and legal forms, types of properties. The revelation of the features of retail pharmaceutical market of Yaroslavl oblast was the purpose of the study. The analysis of the data of regional department of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation n Yaroslavl oblast in the beginning of 20...
CpG DNA as a vaccine adjuvant.
Bode, Christian; Zhao, Gan; Steinhagen, Folkert; Kinjo, Takeshi; Klinman, Dennis M
Synthetic oligodeoxynucleotides (ODNs) containing unmethylated CpG motifs trigger cells that express Toll-like receptor 9 (including human plasmacytoid dendritic cells and B cells) to mount an innate immune response characterized by the production of Th1 and proinflammatory cytokines. When used as vaccine adjuvants, CpG ODNs improve the function of professional antigen-presenting cells and boost the generation of humoral and cellular vaccine-specific immune responses. These effects are optimized by maintaining ODNs and vaccine in close proximity. The adjuvant properties of CpG ODNs are observed when administered either systemically or mucosally, and persist in immunocompromised hosts. Preclinical studies indicate that CpG ODNs improve the activity of vaccines targeting infectious diseases and cancer. Clinical trials demonstrate that CpG ODNs have a good safety profile and increase the immunogenicity of coadministered vaccines. PMID:21506647
CpG Oligonucleotides as Cancer Vaccine Adjuvants
Directory of Open Access Journals (Sweden)
Hidekazu Shirota
Full Text Available Adjuvants improve host responsiveness to co-delivered vaccines through a variety of mechanisms. Agents that trigger cells expressing Toll-like receptors (TLR activate an innate immune response that enhances the induction of vaccine-specific immunity. When administered in combination with vaccines designed to prevent or slow tumor growth, TLR agonists have significantly improved the generation of cytotoxic T lymphocytes. Unfortunately, vaccines containing TLR agonists have rarely been able to eliminate large established tumors when administered systemically. To improve efficacy, attention has focused on delivering TLR agonists intra-tumorally with the intent of altering the tumor microenvironment. Agonists targeting TLRs 7/8 or 9 can reduce the frequency of Tregs while causing immunosuppressive MDSC in the tumor bed to differentiate into tumoricidal macrophages thereby enhancing tumor elimination. This work reviews pre-clinical and clinical studies concerning the utility of TLR 7/8/9 agonists as adjuvants for tumor vaccines.
Adjuvant postoperative radiotherapy for gastric carcinoma with poor prognostic signs
International Nuclear Information System (INIS)
Fifty-seven patients with poor prognostic factors following resection with curative intent for gastric adenocarcinoma T3 or T4, positive lymph nodes, positive resection line) received adjuvant radiotherapy. A dose of 30.0-50.0 Gy was given in 10-25 fraction in one course or with a split of 2 weeks after 15 fractions. This was combined with 5-fluorouracil (5-FU) (375 mg/m2) given i.v. as a bolus during the first 4 days of radiation (n = 49). The 5-year survival was 26%; this rate is higher than the figures mentioned in the literature after surgery alone. The only way to prove the role of adjuvant radiotherapy for gastric carcinoma is a prospective randomized trial. (author). 11 refs.; 2 figs.; 6 tabs
Jorge Álvaro González Ross; Alfredo Javier Moheno Gallardo; Eulalio Elizalde Martínez; José Manuel Pérez Atanasio; Ruth Martínez Martínez
ABSTRACT Objective: To identify whether the use of prophylactic intrasite vancomycin as an adjuvant is a protective factor against deep tissue infection of the surgical site. Methods: Retrospective, descriptive, case-control study evaluating 210 patients, of whom 70 received intrasite vancomycin (case group) and 140 were controls. It was made a follow up for at least one year, reviewing the physical and electronic records. Data were tabulated in spreadsheets (Excel) including all variable...
Tocotrienols are good adjuvants for developing cancer vaccines
International Nuclear Information System (INIS)
Dendritic cells (DCs) have the potential for cancer immunotherapy due to their ability to process and present antigens to T-cells and also in stimulating immune responses. However, DC-based vaccines have only exhibited minimal effectiveness against established tumours in mice and humans. The use of appropriate adjuvant enhances the efficacy of DC based cancer vaccines in treating tumours. In this study we have used tocotrienol-rich fraction (TRF), a non-toxic natural compound, as an adjuvant to enhance the effectiveness of DC vaccines in treating mouse mammary cancers. In the mouse model, six-week-old female BALB/c mice were injected subcutaneously with DC and supplemented with oral TRF daily (DC+TRF) and DC pulsed with tumour lysate from 4T1 cells (DC+TL). Experimental mice were also injected with DC pulsed with tumour lysate and supplemented daily with oral TRF (DC+TL+TRF) while two groups of animal which were supplemented daily with carrier oil (control) and with TRF (TRF). After three times vaccination, mice were inoculated with 4T1 cells in the mammary breast pad to induce tumour. Our study showed that TRF in combination with DC pulsed with tumour lysate (DC+TL+TRF) injected subcutaneously significantly inhibited the growth of 4T1 mammary tumour cells as compared to control group. Analysis of cytokines production from murine splenocytes showed significant increased productions of IFN-γ and IL-12 in experimental mice (DC+TL+TRF) compared to control, mice injected with DC without TRF, mice injected with DC pulsed with tumour lysate and mice supplemented with TRF alone. Higher numbers of cytotoxic T cells (CD8) and natural killer cells (NK) were observed in the peripheral blood of TRF adjuvanted DC pulsed tumour lysate mice. Our study show that TRF has the potential to be an adjuvant to augment DC based immunotherapy
Carbonation of adjuvant concretes based on local Algerian resources
Dakhmouche Chabil, Fatima-Zohra,
The carbonation is a pathology which affects cement-based materials such as concretes and mortars.The carbonated skin of material becomes brittle and losses the protection of inner steels againstcorrosion. The corrosion products generate a degradation of the concrete which may lead to thecollapse of the structure.Six types of adjuvant concretes and two cement pastes have been designed by a rheological study inorder to study the effect of accelerated and natural carbonation on the sustainabili...
Tocotrienols are good adjuvants for developing cancer vaccines
Directory of Open Access Journals (Sweden)
Radhakrishnan Ammu
Full Text Available Abstract Background Dendritic cells (DCs have the potential for cancer immunotherapy due to their ability to process and present antigens to T-cells and also in stimulating immune responses. However, DC-based vaccines have only exhibited minimal effectiveness against established tumours in mice and humans. The use of appropriate adjuvant enhances the efficacy of DC based cancer vaccines in treating tumours. Methods In this study we have used tocotrienol-rich fraction (TRF, a non-toxic natural compound, as an adjuvant to enhance the effectiveness of DC vaccines in treating mouse mammary cancers. In the mouse model, six-week-old female BALB/c mice were injected subcutaneously with DC and supplemented with oral TRF daily (DC+TRF and DC pulsed with tumour lysate from 4T1 cells (DC+TL. Experimental mice were also injected with DC pulsed with tumour lysate and supplemented daily with oral TRF (DC+TL+TRF while two groups of animal which were supplemented daily with carrier oil (control and with TRF (TRF. After three times vaccination, mice were inoculated with 4T1 cells in the mammary breast pad to induce tumour. Results Our study showed that TRF in combination with DC pulsed with tumour lysate (DC+TL+TRF injected subcutaneously significantly inhibited the growth of 4T1 mammary tumour cells as compared to control group. Analysis of cytokines production from murine splenocytes showed significant increased productions of IFN-γ and IL-12 in experimental mice (DC+TL+TRF compared to control, mice injected with DC without TRF, mice injected with DC pulsed with tumour lysate and mice supplemented with TRF alone. Higher numbers of cytotoxic T cells (CD8 and natural killer cells (NK were observed in the peripheral blood of TRF adjuvanted DC pulsed tumour lysate mice. Conclusion Our study show that TRF has the potential to be an adjuvant to augment DC based immunotherapy.
Recombinant human migration inhibitory factor has adjuvant activity.
Weiser, W Y; Pozzi, L M; Titus, R G; David, J R
Recombinant human migration inhibitory factor (MIF), isolated through functional expression cloning in COS-1 cells, up-regulates expression of genes encoding HLA-DR and interleukin 1 beta (IL-1 beta) and elaboration of IL-1 beta by human monocyte-derived macrophages. Administration of soluble bovine serum albumin or human immunodeficiency virus 120-kDa glycoprotein (HIV gp120) to mice in the presence of recombinant MIF together with incomplete Freund's adjuvant induced a strong T-cell prolife...
Adjuvant immunotherapy with BCG in squamous cell bronchial carcinoma.
Jansen, H.M.; The, T H; Orie, N G
Fifty-four patients with evidence of locally advanced primary squamous cell bronchial carcinoma (SCC), and three patients with adenocarcinoma (AC) had lung resection to remove all the visible tumour. After operation an randomly chosen group of 20 SCC patients received adjuvant BCG immunostimulation by scarifications (BCG-A). An additional group of 14 SCC patients, and three AC patients received initially intrapleural BCG treatment and subsequently scarifications (BCG-B). A control group of 20...
Adjuvant Radio-chemotherapy for extrahepatic biliary tract cancers
Mentha Gilles; Roth Arnaud D; Bonet Beltrán Marta; Allal Abdelkarim S
Abstract Background Extrahepatic biliary duct cancers (EBDC) are uncommon malignancies characterized by a poor prognosis with high rate of loco-regional recurrence. The purpose of the present study is to assess the feasibility and the potential impact of adjuvant radiotherapy (RT) in a series of patients treated in one institution. Methods Twenty three patients with non-metastatic bile duct cancer treated surgically with curative intent (4 gallbladder, 7 ampullary and 12 cholangiocarcinoma) r...
Early adjuvant radiotherapy in the treatment of atypical meningioma.
Jenkinson, Michael D; Waqar, Mueez; Farah, Jibril Osman; Farrell, Michael; Barbagallo, Giuseppe M V; McManus, Robin; Looby, Seamus; Hussey, Deirdre; Fitzpatrick, David; Certo, Francesco; Javadpour, Mohsen
Atypical meningiomas have a greater propensity to recur than benign meningiomas and the benefits of early adjuvant radiotherapy are unclear. Existing studies report conflicting results. This retrospective cohort study evaluated the role of early adjuvant radiotherapy following surgical resection of atypical meningioma. A triple center case-note review of adults with newly-diagnosed atypical meningiomas between 2001 and 2010 was performed. Pathology diagnosis was made according to the World Health Organization classification in use at the time of surgery. Patients with multiple meningiomas, neurofibromatosis type 2 and radiation-induced meningiomas were excluded. Extent of resection was defined as gross total resection (GTR; Simpson Grade I-III) or subtotal resection (STR; Simpson Grade IV-V). Survival analysis was performed using the Kaplan-Meier method. One hundred thirty-three patients were identified with a median age of 62years (range 22-86years) and median follow-up of 57.4months (range 0.1-152.2months). Tumors were mostly located in the convexity (50.4%) or falcine/parasagittal regions (27.1%). GTR (achieved in 85%) was associated with longer progression free survival (PFS) (5year PFS 81.2% versus 40.08%, log-rank=11.117, p=0.001) but not overall survival (OS) (5year OS 76.6% versus 39.7%, log-rank=3.652, p=0.056). Following GTR, early adjuvant radiotherapy was administered to 28.3% of patients and did not influence OS (5year OS 77.0% versus 75.7%, log-rank=0.075, p=0.784) or PFS (5year PFS 82.0% versus 79.3%, log-rank=0.059, p=0.808). Although extent of resection emerged as an important prognostic variable, early adjuvant radiotherapy did not influence outcome following GTR of atypical meningiomas. Prospective randomized controlled trials are planned. PMID:26775147
Neo-adjuvant chemotherapy in advanced hypopharyngeal carcinoma
Joshi, P.; V Patil; Joshi, A; V Norohna; Chaturvedi, P.; Chaukar, D.; P Pai; D Nair; Juvekar, S; Agarwal, J. P.; A K D′cruz; Prabhash, K
Objective: The aim of this retrospective study was to find out the role of neo-adjuvant chemotherapy (NACT) in changing the management and outcome of advanced hypopharyngeal cancer patients. Materials and Methods: This is a retrospective analysis of 59 treatment naïve, advanced hypopharyngeal cancer patients presenting to our tertiary care center from April 2010 to October 2011. NACT was given as two (platinum with taxane) or three drug with (platinum, taxane with 5-flurouracil [5 FU]) as 3 w...
Targeted vaccine adjuvants based on modified cholera toxin.
Lycke, Nils
The present review describes immunomodulation with targeted adjuvants that will allow for the development of efficacious mucosal vaccines. We have studied cholera toxin (CT) and derivatives thereof, to rationally design vaccine adjuvant vectors that are both highly efficacious as well as safe and non-toxic. Two strategies were exploited; the first using CT or the enzymatically inactive receptor-binding B-subunit of CT (CTB) and the second, using CTA1 or an enzymatically inactive mutant CTA1R7K., that was linked, in a fusion protein, to the B-cell targeting moiety, DD, from Staphylococcus areus proteinA. Our studies provide compelling evidence that delivery of Ag in the absence of ADP-ribosylation can promote tolerance, whereas, ADP-ribosyltransferase-active conjugates, prevent tolerance but induce IgA immunity. Our analysis revealed unique subsets of mucosal and systemic DC that appeared to be responsible for the ADP-ribosyltransferase sensitive dichotomy between tolerance and IgA immunity. Whether targeting of B cells suffice for tolerance-induction or requires participation of DCs, is at present an unresolved issue. Nevertheless, enzymatic modulation differentiates and matures the DC to promote CD4 T cell help for IgA B cell development. Ag-presentation in the absence of enzyme, as seen with CTA1R7K-DD, expands specific T cells to a similar extent as enzymatically active CTA1-DD, but fails to recruit help for germinal center expansion of activated B cells. We have given special attention to the genes that adjuvants turn on using Affymetrix technology. In particular, modulation of the expression of co-stimulatory molecules on the targeted APC; CD80, CD86, CD83 and B7RP-1, play important roles for the effect of the ADP-ribosylating CTA1-based adjuvants for the development of tolerance or active IgA immunity. PMID:16178769
Effect of polyphenols on neutrophil activation in adjuvant arthritis
Czech Academy of Sciences Publication Activity Database
Nosáľ, R.; Bauerová, K.; Drábiková, K.; Harmatha, Juraj; Jančinová, V.; Perečko, T.; Poništ, S.
Bratislava : Institute of Experimental Pharmacology & Toxicology SAS, 2012 - (Bauer, V.; Mach, M.; Navarová, J.; Sotníková, R.), s. 84-92 ISBN 978-80-971042-0-7. [Drugs: Their Action in Pharmacology and Toxicology. Bratislava (SK), 31.05.2012] Institutional research plan: CEZ:AV0Z40550506 Keywords : adjuvant arthritis * stilbenes * curcumin Subject RIV: CC - Organic Chemistry
Post-prostatectomy radiotherapy in the adjuvant or relapse setting
International Nuclear Information System (INIS)
Although screening with prostate specific antigen (PSA) has led to a greater proportion of patients being diagnosed with clinically organ-confined prostate cancer, pathologic extension outside of the prostate (pathologic Stage C) is still found in 25% of patients undergoing radical prostatectomy. In the pre-PSA era, the pathologic findings at surgery were used to select patients for adjuvant therapy for pathologic Stage C prostate cancer. The presence of positive surgical margins, perforation of the prostate capsule, and/or poorly differentiated histology (Gleason score > 7) all independently predicted for an increased risk of local relapse after radical prostatectomy. Seminal vesicle involvement, while also a risk factor for local relapse, was found to be more predictive of distant metastases. Adjuvant radiotherapy was often recommended for patients with these adverse risk factors. While numerous retrospective studies have found that post-prostatectomy pelvic irradiation significantly improves local control, there are no prospective randomized trial demonstrating a survival advantage for this type of treatment. The widespread availability of PSA has enabled the clinician to detect early recurrences after radical prostatectomy. Following radical prostatectomy, the PSA should drop to undetectable levels; patients with measurable PSA in the serum after this operation almost certainly have residual cancer present. Without adjuvant therapy, 50%-75% of patients with pathologic Stage C prostate cancer will develop a rising PSA within 4 years after surgery. The addition of adjuvant pelvic radiotherapy (i.e., prior to the development of a rising PSA) can reduce this failure rate by 50%, particularly in the group of patients without seminal vesicle involvement. In contrast, if one waits to deliver pelvic radiotherapy until the PSA begins to rise, the success rate is considerably lower (< 50% disease-free survival in most series). In summary, the time to institute pelvic
Cocoa intake attenuates oxidative stress associated with rat adjuvant arthritis
Ramos Romero, Sara; Pérez-Cano, Francisco J.; Ramiro Puig, Emma; Franch i Masferrer, Àngels; Castell, Margarida
Cocoa contains flavonoids with antioxidant properties. The aim of this study was to ascertain the effect of cocoa intake on oxidative stress associated with a model of chronic inflammation such as adjuvant arthritis. Female Wistar rats were fed with a 5 or 10% cocoa enriched diet or were given p.o. a quercetin suspension every other day for 10 days. Arthritis was induced by a heat killed Mycobacterium butyricum suspension. Reactive oxygen species (ROS) produced by macrophages, and splenic sup...
Controversies in the Adjuvant Therapy of Endometrial Cancer
Sheng-Mou Hsiao; Lin-Hung Wei
Endometrial cancer is the most common malignancy of the female genital tract. Surgical treatment includes hysterectomy, bilateral salpingo-oophorectomy, and an appropriate staging procedure. Relapse of endometrial cancer may occur in patients with high risk factors, such as old age, grade 3 cancer, deep myometrial invasion, and papillary serous and clear cell types. In recent years, several randomized trials reported the results of adjuvant therapy for patients with high risk factors. Nonethe...
Bode, Christian; Zhao, Gan; Steinhagen, Folkert; Kinjo, Takeshi; Klinman, Dennis M.
Synthetic oligodeoxynucleotides (ODNs) containing unmethylated CpG motifs trigger cells that express Toll-like receptor 9 (including human plasmacytoid dendritic cells and B cells) to mount an innate immune response characterized by the production of Th1 and proinflammatory cytokines. When used as vaccine adjuvants, CpG ODNs improve the function of professional antigen-presenting cells and boost the generation of humoral and cellular vaccine-specific immune responses. These effects are optimi...
[Adjuvant treatment of colon cancer MOSAIC study's main results].
André, Thierry; Tournigand, Christophe; Achille, Emmanuel; Tubiana-Mathieu, Nicole; Lledo, Gérard; Raoul, Yves; Carola, Elisabeth; Flesch, Michel; Muron, Thierry; Boutan-Laroze, Arnaud; Guérin Meyer, Véronique; Boaziz, Catherine; Maigre, Michel; Ganem, Gérard; Mousseau, Mireille; Mounedji-Boudiaf, Lamia; de Gramont, Aimery
Oxaliplatin in combination with 5-fluorouracil/leucovorin (LV5FU) improves the response rate and survival of patients with metastatic colorectal cancer. The objective of the Mosaic study was to evaluate the efficacy of this association in the adjuvant treatment of stage II and III colon cancer. This international study, including 2,246 patients, compared the efficacy of standard treatment with LV5FU2 alone to that of oxaliplatin-LV5FU (Folfox4 regimen) following R0 resection of the primary tumour. Both treatments were administered every two weeks for six months. At 3-year follow-up, the risk of relapse was decreased by 23% in the Folfox4 group (p = 0.002). The protocol was well tolerated, with an identical overall mortality during treatment (0.5%) in both groups. The main specific complication, peripheral sensory neuropathy was reversible in the great majority of cases. A new analysis at 4-year follow-up (median 48.6 months) confirmed the superior efficacy of the Folfox4 regimen compared to the standard treatment, the reduction in relapse risk being 24% (p = 0.0008). On the strength of these results, oxaliplatin was granted a marketing authorization for the indication adjuvant treatment of stage III colon cancer. Based on the data currently available, physicians should consider adjuvant treatment for stage II patients, making each individual decision for treatment on a case-by-case basis. PMID:16483940
Immune responses to Mycoplasma bovis proteins formulated with different adjuvants.
Prysliak, Tracy; Perez-Casal, Jose
Most vaccines for protection against Mycoplasma bovis disease are made of bacterins, and they offer varying degrees of protection. Our focus is on the development of a subunit-based protective vaccine, and to that end, we have identified 10 novel vaccine candidates. After formulation of these candidates with TriAdj, an experimental tri-component novel vaccine adjuvant developed at VIDO-InterVac, we measured humoral and cell-mediated immune responses in vaccinated animals. In addition, we compared the immune responses after formulation with TriAdj with the responses measured in animals vaccinated with a mix of a commercial adjuvant (Emulsigen™) and 2 of the components of the TriAdj, namely polyinosinic:polycytidylic acid (poly I:C) and the cationic innate defense regulator (IDR) peptide 1002 (VQRWLIVWRIRK). In this latter trial, we detected significant IgG1 humoral immune responses to 8 out of 10 M. bovis proteins, and IgG2 responses to 7 out of 10 proteins. Thus, we concluded that the commercial adjuvant formulated with poly I:C and the IDR peptide 1002 is the best formulation for the experimental vaccine. PMID:27105454
Attenuation of antigenic immunogenicity by kynurenine, a novel suppressive adjuvant.
Duan, Zhiqing; Duan, Yunqing; Lei, Huangui; Hu, Ningzhu; Shi, Jiandong; Shen, Dong; Wang, Xi; Hu, Yunzhang
A novel therapeutic strategy is required for autoimmune diseases characterized by the production of autoantibody, because current clinical strategies have limitations. Vaccination against autoimmune diseases is a feasible strategy because vaccines induce immune response memory and the antigen specificity. However, no suitable adjuvant is available to direct the immune response toward tolerance or suppression. In the current study, we evaluated whether kynurenine (Kyn) could serve as a novel suppressive adjuvant to decrease the humoral immune responses against hepatitis A virus (HAV) in the ICR mouse model in vivo and lipopolysaccharide (LPS) in B cells in vitro. The underlying mechanisms of Kyn-mediated suppression of LPS-induced IgM responses were explored. The results showed that Kyn significantly decreased HAV immunogenicity when co-administered with HAV, and that Kyn (100 μM/1000 μM) impaired IgM generation compared with that induced by LPS alone. We also demonstrated that microRNA30b (miR30b) played a critical role in the process of Kyn-mediated suppression of IgM responses induced by LPS, and that Bach2, a transcriptional repressor of B cell terminal differentiation, was a novel target of miR30b. These findings suggest that Kyn can serve as a novel and effective suppressive adjuvant for vaccines. PMID:24583631
Analysis of adjuvant treatment with chemoradiation in gastric cancer
International Nuclear Information System (INIS)
The Hospital San Juan de Dios has analyzed the benefit of patients with gastric cancer who undergo surgery after receiving adjuvant chemoradiation. A retrospective study was performed reviewing records of patients during the period 1 January 2001 to December 31, 2005. These patients have been discharged with a diagnosis of gastric cancer and have received a complete resection with curative gastric malignancy and adjuvant chemoradiation according to the protocol established by Dr. MacDonald. In the study 0116. 743 patients were discharged to Hospital San Juan de Dios, 1 in 20 has been possible to diagnose gastric cancer at early stages for a total of 28 patients. The results obtained were compared at the Hospital San Juan de Dios with those published by Dr. MacDonald. The over-life of 3 years in the chemoradiation group in Hospital San Juan de Dios has been of 42.9% and 50% in the study MacDonald. The group that has not received adjuvant the over-life in the same period has been of 20 % in HSJD and 41% in the study MacDonald, being lower percentage of patients with this over-life, but greater range of difference.
[Development of Nucleic Acid-Based Adjuvant for Cancer Immunotherapy].
Kobiyama, Kouji; Ishii, Ken J
Since the discovery of the human T cell-defined tumor antigen, the cancer immunotherapy field has rapidly progressed, with the research and development of cancer immunotherapy, including cancer vaccines, being conducted actively. However, the disadvantages of most cancer vaccines include relatively weak immunogenicity and immune escape or exhaustion. Adjuvants with innate immunostimulatory activities have been used to overcome these issues, and these agents have been shown to enhance the immunogenicity of cancer vaccines and to act as mono-therapeutic anti-tumor agents. CpG ODN, an agonist for TLR9, is one of the promising nucleic acid-based adjuvants, and it is a potent inducer of innate immune effector functions. CpG ODN suppresses tumor growth in the absence of tumor antigens and peptide administration. Therefore, CpG ODN is expected to be useful as a cancer vaccine adjuvant as well as a cancer immunotherapy agent. In this review, we discuss the potential therapeutic applications and mechanisms of CpG ODN for cancer immunotherapy. PMID:26469159
External validation of Adjuvant! Online breast cancer prognosis tool. Prioritising recommendations for improvement.
Directory of Open Access Journals (Sweden)
David Hajage
Full Text Available BACKGROUND: Adjuvant! Online is a web-based application designed to provide 10 years survival probability of patients with breast cancer. Several predictors have not been assessed in the original Adjuvant! Online study. We provide the validation of Adjuvant! Online algorithm on two breast cancer datasets, and we determined whether the accuracy of Adjuvant! Online is improved with other well-known prognostic factors. PATIENTS AND METHODS: The French data set is composed of 456 women with early breast cancer. The Dutch data set is composed of 295 women less than 52 years of age. Agreement between observation and Adjuvant! Online prediction was checked, and logistic models were performed to estimate the prognostic information added by risk factors to Adjuvant! Online prediction. RESULTS: Adjuvant! Online prediction was overall well-calibrated in the French data set but failed in some subgroups of such high grade and HER2 positive patients. HER2 status, Mitotic Index and Ki67 added significant information to Adjuvant! Online prediction. In the Dutch data set, the overall 10-year survival was overestimated by Adjuvant! Online, particularly in patients less than 40 years old. CONCLUSION: Adjuvant! Online needs to be updated to adjust overoptimistic results in young and high grade patients, and should consider new predictors such as Ki67, HER2 and Mitotic Index.
Recommendations on the environmental risk assessment of pharmaceuticals: Effect characterization.
Schmitt, H.; Boucard, T.; Garric, J.; Jensen, J.; Parrott, J.; Pery, A.; Rombke, J.; Straub, J.O.; Hutchinson, T.H.; Sanchez-Arguello, P.; Wennmalm, A.; Duis, K.
The effects testing of pharmaceuticals consists of a tiered investigation of ecotoxicological endpoints. However, effects testing has to be performed only when the predicted environmental concentrations (PECs) of pharmaceuticals are above certain action limits. To study the appropriateness of these
Risks to aquatic organisms posed by human pharmaceutical use
In order to help prioritize future research efforts within the US, risks associated with exposure to human prescription pharmaceutical residues in wastewater were estimated from marketing and pharmacological data. Masses of 371 active pharmaceutical ingredients (APIs) dispensed ...
Al adjuvants can be tracked in viable cells by lumogallion staining.
Mile, Irene; Svensson, Andreas; Darabi, Anna; Mold, Matthew; Siesjö, Peter; Eriksson, Håkan
The mechanism behind the adjuvant effect of aluminum salts is poorly understood notwithstanding that aluminum salts have been used for decades in clinical vaccines. In an aqueous environment and at a nearly neutral pH, the aluminum salts form particulate aggregates, and one plausible explanation of the lack of information regarding the mechanisms could be the absence of an efficient method of tracking phagocytosed aluminum adjuvants and thereby the intracellular location of the adjuvant. In this paper, we want to report upon the use of lumogallion staining enabling the detection of phagocytosed aluminum adjuvants inside viable cells. Including micromolar concentrations of lumogallion in the culture medium resulted in a strong fluorescence signal from cells that had phagocytosed the aluminum adjuvant. The fluorescence appeared as spots in the cytoplasm and by confocal microscopy and co-staining with probes presenting fluorescence in the far-red region of the spectrum, aluminum adjuvants could to a certain extent be identified as localized in acidic vesicles, i.e., lysosomes. Staining and detection of intracellular aluminum adjuvants was achieved not only by diffusion of lumogallion into the cytoplasm, thereby highlighting the presence of the adjuvant, but also by pre-staining the aluminum adjuvant prior to incubation with cells. Pre-staining of aluminum adjuvants resulted in bright fluorescent particulate aggregates that remained fluorescent for weeks and with only a minor reduction of fluorescence upon extensive washing or incubation with cells. Both aluminum oxyhydroxide and aluminum hydroxyphosphate, two of the most commonly used aluminum adjuvants in clinical vaccines, could be pre-stained with lumogallion and were easily tracked intracellularly after incubation with phagocytosing cells. Staining of viable cells using lumogallion will be a useful method in investigations of the mechanisms behind aluminum adjuvants' differentiation of antigen-presenting cells
Business Model Innovation in the Pharmaceutical Industry
DEFF Research Database (Denmark)
Ahrensbach Rasmussen, Klement; Foss, Nicolai Juul
Based on interviews in LEO Pharma, UCB Pharma and Novo Nordisk, we document how deep-seated changes in the pharmaceutical industry related to increasing demands from payers, the strengthening of the role of patients, changing legal demands, and declining technological opportunity, drive a process...
The Future of Pharmaceutical Manufacturing Sciences
DEFF Research Database (Denmark)
Rantanen, Jukka; Khinast, Johannes
The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial-scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies is...
Electromembrane extraction for pharmaceutical and biomedical analysis
DEFF Research Database (Denmark)
Huang, Chuixiu; Seip, Knut Fredrik; Gjelstad, Astrid;
present paper discusses recent development of EME. The paper focuses on the principles of EME, and discusses how to optimize operational parameters. In addition, pharmaceutical and biomedical applications of EME are reviewed, with emphasis on basic drugs, acidic drugs, amino acids, and peptides. Finally...
Quantification of the compactibility of pharmaceutical powders
DEFF Research Database (Denmark)
Sonnergaard, Jørn
The purpose of this study is to investigate and to quantify the compactibility of pharmaceutical powders by a simple linear relationship between the diametral compressive strength of tablets and the applied compaction pressure. The mechanical strength of the tablets is characterized as the crushing...
New pharmaceuticals in inflammatory bowel disease
Łodyga, Michał; Eder, Piotr; Bartnik, Witold; Gonciarz, Maciej; Kłopocka, Maria; Linke, Krzysztof; Małecka-Panas, Ewa; Radwan, Piotr; Rydzewska, Grażyna
This paper complements the previously published Guidelines of the Working Group of the Polish Society of Gastroenterology and former National Consultant in Gastroenterology regarding the management of patients with Crohn's disease and ulcerative colitis. Attention was focused on the new pharmaceutical recently registered for inflammatory bowel disease treatment.
Recent advances in pharmaceutical sciences V
Muñoz-Torrero López-Ibarra, Diego; Vinardell Martínez-Hidalgo, Ma. Pilar; Palazón Barandela, Javier
This E-book is the fifth volume of a series that compiles contributions from different areas of the multidisciplinary field of Pharmaceutical Sciences. The E-book consists of 11 chapters that cover the areas of organic chemistry, health and environmental management, plant physiology, food science, toxicology, botany, parasitology, physiology, biochemistry and molecular biology, microbiology, and pharmacology.
Pharmaceutical technology, biopharmaceutics and drug delivery.
Youn, Yu Seok; Lee, Beom-Jin
The 40th annual international conference of the Korean Society of Pharmaceutical Sciences and Technology on Pharmaceutical Technology, Biopharmaceutics and Drug Delivery was held on 2-3 December 2010 in Jeju Special Self-Governing Providence, Korea, to celebrate its 40th anniversary. A comprehensive review of a wide spectrum of recent topics on pharmaceutical technology, biopharmaceutics and drug delivery was presented. Invited lectures and poster presentations over 2 days were divided into six parallel sessions covering areas such as biotechnology, biopharmaceutics, drug delivery, formulation/manufacture, regulatory science and frontier science. Among these, there were two sessions related to regulatory science and biopharmaceutics that were co-sponsored by the Korea Food and Drug Administration. In fact, this conference provided an opportunity for many investigators to discuss their research, collect new information and to promote the advancement of knowledge in each pharmaceutical area. This conference report summarizes the keynote podium presentations provided by many distinguished speakers, including Gordon L Amidon of the University of Michigan. PMID:22833999
Potential Applications of Polymer Microchips in Pharmaceuticals
Institute of Scientific and Technical Information of China (English)
James J. Bao
Some of the most recent development in polymer based microchips have been reviewed. Different methods used in fabricating ploymer microchips are introduced. The inportance and applications of the ploymer microchip in pharmaceutical and other areas are discussed. Finally, the potential problems and development areas in polymer microchip technology are also addressed.
[Archeology of the radio pharmaceutical advertisement].
Lefebvre, Thierry
After Second World War, a debate sets in France the partisans and the detractors of the radio advertisement, in particular pharmaceutical advertisement. In this article, the author revises campaigns led, during the thirties, by Robert Desnos for Armand Salacrou. PMID:12731488
A Study on Summer Pharmaceutical Industrial Training
Directory of Open Access Journals (Sweden)
Full Text Available Practical exposure of industrial operation, set up and management is very crucial part in learning and to be skilled for competitive and global demand in pharmaceutical industry. To fulfill these objectives industrial training is mandatory for the award of B. Pharm. Degree. Being a student who wants to mark in industrial field, the best place to gain practical understanding of production is to do summer training in the production department of Pharmaceutical Industry which can be regarded as one of the most dynamic industry in India. The student have proud to work as an internee in pharmaceutical industry and the experience will surely help me in future assignments as a marketing professional. The absolute guidance and concern of higher management of the staff of all departments especially the marketing department facilitated in making my summer Training a wonderful learning experience in all aspects. Summer training is given for six weeks was based on industrial project. Through these projects, the trainee become able to get direct interaction with different chemists along with staff of Production, Q.A., Q.C. and Logistics, Administration and Human Resources Departments of pharmaceutical industry.
Modeling the effects of pharmaceutical marketing
Leeflang, P.S.H.; Wieringa, J.E.
Successful innovation of prescription drugs requires a substantial amount of marketing support. There is, however, much concern about the effects of marketing expenditures on the demand of pharmaceutical products (Manchanda et al., Market Lett 16(3/4):293-308, 2005). For example, excessive marketing
Pharmaceuticals in waters - problem and its solution
Czech Academy of Sciences Publication Activity Database
Vaněk, Tomáš; Soudek, Petr; Maršík, Petr; Hudcová, T.; Syrovátka, J.
Boca Raton: CRC Press, 2014 - (Zhenqi, H.), s. 381-384 ISBN 978-1-138-02724-4 R&D Projects: GA TA ČR TA01020573; GA ČR(CZ) GA14-22593S Institutional support: RVO:61389030 Keywords : pharmaceuticals * waste water s * degradation Subject RIV: DJ - Water Pollution ; Quality
Drug Information Residency Rotation with Pharmaceutical Industry.
Cramer, Richard L.
Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…
Developing Closer Ties with the Pharmaceutical Industry.
Reid, Gregor; Hoddinott, Susan
The need for research administrators to understand and appreciate the pharmaceutical industry's research and development environment is discussed, using examples from Canada. The research administrator's role in the technology transfer process and implications for faculty are examined. Ways to build closer school-industry ties are discussed. (MSE)
Benchmarking in radiation protection in pharmaceutical industries
International Nuclear Information System (INIS)
A benchmarking on radiation protection in seven pharmaceutical companies in Germany and Switzerland was carried out. As the result relevant parameters describing the performance and costs of radiation protection were acquired and compiled and subsequently depicted in figures in order to make these data comparable. (orig.)
Strategy & structure of the pharmaceutical industry
Bernardo Batiz-Lazo; Sarah Holland
The case looks at the development of the modern pharmaceutical industry with an emphasis on events in the late 1990s. The various forces affecting the competitive environment around the discovery, development, production, distribution and marketing of prescription and non- prescription drugs are discussed in terms of their origins and recent developments.
Effects of pharmaceuticals on immune parameters of aquatic invertebrates
V. Matozzo
Pharmaceuticals are a large group of chemicals used either by humans for personal health or by agribusiness to enhance the growth and health of livestock. Pharmaceuticals are considered to be emerging environmental contaminants. Indeed, several studies have shown that these compounds continuously enter aquatic ecosystems. Both pharmaceutical consumption and erroneous discharge of unused or expired medications make notable contributions to the introduction of pharmaceuticals into the environme...
Stability of Pharmaceuticals in a Simulated Marine Environment
Smellror, Kine Johansen
In the past few decades there has been an increasing awareness of pharmaceuticals in the environment and pharmaceuticals as environmental pollutants. Pharmaceuticals find their way to the aquatic environment mostly through sewage treatment plants. The potential toxicity of pharmaceuticals is of great interest as they have been discovered in air, water, soil, sediment and biota. The aim of the thesis was to investigate the stability of selective serotonin reuptake inhibitors (SSRIs) in se...
A Review on quality by design approach (QBD) for Pharmaceuticals
Vemuri Pavan Kumar; N. Vishal Gupta
Quality by Design is the modern approach for quality of pharmaceuticals. It describes use of Quality by Design to ensure quality of Pharmaceuticals. In this review, the Quality by Design is described and some of its elements identified. Process parameters and quality attributes are identified for each unit operation. Benefits, opportunities and steps involved in Quality by Design of Pharmaceutical products are described. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 ...
Do cost-sharing and entry deregulation curb pharmaceutical Innovation?
Grossmann, Volker
This paper examines the role of both cost-sharing schemes in health insurance systems and entry regulation for pharmaceutical R&D expenditure, drug prices, aggregate productivity, and income. The analysis suggests that both an increase in the coinsurance rate and stricter price regulations adversely affect R&D spending in the pharmaceutical sector. In contrast, entry deregulation may lead to quality-improvements of pharmaceuticals, despite reducing price-setting power of pharmaceutical compan...
Pharmaceutical Marketing in the Sanitary-Veterinary Sector
Mihaela Cornelia Prejmerean; Simona Vasilache
The paper discusses the particular problems marketing practice encounters in the pharmaceutical sector, investigating some of their underlying causes. The span of the pharmaceutical sector is then restricted to veterinary pharmaceutical marketing, as a domain in which not the clients themselves are targeted, but their physicians and owners, which are to decide on their behalf. If pharmaceutical marketing, in general, is to be doomed as manipulation, which would be the implications of marketin...
Rx Roulette: combatting counterfeit pharmaceuticals in developing nations
Lybecker, Kristina M.
The debate over access to medicines has principally centered on pharmaceutical patents and prohibitively high drug prices. Although a less recognized problem, counterfeit pharmaceuticals are certainly a more insidious barrier to access. Pharmaceutical counterfeiting is an invisible threat, not only by nature, but also because the industry has historically downplayed it. However, that has changed. Pharmaceutical firms now not only readily concede counterfeiting is a threat to their business, b...
Management model of the pharmaceutical enterprise competitiveness
Directory of Open Access Journals (Sweden)
Ayrat Izmailov
Full Text Available Competition and Competitiveness (COP of the enterprise are important in economic terms , acquires special importance in this era of globalization . Highlevel of COP is the guarantor of high returns. Consequently, under the current model of socio— economic development of the Russian Federation issuesCOP occupy a dominant place in the theory of the national economy. Despite this, to date, there is no single generally accepted definition of «competitiveness». An important characteristic of the COP of the company is its management model. Problem poses on industries in general, affect the approachesused in the management of the firms operating in these sectors. The specificity of the industry in which the company operates, may affect the impact ofindustry-wide problems at the individual enterprise. To this industry include pharmaceutical. Today's economic situation for Russian companies in thepharmaceutical industry is characterized by a low level of innovation component, low-profit orientation on the production of products (generics , difficultiesin the creation and registration of new products that eventually forms a low competitiveness of not only individual enterprises, but also the entireindustry . Because of the strong competitive pressure from the nearest neighbors — China, India and other countries, as well as presence in the marketa large number of manufacturers of large multinational pharmaceutical corporations, the development of Russian pharmaceutical COP greatly complicated.Import volumes of medicines, pharmaceutical substances, pharmaceutical goods in recent years tend to increase. Pricing and competitive strategy ,used by foreign producers adversely affects not only the individual Russian companies , but in general, a number of pharmaceutical and related ( chemical,biochemical industries. In this situation, one of the main levers of influence on the situation at the enterprise level is the management of the COP
Bioremediation Kinetics of Pharmaceutical Industrial Effluent
Directory of Open Access Journals (Sweden)
M. Šabić
Full Text Available In recent years, concerns about the occurrence and fate of pharmaceuticals that could be present in water and wastewater has gained increasing attention. With the public's enhanced awareness of eco-safety, environmentally benign methods based on microorganisms have become more accepted methods of removing pollutants from aquatic systems. This study investigates bioremediation of pharmaceutical wastewater from pharmaceutical company Pliva Hrvatska d.o.o., using activated sludge and bioaugmented activated sludge with isolated mixed bacterial culture. The experiments were conducted in a batch reactor in submerged conditions, at initial concentration of organic matter in pharmaceutical wastewater, expressed as COD, 5.01 g dm–3 and different initial concentrations of activated sludge, which ranged from 1.16 to 3.54 g dm–3. During the experiments, the COD, pH, concentrations of dissolved oxygen and biomass were monitored. Microscopic analyses were performed to monitor the quality of activated sludge. Before starting with the bioremediation in the batch reactor, toxicity of the pharmaceutical wastewater was determined by toxicity test using bacteria Vibrio fischeri. The obtained results showed that the effective concentration of the pharmaceutical wastewater was EC50 = 17 % and toxicity impact index was TII50 = 5.9, meaning that the untreated pharmaceutical industrial effluent must not be discharged into the environment before treatment. The results of the pharmaceutical wastewater bioremediation process in the batch reactor are presented in Table 1. The ratio γXv ⁄ γX maintained high values throughout all experiments and ranged from 0.90 and 0.95, suggesting that the concentrations of biomass remained unchanged during the experiments. The important kinetic parameters required for performance of the biological removal process, namely μmax, Ks, Ki, Y and kd were calculated from batch experiments (Table 2. Figs. 1 and 2 show the experimental
In vitro cytokine induction by TLR-activating vaccine adjuvants in human blood varies by age and adjuvant.
van Haren, Simon D; Ganapathi, Lakshmi; Bergelson, Ilana; Dowling, David J; Banks, Michaela; Samuels, Ronald C; Reed, Steven G; Marshall, Jason D; Levy, Ofer
Most infections occur in early life, prompting development of novel adjuvanted vaccines to protect newborns and infants. Several Toll-like receptor (TLR) agonists (TLRAs) are components of licensed vaccine formulations or are in development as candidate adjuvants. However, the type and magnitude of immune responses to TLRAs may vary with the TLR activated as well as age and geographic location. Most notably, in newborns, as compared to adults, the immune response to TLRAs is polarized with lower Th1 cytokine production and robust Th2 and anti-inflammatory cytokine production. The ontogeny of TLR-mediated cytokine responses in international cohorts has been reported, but no study has compared cytokine responses to TLRAs between U.S. neonates and infants at the age of 6months. Both are critical age groups for the currently pediatric vaccine schedule. In this study, we report quantitative differences in the production of a panel of 14 cytokines and chemokines after in vitro stimulation of newborn cord blood and infant and adult peripheral blood with agonists of TLR4, including monophosphoryl lipid A (MPLA) and glucopyranosyl lipid Adjuvant aqueous formulation (GLA-AF), as well as agonists of TLR7/8 (R848) and TLR9 (CpG). Both TLR4 agonists, MPLA and GLA-AF, induced greater concentrations of Th1 cytokines CXCL10, TNF and Interleukin (IL)-12p70 in infant and adult blood compared to newborn blood. All the tested TLRAs induced greater infant IFN-α2 production compared to newborn and adult blood. In contrast, CpG induced greater IFN-γ, IL-1β, IL-4, IL-12p40, IL-10 and CXCL8 in newborn than in infant and adult blood. Overall, to the extent that these in vitro studies mirror responses in vivo, our study demonstrates distinct age-specific effects of TLRAs that may inform their development as candidate adjuvants for early life vaccines. PMID:27081760
Informed consent: Enforcing pharmaceutical companies' obligations abroad.
Lee, Stacey B
The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections. PMID:20930251
Is the pharmaceutical market in Bulgaria innovative?
Stoimenova, A; Stankova, M; Samev, K; Petrova, G
After the turn to market oriented economy a lot of drugs were authorized for sale in the East European countries. Because of the limited resources of these countries, mainly generic or brand generic products were licensed. The number of the patented drugs on the market could be used as measure of the market attractiveness to the R&D producers. The study shows the analysis of the innovativeness of the Bulgarian drug market comparing the registration and the patient activity of the producers. The number of the authorized products for five years period (1990-2000) and share of the patented products were investigated. During the observed period the number of newly authorized pharmaceuticals increased almost seven times from 800 (650 INN) to 6000 (2000 INN) dosage forms. The prevailing part of the newly registered drugs was found to be brand generics and possess only trade name protection. The share of drugs that are patented is less than five percent of all newly registered medicines, and among the fifty most commonly prescribed and sold medicines between 1996-2000, only 0.5 percent of drugs were patented. Obviously the Bulgarian pharmaceutical market is very competitive but not that attractive for most of the R&D producers. In general the registration of the patent protected products is increasing during the years and especially after harmonization of the related legislation with the EU requirements. The patent activity of the pharmaceutical companies regarding newly authorized drugs is influenced by the structure of morbidity and population. During the last two years the patent activity is increasing and is oriented mainly towards the protection of newly authorized drugs or pharmaceutical forms and obligatory registration of trademarks for the privatized Bulgarian pharmaceutical manufacturers. PMID:14677267
Modelling of drying processes of pharmaceutical granules. Pharmaceutical Sciences for the Future of Medicines
DEFF Research Database (Denmark)
Mortier, S.T.F.C.; Vedantam, S.; De Beer, T.;
Tablets are conventionally produced via consecutive batch process steps. Recent introduction of continuous process equipment is gaining industrial importance in pharmaceutics. Transition to continuous production requires improved understanding of all operations, necessitating the development of...... mechanistic models of multi‐phase systems which in the end allow process control. This contribution focuses on continuous fluidized bed drying of pharmaceutical wet granules. A stepwise approach is used in model development, starting with the drying behaviour of single granules. Experiments to determine the...
The pharmaceutical biochemistry group: where pharmaceutical chemistry meets biology and drug delivery
Kalia, Yogeshvar; Perozzo, Remo; Scapozza, Leonardo
Successful drug discovery and development of new therapeutics is a long, expensive multidisciplinary process needing innovation and the integration of smart cutting edge science and technology to overcome the challenges in taking a drug from the bench to the bedside. The research activities of the Pharmaceutical Biochemistry group span the drug discovery and development process, providing an interface that brings together pharmaceutical chemistry, biochemistry, structural biology, computation...
Pharmaceutical crystallography: is there a devil in the details?
DEFF Research Database (Denmark)
Bond, A. D.
Modern instruments for small-molecule crystallography continue to become more sophisticated and more automated. This technical progress provides a basis for frontier research in chemical and pharmaceutical crystallography, but it also encourages analytical crystallographers to become more complac...... presented for pharmaceutical compounds, and the potential importance of the "details" in pharmaceutical crystallography is discussed....
42 CFR 482.25 - Condition of participation: Pharmaceutical services.
... the hospital's organized pharmaceutical service. (a) Standard: Pharmacy management and administration... Hospital Functions § 482.25 Condition of participation: Pharmaceutical services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by...
A perspective on PSE in pharmaceutical process development and innovation
DEFF Research Database (Denmark)
Gernaey, Krist; Cervera Padrell, Albert Emili; Woodley, John
The pharmaceutical industry is under growing pressure to increase efficiency, both in production and in process development. This paper discusses the central role of Process Systems Engineering (PSE) methods and tools in pharmaceutical process development and innovation, and searches for answers to...... pharmaceutical manufacturing and green processes, and is illustrated with a series of short examples taken from the literature and ongoing research projects....
Cost-utility analysis of adjuvant goserelin (Zoladex and adjuvant chemotherapy in premenopausal women with breast cancer
Directory of Open Access Journals (Sweden)
Cheng Tsui
Full Text Available Abstract Background Increased health care costs have made it incumbent on health-care facilities and physicians to demonstrate both clinical and cost efficacy when recommending treatments. Though studies have examined the cost-effectiveness of adjuvant goserelin with radiotherapy for locally advanced prostate cancer, few have compared the cost-effectiveness of adjuvant goserelin to adjuvant chemotherapy alone in premenopausal breast cancer. Methods In this retrospective study at one hospital, the records of 152 patients with stage Ia to IIIa ER + breast cancer who received goserelin or chemotherapy were reviewed. Survival analysis was assessed by the Kaplan-Meier method. Patients were interviewed to evaluate their quality of life using the European Organization for Research and Treatment Quality of Life questionnaire (EORTC-QLQ-C30, version 4.0, and to obtain the utility value by the standard gamble (SG and visual scale (VS methods. Total medical cost was assessed from the (National Health Insurance NHI payer's perspective. Results Survival at 11 years was significantly better in the groserelin group (P Conclusions Goserelin therapy results in better survival and higher utility-weighted life-years, and is more cost-effective than TC or TEC chemotherapy.
Adjuvant endocrine and chemotherapy for early breast cancer
International Nuclear Information System (INIS)
Objective: Present the results of the 1995 World Overview which will be held in Oxford England two weeks before ASTRO. Discuss the interpretation and application of these results. Review current research topics on the use of adjuvant endocrine and chemotherapy for early breast cancer. The survival benefits from adjuvant chemotherapy in premenopausal women and adjuvant tamoxifen in postmenopausal women are well established. Each will reduce the annual odds of death by about 25% resulting in a 10 year survival difference of 8-10%. By the time of this presentation, the results of the 1995 Adjuvant Therapy Overview should be with 10+ years of follow-up, and if possible these will be summarized. Current efforts to improve on previous results are focused on the following areas: Optimal chemotherapy dose. Decreasing dose will compromise patient survival. It is not as certain that increasing dose will have as much impact in improving survival. The NSABP was unable to demonstrate an improvement in survival by modestly increasing the dose of cyclophosphamide alone. However, recent results of a Canadian study of CEF (cyclophosphamide, epidoxorubicin, and 5-fluorouracil) and an Intergroup trial of an intense 16 week polychemotherapy program keep alive the possibility that dose escalation is still a very important question. An NSABP trial evaluating even greater cyclophosphamide dose escalation, an Intergroup evaluation of different doxorubicin doses, and two Intergroup trials evaluating very high dose chemotherapy and bone marrow transplantation should provide definitive evidence regarding the importance of dose. Drug sequence. A study from Milan suggests that initial treatment with single agent doxorubicin followed by CMF will be superior to alternating doxorubicin and CMF. This has not been confirmed yet, and the reason for increased benefit from such a sequence is not entirely clear. This concept is being explored further in an Intergroup trial comparing four cycles of
Review on adjuvant chemotherapy for rectal cancer - why do treatment guidelines differ so much?
DEFF Research Database (Denmark)
Poulsen, Laurids Ø; Qvortrup, Camilla; Pfeiffer, Per;
) radiotherapy, four randomized studies were found where use of adjuvant chemotherapy showed no benefit in survival. Three trials were found in which a subset of patients received preoperative (chemo) radiotherapy. Two of these trials showed a statistically significant benefit of adjuvant chemotherapy. Twenty......BACKGROUND: The use of postoperative adjuvant chemotherapy is controversial for rectal adenocarcinoma. Both international and national guidelines display a great span varying from recommending no adjuvant chemotherapy at all, over single drug 5-fluororuacil (5-FU), to combinations of 5-FU...... trials were identified in which the patients did not receive preoperative (chemo) radiotherapy, including five Asian studies in which a statistically significant benefit from adjuvant chemotherapy was reported. CONCLUSIONS: Most of the data found did not support the use of postoperative adjuvant...
Development of a minimal saponin vaccine adjuvant based on QS-21
Fernández-Tejada, Alberto; Chea, Eric K.; George, Constantine; Pillarsetty, Nagavarakishore; Gardner, Jeffrey R.; Livingston, Philip O.; Ragupathi, Govind; Lewis, Jason S.; Tan, Derek S.; Gin, David Y.
Adjuvants are materials added to vaccines to enhance the immunological response to an antigen. QS-21 is a natural product adjuvant under investigation in numerous vaccine clinical trials, but its use is constrained by scarcity, toxicity, instability and an enigmatic molecular mechanism of action. Herein we describe the development of a minimal QS-21 analogue that decouples adjuvant activity from toxicity and provides a powerful platform for mechanistic investigations. We found that the entire branched trisaccharide domain of QS-21 is dispensable for adjuvant activity and that the C4-aldehyde substituent, previously proposed to bind covalently to an unknown cellular target, is also not required. Biodistribution studies revealed that active adjuvants were retained preferentially at the injection site and the nearest draining lymph nodes compared with the attenuated variants. Overall, these studies have yielded critical insights into saponin structure-function relationships, provided practical synthetic access to non-toxic adjuvants, and established a platform for detailed mechanistic studies.
GLA-AF, an Emulsion-Free Vaccine Adjuvant for Pandemic Influenza
Clegg, Christopher H.; Roque, Richard; Perrone, Lucy A.; Rininger, Joseph A.; Bowen, Richard; Reed, Steven G.
The ongoing threat from Influenza necessitates the development of new vaccine and adjuvant technologies that can maximize vaccine immunogenicity, shorten production cycles, and increase global vaccine supply. Currently, the most successful adjuvants for Influenza vaccines are squalene-based oil-in-water emulsions. These adjuvants enhance seroprotective antibody titers to homologous and heterologous strains of virus, and augment a significant dose sparing activity that could improve vaccine ma...
Chitin, Chitosan, and Glycated Chitosan Regulate Immune Responses: The Novel Adjuvants for Cancer Vaccine
Xiaosong Li; Min Min; Nan Du; Ying Gu; Tomas Hode; Mark Naylor; Dianjun Chen; Nordquist, Robert E.; Chen, Wei R.
With the development of cancer immunotherapy, cancer vaccine has become a novel modality for cancer treatment, and the important role of adjuvant has been realized recently. Chitin, chitosan, and their derivatives have shown their advantages as adjuvants for cancer vaccine. In this paper, the adjuvant properties of chitin and chitosan were discussed, and some detailed information about glycated chitosan and chitosan nanoparticles was also presented to illustrate the trend for future development.
Adjuvant radiotherapy for melanoma metastatic to axillary and inguinal nodes: Regional tumor control and late effects
Ahmed SK; Kottschade LA; Markovic SN; Garces YI; Foote RL
Background: Adjuvant radiotherapy reduces nodal recurrence in metastatic melanoma. The purpose of this study was to examine the effects of adjuvant radiotherapy on in-field nodal control of melanoma metastatic to axillary and inguinal lymph nodes. Methods: The medical records of patients who received adjuvant radiotherapy from January 1, 2003, through December 31, 2011, at Mayo Clinic were reviewed. Results: In the 20 patients identified, the rates of 2-year overall survival, nodal control, a...
Vaccination of Atlantic cod (Gadus morhua L.) against atypical furunculosis using different adjuvants
Hamid, Lemia M.O
In recent years increased attention has been focussed on fish vaccines and vaccination against diseases in farmed fish. In this study, efficacy and side effects of vaccination against atypical furunculosis in Atlantic cod (Gadus morhua L.) were studied in an experimental trial by using different adjuvants. The different adjuvanted vaccines were administered by intraperitoneal injection (i.p.) to Atlantic cod. The adjuvants used were CpG DNA, Aluminium hydroxide (Alhydrogel), an...
Wilson Luiz da COSTA JUNIOR; Felipe Jose Fernandez COIMBRA; Batista, Thales Paulo; RIBEIRO, Heber Salvador de Castro; DINIZ, Alessandro Landskron
Context Whether adjuvant chemoradiotherapy may contribute to improve survival outcomes after D2-gastrectomy remains controvertial. Objective To explore the clinical utility of N-Ratio in selecting gastric cancer patients for adjuvant chemoradiotherapy after D2-gastrectomy. Methods A retrospective cohort study was carried out on gastric cancer patients who underwent D2-gastrectomy alone or D2-gastrectomy plus adjuvant chemoradiotherapy (INT-0116 protocol) at the Hospital A. C. Camargo from...
Insight into the cellular fate and toxicity of aluminium adjuvants used in clinically approved human vaccinations
Mold, M; Shardlow, E; Exley, C.
Aluminium adjuvants remain the most widely used and effective adjuvants in vaccination and immunotherapy. Herein, the particle size distribution (PSD) of aluminium oxyhydroxide and aluminium hydroxyphosphate adjuvants was elucidated in attempt to correlate these properties with the biological responses observed post vaccination. Heightened solubility and potentially the generation of Al3+ in the lysosomal environment were positively correlated with an increase in cell mortality in vitro, pote...
Development of a minimal saponin vaccine adjuvant based on QS-21
Fernández-Tejada, Alberto; Chea, Eric K.; George, Constantine; Pillarsetty, Nagavarakishore; Gardner, Jeffrey R.; LIVINGSTON, PHILIP O.; Ragupathi, Govind; Lewis, Jason S.; Tan, Derek S.; Gin, David Y.
Adjuvants are materials added to vaccines to enhance the immunological response to an antigen. QS-21 is a natural product adjuvant under investigation in numerous vaccine clinical trials, but its use is constrained by scarcity, toxicity, instability, and an enigmatic molecular mechanism of action. Herein, we describe the development of a minimal QS-21 analogue that decouples adjuvant activity from toxicity and provides a powerful platform for mechanistic investigations. We found that the enti...
Behavior of selected pharmaceuticals in topsoil of Greyic Phaeozem
Kodesova, Radka; Klement, Ales; Kocarek, Martin; Fer, Miroslav; Golovko, Oksana; Grabic, Roman; Jaksik, Ondrej
It has been documented in several studies that soil may be contaminated by human or veterinary pharmaceuticals. Some of pharmaceutical ingredient may be retained in soils. The rest can be transported to the surface and groundwater through surface runoff and infiltration. Mobility of contaminants in soils is dependent on many soil and pharmaceutical properties (e.g. pharmaceutical adsorption on soil particles and pharmaceutical degradation). The goals of this study were: (1) to measure adsorption isotherms of selected pharmaceuticals in one soil; (2) to evaluate degradation of selected pharmaceuticals in this soil, and (3) to evaluate impact of applied pharmaceuticals on biological activity in soil, which influences pharmaceutical decomposition. Batch sorption tests were performed for 7 selected pharmaceuticals (beta blockers Atenolol and Metoprolol, anticonvulsant Carbamazepin, and antibiotics Clarithromycin, Clindamycin, Trimetoprim and Sulfamethoxazol) and one soil (topsoil of Greyic Phaeozem from Čáslav). The same concentrations (0.5, 1, 2.5, 5 and 10 mg/l) were used for almost all pharmaceuticals except Clarithromycin (0.033, 0.08, 0.165, 0.25, 0.33 mg/l). The Freundlich equations were used to describe adsorption isotherms. Degradation of all 7 pharmaceuticals was also studied. Solutes of different pharmaceuticals (concentration of 8.3 mg/l) were added into the plastic bottles (one pharmaceutical per bottle) with soil. Concentrations of pharmaceuticals remaining in soil 1, 2, 5, 12, 23, 40 and 61 days after the pharmaceutical application were analyzed. Colony forming unites were evaluated to describe microbial activity in time affected by different pharmaceuticals. Adsorption of studied pharmaceuticals on soil particles decreasing as follows: Clarithromycin, Trimetoprim, Metoprolol, Clindamycin, Atenolol, Carbamazepin, Sulfamethoxazol. Degradation rates in some degree reflected adsorption of studied pharmaceuticals on soil particles and increased with
Jordanian pharmaceutical companies: are their marketing efforts paying off?
Al-Shaikh, Mustafa S; Torres, Ivonne M; Zuniga, Miguel A; Ghunaim, Ayman
The pharmaceuticals industry is one of the main industries in Jordan. Jordanian pharmaceuticals rank third in the export industry of this country. This study aims to examine the strengths that Jordanian pharmaceutical companies have, which, in turn, form their competitiveness base. In addition, this study aims to identify their weaknesses and the effects of marketing their products in the local market. What is the relationship between Jordanian pharmaceutical product quality, price and value, and the competitiveness of pharmaceutical companies in the local market? Our study aims to answer this and other questions. Our results and practical implications are discussed. PMID:21590563
INAA of polyacrylic hydrogels of pharmaceutical grade
International Nuclear Information System (INIS)
Polyacrylic acid (PA) and its salts are promising biomaterials used in the pharmaceutical industry. They could be used as pharmaceutical additives, as a burn dressing and also in the slow released implants or trans-derma patch formulations. Polyacrylic acid of pharmaceutical grade can be obtained by gamma irradiation polymerization. The influence of the raw materials and of the technological procedure on the final product purity has been investigated by Instrumental Neutron Activation Analysis (INAA) method. The following materials have been analyzed by INAA: 1) acrylic acid of technical grade; 2) acrylic acid purified by double crystallisation; 3) NaOH of analytical grade; 4) CaCl-2·6H2O of pharmaceutical grade; 5) CaCl2·2H2O of analytical grade; 6) granulated PANa; 7) ungranulated PANa; 8) ungranulated PANaCa; 9) PANaCa granulated by milling in IFIN-HH using the mill nr. 1; 10) PANaCa granulated by milling in Institute of Chemical and Pharmaceutical Research (ICPR); 11) PANaCa granulated by milling in IFIN-HH using the mill nr. 2. The first five samples, marked from 1 to 5, are raw materials and the other six samples, marked from 6 to 11, are the final polyacrylic structures processed by various technological procedures. The samples together with the appropriate reference materials have been irradiated at WWR-S reactor in a neutron flux of 2.5·1012 cm-2s-1 and the induced radioactivity was registered by a HPGe detector (EG/G ORTEC) of 30% efficiency and 2.1 keV resolution. The concentrations of As, Br, Ce, Co, Cr, Fe, La, Sb, Sc, Zn have been determined. For the final polyacrylic structures, except for granulated PANa (sample 6), only the elements Co, Cr, Fe, Sc, Zn were found at the following concentration levels: tens of ppm (Co), ppm (Zn), hundreds of ppb (Cr), tens of ppb (Co), ppb (Co, Sc), 10-1 ppb (Sc). In the granulated PANa, in comparison with the other analyzed final products, similar concentration values were found for Fe, Sc and Zn, higher values
Pharmaceutical policy regarding generic drugs in Belgium.
Simoens, Steven; De Bruyn, Kristien; Bogaert, Marc; Laekeman, Gert
Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies are fuelling the development of generic drug markets in EU countries. However, in Belgium, the market for generic drugs is underdeveloped compared with other countries. To promote the use of generic drugs, the government introduced a reference pricing (RP) scheme in 2001. The aim of this paper is to discuss Belgian pharmaceutical policy regarding generic drugs and to analyse how the Belgian drug market has evolved following initiation of the RP scheme. The market share held by generic drugs increased following implementation of the RP scheme. Focusing on volume, average market share (by semester) for generic drugs amounted to 2.05% of the total pharmaceutical market from January 1998 to June 2001, compared with 6.11% from July 2001 to December 2003. As new generic drugs are introduced, their market share tends to increase in the first couple of months, after which it levels off. Faced with increasing generic competition, some manufacturers have launched new variants of their original drug, thereby effectively extending the period of patent protection. Strategies consisting of price reductions in return for the abolition of prescribing conditions and the launch of new dosages or formulations appear to have been successful in maintaining the market share of original drugs. Nevertheless, the introduction of the RP scheme was associated with savings amounting to 1.8% of pharmaceutical expenditure by the third-party payer in 2001 and 2.1% in 2002. The findings of this paper indicate that the RP scheme has stimulated the Belgian generic drug market. However, existing policy has largely failed to take into account the role that physicians and pharmacists can play in stimulating generic drug use. Therefore, further development of the Belgian generic drug market seems to hinge on the creation of appropriate incentives for physicians to prescribe, and for pharmacists to
Improved survival with early adjuvant chemotherapy after colonic resection for stage III colonic cancer
DEFF Research Database (Denmark)
Klein, Mads; Azaquoun, Najah; Jensen, Benny Vittrup;
BACKGROUND AND OBJECTIVES: In stage III colonic cancer, time from surgery to start of adjuvant chemotherapy may influence survival. In this study, we evaluated the effect of timing of adjuvant therapy on survival. METHODS: Database study from the Danish Colorectal Cancer Group's national database....... RESULTS: The final population included 1,827 patients scheduled for adjuvant chemotherapy. Adjuvant therapy started within 4 and 8 weeks improved survival when compared to start later than 8 weeks (HR [95%CI]: 1.7 [1.1-2.6]; P = 0.024 and 1.4 [1.07-1.8]; P = 0.013, respectively), whereas there was no...
Effects of pharmaceuticals on immune parameters of aquatic invertebrates
Directory of Open Access Journals (Sweden)
V Matozzo
Full Text Available Pharmaceuticals are a large group of chemicals used either by humans for personal health or by agribusiness to enhance the growth and health of livestock. Pharmaceuticals are considered to be emerging environmental contaminants. Indeed, several studies have shown that these compounds continuously enter aquatic ecosystems. Both pharmaceutical consumption and erroneous discharge of unused or expired medications make notable contributions to the introduction of pharmaceuticals into the environment. Additionally, pharmaceuticals consumed by humans and livestock are not entirely absorbed by organisms and are excreted and passed into wastewater and surface water. Although most pharmaceuticals are designed for human consumption, they can affect non-target organisms that share certain homologous receptors with humans. This review intends to summarise the most recent information concerning the effects of some classes of pharmaceuticals on the immune parameters of aquatic invertebrates.
Chitosan Modification and Pharmaceutical/Biomedical Applications
Directory of Open Access Journals (Sweden)
Jiali Zhang
Full Text Available Chitosan has received much attention as a functional biopolymer for diverse applications, especially in pharmaceutics and medicine. Our recent efforts focused on the chemical and biological modification of chitosan in order to increase its solubility in aqueous solutions and absorbability in the in vivo system, thus for a better use of chitosan. This review summarizes chitosan modification and its pharmaceutical/biomedical applications based on our achievements as well as the domestic and overseas developments: (1 enzymatic preparation of low molecular weight chitosans/chitooligosaccharides with their hypocholesterolemic and immuno-modulating effects; (2 the effects of chitin, chitosan and their derivatives on blood hemostasis; and (3 synthesis of a non-toxic ion ligand—D-Glucosaminic acid from Oxidation of D-Glucosamine for cancer and diabetes therapy.
LEARNING ORGANISATION CHALLENGE FOR ROMANIAN PHARMACEUTICAL SMEs
Directory of Open Access Journals (Sweden)
Otilia-Maria BORDEIANU
Full Text Available The concept of the learning organization has gone through many changes both theoretically and also as practical implementation. Learning organizations do not appear automatically, they require a strong commitment for developing the skills needed in the workplace, and this commitment should start from the top of the organization. The learning process should be managed at different levels within the organization. Learning, therefore, is made up of several different components and requires a special management. Successful companies are the result of carefully cultivated attitudes, commitments and management processes. This paper investigates the learning organization dimensions analysed in case of pharmaceutical SMEs from Romania. The results obtained in this study allow us to draw relevant conclusions, constituting a practical starting point for businesses. The paper highlights the fact that SMEs pharmaceutical companies have taken important steps toward learning organization model, but reaching different levels from one key dimension to another.
Radiation sterilization of pharmaceuticals and polymers
International Nuclear Information System (INIS)
Radiation, in the form of high energy electrons as well as gamma radiation, has featured in the last 15 yr as a promising sterilization agent for many heat sensitive and ethylene oxide incompatible pharmaceuticals and polymers of medical usage. This article deals with (i) a comparison of the various methods of sterilization and their shortcomings, (ii) modes of interaction of radiation with matter, (iii) the types of radiation sources in common use, (iv) dosimetry, (v) dose rate effect, (vi) a literature survey of the radiation effect on pharmaceuticals in solid form as well as in aqueous solution and on polymers in the form of plastic medical products and (vii) the evaluation of the irradiated products. The effect of dose rate on the stability of these materials is emphasized. Either very little work has been done on the dose rate effect or the published information is scanty. The literature survey covers the recent period of 5 to 6 years. (author)
Pharmaceutical Applications of Polymeric Nano materials
International Nuclear Information System (INIS)
With significant attention focused on nano science and nano technology in recent years, nano materials have been used in a wide variety of applications such as automotive, environmental, energy, catalysis, biomedical, drug delivery, and polymeric industries. Among those fields, the application of nano materials with pharmaceutical science is an emerging and rapidly growing field and has drawn increasing attention recently. Research and development in this field is mainly focused on several aspects such as the discoveries of novel functional nano materials, exploration on nanoparticles with controlled and targeted drug delivery characteristics, and investigation of bio functionalized and diagnostic nano materials. In this special issue, we have invited a few papers related to recent advances in pharmaceutical application of polymeric nano materials
Physician Agency and Adoption of Generic Pharmaceuticals
Toshiaki Iizuka
I examine physician agency in health care services in the context of the choice between brand-name and generic pharmaceuticals. I examine micro-panel data from Japan, where physicians can legally make profits by prescribing and dispensing drugs. The results indicate that physicians often fail to internalize patient costs, explaining why cheaper generics are infrequently adopted. Doctors respond to markup differentials between the two versions, indicating another agency problem. However, gener...
Prospects for Anti-Biofilm Pharmaceuticals
Stewart, Philip S.
This commentary highlights several avenues currently being pursued in research labs to the development of new anti-biofilm pharmaceuticals. There is a real need for alternative therapeutic modalities for treating the persistent infections that sometimes form on implanted medical devices or compromised niches within the body. Strategies being researched include discovering new antimicrobial agents that kill microorganisms in biofilms more effectively than do existing antibiotics, designing dru...
Community pharmacy: Going beyond dispensing pharmaceuticals
Monge, Ana Catarina
The aim of this study is to understand if it is possible to predict health crisis based on biochemical and physiological measurements made at the pharmacy, and, if needed, refer patients to the doctor. This would avoid emergency services and increase pharmacies' income. Three pharmaceutical consultations were made, where these parameters were measured and the therapeutics registered. The short duration of the study (three months) and the small sample (57 patients) did not allow...
On the Shelf Life of Pharmaceutical Products
Capen, Robert; Christopher, David; Forenzo, Patrick; Ireland, Charles; Liu, Oscar; Lyapustina, Svetlana; O'Neill, John; Patterson, Nate; Quinlan, Michelle; Sandell, Dennis; Schwenke, James; Stroup, Walter; Tougas, Terrence
This article proposes new terminology that distinguishes between different concepts involved in the discussion of the shelf life of pharmaceutical products. Such comprehensive and common language is currently lacking from various guidelines, which confuses implementation and impedes comparisons of different methodologies. The five new terms that are necessary for a coherent discussion of shelf life are: true shelf life, estimated shelf life, supported shelf life, maximum shelf life, and label...
Ecotoxicity and genotoxicity assessment of cytostatic pharmaceuticals
Czech Academy of Sciences Publication Activity Database
Zounková, R.; Odráška, P.; Doležalová, L.; Hilscherová, Klára; Maršálek, Blahoslav; Bláha, Luděk
Roč. 26, č. 10 (2007), s. 2208-2214. ISSN 0730-7268 Grant ostatní: GA MŠk(CZ) 2B06171; ECODIS(XE) 518043-1 Institutional research plan: CEZ:AV0Z60050516 Source of funding: R - rámcový projekt EK Keywords : cytostatic pharmaceuticals * genotoxicity * antineoplastics Subject RIV: EF - Botanics Impact factor: 2.309, year: 2007
Recent advances in pharmaceutical sciences IV
Muñoz-Torrero López-Ibarra, Diego; Manuel Vázquez-Carrera; Estelrich i Latràs, Joan
Like in the three previous editions, this E-book compiles a series of contributions in the multidisciplinary research arena of Pharmaceutical Sciences. The E-book has been organized in 12 chapters, whose main topics belong to the fields of pharmacology, physical chemistry, plant physiology, microbiology, physiology, preventive medicine and public health, food science, botany, clinical pharmacy and pharmacotherapy, organic chemistry, biochemistry and molecular biology, and pa...
Information flow in the pharmaceutical supply chain
Yousefi, Nazila; Alibabaei, Ahmad
Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, man...
Srivastava Saurabh; Rana A.C.; Bala Rajni
Taste is an important factor in the development of dosage form. Nevertheless it is that arena of product development that has been overlooked and undermined for its importance. The problem of bitter and obnoxious taste of is a challenge to the pharmacist in the present scenario. Taste is an important parameter governing compliance. Several oral pharmaceuticals and bulking agents have unpleasant, bitter-tasting components. In numerous cases, the bitter taste modality is an undesirable trait of...
Economic misconceptions in the pharmaceutical industry
George Teeling‐Smith
The pharmaceutical industry has failed to defend itself effectively against criticisms of its economic behaviour, because it has largely failed to understand the factors affecting its own economic structure. These concern the importance of competitive research and pricing, and the need to protect and nurture the fruits of its innovation by the use of patents, brand names and sales promotion. There is still need for a better understanding of the importance of these factors both outside the ind...
Bayesian Design Space applied to Pharmaceutical Development
Lebrun, Pierre
Given the guidelines such as the Q8 document published by the International Conference on Harmonization (ICH), that describe the "Quality by Design" paradigm for the Pharmaceutical Development, the aim of this work is to provide a complete methodology addressing this problematic. As a result, various Design Spaces were obtained for different analytical methods and a manufacturing process. In Q8, Design Space has been defined as the "the multidimensional combination and interaction of input...
Introduction of Tianjin Institute of Pharmaceutical Research
Institute of Scientific and Technical Information of China (English)
Tianjin Institute of Pharmaceutical Research (TIPR),founded in 1959,was ever affiliated to the State Food and Drug Administration,P. R. China (SFDA). It has turned to a wholly state-owned hi-tech enterprise since 2000,mainly focusing on research and development of new drugs. Organization and research direction TIPR's research fields include chemical synthetic medicines,traditional Chinese medicines,pharmacology,
Professiology and Education of Pharmaceutical Industry Specialists
Starostenkova T.A.
The article investigates the pharmaceutical industry professions. In this field, new professions has emerged, and the functions of the traditional ones has changed. Changed are also the content of activities and the level of responsibility of specialists. All this requires improved employees training. Scientific basis for the professional standards, educational standards and educational programs are different job analysis. The author substantiates the need for job description research for dif...
Green chemistry: A tool in Pharmaceutical Chemistry
Smita Talaviya; Falguni Majumdar
Green chemistry expresses an area of research developing from scientific discoveries about pollution awareness and it utilizes a set of principles that reduces or eliminates the use or generation of hazardous substances in all steps of particular synthesis or process. Chemists and medicinal scientists can greatly reduce the risk to human health and the environment by following all the valuable principles of green chemistry. The most simple and direct way to apply green chemistry in pharmaceut...
Radiosterilization of medical products, pharmaceuticals and bioproducts
International Nuclear Information System (INIS)
A Panel on the Radiosterilization of Medical Products, Pharmaceuticals and Bioproducts was convened by the International Atomic Energy Agency on 17-19 January 1966 at its headquarters in Vienna. The purpose of the meeting was to survey the activities of the Member States in this field with a view to preparing the way for an international code of practice for the radiosterilization of medical products, in conformity with existing legal international rules. Refs, figs and tabs
Corporate social responsibility: A pharmaceutical analysis
D. J. Theron
In the modern business environment organisations need to address two important aspects affecting their operations: the quality of management and the impact of their operations on the well-being of the society in which they operate. This dualism often results in economic, political and social dilemmas influencing the viability of organisations in general, and more specifically and recently, local and international pharmaceutical organisations operating in South Africa. This article consi...
Spectrophotometric analysis of Cabergoline in pharmaceutical preparations
Salman, Demet; Dogan, Aysegul; Basci, Nursabah E.
Cabergoline (CAB) is a synthetic ergoline dopamine agonist with high affinity to D2 receptors, thus used for the treatment of Parkinson's patients and hyperprolactinemia disorders. In this study, simple, fast, reliable and validated UV-VIS and 2nd order derivative spectrophotometric methods for determination of CAB in pharmaceutical preparations were developed without any previous sample preparation step. Determination of CAB was performed at 280 nm wavelength by UV-VIS spectrophotometry and ...
Chemical detection of radiosterilization of pharmaceuticals
International Nuclear Information System (INIS)
The radiosterilization of pharmaceuticals is to be encouraged for application to heat sensitive drugs or to ethylene oxide incompatible products, but scientists should focus on the safety of the radiolytic products. The author presents methods of chemical analysis to determine the radiolytic products of drugs after radiosterilization at different doses, and explains that a radiation sterilized drug would be considered as new product in order to establish that any traces of radiolytic products are not toxic. 4 refs
[Alternatives to pharmaceutical distribution and reimbursement].
Meneu, R
In Spain pharmaceutical distribution is carried out mainly thorugh the 20,000 independent pharmacies located throughout the country. This situation contrasts with that in other countries where other health care providers play a major role in drug dispensation or where pharmacies form part of industrial conglomerates or commercial chains. We describe the pharmaceutical distribution chain in Spain wholesale and through the pharmacies and place particular emphasis on five aspects of relevance when considering alternatives: ownership of the pharmacy and norms of professional service, criteria for setting up a pharmacy, monopoly on dispensing, automatic ageement with the Spanish national health system and reimbursement system. Several alternatives found in comparable countries are described: mail order and on-line distribution, sale of over-the counter pharmaceutical products in establishments other than pharmacies, the estabilishment of pharmaceutical chains, dispensing by providers, the repercussions of electronic prescribing and the possibilities of the still-emerging Pharmacuetical Care. The characteristics of pharmacy reimbursement systems are also reviewed. We recommend modification of limitations on ownership of pharmacies, the establishment of optional agreements between pharmacies and the Spanish national health system and the authorization of alternative or complementary channels of distribution for some products. We propose a mixed model of reimbursement that would include: a) a ficed price for dispensing; b) almost total return of the cost of the product; c) reimbursement for services explicity defined by the financer, and d) the possibility of a selective fixed payment for certain situations depending on the agreed services or a guaranteed minimum income. PMID:11958754
Application of radioisotopes in pharmaceutical research
International Nuclear Information System (INIS)
Full text: To use of radioisotopes in the processes of receiving radiopharmaceutical diagnostic means it is widely know [1]. Radioactivity labeled chemical compounds, pharmacological kinetics of which allows one solving a concrete diagnostic problem in an organism are used in radio pharmaceutics. In spite of this choice of the radioisotope, possessing the most favorable nuclei-physical characteristics for it to be detected and minimization of beam loadings, be of great importance. Development of a method of introduction of a radioisotope also has important value, as it is included into chemical structure of a radiopharmaceutical preparation. One more way of use of radioisotopes in pharmaceutics is their use as a radioactive mark at a stage of creation of a new medical product. And in this case, all those moments, which are listed above, take place. Preparations labeling by radioisotopes are used basically for their studying pharmacological kinetics. In Institute of nuclear physics AS RU, in recent years, works are done on studying pharmacological kinetics of some new medical products, which have been synthesized in the Tashkent pharmaceutical institute. These preparations are on the basis of microelements with a complex set of properties possessing expressed biological activity and have great value in pharmaceutical science of Republic of Uzbekistan. Reception of labeled compounds of all preparations was carried out by a method of introduction of a radioisotope at a stage of their synthesis. The work presents the results of researches on synthesis and study of pharmacological kinetics of radioactively labeled preparations - PIRACIN, labeled by radioisotope 69mZn; FERAMED, labeled by radioisotope 59Fe; COBAVIT, labeled by radioisotope 57Co; VUC, labeled by radioisotope57Co
Long-term side effects of adjuvant breast cancer treatment
Buijs, Ciska
Breast cancer is the most common malignancy in women. Breast cancer accounts for one-third of all cancers in females and 24% of the patients are younger than 55 years of age. More than 10% all Dutch women will develop breast cancer and 70-80% of all breast cancer patients will survive over 5 years. In the absence of distant metastases, patients receive loco-regional therapy with or without adjuvant systemic therapy. Loco-regional therapy consists of either a modified radical mastectomy, in so...
Adjuvant chemo-radiation for gastric adenocarcinoma: an institutional experience
International Nuclear Information System (INIS)
Studies have shown that surgery alone is less than satisfactory in the management of early gastric cancer, with cure rates approaching 40%. The role of adjuvant therapy was indefinite until three large, randomized controlled trials showed the survival benefit of adjuvant therapy over surgery alone. Chemoradiation therapy has been criticized for its high toxicity. 24 patients diagnosed between September 2001 and July 2007 were treated with adjuvant chemoradiation. 18 patients had the classical MacDonald regimen of 4500 cGy of XRT and chemotherapy with 5-fluorouracil (5FU) and leucovorin, while chemotherapy consisted of 5FU/Cisplatin for 6 patients. This series consisted of non-metastatic patients, 17 females and 7 males with a median age of 62.5 years. 23 patients (96%) had a performance status of 0 or 1. The full course of radiation therapy (4500 cGy) was completed by 22 patients (91.7%). Only 7 patients (36.8%) completed the total planned courses of chemotherapy. 2 local relapses (10%), 2 regional relapses (10%) and 2 distant relapses (10%) were recorded. Time to progression has not been reached. 9 patients (37.5%) died during follow-up with a median overall survival of 75 months. Patients lost a mean of 4 Kgs during radiation therapy. We recorded 6 episodes of febrile neutropenia and the most frequent toxicity was gastro-intestinal in 17 patients (70.8%) with 9 (36%) patients suffering grade 3 or 4 toxicity and 5 patients (20%) suffering from grade 3 or 4 neutropenia. 4 (17%) patients required total parenteral nutrition for a mean duration of 20 days. 4 patients suffered septic shock (17%) and 1 patient developed a deep venous thrombosis and a pulmonary embolus. Adjuvant chemo-radiation for gastric cancer is a standard at our institution and has resulted in few relapses and an interesting median survival. Toxicity rates were serious and this remains a harsh regimen with only 36.8% of patients completing the full planned courses of chemotherapy. This is due to
Adjuvant chemo-radiation for gastric adenocarcinoma: an institutional experience
Directory of Open Access Journals (Sweden)
Ghosn Marwan G
Full Text Available Abstract Background Studies have shown that surgery alone is less than satisfactory in the management of early gastric cancer, with cure rates approaching 40%. The role of adjuvant therapy was indefinite until three large, randomized controlled trials showed the survival benefit of adjuvant therapy over surgery alone. Chemoradiation therapy has been criticized for its high toxicity. Methods 24 patients diagnosed between September 2001 and July 2007 were treated with adjuvant chemoradiation. 18 patients had the classical MacDonald regimen of 4500 cGy of XRT and chemotherapy with 5-fluorouracil (5FU and leucovorin, while chemotherapy consisted of 5FU/Cisplatin for 6 patients. Results This series consisted of non-metastatic patients, 17 females and 7 males with a median age of 62.5 years. 23 patients (96% had a performance status of 0 or 1. The full course of radiation therapy (4500 cGy was completed by 22 patients (91.7%. Only 7 patients (36.8% completed the total planned courses of chemotherapy. 2 local relapses (10%, 2 regional relapses (10% and 2 distant relapses (10% were recorded. Time to progression has not been reached. 9 patients (37.5% died during follow-up with a median overall survival of 75 months. Patients lost a mean of 4 Kgs during radiation therapy. We recorded 6 episodes of febrile neutropenia and the most frequent toxicity was gastro-intestinal in 17 patients (70.8% with 9 (36% patients suffering grade 3 or 4 toxicity and 5 patients (20% suffering from grade 3 or 4 neutropenia. 4 (17% patients required total parenteral nutrition for a mean duration of 20 days. 4 patients suffered septic shock (17% and 1 patient developed a deep venous thrombosis and a pulmonary embolus. Conclusions Adjuvant chemo-radiation for gastric cancer is a standard at our institution and has resulted in few relapses and an interesting median survival. Toxicity rates were serious and this remains a harsh regimen with only 36.8% of patients completing the
Corporate social responsibility: A pharmaceutical analysis
Directory of Open Access Journals (Sweden)
D. J. Theron
Full Text Available In the modern business environment organisations need to address two important aspects affecting their operations: the quality of management and the impact of their operations on the well-being of the society in which they operate. This dualism often results in economic, political and social dilemmas influencing the viability of organisations in general, and more specifically and recently, local and international pharmaceutical organisations operating in South Africa. This article considers the aspect of corporate social responsibility (CSR in general and attempts to identify the social-related issues impacting on the pharmaceutical industry by means of content analysis - a research technique for making replicable and valid inferences from data. It furthermore describes the re-action of pharmaceutical organisations when confronted with such social demands, and finally analyses the management of CSR against four criteria of CSR. The article confirms the importance of managers to manage CSR towards society in a proactive manner. It furthermore suggests that the "hard" factors of strategic management and financial performance should be balanced with "soft" social/people issues. It also recommends that the industry should consider - and if applicable - endorse the concept of Issues Management as an approach to the proactive management of CSR.
Pharmaceutical applications of supercritical carbon dioxide.
Kaiser, C S; Römpp, H; Schmidt, P C
The appearance of a supercritical state was already observed at the beginning of the 19th century. Nevertheless, the industrial extraction of plant and other natural materials started about twenty years ago with the decaffeination of coffee. Today carbon dioxide is the most common gas for supercritical fluid extraction in food and pharmaceutical industry. Since pure supercritical carbon dioxide is a lipophilic solvent, mixtures with organic solvents, especially alcohols, are used to increase the polarity of the extraction fluid; more polar compounds can be extracted in this way. The main fields of interest are the extraction of vegetable oils from plant material in analytical and preparative scale, the preparation of essential oils for food and cosmetic industry and the isolation of substances of pharmaceutical relevance. Progress in research was made by the precise measurement of phase equilibria data by means of different methods. Apart from extraction, supercritical fluid chromatography was introduced in the field of analytics, as well as micro- and nanoparticle formation using supercritical fluids as solvent or antisolvent. This review presents pharmaceutical relevant literature of the last twenty years with special emphasis on extraction of natural materials. PMID:11802652
Defining Patient Centric Pharmaceutical Drug Product Design.
Stegemann, Sven; Ternik, Robert L; Onder, Graziano; Khan, Mansoor A; van Riet-Nales, Diana A
The term "patient centered," "patient centric," or "patient centricity" is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient's quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that the pharmaceutical drug product design is also adequately addressing the particular patient's needs, i.e., assuring adequate patient adherence and the anticipate drug safety and effectiveness. Relevant pharmaceutical design aspects may e.g., involve the selection of the route of administration, the tablet size and shape, the ease of opening the package, the ability to read the user instruction, or the ability to follow the recommended (in-use) storage conditions. Currently, a harmonized definition on patient centric drug development/design has not yet been established. To stimulate scientific research and discussions and the consistent interpretation of test results, it is essential that such a definition is established. We have developed a first draft definition through various rounds of discussions within an interdisciplinary AAPS focus group of experts. This publication summarizes the outcomes and is intended to stimulate further discussions with all stakeholders towards a common definition of patient centric pharmaceutical drug product design that is useable across all disciplines involved. PMID:27317470
Soft condensed matter in pharmaceutical design.
Paradossi, Gaio; Cavalieri, Francesca; Chiessi, Ester
In recent years pharmaceutical design has been facing the needs expressed by new therapeutic methodologies such as gene therapy, targeted delivery and closely related diagnostic fields as contrast enhancing agents for ultrasonic investigations. In this context pharmaceutical research has diversified the efforts toward a more integrated approach where the efficacy of an active molecule is enhanced and assisted by the surrounding carrier. Usually this drug platform is a hydrogel matrix, a multicomponent system constituted by an aqueous solution and a polymeric moiety imparting different functions to the matrix, as responsiveness to external stimuli, affinity to receptors, controlled drug release. Such devices represent one of the leading topics of the soft condensed matter recent research, a domain where physics, chemistry and bioengineering cross each other with the aim to achieve an integrated description of these materials. In this respect modern drug design will make use more and more of concepts proper of soft condensed polymer and colloidal sciences. In this review we will describe the state-of-art in the field of the matrices used in innovative drug formulations with a particular emphasis on the implications to pharmaceutical design along with the experimental and theoretical investigation tools worked out in the last decade. PMID:16611124
Systems Medicine in Pharmaceutical Research and Development.
Kuepfer, Lars; Schuppert, Andreas
The development of new drug therapies requires substantial and ever increasing investments from the pharmaceutical company. Ten years ago, the average time from early target identification and optimization until initial market authorization of a new drug compound took more than 10 years and involved costs in the order of one billion US dollars. Recent studies indicate even a significant growth of costs in the meanwhile, mainly driven by the increasing complexity of diseases addressed by pharmaceutical research.Modeling and simulation are proven approaches to handle highly complex systems; hence, systems medicine is expected to control the spiral of complexity of diseases and increasing costs. Today, the main focus of systems medicine applications in industry is on mechanistic modeling. Biological mechanisms are represented by explicit equations enabling insight into the cooperation of all relevant mechanisms. Mechanistic modeling is widely accepted in pharmacokinetics, but prediction from cell behavior to patients is rarely possible due to lacks in our understanding of the controlling mechanisms. Data-driven modeling aims to compensate these lacks by the use of advanced statistical and machine learning methods. Future progress in pharmaceutical research and development will require integrated hybrid modeling technologies allowing realization of the benefits of both mechanistic and data-driven modeling. In this chapter, we sketch typical industrial application areas for both modeling techniques and derive the requirements for future technology development. PMID:26677181
Future Perspectives of Pharmaceutical Research and Development
Directory of Open Access Journals (Sweden)
Shein-Chung Chow
Full Text Available As more and more innovative drug products (e.g., chemical drug and biological drug products are going off patent protection, the development of generics/biosimilars products have become the center of attention of many pharmaceutical companies. In addition, as new drug research and development has reached the bottle-neck, the pharmaceutical industry begin to focus on the search for new or alternative medicines such as traditional Chinese medicine that can treat critical and/or life-threatening diseases. To ensure that there is high probability of success, advanced technology and/or methodology and innovative thinking of trial designs are necessarily applied. The advanced technology/methodology include two-way translational process from bench-to-bedside in translational research, micro-dosing approach for safety evaluation, and big-data analytics for identifying hidden clinical benefits of some test treatments. The innovative thinking of trial designs are referred to adaptive trial designs for identifying optimal clinical benefits of the test treatment under investigation and/or biomarker induced targeted clinical trials for personalized (precision medicine. Along this line, this short commentary provides perspectives of future pharmaceutical development of biosimilar products and traditional Chinese medicine.
Innovation strategies of Mexican pharmaceutical firms
Directory of Open Access Journals (Sweden)
José Luis Solleiro
Full Text Available Mexican pharmaceutical market is the most important in Latin America and a significant number of global firms have different business activities in this country: production, licensing of patents, alliances with Mexican firms, distribution facilities or partnerships, etc. In terms of innovation, global pharmaceutical industry has passed through structural changes mainly of technological and institutional nature. These changes have been influential along the whole value chain and have triggered transformations in firm's organization, market structure and sector's investments. Mexico's industry, in spite of having a very attractive domestic market, has serious limitations for technology development. Very little resources are invested in R&D and lack of articulation between research labs and industry provoke that Mexico has only exceptional innovation achievements and a high technological dependence. At the same time, some Mexican companies have developed new strategies to be competitive in open markets and have shown that a combination of competitive intelligence, rapid adoption of technologies, collaboration with advanced firms and research institutes, permanent training and continuous improvement are key factors for success. This paper deals with the results of a piece of research aimed at developing a model for the effective transfer of technology for Mexican pharmaceutical firms, with a strong component of knowledge and skills to manage the flows of information, people and technologies among firms, research labs, universities and other health organizations.
Directory of Open Access Journals (Sweden)
Shailender Mohan
Full Text Available Due to various advantages such as high-precision dosing, manufacturing efficiency and patient compliance helped making tablets the most popular dosage forms among all available dosages forms. Compaction, which is an essential manufacturing step in the manufacture of tablets, mainly includes compression (i.e. reduction of volume of the powder under consideration and particle rearrangement and consolidation (i.e., formation of interparticulate bond to facilitate stable compaction. The success of the compaction process depends not only on the physico-technical properties of drugs and excipients, but also on the instrument settings with respect to rate and magnitude of force transfer. Tablet manufacturing speed and pre/main compression force profile also have an influence on the quality of the final tablet. Mechanical aspects of tablet formation can be studied using, instrumented punches/dies, instrumented tablet punching machines, and compaction simulators. These have potential application in pharmaceutical research and development, such as studying basic compaction mechanism, various process variables, scale-up parameters, trouble shooting problems, creating compaction data library, and fingerprinting of new active pharmaceutical ingredients (APIs or excipients. Mathematical models, force-time, force-distance, and die-wall force parameters of tablet manufacturing are used to describe work of compaction, elasticity/plasticity, and time dependent deformation behavior of pharmaceuticals powder under consideration.
Directory of Open Access Journals (Sweden)
Ershova Elena Vladimirovna
Full Text Available This article reviews the issues associated with development of an integrated quality management system and its implementation into a galenical pharmaceutical company. Recently, the Russian pharmaceutical industry has been developing extensively: pharmaceutical clusters are being formed, new and innovative technologies are being developed. For the enterprises producing galenical pharmaceutical products, which feature low prices and a high level of competition, development and implementation of management systems is a way to prove their competitiveness. The purpose of this article is to review the architecture and the key elements of integrated management systems for pharmaceutical enterprises, develop an integrated management system in terms of the upcoming revision of ISO 9001:2015, as well as to describe the benefits of implementation of such systems. The presented approach is the result of an educational project implemented within the framework of the MBA programme in "Master of Business Administration (MBA" in the Federal State Budgetary Educational Institution of Continuing Professional Education Pastukhov State Academy of Industrial Management.
Pharmaceutical care in transplant patients in a university hospital: pharmaceutical interventions
Directory of Open Access Journals (Sweden)
Bruna Cristina Cardoso Martins
Full Text Available A descriptive and prospective study was conducted on the pharmaceutical care in the post-transplant outpatient clinic of Hospital Universitario Walter Cantidio of Universidade Federal do Ceará (HUWC/UFC, in Fortaleza- Ceará in the period of April to October of 2011. The aim of the present study was to describe the pharmaceutical interventions performed in a Pharmaceutical Care service structured in the liver and kidney transplant outpatient clinic of an academic hospital. The Pharmaceutical interventions (PI were classified according to Sabater et al.(2005, with significance based on Riba et al.(2000 and the Negative Outcomes associated with Medication (NOM established at the Third Consensus of Granada. Statistical analyses were performed using the Epi Info v.3.5.1 program and hypothesis tests were done with the SigmaPlot v.10.0 program. A chi-squared (X² test was utilized for statistical analysis of the sample. A total of 97 patients were followed, where 54 problems related to medications were identified and 139 PI performed. The main PI were in education of the patient about treatment (n=111; 80% (p<0.05, while the significance of all interventions were appropriate, where 83.4% (n=116 of PI performed in the study period were shown to be "significant" (p<0.05. Through pharmaceutical care, the pharmacist is capable of monitoring the pharmacotherapeutic treatment and intervening when necessary, while being part of the multiprofessional team caring for the transplant patient.
Who Benefits From Adjuvant Radiation Therapy for Gastric Cancer? A Meta-Analysis
International Nuclear Information System (INIS)
Purpose: Large randomized trials have demonstrated significant survival benefits with the use of adjuvant chemotherapy or chemoradiation therapy for gastric cancer. The importance of adjuvant radiation therapy (RT) remains unclear. We performed an up-to-date meta-analysis of randomized trials testing the use of RT for resectable gastric cancer. Methods and Materials: We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials for randomized trials testing adjuvant (including neoadjuvant) RT for resectable gastric cancer. Hazard ratios describing the impact of adjuvant RT on overall survival (OS) and disease-free survival (DFS) were extracted directly from the original studies or calculated from survival curves. Pooled estimates were obtained using the inverse variance method. Subgroup analyses were performed to determine whether the efficacy of RT varies with chemotherapy use, RT timing, geographic region, type of nodal dissection performed, or lymph node status. Results: Thirteen studies met all inclusion criteria and were used for this analysis. Adjuvant RT was associated with a significant improvement in both OS (HR = 0.78, 95% CI: 0.70-0.86, P<.001) and DFS (HR = 0.71, 95% CI: 0.63-0.80, P<.001). In the 5 studies that tested adjuvant chemoradiation therapy against adjuvant chemotherapy, similar effects were seen for OS (HR = 0.83, 95% CI: 0.67-1.03, P=.087) and DFS (HR = 0.77, 95% CI: 0.91-0.65, P=.002). Available data did not reveal any subgroup of patients that does not benefit from adjuvant RT. Conclusion: In randomized trials for resectable gastric cancer, adjuvant RT provides an approximately 20% improvement in both DFS and OS. Available data do not reveal a subgroup of patients that does not benefit from adjuvant RT. Further study is required to optimize the implementation of adjuvant RT for gastric cancer with regard to patient selection and integration with systemic therapy
Development of Novel Protocol for Preclinical Monitoring the Release of Adjuvants Encapsulated Mucosal Delivery Carriers
Directory of Open Access Journals (Sweden)
Mohamed Ibrahim-Saeed
Full Text Available This work contributes in vaccines down-stream process by introducing a novel platform for in-vitro monitoring of vaccine-adjuvant delivery profile as a crucial preclinical optimizing step in mucosal vaccines. Nano and micro particles of Calcium phosphate (Cap vaccine-adjuvant were encapsulated in Chitosan and Alginate polymeric carriers. Adjuvants release profiles monitored in a permeable bag at 37°C, pH 2, incubated in isotonic buffer for 96 hours. The released Calcium in the outer buffer was monitored and compared in-addition to the carrier's swelling and biophysical properties. The adjuvants and carriers did not interfere with the proliferation of cultured hepatocytes an indicator of their safe use; Chitosan's viscosity and swelling were higher than Alginate. Chitosan's Zeta-potential was significantly high positive, while Cap and Alginate were negative. The prepared CaP and Chitosan particles were in nano-size, while the ready-made CaP adjuvant and Alginate were in micro-size using zeta-seizer and scanning electron-micrograph. The release of nano-size particle was in ascending, extended and controlled manner compared to micro-size adjuvant. Moreover, nano-adjuvant release profile from Chitosan was superior compared to Alginate. The core controlling factors in vaccine-adjuvant sustained release includes; smaller adjuvant particles (nano-size, carrier's low swelling, high viscosity and importantly carrier-adjuvant entrapment reversibility. Chitosan offers sustained ascending superior capacity in releasing Nano-Cap adjuvant. This novel in-vitro pre-clinical study answer a crucial downstream preparative step for optimizing mucosal vaccines before their direct routine in-vivo trial on animal regardless of adjuvant's particle size or delivery kinetics.
[The Korean Pharmaceutical Industry and the Expansion of the General Pharmaceuticals Market in the 1950-1960s].
Sihn, Kyu-Hwan
After the Liberation, the Korean economy was dependent on relief supplies and aid after the ruin of the colonial regime and war. The pharmaceutical business also searched for their share in the delivery of military supplies and the distribution of relief supplies. The supply-side pharmaceutical policy made the pharmaceutical market a wholesale business. The gravity of the situation led to an increased importation of medical supplies, and wholesalers took the lead in establishing the distribution structure, whereas consumers and pharmaceutical business were relatively intimidated. The aid provided by the International Cooperation Administration (ICA) marked a turning point in the Korean pharmaceutical industry after the middle of the 1950s. ICA supplied raw materials and equipment funds, while the pharmaceutical business imported advanced technology and capital. The government invited the local production of medical substances, whereas pharmaceutical businesses replaced imported medical substances with locally produced antibiotics. After the 1960s, the production of antibiotics reached saturation. Pharmaceutical businesses needed new markets to break through the stalemate, so they turned their attention to vitamins and health tonics as general pharmaceuticals, as these were suitable for mass production and mass consumption. The modernized patent medicine market after the Opening of Korea was transformed into the contemporized general pharmaceuticals market equipped with the up-to-date facilities and technology in 1960s. Pharmaceutical businesses had to advertise these new products extensively and reform the distribution structure to achieve high profits. With the introduction of TV broadcasting, these businesses invested in TV advertising and generated sizable sales figures. They also established retail pharmacy and chain stores to reform the distribution structure. The end result was a dramatic expansion of the general pharmaceuticals market. The market for
Suppressive effects of QFGJS, a preparation from an anti-arthritic herbal formula, on rat experimental adjuvant-induced arthritis
International Nuclear Information System (INIS)
To analyze the anti-arthritic effects of QFGJS (a pharmaceutical preparation from herbs) on rheumatoid arthritis, adjuvant-induced arthritis (AIA) was established in male SD rats, and two administration protocols, i.e., oral treatment with different doses of QFGJS on the day of arthritis induction or on the day when visible clinical signs of arthritis occurred, were initiated and continued until day 30. Treatments with QFGJS using both administration protocols significantly suppressed the incidence and severity of arthritis in a dose-dependent manner, showing dramatic reduction of paw swelling and ESR throughout the disease progression of AIA. Radiological and histopathological examinations showed markedly decreased tissue and bone destruction of ankle joints in the QFGJS-treated rats. The serum levels of TNF-α, IL-1β, and IL-6 were significantly decreased in the QFGJS-treated rats. QFGJS demonstrates pronounced anti-arthritic effects on AIA, indicating that this herbal preparation would be a potent candidate as a novel botanical drug for further investigation
Adjuvant radiation therapy in metastatic lymph nodes from melanoma
International Nuclear Information System (INIS)
To analyze the outcome after adjuvant radiation therapy with standard fractionation regimen in metastatic lymph nodes (LN) from cutaneous melanoma. 86 successive patients (57 men) were treated for locally advanced melanoma in our institution. 60 patients (69%) underwent LN dissection followed by radiation therapy (RT), while 26 patients (31%) had no radiotherapy. The median number of resected LN was 12 (1 to 36) with 2 metastases (1 to 28). Median survival after the first relapse was 31.8 months. Extracapsular extension was a significant prognostic factor for regional control (p = 0.019). Median total dose was 50 Gy (30 to 70 Gy). A standard fractionation regimen was used (2 Gy/fraction). Median number of fractions was 25 (10 to 44 fractions). Patients were treated with five fractions/week. Patients with extracapsular extension treated with surgery followed by RT (total dose ≥50 Gy) had a better regional control than patients treated by surgery followed by RT with a total dose <50 Gy (80% vs. 35% at 5-year follow-up; p = 0.004). Adjuvant radiotherapy was able to increase regional control in targeted sub-population (LN with extracapsular extension)
Preparation and evaluation of functional foods in adjuvant arthritis
Energy Technology Data Exchange (ETDEWEB)
Al-Okbi, S. Y.; Mohamed, D. A.
Adjuvant arthritis is an animal model that closely resembles rheumatoid arthritis in humans. It is a successful working model used to study new anti-inflammatory agents. In previous studies (animal and clinical) we have shown that evening primrose oil, fish oil and the methanol extract of date fruits and fenugreek seeds have anti-inflammatory activity and that the methanol extract of dates has an antioxidant effect. Based on these studies, the aim of the present study was to prepare 7 functional foods containing such bioactive fractions separately or in combination and to evaluate them in adjuvant arthritis in rats, study the stability of bioactive ingredients and evaluate their sensory properties. The studied biochemical parameters were erythrocyte sedimentation rate, erythrocyte superoxide dismutase, glutathione peroxidase and plasma copper, zinc and interlukin 2. Nutritional parameters, including body weight gain, food intake and food efficiency ratio were monitored during the feeding of the functional foods. The bioactive ingredients assessed were total phenolic contents and fatty acids. The results showed improvement in the biochemical parameters, body weight gain and food efficiency ratio of arthritic rats fed on the functional foods with different degrees. All the prepared functional foods were sensory accepted. The active ingredients showed stability during storage. In conclusion, all the tested functional foods showed promising antiinflammatory activity and were determined to be acceptable through sensory evaluation which means that their potential beneficial use as dietary supplements in rheumatoid arthritis patients may be recommended. (Author) 42 refs.
Adjuvant chemoradiotherapy for adenocarcinoma of the stomach. A new progress?
International Nuclear Information System (INIS)
Frequency of local and distant failures after gastrectomy has led to extended lymph nodes dissection to obtain a better locoregional control. However, five year survival rates were not significantly different between patients undergoing D2 and D1 lymphadenectomy, and higher morbidity and post operative deaths were reported in large randomized trials (respectively 25% vs 48% and 4 vs 13%). Additionally, several met-analysis failed to demonstrate a significant survival advantage with adjuvant chemotherapy. The results of the first trial demonstrating one advantage to adjuvant post-operative chemoradiotherapy should modify the standard care. Disease free and overall survival after surgery alone and after surgery and concurrent chemoradiotherapy were respectively 31% vs 48% and 41% vs 50%. The inter-group trial demonstrate that better local control improve survival if radiation fields include stamps, tumour bed, proximal nodal chains and nodes corresponding to D2 extended lymph nodes dissection. Treatment was feasible with few severe toxic effects (1%). Of the 281 patients, 17% stopped treatment because toxic effects. Technical modalities of radiotherapy and post-operative nutrition support which are critical points of interest for this treatment, are also discussed. (authors)
Alginate Nanoparticles as a Promising Adjuvant and Vaccine Delivery System
Directory of Open Access Journals (Sweden)
F Sarei
Full Text Available During last decades, diphtheria has remained as a serious disease that still outbreaks and can occur worldwide. Recently, new vaccine delivery systems have been developed by using the biodegradable and biocompatible polymers such as alginate. Alginate nanoparticles as a carrier with adjuvant and prolong release properties that enhance the immunogenicity of vaccines. In this study diphtheria toxoid loaded nanoparticles were prepared by ionic gelation technique and characterized with respect to size, zeta potential, morphology, encapsulation efficiency, release profile, and immunogenicity. Appropriate parameters (calcium chloride and sodium alginate concentration, homogenization rate and homogenization time redounded to the formation of suitable nanoparticles with a mean diameter of 70±0.5 nm. The loading studies of the nanoparticles resulted in high loading capacities (>90% and subsequent release studies showed prolong profile. The stability and antigenicity of toxoid were evaluated by sodium dodecyl sulfate polyacrylamide gel electrophoresis and ouchterlony test and proved that the encapsulation process did not affect the antigenic integrity and activity. Guinea pigs immunized with the diphtheria toxoid-loaded alginate nanoparticles showed highest humoral immune response than conventional vaccine. It is concluded that, with regard to the desirable properties of nanoparticles and high immunogenicity, alginate nanoparticles could be considered as a new promising vaccine delivery and adjuvant system.
Exercise as an Adjuvant Therapy for Hematopoietic Stem Cell Mobilization
Emmons, Russell; Niemiro, Grace M.; De Lisio, Michael
Hematopoietic stem cell transplant (HSCT) using mobilized peripheral blood hematopoietic stem cells (HSPCs) is the only curative strategy for many patients suffering from hematological malignancies. HSPC collection protocols rely on pharmacological agents to mobilize HSPCs to peripheral blood. Limitations including variable donor responses and long dosing protocols merit further investigations into adjuvant therapies to enhance the efficiency of HSPCs collection. Exercise, a safe and feasible intervention in patients undergoing HSCT, has been previously shown to robustly stimulate HSPC mobilization from the bone marrow. Exercise-induced HSPC mobilization is transient limiting its current clinical potential. Thus, a deeper investigation of the mechanisms responsible for exercise-induced HSPC mobilization and the factors responsible for removal of HSPCs from circulation following exercise is warranted. The present review will describe current research on exercise and HSPC mobilization, outline the potential mechanisms responsible for exercise-induced HSPC mobilization, and highlight potential sites for HSPC homing following exercise. We also outline current barriers to the implementation of exercise as an adjuvant therapy for HSPC mobilization and suggest potential strategies to overcome these barriers. PMID:27123008
Dynamics of antigen delivery and the functional roles of L121-adjuvant.
Shen, Shan-Shan; Yang, Ya-Wun
This study investigates the intracellular transport of protein antigens facilitated by L121-adjuvants and examines the associated cytotoxic T lymphocyte (CTL) effect. EL4 mouse thymoma cells were treated with L121-adjuvant and stained with AnnexinV-propidium iodide (PI) followed by flow cytometric analysis. The intracellular trafficking dynamics of bovine serum albumin (BSA)-FITC in the J774.A.1 macrophages, influenced by the L121-adjuvant, was visualized by confocal microscopy. The antigen-specific cytotoxic T lymphocyte (CTL) effect induced by the L121-adjuvant was determined by the cleavage-specific fluorogenic caspase substrate. The trafficking of BSA-FITC in the J774A.1 cells by confocal microscopy illustrated that the L121-adjuvant facilitated the intracellular transport of proteins to the subcellular compartments, including the lysosome, endoplasmic reticulum (ER), and the cis-Golgi apparatus. The L121-adjuvant also facilitated antigen delivery to the dendritic cells in the lymph nodes. Immunization of mice with the L121-adjuvant resulted in cell-mediated cytotoxic responses in the target cells, as detected by PhiPhiLux, a fluorogenic caspase substrate. Taken together, the L121-adjuvant improved the dynamics of protein delivery to antigen presenting cells, and also induced caspase activation, thereby illustrating the mechanism of antigen-specific CTL effects. PMID:25917678
Aluminum hydroxide adjuvant differentially activates the three complement pathways with major involvement of the alternative pathway
DEFF Research Database (Denmark)
Güven, Esin; Duus, Karen; Laursen, Inga;
Al(OH)3 is the most common adjuvant in human vaccines, but its mode of action remains poorly understood. Complement involvement in the adjuvant properties of Al(OH)3 has been suggested in several reports together with a depot effect. It is here confirmed that Al(OH)3 treatment of serum depletes c...
Unraveling molecular signatures of immunostimulatory adjuvants in the female genital tract through systems biology.
Directory of Open Access Journals (Sweden)
Madelene Lindqvist
Full Text Available Sexually transmitted infections (STIs unequivocally represent a major public health concern in both industrialized and developing countries. Previous efforts to develop vaccines for systemic immunization against a large number of STIs in humans have been unsuccessful. There is currently a drive to develop mucosal vaccines and adjuvants for delivery through the genital tract to confer protective immunity against STIs. Identification of molecular signatures that can be used as biomarkers for adjuvant potency can inform rational development of potent mucosal adjuvants. Here, we used systems biology to study global gene expression and signature molecules and pathways in the mouse vagina after treatment with two classes of experimental adjuvants. The Toll-like receptor 9 agonist CpG ODN and the invariant natural killer T cell agonist alpha-galactosylceramide, which we previously identified as equally potent vaginal adjuvants, were selected for this study. Our integrated analysis of genome-wide transcriptome data determined which signature pathways, processes and networks are shared by or otherwise exclusive to these 2 classes of experimental vaginal adjuvants in the mouse vagina. To our knowledge, this is the first integrated genome-wide transcriptome analysis of the effects of immunomodulatory adjuvants on the female genital tract of a mammal. These results could inform rational development of effective mucosal adjuvants for vaccination against STIs.
Antibody response in silver catfish (Rhamdia quelen) immunized with a model antigen associated with different adjuvants.
Pavan, T R; Di Domenico, J; Kirsten, K S; Nied, C O; Frandoloso, R; Kreutz, L C
Adjuvants are essential to boost the immune response to inoculated antigen and play a central role in vaccine development. In this study, we investigated the efficacy of several adjuvants in the production of anti-bovine serum albumin (BSA) antibodies in silver catfish. Two hundred and seventy juvenile silver catfish (60-80 g) of both sexes were intraperitoneally vaccinated with BSA (200 µg/fish) alone or mixed to the following adjuvants: Freund's complete adjuvant (FCA), Freund's incomplete adjuvant (FIA), aluminum hydroxide (AlOH), Montanide, four types of cytosine-phosphate-guanine (CpG) oligodeoxynucleotides (ODNs) and three concentrations of β-glucan, and the immune enhancing property was evaluated by measuring anti-BSA antibodies in blood samples at biweekly intervals. Our results demonstrated that CpGs ODNs and β-glucan were as effective as classical adjuvants (FCA, FIA, AlOH and Montanide) in promoting anti-BSA antibodies and that the kinetics of antibody production induced by all adjuvants used in our study had a similar trend to that observed in other fish species, with a peak at 28 days post-vaccination. These results may be useful for the selection of adjuvants for vaccine formulation intended for silver catfish and for the development of vaccine and vaccination strategies to other fish species. PMID:27464022
Current adjuvant treatment modalities for gastric cancer: From history to the future.
Kilic, Leyla; Ordu, Cetin; Yildiz, Ibrahim; Sen, Fatma; Keskin, Serkan; Ciftci, Rumeysa; Pilanci, Kezban Nur
The discrepancy between the surgical technique and the type of adjuvant chemotherapy used in clinical trials and patient outcomes in terms of overall survival rates has led to the generation of different adjuvant treatment protocols in distinct parts of the world. The adjuvant treatment recommendation is generally chemoradiotherapy in the United States, perioperative chemotherapy in the United Kingdom and parts of Europe, and chemotherapy in Asia. These options mainly rely on the United States Intergroup-0116, United Kingdom British Medical Research Council Adjuvant Gastric Infusional Chemotherapy, and the Asian Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer and Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer trials. However, the benefits were evident for only certain patients, which were not very homogeneous regarding the type of surgery, chemotherapy regimens, and stage of disease. Whether the dissimilarities in survival are attributable to surgical technique or intrinsic biological differences is a subject of debate. Regardless of the extent of surgery, multimodal therapy may offer modest survival advantage at least for diseases with lymph node involvement. Moreover, in the era of individualized treatment for most of the other cancer types, identification of special subgroups comprising those who will derive more or no benefit from adjuvant therapy merits further investigation. The aim of this review is to reveal the historical evolution and future reflections of adjuvant treatment modalities for resected gastric cancer patients. PMID:27190583
Enhanced Protection against Bovine Tuberculosis after Coadministration of Mycobacterium bovis BCG with a Mycobacterial Protein Vaccine-Adjuvant Combination but Not after Coadministration of Adjuvant Alone▿
Wedlock, D. Neil; Denis, Michel; Painter, Gavin F; Ainge, Gary D.; Vordermeier, H. Martin; Hewinson, R Glyn; Buddle, Bryce M.
Current efforts are aimed at optimizing the protective efficacy of Mycobacterium bovis BCG by the use of vaccine combinations. We have recently demonstrated that the protection afforded by BCG alone is enhanced by vaccinating cattle with a combination of vaccines comprising BCG and a protein tuberculosis vaccine, namely, culture filtrate proteins (CFPs) from M. bovis plus an adjuvant. In the current study, three different adjuvant systems were compared. The CFP was formulated with a depot adj...
Cell Recruitment and Cytokines in Skin Mice Sensitized with the Vaccine Adjuvants: Saponin, Incomplete Freund's Adjuvant, and Monophosphoryl Lipid A
Vitoriano-Souza, Juliana; Moreira, Nádia das Dores; Teixeira-Carvalho, Andréa; Carneiro, Cláudia Martins; Siqueira, Fernando Augusto Mathias; Vieira, Paula Melo de Abreu; Giunchetti, Rodolfo Cordeiro; Moura, Sandra Aparecida de Lima; Fujiwara, Ricardo Toshio; Melo, Maria Norma; Reis, Alexandre Barbosa
Vaccine adjuvants are substances associated with antigens that are fundamental to the formation of an intense, durable, and fast immune response. In this context, the use of vaccine adjuvants to generate an effective cellular immune response is crucial for the design and development of vaccines against visceral leishmaniasis. The objective of this study was to evaluate innate inflammatory response induced by the vaccine adjuvants saponin (SAP), incomplete Freund's adjuvant (IFA), and monophosphoryl lipid A (MPL). After a single dose of adjuvant was injected into the skin of mice, we analyzed inflammatory reaction, selective cell migration, and cytokine production at the injection site, and inflammatory cell influx in the peripheral blood. We found that all vaccine adjuvants were able to promote cell recruitment to the site without tissue damage. In addition, they induced selective migration of neutrophils, macrophages, and lymphocytes. The influx of neutrophils was notable at 12 h in all groups, but at other time points it was most evident after inoculation with SAP. With regard to cytokines, the SAP led to production of interleukin (IL)-2, IL-6, and IL-4. IFA promoted production of tumor necrosis factor (TNF)-α, interferon (IFN)-γ, IL-6, IL-17, IL-4, and IL-10. We also observed that MPL induced high production of IL-2, TNF-α, and IFN-γ, in addition to IL-6, IL-17, and IL-10. In peripheral blood, values of certain cell populations in the local response changed after stimulation. Our data demonstrate that the three vaccine adjuvants stimulate the early events of innate immune response at the injection site, suggesting their ability to increase the immunogenicity of co-administered antigens. Moreover, this work provides relevant information about elements of innate and acquired immune response induced by vaccine adjuvants administered alone. PMID:22829882
Antibody-antigen-adjuvant conjugates enable co-delivery of antigen and adjuvant to dendritic cells in cis but only have partial targeting specificity.
Directory of Open Access Journals (Sweden)
Martin Kreutz
Full Text Available Antibody-antigen conjugates, which promote antigen-presentation by dendritic cells (DC by means of targeted delivery of antigen to particular DC subsets, represent a powerful vaccination approach. To ensure immunity rather than tolerance induction the co-administration of a suitable adjuvant is paramount. However, co-administration of unlinked adjuvant cannot ensure that all cells targeted by the antibody conjugates are appropriately activated. Furthermore, antigen-presenting cells (APC that do not present the desired antigen are equally strongly activated and could prime undesired responses against self-antigens. We, therefore, were interested in exploring targeted co-delivery of antigen and adjuvant in cis in form of antibody-antigen-adjuvant conjugates for the induction of anti-tumour immunity. In this study, we report on the assembly and characterization of conjugates consisting of DEC205-specific antibody, the model antigen ovalbumin (OVA and CpG oligodeoxynucleotides (ODN. We show that such conjugates are more potent at inducing cytotoxic T lymphocyte (CTL responses than control conjugates mixed with soluble CpG. However, our study also reveals that the nucleic acid moiety of such antibody-antigen-adjuvant conjugates alters their binding and uptake and allows delivery of the antigen and the adjuvant to cells partially independently of DEC205. Nevertheless, antibody-antigen-adjuvant conjugates are superior to antibody-free antigen-adjuvant conjugates in priming CTL responses and efficiently induce anti-tumour immunity in the murine B16 pseudo-metastasis model. A better understanding of the role of the antibody moiety is required to inform future conjugate vaccination strategies for efficient induction of anti-tumour responses.
Quality of adjuvant CMF chemotherapy for node-positive primary breast cancer : a population-based study
Schaapveld, M; de Vries, EGE; van der Graaf, WTA; Otter, R; Willemse, PHB
Purpose: Adjuvant 'classical' oral cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) has long been the mainstay of adjuvant chemotherapy for premenopausal breast cancer patients. The Comprehensive Cancer Center North Netherlands (CCCN) breast cancer working group performed a retrospective aud
Preliminary results of capecitabine metronomic chemotherapy in operable triple-negative breast cancer after standard adjuvant therapy – A single-arm phase II study
Directory of Open Access Journals (Sweden)
Hanan Shawky
Conclusion: One year of capecitabine metronomic therapy preceded by standard adjuvant chemotherapy, is active and well-tolerated in TNBC patients previously treated with standard adjuvant chemotherapy.
Effect of particulate adjuvant on the anthrax protective antigen dose required for effective nasal vaccination.
Bento, Dulce; Staats, Herman F; Borges, Olga
Successful vaccine development is dependent on the development of effective adjuvants since the poor immunogenicity of modern subunit vaccines typically requires the use of potent adjuvants and high antigen doses. In recent years, adjuvant formulations combining both immunopotentiators and delivery systems have emerged as a promising strategy to develop effective and improved vaccines. In this study we investigate if the association of the mast cell activating adjuvant compound 48/80 (C48/80) with chitosan nanoparticles would promote an antigen dose sparing effect when administered intranasally. Even though the induction of strong mucosal immunity required higher antigen doses, incorporation of C48/80 into nanoparticles provided significant dose sparing when compared to antigen and C48/80 in solution with no significant effect on serum neutralizing antibodies titers. These results suggest the potential of this novel adjuvant combination to improve the immunogenicity of a vaccine and decrease the antigen dose required for vaccination. PMID:26087299
Pseudo-Mannosylated DC-SIGN Ligands as Potential Adjuvants for HIV Vaccines
Directory of Open Access Journals (Sweden)
Angela Berzi
Full Text Available The development of new and effective adjuvants may play a fundamental role in improving HIV vaccine efficacy. New classes of vaccine adjuvants activate innate immunity receptors, notably toll like receptors (TLRs. Adjuvants targeting the C-Type lectin receptor DC-SIGN may be alternative or complementary to adjuvants based on TRL activation. Herein we evaluate the ability of the glycomimetic DC-SIGN ligand Polyman 19 (PM 19 to modulate innate immune responses. Results showed that PM 19 alone, or in combination with TLR agonists, induces the expression of cytokines, β chemokines and co-stimulatory molecules that may, in turn, modulate adaptive immunity and exert anti-viral effects. These results indicate that the suitability of this compound as a vaccine adjuvant should be further evaluated.
Evaluation of adjuvants for a candidate conjugate vaccine against benzo[a]pyrene.
Schellenberger, Mario T; Farinelle, Sophie; Willième, Stéphanie; Muller, Claude P
We have recently developed an experimental vaccine based on benzo[a]pyrene (B[a]P) conjugated to tetanus toxoid as a carrier protein. In combination with Freund adjuvant, this vaccine induces high levels of B[a]P-specific antibodies to protect against detrimental effects of this carcinogen. Here we evaluate this conjugate vaccine by replacing Freund adjuvant by adjuvants that are potentially compatible with their use in humans. We showed that all adjuvants tested induced specific antibodies against B[a]P and 7,8-diol-B[a]P, its carcinogenic metabolite. The best antibody levels were obtained with Quil A, MF-59 and Alum. Biological activity in terms of enhanced retention of B[a]P was confirmed in mice immunised with Quil A, Montanide, Alum and MF-59. Our findings demonstrate that a vaccination against B[a]P is feasible in combination with adjuvants licensed in humans. PMID:21245662
Adjuvant Whole Brain Radiotherapy: Strong Emotions Decide But Rational Studies Are Needed
International Nuclear Information System (INIS)
Brain metastases are common in cancer patients and cause considerable morbidity and mortality. For patients with limited disease and good performance status, treatment typically involves a combination of focal measures (e.g., surgical resection or radiosurgery) for the radiographically apparent disease, followed by adjuvant whole brain radiotherapy (WBRT) to treat subclinical disease. Because of concerns regarding the toxicity of WBRT, especially neurocognitive deterioration, many have advocated withholding adjuvant WBRT. Recently published studies have shed more light on the efficacy of adjuvant WBRT and the neurocognitive effects of WBRT. However, the inclusion of neurocognitive and quality-of-life data in clinical trials are still required to better define the role of adjuvant WBRT. Currently, two Phase III trials are underway, one in Europe and one in North America, that will determine the effect of adjuvant WBRT on patients' quality of life, neurocognitive function, and survival
Coordinated research project on radiation sterilization and decontamination of pharmaceuticals and pharmaceutical raw materials. CRP report
International Nuclear Information System (INIS)
Radiation processing is a very convenient tool for imparting desirable effects in materials and it has been an area of enormous interest in the last few decades. Radiation processing of synthetic and natural polymers for improving their characteristics is largely used in laboratory and industrial scale. Radiation sterilization is a well developed and established technology for many products. It is especially useful for the treatment of pharmaceuticals due to flexibility of radiation processing to be carried out at any desired temperature, sterilizability of mixed products in kits, offering simultaneous sterilization and modification of polymer based formulations. The success of radiation technology for processing of synthetic and natural polymers and treatment of pharmaceuticals has been based, to a large extent, on empirical knowledge. But now, the applications of natural polymers are being sought in knowledge-demanding areas such as pharmacy and biotechnology. Reliable analytical methods are being developed for controlling of degradation effects of radiation on polymers. Procedures and chemical formulations are being investigated enhancing or preventing degradation effects depending on the desired application of the process. The Coordinated Research Project (CRP) on the use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutical raw materials has been completed in 2002. The overall objective of the CRP was to coordinate the research and development programmes carried out in different countries in use of radiation processing for sterilization or decontamination of pharmaceuticals and pharmaceutic raw materials. It has been concluded that in addition to well known advantages of radiation sterilization being a well developed and established technology requiring the control of only one parameter, dose, to achieve sterilization; it is especially useful for the treatment of pharmaceuticals due to flexibility of radiation
Formulation, High Throughput In Vitro Screening and In Vivo Functional Characterization of Nanoemulsion-Based Intranasal Vaccine Adjuvants
Pamela T. Wong; Leroueil, Pascale R.; Smith, Douglas M.; Ciotti, Susan; Bielinska, Anna U.; Janczak, Katarzyna W.; Mullen, Catherine H.; Groom, Jeffrey V.; Taylor, Erin M; Passmore, Crystal; Makidon, Paul E.; O'Konek, Jessica J.; Myc, Andrzej; Hamouda, Tarek; Baker, James R.
Vaccine adjuvants have been reported to induce both mucosal and systemic immunity when applied to mucosal surfaces and this dual response appears important for protection against certain pathogens. Despite the potential advantages, however, no mucosal adjuvants are currently approved for human use. Evaluating compounds as mucosal adjuvants is a slow and costly process due to the need for lengthy animal immunogenicity studies. We have constructed a library of 112 intranasal adjuvant candidate ...
Pilot scale production of the vaccine adjuvant Proteoliposome derived Cochleates (AFCo1) from Neisseria meningitidis serogroup B
The use of new adjuvants in vaccine formulations is a subject of current research. Only few parenteral adjuvants have been licensed. We have developed a mucosal and parenteral adjuvant known as AFCo1 (Adjuvant Finlay Cochleate 1, derived from proteoliposomes of N. meningitidis B) using a dialysis procedure to produce them on lab scale. The immunogenicity of the AFCo1 produced by dialysis has been already evaluated, but it was necessary to demonstrate the feasibility of a larger-scale manufact...
Pharmaceutical industry exposure in our hospitals: the final frontier.
Dean, Jessica; Loh, Erwin; Coleman, Justin J
Despite recent changes in attitudes, most hospitals continue to experience pharmaceutical industry presence. Pharmaceutical industry presence may be necessary and beneficial in the context of sponsorship of clinical trials with appropriate governance. Doctors continue to hold positive attitudes towards market-oriented activities of the pharmaceutical and medical device industries. Despite evidence to the contrary, doctors believe they are able to effectively manage pharmaceutical sales representative interactions such that their own prescribing is not adversely impacted. Doctors also share a belief that small gifts and benefits are harmless. There may be significant financial burden associated with divestment of such sponsorship by hospitals. Change requires education and effective policies to manage pharmaceutical industry relationships and conflicts of interest. We discuss case studies involving students and public hospital doctors to show that divestment is possible without significant financial detriment. Health services need to be proactive in transitioning financial and cultural reliance on pharmaceutical industry sponsorship to other potentially less harmful sources. PMID:26763810
A new e-beam application in the pharmaceutical industry
International Nuclear Information System (INIS)
The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical company, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a 'miniature' low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations governing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned
Source, occurrence, and fate of pharmaceuticals in natural waters
Daneshvar, Atlasi
The consumption of pharmaceuticals has increased in the last few decades. After usage, pharmaceuticals are excreted via urine and feces and transported to wastewater treatment plants (WWTPs) where they are subjected to treatment processes, and finally discharged into rivers. In order to assess aquatic risk associated with short- and long-term exposure to pharmaceuticals, temporal-spatial variability in the concentrations should be monitored in different water compartments. In this thesis, occ...
The behaviour of pharmaceuticals in anaerobic digester sludge
Campbell, Alison
Pharmaceuticals are biologically active compounds that may be consumed in hundreds of tonnes per year, and which are excreted into municipal sewerage systems. Many pharmaceuticals persist during sewage treatment, and significant environmental risk has been linked to incomplete removal of pharmaceuticals. Evaluation of this risk is important and should be as representative as possible, taking into consideration all significant exposure routes and removal processes. Sludge treatment processes a...
The important and clinical pharmaceutical aspects of radiopharmaceuticals usage
Janevik-Ivanovska, Emilija; Gjorgieva, Darinka; Smilkov, Katarina
The aim of this paper is to devote the development of new radiopharmaceuticals for nuclear medicine application and methods of quality assurance stressing the pharmaceutical aspects. Preparation, distribution, storage and use of radiopharmaceuticals involves a number of pharmaceuticals and radiation protection problems emphasized by the rapidly increasing use of this type of drug relevant for the patient, for the staff and for the environment. To study the pharmaceutical aspects of rad...
New Zealand consumers' perceptions of private insurance for pharmaceuticals
Ragupathy, Rajan; Babar, Zaheer-Ud-Din; Mirza, Wasif; Daiya, Mitali; Chandra, Himesh; Yousif, Ali; Girn, Maninder
Private insurance plays a minor role in paying for pharmaceuticals in New Zealand, despite controversy about access through the public health system. The present study examines New Zealand consumers' perceptions of private insurance for pharmaceuticals. A self-administered questionnaire was completed by 433 consumers at thirty pharmacies. The questionnaire included 18 questions on demographics, insurance status, perceptions of private insurance for pharmaceuticals and confidence in the public...
Transgenic Plants as Expression Factories for Bio Pharmaceuticals
Wani, Shabir. H.; Sah, Saroj K.
At present agriculture not only provides food, but is also used for the production of pharmaceuticals or industrial compounds such as pharmaceutical drugs, vaccines along with biodegradable plastic and industrial chemicals. Since last three decades, plant genetic engineering has played a vital role in the production of bio-pharmaceutical products from crops. Due to technological advancement of genetic engineering, biotechnologist are able to engineer plants by using living organism with the h...
Microbiological testing of pharmaceuticals and cosmetics in Egypt
Zeitoun, Hend; Kassem, Mervat; Raafat, Dina; AbouShlieb, Hamida; Fanaki, Nourhan
Background Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process, especially from a medical as well as an economic point of view. Depending upon the product and its intended use, the identification of isolates should not merely be limited to the United States Pharmacopeia (USP) indicator organisms. Results Eighty-five pre-used non-sterile pharmaceuticals collected from random consumers in Egypt were examined for the eventual presence of b...
Mechanistic approach to predicting the sorption characteristics of pharmaceuticals
Berthod, Laurence Mireille Claire
Over the past forty years concerns over the presence of pharmaceuticals in the environment have grown considerably. Some pharmaceuticals can be effectively biodegraded in wastewater treatment plants but others can be sorbed onto sludges that are often subsequently used as fertilisers or disposed of to landfill. This work aimed to understand how a given pharmaceutical will be distributed between aqueous and solid phases (characterised by the sorbed:dissolved partition coefficient, Kd) withi...
Removal of Pharmaceuticals in Conventional Wastewater Treatment Plants
Dordio, A.; Carvalho, A. J. P.
Over the latest years, the occurrence of pharmaceutical residues in the environment has attracted great interest, in particular in regard to the possible harmful effects of many of these pollutants to living organisms. One of the main sources of pharmaceuticals in the environment is the discharge of effluents from wastewater treatment plants (WWTPs), where their removal is often incomplete. The widespread use of pharmaceuticals and their generally inefficient removal by most WWTPs are the mai...
Evaluating the Cost-effectiveness of Pharmaceuticals in Canada
Katherine Boothe
Canada adopted guidelines for the economic evaluation of pharmaceuticals in 1994, and a central process for drug assessment in 2003. The context and the way the issue reached the agenda in the two time periods differed. The guidelines were adopted amidst growing academic interest in methods for economic evaluation of pharmaceuticals in Canada and internationally, and were first promoted by an entrepreneur from the pharmaceutical industry. The Common Drug Review (CDR) was adopted in a context ...
Innovation and Competitive Capacity in Bangladeshs Pharmaceutical Sector
Gehl Sampath, Padmashree
The global pharmaceutical sector is highly patent intensive, and firms rely on product, process and formulation patents to protect their innovations. Intellectual property rights on pharmaceutical products, as contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (hereafter, the TRIPS Agreement) have been defended on grounds of extensive R&D investments required to discover and develop new drugs. But at the same time, grant of uniform pharmaceutical patents in al...
The pharmaceutical sector is one of the state's largest suppliers of goods and services, one of the biggest taxpayers contributing to the state budget revenue, as well as the state's largest creditor. Until 2007, inclusively, the development of the pharmaceutical sector was spectacular. Following that year a relative stagnation was registered. This paper focuses on the presentation of the pharmaceutical market's situation in terms of its three components: production, wholesale and...
The pharmaceutical sector is one of the state's largest suppliers of goods and services, one of the biggest taxpayers contributing to the state budget revenue, as well as the state's largest creditor. Until 2007, inclusively, the development of the pharmaceutical sector was spectacular. Following that year a relative stagnation was registered. This paper focuses on the presentation of the pharmaceutical market's situation in terms of its three components: production, wholesale and retail trad...
High-pressure biotechnology in medicine and pharmaceutical science
Masson Patrick; Tonello Carole; Balny Claude
High-pressure (HP) biotechnology is an emerging technique initially applied for food processing and more recently in pharmaceutical and medical sciences. Pressure can stabilize enzymes and modulate both their activity and specificity. HP engineering of proteins may be used for enzyme-catalyzed synthesis of fine chemicals, pharmaceuticals, and production of modified proteins of medical or pharmaceutical interest. HP inactivation of biological agents is expected to be applicable to sterilizatio...
Demand Forecasting In Pharmaceutical Industry Using Neuro-Fuzzy Approach
Taskin, M.Fatih; Candan, Gökçe; Yazgan, Harun Reşit
Because of human healthcare, the pharmaceutical industry can be considered as one of the most significant industrial sector. For this reason, demand forecasting in pharmaceutical industry has more complex structure than other sectors. Human factors, seasonal and epidemic diseases, market shares of the competitive products and marketing conditions are considered as main external factors for forecasting pharmaceutical product. Additionally, active ingredients rate is also important factor for f...
Mihaela BÎRSAN; ªtefãniþã ªUªU
The evolution of the pharmaceutical industry was a positive constant with the indicators of industrial production even in years of crisis. Although the economic crisis in Romania decreased average growth rate of pharmaceutical companies, market value is expected to increase. The explanation comes from the fact that in order to boost productivity, pharmaceutical companies are turning to emerging countries with aging populations such as open new markets for future development. Add to this the r...
Institutional mistrust in the organization of pharmaceutical clinical trials
Fisher, Jill A.
In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects' compliance to study protocols. Concern with these two critical issues lea...
ŞERBULESCU, Luminiţa; BUTNARU, Ana
The management of logistic operations has a very important role in the case of pharmaceutical products. The purpose of this article is to analyze the particularity of the logistic operations management in the pharmaceutical domain. This is seen in the fact that there is the obligatory of using the exclusive distribution system, because the carriers do not have selling right to the final users. In the pharmaceutical domain, the logistic channels may be represented by a system of vertical marke...
Attitudes of general practitioners in New Zealand to pharmaceutical representatives.
Thomson, A N; Craig, B J; Barham, P. M.
BACKGROUND. Pharmaceutical representatives are a vital component of the marketing of pharmaceutical products and an important source of prescribing information for general practitioners. AIM. A study was undertaken to explore the attitudes of New Zealand general practitioners to pharmaceutical representatives. METHOD. A questionnaire survey of 100 general practitioners was undertaken to which 67 general practitioners responded. RESULTS. The provision of practical prescribing advice by represe...
Gordeev, A.
This section "Forum" is about the pharmaceutical industry in Russia. We were encouraged to debate this topic after the unveiling of the Strategy of Development of the Pharmaceutical Industry in the Russian Federation developed by the Ministry of Industry and Trade of the Russian Federation. The majority of our experts, who are authorities in the federal government, business, academia, and industrial science, believe that Russia needs a fully developed pharmaceutical industry. What are the mai...
Assessment of Pharmaceutical Equivalence: Difference Test or Equivalence Test?
Lourenço, Felipe R.; Pinto, Terezinha J. A.
Pharmaceutical equivalence is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. The aim of this paper is to compare traditional difference testing to two one-side equivalence tests in the assessment of pharmaceutical equivalence, by means of equivalence studies between similar, generic and reference products of acyclovir cream, atropine sulfate injection, merop...
Identification and stability of calcipotriol pseudopolymorphs in pharmaceutical creams
Kontoyannis, Christos; Orkoula, Malvina
Calcipotriol is a vitamin D analogue and is used as active pharmaceutical ingredient in pharmaceutical formulations against psoriasis. It exists in two pseudopolymorphs, anhydrate and monohydrate, the latter of which, can be found in the commercially available cream Dovonex®. The percentage of the API in the cream is as low as 0.005 wt %. Methodologies were developed for monitoring calcipotriol's hydrate state in creams exhibiting pharmaceutical strength considerably lower than the detec...
Challenges of Globalisation in the World Pharmaceutical Industry
Dragan Kesic
The world pharmaceutical industry has been steadily consolidating in the last couple of years. There are significant processes of oligopolisation. Intensive globalisation processes, increasing competitiveness, changes in competitors and the fight for global markets and customers create new demands and challenges for the top management of pharmaceutical companies which require new management approaches. We may estimate that strategic alliansing in the world pharmaceutical industry will continu...
Renata Dobrucka
Background: In recent years, pharmaceutical packaging market was one of the fastest growing areas of the packaging industry. At the same time the packaging manufacturers put high demands on quality and safety. Methods: Review of innovations in packaging systems for pharmaceutical products was made including newest information of researches and achievements of recent years. Results and conclusion: Observed in recent years the development of pharmaceutical packaging market expan...
Pharmaceutical crops have a mixed outlook in California
Marvier, Michelle
Crops are being genetically engineered to produce a wide variety of drugs, vaccines and other pharmaceutical proteins. Although these crops may open the door to less expensive and more-readily available drugs, there is concern regarding the potential for contamination of human food and livestock feed, as well as environmental harm. The outlook for the production of pharmaceutical crops in California currently appears mixed. To date, 18 federal permits for field trials involving pharmaceutical...
Measurement uncertainty in pharmaceutical analysis and its application
Marcus Augusto Lyrio Traple; Alessandro Morais Saviano; Fabiane Lacerda Francisco; Felipe Rebello Lourenço
The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment o...
Patent Protection of Pharmaceutical Products in the Globalising World Economy
Ants Kukrus; Raul Kartus
Patenting new products in pharmaceuticals industry is of greater importance than in the other high technology branches of industry nowadays. Concentration of manufacturing takes place in pharmaceuticals industry as well as in the other branches of industry and it is characterised by the joining of firms. However, there are several specific features in patenting pharmaceutical products. Enforcement of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) made...
Academic psychiatry and the pharmaceutical industry.
Ban, Thomas A
In the second half of the 19th century new drugs introduced by the pharmaceutical industry helped lead to the establishment of academic departments in psychiatry. Causal treatment of cerebral pellagra by nicotinic acid and cerebral syphilis by penicillin in the first half of the 20th century led to major changes in the diagnostic distribution of psychiatric patients. In the second half of the 20th century with the introduction of a rapidly growing number of psychotropic drugs, pharmacotherapy became the primary form of treatment in mental illness. Psychiatrists today perceive neuropharmacology as one of the basic sciences of psychiatry and psychopharmacology as the bridge between the mode of action and the clinical indications of psychotropic drugs. Pharmacotherapy with psychotropic drugs focused attention on the differential responsiveness to the same drug within the same diagnostic category. Yet, instead of re-evaluating psychiatric nosology and conducting research in psychopathology, a statistical methodology was adopted for the demonstration of therapeutic effectiveness in pharmacologically heterogeneous populations. Employment of consensus-based classifications and psychiatric rating scales in the clinical development of psychotropic drugs led to semi-finished products, which are prescribed indiscriminately. Replacement of single-center clinical trials by multi-center centrally coordinated clinical investigations led to the control of education in pharmacotherapy by the pharmaceutical industry. To separate education from marketing, the identification of the treatment-responsive forms of illness and the delineation of the therapeutic profile of psychotropic drugs are proposed with the employment of a new methodology, the "Composite Diagnostic Evaluation System." It is postulated that development of a pharmacologically valid psychiatric nosology with the employment of a "nosologic matrix" would provide the pharmaceutical industry with the necessary feedback to
Spectrofluorimetric determination of fluoroquinolones in pharmaceutical preparations
Ulu, Sevgi Tatar
Simple, rapid and highly sensitive spectrofluorimetric method is presented for the determination of four fluoroquinolone (FQ) drugs, ciprofloxacin, enoxacin, norfloxacin and moxifloxacin in pharmaceutical preparations. Proposed method is based on the derivatization of FQ with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in borate buffer of pH 9.0 to yield a yellow product. The optimum experimental conditions have been studied carefully. Beer's law is obeyed over the concentration range of 23.5-500 ng mL -1 for ciprofloxacin, 28.5-700 ng mL -1 for enoxacin, 29.5-800 ng mL -1 for norfloxacin and 33.5-1000 ng mL -1 for moxifloxacin using NBD-Cl reagent, respectively. The detection limits were found to be 7.0 ng mL -1 for ciprofloxacin, 8.5 ng mL -1 for enoxacin, 9.2 ng mL -1 for norfloxacin and 9.98 ng mL -1 for moxifloxacin, respectively. Intra-day and inter-day relative standard deviation and relative mean error values at three different concentrations were determined. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed methods. The method is highly sensitive and specific. The results obtained are in good agreement with those obtained by the official and reference method. The results presented in this report show that the applied spectrofluorimetric method is acceptable for the determination of the four FQ in the pharmaceutical preparations. Common excipients used as additives in pharmaceutical preparations do not interfere with the proposed method.
Lipids in pharmaceutical and cosmetic preparations
González Rodríguez, María Luisa; Rabasco Alvarez, Antonio M.
In this paper, a review of the applications of lipids in the pharmaceutical field has been reported. In a first stage, different lipids used as excipients in cosmetics and medicines have been described. Many vegetable oils are used in this sense: almond oil, apricot oil, avocado oil, borage oil, coffee oil, safflower oil, etc.; from de animal source, fish oil and bird oil can be employed as excipients in cosmetical formulations. Fats and waxes may be also used for this purpose. A broad range ...
Microbiological investigations for radiation treatment of pharmaceuticals
Dám, A.; Gazsó, L. G.; Grigorova, P.
Several antibiotics, excipients were investigated in dry state to estimate the safety sterilization dose as well as herbs extract powders to reduce the microbial count by radiation treatment. The sterilization dose of pharmaceuticals were calculated individually for each product based on the bioburden, the radiosensitivity of contaminating microflora and the required sterility assurance level. According to our results all of the materials investigated can be sterilized by less than 10 kGy. For herbs extract 1 kGy was enough to reduce the initial count close to the acceptable level.
Microbiological investigations for radiation treatment of pharmaceuticals
Energy Technology Data Exchange (ETDEWEB)
Dam, A.; Gazso, L.G. (' Frederic Joliot-Curie' National Research Inst. for Radiobiology and Radiohygiene, Budapest (Hungary)); Grigorova, P. (Pharmachim, Sofia (Bulgaria))
Several antibiotics, excipients were investigated in dry states to estimate the safety sterilization dose as well as herbs extract powders to reduce the microbial count by radiation treatment. The sterilization dose of pharmaceuticals were calculated individually for each product based on the bioburden, the radiosensitivity of contaminating microflora and the required sterility assurance level. According to our results all of the materials investigated can be sterilized by less than 10 kGy. For herbs extract 1 kGy was enough to reduce the initial count close to the acceptable level. (author).
V.Kalyana Chakravarthy
An isocratic reverse phase liquid chromatography (RP-LC) method has been developed and subsequently validated for the determination of Entecavir in pharmaceutical formulation. Separation was achieved with a Develosil ODS MG-5 (250 mmx4.6 mm I.D; particle size 5 µm) and Trifluoroacetic acid Buffer (0.5 ml in 2000ml of water v/v): Acetonitrile (93:7) as eluent at flow rate 1.0 mL/min. UV detection was performed at 254nm. The method is simple, rapid, and selective. The described method of Enteca...
Microbiological investigations for radiation treatment of pharmaceuticals
International Nuclear Information System (INIS)
Several antibiotics, excipients were investigated in dry states to estimate the safety sterilization dose as well as herbs extract powders to reduce the microbial count by radiation treatment. The sterilization dose of pharmaceuticals were calculated individually for each product based on the bioburden, the radiosensitivity of contaminating microflora and the required sterility assurance level. According to our results all of the materials investigated can be sterilized by less than 10 kGy. For herbs extract 1 kGy was enough to reduce the initial count close to the acceptable level. (author)
In silico toxicology for the pharmaceutical sciences
International Nuclear Information System (INIS)
The applied use of in silico technologies (a.k.a. computational toxicology, in silico toxicology, computer-assisted tox, e-tox, i-drug discovery, predictive ADME, etc.) for predicting preclinical toxicological endpoints, clinical adverse effects, and metabolism of pharmaceutical substances has become of high interest to the scientific community and the public. The increased accessibility of these technologies for scientists and recent regulations permitting their use for chemical risk assessment supports this notion. The scientific community is interested in the appropriate use of such technologies as a tool to enhance product development and safety of pharmaceuticals and other xenobiotics, while ensuring the reliability and accuracy of in silico approaches for the toxicological and pharmacological sciences. For pharmaceutical substances, this means active and impurity chemicals in the drug product may be screened using specialized software and databases designed to cover these substances through a chemical structure-based screening process and algorithm specific to a given software program. A major goal for use of these software programs is to enable industry scientists not only to enhance the discovery process but also to ensure the judicious use of in silico tools to support risk assessments of drug-induced toxicities and in safety evaluations. However, a great amount of applied research is still needed, and there are many limitations with these approaches which are described in this review. Currently, there is a wide range of endpoints available from predictive quantitative structure-activity relationship models driven by many different computational software programs and data sources, and this is only expected to grow. For example, there are models based on non-proprietary and/or proprietary information specific to assessing potential rodent carcinogenicity, in silico screens for ICH genetic toxicity assays, reproductive and developmental toxicity, theoretical
Radio decontamination experiences of pharmaceuticals products
International Nuclear Information System (INIS)
The possibilities for the radio decontamination radioimmunodetection of Mafenide 10% cream, Bariopac powder and Ranitidine raw material by means of the application of different dose level of gamma rays were studied. Microbiological and Physicochemical evaluations were carried out before and after the treatment . The industrial production was irradiated with 3 and 1 kGy as the adequate dose, in a continuous way. It was concluded that the application of ionising radiations with decontamination aims is an alternative to guarantee the microbiological quality of these pharmaceuticals
New Product Introduction in the Pharmaceutical Industry
DEFF Research Database (Denmark)
Hansen, Klaus Reinholdt Nyhuus
Due to the limited time of the monopoly provided by patent protection that is used for recouping the R&D investment, pharmaceutical companies focus on keeping time-to-market for new products as short as possible. This process is however getting more uncertain, as the outcome of clinical trials is...... system is also developed. It captures the ramp-up phase in a better way, while considering inventory build up, plant validation and limited shelf life. The performance of several ramp-up functions is tested and insights into ramp-up management are presented. The dissertation is concluded with showing the...
Study on radiosterilization of pharmaceutical starch
International Nuclear Information System (INIS)
After treated with γ-ray, the loading of microbe in pharmaceutical starch was decreased sharply. If the microbe loading is in the range of 1.0∼1.5 x 104, the optimum absorbed dose is 3.0∼5.0 kGy. The results showed that there was a significant relationship between absorbed dose and amount of survival bacteria. The D10 value of bacteria is 0.7 kGy. On the other hand, change of radiation technology in the same radiation field could affect the result of radiosterilization. No toxicity was found with irradiated starch in the test period in mouse
Pharmaceuticals Exposed to the Space Environment: Problems and Prospects
Jaworske, Donald A.; Myers, Jerry G.
The NASA Human Research Program (HRP) Health Countermeasures Element maintains ongoing efforts to inform detailed risks, gaps, and further questions associated with the use of pharmaceuticals in space. Most recently, the Pharmacology Risk Report, released in 2010, illustrates the problems associated with maintaining pharmaceutical efficacy. Since the report, one key publication includes evaluation of pharmaceutical products stored on the International Space Station (ISS). This study shows that selected pharmaceuticals on ISS have a shorter shelf-life in space than corresponding terrestrial controls. The HRP Human Research Roadmap for planetary exploration identifies the risk of ineffective or toxic medications due to long-term storage during missions to Mars. The roadmap also identifies the need to understand and predict how pharmaceuticals will behave when exposed to radiation for long durations. Terrestrial studies of returned samples offer a start for predictive modeling. This paper shows that pharmaceuticals returned to Earth for post-flight analyses are amenable to a Weibull distribution analysis in order to support probabilistic risk assessment modeling. The paper also considers the prospect of passive payloads of key pharmaceuticals on sample return missions outside of Earth's magnetic field to gather additional statistics. Ongoing work in radiation chemistry suggests possible mitigation strategies where future work could be done at cryogenic temperatures to explore methods for preserving the strength of pharmaceuticals in the space radiation environment, perhaps one day leading to an architecture where pharmaceuticals are cached on the Martian surface and preserved cryogenically.
Electrochemical treatment of pharmaceutical and industrial wastewater by anodic oxidation
Energy Technology Data Exchange (ETDEWEB)
Menapace, H. M.; Fellerer, M.; Treschnitzer, M.
In modern medicine pharmaceuticals play a decisive role: because of an increased life expectancy and intensive care medicine an increasing amount of pharmaceuticals is produced. thus these substances are consumed in a mass of tons per year in industrialized countries. Wastewater effluents from sewage treatment plants (STP) are important point sources for residues of pharmaceuticals and complexing agents in the aquatic environment. For this reason a research project, which started in December 2006, was established to eliminate pharmaceutical substances and complexing agents found in wastewater as micropollutants. (Author)
Pharmaceutical laws and regulations in Iran: An overview
Zaboli, Pardis; Hashemi-Meshkini, Amir; Varmaghani, Mehdi; Gholami, Hadi; Vazirian, Iman; Zekri, Hedieh-Sadat; Eslamitabar, Shahriar; Kebriaeezadeh, Abbas
The pharmaceutical legal framework is a very important infrastructure in achieving predefined goals in pharmaceutical sector: Accessibility, quality, and rational use of medicine. This study aims to review the current pharmaceutical sector-related legal provisions in Iran where the Food and Drug Organization (FDO) is in charge of regulating all issues related to the pharmaceutical sector. The main laws and regulations enacted by parliament and cabinet and even internal regulations enacted by the Ministry of Health or Iran FDO are reviewed. Different laws and regulations are categorized according to the main goals of Iran national drug policy.
RFID in the pharmaceutical industry: addressing counterfeits with technology.
Taylor, Douglas
The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity. PMID:25308613
[Drug patents and other ways to protect pharmaceutical research].
Ohana, Patrick; Tardieu, Sophie; Blin, Olivier; Tassy, Sébastien; Sambuc, Roland
Pharmaceutical research constitutes a significant cost for pharmaceutical companies. Because of the importance of the financial investment in research projects, companies must protect their discoveries. There are multiple ways to do this. First, the legal avenue can be divided into three parts: a pharmaceutical company can protect a new drug by a patent, then an additional patent or a secondary patent; moreover, since 1992 in Europe, the pharmaceutical industry has been able to extend a patent by the "Supplementary Protection Certificate" (le Certificat Complémentaire de Protection [CCP]). The nonjuridical way is to use the chiral "switch", which can extend patents close to expiring, thus enhancing profitability. PMID:15359623
Measurement uncertainty in pharmaceutical analysis and its application
Institute of Scientific and Technical Information of China (English)
Marcus Augusto Lyrio Traple; Alessandro Morais Saviano; Fabiane Lacerda Francisco; Felipe Rebello Lourençon
The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment of pharmaceutical equivalence and stability study of drug products.
Basic principles of pharmaceutical science in Ayurvĕda.
Subhose, Varanasi; Srinivas, Pitta; Narayana, Ala
Pharmaceutical is one of the allied branches of science, which is closely associated with Medical science. Today pharmaceutical chemistry and pharmacognosy are playing important role in treatment for a disease and its prevention. Herbal medicines are being used by about 80% of the world population mostly in the developing countries in the primary health care. There has been an upsurge in demand for the Phyto-pharmaceutical products of Ayurvĕda in western nations, because of the fact that the synthetic drugs are considered to be unsafe. Due to this many national and multinational pharmaceutical companies are now concentrating on manufacturing of Ayurvĕdic Phyto-pharmaceutical products. Ayurvĕda is the Indian traditional system of medicine, which also deals about pharmaceutical science. The Ayurvĕdic knowledge of the pharmaceutical science is scattered in Ayurvĕdic classical texts. Săranghadhara Samhita, which is written by Săranghadhara, explain systematically about the information of the Ayurvĕdic pharmaceutical science and also updated it. Industrialized manufacturing of Ayurvĕdic dosage forms has brought in new challenges like deviation from basic concepts of medicine preparation. Săranghadhara Samrhită the devout text on pharmaceutics in Ayurvĕda comes handy to solve such problems, as the methods described are very lucid and easy to follow. PMID:17333665
Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review.
Directory of Open Access Journals (Sweden)
Sonali S. Bharate
Full Text Available Studies of active drug/excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. The potential physical and chemical interactions between drugs and excipients can affect the chemical nature, the stability and bioavailability of drugs and, consequently, their therapeutic efficacy and safety. The present review covers the literaturereports of interaction and incompatibilities of commonly used pharmaceutical excipients with different active pharmaceutical ingredients in solid dosage forms. Examples of active drug/excipientinteractions, such as transacylation, the Maillard browning reaction, acid base reactions and physical changes are discussed for different active pharmaceutical ingredients belonging to different therapeuticcategories viz antiviral, anti-inflammatory, antidiabetic, antihypertensive, anti-convulsant, antibiotic,bronchodialator, antimalarial, antiemetic, antiamoebic, antipsychotic, antidepressant, anticancer, anticoagulant and sedative/hypnotic drugs and vitamins. Once the solid-state reactions of a pharmaceutical system are understood, the necessary steps can be taken to avoid reactivity and improve the stability of drug substances and products.
A simple and sensitive spectrofluorimetric method for analysis of some nitrofuran drugs in pharmaceutical preparations.
Belal, Tarek Saied
A simple, rapid, selective and sensitive spectrofluorimetric method was described for the analysis of three nitrofuran drugs, namely, nifuroxazide (NX), nitrofurantoin (NT) and nitrofurazone (NZ). The method involved the alkaline hydrolysis of the studied drugs by warming with 0.1 M sodium hydroxide solution then dilution with distilled water for NX or 2-propanol for NT and NZ. The formed fluorophores were measured at 465 nm (lambda (Ex) 265 nm), 458 nm (lambda (Ex) 245 nm) and 445 nm (lambda (Ex) 245 nm) for NX, NT and NZ, respectively. The reaction pathway was discussed and the structures of the fluorescent products were proposed. The different experimental parameters were studied and optimized. Regression analysis showed good correlation between fluorescence intensity and concentration over the ranges 0.08-1.00, 0.02-0.24 and 0.004-0.050 microg ml(-1) for NX, NT and NZ, respectively. The limits of detection of the method were 8.0, 1.9 and 0.3 ng ml(-1) for NX, NT and NZ, respectively. The proposed method was validated in terms of accuracy, precision and specificity, and it was successfully applied for the assay of the three nitrofurans in their different dosage forms. No interference was observed from common pharmaceutical adjuvants. The results were favorably compared with those obtained by reference spectrophotometric methods. PMID:18246413
Access to pharmaceutical products in six European countries – analysis of different pharmaceutical distribution systems
Directory of Open Access Journals (Sweden)
Evelyn Walter
Full Text Available OBJECTIVES: The aim of the study was to draw a comprehensive picture of the pharmaceutical wholesale sector, outlining its socio-economic importance compared to different distribution systems such as short-line wholesaling, direct sales from manufacturers, Reduced Wholesale Arrangements (RWA and Direct to Pharmacy (DTP arrangements. Its role is considered from an economic, effectiveness and, most importantly, a public health viewpoint with qualitative and quantitative methods, focusing on France, Germany, Italy, the Netherlands, Spain and the UK.METHODS: First, data has been sourced from annual GIRP and IMS-Health statistics; second, a systematic literature research verified the empirical findings; third, an online-questionnaire was directed to pharmacies. Further data have been sourced from a questionnaire, addressing GIRP-full-member associations and wholesale companies (return rate 86%.RESULTS: On a weighted average, pharmaceutical full-line wholesalers in the observed countries alone pre-finance € 10.2 bn over a period of 41 days the entire medicine-market and secure the cash-flow of the social-insurers (Germany: € 2.60 bn for 38 days; Italy: € 2.27 bn for 68 days; the UK: € 1.48 bn for 36 days; France: € 1.28 bn for 22 days; Spain: € 969.76 m for 27 days; the Netherlands: € 399.09 m for 30 days on average. On average, pharmaceutical full-line wholesalers are bundling products of 18.28 manufacturers per delivery. The process costs would increase by € 164,922.43 to € 171,510.06 per year, if there were no pharmaceutical full-line wholesalers. These additional costs would have to be paid by manufacturers, pharmacies and finally by patients. Regarding the satisfaction with different distribution models, the results of the online-questionnaire show that pharmacists in the observed countries are very satisfied with the distribution through their pharmaceutical full-line wholesalers.CONCLUSIONS: The study showed that
Pashkus V.Y.; Pashkus N.A
The article deals with the development of pharmaceutical clusters. We study the development of the Russian pharmaceutical market, highlighted areas where there are promising pharmaceutical companies engaged in innovative activities and using modern marketing strategies, including breakthrough positioning strategy. The aim is to develop a tool positioning regional pharmaceutical cluster region-specific manufacturers and features segments of the pharmaceutical market, including: formulations, d...
M. M. Bahlol; T. P. Lagutkina
Purpose. Pharmaceutical industry is transnational and globally important. Many pharmaceutical companies operate their business in multinational and international forms in different countries. Diverse researches from different countries indicated and confirmed marketing promotion importance in pharmaceutical field. Therefore, marketing promotion and its effects are a very important issue that should be globally investigated in real life and evidence context. We oriented our research according ...
Utilization of a Green Brominating Agent for the Spectrophotometric Determination of Pipazethate HCl in Pure Form and Pharmaceutical Preparations
Directory of Open Access Journals (Sweden)
Ayman A. Gouda
Full Text Available Five simple, accurate, and sensitive spectrophotometric methods (A–E have been described for the indirect assay of pipazethate HCl (PZT either in pure form or in pharmaceutical preparations. The proposed methods are based on the bromination of pipazethate HCl with a solution of excess bromate-bromide mixture in hydrochloric acid medium and subsequent estimation of the residual bromine by different reaction schemes. In the first three methods (A–C, the determination of the residual bromine is based on its ability to bleach the color of methyl orange, indigo carmine, or thymol blue dyes and measuring the absorbance at 520, 610, and 550 nm for methods A, B, and C, respectively. Methods D and E involves treating the unreacted bromine with a measured excess of iron(II, and the remaining iron(II is complexed with 1,10-phenanthroline, and the increase in absorbance is measured at 510 nm for method D and the resulting iron(III is complexed with thiocyanate and the absorbance is measured at 480 nm for method E. The different experimental parameters affecting the development and stability of the color are carefully studied and optimized. Regression analysis of the Beer-Lambert plots showed good correlation in the concentration ranges of 0.5–8.0 μg . The apparent molar absorptivity, Sandell's sensitivity, detection and quantitation limits were evaluated. The proposed methods have been applied and validated successfully for the analysis of the drug in its pure form and pharmaceutical formulations with mean recoveries of 99.94%–100.15% and relative standard deviation ≤1.53. No interference was observed from a common pharmaceutical adjuvant. Statistical comparison of the results with the reference method shows excellent agreement and indicates no significant difference in accuracy and precision.
Adjuvant therapy in case of mammary carcinoma (high risk)
International Nuclear Information System (INIS)
108 patients with high risk stage of a mammary carcinoma (four or more positive axillar lymph nodes) were submitted after surgery to a prospectively randomized study: a postirradiation in three series with additional administration of tamoxifen was opposed to a reduced-dose irradiation and subsequent simultaneous combination of polychemotherapy and irradiation. In patients with an age of less than 50 years, the combination of chemotherapy and radiotherapy caused a significant prolongation of the recurrence-free interval (>57 months versus 12,75 months). The comparison with literature shows that an average interval of 39.1 months without recurrences for the total group of patients treated with combination therapy corresponds to the result of a high-dose adjuvant CMF therapy. With respect to mean life expectancy, there was no significant difference between both groups of randomization. (orig.)
Long-term side effects of adjuvant CNS therapy
International Nuclear Information System (INIS)
Adjuvant CNS therapy is nowadays carried out almost as a rule in patients with acute lymphatic leukaemia (ALL), and to a lesser extent also in patients with small-cell lung cancer. The present investigations of the potential long-term toxicity of these measures, however, still lack sufficient biometrical substantiation, the more so as a required quantity of random sample is not reached. Moreover, many conclusions are biased by inadequately defined patient selection. Due to the inconstancy of the phenomena observed clinically, therefore, it is particularly the relevance of cerebral maturity at the beginning of treatment to the development of intelligence, of academic achievement and of social behaviour, which remains undecided despite the defects of the white substance verified both by histopathological investigations and imaging procedures. (orig.)
Uncaria tomentosa—Adjuvant Treatment for Breast Cancer: Clinical Trial
Directory of Open Access Journals (Sweden)
Maria do Carmo Santos Araújo
Full Text Available Breast cancer is the most frequent neoplasm affecting women worldwide. Some of the recommended treatments involve chemotherapy whose toxic effects include leukopenia and neutropenia. This study assessed the effectiveness of Uncaria tomentosa (Ut in reducing the adverse effects of chemotherapy through a randomized clinical trial. Patients with Invasive Ductal Carcinoma—Stage II, who underwent a treatment regimen known as FAC (Fluorouracil, Doxorubicin, Cyclophosphamide, were divided into two groups: the UtCa received chemotherapy plus 300 mg dry Ut extract per day and the Ca group that only received chemotherapy and served as the control experiment. Blood samples were collected before each one of the six chemotherapy cycles and blood counts, immunological parameters, antioxidant enzymes, and oxidative stress were analyzed. Uncaria tomentosa reduced the neutropenia caused by chemotherapy and was also able to restore cellular DNA damage. We concluded that Ut is an effective adjuvant treatment for breast cancer.
Lactic acid bacteria as adjuvants for sublingual allergy vaccines.
Van Overtvelt, Laurence; Moussu, Helene; Horiot, Stéphane; Samson, Sandrine; Lombardi, Vincent; Mascarell, Laurent; van de Moer, Ariane; Bourdet-Sicard, Raphaëlle; Moingeon, Philippe
We compared immunomodulatory properties of 11 strains of lactic acid bacteria as well as their capacity to enhance sublingual immunotherapy efficacy in a murine asthma model. Two types of bacterial strains were identified, including: (i) potent inducers of IL-12p70 and IL-10 in dendritic cells, supporting IFN-gamma and IL-10 production in CD4+ T cells such as Lactobacillus helveticus; (ii) pure Th1 inducers such as L. casei. Sublingual administration in ovalbumin-sensitized mice of L. helveticus, but not L. casei, reduced airways hyperresponsiveness, bronchial inflammation and proliferation of specific T cells in cervical lymph nodes. Thus, probiotics acting as a Th1/possibly Treg, but not Th1 adjuvant, potentiate tolerance induction via the sublingual route. PMID:20175969
Hypofractionated Adjuvant Whole Breast Radiotherapy: Progress and Prospects
International Nuclear Information System (INIS)
Published results of randomised trials involving >7000 women confirm the safety and efficacy of hypofractionated schedules of adjuvant radiotherapy for women with early breast cancer using fraction sizes between 2 and 3 Gy assuming appropriate downward adjustments to total dose. Unnecessary concerns relating to heart tolerance, suboptimal dose distribution and duration of follow up need not discourage the routine adoption of 15- or 16-fraction schedules in women treated by breast conservation surgery for early breast cancer. Regardless of fractionation regimen, dose escalation to the index quadrant in high risk subgroups will result in a greater relative increase in late adverse effects than tumour control, a therapeutic disadvantage that can only be overcome by exploiting a marked dose-volume effect. A 15-fraction schedule of whole breast radiotherapy is unlikely to represent the lower limits of hypofractionation, and the preliminary results of a 5-fraction regimen are encouraging
Directory of Open Access Journals (Sweden)
V. S. Polovinkina
Full Text Available Bacterial DNA, along with other bacterial pathogen-associated molecular structures, may activate both innate and adaptive immune systems. This activity is associated with by nonmethylated CpG dinucleotides, which are present in the bDNA molecule, and it may be simulated by synthetic CpG oligodeoxynucleotides (ODNs. Non-methylated CpG motifs are recognized by Toll-like receptor 9 that triggers the induction of cell signaling pathways, activating proinflammatory cytokine synthesis by immune competent cells, and triggering the immune protection mechanisms. In present review we consider structure, functions, adjuvant features, immune properties and potential clinical applications of bacterial DNA and various classes of synthetic non-methylated CpG-ODNs.
Pharmaceuticals and Their Impact on the Environment
Directory of Open Access Journals (Sweden)
Tomić, S
Full Text Available Pharmaceuticals are a class of emerging environmental contaminants that are extensively and increasingly being used in human and veterinary medicine and are released continuously into the environment. A variety of pharmaceuticals have been detected in many environmental samples worldwide. The establishment of chemical analysis methods able to determine more polar compounds allow the determination and identification of trace quantities of drugs and their metabolites. Most regulatory agencies require that environmental risk assessment is performed as an integral part of their approval procedures for the marketing for medicinal products. Marketing approval for medicinal products in the European Union is regulated by the Directive 2001/83/EC. Based on the Directive, the European Medicines Agency (EMA has published guidelines describing the procedure for the environmental risk assessment for medicinal products marketed in the EU. The requirements for the Environmental risk assessment (ERA in Croatia are regulated by the Medicinal Products Act (Official Gazette No. 71/07 and the Ordinance on the Procedure and Method for Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 113/08.
Towards a healthy use of pharmaceuticals.
Laporte, J R
This paper examines 4 factors which determine the kind and the quantity of medicines used in a community: drug promotion, the disease pattern, the pharmaceutical supply, and the structure and priorities of the health system. The use of drugs is a method whereby manufacturers exert pressure to ensure a constant expansion of the market, rather than trying to fulfill a real need. Drug promotion is an obvious determinant of irrational and unhealthy use of drugs. The pharmaceutical industry spends between 15 and 25% of its total budget on promotional activities, and this proportion is even higher in 3rd World countries. The general assumption that the prescription of a medicine has some relationship with the disease the patient is suffering from is unsupported by the evidence. It has never been proven that an infinite number of drugs provides any greater benefits for public heaath than a more limited number of products. The existence of a large number of drugs may result in confusion at all levels of the therapeutic chain, and represent a waste of manpower and money. The economic and human resources allocated to health systems are the main determinants of drug consumption. Drug utilization, as defined by the WHO, involves 3 elements: the drug supply; the use of the drug in the health system; and the use of the drug beyond the health system. PMID:12341047
Energy saving opportunities in Jordanian pharmaceutical industries
Directory of Open Access Journals (Sweden)
Areen Al-Ali
Full Text Available An investigation of energy consumption saving opportunities in Jordanian pharmaceutical industry has been carried out in this paper, current status of energy consumption, possible saving techniques, and recommendations that could be implemented successfully through Energy Saving Program (ESP is explored. All variables that influence energy consumption are considered accordingly using a suitable methodology. This methodology integrates a simulation programs into the analysis process; thereafter an accurate analysis and a reliable assessment for energy consumption is provided. HAP 4.41software has been used to simulate and to calculate energy consumption and costs. One biggest Jordanian pharmaceutical facility that produces Penicillin and Cephalosporin products is considered as an illustrative example, the facility consists of four main energy consumption centers and includes consuming systems namely; HVAC (Heating, Ventilating and Air Conditioning system, lighting, compressed air, steam boilers, and miscellaneous equipments like computers, refrigerators, fume hoods, etc. Historical energy consumption quantities are estimated, details of energy data are tabulated accordingly input data files for the computer simulation method using HAP 4.41 are created. Energy saving recommendations has been decided and incorporated into the ESP system. The paper concluded with a good quality room of energy saving opportunities that mirrored positively on the national energy bill with a reduction of 13% of the total annual energy consumption.
Pharmaceutical wastewater treatment: a physicochemical study
International Nuclear Information System (INIS)
A physicochemical study for the treatment of pharmaceutical wastewater was performed. Objective of the laboratory investigation was to study the removal of color, Total Dissolved Solids (TDS), Biochemical Oxygen Demand (BOD), Chemical Oxygen Demand (COD), turbidity and phenol and bring them up to the allowable limits for reuse purposes. Efficiency of coagulation, flocculation, sedimentation, sand filtration followed by activated carbon adsorption was determined. It was found that tested coagulants (alum, ferric chloride, and ferrous sulphate) are not much effective and required high dosage for the removal; of TSS, BOD, COD and turbidity. Alum was found to be more effective among tested coagulants and reduce TSS, BOD, COD and turbidity 79.6%, 34.8, 48.6% and 69.2% respectively. Sand filtration further reduced the studied parameters 97.7%, 95.7%, 93.9% and 76.9% respectively. As the concentration of phenol in the studied pharmaceutical wastewater was 100 mg/l, granular activated carbon was used to remove phenol up to the allowable limit for reuse purpose. Activated carbon adsorption further reduces phenol, TDS, TSS, BOD, and COD up to 99.9%, 99.1%, 21.4%, 81.3% and 71.1% respectively. High removal of color observed after activated carbon adsorption. It was concluded that the suggested treatment scheme is suitable to bring the effluent quality up to the water quality standards. (author)
Old Yet New--Pharmaceuticals from Plants
Houghton, Peter J.
Plants or their crude extracts have been used since prehistory to treat human ailments. Plants are still used in this way in many parts of the world, but Western scientific medicine has tended to isolate active compounds, or make derivatives of them, for use as drugs. Compounds produced by the plant have been important pharmaceuticals since the isolation of morphine almost two hundred years ago and new naturally occurring compounds such as paclitaxel are continually being introduced commercially. Bioactive molecules may also be produced from chemicals found in plants by chemical modification using synthetic chemistry or microorganisms (as in the production of steroids). A third major contribution of plant chemicals to drugs is their utilization as templates for the design of new compounds made by synthesis (e.g. the discovery of aspirin and related compounds from substances in willow bark). New pharmaceuticals from plants are being discovered by examining traditional medicines and by large-scale bioassay screening processes. In addition, the chemical survival systems of plants that exist in hostile environments are receiving increasing attention as leads to discover active compounds. The knowledge of botanical relationships helps find new sources of known compounds of interest and novel compounds with similar structures from related species. Future prospects for the discovery of new compounds from plants are broadened by the new technologies of gene manipulation, tissue culture, and combinatorial chemistry, so it is very likely that natural products from plants will continue to play an important role in the fight against disease.
Editorial Nano structures for Medicine and Pharmaceuticals
International Nuclear Information System (INIS)
The rapid developments in nano structured materials and nano technology will have profound impact in many areas of biomedical applications including delivery of drugs and biomolecules, tissue engineering, detection of bio markers, cancer diagnosis, cancer therapy, and imaging. This field is expanding quickly, and a lot of work is ongoing in the design, characterization, synthesis, and application of materials, for controlling shape and size at nanometer scale to develop highly advanced materials for biomedical application and even to design better pharmaceutical products. In recent years, novel nano structure with multi functionalities has been focused on the use of nano structures toward solving problems of biology and medicine. The main scope of this special issue is to demonstrate the latest achievement of nano technology and its application in nano medicine particularly in new approaches for drug delivery such as targeted drug delivery system, nano structure for drug storage, nano materials for tissue engineering, medical diagnosis and treatment, and generation of new kinds of materials from biological sources. Therefore, many critical issues in nano structured materials, particularly their applications in biomedicine, must be addressed before clinical applications. This special issue devotes several review and research articles encompassing various aspects of nano materials for medicine and pharmaceuticals.
[Trends in pharmaceutical care for men].
Glaeske, Gerd
Over the past few years, perceptible changes - both fundamental and specific - have taken place in pharmaceutical care for men. While the most striking difference persists, namely that between somatic drug therapies for men and drugs for the treatment of psychological disorders and diseases, the large discrepancies that long existed between the quantities prescribed for men and women have meanwhile not only evened out, but men are even prescribed larger quantities than women if they undergo drug therapy. An analysis of the drugs prescribed particularly for men revealed that they are primarily prescribed for the treatment of cardiovascular diseases (hypertension and cardiac insufficiency) and metabolic disorders (diabetes, gout), especially in elderly patients. The evaluation also showed that the drugs prescribed most frequently for younger men also included psychostimulants and antidepressants, such as SSRIs, for diagnoses of ADHD and depression.Besides these prescribed medicaments, other drugs must also be taken into account that reflect men's gender-specific everyday needs. These include drugs for treating erectile dysfunction, hair growth products or drugs for male menopause or to build muscle. The sometimes serious undesired effects of these products are often given small attention because of the desired benefit of supporting the perceived male role. While hormones are widely used in anabolic steroids, the use of hormones in contraceptive pills for men is evidently still far away from the aforementioned trends in pharmaceutical care for men. PMID:27351435
Pharmaceutical significance of cellulose: A review
Directory of Open Access Journals (Sweden)
Full Text Available The amalgamation of polymer and pharmaceutical sciences led to the introduction of polymer in the design and development of drug delivery systems. Polymeric delivery systems are mainly intended to achieve controlled or sustained drug delivery. Polysaccharides fabricated into hydrophilic matrices remain popular biomaterials for controlled-release dosage forms and the most abundant naturally occurring biopolymer is cellulose; so hdroxypropylmethyl cellulose, hydroxypropyl cellulose, microcrystalline cellulose and hydroxyethyl cellulose can be used for production of time controlled delivery systems. Additionally microcrystalline cellulose, sodium carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose as well as hydroxypropyl cellulose are used to coat tablets. Cellulose acetate phthalate and hydroxymethyl cellulose phthalate are also used for enteric coating of tablets. Targeting of drugs to the colon following oral administration has also been accomplished by using polysaccharides such as hdroxypropylmethyl cellulose and hydroxypropyl cellulose in hydrated form; also they act as binders that swell when hydrated by gastric media and delay absorption. This paper assembles the current knowledge on the structure and chemistry of cellulose, and in the development of innovative cellulose esters and ethers for pharmaceuticals.
Carcinoma of the male breast: A review of adjuvant therapy
International Nuclear Information System (INIS)
The purpose of the present paper was to evaluate the characteristics and outcomes of male breast cancer patients seen for adjuvant therapy at a single institution. A retrospective review of computerized records in the Departments of Medical and Radiation Oncology at the Royal Prince Alfred Hospital (RPAH) was undertaken. Between 1983 and 1996, 24 men were referred for treatment of breast cancer. Of these, 19 had localized breast cancer, four had metastatic disease and one had ductal carcinoma in situ (DCIS). The median age was 57.5 years (range: 26-78) and median follow-up was 6.2 years (range: 0.6-36). Pathological staging was performed. Survival was assessed using actuarial life table analysis. All patients underwent surgery. Eleven patients received radiotherapy. The median dose and dose per fraction were 50 Gy and 2 Gy, respectively. Adjuvant systemic therapy was delivered to 10 patients, of whom nine were node-positive. Four patients received chemotherapy alone, three patients received chemotherapy and tamoxifen, and three patients received tamoxifen only. Seven patients relapsed (one local, five distant, one both). Of the two patients with local relapses, one had received radiotherapy. Of the distant failures, four of six patients had no systemic therapy. There were only two node-positive patients who were not given systemic treatment and both relapsed. Median survival in all patients with invasive cancer was 7.5 years, and in those with localized disease it was 7.6 years. The median survival of node-positive patients was 3.8 years. In node-negative patients the median survival had not been reached at a median follow-up of 6.2 years. Systemic therapy was found to be beneficial in patients with node-positive disease. Chemotherapy was administered more frequently than hormonal therapy. The median survivals were consistent with those reported in other series. Copyright (1999) Blackwell Science Pty Ltd
Effective polymer adjuvants for sustained delivery of protein subunit vaccines.
Adams, Justin R; Haughney, Shannon L; Mallapragada, Surya K
We have synthesized thermogelling cationic amphiphilic pentablock copolymers that have the potential to act as injectable vaccine carriers and adjuvants that can simultaneously provide sustained delivery and enhance the immunogenicity of released antigen. While these pentablock copolymers have shown efficacy in DNA delivery in past studies, the ability to deliver both DNA and protein for subunit vaccines using the same polymeric carrier can provide greater flexibility and efficacy. We demonstrate the ability of these pentablock copolymers, and the parent triblock Pluronic copolymers to slowly release structurally intact and antigenically stable protein antigens in vitro, create an antigen depot through long-term injection-site persistence and enhance the in vivo immune response to these antigens. We show release of the model protein antigen ovalbumin in vitro from the thermogelling block copolymers with the primary, secondary and tertiary structures of the released protein unchanged compared to the native protein, and its antigenicity preserved upon release. The block copolymers form a gel at physiological temperatures that serves as an antigenic depot and persists in vivo at the site of injection for over 50days. The pentablock copolymers show a significant fivefold enhancement in the immune response compared to soluble protein alone, even 6weeks after the administration, based on measurement of antibody titers. These results demonstrate the potential of these block copolymers hydrogels to persist for several weeks and sustain the release of antigen with minimal effects on protein stability and antigenicity; and their ability to be used simultaneously as a sustained delivery device as well as a subunit vaccine adjuvant platform. PMID:25484331
Biopersistence and brain translocation of aluminum adjuvants of vaccines
Directory of Open Access Journals (Sweden)
Romain Kroum Gherardi
Full Text Available Aluminum oxyhydroxide (alum is a crystaline compound widely used as an immunologic adjuvant of vaccines. Concerns linked to the use of alum particles emerged following recognition of their causative role in the so-called macrophagic myofasciitis (MMF lesion detected in patients with myalgic encephalomyelitis/chronic fatigue/syndrome. MMF revealed an unexpectedly long-lasting biopersistence of alum within immune cells in presumably susceptible individuals, stressing the previous fundamental misconception of its biodisposition. We previously showed that poorly biodegradable aluminum-coated particles injected into muscle are promptly phagocytozed in muscle and the draining lymph nodes, and can disseminate within phagocytic cells throughout the body and slowly accumulate in brain. This strongly suggests that long-term adjuvant biopersistence within phagocytic cells is a prerequisite for slow brain translocation and delayed neurotoxicity. The understanding of basic mechanisms of particle biopersistence and brain translocation represents a major health challenge, since it could help to define susceptibility factors to develop chronic neurotoxic damage. Biopersistence of alum may be linked to its lysosome-destabilizing effect, which is likely due to direct crystal-induced rupture of phagolysosomal membranes. Macrophages that continuously perceive foreign particles in their cytosol will likely reiterate, with variable interindividual efficiency, a dedicated form of autophagy (xenophagy until they dispose of alien materials. Successful compartmentalization of particles within double membrane autophagosomes and subsequent fusion with repaired and re-acidified lysosomes will expose alum to lysosomal acidic pH, the sole factor that can solubilize alum particles. Brain translocation of alum particles is linked to a Trojan horse mechanism previously described for infectious particles (HIV, HCV, that obeys to CCL2 signaling the major inflammatory monocyte
Pharmaceutical care education in Kuwait: pharmacy students' perspectives
Directory of Open Access Journals (Sweden)
Katoue MG
Full Text Available Background: Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients' quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective: To investigate pharmacy students' attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods: A descriptive, cross-sectional survey of pharmacy students (n=126 was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results: The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%, lack of pharmacist time (83.3%, organizational obstacles (82.6%, and pharmacists' physical separation from patient care areas (82.6%. Conclusion: Pharmacy students' attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University
[Recent Status of Postoperative Adjuvant Chemotherapy after Completely Resected Lung Cancer].
Naito, Masahito; Tsuboi, Masahiro
Several landmark study elucidated that adjuvant cisplatin-based chemotherapy for stage II-IIIA non-small cell lung cancer (NSCLC)patients after appropriate surgical resection can significantly improve 5-year survival rate. Meta-analysis of modern cisplatin based adjuvant chemotherapy trial confirmed this benefit. Furthermore, in Japan, large randomized trial and metaanalysis assessing the efficacy of uracil-tegafur(UFT)for stage I patients with completely resected NSCLC reported that UFT can significantly improve 5-year survival rate. Meta-analysis of subgroup assessed that effectiveness of UFT for stage I NSCLC patients with a tumor lager than 2 cm. According to these evidence, cisplatin-based adjuvant chemotherapy for stage II-III A NSCLC and UFT for stage I NSCLC patients with a tumor lager than 2 cm are used standard postoperative adjuvant chemotherapy in Japan. In recent year, it is presumed that personalized care will be necessary to re-evaluate strategies for postoperative adjuvant chemotherapy of lung cancer. Considering histological subtype of lung cancer, several randomize trial for postoperative adjuvant chemotherapy with non-squamous NSCLC or high neuroendocrine tumor of lung are ongoing. In addition, recent studies of biological research indicate that some tumor marker such as ERCC1 may had a predictive value for selecting patients who will derive the benefit from adjuvant chemotherapy. PMID:27067681
Effect of Cornus officinalis glycoside on adjuvant-induced arthritis in rats
Institute of Scientific and Technical Information of China (English)
The aim of this study was to explore the effect of Cornus officinalis glucosides (COG) on adjuvant-induced arthritis in rats and its mechanism. Seventy-two rats were divided into six groups of normal, model, Dexasone (0. 125 mg/kg), high-dose COG (240 mg/kg), mid-dose COG (120 mg/kg),and low-dose COG (60 mg/kg). Rat arthritis was induced by injection of Freund's complete adjuvant in the hind paws. All treatment started from the day the arthritis was induced. The edema degree of the adjuvant injection location was determined on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 20, 23 and the opposite side was observed on days 11, 13, 15, 17, 20, 23 after the injection of adjuvant. All rats were sacrificed on day 24 after the injection of adjuvant for microscopic examination of the ankle, and for the study of the immunological molecular mechanism. The results showed that the COG significantly suppressed both the primary and secondary edema, improved pathological injuries of adjuvant arthritis (AA)rat ankles, significantly suppressed the proliferation of T lymphocytes and DTH reaction. It significantly suppressed IL-1, IL-6 and TNF-α production from peritoneal macrophages and PGE2 in plasma. In conclusion, the Cornus officinalis glucosides (COG) is able to prevent and cure the rat adjuvant-induced arthritis, and can suppress the production of pro-inflammatory cytokine IL-1, IL-6, TNF-α and PGE2.
[Foundation of pharmaceutical policy in the Federation of Bosnia-Herzegovina].
Lucić, S; Nenadić, D
Pharmaceuticals are inevitable domain of disease prevention, diagnostics and treatment. The basic objective of pharmaceutical sector reform is to meet the needs of the majority of the population with the essential pharmaceuticals, which are proven as effective, evaluated quality and affordable prices. That objective could be achieved by undertaking a range of measures within the national pharmaceutical policy as an integral part of the overall health, policy in the country. Key elements of that policy should be: pharmaceutical management at the level of the Federal Ministry of Health and cantonal ministrie of health, pharmaceutical legislative documents, rationalization of pharmaceutical therapy (choices of essential pharmaceuticals, choices of pharmaceuticals covered by the resources of health insurance funds, list of hospital pharmaceuticals, selections during pharmaceuticals registration, educational measures, surveillance of measures), spreading information on pharmaceuticals by the pharmaceutical information centre, pharmaceutical supply (local pharmaceutical production, pharmaceuticals import, humanitarian assistance), funding of pharmaceuticals costs (cantonal and hospital lists of pharmaceuticals,) other reform strategies (quality control of pharmaceuticals, surveillance of side-effects, role of pharmacists in health system, environment protection) and strengthening of inspector surveillance. PMID:9623088
Changing Adjuvant Breast-Cancer Therapy with a Signal for Prevention.
Chlebowski, RT; Budoff, MJ
Five randomized, full-scale studies have reported that 10 years of adjuvant endocrine therapy is beneficial for postmenopausal women with hormone-receptor-positive breast cancer. However, no prior study has involved more than 5 years of aromatase-inhibitor use or assessed a duration of adjuvant endocrine therapy of more than 10 years.(1) Goss and colleagues(2) now provide results from the MA.17R trial supporting the use of an aromatase inhibitor for 10 years and the use of adjuvant endocrine ...
Predictive factor for the response to adjuvant therapy with emphasis in breast cancer
International Nuclear Information System (INIS)
One of the major challenges of early-stage breast cancer is to select the adjuvant therapy that ensures the most benefits and the least harm for the patient. The definition of accurate predictive factors is therefore of paramount importance. So far the choice of adjuvant therapy has been based on the number of affected lymph nodes and the hormone receptor status of the patient. This paper evaluates the use of other tumor-related markers as predictive factors for adjuvant therapy. These include HER2, p53 and Bcl-2, cathepsin B, p27, proliferating cell nuclear antigen (PCNA), cyclin D, Ki-67, and vascular endothelial growth factor (VEGF)
Application of radio-detoxified endotoxin as adjuvant for experimental foot-and-mouth disease vaccine
International Nuclear Information System (INIS)
The immunity enhancing adjuvant activity of radiodetoxified endotoxin (RD-LPS) on the potency of 'C' type foot-and-mouth (FMD) vaccine was tested in different animal species. For radiodetoxification 5 Mrad gamma radiation was used. The suitable quantity of RD-LSP (20 μg per mouse) adjuvated FMD vaccines of lower antigen content better than those of higher one. In cattle and sheep the adjuvant effect of oil + RD + LPS surpassed only slightly that of oil alone. The effect of RD-LPS in pig was very pronounced when applied in small doses but further studies in larger animal populations have to confirm this result. (author)
CpG-DNA enhancement the immune elicited as adjuvant of foot- and- mouth disease vaccine
Morshedi, A.; Daghighi, M.; Mahravani, H.
In the present study the effect of the locally produced genetic adjuvant of ginea pig specific CpG-motif-containing oligodeoxynucleotide (CpG-ODN) in an inactivated FMD virus vaccine was evaluated. Boosting the ginea pigs with FMD vaccine along with CpG-ODN adjuvant produced relatively higher ratio (5-fold) of FMDV-specific IgG2a / IgG1 than those vaccinated in the absence of CpG-ODN. The neutralizing antibody (NA) titer induced by FMD vaccine along with CpG-ODN adjuvant was significantly hig...
Pilot study of postoperative adjuvant chemoradiation for advanced gastric cancer: Adjuvant 5-FU/cisplatin and chemoradiation with capecitabine
Institute of Scientific and Technical Information of China (English)
Hyung-Sik Lee; Min-Chan Kim; Youngmin Choi; Won-Joo Hur; Hyo-Jin Kim; Hyuk-Chan Kwon; Sung-Hyun Kim; Jae-Seok Kim; Jong-Hoon Lee; Ghap-Joong Jung
AIM: To evaluate the efficacy and toxicity of postoperative chemoradiation using FP chemotherapy and oral capecitabine during radiation for advanced gastric cancer following curative resection.METHODS: Thirty-one patients who had underwent a potentially curative resection for Stage Ⅲ and Ⅳ (MO) gastric cancer were enrolled. Therapy consists of one cycle of FP (continuous infusion of 5-FU 1000 mg/m2 on d 1 to 5 and cisplatin 60 mg/m2 on d 1) followed by 4500 cGy (180 cGy/d) with capecitabine (1650 mg/m2 daily throughout radiotherapy). Four wk after completion of the radiotherapy, patients received three additional cycles of FP every three wk. The median follow-up duration was 22.2 mo.RESULTS: The 3-year disease free and overall survival in this study were 82.7% and 83.4%, respectively. Four patients (12.9%) showed relapse during follow-up. Eight patients did not complete all planned adjuvant therapy.Grade 3/4 toxicities included neutropenia in 50.2%, anemia in 12.9%, thrombocytopenia in 3.2% and nausea/vomiting in 3.2%. Neither grade 3/4 hand foot syndrome nor treatment related febrile neutropenia or death were observed.CONCLUSION: These preliminary results suggest that this postoperative adjuvant chemoradiation regimen of FP before and after capecitabine and concurrent radiotherapy appears well tolerated and offers a comparable toxicity profile to the chemoradiation regimen utilized in INT-0116. This treatment modality allowed successful loco-regional control rate and 3-year overall survival.
Introductory Level Problems Illustrating Concepts in Pharmaceutical Engineering
McIver, Keith; Whitaker, Kathryn; De Delva, Vladimir; Farrell, Stephanie; Savelski, Mariano J.; Slater, C. Stewart
Textbook style problems including detailed solutions introducing pharmaceutical topics at the level of an introductory chemical engineering course have been created. The problems illustrate and teach subjects which students would learn if they were to pursue a career in pharmaceutical engineering, including the unique terminology of the field,…
Adsorptive removal of selected pharmaceuticals by mesoporous silica SBA-15
Energy Technology Data Exchange (ETDEWEB)
Bui, Tung Xuan, E-mail: firstname.lastname@example.com [Department of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of); Choi, Heechul, E-mail: firstname.lastname@example.com [Department of Environmental Science and Engineering, Gwangju Institute of Science and Technology (GIST), 261 Cheomdan-gwagiro, Buk-gu, Gwangju 500-712 (Korea, Republic of)
The removal of five selected pharmaceuticals, viz., carbamazepine, clofibric acid, diclofenac, ibuprofen, and ketoprofen was examined by batch sorption experiments onto a synthesized mesoporous silica SBA-15. SBA-15 was synthesized and characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), N{sub 2} adsorption-desorption measurement, and point of zero charge (PZC) measurement. Pharmaceutical adsorption kinetics was rapid and occurred on a scale of minutes, following a pseudo-second-order rate expression. Adsorption isotherms were best fitted by the Freundlich isotherm model. High removal rates of individual pharmaceuticals were achieved in acidic media (pH 3-5) and reached 85.2% for carbamazepine, 88.3% for diclofenac, 93.0% for ibuprofen, 94.3% for ketoprofen, and 49.0% for clofibric acid at pH 3 but decreased with increase in pH. SBA-15 also showed high efficiency for removal of a mixture of 5 pharmaceuticals. Except for clofibric acid (35.6%), the removal of pharmaceuticals in the mixture ranged from 75.2 to 89.3%. Based on adsorption and desorption results, the mechanism of the selected pharmaceuticals was found to be a hydrophilic interaction, providing valuable information for further studies to design materials for the purpose. The results of this study suggest that mesoporous-silica-based materials are promising adsorbents for removing pharmaceuticals from not only surface water but also wastewater of pharmaceutical industrial manufactures.
Internet as a Medium of Pharmaceutical Companies Promotional Activities
Darko Pantelic
Pharmaceuticals market is highly regulated, and it can be stated that prescription (legal or ethical) drugs have a status of substances in controlled circulation. Promotional activities are also under strict legislation, further burdened with ethical consideration and public scrutiny. Internet as liberal and hard to control medium brings entirely new sets of solutions and/or problems to pharmaceuticals market(ers).
Electrospray crystallization for nanosized pharmaceuticals with improved properties
Radacsi, N.; Ambrus, R.; Szunyogh, T.; Szabó-Révész, P.; Stankiewicz, A.; Heijden, A.E.D.M. van der; Horst, J.H. ter
Many new pharmaceuticals have low water solubility, hampering their pharmaceutical activity upon administering. One approach to increase solution concentrations during drug administration is to increase the surface-to-volume ratio by decreasing the crystal product size. Sub-micrometer-sized niflumic
Application of Incoherent Inelastic Neutron Scattering in Pharmaceutical Analysis
DEFF Research Database (Denmark)
Bordallo, Heloisa N.; A. Zakharov, Boris; Boidyreva, E.V.;
This study centers on the use of inelastic neutron scattering as an alternative tool for physical characterization of solid pharmaceutical drugs. On the basis of such approach, relaxation processes in the pharmaceutical compound phenacetin (p-ethoxyacetanilide, C(10)H(13)NO(2)) were evidenced on ...
75 FR 16157 - Pharmaceutical Supply Chain; Public Workshop
... HUMAN SERVICES Food and Drug Administration Pharmaceutical Supply Chain; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ``2010 PDA/FDA Pharmaceutical Supply Chain...
Adsorptive removal of selected pharmaceuticals by mesoporous silica SBA-15
International Nuclear Information System (INIS)
The removal of five selected pharmaceuticals, viz., carbamazepine, clofibric acid, diclofenac, ibuprofen, and ketoprofen was examined by batch sorption experiments onto a synthesized mesoporous silica SBA-15. SBA-15 was synthesized and characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), N2 adsorption-desorption measurement, and point of zero charge (PZC) measurement. Pharmaceutical adsorption kinetics was rapid and occurred on a scale of minutes, following a pseudo-second-order rate expression. Adsorption isotherms were best fitted by the Freundlich isotherm model. High removal rates of individual pharmaceuticals were achieved in acidic media (pH 3-5) and reached 85.2% for carbamazepine, 88.3% for diclofenac, 93.0% for ibuprofen, 94.3% for ketoprofen, and 49.0% for clofibric acid at pH 3 but decreased with increase in pH. SBA-15 also showed high efficiency for removal of a mixture of 5 pharmaceuticals. Except for clofibric acid (35.6%), the removal of pharmaceuticals in the mixture ranged from 75.2 to 89.3%. Based on adsorption and desorption results, the mechanism of the selected pharmaceuticals was found to be a hydrophilic interaction, providing valuable information for further studies to design materials for the purpose. The results of this study suggest that mesoporous-silica-based materials are promising adsorbents for removing pharmaceuticals from not only surface water but also wastewater of pharmaceutical industrial manufactures.
Pharmaceutical industry sponsorship and research outcome and quality: systematic review
Lexchin, Joel; Bero, Lisa A. Ph.D.; Djulbegovic, Benjamin; Otavio CLARK
Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support.
Ways of Learning in the Pharmaceutical Sales Industry
Hunter, Carrie Patricia
Purpose: The purpose of this paper is to document the ways pharmaceutical representatives learn for work and report attributes of (in)formality and other characteristics of ways of learning perceived as effective and frequently used. Design/methodology/approach: A total of agents 20 from 11 pharmaceutical manufacturers across Canada participated…
[Commercialization of results of intellectual activities in pharmaceutical industry].
Posylkina, O V; Timaniuk, V N; Gladukh, E V
An analysis has been done of those causes impending the development of innovative processes and commercialization of results of intellectual activities in the economics of Ukraine and its pharmaceutical sector. Possible ways for rectifying the prevailing situation are considered. A scheme is proposed of staged commercialization of developments involving creation of new pharmaceutical preparations. PMID:12669531
New opportunities for biocatalysis: making pharmaceutical processes greener
DEFF Research Database (Denmark)
Woodley, John
The pharmaceutical industry requires synthetic routes to be environmentally compatible as well as to fulfill the demands of process economics and product specification and to continually reduce development times. Biocatalysis has the potential to deliver 'greener' chemical syntheses, and in this...... biocatalysis for making pharmaceutical processes greener....
Pharmacists' Perceptions of the Economic Value of Compounded Pharmaceuticals: A Comparison of Compounded and Commercial Pharmaceuticals in Select Disease States.
Lobb, William B; Wilkin, Noel E; Holmes, Erin R
Studies have been conducted to assess patient satisfaction with compounded pharmaceuticals and to directly compare compounded pharmaceuticals with their comparable commercial pharmaceuticals. Yet, the economic value of or potential for economic value derived from compounded pharmaceuticals relative to commercial pharmaceuticals is still not known. Therefore, the purpose of this study was to assess and compare compounding and non-compounding pharmacists' perceptions of the economic value of compounded preparations relative to commercial products. In-depth interviews with 10 compounding pharmacists and physicians who prescribe compounded prescription pharmaceutical preparations were conducted to help develop a self-administered questionnaire distributed to 50 compounding and 50 non-compounding pharmacists. Compounding and non-compounding pharmacists' perceptions differed most often in the context of compounded pharmaceuticals for pediatric patients. However, both groups responded with moderate agreement that compounded prescription treatments are more profitable for the pharmacy than commercial prescription treatments in most therapeutic areas. This research sought to understand the perception of pharmacists of areas for potential direct and indirect economic cost savings as a result of compounding. For all items whereby compounding and non-compounding pharmacists' ratings were significantly different, compounding pharmacists more strongly believed that compounding pharmaceuticals offered benefit and vice versa. The differences in ratings that were most common were those that directly compared the economic value of compounding and commercial pharmaceuticals, with compounding pharmacists more strongly agreeing with the potential cost savings associated with compounded pharmaceuticals. Based on these findings, prescription compounds are believed to have a benefit to the health system by those who provide them. Future research should proactively explore the economic
77 FR 12621 - Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals Inc.
... FR 81978, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals...), and determined that the registration of Mylan Pharmaceuticals, Inc. to import the basic classes...
76 FR 78258 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...
... Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to Aid Public... Agreement Containing Consent Order (``Consent Agreement'') from Valeant Pharmaceuticals International, Inc... Dermatologics division of Janssen Pharmaceuticals, Inc. (``Janssen''), a wholly owned subsidiary of...
78 FR 46371 - Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals, Inc.
... FR 12101, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523, made application... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Meda Pharmaceuticals... 952(a), and determined that the registration of Meda Pharmaceuticals Inc., to import the basic...
78 FR 19016 - Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc.
... FR 72409, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made... Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals... Mylan Pharmaceuticals, Inc. to import the basic classes of controlled substances is consistent with...
Microbial Removal of the Pharmaceutical Compounds Ibuprofen and Diclofenac from Wastewater
Langenhoff, A.A.M.; Inderfurth, N.S.; Veuskens, T.; Schraa, G.; Blokland, M.; Kujawa-Roeleveld, K.; Rijnaarts, H.H.M.
Studies on the occurrence of pharmaceuticals show that the widely used pharmaceuticals ibuprofen and diclofenac are present in relevant concentrations in the environment. A pilot plant treating hospital wastewater with relevant concentrations of these pharmaceuticals was evaluated for its performanc
75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities
... AGENCY Best Management Practices for Unused Pharmaceuticals at Health Care Facilities AGENCY... guidance document entitled, Best Management Practices for Unused Pharmaceuticals at Health Care Facilities... been studying unused pharmaceutical disposal practices at health care facilities, prompted by...
Potent response of QS-21 as a vaccine adjuvant in the skin when delivered with the Nanopatch, resulted in adjuvant dose sparing.
Ng, Hwee-Ing; Fernando, Germain J P; Depelsenaire, Alexandra C I; Kendall, Mark A F
Adjuvants play a key role in boosting immunogenicity of vaccines, particularly for subunit protein vaccines. In this study we investigated the induction of antibody response against trivalent influenza subunit protein antigen and a saponin adjuvant, QS-21. Clinical trials of QS-21 have demonstrated the safety but, also a need of high dose for optimal immunity, which could possibly reduce patient acceptability. Here, we proposed the use of a skin delivery technology - the Nanopatch - to reduce both adjuvant and antigen dose but also retain its immune stimulating effects when compared to the conventional needle and syringe intramuscular (IM) delivery. We have demonstrated that Nanopatch delivery to skin requires only 1/100(th) of the IM antigen dose to induce equivalent humoral response. QS-21 enhanced humoral response in both skin and muscle route. Additionally, Nanopatch has demonstrated 30-fold adjuvant QS-21 dose sparing while retaining immune stimulating effects compared to IM. QS-21 induced localised, controlled cell death in the skin, suggesting that the danger signals released from dead cells contributed to the enhanced immunogenicity. Taken together, these findings demonstrated the suitability of reduced dose of QS-21 and the antigen using the Nanopatch to enhance humoral responses, and the potential to increase patient acceptability of QS-21 adjuvant. PMID:27404789
Lipids in pharmaceutical and cosmetic preparations
Directory of Open Access Journals (Sweden)
González Rodríguez, María Luisa
Full Text Available In this paper, a review of the applications of lipids in the pharmaceutical field has been reported. In a first stage, different lipids used as excipients in cosmetics and medicines have been described. Many vegetable oils are used in this sense: almond oil, apricot oil, avocado oil, borage oil, coffee oil, safflower oil, etc.; from de animal source, fish oil and bird oil can be employed as excipients in cosmetical formulations. Fats and waxes may be also used for this purpose. A broad range of phospholipids are suitable for use in cosmetics, pharmaceuticals and diagnosis. These substances are used as vehicle for therapeutic substances, such as liposomes. Finally, a study of lipids, as a function of their biological activity, as active substances for the elaboration of pharmaceuticals, cosmetics or nutritional supplements, was carried out. Carotenoids, retinoids, tocopherols are used for their antioxidant properties, that are important to health and diagnostic medicine.En el presente trabajo se ha llevado a cabo una revisión sobre las aplicaciones de los lípidos en el campo famacéutico. En un primer apartado, se describieron los diferentes lípidos utilizados como excipientes en cosmética y medicina. En este sentido, se utilizan muchos aceites vegetales, como el aceite de almendra, albaricoque, aguacate, borraja, café, cártamo, etc.; a partir de fuente animal, pueden emplearse como excipientes en formulaciones cosméticas los aceites de pescados y de aves. También se utilizan con este propósito las grasas y las ceras. Así mismo se revisan los fosfolípidos empleados en cosmética y en diagnosis, que actúan como vehículos transportadores de sustancias activas, como los liposomas. Finalmente, se llevó a cabo un estudio de los lípidos, en función de su actividad biológica, como sustancias activas que forman parte de la elaboración de formulaciones cosméticas, farmacéuticas o suplementos nutricionales. Los carotenoides, retinoides
Membrane bioprocesses for pharmaceutical micropollutant removal from waters.
de Cazes, Matthias; Abejón, Ricardo; Belleville, Marie-Pierre; Sanchez-Marcano, José
The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW) containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds. PMID:25295629
Occurrence and treatment efficiency of pharmaceuticals in landfill leachates.
Lu, Mu-Chen; Chen, Yao Yin; Chiou, Mei-Rung; Chen, Men Yu; Fan, Huan-Jung
Landfill leachates might contain pharmaceuticals due to the expired or unwanted drugs were disposed of at landfills. These pharmaceuticals might pose a threat to soil and groundwater. Therefore, this study investigated the distributions of pharmaceutical residues and toxicities among four typical municipal landfill leachates. Twenty six pharmaceuticals were investigated in this study and fifteen of them were found in all samples from four leachates. In addition, ampicillin and methylenedioxymethamphetamine (MDMA) were detected in urban landfills (A1 and A2) but were not in rural and suburb landfills (B and C). On the other hand, some compounds were much more abundant in suburb/rural landfill leachates than those in urban landfills including diclofenac, gemfibrozil and amphetamine. Landfill leachate treatment plants could not remove most of the pharmaceuticals effectively. Landfill leachates without proper treatments would have significant adverse health impacts on human and aquatic life. PMID:27026494
Cleaner production at pharmaceutical industry: first steps assessment
Directory of Open Access Journals (Sweden)
Edilaine Conceição Rezende
Full Text Available The Cleaner Production (CP is an environmental management system effective to comply the environmental obligations and promote sustainable development of enterprises. In this study, the implementing possibilities of CP practices were evaluated to pharmaceutical industry, through prior identification procedures for Pharmaceutical Manufacturing Practices. The study was conducted in a scientific and health care institution, which produces pharmaceutical drugs and makes assistance for public health. The production process was evaluated and made a survey of the main points of waste and sewage generations in each stage, in order to diagnose the measures of CP established and propose new actions. Thus, by using this tool, it was possible to demonstrate the reduction of environmental impacts associated with pharmaceutical production. The Pharmaceutical Manufacturing Practices also contributed to the implementation of measures CP, preserving the final product quality, and generating environmental and economic benefits.
Strategic Development Trends in the World Pharmaceutical Industry
Directory of Open Access Journals (Sweden)
Dragan Kesič
Full Text Available The main purpose of the paper is to research and evaluate the strategicdevelopment trends in the world pharmaceutical industry in the period1996–2006.We aim to find that mergers and acquisitions prevailas a vital strategic development option in the world pharmaceutical industry.The research examines the exploratory hypothesis that the intensiveglobalization process, increased competitiveness and changedstructure of competitors, strongly influence the consolidation developmenttrends in the world pharmaceutical industry which result in anincreased number of mergers and acquisitions. The intensive consolidationof the world pharmaceutical industry is a market driven processand conditioned by several strategic issues, such as lack of brand newproducts, increased competitiveness, fast globalization process, intensiveglobal marketing and sales activities, changed structure of competitors,fight for global market shares and customers' loyalty. There isclear evidence that the world pharmaceutical industry and market areboth becoming more oligopolistic and monopolistic.
Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters
Directory of Open Access Journals (Sweden)
Matthias de Cazes
Full Text Available The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds.
Membrane Bioprocesses for Pharmaceutical Micropollutant Removal from Waters
de Cazes, Matthias; Abejón, Ricardo; Belleville, Marie-Pierre; Sanchez-Marcano, José
The purpose of this review work is to give an overview of the research reported on bioprocesses for the treatment of domestic or industrial wastewaters (WW) containing pharmaceuticals. Conventional WW treatment technologies are not efficient enough to completely remove all pharmaceuticals from water. Indeed, these compounds are becoming an actual public health problem, because they are more and more present in underground and even in potable waters. Different types of bioprocesses are described in this work: from classical activated sludge systems, which allow the depletion of pharmaceuticals by bio-degradation and adsorption, to enzymatic reactions, which are more focused on the treatment of WW containing a relatively high content of pharmaceuticals and less organic carbon pollution than classical WW. Different aspects concerning the advantages of membrane bioreactors for pharmaceuticals removal are discussed, as well as the more recent studies on enzymatic membrane reactors to the depletion of these recalcitrant compounds. PMID:25295629
Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations.
Elder, David P; Kuentz, Martin; Holm, René
Practically all medications contain excipients, which are added for the purpose of production enhancement, patient acceptability, improving stability, controlling release etc. Typically excipients are the major components of a drug product, with the active molecule only present in relatively small amounts. Historically, excipients were termed inactive components. However, as highlighted in the present paper; excipients can have an impact on the absorption, distribution, metabolism and elimination (ADME) processes of the co-administered drug, which is important information when selecting excipients for any new formulation. Further, this review also provides a description of the regulatory processes to get new excipients approved in different regions and a discussion of the recent regulatory initiatives, e.g. excipients for paediatric formulations, thereby providing points to consider for the pharmaceutical scientist when selecting excipients for a new drug formulation. PMID:26699228
Pancreatin irradiation for medical and pharmaceutical applications
International Nuclear Information System (INIS)
Pancreatin is an enzyme mix conformed substance used in medical and pharmaceutical applications principally. Due to its origin and processing method, pancreatin possibly requires to undergo a decontamination process. Thus, sample of powered pancreatin were packed in polyethylene bags and gamma irradiated at 2, 3, 5, 6, 7, 8, 13 y 25 kGy. Microbiological and physico-chemical tests specified in the US Pharmacopea were performed to the irradiated samples and control in order to determine the optimum decontamination dose which will permit the commercial use of the product. It was determined that 5 kGy as minimum dose was adequate to reduce in 3 log cycles the initial bioburden of the product, which was composed principally by aerobic mesophiles, specifically sporulated bacilli. Moreover, results of assays involved loss of drying, enzymatic activity, colour and odour performed in irradiated samples showed no significant alterations respecting the control. (author)
Nonclinical statistics for pharmaceutical and biotechnology industries
This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The cha...