Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, May 31, 2013
What are Bulk Ingredients and Why are they Necessary for Compounding?
When a medical practitioner determines that a medication needs to be compounded to meet the needs of patients ...
... it is because there is no commercially available, FDA- approved medication to fit that patient’s medical need. While there may be commercially available FDA-approved medications containing the active ingredient being prescribed, the dosage form, strength or flavor of the medication may be one that the patient physically cannot tolerate. In other cases, excipients such as fillers and preservatives found within the commercially available medication may prohibit the patient from being able to take the medication due to sensitivities or allergies to these substances.
When a drug is customized, or compounded, to meet the identified needs of patients or groups of patients, it is common practice to use only ingredients necessary to achieve the prescribed compounded medication. This means starting with the active pharmaceutical ingredients (API) in its purist form, and then adding only the excipients necessary to achieve the prescribed dosage-form, strength, and where specified, flavor. These are the essential ingredients that make the medicine what it is, and are commonly referred to as bulk ingredients. Using bulk ingredients in a compounded medication is the surest, safest way of satisfying the prescriber’s request for medication to meet the special, customized needs of the patient.
Replacing bulk ingredients used in compounds, particularly a bulk API, with an API from an existing commercially available medication, such as a tablet or capsule, has the potential for serious health problems for those patients using that medication, for two main reasons. First, because the active ingredient makes up only a small portion of the overall ingredients used in commercial tablets or capsules, it is impossible to separate the active ingredient from the other excipients (fillers, binders, dyes, flavorings, preservatives and other materials). Without being able to separate these excipients means that they would then become incorporated into the finished compounded medication.
Dawa za binadamu, Dawa za binadamu, Dawa za wanyama, Dawa za wanyama, Sheria ya Pharmacy, Sheria ya Dawa, Sheria ya Compounding, Dawa za binadamu, Dawa za wanyama, Dawa za binadamu, Dawa za wanyama, Dawa za binadamu, Dawa za binadamu, Dawa za wanyama, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa, Dawa za dawa. Wakati daktari anaamua kwamba dawa inahitaji kuwa mchanganyiko ili kukidhi mahitaji ya wagonjwa, ni kwa sababu hakuna kibiashara inapatikana, FDA-kubaliwa dawa ya kufaa kwamba mgonjwa mahitaji ya matibabu. Ingawa kunaweza kuwa na dawa zinazopatikana kibiashara zilizoidhinishwa na FDA zenye kiungo hai kinachoagizwa, fomu ya kipimo, nguvu au ladha ya dawa inaweza kuwa moja ambayo mgonjwa hawezi kuvumilia kimwili. Katika kesi nyingine, excipients kama vile fillers na preservatives kupatikana ndani ya dawa kibiashara inapatikana inaweza kuzuia mgonjwa kutoka kuwa na uwezo wa kuchukua dawa kutokana na unyeti au mzio kwa vitu hivi. Wakati dawa ni customized, au mchanganyiko, ili kukidhi mahitaji ya wagonjwa au makundi ya wagonjwa, ni kawaida kutumia viungo tu muhimu kufikia dawa ya mchanganyiko uliopendekezwa. Hii inamaanisha kuanza na viungo vya dawa (API) katika fomu yake safi, na kisha kuongeza tu excipients muhimu kufikia fomu ya kipimo, nguvu, na ambapo maalum, ladha. Hizi ni viungo muhimu kwamba kufanya dawa nini ni, na ni kawaida inajulikana kama viungo wingi. Kutumia viungo vya wingi katika dawa iliyochanganywa ni njia ya uhakika, salama ya kuridhisha ombi la mtoa dawa kwa dawa ili kukidhi mahitaji maalum, ya kibinafsi ya mgonjwa. Kuchukua nafasi ya viungo vya bulk kutumika katika misombo, hasa bulk API, na API kutoka kwa dawa iliyopo ya kibiashara, kama vile kibao au capsule, ina uwezekano wa matatizo makubwa ya afya kwa wagonjwa wanaotumia dawa hiyo, kwa sababu mbili kuu. Kwa sababu hii, kwa sababu dutu hiyo ni sehemu ndogo tu ya dutu zote zinazotumiwa katika vidonge au vidonge vya kibiashara, haiwezekani kutenganisha dutu hiyo na dutu nyingine (vitu vya kujaza, viunganishi, rangi, ladha, vifaa vya kuhifadhi na vifaa vingine). Bila kuwa na uwezo wa kutenganisha excipients hizi ina maana kwamba wao kisha kuwa kuingizwa katika kumaliza dawa mchanganyiko.