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document
[ Pharmacokinetics of theophylline in sustained-release formulation in young asthmatics ] . Pharmacokinetics of two theophylline ( CAS 58-55-9 ) sustained release preparations ( T : Bronchoretard Capsules/R : Capsule formulation from the US market ) were investigated in an open randomised two-way crossover design . The capsules of the test formulation were opened and administered on a tablespoonful of apple sauce . Nineteen asthmatics aged 6 to 12 years participated in this study . Following individual dosing of 100-300 mg theophylline twice a day , a pharmacokinetic profile for 24 h was derived after seven days of multiple dosing . All relevant parameters for rate ( Cmax ss , Cmin ss , Cav ss , plateau time , peak-trough fluctuation , nocturnal excess , tmax ss ) and extent of absorption ( AUCss ) were calculated for both formulations . With long plateau times ( T : 17.3 h ) and small peak-trough fluctuations ( T : 49.0 % ) , established quality criteria for high quality theophylline preparations were fulfilled by the test formulation . Furthermore , symmetrical peaks resulted after morning and evening administration of the test formulation . In conclusion , smooth and predictable concentration/time profiles were achieved , enabling an efficacious and safe therapy of asthma . This individual mode of administration allows not only a perfect dose titration in young asthmatics , but is also helpful to patients who have difficulty in swallowing large dosage forms .
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Intervention_Pharmacological
two theophylline ( CAS 58-55-9 ) sustained release preparations
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Intervention_Pharmacological
T : Bronchoretard Capsules/R : Capsule formulation from the US market
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Intervention_Pharmacological
Following individual dosing of 100-300 mg theophylline twice a day
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Intervention_Pharmacological
pharmacokinetic profile for 24 h was derived after seven days of multiple dosing
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Outcome_Physical
Cmax ss , Cmin ss , Cav ss , plateau time , peak-trough fluctuation , nocturnal excess , tmax ss
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Outcome_Physical
extent of absorption
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Outcome_Other
plateau times
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Outcome_Other
small peak-trough fluctuations
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Outcome_Other
symmetrical peaks
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Outcome_Physical
concentration/time profiles
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Participant_Condition
young asthmatics ]
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Participant_Age
Nineteen asthmatics aged 6 to 12 years