Study on the influence of food on the absorption of theophylline from a controlled-release preparation.
The possible influence of food and fat content of meals on the bioavailability and pharmacokinetics of a 350 mg sustained-release theophylline (CAS 58-55-9) preparation (Bronchoretard) was investigated after single-dose oral administration to 18 volunteers in a randomized 3-way cross-over design. The treatments investigating an administration of the test preparation in a fasting state, after a standard meal and after a high-caloric fat evening meal, according to the commonly applied rules, could be shown to be equivalent with respect to the amount of bioavailability (AUC) and the observed maximal concentrations (Cmax). Pharmacokinetic parameters describing sustained-release characteristics were not changed either to any relevant degree. As expected, the co-administration of food resulted in a physiologically determined delay in absorption, which probably is not therapeutically relevant during long-term administration.
Pabst
G
G
L. A. B. Gesellschaft für pharmakologische Untersuchungen mbH & Co, Neu-Ulm, Fed. Rep. of Germany.
Weber
W
W
Müller
M
M
Barkworth
M F
MF
D000328:Adult; D001682:Biological Availability; D003692:Delayed-Action Preparations; D004041:Dietary Fats / Q000494:pharmacology; D005502:Food; D006801:Humans; D007408:Intestinal Absorption; D008297:Male; D013806:Theophylline / Q000008:administration & dosage / Q000493:pharmacokinetics*
D003692:Delayed-Action Preparations; D004041:Dietary Fats; D013806:Theophylline