Effect of food on bioavailability of pseudoephedrine and brompheniramine administered from a gastrointestinal therapeutic system.
The purpose of this study was to determine how a high-fat meal affects the delivery and absorption of pseudoephedrine and brompheniramine maleate when delivered from a gastrointestinal therapeutic system (GITS). This study was a randomized, complete crossover trial with 12 healthy male volunteers who were given single doses of the 24-h GITS under fed and fasted conditions. Pharmacokinetic parameters for both drugs were comparable between fed and fasted treatments, except for a shorter time to maximum concentration of pseudoephedrine for fed subjects (p = 0.002). Bioavailability of pseudoephedrine was 91% for fed relative to fasted treatment; for brompheniramine it was 89%. These results indicate that codelivery of the two drugs from the GITS is reliable and prolonged, and that the resulting absorption of pseudoephedrine and brompheniramine is minimally affected by food.
Chao
S T
ST
Alza Corporation, Palo Alto, CA 94303-0802.
Prather
D
D
Pinson
D
D
Coen
P
P
Pruitt
B
B
Knowles
M
M
Place
V
V
D000328:Adult; D001682:Biological Availability; D001977:Brompheniramine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D004041:Dietary Fats / Q000494:pharmacology; D004064:Digestive System / Q000378:metabolism; D004809:Ephedrine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D005502:Food; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D008297:Male; D013608:Tablets, Enteric-Coated
D004041:Dietary Fats; D013608:Tablets, Enteric-Coated; D004809:Ephedrine; D001977:Brompheniramine