Abstract
Objective:
To assess the bioequivalence between two extended-release formulations of theophylline using saliva as the biologic fluid.
Design:
Randomized two-way crossover design.
Participants:
Eight healthy, nonsmoking volunteers (7 women, 1 man) between 23 and 41 years of age took a single dose (250 mg) of two extended-release formulations of theophylline (form A, tablet; form B, capsule).
Results:
Significant differences were found at 2, 4, 6, and 8 hours (p < 0.001), with the in vitro dissolution test between both formulations. ANOVA for AUC, maximum concentration (Cmax), average concentration, and %Cmax – 100 showed significant differences between both formulations in the in vivo trial.
Conclusions:
The tablet and capsule formulations of extended-release theophylline are bioinequivalent when saliva is used as the biologic fluid for performing these studies.
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