Abstract
After the in vitro dissolution profiles of three Mexican carbamazepine products and the innovator product (Tegretol) in four different dissolution media: HC1 0.1 N, simulated gastric fluid, simulated intestinal fluid, and water containing 1% sodium lauryl sulfate (USP method) were assesed, their bioequivalence was evaluated in 12 healthy volunteers in a randomized crossover study. Single oral doses of 400 mg of each product were administered at intervals of 2 weeks. The products tested in this study showed significant differences in the peak concentration and the area under the curve ( p< 0.05). A faster dissolution was observed when USP method was used; however, no correlation was observed between the in vivo parameters and the in vitro dissolution results with this method. A linear relationship was found between the area under the curve and the percent dissolved at 45, 60 and 90 min when simulated intestinal fluid was used.
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