Comparative in vitro dissolution study of carbamazepine immediate-release products using the USP paddles method and the flow-through cell system

摘要

Dissolution profiles of four carbamazepine immediate-release generic products (200mg tablets) and the reference product Tegretol(R) were evaluated using the USP paddles method and an alternative method with the flow-through cell system, USP Apparatus 4. Under official conditions all products met the Q specification, dissolution profiles of generic products were similar to the dissolution profile of the reference product (f"250) and model-independent parameters showed non significant differences to the reference product except mean dissolution time for product A (p0.05). On the other hand, when the flow-through cell system was used, none of the products met the pharmacopeial specification at 15min and product A did not reach dissolution criteria at 60min, dissolution profiles of all generic products were not similar to the reference product profile (f"250) and all model-independent parameters showed significant differences compared to the reference product (p0.05). Weibull's model was more useful for adjusting the dissolution data of all products in both USP apparatuses and Td values showed significant differences compared to the reference product (p0.05) when USP Apparatus 4 was used. These results indicate that the proposed method, using the flow-through cell system, is more discriminative in evaluating both, rate and extent of carbamazepine dissolution process from immediate-release generic products.