Product Evaluation of Carbamazepine 200mg Controlled Release Tablets using an in vitro-in vivo Correlation Simulation Model

Abstract

Evaluation of the dissolution characteristics of drugs and their bioavailability can be conducted using an in vitro-in vivo correlation model. This can help in assessing the products available in the market for quality. Random testing in post-marketing surveillance would gauge the quality of the drug products. This study involved evaluation of three batches of controlled-release carbamazepine, Tegretol 200mg CR® tablets through dissolution tests from which a dissolution profile and blood concentration-time profile were derived. The in vitro-in vivo correlation simulation model was used to determine the Area Under Curve and Maximum Plasma Concentration and demonstrate bioequivalence of the product batches. The three batches exhibited similarity upon statistical analysis. The results also correspond to the values obtained in literature from bioequivalence studies. In vitro-in vivo correlation can thus be a useful instrument in pharmacovigilance for marketed drug products.

Keywords: IVIVC, carbamazepine, bioavailability, pharmacokinetic parameters, dissolution