Discriminatory dissolution method for quality control measurements of carbamazepine immediate release tablets based on in vitro–in vivo investigations

Abstract

The purpose of this study was to identify a discriminatory dissolution method able to predict the in vivo performance of tablet formulations designed for carbamazepine (CBZ). After evaluation of dissolution medium and rotation speed using a 25 central composite design and investigation of the in vivo release behaviors in beagle dogs, the dissolution method of CBZ 100 mg tablets was validated using a USP apparatus II, at a rotation speed of 75 rpm, and 900 ml deaerated water with 0.5% sodium lauryl sulfate (w/v) as the dissolution medium. Dissolution profiles were evaluated by the Weibull parameters and the modified fit factor, ƒ1,area. The in vitro–in vivo relationship of CBZ tablets was examined. Compared with the results from the USP and Chinese Pharmacopoeia monograph, the proposed system provides a superior discriminatory method. Since the dissolution method in pharmacopoeia for CBZ tablets is unable to distinguish between a good and a bad product, the method presented here can be used for the quality control testing of CBZ tablets.