In vitro evaluation of carbamazepine 200 mg tablets

Abstract

A comparative in-vitro performance of carbamazepine 200mg tablet products available on the Kenyan market was evaluated. The products which include the innovator product, Tegretol, have similar quality consonant with pharmacopoeal specifications. A batch of one of the products had a carbamazepine content of 106.6% label claim which was outside the upper limits of 105%. One product packaged in multiple-unit containers of a 1000, had an unacceptable high friability of 6.82% loss in weight. All products had good dissolution profiles and released at least 70% of the dose within 45 minutes. Drug dissolution from tablets was found to vary between batches for one product. At each sampling time, most generics had wide variations in amount of dissolved drug. The effect of such variations on tablet efficacy cannot be ascertained in the absence of bioavailability data