Abstract

This investigation is undertaken with an aim to develop pharmaceutically equivalent, stable, cost effective and quality improved formulation of Clopidogrel bisulphate immediate release tablets. The task of developing immediate release tablet is accomplished by using a suitable diluents and super disintegrant. Faster disintegration of the tablet administrated orally minimizes absorption time and improves its bioavailability in less time. Immediate Release tablet of Anti plate drug is formulated using direct compression using super disintegrant Cross povidone.

Clopidogrel is an inhibitor of platelet activation and decreases subsequent platelet aggregation. The current study involves preparation and evaluation of Clopidogrel bisulphate tablets, comparison of dissolution rate of final formula with innovator’s product and estimation of similarity and difference factors. The kinetics study shows that the fast dissolving tablet formulation followed first order kinetic model explaining the diffusion controlled release mechanism. the similarity and dissimilarity factor obtained for Clopidogrel bisulphate was found to be within the standards. The formulation F-8 exhibited similar release profile to that of innovators product at each time point. Hence, F-8 was considered as the best formulation.

Key words:

Clopidogrel bisulphate, Immediate Release Tablets, Direct Compression