Abstract

FORMULATION AND IN-VITRO EVALUATION OF IMMEDIATE RELEASE TABLETS CONTAINING ANTIPLATELET DRUG: CLOPIDOGREL

Srikant Pimple*, Pravin Maurya, Akash Joshi, Amit Jain, Dr. Mukund Gurjar,Mahesh Shah

ABSTRACT

The present investigation was undertaken with an aim to develop pharmaceutically equivalent, stable, cost effective, and quality improved formulation of Clopidogrel bisulfate immediate release tablets. The current study involves formulation and evaluation of Clopidogrel bisulfate immediate release tablets, comparison of dissolution rate of optimized formula with innovator and estimation of similarity factors. Preformulation study such as solubility analysis, intrinsic dissolution, drug-excipients compatibility and hygroscopicity was conducted. Initial batches were formulated by direct compression technique, using roller compaction approach but it resulted in surface irregularities of tablets like sticking and capping. Next trials weretaken by using wet granulation techniques. It resulted in slight sticking during compression, disintegration time was on higher side and dissolution was slow. In further batches quantity of solvent used for the preparation of binder solution was decreased. It resulted in decreased disintegration time, sticking was not observed and dissolution matched with innovator. Modification was done in preparing the coating solution. Colloidal mill was used to homogenize the coating solution which further improves the appearance of formulations. Scale up batches were also taken with less binder solvent in Planetary Mixer as well in Rapid Mixer Granulator so as to check the feasibility on long run of compression on production scale. No sticking was observed and all physical and chemical parameters of tablets were found within limits. Scale up batch was also taken with alternate vendor of API and results were reproducible. In order to investigate the mode of release from the tablets different release models were applied.

Keywords: Clopidogrel Bisulfate, Dissolution, Disintegration time, Colloidal mill, Stability Studies, Release kinetics.