Formulation and Evaluation of Control Release Clopidogrel Bisulphate Microspheres

Abstract

This study focuses on the formulation and evaluation of controlled-release microspheres for clopidogrel bisulfate, an antiplatelet agent widely used in the prevention of cardiovascular events. The objective was to develop a sustained-release delivery system that enhances the therapeutic efficacy of clopidogrel while improving patient compliance through reduced dosing frequency. Various biocompatible and biodegradable polymers, including poly (lactic-co-glycolic acid) (PLGA) and HPMC, were utilized to fabricate the microspheres using the solvent evaporation technique. The resulting microspheres were characterized for their physical properties, including particle size, morphology. In vitro drug release studies were conducted to evaluate the release kinetics of clopidogrel bisulfate from the microspheres over an extended period. The results indicated that the formulation achieved a sustained release profile, with a significant reduction in the initial burst release compared to conventional dosage forms. Kinetic modeling of the release data suggested a diffusion-controlled mechanism, indicating that the microspheres can maintain therapeutic drug levels for a prolonged duration.

Keywords: Anti-platelet agent, Microspheres, biocompatible, sustained-release delivery system.