Formulation and Evaluation of Clopidogrel Bisulphate Microspheres Using HPMC Polymer

Abstract

ckground: Clopidogrel bisulphate is an antiplatelet agent used in the prevention of atherothrombotic events. Polymeric microspheres offer a potential approach for modifying drug-release behaviour and improving formulation performance. The present study aimed to formulate and evaluate clopidogrel bisulphate-loaded hydroxypropyl methylcellulose (HPMC) microspheres.

Methods: Clopidogrel bisulphate-loaded HPMC microspheres were prepared using the solvent extraction method. The prepared formulations (F1–F5) were evaluated for micromeritic properties, particle size, zeta potential, percentage yield, drug encapsulation efficiency, drug-loading capacity and in-vitro drug release. A UV spectrophotometric calibration curve was established over the concentration range of 4–40 µg/mL at 240 nm.

Results: The percentage yield ranged from 80.73% to 97.37%, while encapsulation efficiency ranged from 68.59% to 78.10%. Drug-loading capacity varied from 30.98% to 49.21%. The reported particle-size values ranged from 0.3652 to 0.7832 µm, and zeta potential values ranged from −23.22 to −29.76 mV. Among the evaluated formulations, F3 showed the highest reported cumulative drug release at 24 hours (95.56%), compared with F1 (73.21%), F2 (82.22%), F4 (89.22%) and F5 (86.90%).

Conclusion: Clopidogrel bisulphate-loaded HPMC microspheres were successfully prepared and evaluated. Based on the reported in-vitro drug-release results, F3 was identified as the best-performing formulation among those studied. Further investigation, including confirmation of formulation composition, detailed release-kinetic analysis and appropriate stability and pharmacokinetic studies, is required to establish its overall performance.