Preparation, Characterization and In vitro Evaluation of Solid Dispersion Formulation of Clopidogrel Using Hydrophilic Polymers

Clopidogrel bisulfate is a BCS class II drug with low water solubility leading to problematic dissolution behavior for oral drug delivery. The solid dispersion method was used to investigate the improvement of the dissolution profile of clopidogrel. Solid dispersions of clopidogrel were formulated using two polymers, PEG 6000 and poloxamer 188, at varying ratios through physical mixing and solvent evaporation techniques. A low-cost UV-Vis spectroscopic analytical method was developed at a λmax of 219 nm and validated following ICH guidelines. The dissolution of clopidogrel from solid dispersion improved significantly compared to pure drug, fitting most of the kinetics into the Korsmeyer-Peppas model. Comparisons showed that the binary solid dispersion formulation with clopidogrel: poloxmaer 188 at a ratio of 1:5 made…