Formulation and Evaluation of Antiplatelet Clopidogrel Tablet using β-cyclodextrin for Solubility Enhancement

Cardiovascular diseases (CVDs) are a major cause of global morbidity and mortality, necessitating effective therapeutic strategies. Clopidogrel, an antiplatelet drug, is crucial for preventing thrombotic events but suffers from poor aqueous solubility, affecting its bioavailability. This study investigates the enhancement of clopidogrel's solubility through its inclusion in β-cyclodextrin complexes prepared by the solvent evaporation method. Saturation solubility studies demonstrated that the complexes significantly improved solubility, with values of 4.5 µg/ml for formulation F1, 7.7 µg/ml for F5, and 6.2 µg/ml for F9. Tablet formulations incorporating these complexes were evaluated for physicochemical properties, including angle of repose (21.56° to 49.85°), bulk density (0.48 to 0.694 g/cm³), tapped density (0.625 to 0.834 g/cm³), Carr's Index (16.67% to 29.09%), and Hausner's ratio (1.2 to 1.44). Hardness ranged from 4.34 ± 0.26 kg/cm² to 6.75 ± 0.25 kg/cm², with friability between 0.2% and 0.5%. Disintegration times varied from 42 to 58 seconds. In-vitro drug release studies in 0.1 N HCl revealed that formulation F9 achieved a release of 44.89% at 2 minutes, 67.71% at 4 minutes, 84.13% at 6 minutes, and 93.21% at 8 minutes. These findings suggest that β-cyclodextrin significantly enhances clopidogrel's solubility and dissolution, potentially improving its clinical efficacy and patient outcomes.