Comparative dissolution and polymorphism study of clopidogrel bisulfate tablets available in Argentine

NR SPERANDEO

J. Applied Pharmaceutical Science

MediPoeia

Año: 2020 vol. 10 p. 62 - 62

2231-3354

lopidogrel bisulfate (CLP) is an antiplatelet agent which exists in several solid forms. The aim of this study was to survey the dissolution performance of eight 75 mg CLP products available in Argentine, including the innovator brand (Plavix®), and the solid form of CLP in tablets. Dissolution behaviour was evaluated by the United States Pharmacopeia (USP) 39 method (paddle, pH 2.0). The polymorphic state of CLP was investigated using powder X-ray diffraction (PXRD). The release profiles were compared using the similarity factor f2, bootstrap-based f2, dissolution efficiency (DE), medium dissolution time (MDT), and several kinetic models. All products met the USP specification at 30 min but their release characteristics vary widely. Statistical comparison of profiles indicated that only two products were found to be similar (p > 0.05) to Plavix® in terms of DE and MDT values. Kinetically, Plavix® and two products fitted to Weibull model, although they differed in model parameters. P