Assessment of Drug Release Kinetics and Quality of Naproxen Generic Tablets in Bangladesh

Abstract

The present study aimed to compare the in vitro equivalence of different generic tablets of naproxen available with the reference brand in the Bangladesh pharmaceutical market. As naproxen belongs to the biopharmaceutics classification system (BCS) class-II drug, interchangeability among commercial products must be demonstrated through in vivo bioequivalence studies. However, in Bangladesh, such studies remain to be performed. An in vitro dissolution study was carried out using the United States Pharmacopoeia (USP) paddle method and the dissolution profiles of the generic products were compared with the reference brand. Quality assessment parameters including hardness, friability, and disintegration time were also evaluated. Similar dissolution behavior was found with the reference brand using a modeldependent and model-independent approach (f2 > 50, f1 < 15), and there were no statistically significant differences. The best-fit kinetic model was the Korsmeyer-Peppas model, indicating that the mechanism of dissolution is predominantly diffusion. All commercial products complied with the official specifications. The results from this study suggest that the naproxen formulations available in the Bangladesh market could be used interchangeably for optimal therapeutic outcomes.