AN ADVANCED COMPARATIVE EVALUATION OF ATORVASTATIN CALCIUM TABLET BRANDS AVAILABLE IN THE MALAYSIAN MARKET THROUGH COMPREHENSIVE QUANTITATIVE AND QUALITATIVE ANALYSES OF THEIR EFFICACY, SAFETY PROFILES, FORMULATION QUALITY

Introduction: Atorvastatin calcium is one of the most prescribed members of its class for the treatment of hyperlipidemia. Currently, there are various brands of atorvastatin calcium tablets available in the Malaysian market and the performance of each may vary, leading to patients questioning the interchangeability between innovator and generics. Objectives: The main purpose of this study is to assess the quality of different brands of atorvastatin calcium tablets marketed in Malaysia, with emphasis on their dissolution profile, and evaluate their bioequivalence. Method: Innovator brand (coded as A) and five generic brands (coded as B to F) of 20 mg atorvastatin calcium tablets were subjected to in vitro tests for organoleptic characterization, identity, content uniformity, weight variation, thickness, diameter, hardness, friability, disintegration, and dissolution according to procedures described in the monograph. Result: All brands of atorvastatin calcium tablets complied with the specifications of the tests conducted. With regard to dissolution test, all the investigated brands released more than 80% of their drug content in 30 minutes. Brand A displayed the greatest dissolution profile followed by Brand D where both depicted nearly 100% release of atorvastatin calcium within 60 minutes, while Brand F showed the lowest percentage of drug release at 92.94% in the same time frame. Conclusion: The findings support that all the atorvastatin calcium brands under evaluation are of good pharmaceutical quality. Though slight differences exist in the dissolution profile between innovator and generic brands, they are still within the acceptable limits and hence it was determined that these brands could be used interchangeably.