Quality Attributes Comparison of Selected Brands of Rosuvastatin Calcium Tablets Marketed in the US and Bangladesh

Abstract

Aims: This study investigated whether locally marketed rosuvastatin calcium tablets in Bangladesh have comparable physical and chemical attributes, including in vitro bioequivalence profiles, to the proprietary brand. Methodology: Nine generic products (G1-G9) containing 10 mg of rosuvastatin calcium were compared to the proprietary brand Crestor® (R1) and an FDA approved generic rosuvastatin calcium tablet (R2). Weight variation, diameter, thickness, friability, drug content, disintegration time and dissolution profiles were tested according to United States Pharmacopeia (USP) guidelines. In vitro bioequivalence requirements were assessed by calculating difference (f1) and similarity (f2) factors. Results: The generic products complied with the pharmacopeial requirements for weight variation, disintegration time and friability. All the tablets had drug ranging between 92%-105% and released more than 80% of rosuvastatin within first 15-30 minutes. However, for brands G5, G7 and G8 the f1 values were 15.7%, 15.82% and 25.21% respectively and their f2 values were 41.8, 41.6 and 32.6 respectively whereas for G9 the f2 value was 43.4. These brands have thus failed to meet in vitro bioequivalence requirements. Conclusion: We conclude that few substandard generics of rosuvastatin calcium has somehow found its way to the market and further studies are required to ascertain their noncompliance.