Comparison of Rosuvastatin Calcium Tablets Marketed in Saudi Arabia Under Biowaiver Conditions: In Vitro Quality Control Dissolution Study

Abstract

Rosuvastatin (RST) calcium is used to treat hyperlipidemia, and several generic brands of RST calcium are available in Saudi Arabia along with the innovator. The current study aimed to compare two generic brands of RST with the innovator with respect to physicochemical parameters and dissolution data under biowaiver conditions. Two generic brands of RST calcium tablets, Resova and Ivarin, were purchased from the local market. Their pharmaceutical equivalence with the innovator brand, Crestor, was determined according to United States Pharmacopeia (USP) methods for assessment of various parameters, including weight, friability, hardness, disintegration, and in vitro dissolution in three different mediums. Drug content was highest for Crestor (104.14%), and Ivarin had the lowest (99.7%). Dissolution of RST calcium tablets in 0.1 N hydrochloric acid (HCl) (pH 1.2) revealed that Crestor released the highest amount of drug (88.9%) at the end of 60 min; Resova and Ivarin released 88.7% and 75.2%, respectively. The amount of drug released was higher in 0.05 M phosphate buffer (pH 6.8) for all the brands, showing 98.5%, 98.8%, and 98.4% release at 60 min for Crestor, Resova, and Ivarin, respectively. In 0.05 M sodium citrate buffer (pH 6.6), maximum release of the drug was achieved, showing 99.1%, 102.1%, and 99.8% for Crestor, Resova, and Ivarin, respectively. Similarity factor analysis demonstrated equivalence of the generic brands with the innovator brand. In conclusion, the tested brands of RST calcium tablets passed the standards set by USP, allowing interchangeability of generic and brand name products.