Evaluation of Dissolution Profiles in Vitro Between Brand Name Drug and Generics of Cyclosporine Capsules

OBJECTIVE To compare the dissolution profiles of brand name drug and generics of cyclosporine capsules in four different mediums. METHODS The dissolution profiles of brand name drug and generics of cyclosporine capsules in water, 0.1 mol·L^-1 hydrochloric acid solution, pH 4.5 acetate buffer and pH 6.8 phosphate buffer were determined and the similarity was investigated according to the similarity factors(f₂). RESULTS The dissolution profile of three batches of generics were all different from brand name drug in water(f₂<50, the average f₂ was 40.20, RSD was 2.53%), there were high similarity of the dissolution profiles of generics and brand name drug in 0.1 mol·L^-1 hydrochloric acid solution, pH 4.5 acetate buffer and pH 6.8 phosphate buffer(f₂>50, the average f₂ were 61.60, 63.56, 81.57 in order, RSD were 2.23%, 3.15%, 0.45% in order). CONCLUSION The dissolution profile of generics is different from brand name drug in water. while the dissolution profiles of generics are similar to brand name drug in other three mediums. so there may be some differences in the manufacturing process between the brand drug and generics, which should be paid attention on in clinical use.