Abstract

COST EFFECTIVE FORMULATION DEVELOPMENT OF ROSUVASTATIN IN COMPARED TO INNOVATOR BRAND & EVALUATION OF INTERCHANGEABILITY VIA IN-VITRO BIOEQUIVALENCE STUDY

*Farzana Hasin, Md. Abdur Rouf Al Mamun, Md. Ershad Alam, Chinmoy Kumar Saha, Md. Hafizur Rahman and Sanjida Akter

Abstract

Generic Rosuvastatin formulation has been developed which is comparatively cost-effective as well as bio-similar in efficacy in compared with the Brand drug Crestor (Rosuvastatin). Research shows that overpriced medicines causes huge national burden and health care expenses has gone out of control. A Study results shows that millions of adults patients skip over medications to buy due to their high cost (Robin A. Cohen, Maria A. Villarroel, NCSH Researchers. 2013).[1] Research also found that patients are used to save money on drugs costs and they asked doctors for lower-cost medications, buying prescription drugs from other countries and using alternative therapies. So, high drugs costs problems can be handled by development of cost-effective generic drugs with same therapeutic efficacy or bio-similar to brand name drugs. According to US. FDA - a generic medicine give the identical clinical benefit and works in the same way like other brand-name version drugs. This standard applies to all FDA-approved generic medicines in safety, dosage form, strength, quality, route of administration, and intended use”(US FDA 2017).[2] So, with the main focusing of cost-defective formulation development, we have tried to evaluate the overall quality of developed drugs from the points of - dosage form, therapeutic efficacy, strength, safety, route of administration, performance quality, characteristics and intended use. We have conducted an In-Vitro Bio-Equivalence Study to establish the bio-similarity of Generic Rosuvastatin and we have achieved similar results like Brand name Rosuvastatin- Crestor. New developed Generic Rosuvastatin tablets found therapeutically bio-equivalent as the Brand name innovator and more cost-effective than brand drug.

Keywords: Rosuvastatin, Formulation, Cost-Effectiveness, Bio-similarity, Direct Compression Method, Dissolution profile, Bio-equivance Study.