COST EFFECTIVE FORMULATION DEVELOPMENT OF ROSUVASTATIN IN COMPARED TO INNOVATOR BRAND & EVALUATION OF INTERCHANGEABILITY VIA IN-VITRO BIO-EQUIVALENCE STUDY
Journal Title: World Journal of Pharmaceutical Research - Year 2017, Vol 6, Issue 11
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.
Authors and Affiliations
Farzana Hasin
Keywords
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