Abstract

FORMULATION, DEVELOPMENT AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF ATORVASTATIN CALCIUM USP

P. Palanisamy*, R. Margret Chandira, B. Jaykar, A. Pasupathi, B. S. Venkateshwarlu

Abstract

The aim of present investigation is to develop immediate release formulation of Atorvastatin calcium for oral drug delivery by using suitable concentration of superdisingrants. Croscarmellose sodium (AC-DI-SOL), povidone, MCC, Magnesium stearate was used to formulate the immediate release tablet. Croscarmellose sodium was used as superdisintegrant and povidone was used as a binder to control the release of drug. Special care was taken for Atorvastatin calcium processing in low humidity condition and geometric mixing is applied to avoid content uniformity and segregation. The flow properties of the powdered blend for all the batches were found to be good and free flowing. The weight variation, hardness and friability of all the formulated tablets within the specified requirements. The disintegration times for the formulated tablets are within the range of USP. For Atorvastatin calcium IR tablets direct granulat ion was method of choice. Film coating of Protectab HP-1 Erythrocin Supra aqueous coating 3%w/w was done. Results found that release profile of batch no.ATF7 matches with Innovator product. The Percentage cumulative drug release of batch. No. ATF7 was found at 30 Minutes 103.12%. From results it can be inferred that release profile of Batch. No: ATF7matches with that of innovator product, also f1&f2 values are good enough to comply with the innovator‟s product INNOVATOR have reported similar kind of results for studies with Atorvastatin calcium.

Keywords: Atorvastatin calcium, Immediate release, Anticholestermic agent, HMG-CoA reductase Inhibitor.