Abstract

FORMULATION AND EVALUATION OF AMLODIPINE BESYLATE OSMOTIC TABLETS

D.Sherly, S.Palanichamy, M.Rajesh* and P.Solairaj

Abstract

Osmotically controlled oral drug delivery systems utilize osmotic pressure as the energy source for the controlled delivery of drugs thereby, it is possible to achieve and sustain a drug plasma concentration within the therapeutic window, which reduces the side effects and frequency of administration. The present work was aimed to formulate and evaluate osmotic pump delivery system of Amlodipine Besylate using two osmogens (NaCl and KCl) by wet granulation method. The osmogens used in this study did not alter the physicochemical properties of drug, as tested by FTIR. Prior to compression, the prepared granules were evaluated for flow and compression characteristics. After compression, the tablets were evaluated for thickness, hardness, weight variation, friability, percentage of weight gain, drug content, and in vitro release studies. The tablets were further coated and evaluation of coated tablets were performed and compared with uncoated tablets. The percentage of weight gain after coating was found to be between 5.57-7.11%. The drug content in the coated as well as uncoated tablets was found to be within the prescribed limits. A slow drug release was observed in coated tablets compared to uncoated formulations. In conclusion, Amlodipine Besylate may be successfully formulated as elementary osmotic pump tablets to provide a control release of drug upto 24 hours.

Keywords: Amlodipine Besylate, osmotic pressure, coated tablets, control release.