Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF FAST DISSOLVING TABLET OF SIMVASTATIN BY MELT GRANULATION PROCESS

S.S.Bareth*, A.Kumari, Sharma Komal Ben, S.S.Saurabh, K.S.Rathore, R.Issarani

ABSTRACT

The main objective of this study is to improve the dissolution and there by bioavailability of simvastatin, a practically insoluble anti-hyperlipidemic drug, by making fast dissolving tablet using melts granulation process. In particular, the granules of simvastatin were prepared using polyethylene glycol 400 and 6000 as hydrophilic meltable binder without using any solvent as granulating agent in the ratio of 4:6 resulting in a blend with melting point 37°C which would melt when placed in the mouth. The preparation of fast dissolving tablets of simvastatin was done by using moulding technique. The prepared FDTs were evaluated for hardness, friability, thickness, disintegration time. The dissolution profile of Simvastatin tablets was determined according to USP method and compared to that of a commercial product. The formulated FDTs of Simvastatin exhibited acceptable flow ability and compressibility. The fast dissolving Tablets showed more than 90% release within 50-60 min. Response surface methodology was performed including three dimensional response surface plots and 2 D counter plots for representation of design space. The optimised batch was subjected to stability study at 25°C and 60% RH for one month. The shelf life at 5°C was determined using bracket method and Q rule and was found to be 1.0- 1.25 year.

Keywords: Simvastatin, Melt granulation technique, Dissolution enhancement, PEG 400 and 6000.