Abstract

FORMULATION AND IN-VITRO EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF SIMVASTATIN USING TAMARIND SEED POLYSACCHARIDE AS RELEASE MODIFIER

Dr. M. Sunitha Reddy* and K. Kiranmai

Abstract

The present study was aimed to develop sustained release matrix tablets of Simvastatin using tamarind seed polysaccharide as a matrix forming hydrophilic polymer. Simvastatin is an anti-hyperlipedaemic drug with short half life (t1/2) of 3hrs and usually oral dosage regimen (5-40mg) taken to 4 times a day. To reduce the frequency of administration and also to improve the patient compliance, sustained release formulation of Simvastatin is desirable. The Simvastatin matrix tablets were prepared by wet granulation method using tamarind seed polysaccharide as release retardant. Six formulations of different drug: polymer concentrations were formulated. First three formulations contain drug with tamarind seed polysaccharide and other three formulations contains drug with polymer combination of TSP: HPMC K100M -F1 (1:1), F2 (1:2), F3 (1:3) F4 (1:1), F5 (1:2) and F6 (1:3). Simvastatin sustained release matrix tablets are evaluated for pre-compression parameters and post-compression parameters; all the parameters were found to be within the limits. The dissolution studies were performed using USP apparatus type-II in 0.1NHCl (2 hours) and pH 6.8 phosphate buffer (10 hours) as dissolution medium for 12 hours. These studies showed that formulation F3 consisting of drug: polymer in the ratio of 1:3 was found to sustain the release of Simvastatin over a period of 12hrs.The optimized formulation was subjected to different kinetic models including zero order, first order, Higuchi model and Korsmeyer peppas model. The final optimized formulation F3 was subjected to Stability studies for 3 months according to ICH guidelines.

Keywords: Simvastatin, Sustained release, Tamarind seed polysaccharide.