Abstract

FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF SAROGLITAZAR BY USING NATURAL AND SYNTHETIC POLYMERS

Nethravathi.A*, Nayana.S.M, Kirankumar Navade, K.Sumana, B.Someswara Rao, Suresh V.Kulkarni

ABSTRACT

The objective of the present work is to design of novel sustained release matrix tablets of Saroglitazar influence of natural, synthetic polymers, filler on the release rate and in vitro evaluation. Saroglitazar is anti-diabetic drug used extensively in the treatment of diabetes Type II. Saroglitazar is one of emerging short acting drug. Saroglitazar is practically insoluble in water because of this reason it is suitable to develop sustained release matrix tablet using hydrophilic polymers. The polymers like Xanthun Gum,Guar Gum, Eudragit, and HPMC K- 100, Ethyl cellulose were utilized in the formulation of matrix tablets containing Saroglitazar by wet granulation technique and evaluated for its in-vitro drug release. Natural polymer arehydrophilic in nature and rate controlling polymers. Granules were preparedand evaluated for loose bulk density, tapped bulk density, compressibility index and angle of repose, shows satisfactory results. Formulation was optimized on the basis of acceptable tablet properties (hardness, friability, drug content and weight variations), in vitro drug release and stability studies. All the formulations showed compliance with Pharmacopeial standards. The in vitro release study of matrix tablets were carried out inpH 1.2 HCl for 2 hours and pH 7.4 phosphate bufferfor the remaining 10 hoursas dissolution medium. Amongall the formulations, F7 shows 98.5% of drug which was better controlled release at the end of 12 hrs. It has been found that the optimized formulation F7 Containing 20 mg powder of HPMC K 100, as drug retarding polymer shows better sustained effect for 12 hr, The results indicated that a decrease in release kinetics of the drugwas observed by increasing the polymer concentration. The release data was fitted to various mathematical models such as, Higuchi, Korsmeyer- Peppas, First-order, and Zero order to evaluate the kinetics and mechanism of the drug release. The stability studies were carried out according to ICH guideline which indicates that the selected formulations were stable.

Keywords: HPMC K -100, Xanthun gum, Guar gum and Eudragit. Matrix tablet, Sustained release, Wet granulation.