Abstract

FORMULATION AND EVALUATION OF SUSTAINED RELEASE BILAYER TABLETS OF LOSARTAN POTASSIUM

Sanjit Kr. Roy*¹, Sweet Naskar²

Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700032, India.

Abstract

The present study was to formulate and evaluate of sustained release bilayer tablets of losartan potassium. The tablets were prepared by direct compression method by using superdisintegrants sodium starch glycolate (SSG) for immediate release layer and mucoadhesive materials such as hydroxypropylmethylcellulose (HPMC-K4M) and carbopol 940 P for sustained release layer. The blends were evaluated to bulk density, tap density, compressibility index and angle of repose. The tablets were evaluated to thickness, hardness, diameter, weight variation, drug content uniformity, friability and In vitro drug release studies. In vitro drug release studies were performed by using USP type II apparatus (paddle method) at 50 rpm in 900 ml of 0.1N HCl as dissolution medium for first 2 hours and later replacing it with 900 ml pH 6.8 phosphate buffer solution for the remaining time period at 37±0.5oC. The formulation ME5 containing HPMC-K4M and carbopol 940 P in the ratio of 1:1 gave an initial burst effect and followed by sustained release of drug without disintegration up to 30 hours. Hence, formulation ME5 was considered to be the optimized formulation which showed the best drug release profile up to 30 hours and fulfilled the many requirements reduced dosing frequency, increase the bioavailability and provide better patient compliance. The results of FTIR analysis showed that there was no physical and chemical interaction between drug and other excipients.

Keywords: Losartan potassium, Mucoadhesive materials, Sustained release bilayer tablet.