FORMULATION AND EVALUATION OF NEVIRAPINE SUSTAINED RELEASETABLETS WITH DIFFERENT HYDROPHILIC POLYMERS

Abstract

The present study was aimed to develop generic formulation of sustained release (SR) tablets of Nevirapine anhydrous (NVP) using different hydrophilic polymers in order to increase the gastric residence time (GRT) and comparison of natural and synthetic polymer for better sustained effect. The drug: polymer interaction was determined by IR spectroscopic method. Nevirapine NVP (SR) tablets were prepared by wet granulation method by employing various hydrophilic polymers like HPMC K4M, K100M, xanthan gum and tragacanth. They are prepared by using water as a granulating fluid. The prepared granules were evaluated for various physicochemical parameters as per Indian pharmacopoeia (I.P) and compressed into tablets. In-vitro release profiles of NVP from SR tablets were determined using USP apparatus type I (Basket), at 50 rpm and bath temperature of 37ºC. Tablets dissolution was carried out in 900ml of media (0.04M sodium phosphate buffer pH 6.8 containing 2% SLS). Samples were withdrawn at predetermined time intervals up to 12 Hrs and analyzed using UV detector at a wavelength of 282nm. Among these all formulations (F1 to F5), batch F2 was best formulation and showed very slow release i.e. 76.02% in 12 h and it is nearly similar with innovator product (i2=82.00). The drug release of the other formulation was higher from the innovator product. So the formulation with HPMC K4M shows better sustained release effect than the other polymers. The developed SR tablets of NVP may be used for sustained drug release for at least 12hrs, thereby improving the bioavailability and patient compliance.