Formulation and evaluation of nevirapine extended release tablets

Abstract

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) drug which is used in the treatment human immunodeficiency virus type 1 (HIV-1) infections. The present study is to develop a pharmaceutically stable, cost effective, pharmaceutically equivalent, and quality improved formulation of Nevirapine ER tablets. To achieve this goal various prototype formulation trials will be taken and evaluated with respect to the various quality control tests such as dissolution, assay, acid resistance. The formula will be finalized by comparing the invitro dissolution profile with that of the marketed VIRAMUNE XR Tablets. In this study Nevirapine Extended release tablets were prepared by using hydrophobic polymers. Thirteen formulations of extended release tablets of Nevirapine were developed by using Lactose Monohydrate and Micro crystalline cellulose as diluent and Magnesium stearate as lubricant in different proportions and varying grades of Eudragit, Ethyl Cellulose and povidone          in different proportions. The formulation F12 was found to be best of all the formulations showing drug release matching the innovator product. The formulation F12 was evaluated for all the quality control tests.