ABSTRACT
Objective: Nevirapine (NVP) is a non nucleoside reverse transcriptase inhibitor widely used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus disease. The present study was aimed to develop generic formulation of extended release (ER) tablets of Nevirapine anhydrous (NVP) using hydrophilic polymer. Method: Nevirapine NVP(ER) tablets were prepared by different manufacturing technology i.e. direct compression, roller compaction, and wet granulation method by employing hydrophilic polymer (HPMC K15M).The matrix granules were prepared by mixing drug along with polymer and diluents in different polymer ratio from wet granulation technology used water as a granulating fluid. Results: The prepared granules were evaluated for various physicochemical parameters by official procedure and compressed in tablets. The In-vitro release profile of various batches was prepared by different technologies and has been compared with the innovator product. In-vitro release profiles of NVP from ER tablets were determined using USP apparatus type II (Paddle), 50 rpm and bath temperature 37ºC. Dissolution of tablets was carried out in 900 ml of media (phosphate buffer pH 6.8). Samples were withdrawn at predetermined time intervals up to 24 hrs and analyzed using UV detector at a wavelength of 247 nm. Conclusion: Stress stability studies indicated that the formulation is stable and In-vitro release profile study showed that formulation using wet granulation technology.