Development and Evaluation of Nevirapine Extended Release Tablets using QbD Approach

Objective:To develop and evaluate Nevirapine (NVP) Extended release tablets for reducing the dosing frequency using Methylcellulose USP Methocel A15-LV and Hypromellose USP Methocel K4M Premium CR used as rate retarding polymers and Magnesium stearate as lubricant. Methods: Tablets were prepared by using roller compaction technique by employing Quality by Design (QbD) and Design of Experimentation (DoE) to study the effect of various process related parameters like Bulk density, Tapped density, Compressibility index, mesh size and in-vitro release data at 20th hour. Results: Obtained results had suggested that concentration of polymer had shown a potential effect over various process parameters and in-vitro drug release studies suggested that formulated tablets had shown a sustained release up to 24h when compared with marketed formulations. Conclusion: From the obtained results it can be concluded that formulation of Nevirapine ER Tablets employing QbD lead to a single dose per day in the management of HIV/AIDS.