FORMULATION AND EVALUATION OF NAFTOPIDIL IMMEDIATE RELEASE TABLETS

Abstract: The aim and objectives of the present study is to develop a pharmaceutically stable, cost effective and quality improved formulation of Naftopidil immediate release tablets. Naftopidil immediate release tablets were formulated by using microcrystalline cellulose (diluent), Sodium starch glycollate (super disintegrant), Povidone K 30 (binder) and magnesium stearate (lubricant) and Aerosil 200 pharma (carrier/glidant).The granules were compressed into tablets and were analyzed for the parameters such as average weight, disintegration time, friability, thickness, weight variation, hardness and drug content. The formulation F12 showed improved disintegration time when compared to innovator product. The dissolution profile of the formulation F10 and F12 was found to have equivalent percentage drug release with that of the innovator product (f2=70.65). No significant change was observed in the drug content, physical properties and dissolution rate of these tablets after the storage period of 2 months at 40o C and 75% RH. The formulation F12 and process can be easily scaled up and can be easily employed in large scale production because the process is simple, cost effective, and pharmaceutically stable and also yields reproducible good tablets. Key Words: Naftopidil,Microcrystalline cellulose,Sodium starch glycollate, Povidone K 30, magnesium stearate, Aerosil 200, Superdisintegrants, Immediate Release, Dissolution Studies