Journal article Open Access
Dr. M. Sunitha Reddy*, Goparaju Ramya, S. Muhammad Fazal Ul Haq
The goal of present study is to formulate and evaluate controlled release dosage form of Naproxen sodium using bilayer tablet technology, by wet granulation process. During this wet granulation process various parameters were studied like granulation , dried granules LOD, compression parameters and formula was optimized. In this wet granulation process various controlled release polymers were used like HPMC K4M, HPMC K15, HPMC K 100. Among the used polymers HPMC K4M Showed the high retarding the drug release rate, due to it contain high viscosity in nature. The drug and excipient computability studies and Preformulation studies were performed. In vitro dissolution test was performed by using USP type II (Paddle) apparatus, 1000 ml of phosphate buffer pH7.5 and the paddle was rotated at 50 rpm at temperature (37ºC ± 0.5ºC) similar as that of reference listed drug. The finished tablets were subjected to evaluation parameters and study on pH of different media were studied on controlled release tablets. Three months Stability studies indicate that it was similar as that of innovator product.