A comparative study on Naproxen Sodium tablets formulating with different super disintegrants

Abstract

Naproxen, a commonly used non-steroidal anti-inflammatory drug (NSAID), for pain management and immediate release tablet is more patient convenient for managing pain immediately. In this study, six different formulations (F1-F6) of naproxen immediate release tablets were prepared by wet granulation method and were designed to increase disintegration and drug release property by using two super disintegrants named sodium starch glycolate and crospovidone in different concentrations. After preparing the formulations, the physicochemical properties were evaluated according to the United States Pharmacopoeia (USP) guideline. Among all the formulations, F6 proved to be the best immediate release formulation in terms of disintegration time (1.23 min) and dissolution (99.56% after 30 minutes). Other tablet properties of formulation F6 like average weight, diameter, thickness, hardness and friability were also within the USP limit. Drug release kinetics were analyzed through different models such as zero order, first order, Higuchi, Korsmeyer-Peppas and Hixson-Crowell model where the optimized formulation (F6) was best fitted in Hixson-Crowell model. The release mechanism of naproxen followed non-swellable matrix-diffusion, Quasi-Fickian diffusion. Moreover, F6 formulation was stable at 45 °C/ 75% RH for a period of three months and compatibility study was conducted by using Fourier Transform Infrared Spectroscopy (FTIR) where no change was found in stability and peak positions. The optimized formulation (F6) was compared with eight (8) different naproxen immediate release tablet brands (B1-B8) available in market based on dissolution. F6 showed better release property than the marketed tablets. Thus, it can be comprehended that the formulation F6 was robust and stable with a better immediate release property.