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.
Highlights
An immediate release dosage form allows a manufacturer to extend market exclusivity as well as offers patient convenient dosage form or dosage regimen
Six different formulations (F1F6) 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
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
Summary
An immediate release dosage form allows a manufacturer to extend market exclusivity as well as offers patient convenient dosage form or dosage regimen. Immediate release tablets are designed in such a way that disintegrate fast and release the medications without any special rate controlling features. Immediate release tablets are gaining popularity and acceptance as a drug delivery system since they are easy to administer, have fast onset of action, are cost-effective and ensure better patient compliance [1]. A non-steroidal anti-inflammatory drug (NSAID), possesses analgesic and antipyretic properties. Its sodium derivative is an odorless crystalline powder that is absorbed quickly and entirely from the alimentary tract with 95% of in-vivo bioavailability and extensively metabolized to 6-o-desmethyl naproxen [2]. Corresponding author E-mail address: Sikdar et al / GSC Biological and Pharmaceutical Sciences 2019, 09(03), 076–084
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