DESIGN AND DEVELOPMENT OF ANTI-INFLAMMATORY DRUG NAPROXEN SOLID DISPERSIONS AND FORMULATIONS BY FACTORIAL DESIGN APPROACH

Abstract

Naproxen is a non-steroidal anti-inflammatory (NSAID) drug that can be used as an analgesic, anti-inflammatory, and antipyretic. Objectives: The study’s major goal was to improve the drug’s solubility and dissolution rate, as well as its oral bioavailability. Methods: Physical mixture, kneading process, and solvent evaporation method were used to make Naproxen solid dispersions (SDs). Using a two-level factorial design and three independent components, X1 β-Cyclodextrin, X2: Kolliphor p-188, and X3: PVPK-30 and designed by a Design expert (DOE). The formulation was studied by flow parameters, physical characteristics, Fourier-transform infrared spectroscopy, and comparative investigations with commercially available Naprosyn and F2. Major Results: In vitro performance of solid dispersions SD’s was favorable (100% drug release 20 minutes), compared to a pure drug, where 100 percent drug release takes 80 minutes. The FTIR spectra of pure drug and combinations with excipients were having no chemical interaction. The F44<F88<F77<F11<F66<F55<F33<F2 depicts the order of released various formulations. The release profiles of F2 and the Naprosyn tablet are similar. These findings suggest that a new naproxen tablet formulation, including the β-Cyclodextrin: Kolliphor - p188 complex, could be a viable alternative for improving oral bioavailability.