Formulation and Optimization of Nanoparticale by 32 Factorial Design for Colon Targeting

Abstract

The aim of the present study was to develop stable nanoparticulate formulation for sustained release of Prednisolone. Chitosan nanoparticles were prepared by ionic gelation method using tripolyphosphate as cross-linking agent. Different nanoparticulate formulations were prepared by using 32 factorial design in which varying the concentration of chitosan (0.1% to 0.3%), concentration of tripolyphosphate (0.02% to 0.03%) as two factors. The effect of these factors on the particle size, % entrapment efficiency and in vitro drug release was evaluated to develop an optimized formulation. Particle size, % entrapment efficiency and in vitro release of optimized formulation were found to be 168.1nm, 78.53% and 70.80% respectively. ANOVA study applied with p < 0.01 suggests that model is significant & Contour, Surface response & overlay plot was contract to optimize the formulation. Optimized formulation (C-10) showed sustained drug release at the end of 11th hour compared to other formulations. Based on release kinetic model, the drug release data fit well to higuchi model (r2 = 0.9935) indicating the diffusion limited drug release from nanoparticles. Drug release mechanism according to Korsmeyer-Peppas model was found anomalous transport (n = 0.5847). Scanning electron microscopy (SEM) revealed that the nanoparticles were spherical in shape and there was no crystallization of drug and other excipients. Drug-excipients compatibility confirmed by FTIR study.