Design of colon specific delivery of sulfasalazine loaded nanoparticles for inflammatory bowel syndrome: Application of experimental design

Sulfasalazine is the first line treatment for Inflammatory Bowel syndrome. Conventional formulation have poor targeting properties for colon site. Therefore designof colon specific nanoparticles (NP) is an ideal for better therapeutic outcome. The study aims to formulate and evaluate polymeric Nanoparticles loaded with Sulfasalazine to target the colon. The nanoparticles were prepared by Nano-precipitation method using pH dependent polymer and the prepared nanoparticles were evaluated for FTIR, morphology, pH, Viscosity, Entrapment efficiency, particle size and zeta potential etc. The nanoparticles were used to formulate core tablet and core tablets were coated with Eudragit S100. The tablets were evaluated for hardness, friability, thickness, weight variation and In vitro release study. Totally six formulations were developed for preliminary trial with varying concentration of polymers. From the preliminary trial, code F₂ batch was found to be best formulation. The F₂ batch was fitted to central composite design with two independent factors i.e. Concentration of Eudragit S100 (X₁) and polyvinyl alcohol (X₂) with four dependent variables i.e. Entrapment efficiency -Y₁; Hardness- Y₂; Friability-Y₃ and In-vitro drug release- Y₄. The formulation (code R6) was found to be the optimizedformulation. The optimized colon targeted tablets provide satisfactory release and might be suitable for colon targeting of sulfasalazine with better therapeutic effect.