FORMULATION AND OPTIMIZATION OF OSMOTICALLY CONTROLLED, MICROBIALLY TRIGGERED COLON TARGETED SYSTEM USING FACE CENTERED CENTRAL COMPOSITE DESIGN

The purpose of present investigation was to achieve successful delivery especially to colon using microbially triggered, osmotically controlled approach. Prednisolone was chosen model drug for treatment of inflammatory bowel disease (IBD). Prednisolone-β-cyclodextrin complex were prepared and phase solubility study was carried out. Cellulose acetate solution containing chitosan was used to prepare semi-permeable. Face centered central composite design was employed to study the effect on independent variables (concentration of sodium chloride, polyethylene glycol, and chitosan), % cumulative release and disintegration time. Both independent variables, the proportion of chitosan (X₁) and proportion of NaCl and PEG (X₂) had an influence on the % drug release in both the media (buffers and buffer with rat ceacal content).   Formulations were evaluated for their Preformulation parameters and found within the specified limit. Formulation code F8 and S8 were the optimized batches with an in vitro release of 83.77 and 99.13 % respectively. The formulations containing PEG was found to be a promising drug delivery system better release kinetics