FORMULATION AND DEVELOPMENT OF ENTERIC COATED TABLETS OF PREDNISOLONE AS A COLON TARGETED DRUG DELIVERY

: In the present investigation an attempt was made to reduce the frequency of dose administration, to prevent ulcerative colitis and to improve the patient compliance by developing sustain release (SR) tablet of prednisolone. And also to reduce the side effect of anti inflammatory drug in G.I Tract by developing delayed release (DR) tablet of prednisolone using Eudragit S 100 as enteric coating. The aim of the present study is to develop colon specific drug delivery of prednisolone sustained release matrix tablets for ulcerative colitis using HPMC K-4M and HPMC K-100M as a semi synthetic polymer. Prednisolone based tablets were coated using methacrylic acid copolymers Eudragit S100 by spraying organic system. The matrix tablets of prednisolone are subjected to an in vitro drug release study using simulated colonic fluid of pH 7.2 as the dissolution medium. Colon drug delivery is advantageous in the treatment of colonic disease and oral delivery of drugs unstable or susceptible to enzymatic degradation in upper GI tract. In this study, coated tablets that is resistant to gastric and small intestinal pH conditions but can be easily dissolved in colonic pH. The results also demonstrated that a Eudragit S100 can be successfully used for organic system to coat tablets for colon targeted delivery of drug. Among the eight formulations, T6 batch results match with our theoretically profile. Optimized formulation was found stable during accelerated stability study for 3 months at 400C/75% RH.