In vitro and in vivo Evaluation of Natural Polymers Loaded Core-in-Cup Tablets of Budesonide for Potential Application in the Prophylaxis of Ulcerative Colitis

In the present study, an effort was made to develop the colon targeted drug delivery system of budesonide was designed with the intention of delivering the drug in the colon region for effective treatment of inflammatory bowel disease. Colon targeted core-in-cup tablets were prepared in two steps. Core tablets and cup tablets were prepared separately. The core tablets were kept in cup tablets and coated by using cellulose acetate phthalate as enteric coating polymers. The core-in-cup tablets were subjected to various evaluation techniques. In order to simulate the pH changes along the GI tract, three dissolution media with pH 1.2, 7.4 and 6.8 were sequentially used. FTIR study confirmed that there was no interaction between drug and polymer. The physicochemical parameters of all the formulations were found to be in compliance with the pharmacopoeial standards. The results confirmed that the tablets coated with 10% w/w cellulose acetate phthalate showed a lag time of 5 hr corresponds to time required to reach colonic region. Among all the formulations Budesonide tablets prepared with Moringa olifera gum in 1:1.5 ratios shown sustained drug release for a period of 12 hours. The correlation coefficient values of dissolution kinetics data clearly indicated that the drug release followed zero order kinetics and the mechanism of drug release was governed by peppas-korsmeyer model. The obtained results revealed the capability of the system in delaying drug release for a programmable period of time and for effective treatment of inflammatory bowel disease in the colon region