Formulation And Evaluation Of A Colon Targeted Capsule For Ulceritive Colitis

Abstract

The objective of the study was to develop a colon targeted capsule of Mesalamine. Mesalamine is used for the treatment of Ulcerative Colitis. Here a combination approach is used for colon targeted therapy which combines the mechanism of both time release function and pH sensing function. This dosage form contain active ingredient and an organic acid filled in a capsule and coated with three layered film consisting of an acid soluble polymer (Eudragit E100) ,a water soluble polymer(HPMC K 100)  and an enteric polymer(Eudragit S 100).Central Composite Design (CCD) using design expert software was employed in formulating and optimizing the capsules with two independent variables such as the concentration of Eudragit E 100 (X1) and concentration of succinic acid (X2) and dependent variables such as percentage drug release in 8 hours (Y1) and percentage drug release in   9 hours (Y2).Evaluation studies were performed which includes all preformulation and post formulation studies. From the analysis, it was found that, a predictable timed-release mechanism of a drug can be attained. The outer enteric coating provided acceptable acid-resistibility. All these results suggested that this approach can provide a useful and practical means for colon-targeted delivery of drugs.