Development and In‑Vitro Evaluation of Colon Specific Indomethacin Matrix Tablet for the Treatment of Inflammatory Bowel Disease

Abstract

IBD is a chronic inflammatory disease of the gastrointestinal tract, particularly small and large intestine consisting of ulcerative colitis (UC) and Crohn’s disease (CD). Oral route of drug delivery is considered as the most appropriate route of drug delivery of drugs. But this route has certain limitations of poor bioavailability due to gastric degradation and increase in dose size and frequency. Therefore, the present aim of the study is to prepare and evaluate Indomethacin loaded matrix tablet using guar gum, HPMC (release controlling polymer) and citric acid to facilitate the drug solubility in the colon. A total 8 different formulations were prepared by wet granulation method and coated with Eudragit S 100 polymer a pH dependent enteric coating polymer which dissolve at colonic pH (7.4) and specifically release the drug in the colon region in sustain release fashion. The granules evaluated for its micrometrics properties and tablets were evaluated for its hardness, thickness, friability, weight variation, drug content, and in‑vitro drug release studies. The % cumulative drug release profile of all tablets was little and insignificant at pH 1.2 and 6.8. In colonic pH the coating dissolves tablets starts to release drugs. Among all the formulation the formulation F3 having guar gum and HPMC ratio 3:1 shows a maximum release of drug of 80.41±6.5%. At 24 h. The study demonstrated that the prepared tablets can release the Indomethacin in sustained release manner and helps in management of IBD with reduced side effect of the therapy. The results of this study show that oral administration of aspartame (250mg/kg body weight) was correlated to a significant increase in the lipid profile, fasting blood glucose and some marker enzymes and this increase is time related.