Abstract

FORMULATION AND ESTIMATION OF MESALAMINE BILAYER TABLET FOR COLON TARGETED DRUG DELIVERY

V. Ranjith*, Dr. S. K. Senthilkumar, P. Anitha, S. Aswini, R. Elavarasan, S. Gogulalakshmi and K. Janani

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Abstract

Ulcerative colitis is a chronic inflammatory bowel disease that affects the colon and rectum. Mesalamine, a 5-aminosalicylic acid (5-ASA), is a commonly used medication for the treatment of ulcerative colitis. However, its oral administration is associated with systemic side effects and low bioavailability in the colon. This study aimed to develop a bilayer tablet for colon-specific delivery of mesalamine to improve its therapeutic efficacy and reduce side effects. The bilayer tablet consisted of an immediate release layer containing mesalamine and a sustained release layer containing guar gum as a sustained release polymer. The tablets were enteric coated with Eudragit L100 to prevent release in the stomach and small intestine. The tablets were evaluated for their physical properties, in vitro drug release, and disintegration time. The results showed that the bilayer tablets exhibited good physical properties, with a weight variation of ±5%, friability of ≤1%, and hardness of 10 kg/cm². The in vitro drug release study revealed that the tablets releases of mesalamine in 9 hours in phosphate buffer pH 7.4, indicating its sustained release profile. In conclusion, the developed enteric coated bilayer tablet is a promising delivery system for colon-specific delivery of mesalamine, which can improve its therapeutic efficacy and reduce side effects. This formulation has the potential to provide a more effective treatment option for patients with ulcerative colitis.

Keywords: Mesalamine, ulcerative colitis (UC), guar gum, eudragit L100, enteric coated bilayer tablet.