Formulation and In-vitro Evaluation of Mesalamine Rectal Suppositories for Ulcerative Colitis

Mesalamine, also known as 5-aminosalicylic acid is an anti inflammatory drug used to treat inflammatory bowel disease like Ulcerative colitis and Crohn’s disease. The objective of this study was to optimize the best formula for the rectal suppositories of mesalamine with different bases. Suppositories were prepared by fusion method using different bases (cocoa butter alone, cocoa butter: paraffin, cocoa butter: PEG 6000) in varying quantity keeping other excipients constants. Base optimization study was conducted before formulation of suppositories. All suppositories were evaluated for physical characteristics and various parameters like: displacement value, weight variation, melting point, liquefaction time, hardness test, drug content, and in-vitro release profile. All the developed formulations were within the required limits for BP 2014. However, formulation F3 which is composed of cocoa butter: PEG 6000 in the ratio of 1:1 showed better release of drug around 91.48%. Mesalamine rectal suppositories containing a new base combination of Cocoa butter with PEG 6000 have good physical properties and release profile. Since this formula is potential to be used as a better therapeutic candidate for ulcerative colitis