FORMULATION AND EVALUATING OF MESALAMINE USP DELAYED RELEASE TABLETS USING TWO DIFFERENT COATING POLYMERS

Mesalamine (5-aminosalicylic acid) is a locally acting anti-inflammatory drug widely used in the treatment and maintenance of remission in inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease. Due to its instability in gastric conditions and the requirement for site-specific drug delivery to the colon, delayed-release formulations are essential. The present study focuses on the formulation and evaluation of Mesalamine USP delayed-release tablets using two different coating polymers. Tablets were prepared by the wet granulation method using suitable binders and lubricants, followed by compression and enteric coating. Pre-compression parameters such as angle of repose, bulk density, Carr’s compressibility index, and Hausner’s ratio were evaluated to assess flow properties. Post-compression evaluations including weight variation, hardness, friability, disintegration, and dissolution studies were performed. Drug content uniformity was analyzed using HPLC. The results demonstrated satisfactory physicochemical properties, acceptable flow behavior, and effective delayed drug release in both formulations. The study concludes that Mesalamine delayed-release tablets coated with appropriate polymers can successfully target colonic drug delivery and enhance therapeutic efficacy.