Mesalazine tablet having improved dissolution

Abstract

The invention provides a method for preparing a mesalazine enteric coated tablet comprising: (i) granulating a composition comprising mesalazine, a pharmaceutically acceptable salt, or ester thereof, into mesalazine granulates; (ii) tabletting a core composition comprising the mesalazine granulates obtained in (i) to obtain a tablet core; (iii) coating the tablet core obtained in (ii) with at least an enteric coating; where the tablet core hardness is controlled to be comprised between 80 N and 105 N.

Description

Background of the invention [0001] Mesalamine, or 5-aminosalicylic acid, is an aminosalicylate prescribed to treat inflammatory bowel disease (IBD). IBD itself can manifest in various forms, the most common being Crohn's disease and ulcerative colitis (UC). Crohn's disease (CD) is a chronic transmural enteritis that can affect the entire gastrointestinal tract, usually in a discontinuous pattern. The initial location of CD is most often in the lower ileum. Inflammation usually spreads from here to the proximal portion of the small intestine. Often, however, the colon is also involved. Ulcerative colitis is a chronic inflammatory bowel disease that affects only the colon and shows a continuous distribution in the gastrointestinal mucosa. In most patients, it is primarily the distal portion of the colon and rectum that is inflamed, often with proximal spread. In the most severe cases, the entire colon is affected ("pancolitis"). [0002] To date, there is no cure for Crohn...

AI Technical Summary

Problems solved by technology

Because not bioequivalent, these Disphar tablets have still not been shown to be non-inferior to In other words, the two products have not been proven to be equally effective

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