A method for preparing a Pharmaceutical composition comprising 5-aminosalicylic acid for use in the treatment of ulcerative colitis and Crohn's disease

摘要

Claim 1: a method for the preparation of Granules comprising 5-aminosalicylic acid (5-asa) or a pharmaceutically acceptable Salt or Ester thereof and a pharmaceutically acceptable Binder comprising: (a) Dissolving the Binder in a pharmaceutically acceptable solve NTE, (b) mixing the Binder dissolved with 5-asa to form a Wet Mass,(c) to extrude The Dough Wet Granules, and (d) Drying the Granules to evaporate the Solvent, wherein the Solvent is covered by at least 50% w / W of water.Claim 18: a method for the preparation of prolonged Release Tablets, useful for the treatment of ulcerative colitis or Crohn's disease, which comprises the steps of (a) mixing 5-aminosalicylic acid or a pharmaceutically acceptable Salt or Ester thereof and a Umbrella Nte pharmaceutically acceptable in a Solvent comprising at least 50% w / W of WaterAnd then Extruding the mixture produced by evaporation of the Solvent to provide Granules, Granules (b) apply to such a Coating composition comprising a solution of a Coating material in a pharmaceutically acceptable Organic Solvent so as to provide re Granules Covered by evaporation of the solvent.(c) MIX THE Granules coated with one or more pharmaceutically acceptable excipients in tablets, and (d) Forming Tablets from the resulting mixture.