Patent ID: 8697135
Filing Date: 2014-04-15
Classification: A61J,A61K,A61P

Abstract:
1. A method for the preparation of granules comprising 5-aminosalicylic acid (5-ASA) or a pharmaceutically acceptable salt or ester thereof, comprising: (a) mixing polyvinyl pyrrolidone as a pharmaceutically acceptable binder in a solvent, the solvent consisting of at least 85% w/w water and up to 15% w/w organic solvent, to form a solvent-binder mixture; (b) mixing the solvent-binder mixture with 5-ASA to form a wet mass consisting of 5-ASA, binder, and solvent, in which the solvent is present in amount up to 35% by weight of the weight of 5-ASA; (c) extruding the wet mass to form strong, smooth granules comprising 5-ASA and binder; and (d) drying the granules in a continuous fluid bed dryer to produce dried granules in which the weight ratio of the binder to 5-ASA is up to 6:5:100 and more than 85% of the dried granules have a particle size of 850 to 1000 μm.