Patent ID: 8858992
Filing Date: 2014-10-14
Classification: A61K,A61P,B32B,Y10T

Abstract:
1. A pharmaceutical formulation suitable for oral administration and in the form of coated, flowable granules comprising: 92 to 98% by weight of mesalazine or a pharmaceutically acceptable salt thereof; 2 to 8% by weight of polyvinylpyrrolidone; and a coating comprising ethylcellulose, the ratio of the weight of the coating to the weight of the mesalazine or pharmaceutically acceptable salt thereof being 0.7-3%; the coated, flowable granules being in a sachet, capsule or blister package; wherein the coated granules, when suspended in an aqueous buffer at pH 7.5, release the mesalazine according to a release profile in which: a) 5-25% of the total amount of mesalazine or pharmaceutically acceptable salt thereof in the granules is released after 15 min; b) 30-70% of the total amount of mesalazine or pharmaceutically acceptable salt thereof in the granules is released after 90 min; and c) 75-100% of the total amount of mesalazine or pharmaceutically acceptable salt thereof in the granules is released after 240 min; when measured in a model system using a USP Paddle System 2 operated at 37° C. with stirring at 100 rpm.