Patent ID: 9707182
Date: 2017-07-18
CPC Classifications: A61K,A61P

Claim:
1. A sustained release pharmaceutical dosage form in the form of a capsule, sachet or pouch, comprising: a) an inert core, b) a first sustained release sugar matrix layer surrounding the inert core, the sugar matrix layer comprising budesonide, a water insoluble polymer and sugar, wherein the ratio of sugar to water insoluble polymer is greater than 3:1; and c) a second delayed release film coating surrounding the sustained release sugar matrix layer, wherein, the sustained release pharmaceutical dosage form when tested for dissolution in a USP Apparatus II at 75 rpm in 1000 ml of 0.1 N HCl for 2 hours followed by a change to pH 5.5 buffer, exhibits the following dissolution profile a) less than 5% of total budesonide is released after 2 hours; b) from about 5% to about 15% of total budesonide is released after 3 hours; c) from about 15% to about 20% of total budesonide is released after 4 hours; d) from about 30% to about 40% of total budesonide is released after 6 hours; e) from about 40% to about 50% of total budesonide is released after 8 hours; f) not less than 50% of total budesonide is released after 10 hours.