| 摘要 |
The invention discloses a method of maintaining remission of ulcerative colitis in patients, comprising administering to the subject in the morning without food four gelatin capsules in a hard shell comprising 0.375 g daily dosage of a delayed and extended release granulated mesalamine formulation, wherein the granulated form of mesalamine comprises an inner polymer matrix mesalamine core that is surrounded by an outer flavor coating, a middle coating, and an inner enteric pH dependent delayed release coating which dissolves at approximately pH 6, but resists dissolution in the stomach, wherein this method maintains remission of ulcerative colitis in a patient for the period of at least 6 months, and said formulation is not co-administered with antacids, and where from 85 to 90% of mesalamine releases throughout terminal ileum and colon. The remission is defined by Sutherland Disease Activity Index (DAI) scores 0 or 1. |
