Patent ID: 7141249
Filing Date: 2006-11-28
Classification: A61K,A61P,Y10S

Abstract:
1. A fast-dissolving pharmaceutical composition in a solid dosage form, comprising micronized (R)-2-(4-bromo-2-fluorobenzyl)-1,2,3,4-tetrahydropyrrolo[1,2-a]pyrazine-4-spiro-3′-pyrrolidine-1,2′,3,5′-tetrone (hereinafter referred to as “AS-3201”) having a mean particle size of in a range of about 1.5 μm to less than about 10 μm in a ratio of about 0.5% by weight to about 25% by weight of the total weight of the pharmaceutical composition, and as a stabilizer at least one acidic substance having a pKa less than about 5.6, wherein the acidic substance is a member selected from the group consisting of citric acid, tartaric acid, maleic acid, and phosphoric acid, and wherein when in a dissolution percentage of AS-3201 from the composition is measured according to the Paddle method, 50% or more of the AS-3201 in the composition is dissolved with 15 minutes from the start of the method.