Patent ID: 7465462
Filing Date: 2008-12-16
Classification: A61K,A61P

Abstract:
1. A multiparticulate controlled release selective serotonin reuptake inhibitor (SSRI) composition for oral administration comprising two quantities of particles, each of the particles comprising (i) an inert non-pareil core, (ii) an SSRI layer comprising fluvoxamine or a pharmaceutically-acceptable salt thereof disposed over the inert core, and (iii) a coating of a rate-controlling polymeric acrylate, methacrylate lacquer, or a mixture thereof disposed over the fluvoxamine, wherein the composition allows the controlled release of the fluvoxamine over a period of not less than about 12 hours following oral administration, wherein the rate-controlling polymeric acrylate or methacrylate lacquer coating of the first quantity of particles is present in a first amount, and the rate-controlling polymeric acrylate or methacrylate lacquer coating of the second quantity of particles is present in a second amount that is different from the first amount, and wherein the fluvoxamine release rate from the composition exhibits the following in vitro dissolution pattern when measured using a USP type II dissolution apparatus (paddle) according to US Pharmacopeia XXII in 0.05 M phosphate buffer at pH 6.8: (a) no more than about 15% of the total fluvoxamine is released after 0.5 of an hour of measurement in the apparatus; (b) no more than about 25% of the total fluvoxamine is released after 1 hour of measurement in the apparatus; (c) between about 20% and 75% of the total fluvoxamine is released after 2 hours of measurement in the apparatus; (d) not less than about 75% of the total fluvoxamine is released after 4 hours of measurement in the apparatus; and (e) not less than about 85% of the total fluvoxamine is released after 6 hours of measurement in the apparatus.