Patent ID: 8128958
Filing Date: 2012-03-06
Classification: A61K,A61P

Abstract:
1. A method for maintaining an effective plasma concentration of tamsulosin or a pharmaceutically acceptable salt thereof in an individual while reducing postural hypotension, said method comprising: orally administering a pharmaceutical composition containing tamsulosin or a pharmaceutically acceptable salt thereof and a carrier for a sustained-release pharmaceutical composition, wherein said composition is a member selected from the group consisting of; (B) a preparation of an osmotic pump formulation comprising a two-layered compressed core containing tamsulosin or a pharmaceutically acceptable salt thereof containing a poly(alkylene oxide) polymer with a number average molecular weight of 100,000 to 750,000 and a push layer containing a poly(alkylene oxide) polymer with a number average molecular weight of 1,000,000 to 15,000,000 coated with a semipermeable membrane containing a member selected from the group consisting of a cellulose ester, a cellulose ether and a cellulose ester-ether; (C) a gel preparation in which a plurality of gums are combined comprising a hetero polysaccharide gum selected from the group consisting of xanthan gum and a xanthan gum derivative selected from a deacylated xanthan gum, a carboxymethyl ether and propylene glycol ester and a homo polysaccharide gum, which is locust bean, a water-soluble cationic cross-linking agent, an inert diluent, and ethyl cellulose; (D) a multi-layered tablet preparation comprising 3 layers, i) a first layer comprising a mixture or granules containing 5 to 90 w/w % of a water-soluble polymer in the first layer and having a property of being swollen by contact to environmental fluids and ethyl cellulose; ii) a second layer comprising a water-soluble polymer of hydroxymethylcellulose, auxiliary substances of microcrystalline cellulose and polyvinylpyrrolidone and containing tamsulosin or a pharmaceutically acceptable salt thereof which is adjacent to the first layer and, iii) a third layer being adhered to the second layer which comprises ethyl cellulose and a water-soluble polymer which is gelled and/or swollen followed by free disintegration, wherein said water-soluble polymer in the first, second and third layers can be the same or different and is a member selected from the group consisting of hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose and hydroxypropyl cellulose; and wherein even for 8 to 24 hours after administering, said composition selected from the group consisting of B, C, and D, still releases tamsulosin to be absorbed in vivo; and maintaining an effective plasma concentration of tamsulosin or a pharmaceutically acceptable salt thereof, said effective plasma concentration indicated by a ratio (C