Pharmaceutical composition for modified release

A - Human Necessities – 61 – K

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Details

A61K 31/426 (2006.01) A61K 47/02 (2006.01) A61K 47/10 (2006.01) A61K 47/12 (2006.01) A61K 47/14 (2006.01) A61K 47/18 (2006.01) A61K 47/22 (2006.01) A61K 47/26 (2006.01) A61K 47/32 (2006.01) A61K 47/34 (2006.01) A61K 47/38 (2006.01) A61P 3/10 (2006.01) A61P 13/10 (2006.01)

Patent

CA 2740342

A pharmaceutical composition for modified release, comprising (1) (R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2- hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, or a pharmaceutically acceptable salt thereof, (2) at least one additive which ensures penetration of water into the pharmaceutical composition and which has a solubility such that the volume of water required for dissolving 1 g of the additive is 10 mL or less, and (3) a hydrogel-forming polymer having an average molecular weight of approximately 100,000 or more, or a viscosity of 12 mPa.cndot.s or more at a 5% aqueous solution at 25°C is disclosed.

La présente invention concerne une composition pharmaceutique à libération contrôlée contenant (1) de lanilide de lacide (R)-2-(2-aminothiazol-4-yl)-4'-[2-[(2-hydroxy-2-phényléthyl)amino]éthyl]acétique ou lun de ses sels pharmaceutiquement acceptables, (2) un ou plusieurs additifs pour obtenir une infiltration deau à lintérieur de la préparation, lesdits additifs présentant une solubilité telle que la quantité deau requise pour dissoudre 1 g des additifs nest pas supérieure à 10 ml et (3) un matériau polymère pour former un hydrogel, ledit matériau polymère présentant une masse moléculaire moyenne denviron 100 000 ou supérieure et une viscosité non inférieure à 12 mPa·s mesurée dans la forme dune solution aqueuse à 5 % à 25° C.

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