Pharmaceutical composition for oral administration

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/439 (2006.01) A61K 31/18 (2006.01) A61K 47/10 (2006.01) A61K 47/26 (2006.01) A61K 47/32 (2006.01) A61K 47/38 (2006.01) A61P 13/02 (2006.01) A61P 13/08 (2006.01)

Patent

CA 2751039

The present invention relates to a pharmaceutical composition for oral administration comprising a modified release portion containing tamsulosin or a pharmaceutically acceptable salt thereof, and an immediate release portion containing solifenacin or a pharmaceutically acceptable salt thereof and a hydrophilic substance. In the pharmaceutical composition, the dissolution rate of each drug (in particular, solifenacin contained in the immediate release portion) is similar to those of the current single drug formulations, and the maximum percentage of drag dissolution of each drug (in particular, solifenacin contained in the immediate release portion) is 90% or more. Therefore, the pharmaceutical composition is a single formulation (i.e., a combined formulation) with a bioavailability equivalent to those of the current single drug formulations.

La présente invention concerne une composition pharmaceutique pour une administration orale, qui comprend une partie à libération contrôlée, laquelle comprend de la tamsulosine ou l'un de ses sels pharmaceutiquement acceptables, et une partie à libération rapide, qui comprend de la solifénacine ou l'un de ses sels pharmaceutiquement acceptables ainsi qu'une substance hydrophile. Dans la composition pharmaceutique, les vitesses de dissolution des médicaments (particulièrement la solifénacine contenue dans la partie à libération rapide) sont inchangées par rapport aux préparations pharmaceutiques classiques et les vitesses maximales de dissolution des médicaments individuels (particulièrement la solifénacine contenue dans la partie à libération rapide) sont supérieures ou égales à 90 %. Par conséquent, la composition pharmaceutique est une préparation simple (une préparation combinée) présentant un taux équivalent de biodisponibilité par rapport à ceux des préparations pharmaceutiques classiques.

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