Galenical formulations of organic compounds

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/22 (2006.01) A61K 9/20 (2006.01) A61K 9/24 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 31/41 (2006.01) A61K 45/06 (2006.01)

Patent

CA 2698330

The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically ef-fective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Valsartan, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component a) of 80% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component b) of 25% or more after 30 minutes, and 40% or more after 60 minutes at pH 4.5.

La présente invention concerne une combinaison pharmaceutique orale de dose fixe comportant: a) une quantité thérapeutiquement efficace d'aliskirène, ou un sel pharmaceutiquement acceptable de celui-ci, (b) une quantité thérapeutiquement efficace de valsartan, ou un sel pharmaceutiquement acceptable de celui-ci, la combinaison pharmaceutique orale de dose fixe présentant une dissolution in vitro de constituant a) égale ou inférieure à 80% après 10 minutes et égale ou inférieure à 98% après 20 minutes, et un profil de dissolution de constituant b) égal ou supérieur à 25% après 30 minutes, et égal ou supérieur à 40% après 60 minutes à un pH de 4,5.

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