Pharmaceutical formulations and processes for their preparation

A - Human Necessities – 61 – K

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Details

A61K 47/12 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 31/42 (2006.01) C07D 261/04 (2006.01)

Patent

CA 2314148

Provided is a pharmaceutical composition comprising a tablet or capsule containing a pharmacologically effective amount of a pharmaceutical compound, or a pharmaceutically acceptable salt thereof, having an amidine-based group and an optional ester group, a pharmaceutically acceptable solid carrier, and a pharmaceutically acceptable acid in an amount to modify the pH of the composition to substantially that of the compound at pH of maximum stability. Such a composition is prepared by adding water during formulation manufacture and contacting the compound during formulation manufacture with a pharmaceutically acceptable acid having a pH in a saturated aqueous solution substantially that of the compound at pH of maximum stability.

L'invention concerne une composition pharmaceutique sous forme de comprimé ou de capsule comprenant une quantité pharmacologiquement efficace d'un composé pharmaceutique, ou d'un sel pharmaceutiquement acceptable dudit composé, lequel contient un groupe à base d'amidine et un groupe ester facultatif, un excipient solide pharmaceutiquement acceptable, et un acide pharmaceutiquement acceptable en quantité suffisante pour amener le pH de la composition à un pH sensiblement identique à celui du composé lorsqu'il a atteint un pH d'une stabilité maximale. On prépare cette composition en ajoutant de l'eau et en mettant en contact le composé avec un acide pharmaceutiquement acceptable ayant un pH, dans une solution aqueuse saturée sensiblement identique à celui du composé lorsqu'il a atteint un pH d'une stabilité maximale.

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