Coformulation methods and their products

Details Coformulation methods and their products Coformulation methods and their products

A - Human Necessities

61

K

A61K 9/16 (2006.01)

Patent

CA 2382556

A coformulation of an active (preferably pharmaceutically active, for instance a COX-2 enzyme inhibitor) substance and an oligomeric or polymeric excipient, containing at least 10 % of the active, between 80 and 100 % of which is amorphous. The amorphous phase is stable, with respect to the crystalline phase(s), for at least theree months after its preparation when stored at between O and 10 ~C. The invention also provides processes, preferably involving SEDSTM particle formation, for preparing such a coformulation.

L'invention concerne une coformulation d'une substance active (de préférence active au plan pharmaceutique, comme par exemple un inhibiteur enzymatique COX-2) et d'un excipient oligomère ou polymère, contenant au moins 10 % de substance active dont 80 à 100 % est actif. La phase amorphe est stable, par rapport à la/aux phases cristallines, pendant au moins trois mois après sa préparation, lorsqu'elle est stockée entre 0 et 10 ·C. L'invention porte également sur des procédés, impliquant de préférence la formation de particules SEDS?TM¿, pour la préparation de ladite coformulation.

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