Stable liquid parenteral parecoxib formulation

A - Human Necessities – 61 – K

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Details

A61K 31/42 (2006.01) A61K 47/00 (2006.01) A61K 47/10 (2006.01)

Patent

CA 2488526

A parenterally deliverable pharmaceutical composition comprises a water soluble parecoxib salt, in dissolved and/or solubilized form in a solvent liquid that comprises water and one or more nonaqueous solubilizer(s). Valdecoxib formed by conversion of parecoxib is solubilized by the nonaqueous solubilizer(s), which are substantially inert with respect to such conversion. The composition has parecoxib salt stabilizing means for inhibiting precipitation of parecoxib free acid. The composition is storage stable and is suitable for parenteral administration to treat a COX-2 mediated condition or disorder.

L'invention concerne une composition pharmaceutique destinée à être administrée par voie parentérale, comprenant un sel de parecoxib soluble dans l'eau, sous forme dissoute et/ou solubilisée dans un solvant liquide comprenant de l'eau et un ou plusieurs agents de solubilisation non aqueux. Le valdecoxib formé par conversion du parecoxib est solubilisé par les agents de solubilisation non aqueux, qui sont sensiblement inertes par rapport à une telle conversion. La composition contient des moyens de stabilisation du sel de parecoxib destinés à inhiber la précipitation d'acide sans parecoxib. La composition est stable au stockage et est adaptée pour être administrée par voie parentérale pour traiter un état ou un trouble médié par COX-2.

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