Pharmaceutically stable oxaliplatinum preparation for...

A - Human Necessities – 61 – K

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A61K 31/282 (2006.01) A61K 9/08 (2006.01) A61K 31/555 (2006.01) A61K 33/24 (2006.01) A61K 47/10 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2382389

The invention concerns a pharmaceutically stable oxaliplatinum preparation for parenteral administration, the oxaliplatinum being in a precipitate-free, colourless and clear solution after being preserved for a pharmaceutically acceptable duration. In said preparation, the oxiplatinum is contained in solution in a solvent at a concentration of at least 7 mg/ml and the solvent comprises a sufficient amount of at least a hydroxylated derivative selected among 1,2-propane-diol, glycerol, maltitol, saccharose and inositol. The invention also concerns a method for preparing said solution.

La présente invention concerne une préparation pharmaceutique stable d'oxaliplatine pour administration par voie parentérale, l'oxaliplatine se trouvant en solution limpide, incolore et exempte de précipité après conservation pendant une durée pharmaceutiquement acceptable. Dans cette préparation, l'oxaliplatine se trouve en solution dans un solvant à une concentration d'au moins 7 mg/ml et le solvant comprend une quantité suffisante d'au moins un dérivé hydroxylé choisi parmi les 1,2-propane-diol, glycérol, maltitol, saccharose et inositol. L'invention concerne également un procédé de préparation de ladite préparation.

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