A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/08 (2006.01) A61K 9/00 (2006.01) A61K 31/282 (2006.01) A61K 47/26 (2006.01)
Patent
CA 2675788
A pharmaceutical composition, intended particularly for potential administration and for treatment of tumor diseases sensitive to oxaliplatinum, comprises oxaliplatinum as the active compound, a pharmaceutically acceptable aqueous solvent and a stabilizing agent in stabilizingly effective amount. The stabilizing agent includes at least one compound selected from the group consisting of acids derived from neutral alcoholic sugars, lactones of these acids and salts of these acids. In a method of producing such a pharmaceutical composition, oxaliplatinum is dissolved in an aqueous solvent, whereupon to the obtained oxaliplatinum solution is added at least one acid derived from a neutral alcoholic sugar and/or at least one lactone of these acids and/or at least one salt of these acids, and optionally the pH value of the solution is adjusted by addition of an alkali metal hydroxide and/or an alkali earth metal hydroxide to pH 3.5 - 6.5, whereupon the obtained solution is sterilized and filled into individual package units and optionally inertized with nitrogen or argon.
L'invention concerne une composition pharmaceutique, particulièrement destinée à une administration potentielle et pour le traitement de maladies tumorales sensibles à l'oxaliplatine. Cette composition comprend de l'oxaliplatine comme composé actif, un solvant aqueux pharmaceutiquement acceptable et un agent stabilisant en une quantité efficace pour assurer la stabilisation. L'agent stabilisant comprend au moins un composé choisi parmi le groupe constitué par les acides issus de sucres alcooliques neutres, les lactones de ces acides et les sels de ces acides. Dans un procédé de fabrication d'une telle composition pharmaceutique, on dissout de l'oxaliplatine dans un solvant aqueux. On ajoute à la solution d'oxaliplatine obtenue au moins un acide issu d'un sucre alcoolique neutre et/ou au moins une lactone de ces acides et/ou au moins un sel de ces acides, et facultativement on ajuste la valeur de pH de la solution en ajoutant un hydroxyde de métal alcalin et/ou un hydroxyde de métal alcalino-terreux à pH 3,5-6,5. La solution obtenue est ensuite stérilisée et introduite dans des unités de conditionnement individuelles et facultativement rendue inerte par de l'azote ou de l'argon.
Matejkova Bozena
Tkadleckova Hana
Zak Frantisek
Zaludek Borek
Zatloukalova Libuse
Ogilvy Renault Llp/s.e.n.c.r.l.,s.r.l.
Pliva - Lachema A.s.
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