Stable pharmaceutical compositions of 5,10...

A - Human Necessities – 61 – K

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A61K 9/19 (2006.01) A61K 31/194 (2006.01) A61K 31/375 (2006.01) A61K 31/519 (2006.01)

Patent

CA 2631755

The invention provides a stable lyophilized composition of 5,10 methylenetetrahydrofolate suitable for use in the treatment of cancer and other therapies. The composition comprises 5,10-MTHF in combination with citric acid and ascorbic acid, with the ratio of citric acid to ascorbic acid from about 0.75:1 to about 2.25:1 by weight, and the ratio of total citric acid and ascorbic acid to 5,10-MTHF from about 1.4:1 to about 3.4:1 by weight. Prior to lyophilization, the solution is adjusted to an essentially neutral pH.

L'invention concerne une composition lyophilisée stable de 5,10 méthylènetétrahydrofolate appropriée pour être utilisée dans le traitement du cancer et dans d'autres thérapies. La composition comprend du 5,10-MTHF en combinaison avec de l'acide citrique et de l'acide ascorbique, le rapport de l'acide citrique sur l'acide ascorbique étant compris entre environ 0,75:1 et environ 2,25:1 en poids, et le rapport de l'acide citrique et de l'acide ascorbique total sur le 5,10-MTHF étant compris entre environ 1,4:1 et environ 3,4:1 en poids. Préalablement à la lyophilisation, la solution est portée à un pH sensiblement neutre.

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