Freeze-dried preparation containing methylcobalamin and...

Details Freeze-dried preparation containing methylcobalamin and... Freeze-dried preparation containing methylcobalamin and...

A - Human Necessities

61

K

A61K 31/714 (2006.01) A61K 47/10 (2006.01) A61K 47/26 (2006.01) A61P 25/00 (2006.01)

Patent

CA 2521928

Freeze-dried preparations comprising methylcobalamin in high content, which excel in aging stability and can be used in high-concentration therapy of methylcobalamin. In particular, freeze-dried preparations comprising methylcobalamin or a pharmacologically acceptable salt thereof and an excipient, wherein the excipient is at least in amorphous form. Further, the freeze-dried preparations are characterized in that when the excipient contains sugar and sugar alcohol, the excipient in amorphous form is contained in an amount of at least 20 wt.% based on the total weight of sugar and sugar alcohol.

L'invention concerne des préparations à haute teneur en méthylcobalamine, qui possèdent d'excellentes propriétés de stabilité au vieillissement et peuvent être utilisées dans un traitement comprenant une forte concentration de méthylcobalamine. Elle concerne en particulier des préparations lyophilisées renfermant de la méthylcobalamine ou un sel pharmacologiquement acceptable de celle-ci ainsi qu'un excipient, ce dernier étant au moins sous une forme amorphe. Ces préparations sont en outre caractérisées en ce que l'excipient renferme un sucre et un polyol, l'excipient sous une forme amorphe étant présent à raison d'au moins 20 % du poids total de sucre et de polyol.

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