Stabilized and lyophilized formulation of anthracycline...

Details Stabilized and lyophilized formulation of anthracycline... Stabilized and lyophilized formulation of anthracycline...

A - Human Necessities

61

K

A61K 31/7004 (2006.01) A61K 31/198 (2006.01)

Patent

CA 2762348

Disclosed is a lyophilized amrubicin preparation.  In the preparation of the preparation, the concentration of an aqueous solution before lyophilization is adjusted to about 7.5 mg(titer)/mL or more, whereby the generation of a desugared material can be reduced and the preparation can exhibit higher stability even when the preparation is stored for a long period.  Also disclosed is a process for producing the preparation.  The preparation is useful as a chemotherapeutic agent for cancer.

L'invention porte sur une préparation d'amrubicine lyophilisée. Dans la préparation de la préparation, on règle la concentration d'une solution aqueuse avant lyophilisation à égale ou supérieure à environ 7,5 mg (titre)/ml, grâce à quoi on peut réduire la génération d'un matériau exempt de sucre et la préparation peut présenter une stabilité supérieure même lorsque la préparation est stockée pendant une longue période. L'invention porte également sur un procédé de production de la préparation. La préparation est utile en tant qu'agent chimio-thérapeutique pour le cancer.

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