Crystalline amifostine compositions and methods for the...

Details Crystalline amifostine compositions and methods for the... Crystalline amifostine compositions and methods for the...

C - Chemistry, Metallurgy

07

F

C07F 9/165 (2006.01) A61K 31/66 (2006.01) A61K 47/02 (2006.01) A61K 47/18 (2006.01) A61K 47/26 (2006.01)

Patent

CA 2120133

The present invention relates to a sterile, stable vacuum dried crystalline amifostine composition and, optionally, pharmaceutically acceptable excipient(s). Typically, the crystalline compositions of the present invention exhibit enhanced stability at temperatures ranging from about 4°C to about ambient temperature for a period of at least 2 years relative to existing solid vacuum dried amorphous amifostine preparations. The reconstituted compositions of the present invention are suitable for administration to humans as a radio- or chemoprotecting agent.

La présente invention a trait à une composition constituée d'amifostine cristalline stérile et stable séchée sous vide et, optionnellement, d'excipients pharmaceutiques acceptables. De façon générale, les compositions cristallines faisant l'objet de cette invention présentent une stabilité accrue à une température variant entre environ 4 degrés Celsius et la température ambiante, pour une période d'au moins deux ans, par opposition aux compositions existantes d'amifostine amorphe solide séchée sous vide. Les compositions reconstituées visées par la présente invention peuvent être administrées à des humains en tant qu'agents de protection contre les rayonnements ionisants et les substances chimiques.

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