Stable amorphous amifostine compositions and methods for the...

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A61K 31/661 (2006.01) A61K 9/19 (2006.01) A61K 31/66 (2006.01) A61K 47/16 (2006.01) A61K 47/18 (2006.01) A61P 39/00 (2006.01)

Patent

CA 2350815

The present invention relates to sterile, stable dosage forms suitable for reconstitution and parenteral administration to a patient, said dosage form comprising an amorphous aminoalkyl dihydrogen phosphorothioate, and amifostine in particular. The invention further relates to a method of preparing such a dosage form, which typically exhibits enhanced thermal stability as compared to existing vacuum dried amorphous amifostine.

L'invention concerne des formes galéniques stables et stériles pouvant être reconstituées et administrées par voie parentérale chez un patient. Ces formes galéniques contiennent un aminoalkyl-dihydrogèno-phosphorothioate amorphe, et plus précisément de l'amifostine amorphe. L'invention concerne également un procédé de préparation de ces formes galéniques, qui présente une stabilité thermique supérieure à celle de l'actuelle amifostine amorphe séchée sous vide.

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