Stable amorphous amifostine composition, and preparation...

A - Human Necessities – 61 – K

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A61K 31/661 (2006.01) A61K 9/19 (2006.01) A61K 47/16 (2006.01)

Patent

CA 2391418

The present invention relates to a sterile, stable dosage forms suitable for reconstitution and parenteral administration to a patient, said dosage form comprising and amorphous aminoalkyl dihydrogen phosphorothioate, and of 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.

La présente invention concerne des formes de dosages stables stériles convenant pour la reconstitution et l'administration parentérale chez un patient, cette forme de dosage comprenant un aminoalkyle dihydrogène phosphorothioate amorphe, d'amifostine en particulier. L'invention concerne également un procédé de préparation de cette forme de dosage qui présente généralement une stabilité à la chaleur améliorée comparée à l'amifostine amorphe desséchée sous vide existante.

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