Stable amorphous amifostine compositions and methods for the preparation and use of same

An amifostine and amorphous technology, which is applied in the directions of active ingredients of phosphorus compounds, pharmaceutical combinations, medical preparations of non-active ingredients, etc., can solve the problems of undisclosed amorphous heat-stable amifostine and the like
CN1195549CInactive Publication Date: 2005-04-06MEDIMMUNE ONCOLOGY
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
MEDIMMUNE ONCOLOGY
Publication Date
2005-04-06
Estimated Expiration
Not applicable · inactive patent

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Abstract

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.
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Description

1. Field of Invention

[0001] The present invention relates to a heat stabilized dosage form of S-2-(3-aminopropylamino)ethyl dihydrogen thiophosphate (amifostine) and a method for preparing the same substance. The reformulated form of the invention is suitable for administration to humans, for example, as a radioprotectant or chemoprotectant. 2. Background of the invention

[0002] U.S. Patent No. 3,892,824 discloses the compound S-2-(3-aminopropylamino)ethyl dihydrogen phosphorothioate (which is also known as amifostine, ethiofos, Ethyol  , NSC 296961 and WR-2721 and it is hereinafter referred to as "Amifostine") and other aminothiol compounds. These compounds were originally developed as anti-radiation drugs (radioprotectants), especially before exposure to x-rays or nuclear radiation, to avoid the harmful effects of such exposure that may be encountered during military conflicts.

[0003] In addition to its use as a military anti-radiation drug, it has been proven that amifos...

Claims

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