PROCESS FOR PREPARING A PHARMACEUTICAL PREPARATION CONTAINING AMIFOSTIN, AMIFOSTIN, PHARMACEUTICAL CONTAINING AMIFOSTIN, PROCESS OF ITS PREPARATION AND MEDICINAL FORM OF CRYSTALLINE AMIFOSTIN

摘要

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 DEG 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.