Ifosfamide lyophilisate and process for its preparation

A process for the preparation of an ifosfamide lyophilizate which comprises freezing an aqueous or aqueous-ethanolic solution of ifosfamide containing 1 to 13 percent by weight of ifosfamide and 0.1 to 17 parts by weight of a hexitol selected from the group consisting of mannitol, dulcitol and sorbitol for each part by weight of ifosfamide as well as 0 to 16.9 parts by weight for each part by weight of ifosfamide, of other conventional pharmaceutical auxiliary substances, the total amount of said hexitol and said other conventional pharmaceutical auxiliary substances, the total amount of said hexitol and said other conventional pharmaceutical auxiliary substances being up to 17 parts by weight for each part by weight of ifosfamide, at between -70.degree. and 0.degree. C. and removing the water from the so-obtained product while it is in the frozen state.

A process as set forth in claim 7 or claim 9 in which the ethanol is removed at a pressure of 5.times.10.sup.-1 mbar and a temperature between 25.degree. and +5.degree. C.

Ifosfamide lyophilizate produced by a process comprising freezing an aqueous or aqueous-ethanolic solution of ifosfamide containing 0.1 to 17 parts by weight of a hexitol selected from the group consisting of mannitol, dulcitol and sorbitol for each part by weight of ifosfamide as well as 0 to 16.9 parts by weight for each part by weight of ifosfamide, of other conventional pharmaceutical auxiliary substances, the total amount of said hexitol and said other conventional pharmaceutical auxiliary substances being up to 17 parts by weight for each part by weight of ifosfamide, at between -70.degree. and 0.degree. C. and removing the water from the so-obtained product while it is in the frozen state.