Lyophilized cyclophosphamide

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Phosphorus containing other than solely as part of an...

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A61K 3166

Patent

active

054139953

ABSTRACT:
A lyophilized pharmaceutical solid composition containing cyclophosphamide for reconstitution with water to provide a solution for oral or parenteral administration. This lyophilized cyclophosphamide solid composition demonstrates improved stability, solubility characteristics and enhanced appearance compared with currently available dry powder pre-mix compositions of cyclophosphamide. The lyophilized solid composition contains about 20 parts by weight of cyclophosphamide, about 11/4-2 parts by weight of water and from about 10-85 parts by weight of excipient which is comprised mainly of mannitol. Processes for making the composition are disclosed.

REFERENCES:
patent: 3018302 (1962-01-01), Arnold et al.
patent: 3732340 (1973-05-01), Arnold et al.
Brooke, et al., American Journal of Hospital Pharmacy, 32:44-45 (1975).
Lachman, et al., "The Theory and Practice of Industrial Pharmacy", 2nd Ed., Lea & Febiger, Philadelphia, Pa., pp. 521-524 (1976).
Anon., "Remington's Pharmaceutical Sciences", 15th Ed., Mack Publishing Co., Easton, Pa., pp. 1483-1485 (1975).

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