Method for lyophilization of cyclophosphamide and product

Details Method for lyophilization of cyclophosphamide and product Method for lyophilization of cyclophosphamide and product

1994-04-22

1995-05-23

Raymond, Richard L.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Carbohydrate doai

514 53, 514 90, 514110, 514561, 514777, 514960, A61K 31715

Patent

active

054182239

ABSTRACT:
A process for preparing a pharmaceutical preparation consisting essentially of a lyophilized cake of cyclophosphamide monohydrate and a bulking agent which comprises freezing cyclophosphamide, a bulking agent, and water, lyophilizing part of the water, obtaining and melting a supersaturated cyclophosphamide-bulking agent solution, precipitating cyclophosphamide as a hydrated polymorph, refreezing the solution and lyophilizing the water not bound to cyclophosphamide or the bulking agent.

REFERENCES:
patent: 4537883 (1985-08-01), Alexander et al.
patent: 4659699 (1987-04-01), Francis
patent: 5036060 (1991-07-01), Alam
Kovalcik et al, "The Stability of Cyclophosphamide . . . excipients", J. Parenter. Sci. & Technol. 42, 29-37 (1988).

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