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|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.|
|Inventor(s):||Alexander; Robert L. (Evansville, IN), Bequette; Robert J. (Evansville, IN), Kensler; Terry T. (Evansville, IN), Scott; Joseph A. (Evansville, IN)|
|Assignee:||Mead Johnson & Company (Evansville, IN)|
|Filing Date:||Dec 23, 1991|
|Claims:||1. A hydrated lyophilizate composition for reconstitution with water with improved stability and enhanced appearance comprising about 100 parts by weight of cyclophosphamide, taken as the anhydride, from about 61/4 to about 10 parts by weight of water and from about 50 to about 75 parts by weight of sodium bicarbonate. |
2. A hydrated lyophilizate composition for reconstitution with water with improved stability and enhanced appearance comprising cyclosphosphamide, sodium bicarbonate in an amount sufficient to form a lyophilized cake retaining its original shape and capable of easy dissolution on reconstitution with water, and which has been rehydrated in order to impart improved thermal stability to the cyclophosphamide.