Claims
- 1. A pharmaceutical preparation consisting essentially of a lyophilized cake of cyclophosphamide monohydrate and lactose wherein said cake is prepared by the process of
- freezing a bulk solution containing cyclophosphamide, lactose, and water;
- removing a first portion of the water from said frozen solution by lyophilization, such that upon melting said cake a solution supersaturated with said cyclophosphamide and said lactose is obtained;
- melting said solution to produce said supersaturated solution;
- precipitating said cyclophosphamide as a hydrated polymorph;
- re-freezing said solution; and
- removing by lyophilization water not bound to said cyclophosphamide or said lactose to yield a lyophilizate consisting essentially of cyclophosphamide monohydrate and said lactose.
- 2. The pharmaceutical preparation of claim 1 wherein, said bulk solution contains said cyclophosphamide in an amount of about 3.0 to 3.3 percent and said lactose in an amount of about 2 to 7 percent.
- 3. The pharmaceutical preparation of claim 1 wherein said lactose is present in an amount of about 0.3 to 1.7 parts per 1 part said cyclophosphamide monohydrate.
- 4. The pharmaceutical preparation of claim 3 wherein said lactose and said cyclophosphamide monohydrate are present in approximately equal amounts.
Parent Case Info
This is a continuation of co-pending application Ser. No. 07/805,181, filed Dec. 10, 1991, now abandoned.
US Referenced Citations (3)
Non-Patent Literature Citations (1)
Entry |
Kovalcik et al "The Stability of Cyclophosphamide . . ." Chem Abstract 108(4): 210088; 1988. |
Continuations (1)
|
Number |
Date |
Country |
Parent |
805181 |
Dec 1991 |
|