Claims
- 1. A lyophilized cyclophosphamide composition comprising cyclophosphamide, sodium bicarbonate, and water wherein the amount of water is about 13 to 26% by weight based upon the total weight of said composition and the weight ratio of cyclophosphamide to sodium bicarbonate is from about 1:0.5 to 1:1.
- 2. The composition of claim 1 wherein the weight ratio of said cyclophosphamide to said sodium bicarbonate ranges from about 1:0.75 to 1:0.85.
- 3. The composition of claim 2 wherein said water is present in an amount of about 13 to 21%.
- 4. The composition of claim 3 wherein said water is present in an amount of about 14 to 18%.
- 5. The composition of claim 1 wherein said composition is prepared from a solution of cyclophosphamide and sodium bicarbonate in water having a pH in the range of approximately 8 to 8.5.
- 6. The composition of claim 5 wherein said solution has a pH of approximately 8.2.
- 7. The composition of claim 5 wherein said composition is prepared by lyophilizing said solution and hydrating the lyophile at a relative humidity of 85% or greater.
- 8. A lyophilized cyclophosphamide composition comprising cyclophosphamide, sodium bicarbonate, and water, said cyclophosphamide and said sodium bicarbonate being present in a weight ratio of 1:0.8 and said water being present in an amount of about 14 to 18% based upon the total weight of said composition.
- 9. The composition of claim 8 wherein said composition is prepared from a solution of cyclophosphamide and sodium bicarbonate in water having a pH in the range of approximately 8 to 8.5.
- 10. The composition of claim 9 wherein said solution as a pH of approximately 8.2.
- 11. The composition of claim 10 wherein said composition is prepared by lyophilizing said solution and hydrating said lyophile at a relative humidity of at least 85%.
- 12. A hydrated lyophilized cyclophosphamide composition comprising cyclophosphamide, sodium bicarbonate, and water wherein the amount of water is about 13-26% by weight based on the total weight of the composition and the weight ratio of cyclophosphamide to sodium bicarbonate is from about 1:0.5 to about 1:1.5, and wherein said lyophilized composition is prepared from a bulk solution of cyclophosphamide and sodium bicarbonate in water having a pH in the range of approximately 8 to 8.5.
- 13. The composition of claim 12 wherein said bulk solution has a pH of about 8.2.
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation-in-part of U.S. application Ser. No. 270,707, filed Nov. 14, 1988, now abandoned.
US Referenced Citations (3)
Number |
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4537883 |
Alexander et al. |
Aug 1985 |
|
4659699 |
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|
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|
Foreign Referenced Citations (1)
Number |
Date |
Country |
0401894 |
Dec 1990 |
EPX |
Non-Patent Literature Citations (1)
Entry |
Kovalcik et al., "The Stability of Cyclophosphamide in Lyophilized Cakes", Journal of Parenteral Science and Technology, vol. 42, No. 1, 1188, pp. 29-37 (1988). |
Continuation in Parts (1)
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Number |
Date |
Country |
Parent |
270707 |
Nov 1988 |
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