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Claims for Patent: 4,537,883

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Claims for Patent: 4,537,883

Title: Lyophilized cyclophosphamide
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)
Application Number:06/589,202
Patent Claims: 1. A hydrated lyophilizate composition with improved stability, superior solubility characteristics and enhanced appearance comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 85 parts by weight of mannitol.

2. The hydrated lyophilizate composition of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 40 parts by weight of mannitol.

3. The hydrated lyophilizate of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 20 parts by weight of mannitol.

4. The hydrated lyophilizate composition of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and about 15 parts by weight of mannitol.

5. The hydrated lyophilizate composition of claim 1 comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/2 parts by weight of water and from about 10 to 40 parts by weight of mannitol.

6. A single dose formulation comprising the hydrated lyophilizate composition of claim 4 in a single dose vial container means of sufficient size to allow reconstitution with water to give an intended volume of solution of desired cyclophosphamide concentration for administration.

7. The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 100 mg cyclophosphamide, taken as the anhydride, 75 mg mannitol and 7 mg water.

8. The single dose of claim 7 wherein said composition is reconstituted with 5 mL of water to provide solution for administration.

9. The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 200 mg cyclophosphamide, taken as the anhydride, 150 mg mannitol and 14 mg water.

10. The single dose of claim 9 wherein said composition is reconstituted with 10 mL of water to provide solution for administration.

11. The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 500 mg cyclophosphamide, taken as the anhydride, 375 mg mannitol and 35 mg water.

12. The single dose of claim 11 wherein said composition is reconstituted with 25 mL of water to provide solution for administration.

13. The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 1,000 mg cyclophosphamide, taken as the anhydride, 750 mg mannitol and 70 mg water.

14. The single dose of claim 13 wherein said composition is reconstituted with 50 ml of water to provide solution for administration.

15. The single dose form of claim 6 wherein the hydrated lyophilizate composition comprises approximately 2,000 mg cyclophosphamide, taken as the anhydride, 1,500 mg mannitol and 140 mg water.

16. The single dose of claim 15 wherein said composition is reconstituted with 100 mL of water to provide solution for administration.
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