Claims
- 1. A pharmaceutical composition comprising an epothilone together with a pharmaceutically acceptable carrier, wherein the epothilone is provided in a therapeutically acceptable concentration upon administration to a patient.
- 2. The pharmaceutical composition of claim 1 wherein the composition is administered orally.
- 3. The pharmaceutical composition of claim 1, wherein the composition comprises at least one cyclodextrin.
- 4. The pharmaceutical composition of claim 3, wherein the cyclodextrin is selected from the group consisting of β-cyclodextrin, hydroxypropyl-β-cyclodextrin, and sulfopropyl-β-cyclodextrin.
- 5. The pharmaceutical composition of claim 4, wherein the epothilone is selected from the group consisting of epothilone D, epothilone B, 9,10-dehydro-epothilone D, and 9,10-dehydro-epothilone B.
- 6. The pharmaceutical composition of claim 5, wherein the epothilone is epothilone D.
- 7. The pharmaceutical composition of claim 6, wherein the cyclodextrin is hydroxypropyl-β-cyclodextrin.
- 8. The pharmaceutical composition of claim 6, wherein the cyclodextrin is sulfopropyl-β-cyclodextrin.
- 9. A lyophilized mixture comprising an epothilone and a cyclodextrin.
- 10. The lyophilized mixture of claim 9, wherein the cyclodextrin is selected from the group consisting of β-cyclodextrin, hydroxypropyl-β-cyclodextrin, and sulfopropyl-β-cyclodextrin.
- 11. The lyophilized mixture of claim 10, wherein the epothilone is selected from the group consisting of epothilone D, epothilone B, 9,10-dehydro-epothilone D, and 9,10-dehydro-epothilone B.
- 12. The lyophilized mixture of claim 11, wherein the epothilone is epothilone D.
- 13. The lyophilized mixture of claim 12, wherein the cyclodextrin is hydroxypropyl-β-cyclodextrin.
- 14. The lyophilized mixture of claim 12, wherein the cyclodextrin is sulfopropyl-β-cyclodextrin.
- 15. A method of preparing a pharmaceutical composition of claim 1, said method comprising the steps of
obtaining a lyophilate of claim 9; and dissolving said lyophilate in a suitable reconstitution solvent.
- 16. The method of claim 15, wherein the reconstitution solvent comprises one or more of an alcohol and a glycol.
- 17. The method of claim 16, wherein the alcohol is ethanol and the polyene glycol is selected from the group consisting of propylene glycol, polyethylene glycol 400, and polyethoxyethylene sorbitan monooleate.
- 18. The method of claim 17, wherein the glycol is polyethoxyethylene sorbitan monooleate.
- 19. The method of claim 18, wherein the reconstitution solvent comprises water at between about 10% (v/v) and about 70% (v/v), and polyethoxyethylene sorbitan monooleate at between about 25% (v/v) and about 10% (v/v).
- 20. The method of claim 19, wherein the reconstitution solvent comprises water, ethanol, and polyethoxyethylene sorbitan monooleate in a volume/volume/volume ratio selected from the group consisting of about 10/65/25, about 20/55/25, about 40/35/25, about 62.5/12.5/25, about 60/20/20, and about 60/25/15.
- 21. The method of claim 20, wherein the reconstitution solvent comprises water, ethanol, and polyethoxyethylene sorbitan monooleate in a volume/volume/volume ratio of about 60/25/15.
- 22. A soft gel cap comprising a pharmaceutical composition of claim 1.
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Applications Serial No. 60/417,536, filed 9 Oct. 2002, and Serial No. 60/426,585, filed 14 Nov. 2002, each of which is incorporated herein in its entirety.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60417536 |
Oct 2002 |
US |
|
60426585 |
Nov 2002 |
US |