Claims
- 1. Venlafaxine hydrochloride having an X-ray powder diffraction pattern substantially the same as that shown in FIG. 1.
- 2. The venlafaxine hydrochloride of claim 1, wherein the venlafaxine hydrochloride is anhydrous.
- 3. The venlafaxine hydrochloride of claim 1, wherein the melting point of the venlafaxine hydrochloride is about 219° C.
- 4. Substantially pure venlafaxine hydrochloride having an X-ray powder diffraction pattern substantially the same as that shown in FIG. 1.
- 5. A crystalline polymorph of venlafaxine hydrochloride exhibiting an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2θ at about 5.67, 7.28, 9.14, 9.67, 10.77, 11.31, 14.01, 14.54, 14.85, 15.48, 15.81, 16.17, 16.94, 17.68, 18.02, 18.48, 19.29, 19.69, 20.46, 20.74, 21.86, 22.33, 22.67, 22.95, 23.17, 24.06, 24.61, 25.13, 26.62, 26.97, 27.64, 28.25, 29.01, 29.96, 31.01, 31.61, 32.75, 34.54, 35.50, 35.95 and 36.91.
- 6. A crystalline polymorph of venlafaxine hydrochloride exhibiting an X-ray powder diffraction pattern having characteristic peaks expressed in degrees 2θ at about 5.67, 7.28, 9.14, 9.67, 10.77, 14.01, 14.54, 16.17, 19.69, and 20.74.
- 7. A pharmaceutical composition comprising a therapeutically effective amount of the venlafaxine hydrochloride of claim 1 and a pharmaceutically acceptable carrier or diluent.
- 8. The pharmaceutical composition of claim 6, wherein the venlafaxine hydrochloride is substantially pure.
- 9. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition contains less than 1 % by weight of crystalline polymorphs of venlafaxine hydrochloride having an X-ray powder diffraction pattern substantially the same as that shown in FIG. 1, based upon 100% total weight of venlafaxine hydrochloride in the pharmaceutical composition.
- 10. The pharmaceutical composition of claim 6, wherein the composition comprises a plurality of spheroids comprising the venlafaxine hydrochloride.
- 11. A method of treating depression in a mammal in need thereof comprising administering to the mammal an anti-depressive effective amount of the venlafaxine hydrochloride of claim 1.
- 12. A method of treating generalized anxiety disorder in a mammal in need thereof comprising administering to the mammal an effective amount of the venlafaxine hydrochloride of claim 1.
- 13. A method of treating social anxiety disorder in a mammal in need thereof comprising administering to the mammal an effective amount of venlafaxine hydrochloride monohydrate of claim 1.
- 14. A method of treating post traumatic stress disorder in a mammal in need thereof comprising administering to the mammal an effective amount of venlafaxine hydrochloride monohydrate of claim 1.
- 15. A method of treating panic disorder in a mammal in need thereof comprising administering to the mammal an effective amount of venlafaxine hydrochloride monohydrate of claim 1.
- 16. A method of preventing relapse or recurrence of depression disorder in a mammal in need thereof comprising administering to the mammal an effective amount of venlafaxine hydrochloride monohydrate of claim 1.
- 17. A method of preparing anhydrous venlafaxine hydrochloride having an X-ray powder diffraction pattern substantially the same as that shown in FIG. 1, the method comprising heating form I or II of venlafaxine hydrochloride or a mixture thereof to at least about 197° C. for a time sufficient to form the anhydrous venlafaxine hydrochloride.
- 18. The method of claim 16, wherein the venlafaxine hydrochloride is heated to at least about 200° C.
- 19. The method of claim 16, wherein the venlafaxine hydrochloride is heated for at least about 60 minutes.
- 20. The method of claim 18, wherein the venlafaxine hydrochloride is heated for at least 150 minutes.
- 21. A method of preparing a crystalline polymorph of venlafaxine hydrochloride in substantially pure form, the method comprising:
(a) obtaining venlafaxine hydrochloride having an X-ray powder diffraction pattern substantially the same as that shown in FIG. 1 in substantially pure form; and (b) converting the venlafaxine hydrochloride of step (a) into a different crystalline polymorphic form.
- 22. The method of claim 20, wherein the venlafaxine hydrochloride formed in step (b) is Form I of venlafaxine hydrochloride.
- 23. The method of claim 20 wherein the venlafaxine hydrochloride formed in step (b) is Form II of venlafaxine hydrochloride.
Parent Case Info
[0001] This application claims priority from copending provisional application serial No. 60/335,822, filed on Dec. 5, 2001, the entire disclosure of which is hereby incorporated by reference.
Provisional Applications (1)
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Number |
Date |
Country |
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60335822 |
Dec 2001 |
US |