Claims
- 1. A venlafaxine maleate compound.
- 2. The venlafaxine maleate compound according to claim 1, which is crystalline venlafaxine maleate.
- 3. The venlafaxine maleate compound according to claim 2, which is crystalline venlafaxine hydrogenmaleate.
- 4. The venlafaxine maleate compound according to claim 3, which is crystalline venlafaxine maleate anhydrate.
- 5. The venlafaxine maleate compound according to claim 1, wherein said venlafaxine is pure or substantially pure (+) or (−) venlafaxine enantiomer.
- 6. A pharmaceutical composition comprising a venlafaxine maleate compound and a pharmaceutically acceptable excipient.
- 7. The pharmaceutical composition according to claim 6, wherein said excipient is selected from the group consisting of calcium phosphates, microcrystalline cellulose, cellulose derivatives, polyvinylpyrrolidones, sugars, and combinations thereof.
- 8. The composition according to claim 6, wherein said composition is a unit dosage form and said venlafaxine maleate is contained in an amount between 30 mg and 300 mg, calculated on venlafaxine free base.
- 9. The pharmaceutical composition according to claim 6, wherein said composition is in the form of a tablet.
- 10. The pharmaceutical composition according to claim 9, wherein said composition is an extended release composition.
- 11. The composition according to claim 10, wherein said composition is a hydrogel tablet.
- 12. The composition according to claim 11, wherein said composition is a once daily dose tablet.
- 13. The composition according to claim 9, wherein said tablet comprises hydroxypropylmethyl cellulose and venlafaxine maleate.
- 14. The composition according to claim 12, wherein said tablet comprises hydroxypropylmethyl cellulose and venlafaxine maleate.
- 15. The composition according to claim 12, wherein said composition has a dissolution profile such that less than 30% of said venlafaxine maleate is released from said composition in 2 hours using either purified water or SGF at 37° C. with stirring at 100 r.p.m. in a basket apparatus.
- 16. The composition according to claim 15, wherein said composition has a release profile that satisfies the following
- 17. The composition according to claim 6, wherein said composition is in the form of pellets.
- 18. The composition according to claim 17, wherein said composition is a once daily dose capsule.
- 19. The composition according to claim 17, wherein said pellets have a dissolution profile that satisfies the following criteria:
- 20. A method for treating a venlafaxine-treatable disease or condition, which comprise administering to a patient in need thereof an effective amount of a venlafaxine maleate compound.
- 21. The method according to claim 20, wherein said venlafaxine maleate compound is administered in the form of a tablet.
- 22. The method according to claim 21, wherein said patient suffers from depression and said effective amount of venlafaxine maleate is an antidepressant amount.
- 23. The method according to claim 20, wherein said venlafaxine maleate compound is administered once daily.
- 24. The method according to claim 23, wherein said venlafaxine maleate compound is administered orally in the form of one or two tablets once daily.
- 25. A process for making venlafaxine maleate comprising contacting a venlafaxine substrate and maleate substrate in a suitable solvent, optionally followed by preparation of venlafaxine maleate from the solvent.
- 26. A low water-soluble venlafaxine salt other than venlafaxine besylate.
- 27. The low-water-soluble venlafaxine salt according to claim 26 in the form of a precipitate.
- 28. The low water-soluble venlafaxine salt according to claim 26 that has a water solubility of not more than 380 mg/ml at ambient conditions.
- 29. A pharmaceutical composition comprising a low water-soluble venlafaxine salt compound, other than venlafaxine besylate, and a hydrophilic matrix material.
- 30. The pharmaceutical composition according to claim 29, wherein said composition is in the form of a hydrogel tablet.
- 31. The pharmaceutical composition according to claim 30, wherein said tablet has a release profile that satisfies the following
- 32. The composition according to claim 30, wherein said composition is a once daily dose tablet.
- 33. The composition according to claim 30, wherein said tablet comprises hydroxypropylmethyl cellulose, microcrystalline cellulose, and said low water-soluble venlafaxine salt.
- 34. A method for treating a venlafaxine-treatable disease or condition, which comprises administering to a patient in need thereof an effective amount of the pharmaceutical composition according to claim 29.
- 35. The method according to claim 34, wherein said pharmaceutical composition is administered in the form of a tablet.
- 36. The method according to claim 34, wherein said patient suffers from depression and said effective amount is an antidepressant amount.
- 37. The method according to claim 34, wherein said pharmaceutical composition is administered once daily.
- 38. The method according to claim 37, wherein said pharmaceutical composition is administered orally in the form of one or two tablets once daily.
Parent Case Info
[0001] This application claims the benefit of priority under 35 U.S.C. §119 from U.S. provisional application serial No. 60/367,704, filed Mar. 28, 2002 and from U.S. provisional application serial No. 60/372,447, filed Apr. 16, 2002; the entire contents of each application being incorporated herein by reference.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60367704 |
Mar 2002 |
US |
|
60372447 |
Apr 2002 |
US |