Compositions of R(+) and S(−) pramipexole and methods of using the same

• US 8,017,598 B2
• Filed: 05/16/2007
• Issued: 09/13/2011
• Est. Priority Date: 05/16/2006
• Status: Active Grant

• Current Assignee: Knopp Biosciences LLC
• Original Assignee: Knopp Neurosciences Inc. (Knopp Biosciences LLC)
• Inventors: Petzinger, Thomas Jr., Gribkoff, Valentin, Bozik, Michael E.
• Primary Examiner(s): Sznaidman; Marcos L
• Application Number:
  US11/749,497
• Publication Number:
  US 20080014259A1
• Time in Patent Office: 1,581 Days
• Field of Search: 514/183, 514/367
• US Class Current: 514/183
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/428 condensed with carbocyclic rings
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 39/06 Free radical scavengers or antioxidants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Compositions of predetermined amounts of R(+) pramipexole and S(−) pramipexole and methods of using the same, including for the treatment and prevention of Parkinson'"'"'s disease, are provided.

Claims

1. A method of treating Parkinson'"'"'s disease or the symptoms thereof comprising administering a solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole, wherein said therapeutically effective amount of R(+) pramipexole is from 100 milligrams to 3,000 milligrams and said amount of S(−

) pramipexole is from 1.5 milligrams to 4.5 milligrams.

2. The method of claim 1, wherein said therapeutically effective amount of R(+) pramipexole is from 300 milligrams to 1,500 milligrams.

3. The method of claim 1, wherein said therapeutically effective amount of R(+) pramipexole is from 500 milligrams to 1,000 milligrams.

4. The method of claim 1, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered from one to five times a day.

5. The method of claim 1, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered three times a day.

6. The method of claim 1, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is a single pharmaceutical composition.

7. The method of claim 1, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is more than one pharmaceutical composition.

8. The method of claim 1, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered once a day.

9. The method of claim 1, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered two times a day.

10. The method of claim 1, wherein said solid unit dose is selected from a tablet, a capsule, a lozenge, a pellet, a granule, a bead, a cachet, an implant, a suppository, a pessary, and a powder.

11. The method of claim 1, wherein said solid unit dose is a pharmaceutical composition selected from an immediate release pharmaceutical composition and a sustained release pharmaceutical composition.

39. The method of claim 1, wherein said solid unit dose is administered in a route selected from orally, topically, sublingually, bucally, intravaginally, and rectally.

41. The method of claim 1, wherein said amount of S(−

) pramipexole is 1.5 milligrams.

12. A method of treating Parkinson'"'"'s disease or the symptoms thereof comprising orally administering a unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole, wherein said therapeutically effective amount of R(+) pramipexole is from 100 milligrams to 3,000 milligrams and said amount of S(−

) pramipexole is from 1.5 milligrams to 4.5 milligrams.

13. The method of claim 12, wherein said therapeutically effective amount of R(+) pramipexole is from 300 milligrams to 1,500 milligrams.

14. The method of claim 12, wherein said therapeutically effective amount of R(+) pramipexole is from 500 milligrams to 1,000 milligrams.

15. The method of claim 12, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered from one to five times a day.

16. The method of claim 12, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered three times a day.

17. The method of claim 12, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is a single pharmaceutical composition.

18. The method of claim 12, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is more than one pharmaceutical composition.

19. The method of claim 12, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered once a day.

20. The method of claim 12, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered two times a day.

21. The method of claim 12, wherein said unit dose is selected from a tablet, a capsule, a lozenge, a pellet, a granule, a bead, a cachet, a powder, and a liquid.

22. The method of claim 12, wherein said unit dose is a pharmaceutical composition selected from an immediate release pharmaceutical composition and a sustained release pharmaceutical composition.

42. The method of claim 12, wherein said amount of S(−

) pramipexole is 1.5 milligrams.

23. A method of treating Parkinson'"'"'s disease or the symptoms thereof comprising administering a solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole, wherein said therapeutically effective amount of R(+) pramipexole is from 100 milligrams to 3,000 milligrams and said amount of S(−

) pramipexole is 4.5 milligrams.

24. The method of claim 23, wherein said therapeutically effective amount of R(+) pramipexole is from 300 milligrams to 1,500 milligrams.

25. The method of claim 23, wherein said therapeutically effective amount of R(+) pramipexole is from 500 milligrams to 1,000 milligrams.

26. The method of claim 23, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is a single pharmaceutical composition.

27. The method of claim 23, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is more than one pharmaceutical composition.

28. The method of claim 23, wherein said solid unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered once a day.

29. The method of claim 23, wherein said solid unit dose is selected from a tablet, a capsule, a lozenge, a pellet, a granule, a bead, a cachet, an implant, a suppository, a pessary, and a powder.

30. The method of claim 23, wherein said solid unit dose is a pharmaceutical composition selected from an immediate release pharmaceutical composition and a sustained release pharmaceutical composition.

40. The method of claim 23, wherein said solid unit dose is administered in a route selected from orally, topically, sublingually bucally, intravaginally, and rectally.

31. A method of treating Parkinson'"'"'s disease or the symptoms thereof comprising orally administering a unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole, wherein said therapeutically effective amount of R(+) pramipexole is from 100 milligrams to 3,000 milligrams and said amount of S(−

) pramipexole is 4.5 milligrams.

32. The method of claim 31, wherein said therapeutically effective amount of R(+) pramipexole is from 300 milligrams to 1,500 milligrams.

33. The method of claim 31, wherein said therapeutically effective amount of R(+) pramipexole is from 500 milligrams to 1,000 milligrams.

34. The method of claim 31, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is a single pharmaceutical composition.

35. The method of claim 31, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is more than one pharmaceutical composition.

36. The method of claim 31, wherein said unit dose of a therapeutically effective amount of R(+) pramipexole and an amount of S(−

) pramipexole is administered once a day.

37. The method of claim 31, wherein said unit dose is selected from a tablet, a capsule, a lozenge, a pellet, a granule, a bead, a cachet, a powder, and a liquid.

38. The method of claim 31, wherein said unit dose is a pharmaceutical composition selected from an immediate release pharmaceutical composition and a sustained release pharmaceutical composition.