COMPOSITIONS AND METHODS OF USING R(+) PRAMIPEXOLE

• US 20070259930A1
• Filed: 04/10/2007
• Published: 11/08/2007
• Est. Priority Date: 04/10/2006
• Status: Abandoned Application

• Current Assignee: Knopp Biosciences LLC
• Original Assignee: Knopp Neurosciences Inc. (Knopp Biosciences LLC)
• Inventors: Bozik, Michael, Petzinger, Thomas, Hebrank, Gregory
• Application Number:
  US11/733,642
• Publication Number:
  US 20070259930A1
• Time in Patent Office: Days
• US Class Current: 514/367
• CPC Class Codes: A61K 31/428 condensed with carbocyclic rings
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Pharmaceutical compositions of R(+) pramipexole and methods of using such compositions for the treatment or prevention of diseases associated with or related to mitochondrial dysfunction or increased oxidative stress are disclosed.

Claims

1. A method of treating age-related macular degeneration comprising administering a therapeutically effective amount of R(+) pramipexole.

2. The method of claim 1, wherein said therapeutically effective amount of R(+) pramipexole is administered in a pharmaceutical composition.

3. The method of claim 2, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 80% or greater.

4. The method of claim 2, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 90% or greater.

5. The method of claim 2, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 95% or greater.

6. The method of claim 2, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 99% or greater.

7. The method of claim 1, wherein said the therapeutically effective amount of R(+) pramipexole is from about 50 milligrams to about 5000 milligrams.

8. The method of claim 1, wherein the therapeutically effective amount of R(+) pramipexole is from about 100 milligrams to about 3000 milligrams.

9. The method of claim 1, wherein the therapeutically effective amount of R(+) pramipexole is from about 300 milligrams to about 1500 milligrams.

10. The method of claim 1, wherein the therapeutically effective amount of R(+) pramipexole is from about 500 milligrams to about 1000 milligrams.

11. The method of claim 2, wherein said pharmaceutical composition is suitable for oral administration.

12. The method of claim 2, wherein said pharmaceutical composition is a solid oral dosage form.

13. The method of claim 2, wherein said pharmaceutical composition is a tablet.

14. The method of claim 2, wherein said pharmaceutical composition is a capsule.

15. The method of claim 2, wherein said pharmaceutical composition is a suitable for ocular administration.

16. The method of claim 2, wherein said pharmaceutical composition further comprises S(−

) pramipexole in an amount that does not provide significant dopamine agonist activity.

17. The method of claim 2, wherein said pharmaceutical composition consists essentially of R(+) pramipexole.

18. The method of claim 2, wherein said pharmaceutical compositions further comprises an agent useful in treating age-related macular degeneration.

19. A method of treating of treating type II diabetes comprising administering a therapeutically effective amount of R(+) pramipexole.

20. The method of claim 19, wherein said therapeutically effective amount of R(+) pramipexole is administered in a pharmaceutical composition.

21. The method of claim 20, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 80% or greater.

22. The method of claim 20, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 90% or greater.

23. The method of claim 20, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 95% or greater.

24. The method of claim 20, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 99% or greater.

25. The method of claim 19, wherein said the therapeutically effective amount of R(+) pramipexole is from about 50 milligrams to about 5000 milligrams.

26. The method of claim 19, wherein the therapeutically effective amount of R(+) pramipexole is from about 100 milligrams to about 3000 milligrams.

27. The method of claim 19, wherein the therapeutically effective amount of R(+) pramipexole is from about 300 milligrams to about 1500 milligrams.

28. The method of claim 19, wherein the therapeutically effective amount of R(+) pramipexole is from about 500 milligrams to about 1000 milligrams.

29. The method of claim 20, wherein said pharmaceutical composition is suitable for oral administration.

30. The method of claim 20, wherein said pharmaceutical composition is a solid oral dosage form.

31. The method of claim 20, wherein said pharmaceutical composition is a tablet.

32. The method of claim 20, wherein said pharmaceutical composition is a capsule.

33. The method of claim 20, wherein said pharmaceutical composition further comprises S(−

) pramipexole in an amount that does not provide significant dopamine agonist activity.

34. The method of claim 20, wherein said pharmaceutical composition consists essentially of R(+) pramipexole.

35. The method of claim 20, wherein said pharmaceutical composition further comprises an agent useful in treating type II diabetes.

36. A method of treating of treating skin disorders comprising administering a therapeutically effective amount of R(+) pramipexole.

37. The method of claim 36, wherein said therapeutically effective amount of R(+) pramipexole is administered in a pharmaceutical composition.

38. The method of claim 37, wherein said pharmaceutical composition has a chiral purity of the R(+) enantiomer of pramipexole of 80% or greater.

39. The method of claim 37, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 90% or greater.

40. The method of claim 37, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 95% or grater.

41. The method of claim 37, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 99% or greater.

42. The method of claim 36, wherein said the therapeutically effective amount of R(+) pramipexole is from about 50 milligrams to about 5000 milligrams.

43. The method of claim 36, wherein the therapeutically effective amount of R(+) pramipexole is from about 100 milligrams to about 3000 milligrams.

44. The method of claim 36, wherein the therapeutically effective amount of R(+) pramipexole is from about 300 millgrams to about 1500 milligrams.

45. The method of claim 36, wherein the therapeutically effective amount of R(+) pramipexole is from about 500 milligrams to about 1000 milligrams.

46. The method of claim 37, wherein said pharmaceutical composition is suitable for oral administration.

47. The method of claim 37, wherein said pharmaceutical composition is a solid oral dosage form.

48. The method of claim 37, wherein said pharmaceutical composition is a tablet.

49. The method of claim 37, wherein said pharmaceutical competition is a capsule.

50. The method of claim 37, wherein said pharmaceutical composition is suitable for topical administration.

51. The method of claim 37, wherein said pharmaceutical composition further comprises S(−

) pramipexole in an amount that does not provide significant dopamine agonist activity.

52. The method of claim 37, wherein said pharmaceutical consists essentially of R(+) pramipexole.

53. The method of claim 37, wherein the pharmaceutical compositions further comprises an agent useful in treating skin disorders.

54. A method of treating of treating cardiovascular disorders comprising administering a therapeutically effective amount of R(+) pramipexole.

55. The method of claim 54, wherein said therapeutically effective amount of R(+) pramipexole is administered in a pharmaceutical composition.

56. The method of claim 55, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 80% or greater.

57. The method of claim 55, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 90% or greater.

58. The method of claim 55, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 95% or greater.

59. The method of claim 55, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 99% or greater.

60. The method of claim 54, wherein said the therapeutically effective amount of R(+) pramipexole is from about 50 milligrams to about 5000 milligrams.

61. The method of claim 54, wherein the therapeutically effective amount of R(+) pramipexole is from about 100 milligrams to about 3000 milligrams.

62. The method of claim 54, wherein the therapeutically effective amount of R(+) pramipexole is from about 300 milligrams to about 1500 milligrams.

63. The method of claim 54, wherein the therapeutically effective amount of R(+) pramipexole is from about 500 milligrams to about 1000 milligrams.

64. The method of claim 55, wherein said pharmaceutical composition is suitable for oral administration.

65. The method of claim 55, wherein said pharmaceutical composition is a solid oral dosage form.

66. The method of claim 55, wherein said pharmaceutical composition is a tablet.

67. The method of claim 55, wherein said pharmaceutical composition is a capsule.

68. The method of claim 55, wherein said pharmaceutical composition further comprises S(−

) pramipexole in an amount that does not provide significant dopamine agonist activity.

69. The method of claim 55, wherein said pharmaceutical composition consists essentially of R(+) pramipexole.

70. The method of claim 55, wherein the pharmaceutical compositions further comprises an agent useful in treating cardiovascular disorders.

71. A method of treating of treating inflammatory disorders comprising administering a therapeutically effective amount of R(+) pramipexole.

72. The method of claim 71, wherein said therapeutically effective amount of R(+) pramipexole is administered in a pharmaceutical composition.

73. The method of claim 72, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 80% or greater.

74. The method of claim 72, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 90% or greater.

75. The method of claim 72, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 95% or greater.

76. The method of claim 72, wherein said pharmaceutical composition has a chiral purity for the R(+) enantiomer of pramipexole of 99% or greater.

77. The method of claim 71, wherein said the therapeutically effective amount of R(+) pramipexole is from about 50 milligrams to about 5000 milligrams.

78. The method of claim 71, wherein the therapeutically effective amount of R(+) pramipexole is from about 100 milligrams to about 3000 milligrams.

79. The method of claim 71, wherein the therapeutically effective amount of R(+) pramipexole is from about 300 milligrams to about 1500 milligrams.

80. The method of claim 71, wherein the therapeutically effective amount of R(+) pramipexole is from about 500 milligrams to about 1000 milligrams.

81. The method of claim 72, wherein said pharmaceutical composition is suitable for oral administration.

82. The method of claim 72, wherein said pharmaceutical composition is a solid oral dosage form.

83. The method of claim 72, wherein said pharmaceutical composition is a tablet.

84. The method of claim 72, wherein said pharmaceutical composition further comprises S(−

) pramipexole in an amount that does not provide significant dopamine agonist activity.

85. The method of claim 72, wherein said pharmaceutical composition consists essentially of R(+) pramipexole.

86. The method of claim 72, wherein the pharmaceutical compositions further comprises an agent useful in treating inflammatory disorders.