Device and method for the treatment of erectile dysfunction

• US 7,087,240 B1
• Filed: 06/25/1999
• Issued: 08/08/2006
• Est. Priority Date: 06/25/1998
• Status: Expired due to Fees

• Current Assignee: Thallium Holding Company, LLC
• Original Assignee: Lavipharm Laboratories Inc (Lavipharm SA)
• Inventors: Fotinos, Spiros
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): HAWES, PILI ASABI
• Application Number:
  US09/340,338
• Time in Patent Office: 2,601 Days
• Field of Search: 424/448, 424/449, 424/484, 424/443, 424/444, 424/445, 424/447, 424/400, 424/486
• US Class Current: 424/449
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/7053 obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene

Abstract

Devices and methods for treatment of erectile dysfunction and methods of manufacture and of use are provided. The devices include filmogenic material, a therapeutic agent, a permeation enhancer, and other ingredients. An embodiment of the device includes a backing and a release liner.

Claims

1. A delivery device for treatment of erectile dysfunction in a patient, comprising a disk, wherein the disk is made of a mixture of materials comprising a filmogenic polymer and an effective dose of a therapeutic agent suitable for treating erectile dysfunction, wherein the device does not comprise a backing layer, wherein the device does not comprise a release liner, and wherein the therapeutic agent is misoprostol.

2. The delivery device of claim 1, wherein the filmogenic polymer is selected from the group consisting of a synthetic polymer, a semi-synthetic polymer, and a naturally occurring polymer.

3. The delivery device of claim 1, wherein the disk further comprises a plasticizer in an amount of less than 30 wt %.

4. The delivery device of claim 3, wherein the plasticizer is a polyethylene glycol (PEG).

5. The delivery device of claim 4, wherein the polyethylene glycol is PEG 400.

6. The delivery device of claim 1, wherein the delivery device is a transdermal device.

7. The delivery device of claim 1, wherein the delivery device is a transmucosal device.

8. A delivery device for treatment of erectile dysfunction in a patient, comprising a disk, wherein the disk is made of a mixture of materials comprising a filmogenic polymer and an effective dose of a therapeutic agent suitable for treating erectile dysfunction, wherein the device does not comprise a backing layer, wherein the device does not comprise a release liner, wherein the filmogenic polymer is selected from the group consisting of a synthetic polymer, a semi-synthetic polymer, and a naturally occurring polymer, and wherein the disk comprises 70 to 95 wt % filmogenic polymer.

9. The delivery device of claim 8, wherein the filmogenic polymer is polyvinyl pyrrolidone.

10. The delivery device of claim 8, wherein the filmogenic polymer is gliadin.

11. The delivery device of claim 8, wherein the therapeutic agent is selected from the group consisting of a vasodilator, a smooth muscle relaxant, an anti-depressant, a parasympathetic stimulator, a renin-angiotensin system inhibitor, a local anesthetic, an ∝

-blocker, and a calcium channel blocker.

12. The delivery device of claim 8, wherein the therapeutic agent is selected from the group consisting of prostaglandin, a testosterone, a yohimbine, a pentoxifylline, a trazodone, an apomorphine, a sildenafil, aminoxidil, a misoprostol, a papaverine, a nitroglycerin, a phentolamine, a moxisylyte, a linsidomine, a linear peptide, a cyclic peptide, and a pyridylguanidine compound.

13. The delivery device of claim 8, wherein the therapeutic agent is a prostaglandin.

14. The delivery device of claim 13, wherein the therapeutic agent is prostaglandin E1.

15. A delivery device for the treatment of erectile dysfunction in a patient, comprising a disk, wherein the disk is made or a mixture of materials comprising a filmogenic polymer and an effective dose of a therapeutic agent suitable for treating erectile dysfunction, wherein the disk comprises 70 to 95 wt % filmogenic polymer.

16. The delivery device of claim 15, wherein the filmogenic polymer is selected from the group consisting of a synthetic polymer, a semi-synthetic polymer, and a naturally occurring polymer.

17. The delivery device of claim 15, wherein the filmogenic polymer is polyvinyl pyrrolidone.

18. The delivery device of claim 15, wherein the therapeutic agent is misoprostol.

19. The delivery device or claim 15, wherein the therapeutic agent is a prostaglandin.

20. The delivery device of claim 19, wherein the prostaglandin is prostaglandin E1.

21. The delivery device of claim 15, wherein the mixture of materials further comprises a plasticizer in an amount of less than 30 wt %.

22. The delivery device of claim 21, wherein the plasticizer is a polyethylene glycol (PEG).

23. The delivery device of claim 22, wherein the polyethylene glycol is PEG 400.

24. The delivery device of claim 15, wherein the delivery device is a transdermal device.

25. The delivery device of claim 15, wherein the delivery device is a transmucosal device.

26. The delivery device of claim 15, wherein the therapeutic agent is selected from the group consisting of a vasodilator, a smooth muscle relaxant, an anti-depressant, a parasympathetic stimulator, a renin-angiotensin system inhibitor, a local anesthetic, an ∝

-blocker, and a calcium channel blocker.

27. The delivery device of claim 15, wherein the therapeutic agent is selected from the group consisting of prostaglandin, a testosterone, a yohimbine, a pentoxifylline, a trazodone, an apomorphine, a sildenafil, aminoxidil, a misoprostol, a papaverine, a nitroglycerin, a phentolamine, a moxisylyte, a linsidomine, a linear peptide, a cyclic peptide, and a pyridylguanidine compound.

28. A delivery device for the treatment of erectile dysfunction in a patient, comprising a disk, wherein the disk is made of a mixture of materials comprising 90 to 95 wt % polyvinyl pyrrolidone and an effective dose of a therapeutic agent suitable for treating erectile dysfunction.

29. The delivery device of claim 28, wherein the therapeutic agent is selected from the group consisting of a vasodilator, a smooth muscle relaxant, an anti-depressant, a parasympathetic stimulator, a renin-angiotensin system inhibitor, a local anesthetic, an ∝

-blocker, and a calcium channel blocker.

30. The delivery device of claim 28, wherein the therapeutic agent is selected from the group consisting of prostaglandin, a testosterone, a yohimbine, a pentoxifylline, a trazodone, an apomorphine, a sildenafil, aminoxidil, a misoprostol, a papaverine, a nitroglycerin, a phentolamine, a moxisylyte, a linsidomine, a linear peptide, a cyclic peptide, and a pyridylguanidine compound.

31. The delivery device of claim 28, wherein the therapeutic agent is misoprostol.

32. The delivery device of claim 28, wherein the therapeutic agent is a prostaglandin.

33. The delivery device of claim 32, wherein the prostaglandin is prostaglandin E1.

34. The delivery device of claim 28, wherein the mixture of materials further comprises a plasticizer.

35. The delivery device of claim 34, wherein the plasticizer is a polyethylene glycol (PEG).

36. The delivery device of claim 35, wherein the polyethylene glycol is PEG 400.

37. The delivery device of claim 28, wherein the delivery device is a transdermal device.

38. The delivery device of claim 28, wherein the delivery device is a transmucosal device.

39. A delivery device for the treatment of erectile dysfunction in a patient, comprising a disk, wherein the disk is made of a mixture of materials comprising 90 to 95 wt % polyvinyl pyrrolidone, an effective dose of a therapeutic agent suitable for treating erectile dysfunction and a plasticizer, wherein the device does not comprise a backing layer and wherein the device does not comprise a release liner.

40. The delivery device of claim 39, wherein the therapeutic agent is misoprostol and the plasticizer is PEG 400.

41. The delivery device of claim 39, wherein the therapeutic agent is a prostaglandin.

42. The delivery device of claim 41, wherein the prostaglandin is prostaglandin E1.

43. The delivery device of claim 39, wherein the therapeutic agent is selected from the group consisting of prostaglandin, a testosterone, a yohimbine, a pentoxifylline, a trazodone, an apomorphine, a sildenafil, aminoxidil, a misoprostol, a papaverine, a nitroglycerin, a phentolamine, a moxisylyte, a linsidomine, a linear peptide, a cyclic peptide, and a pyridylguanidine compound.

44. The delivery device of claim 39, wherein the therapeutic agent is selected from the group consisting of a vasodilator, a smooth muscle relaxant, an anti-depressant, a parasympathetic stimulator, a renin-angiotensin system inhibitor, a local anesthetic, an ∝

-blocker, and a calcium channel blocker.

45. A delivery device for the treatment of erectile dysfunction in a patient, comprising a disk;

wherein the disk is made of a mixture of materials comprising 70 to 95 wt % filmogenic polymer, an effective dose of a therapeutic agent suitable for treating erectile dysfunction, and at least one additive selected from the group consisting of a stabilizer, a solubilizer, and enhancer and a plasticizer.

46. The delivery device of claim 45, wherein the at least one additive comprises an enhancer selected from the group consisting of a glycolipid, a non-esterified fatty acid, an aliphatic alcohol, a fatty acid ester of an aliphatic alcohol, a cyclohexanol, a fatty acid ester of glycerol, a glycol, an aliphatic alcohol ether of a glycol, and a surfactant.

47. The delivery device of claim 45, wherein the therapeutic agent is a prostaglandin.

48. The delivery device of claim 47, wherein the prostaglandin is prostaglandin E1.

49. The delivery device of claim 47, wherein the at least one additive comprises a plasticizer.

50. The delivery device of claim 49, wherein the plasticizer is a polyethylene glycol.

51. The delivery device of claim 45, wherein the filmogenic polymer is selected from the group consisting of a synthetic polymer, a semi-synthetic polymer, and a naturally occurring polymer.

52. The delivery device of claim 45, wherein the therapeutic agent is selected from the group consisting of prostaglandin, a testosterone, a yohimbine, a pentoxifylline, a trazodone, an apomorphine, a sildenafil, a minoxidil, a misoprostol, a papaverine, a nitroglycerin, a phentolamine, a moxisylyte, a linsidomine, a linear peptide, a cyclic peptide, and a pyridylguanidine compound.

53. The delivery device of claim 45, wherein the therapeutic agent is selected from the group consisting of a vasodilator, a smooth muscle relaxant, an anti-depressant, a parasympathetic stimulator, a renin-angiotensin system inhibitor, a local anesthetic, an ∝

-blocker, and a calcium channel blocker.

54. A method of treating erectile dysfunction, comprising:

selecting a device comprising a disk, wherein the disk is made of a mixture of materials comprising a filmogenic polymer and an effective dose of a therapeutic agent suitable for treating erectile dysfunction, wherein the disk comprises 70 to 95 wt % filmogenic polymer, wherein the device does not comprise a backing layer and wherein the device does not comprise a release liner;

wetting a penile surface; and

placing the device in contact with the wetted surface, thereby wetting the disk and delivering the at least one therapeutic agent to the penile surface in a time period that is desirable to obtain a positive response.

55. The method according to claim 54, wherein the therapeutic agent is selected from the group consisting of a vasodilator, a smooth muscle relaxant, an anti-depressant, a parasympathetic stimulator, a renin-angiotensin system inhibitor, a local anesthetic, an ∝

-blocker, and a calcium channel blocker.

56. The method according to claim 54, wherein the therapeutic agent is selected from the group consisting of a prostaglandin, a testosterone, a yohimbine, a pentoxifylline, a trazodone, an apomorphine, a sildenafil, aminoxidil, a misoprostol, a papaverine, a nitroglycerin, a phentolamine, a moxisylyte, a linsidomine, a linear peptide, a cyclic peptide, and a pyridylguanidine compound.

57. The method according to claim 54, wherein the therapeutic agent is present in a range of 0.1–

15 wt %.

58. The method according to claim 56, wherein the therapeutic agent is misoprostol.

59. The method according to claim 54, wherein the plasticizer is present in an amount that is less than 30 wt %.

60. The method according to claim 59, wherein the plasticizer is a polyethylene glycol (PEG).

61. The method according to claim 60, wherein the polyethylene glycol is PEG 400.

62. The method according to claim 54, wherein the filmogenic polymer is a synthetic polymer.

63. The method according to claim 62, wherein the synthetic polymer is polyvinyl pyrrolidone.

64. The delivery device of claim 54, wherein the filmogenic polymer is a naturally occurring polymer.

65. The method according to claim 64, wherein the filmogenic polymer is a plant protein.

66. The method according to claim 65, wherein the plant protein is a prolamine.

67. The method according to claim 66, wherein the prolamine is a gliadin.

68. The method according to claim 54, wherein the time period is 5–

100 minutes.

69. The method according to claim 68, wherein the time period is 30–

60 minutes.

70. The method according to claim 54, wherein the penile surface is selected from the group consisting of (a) the shaft, (b) the glans and (c) both the shaft and the glans.

71. A method of treating erectile dysfunction, comprising:

selecting a device comprising a disk, wherein the disk is made of a mixture of materials, wherein the disk is made of a mixture of materials comprising 90 to 95 wt % polyvinyl pyrrolidone, polyethylene glycol and an effective dose of misoprostol suitable for treating erectile dysfunction;

wetting a penile surface; and

placing the device in contact with the wetted surface, thereby wetting the disk and delivering the at least one therapeutic agent to the penile surface in a time period that is desirable to obtain a positive response.

72. The method according to claim 71, wherein the penile surface is selected from the group consisting of (a) the shaft, (b) the glans and (c) both the shaft and the glans.