Device and method for the treatment of erectile dysfunction
View Patent ↗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.
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.