Claims
- 1. A method of treating erectile dysfunction in a patient needing such treatment comprising the steps:
placing in the fossa navicularis of the patient an amount of a semi-solid vasoactive prostaglandin composition effective to increase blood flow in the glans penis; comprising
a vasoactive prostaglandin; a penetration enhancer; a polymer selected from the group consisting of polysaccharide gums and polyacrylic acid polymers; a lipophilic component that is selected from the group consisting of an aliphatic C1 to C8 alcohol, an aliphatic C8 to C30 ester, and a mixture thereof, an acidic buffer system; and providing at least one erotic stimulus selected from the group consisting of olfactory stimuli, visual stimuli, auditory stimuli and tactile stimuli.
- 2. The method in accordance with claim 1 wherein the vasoactive prostaglandin is selected from the group consisting of PGE1, PGA1, PGB1, PGF1α, 19-hydroxy-PGA1, 19-hydroxy-PGB1, PGE2, PGA2, PGB2, 19-hydroxy-PGA2, 19-hydroxy-PGB2, PGE3, PGF3 and mixtures thereof.
- 3. The method in accordance with claim 1 wherein the vasoactive prostaglandin is prostaglandin E1.
- 4. The method of claim 1 wherein the vasoactive prostaglandin is present in the amount of about 0.1 mg to about 0.5 mg.
- 5. The method of claim 1 wherein the vasoactive prostaglandin is present in the amount of about 0.2 mg to about 0.3 mg.
- 6. The method in accordance with claim 1 wherein the polymer is a polyacrylic acid polymer.
- 7. The method in accordance with claim 1 wherein the polymer is a shear-thinning polysaccharide gum.
- 8. The method in accordance with claim 7 wherein the shear-thinning polysaccharide gum is a galactomannan gum.
- 9. The method in accordance with claim 7, wherein the shear-thinning polysaccharide gum is a modified galactomannan gum.
- 10. The method in accordance with claim 9 wherein the modified galactomannan gum is a modified guar gum.
- 11. The method in accordance with claim 1 wherein the penetration enhancer is selected from the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, an (N-substituted)-alkanol alkanoate, pharmaceutically acceptable salts thereof and mixtures thereof.
- 12. The method in accordance with claim 11 wherein the penetration enhancer is dodecyl 2-(N,N-dimethylamino)-propionate.
- 13. The method in accordance with claim 1 wherein the lipophilic component comprises at least one aliphatic C8 to C30 ester.
- 14. The method in accordance with claim 1 wherein the lipophilic component comprises at least one glyceryl ester selected from the group consisting monoglycerides, diglycerides, triglycerides, and mixtures thereof.
- 15. The method in accordance with claim 1 wherein the lipophilic component comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof.
- 16. The method in accordance with claim 1 wherein the acidic buffer system provides a buffered pH value for said composition in the range of about 3 to about 6.5.
- 17. The method in accordance with claim 1 wherein the composition further comprises an emulsifier selected from the group consisting of sucrose esters, polyoxyethylene sorbitan esters, long chain alcohols, and glyceryl esters.
- 18. The method in accordance with claim 1 wherein the emulsifier comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof.
- 19. The method in accordance with claim 1 wherein the composition further comprises up to about 5 percent myrtenol, based on the total weight of the composition.
- 20. The method in accordance with claim 1 wherein the composition further comprises a preservative.
- 21. The method in accordance with claim 1 wherein the composition further comprises a topical anesthetic.
- 22. The method in accordance with claim 1 wherein the composition further comprises a fragrance.
- 23. A method of improving microcirculation in the glans penis in a patient needing such treatment comprising:
placing in the fossa navicularis of the patient an amount of a semi-solid vasoactive prostaglandin composition effective to increase blood flow in the glans penis; comprising
a vasoactive prostaglandin; a penetration enhancer that is chosen from the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, an (N-substituted)-alkanol alkanoate, pharmaceutically acceptable salts thereof and a mixture thereof; a polysaccharide gum; a lipophilic component that is a selected from the group consisting of an aliphatic C1 to C8 alcohol, an aliphatic C8 to C30 ester, and a mixture thereof; and an acidic buffer system.
- 24. The method in accordance with claim 23 wherein the vasoactive prostaglandin is selected from the group consisting of PGE1, PGA1, PGB1, PGF1α, 19-hydroxy-PGA1, 19-hydroxy-PGB1, PGE2, PGA2, PGB2, 19-hydroxy-PGA2, 19-hydroxy-PGB2, PGE3, PGF3 and mixtures thereof.
- 25. The method in accordance with claim 23 wherein the vasoactive prostaglandin is prostaglandin E1.
- 26. The method in accordance with claim 23 wherein the polysaccharide gum is a shear-thinning polysaccharide gum.
- 27. The method in accordance with claim 23 wherein the shear-thinning polysaccharide gum is a galactomannan gum.
- 28. The method in accordance with claim 26 wherein the shear-thinning polysaccharide gum is a modified galactomannan gum.
- 29. The method in accordance with claim 28 wherein the modified galactomannan gum is a modified guar gum.
- 30. The method in accordance with claim 23 wherein the penetration enhancer is dodecyl 2-(N,N-dimethylamino)-propionate.
- 31. The method in accordance with claim 23 wherein the lipophilic component comprises at least one aliphatic C8 to C30 ester.
- 32. The method in accordance with claim 23 wherein the lipophilic component comprises at least one glyceryl ester selected from the group consisting monoglycerides, diglycerides, triglycerides, and mixtures thereof.
- 33. The method in accordance with claim 23 wherein the lipophilic component comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof.
- 34. The method in accordance with claim 23 wherein the acidic buffer system provides a buffered pH value for said composition in the range of about 3 to about 6.5.
- 35. The method in accordance with claim 23 wherein the composition further comprises an emulsifier selected from the group consisting of sucrose esters, polyoxyethylene sorbitan esters, long chain alcohols, and glyceryl esters.
- 36. The method in accordance with claim 23 wherein the emulsifier comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof.
- 37. The method in accordance with claim 23 wherein the composition further comprises a fragrance.
- 38. The method in accordance with claim 23 wherein the composition further comprises up to about 5 percent myrtenol, based on the total weight of the composition.
- 39. The method in accordance with claim 23 wherein the composition further comprises a preservative.
- 40. The method in accordance with claim 23 wherein the composition further comprises a topical anesthetic.
- 41. A method of treating erectile dysfunction in a patient needing such treatment comprising the steps:
placing in the fossa navicularis of the patient an amount of a semi-solid vasoactive prostaglandin composition effective to increase blood microcirculation in the glans penis; comprising
a vasoactive prostaglandin; a penetration enhancer that is selected from the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, an (N-substituted)-alkanol alkanoate, pharmaceutically acceptable salts thereof and a mixture thereof; a polyacrylic acid polymer; a lipophilic component which is selected from the group consisting of an aliphatic C1 to C8 alcohol, an aliphatic C8 to C30 ester, and a mixture thereof, an acidic buffer system; and providing at least one erotic stimulus selected from the group consisting of olfactory stimuli, visual stimuli, auditory stimuli and tactile stimuli.
- 42. The method in accordance with claim 41 wherein the vasoactive prostaglandin is selected from the group consisting of PGE1, PGA1, PGB1, PGF1α, 19-hydroxy-PGA1, 19-hydroxy-PGB1, PGE2, PGA2, PGB2, 19-hydroxy-PGA2, 19-hydroxy-PGB2, PGE3, PGF3 and mixtures thereof.
- 43. The method in accordance with claim 41 wherein the vasoactive prostaglandin is prostaglandin E1.
- 44. The method in accordance with claim 41 wherein the polyacrylic acid polymer is a shear-thinning polyacrylic acid polymer.
- 45. The method in accordance with claim 41 wherein the penetration enhancer is dodecyl 2-(N,N-dimethylamino)-propionate.
- 46. The method in accordance with claim 41 wherein the lipophilic component comprises at least one aliphatic C8 to C30 ester.
- 47. The method in accordance with claim 41 wherein the lipophilic component comprises at least one glyceryl ester selected from the group consisting monoglycerides, diglycerides, triglycerides, and mixtures thereof.
- 48. The method in accordance with claim 41 wherein the lipophilic component comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof.
- 49. The method in accordance with claim 41 wherein the acidic buffer system provides a buffered pH value for said composition in the range of about 3 to about 6.5.
- 50. The method in accordance with claim 41 wherein the composition further comprises an emulsifier selected from the group consisting of sucrose esters, polyoxyethylene sorbitan esters, long chain alcohols, and glyceryl esters.
- 51. The method in accordance with claim 41 wherein the emulsifier comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof.
- 52. The method in accordance with claim 41 wherein the composition further comprises up to about 5 percent myrtenol, based on the total weight of the composition.
- 53. The method in accordance with claim 41 wherein the composition further comprises a preservative.
- 54. The method in accordance with claim 41 wherein the composition further comprises a topical anesthetic.
- 55. A method of producing tumescence of the glans penis in a patient needing such treatment comprising the steps of:
placing in the fossa navicularis of the patient an amount of a semi-solid vasoactive prostaglandin composition effective to increase blood microcirculation in the glans penis, the composition comprising
a vasoactive prostaglandin; a penetration enhancer that is selected from the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, an (N-substituted)-alkanol alkanoate, pharmaceutically acceptable salts thereof and a mixture thereof; a polymer selected from the group consisting of polysaccharide gums and polyacrylic acid polymers; a lipophilic component which is selected from the group consisting of an aliphatic C1 to C8 alcohol, an aliphatic C8 to C30 ester, and a mixture thereof, and an acidic buffer system; thereby producing tumescence of the glans penis.
- 56. The method of claim 55 further producing tumescence of the corpora cavernosa.
- 57. A method of treating erectile dysfunction in a patient needing such treatment comprising the steps of:
placing in the fossa navicularis of the patient an amount of a semi-solid vasoactive prostaglandin composition effective to increase blood microcirculation in the glans penis, the composition comprising
about 0.05 mg to about 0.8 mg of prostaglandin E1; a penetration enhancer that is selected from the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, an (N-substituted)-alkanol alkanoate, pharmaceutically acceptable salts thereof and a mixture thereof, a polymer selected from the group consisting of polysaccharide gums and polyacrylic acid polymers; a lipophilic component that is selected from the group consisting of an aliphatic C1 to C8 alcohol, an aliphatic C8 to C30 ester, and a mixture thereof, an acidic buffer system; and providing at least one erotic stimulus selected from the group consisting of olfactory stimuli, visual stimuli, auditory stimuli and tactile stimuli.
- 58. The method of claim 57 wherein prostaglandin is present in the amount of about 0.1 mg to about 0.5 mg.
- 59. The method of claim 57 wherein prostaglandin E1 is present in the amount of about 0.2 mg to about 0.3 mg.
- 60. An article of manufacture comprising an unit dose of a composition comprising a vasoactive prostaglandin, a penetration enhancer, a polymer selected from the group consisting of polysaccharide gums and polyacrylic acid polymers, a lipophilic component and an acidic buffer in a suitable container in combination with labeling instructions.
- 61. The article of manufacture of claim 60 wherein the vasoactive prostaglandin is prostaglandin E1 present in the amount of about 0.05 mg to about 0.8 mg.
- 62. The article of manufacture of claim 60 wherein the vasoactive prostaglandin is prostaglandin E1 present in the amount of about 0.1 mg to about 0.5 mg.
- 63. The article of manufacture of claim 60 wherein the vasoactive prostaglandin is prostaglandin E1 present in the amount of about 0.2 mg to about 0.3 mg.
- 64. A composition comprising:
an amount of a vasoactive prostaglandin effective to increase blood flow in the glans penis; a piperazinyl quinazoline antihypertensive; a penetration enhancer; a polymer selected from the group consisting of polysaccharide gums and polyacrylic acid polymers; a lipophilic component selected from the group consisting of an aliphatic C1 to C8 alcohol, an aliphatic C8 to C30 ester, and a mixture thereof; and an acidic buffer system.
- 65. The composition of claim 64 wherein the piperazinyl quinazoline antihypertensive is selected from the group consisting of alfuzosin, bunazosin, doxazosin, prazosin, terazosin, trimazosin and mixtures thereof.
- 66. The composition of claim 64 wherein the vasoactive prostaglandin is prostaglandin E1 present in the amount of about 0.05 mg to about 0.8 mg.
- 67. The composition of claim 64 wherein the vasoactive prostaglandin is prostaglandin E1 present in the amount of about 0.1 mg to about 0.5 mg.
- 68. The composition of claim 64 wherein the vasoactive prostaglandin is prostaglandin E1 present in the amount of about 0.2 mg to about 0.3 mg.
- 69. The composition of claim 64 wherein the piperazinyl quinazoline antihypertensive is present in the amount of about 0.1 mg to about 2.0 mg
CROSS REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S. Provisional Application No. 60/357,282, filed Feb. 15, 2002. The entire contents of the above application are incorporated herein by reference in entirety.
Provisional Applications (1)
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Number |
Date |
Country |
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60357282 |
Feb 2002 |
US |