Claims
- 1. A method of treating erectile dysfunction in a patient suffering from a co-morbid condition comprising the step of:
placing an erection-inducing amount of a semi-solid composition in the fossa navicularis of the patient, the semi-solid composition comprising:
a vasoactive prostaglandin; a penetration enhancer; a polymeric thickener selected from the group consisting of a polysaccharide gum and a polyacrylic acid polymer; 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.
- 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 in accordance with claim 1 wherein the vasoactive prostaglandin is present in the amount of 0.001 weight percent to about 1 weight percent, based on the total weight of the composition.
- 5. The method in accordance with claim 1 wherein the vasoactive prostaglandin is present in the amount of about 0.07 weight percent to about 0.4 weight percent, based on the total weight of the composition.
- 6. The method of claim 1 wherein the semi-solid composition is packaged as a unit dose and the vasoactive prostaglandin is present in the amount of about 0.05 mg to about 0.8 mg per unit dose.
- 7. The method in accordance with claim 1 wherein the polymeric thickener is a polyacrylic acid polymer.
- 8. The method in accordance with claim 1 wherein the polymeric thickener is a shear-thinning polysaccharide gum.
- 9. The method in accordance with claim 8 wherein the shear-thinning polysaccharide gum is a galactomannan gum.
- 10. The method in accordance with claim 8 wherein the shear-thinning polysaccharide gum is a modified galactomannan gum.
- 11. The method in accordance with claim 10 wherein the modified galactomannan gum is a modified guar gum.
- 12. The method in accordance with claim 1 wherein the composition has a viscosity of about 5,000 cps to about 20,000 cps.
- 13. The method in accordance with claim 1 wherein the composition has a viscosity of about 7,000 cps to about 13,000 cps.
- 14. 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 alkyl-2-(N,N-disubstituted amino)-alkanoate, an (N-substituted amino)-alkanol alkanoate, an (N,N-disubstituted amino)-alkanol alkanoate, pharmaceutically acceptable salts thereof and mixtures thereof.
- 15. The method in accordance with claim 1 wherein the penetration enhancer is dodecyl 2-(N,N-dimethylamino)-propionate hydrochloride.
- 16. The method in accordance with claim 1 wherein the lipophilic component comprises at least one aliphatic C8 to C30 ester.
- 17. 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.
- 18. 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.
- 19. 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 7.4.
- 20. 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.
- 21. 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.
- 22. 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.
- 23. 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.
- 24. The method in accordance with claim 1 wherein the composition further comprises a preservative.
- 25. The method in accordance with claim 1 wherein the composition further comprises a topical anesthetic.
- 26. The method in accordance with claim 1 wherein the composition further comprises a fragrance.
- 27. The method in accordance with claim 1 further comprising administering the composition on demand.
- 28. The method in accordance with claim 1 further comprising administering the composition about 5 minutes to about 15 minutes before sexual intercourse.
- 29. The method in accordance with claim 1 further comprising administering the semi-solid prostaglandin E1 composition at least twice a week.
- 30. The method in accordance with claim 1 further comprising administering the semi-solid prostaglandin E1 composition every other day.
- 31. The method in accordance with claim 1 further comprising administering the semi-solid prostaglandin E1 composition daily.
- 32. The method in accordance with claim 3 wherein the composition is packaged as a unit dose and prostaglandin E1 is present in the amount of about 0.1 mg to about 0.5 mg per unit dose.
- 33. The method in accordance with claim 3 wherein the composition is packaged as a unit dose and prostaglandin E1 is present in the amount of about 0.1 mg to about 0.3 mg per unit dose.
- 34. The method in accordance with claim 3 wherein the composition comprises:
about 0.001 weight percent to about 1 weight percent prostaglandin E1; about 0.5 weight percent to about 10 weight percent dodecyl 2-(N,N dimethylamino)-propionate hydrochloride; about 0.5 weight percent to about 10 weight percent ethyl alcohol; about 0.5 weight percent to about 10 weight percent ethyl laurate; and about 0.01 weight percent to about 5 weight percent modified guar gum, based on the total weight of the composition.
- 35. A method of treating erectile dysfunction in a patient suffering from the co-morbid condition of diabetes mellitus comprising the step of placing in the fossa navicularis of the patient an erection-inducing amount of a semi-solid prostaglandin E1 composition comprising:
a penetration enhancer; a shear-thinning polymeric thickener selected from the group consisting of a polysaccharide gum and a polyacrylic acid polymer; a 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; and an acidic buffer system.
- 36. A method of treating erectile dysfunction in a patient suffering from the co-morbid condition of hypertension comprising the step of placing in the fossa navicularis of the patient an erection-inducing amount of a semi-solid prostaglandin E1 composition comprising:
a penetration enhancer; a shear-thinning polymeric thickener selected from the group consisting of a polysaccharide gum and a polyacrylic acid polymer; a 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; and an acidic buffer system.
- 37. A method of treating erectile dysfunction in a patient suffering from the co-morbid condition of cardiac disease comprising the step of placing in the fossa navicularis of the patient an erection-inducing amount of a semi-solid prostaglandin E1 composition comprising:
a penetration enhancer; a shear-thinning polymeric thickener selected from the group consisting of a polysaccharide gum and a polyacrylic acid polymer; a 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; and an acidic buffer system.
- 38. A method of treating erectile dysfunction in a patient having the co-morbid condition of recovering from prostatectomy comprising the step of placing in the fossa navicularis of the patient an erection-inducing amount of a semi-solid prostaglandin E1 composition comprising:
a penetration enhancer; a shear-thinning polymeric thickener selected from the group consisting of a polysaccharide gum and a polyacrylic acid polymer; a 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; and an acidic buffer system.
- 39. A method of treating a patient suffering from erectile dysfunction unresponsive to oral phosphodiesterase-5 inhibitor therapy comprising the step of placing in the fossa navicularis of the patient an erection-inducing amount of a semi-solid prostaglandin E1 composition comprising:
a penetration enhancer; a shear-thinning polymeric thickener selected from the group consisting of a polysaccharide gum and a polyacrylic acid polymer; a 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; and an acidic buffer system.
- 40. The use of prostaglandin E1;
a penetration enhancer selected from the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, an alkyl-2-(N,N-disubstituted amino)-alkanoate, an (N-substituted amino)-alkanol alkanoate, an (N,N-disubstituted amino)-alkanol alkanoate, pharmaceutically acceptable salts thereof and mixtures thereof; a polymeric thickener selected from the group consisting of a polysaccharide gum and a polyacrylic acid polymer; 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 for the preparation of a pharmaceutical composition for treating erectile dysfunction in a patient suffering from a co-morbid condition including at least one of diabetes mellitus, hypertension, cardiac disease, history of prostatectomy or erectile dysfunction unresponsive to oral phosphodiesterase-5 inhibitor therapy, whereby the pharmaceutical composition is to be placed in the fossa navicularis of the patient.
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application No. 60/483,278, filed Jun. 27, 2003, and is a continuation-in-part of co-pending application Ser. No. 10/236,485, filed Sep. 6, 2002, which is a continuation-in-part of co-pending application Ser. No. 09/947,617, filed Sep. 6, 2001, which is a continuation-in-part of application Ser. No. 09/480,738, now U.S. Pat. No. 6,323,241, and a continuation-in-part of International Application Serial No. PCT/US00/00852, filed Jan. 10, 2001, the entire contents of which are incorporated herein by reference.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60483278 |
Jun 2003 |
US |
Continuation in Parts (4)
|
Number |
Date |
Country |
Parent |
10236485 |
Sep 2002 |
US |
Child |
10656906 |
Sep 2003 |
US |
Parent |
09947617 |
Sep 2001 |
US |
Child |
10236485 |
|
US |
Parent |
09480738 |
Jan 2000 |
US |
Child |
09947617 |
Sep 2001 |
US |
Parent |
PCT/US01/00852 |
Jan 2001 |
US |
Child |
09947617 |
Sep 2001 |
US |