Claims
- 1. A semi-solid composition comprising:
a vasoactive prostaglandin; a skin penetration enhancer which is a member of the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, a (N-substituted)-alkanol alkanoate, a pharmaceutically acceptable salts thereof and a mixture thereof; a shear-thinning polysaccharide; a lipophilic compound which is a member of 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 semi-solid composition of 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 semi-solid composition of claim 1, wherein the shear-thinning polysaccharide has a viscosity of about 5,000 centipoise to about 20,000 centipoise.
- 4. The semi-solid composition of claim 1, wherein the shear-thinning polysaccharide has a viscosity of about 7,000 centipoise to about 13,000 centipoise.
- 5. The semi-solid composition of claim 1, wherein the shear-thinning polysaccharide is a modified galactomannan gum.
- 6. The semi-solid composition of claim 5, wherein the modified galactomannan gum is a modified guar gum.
- 7. The semi-solid composition of claim 1, wherein the lipophilic compound is at least one aliphatic C8 to C30 ester.
- 8. The semi-solid composition of claim 1, wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting monoglycerides, diglycerides, triglycerides, and mixtures thereof.
- 9. The semi-solid composition of claim 1, wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolean, trimyristin, tristearin, and mixtures thereof.
- 10. The semi-solid composition of 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.
- 11. The semi-solid composition of 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.
- 12. The semi-solid composition of claim 1, wherein the emulsifier is at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolean, trimyristin, tristearin, and mixtures thereof.
- 13. The semi-solid composition of claim 1, wherein the composition further comprises a fragrance.
- 14. The semi-solid composition of claim 1, wherein the composition further comprises up to about 5 percent myrtenol, based on the total weight of the composition.
- 15. The semi-solid composition of claim 1, wherein the composition further comprises a preservative.
- 16. The semi-solid composition of claim 1, wherein the composition further comprises a topical anesthetic.
- 17. A method of treating erectile dysfunction in a patient needing such treatment comprising:
applying in the fossa navicularis of the patient an effective erection-inducing amount of a semi-solid prostaglandin composition comprising a vasoactive prostaglandin; a skin penetration enhancer which is a member of the group consisting of an alkyl-2-(N-substituted amino)-alkanoate, a (N-substituted)-alkanol alkanoate, a pharmaceutically acceptable salts thereof and a mixture thereof; a shear-thinning polysaccharide; a lipophilic compound which is a member of 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.
- 18. The method in accordance with claim 17, wherein the shear-thinning polysaccharide is a modified galactomannan gum.
- 19. The method in accordance with claim 18 wherein the modified galactomannan gum is a modified guar gum.
- 20. The method in accordance with claim 17 wherein the lipophilic compound is at least one aliphatic C8 to C30 ester.
- 21. The method in accordance with claim 16 wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting monoglycerides, diglycerides, triglycerides, and mixtures thereof.
- 22. The method in accordance with claim 17 wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolean, trimyristin, tristearin, and mixtures thereof.
- 23. The method in accordance with claim 17 wherein the acidic buffer system provides a buffered pH value for said composition in the range of about 3 to about 6.5.
- 24. The method in accordance with claim 17 wherein the composition further comprises an emulsifier selected from the group consisting of sucrose esters, polyoxyethylene sorbitan esters, long chain alcohols, and glyceryl esters.
- 25. The method in accordance with claim 17 wherein the emulsifier is at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolean, trimyristin, tristearin, and mixtures thereof.
- 26. The method in accordance with claim 17 wherein the composition further comprises a fragrance.
- 27. The method in accordance with claim 17 wherein the composition further comprises up to about 5 percent myrtenol, based on the total weight of the composition.
- 28. The method in accordance with claim 17 wherein the composition further comprises a preservative.
- 29. The method in accordance with claim 17 wherein the composition further comprises a topical anesthetic.
- 30. A prostaglandin E1 composition comprising prostaglandin E1 suitable for administration in the fossa navicularis comprising:
a shear-thinning modified galactomannan gum; a prostaglandin selected from the group consisting of PGE1, pharmaceutically acceptable salts thereof, lower alkyl esters thereof and mixtures thereof; about 0.5 percent to about 10 percent DDAIP or a pharmaceutically acceptable salt thereof, based on the total weight of the composition; about 0.5 percent to about 10 percent, based on the total weight of the composition, of a lower alcohol selected from the group consisting of ethanol, propanol, isopropanol and mixtures thereof; about 0.5 percent to about 10 percent of an ester selected from the group consisting of ethyl laurate, isopropyl myristate, isopropyl laurate and mixtures thereof, based on the total weight of the composition; and an acidic buffer system.
- 31. The composition of claim 30, further comprising an emulsifier selected from the group consisting of sucrose esters, polyoxyethylene sorbitan esters, long chain alcohols, and glyceryl esters.
- 32. The composition of claim 30, wherein said emulsifier is a sucrose stearate.
- 33. The composition of claim 30 wherein the emulsifier comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolean, trimyristin, tristearin, and mixtures thereof.
- 34. The composition of claim 30 wherein the composition further comprises a fragrance.
- 35. The composition of claim 30 wherein the composition further comprises up to about 5 percent myrtenol, based on the total weight of the composition.
- 36. The composition of claim 30 wherein the composition further comprises composition further comprises a preservative.
- 37. The composition of claim 30 wherein the composition further comprises a topical anesthetic.
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of co-pending application Ser. No. 09/947,617, filed Sep. 6, 2001, that 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/US01/00852, filed Jan. 10, 2001.
Continuation in Parts (3)
|
Number |
Date |
Country |
Parent |
09947617 |
Sep 2001 |
US |
Child |
10236485 |
Sep 2002 |
US |
Parent |
09480738 |
Jan 2000 |
US |
Child |
09947617 |
Sep 2001 |
US |
Parent |
PCT/US01/00852 |
Jan 2001 |
US |
Child |
09947617 |
Sep 2001 |
US |