Compositions and methods for amelioration of human female sexual dysfunction
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-031/557
A61K-047/00
A61L-002/16
출원번호
US-0188554
(2002-07-02)
발명자
/ 주소
Yeager, James L.
Bü
yü
ktimkin, Nadir
Bü
yü
ktimkin, Servet
출원인 / 주소
NexMed (Holdings) , Inc.
대리인 / 주소
Bowditch & Dewey, LLP
인용정보
피인용 횟수 :
19인용 특허 :
56
초록▼
The invention provides compositions and methods suitable for ameliorating female sexual dysfunction, and in particular, female sexual arousal disorder. In one embodiment, the invention provides a semisolid composition suitable for topical application comprising: an effective amount of a vasoactive p
The invention provides compositions and methods suitable for ameliorating female sexual dysfunction, and in particular, female sexual arousal disorder. In one embodiment, the invention provides a semisolid composition suitable for topical application comprising: an effective amount of a vasoactive prostaglandin, a polysaccharide thickener, a lipophilic component, and an acidic buffer system.
대표청구항▼
1. A method for ameliorating female sexual arousal disorder, comprising the step of administering a composition to the genitalia of a human female in need of treatment, the composition comprising:an amount of a vasoactive prostaglandin effective to produce an increase in sexual arousal;a shear-thinn
1. A method for ameliorating female sexual arousal disorder, comprising the step of administering a composition to the genitalia of a human female in need of treatment, the composition comprising:an amount of a vasoactive prostaglandin effective to produce an increase in sexual arousal;a shear-thinning polysaccharide gum;a lipophilic component chosen from the group consisting of an aliphatic C 1 to C 8 alcohol, an aliphatic C 8 to C 30 ester, and mixtures thereof;a penetration enhancer chosen from the group consisting of alkyl-2-(N-substituted amino) alkanoates, (N-substituted amino) alkanol alkanoates, pharmaceutically acceptable salts thereof and mixtures thereof;water; andan acidic buffer system that provides a buffered pH of about 3.0 to about 7.4,wherein treatment increases subjective sexual arousal thereby alleviating symptoms of female sexual arousal disorder, wherein female sexual arousal disorder is the persistent or recurrent inability to attain, or to maintain, sufficient sexual excitement, which causes personal distress. 2. The method in accordance with claim 1, wherein the vasoactive prostaglandin is selected from the group consisting of PGE 1 , PGA 1 , PGB 1 , PGF 1α , 19-hydroxy-PGA 1 , 19-hydroxy-PGB 1 , PGE 2 , PGA 2 , PGB 2 , 19-hydroxy-PGA 2 , 19-hydroxy-PGB 2 , PGE 3 , PGF 3 and mixtures thereof. 3. The method in accordance with claim 1, wherein the shear-thinning polysaccharide gum is a modified galactomannan gum. 4. The method in accordance with claim 3, wherein the modified galactomannan gum is a modified guar gum. 5. The method in accordance with claim 1, wherein the lipophilic compound is at least one aliphatic C 8 to C 30 ester. 6. The method in accordance with claim 1, wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting monoglycerides, diglycerides, triglycerides, and mixtures thereof. 7. The method in accordance with claim 1, wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof. 8. 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 6.0. 9. 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. 10. The method in accordance with claim 1, wherein the emulsifier is at least one glyceryl ester selected from the group consisting of glyceryl monoolcate, triolein, trimyristin, tristearin, and mixtures thereof. 11. The method in accordance with claim 1, wherein the composition further comprises a fragrance. 12. The method in accordance with claim 1, wherein the composition further comprises a preservative. 13. The method in accordance with claim 1, wherein the composition further comprises a topical anesthetic. 14. A method for ameliorating female sexual arousal disorder, comprising the step of applying a shear-thinning semi-solid prostaglandin composition to the genitalia of a human female in need of treatment, the composition comprising:a modified polysaccharide gum;a prostaglandin selected from the group consisting of PGE 1 , 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 ;water; andan acidic buffer system that provides a buffered pH of about 3.0 to about 7.4, wherein treatment increases subjective sexual arousal thereby alleviating symptoms of female sexual arousal disorder, wherein female sexual arousal disorder is the persistent or recurrent inability to attain, or to maintain, sufficient sexual excitement, which causes personal distress. 15. The method in accordance with claim 14, further comprising an emulsifier selected from the group consisting of sucrose esters, polyoxyethylene sorbitan esters, long chain alcohols, and glyceryl esters. 16. The method in accordance with claim 15, wherein the emulsifier is a sucrose stearate. 17. The method in accordance with claim 15, wherein the emulsifier comprises at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof. 18. The method in accordance with claim 14, wherein the composition further comprises a fragrance. 19. The method in accordance with claim 14 wherein the composition comprises a preservative. 20. The method in accordance with claim 14, wherein the composition further comprises a topical anesthetic. 21. A method for ameliorating female sexual arousal disorder, comprising the step of administering a shear-thinning semi-solid composition to the genitalia of a human female in need of treatment, the composition comprising:an amount of a vasoactive prostaglandin effective to produce an increase in sexual arousal;a polyacrylic polymer;a lipophilic component chosen from the group consisting of an aliphatic C 1 to C 8 alcohol, an aliphatic C 8 to C 30 ester, and mixtures thereof;a penetration enhancer chosen from the group consisting of alkyl-2-(N-substituted amino) alkanoates, (N-substituted amino) alkanol alkanoates, pharmaceutically acceptable salts thereof and mixtures thereof;water; andan acidic buffer system that provides a buffered pH of about 3.0 to about 7.4,wherein treatment increases subjective sexual arousal thereby alleviating symptoms of female sexual arousal disorder, wherein female sexual arousal disorder is the persistent or recurrent inability to attain, or to maintain, sufficient sexual excitement, which causes personal distress. 22. The method in accordance with claim 21, wherein the vasoactive prostaglandin is selected from the group consisting of PGE 1 , PGA 1 , PGB 1 , PGF 1α , 19-hydroxy-PGA 1 , 19-hydroxy-PGB 1 , PGE 2 , PGA 2 , PGB 2 , 19-hydroxy-PGA 2 , 19-hydroxy-PGB 2 , PGE 3 , PGF 3 and mixtures thereof. 23. The method in accordance with claim 21, wherein the lipophilic compound is at least one aliphatic C 8 to C 30 ester. 24. The method in accordance with claim 21, wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting monoglycerides, diglycerides, triglycerides, and mixtures thereof. 25. The method in accordance with claim 21, wherein the lipophilic compound is at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof. 26. The method in accordance with claim 21, wherein the acidic buffer system provides a buffered pH value for said composition in the range of about 3 to about 6.0. 27. The method in accordance with claim 21, wherein the composition further comprises an emulsifier selected from the group consisting of sucrose esters, polyoxyethylene sorbitan esters, long chain alcohols, and glyceryl esters. 28. The method in accordance with claim 21, wherein the emulsifier is at least one glyceryl ester selected from the group consisting of glyceryl monooleate, triolein, trimyristin, tristearin, and mixtures thereof. 29. The method in accordance with claim 21, wherein the composition further comprises a fragrance. 30. The method in accordance with claim 21, wherein the composition further comprises a preservative. 31. The method in accordance with claim 21, wherein the compositio n further comprises a topical anesthetic.
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