Topical compositions and methods for making and using same
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-031/569
A61K-047/10
A61K-047/38
A61K-009/00
A61K-047/26
A61K-009/06
A61K-031/56
출원번호
US-0941201
(2013-07-12)
등록번호
US-9433680
(2016-09-06)
발명자
/ 주소
Hardas, Bhushan
Dalton, Donna
Scheppler, Petra
Hensche, Anja
Boderke, Peter
출원인 / 주소
MERZ PHARMACEUTICALS, LLC
대리인 / 주소
Reid, Andrea L. C.
인용정보
피인용 횟수 :
0인용 특허 :
25
초록
The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
대표청구항▼
1. A gel composition comprising from about 0.01 wt % to about 0.5 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, from about 15 wt % to about 25 wt % of a glycol solvent, from about 0.75 wt % to about 2.25 wt % of a hydroxyl cellulose, from about 1 wt % to less than about 1
1. A gel composition comprising from about 0.01 wt % to about 0.5 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, from about 15 wt % to about 25 wt % of a glycol solvent, from about 0.75 wt % to about 2.25 wt % of a hydroxyl cellulose, from about 1 wt % to less than about 10 wt % of a polysorbate solubilizing agent, from about 1 wt % to less than about 10 wt % of a second solubilizing agent, optionally a third solubilizing agent, and optionally one or more of: a diluent, a pH adjuster, a chelating agent, a preservative, a fragrance, and a coloring agent; wherein the gel composition contains no alkyl alcohol, and wherein the composition contains no active agent in addition to the fluticasone, or a pharmaceutically acceptable salt thereof. 2. The gel composition of claim 1, comprising from about 0.01 wt % to about 0.1 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, from about 15 wt % to about 25 wt % of a glycol solvent, from about 0.75 wt % to about 2.25 wt % of a hydroxy cellulose, from about 3 wt % to about 8 wt % of a polysorbate solubilizing agent, from about 1 wt % to less than about 10 wt % of a second solubilizing agent, optionally a third solubilizing agent, and optionally one or more of: a diluent, a pH adjuster, a chelating agent, a preservative, a fragrance, and a coloring agent. 3. The gel composition of claim 1, comprising from about 0.01 wt % to about 0.1 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, from about 15 wt % to about 25 wt % propylene glycol, from about 0.75 wt % to about 2.25 wt % hydroxyethyl cellulose, from about 3 wt % to about 8 wt % Polysorbate 20, from about 1 wt % to less than about 10 wt % of a second solubilizing agent, optionally a third solubilizing agent, and optionally one or more of: a diluent, a pH adjuster, a chelating agent, a preservative, a fragrance, and a coloring agent. 4. The gel composition of claim 1, comprising from about 0.01 wt % to about 0.1 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, from about 15 wt % to about 25 wt % propylene glycol, from about 1.5 wt % to about 2.0 wt % hydroxyethyl cellulose, from about 3 wt % to about 8 wt % Polysorbate 20, from about 1 wt % to less than about 10 wt % of a second solubilizing agent selected from an alcohol or glycol ether solubilizing agent, optionally from about 1 wt % to less than about 10 wt % of a third solubilizing agent, and optionally one or more of: a diluent, a pH adjuster, a chelating agent, a preservative, a fragrance, and a coloring agent. 5. The gel composition of claim 1, wherein the fluticasone or a pharmaceutically acceptable salt or ester thereof is present in an amount of from about 0.01 wt % to about 0.1 wt %. 6. The gel composition of claim 1, wherein the glycol solvent is present in an amount of about 18 wt % to about 22 wt %. 7. The gel composition of claim 6, wherein the glycol solvent is propylene glycol. 8. The gel composition of claim 1, wherein the hydroxy cellulose is present in an amount of from about 1.5 wt % to about 2.0 wt %. 9. The gel composition of claim 1, wherein the hydroxy cellulose is hydroxyethyl cellulose. 10. The gel composition of claim 1, wherein the polysorbate solubilizing agent is present in an amount of from about 3 wt % to about 8 wt %. 11. The gel composition of claim 1, wherein the polysorbate solubilizing agent is Polysorbate 20. 12. The gel composition of claim 1, wherein the polysorbate solubilizing agent is Polysorbate 80. 13. The gel composition of claim 1, wherein the fluticasone, or pharmaceutically acceptable salt or ester thereof, is fluticasone propionate. 14. The gel composition of claim 1, wherein the preservative is benzyl alcohol. 15. The gel composition of claim 14, wherein the benzyl alcohol is present in an amount of about 1.0 wt %. 16. The gel composition of claim 1, comprising from about 0.01 wt % to about 0.075 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, from about 15 wt % to about 25 wt % propylene glycol, from about 1.5 wt % to about 2.0 wt % hydroxyethyl cellulose, from about 3 wt % to about 8 wt % Polysorbate 20, from about 1 wt % to less than about 10 wt % of a second solubilizing agent selected from an alcohol or glycol ether solubilizing agent, optionally from about 1 wt % to less than about 10 wt % of a third solubilizing agent selected from an alcohol or glycol ether solubilizing agent, and optionally one or more of: a diluent, a pH adjuster, a chelating agent, a preservative, a fragrance, and a coloring agent. 17. The gel composition of claim 16, wherein the second solubilizing agent is a glycol ether solubilizing agent. 18. The gel composition of claim 17, wherein the second solubilizing agent is diethylene glycol monoethylether. 19. The gel composition of claim 18, wherein the diethylene glycol monoethylether is present in an amount of about 1 wt % to about 3 wt %. 20. The gel composition of claim 19, wherein the fluticasone or pharmaceutically acceptable salt or ester thereof is fluticasone propionate. 21. The gel composition of claim 20, wherein the preservative is benzyl alcohol. 22. The gel composition of claim 21, wherein the benzyl alcohol is present in an amount of about 1.0 wt %. 23. The gel composition of claim 1, comprising about 0.025 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, about 20 wt % propylene glycol, about 1.5 wt % to about 2.0 wt % hydroxyethyl cellulose, from about 3 wt % to about 8 wt % Polysorbate 20, from about 1 wt % to about 3 wt % of a glycol ether solubilizing agent, and optionally one or more of: a diluent, a pH adjuster, a chelating agent, a preservative, a fragrance, and a coloring agent. 24. The gel composition of claim 1, comprising about 0.025 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, about 20 wt % propylene glycol, about 1.75 wt % hydroxyethyl cellulose, about 5 wt % Polysorbate 20, about 1.5 wt % diethylene glycol monoethylether, water, 0.02 wt % ethylenediaminetetracetic acid (EDTA) or a salt thereof, and optionally a preservative, a pH adjuster, a fragrance, and a coloring agent. 25. The gel composition of claim 24, wherein the fluticasone or pharmaceutically acceptable salt or ester thereof is fluticasone propionate. 26. The gel composition of claim 25, wherein the preservative is benzyl alcohol. 27. The gel composition of claim 26, wherein the benzyl alcohol is present in an amount of about 1.0 wt %.
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이 특허에 인용된 특허 (25)
Quigley ; Jr. John W. ; Hou Sui Yuen Eddie ; Chaudhuri Bhaskar, Antifungal/steroid topical compositions.
Carrara,Dario; Porto,Gabriel; Rodriguez,Jorge, Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels.
Carrara,Dario; Porto,Gabriel; Rodriguez,Jorge, Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels.
Suvanprakorn, Pichit; Vayumhasuwan, Panida; Zaias, Nardo, Increased effectiveness of allylamine drug compounds for topical treatment of fungal infections of the skin and skin appendages.
Suvanprakorn, Pichit; Vayumhasuwan, Panida; Zaias, Nardo, Increased effectiveness of allylamine drug compounds for topical treatment of fungal infections of the skin and skin appendages.
Smith Robert A. (42 Bigge Street Liverpool ; New South Wales ; 2170 AUX) Goodman Maxine (8/95 Chiswick Road Greenacre ; New South Wales 2190 AUX), Pharmaceutical gel composition.
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