Topical compositions and methods for making and using same
View Patent ↗The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
1. A method of treating an inflammatory disease, disorder, or condition of the skin in a patient in need thereof, comprising administering to a patient in need thereof a topical 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.
2. The method of claim 1 , wherein the topical gel composition comprises 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 method of claim 2 , wherein the glycol solvent is present in an amount of about 18 wt % to about 22 wt %.
4. The method of claim 3 , wherein the glycol solvent is propylene glycol.
5. The method of claim 2 , wherein the hydroxy cellulose is present in an amount of from about 1.5 wt % to about 2.0 wt %.
6. The method of claim 5 , wherein the hydroxy cellulose is hydroxyethyl cellulose.
7. The method of claim 2 , wherein the polysorbate solubilizing agent is Polysorbate 20.
8. The method of claim 2 , wherein the polysorbate solubilizing agent is Polysorbate 80.
9. The method of claim 1 , wherein the topical gel composition comprises 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.
10. The method of claim 1 , wherein the topical gel composition comprises 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.
11. The method according to claim 1 , wherein the inflammatory disease, disorder, or condition of the skin is atopic dermatitis, psoriasis, eczema, acne, rosacea, or a lichenoid disorder.
12. The method according to claim 11 , wherein the inflammatory disease, disorder, or condition of the skin is atopic dermatitis.
13. The method according to claim 1 , wherein the topical gel composition is administered to an affected area of said patient in an amount sufficient to cover the affected area plus a margin of healthy skin or tissue surrounding the affected area.
14. The method according to claim 13 , wherein the topical gel composition is administered to the affected area of said patient once or twice per day.
15. The method according to claim 13 , wherein the topical gel composition is administered to the affected area of said patient twice per day.
16. The method according to claim 13 , wherein the topical gel composition is administered to the affected area of said patient from 1 week to 4 weeks.
17. The method according to claim 16 , wherein the topical gel composition is administered to the affected area of said patient for 1 week, for 2 weeks, for 3 weeks, or for 4 weeks.
18. The method according to claim 13 , wherein the amount of topical gel composition administered is from about 1 gram to about 8 grams, from about 1 gram to about 4 grams, from about 2 grams to about 5 grams, from about 2 grams to about 7 grams, or from about 3 grams to about 8 grams.