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 atopic dermatitis in a patient in need thereof, comprising administering to a patient in need thereof a topical gel composition comprising about 0.025 wt % fluticasone, or a pharmaceutically acceptable salt or ester thereof, about 18 to 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.
2. The method according to claim 1 , wherein the topical gel composition comprises 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.
3. The method according to claim 2 , wherein the fluticasone or pharmaceutically acceptable salt or ester thereof is fluticasone propionate.
4. The method according to claim 2 , wherein the preservative is benzyl alcohol present in an amount of about 1.0 wt %.
5. 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.
6. The method according to claim 5 , wherein the topical gel composition is administered to the affected area of said patient once or twice per day.
7. The method according to claim 5 , wherein the topical gel composition is administered to the affected area of said patient twice per day.
8. The method according to claim 5 , wherein the topical gel composition is administered to the affected area of said patient from 1 week to 4 weeks.
9. The method according to claim 8 , wherein the topical gel composition is administered to the affected area of said patient for 1 week.
10. The method according to claim 8 , wherein the topical gel composition is administered to the affected area of said patient for 2 weeks.
11. The method according to claim 8 , wherein the topical gel composition is administered to the affected area of said patient for 3 weeks.
12. The method according to claim 8 , wherein the topical gel composition is administered to the affected area of said patient for 4 weeks.
13. The method according to claim 5 , wherein the amount of topical gel composition administered is from about 1 gram to about 8 grams.
14. The method according to claim 13 , wherein the amount of topical gel composition administered is from about 1 gram to about 4 grams.
15. The method according to claim 13 , wherein the amount of topical gel composition administered is from about 2 grams to about 5 grams.
16. The method according to claim 13 , wherein the amount of topical gel composition administered is from about 2 grams to about 7 grams.
17. The method according to claim 13 , wherein the amount of topical gel composition administered is from about 3 grams to about 8 grams.