Details for Patent: 9,446,131

Title:	Topical compositions and methods for making and using same
Abstract:	The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
Inventor(s):	Hardas; Bhushan (Summerfield, NC), Dalton; Donna (High Point, NC), Scheppler; Petra (Mainz, DE), Buch; Anja (Eschborn, DE), Boderke; Peter (Schwalbach, DE)
Assignee:	MERZ PHARMACEUTICALS, LLC (Raleigh, NC)
Filing Date:	Dec 18, 2015
Application Number:	14/974,502
Claims:	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.