Details for Patent: 9,452,173

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 (Summerville, 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:	Jan 31, 2014
Application Number:	14/764,545
Claims:	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.