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Last Updated: November 26, 2020

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Claims for Patent: 10,071,054

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Summary for Patent: 10,071,054
Title:Econazole composition and methods of treatment therewith
Abstract: The invention provides a water-based composition for treating an infection by a dermatophyte fungus comprising econazole or a pharmaceutically acceptable salt thereof. Also provided are methods of treatment utilizing the water-based foam composition, as well as its preparation.
Inventor(s): Hensby; Christopher N. (Saint Germain en Laye, FR), Silvander; Mats (Uppsala, SE)
Assignee: Exeltis USA Dermatology, Inc. (Chatham, NJ)
Application Number:13/198,998
Patent Claims: 1. A method of treating an infection by dermatophyte fungus comprising: applying to an infected skin area a water-based foam composition, wherein the foam remains stably adherent to the skin area for at least 30 seconds following the applying, and, wherein the water-based foam composition consists of: econazole or a pharmaceutically acceptable salt thereof; 8.0-9.0 wt. % of one or more C12-C22 fatty acids; 0.5-2.0 wt. % of an emollient selected from the group consisting of: a silicone oil, a petrolatum, and a combination thereof; 3.0-4.0 wt. % of one of more emulsifying agents; 1.0-2.5 wt. % of one or more film-forming polymers; 6.0-9.0 wt. % of one or more humectants selected from the group consisting of: glycerol and propylene glycol; a titrating agent comprising triethanolamine in an amount of 1.0 to 3.0% by weight of the water-based foam composition so that an amount of the fatty acid component is in the ionized form and a remaining part of the fatty acid component is in the non-ionized form; one or more propellants; and water; wherein the composition has a pH of about 6-9.

2. The method of claim 1, wherein the infection is tinea pedis, tinea cruris, tinea corporis, or tinea versicolor.

3. The method of claim 2, wherein the infection is tinea pedis.

4. The method of claim 3, wherein the infection is interdigital tinea pedis.

5. The method of claim 1, further comprising shaking the water-based foam composition prior to application.

6. The method of claim 1, wherein the water-based foam composition is essentially free of C1 to C6 alcohols, not including polyols.

7. The method of claim 1, wherein the water-based foam composition is non-comedogenic.

8. The method of claim 1, wherein the composition consists of, by weight % of the composition: stearic acid in an amount in the range of 2.0-8.0%; polyvinyl pyrrolidone in an amount in the range of 1.0-5.0%; econazole nitrate in an amount in the range of 0.5-1.5%; propylene glycol in an amount in the range of 4.0-8.0%; glycerin in an amount in the range of 1.0-5.0%; dimethicone in an amount in the range of 0.5-5.0%; triethanolamine in an amount in the range of 2.0-3.0%; and polysorbate 20 in an amount in the range of 1.0-4.0%.

9. A method of treating an infection by dermatophyte fungus comprising: applying to an infected skin area a water-based foam composition, wherein the water-based foam composition consists of: econazole or a pharmaceutically acceptable salt thereof; 8.0-9.0 wt. % of one or more fatty acids, the fatty acid having an ionized form and a non-ionized form, and selected such that 75 mole % or more is C12-C22 fatty acid; 3.0-4.5 wt. % of one or more emulsifying agents; 1.5-2.5 wt. % of one or more film-forming polymers; 0.5-1.5 wt. % of one or more emollients; 7.0-8.0 wt. % of one or more humectants; a titrating agent comprising triethanolamine in an amount of 2.0 to 3.0% by weight of the water-based foam composition so that an amount of the fatty acid component is in the ionized form and a remaining part of the fatty acid component is in the non-ionized form; one or more propellants; and water; wherein the composition has a pH of about 6-9.

10. The method of claim 9, wherein the composition consists of: stearic acid, polyvinyl pyrrolidone, econazole nitrate, propylene glycol, glycerin, dimethicone, triethanolamine, polysorbate 20, one or more propellants, and water.

11. The method of claim 10, wherein a propellant is propane, butane, isobutene, another hydrocarbon, hydrofluorocarbon, or a chlorofluorocarbon.

12. The method of claim 1, wherein the water-based foam composition consists of: 0.5-1.5 wt. % of econazole nitrate; 8.0-9.0 wt. % of stearic acid substantially in an ionized form; 1.0-2.5 wt. % of povidone 6-9 wt. % of one or more humectants, the one or more humectants being one or both of propylene glycol and glycerol; 0.5-2 wt. % of dimethicone 2.0-3.0 wt. % of triethanolamine 3.0-4.0 wt. % of polysorbate 20; water; and one or more propellants; wherein the composition has a pH in the range of about 6-9; and wherein the weight % of the above ingredients are provided exclusive of the one or more propellants present in the composition.

13. The method of claim 12, wherein the water-based foam composition consists of: 1.0 wt. % econazole nitrate; 8.0 wt. % of stearic acid; 1.9-2.5 wt. % of povidone 5.8 wt. % of propylene glycol 1.7 wt. % of glycerol; 0.95 wt. % of dimethicone 2.6 wt. % of triethanolamine 3.7 wt. % of polysorbate 20; water; and one or more propellants.

14. A foamable composition, consisting of: 2-8 percent by weight of stearic acid; 1-5 percent by weight of polyvinylpyrrolidone; 0.5-1.5 percent by weight econazole or a pharmaceutically acceptable salt thereof; 4-8 percent by weight of propylene glycol; 1-5 percent by weight of glycerin; 0.5-5 percent by weight of dimethicone; 2-3 percent by weight of triethanolamine; 1-4 percent by weight of polysorbate 20; one or more propellants; and water: wherein the composition has a pH of about 6-9; and wherein an amount of the fatty acid component is in the ionized form and a remaining part of the fatty acid component is in the non-ionized form.

15. The composition of claim 14, packaged in a dispensing device.

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