Econazole composition and methods of treatment therewith

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.