Econazole composition and methods of treatment therewith

1. A method for preparing a water-based foamable composition provided in a dispensing device for treatment of an infection caused by dermatophyte fungus comprising:

mixing econazole or a pharmaceutically-acceptable salt thereof with an emulsifying agent to create a slurry;

adding the slurry to a mixture comprising stearic acid, a film-forming polymer and water to produce a water-based composition;

adding a titrating agent to the composition in an amount sufficient to achieve a pH of the composition in the range of 4-9; and heating the composition at about 50-55° C. containing the titrating agent and

providing the composition in a dispensing device to provide the water-based foamable composition.

2. The method of claim 1 , further comprising adding one or more of an emollient and a humectant to the mixture.

3. The method of claim 1 , wherein the composition is a two-phase emulsion.

4. The method of claim 1 , wherein the composition is essentially free of C1 to C6 alcohols, not including polyols.

5. The method of claim 1 , wherein the composition lacks a preservative other than the econazole or the pharmaceutically-acceptable salt thereof.

6. The method of claim 1 , wherein the composition is non-comedogenic.

7. The method of claim 1 , wherein the composition comprises, by weight % of the composition excluding any propellants:

stearic acid in an amount in the range of 2.0-8.0%;

polyvinyl pyrrolidine 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%.

8. The method of claim 2 , wherein the composition consists of: econazole or a pharmaceutically-acceptable salt thereof;

stearic acid in an amount in the range of 2.0-10.0%; one or more emulsifying agents in an amount in the range of 0.5-4.0%; one or more film-forming polymers in an amount in the range of 0.5-5.0%; one or more emollients in an amount in the range of 0.5-5.0%;

one or more humectants in an amount in the range of 4.0-12.0%;

one or more titrating agents in an amount sufficient to achieve a pH of the composition in the range of 4-9;

one or more propellants; and

water.

9. The method of claim 8 , wherein the composition consists of:

stearic acid, polyvinyl pyrrolidone, econazole nitrate, polypropylene glycol, glycerin, dimethicone, triethanolamine, polysorbate 20, one or more propellants, and water.

10. The method of claim 1 , further comprising providing one or more propellants in the dispensing device.

11. A method for preparing a water-based composition that is foamable upon aerosol delivery, the method comprising, per 100 g of the water-based composition:

mixing 2.0-8.0 g stearic acid, 1.0-5.0 g polyvinylpyrrolidone, 4.0-8.0 g propylene glycol, 1.0-5.0 g glycerin, 0.5-5.0 g dimethicone, with water and heating the resulting mixture to promote solubilization;

mixing 0.5-1.5 g of econazole nitrate with 1.0-4.0 g polysorbate 20 to create a slurry phase;

adding the slurry phase to the mixture;

heating the mixture at a temperature to substantially melt the stearic acid;

homogenizing the mixture after the adding step; and

allowing the mixture to cool to about 28-32° C.

12. The method of claim 11 , further comprising adding triethanolamine to the mixture after the adding step to achieve a pH of the mixture in the range of 4-9.