Econazole composition and methods of treatment therewith
Inventors
Hensby, Christopher N. • Silvander, Mats
Assignees
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Publication Number
US-10543172-B2
Publication Date
2020-01-28
Expiration Date
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.
Core Innovation
The invention relates to a water-based foamable composition provided in a dispensing device for treatment of an infection caused by dermatophyte fungus. The formulation includes econazole or a pharmaceutically-acceptable salt thereof and uses stearic acid, a film-forming polymer and water, with pH adjustment to a range of 4-9 using a titrating agent.
Econazole or econazole nitrate is mixed with an emulsifying agent to create a slurry, and the slurry is added to a mixture comprising stearic acid, a film-forming polymer, and water. The composition is heated, homogenized, and provided in a dispensing device to provide the water-based foamable composition.
A more specific claimed method prepares a water-based composition foamable upon aerosol delivery. It includes mixing stearic acid, polyvinylpyrrolidone, propylene glycol, glycerin, dimethicone with water and heating to promote solubilization, adding the slurry phase, heating to substantially melt the stearic acid, and allowing the mixture to cool to about 28-32°C.
Claims Coverage
The partial content provides two independent claims covering methods of preparing water-based foamable econazole compositions provided in a dispensing device for dermatophyte infections, with pH adjustment in the range of 4-9 and heating/homogenization steps.
Foamable water-based econazole composition in a dispensing device
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, adding a titrating agent to achieve a pH in the range of 4-9, heating the composition, and providing the composition in a dispensing device.
Aerosol-deliverable foamable water-based composition using stearic acid melt, slurry addition, homogenization, and cooling
A method for preparing a water-based composition foamable upon aerosol delivery, comprising mixing stearic acid, polyvinylpyrrolidone, propylene glycol, glycerin, dimethicone with water and heating to promote solubilization; mixing econazole nitrate with polysorbate 20 to create a slurry phase; adding the slurry phase to the mixture; heating to substantially melt the stearic acid; homogenizing the mixture after the adding step; and allowing the mixture to cool to about 28-32°C.
Across both independent claims, the core claim coverage is directed to preparing water-based foamable compositions containing econazole or econazole nitrate and stearic acid, including formation of an econazole slurry, incorporation into a water-based stearic-acid-containing mixture, pH adjustment to 4-9 using a titrating agent, and heating/homogenizing steps to achieve a foamable composition delivered from a dispensing device or upon aerosol delivery.
Stated Advantages
Documented Applications
No documented applications found
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