Econazole composition and methods of treatment therewith
Inventors
Hensby, Christopher N. • Silvander, Mats
Assignees
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Publication Number
US-10071054-B2
Publication Date
2018-09-11
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 provides a water-based foam composition for treating an infection by dermatophyte fungus. The foam is applied to an infected skin area and remains stably adherent to the skin area for at least 30 seconds following applying. The foam composition includes econazole or a pharmaceutically acceptable salt thereof and a formulation package with specific components and a defined pH of about 6-9.
The formulation is characterized by fatty acids present in an ionized form and a remaining part in a non-ionized form, achieved using a titrating agent comprising triethanolamine in an amount that sets the ionized and non-ionized fractions. The foam additionally includes one or more C12-C22 fatty acids, an emollient selected from silicone oil, petrolatum, and combinations thereof, emulsifying agents, film-forming polymers, humectants, one or more propellants, and water.
The composition is water-based and foamable. The vehicle with the antifungal supports non-irritating and non-sensitizing properties, and provides a non-greasy feel and a non-watery feel.
Claims Coverage
The independent claims cover three inventive features: treating dermatophyte fungus skin infections with a stably adherent water-based foam, a foamable composition with defined ingredient ranges and ionic-fatty-acid partitioning, and a water-based foam composition with pH about 6-9. Across the independent claims, the core coverage combines econazole, triethanolamine titration to form ionized and non-ionized fatty acids, defined classes or ranges of emulsifying agents, film-forming polymers, humectants, emollients, propellants, and water.
Adherent water-based foam treatment of dermatophyte fungus infection
A method of treating an infection by dermatophyte fungus by applying to an infected skin area a water-based foam composition that remains stably adherent to the skin area for at least 30 seconds following applying, where the composition includes econazole or a pharmaceutically acceptable salt thereof, one or more C12-C22 fatty acids, an emollient selected from silicone oil, petrolatum, or combinations thereof, emulsifying agents, film-forming polymers, humectants, one or more propellants, and water, with pH about 6-9.
Ionized and non-ionized fatty-acid water-based foam treatment
A method of treating an infection by dermatophyte fungus by applying to an infected skin area a water-based foam composition that includes econazole or a pharmaceutically acceptable salt thereof, fatty acids having ionized and non-ionized forms, a titrating agent comprising triethanolamine so that the fatty acid component is in the ionized form and a remaining part is in the non-ionized form, emulsifying agents, film-forming polymers, emollients, humectants, one or more propellants, and water, with pH about 6-9.
Foamable composition with specified ranges and ionized and non-ionized fatty-acid partitioning
A foamable composition including stearic acid, polyvinylpyrrolidone, econazole or a pharmaceutically acceptable salt thereof, propylene glycol, glycerin, dimethicone, triethanolamine, polysorbate 20, one or more propellants, and water, wherein the composition has a pH of about 6-9 and an amount of the fatty acid component is in the ionized form and a remaining part is in the non-ionized form.
The claim set centers on water-based foam formulations and methods for dermatophyte fungus infections using econazole with a triethanolamine-titrated fatty-acid system and defined formulation components. One independent method claim further requires stable skin adhesion for at least 30 seconds after application.
Stated Advantages
Non-irritating.
Non-sensitizing.
Non-greasy feel.
Non-watery feel.
Foamable stable adherence behavior.
Antimicrobial vehicle activity supporting reduced preservatives.
Non-comedogenicity.
Comparable safety in a multicenter tinea pedis trial and superior cure rates for econazole nitrate foam versus foam vehicle.
Documented Applications
Treating dermatophyte fungus infections on skin, including tinea pedis, tinea cruris, tinea corporis, and tinea versicolor.
Treating cutaneous candidiasis.
Use of an econazole nitrate foam or econazole nitrate cream formulation in a multicenter tinea pedis clinical trial compared with a foam vehicle, including safety and cure rate outcomes.
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