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Claims for Patent: 7,553,835

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Claims for Patent: 7,553,835

Title:Topical antifungal composition
Abstract:The subject matter relates to a topical, foamable composition including at least one antifungal agent, said composition characterised in that said at least one antifungal agent is able to penetrate the upper layers of skin and is retained in or on an area to be treated for a prolonged period of time, and in that it has a residual non-volatile component content of less than 25%. The subject matter furthermore relates to a method of treating fungal diseases including jock itch, tinea, dandruff and sebborheic dermatitis by applying to the affected area of a patient requiring such treatment the antifungal composition.
Inventor(s): Davey; Greg (Rowville, AU), Abram; Albert Zorko (Rowville, AU)
Assignee: Stiefel Research Australia Pty Ltd (Rowville, AU)
Application Number:09/529,033
Patent Claims: 1. A method for treating fungal diseases, said method comprising: (a) providing a topical, foamable composition consisting essentially of one or more antifungal agents selected from the group consisting of an imidazole compound and a triazole compound, wherein the antifungal agent is capable of penetrating the upper layers of skin of a user, at least one surfactant selected from the group consisting of a quaternary compound, ethoxylated sorbitan stearate, ethoxylated sorbitan palmitate, ethoxylated sorbitan oleate, and mixtures thereof, water, a lower alcohol content of greater than 10% by weight, a long chain alcohol, and hydrocarbon gas propellant in an amount of less than 60% by weight of the total composition, wherein the composition is a temperature sensitive quick breaking foam or mousse and has a residual non-volatile component content of less than 25% by weight; and (b) applying said topical, foamable composition to user's skin, whereupon said antifungal agent is retained in or on skin for a period of time sufficient to achieve skin penetration.

2. The method of claim 1 wherein the content of said residual non-volatile component is less than 10% by weight.

3. The method of claim 2 wherein the content of said residual non-volatile component is less than 6% by weight.

4. The method of claim 1 wherein the composition has a hydrocarbon gas propellant content of less than 10% by weight.

5. The method of claim 1 wherein the provided topical, foamable composition consists essentially of: up to 5% by weight of long chain alcohol; up to 10% by weight of propylene glycol; up to 5% by weight of the antifungal agent; up to 90% by weight of lower alcohol solvent; up to 5% by weight of surfactant selected from the group consisting of a quaternary compound, ethoxylated sorbitan stearate, ethoxylated sorbitan palmitate, ethoxylated sorbitan oleate, and mixtures thereof; 5-95% by weight of water; and up to 20% by weight of a hydrocarbon gas propellant.

6. The method of claim 1 wherein the lower alcohol content is greater than 50% by weight.

7. The method of claim 1 wherein the lower alcohol is ethanol.

8. The method of claim 1 wherein the lower alcohol and water are present in a ratio of about 1.65 to about 1 by weight.

9. The method of claim 1 wherein the long chain alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and mixtures thereof.

10. The method of claim 1 wherein the antifungal agent is an imidazole compound.

11. The method of claim 1 wherein the antifungal agent is ketoconazole.

12. A topical, foamable composition consisting essentially of: (a) one or more antifungal agents selected from the group consisting of an imidazole compound and a triazole compound; (b) at least one surfactant selected from the group consisting of a quaternary compound, ethoxylated sorbitan stearate, ethoxylated sorbitan palmitate, ethoxylated sorbitan oleate, and mixtures thereof; (c) a lower alcohol content of greater than 10% by weight; (d) water; (e) a long chain alcohol; (f) hydrocarbon gas propellant in an amount of less than 60% by weight; and wherein said composition is a temperature-sensitive, quick-breaking foam or mousse, and has a residual non-volatile component content of less than 25% by weight.

13. The composition of claim 12 wherein the content of said residual non-volatile component is less than 10% by weight.

14. The composition of claim 13 wherein the content of said residual non-volatile component is less than 6% by weight.

15. The composition of claim 12 wherein the hydrocarbon gas propellant is present in an amount of less than 10% by weight.

16. The composition of claim 12 consisting essentially of: up to 5% by weight of long chain alcohol; up to 10% by weight of propylene glycol; up to 5% by weight of the antifungal agent; up to 90% by weight of lower alcohol solvent; up to 5% by weight of surfactant selected from the group consisting of a quaternary compound, ethoxylated sorbitan stearate, ethoxylated sorbitan palmitate, ethoxylated sorbitan oleate, and mixtures thereof; 5-95% by weight of water; and up to 20% by weight of a hydrocarbon gas propellant.

17. The composition of claim 12 wherein the lower alcohol content is greater than 50% by weight.

18. The composition of claim 12 wherein the lower alcohol is ethanol.

19. The composition of claim 12 wherein the lower alcohol and water are present in a ratio of about 1.65 to about 1 by weight.

20. The composition of claim 12 wherein the long chain alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and mixtures thereof.

21. The composition as claimed in claim 12 wherein the antifungal is an imidazole compound.

22. The composition as claimed in claim 12 wherein the antifungal agent is ketoconazole.

23. The topical, foamable composition of claim 12 consisting essentially of: (a) up to 5% by weight of one or more antifungal agents selected from the group consisting of an imidazole compound and a triazole compound, wherein the antifungal agent is capable of penetrating the upper layers of skin of a user; (b) a lower alcohol content of greater than 50% by weight and up to 90% by weight, wherein said lower alcohol is ethanol; (c) up to 5% by weight of surfactant selected from the group consisting of a quaternary compound, ethoxylated sorbitan stearate, ethoxylated sorbitan palmitate, ethoxylated sorbitan oleate, and mixtures thereof; (d) up to 5% by weight of a long chain alcohol or mixtures thereof; (e) up to 10% by weight propylene glycol; (f) 5-34% by weight water; and (g) less than 10% by weight hydrocarbon gas propellant; wherein said antifungal agent is retained in or on skin for a period of time sufficient to penetrate the epidermis of a user.

24. The topical, foamable composition of claim 23 wherein the imidazole compound is ketoconazole.

25. The topical, foamable composition of claim 23 wherein the surfactant is polyoxyethylene sorbitan monostearate.

26. The topical, foamable composition of claim 23 wherein the long chain alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and mixtures thereof.

27. The topical, foamable composition of claim 12 consisting essentially of: (a) up to 5% by weight of one or more antifungal agents selected from the group consisting of an imidazole compound and a triazole compound; (b) ethanol at greater than 50% by weight and up to 90% by weight; (c) up to 5% by weight polyoxyethylene sorbitan monostearate; (d) up to 5% by weight cetyl alcohol or stearyl alcohol or mixtures thereof; (e) up to 10% by weight propylene glycol; (f) 5 to about 34% by weight water; and (g) less than 10% by weight hydrocarbon gas propellant; wherein said antifungal agent is retained in or on skin for a period of time sufficient to penetrate the epidermis of a user.

28. The topical, foamable composition of claim 27 wherein the imidazole compound is ketoconazole.
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