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Claims for Patent: 8,927,595

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Claims for Patent: 8,927,595

Title:Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment resistant strains of head lice
Abstract: An avermectin-based topical formulation is disclosed which is useful for prevention and treatment of head lice (Pediculus humanus capitis). This topical formulation may be formulated as a shampoo-condition which comprises an effective amount of avermectin, solubilizers, suspending agents, preservatives, non-ionic surfactants, humectants, a silicone compound, and water. Also disclosed are methods of using the topical formulations disclosed within this specification to treat either a susceptible or treatment-resistant strain of lice, as well as uses in the manufacture of a medicament for treating or preventing a lice infestation from a susceptible or treatment-resistant strain in a human patient.
Inventor(s): Spring; Nicholas (Horsham, PA), Gwozdz; Garry T. (Bethlehem, PA)
Assignee: Sanofi-Topaz, Inc. (Wilmington, DE)
Application Number:13/116,547
Patent Claims: 1. A method for the treatment or prophylaxis of lice infestation, the method comprising steps of: a) applying topically to a surface area of a host who is suffering from or susceptible to infestation with lice a formulation comprising: an effective amount of dissolved ivermectin; about 20% to about 35% by weight olive oil; about 1% to about 5% by weight shea butter; nonionic surfactants comprising oleyl alcohol, sorbitan tristearate, and lanolin alcohol; a solubilizing agent comprising cetyl acetate, polysorbate 80, and acetylated lanolin alcohol; about 0.01% to about 2% by weight methylparaben; about 0.01% to about 0.5% by weight propylparaben; about 1% to about 5% by weight of a conditioner comprising cyclomethicone; and about 30% to about 40% by weight water; and b) maintaining the composition in contact with the surface area for a period of time that is from about 1 to about 60 minutes in length.

2. The method of claim 1, further comprising a step of: c) washing the area with water.

3. The method of claim 1, wherein the lice are head lice and the surface area comprises head hair of the host.

4. The method of claim 1, wherein the lice are body lice and the surface area comprises a body area of the host.

5. The method of claim 1, wherein the lice are pubic lice and the surface area comprises a pubic area, facial hair, eyelashes, eyebrows, armpits, chest hair, or scalp of the host.

6. The method of claim 1, wherein the lice are resistant to one or more of pyrethrin, permethrin and malathion.

7. The method of claim 1, wherein the step of applying comprises applying to a host who has previously used one or more of a pyrethrin, permethrin and malathion containing formulation.

8. The method of claim 1, wherein the lice are susceptible to ivermectin.

9. The method of claim 1, wherein the step of applying comprises applying to a host who has not previously used one or more of a pyrethrin, permethrin and malathion containing formulation.

10. The method of claim 1, wherein the period of time is from about 3 minutes to about 60 minutes in length.

11. The method of claim 1, wherein the period of time is about 3 minutes in length.

12. The method of claim 1, wherein the period of time is about 5 minutes in length.

13. The method of claim 1, wherein the period of time is about 10 minutes in length.

14. The method of claim 1, wherein the formulation is in the form of a lotion.

15. The method of claim 1, wherein the step of applying comprises applying a unit dose of about 1 ml to about 100 ml of the formulation.

16. The method of claim 1, wherein the step of applying comprises applying a unit dose of about 3 ml to about 75 ml of the formulation.

17. The method of claim 15 or 16, wherein the unit dose comprises from about 0.1% to about 2.0% w/v ivermectin.

18. The method of claim 15 or 16, wherein the unit dose comprises about 0.5% w/v ivermectin.

19. The method of claim 1, wherein the formulation does not include any glycols.

20. The method of claim 1, wherein the formulation comprises below 5% by weight of a glycol.

21. The method of claim 1, wherein the olive oil is present in an amount of about 27.5% by weight of the formulation.

22. The method of claim 1, wherein the ivermectin is present in an amount of about 0.25% to about 1% by weight of the formulation.

23. The method of claim 1, wherein the formulation is formulated as a cream, gel, pomade, shampoo-conditioner, cream rinse or lotion.

24. The method of claim 23, wherein the formulation is formulated as a cream.

25. The method of claim 1, wherein the formulation is indirectly ovicidal.

26. The method of claim 1, wherein the formulation has a volume of about 1 mL to about 100 mL and contains a unit dose of ivermectin.

27. The method of claim 1, wherein the formulation comprises oleyl alcohol and lanolin alcohol with a combined concentration of about 10% to about 35% by weight.

28. The method of claim 1, wherein the formulation comprises oleyl alcohol and lanolin alcohol with a combined concentration of about 18% to about 24% by weight.

29. The method of claim 1, wherein the formulation comprises about 5% to about 15% by weight oleyl alcohol.

30. The method of claim 1, wherein the formulation comprises about 3% to about 15% by weight lanolin alcohol.

31. The method of claim 1, wherein the formulation comprises about 5% to about 10% by weight lanolin alcohol.

32. The method of claim 1, wherein the formulation comprises about 0.1% to about 3% by weight sorbitan tristearate.

33. The method of claim 1, wherein the formulation comprises about 0.5% to about 10% by weight cetyl acetate.

34. The method of claim 1, wherein the formulation comprises about 1% to about 4% by weight cetyl acetate.

35. The method of claim 1, wherein the formulation comprises about 5% to about 25% by weight polysorbate 80.

36. The method of claim 1, wherein the formulation comprises about 10% to about 15% by weight polysorbate 80.

37. The method of claim 1, wherein the formulation comprises about 0.10% to about 3% by weight acetylated lanolin alcohol.

38. The method of claim 1, wherein the formulation comprises about 0.5% to about 1% by weight acetylated lanolin alcohol.

39. The method of claim 1, wherein the ivermectin is present in an amount of about 0.05% to about 5% by weight of the formulation.

40. The method of claim 1, wherein the olive oil is present in an amount of about 20% to about 30% by weight of the formulation.

41. The method of claim 1, wherein the olive oil is present in an amount of about 25% to about 28% by weight of the formulation.
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