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Claims for Patent: 8,791,153

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Claims for Patent: 8,791,153

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 (Jenkintown, PA), Gwozdz; Garry T (Bethlehem, PA)
Assignee: Sanofi-Topaz, Inc. (Wilmington, DE)
Application Number:11/871,660
Patent Claims: 1. A topical 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.

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

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

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

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

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

7. The formulation of claim 6, wherein the formulation is formulated as a cream.

8. The formulation of claim 1, wherein the formulation is for use in the prophylactic or therapeutic treatment of a head lice infestation in a human.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

25. The formulation 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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