Details 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)
Filing Date:	Oct 12, 2007
Application Number:	11/871,660
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.