Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment-resistant strains of head lice
View Patent ↗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.
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.