Topical Avermectin Formulations and Methods For Elimination and Prophylaxis of Susceptible and Treatment Resistant Strains of Head Lice
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, nonionic 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 .- 20 . (canceled)
21 . A method for treatment or prophylaxis of a lice infestation, the method comprising:
(a) applying a pediculicidal formulation to a human scalp infested with lice; wherein the pediculicidal formulation comprises:
about 0.1% to about 2.0% by weight ivermectin;
less than about 30% of a pharmaceutically acceptable glycol;
at least one suspending agent;
about 10 to about 35% of at least one non-iononic surfactant; and
water,
(b) maintaining the topical pediculicidal formulation on the scalp for about 1 to about 60 minutes to provide treated lice; and
(c) removing the pediculicidal formulation from the scalp,
wherein the treated lice have a faster mortality response than lice treated with unformulated 0.5% ivermectin.
22 . The method of claim 21 , wherein the pediculicidal formulation is packaged as a single dose.
23 . The method of claim 21 , wherein the pediculicidal formulation comprises about 0.5% by weight ivermectin.
24 . The method of claim 21 , wherein the at least one suspending agent is selected from the group consisting of fatty oils, fats and combinations thereof.
25 . The method of claim 21 , wherein the pediculicidal formulation comprises at least two suspending agents, wherein the at least two suspending agents comprise a fatty oil and a fat.
26 . The method of claim 25 , wherein the fatty oil is olive oil.
27 . The method of claim 5 , wherein the fat is shea butter.
28 . The method of claim 21 , wherein the pediculicidal formulation comprises at least two non-ionic surfactants.
29 . The method of claim 28 , wherein the at least two non-ionic surfactants are selected from the group consisting of fatty alcohols, sorbitan tristearate and combinations thereof.
30 . The method of claim 29 , wherein the fatty alcohol is selected from the group consisting of oleyl alcohol, lanolin alcohol and combinations thereof.
31 . The method of claim 1 , wherein the pediculicidal formulation comprises less than about 25% of a pharmaceutically acceptable glycol.
32 . The method of claim 21 , wherein the pediculicidal formulation comprises less than about 20% of a pharmaceutically acceptable glycol.
33 . The method of claim 21 , wherein the pediculicidal formulation comprises less than about 15% of a pharmaceutically acceptable glycol.
34 . The method of claim 21 , wherein the pediculicidal formulation comprises less than about 10% of a pharmaceutically acceptable glycol.
35 . The method of claim 21 , wherein the pediculicidal formulation has the texture of a gel or shampoo-conditioner.
36 . The method of claim 21 , wherein the pediculicidal formulation has the texture of a lotion.
37 . The method of claim 21 , wherein the non-ionic surfactant is selected from stearyl acetate, oleyl acetate and combinations thereof.
38 . The method of claim 21 , wherein the pediculicidal formulation is maintained on the scalp for about 3 to about 60 minutes.
39 . The method of claim 21 , wherein the pediculicidal formulation is maintained on the scalp for about 10 minutes.
40 . The method of claim 21 , further comprising (d) removing the pediculicidal formulation from the scalp by rinsing.