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(12) Patent Application Publication (10) Pub. No.: US 2007/0020304 A1 Tamarkin Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2007/0020304 A1 Tamarkin Et Al US 20070020304A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0020304 A1 Tamarkin et al. (43) Pub. Date: Jan. 25, 2007 (54) NON-FLAMMABLE INSECTICDE on Nov. 29, 2002. Provisional application No. 60/696, COMPOSITION AND USES THEREOF 878, filed on Jul. 6, 2005. (75) Inventors: Dov Tamarkin, Maccabim (IL); Doron (30) Foreign Application Priority Data Friedman, Karmei Yosef (IL); Meir Eini, Ness Ziona (IL) Oct. 25, 2002 (IL)................................................. 1524.86 Correspondence Address: Publication Classification WILMER CUTLER PICKERING HALE AND DORR LLP (51) Int. Cl. 6O STATE STREET AOIN 25/00 (2006.01) BOSTON, MA 02109 (US) (52) U.S. Cl. .............................................................. 424/405 (73) Assignee: Foamix Ltd., Rehovot (IL) (57) ABSTRACT The present invention provides a safe and effective insecti (21) Appl. No.: 11/481,596 cide composition Suitable for treating a subject infested with a parasitic anthropode or to prevent infestation by an arthro (22) Filed: Jul. 6, 2006 pod. The insecticide composition is a foamable composition, Related U.S. Application Data including a first insecticide; at least one organic carrier selected from a hydrophobic organic carrier, a polar solvent, (63) Continuation-in-part of application No. 10/911,367, an emollient and mixtures thereof, at a concentration of filed on Aug. 4, 2004. about 2% to about 5%, or about 5% to about 10%; or about Continuation-in-part of application No. 10/532,618, 10% to about 20%; or about 20% to about 50% by weight; filed on Dec. 22, 2005, filed as 371 of international about 0.1% to about 5% by weight of a surface-active agent; application No. PCT/IB03/05527, filed on Oct. 24, about 0.01% to about 5% by weight of at least one polymeric 2003. agent selected from a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent; and (5) a (60) Provisional application No. 60/492,385, filed on Aug. liquefied or compressed gas propellant at a concentration of 4, 2003. Provisional application No. 60/429.546, filed about 3% to about 25% by weight of the total composition. US 2007/0020304 A1 Jan. 25, 2007 NON-FLAMMABLE INSECTICDE COMPOSITION and tenderness around the bite, which may gradually spread, AND USES THEREOF and sometimes can become serious. CROSS REFERENCE TO RELATED 0010 Resistance of insects to pesticides is commonly APPLICATIONS known. For example, resistance of lice to 1 percent per methrin has been reported in the US and elsewhere. There 0001. This application is a continuation-in-part applica are two broad mechanisms by which insect pests develop tion of co-pending U.S. patent application Ser. No. 10/532, resistance to insecticides. They may produce large amounts 618 filed on Apr. 25, 2005 which is a 371 application of of enzymes, such as esterases which either break down the International Patent Application No. IB03/005527, designat insecticide molecule or bind to it so tightly that it cannot ing the United States and filed on Oct. 24, 2003, which function (a process known as sequestration). The second claims the benefit of priority under 35 U.S.C. S119(e) to U.S. mechanism involves mutation of the insecticide target site, Patent Application Ser. No. 60/429,546, filed on Nov. 29, Such as the acetylcholinesterase enzyme in the nervous 2002, both entitled “Cosmetic and Pharmaceutical Foam,” system. This effectively blocks the action of the insecticide. and which claims the benefit of priority under 35 Both types of mechanism have been studied in various USCS 119(a) to Israeli Patent Application No. 152486, filed species of insect. Oct. 25, 2002, all of which are hereby incorporated in their entirety by reference. 0011. A common way to overcome resistance is to add a secondary active agent, which impedes that resistance 0002 This application is a continuation-in-part applica mechanism. An example of Such secondary active agent is tion of co-pending U.S. patent application Ser. No. 10/911, piperony butoxide, which inhibits the ability of insects to 367, filed on Aug. 4, 2004, which claims the benefit of degrade insecticides such as pyrethrum. Another approach is priority under 35 U.S.C. S 119(e) to U.S. Patent Application to add Volatile solvents such as ethanol and propanol to the Ser. No. 60/492.385, filed on Aug. 4, 2003, both entitled insecticide formulation. “Foam Carrier Containing Amphiphilic Copolymer Gelling Agent” and both hereby incorporated in their entirety by 0012 U.S. Pat. No. 5,783.202 provides a pediculicidal reference. mousse composition containing (a) from about 0.1 to about 10% w/w of a pediculicidal agent, preferably, pyrethrin, and, 0003. This application claims the benefit of priority under optionally from about 0.5 to about 15% w/w of a synergizer 35 U.S.C. S119(e) to U.S. Patent Application Ser. No. therefor, such as piperonyl butoxide, (b) about 70 to about 60/696,878, filed on Jul. 6, 2005, entitled “Non-Flammable 97% w/w of a foaming agent, which is preferably a quick Insecticide Composition and Uses Thereof.” which is hereby breaking alcoholic foaming agent; and (c) from about 3 to incorporated in its entirety by reference. about 20% w/w of an aerosol propellant. BACKGROUND OF THE INVENTION 0013 A pediculocide mousse, which contains the active ingredients piperonyl butoxide (4%) and pyrethrum (0.33%) 0004. This invention relates to foamed insecticide com and the inactive ingredients cetearyl alcohol, isobutane, positions. PEG-20 Stearate, propane, propylene glycol, purified water, 0005. An insecticide is a compound used to kill or quaternium-52, SD Alcohol 3-C (26.5% w/w) is commer prevent the growth of parasite arthropods, Such as insects cially available under the name “RID Lice Killing Mousse” and/or arachnids and/or crustacean; or a compound used to (Bayer Corporation). However, this product possesses at repel or prevent infestation by parasite arthropods, such as least four disadvantages: (1) Irritability: due to the high insects and/or arachnids and/or crustacean. Common infes alcohol content, the incidence of skin and eye irritation is tations in humans include lice and scabies. high; (2) “Quick breaking property: the foam is thermo sensitive and breaks down rapidly at body temperature so 0006 Infestation with lice is referred to as pediculosis. that is cannot easily bespread manually throughout the scalp Lice are ectoparasites that live on the body. The 3 types of area; (3) Skin drying; and (4) Inflammability: 26.3% alcohol lice that parasitize humans are Pediculus humanus capitis renders the foam inflammable. A test according to European (head louse), Pediculus humanus corporis (body louse), and Standard prEN 14851, titled “Aerosol containers—Aerosol Pthirus pubis (pubic louse). foam flammability test” reveals that this product is inflam 0007 Every year, between six and 12 million people in mable. the United States, primarily children three to 10 years of age, are infested with head lice. Girls are at greater risk because 0014 Thus, the development of new formulations of they have more frequent head-to-head contact. Head lice permethrin, which will overcome these and other disadvan affect people across the Socioeconomic spectrum. tages, is warranted. 0008 Scabies is an infestation of the skin with the 0015. Furthermore, an easy to use product that addresses microscopic mite Sarcoptes scabei. Infestation is common, the frequent skin and eye irritation associated with pedicu found worldwide, and affects people of all races and social locide shampoo, cream rinses and lotions is highly desirable. classes. Scabies spreads rapidly under crowded conditions where there is frequent skin-to-skin contact between people, SUMMARY OF THE INVENTION Such as in hospitals, institutions, child-care facilities, and 0016. The present invention provides a safe and effective nursing homes. insecticide composition. In one aspect, the composition of 0009. Occasionally, a skin infection develops following a the present invention is Suitable for treating a subject bite. Scratching as a result of insect bites can damage the infested with a parasiteor preventing infestation by a para skin and allow bacteria to get in. Infection causes redness site. In some embodiments, the parasite is an arthropod. US 2007/0020304 A1 Jan. 25, 2007 0017. In one or more embodiments, the insecticide com hydroxyl group. Such as ethanol, propanol, isopropanol, position is a foamable composition, including: butanol, iso-butanol, t-butanol and pentanol, are considered less desirable solvents or polar solvents due to their skin 0018 (1) a first insecticide: irritating effect. This disadvantage is particularly meaningful 0.019 (2) at least one organic carrier selected from a in the case of an insecticide treatment, which is often hydrophobic organic carrier, a polar solvent, an emollient directed to sensitive and damaged skin and mucosal tissues. and mixtures thereof, at a concentration of about 2% to Thus, in one or more embodiments, the composition is about 5%, or about 5% to about 10%; or about 10% to about substantially alcohol-free and includes less than about 5% 20%; or about 20% to about 50% by weight; final concentration of lower alcohols, preferably less than 0020 (3) a surface-active agent; about 2%, more preferably less than about 1%. 0021 (4) about 0.01% to about 5% by weight of at least Insecticide one polymeric agent selected from a bioadhesive agent, a 0033. In the context of one or more embodiments of the gelling agent, a film forming agent and a phase change present invention, an insecticide is a compound used to kill agent; and or prevent the growth of parasite arthropods, such as insects, 0022 (5) a liquefied or compressed gas propellant at a arachnids and crustaceans, or a compound used to repel or concentration of about 3% to about 25% by weight of the prevent infestation by these parasite arthropods.
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