MXPA00012905A - Formulations for controlling human lice - Google Patents

Abstract

Safer pediculicidal formulations comprising a spinosyn, or a physiologically acceptable derivative or salt thereof, and a physiologically acceptable carrier, and methods of controlling lice infestations in a human with these formulations are provided.

Description

FORMULATIONS TO CONTROL LICE IN HUMANS DESCRIPTION OF THE INVENTION The infestation of the human body by lice is a social and health problem increasingly prevalent in many countries, including the United States. Lice are very small insects (approximately 2-3 mm in length). They deposit eggs in either the hair or the fibers of the cloth and bind them firmly with a excretion similar to a cement. The eggs usually hatch in about 6 to 10 days, depending on the temperature. The empty shells remaining after the nymphs emerge from the eggs resemble white grains of sand. These shells are called nits. The order Anoplura or sucking lice are parasites found in or near all groups of mammals. Of the 15 recognized families of Anoplura, two families, Pediculidae and Pthiridae have species that are find in humans. Pediculus humanus is the only species in the Pediculidae family that infest humans. Includes the head louse, Pediculus humanus capi tis; and the body louse or clothing, Pediculus humanus humanus, sometimes called Pediculus corporis. The crabs, Pthirus pubis, is a different species and is the Ref: 125586 only member of the Pthiridae family that infest humans. As used herein, the term "human louse or lice" includes a member of the genus Pediculus humanus or Pthirus pubis. 5 Human lice are spread by overcrowding and the common use of clothing and combs. Initially, infestations almost always resulted in irritation, but irritation could cause irritated area infections. There are at least three major diseases that are transmitted mainly by lice: epidemic typhus, trench fever and recurrent fever. Although the human lice varieties are related, each of them has specific characteristics regarding habitat and feeding. For example, head lice are small, hard-bodied ectoparasites that get stuck in the hair as they feed, mate and lay eggs. The louse must remain in the head or die in a short period of time. Head lice proliferate at incredible speed. A louse is ready to mate and reproduce after 10 hours of hatching. Under ideal conditions, a female louse can produce up to 300 eggs during its life. The ideal conditions 25 include an adequate food supply, a -., ^ ¿^^ > »^ _t. »* Iu ?? f¿ &abA? I *. ~« *. . . ~ ^ G ^ a-Sa.? * YzS g ** ^ "^ - ^^^^ ^ ^ && & < e¿¿ ^ **« * m? T environmental temperature of approximately 28 at approximately 32 ° C and a relative humidity of approximately 70 to 90% Bad hygiene and personal grooming habits are also known to contribute significantly to the spread of head lice, so head lice infestations are serious in geographic areas. where the inhabitants have housing and hygienic practices below normal, however, lice can be a problem even when the conditions are relatively sanitary.The hard chitinous exoskeleton of the louse serves as protection for the external elements. (or ova) are similarly protected by a chitinous pod that surrounds the egg and are attached to the hair.Although lice can be affected by the use of an insecticide, the eggs often remain resistant to attack. an infestac Ion by louse includes both a pediculicide, which kills adult lice, and an ovicide, which interrupts the development of the eggs. Biologically active agents have been used for some time in an attempt to control lice. For example, lindane, gamma-benzene hexachloride), organophosphates (malathion), natural pyrethrins and synthetic compounds known as pyrethroids (such as permethrin) have been used as pediculicides in formulations for the treatment of lice. However, these agents have drawbacks. For example, lindane has a poor safety profile and lice have developed resistance to this substance. Natural pyrethrins require frequent follow-up treatments because they only provide a short-term residual action. Synthetic pyrethroids, although more effective against lice than natural pediculicides, are often more toxic to the subject being treated. Spinosyns (also known as factors A83453) are agricultural insecticides that have shown activity against 1) cuncunilla of chargas and other insects of the order Lepidoptera, 2) louse of cotton and other members of the order Homoptera and 3) stable fly, blue fly of meat and mosquitoes, which are members of insect order Diptera (see U.S. Patent No. 5,362,634, infra). Spinosyn A has an excellent safety for humans and animals and an excellent toxicological profile. The present invention relates to formulations for controlling infestation by lice in a human being, comprising a spinosyn or a physiologically acceptable salt or derivative thereof and a physiologically acceptable carrier. The present invention further relates to methods for controlling an infestation by lice in a human being, comprising the topical administration to humans, of an amount of a spinosyn or a physiologically acceptable derivative / salt thereof, which controls the lice. The formulations and methods of the present invention are safer and more effective than those currently available. A particular benefit of the formulations is their effectiveness against lice species that have become resistant to the products currently used. The preferred formulations and methods of the present invention are hair care formulations, such as shampoos, lotions and conditioners, and methods for the use of these hair care formulations, to control an infestation by lice in a human being. Especially useful pediculicidal / ovicidal (anti-louse) formulations of the present invention are hair care formulations. Especially useful hair care formulations are shampoos. In another aspect, the present invention provides the use of a spinosyn, or a physiologically acceptable salt or derivative thereof, or a formulation which contains either a spinosyn or a derivative or salt thereof, for the manufacture of a medicament for controlling lice in a human being. The term "controlling an infestation by lice" as used herein, refers to the treatment of an active lice infestation or the prevention of an infestation in a human being who is likely to be exposed to a lice infestation. Spinosyns are fermentation products of natural origin. These are macrolides produced by the cultivation of Saccharopolyspora spinosa. The fermentation produces multifactors, including spinosyn A and spinosyn D (also called A83543A and A83543D). Spinosyn A and spinosyn D are two spinosyns that are most active as insecticides. A product comprised primarily of these two spinosyns (approximately 85% A and 15% D) is commercially available from Dow Agrosciences under the trade name spinosad. The name "spinosad" comes from a contraction of spinosyns "A" and "D". Each spinosyn has a 12-membered macrocyclic ring that is part of an unusual tetracyclic ring system to which two different sugars are attached, the amino sugars forosamine and the neutral sugar 2N, 3N, 4N-tri-0-methyl-rhamnose. This unique structure sets apart the spinosyns from the other macrocyclic compounds. Spinosyn A (A83543A) was the first isolated and identified spinosyn from the fermentation broth of Saccharapolyspora spinosa. Subsequent examination of the fermentation broth revealed that the progenitor strain of S. spinosa produced a number of spinosyns, which were designated from A to J (A83543A to J). Compared to spinosyn A, spinosyns B-J are characterized by differences in the amino group substitution patterns of the forosamine, in selected sites of the tetracyclic ring system and in 2N, 3N, 4N-tri-0-methylrimanose. The strains of S. spinosa currently in use produce a mixture of spinosyns from which the primary components are spinosyn A (~ 85%) and spinosyn D (~ 15%). Additional spinosyns have been identified, which were assigned the letters from K to W, from mutant strains of S. spinosa. The term "spinosyn or a derivative thereof" as used herein, refers to an individual spinosy factor (A, B, C, D, E, F, G, H, J, K, L, M , N, O, P, Q, R, ST, U, V, W or Y), a N-desmethyl derivative of an individual spinosyne factor or a combination thereof. For convenience, the term "component ? ÚSJUr tp a & fliw - - - »& -. > "J & 8fc"; "M_" spinosyn "will also be used herein to refer to an individual spinosyn or a physiologically acceptable salt or derivative thereof, or a combination thereof 5 Boeck et al. described the spinosynes AH and J (which he named factors A83543 A, B, C, D, E, F, G, H and J) and salts thereof, in US Pat. Nos. 5,363,634 (issued November 8) 1994), 5,496,932 (issued March 5, 1996), and 5,571,901 (issued November 5, 1996). Mynderse et al. described the spinosyns L-N (which they called factors A83543 L, M and N), their N-demethyl derivatives and salts thereof, in US Pat. No. 5,202,242 (issued April 13, 1993); and Turner et a. described the QT spinosyns (referred to as factors A83543 Q, R, S and T), their N-demethyl derivatives and salts thereof, in US Pat. Nos. 5,591,606 (issued January 7, 1997) and 5,631,155 ( issued on May 29, 1997). These patents are incorporated herein by reference. Spinosyns K, O, P, U, V, W and Y are described, for example, in Cari V. DeAmicis, James E. Dripps, Chris J. Hatton and Laura I. Karr in American Chemical Society's Symposium Series: Phytochemicals for Pest Control, Chapter 11, "Physical and Biological Properties of Spinosyns: Novel Macrolide Pest-Control Agents from Fermentation ", pages 146-154 (1997) Spinosynes can react to form salts Salts that are physiologically acceptable are also useful in the formulations and methods of the present invention. standard procedures for the preparation of salts For example, spinosyn A can be neutralized with an appropriate acid to form an acid addition salt.

Acid addition salts of the spinosyns are particularly useful. Representatives of such acid addition salts include salts formed by the reaction of an organic or inorganic acid such as, for example, sulfuric, hydrochloric, phosphoric, acetic acid, Succinic, citric, lactic, maleic, fumaric, colic, pamoic, mucic, glutamic, camphoric, glutaric, glycolic, italic, tartaric, formic, lauric, stearic, salicylic, methanesulfonic, benzenesulfonic, sorbic, picric, benzoic, cinnamic and the like . In addition to the spinosyn component, the formulations of the present invention may include one or more compounds having activity against lice, such as for example synthetic pyrethroids, natural pyrethrins and lindane. All relationships, percentages and parts described herein, are given "by weight" unless otherwise specified. The anti-lice formulations of the present invention can be formulated in a number of ways. Particularly useful formulations are shampoos, conditioners and lotions. These formulations optionally also comprise one or more of the following: a) a surfactant; b) from about 1 to about 10% of a non-volatile silicone material; and / or c) from about 0.5 to about 5% of a suspending agent. The shampoo formulations of the present invention comprise a spinosyn or a physiologically acceptable salt or derivative thereof, together with water, a surfactant and an amide, and optionally may comprise another anti-louse agent, a silicone compound, a suspending agent and others. Cosmetically acceptable components. Human hair becomes dirty due to contact with the surrounding atmosphere and the accumulation of sebum secreted by the head. When the hair gets dirty, it has a dirty feeling and an unattractive appearance. The shampoo formulations of the present invention both clean the hair and effectively control lice infestation. - li ¬ when used in a shampoo formulation, the spinosyn component is present in an amount of from about 0.1 to about 30%, preferably from about 1 to about 10%. The surfactants suitable for use in these formulations can be any of a wide variety of synthetic anionic, amphoteric, zwitterionic and nonionic surfactants. Surfactants are generally present in shampoo formulations in amounts of about 5 to about 30%, preferably about 15 to about 25%. Examples of synthetic anionic surfactants are the alkali metal salts of organic sulfuric reaction products having an alkyl radical which contains from 8 to 22 carbon atoms and an ester radical of sulfonic acid or sulfuric acid (in the term alkyl the alkyl portion of the higher acyl radicals is included). Sodium, ammonium, potassium or triethanolamine alkyl sulfates are preferred, especially those obtained by sulfation of higher alcohols (from 8 to 18 carbon atoms); monoglycerides sulfates and sodium sulfonates of coconut oil fatty acid; Sodium or potassium salts of sulfuric acid esters of the reaction product of 1 mole of a fatty alcohol Higher (e.g., tallow alcohol or alcohol of coconut) with one to 12 moles of ethylene oxide, the sodium or potassium salts of alkylphenoletylene oxide ether sulfate having 1 to 10 ethylene oxide units per molecule and wherein the alkyl radicals contain from 8 to 12 carbon atoms; sodium alkyl glyceryl ether sulfonates, the product of the reaction of fatty acids having from 10 to 22 carbon atoms esterified with isethionic acid and neutralized with sodium hydroxide; and water-soluble salts of condensation products of fatty acids with sarcosine. Examples of zwitterionic surfactants are derivatives of aliphatic quaternary ammonium, phosphonium and sulfonium compounds, wherein the aliphatic radicals can be straight or branched chain and wherein one of the aliphatic substituents contains from 8 to 18 carbon atoms and one contains a water-solubilizing anionic group, eg, carboxy, sulfonate, sulfate, phosphate or phosphonate. A general formula for these compounds is: wherein R) 2 contains an alkyl, alkenyl or hydroxyalkyl radical of from about 8 to about 18 carbon atoms, from 0 to about 10 portions of ethylene oxide and from 0 to 1 glyceryl portions; And it is a nitrogen, phosphorus or sulfur atom; R3 is an alkyl or monohydroxyalkyl group of 1 to about 3 carbon atoms; x is 1 when Y is sulfur and 2 when Y is nitrogen or phosphorus; R 4 is an alkylene or hydroxyalkylene radical of 1 to about 4 carbon atoms and Z is a carboxylate, sulfonate, sulfate, phosphonate or phosphate radical. Some examples include: 4- [N, N-di (2-hydroxyethyl) -N-octadecylammonio] -butane 1-carboxylate; 5- [S-3-hydroxypropyl-S-hexadecylsulfonium] -3-hydroxypentane-1-sulfate; 1-phosphate of 3- [P, P-diethyl-P-3,6,9-trioxatetradexocylphosphonium] -2-hydroxypropane; 1-phosphate of 3- [N, N-dipropyl-N-3-dodecoxy-2-hydroxypropylammonio] -propane; 3- (N, N-dimethyl-N-hexadecylammonium) -propane-1-sulfonate; 3- (N, N-dimethyl-N-hexadecylammonium) -2-hydroxypropane-1-sulfonate; N, N-di (2-hydroxyethyl) -N- (2-hydroxydecyl) -ammonium] -butane-1-carboxylate; 1-phosphate of 3- [S-ethyl-S- (3-dodecoxy-2-hydroxypropyl) -sulfonium] -propane; 1-phosphonate 3- [P, P-dimethyl-P-dodecylphosphonium] -propane; and 5- (N, N-di- (3-hydroxypropyl) -N-hexadecylammonium] -2-hydroxypentane-1-sulfate Other zwitterionic surfactants, such as betaines, are also useful in the formulations of the present invention. examples of betaines include the higher alkyl betaines, such as cocodimethylcarboxymethyl betaine, lauryldimethylcarboxymethyl betaine, lauryldimethyl-alpha-carboxyethyl betaine, cetyldimethylcarboxymethyl betaine, lauryl-bis- (2-hydroxyethyl) -carboxymethyl betaine, stearyl-bis- (2-hydroxypropyl) -carboxymethyl betaine, oleyldimethyl-gamma-carboxypropyl betaine and lauryl-bis- (2-hydroxypropyl) -alpha-carboxyethyl betaine The sulfobetaines can be represented by cocodimethylsulfopropyl betaine, stearyldimethylsulfopropyl betaine, lauryldimethylsulfoethyl-betaine, lauryl-bis- (2- hydroxyethyl) -sulfopropyl betaine and the like Amidobetaines and amidosulfobetaines, wherein a radical RCONH (CH2) 3 is attached to the nitrogen atom of betaine, also they are useful in the formulations of the present invention.

Examples of amphoteric surfactants that can be used in the formulations of the present invention are those derived from secondary or tertiary aliphatic amines, wherein the aliphatic radical is straight or branched chain and wherein one of the aliphatic substituents contains about 8 to about 18 carbon atoms and one contains an anionic water-solubilizing group, eg carboxy, sulfonate, sulfate, phosphate or phosphonate. Examples of surfactants Amphoteric acids are sodium 3-dodecylaminopropionate, sodium 3-dodecylaminopropane sulfonate, N-alkyltaurines such as that prepared by reacting N-dodecylamine with sodium isothionate (see US Pat. No. 2,658,072, Example 3), alkyl aspartic acids N-15 above (see US Patent No. 2,438,091) and products sold under the trade name "Miranol" and which are described in US Patent No. 2,528,378. Nonionic surfactants, which are preferably used in combination with an anionic surfactant, amphoteric or zwitterionic, are compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkylaromatic in nature. Some examples of nonionic surfactants include: 1) Polyethylene oxide condensates of alkyl phenols, e.g., the condensation products of alkylphenols having an alkyl group containing from about 6 to 12 carbon atoms in a The configuration is either linear, or chain branched, with ethylene oxide, wherein the ethylene oxide is present in amounts of 10 to 60 moles of ethylene oxide for each mole of alkylphenol. The alkyl substituent in these compounds can be derived from polymerized propylene, diisobutylene, octane or unborn, for example. 2) Condensates of ethylene oxides with a product of the reaction of propylene oxide with ethylenediamine products, which may have various formulations depending on the desired balance between the hydrophobic and hydrophilic elements. For example, compounds containing from about 40 to about 80% polyoxyethylene by weight and having a molecular weight of from about 5,000 to about 11,000 resulting from the reaction of ethylene oxide groups with a hydrophobic base comprising the reaction product of ethylenediamine with an excess of propylene oxide and having a molecular weight in the order of 2,500 to 3,000 are satisfactory. 3) The product of the condensation of aliphatic alcohols having 8 to 18 carbon atoms, either -ssa * á *)? ái * A ~?! *. ^^? ^ 9sm? A ^^ & r ^ £ ^ iSisr & kZii- & .--; ^ 7 - li ¬ in a straight or branched chain configuration, with ethylene oxide, eg, an ethylene oxide of condensed coconut alcohol having from 10 to 30 moles of ethylene oxide for each mole of coconut alcohol, wherein the fraction of Coconut alcohol has 10 to 14 carbon atoms. 4) Long chain tertiary amine oxides corresponding to the following general formula: R1RZR3 - + • O wherein Ri contains an alkyl, alkenyl or monohydroxyalkyl radical of from about 8 to about 18 carbon atoms, from 0 to about 10 portions of ethylene oxide and from 0 to 1 glyceryl portions, and R2 and R3 contain from 1 to about 3 carbon atoms and from 0 to about 1 hydroxy groups, e.g., methyl, ethyl, propyl, hydroxyethyl or hydroxypropyl. The arrow in the formula represents a semipolar link. Some examples of amine oxides suitable for use in the formulations of the present invention, include dimethyldodecylamine oxide, oleyl-di- (2-hydroxyethyl) -amine oxide, dimethyloctylamine oxide, dimethyldecylamine oxide, dimethyltetradecylamine oxide, 3, 6, 9-trioxaheptadecyldietylamine oxide, di (2-hydroxyethyl) oxide tetradecylamine, 2-oxide dodecoxyethyldimethylamine, 3-dodecoxy-2-hydroxypropyl-di- (3-hydroxypropyl) -amine oxide and dimethylhexadecylamine oxide. 5) Long chain tertiary phosphine oxides of the following general formula: RRRfc 0 wherein R contains an alkyl, alkenyl or monohydroxyalkyl radical of about 8 to 18 carbon atoms, from 0 to about 10 ethylene oxide portions and from 0 to 1 glyceryl portions, and R 'and Rn are each an alkyl group or monohydroxyalkyl containing from 1 to 3 carbon atoms. The arrow in the formula represents a semipolar link. Examples of suitable phosphine oxides include: dodecyldimethylphosphine oxide, tetradecyldimethylphosphine oxide, tetradecylmethylethylphosphine oxide, 3, 6, 9-trioxaoctadecyldimethylphosphine oxide, cetyl dimethylphosphine oxide, 3-dodecoxy-2-hydroxypropyl-di- (2- hydroxyethyl) -phosphine, stearyldimethylphosphine oxide, cetylethylpropylphosphine oxide, oleyldiethylphosphine oxide, dodecyldiethylphosphine oxide, tetradecyldiethylphosphine oxide, dodecyldipropylphosphine oxide, dodecyl di (hydroxymethyl) -phosphine, dodecyldi (2-hydroxyethyl) -phosphine oxide, tetradecylmethyl-2-hydroxypropylphosphine oxide, oleyldimethylphosphine oxide, 2-hydroxydedecyldimethylphosphine oxide. 6) Long chain dialkyl sulfides containing a short chain alkyl radical or a hydroxyalkyl radical of 1 to 3 carbon atoms (usually methyl) and a long chain hydrophobic radical containing alkyl, alkenyl, hydroxyalkyl or ketoalkyl radicals of about 8 to about 20 carbon atoms, from about 0 to about 10 portions of ethylene oxide and from 0 to 1 glyceryl portions. Some examples include: octadecylmethylsulfoxide, 2-ketothrecylmethylsulfoxide, 3,6,9-trioxaoctadecyl-2-hydroxyethyl sulfoxide, dodecylmethylsulfoxide, oleyl-3-hydroxypropylsulfoxide, tetradecylmethylsulfoxide, 3-methoxytridecylmethylsulfoxide, 3-hydroxytridecylmethylsulfoxide and 3-hydroxy-4-dodecoxybutylmethylsulfoxide. Numerous additional non-soap surfactants are described in McCutcheon's Detergents and Emulsifiers, 1998 annual, published by M.C. Publishing Company, Inc .; McCutcheon Division, 175 Rock Rd., Glen Rock, NJ, 07425, U.S.A. ~ ¿& £ fassiaE * r. ~ L. a ^ - ^ • sa ^; * ^. -. ,. The anionic surfactants, particularly the alkyl sulfates, ethoxylated alkyl sulfates and mixtures thereof, as well as the amidobetaines are preferred for use in the shampoo formulations of the present invention. The amides increase the foaming of the formulations by emulsifying the components of the shampoo and the active component (s). The amides used in the present formulations can be any of the fatty acid alkanolamides known to be used in shampoos. These are usually monoethanolamides and fatty acid diethanolamides having from about 8 to about 14 carbon atoms, other suitable amides are those having multiple ethoxy groups, such as PEG-3 lauramide. In shampoo formulations, the amide is generally present at a level of from about 1 to about 7%, preferably from about 2 to about 5% of the formulation. Preferred amides are coconut monoethanolamide, coconut diethanolamide and mixtures thereof. The shampoo formulations of the present invention also contain water. Water is typically present in the shampoos at levels of from about 50 to about 80%, preferably from about 60 to about 75%. After adding water, the relative viscosity of the formulation generally ranges from about 4,000 to about 25,000 centipoise (cp), preferably from about 4,000 to about 12,000 cp, more preferably from about 4,000 to about 5,500 cp, measured at 1 rpm at 26.7 ° C for 3 minutes, using a Wells-Brookfield viscometer, model DV-CP-2 DVII, or Cone model CP-41. The viscosity modifiers and Hydrotropes can be included to give the formulation a viscosity within these ranges. Shampoo formulations may also include one or more optional components, such as silicone compounds, suspending agents and components that cause the formulation is cosmetically more acceptable. The silicone compounds condition the hair and facilitate the removal of dead lice, their eggs and nits. Non-volatile silicone materials are used at levels of approximately 1 to approximately 10% of the formulations. Examples of useful silicone compounds are those described in U.S. Patent No. 5,292,504 to Cardin et al., Issued March 8, 1994, which is incorporated herein by reference. i rfg-. & amp; amp; amp; & amp; & amp; < RTI > Compounds containing non-volatile silicones are preferred and are used at levels of from about 0.1 to about 10%, preferably from about 0.25 to about 3% by weight of the formulation . Examples of non-volatile silicones are polyalkylsiloxanes, polyalkylarylsiloxanes, polyethersiloxane copolymers and mixtures thereof. Useful polyalkylsiloxanes include, for example, polydimethylsiloxanes (PDMS) with viscosities ranging from about 5 to 15,000,000 cp at 25 ° C. These siloxanes are available, for example, in the General Electric Company as the Viscasil series and in Dow Corning as the Dow Corning 200 series. The viscosity can be measured by means of a glass capillary viscometer, as established in the method of test of Dow Corning Corporation CTM0004, July 20, 1970. Useful polyalkylaryl siloxanes include polymethylphenylsiloxanes having viscosities from about 5 to about 15,000,000 cp at 25 ° C. These siloxanes are available, for example, in General Electric Company as the SF 1075 methylphenyl fluid or in Dow Corning as 556 Cosmetic Grade Fluid. Polyethersiloxane copolymers include polydimethylsiloxanes modified with polypropylene oxide (available, for example, in Dow Corning as DC-1248), ethylene oxide or mixtures of ethylene oxide and propylene oxide. Insoluble in water are more useful. The siloxanes are able to condition the hair due to its ability to lubricate the hair, providing benefits for wet and dry combing. Higher molecular weight viscous siloxanes provide the best conditioning benefits and, therefore, are preferred. The fluids and gums of the siloxane polymers are the most desirable. Siloxane polymer gums are rigid as opposed to a liquid or fluid, with high molecular weight of about 200,000 to about 1,000,000 and with viscosities of about 100,000 to about 150,000,000 cp at 25 ° C. Such gums are described in U.S. Patent No. 5,292,504 (supra). Suspending agents can be included to improve long-term stability. Useful suspending agents include fatty amphiphilic crystalline materials having needle-like structures or platelets, polymeric materials, clays, fuming metal oxides and mixtures thereof. These agents are known in the art (see U.S. Patent No. 5,292,504). Suitable crystalline amphiphilic materials are those having needle or type structures .nuaS ^ m ^ mt ^ wK .. ^ MEs ^ - ^ atÉas - platelet. Such compounds include long chain acyl derivatives (from 16 to 22 carbon atoms) such as ethylene glycol esters of fatty acids (e.g. ethylene glycol distearate); long chain alkanolamides (16 to 22 5 carbon atoms) of fatty acids, such as stearamide MEA, stearyl stearate and distearyl dithiopropionate; and mixtures thereof. Polymeric materials that are useful as suspending agents include polycyclic acids crosslinked (such as the Carbopol series, available from B.F. Goodricch Chemical Company), guara gum and its derivatives, xanthan gum, crosslinked ethylene / maleic anhydride copolymers and mixtures thereof. The clays and oxides of smoky metals also are effective as suspending agents. Some examples include magnesium and aluminum silicates (such as the Veegum series, available from R. T. Vanderbilt Company, Inc.), sodium and aluminum silicates (such as the Laponite series, available from Laponite, United States), silica smokers, fuming alumina, fuming titania and mixtures thereof. In the shampoo formulations of the present invention, the suspending agents are generally present in amounts of about 0.5 to about 5%, preferably from 0.5 to about - < afe ** .- * -, * ~. ^ ^ * - "*? *» ¿^ & 3i? tf? * &'' & ** > *! and *, 3%. Long chain acyl derivatives such as ethylene glycol esters of fatty acids are preferred. The most preferred one is ethylene glycol distearate. Other optional components can improve the cosmetic acceptability of the formulations, which are known in the art and include, for example, preservatives such as methylparaben, propylparaben, methylisothiazolinone and imidazolidinyl urea; Thickening agents and viscosity modifiers such as amine oxides, block polymers of ethylene oxide and propylene oxide (such as Pluronic F88 marketed by BASF Wyandotte), fatty alcohols (such as cetearyl alcohol), sodium chloride, ammonium chloride, sodium sulfate, polyvinyl alcohol , propylene glycol and alcohol ethyl; hydrotropes such as xylene sulfonate, pH adjusting agents such as citric acid, succinic acid, phosphoric acid, sodium hydroxide and sodium carbonate; perfumes, dyes, quaternary ammonium compounds, such as Polyquaternium 41, agents sequestrants such as disodium ethylenediaminetetraacetate; and pearlizing agents such as ethylene glycol distearate acid ester, stearic acid diesters and polyethylene glycol palmitic acid and stearic acid monoethanolamide. Generally these optional components set individually used at a level of about 0.1 to about 10% of the formulation. The shampoo formulations of the present invention are used in a conventional manner to clean the hair. About 10 to about 30 g of the formulation are applied to the wet hair and it is well spread throughout the hair and scalp. The formulation is left on the hair and scalp for about 6 to 10 minutes and then removed by rinsing. This process is repeated until the hair is clean. lindane These conditioning formulations can also be used effectively for the treatment of lice infestation. Hair conditioners are products that improve the look, feel and manageability of hair. Conditioners are particularly important when the hair has been damaged by treatments such as application of permanent waving, drying, mistreatment and discoloration, or by atmospheric conditions such as sunlight, which cause photocatalyzed oxidation. These factors can cause the hair to have a poor texture, making it difficult to handle and comb it, whether dry or wet. When used in a hair conditioner formulation, the spinosyn component is present at a level of from about 0.1 to about 30%, preferably from about 1 to about 10%. Conditioning products are well known and include "rinse-type" products, which are rinsed off shortly after being applied to clean hair and "deep conditioners" which remain in the hair for extended periods of time. A group of conditioners useful in the hair conditioner formulations of the present invention are long-chain quaternary ammonium compounds combined with lipid materials, such as fatty alcohols (see US Patent No. 3,155,591 to Hilfer, issued March 3, 1995). November 1964 and 5 US Patent No. 4,269,824 to Villamarin et al., issued May 26, 1981). Another group of conditioners are lipid and quaternary ammonium compounds. These conditioners are used to form gel-type conditioning products that have good cosmetic and rheological characteristics during use. These types of gel-like formulations are generally described in the following documents: Barry, "The Self Bodying Action of the Mixed Emulsifier Sodium Docecil Sulfate / Cetyl Alcohol", J. of Colloid and Interface Science, 28, 82-91 (1968 (; Barry et al., "The Self-Bodying Action of Alkyltrimethylammonium Bromides / Cetostearyl Alcohol Mixed Emulsifiers; Influence of Quarternary Chain Length ", J. of Colloid and Interface Science, 35, 689-708 (1971 (, and Barry et al.," Rheology of Systems Containing Cetomacrogo / 1000 - (cetostearyl alcohol), I. Self-Bodying Action, "J. of Colloid and Interface Science, 38, 616-625 (1972) .The lipid materials used in these conditioners are present at a level of about 0.5 to about 3%. These lipids they are essentially insoluble in water and contain hydrophobic and hydrophilic portions. These include materials derived from natural and synthetic fatty acids which are selected from the group consisting of acids, acid derivatives, alcohols, esters, ethers, ketones, amides and mixtures thereof, having alkyl chain lengths of about 12 to about 22 carbon atoms, preferably 16 to 18 carbon atoms in length. Fatty alcohols and fatty esters are preferred. Useful fatty alcohols are known (see, for example, U.S. Patent No. 3,155,591, supra; U.S. Patent No. 4,165,369 (Watanabe et al., Issued May 26, 1981); British Patent Specification No. 1,532,585, published November 15, 1978; Fukushima et al., "The Effect of Cetostearyl Alcohol in Cosmetic Emulsions", Cosmetics & Toiletries, 98, 89-102 (1983); and Hunting, Enclyclopedia of Conditioning Rinse Ingredients, in 204 (1987). Fatty alcohols are alcohols of 12 to 16 carbon atoms which are selected from the group consisting of cetearyl alcohol, cetyl alcohol, isostearyl alcohol, lanolin alcohol, lauryl alcohol, oleyl alcohol, stearyl alcohol and mixtures thereof. Preferred are cetyl alcohol, stearyl alcohol and «.-. Y-.g- ~ S ?? XYí? -:., -..- •, - .. * yy.y.i -. -. . -, - ,. ^ ¿-X¿ü * 3zMjSÉJ & > .sY? mixtures thereof. A particularly preferred fatty alcohol is comprised of a mixture of cetyl alcohol and stearyl alcohol containing from about 55 to about 65% (by weight of the mixture) of cetyl alcohol. Useful fatty esters are also known (see Kaufman et al., U.S. Patent No. 3,341,465, issued September 12, 1967). Fatty esters are fatty acids in which the active hydrogen has been replaced by the alkyl group of a monohydric alcohol. The monohydric alcohols are fatty alcohols as described, supra. Fatty esters useful in these conditioner formulations include cetyl lactate, cetyl octanoate, cetyl palmitate, cetyl stearate, glyceryl monostearate, glyceryl laurate, glyceryl myristate, glyceryl oleate, glyceryl stearate, glyceryl monoacetate. and mixtures thereof. Cetyl palmitate and glycerol monostearate or mixtures thereof are preferred. Cationic surfactants can be used in these conditioner formulations, either alone or in combination, generally in an amount of about 0.1 to about 5% of the final formulation. These surfactants contain amino or feá = i. -B ^ »-» faith < Hydrophilic quaternary ammonium having positive charge when dissolved in the aqueous formulations of the present invention. These cationic surfactants are known in the art (see McCutcheon's Detergents &Emulsifiers, supra, Schwartz et al., Surface Active Agents, Their Chemistry and Technology, New York: Interscience Publishers, 1949, US Patent No. 3,155,591, supra, US Pat. No. 3,929,678 (Laughiin et al., Issued December 30, 1975), US Patent No. 3,959,461 (Bailey et al., Issued May 25, 1976), and US Patent No. 4,387,090 (Bolich, Jr., Issued June 7, 1983.) Useful quaternary ammonium cationic surfactant materials are those of the general formula: wherein Ri is a hydrogen atom, an aliphatic group of 1 to 22 carbon atoms or an aromatic, aryl or alkylaryl group having from 12 to 22 carbon atoms; R2 is an aliphatic group of 1 to 22 carbon atoms; R3 and R4 are each alkyl groups of 1 to 3 carbon atoms and X is an anion selected from the group consisting of halogen, acetate, phosphate, nitrate and alkyl sulfate. ^^ iS ^ ^^^. ^^^ ¡^ S ^^ Aliphatic groups may contain bonds and other groups such as amido groups, in addition to carbon and hydrogen atoms. Other useful quaternary ammonium salts have the formula: R2 R4 ++ R N- (CH2) 3-f ^ 6 2X R3 Rs wherein at least one, but not more than 3 of the R groups is an aliphatic group having from 16 to 22 carbon atoms and the remaining R groups are selected from the group Which consists of hydrogen atoms and alkyl radicals of 1 to 4 carbon atoms, and X is an ion selected from the group consisting of halogen, acetate, phosphate, nitrate and alkyl radicals. Sebacic propane diammonium dichloride is an example of this type of salt quaternary ammonium. The quaternary ammonium salts useful herein also include the dialkyldimethylammonium chlorides, wherein the alkyl groups have from 12 to 22 carbon atoms. These alkyl groups are can be derived from long chain fatty acids, such as hydrogenated tallow fatty acid. The tallow fatty acid gives rise to quaternary compounds where Ri and R2 they predominantly have 16 to 18 carbon atoms. Examples include ditallowdimethylammonium chloride, ditallowdimethylammonium methylisulfate, dihexadecyldimethylammonium chloride, di (hydrogenated tallow) -dimethylammonium chloride, dioctadecyldimethyl-ammonium chloride, diemyldimethylammonium chloride, didocosyldimethylammonium chloride, di (hydrogenated tallow) -dimethylammonium acetate, dihexadecyldimethylammonium chloride, dihexadecyldimethylammonium acetate, disodium propylammonium phosphate, ditallowdimethylammonium nitrate, di (alkyl-coconut) -dimethylammonium chloride and stearyldimethyl-benzylammonium chloride. Preferred quaternary ammonium salts useful herein include ditallowdimethylammonium chloride, dicetyldimethylammonium chloride, stearyldimethylbenzyl ammonium chloride, cetyltrimethylammonium chloride, tricetylmethylammonium chloride, and mixtures thereof. Di (hydrogenated tallow) -dimethylammonium chloride (Quaternium-18) is a particularly preferred quaternary ammonium salt and is available from Sherex Chemical Company, Inc. under the names Adogen 442 and Adogen 442-100P. Salts of primary, secondary and tertiary fatty amines can also be used as cationic surfactant. Alkyl groups of such amines preferably have from 12 to 22 carbon atoms and may or may not be substituted. Secondary and tertiary amines are preferred; and tertiary amines are particularly preferred. Examples of useful amines include stearamidopropyldimethylamine, diethylaminoethyl-5-stearamine, dimethylstearamine, dimethyloxyamine, soyamine, myristylamine, tridecylamine, ethylstearylamine, N-sebopropanediamine, ethoxylated stearylamine) 5 moles of ethylene oxide), dihydroxyethylstearylamine and arachidylbehenylamine. The right amine salts include the halogen, acetate, phosphate, nitrate, citrate, lactate and alkyl sulfate salts. Some examples include stearylamine hydrochloride, soyamine chloride, stearylamine formate, N-sebopropanediamine dichloride, and stearmidopropyldimethyl-15-amine citrate. Useful cationic amine surfactants are also described in U.S. Patent No. 4,275,055 (Nachtigal et al., Issued June 23, 1982). Water is an essential ingredient in conditioning formulations. Water is added in the The last stage of the preparation of the conditioner, using an amount sufficient to bring the mixture (c.b.p.) to 100%. The optional ingredients in the conditioner formulations include conditioning agents for silicone that can be used for their characteristics igj «w ^ i¿ ^ * ^ ± y-Jága ^^^^» > ^ 2 ^, ^. »-r- ^ SfesS l§ife? Ii¡Mfea '-«, - jMiM¡ -a, < > & * • »« .fcgguafe cosmetic and rheological. Silicone oils and silicone polymers are well-known conditioning agents. For example, volatile silicones, organilicone polymers in water-alcohol mixtures and volatile silicone fluids are described in US Pat. No. 5,292,502 supra. The formulation may include one or more silicones of those described for use in the shampoo formulations, supra. These silicones include volatile and non-volatile polyalkylsiloxanes, polyalkylarylsiloxanes and mixtures thereof. These can be used in amounts of about 0.2 to about 5% of the final formulation. As with shampoos, the higher viscosity silicone gums of the siloxanes described above are preferred. These gums are rigid, as opposed to fluids, with high molecular weights of about 200,000 to about 1,000,000 and viscosities of about 100,000 to about 20,000,000,000 cp, at 25 ° C. Most preferred are polydimethylsiloxane gums. A significant amount of the lipid material of the conditioner is often deposited on the hair, leaving it greasy. Therefore, the conditioner formulations may incorporate silicone copolyols ^ Y - ^? ? ^ ^ -S¿ ^^^^? ^^^^ ¿, -s ^ ^ ^ ^ ^ ^ ^ S ^ - to provide optimal conditioning benefits with lice treatment. See European Patent Application 155,806, published September 25, 1985. 5 Silicone copolyols are dimethyl polysiloxanes modified with polyalkylene oxide, referred to herein as "dimethicone copolyols", which act as emulsifiers and reduce the deposition of vehicle materials (materials lipids and / or cationic surfactants) on the hair. Useful dimethicone copolyols are also described in U.S. Patent No. 5,292,504, supra. The silicone copolyol is generally present in an amount of about 0.1 to about 10%, preferably from about 0.1 to about 2% of the final formulation. Dimethicone copolyols are preferred for this use. Dow Corning 190 silicone surfactant is a preferred dimethicone copolyol. 20 The formulations may also contain components that modify the physical and performance characteristics of the conditioning product. Such components include additional surfactants, salts, buffer solutions, thickeners, solvents, opacifiers, pearl agents, preservatives, fragrances, dyes, dyes, pigments, chelants, sunscreens, vitamins and medicinal agents. Examples of these types of components are described in U.S. Patent No. 4,387,090 (Bolich, Jr., issued June 7, 1983). The formulations may also contain optional surfactant materials in amounts such that the total level of surfactant present in the formulation (including the cationic surfactant carrier material, described supra) is from about 0.05 to about 5%. These optional surfactant materials may be anionic, non-ionic or amphoteric. some examples are ceteareth-20, steareth-20, sorbitan monoesters, sodium tallowalkylsulfate and sebo-betaine. Optional surfactant materials are described in McCutcheon's Detergents &; Emulsifiers, supra; Schwarts et al., Supra; and in U.S. Patent No. 3,929,678 supra. The preferred optional surfactant materials are non-ionic. Such surfactants are commonly produced by the condensation of an alkylene oxide (hydrophilic in nature) with an organic hydrophobic compound; that is, normally of aliphatic or alkylaromatic nature. The length of the hydrophilic or polyalkylene portion that condenses with any compound Particular hydrophobic, can be adjusted to obtain a water-soluble compound that contains the desired degree of balance between the hydrophilic and hydrophobic elements. Such nonionic surfactants include the condensates of alkylphenols with polyethylene oxide, the products of the condensation of aliphatic alcohols with ethylene oxide, products of the condensation of ethylene oxide with a hydrophobic base formed by the condensation of propylene oxide with propylene glycol, and condensation products of ethylene oxide with the product resulting from the reaction of propylene oxide with ethylene diamine. Another variety of nonionic surfactants are non-polar nonionic surfactants, typified by amine oxide surfactants. Preferred nonionic surfactants include ceteareth-20, steareth-20 and ceteth-2. You can also add salts and regulatory solutions in order to modify the rheology of the product. For example, salts such as potassium chloride, ammonium chloride and sodium chloride may be added in amounts of about 0.001 to about 1%. Regulatory solutions such as citrate or phosphate buffer solutions can also be added. The formulations of the present as finally formulated, preferably have a pH of from about 3 to about 10, preferably from about 3 to about 7. Additional conditioning components can also be incorporated into the formulations. For example, proteins can be added in amounts of about 0.1 to about 10%. Cationic proteins can serve as surfactant carrier materials. Thickening agents are preferred optional components. Such thickeners include nonionic thickening agents that are incorporated in amounts of about 0.1 to about 8%. Such agents are polymers that exhibit viscosities that exceed about 20,000 cp at low cut (approximately 10"2 sec" 1). Some examples are polyoxyethylene, guara gum, methylcellulose, methylhydroxypropylcellulose, polypropylcellulose, polypropylhydroxyethylcellulose, hydroxyethylcellulose, starches and starch derivatives and mixtures thereof. Nonionic thickening agents are described in U.S. Patent No. 4,387,090 (Bolich et al., Issued June 7, 1983). The thickening agents are used to give the formulation a viscosity of about 10.625 to about 14.375 cp (measured with a Wells-Brookfield viscometer, model RVT DV-CP-2, model DV-11, model Cone CP-52, using H ml at 1 r.p.m., at 26.7 ° C for 1 minute). The hair conditioner formulations of the present invention are generally used on the hair after all the shampoo has been removed by rinsing with water. The present invention also provides a method for treating human hair to kill and facilitate the removal of lice and lice eggs, comprising the steps of: (a) applying from about 10 to about 30 grams of a formulation of the present invention , to damp hair; (b) rubbing the formulation throughout the scalp; (c) leaving the formulation in the hair and scalp for approximately 6 to 10 minutes; and (d) removing the hair formulation by rinsing with water. Lotions against lice that comprise a spinosyn or a physiologically acceptable salt or derivative thereof and a lotion vehicle are another aspect of the present invention. These lotions can be applied directly to hair in liquid form or in the form of dew. They are formulated to be applied to hair »< »* A - *? J < ma »j. »-,. c • t ^ rl? Ja > llíutt? ß ^? ^! ?? "Jíi ~ ^ tai) tur« tr. ·. I. Yi¡-yS ^? Í ^ mt¿í? T?., ^. ». > Y ¿, '-? Í ^ ? ...... «K« »" ut- ^ «*«. »Nra» *? & .2, * .. for a period of time and not immediately removed by rinsing with water. When used in a lotion formulation, the spinosyn component is generally present in an amount of from about 0.1 to about 30%, preferably from about 1 to about 10%. In addition to the spinosyn component, the lotion formulations comprise a liquid carrier such as alcohol, water or a mixture thereof, to assist to the distribution of the spinosyn component in the hair. Suitable alcohols are monohydric alcohols such as methanol, ethanol, isopropanol or mixtures thereof. As the alcohols can have a deteriorating effect on the stability of the formulations, water alone is preferred as a vehicle. The vehicle is added in an amount sufficient for (c.b.p.) that the formulation reaches 100%. The lotion formulations may include optional components to provide benefits to the hair in addition to the activity against lice. Optional components include: preservatives and antimicrobials, such as DMDM hydantoin and tetrasodium AEDT; agents for pH balancing such as sodium citrate and citric acid; emulsifiers such as 5 PEG-60, castor oil; and thickeners and modifiers &UMÚL k * - & *. ? .A-, viscosity such as polyvinylpyrrolidone. When included, such components are generally used individually in amounts of about 0.01 to about 10%. It is possible to include conditioning agents to facilitate the removal of dead lice and eggs from the hair and to provide a good combing both wet and dry. The same types of conditioning agents described in the supra conditioning formulations can be used in the lotions; these include quaternary ammonium salts, fatty amines and mixtures thereof. The conditioning agents are used in amounts of from about 0.1 to about 1%, preferably from about 0.4 to about 0.6%. The preferred conditioning agents are the quaternary ammonium salts. Preferred quaternary ammonium salts include dialkyldimethylammonium chloride, wherein the alkyl groups have from 12 to 22 carbon atoms. These alkyl groups can be derived from long chain fatty acids, such as hydrogenated tallow fatty acid. The tallow fatty acid gives rise to quaternary compounds in which Ri and R2 predominantly have 16 to 18 carbon atoms. Examples of quaternary ammonium salts useful in lotion formulations include di (tallow) chloride m.sub.2 * hydrogenated) -dimethylammonium, dicetyldimethylammonium chloride, tricetylmethylammonium chloride, cetyltrimethylammonium chloride, stearyldimethylbenzylammonium chloride and mixtures thereof. The most preferred 5 is dicetyl dimethyl ammonium chloride. It is also possible to add synergistic agents of alcohol to the lotion formulations to increase their activity against lice. The alcohols used in the lotion formulations are selected from the group consists of phenylalkanols of 2 to 6 carbon atoms, phenyldiols of 2 to 6 carbon atoms, alkylene diols of 2 to 8 carbon atoms and mixtures thereof. These synergistic agents can be included in amounts of about 0.25 to about 10%, wherein the The amount of phenylalkanols, phenyldiols and mixtures thereof does not exceed 5% of the formulation. Preferably, the amount is from about 0.5 to about 5% of the formulation, more preferably from about 2 to about 4%. A preferred synergistic agent is Hexylene glycol. The lotion formulations are applied directly to the hair. The amount of lotion used generally ranges from about 10 to about 50 ml. The lotion is rubbed on the hair and left on the for about 10 minutes, preferably, for approximately 30 minutes. Then the hair is cleaned, usually with a shampoo, before rinsing with water. The following examples illustrate the formulations of the present invention. EXAMPLE 1 A lotion formulation was prepared as follows: Spinosyn is added to a tank containing a mixture of PEG-60 castor oil, hexylene glycol, propylene glycol and dicetyl dimethyl ammonium chloride, at a temperature between 35 and 38 ° C. In a second tank, it to mix the polyvinylpyrrolidone, DMDM hydantoin, tetrasodium AEDT and citric acid and the mixture is brought to a temperature between 35 and 38 ° C. The contents of the first tank are added to the second tank and mixed until the mixture is uniform. The mixture is cooled to approximately 27 ° C and distributed in storage tanks. EXAMPLE 2 A lotion formulation was prepared using the procedure described in Example 1, but with the following formula: EXAMPLE 3 A lotion formulation was prepared by the procedure described in Example 1, but with the following formula: To control an infestation by lice, the lotion formulations of Examples 1 to 3 are applied to the hair and left for at least an hour before being removed by shampooing or shampooing. rinse with water.

EXAMPLE 4 A shampoo formulation was prepared in the following manner: The ammonium lauryl sulfate is added to a tank and heated to a temperature between 66 and about 69 ° C. While maintaining this temperature, an aqueous solution of monosodium phosphate is added and then an aqueous solution of disodium phosphate. When reaching 69 ° C, Ammonium xylene sulfonate is added to the mixture and heated to a temperature of about 74 to about 11 ° C; the coconut monoethanolamide is added, mixed until well dispersed, the ethylene glycol distearate added and approximately 4.5% water. The mixture is continued until it is homogeneous and cooled to approximately 41 ° C. The mixture is pumped into a second tank and ammonium laurethulfate, DMDM hydantoin and an aqueous solution of citric acid are added. The spinosyn is added to the second tank and an amount of water c.b.p. 100% It is mixed well, cooled to a temperature of about 27 ° C and the mixture is pumped into storage tanks. EXAMPLE 5 A shampoo formulation was prepared in the following manner: xThe silicone rubber is obtained from The General Electric Co. under the name Goma SE-30 or SE-76. Approximately 0.5% of ammonium laureth sulfate and dimethicone are added to a vessel and mixed for approximately 30 minutes. Approximately 2% ammonium laurethulfate is added to a processing tank and heated to a temperature of 68 to 71 ° C. Approximately 0.12% stearyl alcohol, approximately 0.06% cetyl alcohol and the contents of the first container are added to the processing tank. Mix until uniform, keeping the mixture at a temperature between 68 and 71 ° C. To a second processing tank, ammonium lauryl sulfate is added and heated to approximately 71 ° C. Maintaining this . * * & a & ^ and temperature, 0.05% ammonium chloride, approximately 18% water, ammonium xylene sulfonate and the rest of stearyl alcohol and cetyl alcohol are added. To the second tank are added coconut monoethanolamide, tricetylmethylammonium chloride, ethylene glycol distearate, approximately half of the DMDM hydantoin and the contents of the first tank, maintaining the temperature at approximately 77 ° C. Mix until the mixture is homogeneous and then cool to about 41 ° C. The mixture is pumped to a third tank and the rest of the ammonium laureth sulfate, DMDM hydantoin and sodium chloride are added. Spinosyn is added to the mixture and a quantity c.b.p. 100% water Mix well, cool to a temperature of approximately 27 ° and the mixture is pumped to storage tanks. EXAMPLE 6 A shampoo formulation was prepared in the following manner: Approximately 6.5% of the water and ammonium laureth sulfate are added to a mixing tank and the mixture is heated to a temperature of about 35 ° C. Maintaining this temperature, the following components are added individually and in sequence, mixing each component so that it is incorporated well into the batch: ammonium lauryl sulfate, ammonium xylene sulfonate, monosodium phosphate, disodium phosphate, DMDM hydantoin, sodium, a solution of citric acid and water, a solution of coconut diethanolamine and isostearylethylammonium ethosulfate. Spinosyn is added to the mixture and a quantity of water c.b.p. 100% Mix well, cool to approximately 27 ° C and mix pumped to storage tanks.

EXAMPLE 7 A conditioner formulation was prepared in accordance with the present invention, as follows: xThe silicone rubber is available from The General Electric Co. under the name Goma SE-30 or SE-76. All components are combined, except DMDM hydantoin, citric acid, silicone rubber, cyclomethicone * .- -ß-á A ta & & - & amp &ms & * fcik¿ aft •: -.? ¿s¿- -. and espmosina, in a processing tank and the mixture is heated to approximately 88 ° C. After the solution is well mixed, it is cooled to approximately 48 ° C. In a separate tank, the silicone rubber and the cyclomethicone are mixed, heating and stirring to form a gum solution. Spinosyn is added to this mixture. The gum solution and all the remaining components are added and water c.b.p. Mix well, cool to approximately 27 ° C and mix pumped to storage tanks. EXAMPLE 8 A conditioning formulation was prepared by the procedure described in Example 7, but using the following formula: xThe silicone rubber is available from The General Electric Co. under the name Goma SE-30 or SE-76. This lice conditioner product is prepared in a manner similar to that described in Example 7. EXAMPLE 9 Efficacy of Shampoo Formulations Shampoo formulations containing various concentrations of spinosad were used in this study. The formulations were prepared by wet grinding for 30 minutes, with sufficient technical grade spinosad in a commercially available shampoo (Johnson 's® Baby Shampoo, Honey and Vitamin E Moisturizing Formula, Johnson &Johnson Consumer Products, Inc. ) to form a 10% spinosad / shampoo concentrate. This mixture was diluted with additional shampoo to prepare the following concentrations of spinosad: 10% (used as originally prepared), 1%, 0.1% and 0.01% spinosad / shampoo (w / w). The four concentrations of spinosad in shampoo and a control of tap water were tested against adult human lice (Pediculus humanus humanus) in accordance with a standard test, ASTM Standard E 938-83 (Reapproved 1988), this is available in the North American Society for Test and Materials, 100 Barr Harbor Drive, West Conshohocken, Pennsylvania, USA [http://www.astm.org/] In this test, 25 lice were immersed in each of the four shampoo concentrations for 10 minutes, then washed with water for 1 minute and rinsed with water for another minute. In the control group, 25 adult lice (Pediculus humanus humanus) were immersed in running water for 10 minutes, then washed with water for 1 minute and rinsed with water for another minute. A total of 5 trials were performed. After one hour, the lice were examined to determine the number of knocked down. The number of "knocked down" was measured as the rapid immobilization (within a period of one minute) of the activity of the insect that causes from a moribund state to death). After 24 hours, the lice were examined again to determine the number of deaths. The results of this study are summarized in Table 1. TABLE 1 Comparison of Pediculicidal Effects of Espinosad in Shampoos at Various Concentrations The study showed that shampoo formulations containing 1 and 10% spinosad were highly effective as pediculicides, providing a mortality +24 hours of 100%. The 10% concentration produced the most rapid knockdown effect (96.6% in +1 hour) and even the 1% concentration produced a knockdown rate of 48%. The 0.1% spinosad / shampoo formulation was also an effective pediculicide, providing almost 100% mortality after 24 hours.

A6á? »Mie ¿&Mj It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects to which it refers.

Claims (15)

1. CLAIMS Having described the invention as an antecedent, the content of the following claims is claimed as property: 1. A formulation for controlling the infestation by lice in a human being, characterized in that it comprises as an active ingredient a spinosyn or a physiologically acceptable salt or derivative thereof. the same, associated with a physiologically acceptable vehicle.
2. 2. A formulation according to claim 1, characterized in that it is a hair care formulation.
3. 3. A formulation according to any of claims 1 or 2, characterized in that it is a shampoo.
4. 4. A formulation according to any of claims 1, 2 or 3, characterized in that it additionally comprises a surfactant.
5. 5. A formulation according to any of claims 3 or 4, characterized in that it comprises: (a) from about 0.1 to about 2.556 of a spinosyn, or a physiologically acceptable salt or derivative thereof; (b) from about 5 to about 30% of a synthetic surfactant; (c) from about 1 to about 7% of an amide; and (d) water.
6. 6. A formulation according to any of claims 1 to 5, characterized in that it further comprises from about 1 to about 10% of a non-volatile silicone material.
7. 7. A formulation according to any of claims 1 to 6, characterized in that it additionally comprises from about 0.5 to about 5% of a suspending agent.
8. 8. The use of a spinosyn or a physiologically acceptable derivative or salt thereof, or a formulation containing any of these entities, for the manufacture of a medicament for controlling lice in a human being.
9. 9. The use according to claim 8, characterized in that the louse is Pediculus humanus capi tis or Pediculus humanus humanus.
10. 10. The use according to claim 10, characterized in that the louse is Pthirus pubis.
11. 11. A method for controlling a lice infestation in a human being, characterized in that it comprises the topical administration of a formulation according to any of claims 1 to 4, to the human.
12. 12. The method according to claim 11, characterized in that the louse causing the infestation is Pediculus humanus capi tis.
13. 13. The method according to claim 11, characterized in that the louse causing the infestation is Pediculus humanus humanus.
14. The method according to claim 11, characterized in that the louse causing the infestation is Pthirus pubis.
15. 15. A method for treating human hair to kill and facilitate the removal of lice and their eggs, characterized in that it comprises the steps of: (a) applying from about 10 to about 30 g of a formulation comprising a spinosyn or a derivative or physiologically acceptable salt thereof, and a physiologically acceptable carrier, to wet hair; (b) rub the formulation on the entire hair and scalp; (c) leaving the formulation in the hair and scalp for approximately 6 to 10 minutes; and (d) removing the hair formulation by rinsing with water.