Patent Description:
Antimicrobial personal care compositions are known in the art. Especially useful are antimicrobial cleansing compositions, which typically are used to cleanse the skin and to destroy bacteria and other microorganisms present on the skin, especially the hands, arms, and face of the user.

Antimicrobial compositions are used, for example, in the health care industry; long term care, hospitality and health / exercise facilities; food service industry, meat processing industry, and in the private sector by individual consumers. The widespread use of antimicrobial compositions indicates the importance consumers place on controlling bacteria and other microorganism populations on skin. It is important, however, that antimicrobial populations provide a substantial and broad spectrum reduction in microorganism populations quickly and without problems associated with toxicity and skin irritation.

In particular, antimicrobial cleansing compositions typically contain an active antimicrobial agent, skin conditioning agents for cosmetic effects, and dyes, perfumes, and optional thickening agents, such as clays, polymers, cellulosic derivatives, or colloids, for aesthetic effects, all in an aqueous carrier.

Several different classes of antimicrobial agents have been used in antimicrobial cleansing compositions. These include active ingredients selected from the following classes: phenolic compounds, carbanalide compounds, lower alcohols, surface active agents halogens, and carboxylic acids. Each of these classes has their own unique advantages and challenges. Examples of specific antimicrobial agents include PCMX (para-chlorometa xylenol), Triclosan, Triclocarban, benzyl alcohol, quaternary ammonium compounds (QAC), iodine and iodine complexes and biguanides (e.g., chlorhexidine digluconate). At this time Triclosan is the dominant antimicrobial active ingredient in the dermal cleanser market.

Although there is an increasing consumer demand for products which have both an activity against bacteria and other microorganisms, there is an even greater demand to fulfill the consumer's expectations with regard to their level of concern with certain biocides such as Triclocarban and Triclosan.

Triclosan is disfavored as an antimicrobial agent due to environmental persistence and health concerns due to the possible formation of intermediate and/or environmental by products. Thus, a need exists for an efficacious antimicrobial personal care composition which is substantially free of biocides such as Triclocarban and Triclosan but that still provides a high foam level desired by consumers and is mild to the skin. The present invention is directed to such antimicrobial compositions.

<CIT> discloses an antimicrobial dermal cleanser comprising a cationic active ingredient, a quaternized sugar-derived surfactant, a foam boosting surfactant, chelators and water. The composition is free of triclosan. The compositions disclosed are stable and have a pH of to to <NUM>. The cleanser exhibits high cidal activity against bacteria, fungus, virus, provides copious foam and foam stability, improves skin compatibility and exhibits reduced tissue irritancy potential.

<CIT> discloses a foamable, sterilizing-cleansing agent comprising <NUM> to <NUM> % of an alkyl dimethyl benzyl ammonium salt type cationic surfactant containing <NUM> to <NUM> mass% of lauryl dimethyl benzyl ammonium salt; <NUM> to <NUM> % of a polyoxyalkylene alkyl ether type non-ionic surfactant, which is preferably a polyoxyethylene alkyl ether or a polyoxyethylene polyoxypropylene alkyl ether (copolymer); <NUM> to <NUM> % of a non-ionic surfactant such as alkylamine oxide, fatty acid alkanol amide or alkyl polyglucoside; and water. The compositions may also comprise glycols such as propylene glycol or PEG as a carrier. The sterilising-cleansing agent may contain <NUM> to <NUM> % of metal chelating agents, preferably ethylenediamine tetraacetic acid tetrasodium salt.

The above-mentioned disadvantages of current antimicrobial compositions are addressed by embodiments of the present invention and will be understood by reading and studying the following specification. The following summary is made by way of example. It is merely provided to aid the reader in understanding some of the aspects of the invention.

In accordance with the present invention, a composition according to claim <NUM> that exhibits rapid cidal efficacy and high foaming attributes is provided. The antimicrobial composition comprises a cationic active ingredient, a foam boosting surfactant which may encompass nonionic surfactants, cationic surfactants or amphoteric surfactants, a novel foam boosting copolymer, a chelating agent, a foam stabilizer and water. The present antimicrobial compositions are substantially free of the antimicrobial agent triclosan (i.e., <NUM>,<NUM>,<NUM>'-trichloro-<NUM>'hydroxy-diphenylether), anionic surfactants and C<NUM> to C<NUM> alcohols and have rapid cidal efficacy. The compositions also provide stable copious foam and may optionally contain ingredients to increase skin compatibility and skin health.

Accordingly, one aspect of the present invention is to provide an antimicrobial composition for reducing microbial population on dermal tissue, the antimicrobial composition can comprise: (a) <NUM> wt. % to <NUM> wt. %, by weight of cationic actives; (b) <NUM> wt. % to <NUM> wt. %, by weight of a foam boosting surfactant; (c) <NUM> wt. % to <NUM> wt. % dermal adjuvants (d) <NUM> wt. % to <NUM> wt. %, by weight of a foam boosting polymer, (e) <NUM> wt. % to <NUM> wt. % of a foam stabilizer, (f) from <NUM> wt. % <NUM> wt. % of a chelating agent such that the chelating agent forms a calcium-chelating agent complex with a stability constant (expressed in logarithmic form) greater than <NUM> and (g) water or other suitable diluent wherein the composition it substantially free of triclosan, anionic surfactants and C<NUM> to C<NUM> alcohols.

Another aspect of the present invention is to provide an antimicrobial composition for reducing microbial population on dermal tissue which is stable and has a pH of <NUM> to <NUM>. The present composition also exhibits excellent esthetic properties, such as copious foam and foam stability and may optionally contain ingredients to increase skin compatibility and skin health. Moreover, the composition may exhibit reduced tissue irritancy potential.

A further aspect of the present disclosure is to provide personal use products based on an antimicrobial composition of the present invention, for example, a skin cleanser, a surgical scrub, a hand sanitizer gel, a disinfectant, and antiseptic wash.

A further aspect of the present invention is to provide a use of the antimicrobial dermal concentrate of claim <NUM> wherein the concentrate is diluted at the point of use to form a use solution wherein the ratio of concentrate to water is from <NUM>: <NUM> to <NUM>:<NUM>.

A further aspect of the present invention is to provide an antimicrobial use solution comprising the antimicrobial dermal concentrate of claims <NUM> to <NUM>, wherein the ratio of concentrate to water is from <NUM>: <NUM> to <NUM>:<NUM>.

A further aspect of the present disclosure is to provide a method of reducing gram positive and/or gram negative bacteria populations on mammalian tissue, including human tissue, by contacting the tissue, like the dermis, with a composition of the present invention for a sufficient time, such as <NUM> seconds to <NUM> minutes, to reduce the bacteria level to a desired level. Antimicrobial efficacy is applicable to viral and fungal organisms as well as gram positive and gram negative bacteria.

As used herein, weight percent (wt-%), percent by weight, and % by weight are synonyms that refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition and multiplied by <NUM>.

As used herein, the term "cationic active" is defined as the ingredient that provides antimicrobial cidal activity.

As used herein, the term "skin care active" is defined as the ingredient or ingredients that improve or maintain the health of the dermal barrier.

The term "alkyl" refers to a straight or branched chain monovalent hydrocarbon radical having a specified number of carbon atoms. As used herein, "alkyl" refers to a linear or branched C<NUM>-C<NUM> carbon chain.

The term "microbial" or "microbial population" refers to bacterial, fungal, yeast, or viral population or combinations thereof or any mixture thereof in a laboratory or natural setting.

The term rapid cidal efficacy refers to ≥<NUM> log kill in up to <NUM> seconds in the in vitro time kill test ASTM E <NUM>.

The term "surfactant" or "surface active agent" refers to an organic chemical that when added to a liquid changes the properties of that liquid at a surface or interface.

"Cleansing" means to perform or aid in soil removal, bleaching, microbial population reduction, rinsing, or combination thereof.

As used herein, the term "free" or "substantially free" refers to compositions completely lacking the component or having such a small amount of the component that the component does not affect the effectiveness of the composition. The component may be present as an impurity or as a contaminant and shall be less than <NUM> wt. In another embodiment, the amount of the component is less than <NUM> wt. % and in yet another embodiment, the amount of component is less than <NUM> wt.

The term "actives" or "percent actives" or "percent by weight actives" or "actives concentration" are used interchangeably herein and refers to the concentration of those ingredients involved in cleansing expressed as a percentage minus inert ingredients such as water or salts.

As used herein, the term "substantially free of triclosan" is defined as meaning that the composition contains <NUM>% to <NUM>% by weight, in total, of triclosan. In particular, triclosan may be present in an antimicrobial composition in a total amount of <NUM>% or less either as a by-product or as a component of an ingredient in the composition, but triclosan is not intentionally introduced into the composition.

The present invention relates to an antimicrobial composition that exhibits rapid cidal antimicrobial efficacy and high foaming attributes. The antimicrobial composition comprises a cationic active ingredient, a foam boosting surfactant which may encompass nonionic surfactants, amphoteric surfactants, or cationic surfactants and water. The present antimicrobial compositions are substantially free of the antimicrobial agent triclosan (i.e., <NUM>,<NUM>,<NUM>'-trichloro-<NUM>'hydroxy-diphenylether), anionic surfactants and C<NUM> to C<NUM> alcohols, has rapid cidal efficacy and provide stable copious foam and may optionally contain ingredients to increase skin compatibility and skin health.

In one embodiment, an antimicrobial composition for reducing microbial population on dermal tissue includes: (a) <NUM> wt. % to <NUM> wt. %, by weight of cationic actives; (b) <NUM> wt. % to <NUM> wt. %, by weight of a foam boosting surfactant; (c) <NUM> wt. % to <NUM> wt. % dermal adjuvants and (d) water or other suitable diluent.

Another aspect of the present invention is to provide an antimicrobial composition for reducing microbial population on dermal tissue which is stable and has a pH of <NUM> to <NUM>. The present composition also surprisingly exhibits excellent esthetic properties, such as copious foam and foam stability and may optionally contain ingredients to increase skin compatibility and skin health. Moreover, the composition may exhibit reduced tissue irritancy potential.

A further aspect of the present invention is to provide personal use products based on an antimicrobial composition of the present invention, for example, a skin cleanser, a surgical scrub, a hand sanitizer gel, and a disinfectant.

A further aspect of the present disclosure is to provide a method of reducing gram positive and/or gram negative bacteria populations on mammalian tissue, including human tissue, by contacting the tissue, like the dermis, with a composition of the present invention for a sufficient time, such as <NUM> seconds to <NUM> minutes, to reduce the bacteria level to a desired level.

The following illustrates embodiments of the present invention.

A cationic active is present in an antimicrobial composition for reducing microbial population on the dermal tissue of a mammal of the present invention in an amount of <NUM> wt. % to <NUM> wt. %, and preferably <NUM> wt. % to <NUM> wt. %, by weight of the composition.

The amount of antimicrobial agent in the composition is related to the end use of the composition. The amount of antimicrobial agent is sufficient in the compositions of the invention to achieve a microbial kill in a short contact time, for example, <NUM> to <NUM> seconds.

Cationic active ingredients are an antimicrobial agent useful in the present invention. The cationic or cationically-active ingredients are substances based on nitrogen centered cationic moieties with net positive change. According to theinvention, the cationic or cationically-active ingredients are preferably selected from the group consisting of cationic polymers, cationic surfactants, cationic monomers, cationic silicon compounds, cationic derivatized protein hydrolyzates and betaine with at least one cationic or cationically-active group.

Suitable cationic active ingredients contain quaternary ammonium groups. Suitable cationic active ingredients especially include those of the general formula:.

wherein R<NUM>, R<NUM>, R<NUM> and R<NUM> independently of each other represent alkyl groups, aliphatic groups, aromatic groups, alkoxy groups, polyoxyalkylene groups, alkylamido groups, hydroxyalkyl groups, aryl groups, H+ ions, each with from <NUM> to <NUM> carbon atoms, with the provision that at least one of the groups R<NUM>, R<NUM>, R<NUM> and R<NUM> has at least eight carbon atoms and wherein X(-) represents an anion, for example, a halogen, acetate, phosphate, nitrate or alkyl sulfate, preferably a chloride. The aliphatic groups can also contain cross-linking or other groups, for example additional amino groups, in addition to the carbon and hydrogen atoms.

Particular cationic active ingredients include, for example alkyl dimethyl benzyl ammonium chloride (ADBAC), alkyl dimethyl ethylbenzyl ammonium chloride, dialkyl dimethyl ammonium chloride, benzethonium chloride, N, N-bis-(<NUM>-aminopropyl) dodecylamine, chlorhexidine gluconate, PHMB (polyhexamethylene biguanide), salt of a biguanide, a substituted biguanide derivative, an organic salt of a quaternary ammonium containing compound or an inorganic salt of a quaternary ammonium containing compound or mixtures thereof. According to the invention, the cationic active ingredient is selected from the group consisting of a salt of a biguanide, a substituted biguanide, an organic salt of a quaternary ammonium containing compound or an inorganic salt of a quaternary ammonium containing compound, chlorohexidine gluconate (CHG).

In accordance with an important feature of the present invention, a present antimicrobial composition is substantially free of triclosan. The phrase "substantially freeof triclosan" is defined as meaning that the composition contains <NUM>% to <NUM>% by weight, in total, of triclosan. In particular, triclosan may be present in an antimicrobial composition in a total amount of <NUM>% or less either as a by-product or as a component of an ingredient in the composition, but triclosan is not intentionally introduced into the composition.

Triclosan is disfavored as an antimicrobial agent due to environmental and health concerns due to the possible formation of intermediate and/or environmental by products.

In addition to an antimicrobial agent, and a quaternized sugar-derived surfactant the present antimicrobial composition for reducing microbial population on the dermal tissue of a mammal of the present invention also contains one or more foam boosting surfactants. The one or more foam boosting surfactants is present in an amount of <NUM>% to <NUM>%, and preferably <NUM>% to <NUM>%, by weight, of the composition.

The amount of foam boosting surfactant present in the composition is related to the amount of the cationic active in the composition, the amount of the quaternized sugar-derived surfactant in the composition, the identity of the foam boosting surfactant, and the end use of the composition.

The foam-boosting surfactant can be (a) nonionic surfactants or cationic surfactants, or mixtures thereof. The formulation is substantially free of anionic or zwitterionic surfactants.

Examples of non ionic foam-boosting co-surfactants include alkyl amine oxide, alkyl ether amine oxide, alkyl alcohol alkoxylates, aryl alcohol alkoxylates, substituted alcohol alkoxylates, block nonionic copolymers, heteric nonionic copolymers, alkanolamides, substituted amides, or polyethoxylated glycerol derivatives.

The antimicrobial composition can contain a nonionic surfactant component that includes a detersive amount of nonionic surfactant or a mixture of nonionic surfactants. Typically, a nonionic surfactant has a hydrophobic region, such as a long chain alkyl group or an alkylated aryl group, and a hydrophilic group comprising an ethoxy and/or other hydrophilic moieties. As defined herein, a "nonionic foam-boosting surfactant" has a hydrophobic region having an alkyl group containing six to eighteen carbon atoms, and an average of one to about twenty ethoxy and/or propoxy moieties. Examples of non ionic foam-boosting co-surfactants include alkyl amine oxide, alkyl ether amine oxide, alkyl alcohol alkoxylates, aryl alcohol alkoxylates, substituted alcohol alkoxylates, block nonionic copolymers, heteric nonionic copolymers, alkanolamides, or polyethoxylated glycerol esters, and mixtures thereof.

Numerous other nonionic surfactants are disclosed in <NPL>; in the <NPL>; and in the <NPL>.

The antimicrobial composition can contain an amphoteric surfactant component that includes a detersive amount of amphoteric surfactant or a mixture of amphoteric surfactants. Suitable amphoteric surfactants that can be used include imidiazolines and imidiazoline derivatives, isethionates, betaine derivatives, amphoacetate derivatives, propionates, and mixtures thereof.

The antimicrobial composition may contain a cationic surfactant component that includes a detersive amount of cationic surfactant or a mixture of cationic surfactants. Cationic surfactants that can be used in the antimicrobial composition include quaternized sugar-derived surfactants, quaternized polysaccharides, alkyl polysaccharides, alkoxylated amines, alkoxylated ether amines, phospholipids, phospholipid derivatives, and mixtures thereof. Particularly preferred is a quaternized sugar-derived surfactant. The quaternized sugar surfactant may be present in an amount of <NUM>% to <NUM>%, and preferably <NUM>% to <NUM>%, by weight, of the composition.

The amount of quaternized sugar-derived surfactant present in the composition is related to the amount of the cationic active in the composition, to the identity of the quaternized sugar-derived surfactant, and the end use of the composition.

The quaternized sugar-derived surfactant is a quaternized alkyl polyglucoside or a polyquaternized alkyl polyglucoside, and the like.

In one embodiment, the antimicrobial composition includes a polyquaternary functionalized alkyl polyglucoside, a cationic active ingredient, water, and an optional foam boosting surfactant. The poly quaternary functionalized alkyl polyglucoside is a cationic surfactant naturally derived from alkyl polyglucosides and has a sugar backbone. Poly quaternary alkyl polyglucosides have the following representative formula:
<CHM>.

Wherein R is an alkyl group having from <NUM> to <NUM> carbon atoms and n is an integer ranging from <NUM> to <NUM>. Examples of suitable poly quaternary functionalized alkyl polyglucosides components which can be used in the cleansing compositions according to the present invention include those in which the R alkyl moiety contains from <NUM> to <NUM>-carbon atoms. In a preferred embodiment the quaternary functionalized alkyl polyglucoside contains primarily <NUM>-<NUM> carbon atoms. Examples of commercially suitable poly quaternary functionalized alkyl polyglucosides useful in cleansing compositions of the present invention include: Poly Suga ®Quat series of quaternary functionalized alkyl polyglucosides, available from Colonial Chemical, Inc. , located in South Pittsburg, TN.

In another embodiment, the antimicrobial composition includes a quaternary functionalized alkyl polyglucoside, a cationic active ingredient, water, and an optional foam boosting surfactant. The quaternary functionalized alkyl polyglucoside is a naturally derived cationic surfactant from alkyl polyglucosides and has a sugar backbone. Quaternary functionalized alkyl polyglucosides have the following representative formula:
<CHM>.

Wherein R<NUM> is an alkyl group having from <NUM> to <NUM> carbon atoms, and R<NUM> is CH<NUM>(CH<NUM>)n' where n' is an integer ranging from <NUM>-<NUM>. Examples of suitable quaternary functionalized alkyl polyglucosides components which can be used in the cleansing compositions according to the present invention include those in which the R<NUM> alkyl moiety contains primarily <NUM>-<NUM> carbon atoms, the R<NUM> group is CH<NUM> and n is the degree of polymerization of <NUM>-<NUM>. Further examples of a suitable quaternary functionalized alkyl polyglucoside include the antimicrobial and antifungal quaternary functionalized alkyl polyglucosides described in <CIT> and <CIT>. Examples of commercially suitable quaternary functionalized alkyl polyglucosides useful in cleansing compositions of the present invention include: Suga ®Quat TM <NUM> (primarily C<NUM> quaternary functionalized alkyl polyglucoside), Suga ®Quat L <NUM> (primarily C<NUM> quaternary functionalized alkyl polyglucoside), and Suga ®Quat S <NUM> (primarily C<NUM> quaternary functionalized alkyl polyglucoside) available from Colonial Chemical, Inc. , located in South Pittsburg, TN.

The composition can contain from <NUM> wt. % to <NUM> wt. % of dermal adjuvants, preferably from <NUM> wt. % to <NUM> wt. % of dermal adjuvants. Dermal adjuvants/skin care actives generally include any substance which improves or maintains the health of the dermal barrier. Some examples include emollients and skin moisturizer/protectants.

The composition can include emollients which are polymers such as dimethyl siloxanes Examples of high include dicaprylyl carbonate, dibutyl adipate, hexyl laurate, dicaprylyl ether, propylheptyl caprylate, <NUM>-<NUM> centistoke silicone oil, D4, <NUM>, or <NUM> cyclic siloxane, isocetyl palmitate, hydrogentated polyisobutene, and diethylhexylcarbonate. Polymers such as dimethyl siloxanes examples include capric/caprylic triglyceride, C12-<NUM> alkyl benzoate, capric triglyceride, caprylic triglyceride, isopropyl myristrate, isopropyl palmitate, octyldodecanol, decyl oleate, cocoglycerides, ethylhexyl stearate, ceteraryl isononanoate, cetearyl ethyhexanonate, decyl cocoate, cetyl dimethicone, ethylhexyl palmitate, PPG-<NUM> stearyl ether, PPG-<NUM> stearyl ether, Dimethicone fluid, and PPG-<NUM> butyl ether.

These materials also may include polymers such as siloxanes examples include mono-, di-, and tri-glycerides and butters and hydrogenated versions of seed and nut oils including; palm oil, coconut oil, vegetable oil, avocado oil, canola oil, corn oil, soy bean oil, sunflower oil, safflower oil, meadowfoam seed oil, bilberry seed oil, watermelon seed oil, olive oil, cranberry, macadamia nut oil, argan oil, pomegranate oil, argan moraccan oil, blue berry oil, raspberry oil, walnut oil, pecan oil, peanut oil, bayberry oil, mango seed oil, Marula oil, castor oil: Shea butter, jojoba oil, hydrolyzed jojoba oil, Carnauba butter, Carnauba wax, castor isostearate succinate stearyl heptanoate, cetyl ricinoleate, oleyl frucate, sucrose monostearate, sucrose distearate, sucrose tristearate, sucrose tetrastearate, candela wax, soybean wax, Rapeseed wax, palm wax, bees wax, petrolatum, myristyl myristate, Oleyl Erucate, squalane, stearyl alcohol, Cetearyl isononanoate, polyisobutene, glyceryl stearate, glyceryl distearate, cetyl alcohol, lanolin, lanolin ethoxylate, low molecular weight polyethylene waxes, lower molecular weight polypropylene waxes, PEG-<NUM> glyceryl cocoate, PEG-<NUM> Glyceryl cocoate, PEG-<NUM> Glyceryl stearate, PEG-<NUM> Ricinoleate, PEG-<NUM> Raspberriate, Linear (otherwise known as bis) and Pendent versions of including hydroxyl terminated and methyl ether terminated; PEG- <NUM> to PEG-<NUM> Dimethicone (including: PEG-<NUM> Dimethicone, PEG-<NUM> Dimethicone, PEG-<NUM> Dimethicone, PEG-<NUM> Dimethicone, PEG-<NUM> Methyl ether dimethicone, PEG-<NUM> Dimethicone, PEG-<NUM> Dimethicone, PEG-<NUM> Dimethicone, PEG-<NUM> Dimethicone), bis-PEG/PPG-<NUM>/<NUM> Dimethicone, PEG/PPG <NUM>/<NUM> Dimethicone, PEG/PPG <NUM>/<NUM> Butyl Ether Dimethicone, PEG/PPG <NUM>/<NUM> Dimethicone, PEG/PPG <NUM>/<NUM> Dimethicone.

Alkyl modified dimethicone (stearoxy dimethicone, behenoxy dimethicone, cetyl dimethicone, certeryl methicone C30-<NUM> Alkyl cetearyl dimethicone copolymer, C30-<NUM> Alkyl dimethicone, caprylyl methicone, PEG-<NUM> dimethicone/dimer dilinoleic acid copolymer, Bis-PEG-<NUM> Dimethicone/Dimer Dilinoleate Copolymer, Stearoxymethicone/Dimethicone Copolymer, Dipheyl dimethicone, Lauryl polyglycerol-<NUM> polydimethylsiloxyethyl dimethicone, Lauryl PEG-<NUM> polydimethylsiloxyethyl dimethicone), Dimethicone fluid (>20cst), quaternized ammonia silicone polymers, Amino silicones, silicone quaternium-<NUM>, Amodimethicone, phenyltrimethicone, amino silicone polyethers, Polyglycerol-<NUM> Disiloxane dimethicone, Polyglycerol-<NUM> polydimethylsiloxyethyl dimethicone, and PEG-<NUM> polydimethylsiloxyethyl dimethicone.

Emollients, if present may be in an amount of from <NUM> wt. % to <NUM> wt. %, preferably from <NUM> wt. % to <NUM> wt. % and more preferably from <NUM> wt. % to <NUM> wt.

The composition can include at least one additional skin conditioner such as vitamins, a humectant, an occlusive agent, or other moisturizer to provide skin moisturizing, skin softening, skin barrier maintenance, anti-irritation, or other skin health benefits. Some examples of additional skin conditioners include alkyl benzoate, myristyl myristate, cetyl myristate, gelatin, carboxylic acid, lactic acid, glyceryl dioleate, methyl laurate, PPG-<NUM> laurate, lauryl lacylate allantoin, octyl palmitate, lanolin, propylene glycol, butylene glycol, ethylene glycol, caprylyl glycol, monobutyl ether, glycerine, fatty acids, proline, natural oils such as almond, mineral, canola, sesame, soybean, pyrrolidine, wheat germ, hydrolyzed wheat protein, hydrolyzed oat protein, hydrolyzed collagen, corn, peanut and olive oil, isopropyl myristate, myristyl alcohol, aloe vera, algae extract, gluconic acid, hydrolyzed silk protein, <NUM>,<NUM>-propane-diol, Vitamin E, nicatinamide, stearyl alcohol, isopropyl palmitate, sorbitol, amino acid complexes, panthenol, allantoin, Dihydroxypropyltrimonium Chloride, quaternized hydrolyzed protein such as collagen, oat, wheat, inositol, fructose, sucrose, hydrolyzed plant proteins, seaweed extract, polyethylene glycol, ammonium lactate, sodium hyaluronate, and cyclic peptides.

Some examples of humectants include hydroxyethyl urea, agarose, urea, sodium PCA, arginine PCA, fructose, glucose, glutamic acid, glycerine, honey, lactose, maltose, polyethylene glycol, sorbitol and mixtures thereof.

Some examples of occlusive agents include petrolatum, shea butter, avocado oil, balm mint oil, cod liver oil, mineral oil, trimyristin, stearyl stearate, synthetic wax, or mixtures thereof. Some examples of other moisturizers include ethyl hexylglycerin, cholesterol, cystine, hyaluronic acid, keratin, lecithin, egg yolk, glycine, PPG-<NUM>, polyquaternium polymers such as polyquaternium-<NUM>, behentrimonium chloride, dihydroxypropyl PEG-<NUM> linoleammonium chloride, glycerol oleate, PEG-<NUM> glyceryl cocoate, cocoglucoside, PEG-<NUM> hydrogenated glyceryl palmate, panthenol, retinol, salicylic acid, vegetable oil, methyl gluceth-<NUM>, methyl gluceth-<NUM>, ethoxylated derivatives of skin conditioners such as glycereth-<NUM> and ethoxylated shea butter, and mixtures thereof. Finally, some examples of anti-irritants include bisabolol and panthenol.

The skin conditioner component is present in lower amounts that seen in traditional commercial skin sanitizers. Applicants have found that due to the chronic use of such sanitizers, lower amounts can be used with similar health benefits and less tacky residue. The skin conditioner or combination thereof in total is present in the composition in an amount from <NUM> wt. % to <NUM> wt. %, preferably from <NUM> wt. % to <NUM> wt. %, and more preferably from <NUM> wt. % to <NUM> wt.

The composition of the invention includes a novel foam boosting copolymer. The foam boosting copolymer is present in an amount of from <NUM> wt. % to <NUM> wt. %, preferably from <NUM> to <NUM> wt.

Copolymers which function according to the invention comprise a hydrophobically modified cationic polymer obtainable from the polymerization of the following structural units:.

The first structural unit is a water-soluble cationic ethylenically unsaturated monomer. The first structural unit can be a dialkyl diallyl ammonium with halides, hydrogensulfate or methosulfate as counterions according to formula (I):
<CHM>
wherein:.

In another embodiment, the first structural unit is a quaternary or acid salt of dialkyl amino alkyl (meth)acrylate. In a further embodiment, the first structural unit is an acid salt of a dialkyl amino alkyl (meth) acrylamide or a quaternary dialkyl amino alkyl (meth) acrylamide according to formula (II):
<CHM>
wherein:.

In one embodiment of the present invention, it is preferred that, in the cationic monomer of the formula (II), wherein:.

Suitable examples of the first structural unit are diallyl dimethyl ammonium chloride (DADMAC), (<NUM>-acrylamidopropyl)-trimethylammonium chloride (APTAC), (<NUM>-methacryl-amidopropyl)-trimethylammonium chloride (MAPTAC), dimethylaminopropylacrylat methochlorid, dimethylaminopropylmethacrylat methochlorid. Further suitable examples of the first structural unit are [<NUM>-(Acryloyloxy)ethyl]trimethylammonium chloride, also referred to as dimethylaminoethyl acrylate methochloride (DMA3*MeCl), or trimethyl-[<NUM>-(<NUM>-methylprop-<NUM>-enoyloxy)ethyl]azanium chloride, also referred as dimethylaminoethyl methacrylate methochloride(DMAEMA*MeCl). Preferably, the first structural unit is DADMAC.

The second structural unit is acylamide or methacrylamide
All wt % for each of the structural units are calculated based on <NUM>% by weight of all structural units derived from all the monomers in the co polymer. A preferred copolymer is a DADMAC/(meth)acrylamide copolymer with a molecular weight of approximately <NUM>,<NUM>,<NUM> such as the Mackermium <NUM> line of copolymers available from Rhodia, Inc.

The composition includes a foam solubilizer which includes an organic solvent, other than a short chain alcohol, typically soluble in both water and oil. Examples of foam solubilizers according to the present disclosure include: polyols, such as glycerol (glycerin), propylene glycol, hexylene glycol, diethylene glycol, propylene glycol n-alkanols, terpenes, di-terpenes, tri-terpenes, terpen-ols, limonene, terpene-ol, l-menthol, dioxolane, ethylene glycol, other glycols, sulfoxides, such as dimethylsulfoxide (DMSO), dimethylformanide, methyl dodecyl sulfoxide, dimethylacetamide; monooleate of ethoxylated glycerides (with <NUM> to <NUM> ethylene oxide units); azone (<NUM>-dodecylazacycloheptan-<NUM>-one), <NUM>-(n-nonyl)-<NUM>,<NUM>-dioxolane; esters, such as isopropyl myristate/palmitate, ethyl acetate, butyl acetate, methyl proprionate, capric/caprylic triglycerides, octylmyristate, dodecyl-myristate; myristyl alcohol, lauryl alcohol, lauric acid, lauryl lactate ketones; amides, such as acetamide oleates such as triolein; various alkanoic acids such as caprylic acid; lactam compounds, such as azone; alkanols, such as dialkylamino acetates, and admixtures thereof. According to one preferred embodiment the foam solubilizer is hexylene glycol.

The foam solubilizer is present in the composition in an amount of from <NUM> wt. % to <NUM> wt. %, preferably from <NUM> wt. % to <NUM> wt.

According to the present invention, the foam solubilizer is a foam stabilizing linear or branched C<NUM>-<NUM> diol with the structure
<CHM>
wherein R<NUM> = H, CH<NUM>, CH<NUM>CH<NUM>, CH<NUM>CH<NUM>CH<NUM>, C(CH<NUM>)<NUM>, CH(CH<NUM>)<NUM> or combinations thereof and R<NUM> is a branched or linear C<NUM>-C<NUM> alkyl chain.

The composition is generally a concentrate or a ready to use composition that includes a chelating agent. In general, a chelating agent is a molecule capable of coordinating (i.e., binding) the metal ions commonly found in water sources to prevent the metal ions from interfering with the action of the other ingredients. Examples of chelating agents according to the disclosure include phosphonic acid and phosphonates, phosphates, aminocarboxylates and their derivatives, pyrophosphates, ethylenediamine and ethylenetriamine derivatives, hydroxyacids, and mono-, di-, and tri-carboxylates and their corresponding acids. In certain embodiments the composition is phosphate free. Preferred chelating agents form calcium-chelating agent complexes with a stability constant (expressed in logarithmic form) of <NUM> or greater. The calcium-chelating agent stability constant (K) is the measure of the stability of a calcium-chelating agent complex (CaL) formed by the reaction of a calcium ion (Ca) with a chelating agent (L) in aqueous solution.

The stability constant is expressed as: <MAT> Where:.

Chelating agents of the invention are selected from the group comprising ethylenediaminetetraacetic acid (EDTA); diethylenetriaminepentacetic acid (DTPA); methylglycine-N,N-diacetic acid (MGDA); glutamic acid-N,N-diacetic acid (GLDA); Aspartic acid-N,N-diacetic acid (ASDA) and alkali, alkali earth metal, transition metal and/or ammonium salts thereof.

The carrier of the present antimicrobial composition comprises water, propylene glycol, glycerols, alcohols or mixtures thereof. It should be appreciated that the water may be provided as deionized water or as softened water. The water provided as part of the composition can be relatively free of hardness. It is expected that the water can be deionized to remove a portion of the dissolved solids. That is, the concentrate can be formulated with water that includes dissolved solids, and can be formulated with water that can be characterized as hard water.

The antimicrobial composition of the present invention does not rely upon a low pH or a high pH to provide a rapid reduction in microbial populations. Antimicrobial populations of the present invention have a pH of <NUM> to <NUM>. Within this pH range, the present compositions effectively reduce microbial populations, and are consumer acceptable, i.e., are mild to the skin, are phase stable, and generate copious, stable foam.

The antimicrobial composition can include additional components or agents, such as additional functional materials. As such, in some embodiments, the antimicrobial composition including the cationic active ingredients and quaternary sugar-derived surfactants may provide a large amount, or even all of the total weight of the antimicrobial composition, for example, in embodiments having few or no additional functional materials disposed therein. The functional materials provide desired properties and functionalities to the antimicrobial composition. For the purpose of this application, the term "functional materials" include a material that when dispersed or dissolved in a use and/or concentrate solution, such as an aqueous solution, provides a beneficial property in a particular use. The antimicrobial composition containing the cationic active ingredients and the quaternized sugar-derived surfactants may optionally contain additional surfactants, pH adjusting compound, preservatives, antioxidants, fragrances, dyes, other disinfectants, sanitizers, thickening or gelling agents, or mixtures thereof. Some particular examples of functional materials are discussed in more detail below, but it should be understood by those of skill in the art and others that the particular materials discussed are given by way of example only, and that a broad variety of other functional materials may be used. For example, may of the functional material discussed below relate to materials used in disinfecting and/or cleansing applications, but it should be understood that other embodiments may include functional materials for use in other applications.

The composition may optionally include a preservative. Generally, preservatives fall into specific classes including phenolics, halogen compounds, quaternary ammonium compounds, metal derivatives, amines, alkanolamines, nitro derivatives, biguanides, analides, organosulfur and sulfur-nitrogen compounds, alkyl parabens, and miscellaneous compounds. Some examples of phenolic antimicrobial agents include pentachlorophenol, orthophenylphenol, chloroxylenol, p-chloro-m-cresol, p-chlorophenol, chlorothymol, m-cresol, o-cresol, p-cresol, isopropyl cresols, mixed cresols, phenoxyethanol, phenoxyethylparaben, phenoxyisopropanol, phenyl paraben, resorcinol, and derivatives thereof. Some examples of halogen compounds include sodium trichloroisocyanurate, sodium dichloroisocyanurate, iodine-poly(vinylpyrolidin-onen) complexes, and bromine compounds such as <NUM>-bromo-<NUM>-nitropropane-<NUM>,<NUM>-diol, and derivatives thereof. Some examples of quaternary ammonium compounds include benzalkonium chloride, benzethonium chloride, behentrimonium chloride, cetrimonium chloride, and derivatives thereof. Some examples of amines and nitro containing compounds include hexahydro-<NUM>,<NUM>,<NUM>-tris(<NUM>-hydroxyethyl)-s-triazine, dithiocarbamates such as sodium dimethyldithiocarbamate, and derivatives thereof. Some examples of biguanides include polyaminopropyl biguanide and chlorhexidine gluconate. Some examples of alkyl parabens include methyl, ethyl, propyl and butyl parabens.

The preservative is preferably present in the composition in an amount from <NUM> to <NUM> wt. %, from <NUM> to <NUM> wt. %, and from <NUM> to <NUM> wt.

The composition may optionally include a thickener. Exemplary thickeners include (<NUM>) cellulosic thickeners and their derivatives, (<NUM>) natural gums, (<NUM>) starches, (<NUM>) stearates, and (<NUM>) fatty acid alcohols, (<NUM>) acrylic acid polymers and crosspolymers (example "carbomer", (<NUM>) Aristoflex AVC (need generic category name) Some examples of cellulosic thickeners include carboxymethyl hydroxyethylcellulose, cellulose, hydroxybutyl methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropyl methyl cellulose, methylcellulose, microcrystalline cellulose, and sodium cellulose sulfate. Some examples of natural gums include acacia, calcium carrageenan, guar, gelatin, guar gum, hydroxypropyl guar, karaya gum, kelp, locust bean gum, pectin, sodium carrageenan, tragacanth gum, and xanthan gum. Some examples of starches include oat flour, potato starch, wheat flour, and wheat starch. Some examples of stearates include PEG-<NUM> distearate, and methoxy PEG-<NUM>/dodecyl glycol copolymer. Some examples of fatty acid alcohols include caprylic alcohol, cetearyl alcohol, lauryl alcohol, oleyl alcohol, and palm kernel alcohol.

The amount of thickener in the composition depends on the desired viscosity of the composition.

The composition may optionally contain additional surfactant or combination of surfactants. These can be selected from water soluble or water dispersible nonionic, semi-polar nonionic, cationic, amphoteric, or surface-active agents; or any combination thereof. The particular surfactant or surfactant mixture chosen for use in the process and products of this invention can depend on the conditions of final utility, including method of manufacture, physical product form, and use pH. The composition is substantially free of anionic or zwitterionic surfactants.

A typical listing of the classes and species of surfactants useful herein appears in <CIT>. Additional surfactants, if present may be in the amount of from <NUM> to <NUM> wt. %, from <NUM> to <NUM> wt. % and from <NUM> to <NUM> wt.

Sanitizer compositions of the present invention can have a pH of <NUM> to <NUM>. Within this pH range, the present compositions effectively reduce microbial populations, and are consumer acceptable, i.e., are mild to the skin, are phase stable, and generate copious, stable foam. In some instances a pH adjusting compound may be necessary in a sufficient amount to provide a desired composition pH. To achieve the full advantage of the present invention, the pH-adjusting compound is present in an amount of <NUM> % to <NUM>%, by weight.

Examples of basic pH-adjusting compounds include ammonia; mono-, di-, and trialkyl amines; mono-, di-, and trialkanolamines; alkali metal and alkaline earth metal hydroxides; alkali metal phosphates; alkali sulfates; alkali metal carbonates; and mixtures thereof. However, the identity of the basic pH adjuster is not limited, and any basic pH-adjusting compound known in the art can be used. Specific, nonlimiting examples of basic pH-adjusting compounds are ammonia; sodium, potassium, and lithium hydroxide; sodium and potassium phosphates, including hydrogen and dihydrogen phosphates; sodium and potassium carbonate and bicarbonate; sodium and potassium sulfate and bisulfate; monoethanolamine; trimethylamine; isopropanolamine; diethanolamine; and triethanolamine.

The identity of an acidic pH-adjusting compound is not limited and any acidic pH-adjusting compound known in the art, alone or in combination, can be used. Examples of specific acidic pH-adjusting compounds are the mineral acids and polycarboxylic acids. Nonlimiting examples of mineral acids are hydrochloric acid, nitric acid, phosphoric acid, and sulfuric acid. Nonlimiting examples of polycarboxylic acids are citric acid, glycolic acid, and lactic acid.

The composition may optionally include an antioxidant for improved skin condition through the removal of free radicals, and improved product stability. Some examples of antioxidants include retinol and retinol derivatives, ascorbic acid and ascorbic acid derivatives, BHA, BHT, beta carotene, cysteine, erythorbic acid, hydroquinone, and tocopherol and tocopherol derivatives.

If an antioxidant is included, it is preferably present in the composition in an amount from <NUM> to <NUM> wt. %, from <NUM> to <NUM> wt. %, and from <NUM> to <NUM> wt.

The composition may optionally include a fragrance. Examples of possible fragrances include to natural oils or naturally derived materials, and synthetic fragrances such as hydrocarbons, alcohols, aldehydes, ketones, esters, lactones, ethers, nitriles, and polyfunctionals. Examples of natural oils include the following: basil (Ocimum basilicum) oil, bay (Pimento acris) oil, bee balm (Monarda didyma) oil, bergamot (Citrus aurantium bergamia) oil, cardamom (Elettaria cardamomum) oil, cedarwood (Cedrus atlantica) oil, chamomile (Anthemis nobilis) oil, cinnamon (Cinnamomum cassia) oil, citronella (Cymbopogon nardus) oil, clary (Salvia sclarea) oil, clove (Eugenia caryophyllus) oil, cloveleaf (Eufenia caryophyllus) oil, Cyperus esculentus oil, cypress (Cupressus sempervirens) oil, Eucalyptus citriodora oil, geranium maculatum oil, ginger (Zingiber officinale) oil, grapefruit (Citrus grandis) oil, hazel (Corylus avellana) nut oil, jasmine (Jasminum officinale) oil, Juniperus communis oil, Juniperus oxycedrus tar, Juniperus virginiana oil, kiwi (Actinidia chinensis) water, lavandin (Lavandula hybrida) oil, lavender (Lavandula angustifolia) oil, lavender (Lavandula angustifolia) water, lemon (Citrus medica limonum) oil, lemongrass (Cymbopogon schoenanthus) oil, lime (Citrus aurantifolia) oil, linden (Tilia cordata) oil, linden (Tilia cordata) water, mandarin orange (Citrus nobilis) oil, nutmeg (Myristica fragrans) oil, orange (Citrus aurantium dulcis) flower oil, orange (Citrus aurantium dulcis) oil, orange (Citrus aurantium dulcis) water, patchouli (Pogostemon cablin) oil, peppermint (Menthe piperita) oil, peppermint (Menthe peperita) water, rosemary (Rosmarinus officinalis) oil, rose oil, rose (Rosa damascena) extract, rose (Rosa multiflora) extract, rosewood (Aniba rosaeodora) extract, sage (Salvia officinalis) oil, sandalwood (Santalum album) oil, spearmint (Menthe viridis) oil, tea tree (Melaleuca alternifolia) oil, and ylang ylang (Cananga odorata) oil. Some examples of synthetic hydrocarbon fragrances include caryophyllene, β-farnesene, limonene, α-pinene, and β-pinene. Some examples of synthetic alcohol fragrances include bacdanol, citronellol, linalool, phenethyl alcohol, and α-terpineol (R=H). Some examples of synthetic aldehyde fragrances include <NUM>-methyl undecanal, citral, hexyl cinnamic aldehyde, isocycolcitral, lilial, and <NUM>-undecenal. Some examples of synthetic ketone fragrances include cashmeran, α-ionone, isocyclemone E, koavone, muscone, and tonalide. Some examples of synthetic ester fragrances include benzyl acetate, <NUM>-t-butylcyclohexyl acetate (cis and trans), cedryl acetate, cyclacet, isobornyl acetate, and α-terpinyl acetate (R=acetyl). Some examples of synthetic lactone fragrances include coumarin, jasmine lactone, muskalactone, and peach aldehyde. Some examples of synthetic ether fragrances include ambroxan, anther, and galaxolide. Some examples of synthetic nitrile fragrances include cinnamonitrile and gernonitrile. Finally, some examples of synthetic polyfunctional fragrances include amyl salicylate, isoeugenol, hedione, heliotropine, lyral, and vanillin.

The composition may include a mixture of fragrances including a mixture of natural and synthetic fragrances. The fragrance can be present in a composition in an amount up to <NUM> wt. %, preferably from <NUM> to <NUM> wt. %, from <NUM> to <NUM> wt. %, and from <NUM> to <NUM> wt.

The composition may optionally include a dye. Examples of dyes include any water soluble or product soluble dye, any FD&C or D&C approved dye.

The compositions of to the invention are easily produced by any of a number of known art techniques. Conveniently, a part of the water is supplied to a suitable mixing vessel further provided with a stirrer or agitator, and while stirring, the remaining constituents are added to the mixing vessel, including any final amount of water needed to provide to <NUM>% wt. of the inventive composition.

The compositions may be packaged in any suitable container particularly flasks or bottles, including squeeze-type or pump bottles, as well as bottles provided with a spray apparatus (e.g. trigger spray) which is used to dispense the composition by spraying. The selected packaging may have a pump head foamer. Examples of commercially available pump head foamers include the F2 foamer from Rexam PLC (London, England, formerly Airspray), and the RF-<NUM> Palm Foamer from Rieke Corporation (Auburn, Indiana). Accordingly the compositions are desirably provided as concentrates or ready to use products in a manual or automated dispensing equipment.

The composition may be provided in various packaging sizes. Examples of packaging sizes include <NUM> (<NUM> oz), <NUM> and <NUM> liter bottles.

Whereas the compositions of the present invention are intended to be used in the types of liquid forms described, nothing in this specification shall be understood as to limit the use of the composition according to the invention with a further amount of water to form a solution there from. Conversely, nothing in the specification shall be also understood to limit the forming of a "super-concentrated" composition based upon the composition described above. Such a super-concentrated ingredient composition is essentially the same as the compositions described above except in that they include a lesser amount of water.

The invention includes compositions and methods for reducing the population of a microorganism on skin. These compositions and methods can operate by contacting the body with a composition of the invention. Contacting can include any of numerous methods for applying a composition of the invention, such as spraying the compositions, immersing, foam or gel treating the skin with the composition, or a combination thereof. The compositions and methods may be used without further dilution with water or other suitable diluents or may be supplied as concentrated compositions. The concentrated compositions may be diluted prior to packaging or diluted prior to/at the point of use. The concentrated compositions may be diluted at a concentrate: diluent ratio from <NUM>:<NUM> to <NUM>:<NUM>. More preferably, the concentrated compositions may be diluted at a concentrate:diluent ration from <NUM>:<NUM> to <NUM>: <NUM>. The concentrated compositions may be diluted manually or through automated dispensing and/or diluting equipment.

The compositions of the invention may be combined with treated or untreated water. For example, the compositions may be combined with aerated, chlorinated, desalinated, disinfected, reverse osmosis (RO) and/or filtered water. The compositions may also be combined with water sources containing mineral ions such as calcium, magnesium, iron, copper, manganese, bicarbonate, phosphate, silicate, sulfate, fluoride, chloride, bromide, hydroxide, nitrate, and nitrite. Additionally the concentrate compositions may be diluted at or prior to the point of use with water pretreated with coagulant and/or flocculants.

The compositions of the invention can be included in any skin application products such, sanitizers, deodorizers, antiseptics, fungicides, germicides, virucides, waterless hand sanitizers, and pre- or post-surgical scrubs, preoperative skin preps.

The antimicrobial composition of the present invention has a high broad spectrum of antimicrobial efficacy, high foam and reduced irritation to mammalian tissue. Exemplary compositions are provided in the following tables.

The present invention is more particularly described in the following examples that are intended as illustrations only. Unless otherwise noted, all parts, percentages, and ratios reported in the following examples are on a weight basis, and all reagents used in the examples were obtained, or are available, from the chemical suppliers described below, or may be synthesized by conventional techniques.

Materials used in the described embodiments include, but are not limited to: Stearyldimonium-hydroxypropyl Laurylglucosides Chloride, Cocoglucosides Hydroxypropyl-trimonium Chloride, Laurylglucosides Hydroxypropyl-trimonium Chloride, Poly (Lauryldimonium-hydroxypropyl Decylglucosides Chloride), Poly (Stearyldimonium-hydroxypropyl Decylglucosides Chloride), Poly (Stearyldimonium-hydroxypropyl Laruylglucosides Chloride), Poly (Trimonium-hydroxypropyl Cocoglucosides Chloride).

The following methods were used in the preparation and testing of the examples:.

(a) Determination of Time Kill Activity: The activity of antimicrobial compositions was measured by the time kill method [ASTM E <NUM> Standard Guide for Assessment of Antimicrobial Activity Using a Time Kill Procedure], whereby the survival of challenged organisms exposed to an antimicrobial test composition is deterred as a function of time. In this test, a diluted aliquot of the composition is brought into contact with a known population of test bacteria for a specified time period at a specified temperature. The test composition is neutralized at the end of the time period, which arrests the antimicrobial activity of the composition. The percent or, alternatively, log reduction from the original bacteria population is calculated. In general, the time kill method is known to those skilled in the art. In addition, comparative data on the foam profile of representative systems is shown. (b) The composition can be tested at any concentration from <NUM>-<NUM>%. The choice of which concentration to use is at the discretion of the investigator, and suitable concentrations are readily determined by those skilled in the art. All testing if performed in triplicate, the results are combined, and the average log reduction is reported. (c) The choice of contact time period also is at the discretion of the investigator. Any contact time period can be chosen. Typical contact times range from <NUM> second to <NUM> minutes, with <NUM> seconds and <NUM> minute being typical contact times. The contact temperature also can be any temperature, typically room temperature, or about <NUM> degrees Celsius. (d) The microbial suspension, or test inoculum, is prepared by growing a microbial culture on any appropriate solid media (e.g., agar). The microbial population then is washed from the agar with sterile physiological saline and the population of the microbial suspension is adjusted to about <NUM><NUM> colony forming units per ml (cfu/ml). (e) The table below lists the test microbial cultures used in the following tests and includes the name of the bacteria, the ATCC (American Type Culture Collection) identification number, and the abbreviation for the name of the organism used hereafter.

aureus is a Gram positive bacteria, whereas, E. coli is a Gram negative bacteria. The log reduction is calculated using the formula:<MAT>.

The foam height was determined with the following procedural steps:.

The foam stability was determined by using the difference between the foam/ air interference and the foam/aqueous interface <NUM> minutes after pouring a <NUM>% solution into a <NUM> beaker.

In vitro irritancy was assessed by an external testing facility using Matek Corporation's "EpiDerm MTT ET-<NUM> Protocol (EPI-<NUM>)".

The test consists of a topical exposure of the neat test chemical to a reconstructed human epidermis (RhE) model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [(<NUM>-<NUM>,<NUM>-dimethyl thiazole <NUM>-yl) <NUM>,<NUM>-diphenyltetrazolium bromide], present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The reduction of the viability of tissues exposed to chemicals in comparison to negative controls (treated with water) is used to predict the skin irritation potential.

EpiDerm tissues are conditioned by incubation of release transport-stress related compounds and debris overnight. After pre-incubation, tissues are topically exposed to the test chemicals for <NUM> minutes. Preferably, three tissues are used per test chemical (TC) and for the positive control (PC) and negative control (NC). Tissues are then thoroughly rinsed, blotted to remove the test substances, and transferred to fresh medium. Tissues are incubated for <NUM> hrs. Afterwards, the MTT assay is performed by transferring the tissues to <NUM>-well plates containing MTT medium (<NUM>/mL) after a <NUM> hr MTT incubation, the blue formazan salt formed by cellular mitochondria is extracted with <NUM>/tissue of isopropanol and the optical density of the extracted formazan is determined using a spectrophotometer at <NUM>. Relative cell viability is calculated for each tissue as % of the mean of the negative control tissues. Skin irritation potential of the test material is predicted if the remaining relative cell viability is below <NUM>%.

The foam resistance was determined by measuring <NUM> grams of the test product into a blender and blending for about <NUM> seconds on medium speed. Thereafter, the test solution was poured into a cylinder and a plastic ball was dropped into the test solution and timed to determine how many seconds it took for the plastic ball to drop from a first pre-determined level to a second pre-determined level, e.g., from <NUM> mark on the cylinder to the <NUM> mark on the cylinder.

The following Figures demonstrate efficacy data of the antimicrobial composition, using various cationic active ingredients, quaternary sugar-derived surfactants and foam boosting surfactants.

Table <NUM> and <FIG> (Log Kill of Cationic Active Ingredients): The following figures illustrate the efficacy following a <NUM> second exposure time of three different cationic active ingredients, specifically, <NUM> % Quat (Benzalkonium Chloride), <NUM>% CHG (Chlorhexidine Gluconate), and <NUM>% PHMB (polyhexamethylene biguanide) in a representative surfactant system.

Table <NUM> illustrates the formulas for the three cationic active ingredient systems tested. Both the quaternary sugar-derived surfactant and foam boosting surfactant were held constant and only the cationic active ingredient was changed between the three tests performed. The results are illustrated in <FIG>.

As illustrated in <FIG>, all three cationic active ingredients had high cidal activity against S. aureus and E. coli bacteria within a <NUM> second exposure time.

Table <NUM> and <FIG> (Log Kill of Quaternary Sugar-Derived Surfactants): Next, Applicants tested the efficacy against S. aureus and E. coli bacteria with increased concentrations of quaternary sugar-derived surfactants, specifically, Poly (Trimoniumhydroxypropyl Cocogluocosides Chloride). The amount and type of cationic active ingredient (<NUM>% ADBAC Quat) and foam boosting surfactant (<NUM>% Alkyl Dimethyl Amine Oxide) was held constant. Table <NUM> below illustrates the quantitative results of this test and <FIG> illustrates the graphical results.

As Table <NUM> and <FIG> illustrate, the quaternary sugar-derived surfactant has a high cidal activity against S. aureus and E. coli bacteria after only <NUM> seconds of exposure. Also, the tolerance of the quaternary sugar derived surfactant against bacteria is shown. Furthermore, it is clearly illustrated that an increased concentration of quaternary sugar-derived surfactant maintains a good log kill of bacteria up until a <NUM> to <NUM> ratio of quaternary sugar-derived surfactant to cationic active ingredients.

Table <NUM> and <FIG> (Log Kill of Foam Boosting Surfactants): Table <NUM> and <FIG> illustrate the efficacy with increased concentrations of foam boosting surfactants, specifically, amine oxide. The amount and type of cationic active ingredient (<NUM>% ADBAC Quat) and Quaternary sugar-derived surfactant (<NUM> % Poly Trimoniumhydroxypropyl Cocoglucosides Chloride) were held constant. Table <NUM> below illustrates the quantitative results of this test and <FIG> illustrates the graphical results.

As Table <NUM> and <FIG> illustrate, the foam boosting surfactant has a high cidal activity against S. aureus and E. coli bacteria after only <NUM> seconds of exposure. Also, the tolerance of the foam boosting surfactant against bacteria is shown. Furthermore, it is clearly illustrated that a broad range of foam boosting surfactant maintains a good log kill of bacteria.

Applicants tested the dermal irritancy (mildness) of an antimicrobial Dermal Cleanser as illustrated in Table <NUM> to four commercially available antimicrobial soaps. Commercially Available Products A, C and D are available by Gojo Medicated, Akron, Ohio and Commercially Available Product B is available by Dial a subsidiary of Henkel Corporation, Dusseldorf, Germany. As illustrated in <FIG>, the antimicrobial dermal cleanser according to Table <NUM> has a high relative mildness index especially in comparison to antimicrobial hand soaps that are commercially available.

Applicants tested the foam profile of an antimicrobial Dermal Cleanser as illustrated in Table <NUM> to three commercially available antimicrobial soaps. As illustrated in <FIG>, the antimicrobial dermal cleanser according to Table <NUM> has both good foam volume and foam stability especially in comparison to antimicrobial hand soaps that are commercially available.

Applicants tested the efficacy against S. aureus and E. coli bacteria with various quaternary sugar-derived surfactants, held constant at <NUM>%. The amount and type of cationic active ingredient (<NUM>% ADBAC Quat) and foam boosting surfactant (<NUM>% Alkyl Dimethyl Amine Oxide) was held constant.

As Table <NUM> illustrates, a high log kill is maintained against S. aureus and E. coli bacteria for both quaternized sugar-derived surfactants and polyquaternized sugar-derived surfactants. The chain length of the sugar quaternary surfactant may be altered and yet still maintain high efficacy. The graphical results of the test are illustrated in <FIG>.

Applicants tested the foam rigidity of an embodiment for use in dermal applications as shown below in Table <NUM> in comparison to two commercially available products, Commercial Products E and F. Commercial Products E and F are traditional anionic surfactant base dermal washes containing a cationic active. Commercial Product E is commercially available by Proctor & Gamble, Cincinnati, Ohio and Commercial Product F is commercially available by Deb Group Limited, United Kingdom, England. The results of the foam rigidity test are illustrated in <FIG>. As illustrated in <FIG>, the foam rigidity of the dermal wash according to Table <NUM> is greater than commercially available cationic active dermal washes with a traditional anionic surfactant base.

Foam Rigidity Formula of Current Invention (pH of <NUM>-<NUM>):.

Applicants tested the efficacy of the dermal cleanser of the current invention by determining the log reduction of both gram positive and gram negative bacterial after <NUM> seconds of exposure.

Dermal Cleanser of Current Invention (pH of <NUM>-<NUM>):.

Applicants tested the efficacy of the surgical scrub of the current invention by determining the log reduction of both gram positive and gram negative bacterial after <NUM> seconds of exposure.

Surgical Scrub of Current Invention (pH of <NUM>-<NUM>):.

All samples were prepared using a <NUM>% solution of examples <NUM>-<NUM> (tables <NUM> to <NUM>) diluted in deionized water or <NUM> grain hardness water as indicated. The samples were then adjusted to the appropriate pH using lactic acid.

The results are shown in tables <NUM> and <NUM>. The results of table <NUM> are depicted graphically in <FIG>.

From table <NUM>, one can see that the addition of chelating agent in example <NUM> allows for identical antimicrobial activity indeionized water.

From table <NUM> one can see that the ready to use composition of the invention demonstrates stable antimicrobial activity across various pH differences.

Comparison of Chelating Agents Iminodisuccinic Acid (IDS) and Ethylenediamine Tetraacetic Acid (EDTA) at pH = <NUM>.

The antimicrobial compositions of the invention where made with the same components with the exception of the two different chelating agents as indicated below in Table <NUM>.

The results are shown in in Table <NUM>.

The testing results indicate that antimicrobial efficacy is enhanced by chelating agents with high stability constants for Ca<NUM>+ and Mg<NUM>+.

The above samples were made and tested in Examples <NUM> and <NUM>.

Claim 1:
An antimicrobial dermal concentrate comprising:
(a) a cationic active ingredient selected from the group consisting of a salt of a biguanide, a substituted biguanide, an organic salt of a quaternary ammonium containing compound or an inorganic salt of a quaternary ammonium containing compound, and chlorohexidine gluconate (CHG);
(b) a quaternized sugar-derived surfacant;
(c) a foam boosting surfactant comprising an alkyl amine oxide, alkyl ether amine oxide, and polyethoxylated glycerol esters, or a combination thereof;
(d) a foam boosting copolymer, wherein the foam boosting copolymer is a dimethyldiallylammonium chloride-acrylamide copolymer;
(e) a foam stabilizing, linear or branched C<NUM>-<NUM> diol with the structure
<CHM>
wherein R<NUM> = H, CH<NUM>, CH<NUM>CH<NUM>, CH<NUM>CH<NUM>CH<NUM>, C(CH<NUM>)<NUM>, CH(CH<NUM>)<NUM> or combinations thereof and R<NUM> is a branched or linear C<NUM>-C<NUM> alkyl chain
(f) an aminocarboxylate chelating agent capable of forming a calcium-chelating agent complex with a stability constant (expressed logarithmically) of <NUM> or greater, wherein the chelating agent is selected from the group consisting of ethylenediaminetetraacetic acid (EDTA); diethylenetriaminepentacetic acid (DTPA); methylglycine-N,N-diacetic acid (MGDA); glutamic acid-N,N-diacetic acid (GLDA); aspartic acid-N,N-diacetic acid (ASDA) and alkali, alkali earth metal, transition metal and/or ammonium salts thereof; and
(g) water,
wherein the concentrate is substantially free of anionic surfactants, triclosan, and C<NUM>-<NUM> alcohols.