Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
  • A61L2/186—Peroxide solutions
• • A—HUMAN NECESSITIES
  • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
  • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
  • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
  • A01N25/02—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests containing liquids as carriers, diluents or solvents
• • A—HUMAN NECESSITIES
  • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
  • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
  • A01N39/00—Biocides, pest repellants or attractants, or plant growth regulators containing aryloxy- or arylthio-aliphatic or cycloaliphatic compounds, containing the group or, e.g. phenoxyethylamine, phenylthio-acetonitrile, phenoxyacetone

Definitions

• Alcoholic gel-based hand sanitizers have been successfully commercialized to the health care and consumer markets. These products are convenient to use and effective at killing germs. However, since these products typically contain 60-70% ethanol, they are highly flammable. Therefore, special storage and handling procedures have been developed to store and transport these products. Not only have the flammability of these products increased their storage and distribution costs, but they have foreclosed several markets, such as the airline industry.
• alcohol-based sanitizers may cause skin drying and irritation.
• the inventor has discovered a composition which when applied to the palms of the hands and upon rubbing, quickly dries and sanitizes the hands without the use of alcohol.
• the present invention is directed to a composition including (a) a sanitizing effective amount of an antimicrobial agent, (b) a water-soluble silicone, (c) a humectant selected from the group consisting of hydrogenated starch hydrolysates, glycerin, and mixtures thereof, and (d) water.
• This composition is non-flammable, bactericidal, and quick drying.
• This composition is preferably substantially free of alcohol and more preferably contains less than about 0.5 or 1% by weight of alcohol, based upon 100%) by weight of total composition.
• the hand sanitizer of the present invention is non-flammable, disinfects and/or sanitizes surfaces rapidly, and quickly dries after application.
• Another embodiment is a method of disinfecting and/or sanitizing a surface which comprises applying the aforementioned hand sanitizer composition to the surface.
• the hand sanitizer composition may be topically applied to hands, face and other surfaces of the body to disinfect and sanitize the same.
• Suitable antimicrobial agents include, but are not limited to, quaternary ammonium compounds, phenolic based compounds, and mixtures thereof.
• Preferred quaternary ammonium compounds include, but are not limited to, benzethonium chloride, available as Hyamine ® 1622 from Lonza Inc. of Fair Lawn, NJ; benzalkonium chloride, available as Hyamine ® 3500 USP from Lonza Inc.; and mixtures thereof.
• Preferred phenolic based compounds include, but are not limited to, trichloro-2- hydroydiphenylether (triclosan) and para-chloro-meta-xylenol (PCMX).
• the water-soluble silicone functions as a spreading agent to promote drying and lubricity to the skin.
• a preferred water-soluble silicone is dimethicone [dimethyl, methyl (propylpoyethylene oxide polypropylene oxide, acetate) siloxane] available as Dow Corning ® 190 Surfactant from Dow Corning Corp. of Midland, ML.
• Suitable humectants include, but are not limited to, those listed on pages 1661 and 1662 of the 7 th Edition of the International Cosmetic Ingredient Dictionary and Handbook, which is hereby incorporated by reference.
• suitable humectants include acetamide MEA, agarose, ammonium lactate, arginine PCA, benzyl hyaluronate, carboxymethyl chitosan succinamide, chitosan PCA, copper PCA, corn glycerides, diglycerin, dimethyl imidazolidinone, erythritol, fructose, glucamine, glucose, glucose glutamate, glucuronic acid, glutamic acid, glycereth-7, glycereth-12, glycereth-20, glycereth-26, glycereth-31, glycerin, honey, hydrogenated honey, hydrogenated starch hydrolysate, hydrolyzed com
• PGEs polyglyceryl esters
• the polyglyceryl esters which may be used in the subject invention may be represented by the following general formula:
• R 5 OCH 2 -CH(OR 4 )-CH 2 -(O-CH 2 CH(OR 3 )-CH 2 ) n -O-CH 2 -CH(OR 2 )-CH 2 OR' , wherein R is hydrogen or an acyl group (R-CO-) of a fatty acid moiety having from 8 to 22 carbon atoms, the number of R groups is from 1 to 12, and n is from 0 to 10.
• the backbone is generally prepared by a condensation reaction which gives a normal distribution pattern in the final polymer.
• the average number of glycerin units in the base polyol will always total n+2.
• the PGEs used in the formulations of the invention have a molecular weight of from 600 to 3500, preferably from 800 to 1200.
• the fatty acid used to prepare the PGE can be selected from a broad range of structural types such as straight chain or branched and saturated or unsaturated. In some cases, the fatty acid chain length distribution will be a specific blend or will match that found in natural oils such as, for example, almond or sunflower oils.
• the preferred fatty acids have from 14 to 18 carbon atoms. The 18-carbon acid is the most desirable.
• the best PGEs are of decaglyceryl series where approximately 10 moles of glycerin are reacted to form the polyglycerol moiety and where there is one ester group, i.e., a monoester. In such cases, if one R equals a fatty acid moiety, then the other Rs would be hydrogen.
• the monoesters are not 100% but in the range of between 30% and 70%) of the composition. The remainder, based on a statistical distribution, will be di-, tri- or higher esters along with some unreacted polyol.
• Particularly useful PGEs include decaglyceral monostearate, monoleate, decaoleate, hexaoleate, distearate, dodecaoleate, decaglyceryl dioleate, monosunflower-ate, and monoalmond-ate; triglyceryl monostearate and triglyceryl monopalmitate; and octaglyceryl dilaurate.
• solvents must be non-alcoholic. As a practical matter, water is preferred.
• the composition may include other adjuvants known in the art, such as colorants, pH adjusting agents, fragrances, preservatives, thickeners, and any combination thereof.
• the thickener is a nonionic or a cationic compound due to the cationic nature of quaternary ammonium compounds.
• preferred thickeners include hydroxypropyl methylcellulose (Methocel J12MSTM from Dow Chemical Co. of Midland, MI), xanthan gum (Keltrol TTM from Monsanto of Saint Louis, MO), acrylic copolymers (such as Structure PlusTM from National Starch and Chemical of Island Falls, ME); and mixtures thereof.
• preservatives can be used. These include: alkanol-substituted DMH compounds as defined in U.S. Patent Nos. 3,987,184 and 4,172,140. These are condensation products of 5,5-dimethylhydantoin with 1, 2, or more moles of formaldehyde (e.g., l,3-dimethylol-5,5-dimethylhydantoin, l-methylol-5,5- dimethylhydantoin, or 3-methylol-5,5-dimethylhydantoin, 1,3-dimethyioloxymethylene- 5 , 5 -dimethylhydantoin, 1 -methylol-3 -methyloloxymethylene-5 ,5 -dimethylhydantoin and l,3-dimethyloloxymethylene-5,5-dimethylhydantoin, and mixtures thereof).
• a preferred preservative is Glydant ® Plus Liquid, available from Lonza
• Isothiazolones may also be used. These have formula I:
• isothiazolone components include 5-chloro-2-methyl- 4-isothiazolin-3-one (CMI) and 2-methyl-4-isothiazolin-3-one (MI), and 2.8:1 mixtures of CMI/MI.
• CMI 5-chloro-2-methyl- 4-isothiazolin-3-one
• MI 2-methyl-4-isothiazolin-3-one
• Other 3-isothiazolones can be used in the invention, including 4-chloro-2-methyl-4-isothiazolin-3-one, dichloroisothiazolones such as 4,5-dichloro-2-methyl-4-isothiazolin-3-one, bromoisothiazolones such as
• composition is preferably substantially free of alcohol and more preferably contains less than about 0.1, 0.5, or 1% by weight of alcohol, based upon 100% weight of total composition.
• a concentrate is preferably first formed.
• the concentrate is diluted with 5 to 20 times its weight of a solvent with or without dissolved constituents.
• the concentrate will contain the antimicrobial agent, the spreading' agent, and the humectant dissolved in the solvent.
• the preservative, colorant and fragrance may be included.
• the concentrate Before use, the concentrate is diluted, preferably with the same solvent as was used in the concentrate.
• the diluent will contain, if desirable, a thickener, the preservative, the colorant and/or the fragrance, though the last three may also be included in the concentrate. Since these latter components are quite soluble, it is of little consequence whether they form part of the concentrate or are dissolved in the diluent.
• the thickener cannot be added to the concentrate.
• Table I illustrates the components and the ranges of components present in the concentrate.
• compositions may be obtained by diluting the concentrate shown in Table I or by blending all of the components at essentially the same time.
• the use dilution and concentrate are stable single phase solutions.
• the components selected are generally recognized as safe and effective.
• the use dilution has a pH of broadly from 5 to 8 and preferably from 6 to 7.
• the viscosity may vary from 1 to 500 cps depending on the application. Where a thickener is used, it may be necessary to adjust the pH to about 8 (using any appropriate base such as an alkali or alkaline earth metal, preferably sodium hydroxide) to form a clear solution. After the clear solution is formed, the pH of the use dilution maybe adjusted to be in the preferred range without loss of clarity.
• a non-alcoholic hand sanitizer concentrate of the invention may be prepared by mixing the ingredients shown in Table III below.
• the use dilution of the invention may be prepared by diluting 10 parts of the concentrate with 90 parts of the diluent shown in Table IV. Table TV
• the resulting non-alcoholic hand sanitizer composition shown in Table V below was prepared by mixing the concentrate of Table JJI with the diluent of Table IV:
• the above composition is a clear liquid having a pH of about 6-8 and a specific gravity of about 8.5 lbs/gal.
• the sanitizer is used by applying a small amount to hands and rubbing the hands together as washing hands.
• Example 2 The antimicrobial efficacy of the non-alcoholic hand sanitizer formulation of Example 1 was determined against the bacteria listed in Table VI as follows. The bacteria were grown overnight on separate agar-solidified growth mediums. Each growth medium was then suspended in a phosphate buffer and diluted to a concentration of 3 x 10 8 bacteria per ml. 1 ml of the cell suspension was added to 10 ml of the non-alcoholic hand sanitizer formulation and mixed well. After one minute, an aliquot was removed and transferred to a neutralizing tube containing Letheen broth, modified to include additional Tween ® 80, available from Uniquema Chemicals of Wilmington, DE, and lecithin. The number of bacteria in the neutralizing tube were counted by performing serial dilutions in microwell plates.
• the bacterial reduction for the non-alcoholic hand sanitizer formulation was calculated based on the results from the unchallenged control. The results are shown in Table VI.
• Table VJJ shows the log of the bacterial count after exposure to the control solution for 1 minute and the log of the bacterial count before exposure to the non-alcoholic hand sanitizer formulation.

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• Chemical & Material Sciences (AREA)
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• Toxicology (AREA)
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Citations (10)

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• 2001
  • 2001-12-21 US US10/032,203 patent/US6559322B1/en not_active Expired - Lifetime
• 2002
  • 2002-06-04 WO PCT/US2002/017828 patent/WO2002102151A1/en not_active Application Discontinuation

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