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WO2010063988A1 - Compositions germicides topiques - Google Patents

Compositions germicides topiques Download PDF

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Publication number
WO2010063988A1
WO2010063988A1 PCT/GB2009/002764 GB2009002764W WO2010063988A1 WO 2010063988 A1 WO2010063988 A1 WO 2010063988A1 GB 2009002764 W GB2009002764 W GB 2009002764W WO 2010063988 A1 WO2010063988 A1 WO 2010063988A1
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WO
WIPO (PCT)
Prior art keywords
constituent
compositions
topical
optionally
silicone
Prior art date
Application number
PCT/GB2009/002764
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English (en)
Inventor
Sandra-Judith Guerra-Vega
William Lenzetti
Original Assignee
Reckitt & Colman (Overseas) Limited
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Filing date
Publication date
Application filed by Reckitt & Colman (Overseas) Limited filed Critical Reckitt & Colman (Overseas) Limited
Publication of WO2010063988A1 publication Critical patent/WO2010063988A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/731—Cellulose; Quaternized cellulose derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
    • A61K8/89—Polysiloxanes
    • A61K8/891—Polysiloxanes saturated, e.g. dimethicone, phenyl trimethicone, C24-C28 methicone or stearyl dimethicone
    • A61K8/894—Polysiloxanes saturated, e.g. dimethicone, phenyl trimethicone, C24-C28 methicone or stearyl dimethicone modified by a polyoxyalkylene group, e.g. cetyl dimethicone copolyol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/90—Block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/005—Antimicrobial preparations
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the present invention relates to viscous germicidal topical compositions which have a high alcohol content, and which provide a germicidal benefit to dermal surfaces upon which the compositions are applied.
  • Topical compositions per se, are well-known in the cosmetic, dermatological as well as in the pharmaceutical fields. Most topical compositions are intended to provide at least one but generally provide multiple or more specific benefits after being applied to the human skin.
  • personal care compositions which are primarily intended to be soaps for general cleaning of the human skin such as hand soaps or body wash soaps are well known in the fields of cosmetics and personal care products. While providing a primary cleaning benefit, such personal care compositions frequently also provide ancillary benefits such as moisturizing and nourishing the skin.
  • Such personal care compositions which provide a good general cleaning benefit are usually based on one or more anionic soaps or anionic surfactants which are recognized to provide good cleaning and good foaming. However, such compositions typically provide only limited germicidal benefits.
  • compositions which are primarily directed to provide an germicidal benefit to the epidermis or other body part when applied thereto.
  • Such typically take the form of viscous gels and are often largely comprised of an alcohol, usually ethanol, with further constituents, e.g., thickeners.
  • alcohol usually ethanol
  • thickeners further constituents
  • topical germicidal compositions for application to the epidermis, e.g., hands, arms, legs, face, scalp as well as other body areas.
  • a method for the manufacture or production of improved topical germicidal composition as set forth herein.
  • an improved method for the treatment of the skin (epidermis) as well as other body surface including the hair which method includes the application of a cleaning and/or germicidally effective amount of the topical composition described herein in order to provide an effective cleaning and/or germicidal benefit.
  • topical germicidal compositions for application to the epidermis, e.g., hands, arms, legs, face, scalp as well as other body areas.
  • the topical germicidal compositions are those which are flowable and exhibit an initial viscosity of at in the range of 10 - 100,000 cP at 25 °C as measured using conventional quantitative methods.
  • These topical germicidal compositions comprise (in preferred embodiments consist of, or consist essentially of): about 50%wt. - 95%wt, preferably about 60% wt. - 90%wt.
  • an alcohol constituent comprising one or more Ci-C 4 monohydric alcohols
  • a silicone emulsif ⁇ er constituent which preferably comprises PEG/PPG dimethicone in a liquid silicone carrier and/or comprises a PEG/PPG cyclopentasiloxane; and optionally but preferably further includes a volatile linear silicone constituent; an ion source, such as a salt; a thickener constituent based on one or more cellulose derivatives, such as hydroxypropylmethylcellulose; optionally one or more further constituents for improving the aesthetic or other technical characteristics of the invention, optionally but preferably up to 30%wt. of water, but preferably not more than about
  • topical germicidal compositions for application to the epidermis, e.g., hands, arms, legs, face, scalp as well as other body areas.
  • the topical germicidal compositions are those which are flowable and exhibit an initial viscosity of at in the range of 10 - 100,000 cP at 25°C as measured using conventional quantitative methods.
  • These topical germicidal compositions comprise (in preferred embodiments consist of or consist essentially of): about 50%wt. - 95%wt, preferably about 60%wt. - 90%wt.
  • an alcohol constituent comprising one or more Ci-C 4 monohydric alcohols
  • a silicone emulsifier constituent which preferably comprises PEG/PPG dimethicone in a liquid silicone carrier and/or comprises a PEG/PPG cyclopentasiloxane
  • a thickener constituent based on one or more cellulose derivatives, such as hydroxypropylmethylcellulose; optionally, but preferably, a volatile linear silicone constituent; optionally, but preferably, an ion source, such as a salt; optionally one or more further constituents for improving the aesthetic or other technical characteristics of the invention, > optionally, but preferably, up to 30%wt. of water, but preferably not more than about 15%wt.
  • compositions provide a topical germicidal benefit when applied to the skin or parts of the body.
  • topical germicidal compositions for application to the epidermis, e.g., hands, arms, legs, face, scalp as well as other body areas.
  • the topical germicidal compositions are those which are flowable and exhibit an initial viscosity of at in the range of 10 - 100,000 cP at 25°C as measured using conventional quantitative methods.
  • These topical germicidal compositions comprise (in preferred embodiments consist of or consist essentially of): about 50%wt. — 95%wt.
  • an alcohol constituent comprising one or more Cj-C 4 monohydric alcohols
  • a silicone emulsifier constituent which preferably comprises PEG/PPG dimethicone in a liquid silicone carrier and/or comprises a PEG/PPG cyclopentasiloxane
  • a volatile linear silicone constituent such as a salt
  • an ion source such as a salt
  • a thickener constituent based on one or more cellulose derivatives, such as hydroxypropylmethylcellulose
  • optionally one or more further constituents for improving the aesthetic or other technical characteristics of the invention optionally, but preferably, up to 30%wt. of water, but preferably not more than about 15%wt.
  • compositions provide a topical germicidal benefit when applied to the skin or parts of the body.
  • the present invention provides a topical germicidal composition according to the first, second or third aspects of the invention, characterized in that the said composition is effective against one or more, preferably at least two or more of the following microorganisms: B. cepacia, E. coli , S. aureus, S. marcenscens, S. pyogenes, S. epidermidis, E.faecalis, K. pneumoniae, P. aeruginosa, E. hirae, S. pneumoniae, C. albicans, S. enterica, and methicillin resistant Staphylococcus aureus ("MRSA").
  • MRSA methicillin resistant Staphylococcus aureus
  • the primary constituent of the topical germicidal compositions is an alcohol constituent, comprising one or more CrC 4 monohydric alcohols, e.g., one or more alcohols selected from methanol, ethanol, n-propanol, isopropanol, and all isomers of butanol.
  • Isopropanol although often used on the skin, is less desirable for use in the present invention because of its severe defatting tendency. Its defatting tendency may, however, be compensated for by adding sufficient emollient ingredient if desired to offset this tendency.
  • Preferred alcohols according to the present invention are however ethanol and n-propanol.
  • the alcohols when more than one alcohol is used, the alcohols are mixed at a concentration that is peak for their activity. Ethanol is included for its reduced defatting activity and for activity against viruses, especially the lipophilic group; while the inclusion of n-propanol enhances the contribution of the alcohol constituent to the overall germicidal efficacy of the topical germicidal compositions of which they form a part.
  • the alcohol constituent comprises at least 50%wt, or (in order of increasing preference) at least 55%wt., 60%wt., 65%wt, 70%wt, 75%wt, 80%wt, 85%wt, 90%wt, 95%wt, and especially preferably comprises at least 100%wt. ethanol.
  • the alcohol constituent itself comprises at least 50%wt., preferably comprises at least 55%wt., still more preferably comprises at least 60%wt. of the topical germicidal compositions of which it forms a part.
  • the alcohol constituent desirably comprises not more than 90%wt., preferably not more than 85%wt, yet more preferably not more than 80%wt, still more preferably not more than 75%wt, and especially preferably comprises not more than 70%wt. of the topical germicidal compositions.
  • a next essential constituent of the present invention is a silicone emulsifier constituent, which preferably comprises PEG/PPG dimethicone in a liquid silicone carrier and/or comprises a PEG/PPG cyclopentasiloxane.
  • the silicone emulsifier constituent may be a polydiorganosiloxanepolyoxyalkylene copolymer containing at least one polydiorganosiloxane segment and at least one polyoxyalkylene segment.
  • the polyoxyalkylene segments may be bonded to the polydiorganosiloxane segments with silicon-oxygen-carbon bonds and/or with silicon-carbon bonds.
  • the polydiorganosiloxane segments consist essentially of siloxane units which are interlinked by Si-O-Si linkages and which have the formula:
  • RbSiO(4 ⁇ b ⁇ y 2 The value of b may range from 0 to 3 for said siloxane units with the provision that there is an average of approximately 2, i.e. from 1.9 to 2.1 R radicals for every silicon in the copolymer.
  • Suitable siloxane units thus include R 3 SiCv 2 , R 2 Si0 2/2 , RSiO 3/2 , and SiO 4/2 siloxane units taken in such molar amounts so that b has an average value of approximately 2 in the copolymer.
  • Said siloxane units may be arranged in linear, cyclic and/or branched fashion.
  • the R radicals may be any radical selected from the group consisting of methyl, ethyl, vinyl, phenyl, and a divalent radical bonding a polyoxyalkylene segment to the polydiorganosiloxane segment. At least 95 percent of all R radicals are methyl radicals; preferably there is at least one methyl radical bonded to each silicon atom in (d). Divalent R radicals preferably contain no more than 6 carbon atoms. Examples of divalent R radicals include — O-, — C m H 2m O— , ⁇ C m H 2m — and — C m H 2m CO 2 — where m is an integer greater than zero.
  • the polydiorganosiloxanepolyoxyalkylene copolymer may comprise one or more of said polydiorganosiloxane segments.
  • the number of and average molecular weight of the polydiorganosiloxane segments in the copolymer is related to the desired weight ratio, hereinafter described, of said segments in the copolymer.
  • the polydiorganosiloxanepolyoxyalkylene copolymer comprises on polydiorganosiloxane segment having bonded thereto one or more polyoxyalkylene segments.
  • the polyoxyalkylene segments of the polydiorganosiloxanepolyoxyalkylene copolymer consist essentially of oxyethylene units of the formula --CH 2 CH 2 O--, alone, or in combination with oxypropylene units of the formula -CH 2 CH(CH 3 )O-, wherein preferably, an average of at least half of the oxyalkylene units in the polyoxyalkylene segments being oxyethylene units.
  • Suitable emulsions of this invention are not formed when the polyoxyalkylene segments contain more than 50 mol percent of the relatively hydrophobic oxypropylene unit.
  • the polyoxyalkylene segments thus correspond to the formula ⁇ -CH 2 CH 2 O-) P ⁇ -CH 2 CH(CH 3 )O-) q wherein the oxyalkylene units may be arranged in any suitable fashion such as random, alternating and block.
  • the average values of p and q are such that p is greater than or equal to q and the sum of p+q is sufficient to provide an average molecular weight of at least 1,000 for the polyoxyalkylene segments.
  • the average molecular weight of the polyoxyalkylene segments has a value of from 1,500 to 5,000.
  • the polyoxyalkylene segments of the polydiorganosiloxanepolyoxyalkylene copolymer are bonded to the polydiorganosiloxane segments of said copolymer by at least one terminal portion of said polyoxyalkylene segment, said bonding being by way of a divalent R radical, hereinbefore described. It is to be understood that said bonding may be by both terminal portions of said polyoxyalkylene segment in those copolymers comprising more than one polydiorganosiloxane segments. Any terminal portion of the polyoxyalkylene segment of the polydiorganosiloxanepolyoxyalkylene copolymer that is not bonded to a polydiorganosiloxane segment is satisfied by a terminating radical.
  • terminating radical is not critical and may be monovalent, thereby terminating one polyoxyalkylene segment, or polyvalent, thereby terminating more than one polyoxyalkylene segment.
  • Said terminating radicals are made up of atoms selected from the group consisting of carbon, hydrogen, nitrogen, and oxygen.
  • Illustrative of said terminating radical are hydrogen; hydroxyl; alkyl, such as methyl, ethyl, propyl, butyl; benzyl; aryl, such as phenyl; alkoxy such as methoxy, ethoxy, propoxy, butoxy; benzyloxy; aryloxy, such as phenoxy; alkenyloxy, such as vinyloxy and allyloxy; acyloxy, such as acetoxy, acryloxy and propionoxy and amino such as dimethylamino.
  • the number of and average molecular weights of the segments in the polydiorganosiloxanepolyoxyalkylene copolymer are such that the weight ratio of polydiorganosiloxane segments to polyoxyalkylene segments in the polydiorganosiloxanepolyoxyalkylene copolymer has a value of from 2 to 8, and preferably from 2.5 to 4.0. This weight ratio will insure that the copolymer (d) has a preferential solubility in the volatile liquid, a condition necessary for the formation of stable water-in-oil type emulsions of this invention.
  • the weight ratio of polydiorganosiloxane segments to polyoxyalkylene segments in polydiorganosiloxanepolyoxyalkylene copolymer is calculated on the basis of the total weight of polydiorganosiloxane and the total weight of polyoxyalkylene that is joined in the copolymerization process. For example, if 100 parts by weight of polydiorganosiloxane is joined completely by an addition process, which utilizes silicon-bonded hydrogen radicals, with 20 parts by weight of polyoxyalkylene, said weight ratio of the resulting copolymer has a value of 5.
  • the weight ratio of polydiorganosiloxane to polyoxyalkylene in the resulting copolymer may not be identical with the weight ratio of the corresponding reactants, due to the loss of the weight of the displaced groups.
  • the error introduced into the calculation of said weight ratio by ignoring the loss of said displaced groups is usually insignificant.
  • the weight ratio of polydiorganosiloxane to polyoxyalkylene in copolymer (d) may be calculated from the weight of reactants that react to form the copolymer or said weight ratio may be determined by suitable analysis of the resulting copolymer itself.
  • suitable analytical techniques such as elemental analysis, nuclear magnetic resonance spectroscopy, silicon substituent analysis and infra-red spectroscopy may be found in "Analysis of Silicones", A. Lee Smith, Ed., John Wiley and Sons, New York, 1974.
  • the said copolymer may include a block arrangement of segments such as denoted by the formulae (AB ) c , A(B A) c and B(AB) C or a pendant arrangement of segments such as (ABa) c or combinations thereof wherein A denotes a polydiorganosiloxane segment, B denotes a polyoxyalkylene segment and c and d respectively denote integers greater than zero and greater than one.
  • the polydiorganosiloxanepolyoxyalkylene copolymer may be prepared by modifications of the well-known methods described in the polydiorganosiloxane-polyoxyalkylene copolymer art.
  • the following patents are hereby incorporated by reference to show the preparation of exemplarly polydiorganosiloxane-polyoxyalkylene copolymers: Haluska, U.S. Pat. No. 2,868,824; Haluska, U.S. Pat. No. Re 25,727; Bailey, U.S. Pat. No. 3,172,899; Pater, U.S. Pat. No. 3,234,252, Simmler, et al. U.S. Pat. No.
  • silicone emulsif ⁇ ers are one or more compounds which may be represented by the structure:
  • R , 1 represents a Ci-C 30 straight chained, branched or cyclic alkyl group
  • R represents a moiety selected from:
  • n represents an integer from about 3 to about 10
  • R3 and R4 are sleeted from hydrogen and C1-C6 straight chain, or branched chain alkyl groups with the proviso that R3 and R4 are not simultaneously the same
  • each of m, p, x and y are independently selected from integers of zero or greater, such that the molecule has a molecular weight of between about 200 to about 20,000,000 and wherein both m and p are not both simultaneously zero
  • z is selected from integers of 1 or greater.
  • silicone emulsifiers are silicone polyethers, viz., a polydiorganosiloxanepolyoxyalkylene copolymer containing at least one polydiorganosiloxane segment and at least one polyoxyalkylene segment, include PEG/PPG- 18/18 dimethicone, available as a blend with cyclopentasiloxane as DC5225C or DC5185 from Dow Corning, Inc.
  • PEG/PPG-20/15 dimethicone available as a blend with cyclopentasiloxane as SFl 528 from Kobo
  • PEG-9 dimethicone available as KF6017 or KF6028 from Shin-Etsu
  • cetyl dimethicone copolyol-polyglyceryl-4-isostearate-hexylaurate available as AB IL® WE 09 from Goldschmidt Chemical Corporation, Hopewell, VA
  • cetyl dimethicone copolyol (AB IL® EM 90), bis- PEG/PPG-14/14 dimethicone, cyclopentasiloxane (AB IL® EM 97), laurylmethicone copolyol (5200), Cyclomethicone (and) Dimethicone Copolyol available as DC 3225 C from Dow Corning, and Cyclopentasiloxane and Dimethicone Copolyol available as GE
  • the silicone emulsifiers comprise may be present in any amount of from at least about 0.01%wt. to at least about 45%wt, preferably are present in amounts of at least about 0.01 - 35%wt. based on the total weight of the topical germicidal composition of which it forms a part.
  • the silicone emulsifier constituent is present in amount of from l%wt. to 30%wt., more preferably from about 2%wt., to about 25%wt.
  • Particularly preferred amounts of the silicone emulsifiers are described with reference to one or more of the examples.
  • the preferred PEG/PPG dimethicones may be provided in a liquid carrier, especially in a liquid silicone carrier, as a commercial preparation, including one or more of those identified above.
  • the PEG/PPG dimethicones typically comprise up to about 20%wt, more frequently up to about 10%wt. of the commercial preparation used as the silicone emulsifier constituent, with the balance being the liquid carrier, typically a liquid silicone and in some cases, a small amount of water or organic liquid.
  • largely alcoholic compositions may be emulsified using the silicone emulsifier constituent, particularly wherein the silicone emulsifier constituent is based on comprises PEG/PPG dimethicone in a liquid silicone carrier, and wherein at least 50%wt., but preferably greater amounts of Ci-C 4 monohydric alcohols, especially Ci-C 4 linear monohydric alcohols and especially ethanol are present in the germicidal topical compositions.
  • compositions of the invention may also include at least one volatile linear silicone, which may be present as a constituent separate from the silicone emulsif ⁇ er constituent or which may form part of the silicone emulsif ⁇ er constituent.
  • the volatile linear silicone is advantageously a polydimethylsiloxane or dimethicone which has a relatively low average molecular weight, a relatively low viscosity and a significant vapor pressure at 25° C. (i.e. one gram of fluid placed on No. 1 filter paper leaves substantially no visible residue after thirty minutes at room temperture). It also typically has a boiling point under 250° C.
  • the volatile linear silicone (or volatile dimethicone) is represented by the formula
  • n is an integer of about 0 to about 6, preferably about 1 to about 4.
  • alkyl group e.g. of 2 to 10 carbon atoms
  • the volatile linear silicone preferably has a viscosity of less than about 5 cst (or less than about 5 cP), preferably between about 0.6 and 3.0 cst, more preferably between 1.0 and 2.0 cst. (For silicones with a specific gravity at 25° C.
  • suitable volatile linear silicones include DM Fluid 0.65 cs (hexamethyldisiloxane), DM Fluid 1.0 cs (octamethyltrisiloxane), DM Fluid 1.5 cs, DM Fluid 2.0 cs (dodecamethylpentasiloxane), DC 2-1184 and DC 2-1731, all of the foregoing being available from Dow Corning.
  • a particularly preferred volatile linear silicone is a material commercially available as DC 2-1184, which has a viscosity of about 1.7 cst and an average molecular weight of about 320 (i.e. n is about 1 to 3 in the above formula).
  • the volatile linear silicone may be present in any amount of from 0%wt., but when present are desirably present in amounts of from 0.01%wt. to 40%wt, based on the total weight of the topical germicidal composition of which it forms a part.
  • the volatile linear silicone is present in amount of from 0.1%wt. to 8%wt, more preferably from about 3%wt., to about 7%wt. Particularly preferred amounts of the volatile linear silicone are described with reference to one or more of the examples.
  • the compositions of the invention optionally but preferably also include an ion source. Such a source of ions are essential to ensure that thickening of the compositions results when combining the individual constituents.
  • Such ions may be provided by the inclusion of or the addition of one or more inorganic materials, such as alkali metal salts, to the topical germicidal compositions. It has been observed by the inventor that the presence of available ions favorably improve the thickening of the compositions, but at the same time do not undesirably detract from the storage stability of the topical germicidal compositions. These ions may be added to the compositions separately, or they may form part of a different material which is used in the topical germicidal compositions and thereby become included in the same.
  • Exemplary useful salts are water-soluble salts, including alkali metal salts, alkali hydroxides, alkali carbonates and alkali sulfates.
  • Exemplary useful alkali metal salts include monovalent and divalent salts, such as one or more of: magnesium sulfate, calcium sulfate, potassium sulfate and sodium chloride.
  • Particularly preferred as an ion source are the materials described in the following examples.
  • the ion source, especially wherein the ion source is an alkali metal salt may be present in the topical germicidal compositions in any effective amount, but advantageously are present in an amount of between 0.01%wt.and 5%wt, preferably is present in an amount of from 0.1 %wt. to 2%wt., and still more preferably is present in an amount of between about 0.5%wt.
  • compositions of the invention optionally but advantageously also include a thickener constituent based on cellulose or one or more cellulose derivatives, and in certain preferred embodiments such a thickener constituent is necessarily present.
  • exemplary useful cellulose derivatives useful as a thickener constituent include methyl cellulose ethyl cellulose, hydroxymethyl cellulose hydroxy ethyl cellulose, hydroxy propyl cellulose, carboxy methyl cellulose, carboxy methyl hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxy propyl methyl cellulose, ethylhydroxymethyl cellulose and ethyl hydroxy ethyl cellulose.
  • hydroxypropyl methyl cellulose is particularly preferred for use in preferred compositions of the invention.
  • the thickener constituent based on cellulose or one or more cellulose derivatives may be present in any amount which is found to provide a desired initial viscosity as well as viscosities to aged samples of the topical germicidal treatment compositions, advantageously the thickener constituent based on cellulose or one or more cellulose derivatives is present in amounts of from about 0.01 %wt. to about 5%wt, preferably is present in amounts of (in order of increasing preference) 0.1%wt., 0.15%wt., 0.2%wt., 0.25%wt. or greater amounts.
  • the thickener constituent based on cellulose or one or more cellulose derivatives is present in amounts not in excess of 5%wt, and preferably is present in amount not greater than (in order of increasing preference) 0.45%wt., 4%wt, 3.5%wt, 3%wt, 2.5%wt, 2%wt., 1.5%wt., l%wt, 0.8%wt., 0.7%wt, 0.6%wt., and 0.5%wt., based on the total weight of the compositions of which the thickener constituent based on cellulose or one or more cellulose derivatives constituent forms a part.
  • a further ancillary thickener constituent are one or more thickener constituents based on crosslinked polycarboxylate and/or polyacrylate polymer thickeners; including those typically exhibit a molecular weight from about 500,000 to about 4,000,000, and generally have degrees of crosslinking of from about 0.25% to about 15%.
  • Such crosslinked polycarboxylate and/or polyacrylate polymers may include in their structure other monomers besides acrylic acid such as ethylene and propylene which act as diluents, and maleic anhydride which acts as a source of additional carboxylic groups.
  • Such thickener constituents based on crosslinked polycarboxylate and/or polyacrylate polymer thickeners are widely commercially available and include, e.g., polycarboxylate polymers and/or polyacrylate polymers sold under trade names Carbopol®, Acrysol® ICS-I and Sokalan®.
  • a further ancillary thickener constituent are one or more clay thickeners.
  • Exemplary clay thickeners comprise, for example, colloid-forming clays, for example, such as smectite and attapulgite types of clay thickeners.
  • the clay materials can be described as expandable layered clays, i.e., aluminosilicates and magnesium silicates.
  • expandable as used to describe the instant clays relates to the ability of the layered clay structure to be swollen, or expanded, on contact with water.
  • the expandable clays used herein are those materials classified geologically as smectites (or montmorillonite) and attapulgites (or polygorskites).
  • a further ancillary thickener constituent are one or more thickeners based on naturally occurring polysaccharide polymers such as xanthan gum, guar gum, locust bean gum, tragacanth gum, or derivatives thereof. Any of the ancillary thickeners, whether present singly or in combination with at least one further ancillary thickener constituent may be present in any amount which is found effective in achieving a desired degree of thickening. When present, advantageously such one or more ancillary thickener constituents may be present in amounts of from about 0.001%wt. to about 7%wt, preferably from about 0.01 %wt.
  • one or more of the recited ancillary thickeners are expressly excluded from the topical germicidal compositions.
  • At least one or more of the recited ancillary thickeners are expressly present within from the topical germicidal compositions concurrently with a thickener constituent based on cellulose or one or more cellulose derivatives.
  • at least one or more of the recited ancillary thickeners are expressly present within from the topical germicidal compositions in the place of the thickener constituent based on cellulose or one or more cellulose derivatives, which latter thickener constituent is absent from the topical germicidal compositions.
  • compositions according to the invention may be provided in a variety of product forms, e.g., viscous flowable forms, such as gels, creams or pastes as well as readily flowable forms adapted to be poured from a bottle or flask, or more flowable forms suitable to be dispensed from such a bottle, flask or other reservoir via a nozzle or a pump, e.g., a manually operable pump or a manually operable trigger spray.
  • viscous flowable forms such as gels, creams or pastes as well as readily flowable forms adapted to be poured from a bottle or flask, or more flowable forms suitable to be dispensed from such a bottle, flask or other reservoir via a nozzle or a pump, e.g., a manually operable pump or a manually operable trigger spray.
  • a minor amount of water may be present in the topical germicidal compsitions, and if present, is added to order to provide to 100% by weight of the compositions of the invention.
  • the water may be tap water, but is preferably distilled and is most preferably deionized water or "soft" water. If the water is tap water, it is preferably substantially free of any undesirable impurities such as organics or inorganics, especially minerals salts which are present in hard water which may thus undesirably interfere with the operation of the constituents present in the topical germicidal compositions according to the present invention.
  • water may be present in various amounts of up to about 25%wt. of the total weight of the composition of which it forms a part, although it is frequently present in reduced amounts, e.g., 24%, 23%, 22%, 21%, 20%, 19%, 18%, 17%, 16%, and 15%wt.
  • compositions of the invention in which no water is added to the constituents "as supplied" from their respective suppliers are also contemplated, as frequently one or more constituents may be supplied with an aqueous or aqueous/organic liquid carrier.
  • the topical germicidal compositions are preferably flowable, and depending upon the product form may be provided in variety of viscosity ranges suited for a particular product type.
  • the topical germicidal compositions may be provided as thin "cosmetic milk" product format, and may have a viscosity as little at about 500 cP typically to about 2500 cP, while in a "lotion" product format may have somewhat higher viscosities as well, typically in the range of from about 2000 cP to about 10,000 cP, preferably in the range of about 2000 to about 8000 cP, while in a more viscous format such as a gel or thickened lotion may have a viscosity of about 9,000 cP or more, such as between about 10,000 cP and about 20,000 cP.
  • viscous forms of the topical germicidal compositions may be formed and are contemplated to be within the scope of the present invention, e.g., in the range of 10 - 100,000 cP at 25°C as measured using conventional quantitative methods e.g., as measured at 20 0 C or 25°C by a - Brookfield Type LVT or Type RVT viscometer using a standard spindle, (e.g., a #3 spindle) or alternately using a "T-bar" operating under a "heliopath” rather than rotational mode of operation as would be practiced with a spindle.
  • a standard spindle e.g., a #3 spindle
  • a "T-bar" operating under a "heliopath” rather than rotational mode of operation as would be practiced with a spindle.
  • the aforesaid viscosities are ones which may be based on the "as mixed" topical germicidal compositions but preferably are evaluated after at least 1 week, preferably at least 2 weeks of storage of a sample of the topical germicidal composition maintained at a temperature of at least 30°C preferably at least 40°C. Certain preferred viscosities and storage time and temperature conditions are disclosed with reference to one or more of the examples.
  • the inventor has surprisingly observed that not only can stable largely alcoholic compositions be emulsified with a silicone emulsif ⁇ er constituent in the substantial absence of water, but further, according to preferred embodiments of the inventive compositions, following storage of the topical germicidal constituents at elevated and/or reduced temperatures and/or for extended periods of time the topical germicidal compositions retain a reasonable proportion of their 'as-mixed' viscosity of the compositions, without separation of the topical germicidal compositions into two or more distinct phases, either into a solid and a liquid phase, or into two or more different liquid phases, following storage of the topical germicidal constituents at elevated and/or reduced temperatures and/or for extended periods of time.
  • topical germicidal compositions Such is not believed to have been heretofore demonstrated in the art, particularly wherein such compositions also exhibit a significant antimicrobial and/or germicidal and/or disinfecting benefit to topical surfaces, e.g., skin or other body parts, upon which the topical germicidal compositions are applied. Furthermore, preferred embodiments of the topical germicidal compositions also provide a satisfactory to superior tactile feel of the topical germicidal compositions applied onto a dermal surface, particularly the hands.
  • topical germicidal compositions are not unduly or undesirably sticky when applied, and notwithstanding the high content of alcohol, the topically germicidal compositions do not significantly, preferably do not perceptually dry or dehydrate the dermal surfaces upon which they are applied.
  • compositions of the invention may include one or more further optional constituents which may be used to improve one or more aesthetic and/or technical characteristics of the composition of which they form a part. Typically they are included in only small amounts, and usually the total amount of any such optional constituents does not exceed 50%wt. of the topical germicidal compositions of which they form a part.
  • the topical germicidal compositions may optionally but preferably contain a non-ionic emulsifier which function as a co-emulsifier constituent.
  • useful co-emulsifiers are selected from ethoxylated fatty alcohols, polyethoxylated fatty alcohols, glycerol mono-fatty acid esters, fatty acid esters of polyethylene glycol, polyethoxylated sorbitan fatty acid esters, alkylglycosides, and alkylpolyolosides, although it is expected that any other anionic, nonionic, cationic, zwitterionic or amphoteric surfactant compound may also function as a useful co-emulsifier constituent.
  • a preferred co-emulsifier constituent is a ethylene oxide condensed with sorbitan fatty acid esters.
  • sorbitan fatty acid esters Such materials are presently commercially available under the tradename TWEEN (ex. ICI) and/or CRILL (ex. Croda) which include polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monopalmitate, polyoxyethylene sorbitan monostearate, polyoxyethylene sorbitan tristearate, polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan trioleates which are available in a variety of grades, and with differing amounts of polyoxylethylene groups per molecule. Particularly preferred co-emulsifiers are described with reference to one or more of the examples.
  • Such co-emulsifiers may be present in any effective amount, and when included, advantageously are present in amounts of from about 0.01%wt. to about 5%wt, preferably from about 0.25%wt. to about 2%wt., based on the total weight of the topical germicidal compositions of which they form a part.
  • the compositions of the invention necessarily include a co-emulsifier constituent.
  • the topical compositions of the invention may optionally comprise one or more emollients which provide softness to the topical germicidal compositions.
  • the inventive compositions may include skin conditioning agents.
  • skin conditioning agents include cationic Polyquaternium-type polymers which are known to the art of topical compositions.
  • Various grades of such cationic polymers may be used, inter alia: homopolymers of diallyldimethylammonium chloride commercially available as Polyquaternium 5; dimethyldiallyammonium chloride homopolymer commercially available as Polyquaternium 6; copolymers of diallyldimethylammonium chloride with acrylamide commercially available as Polyquaternium 7; polymeric quaternary ammonium salt derived from the reaction of hydroxyethyl cellulose with a trimethylammonium substituted epoxide commerically available as polymeric quaternary ammonium salts derived from the reaction of hydroxyethyl cellulose with a trimethylammonium substituted epoxide commercially available as Polyquaternium 10; copolymers of 1 -vinyl-2-pyrrolidine and dimethylamino
  • the one or more cationic polyquaternium-type polymers or other known art skin conditioning agents may be present in amounts of from about from 0.001 - 5 %wt., preferably in amounts from 0.01 - 2.5%wt, but are most desirably present in reduced weight percentages from about 0.05 - l%wt. based on the total weight of the topical germicidal composition of which they form a part.
  • emollients such as one or more of esters, fatty acids and alcohols, polyols and hydrocarbons which may impart a softening effect when topically applied.
  • esters include mono- and di-esters which may be, inter alia, dibutyl adipate, diethyl sebacate, diisopropyl dimerate, dioctyl succinate,
  • branched chain fatty esters include 2-ethyl- hexyl myristate, isopropyl stearate and isostearyl palmitate.
  • Exemplary tribasic acid esters include triisopropyl trilinoleate and trilauryl citrate.
  • Exemplarly straight chain fatty esters include lauryl palmitate, myristyl lactate, oleyl eurcate and stearyl oleate.
  • Further exemplary useful esters include coco-caprylate/caprate (a blend of coco-caprylate and coco-caprate), propylene glycol myristyl ether acetate, diisopropyl adipate and cetyl octanoate.
  • Exemplary useful fatty alcohols and acids include, inter alia, those compounds having from 10 to 20 carbon atoms, preferentially cetyl, myristyl, palmitic and stearyl alcohols and acids.
  • the emollient constituent may be a single compound or a mixture of two or more compounds which provide a beneficial emollient effect.
  • the total amount of the emollient constituent(s) present are sufficient to provide an improved softening effect to the compositions and are advantageously included in amounts of from 0.05 - 10%wt. based on the total weight of the topical germicidal compositions of which they form a part.
  • the emollient constituent(s) are preferably present in amounts from 0.05 - 5%wt, but are most desirably present in reduced weight percentages from about 0.1 - 3%wt. based on the total weight of the topical germicidal composition of which they form a part.
  • the topical germicidal compositions may also include one or more dimethicones or silicones as further skin treatment or skin protectant constituents, which, when present may be included in effective amounts.
  • further skin treatment or skin protectant constituents are advantageously present in amounts from 0.01 - 5%wt, but are most desirably present in reduced weight percentages from about 0.1 - 3%wt. based on the total weight of the topical germicidal compositions of which they form a part.
  • the topical germicidal compositions may optionally comprise one or more humectants, including polyhydric alcohols including polyalkylene glycols as well as alkylene polyols and their derivatives, inter alia, including propylene glycol, dipropylene glycol, polypropylene glycol, polyethylene glycol and derivatives thereof, sorbitol, hydroxypropyl sorbitol, erythritol, threitol, pentaerythritol, xylitol, glucitol, mannitol, hexylene glycol, butylene glycol (e.g., 1,3- butylene glycol), hexane triol (e.g., 1 ,2,6-hexanetriol), glycerine, ethoxylated glycerine and propoxylated glycerine.
  • polyhydric alcohols including polyalkylene glycols as well as alkylene polyols and
  • humectants include sodium 2-pyrrolidone-5- carboxylate, guanidine; glycolic acid and glycolate salts (e.g. ammonium and quaternary alkyl ammonium); lactic acid and lactate salts (e.g. ammonium and quaternary alkyl ammonium); aloe vera in any of its variety of forms (e.g., aloe vera gel); hyaluronic acid and derivatives thereof (e.g., salt derivatives such as sodium hyaluronate); lactamide monoethanolamine; acetamide monoethanolamine; urea; and, panthenol.
  • glycolic acid and glycolate salts e.g. ammonium and quaternary alkyl ammonium
  • lactic acid and lactate salts e.g. ammonium and quaternary alkyl ammonium
  • aloe vera in any of its variety of forms (e.g., aloe vera gel); hyalur
  • humectants include polyols e.g., linear and branched chain alkyl polyhydroxyl compounds such as, propylene glycol, polyethylene glycol, glycerine and sorbitol.
  • exemplary hydrocarbons which may also serve as humectants are those having hydrocarbon chains anywhere from 12 to 30 carbon atoms, particularly, mineral oil, petroleum jelly, squalene and isoparaffms.
  • the humectants may be used singly or two or more humectants may be included in topical germicidal compositions of the invention.
  • one or more humectants may be included in effective amounts, advantageously from 0.01 - 25%wt, preferably from 5 - 15%wt. based on the total weight of the composition of which it forms a part.
  • a humectant is necessarily present in an amount of from 5 - 12.5%wt.
  • a particularly preferred humectant is selected from polyhydroxy alcohols, such as glycerine, and/or alkoxlated polyhydroxy alcohols, such as ethoxylated glycerine and propoxylated glycerine.
  • glycerine is a particularly preferred humectant.
  • the topical germicidal compositions may include one or more powders or pulvurent materials. These powders include mica, chalk, talc, Fullers earth, kaolin, starch, silica, silicates, hydrated aluminum silicate, fumed silica, aluminum starch octenyl succinate as well as comminuted or particulate polymers such as particles of polyamides (Nylons), polyalkyleneterephtalates (PET, PBT), polyolefins (PE) or fluoropolymers (polytetrafluoroethylene) as well as mixtures of two or more thereof.
  • powders include mica, chalk, talc, Fullers earth, kaolin, starch, silica, silicates, hydrated aluminum silicate, fumed silica, aluminum starch octenyl succinate as well as comminuted or particulate polymers such as particles of polyamides (Nylons), polyalkyleneterephtalates (PET, PBT
  • one or more powders in the inventive compositions may provide an improved tactile benefit and/or may act to absorb a part of one or more of the hydrophobic constituents present in the composition and/or may provide an opacifying effect to the compositions.
  • Preferred powders are those based on inorganic materials, e.g., silica, silicates and talc. Such are typically provided to the topical germicidal compositions as finely divided particles. While such powders may be included in any effective amount, when present they are advantageously included in amounts of between about 0.01 %wt. to about 5%wt., preferably between about 0.25%wt. to about 2%wt, based on the total weight of the topical germicidal composition of which they form a part.
  • the topical germicidal compositions may include one or more preservatives.
  • exemplary useful preservatives include compositions which comprise parabens, including methyl parabens and ethyl parabens, glutaraldehyde, formaldehyde, 2-bromo-2-nitropropoane-l,3-diol, 5-chloro- 2-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazoline-3-one, and mixtures thereof.
  • Further suitable preservatives include thos marketed as: KATHON CG/ICP, KATHON CG/ICP II (ex. Rohm and Haas Inc.), PROXEL (ex. Zeneca), SUTTOCIDE A (ex.
  • the preservative When present the preservative is included in any amount found to be effective in retarding or inhibiting the grown of undesired microorganisms in the topical germicidal compositions, particularly during storage for several months at room temperature.
  • the preservative composition is advantageously present in amounts of up to about 1.5%wt, preferably from about 0.00001%wt. to about 0.5%wt., most from about 0.0001%wt. to 0.25%wt. based on the total weight of the topical composition of which it forms a part. Usually however, in light of the high alcohol content such preservatives are not required and are advantageously omitted.
  • the topical germicidal compositions may include a fragrance constituent, which may be based on natural and synthetic fragrances and most commonly are mixtures or blends of a plurality of such fragrances, optionally in conjunction with a carrier such as an organic solvent or a mixture of organic solvents in which the fragrances are dissolved, suspended or dispersed.
  • a fragrance constituent When present in a composition, the fragrance constituent may be present in any effective amount such that it can be discerned by a consumer of the topical germicidal composition, however is advantageously present in amounts of up to about 5%wt, preferably from about 0.0000 l%wt. to about 1.5%wt., most preferably from about 0.0001 %wt. to 0.25%wt.
  • inventive topical germicidal compositions may include one or more colorants, e.g, dyes or pigments which are known to the art be useful in cosmetic or topical compositions which may be used to impart a desired color or tint to the inventive compositions.
  • colorants e.g, dyes or pigments which are known to the art be useful in cosmetic or topical compositions which may be used to impart a desired color or tint to the inventive compositions.
  • Exemplary colorants include pigments, inter alia, inorganic red pigments, such as iron oxide, iron hydroxide and iron titanate; inorganic brown pigments, such as gamma-iron oxide; inorganic yellow pigments, such as iron oxide yellow and loess; inorganic black pigments, such as iron oxide black and carbon black; inorganic violet pigments, such as manganese violet and cobalt violet; inorganic green pigments, such as chromium hydroxide, chromium oxide, cobalt oxide and cobalt titanate; inorganic blue pigments, such as Prussian blue and ultramarine blue; lakes of tar pigments; lakes of natural dyes; and synthetic resin powder complexes of the inorganic pigments as recited above.
  • one or more colorants may be added in amounts of about 0.00 l%wt. to about 0.1% by weight, based on the total weight of the composition of which the colorant(s) forms a part.
  • the topical germicidal compositions of the invention may one or more essential oils which are selected to provide a so-called "aromatherapy benefit” or “holistic benefit” to the user.
  • Essential oils are complex mixtures of different organic molecules, such as terpenes, alcohols, esters, aldehydes, ketones and phenols. Such essential oils are frequently extracted from naturally occurring botanical sources such as flowers, stems, leaves, roots and barks of aromatic plants. While essential oils may be used singly, it is also common to utilize blends of essential oils in order to provide a conjunctive aroma benefit, aromatherapy benefit, holistic benefit and possibly a therapeutic benefit as well.
  • Preferred essential oils providing an aromatherapy benefit for use in the topical germicidal compositions of the present invention include one or more selected from chamomile oil, lavendin oil, lavender oil, grapefruit oil, lemon oil, line oil, mandarin orange oil, orange flower oil and orange oil.
  • Chamomile oil may be used to promote both a fresh, clean and attractive scent and possibly provide a stress-relaxing benefit to the user of the topical composition.
  • Lavender oil, and lavendin may be used to promote both a fresh and attractive scent and possibly also provide a stress-relaxing benefit to the user of the topical composition.
  • grapefruit oil lemon oil, line oil, mandarin orange oil, orange flower oil and orange oil provide a clean citrus scent and may possibly impart a perceived therapeutic benefit as well when used.
  • these one or more essential oils providing an aromatherapy benefit or holistic benefit are present in an amount about 0.00001 wt. % to about 1 wt. %, preferably from about 0.00005 wt. % to about 0.75 wt. %, and more preferably from about 0.0001 wt. % to about 0.5 wt. % of the total weight of the composition. It is to be understood that these one or more essential oils providing an aromatherapy benefit may be used with our without the optional fragrancing constituent recited previously and may be used wholly or partially in place of said fragrancing constituent.
  • the topical germicidal compositions may include one or more antioxidant constituents; certain of these antioxidant constituents may additionally provide an anti-wrinkling benefit to the skin or other topical treatment benefit.
  • antioxidants include but are not limited to, water-soluble antioxidants such as sulfhydryl compounds and their derivatives (e.g., sodium metabisulfite and N-acetyl-cysteine), lipoic acid and dihydrolipoic acid, resveratrol, lactoferrin, glutathione, and ascorbic acid and ascorbic acid derivatives (e.g., ascorbyl palmitate and ascorbyl polypeptide), as well as oil-soluble antioxidants such as butylated hydroxytoluene, retinoids, tocopherols e.g., tocopherol acetate, tocotrienols, and ubiquinone, natural extracts containing antioxidants such as extracts containing flavonoids and isoflavonoids and their derivatives, extracts containing
  • the total amount of such antioxidants are usually not in excess of 5%wt, preferably from 0.0001 - 4%wt. based on the total weight of the topical germicidal compositions of which it forms a part.
  • one or more antioxidants constituents are necessarily present.
  • the topical germicidal compositions may include one or more vitamins.
  • vitamins which can be added include vitamin A, such as vitamin A oil, retinol, retinyl acetate and retinyl palmitate; vitamin B, including vitamin B 2 such as riboflavin, riboflavin butyrate and flavin adenine nucleotide, vitamin B 6 such as pyridoxine hydrochloride, pyridoxine dioctanoate and pyridoxine tripalmitate, vitamin B 12 and its derivatives, and vitamin B] 5 and its derivatives; vitamin C, such as L-ascorbic acid, L-ascorbic acid dipalmitic ester, sodium (L-ascorbic acid)-2-sulfate and dipotassium L-ascorbic acid diphosphate; vitamin D, such as ergocalciferol and cholecarciferol; vitamin E, such as alpha-tocopherol, beta-tocopherol, gamma-tocopherol, dl-alpha-tocopheryl
  • one or more vitamins may be included in effective amounts, advantageously from 0.0001 - l%wt., preferably from 0.001 - 0.75%wt. based on the total weight of the topical germicidal compositions of which it forms a part.
  • the topical germicidal compositions may include one or more light stabilizers as well as UV absorbers or sunscreen constituents.
  • Such materials are known to be useful in cosmetic or topical compositions and impart a degree of stability to the compositions which may comprise one or more components which may be deleteriously affected when exposed to certain sources of light, e.g., sunlight, fluorescent light sources. Other such materials are known to stabilize or improve the effect of colorants which may be present in the compositions.
  • Any cosmetically acceptable material or compound which provides protection for one or more of the constituents in the inventive compositions from photolytic degradation or photo-oxidative degradation may be used. Examples include: triazines including s-triazine, triazine derivatives e.g.
  • any of the foregoing materials provided as acids may used in free acid form or as a salt thereof, e.g., an alkali, alkaline earth, ammonium, alkylammonium, alkanolammonium salt form thereof.
  • the one or more light stabilizers as well as UV absorbers may be included in any effective amount; advantageously such materials are present in amounts of from 0.0001 - l%wt., preferably from 0.001 - 0.5%wt. based on the total weight of the topical germicidal composition of which it forms a part.
  • the inventive topical germicidal compositions may include one or more chelating agents.
  • chelating agents include those known to the art, including by way of non- limiting example; aminopolycarboxylic acids and salts thereof wherein the amino nitrogen has attached thereto two or more substituent groups.
  • Preferred chelating agents include acids and salts, especially the sodium and potassium salts of ethylenediaminetetraacetic acid, diethyl enetriaminepentaacetic acid, N-hydroxyethyl ethyl enediaminetriacetic acid, and of which the sodium salts of ethylenediaminetetraacetic acid may be particularly advantageously used.
  • Such chelating agents may be omitted, or they may be included in generally minor amounts such as from 0.001 - 0.5 %wt. based on the weight of the chelating agents and/or salt forms thereof. Desirably, when present, such chelating agents are included in the present inventive composition in amounts from 0.01 - 0.5%wt., prefeably from about 0.01 - 0.2%wt.
  • the inventive topical germicidal compositions may comprise further one or more further antimicrobial agents.
  • Such further antimicrobial agent is/are one or more compounds which provide an appreciable germicidal benefit.
  • Such further antimicrobial agent desirably provides an effective antimicrobial benefit to treated dermal surfaces, e.g., hands, arms, etc.
  • the further antimicrobial agent may be include one or more cationic surfactant constituents, especially preferably one cationic surfactants which provide an appreciable germicidal benefit.
  • cationic surfactant compositions which may be included in the treatment compositions are those which provide an appreciable germicidal benefit, and especially preferred are quaternary ammonium compounds and salts thereof, which may be characterized by the general structural formula:
  • Ri, R 2 , R 3 and R 4 is a alkyl, aryl or alkylaryl substituent of from 6 to 26 carbon atoms, and the entire cation portion of the molecule has a molecular weight of at least 165.
  • the alkyl substituents may be long-chain alkyl, long-chain alkoxyaryl, long-chain alkylaryl, halogen-substituted long-chain alkylaryl, long-chain alkylphenoxyalkyl, arylalkyl, etc.
  • the remaining substituents on the nitrogen atoms other than the abovementioned alkyl substituents are hydrocarbons usually containing no more than 12 carbon atoms.
  • the substituents Ri, R 2 , R 3 and R 4 may be straight-chained or may be branched, but are preferably straight-chained, and may include one or more amide, ether or ester linkages.
  • the counterion X may be any salt-forming anion which permits water solubility or water miscibility of the quaternary ammonium complex.
  • Preferred quaternary ammonium compounds which act as germicides according to the foregoing formula are those in which R 2 and R 3 are the same or different Cs-Ci 2 alkyl, or R 2 is Ci 2- i 6 alkyl, Cs-isalkylethoxy, C 8- i 8 alkylphenolethoxy and R 3 is benzyl, and X is a halide, for example chloride, bromide or iodide, or is a methosulfate anion.
  • the alkyl groups recited in R 2 and R 3 may be straight-chained or branched, but are preferably substantially linear.
  • the further antimicrobial agent may include one or more of: pyrithiones such as zinc pyrithione, halohydantoins such as dimethyldimethylol hydantoin, methylchloroisothiazolinone/methylisothiazolinone sodium sulfite, sodium bisulfite, imidazolidinyl urea, diazolidinyl urea, benzyl alcohol, 2-bromo-2-nitropropane-l,3-diol, formalin (formaldehyde), iodopropenyl butylcarbamate, chloroacetamide, methanamine, methyldibromonitrile glutaronitrile, glutaraldehyde, 5-bromo-5-nitro-l,3-dioxane, phenethyl alcohol, o-phenylphenol/sodium o-phenylphenol, sodium hydroxymethylglycinate, polymethoxy bicyclic
  • the further antimicrobial agent may include one or more of: biguanides such as polyhexamethylene biguanide, p-chlorophenyl biguanide; 4-chlorobenzhydryl biguanide, l,6-bis-(4- chlorobenzylbiguanido)-hexane (Fluorhexidine®), halogenated hexidine including, but not limited to, chlorhexidine (l,l'-hexamethylene-bis-5-(4-chlorophenyl biguanide)
  • such further antimicrobial agent may be included in the inventive compositions in any effective amount.
  • such amounts are from about 0.0001 - 2%wt., but preferably are from about 0.01 - l%wt. of the topical germicidal composition of which they form a part.
  • the inventive compositions expressly exclude such a further antimicrobial constituent.
  • the topical germicidal compositions of the invention may be advantageously produced by: forming a first aqueous-alcohol premixture which includes a thickener constituent, e.g., hydroxymethylcellulose and an ion source; forming a second silicone based premixture, and then under constant stirring adding the first aqueous-alcohol premixture to the second silicone based premixture at a measured volumetric or mass rate in a homogenizer, optionally at an increasing rotational speed during the addition of the first aqueous-alcohol premixture to the second silicone based premixture in order form a resulting viscous emulsion.
  • a thickener constituent e.g., hydroxymethylcellulose and an ion source
  • an aspect of the invention is a method for producing topical germicidal compositions according to one or more of the methods described herein.
  • the present invention also contemplates a method for providing a cleaning and/or providing an germicidal benefit to skin or other topical surface which method contemplates the topical application of the aqueous topical germicidal compositions as described herein in a cleaning and/or germicidally effective amount.
  • a germicidal benefit is provided to the skin or other topical surface to which the composition has been applied.
  • Preferred embodiments of the topical germicidal compositions exhibit good germicidal efficacy of undesired microorganisms, e.g., S. aureus, E.coli,
  • topical germicidal compositions exhibit antimicrobial efficacy against one or more of certain gram positive pathogens, certain gram negative pathogens, certain viruses, certain fungi and/or certain mold.
  • topical germicidal compositions disclosed herein find a primary use in application to the skin to provide a cleaning and/or germicidal benefit thereto and is contemplated as being provided in a dispenser for use in such a treatment, it is to be understood that this is not to be understood as a limiting definition and that other forms and other uses of the present inventive composition, such as face lotion, milky lotion, cream, face cleansing cream, massage materials, liquid toilet soap, as well as in hair care products such as shampoo, rinse or other hair or scalp treatment are expressly contemplated as being within the scope of the present invention.
  • the topical germicidal compositions of the invention are beneficially formulated as a pourable lotion, a cosmetic milk, a liquid or a spray, but may also be formulated as a more viscous a cream or a gel, which may be transparent, translucent or opaque.
  • the topical germicidal compositions is provided as a translucent composition.
  • the composition can be packaged in a suitable container to suit its viscosity and intended use by the consumer.
  • a lotion or cream can be packaged in a bottle, or can be packaged with a propellant in a propellant-driven aerosol device or alternately may be packaged in a container fitted with a manually operable pump.
  • compositions of the invention When the compositions of the invention have higher viscosities and is in the form of a paste, gel or cream it may conveniently be provided in a resealable container with a relatively wide opening, e.g., ajar, tin, tub or bottle with a removable and replaceable cap or cover.
  • a resealable container with a relatively wide opening, e.g., ajar, tin, tub or bottle with a removable and replaceable cap or cover.
  • Forms of the composition which have low viscosities may be provided in bottles or flasks from which they be dispensed by pouring, or by pumping such as via a manually pumpable trigger pump or manually operable trigger spray pump.
  • the inventive composition can be provided and stored in a non-deformable bottle but more preferably is provided in a squeezable container, such as a tube or deformable bottle which ⁇ provides for easy dispensing of the composition by the consumer.
  • a further aspect of the invention provides a closed container containing the inventive composition as described herein.
  • topical application of the topical germicidal compositions disclosed herein may be applied to the skin on any part of the body, including the skin on the face, neck, chest, back, arms, axilla, hands, legs, and scalp.
  • the topical germicidal compositions disclosed herein may also be used on the hair.
  • the topical germicidal compositions are not ingested or used on mucous tissues.
  • the consumer dispenses a quantity of the topical germicidal composition described herein and applied it to the skin or any other part of the body where they may be retained upon but are beneficially rubbed into the applied skin or other part of the body by the consumer to provide both a skin moisturization benefit concurrently with a germicidal benefit to the treated skin or other part of the body.
  • the thus applied topical germicidal composition is allowed to remain on the skin or other part of the body to which it has been applied, without any subsequent washing or rinsing.
  • the topical germicidal treatment compositions may be rinsed by the consumer under a stream of running water, e.g, in a shower or by immersion into water, e.g, a bath.
  • a further aspect of the invention is directed to the use of the topical germicidal compositions as described herein.
  • the following examples below illustrate exemplary formulations as well as preferred embodiments of the invention. It is to be understood that these examples are provided by way of illustration only and that further useful formulations falling within the scope of the present invention and the claims may be readily produced by one skilled in the art without deviating from the scope and spirit of the invention.
  • compositions which fall within the scope of the invention are identified on Table 1 while compositions which are fall outside the scope of the invention and which are presented for comparative purposes are identified on Table 1C.
  • compositions the constituents were used "as supplied” from their respective suppliers and may constitute less than 100%wt. "actives”, or may have been supplied as constituting 100%wt. "active” of the named compound, as indicated in the following Tables 1, 1C and 2.
  • the amounts indicated on the table refer to %wt. of the named constituent used in a composition, based on a total weight of 100%wt. for an identified composition.
  • Covacryl VIP is an ammonium polyacrylate
  • a measured amount of the sodium chloride was added to the water, then mixed with a laboratory mixer, for 5 minutes or longer if necessary, or until the sodium chloride was dissolved.
  • silicone emulsifier constituent when utilized, other essential or optional constituents, e.g., sorbitan isostearate, glycerine, silica, etc.
  • the contents were manually mixed with a laboratory spatula to ensure good wetting of the constituents.
  • the homogenizer (Greeco Model 11-07) was then utilized to mix the contents of this beaker at a low speed (approximately 1125 rpm) at room temperature; mixing continued until the contents of this beaker were uniform which typically took at least 5 minutes. Cover the beaker with plastic film.
  • the contents of the 1500 ml laboratory beaker containing the hydro-alcoholic phase were slowly transferred into the silicone phase at a relatively constant transfer rate of 15 g/min. which was achieved via the use of a separation funnel whose valve was used to control the supply of the hydro-alcoholic premixture within the separation funnel into the 2000 ml beaker.
  • the speed of the homogenizer was slowly increased in order to ensure that there was a continuous flow of the emulsion through the homogenizer (e.g. when 400 g (for 800 g batch size) of the hydro-alcoholic phase was added, the homogenizer speed was increased to about 1875 rpm.)
  • the homogenizer was controlled to ensure that it did not exceed about 2250 rpm at any point during the process.
  • the homogenizer was allowed to operate at a speed of from about 2000 - 2250 rpm for at least 15 additional minutes to ensure the formation of the resulting emulsion.
  • the homogenizer was removed, and the emulsion was subsequently mixed for at least 10 minute using a laboratory mixer (Heidolph RZR50 mixer), using a U-shaped paddle with a blade diameter of 114.3mm. at a rotational speed of about 50 rpm for at least 10 minutes.
  • a laboratory mixer Heidolph RZR50 mixer
  • compositions retained a significant proportion of their initial viscosity even subsequent to several weeks of storage at elevated temperatures. Additionally none of the foregoing "as mixed" compositions of Table 1 or those tested under the conditions reported on Table 3 exhibited separation but remained homogenous even subsequent to the adverse testing conditions.
  • Germicidal Efficacy A formulation according to the invention as described as El from Table 1 was also evaluated in order to evaluate its antimicrobial efficacy against Staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 10536), Pseudomonas aeruginosa (ATCC 15442) and Enterococcus hirae (ATCC 10541) in accordance with the protocols of British Standard EN 1276, a quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional environments - Test Method and requirements (phase 2, step 1) Ref. No. EN 1276: 1997E the contents of which are herein incorporated by reference.
  • the El composition was further evaluate its antimicrobial efficacy against further test microorganisms ;, identified on Table 5A, in accordance with the following generalized test protocol.
  • test microorganism were sourced from a stock culture, which was next grown on a growth medium appropriate to the specific test organism.
  • a quantity of the test organism was transferred onto agar plate, and on the day of testing of the El composition, the test organism was sourced from the agar plate and used to create a suspension of the test organism in a aqueous sodium chloride diluent to form a test suspension having a concentration of 1x10 8 colony forming units ("CFU") per ml of the test suspension.
  • CFU colony forming units
  • a reference plate of each test microorganism was prepared to a controlled dilution of the test microorganism in an aqueous sodium chloride diluent composition to form a desired concentration, e.g., IxIO "6 or Ix 10 "7 CFU/ml of the test microorganism then pour plated with agar growth media onto a sterile petri dish. After at least 48 hours the incidence of growth was visually evaluated.
  • the reference plate was used as a reference from which to derive the degree of reduction of the test organism which was tested against the El composition.
  • the El composition Prior to testing, the El composition was equilibrated in a temperature controlled water bath, maintained at 25°C +/- 1°C. All further constituents were also equilibrated in the temperature controlled water bath as well. Thereafter, an aliquot of 9 ml of the El composition was mixed with 1 ml of the test suspension in a vessel, vortexed for 2-3 seconds, then the vessel was quickly transferred to the temperature controlled water bath.
  • control plate of each test microorganism was prepared to a controlled dilution of the test microorganism in the aqueous sodium chloride diluted to a desired concentration, e.g., 1x10 6 or 1x10 7 CFU/ml, then pour plated with agar growth media onto a sterile petri dish. After at least 48 hours the incidence of growth was visually evaluated and compared to tested petri plates to derive the 1Og 10 reduction. Further composition control samples were produced as follows. A quantity of the El composition as well as all further materials used in other steps of the test were equilibrated in a temperature controlled water bath, maintained at 25°C +/- 1°C.
  • Counts from the plated aqueous control compositions were compared to the plated composition control samples, which were within 0.5 log !0 of the neutralization control for the test to be considered valid.
  • the production of an aqueous control composition, and a composition control sample was produced for the El composition to ensure the validity of the evaluation of efficacy against a test microorganism.
  • the El composition according to the invention provide excellent germicidal benefits, with the composition exceeding the at least 5 1Og 1 O reduction of each of the four test microorganisms, as reported on Table 5. Further the El composition was also highly effective against the further microorganisms tested and reported on Table 5A, including MRSA.
  • compositions according to the invention disclosed on Table 6 were produced generally according to the protocol outlined above with reference to the compositions according to Table 1 and 1C. Again, in the following compositions, the constituents as identified on Table 2 were used "as supplied” from their respective suppliers and may constitute less than 100%wt. "actives", or may have been supplied as constituting 100%wt. "active” of the named compound. The amounts indicated on the table refer to %wt. of the named constituent used in a composition, based on a total weight of 100%wt. for an identified composition.
  • the viscosity of the compositions of Table 6 were evaluated over a span of several weeks and over a range of temperatures to demonstrate the change in viscosity over time, from the initial viscosity ("as mixed") of the composition to the ultimate viscosities subsequent to storage for different time intervals and at different temperatures. These are reported on the following Table 7. An entry of"—.” indicates that the composition was not tested for the specific time and temperature condition.
  • the initial viscosity of the compositions were evaluated by first producing a composition, thereafter allowing it to rest undisturbed at room temperature (approx.

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Abstract

La présente invention porte sur des compositions germicides topiques comprenant (dans des modes de réalisation préférés, étant constituées de ou étant constituées essentiellement de) : environ entre 50% en poids et 90% en poids d'un constituant alcool comprenant un ou plusieurs C1-C4-alcools monohydriques; un constituant émulsifiant silicone, comprenant de préférence un PEG/PGG diméthicone dans un support silicone liquide et/ou comprenant un PEG/PGG cyclopentasiloxane; de manière optionnelle, un constituant silicone linéaire volatil; de manière optionnelle, une source d'ion; de manière optionnelle mais de préférence, un constituant épaississant à base d'un ou plusieurs dérivés de cellulose; de manière optionnelle, un ou plusieurs constituants servant à améliorer l'esthétique ou d'autres caractéristiques techniques de l'invention; de manière optionnelle, de l'eau; les compositions étant caractérisées en ce qu'elles sont fluides et que, après avoir été stockées à des températures élevées et/ou lors d'intervalles de temps étendus, elles se conservent en tant que compositions à phase unique ne se divisant ni ne se séparant en deux phases ou plus; en outre, lesdites compositions procurent un bénéfice germicide topique lorsqu'on les applique sur la peau ou sur des parties du corps. L'invention concerne également des procédés de production desdites compositions germicides topiques ainsi que des procédés d'utilisation desdites compositions.
PCT/GB2009/002764 2008-12-03 2009-11-26 Compositions germicides topiques WO2010063988A1 (fr)

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WO2012004308A1 (fr) * 2010-07-06 2012-01-12 Krka, D.D., Novo Mesto Formulations aqueuses stables comprenant des ingrédients actifs faiblement solubles dans l'eau
WO2012150891A1 (fr) * 2011-05-02 2012-11-08 Lipidor Ab Composition destinée à l'administration d'un agent pharmacologiquement ou cosmétiquement actif sur une surface d'un organisme vivant
WO2012085523A3 (fr) * 2010-12-24 2013-07-11 Reckitt & Colman (Overseas) Limited Compositions désinfectantes pour la peau contenant une émulsion à base d'alcool
WO2015138705A1 (fr) * 2014-03-13 2015-09-17 Relevo, Inc. Composition de désinfectant persistant
US9844596B2 (en) 2011-06-18 2017-12-19 Thompson Cooper Laboratories, Llc Compositions for depositing agents using highly volatile silicone solvents
US10010073B2 (en) 2014-03-13 2018-07-03 Relevo, Inc. Persistent sanitizer composition based on cyclomethicone

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012004308A1 (fr) * 2010-07-06 2012-01-12 Krka, D.D., Novo Mesto Formulations aqueuses stables comprenant des ingrédients actifs faiblement solubles dans l'eau
EP2409683A1 (fr) * 2010-07-06 2012-01-25 KRKA, D.D., Novo Mesto Formulations aqueuses stables comprenant des ingrédients actifs faiblement solubles dans l'eau
US9017702B2 (en) 2010-07-06 2015-04-28 Krka, D.D., Novo Mesto Stable aqueous formulations comprising poorly water soluble active ingredients
WO2012085523A3 (fr) * 2010-12-24 2013-07-11 Reckitt & Colman (Overseas) Limited Compositions désinfectantes pour la peau contenant une émulsion à base d'alcool
WO2012150891A1 (fr) * 2011-05-02 2012-11-08 Lipidor Ab Composition destinée à l'administration d'un agent pharmacologiquement ou cosmétiquement actif sur une surface d'un organisme vivant
US9844596B2 (en) 2011-06-18 2017-12-19 Thompson Cooper Laboratories, Llc Compositions for depositing agents using highly volatile silicone solvents
WO2015138705A1 (fr) * 2014-03-13 2015-09-17 Relevo, Inc. Composition de désinfectant persistant
US10010073B2 (en) 2014-03-13 2018-07-03 Relevo, Inc. Persistent sanitizer composition based on cyclomethicone

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