EP4291151A1 - Composition antiperspirante - Google Patents

Composition antiperspirante

Info

Publication number
EP4291151A1
EP4291151A1 EP22704914.5A EP22704914A EP4291151A1 EP 4291151 A1 EP4291151 A1 EP 4291151A1 EP 22704914 A EP22704914 A EP 22704914A EP 4291151 A1 EP4291151 A1 EP 4291151A1
Authority
EP
European Patent Office
Prior art keywords
weight
water
oil emulsion
emulsion composition
active ingredients
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22704914.5A
Other languages
German (de)
English (en)
Inventor
Nuria FLORIACH GUAL
Marta FERNÁNDEZ GONZÁLEZ
Sara CAÑAS RIERA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Superquimica SA
Original Assignee
Superquimica SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Superquimica SA filed Critical Superquimica SA
Publication of EP4291151A1 publication Critical patent/EP4291151A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/06—Emulsions
    • A61K8/064—Water-in-oil emulsions, e.g. Water-in-silicone emulsions
    • 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
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/26—Aluminium; Compounds 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
    • 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
    • A61K8/37—Esters of carboxylic acids
    • A61K8/375—Esters of carboxylic acids the alcohol moiety containing more than one hydroxy group
    • 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
    • A61K8/85—Polyesters
    • 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
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A61K8/927—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of insects, e.g. shellac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q15/00—Anti-perspirants or body deodorants

Definitions

  • the present invention relates to the antiperspirant and deodorant field.
  • an effective long lasting invisible water-in-oil emulsion antiperspirant In particular to an effective long lasting invisible water-in-oil emulsion antiperspirant. It also relates to processes for their preparation and their uses in therapy and in cosmetic; such as an antiperspirant and a deodorant agent.
  • Antiperspirant and deodorant compositions are popular personal care products used to prevent or eliminate perspiration and body odor caused by perspiration. Most of antiperspirant compositions commonly used include at least one antiperspirant active ingredient that minimize or prevent the secretion of perspiration by blocking or plugging ducts of sweat-secreting glands. Further, most of the deodorant compositions include at least one deodorant active agent that minimize, prevent and/or eliminate malodor associated with perspiration.
  • the most common antiperspirant active ingredients typically used in these compositions are salts of strong inorganic acids, such as aluminium-containing and/or zirconium-containing salts. These salts upon contact with perspiration enter the sweat duct via diffusion or convection and react with the basic components of perspiration blocking it. Further, these antiperspirants and some other components of the composition often leaves a chalky film on the skin. When the composition dries on the skin or on clothing (which has come into contact with the skin after application of the antiperspirant), the antiperspirant salt often remains visible as a white residue. These white marks attack cellulosic fabrics due to liberation of strong acids from the salts, discolouring and ruining them over time, leaving the clothes with hard-to-remove stains. Besides, most of the antiperspirant compositions contain a high amount of oil components which increase the drying time upon contact with skin, providing an uncomfortable greasy and sticky feeling on application; and also leading to fabric staining.
  • strong inorganic acids such as aluminium-
  • a water-in-oil emulsion composition comprising an effective amount of antiperspirant active ingredients, in combination with at least one of the film-forming agents and at least one of the emollients disclosed in the present application allows having a stable and effective long lasting antiperspiration effect for about 48 hours after its application without causing irritation on skin (of. antiperspirant activity test of the experimental section).
  • the composition of the present invention contains natural and gentle components being non irritant to the skin, having at the same time a pleasant long lasting mild fragrance without the need of using silicones.
  • the composition of the present invention not only cares the skin but also strength and moisturize the skin.
  • composition of the invention had a good cosmeticity, having a very satisfactory acceptability for the users.
  • the composition is uniformly distributed and quickly absorbed/dried without providing any oily or sticky feeling, leaving a dry skin with a comfortable feeling and clean appearance.
  • composition of the invention after its application, does not leave any white marks on the skin and clothes; as well as any stain in textile. In fact, as it is shown in the use test, all users stated that the composition of the invention prevent the appearance of stains on clothing.
  • the water-in-oil emulsion composition of the invention reduces the extent of excessive/abnormal/normal perspiration for a long period of time, as well as avoid the occurrence of unsightly sweat marks on clothing and at the same time minimizing the body odour.
  • the water-in-oil emulsion composition also allows having a good cosmeticity taking care of the skin without providing an oily or sticky feeling, leaving a dry skin with a comfortable feeling and clean appearance.
  • the first aspect of the invention refers to a pharmaceutical or cosmetic water-in-oil emulsion composition
  • a pharmaceutical or cosmetic water-in-oil emulsion composition comprising: (a) a therapeutically or cosmetically effective amount of one or more antiperspirant active ingredients; (b) one or more film-forming agents selected from the group consisting of capryloyl glycerine/sebacic acid copolymer; polyester-7 (and) neopentyl glycol diheptanoate; ethylcellulose (and) diisopropyl adipate; VP/acrylates/lauryl methacrylate copolymer; VP/eicosene copolymer; triacontanyl PVP; and pentylene glycol (and) shellac; and (c) one or more emollients selected from the group consisting of dicaprylyl ether; PPG-14 butyl ether; triheptanoin (and) (C 13 -C
  • the second aspect of the invention refers to the composition of the first aspect of the invention for use in therapy, particularly for the prophylaxis or treatment of a disease or condition that involves an excessive or abnormal transpiration.
  • the third aspect of the invention refers to the use of the composition of the first aspect of the invention as antiperspirant and deodorant agent.
  • any ranges given include both the lower and the upper end-points of the range. Ranges given, such as weight, temperatures, times, weights, and the like, should be considered approximate, unless specifically stated.
  • percentage (%) by weight refers to the percentage of each ingredient of the composition in relation to the total weight of the composition.
  • alkyl refers to a saturated straight, or branched hydrocarbon chain which contains the number of carbon atoms specified in the description or claims. Examples include, among others, the group methyl, ethyl, propyl, isopropyl, butyl, isobutyl, sec-butyl, and tert-butyl.
  • alcohol refers to an "alkane” wherein at least one hydrogen atom is substituted by a hydroxyl group and which contains the number of carbon atoms specified in the description or claims.
  • alkane refers to a saturated, branched or linear hydrocarbon which contains the number of carbon atoms specified in the description or claims.
  • the composition of the first aspect of the invention is a "water-in-oil” emulsion.
  • water-in oil refers to an emulsion that includes a discontinuous phase, that is "water” phase (W) or predominantly aqueous phase, and a continuous phase, that is an "oil” phase, or predominantly organic liquid phase.
  • the oil phase is at least partially immiscible with the water phase.
  • This "water-in-oil emulsion” (W/O) is forming “particles” in a discontinuous water phase.
  • the terms “particles” or “drops” have the same meaning and are used interchangeably.
  • the term “particle size” refers to the particle diameter of the inner water drops (W) discontinuous phase based on an approximate spherical shape of the particle based on a volumetric measurement of the particle.
  • the oil-in-water emulsions of the present invention can also comprise without limitation ellipsoidal and/or cylindrical particles.
  • the method for determining the particle size of the compositions of the present invention can be any method known in the state of the art, for the purpose of the invention the particle size is measured by dynamic light scattering (DLS) technique.
  • DLS dynamic light scattering
  • the water-in-oil emulsion composition of the present invention comprises
  • emollients selected from the group consisting of dicaprylyl ether; PPG-14 butyl ether; triheptanoin (and) (C13-C16) isoparaffin; heptyl undecylenate (and) (C13-C15) alkane; triheptanoin (and) (C13- C15) alkane; diisooctyl succinate; neopentyl glycol diheptanoate; diheptyl succinate; isododecane; dipropylheptyl carbonate; caprylyl caprylate/caprate; propylheptyl caprylate; cetearyl isononanoate; undecane (and) tridecane; (Ci2-Ci5)alkyl benzoate, dibutyl adipate; coco-caprylate; dicaprylyl carbonate; PPG-15 stearyl ether; coco-caprylate/caprate
  • the water-in-oil emulsion composition of the present invention has a viscosity from 0 to 800 ops. In an embodiment, the water-in-oil emulsion composition of the present invention has a viscosity from 100 to 400 ops (1 centipoise (ops) corresponds to ImPa'S).
  • the method for determining the viscosity can be any method known in the state of the art.
  • the viscosity of the water-in-oil emulsion composition is measured by a Brookfield Dv-e Ametek LVDVE115 Digital Low Range Viscometer (splindle: 3 and speed:30 rpm) following the method disclosed in the European Pharmacopoeia 7.0 - 2.2.10. viscosity - rotating viscometer method.
  • the water-in-oil emulsion composition of the present invention comprises (a) a therapeutically or cosmetically effective amount of one or more antiperspirant active ingredients.
  • an "effective amount of the antiperspirant active ingredient” refers to the amount of the antiperspirant active ingredients that provides the therapeutic and/or cosmetic effect after its application on the skin (that is an antiperspirant and/or deodorant effect).
  • antiperspirant active ingredient refers to any compound having antiperspirant activity.
  • Appropriate antiperspirant active ingredients for the present invention may include astringent metallic salts, especially inorganic and organic salts of aluminium, zirconium and zinc, and mixture thereof.
  • the antiperspirant active ingredients may include aluminium-containing and/or zirconium-containing salts or materials, such as, for example, aluminium halides, aluminium chlorohydrate, aluminium hydroxy halides, zirconyl oxyhalides, zirconyl hydroxy halides, and mixtures thereof.
  • the antiperspirant active ingredient is at least an aluminium-containing salt of formula:
  • AI 2 (0H)aClb.xH 2 0 wherein: a is comprised from 2 to 5; the sum of a and b is 6; x is comprised from 1 to 6; and a, b, and x is selected from the group consisting of an integer or a non-integer value.
  • the antiperspirant active ingredient is a zirconium salt of formula:
  • aluminium-containing salts appropriate for the present invention include, but are not limited to, hydrated aluminium chloride ([AI 2 (OH) 5CI] nH 2 0), hydrated sesquihydrate chloride alumina ([AI 2 (OH) 4.5CI1 5] nH 2 0), dihydrochloride hydrated alumina ([AI 2 (OH) 4CI 2 ] nH 2 0), hydrogen chloride hydrated alumina (aluminium-containing salt chlorohydrex) propylene glycol (PG) or polyethylene glycol (PEG) ([AI 2 (OH) 5CI] nH 2 0 + CH3CHOHCH 2 OH or H (OCH) 2 (CH 2 ) 2 OH), hydrated aluminium sesqui hydrogen chloride PG or PEG, aluminium PG or hydrated dihydrochloride PEG, hydrated aluminium hydroxide (AI(OH) 3nH 2 0), aluminium hydroxide, aluminium chloride, aluminium potassium, chlorine hydrate aluminium glycine
  • the antiperspirant active ingredient is selected from the group consisting of aluminium halo hydrate, aluminium-zirconium halo hydrate, aluminium nitro hydrate compounds and mixture thereof.
  • the antiperspirant active ingredient is hydrated aluminium chloride ([Ah(OH) 5CI] nH20), optionally with glycine and calcium chloride.
  • the water-in-oil emulsion comprises from 20 to 60% by weight of one or more antitranspirant active ingredients; particularly an aluminium-containing salt. In an embodiment, the water-in-oil emulsion comprises from 40 to 55% by weight of one or more antitranspirant active ingredients; particularly an aluminium-containing salt. In an embodiment, the water-in-oil emulsion comprises from 20 to 60% by weight of hydrated aluminium chloride; particularly from 40 to 55% by weight.
  • the water-in-oil emulsion composition of the first aspect of the invention comprises (b) one or more film-forming agents disclosed herein.
  • film-forming agent refers to a compound capable of building a thin layer covering the area of application, for example within the armpit skin area.
  • the water-in-oil emulsion composition of the first aspect of the invention comprises: (b) one or more film-forming agents selected from the group consisting of capryloyl glycerine/sebacic acid copolymer; polyester-7 (and) neopentyl glycol diheptanoate; ethylcellulose (and) diisopropyl adipate; VP/acry I ates/l au ry I methacrylate copolymer; VP/eicosene copolymer; triacontanyl PVP; and pentylene glycol (and) shellac.
  • film-forming agents selected from the group consisting of capryloyl glycerine/sebacic acid copolymer; polyester-7 (and) neopentyl glycol diheptanoate; ethylcellulose (and) diisopropyl adipate; VP/acry I ates/l au ry I methacrylate
  • the water-in-oil emulsion composition of the invention comprises (b) at least capryloyl glycerine/sebacic acid copolymer as the film-forming agents.
  • capryloyl glycerine/sebacic acid copolymer is the I NCI name of a copolymer of capryloyl glycerine and sebacic acid monomers, which has the CAS number 1190099-88-7.
  • the water-in-oil emulsion comprises from 0.1 to 10% by weight of one or more film-forming agents as disclosed in the present application; particularly capryloyl glycerine/sebacic acid copolymer. In an embodiment, the water-in-oil emulsion comprises from 1 to 5% by weight of one or more film-forming agents as disclosed in the present application; particularly capryloyl glycerine/sebacic acid copolymer.
  • capryloyl glycerine/sebacic acid copolymer (LEXFILM SUN NATURAL); polyester-7 (and) neopentyl glycol diheptanoate (LEXFILM SUN); ethylcellulose (and) diisopropyl adipate (ANTARONTM ECO GEL); VP/acry I ates/l au ry I methacrylate copolymer (ANTARONTM SENSORY POLYMER); VP/eicosene copolymer (ANTARONTM V-220 POLYMER); triacontanyl PVP (ANTARONTM WP-660 POLYMER); and pentylene glycol (and) shellac (ACTISHELL WR).
  • the water-in-oil emulsion composition of the first aspect of the invention comprises (c) one or more emollients disclosed herein.
  • emollient refers to a substance that makes something soft, and for the purpose of the invention, is capable of soften skin.
  • the water-in-oil emulsion composition of the first aspect of the invention comprises (c) one or more emollient selected from the group consisting of dicaprylyl ether; PPG-14 butyl ether; triheptanoin (and) (C13-C16) isoparaffin; heptyl undecylenate (and) (C13-C15) alkane; triheptanoin (and) (C13-C15) alkane; diisooctyl succinate; neopentyl glycol diheptanoate; diheptyl succinate; isododecane; dipropylheptyl carbonate; caprylyl caprylate/caprate; propylheptyl caprylate; cetearyl isononanoate; undecane (and) tridecane; (Ci2-Cis)alkyl benzoate, dibutyl adipate; coco-caprylate; dicaprylyl carbon
  • the water-in-oil emulsion composition of the invention comprises (c) at least one of the emollients selected from the group consisting of dicaprylyl ether and PPG-14 butyl ether.
  • the water-in-oil emulsion composition of the invention comprises (c) a mixture of dicaprylyl ether and PPG-14 butyl ether as emollients.
  • dicaprylyl ether is the I NCI name of dioctyl ether, 1-octoxyoctane which has the CAS number 629-82-3.
  • PPG-14 butyl ether is the I NCI name of polypropylene glycol monobutyl ether being 14 the number of units of propylene glycol having the CAS number 9003-13-8.
  • the water-in-oil emulsion comprises from 12 to 40% by weight of at least one of the emollients disclosed in the present application; particularly at least one selected from dicaprylyl ether, PPG-14 butyl ether and a mixture thereof.
  • the water-in-oil emulsion composition of the invention comprises (c) a mixture of dicaprylyl ether and PPG-14 butyl ether; particularly from 10 to 30% by weight of dicaprylyl ether and from 2 to 10% by weight of PPG-14 butyl ether.
  • the water-in-oil emulsion comprises from 20 to 30% by weight of at least one of the emollients disclosed in the present application; particularly at least one selected from dicaprylyl ether, PPG-14 butyl ether and a mixture thereof.
  • dicaprylyl ether CETIOL OE
  • PPG-14 butyl ether TEGOSOFT PBE
  • triheptanoin (and) (C13-C16) isoparaffin LXFEEL WOW
  • heptyl undecylenate and) (C13-C15) alkane
  • triheptanoin (and) (C13-C15) alkane LXFEEL WOW A
  • diisooctyl succinate SUSTOLEO DCS
  • neopentyl glycol diheptanoate LEXFEEL 7
  • diheptyl succinate LEXFEEL N50 MB
  • isododecane CREASIL® ID JSQI
  • dipropylheptyl carbonate CETIOL 4 ALL
  • caprylyl caprylate/caprate CETIOL RLF
  • propylheptyl caprylate CETIOL SEN
  • the water-in-oil emulsion composition of the invention comprises:
  • At least one of the antiperspirant active ingredients is an aluminium containing salts;
  • at least one of the film-forming agents is capryloyl glycerine/sebacic acid copolymer;
  • At least one of the emollients is selected from the group consisting of dicaprylyl ether and polypropylene glycol butyl ether
  • the water-in-oil emulsion composition of the invention comprises: (a) from 20 to 60 % by weight of one or more antiperspirant active ingredients;
  • the water-in-oil emulsion composition of the invention comprises:
  • excipients or carriers can include, but not limited to, surfactant, vehicle, preservative, propellant, pH-regulating agent, stabilizing agents, viscosity agent, skin conditioning agent, antioxidant and mixture thereof.
  • surfactant refers to a material which lowers the surface tension of a liquid and the interfacial tension between two liquids, allowing their easier spreading.
  • Surfactants have a hydrophilic head that is attracted to water molecules and a hydrophobic tail that repels water and simultaneously attaches itself to oil and grease in dirt. These opposing forces loosen the dirt and suspend it in the water, having the ability to remove it from surfaces such as the human skin, textiles, and other solids, when surfactants are dissolved in water.
  • appropriate surfactant agents include, but are not limited to, non-ionic surfactants, cationic surfactants, amphoteric surfactants, zwitterionic surfactants, and mixtures thereof.
  • surfactants appropriate for the present invention include, but are not limited to, polyglyceryl-4 diisostearate/ polyhydroxystearate/sebacate, hydrogenated castor oil, polyoxyethylene 2 stearyl ether, polyoxyethylene 20 stearyl ether, and mixture thereof; particularly polyglyceryl-4 diisostearate/ polyhydroxystearate/sebacate (I SOLAN GPS). If present, the amount of surfactant in the compositions of the present invention is from 1% to 8% by weight; particularly from 2 to 5% by weight.
  • the water-in-oil emulsion composition of the invention comprises an emulsifying system having a hydrophile lipophile balance (HLB) from 1 to 9.
  • HLB hydrophile lipophile balance
  • the term "emulsifying system” encompasses either one or more surfactants having each of them a HLB from 1 to 9; or a mixture of surfactants having the mixture a HLB from 1 to 9.
  • the water-in-oil emulsion composition of the invention comprises from 2 to 5% by weight of an emulsifying system having a hydrophile lipophile balance (HLB) from 1 to 9; particularly selected from those mentioned above.
  • vehicle refers to a substance that facilitates the use of the active ingredients mixed with it.
  • vehicles include, but are not limited to, water, glycols such as propylene glycol and butylene glycol; alcohols such as ethanol and isopropanol; particularly water.
  • preservative refers to a material that prevents or reduces or slows down microbial growth, providing that the stability of the emulsion is not affected.
  • suitable preservative agents include, but are not limited to, benzoic acid, butylparaben, ethylparaben, propylparaben, methylparaben, sorbic acid, potassium sorbate, sodium benzoate, potassium sorbate, phenoxyethanol, triclosan, or their mixtures. If present, the amount of the preservatives in the compositions of the present invention is from 0.2 to 3% by weight.
  • the composition of the present invention can be in form of spray optionally comprising one or more propellants.
  • propellant refers to one or more gases that are used to pressurize the composition to facilitate the pulverization of the composition from the container.
  • Some propellants may be a mixture of gases (e.g., A-46 which is a mixture of isobutane, butane and propane).
  • a propellant may be in the form of a liquid (i.e., a liquefied gas) when under pressure within the reservoir of a spray device.
  • a propellant may be in its gaseous state within the head space of the reservoir.
  • a propellant may be present in both a liquefied form and its gaseous state within the reservoir.
  • propellants include 1,1,1 ,2,2-pentafluoroethane, 1,1, 1 ,2-tetrafluoroethane, 1,1, 1 ,2,3,3,3-heptafluoropropane, trans-1 ,3,3,3- tetrafluoroprop-1-ene, dimethyl ether, dichlorodifluoromethane (propellant 12), 1 , 1-dichloro-1 , 1,2,2- tetrafluoroethane (propellant 114), 1 -chloro-1 , 1 -difluoro-2,2-trifluoroethane (propellant 115), 1-chloro-1,1- difluoroethylene (propellant 142B), 1,1 -difluoroethane (propellant 152A), monochlorodifluoromethane, and mixtures thereof.
  • thickener refers to a material that increases its viscosity without substantially modifying its other properties.
  • Appropriate thickener includes, but are not limited to, natural and synthetic or semi-synthetic thickeners which derive from various sources and consist of very different molecular structures including polysaccharides, proteins and alcohols. Examples of appropriate thickener include cetyl alcohol, stearyl alcohol, stearic acid, and cellulose derivatives such as hydroxyethylcellulose, guar gum, locust bean gum, xanthan gum, and gelatine. If present, the amount of the viscosity agent is from 0.1 to 10% by weight.
  • skin conditioning agent refers to a substance that increase the water content of the top layers of the skin and/or give the skin a soft and smooth appearance.
  • appropriate skin conditioning agent agents can include, but are not limited to, esters of glycerine and C15-C25 fatty acid such as glyceryl oleate; C15-C25 fatty alcohol such as lauryl alcohol, myristyl alcohol, palmityl alcohol, stearyl alcohol, linoleyl alcohol, and oleyl alcohol; diols such as propyleneglycol, propanediol, 1,2-hexanediol, ethylhexylglycerine, glycerol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, and dipropylene glycol or diethylene glyco. If present, the amount of skin conditioning agent is from 0.1 to 10% by weight.
  • pH regulating agent and “buffer” and “buffering agent” have the same meaning and are used interchangeable. They refer to a substance that active adjust and regulates the pH value of a solution to which they have been added.
  • pH regulating agents can include, but are not limited to, strong acids (i.e., acids that are completely dissociated in aqueous solution) and strong bases (i.e., bases that are completely dissociated in aqueous solution), acidic buffering agents and alkaline buffering agents, and nicotine. If present, the amount of pH regulating agent is from 0.1 to 1% by weight.
  • the water-in-oil emulsion composition of the present invention can further comprise (e) one or more additional pharmaceutically or cosmetically active ingredients.
  • additional active ingredients and their amounts can readily be determined by those skilled in the art according to the type of formulation being prepared to provide the appropriate pharmaceutically or cosmetically effect.
  • appropriate additional active ingredients can include, but are not limited to, deodorant agents. If present, the amount of additional pharmaceutically or cosmetically active ingredients is from 0.1 to 5%.
  • deodorant active ingredient refers to any topical material that is known or otherwise effective in preventing or eliminating malodor associated with perspiration.
  • Suitable deodorant active agents may be selected from the group consisting of antimicrobial agents (e.g., bacteriocides, fungicides), malodor-absorbing material, and mixture thereof.
  • the water-in-oil emulsion composition of the invention comprises: (a) from 20 to 60 % by weight of one or more antiperspirant active ingredients, particularly aluminium containing salts;
  • surfactants particularly polyglyceryl-4 diisostearate/ polyhydroxystearate/Sebacate; from 0 to 3% by weight of preservatives; from 0 to 5% of stabilizing agent; from 0 to 10% of skin conditioning; and
  • the water-in-oil emulsion composition of the invention comprises: (a) from 20 to 60 % by weight of one or more antiperspirant active ingredients, particularly aluminium containing salts;
  • surfactants particularly polyglyceryl-4 diisostearate/ polyhydroxystearate/Sebacate; from 0.1 to 3% by weight of preservatives; from 0.1 to 3% of stabilizing agent; from 0.1 to 10% of skin conditioning; and
  • the water-in-oil emulsion composition of the invention comprises: (a) from 40 to 55 % by weight of one or more antiperspirant active ingredients, particularly aluminium containing salts;
  • the water-in-oil emulsion composition of the invention comprises:
  • surfactants particularly polyglyceryl-4 diisostearate/ polyhydroxystearate/Sebacate; from 0.1 to 3% by weight of preservatives; from 0.1 to 3% of stabilizing agent; from 0.1 to 6% of skin conditioning; and
  • the water-in-oil emulsion composition of the present invention is a topical pharmaceutical or cosmetic composition comprising one or more appropriate topical pharmaceutically or cosmetically acceptable excipients or carriers.
  • the topical water-in-oil emulsion compositions of the invention can be formulated in several forms that include, but are not limited to, creams, stick, roll-on, spray, soft solids, gels, mousses, ointments and pastes.
  • the topical water-in-oil emulsion composition of the present invention is in form of a spray, optionally the composition further comprises one or more propellants as defined above.
  • the topical water-in-oil emulsion composition of the present invention is in form of a spray, and the composition further comprises one or more propellants as defined above. Additionally, the composition of the present invention may contain other ingredients, such as fragrances, colorants, and other components known in the state of the art for use in topical formulations. In an embodiment, the composition of the present invention is "substantially free” of silicones.
  • silicones for the purpose of the invention, the terms “silicone”, “polymerized siloxanes” and “polysiloxanes” have the same meaning and are used interchangeable. They refer to an inorganic silicon-oxygen backbone chain (-Si-0— Si-O— Si-O— ) with two organic groups attached to each silicon atom.
  • the organic groups are alkyl moieties, particularly methyl.
  • the silicones can be cyclic or lineal; and straight, or branched (such as cage-like). By varying the -Si-O- chain lengths, side groups, and crosslinking, silicones can have a wide variety of consistency (from liquid to gel to rubber to hard plastic), properties and compositions.
  • sicone encompasses dimethicone, dimethicone copolyol, stearyl dimethicone, dimethiconol, amodimethicon, cyclomethicone, cetyl dimethicone, behenoxy dimethicone, stearoxy dimethicone, trimethylsilylamodimethicone, lauryl methicone copolyol, hydroxypropyl polysiloxane, phenyl trimethicone, cetearyl methicone, trimethylsiloxysilicate, polydimethylsiloxane, cyclopentasiloxane and cyclosiloxane.
  • the term “substantially free” refers to a composition comprises less than 1 % by weigth of silicones.
  • the composition of the invention is “free” of silicones.
  • the term “free of” refers to a composition whose content of silicones. is not detectable by any of the commonly used techniques defined in the state of the art.
  • the method for determining the content of ion silicones can be gas chromatography coupled to mass spectrometry.
  • the composition of the invention is “substantially free” or “free” of silicones.
  • the process for the preparation of emulsions comprises: (i) firstly, preparing the aqueous phase(s) and the oil phase separately; and (ii) secondly, mixing both phases until obtaining the water-in-oil-emulsion as it is shown in the experimental section.
  • water-in-oil emulsion composition can be prepared following the general process as defined herein below:
  • Phase A Preparing Phase A by mixing the emollients, the film-forming agents and optionally the surfactants, additional active ingredients (such as deodorant active ingredients) and fragrances.
  • Phase B Preparing Phase B by mixing the antiperspirant active ingredients, and optionally the stabilizing agents, with water.
  • Phase C by mixing the preservatives, skin conditioning agents, antioxidants and additional active ingredients.
  • step (v) optionally mixing the resulting mixture of step (iv) with Phase C.
  • the water-in-oil emulsion of the present invention can be defined by its preparation process.
  • a water-in- oil emulsion composition of the first aspect of the invention obtainable by the process as defined above is also part of the invention.
  • the expressions "obtainable”, “obtained” and equivalent expressions are used interchangeably, and in any case, the expression “obtainable” encompasses the expression “obtained”. All the embodiments disclosed above for the process of the invention applies also for water-in-oil emulsion composition obtainable by this process.
  • a water-in-oil emulsion composition for use in therapy, with the proviso that the composition comprises: a therapeutically effective amount of one or more antiperspirants, and pharmaceutically acceptable excipients or carriers.
  • the water-in-oil emulsion composition of the invention is useful for the prophylaxis and/or treatment of a disease or condition which involves an excessive or abnormal perspiration.
  • Disease or conditions which involve an excessive or abnormal perspiration include hyperhidrosis, chromhidrosis and bromhidrosis.
  • This aspect could be also formulated as the use of water-in-oil emulsion composition as defined above for the preparation of a medicament for the prophylaxis and/or treatment of a disease or condition which involves an excessive or abnormal perspiration.
  • It also relates to a method for the prophylaxis and/or treatment of a mammal suffering or is susceptible to suffer from a disease or condition which involves an excessive or abnormal perspiration, the method comprises administering to said mammal an effective amount of a water-in-oil emulsion composition of the present invention.
  • the water-in-oil emulsion composition of the invention can be used for reducing the normal perspiration of the skin.
  • another aspect of the present invention is a water-in-oil emulsion composition of the invention as defined above in cosmetic; particularly as an antiperspirant agent and a deodorant agent.
  • the composition comprises: a cosmetically effective amount of antiperspirant active ingredients, and cosmetically acceptable excipients or carriers.
  • the topical cosmetic water-in-oil emulsion composition of the invention reduces the extent of sweating, the occurrence of unsightly sweat marks on clothing as well as minimizing body odour.
  • the water-in-oil emulsion composition also allows strengthen and moisturizing the skin.
  • the topical cosmetic composition of the present invention is designed to apply to the body to improve its appearance or to beautify, preserve, cleanse and protect the skin. Therefore, the above cosmetic compositions are adjectivally used for a non-medical application.
  • the word “comprise” and variations of the word are not intended to exclude other technical features, additives, components, or steps. Furthermore, the word “comprise” encompasses the case of “consisting of. Additional objects, advantages and features of the invention will become apparent to those skilled in the art upon examination of the description or may be learned by practice of the invention. The following examples are provided by way of illustration, and they are not intended to be limiting of the present invention. Furthermore, the present invention covers all possible combinations of particular and preferred embodiments described herein.
  • This example illustrates a water-in-oil-emulsion composition in form of spray (Spray 1) in accordance with the present invention.
  • Table 1 shows the qualitive and quantitative composition of the water-in-oil emulsion (Emulsion 1) forming part of the spray of the present invention.
  • Table 2 shows the qualitive and quantitative composition of the water-in-oil spray composition (Spray 1) of the present invention containing the water-in-oil emulsion composition (emulsion 1) disclosed in Table 1.
  • the water-in-oil emulsion 1 was prepared at room temperature following the process disclosed herein below: 1. Preparation of Phase A. Phase A ingredients were mixed one by one under stirring in a first reactor.
  • Phase B Preparation of Phase B. In a separate second reactor, all ingredients of Phase B were mixed one by one under stirring.
  • Phase B was added to Phase A with high-shear mixer and the resulting mixture was stirred for 25 minutes. Then, all Phase C ingredients one by one were added to the resulting mixture (i.e., phase A+B) under stirring.
  • the water-in-oil emulsion spray composition 1 of the present invention disclosed in Table 2 was prepared following the process disclosed herein below.
  • the water-in-oil emulsion 1 was loaded into a container and charged with 85% by weight of the propellant mixture.
  • This example illustrates a comparative water-in-oil emulsion composition in form of spray (Comparative Spray 1) falling outside the scope of the present invention because the water-in-oil emulsion does not contain any film-forming agent.
  • Table 3 shows the qualitive and quantitative composition of the comparative water-in-oil emulsion (Comparative Emulsion 1) forming part of the comparative spray 1 falling outside of the present invention.
  • Table 4 shows the qualitive and quantitative composition of the comparative water-in-oil spray composition (comparative Spray 1) falling outside the scope of the present invention containing the comparative water-in-oil emulsion composition (comparative emulsion 1) disclosed in Table 3.
  • the comparative water-in-oil emulsion 1 was prepared following the same process as defined above for the water-in-oil emulsion 1 using the ingredients and amounts disclosed in Table 3, which implies that the film forming agent is not incorporated to the emulsion.
  • Comparative Water-in-oil emulsion spray composition 1 comparative Spray 1
  • the comparative water-in-oil emulsion spray composition 1 was prepared following the same process as defined above for the water-in-oil emulsion spray composition 1 using the ingredients and amounts disclosed in Table 4.
  • the aim of this study was the evaluation of the antiperspirant efficacy of the composition of the present invention (Emulsion 1) by the olfactory evaluation of the corporal odor by trained examinators. 20 volunteers were recruited and the olfactory evaluation was performed at Oh, 24h and 48h after a unique application of two spray doses in the armpit at a distance of 10-15cm. The study has been carried out under medical responsibility, in accordance with the relevant experimental protocol and following the standards of Good Clinical Practice in its corresponding sections.
  • composition of the invention (Spray 1) in the right armpit; and applying the common use invisible spray of the state of the art falling outside the scope of the invention as comparative test in the left armpit.
  • the research made the olfactory evaluation in both armpits and a side effects register, if any.
  • the aim of this test is to determine the ultimate pressure resistance.
  • the measurement of the ultimate pressure resistance for breaking the clot (film) obtained after the application of the composition of the present invention on the armpit skin allows deducing the efficiency of the antiperspirant composition.
  • the test was performed with the composition of the present invention (Emulsion 1) and the comparative emulsion 2 (without a film-forming agent) falling outside of the scope of the present invention using the SOD4 instrument.
  • the machine includes:
  • Microfluidics chip SMART-PORETM
  • the composition of the present invention allows obtaining a bigger clot with a high coverage rate than the comparative composition. Furthermore, the composition of the present invention also has an increase of about 50% in the burst pressure value in comparison with the comparative composition without the film-forming agent. It means that the composition of the present invention is more effective in terms of antiperspirant effect for a prolonged period of time (48h).
  • the aim of the use test is the assessment of skin acceptability and safety of the composition of the present invention.
  • the study has been carried out under medical responsibility, in accordance with the relevant experimental protocol and following the standards of Good Clinical Practice in its corresponding sections.
  • This study was performed under dermatological control on healthy adult female volunteers. 20 women volunteers were recruited. The study was conducted to verify the absence of discomfort and cumulative irritation reactions (functional and physical signs) associated with the application of the composition of the present invention (Spray 1) under study for 2 weeks, under normal conditions of use. At the end of the study, the assessment made by the participants was collected on the basis of a specific, targeted and adapted questionnaire, making it possible to assess the tolerance of the composition of the present invention under investigation and its acceptability.
  • the researcher After verifying that the informed consent form had been signed, the researcher confirmed that the participants met all the inclusion criteria and none of the exclusion criteria and gave them the composition of the invention containers, explained the mode of use and the recommendations to be followed during the study.
  • the first application was performed in consultation to confirm the correct use of the composition of the invention, under dermatological control.
  • the volunteers applied the composition of the present invention under study in the right armpit and their usual deodorant in the left armpit, which will be their own control. They will apply at least one application per day; if they apply more, this will be reflected in the table describing the participating sample in this report.
  • composition of the invention During the final visit, and after 14 days of the use of the composition of the invention, the participants were asked to complete a questionnaire on their satisfaction with the composition of the invention and with the subjective efficacy observed after use.
  • composition of the invention protects 24 hours or until the next application and the remaining 24% AGREED with this statement.
  • composition of the invention prevents the appearance of stains on clothing.
  • composition of the present invention did not produce any undesirable skin reaction after 14 days of use, according to the evaluation of the researchers.
  • the questionnaire revealed that the overall opinion of the composition of the present invention was positive for 100% of the surveys. Particularly: a. 100% of the participants showed that they were very satisfied or satisfied with the composition of the present invention in general, the spray and the packaging. b. 90% of the participants were satisfied or very satisfied with the overall organoleptic properties, such as for example smell, pleasant fragrance, and with the statement that it is the best they have ever tried. c. 100% of the participants were very satisfied or satisfied with the statement that it protects 24 hours, prevents the appearance of spots, long-lasting fragrance and strengthens the skin. d.
  • compositions comprising aluminium salts as antiperspirant agents
  • Table 5 shows the qualitive and quantitative composition of the water- in-oil emulsions (Emulsions 2-5) forming part of the sprays of the present invention.
  • Table 5 shows the qualitive and quantitative composition of the water-in-oil spray compositions (Sprays 2-5) of the present invention containing the water-in-oil emulsion composition (emulsions 2-5) disclosed in
  • Table 5 The water-in-oil emulsions of Ex. 3-5 were prepared following the preparation process as disclosed in section 1.1.2. using the components disclosed in Table 4.
  • the water-in-oil emulsions of Ex. 2 was prepared following the preparation process as disclosed in section 1.1.2, but heating the resulting mixture of ingredients of phase A at about 65°C before its subsequent mixture with phase B.
  • water-in-oil emulsion spray compositions Ex. 2-5 were also prepared by the process as defined in section 1.1.2 using the water-in-oil emulsions of Ex 2-5. 4.1.2. Compositions comprising Zirconium salts as antiperspirant agents
  • Table 7 shows the qualitive and quantitative composition of the water-in-oil spray compositions (Sprays 6-7) of the present invention containing the water-in-oil emulsion composition (emulsions 6-7) disclosed in Table 6.
  • a coverslip was placed at an angle of about 45° in which one end touches the slip and the sample remains below.
  • the aim of the film-forming test was the evaluation of the filmogenous properties of the water-in-oil emulsions of Examples 1-7 of the present invention by the spreader box technique. Therefore, a film of 30mm and 100mm of thickness were prepared following the method disclosed herein below:
  • the aim of this measurement of the contact angle is the evaluation of the wettability properties of the film created after the deposition of the emulions of the water-in-oil emulsion of the present invention (Ex.1-7) on the PMMA support.
  • the values of contact angle of all the water-in-oil emulsions of the present invention are similar, being all of them between the suitable range mentioned above (0-30). It means that all the water-in-oil emulsions of the invention have the appropriate wettability (hydrophilic character), and therefore, useful as anti perspi rants for a long period of time, avoiding the occurrence of unsightly sweat marks on clothing; minimizing the body odour; and having a good cosmeticity taking care of the skin without providing an oily or sticky feeling, leaving a dry skin with a comfortable feeling and clean appearance; as it is demonstrated for the emulsion of example 1 (see section 3).
  • the channel network is composed of 4 independent channels. The wider parts are the inlet channels and measure roughly 500 pm x 60 pm x 10 mm. Each fluidic line finishes with a thin microfluidic channel: the biopore. They are biomimetic channels representing the sweat duct of a human body. They are 60 pm wide, 60 pm high and 2 mm long. These biopores end on a flat surface representing the skin.
  • the liquid was removed from the recipient and then the propellant present on the spray was also removed.
  • a stencil that had a thickness of 100 pm was used, in order to assured that the quantity of composition is sufficient to react with the sweat and respect the rules imposed by the FDA (2mg /cm2).
  • a pharmaceutical or cosmetic water-in-oil emulsion composition comprising:
  • emollients selected from the group consisting of dicaprylyl ether; PPG-14 butyl ether; triheptanoin (and) (C13-C16) isoparaffin; heptyl undecylenate (and) (C13-C15) alkane; triheptanoin (and) (C13- C15) alkane; diisooctyl succinate; neopentyl glycol diheptanoate; diheptyl succinate; isododecane; dipropylheptyl carbonate; caprylyl caprylate/caprate; propylheptyl caprylate; cetearyl isononanoate; undecane (and) tridecane; (Ci2-Cis)alkyl benzoate, dibutyl adipate; coco-caprylate; dicaprylyl carbonate; PPG-15 stearyl ether; coco-caprylate/caprate
  • the one or more antiperspirant active ingredients are selected from the group consisting of aluminium containing salts, zirconium containing salts and zinc containing salts.
  • Clause 4 The water-in-oil emulsion composition according to any of the clauses 1-3, wherein: (b) at least one of the film-forming agents is capryloyl glycerine/sebacic acid copolymer.
  • At least one of the antiperspirant active ingredients is an aluminium containing salts
  • At least one of the film-forming agents is capryloyl glycerine/sebacic acid copolymer
  • Clause 8 The water-in-oil emulsion composition according to any of the clauses 1-7, comprising: (a) from 40 to 55 % by weight of one or more antiperspirant active ingredients;
  • the pharmaceutically or cosmetically acceptable excipients or carriers are selected from the group consisting of surfactant, vehicle, preservative, propellant, pH-regulating agent, stabilizing agents, viscosity agent, skin conditioning agent, antioxidant and mixture thereof; and optionally, the water-in-oil emulsion composition further comprises: (e) one or more additional pharmaceutically or cosmetically active ingredients.
  • the water-in-oil emulsion composition according to any of the clauses 1-7, 9 or 10 comprising: (a) from 20 to 60 % by weight of one or more antiperspirant active ingredients; (b) from 0.1 to 10 % by weight of one or more film-forming agents;
  • Clause 14 The water-in-oil emulsion composition according to any of the clauses 1-13, which is a topical water-in-oil emulsion spray composition, optionally comprising one or more propellants.

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Abstract

La présente invention concerne une composition d'émulsion d'eau dans l'huile pharmaceutique ou cosmétique comprenant : (a) une quantité thérapeutiquement ou cosmétiquement efficace d'un ou de plusieurs principes actifs anti-transpirants ; (b) un ou plusieurs agents filmogènes ; et (c) un ou plusieurs émollients ; (d) conjointement avec un ou plusieurs excipients ou véhicules pharmaceutiquement ou cosmétiquement acceptables. L'invention concerne également un procédé pour sa préparation et son utilisation en thérapie et en cosmétique ; en particulier en tant qu'agent anti-transpirant/déodorant.
EP22704914.5A 2021-02-11 2022-02-10 Composition antiperspirante Pending EP4291151A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21382105 2021-02-11
PCT/EP2022/053190 WO2022171712A1 (fr) 2021-02-11 2022-02-10 Composition antiperspirante

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EP4291151A1 true EP4291151A1 (fr) 2023-12-20

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FR3046056B1 (fr) * 2015-12-28 2019-12-27 L'oreal Composition anhydre anti-transpirante sous forme d'aerosol comprenant un actif anti-transpirant et un polymere derive de vinylpyrrolidone
RU2736828C1 (ru) * 2016-12-14 2020-11-20 Колгейт-Палмолив Компани Композиции антиперспиранта/дезодоранта, не содержащие алюминия

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