WO2010103505A1 - Composition topique moussante - Google Patents

Composition topique moussante Download PDF

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Publication number
WO2010103505A1
WO2010103505A1 PCT/IL2010/000096 IL2010000096W WO2010103505A1 WO 2010103505 A1 WO2010103505 A1 WO 2010103505A1 IL 2010000096 W IL2010000096 W IL 2010000096W WO 2010103505 A1 WO2010103505 A1 WO 2010103505A1
Authority
WO
WIPO (PCT)
Prior art keywords
composition
oil
emulsion
water
foamable
Prior art date
Application number
PCT/IL2010/000096
Other languages
English (en)
Inventor
David Marcos
Milane Haran
Original Assignee
Trima - Israel Phramaceutical Products Maabarot Ltd.
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 Trima - Israel Phramaceutical Products Maabarot Ltd. filed Critical Trima - Israel Phramaceutical Products Maabarot Ltd.
Publication of WO2010103505A1 publication Critical patent/WO2010103505A1/fr
Priority to US13/226,761 priority Critical patent/US20120064013A1/en

Links

Classifications

    • 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
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/046—Aerosols; Foams
    • 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
    • A61K8/27—Zinc; 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
    • A61K8/37—Esters of carboxylic acids
    • 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
    • A61K8/60—Sugars; 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
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • 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
    • A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; 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
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • 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
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9794—Liliopsida [monocotyledons]
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/122—Foams; Dry foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • the present invention relates to the field of chemical compositions, and more specifically to a foamable composition for topical application, the composition comprising a water in oil emulsion.
  • Topical application involves the absorption of a formulation by and/or through skin, mucous membrane or wound tissue. Topical applications may also be used to protect the skin or mucous membrane from external irritants such as chemicals, biological fluids, sunlight, etc.
  • ointments containing white petroleum as the carrier often form an impermeable barrier, so that metabolic products and excreta from the area to which they are applied are not easily removed or drained away. Furthermore, it may be difficult for an active agent dissolved in the carrier to pass through the white petrolatum barrier layer to the skin, so the efficacy of the drug is reduced. In addition, ointments and creams often do not create an environment for promoting normal respiration of the skin.
  • Foams for topical application are pressurized delivery forms containing one or more ingredients that, upon valve actuation, emit a fine dispersion of liquid and/or solid materials in a gaseous medium.
  • Topical foams utilize compressed gases of various types as propellants, including but not limited to hydrocarbon gases (propane, butane, and isobutane), nitrogen, carbon dioxide, freons, chlorofluorocarbons, and fluorocarbons.
  • Foam formulations are generally easier to apply, are less dense, and spread more easily than other topical dosage forms. Foams may be formulated in various ways to provide emollient or drying functions to the skin, depending on the formulation constituents.
  • Emulsion systems provide a two-phase system including lipophilic or hydrophobic components in one phase and hydrophilic components in the second phase.
  • the foamed emulsion typically is an oil-in-water emulsion in which the hydrophobic component is dispersed in the aqueous continuous phase.
  • WO 04/037225 to Foamix discloses an oil in water emulsion comprising 80-98% water; and US 20040106688 discloses an oil in water emulsion comprising from 50 to 97% by weight of a water phase.
  • US 20080044444 to Foamix discloses foamable compositions comprising a dicarboxylic acid or ester derivative thereof in which the dicarboxylic acid or ester derivative is a stabilizing emollient and or has a therapeutic effect.
  • US 20060281823 discloses a foamable water-in-oil type emulsion composition comprising diglyceride-containing fats and oils and a liquid sugar, having improved in-mouth meltability and thermostability with a low specific gravity and a good eating texture for use in buttercreams or similar products.
  • foams and, in particular, foam emulsions are complicated systems which do not form under all circumstances. Slight shifts in foam emulsion composition, such as by the addition of active ingredients, may destabilize the foam.
  • the prior art does not disclose a foamable, water in oil emulsion for topical application
  • the present invention provides a foamable composition for topical application, the composition comprising a water in oil emulsion.
  • the present invention provides, in at least some embodiments, a foamable water in oil composition comprising an emulsion for topical application, providing a homogenous foam, which is surprisingly stable.
  • the present invention provides a foamable composition comprising a water in oil emulsion, the emulsion comprising up to about 40% (w/w) oil and up to about 60% (w/w) water.
  • the present invention provides a foamable composition
  • a foamable composition comprising a water in oil emulsion, the emulsion comprising up to about 40% (w/w) oil, up to about 60% (w/w) water and at least one surfactant.
  • the present invention provides a foamable composition for topical application, the composition comprising a water in oil emulsion comprising up to about 40% (w/w) oil, up to about 60%
  • the present invention provides the use of a composition for topical application, wherein the composition comprises a water in oil emulsion adapted to be foamable.
  • the composition comprises an emulsion, the emulsion comprising at least one of zinc oxide, hyaluronic acid or zinc hyaluronate, optionally as an active ingredient, although the use of other active ingredients, including natural ingredients of plant or animal origin, such as, for example, Euphrasia Mallow, Chamomile, Hamamelis, or Aloe is considered as being within the scope of the invention.
  • Zinc oxide is commonly used to treat minor burns and skin irritation, and is a preferred ingredient in many creams and ointments for the treatment or prevention of diaper rash.
  • the prior art does not teach a foamable composition
  • a foamable composition comprising a water in oil emulsion, the emulsion comprising at least one of zinc oxide, hyaluronic acid, zinc hyaluronate or a plant extract.
  • a foamable composition comprising an emulsion, the emulsion comprising up to about 25% (w/w of total composition) zinc oxide and up to about 40% (w/w of total composition) oil as a carrier in a water in oil emulsion.
  • a foamable composition comprising a water in oil emulsion, the emulsion comprising at least one of zinc oxide, hyaluronic acid, zinc hyaluronate, or a plant extract.
  • a foamable composition comprising a water in oil emulsion, the emulsion comprising at least one of zinc oxide, hyaluronic acid,zinc hyaluronate, or a plant extract, and at least one surfactant.
  • a foamable water in oil composition comprising at least one of zinc oxide, hyaluronic acid, zinc hyaluronate, or a plant extract, and at least one surfactant comprising a fatty acid ester.
  • a foamable composition comprising a water in oil emulsion, the composition being adapted for delivery from a pressurized container, the emulsion comprising at least one of zinc oxide, hyaluronic acid, zinc hyaluronate, or a plant extract, wherein a foam is formed upon expulsion from said container.
  • a foamable composition comprising a water in oil emulsion for the treatment or prevention of a skin condition, the emulsion comprising at least one of zinc oxide, hyaluronic acid, zinc hyaluronate, or a plant extract.
  • a method for treating or preventing a skin condition comprising administering to the skin a foamable water in oil composition comprising an emulsion, the emulsion comprising at least one of zinc oxide, hyaluronic acid, zinc hyaluronate, as an active ingredient.
  • the plant extract of the present invention may comprise one or more of Euphrasia Mallow, Chamomile, Hamamelis, and Aloe or similar.
  • zinc oxide is preferably present at a concentration in the range of from about 2% to about 20% w/w of total composition.
  • the oil of the present invention may have a low polarity, such as, for example, one or more of mineral oil, triglyceride oil, squalane, tocopherol or its derivatives, avocado oil, macadamia oil, corn oil, olive oil, sesame oil, peanut oil, octyl dodecanate, or oleic acid decyl ester, or combinatations thereof.
  • the oil may have a medium to high polarity.
  • suitable oils include isopropyl myristate, isopropyl palmitate, caprylic / capric triglycerides, propylene glycol dicaprylate
  • the oil of the present invention comprises isopropyl myristate and mineral oil.
  • the composition comprises at least one surfactant.
  • the surfactant or combination of surfactants has a total HLB of less than about 7.
  • At least one surfactant comprises a fatty acid ester.
  • Suitable fatty acid esters include but are not limited to sorbitan fatty acid esters (such as sorbitan monolaurate; sorbitan mono palmitate; sorbitan monooleate, sorbitan dioleate; sorbitan trioleate; sorbitan sesquioleate; sorbitan monolaurate; sorbitan monoisostearate; sorbitan diisostearate; sorbitan sesquistearate); sucrose fatty acid esters (such as sucrose monopalmitate; sucrose monostearate; sucrose distearate; sucrose polystearate); propylene glycol fatty acid esters (such as propylene glycol stearate; propylene glycol alginate); glyceryl fatty acid esters (such as glyceryl monooleate; glyceryl monostearate; glyceryl myristate); polyglyceryl fatty acid esters (such as polyglyceryl 2-stearate; poly
  • the fatty acid ester surfactant comprises glyceryl monooleate. More preferably, the glyceryl monooleate is present at a concentration in the range of from about 0.2% to about 7% w/w of total composition. Additionally or alternatively, the fatty acid ester surfactant comprises sucrose polystearate and sucrose distearate.
  • sucrose polystearate is present at a concentration of up to about 3% w/w of total composition, and sucrose distearate is present at a concentration of up to about 1% w/w of total composition.
  • sucrose polystearate is present at a concentration of about 0.3% w/w of total composition, and sucrose distearate is present at a concentration of about 0.1% w/w of total composition.
  • the composition further comprises a co-emulsifier, such as, for example, beeswax, lanolin, cetyl alcohol, stearyl alcohol, cetostearyl alcohol, stearic acid, palmitic acid or poloxamer.
  • a co-emulsifier such as, for example, beeswax, lanolin, cetyl alcohol, stearyl alcohol, cetostearyl alcohol, stearic acid, palmitic acid or poloxamer.
  • the beeswax is present at a concentration of up to about 4% w/w of total composition.
  • the beeswax is present at a composition of about 2% w/w of total composition.
  • lanolin is present at a concentration of up to about 7% w/w of total composition.
  • the lanolin is present at a concentration of about 2% w/w of total composition.
  • the composition of the present invention further comprises panthenol.
  • Panthenol is a humectant, emollient and moisturizer, which improves hydration, reduces itching and inflammation of the skin and accelerates and improves healing of epidermal wounds.
  • panthenol is present at a concentration of up to about 5% w/w of total composition.
  • the composition of the present invention further comprises aloe vera extract, which is considered to be effective in the treatment of wounds.
  • aloe vera extract is present at a concentration of up to about 1% w/w of total composition.
  • the composition of the present invention further comprises a preservative (such as, for example, benzalkonium chloride, sodium benzoate, benzoic acid, benzyl alcohol, methylparaben, ethylparaben, propylparaben, butylparaben, imidurea, potassium sorbate, sorbic acid, phenoxyethanol, chlorocresol, or bronopol).
  • a preservative such as, for example, benzalkonium chloride, sodium benzoate, benzoic acid, benzyl alcohol, methylparaben, ethylparaben, propylparaben, butylparaben, imidurea, potassium sorbate, sorbic acid, phenoxyethanol, chlorocresol, or bronopol).
  • the composition further comprises a propellant, such as, for example, one or more hydrocarbon gases (propane, butane and isobutane) and/or fluorocarbons (such as Dymel 134a®).
  • a propellant such as, for example, one or more hydrocarbon gases (propane, butane and isobutane) and/or fluorocarbons (such as Dymel 134a®).
  • composition of the present invention is useful, in some embodiments, for the treatment or prevention of a skin condition, such as, for example, diaper rash, psoriasis, eczema, urticaria, scabies, acne, alopecia areata, bullous pemphigoid, dermatitis, atopic dermatitis, impetigo, keloids, pruritis, rosacea, vitiligo, burns, irritation, inflammation, fungal infection, dry skin, skin allergies or diabetic skin conditions.
  • a skin condition such as, for example, diaper rash, psoriasis, eczema, urticaria, scabies, acne, alopecia areata, bullous pemphigoid, dermatitis, atopic dermatitis, impetigo, keloids, pruritis, rosacea, vitiligo, burns, irritation, inflammation, fungal infection, dry skin, skin allergies or diabet
  • composition of the present invention is useful, in some embodiments, for providing a skin soothing and anti-itching effect.
  • composition of the present invention is preferably useful, in some embodiments, for treatment or prevention of diaper rash.
  • Diaper rash is a generalized term indicating any skin irritation, regardless of cause, that develops in the diaper-covered region. While diaper rash is generally thought to affect infants and toddlers, any individual wearing a diaper (for example, an incontinent adult) is a candidate to develop this condition. Contact dermatitis is the most common category of diaper rash. Skin involvement may vary from mild redness to erosion of the top layers of skin. Other categories include skin infections and allergic reactions. Oil in water foam compositions are problematic for treatment of diaper rash, since the composition is easily washed away by the urine and fecal excretions of the subject. Water in oil compositions are preferable in this respect; however, stable water in oil foaming compositions are very difficult to formulate.
  • the composition of the present invention is a cosmetic composition for topical application. Such a composition may be useful for improving the appearance and/or texture of the skin. According to some embodiments, the composition of the present invention may be provided as a medical device.
  • compositions suitable for use in the context of the present invention include compositions wherein the active ingredient is contained in an amount effective to achieve the intended purpose. More specifically, a “therapeutically effective amount” means an amount of active ingredient effective to prevent, alleviate, or ameliorate a skin condition. Determination of a therapeutically effective amount is well within the capability of those skilled in the art, especially in light of the detailed disclosure provided herein.
  • the emulsion was prepared by heating the components of the oil phase and those of the aqueous phase separately to a temperature of between 60°C and 8O 0 C. The phases were then mixed, homogenized and cooled to room temperature. Conductivity of the emulsion was measured according to the manufacturer's instructions, using the OysterTM conductivity/temperature meter (Extech Instruments Corporation, Waltham, MA, USA). The low conductivity obtained showed the emulsion to be of the water in oil type.
  • Foamability of the emulsion was demonstrated by packing in an aluminium can fitted with a delivery valve and pressurizing with a suitable propellant comprising one or more hydrocarbon gases such as propane, butane and isobutane.

Abstract

L'invention concerne une composition moussante pour application topique, la composition comprenant une émulsion eau dans huile.
PCT/IL2010/000096 2009-03-08 2010-02-03 Composition topique moussante WO2010103505A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US13/226,761 US20120064013A1 (en) 2010-02-03 2011-09-07 Foamable topical composition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL197464 2009-03-08
IL197464A IL197464A0 (en) 2009-03-08 2009-03-08 Foamable topical composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/226,761 Continuation-In-Part US20120064013A1 (en) 2010-02-03 2011-09-07 Foamable topical composition

Publications (1)

Publication Number Publication Date
WO2010103505A1 true WO2010103505A1 (fr) 2010-09-16

Family

ID=42111816

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2010/000096 WO2010103505A1 (fr) 2009-03-08 2010-02-03 Composition topique moussante

Country Status (2)

Country Link
IL (1) IL197464A0 (fr)
WO (1) WO2010103505A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120214871A1 (en) * 2011-02-17 2012-08-23 Conopco, Inc., D/B/A Unilever Leave-on nonsolid oil-continuous skin conditioning compositions containing 12-hydroxystearic acid
WO2012035468A3 (fr) * 2010-09-14 2014-01-23 Trima - Israel Pharmaceutical Products Maabarot Ltd. Composition topique moussante

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004037225A2 (fr) 2002-10-25 2004-05-06 Foamix Ltd. Mousse cosmetique et pharmaceutique
US20040106688A1 (en) 2002-09-30 2004-06-03 Kao Corporation Foamable oil-in-water type emulsion
US20060281823A1 (en) 2003-03-07 2006-12-14 Kao Corporation Foamable water-in-oil type emulsion composition
WO2007007208A2 (fr) * 2005-03-11 2007-01-18 Foamix Ltd. Composition et kit d'immunomodulation non steroidiens et utilisations
WO2007085902A2 (fr) * 2005-07-19 2007-08-02 Foamix Ltd. Composition moussante combinant un solvant polaire et un vecteur hydrophobe
US20080044444A1 (en) 2002-10-25 2008-02-21 Foamix Ltd. Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
US20080069779A1 (en) * 2003-08-04 2008-03-20 Foamix Ltd. Foamable vehicle and vitamin and flavonoid pharmaceutical compositions thereof

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040106688A1 (en) 2002-09-30 2004-06-03 Kao Corporation Foamable oil-in-water type emulsion
WO2004037225A2 (fr) 2002-10-25 2004-05-06 Foamix Ltd. Mousse cosmetique et pharmaceutique
US20080044444A1 (en) 2002-10-25 2008-02-21 Foamix Ltd. Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
US20060281823A1 (en) 2003-03-07 2006-12-14 Kao Corporation Foamable water-in-oil type emulsion composition
US20080069779A1 (en) * 2003-08-04 2008-03-20 Foamix Ltd. Foamable vehicle and vitamin and flavonoid pharmaceutical compositions thereof
WO2007007208A2 (fr) * 2005-03-11 2007-01-18 Foamix Ltd. Composition et kit d'immunomodulation non steroidiens et utilisations
WO2007085902A2 (fr) * 2005-07-19 2007-08-02 Foamix Ltd. Composition moussante combinant un solvant polaire et un vecteur hydrophobe

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012035468A3 (fr) * 2010-09-14 2014-01-23 Trima - Israel Pharmaceutical Products Maabarot Ltd. Composition topique moussante
US20120214871A1 (en) * 2011-02-17 2012-08-23 Conopco, Inc., D/B/A Unilever Leave-on nonsolid oil-continuous skin conditioning compositions containing 12-hydroxystearic acid
CN103370043A (zh) * 2011-02-17 2013-10-23 荷兰联合利华有限公司 含有12-羟基硬脂酸的留存型非固体油连续性皮肤调理组合物
CN103370043B (zh) * 2011-02-17 2016-08-10 荷兰联合利华有限公司 含有12-羟基硬脂酸的留存型非固体油连续性皮肤调理组合物

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