WO2022123313A1 - Compositions désinfectantes de la peau contenant de l'huile de manuka - Google Patents

Compositions désinfectantes de la peau contenant de l'huile de manuka Download PDF

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Publication number
WO2022123313A1
WO2022123313A1 PCT/IB2021/000861 IB2021000861W WO2022123313A1 WO 2022123313 A1 WO2022123313 A1 WO 2022123313A1 IB 2021000861 W IB2021000861 W IB 2021000861W WO 2022123313 A1 WO2022123313 A1 WO 2022123313A1
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Prior art keywords
oil
skin
composition
skin sanitizing
sanitizing composition
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PCT/IB2021/000861
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English (en)
Inventor
Robert GIMOUR
Stuart H. CAIRNS
Christine J. HAMES
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Manuka Therapeutics Ltd.
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Application filed by Manuka Therapeutics Ltd. filed Critical Manuka Therapeutics Ltd.
Priority to AU2021396738A priority Critical patent/AU2021396738A1/en
Publication of WO2022123313A1 publication Critical patent/WO2022123313A1/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
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/365—Hydroxycarboxylic acids; Ketocarboxylic 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
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A61K8/922—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • 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
    • 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
    • A61Q19/08—Anti-ageing preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
    • A61K2800/30—Characterized by the absence of a particular group of ingredients

Definitions

  • the application relates to topical compositions for sanitizing the skin in mammals, including humans. More particularly, non-alcohol-based hand sanitizers that include natural ingredients including optional moisturizers or skin protectants incorporated into the sanitizer.
  • sanitizing compositions have been produced that may be applied to a person's skin to rapidly kill and eliminate the presence of common bacterial. Such sanitizers can commonly be applied without the need for the addition of water to function and generally dry within the matter of seconds to eliminate 99% or more of common household bacterial that may be present on the skin.
  • Sanitizer formulations are generally available in the form of a liquid, gel, or foaming composition. Such formulations typically include alcohol as the primary disinfecting agent.
  • the present disclosure generally relates to antimicrobial skin sanitizing compositions including natural, alcohol-free formulations that are effective in killing microorganisms present on a user’s skin. More particularly, the skin sanitizers include a combination of
  • Leptospermum Scoparium oil (manuka oil) and an organic acid (e.g., lactic acid) that provide an effective, rapid acting antimicrobial hand sanitizer to substantially eliminate the presence of bacteria on a user’s skin.
  • the disclosed hand sanitizing formulations may be substantially free of alcohol and/or include only natural ingredients.
  • the disclosed hand sanitizers may also have a viscosity that prevents running when applied to a patient’s skin.
  • the disclosed skin sanitizing formulation may be used as a surgical preparation for a patient’s skin such as in cosmetic surgery. The surgical preparation formulations may be used in place of iodine or chlorhexidine products.
  • a skin sanitizing composition includes Leptospermum Scoparium oil (manuka oil) and an organic acid such as lactic acid.
  • manuka oil Leptospermum Scoparium oil
  • organic acid e.g. lactic acid
  • the disclosed compositions may inhibit the grown of new bacteria on the user’s skin for an extended period of time.
  • the disclosed skin sanitizing composition may also include Nigella Sativa seed oil (black seed oil) or other oils described herein.
  • black black seed oil may help provide excellent and sustained antimicrobial activity as compared to other alcohol-based compositions.
  • the black seed oil if present, may be included in an amount of about 0.1 wt.% to about 4 wt.% of the composition.
  • compositions that comprises “a” surfactant can be interpreted to mean that the composition includes “one or more” surfactants.
  • the term “consists substantially of’ means that at least 95 percent by weight (wt.%) the respective material is made of the recited component.
  • a sanitizing composition that consists substantially of vegan materials means that at least 95 wt.% of the composition is made of vegan materials.
  • the term “consists essentially of’ means that the respective material is formulated of the recited components, but also may include other contaminates that do not materially affect the physical or chemical properties of the material.
  • a composition that “consists essentially of’ a list of materials may include less than 0.5 wt.% other components.
  • essential oil refers to a natural, plant-based oil. Unless indicated otherwise, such oils may be derived from a cold press process or a steam distillation. The method of producing such oils (e.g., steam distillation versus cold press) may alter the compositional makeup and physical and medicinal properties of the oil.
  • the terms “mixture” or “mixing” refers to a physical mixture or physically mixing (e.g., blending) two or more components together. Unless otherwise indicated, a mixture includes emulsions, heterogeneous mixtures, and homogeneous mixtures.
  • the term “natural” refers to an excipient derived from a renewable source such as plants, insects, or animal-based sources, as opposed to synthetic or petroleumbased sources.
  • the phrase “natural oil” may include oils derived from plants, insects (e.g., bees), or animals.
  • An excipient may still be considered “natural” even though the excipient may have undergone a chemical or physical extraction process.
  • essential oils are typically extracted from plants through a distillation process. Essential oils are still considered natural even though processing has occurred to isolate and purify the oil.
  • the terms “preferred” and “preferably” refer to embodiments that may afford certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful and is not intended to exclude other embodiments from the scope of the disclosure.
  • skin sanitizing composition or “topical composition” refers to compositions designed to be applied to the skin of a patient and is not indented for internal consumption or use. Such compositions may include transdermal excipients (e.g., those that penetrate or pass through the layers of the epidermis) and may, in some embodiments, be applied to portions of the skin that include an open wound (e.g., laceration, abrasion, surgical incision, and the like). Skin sanitizing compositions may include, but are not limited to liquids, gels, liquid foams, lotions, ointments, solutions, sprays, or the like.
  • the skin sanitizing compositions may be applied directly to the skin of a patient (e.g., direct application of a liquid) or indirectly to the skin of a patient (e.g., application via a sponge or dressing including the disclosed compositions thereon).
  • the disclosed skin sanitizing compositions are applied to undamaged skin.
  • the embodiments described in this disclosure provide a skin sanitizing composition for the rapid disinfection of a person’s skin or other surfaces.
  • skin sanitizing compositions rely on alcohol as the active disinfectant. Alcohol is effective in rapidly destroying common household bacterial and rapidly dries from a person’s skin making such compositions appealing in several situations.
  • alcohol-based sanitizers typically require the use of anywhere from 60% to 95% alcohol, such as ethanol, in order to be effective.
  • alcohols at these levels can be very drying to the skin and cause irritation and pain if any damage or open wounds are present on the user’s skin.
  • the present disclosure provides an alternative skin sanitizer formulation compared to such alcohol-based, iodine, or chlorhexidine formulations that uses manuka oil and organic acid as the primary disinfectant agents.
  • the disclosed skin sanitizing compositions may be substantially free of alcohol (e.g., contains less than 5 wt.% alcohol, less than 1 wt.% alcohol, or less than 0.1 wt.% alcohol) while still being effective at eliminating 99% or more of common household bacteria from a use’s skin in less than five minutes after application.
  • the disclosed skin sanitizing compositions may provide better skin feel with natural based materials.
  • the disclosed skin sanitizing compositions include a unique mixture of Leptospermum Scoparium oil (manuka oil) and organic acid (e.g., lactic acid), and a carrier composition.
  • manuka oil Leptospermum Scoparium oil
  • organic acid e.g., lactic acid
  • the skin sanitizing compositions disclosed include Leptospermum Scoparium oil (manuka oil). Manuka oil may be extracted from the leaves of a Leptospermum Scoparium plant using a steam distillation process.
  • Leptospermum is the botanical name given to New Zealand’s Manuka tree. There are two species of Leptospermum in New Zealand, distinguishable by white or red pedals they produce. Leptospermum Scoparium or L. Scoparium refers to the white Manuka tree. While the Manuka tree is sometimes referred to as the New Zealand Tea Tree, oil extracted from the Manuka tree should not be confused with “tea tree oil.” In contrast to manuka oil, conventional tea tree oil is derived from the plant Melaleuca alternifolia, commonly found in Australia. Both the Melaleuca alternifolia and Leptospermum Scoparium belong to the myrtle family Myrtaceae commonly known as tea trees however, the oils extracted from each have comparatively different properties and chemical compositions.
  • Manuka oil includes three major groups of compounds including monoterpenes, sesquiterpenes, and (3-triketones.
  • Monoterpenes can include, for example, a- and (3-pinene.
  • Sesquiterpenes can include, for example, a- and (3- eudesmol and (3- caryophyllene.
  • (3- triketones include, for example, flavesone, iso-leptospermone, and leptospermone. Without being bound to a specific theory, the (3-triketones are believed to contribute to the exceptional antimicrobial properties of manuka oil and provide the synergistic effect when combined with organic acids such as lactic acid.
  • the amount (3-triketones contained within manuka oil extract from the Manuka tree can depend on the region within New Zealand in which the Manuka tree is harvested. For example, Manuka trees harvested from the East Cape region of New Zealand contain the highest levels of (3-triketones compared to any other region, presumably due to the unique growing conditions of the region.
  • the levels of (3-triketones within the manuka oil extracted from Manuka trees grown the East Cape region of New Zealand can be greater than 20 weight percent (wt.%), and in some examples greater than 30 wt.%, as compared to Manuka trees harvested from other regions of New Zealand which are typically far less than 20 wt.% and most commonly less than 5 wt.%.
  • the manuka oil used in the disclosed skin sanitizing compositions may be derived from Manuka tress sourced from the East Cape region of New Zealand.
  • the skin sanitizing compositions disclosed include manuka oil having a relatively high concentration of ⁇ -triketones.
  • the manuka oil may include at least 10 wt.% ⁇ -triketones, at least 25 wt.% ⁇ -triketones, at least 30 wt.% ⁇ - triketones, and most preferably at least 40 wt.% ⁇ -triketones.
  • a double steam distillation process may be used to extract and concentrate the manuka oil to increase the relative concentration of ⁇ -triketones within the oil. Sourcing the Manuka oil from Manuka trees harvested from the East Cape region of New Zealand provides a rich concentration of ⁇ -triketones within the extracted oil that likewise preservers the other components present in the extracted oil.
  • Manuka oil is commercially available from Tairawhiti Pharmaceuticals Ltd. of East Cape, New Zealand and New Zealand Manuka Bioactives of Opotiki, New Zealand.
  • New Zealand Manuka Bioactives offers different grades of manuka oil with different levels of ⁇ - triketones including, for example, MpTKTM 5+, MpTKTM 10+, MpTKTM 25+, MpTKTM 30+, and MPTKTM 40+, the #+ designation referring to the weight percent of ⁇ -triketones.
  • New Zealand Manuka Bioactives characterizes its MPTKTM 25+ and higher grades as being sourced from the Manuka trees harvested from the East Cape region of New Zealand.
  • manuka oil has a high antimicrobial activity.
  • skin sanitizing compositions disclosed that include manuka oil may be useful in the rapid destruction of common household bacteria and/or preventing or inhibiting microbial growth on a user’s skin.
  • Manuka oil exhibits good antimicrobial activity against a variety of microbes (e.g., bacteria, fungi, viruses, and the like) including, but not limited to,
  • Bacillus subtilis Bacillus subtilis, Candida albicans, Clostridium species, Fusarium circinatum, gram positive bacteria, Herpes simplex -1 and -2 virus, Micrococcus luteus, Mycobacterium phlei, Sarcina lutea, Staphylococcus species, Legionella pneumophila, Listeria monocytogenes, and others.
  • the disclosed skin sanitizing compositions include a suitable amount of manuka oil to produce the desired sanitizing effect.
  • the disclosed compositions may include about 0.05 wt.% to about 4 wt.% manuka oil, more preferably about 0.05 wt.% to about 0.4 wt.%.
  • the manuka oil used may consist of a great selected that includes at least 25 wt.% ⁇ -triketones.
  • organic acid e.g., lactic acid
  • the disclosed skin sanitizing compositions include manuka oil as described herein (e.g., manuka oil having relatively high concentration of ⁇ -triketones) and one or more organic acids including, but not limited to lactic acid.
  • the selected organic acid may include lactic acid.
  • Lactic acid or lactate, is a naturally occurring chemical byproduct of anaerobic respiration. Lactic acid is produced naturally within the body and is commonly produce in the muscles during exercise. In contrast to other biocide agents, e.g., polychlorinated phenoxy phenols or isothiazolinones, lactic acid in the concentrations disclosed herein does not exhibit harmful side effects to human health or environmental toxicity. Lactic acid also has significant biocide activity against common household bacteria such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Enterococcus hirae, and the like.
  • Lactic acid at moderate concentrations has been shown to provide good effectiveness against gram negative bacteria, but has diminished effectiveness against gram positive bacteria.
  • Lactic acid may be produced through the fermentation process of natural and renewable resources. Microbial fermentation offers advantages, including cheap renewable substrates, low production temperatures, and low energy consumption.
  • the disclosed skin sanitizing compositions include a suitable amount of organic acid (e.g., lactic acid) produce the desired sanitizing effect without.
  • the disclosed compositions may include a non-irritating amount of lactic acid.
  • the disclosed compositions may include about 0.1 wt.% to about 4 wt.% organic acid (e.g., lactic acid).
  • the combination of manuka oil and organic acid (e.g., lactic acid) can allow the concentration of either ingredient or both ingredients to be substantially reduced while still obtaining the same of better sanitizing effectiveness as compared to similar compositions that include either ingredient independently at higher concentrations.
  • manuka oil and organic acid e.g., lactic acid
  • the disclosed skin sanitizing compositions may also include one or more optional additional oil ingredients selected from black seed oil, palmarosa oil, sandalwood oil, thyme oil, lavender oil, patchouli oil, oregano oil, cardamom oil, spearmint oil, bisabolol, and gotukola extract.
  • the disclosed ingredients may have synergistic effects when combined with manuka oil including, for example, providing higher efficacy against bacterial growth, promotion of skin health or wound healing properties, lower MIC, and the like.
  • the skin sanitizing compositions disclosed also include Cymbopogon Martini oil (palmarosa oil). Palmarosa oil may be extracted from the stem and/or grass leaves of a Cymbopogon Martini plant using a steam distillation process. Cymbopogon is the botanical name given to palmarosa grass, also known as Indian geranium, gingergrass, rosha and rosha grass that is native to India and Indochina.
  • the skin sanitizing compositions disclosed includes palmarosa oil and not black seed oil.
  • the disclosed compositions may include about 0.05 wt.% to about 4 wt.% manuka oil, more preferably providing about 0.5 wt.% to about 1.0 wt.% effective triketones, about 0.25 wt.% to about 0.5 wt.% palmarosa oil, and about 0.5 wt.% to about 1.5 wt.% lactic acid.
  • the skin sanitizing compositions disclosed also include black seed oil.
  • Black seed oil may be extracted from the seeds of a. Nigella Sativa plant, which is a small plant with pale purple, blue, or white flowers that grows in Eastern Europe, Western Asia, and the Middle East.
  • the black seed oil may be extracted from the seeds using a cold press process.
  • Black seed oil extracted from the seeds of a Nigella Sativa plant has a high p-cymene and thymoquinone content. Without being bound to a specific scientific theory, it is believed that the thymoquinone contributes to antimicrobial and anti-inflammatory properties of the black seed oil and provides the synergistic effect with manuka oil. Black seed oil may be used on skin to help prevent or inhibit bacterial growth and thereby promote skin health. The anti-inflammatory properties of black seed oil may also help to soothe the skin and reduce the chance of irritation. In skin sanitizing compositions, the black seed oil may also be useful for treating a large number of skin conditions including for example, acne, eczema, and the like thereby improving skin health.
  • the combination of the additional oil ingredients described above and manuka oil may in certain compositions produce surprising synergistic effects when mixed together.
  • the mixture of black seed oil and manuka oil may increase the antimicrobial activity of the composition compared to either of the two oils individually.
  • the mixture of black seed oil and manuka oil shows a broader spectrum of antimicrobial activity and improved activity for longer periods of time. Without being bound to a specific scientific theory, it is believed that the mixture of the additional oil ingredients and manuka oil may not only inhibit the growth of microbes on the surface of the skin but also impede the chance of resistance mutation within the microbe.
  • the skin sanitizing compositions disclosed may remain more effective for a longer period of time with a single application.
  • the ratio of the additional oil ingredients to black seed oil may be about 1:1 to about 10:1 by weight.
  • the ratio of manuka oil to the additional oil ingredients may be adjusted to include a higher weight percent of manuka oil compared to the additional oil ingredients (e.g., about 4:1).
  • the disclosed compositions may include additional oil ingredient, if present, in an amount of about 0.1 wt.% to about 4 wt.% of the composition.
  • the skin sanitizing compositions disclosed also includes a carrier composition.
  • the carrier composition may be water-based and include natural or vegan materials.
  • natural or vegan materials For example, with modem sophisticated consumers, there exists a strong desire and preference to use natural, environmentally friendly materials rather than synthetic- or petroleum-based materials. Accordingly, in preferred embodiments, the carrier composition may consist substantially of or may consist essentially of natural or vegan based materials.
  • typical hand sanitizer formulations use alcohol as the active disinfectant, alcohol has a tendency to dry a user’s skin or cause irritation of pain when applied, particularly if minor abrasions or open wounds are present on the user’s skin.
  • the disclosed sanitizing compositions are preferably substantially free of alcohol (e.g., contains less 5% alcohol) or is completely free of alcohol (e.g., contains no measurable or only trace amounts of alcohol) and consist substantially of or consist essentially of natural or vegan based materials.
  • the carrier composition may include predominately water.
  • Water-based compositions may be particularly useful in the formation of a liquid, gel, or foam thereby allowing for the majority of the composition to evaporate after application.
  • the disclosed compositions that include water may described as the composition including a selected percentage of the listed ingredients with the remainder of the balance being water.
  • the carrier composition may also include one or more optional adjuvants including, but not limited to, one or more antioxidants, buffers, cleansers, emollients, foaming agents, fragrances, emulsifiers, exfoliants, humectants, hydrating agents, lubricants, natural oils, preservatives, surfactants, thickeners, or the like.
  • one or more antioxidants including, but not limited to, one or more antioxidants, buffers, cleansers, emollients, foaming agents, fragrances, emulsifiers, exfoliants, humectants, hydrating agents, lubricants, natural oils, preservatives, surfactants, thickeners, or the like.
  • the disclosed skin sanitizing compositions may include one or more antioxidants and buffers that may help preserve the active ingredients or other adjuvants in the formulation.
  • the buffers preferably help maintain the pH of the composition to be within a non-irritating amount relative to a patient’s skin.
  • Suitable antioxidants may include ascorbic acid or ascorbyl palmitate (vitamin C or a derivative thereof), tocopherol (vitamin E), or the like.
  • Tocopherol is typically derived from vegetable oils and possesses exceptional skin protection properties. For example, tocopherol may be used to absorb UV rays and prevent UV induced free radical damage to the skin as well as prevent other free radical induced damage. Tocopherol has anti-inflammatory properties and helps moisturize the skin.
  • Ascorbyl palmitate is a fat-soluble derivative of ascorbic acid that acts as a free radical scavenger. Unlike the water soluble form (e.g., ascorbic acid), ascorbyl palmitate is able to enter the lipid cell membrane of the skin. Ascorbyl palmitate also supports immune cell activity and helps with the formation and maintenance of collagen within the skin. Tocopherol, ascorbyl palmitate, or ascorbic acid may be produced from natural and vegan- based sources. In preferred embodiments, the skin sanitizing composition includes tocopherol, ascorbyl palmitate, or both.
  • the disclosed skin sanitizing agents may include one or more exfoliants such as glyceryl oleate, or the like.
  • the exfoliant may help remove dead skin cells during application to help promote skin health.
  • the skin sanitizing compositions may include one or more humectants, hydrating agents, or both.
  • Such adjuvants may help moisturize the skin.
  • Humectants in particular tend to pull water from deeper layers of the skin toward the surface to help hydrate the outer layers.
  • Suitable humectants or hydrating agents may include betaine, glycerin, or the like.
  • the skin sanitizing compositions may include one or more surfactants or foaming agents. Such agents may improve the texture of the composition or generate a foam texture upon aeration. Suitable surfactants or foaming agents may include, for example, decyl glucoside, lauryl glucoside, and the like.
  • Anionic surfactants include sodium lauryl sulphate (SLS) or sodium lauryl ether sulphate (SLES); non-ionic surfactants are, e.g., ethoxylated fatty alcohols (Pareth) or alkyl polyglycosides (APG).
  • Another important class of surfactants are the zwitter-ionic betaines (for instance cocamidopropyl betaine, CAPB), which are often used in liquid soaps.
  • the carrier composition may include one or more vitamins A, C, D, E, or K.
  • Preferred vitamins include vitamin A (e.g., retinol or retinol ester), vitamin C (e.g., ascorbyl palmitate or ascorbic acid), and vitamin E (tocopherol).
  • the skin sanitizing composition may also include at least vitamin A (e.g., retinol or retinol ester). The inclusion of retinol in the skin sanitizing composition in conjunction with the other materials disclosed above may be useful for promoting healthy skin.
  • the skin sanitizing composition may be formulated into any suitable type of vehicle including, for example, liquids, creams, foams, gels, ointments, solutions, sprays, or the like.
  • the skin sanitizing composition is formulated into a topical liquid, topical foam, or topical gel. In either instance, the compositions are predominantly composed of a volatile materials (e.g., water) that evaporates upon application.
  • the below examples provide skin sanitizing compositions containing the manuka oil and lactic acid in a carrier composition including other adjuvants.
  • other base carrier compositions or different adjuvants that are not described herein may also be used provided they include the disclose manuka oil and organic acid compositions described herein.
  • the skin sanitizing composition consists substantially or essentially of natural or vegan based materials.
  • the skin sanitizing composition serving as the vehicle for the pharmaceutically active excipients may nevertheless be characterized as consisting substantially or essentially of natural or vegan based materials.
  • the effectiveness of the disclosed skin sanitizing compositions may be determined using any suitable standard.
  • standard tests may include ASTM E2755 - Healthcare Handrub Test Method, which is designed to evaluate how effectively sanitizers inactivate transient bacteria over surfaces of a person’s hands and fingers using a process that simulates bacterial exposure and hand rub use in clinical settings.
  • ASTM E2755 is specifically designed for hand rubs (sanitizers, rinses, sprays, foams, and wipes) that are used without soap and water.
  • ASTM E2755 is conducted using hands of at least eight study participants who have not used antimicrobial products for at least one week prior to the test.
  • the participants’ hands are thoroughly contaminated with a test microorganism (e.g, Staphlylococcus aureus or Serratia marcescens) with a starting baseline number of microorganisms determined.
  • a test microorganism e.g, Staphlylococcus aureus or Serratia marcescens
  • the participants hands are again subject to a cleansing wash and inoculation followed by application of the sanitizer composition to dry contaminated hands and the hands are rubbed thoroughly until the product dries.
  • the activity of the product is determined following a single contamination/antiseptic exposure cycle (simulating occasional use) or after multiple (e.g., ten) contamination/antiseptic exposure cycles (simulating clinical use settings).
  • the multiple application test also helps determine if there is a build-up of non-volatile components on the surface of the hands following repeated use.
  • the effectiveness of the hand rub is determined by comparing the number of microorganisms recovered from contaminated hands after the use of the antiseptic product to the number recovered from contaminated hands that were not exposed to a hand rub product.
  • Compositions exhibiting suitable sanitizing activity may exhibit a reduction of at least about 99% of microorganism recovery or at least about 99.9%.
  • ASTM E2276 methodology which only uses fingerpads for testing but does not include a realistic hand rubbing step
  • ASTM E1053 which is standard practice to assess virucidal activity of compositions intended for disinfection of inanimate, nonporous environmental surfaces.
  • the ASTM E2276 test may be more suitable for situations where the sanitizing composition is applied to the skin in preparation of surgical procedures (e.g., cosmetic surgery) or the like where hand rubbing does not occur.
  • EXAMPLE 1 - Sanitizing Liquid A mixture of the following excipients was prepared to produce a skin sanitizing liquid composition.
  • Example 1 A preparation of the skin sanitizing composition of Example 1 is prepared and tested under against common bacteria. The results of the test is shown in Table 1.
  • Example 2 A preparation of the skin sanitizing composition of Example 1 is prepared and tested under Reed & Muench LD50 Method against MHV-1. The results of the test is shown in Table 2.
  • the MIC test evaluates the lowest concentration of a test substance that prevents growth of the microbe. This is a measure of the antibiotic activity of the test sample.
  • the disclosed skin sanitizing compositions may be tested for MIC using publicly available testing criteria.
  • test samples of the desired active compound can be prepared and serially diluted to give 11 or more different concentrations covering, for example, a 1000-fold range.
  • the test samples may include 50%-0.1% of a stock test sample (e.g., stock samples disclosed in Table 1) that are combined with select bacteria and fungi and incubated over a prescribe period of time.
  • the MIC is useful to determine the lowest concentration of each test sample (mixture of active materials) that inhibits the growth of the microbe as determined by measurement of OD650nm using a Versa Max 96 well plate reader. Measurement of cell concentration can be made at several time points.
  • Example stock sample solutions of active mixture that show promising initial results and may be viable for MIC testing are listed in Table 3.
  • the methodology for growing the different micro-organisms available for evaluation in the MIC studies may be provided by the CLSI standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Approved Standard, Ninth Edition, M07-A9, Vol. 32 No 2, January 2012; Methods for Antimicrobial Susceptibility Testing for Anaerobic Bacteria. Approved Standard, Ninth Edition, Mll-9, January 2018; and Performance Standards for Antifungal Susceptibility Testing of
  • Microorganisms that may be tested include, but are not limited to, Acinetobacter bawnanni; Candida albicans; Co lynebacteriwn diphtheria; Cutibacterium acnes; Enterococcus faecium; Escherichia coli; Proteus vulgans; Pseudomonas aeruginosa; Staphylococcus aureus; Staphylococcus aureus (MRSA); Stapllylococcus capilis; Stapllylococcus epidermidis; Stapllylococcus pseudinlermedius; Streptococcus pyogenes; Tricllophyton menlagrophytes; and Trichophywn rubrum.
  • the samples in Table 3 above show promise against inhibiting growth of one or more of the above microorganisms.
  • Skin formulation compositions of the present disclosure are prepared and tested for evidence of allergic reaction and skin irritation on human skin.
  • the formulations non- allergenic and non-irritating.
  • Skin formulation compositions of the present disclosure are prepared and tested against viruses such as S. aureus, MRSA, S. epidermidis, S. pyogenes, C. acnes, Human alpha herpes virus 1, Human alpha herpes zoster virus attributed to aliments such as cold sores or shingles.
  • viruses such as S. aureus, MRSA, S. epidermidis, S. pyogenes, C. acnes, Human alpha herpes virus 1, Human alpha herpes zoster virus attributed to aliments such as cold sores or shingles.
  • the formulations demonstrate a therapeutic affect in the treatment of cold sores and shingles.
  • Skin formulation compositions of the present disclosure are prepared and tested against various skin ailments including skin aging, collagen production, scarring, UV damage, inflammation, itching, yeast or fungi growth, eczema, and/or psoriasis.
  • the formulations demonstrate a therapeutic affects in the treatment of one or more of the above skin ailments.
  • EXAMPLE 7 Sanitizing Liquid 1L47/65 version] [070] A mixture of the following excipients was prepared to produce a skin sanitizing liquid composition in accordance with the disclosed embodiments and, in one preferable composition, provides triketones from the oils of about 0.66%, Lactic acid of about 0.99% and Palmarosa oil of about 0.34%.
  • a mixture of the following excipients was prepared to produce a skin sanitizing liquid composition in accordance with the disclosed embodiments and, in one preferable composition, provides triketones from the oils of about 1%, Lactic acid of about 0.99% and Palmarosa oil of about 0.34%.

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Abstract

L'invention concerne une composition désinfectante de la peau destinée au traitement d'une affection de la peau, comprenant un mélange d'huile de Leptospermum scoparium (huile de manuka) et d'un acide organique tel que l'acide lactique.
PCT/IB2021/000861 2020-12-09 2021-12-09 Compositions désinfectantes de la peau contenant de l'huile de manuka WO2022123313A1 (fr)

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AU2021396738A AU2021396738A1 (en) 2020-12-09 2021-12-09 Skin sanitizing compositions containing manuka oil

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005200339A (ja) * 2004-01-15 2005-07-28 Takuo Sakai 抗菌剤
US20080247960A1 (en) * 2005-09-16 2008-10-09 Reckitt Benckiser Inc. Foaming Tropical Compositions
WO2012116391A1 (fr) * 2011-02-09 2012-09-07 Lien Wendy Formulation cosmétique ou pharmaceutique

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005200339A (ja) * 2004-01-15 2005-07-28 Takuo Sakai 抗菌剤
US20080247960A1 (en) * 2005-09-16 2008-10-09 Reckitt Benckiser Inc. Foaming Tropical Compositions
WO2012116391A1 (fr) * 2011-02-09 2012-09-07 Lien Wendy Formulation cosmétique ou pharmaceutique

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