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
  • A61K8/18—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
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q19/00—Preparations for care of the skin

Definitions

• a Topical Composition Comprising Saccharide Isomerate for Microbiome
• the present invention relates to a topical composition comprising saccharide isomerate for use as a prebiotic.
• Skin is the outermost protective covering of living beings and is the largest organ in the body. It acts as a barrier and protects the body from external factors. For example, skin prevents entry of harmful or potentially harmful microbes e.g. bacteria, fungi and viruses, from entering the body thereby preventing infection and/or other ill effects that may be caused.
• harmful or potentially harmful microbes e.g. bacteria, fungi and viruses
• microbiome e.g. bacteria, fungi, viruses, archaea
• skin microbiome comprises bacteria that provide a benefit to the host (referred to as commensals or good bugs) e.g.
• Staphylococcus epidermidis S. epidermidis
• harmful or potentially harmful bacteria e.g. Staphylococcus aureus (S. aureus) and Pseudomonas aeruginosa (P. aeruginosa).
• Bacteria like S. aureus and P. aeruginosa are not harmful whilst being present on the skin perse.
• Flowever upon entry in to the human body through e.g. ingestion and through cuts in the skin, these bacteria may become harmful.
• skin microbiome comprises both, good as well as bad bugs.
• a disruption in the balance between the good and the bad bugs is an opportunity when a disease can set in. Therefore, obtaining and maintaining microbiome balancing, i.e. maintaining a surface of the human body, e.g. skin, in healthy and infection free condition, is often desired by people.
• Microbiome balancing may be achieved e.g. by reducing bad bugs through an application of topical compositions comprising one or more antimicrobial compounds.
• topical compositions comprising one or more antimicrobial compounds.
• antimicrobial compounds if not all; contained in such topical compositions, do not work in a selective manner. In other words, antimicrobial compounds do not selectively act only against bad bugs but they also act on good bugs. Thus, usage of such topical compositions often leads to depletion in number of good bugs which is not desired.
• keratinocytes one of the major cell types that is abundantly present in a surface of the human body, e.g. skin, are known to secrete antimicrobial peptides (natural defense system) which primes skin against an attack from bad bugs.
• Microbiome balancing may also be achieved by way of utilizing a prebiotic that promotes growth of good bugs over bad bugs. Usage of a prebiotic thus leads to increase in benefits obtained from good bugs. Good bugs are said to provide benefit to their host through e.g. competing with bad bugs for availability of nutrients and through secretion of metabolites.
• WO2017/201296 discloses compositions and methods for treating acne vulgaris and cites glycerol, maltose, lactose as prebiotic compounds.
• WO 01/70189 (Unilever, 2001 )
• US5858997 (Unilever, 1999)
• WO 97/47280 (Unilever, 1997) relate to methods and composition for skin lightening that comprises saccharide isomerate.
• WO 97/30690 (Unilever, 1997) discloses skin treatment composition comprising 1 % saccharide isomerate.
• US5486352 (Unilever, 1996) discloses sunscreen composition comprising 0.2% saccharide isomerate.
• EP 0 545 716 discloses a two-phase clear-opaque toilet bar composition
• pentavitin saccharide isomerate commercially available from DSM as a moisturizing agent under trade name Pentavitin ® ) wherein it is disclosed as skin treatment active material.
• ZA980040 (Elma Mckenzie) discloses a cosmetic skin treatment composition.
• ZA980040 discloses the cosmetic skin treatment composition that includes 4% saccharide isomerate acting as the keratin binding complex.
• W02017/019612 discloses methods and compositions useful for application to skin and hair comprising hydrolyzed algae extract, saccharide isomerate, and a dermatologically acceptable vehicle wherein the composition or method is capable of moisturizing and/or improving the appearance and/or condition of skin and/or hair.
• WO2015/175536 provides compositions and methods for improving human health and nutrition.
• prebiotics e.g. inulin, fructo-oligosaccharides and gluco-oligosaccharide.
• WO2015175536 in an example therein, describes a deep moisturizer cream that comprises Microbiotic CompositesTM along with other ingredients including saccharide isomerate.
• a topical composition comprising saccharide isomerate when applied on a surface of the human body, provides microbiome balancing. It has also been found that the microbiome balancing so obtained is by way of saccharide isomerate functioning as a prebiotic, i.e. it preferentially promotes growth of good bugs over bad bags.
• the benefit of microbiome balancing could take place through various mechanisms and it is not necessary that every substance that provides microbiome balancing does so by way of the substance being a prebiotic.
• the invention in the present application is by way of a finding that saccharide isomerate behaves as a prebiotic which, to the knowledge of the present inventors, has not been known heretofore.
• the present invention relates to use of a topical composition comprising saccharide isomerate as a prebiotic when applied on a surface of the human body.
• microbiome balancing preferably means maintaining a surface of the human body e.g. skin, scalp including hairs, axilla and oral cavity, in healthy and infection free condition.
• Microbiome balancing is obtained by way of saccharide isomerate functioning as a prebiotic, i.e. preferentially promoting growth of good bugs over bad bugs, on a surface of the human body.
• the present invention relates to a topical composition
• saccharide isomerate for use in providing microbiome balancing when applied on a surface of the human body.
• composition comprising saccharide isomerate provides microbiome balancing.
• Saccharide isomerate functioning as a prebiotic. Saccharide isomerate is found to preferentially promote growth of good bugs, e.g. S. epidermidis over growth of bad bugs e.g. S. aureus. Thus, it has also been found that saccharide isomerate functions as a prebiotic.
• the composition comprises saccharide isomerate in amounts from 0.001 to 10 wt%, more preferably from 0.01 to 8 wt%, even more preferably from 0.1 to 7 wt%, further more preferably from 0.1 to 5 wt% and still more preferably from 0.1 to 3 wt%.
• Saccharide isomerate is commercially available under trade name‘Pentavitin ® ’ (from DSM), under trade name Waterin (from Clariant), under trade names ‘EPS3 Powder’,‘EPS4 Powder’,‘EPS5 Powder’ and‘EPS15 Powder’ (all from Codif) and under trade name‘Hyanify’ (from Lipotec S.A.).
• the composition further comprises an additional prebiotic selected from polyols, monosaccharides, disaccharides, oligosaccharides,
• polysaccharides and mixtures thereof examples include glycerol, sugar alcohols e.g. maltitol, sorbitol, xylitol, erythritol and isomalt and mixtures thereof.
• monosaccharide examples include glucose, fructose, galactose and mixtures thereof.
• Examples of disaccharides that may be used as an additional prebiotic include sucrose, maltose, lactose and mixtures thereof.
• Examples of oligosaccharides that may be used as an additional prebiotic include fructo-oligosaccharides, gluco-oligosaccharide and mixtures thereof.
• Examples of polysaccharides that may be used as an additional prebiotic include inulin.
• an additional prebiotic may be present in the composition preferably from 0.001 to 10 wt%, more preferably from 0.01 to 8 wt%, even more preferably from 0.1 to 7 wt%, further more preferably from 0.1 to 5 wt% and still more preferably from 0.1 to 3 wt%.
• an additional prebiotic may be present in the composition, it may be present in a ratio preferably from 20:1 to 1 :20 to saccharide isomerate, more preferably from 10:1 to 1 :10, even more preferably from 5:1 to 1 :5, further more preferably from 2:1 to 1 :2 and still more preferably in ratio 1 :1 to saccharide isomerate.
• a topical composition according to the first aspect provides microbiome balancing when applied on a surface of the human body.
• a surface of the human body is at least one of skin, scalp including hairs, axilla and oral cavity.
• the present invention relates to use of a topical composition comprising saccharide isomerate for microbiome balancing when applied on a surface of the human body.
• Microbiome balancing is obtained by way of use of a topical composition comprising saccharide isomerate on a surface of the human body.
• a surface of the human body is at least one of skin, scalp including hairs, axilla and oral cavity.
• the use according to this aspect can be therapeutic or non-therapeutic.
• the use is non-therapeutic, including cosmetic.
• the present invention relates to use of a topical composition comprising saccharide isomerate as a prebiotic.
• a topical composition comprising saccharide isomerate is applied on a surface of the human body, it is found to preferentially promote growth of good bugs e.g. S. epidermidis over growth of bad bugs e.g. S. aureus.
• a surface of the human body is at least one of skin, scalp including hairs, axilla and oral cavity.
• the use according to this aspect can be therapeutic or non-therapeutic.
• the use is non-therapeutic, including cosmetic.
• the present invention relates to use of topical a composition comprising saccharide isomerate for improving natural -defense system of a surface of the human body by way of microbiome balancing.
• a surface of the human body is at least one of skin, scalp including hairs, axilla and oral cavity.
• the use according to this aspect can be therapeutic or non-therapeutic.
• the use is non-therapeutic, including cosmetic.
• the present invention relates to a method of improving natural-defense system of a surface of the human body by way of microbiome balancing comprising the step of applying the composition according to the first aspect to the surface of the human body.
• a surface of the human body is at least one of skin, scalp including hairs, axilla and oral cavity.
• the method according to this aspect can be therapeutic or non- therapeutic.
• the method is non-therapeutic, including cosmetic.
• the composition comprises a cosmetically acceptable base.
• ingredients that may be used as cosmetically acceptable base includes water, fatty acids, soaps (salts of fatty acids), alcohols and mixtures thereof.
• the composition comprises water in an amount from 1 to 99 wt%, more preferably from 5 to 90 wt%, even more preferably from 35 to 80 wt% and further more preferably from 40 to 75 wt%.
• alcohols that may be used as cosmetically acceptable base include the alcohol having straight or branched chain of carbon atoms preferably containing from 1 to 16, more preferably from 2 to 10, even more preferably from 3 to 8 carbon atoms.
• alcohol is selected from ethyl alcohol, isopropyl alcohol and mixtures thereof.
• the composition comprises alcohols in amount ranging preferably from 0.1 to 80 wt%, more preferably from 0.1 to 65 wt%, even more preferably from 1 to 50 wt% and further more preferably from 5 to 30 wt%.
• fatty acids include lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid and mixtures thereof.
• the most preferred fatty acid is stearic acid.
• the fatty acid may also be hystric acid which is substantially (generally about 90 to 95%) a mixture of stearic acid and palmitic acid in a ratio of between 55:45 to 45:55.
• cosmetically acceptable base comprises from 1 to 25 wt%, more preferably from 3 to 22 wt%, even more preferably from 5 to 20 wt% and still more preferably from 6 to 18 wt% fatty acid.
• Soap may be formed in-situ by addition of alkaline agents e.g. sodium
• hydroxide or potassium hydroxide may be added externally to the
• composition when potassium hydroxide is added to cosmetically acceptable base comprising stearic acid, potassium stearate thus formed, is understood to be the soap formed in-situ which forms a part of cosmetically acceptable base.
• the composition comprises from 0.1 to 10 wt%, more preferably from 0.1 to 7 wt% even more preferably from 0.1 to 3 wt% soap.
• the composition is preferably in the form of a wash-off or a leave-on
• Leave-on composition preferably means a composition which is not required to be removed from the human body after the application of said composition.
• the composition may be in the form of a deodorant (stick, roll-on or spray), a hand sanitizer, a body lotion, a skin cream and a body spray.
• composition is in the form of a skin cream
• a vanishing cream base that generally comprises from 5 to 25 wt% fatty acid and from 0.1 to 10 wt% soap and from 60 to 80 wt% water as the cosmetically acceptable base, is preferred. Vanishing cream base gives a highly appreciated matt feel to the skin.
• the composition may preferably comprise a conventional deodorant base as the cosmetically acceptable base.
• a deodorant is meant a product in the stick, roll-on, or propellant medium which is used for personal deodorant benefit e.g. application in axilla, the under-arm area, which may or may not contain anti-perspirant actives.
• Deodorant compositions can generally be in the form of firm solids, soft solids, gels, creams, and liquids and are dispensed using applicators appropriate to the physical characteristics of the composition.
• Deodorant compositions which are delivered through roll-ons generally comprise a liquid carrier.
• Such liquid carrier can be hydrophobic or comprise a mixture of both hydrophilic and hydrophobic liquids. They may be in the form of an emulsion or a microemulsion.
• the liquid carrier or mixture of carriers often constitutes from 30 to 95 wt% and in many instances from 40 to 80 wt%.
• Hydrophobic liquid carriers commonly can comprise one or more materials selected within the chemical classes of siloxanes, hydrocarbons, branched aliphatic alcohols, esters and ethers that have a melting point not higher than 25°C and a boiling point of at least 100°C.
• Hydrophilic carrier liquids that can be employed in compositions herein commonly comprise water and/or a mono or polyhydric alcohol or water- miscible homologue.
• Polyhydric alcohols commonly comprise ethylene or propylene glycol, or a homologue can be employed such as diethylene glycol. Other than this suitable other vehicle and component used for deodorant composition can be added.
• Wash-off composition preferably means a composition which is
• a cosmetically acceptable base preferably further comprises a surfactant.
• the cosmetically acceptable base preferably comprises an anionic surfactant e.g. an alkyl sulphate and/or ethoxylated alkyl sulfate surfactant.
• anionic surfactants are preferably present at a level of from 1 to 20 wt%, more preferably from 2 to 16 wt%, even more preferably from 3 to 16 wt%.
• Preferred alkyl sulfates are C8-18 alky sulfates, more preferably C12-18 alkyl sulfates, preferably in the form of a salt with a solubilizing cation such as sodium, potassium, ammonium or substituted ammonium.
• the composition further comprises one or more skin lightening agents.
• skin lightening agents may be selected from niacinamide, resorcinol, phenylethyl resorcinol, 4-alkyl substituted resorcinol e.g.
• 12- hydroxystearic acid is used as a skin lightening agent and not as a fatty acid.
• skin lightening agents that may be used in the composition are niacinamide, resorcinol, phenylethyl resorcinol, 4-alkyl substituted resorcinol e.g. 4-ethyl resorcinol, 4- isopropyl resorcinol and 4-hexyl resorcinol, vitamin B6, 12-hydroxystearic acid, glutathione precursors, galardin and mixtures thereof.
• a skin lightening agent may be added in an amount preferably from 0.001 to 15 wt%, more preferably from 0.01 to 10 wt%, even more preferably from 0.1 to 5 wt% and further more preferably from 0.5 to 3 wt%, in the composition.
• the composition further comprises preservatives to prevent the growth of potentially harmful microorganisms in the composition.
• preservatives examples include alkyl esters of para-hydroxybenzoic acid, hydantoin derivatives, propionate salts, and a variety of quaternary ammonium compounds.
• ingredients that may be used as preservative in the composition are sodium benzoate, iodopropynyl butyl carbamate, methylisothiazolinone, phenoxyethanol, methyl paraben, propyl paraben, imidazolidinyl urea, sodium dehydroacetate, ethylhexylglycerin, benzyl alcohol, alkane diols and mixtures thereof.
• the alkane diols that are suitable for use as preservative are C6-C12 alkanes that are vicinally substituted with hydroxy groups.
• Illustrative examples include 1 ,2- octane diol (caprylyl glycol), 2,3-octane diol, 1 ,2-nonane diol, 1 ,2-decane diol, 1 ,2-hexane diol, 3,4-octane diol, mixtures thereof or the like where caprylyl glycol is typically the most preferred.
• preservatives are added preferably in an amount from 0.001 to 5 wt%, more preferably from 0.01 to 3 wt% and most preferably from 0.02 to 2 wt%.
• the composition further comprises a range of other optional ingredients that include antioxidants, binders, biological additives, buffering agents, colorants, astringents, fragrance, opacifying agents, conditioners, exfoliating agents, pH adjusters, natural extracts, skin sensates, skin soothing agents, emollients, solvents and skin healing agents.
• antioxidants binders, biological additives, buffering agents, colorants, astringents, fragrance, opacifying agents, conditioners, exfoliating agents, pH adjusters, natural extracts, skin sensates, skin soothing agents, emollients, solvents and skin healing agents.
• the composition is formulated in the form of a powder, flake, lotion, cream, gel or mousse. More preferably, the composition is formulated in the form of cream or lotion and most preferably in the form of cream.
• composition is preferably of leave-on type.
• the packaging for the composition of this invention can be a patch, bottle, tube, roll-ball applicator, propellant driven aerosol device, squeeze container or lidded jar.
• S. epidermidis ATCC 12228
• S. aureus ATCC 6538
• P. aeruginosa ATCC 15442
• TTB Tryptic soy broth
• Example 1 Saccharide Isomerate preferentially promotes growth of a good bug e.q. S. epidermidis over a bad bug e.q. S. aureus.
• S. aureus and S. epidermidis were grown in TSB in presence or absence of 2% saccharide isomerate for 24 h at 37°C. At the end of incubation, optical density at 620 nm was recorded for all the test samples. The ratio of growth of the bacteria in presence and absence of saccharide isomerate was found to be as given below:
• saccharide isomerate preferentially supports growth of S. epidermidis over S. aureus. Saccharide isomerate thus functions as a prebiotic thereby providing microbiome balancing.
• test samples were prepared in a 96-well plate and the plate was incubated at 37°C in a plate reader for 24 h.
• optical density was recorded at an interval of every 1 h and; was found to be as shown in table 2A below:
• Table 2A S. epidermidis ferment against S. epidermidis
• test samples were prepared in a 96-well plate and the plate was incubated at 37°C in a plate reader for 24 h.
• optical density was recorded at an interval of every 1 h and; was found to be as shown in table 2B below:
• Table 2B S. epidermidis ferment against S. aureus
• epidermidis in presence of 1 % saccharide isomerate inhibits growth of S. aureus as compared to ferment A (obtained from S. epidermidis in absence of saccharide isomerate).
• test samples were prepared in a 96-well plate and the plate was incubated at 37°C in a plate reader for 24 h.
• ferment B obtained from S. epidermidis in presence of 1 % saccharide isomerate
• ferment A obtained from S. epidermidis in absence of saccharide isomerate
• epidermidis obtained upon fermentation of saccharide isomerate comprises one or more metabolites secreted by S. epidermidis that leads to inhibition of harmful/ potentially harmful bacteria e.g. S. aureus and P. aeruginosa but not S. epidermidis (a commensal) itself.
• Example 3 Identification of metabolite produced in fermentation of saccharide isomerate by S. epidermidis.
• Metabolites produced in fermentation of saccharide isomerate by S. epidermidis were identified using gas chromatography.
• the oven temperature was programmed with an initial temperature of 40°C hold for 2 min; and raised the temperature to 250°C at the ramp of 10°C per minute which was held for 10 min.
• GCMS was used for the analysis of the actives and the compounds were identified using NIST library match.
• the mass source temperature was maintained at 200°C with a scan in the range 40 to 500 m/z.
• Helium was used as a carrier gas and a split less mode of injection was used for this study.
• the major metabolite that was produced in fermentation of saccharide isomerate by S. epidermidis was identified to be lactic acid.
• Example 4 Dose dependent increase in lactic production in fermentation of saccharide isomerate.
• TSB in absence or presence of saccharide isomerate in amounts shown in table below was incubated at 37°C for 24 h under aerobic conditions. At the end of incubation, the test samples were assayed for lactic acid content using gas chromatography as described above.
• Example 5 In vivo study to demonstrate lactic acid production upon
• Example 6 Hand sanitizer composition comprising saccharide isomerate
• Example 7 A vanishing cream composition comprising saccharide isomerate
• a topical composition comprising saccharide isomerate provides microbiome balancing when applied on a surface of the human body.
• the microbiome balancing so obtained is found to be by way of saccharide isomerate functioning as a prebiotic.
• Saccharide isomerate preferentially promoted growth of commensal bacteria e.g. S. epidermidis over harmful/potentially harmful bacteria e.g. S. aureus.
• the major metabolite in fermentation of saccharide isomerate is found to be lactic acid that contributes to natural defence system of a surface of the human body e.g. skin, scalp including hairs, axilla and oral cavity.

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• 2019
  • 2019-08-19 CN CN201980059378.XA patent/CN112672728B/zh active Active
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