Use of starch or its microbial metabolite for delivering personal care benefits

Abstract

The present invention relates to delivering benefits related to maintaining a resilient microbiome on skin through a personal care composition, especially through wash off compositions like soap, body wash or shampoo. This is achieved by using starch or its microbial metabolite preferably in such compositions. It works by upregulating expression levels of Aquaporin-3, Claudin 1, Keratin- 4, Filaggrin- 1 or Desmoglein 1 on skin.

Description

[0001] P0001071 CPL

[0002] 1

[0003] USE OF STARCH OR ITS MICROBIAL METABOLITE FOR DELIVERING PERSONAL CARE BENEFITS

[0004] Field of the Invention

[0005] 5 The present invention relates to delivering benefits related to maintaining resilient microbiome on skin through a personal care composition, especially through wash off compositions like soap, body wash or shampoo.

[0006] Background of the Invention

[0007] Skin is the primary line of defense that protects the human body from invading pathogens, like viruses and bacteria. As a primary defense organ, the skin tissue always remains in constant contact with the environment and therefore it has to face and resolve threats and challenges from invading pathogens and environmental allergens. The exposed skin surface is not only challenged by such foreign bodies, but it also remains in contact and interacts with the resident

[0008] 15 commensal bacteria.

[0009] The consortium of resident commensal bacterial in its normal state is known as a state of balanced microbiome. Various external stimuli like invading microorganisms, pollution, allergens, sunlight etc. can disturb the state of balanced microbiome. The present inventors have been

[0010] 20 working on delivering technologies where the microbiome continues to remain in a balanced state even under such high external disturbances for ensuring that consumers enjoy the benefits of healthy skin. During the course of their extensive experimentation, they have found that use of starch or its microbial metabolite in itself or when used in a personal care compositions including wash off compositions, can upregulate certain genes that deliver this benefit. This leads to

[0011] 25 delivery of many end benefits to skin.

[0012] It is thus an object of the present invention to deliver benefits related to delivering antipigmentation response, ensuring resilient skin or resilient microbiome on skin, through use of personal care or cleansing compositions.

[0013] Summary of the Invention

[0014] The first aspect of the present invention relates to use of starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch or its microbial metabolite for upregulating expression levels of Aquaporin-3 , Claudin 1 , Keratin-4,

[0015] 35 Filaggrin-1 or Desmoglein 1 on skin for providing benefits like delivering anti-pigmentation response, ensuring resilient skin, or resilient microbiome on skin. P0001071 CPL

[0016] 2

[0017] A preferred aspect of the present invention relates to use as claimed in the first aspect wherein the starch or its microbial metabolite is present in a personal care composition.

[0018] Detailed Description of the Invention

[0019] 5 Except in the examples, or where otherwise explicitly indicated, all numbers in this description indicating amounts of material or conditions of reaction, physical properties of materials and / or use may optionally be understood as modified by the word “about”.

[0020] All amounts are by weight of the composition, unless otherwise specified.

[0021] It should be noted that in specifying any range of values, any particular upper value can be associated with any particular lower value.

[0022] For the avoidance of doubt, the word “comprising” is intended to mean “including” but not

[0023] 15 necessarily “consisting of” or “composed of”. In other words, the listed steps or options need not be exhaustive.

[0024] The disclosure of the invention as found herein is to be considered to cover all embodiments as found in the claims as being multiply dependent upon each other irrespective of the fact that

[0025] 20 claims may be found without multiple dependency or redundancy.

[0026] Where a feature is disclosed with respect to a particular aspect of the invention (for example a composition of the invention), such disclosure is also to be considered to apply to any other aspect of the invention (for example a method of the invention) mutatis mutandis.

[0027] 25

[0028] The present invention relates to use of starch or its microbial metabolite for upregulating expression levels of Aquaporin-3, Claudin 1 , Keratin-4, Filaggrin-1 or Desmoglein 1 on skin. This leads to various benefits as given below:

[0029] Anti-pigmentation response: By upregulating the genes targeted, it is possible to regulate melanogenesis in melanocytes and melanosome degradation in keratinocytes thereby leading to improved anti-pigmentation response.

[0030] Durable or resilient skin: Durable or resilient skin is not merely a superficial attribute but a

[0031] 35 reflection of the underlying health and stability of our skin's microbiome. This resilience is P0001071 CPL

[0032] 3 achieved through a well-maintained balance of microorganisms that protect against harmful pathogens, reduce inflammation, retain moisture, and enhance overall skin appearance. The importance of a stable and resilient microbiome cannot be overstated, as it ensures that the skin remains capable of recovering from various environmental stresses. In essence, the durability of

[0033] 5 our skin is intrinsically linked to the harmony and balance of its microbiome, safeguarding our skin's health and vitality.

[0034] Resilient microbiome on skin: The term "resilient microbiome on skin" refers to the strong and adaptive community of microorganisms that inhabit our skin. These microorganisms form a balanced ecosystem that plays a crucial role in maintaining the skin's health and appearance. A resilient microbiome means that this ecosystem can withstand and recover from various environmental stresses, such as pollution, UV radiation, and harsh weather conditions. The resilience of the skin microbiome is achieved by maintaining a diverse and balanced population of beneficial bacteria, fungi, and viruses. These microorganisms work together to protect the skin

[0035] 15 from harmful pathogens, reduce inflammation, retain moisture, and enhance the overall skin barrier. When the microbiome is resilient, it ensures that the skin remains healthy, hydrated, and capable of healing itself effectively. In essence, a resilient microbiome on the skin acts as a protective shield, safeguarding our skin's health and vitality by maintaining harmony and balance within its microbial community.

[0036] 20

[0037] The invention relates to the use of starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch or its microbial metabolite for upregulating expression levels of Aquaporin-3 , Claudin 1 , Keratin-4, Filaggrin-1 or Desmoglein 1 on skin. This use provides one or more benefit selected from: delivering anti-pigmentation response, ensuring resilient skin, or resilient microbiome on skin.

[0038] Starch as used herein refers to component selected from the group consisting of native starch, modified starch and combinations thereof. The term “native starch” as used herein refers to a starch that has been isolated from a natural plant source and that has not been hydrolyzed or

[0039] 30 chemically modified. The term “modified starch” as used herein refers to a starch that has been chemically modified, preferably by esterification.

[0040] Preferably the starch comprises native starch and more preferably is native starch. Preferably, the native starch is selected from potato starch, tapioca starch, maize starch, corn starch or P0001071 CPL

[0041] 4 sweet potato starch. More preferably the native starch is maize starch which is also known as corn starch.

[0042] Preferably the modified starch comprises hydroxyalkylated starch, carboxyalkylated starch,

[0043] 5 succinated starch, or a mixture thereof. More preferably the modified starch comprises hydroxypropylated starch, hydroxyethylated starch, carboxymethylated starch, octenylsuccinated starches, dodecylsuccinated starch or a mixture thereof.

[0044] Preferably, the starch of the present invention has a molar ratio of amylose to amylopectin of from

[0045] 10 1 :99 to 99:1 , more preferably 20:80 to 80:20, even more preferably 20:80 to 30:70. Preferably, the native starch of the present invention has a molar ratio of amylose to amylopectin is from 1 :99 to 99:1 , more preferably 20:80 to 80:20, even more preferably 20:80 to 30:70.

[0046] Preferably, the starch has a bulk density of 200 to 1000 g / L, more preferably 300 to 800 g / L and

[0047] 15 even more preferably 400 to 600 g / L. Preferably, the native starch has a bulk density of 200 to 1000 g / L, more preferably 300 to 800 g / L and even more preferably 400 to 600 g / L.

[0048] Preferably, the starch has a weight average molecular weight of at least 1 KDa, more preferably at least 10 KDa and even more preferably at least 100 KDa. Preferably, the starch has a weight

[0049] 20 average molecular weight of no greater than 100,000,000 KDa, more preferably no greater than 10,000,000 KDa and even more preferably no greater than 1 ,000,000 KDa. Preferably, the native starch has a weight average molecular weight of at least 1 KDa, more preferably at least 10 KDa and even more preferably at least 100 KDa. Preferably, the starch has a weight average molecular weight of no greater than 100,000,000 KDa, more preferably no greater than

[0050] 25 10,000,000 KDa and even more preferably no greater than 1 ,000,000 KDa.

[0051] The use as per the invention could also relate to microbial metabolite of starch for upregulating expression levels of Aquaporin-3, Claudin 1 , Keratin-4, Filaggrin- 1 or Desmoglein 1 on skin. The microbial metabolite of starch is selected from one or more of cyclodextrin, dextrin, glycogen,

[0052] 30 dextran, d-glucose, isomaltose and a-maltose. There are preferably generated in situ on skin due to resident bacteria like Finegoldia magna, Anaerococcus octavius, Anaerococcus prevotii, Cutibacterium acnes, Corynebacterium jeikeium, or Candida parapsilosis.

[0053] The use as per the present invention provides benefits to skin like delivering anti-pigmentation

[0054] 35 response, ensuring resilient skin, or resilient microbiome on skin. P0001071 CPL

[0055] 5

[0056] The starch or its microbial metabolite is preferably included in a personal care composition. The composition of the present invention may be a skin cleansing composition, a skin care composition, a hair care composition, an oral care composition, or a deodorant composition. The composition may be in the form of a solid, soft solid, liquid, emulsion, microemulsion, lotion, cream,

[0057] 5 gel, or aerosol forms.

[0058] Preferably, the starch or its microbial metabolite is present in an amount of 0.0001 to 45% by weight of the composition. More preferably, it is present in amount of 0.001 to 30% by weight of the composition and even more preferably 0.005 to 20% by weight of composition.

[0059] 10

[0060] When the composition is formulated as a personal cleansing composition, the composition preferably comprises a cleansing surfactant, preferably in 1 to 80% by weight of the composition. More than one cleansing surfactant may be included in the composition. The cleaning surfactant may be chosen from soap, non-soap anionic, cationic, non-ionic, amphoteric surfactant and

[0061] 15 mixtures thereof. Many suitable surface-active compounds are available and are fully described in the literature, for example, in "Surface-Active Agents and Detergents", Volumes I and II, by Schwartz, Perry and Berch. The preferred surface-active compounds that can be used are soaps, non-soap anionic, non-ionic surfactant, amphoteric surfactant or a mixture thereof.

[0062] 20 Suitable non-soap anionic surfactants include linear alkylbenzene sulphonate, primary and secondary alkyl sulphates, particularly Cs to C15 primary alkyl sulphates; alkyl ether sulphates; olefin sulphonates; alkyl xylene sulphonates; dialkyl sulphosuccinates; fatty acid ester sulphonates; or a mixture thereof. Sodium salts are generally preferred.

[0063] 25 Most preferred non-soap anionic surfactant are linear alkylbenzene sulphonate, particularly linear alkylbenzene sulphonates having an alkyl chain length of from Cs to C15. It is preferred if the level of linear alkylbenzene sulphonate is from 0 wt% to 30 wt%, more preferably from 1 wt% to 25 wt%, most preferably from 2 wt% to 15 wt%, by weight of the total composition.

[0064] 30 Nonionic surfactants that may be used include the primary and secondary alcohol ethoxylates, especially the Cs to C20 aliphatic alcohols ethoxylated with an average of from 1 to 20 moles of ethylene oxide per mole of alcohol, and more especially the C10 to C15 primary and secondary aliphatic alcohols ethoxylated with an average of from 1 to 10 moles of ethylene oxide per mole of alcohol. Non ethoxylated nonionic surfactants include alkylpolyglycosides, glycerol

[0065] 35 monoethers, and polyhydroxyamides (glucamide). It is preferred that the level of non-ionic P0001071 CPL

[0066] 6 surfactant is from 0 wt% to 30 wt%, preferably from 1 wt% to 25 wt%, most preferably from 2 wt% to 15 wt%, by weight of the composition.

[0067] Suitable amphoteric surfactants preferably are betaine surfactants. Examples of suitable

[0068] 5 amphoteric surfactants include, but are not limited to, alkyl betaines, alkylamido betaines, alkyl sulfobetaines, alkyl sultaines and alkylamido sultaines; preferably, those having 8 to 18 carbons in the alkyl and acyl group. It is preferred that the amount of the amphoteric surfactant is 0 to 20 wt%, more preferably from 1 to 10 wt%, by weight of the composition.

[0069] It is also possible to include certain mono-alkyl cationic surfactants. Cationic surfactants that may be used include quaternary ammonium salts of the general formula R1R2R3R4N+X' wherein the R groups are long or short hydrocarbon chains, typically alkyl, hydroxyalkyl or ethoxylated alkyl groups, and X is a counter-ion (for example, compounds in which R1is a C8-C22 alkyl group, preferably a Cs-C or C12-C14 alkyl group, R2is a methyl group, and R3and R4, which may be the

[0070] 15 same or different, are methyl or hydroxyethyl groups); and cationic esters (for example, choline esters).

[0071] The composition may comprise soap. The soap is preferably a C8-C24 soap, more preferably C10- C20 soap and most preferably C12-C18 soap. The cation of the soap can be alkali metal, alkaline

[0072] 20 earth metal or ammonium. Preferably, the cation of the soap is selected from sodium, potassium or ammonium. More preferably the cation of the soap is sodium or potassium. Fatty acids derived from other suitable oils / fats such as groundnut, soybean, tallow, palm, palm kernel, etc. may also be used in other desired proportions. Soap is preferably present in an amount of 1 to 90%, preferably from 10 to 85%, more preferably 25 to 75% by weight of the composition. The

[0073] 25 composition is preferably in the form of a solid or semi solid form, more preferably in a solid form. Even more preferably the composition is a soap bar. Preferably, the composition is a skin cleansing composition. When water is present, it is preferably present in an amount of at least 1%, more preferably at least 2%, even more preferably at least 5% by weight of the composition. When water is the carrier, a preferred composition comprises 10 to 50%, more preferably 12 to 40% by weight water. Starch or native starch may be present from 5 to 45%, more preferably from 8 to 40% and most preferably from 10 to 35% by weight of the composition.

[0074] Water-soluble skin benefit agents may optionally be formulated into the compositions of the invention. A variety of water-soluble skin benefit agents can be used, and the level can be from

[0075] 35 0.1 to 50% but preferably from 1 to 30% by weight of the composition. These materials include, P0001071 CPL

[0076] 7 but are not limited to, polyhydroxy alcohols. Preferred water-soluble skin benefit agents are glycerin, sorbitol and polyethylene glycol.

[0077] Water-insoluble skin benefit agents may also be formulated into the compositions as conditioners

[0078] 5 and moisturizers. Examples include silicone oils; hydrocarbons such as liquid paraffins, petrolatum, microcrystalline wax, and mineral oil; and vegetable triglycerides such as sunflower seed and cottonseed oils.

[0079] Some compositions may include thickeners. These may be selected from cellulosics, natural

[0080] 10 gums and acrylic polymers but not limited by this thickening agent types. Among the cellulosics are sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose and combinations thereof. Suitable gums include xanthan, pectin, karaya, agar, alginate gums and combinations thereof. Among the acrylic thickeners are homopolymers and copolymers of acrylic and methacrylic acids including carbomers such as Carbopol 1382, Carbopol 982, llltrez, Aqua

[0081] 15 SF-1 and Aqua SF-2 available from the Lubrizol Corporation. Amounts of thickener may range from 0.01 to 3% by weight of the active polymer (outside of solvent or water) in the compositions.

[0082] Preservatives can desirably be incorporated into the compositions of this invention to protect against the growth of potentially harmful microorganisms. Particularly preferred preservatives

[0083] 20 are phenoxyethanol, methyl paraben, propyl paraben, imidazolidinyl urea, sodium dehydroacetate and benzyl alcohol. The preservatives should be selected having regard for the use of the composition and possible incompatibilities between the preservatives and other ingredients. Preservatives are preferably employed in amounts ranging from 0.01 % to 2% by weight of the composition.

[0084] 25

[0085] Preferably the composition comprises water in an amount of at least 5% by weight of the composition, more preferably at least 25%, even more preferably 40 to 90% and still even more preferably at least 60 to 85% by weight of the composition.

[0086] 30 The cosmetic composition refers to a composition suitable for topical application to human skin, preferably is a rinse-off product. The term "rinse-off" as used with reference to compositions herein means a composition that is applied to or rubbed on the skin, and then washed off. Typically, the use is on desired skin surface. The term "skin" as used herein may include the skin on the face, scalp, neck, chest, abdomen, back, arms, under arms, hands, oral cavity, body and / or

[0087] 35 legs. P0001071 CPL

[0088] 8

[0089] For sake of clarity, the composition comprises starch or its microbial metabolite which typically provides a greater benefit selected from delivering anti-pigmentation response, or ensuring resilient skin, or resilient microbiome on skin as compared to same composition which comprises no starch or its microbial metabolite.

[0090] 5

[0091] The present invention also provides starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch, its microbial metabolite or a personal care composition comprising it for use in providing benefit like delivering antipigmentation responseor ensuring resilient skin, or resilient microbiome on skin by way of upregulating expression levels of Aquaporin-3 , Claudin 1 , Keratin-4, Filaggrin-1 or Desmoglein 1 on skin.

[0092] The present invention also provides use of starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch or its microbial metabolite

[0093] 15 for the manufacture of a medicament for providing benefit like delivering anti-pigmentation response, ensuring resilient skin, or resilient microbiome on skin comprising a step of topically applying to skin a composition comprising starch or its microbial metabolite by way of upregulating expression levels of Aquaporin-3 , Claudin 1 , Keratin-4, Filaggrin-1 or Desmoglein 1 on skin.

[0094] 20 The present invention also relates to a method for providing benefit like delivering antipigmentation response ensuring resilient skin, or resilient microbiome on skin by way of upregulating expression levels of Aquaporin-3 , Claudin 1 , Keratin-4, Filaggrin-1 or Desmoglein 1 on skin comprising a step of topically applying to skin a composition comprising starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch or its microbial metabolite.

[0095] Preferably the use is non-therapeutic. Preferably the method is non-therapeutic. The term non- therapeutic typically means for cosmetic purposes and not curative or therapeutic purposes.

[0096] 30 The invention will now be illustrated with the help of the following non-limiting examples P0001071 CPL

[0097] 9

[0098] Examples

[0099] Examples A, B, 1 ,2: Effect of inclusion of starch / starch ferments on upregulation of desired genes Certain amounts of starch were used as shown in Table -1 and Table -2 below to be applied on human keratinocyte cell lines to evaluate the extent of upregulation of desired genes. The

[0100] 5 procedure used was as follows.

[0101] Objective

[0102] To evaluate the skin barrier benefits of starch post fermentation by Cutibacterium acnes 6919.

[0103] 10 Materials and Methods

[0104] Cutibacterium acnes 6919 was procured from ATCC.

[0105] Addex Bio Human Keratinocytes Cell Line (HaCaT) (CAT no. T0020001) was maintained in HIMEDIA High glucose DMEM (CAT no. AL219A) in 5% CO2 at 37°C. The cells were trypsinised

[0106] 15 using Sigma Trypsin — EDTA (T4049) when they were 80-85% confluent. The cells were differentiated using DMEM (CAT no. AL219A) containing 2.8 .M calcium chloride for 72 hours. Differentiated cells were used for further experiments.

[0107] Starch was obtained from the USA.

[0108] 20

[0109] Primers for gene expression studies were procured from Sigma. The RNA isolation kit was purchased from Qiagen (Cat No: 74104). cDNA synthesis was carried out using the Biorad iScript cDNA synthesis kit (Cat7 No: 1708890). Real-time PCR was carried out using the Sigma KiCgStart™ SYBR® Green gPCR ReadyMix™ (Cat No: KCQS00).

[0110] 25

[0111] Culturing bacteria in the presence of cornstarch

[0112] C. acnes bacteria were grown in Brain Heart Infusion agar plates under anaerobic conditions at 37°C for 72 hours. 0.6 OD culture was used to make a cell suspension of C. acnes in BHI broth, which was then used to inoculate the broth containing corn starch.

[0113] 30

[0114] 1% corn starch solution was made in BHI broth. This was serially diluted in respective media to obtain desired starch concentrations (0.005% or 0.01 %). 100 .l of bacterial culture (C. acnes) was added to the broth containing different concentration of starch and the total volume of the test system was made up to 15 ml. The test system was incubated under anaerobic conditions

[0115] 35 at 37°C for 72 hours. After incubation the culture was centrifuged for 15 minutes at 3000rpm. P0001071 CPL

[0116] 10

[0117] The cell free supernatant was collected and sterilized using 0.22p filter and this was used for treating keratinocytes.

[0118] Skin barrier gene expression studies

[0119] 5 HaCaT were differentiated as mentioned before. The cell free supernatants were diluted (1 :10 C. acnes ferments and 1:50 Skin flora ferments in cell culture media and added to differentiated keratinocytes and incubated at 37°C with 5%CC>2 for 18 hours. After incubation the cells were harvested using RLT buffer and used for gene expression studies.

[0120] RNA was isolated from the lysates as per the instructions given in the kit. The quality and the quantity of the total RNA isolated was analysed using 2100 Agilent Bioanalyzer. Reverse transcription was performed using iScript cDNA synthesis kit. Quantitative real time PCR was performed on 7500 fast real time PCR system (Applied Biosystems) using sigma KiCqStart™ SYBR® Green qPCR ReadyMix™. Primers used were the following.

[0121] 15

[0122] Amplification was carried out at 95°C for 30 seconds as the first step, followed by 40 cycles of qRT-PCR at 95°C for 5 seconds, and at 60°C for 20 seconds. mRNA expression was measured in triplicate and was normalized to / 3-actin expression levels.

[0123] Data Analysis

[0124] The gene expression was calculated as fold change based on normalised control. Control was normalised to 1 and the treatment was calculated as a fold change upon control. Fold change value greater than or equal to 1.4 was considered as upregulation.

[0125] 25

[0126] Results

[0127] The data is summarized in Table -1 and Table -2 below: P0001071 CPL

[0128] 11

[0129] Table -1 : Upregulation with 0.005% starch ferments

[0130] Table -2: Upregulation with 0.01% starch ferments

[0131] The data in Tables -1 and -2 above indicates that the use of starch or starch ferments on skin upregulates the desired genes which delivers the claimed benefits.

Claims

P0001071 CPL12Claims1. Use of starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch or its microbial metabolite for upregulating expression levels of Aquaporin-3, Claudin 1 , Keratin-4, Filaggrin -1, or Desmoglein 1 on skin for providing benefits like delivering anti-pigmentation response, ensuring resilient skin, or resilient microbiome on skin.

2. Use as claimed in claim 1 wherein the microbial metabolite is generated in situ on skin due to resident bacteria like Finegoldia magna, Anaerococcus octavius, Anaerococcus prevotii, Cutibacterium acnes, Corynebacterium jeikeium, or Candida parapsilosis.

3. Use as claimed in any one of the preceding claims wherein the use is non-therapeutic.

4. Use as claimed in any one of the preceding claims wherein the starch is native starch preferably corn starch.

5. Use as claimed in any one of the preceding claims wherein the starch or its microbial metabolite is present in a personal care composition.

6. Use as claimed in claim 5 wherein the starch or its microbial metabolite is present in an amount of 0.0001 to 45% by weight of the composition, preferably 0.001 to 30% by weight of the composition.

7. Use as claimed in claim 5 or 6 wherein the personal cleansing composition additionally comprises 1 to 80 wt% surfactant.

8. Starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch, its microbial metabolite or a personal care composition comprising the same for use in providing benefits like delivering antipigmentation response, or ensuring resilient skin, or resilient microbiome on skin by way of upregulating expression levels of Aquaporin-3, Claudin 1 , Keratin-4, Filaggrin-1 or Desmoglein 1 on skin.P0001071 CPL139. A method of providing benefit like delivering anti-pigmentation response, or ensuring resilient skin, or resilient microbiome on skin by way of upregulating expression levels of Aquaporin-3, Claudin 1 , Keratin-4, Filaggrin- 1 or Desmoglein 1 on skin comprising a step of topically applying to skin a composition comprising starch comprising native starch selected from potato starch, tapioca starch, maize starch, corn starch, or sweet potato starch or its microbial metabolite.

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