Intimate feminine hygiene cleansing composition
By using a sulfate-free, water-based cleaning composition containing a combination of specific surfactants and prebiotics and postbiotics, the problem of existing feminine hygiene cleaning compositions affecting microbial balance is solved, achieving a gentle and effective cleaning effect.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-04-14
- Publication Date
- 2026-03-17
AI Technical Summary
Existing feminine hygiene products can easily disrupt the delicate balance of the microbiome and may affect the cell permeability of the intimate area, failing to meet the requirements for gentleness.
The product uses a sulfate-free, water-based cleaning composition containing a non-soap surfactant system, prebiotics, and postbiotics. Specifically, it is a combination of glycinate, betaine, alkyl polyglucosides, and amphoteric acetates. The prebiotics are substances that can be broken down into lactic acid by lactobacilli, and the postbiotics are lactic acid or its salts, ensuring that it does not contain live bacteria.
It achieves rapid cleaning of the female private parts without disturbing the balance of the microbiome. It is gentle and does not affect the cell permeability of the private parts, effectively reducing the number of harmful microorganisms such as E. coli and Gardnerella vaginalis.
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Abstract
Description
Technical Field
[0001] This invention relates to a cleaning composition for feminine hygiene, and more particularly to a composition that balances the microbiome of the female intimate area. Background Technology
[0002] Our skin is the largest organ in the body, especially in terms of surface area. It forms the first line of defense against microorganisms that may invade the body. When the body is infected on the skin or systemically, the traditional approach to addressing such hygiene problems is to treat the skin / body with antimicrobial substances that reduce or kill bacteria. Some bacteria that permanently reside on the skin (called symbiotic bacteria) do not actually cause infection; instead, they are beneficial bacteria that protect the skin from pathogens. Several mechanisms have been proposed to explain this protection, some of the most popular being: physically occupying space on the skin to prevent pathogen colonization; producing metabolites that resist harmful pathogens; generating metabolites that strengthen innate defense mechanisms to prevent infection by harmful pathogens; and providing other benefits such as maintaining skin pH and barrier function. This ensures that the microbiome is maintained in a healthy balance for long-term hygiene and health.
[0003] This approach has even greater significance in the context of cleansing compositions suitable for the intimate parts of the female body.
[0004] Formulated handwashing and bathing products may not be suitable for sensitive areas of a woman's body, particularly the vaginal area. Tissues in the vaginal area are especially sensitive to chemicals and more prone to irritation.
[0005] The vagina is a dynamic ecosystem primarily carrying naturally occurring bacteria, lactobacilli. However, various other organisms, including some potential pathogens, may also be present in lower concentrations. In normal, healthy women, lactobacilli convert glycogen into lactic acid, which provides a physiologically lower pH. The normal vaginal pH in healthy women of reproductive age is 3.8 to 4.2. This acidic pH level provides a degree of protection by making the vagina less suitable for bacteria such as Escherichia coli and Gardnerella vaginalis. Escherichia coli is representative of those bacteria that cause UTIs. However, if this healthy microbiome is disrupted, bacterial vaginosis can occur, leading to vaginal discomfort ranging from itching to burning and vaginal discharge.
[0006] WO20244898 A1 (Unilever) discloses a topical composition having thymol, terpineol, or the like for restoring the microbiome diversity of susceptible skin to levels that indicate healthy skin.
[0007] WO2017055789 A1 (Reckitt) discloses a feminine hygiene preparation that provides antibacterial action while maintaining a healthy balance of the skin's natural flora. It is non-drying, provides moisturizing benefits, and is suitable for daily use, while also providing protection for the intimate area. The composition is claimed to provide antimicrobial benefits against fungi, Gram-positive and Gram-negative bacteria, and also provides gentle cleansing of the skin, including protection of the skin's symbiotic microbiome. The aqueous composition comprises 0.1 to 10 wt% betaine, 0.1 to 5.0 wt% lactic acid, 0.1 to 20 wt% poly(C2-C6) alcohol, optionally up to 10 wt% alkylpolyethoxycarboxylate, up to 10 wt% alkylpolyethoxyamide, and >8 wt% alkyl ether sulfate. The composition has a pH of 3.8 to 4.5. The composition contains a total of 10 to 20 wt% surfactant and 0.1 to 10 wt% metal salt.
[0008] US20190262292 A1 (Reckitt) discloses a feminine hygiene composition having a pH of 3.5 to 5, comprising lactic acid or a salt thereof and a ternary anionic component system. This system comprises a secondary alkyl sulfonate compound, an N-acylsarcosine salt compound, and an aromatic water-soluble compound, preferably a cumene sulfonate compound. The ternary anionic component system is claimed to enhance the antimicrobial efficacy of the primary antimicrobial active ingredient against Staphylococcus aureus, Escherichia coli, Candida albicans, and / or Klebsiella pneumoniae.
[0009] EP1481666 A1 (Rottapharm, 2004) discloses a composition for rebalancing the vaginal ecosystem by reconstructing an environment conducive to the growth of lactobacilli. The composition comprises lactic acid for pH regulation and a maltodextrin-containing nutritional support.
[0010] WO2019093060 (Gallinee) discloses a solid cosmetic formulation with a basic formula including at least one synthetic detergent, at least one prebiotic, and at least one postbiotic. The synthetic detergent includes anionic surfactants (such as sodium dodecyl sulfate, acyl hydroxyethyl sulfonate, sodium alkyl sulfosuccinate, sodium cocoyl hydroxyethyl sulfonate, or disodium dodecyl sulfosuccinate), cationic surfactants such as benzalkonium chloride, or amphoteric surfactants (such as cocamidopropyl betaine, cocoamphoacetate, or even diacetate), or even nonionic surfactants. Prebiotics are considered as indigestible fiber and can be classified as monosaccharides, disaccharides, or oligosaccharides according to their degree of polymerization. The term "postbiotic" is understood to refer to bacterial products or metabolites of probiotic organisms that are biologically active against the host. Lactic acid, acetic acid, butyric acid, propionic acid, fermentation products (e.g., products of the conversion of certain organic substances such as sugars under the action of enzymes secreted by microorganisms), and short-chain fatty acids (containing 1 to 6 carbon atoms) can be considered postbiotics.
[0011] US20190274937 A1 (Univ of Antwerp) discloses a cosmetic cleansing composition with a pH less than 7, comprising at least one organic acid as a preservative and at least one glyceryl ester as a surfactant. This composition exhibits the typical characteristics of soap without negatively impacting the natural microbiome of the skin / vaginal region.
[0012] We have identified a need for fast-acting cleansing compositions for feminine hygiene, but some existing compositions indiscriminately target the many microorganisms that colonize the intimate area, thus potentially disrupting the delicate balance of the microbiome.
[0013] Other existing compositions that selectively target specific types of microorganisms may not meet the requirement of mildness. Such compositions tend to affect the permeability of cells in intimate areas.
[0014] It has been determined that the compositions according to the present invention can meet the above-mentioned technical requirements showing differences, thereby providing an option for fast-acting cleaning compositions for feminine hygiene that do not interfere with the delicate balance of the microbiome, are gentle, and do not affect the permeability of cells in the intimate area. Summary of the Invention
[0015] According to a first aspect of the present invention, a sulfate-free aqueous cleaning composition for feminine hygiene is disclosed, the composition comprising:
[0016] a) 1 to 20% by weight of a non-soap surfactant system comprising a combination of two or more non-soap, sulfate-free surfactants selected from glycinates, betaines, alkyl polyglucosides and amphoteric acetates;
[0017] b) 0.05 to 4% by weight of prebiotics that can be broken down into lactic acid by lactobacilli; and
[0018] c) 0.001 to 3% by weight of lactic acid or its salt added as an after-generator;
[0019] The composition therein does not contain live bacteria, including lactobacilli.
[0020] According to the second aspect, the aqueous composition of claim 1 is disclosed for non-therapeutic use in female genital hygiene.
[0021] According to a third aspect, a non-therapeutic method for providing hygiene of the female private parts is disclosed, which includes a contact time of at least 30 seconds between the female private parts and the composition.
[0022] According to a fourth aspect, a sulfate-free aqueous cleaning composition for providing feminine hygiene is disclosed, the composition comprising:
[0023] a) 1 to 20% by weight of a non-soap surfactant system comprising a combination of two or more sulfate-free surfactants selected from glycine salts, betaine, alkyl polyglucosides and amphoteric acetates;
[0024] b) 0.05 to 4% by weight of prebiotics that can be broken down into lactic acid by lactobacilli; and
[0025] c) 0.001 to 3% by weight of lactic acid or its salt added as an after-generator;
[0026] The composition therein does not contain live bacteria, including lactobacilli.
[0027] According to the fifth aspect, a packaged consumer product is disclosed, comprising an aqueous composition of the first aspect packaged in a plastic bottle made of 100% post-consumer recycled plastic. Detailed Implementation
[0028] These and other aspects, features, and advantages will become apparent to those skilled in the art upon reading the following detailed description and appended claims. For the avoidance of doubt, any feature of one aspect of the invention may be used in any other aspect of the invention. The word “comprising” is intended to mean “including” but not necessarily “consisting of” or “made of”. In other words, the listed steps or options need not be exhaustive. It is worth noting that the examples given in the following description are intended to illustrate the invention and not to limit the invention to those examples alone. Similarly, unless otherwise stated, all percentages are weight / weight percentages. Except in the operational and comparative examples, or where explicitly stated otherwise, all figures representing amounts of material or reaction conditions, physical properties of materials, and / or used in this specification should be understood to be modified by the word “about”. Numerical ranges expressed in the format “from x to y” should be understood to include both x and y. When multiple preferred ranges are described in the format “from x to y” for a particular feature, it should be understood that all ranges combining different endpoints are also considered.
[0029] The term "skin" as used here refers to the skin on any part of the body, including the face, neck, chest, back, arms, armpits, hands, legs, buttocks, and scalp. It is particularly relevant for protecting an infant's skin.
[0030] The term balance refers to the selective reduction of the microbial count of at least one genera of microorganisms considered harmful or at least one genera of microorganisms exhibiting growth characteristics that are not normal for healthy skin, while selectively increasing the microbial count of at least one genera of microorganisms considered beneficial or at least one genera of microorganisms that also do not exhibit normal for healthy skin and whose numbers have decreased.
[0031] Sometimes, distinguishing between beneficial and harmful microorganisms is not easy because they can vary depending on the environment. Therefore, for dysbiotic conditions such as acne or atopic dermatitis, balance means reducing or increasing the count of microorganisms that have changed significantly under conditions contrary to a healthy state. This change can be an abnormal increase or an abnormal decrease in their count. Microorganisms can be described as tiny living organisms such as bacteria, fungi, or viruses. The microbiome, or microbial community, collectively refers to all the microorganisms on or inside the human body. In other words, the microbiome is the community of microorganisms. A balanced microbial community with biodiversity helps maintain health and is essential for human development, immunity, health, and well-being.
[0032] The vaginal ecosystem is mainly controlled by the dominance of lactobacilli. Lactobacilli produce lactic acid, which ensures the regulation and balance of the acidic environment of the female private parts microbiome, thus inhibiting the proliferation of other unwanted microorganisms to at least some extent.
[0033] The normal environment can indeed change for various reasons, including inadequate hygiene and age. When these changes occur, the intimate area, especially the vaginal environment, may harbor unwanted microorganisms such as E. coli and Gardnerella vaginalis.
[0034] In extreme cases, these symptoms may indicate a condition called "vaginitis," which may require medication. However, simple daily routines, such as using beauty cleansing compositions, can provide good protection. However, indiscriminate use of cleansing compositions can lead to more harm. For example, using ordinary soaps, bath compositions, or shampoos to clean the female intimate area can disrupt the delicate microbiome and acidic environment of that area. Therefore, specialized cleansing compositions are necessary, which are available in various forms such as cleansing lotions, gels, wipes, foams, mousses, etc.
[0035] Using this specialized composition may be the best way to restore and rebalance the vaginal ecosystem, or the ecosystem of the female genital area in a broader sense, thereby creating optimal conditions for the development and growth of natural flora while inhibiting the growth of harmful bacteria such as Gardnerella vaginalis.
[0036] The present invention discloses a sulfate-free aqueous cleaning composition for feminine hygiene, the composition comprising:
[0037] a) 1 to 20% by weight of a non-soap surfactant system comprising a combination of two or more sulfate-free surfactants selected from glycine salts, betaines, alkyl polyglucosides and amphoteric acetates;
[0038] b) 0.05 to 4% by weight of prebiotics that can be broken down into lactic acid by lactobacilli; and
[0039] c) 0.001 to 3% by weight of lactic acid or its salt added as an after-generator;
[0040] The composition therein does not contain live bacteria, including lactobacilli.
[0041] Preferably, the non-soap surfactant system comprises a combination of at least three sulfate-free surfactants.
[0042] The compositions of the present invention are aqueous. The term aqueous means that the composition contains water. Preferably, the compositions of the present invention contain 30 to 95% by weight, more preferably 40 to 90% by weight, and even more preferably 50 to 90% by weight of water. Water forms the continuous phase of the composition.
[0043] The term "sulfate-free" means that the compositions of the present invention contain no more than 1% by weight of a sulfated surfactant, particularly sodium dodecyl sulfate and sodium dodecyl ether sulfate.
[0044] All cleaning compositions typically contain one or more surfactants. Surfactants provide the basic cleaning action. Some surfactants are often used in combination to form a "surfactant system." A well-known example is the surfactant system of SLES and CAPB. SLES is sodium dodecyl ethoxysulfate, an anionic surfactant, while CAPB is cocamidopropyl betaine, a betaine-type surfactant.
[0045] The term "non-soap" means that the surfactant is not a soap. Soap means "fatty acid soap," or more simply, "soap" is used here in a general sense, preferably a salt of aliphatic alkanes or alkenes with 6 to 22 carbon atoms, and more preferably 8 to 18 carbon atoms. Typical soap salts are alkali metal or alkanol ammonium salts of these fatty acids, although other metal salts, such as magnesium salts, can also be used. Particularly preferred is that the compositions of the present invention contain less than 1% by weight of soap.
[0046] The compositions of the present invention comprise 1 to 20% by weight of a non-soap surfactant system, said system comprising a combination of two or more sulfate-free surfactants selected from glycinates, betaines, alkyl polyglucosides and amphoteric acetates.
[0047] More preferably, the composition contains 4 to 15% by weight, more preferably 4 to 13% by weight, of a surfactant. The term "system" refers to a combination of surfactants, and when the compositions of the present invention contain a combination, the cumulative amount is within the range defined herein. Alternatively, the composition contains 1 to 20% by weight of a surfactant.
[0048] By using sodium hydroxide, potassium hydroxide or ammonium hydroxide to make C8-C 18 Fatty acyl chlorides react with glycine to form the corresponding C8-C. 18 Alkyl glycine salts are prepared by using alkyl glycine salts.
[0049] Preferably, the amount of glycine salt with a C12 to C18 chain length is dominant (greater than 50%, preferably greater than 60%, more preferably 65 to 100%). More preferably, the total amount of glycine salts with C8, C10, and C12 to C18 chain lengths is 80 to 100%.
[0050] Preferably, the composition contains 0.5 to 5% by weight, more preferably 0.5 to 3% by weight, of a glycine salt, particularly an alkyl glycine salt.
[0051] Betaine is an amphoteric surfactant, which includes formula R 1 -N + -(R 2 (R) 3CH2CO2 - Simple betaine and formula R 1 -CONH(CH2) n -N + -(R 2 (R) 3 The amide betaine of CH2CO2, where n is 2 or 3. Specifically, R... 1 C can be derived from coconut oil 12 and C 14 A mixture of alkyl groups, such that the R group... 1 At least half, preferably at least three-quarters, of them have 10 to 14 carbon atoms. 2 and R 3 Methyl is preferred.
[0052] Another possibility is that betaine is of formula R 1 -N + -(R 2 (R) 3 (CH2)3SO3 - Or R 1 -CONH(CH2) m -N + -(R 2 (R) 3 (CH2)3SO3 - sulfobetaine, wherein m is 2 or 3, or wherein -(CH2)3SO3 - -CH2C(OH)(H)CH2SO3 - Alternative variants of these are available. Preferred betaines include alkylamidopropyl betaine, and in particular cocamidopropyl betaine.
[0053] Preferably, the composition of the present invention contains 0.5% to 8% by weight, more preferably 1.5% to 8% by weight, and most preferably 1.5% to 7.5% by weight of betaine.
[0054] Amphoteric acetates and diacetates are also intended to be covered by possible zwitterions and / or zwitterionic compounds, such as sodium lauryl amphoteric acetate, sodium cocoyl amphoteric acetate, and mixtures thereof.
[0055] Preferred alkyl polyglucosides have the following formula, wherein R2 is selected from alkyl, alkylphenyl, hydroxyalkyl, hydroxyalkylphenyl, and mixtures thereof, wherein the alkyl group contains about 10 to about 18 carbon atoms, preferably about 12 to about 14; n is 0 to 3, preferably 2; t is 0 to about 10, preferably 0; and x is 1.3 to about 10, preferably 1.3 to about 2.7. The glycosyl group is preferably derived from glucose. To prepare these compounds, an alcohol or alkyl polyethoxyl is first formed, and then reacted with glucose or a glucose source to form a glucosyl group (linked at the 1-position). Additional glycosyl units can then be linked between their 1-position and the preceding glycosyl units at the 2-, 3-, 4-, and / or 6-positions, preferably primarily at the 2-position.
[0056] The alkyl polyglucosides used in the context of this invention may or may not be polyalkoxylated.
[0057] According to a specific embodiment, they are selected from compounds having the general formula RO-(G), wherein R' represents a saturated or unsaturated, straight or branched hydrocarbon chain containing 12 to 44 carbon atoms, the group G represents a sugar residue containing 5 to 6 carbon atoms, and a is a number ranging from 1 to 10, preferably 1 to 5, and even more preferably a equal to 1.
[0058] According to a specific embodiment, R represents a branched alkyl group containing 12 to 44 carbon atoms, preferably 16 to 36 carbon atoms, and more preferably 18 to 22 carbon atoms.
[0059] Alkyl polyglucosides are particularly selected from fatty alcohols containing 12 to 44 carbon atoms and ethers or mixtures of glucose, maltose, sucrose, xylose, or fructose, and fatty alcohols containing 12 to 44 carbon atoms and ethers or mixtures of methyl glucose. The aliphatic unit of the ether is particularly selected from cetyl, behenyl, arachidyl, stearyl, palmityl, myristyl, lauryl, hexadecanoyl, and octyldodecyl units, and mixtures thereof, such as cetearyl. Preferably, it is octyldodecyl.
[0060] According to a specific embodiment of the invention, the alkyl polyglucoside is selected from compounds having the formula R'OG, wherein R' represents a saturated branched alkyl group containing 12 to 44, preferably 16 to 36, more preferably 18 to 22 carbon atoms, and the group G represents a sugar residue containing 5 to 6 carbon atoms, preferably a xylose residue.
[0061] Specifically, alkyl polyglucosides are octyl dodecyl xylose, such as the product sold by SEPPIC under the trade name Fluidanov 20X, which is a mixture of 75% octyl dodecyl alcohol and 25% octyl dodecyl xylose.
[0062] Preferably, the pH of the composition of the present invention is from 3.0 to 7.5. More preferably, the pH is from 3.2 to 7.2.
[0063] Preferably, the composition of the present invention is viscous, but not too viscous. Therefore, preferably, the composition contains a rheology modifier such that the viscosity of the composition is in the range of 2500 to 10000 cps. Preferably, the viscosity is measured at 30°C using a Brookfield V2 viscometer (spindle RTV5, 1 minute, 20 rpm). The weight percentage of this component varies depending on the type and grade, and all such conventional adjustments are within the common knowledge of those skilled in the art. Examples of rheology modifiers that can be used include polyethylene glycol distearate, acylates, starch, starch derivatives, waxes, and other polymer thickeners. Preferably, the rheology modifier is an acrylate polymer. Other suitable examples include water-soluble or dispersible polymers, including carbohydrate gums such as cellulose gum, microcrystalline cellulose, cellulose gel, hydroxyethyl cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, guar gum, gum arabic, gum arabic, gum acacia, agar, xanthan gum, and mixtures thereof; modified and unmodified starch granules and pregelatinized cold water-soluble starch; emulsion polymers, such as... 28. 22 or Aqua SF1; cationic polymers, such as modified polysaccharides, including cationic guar gum available from Rhone Poulenc under the trade names Jaguar C13, Jaguar C14, Jaguar C17, or Jaguar C16; cationic modified cellulose, such as UCARE Polymer JR 30 or JR 40 from Amerchol; N- 3000, N- 3196, N- GPX 215 or N- GPX196; a synthetic cationic polymer sold by Nalco, such as 100 280、、 281 and 550; cationic starch, such as that sold by Staley Inc. 100, 200, 300, and 400; cationic galactomannans, such as those from Henkel, Inc. 800 series; LM-200; and polyquaternium-24. High molecular weight polyethylene glycol, for example, is also suitable. WSR-205 (PEG 14M), WSR-N-60K (PEG 45) and WSR-301 (PEG 90M).
[0064] The compositions of the present invention preferably contain inorganic electrolytes, including metal chlorides (e.g., sodium chloride, potassium chloride, calcium chloride, magnesium chloride, zinc chloride, ferric chloride, and aluminum chloride) and metal sulfates (e.g., sodium sulfate and magnesium sulfate, which are not sulfating surfactants). The inorganic electrolytes are separate from any inorganic electrolytes that may be present in the raw materials of the present invention. The amount of inorganic electrolyte in the compositions of the present invention is preferably 0.5% to 5%, more preferably 1% to 5%.
[0065] prebiotics
[0066] The compositions of the present invention comprise 0.05 to 4% by weight of a prebiotic capable of being broken down into lactic acid by lactobacilli. Preferably, the prebiotic is an oligosaccharide, preferably a polysaccharide, glucose, fructose, galactose, sucrose, or lactose. Alternatively, the prebiotic is a fructan, preferably inulin-type. Further alternatively, it is a sugar alcohol, such as glycerol or lactitol. Further alternatively, it is a complex polysaccharide, preferably β-glucan, cellulose, or glycogen.
[0067] preservative
[0068] The compositions of the present invention preferably contain a preservative. Preferably, the preservative is selected from phenoxyethanol, sodium benzoate, or a mixture comprising 4-isopropyl-3-methylphenol, at least one hydrophilic solvent with a log Po / w of 1.2 or less, and at least one lipophilic solvent with a log Po / w greater than 1.2. Most preferably, the preservative is Symguard CD, which comprises a combination of phenylpropanol, o-Cymen-5-ol, and decanediol. Preferably, the compositions of the present invention contain 0.01 to 2% of the preservative.
[0069] Alternatively, the composition may contain a preservative selected from sodium salicylate, p-hydroxybenzoate, hydantoin, benzyl alcohol, benzoic acid, 1,2-alkanediol, iodopropynyl butylcarbamate (IPBC), 5-chloro-2-methyl-2H-isothiazo-3-one, 2-methyl-2H-isothiazo-3-one, octyl glycol, or mixtures thereof.
[0070] Moisturizer
[0071] Further preferably, the composition of the present invention comprises 2 to 20% by weight of the composition, more preferably 2.5 to 20% by weight, even more preferably 3 to 15% by weight, and most preferably 4 to 15% by weight of a moisturizer. Preferably, the moisturizer is propylene glycol, hexanediol, 1,4-dihydroxyhexane, 1,2,6-hexanetriol, sorbitol, butylene glycol, caprylyl glycol, propanediol such as methyl propylene glycol, dipropylene glycol, triethylene glycol, glycerin (glycerol), polyethylene glycol, ethoxydiethylene glycol, polyvinyl sorbitol, glyceryl caprylate / capric ester or a combination thereof.
[0072] Cationic skin conditioning agent
[0073] The compositions of the present invention may also contain cationic skin-sensing agents or polymers, such as cationic cellulose. The cationic polymer is used preferably at a level as low as about 0.1 to 2% by weight, up to the solubility limit of the particular polymer, or preferably up to about 4 to 5% by weight, provided that the solubility limit of the particular cationic polymer or mixture thereof is not exceeded.
[0074] Cationic cellulose is available from Amerchol Corp. (Edison, NJ, USA) under the Polymer JR (trademark) and LR (trademark) series of polymers, which are salts of hydroxyethyl cellulose reacted with trimethylammonium-substituted epoxides, industrially (CTFA) known as polyquaternium salt 10. Another type of cationic cellulose includes polymeric quaternary ammonium salts of hydroxyethyl cellulose reacted with dodecyl dimethylammonium-substituted epoxides, industrially (CTFA) known as polyquaternium salt 24. These materials are available from Amerchol Corp. (Edison, NJ, USA) under the trade name Polymer LM-200.
[0075] One particularly suitable type of cationic polysaccharide polymer is cationic guar gum derivatives, such as guar hydroxypropyltrimethylammonium chloride (available from Rhone-Poulenc under the JAGUAR brand). Examples include JAGUAR C13S with low cationic group substitution and high viscosity; JAGUAR C15 with medium substitution and low viscosity; JAGUAR C17 (high substitution, high viscosity); JAGUAR C16 as a hydroxypropylated cationic guar gum derivative with low levels of substituents and cationic quaternary ammonium groups; JAGUAR 162 as a guar gum with low substitution, high transparency, and medium viscosity; Jaguar Optima with high substitution and low molecular weight; and Jaguar Excel with low substitution and high viscosity. Particularly preferred cationic polymers are JAGUAR C13S, JAGUAR C15, JAGUAR C17, JAGUAR C16, and JAGUARC162, especially JAGUAR C13S, JAGUAR C-14 / BFG, Jaguar Optima, and Jaguar Excel. The JAGUARC14 / BFG material is the same molecule as JAGUAR C13, except that the glyoxal crosslinking agent replaces boron. Other cationic skin-sensing agents known in the art can be used, provided they are compatible with the formulations of this invention.
[0076] Furthermore, the cleaning composition of the present invention may contain 0.001 to 15% by weight of optional ingredients, such as fragrances, chelating agents such as tetrasodium EDTA, EHDP, or mixtures thereof. The composition may further contain antimicrobial agents such as caprylyl glycol, 2-hydroxy-4,2',4'-trichlorodiphenyl ether (DP300), preservatives such as methylisothiazolinone / methylchloroisothiazolinone (Kathon, MIT), dimethyloldimethylhydantoin / iodopropynyl butylcarbamate (Glydant XL1000), and sorbic acid.
[0077] Moisturizer
[0078] The term "emollient" is defined as a substance that softens or improves the elasticity, appearance, and youthfulness of the skin (stratum corneum) by increasing its moisture content, adding or replacing lipids and other skin nutrients; and by maintaining its softness by delaying the decrease in its water content.
[0079] Hydrophobic emollients with a weight-average particle size of less than 1000 or 500 micrometers are defined herein as “finely dispersed oils” and are preferably used at at least 3, 2, 1% by weight up to 15% by weight.
[0080] These hydrophobic emollients include, but are not limited to, the following:
[0081] (a) Silicone oils and their modifiers, such as linear and cyclic polydimethylsiloxanes; amino, alkyl, alkylaryl and aryl silicone oils;
[0082] (b) Fats and oils, including natural fats and oils (triglycerides), such as jojoba, soybean, sunflower, safflower, seaweed, rice bran, avocado, almond, olive, sesame, pepper, castor, coconut, mink oil; cocoa butter, tallow, lard; hardened oils obtained by hydrogenation of the above oils; and synthetic monoglycerides, diglycerides and triglycerides, such as glyceryl myristate and glyceryl 2-ethylhexanoate;
[0083] (c) Waxes, such as carnauba wax, cetacean wax, beeswax, lanolin and their derivatives;
[0084] (d) Hydrophobic plant extracts;
[0085] (e) Hydrocarbons, such as petrolatum, polybutene, and liquid paraffin;
[0086] (f) Microcrystalline waxes, ceresin, squalene, pristan, and mineral oils;
[0087] (g) Higher alcohols, such as lauryl alcohol, cetyl alcohol, stearyl alcohol, oleyl alcohol, behenyl oil, cholesterol and 2-hexyldecyl alcohol;
[0088] (h) esters, such as hexadecyl caprylate, myristyl lactate, hexadecyl lactate, isopropyl myristate, myristyl myristate, isopropyl palmitate, isopropyl adipate, butyl stearate, decyl oleate, cholesterol isostearate, glyceryl monostearate, glyceryl distearate, glyceryl tristearate, alkyl lactate, alkyl citrate, and alkyl tartrate;
[0089] (i) Essential oils and their extracts, such as peppermint, jasmine, camphor, white cedar, bitter orange peel, ryu, turpentine, cinnamon, bergamot, citrus, calamus, pine, lavender, laurel, clove, carnation, eucalyptus, lemon, starflower, thyme, peppermint, rose, sage, sesame, ginger, basil, juniper, lemongrass, rosemary, sandalwood, avocado, grape, grape seed, myrrh, cucumber, watercress, calendula, elderberry, geranium, linden blossom, amaranth, seaweed, ginkgo, ginseng, carrot, guarana, tea tree, jojoba, comfrey, oats, cocoa, orange blossom, vanilla, green tea, royal jelly, aloe vera, menthol, eucalyptol, eugenol, citral, citronellol, borneol, linalool, geraniol, evening primrose, camphene, thymol, senna alcohol, terpenes, limonene and terpene oils;
[0090] (j) A mixture of any of the above components.
[0091] Preferred emollients include petrolatum, natural waxes, partially or fully hydrogenated triglyceride oils, and mixtures thereof. Preferred triglyceride oils include soybean oil or sunflower oil.
[0092] Optional surfactants
[0093] Suitable active agents may be advantageously selected from antimicrobial and antifungal active agents, vitamins, anti-skin atrophy and skin repair active agents, skin barrier repair active agents, nonsteroidal cosmetic soothing active agents, skin tightening agents, antipruritic ingredients, hair growth inhibitors, 5-α reductase inhibitors, peeling enzyme enhancers, anti-glycation agents, local anesthetics, or mixtures thereof.
[0094] Methods and uses
[0095] According to another aspect, the aqueous composition of the first aspect is disclosed for non-therapeutic use in feminine hygiene. When the method or use is inherently non-therapeutic, it is preferably used for cosmetic applications. Alternatively, the use is therapeutic. Therapy refers to a method of bringing the body back from a pathological state to its normal healthy state or a method of preventing a pathological state.
[0096] Preferably, the use results in a reduction of at least 5-log in the count of Gardnerella vaginalis. This species is associated with the female genital area and vaginal microbiome. Gardnerella vaginalis is a facultative anaerobic Gram-negative bacillus that, along with many other bacteria (primarily anaerobic), is involved in bacterial vaginosis in some women due to disruption of the normal vaginal microbiota. Therefore, it is preferable to reduce their numbers as much as possible. The composition is expected to produce rapid results that can be determined by known methods. Results are typically expressed as a logarithmic or percentage reduction in microorganisms after such contact. A reasonably effective composition provides a 3-log logarithmic reduction, equivalent to a 99.9% reduction, a more effective composition provides a 5-log logarithmic reduction, which means a 99.9% reduction, and an even more effective composition provides a 7-log reduction, or 99.99999%. More preferably, its use results in a reduction of no more than 3-log in the count of Lactobacillus curvature, which also colonizes the female genital area, even with a contact time of at least 30 seconds. Curly Lactobacillus is a common rod-shaped species in the genus Lactobacillus and a beneficial microbial species that produces hydrogen peroxide (H2O2). It is found in both the vagina (through vaginal secretions) and the gastrointestinal tract of vertebrates.
[0097] According to another aspect, a non-therapeutic method for providing hygiene to a woman's genital area is disclosed, comprising the step of contacting the genital area with the composition for at least 30 seconds. Preferably, the count of Gardnerella vaginalis colonizing the genital area is reduced by at least 5 log. More preferably, the count of Lactobacillus curvature colonizing the genital area is reduced by no more than 3 log.
[0098] Further according to the present invention, a sulfate-free aqueous cleaning composition for providing feminine hygiene is disclosed, the composition comprising:
[0099] a) 1 to 20% by weight of a non-soap surfactant system comprising a combination of two or more sulfate-free surfactants selected from glycine salts, betaine, alkyl polyglucosides and amphoteric acetates;
[0100] b) 0.05 to 4% by weight of prebiotics that can be broken down into lactic acid by lactobacilli; and
[0101] c) 0.001 to 3% by weight of lactic acid or its salt added as an after-generator;
[0102] The composition therein does not contain live bacteria, including lactobacilli.
[0103] According to another aspect of the invention, a packaged consumer product is disclosed comprising an aqueous composition of the first aspect packaged in a plastic bottle made of 100% post-consumer recycled plastic. The package may be a plaster, bottle, dispenser-equipped bottle, tube, roller applicator, propellant-driven aerosol device, squeeze container, or can with a cap.
[0104] The invention will now be explained in detail through the following non-limiting embodiments.
[0105] Example
[0106] Three cleaning compositions for female feminine hygiene according to the present invention have been prepared. Details of the formulations are provided in Table 1.
[0107] Table 1
[0108]
[0109] Antimicrobial efficacy
[0110] According to ASTM E2783-11, the antimicrobial activity of the water-miscible compounds listed in Table 1 was evaluated using a time-killing procedure. When testing antimicrobial test materials in vitro, this method measures changes in aerobic and anaerobic microbial populations over a specific sampling period. The organisms used are standardized for growth requirements and inoculum preparation and must be grown under the test conditions. The primary objective of this method is to provide a standardized set of conditions and test organisms to facilitate comparative evaluation of antimicrobial materials miscible in aqueous systems.
[0111] The observation results are summarized in Table 2.
[0112] Table 2
[0113]
[0114]
[0115] All formulations showed complete eradication of Gardnerella vaginalis greater than 6-log, but only the formulations in Table 1 showed a maximum reduction of 2.6-log against Lactobacillus curvature.
[0116] The data in Table 2 show that the composition according to the invention is selectively effective and balances the microbiome of the female intimate area.
[0117] Note: ** indicates marketed feminine hygiene products used for comparison.
[0118] Example 2: Mildness and Barrier Properties
[0119] Skin damage caused by cleansers is primarily attributed to the interaction between surfactants and stratum corneum proteins and lipids. In vitro mildness measurements use the solubility of a model protein (zein) and the percentage of lipid retention to screen for potential skin damage caused by surfactants / cleansers.
[0120] Solubility of zein Zeadin is a corn protein with limited water solubility. The solubility of zeadin typically increases in surfactant solutions due to surfactant denaturation and its ability to dissolve other less water-soluble zeadins. Higher zeadin solubility in surfactant / cleaner solutions suggests that the surfactant / cleaner may be more harsh on the skin, as shown in clinical patch studies. [Reference: K.P. Nanth, et al. “A Novel Technology in Mild and Moisturizing Cleansing Liquids”, Cosmetic Dermatology, pp. 307-316, No. 6, Vol. 22, 2009.]
[0121] The solubility of zein was measured by mixing zein powder with 5% test formulation at room temperature for 30 minutes. The dissolved zein was separated from the undissolved portion using a 0.45 μm syringe filter and diluted with 2% sodium dodecyl sulfate (SDS) solution. UV measurements were performed on the diluted zein solution containing 2% SDS. Reported values were calculated as follows:
[0122] UV absorbance = (I 278,样品 -I 278,空白 *Dilution factor*2
[0123] I 278,样品Intensity reading of zein solution at wavelength 278.
[0124] I 278,空白 Intensity reading of the blank solution at wavelength 278.
[0125] Lipid retention test
[0126] Another aspect of the skin damage caused by surfactants / cleansers is due to their ability to dissolve the lipid components of the stratum corneum (fatty acids, cholesterol, and ceramides), leading to impaired skin barrier function. The lipid retention test described below is used to characterize the ability of surfactants / cleansers to dissolve lipids. A higher retention percentage indicates less interaction between the surfactant / cleanser and lipids, which in turn suggests a product that may be gentler on skin lipids. [Reference: K.P. Nanth, et al. “A Novel Technology in Mild and Moisturizing Cleansing Liquids”, Cosmetic Dermatology, pp. 307-316, No. 6, Vol. 22, 2009.]
[0127] A mixture of palmitic acid, stearic acid, cholesterol, and ceramide was cast onto filter paper to simulate the lipid layer of skin. A fluorescent dye (12NBD Stearate) was added to the lipid mixture. The lipid paper was immersed in 10% of the test preparation for 30 minutes at room temperature. At the end of 30 minutes, the lipid paper was removed and washed under DI water for 30 seconds. The lipid paper was then dried at room temperature. After drying, the lipid paper was immersed in N ml of isopropanol (IPA) for approximately 40 minutes. The fluorescence intensity of the IPA extraction solution was measured. The lipid retention percentage was calculated as follows:
[0128] Retention % = (FL intensity of sample lipid paper at 530 nm * N ml) / (NL intensity of untreated lipid paper at 530 nm * 5 ml)
[0129] The observation results are summarized in Table 3.
[0130] Table 3
[0131] Composition zein UV absorbance Lipid retention % A 8.89 7.42 W 9.45 9.11 P 8.52 8.85 water 8.31 61.68 Soap / Synthetic Detergent 30.66 1.21
[0132] The data in Table 3 indicate that the compositions according to the present invention are very mild. As shown in the table above, the prototypes have zein solubility close to that of water, indicating that they are mild on skin proteins.
[0133] The term soap / synthetic detergent refers to a standard cleaning agent containing soap and surfactants.
[0134] Electrical resistance - mildness
[0135] Electrical impedance is a proxy indicator of changes in skin permeability. After the test formulation is applied to the skin of a human cadaver, the electrical impedance of the stratum corneum (or the current passing through the stratum corneum under a fixed applied voltage) is measured at time 0 and at set intervals. A decrease in skin impedance during this time period indicates that the test formulation increases skin permeability (the degree of permeation is reported proportionally to the degree of impedance increase), and thus indicates that the test formulation will lead to a potentially higher degree of skin barrier damage.
[0136] The impedance readings of each cell at different time points were normalized relative to the zero-minute reading for that cell. For each test formulation, the impedance reading at each time point was the average normalized value of the six replicate cells at that time point. Note: SDS = Sodium dodecyl sulfate.
[0137] The observation results are listed in Table 4.
[0138] Table 4
[0139] Time / minute water SDS A W P 0 1.00 1.00 1.00 1.00 1.00 5 1.00 0.94 0.98 0.95 1.00 10 1.01 0.90 0.98 0.93 1.01 15 1.03 0.86 0.97 0.91 1.02 30 0.96 0.76 0.97 0.89 1.02
[0140] Data shows that the skin resistance when treated with the composition of the present invention is comparable to that when treated with water.
Claims
1. A sulfate-free aqueous cleansing composition for feminine intimate hygiene, the composition comprising: a) 1 to 20 wt.% of a non-soap surfactant system comprising a combination of at least three sulfate-free surfactants selected from the group consisting of glycinate, betaine, alkyl polyglucoside, and amphoteric acetate; wherein when the non-soap surfactant system comprises glycinate, the glycinate is in the range of 0.5 to 5 wt.% and the glycinate is C8-Ci2 alkyl glycinate; wherein when the non-soap surfactant system comprises betaine, the betaine is in the range of 0.5 to 8 wt.% and the betaine is alkyl amidopropyl betaine; wherein when the non-soap surfactant system comprises alkyl polyglucoside, the alkyl polyglucoside is selected from the group consisting of an ether or mixture of ethers of a fatty alcohol comprising 12 to 44 carbon atoms and glucose, maltose, sucrose, xylose, or fructose, and an ether or mixture of ethers of a fatty alcohol comprising 12 to 44 carbon atoms and methyl glucose; wherein when the non-soap surfactant system comprises amphoteric acetate, the amphoteric acetate is selected from the group consisting of sodium lauryl amphoacetate, sodium coco amphoacetate, disodium coco di-amphoacetate, and mixtures thereof; b) 0.1 to 5 wt.% of a sudsing suppressor selected from the group consisting of fatty acid monoethanolamide, fatty acid diethanolamide, fatty acid monoethanolamide with a fatty alcohol, fatty acid diethanolamide with a fatty alcohol, fatty acid monoethanolamide with a fatty acid, fatty acid diethanolamide with a fatty acid, fatty acid monoethanolamide with a fatty acid monoethanolamide, fatty acid diethanolamide with a fatty acid diethanolamide, fatty acid monoethanolamide with a fatty acid monoethanolamide with a fatty alcohol, fatty acid diethanolamide with a fatty acid diethanolamide with a fatty alcohol, fatty acid monoethanolamide with a fatty acid monoethanolamide with a fatty acid, fatty acid diethanolamide with a fatty acid diethanolamide with a fatty acid, and mixtures thereof; wherein the sudsing suppressor is in the range of 0.1 to 5 wt.% of the composition; and c) 0.1 to 5 wt.% of a sudsing enhancer selected from the group consisting of fatty acid monoethanolamide, fatty acid diethanolamide, fatty acid monoethanolamide with a fatty alcohol, fatty acid diethanolamide with a fatty alcohol, fatty acid monoethanolamide with a fatty acid, fatty acid diethanolamide with a fatty acid, fatty acid monoethanolamide with a fatty acid monoethanolamide, fatty acid diethanolamide with a fatty acid diethanolamide, fatty acid monoethanolamide with a fatty acid monoethanolamide with a fatty alcohol, fatty acid diethanolamide with a fatty acid diethanolamide with a fatty alcohol, fatty acid monoethanolamide with a fatty acid monoethanolamide with a fatty acid, fatty acid diethanolamide with a fatty acid diethanolamide with a fatty acid, and mixtures thereof; wherein the sudsing enhancer is in the range of 0.1 to 5 wt.% of the composition. 18 alkanoyl glycinate; wherein when the non-soap surfactant system comprises betaine, the betaine is in the range of 0. b) 0.05 to 4 wt.% of a prebiotic capable of being broken down to lactic acid by lactic acid bacteria, wherein the prebiotic is a sugar alcohol, a complex polysaccharide, or a combination thereof; and c) 0.001 to 3 wt.% of lactic acid or a salt thereof added as a postbiotic; wherein the composition is free of live bacteria including Lactobacillus.
2. The aqueous composition of claim 1, wherein the glycinate is sodium cocoyl glycinate.
3. The aqueous composition of claim 1 or 2, wherein the betaine is cocamidopropyl betaine.
4. The aqueous composition of claim 1 or 2, wherein the alkyl polyglucoside is decyl glucoside.
5. The aqueous composition of claim 1 or 2, wherein the amphoteric acetate is disodium cocoamphoacetate.
6. The aqueous composition of claim 1 or 2, wherein the prebiotic is glycogen.
7. The aqueous composition of claim 1 or 2, wherein the pH of the composition is from 3.0 to 7.
5.
8. The aqueous composition of claim 1 or 2, wherein the composition comprises a rheology additive selected from polyethylene glycol distearate, acylate, starch, sugar gum, cationic polymer, cationic galactomannan, high molecular weight polyethylene glycol, wax, or polymeric thickening agent.
9. The aqueous composition of claim 1 or 2, wherein the viscosity of the composition is in the range of 2500 to 10000 cps, wherein the viscosity is determined using a Brookfield V2 viscometer, spindle RTV5, 1 minute, 20 rpm, at 30°C.
10. The aqueous composition of claim 1 or 2, wherein the prebiotic is glycerin or lactitol.
11. The aqueous composition of claim 1 or 2, wherein the composition comprises a preservative selected from sodium benzoate, phenoxyethanol, 4-isopropyl-3-methyl phenol, sodium salicylate, parabens, hydantoin, benzyl alcohol, benzoic acid, 1,2-alkanediols, iodopropynyl butylcarbamate (IPBC), 5-chloro-2-methyl-2H-isothiazol-3-one, 2-methyl-2H-isothiazol-3-one, caprylyl glycol, phenylpropanol, o-cymen-5-ol, and decanediol, or mixtures thereof.
12. The aqueous composition of claim 1 or 2, wherein the composition comprises 2 to 15 wt.% of a humectant selected from propylene glycol, hexylene glycol, 1,4-dihydroxyhexane, 1,2,6-hexanetriol, sorbitol, butylene glycol, caprylyl glycol, propane diols such as methyl propylene glycol, dipropylene glycol, tripropylene glycol, glycerin (propanetriol), polyethylene glycol, ethoxydiglycerol, polyethylene sorbitol, glyceryl caprylate / caprate, and combinations thereof.
13. The aqueous composition of claim 1 or 2, wherein the composition reduces the count of at least Gardnerella vaginalis, but not at least Lactobacillus crispatus, residing in the female intimate area by at least 5-log, according to ASTM E2783-11 using the time-kill procedure.
14. Non-therapeutic use of the aqueous composition according to any one of claims 1 to 13 for intimate hygiene of a woman.
15. A non-therapeutic method of providing intimate hygiene of a woman comprising the step of contacting the intimate area of a woman with the composition according to any one of claims 1 to 13 for a contact time of at least 30 seconds.
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