Composition for intimate use serum

Abstract

A method of restoring and / or maintaining a healthy genital ecosystem comprising administering a genital care composition including: - a postbiotic, - plant-based glycogen, and - plant-based stem cells.

Description

[0001] COMPOSITION FOR INTIMATE USE SERUM

[0002] The present invention relates to the maintenance of genital and urinary health. Described herein compositions and methods for improving genital and urinary health and in particular, a vaginal care composition comprising plant-based stem cells.

[0003] Vaginal and urinary health issues are underfunded, leading to reactionary solutions, not prevention. The symptoms of poor genital and urinary health cause discomfort, pain, and can even become life-threatening over time. There is also a stigma, and a feeling of shame that keeps these common issues from being openly discussed by women. Currently available products are ineffective at treating the real cause of the problem.

[0004] Urinary Tract Infections (UTIs), bacterial vaginosis (BV), yeast infections, vaginal dryness, itchiness and odour are not the root problem; they are merely symptoms of the real problem. These conditions can lead to ongoing discomfort and long-term disability, with symptoms like odour, dryness, and irritation, which severely impact quality of life.

[0005] Vaginal health imbalances affect millions of women yet remains critically under-addressed. Around 90% of women have an imbalance in their vaginal microbiomes, around 50% of menopausal women suffer vaginal dryness, and around 50% of women have recurring UTIs, BV, or yeast infections.

[0006] According to one aspect of the present invention there is provided a method of restoring and / or maintaining a healthy genital ecosystem comprising administering a genital care composition including:-

[0007] • a postbiotic

[0008] • plant-based glycogen ,and

[0009] • plant-based stem cells.

[0010] According to a second aspect of the present invention there is provided a method of restoring and / or maintaining a healthy vaginal ecosystem comprising a female user administering an amount of a vaginal care composition to her vaginal area and, optionally, one or more of her vulva, vestibule, labia majora, labia minora, or external urogenital tract; wherein the vaginal care composition comprises:-

[0011] • a postbiotic

[0012] • plant-based glycogen ,and

[0013] • plant-based stem cells.

[0014] Owing to these two aspects, the composition applied as a serum to the genital area fortifies the skin barrier, strengthens the ecosystem microbiome and mimics the body's natural secretions.

[0015] As used herein, “vaginal area" means the vaginal canal and the vulva, including the vaginal orifice, vaginal introitus, vulvar vestibule, labia majora, labia minora, external urogenital tract, urethral orifice, clitoris, and vulvar skin which is bounded longitudinally by the mons pubis and anus and bounded laterally by the genitocrural folds.

[0016] As used herein, “vaginal care composition" means any composition that is suitable for application to the vaginal area and which is useful for restoring and / or maintaining a healthy genital ecosystem.

[0017] The vaginal care compositions described herein are suitable for application to the vaginal area and, optionally, the external vaginal tissues. The vaginal care composition is preferably non-irritating and substantially free of ingredients that are less suitable for application to these tissues.

[0018] In order that the present invention can be clearly and completely disclosed, reference will now be made, by way of example only, to the accompanying drawings in which:- Figure 1 is a diagrammatic view of an optimal vaginal ecosystem,

[0019] Figure 2 is a view similar to Figure 1 but of a non-optimal vaginal ecosystem,

[0020] Figure 3 is a flowchart of currently known solutions that mask symptoms, yet worsen the underlying health issues, and Figure 4 is a graph showing restoration and maintenance of a vaginal ecosystem by use of a vaginal care composition over time.

[0021] Referring to Figures 1 and 2, vaginal pH level is a critical factor in maintaining good vaginal health. It is determined by hydrogen ion 2 activity and is an indication of whether the local environment 4 (or microbiome) is acidic or alkaline. A normal vaginal pH typically ranges between about 3.8 and about 5.0, reflecting a moderately acidic state. Referring specifically to Figure 1, a lower pH value, indicating increased acidity compared to blood or interstitial fluids, can help protect the vaginal mucosa 6 (that is the soft tissue that lines the vaginal canal) from harmful organisms. The cells of the mucosa 6 are in good condition forming a barrier to the ingress of potential pathogens or other potentially harmful microorganisms and / or substances. Various factors, including age, vaginal hydration, diet, and sexual activity, can influence vaginal pH value. For women of reproductive age, a normal vaginal pH level range is typically between around 4.0 and around 4.5, but it may be slightly higher in premenarchal and postmenopausal women. The maintenance of a healthy vaginal pH involves complex interactions among factors such as Lactobacillus acidophilus bacteria 8, oestrogen levels, glycogen, and existing flora and pathogens.

[0022] The Lactobacillus acidophilus bacteria 8, in particular, plays a crucial role in maintaining good vaginal health by fermenting glycogen from the vaginal mucosa 6, producing lactic acid 10 and the hydrogen ions 2. This metabolic process results in an acidic pH of about 4 to about 4.5, creating a protective barrier against harmful microorganisms. An imbalance in the vaginal ecosystem (as seen in Figure 2) can lead to changes in pH, potentially indicating the presence of bacterial pathogens 12 or changes in hormonal status. Therefore, monitoring vaginal pH levels can be valuable in assessing vaginal health and identifying potential infections or imbalances. Figure 2 shows how disruption of cells of the mucosa 6 caused by, for example, one or more of hormonal fluctuations, diet, sexual activity, stress, prescription medicine, currently know intimate care products and personal lubricants. If this kind of cell disruption is not attended to, imbalances in the vaginal microbiome will worsen over time and these imbalances can include metabolic imbalances and an imbalance in the diversity of the bacterial population of the microbiome, resulting in an environment which allows harmful pathogens to make ingress into the mucosal lining causing discomfort and a number of unpleasant symptoms, as shown in Figure 3. The result of untreated microbiome and skin barrier imbalances is a continuing and worsening cyclical event.

[0023] Osmolality refers to the concentration of a solution, expressed as the total number of solute particles per kilogram. Any preparation containing water therefore contains a quantity of dissolved particles, this quantity is measured in mOsm / Kg and influences the osmotic process between a cell and its external environment. Normal osmolality for female vaginal secretions fall between around 260 to around 290 mOsm / kg, while for men’s semen, it ranges from about 250 to about 380 mOsm / kg.

[0024] The greater the osmolality of intimate care products the more the potential to cause mucosal irritation and tissue damage. High osmolality of personal lubricants has also been associated with cytotoxicity.

[0025] The concentration of glycols, such as glycerol, glycerin and propylene glycol, is the foremost determinant of osmolality. These glycols function as humectants and emollients, with glycerol, glycerin and propylene glycol being the prevailing known choices. To ensure that the osmolality of a personal intimate use product remains low, the World Health Organisation recommends limiting the concentration of glycerol to no more than 9.9% mass fraction (w / w) and the concentration of propylene glycol (or a combination of glycols) to approximately 8.3% mass fraction (w / w). In addition to their primary influence on osmolality and mucosal irritation, glycols have demonstrated adverse effects in both animal and in vitro investigations. In a mouse model, vaginal application of glycerol monolaurate, glycerin, propylene glycol, and polyethylene glycol (PEG8) significantly heightened susceptibility to herpes simplex virus 2 (HSV-2). In vitro studies have demonstrated that an over-the-counter personal lubricant containing propylene glycol, glycerin, and methylparaben can eliminate helpful Lactobacillus crispatus. This species is a key component of the vaginal microbiome, contributing to the maintenance of a healthy mucosal barrier and acidic pH. Small amounts of glycerin / glycerol and their byproducts have also been found to act as a nutritional source for the yeast Candida albicans.

[0026] Thus, a vaginal care composition comprising:- a postbiotic, plant-based glycogen ,and plant-based stem cells, can be advantageous is restoring and / or maintaining a healthy vaginal microbiome.

[0027] Postbiotics are the byproduct of fermented live bacteria (probiotics) or inactivated microorganisms. The process of fermentation releases nutrients inside of the bacteria and holds concentrated and nourishing health benefits that help to balance the vaginal microbiome. A preferred postbiotic is Lactobacillus Ferment Lysate which is able to accelerate cell repair by promoting cell renewal and increasing collagen production. Collagen is an essential protein responsible for skin strength and structure, significantly contributing to firmness and resilience. By simultaneously increasing the removal of cell flakes, the hydration of the cells is improved.

[0028] Glycogen is a highly branched structure of repeating glucose units that are linked together by specific bonds, termed a (1-4) and a (1-6) glycosidic bonds. The structure of glycogen itself is very dense, making this molecule an ideal storage unit of energy inside the cell.

[0029] Plant-based glycogen (or phytoglycogen) is isolated from plant material. The preferred phytoglycogen is PhytoSpherix™ (available from Mibelle biochemistry) is a sustainable special non-GMO sweet corn. It is chemically identical to the glycogen stored in animal cells but is produced and stored in plants. In vitro and in vivo studies have shown that this type of phytoglygogen:-

[0030] • stimulates Adenosine triphosphate (ATP) production and increases cell proliferation and metabolic activity (a preferred energy substrate for cell metabolism is glucose. When energy is needed, glucose is broken down into a series of biochemical reactions that release energy in the form of ATP. One of the densest storage units of glucose in the cell is glycogen)

[0031] • increases hyaluronic acid and collagen production

[0032] • provides fast and long-lasting hydrating effects

[0033] • effectively reduces visible wrinkles boosts the effects of hyaluronic acid in a composition reduces hyperpigmentation.

[0034] The structure of PhytoSpherix™ clearly differentiates it from other polysaccharides found in plants, such as amylopectin. PhytoSpherix™ is made up of a-l,4-linked glucose units, which form linear chains that branch after every 10 units of glucose (via a-1,6 glycosidic bonds). This number of branches is almost double that of normal maize amylopectin, which branches out after every 20 units of glucose.

[0035] PhytoSpherix™ is a compact, spherical, and water-soluble molecule. The highly branched dendrimer structure of PhytoSpherix™ further yields some interesting properties, including high water-binding, low viscosity, and high stability in water. The efficient water-binding capacity enhances the moisturizing properties of compositions containing it.

[0036] Living organisms require energy to perform the tasks of everyday life. At the cellular level, the energy is used for overall cell maintenance, protection, and the production of molecules that are essential for cell and organ function. Cells which are continuously exposed to external environmental factors such as sunlight or pollution, greatly rely on large amounts of energy to combat cellular damage. Therefore, increasing cell energy levels is a good approach to improve a particular microbiome. Hyaluronic acid and collagen are needed to maintain healthy cells in the vaginal microbiome. To produce these molecules, the cells require energy. However, reduced energy levels (resulting, for example, through increasing age) can lead to impaired production of these essential molecules. Moreover, glycogen is the complex form of sugar present in the vaginal epithelium and levels increase as the levels of oestrogen rise during puberty. Glycogen is metabolized by the lactobacillus bacterial species into lactic acid to maintain the ideal pH level in the vaginal microbiome. Free glycogen could be released from vaginal epithelial cells as well as by cell lysis and whilst vaginal lactobacilli do not directly metabolise glycogen, they metabolise the human a-amylase breakdown products, glucose and maltose through fermentation that produces lactic acid. Treating women with vaginal glycogen thus enhances colonisation with lactobacilli and promotes vaginal health although glycogen is also an energy source for bacteria associated with BV and so long-term support of lactobacilli is an advantage. The level of the phytoglycogen in the vaginal care composition is preferably around 0.3wt%.

[0037] Plant stem cells have been found to vitalize animal cells. PhytoCellTec™ Goji (available from Mibelle biochemistry) is a Lycium barbarum callus culture extract based on a plant stem cell culture of a goji seedling that vitalizes mesenchymal stem cells. Goji plant stem cells can be used in the vagina care composition in order to improve the function of stem cells in the vaginal microbiome. With increasing age, the production of collagen and elastin in animal cells is reduced. Mesenchymal stem cells have been shown to improve collagen production and regenerate cells. These processes are mediated by vesicles known as exosomes which are produced and secreted by these stem cells. The plant stem cells should make up about 0.3wt% to about 1.0wt% of the vaginal care composition.

[0038] Other preferred compounds to enhance benefits provided by the vaginal care composition include one or more of the following:-

[0039] • Prebiotics to beneficially affect the host by selectively stimulating the growth and / or activity of one or a limited number of bacteria, and thus improve host health.

[0040] Prebiotics act as food for bacteria, and so can be selected to allow beneficial bacteria to grow and thrive. Fructooligosaccharide has been shown to have potential prebiotic properties specifically on three beneficial species: Lactobacillus crispatus, Lactobacillus jensenii and Lactobacillus vaginalis and preventing the risk of bacterial vaginosis. For an optimal result, around lwt% to around 3wt% of the composition can be a prebiotic. Lactulose is an alternative selection. It has the capability to specifically encourage the growth of vaginal lactobacilli while inhibiting the proliferation of pathogenic or dysbiotic organisms. Additionally, it fosters a favorable acidic environment conducive to vaginal health. If lactulose is selected the level for optimal result would be about 0.5wt%.

[0041] • Sodium Hyaluronate: A study has demonstrated a compelling synergistic effect between glycogen and hyaluronic acid, resulting in significantly enhanced hydration (+199% within 1 hour). For an optimal result the level of HA in the vaginal care composition should be about 0.1wt% to about 0.3wt%.

[0042] • Preservatives are crucial for maintaining the safety of personal care compositions by effectively managing microbial contamination. Organic acids, alcohols, phenols and aldehydes are frequently employed as preservatives, playing a vital role in inhibiting the growth of bacteria, fungi, and moulds in substrates that could otherwise serve as a nutrient-rich environment for microbial contaminants. The preservatives system must have a broad spectrum of activity and be compatible with the product ingredients as well as being stable over the shelf-life and intended usage time. The effects of these compounds can influence the intimate natural microbiome. Ordinarily, the microbiome is at its healthiest when the population of bacteria is diverse. This is the case for the skin microbiome as well as the gut microbiome. However, the vaginal and vulvar microbiome act in an opposite way. When there is a high diversity in the vulvar and vaginal microbiome, it draws attention to an underlying problem that needs addressing. These microorganisms play a crucial role in both women's reproductive health and overall well-being. A healthy vaginal microbiota is characterized by a low-diversity environment, primarily consisting of lactic acid-producing Lactobacillus species. In females of reproductive age, it is noted that the Lactobacillus species is a key characteristic of a healthy vaginal microbiome. These include: L. iners, L. crispatus, L. gasseri, and L. jensenii. On the other hand, species such as Prevotella, Atopobium, Gardnerella, Megasphaera, and Mobiluncus are associated with an unhealthy or abnormal vaginal microbiota. A blend Potassium Sorbate / Sodium Benzoate is a preferred form of preservative.

[0043] • Avina sativa kernel extract (from oats). Oats are rich in beneficial compounds like the soluble fibre beta glucan, lipids, omega-3 fatty acids, and other cell-nourishing elements. It offers high levels of protective and soothing properties and should be at a level of around 0.3wt% to 1.0wt% of the vaginal care composition. • Buffering agent to achieve a pH level closer to that of the vulvar lining. Citric acid and lactic acid can be utilized as buffering agents, preserving the vaginal microbiome integrity.

[0044] • Thickening agent. A combination of Xanthan gum along with Hydroxyethyl cellulose and / or Carob Gum is a favourable option. These gums are considered safe for use in intimate areas of the body.

[0045] A preferred embodiment of the vaginal care composition according to the present invention comprises the following:-

[0046] The water provides a carrier for water soluble ingredients as well as a moisturization benefit.

[0047] This vaginal care composition fortifies the skin barrier, strengthens the microbiome and mimics the body's natural secretions and which is free from any harsh ingredients like fragrances and parabens.

[0048] The vaginal care composition provides a water-based intimate moisturiser, in gel form that is transparent, has no perfume and no taste. The vulva / vaginal pH friendly composition also has the following beneficial features:-

[0049] - iso-osmolar with vulvar / vaginal / perianal tissues

[0050] - sperm-friendly

[0051] - maintains a healthy vaginal flora - repairs and regenerates skin barrier

[0052] - improves moisturisation level

[0053] When used, the immediate benefit felt by users is a soothing and hydration (+200% within 1 hour) of the intimate area, providing instant comfort resulting from the combination of hyaluronic acid and glycogen. The composition mimics natural moisture while soothing the intimate area. With daily use in the short term (less than 4 weeks) a balanced vaginal pH level is maintained to minimize odour, itching and discomfort. Enhanced cellular activity with 83% increase in hyaluronic acid and 60% increase in collagen production. Thus, the cells are strengthened, enhancing elasticity and hydration. Continuing daily use of the composition into the long term (more than 4 weeks) shows increases skin density by 6% in 28 days, increases in skin hydration by 53.3% from baseline, and the supporting of a healthy vaginal microbiota to keep the intimate area moisturized and comfortable, reducing the risk of infections.

[0054] The composition also provides a preventative function to prevent intimate infections / problems like bacterial vaginosis, dryness, and irritation by supporting the microbiome and the cell strength and structure. There is also a reduction in the susceptibility to microtears and the discomfort that arises therefrom.

[0055] Referring to Figure 4, plant-based stem cells combined with an osmolality of 270 mOsm / kg of the composition helps repair and strengthen the cells while boosting collagen production (as shown by the lower line 14 of the graph of Figure 4). Advantageously, prebiotics, postbiotics, and lactic acid work together to maintain the skin's microbiome and pH balance (as shown by the middle line 16 of the graph of Figure 4). This targets unwanted odour, itchiness, urinary tract Infections, bacterial vaginosis, and yeast infections. Furthermore, the combination of hyaluronic acid and phytoglycogen for instant and long-lasting skin hydration results in a 200% increase in moisturisation within 1 hour of application (the upper line 18 of the graph in Figure 4). This reduces dryness, calms irritation, and relieves discomfort.

[0056] Hyper-osmolar (high osmolality) lubricants draw water out of cells, shrinking them until they slough off the surface. As the cells shrivel, they send out pro-inflammatory cytokines to the immune system and reduce anti-inflammatory signals. Rapid shedding of the outer layer of epithelial cells make the tissue susceptible to infectious agents like bacteria and viruses. Iso- osmolar (balanced osmolality) lubricants, on the other hand, do not change anything. When hypo-osmolar (low osmolality) lubricants are applied, fluid is drawn into the epithelial cells, causing them to swell. The present composition not only supports a healthy microbiome and fortifies cells, it also enhances sexual pleasure, and provides a comprehensive, intimate care solution.

[0057] The vaginal care composition may be provided, for example, in a manually spreadable form, such as a gel, serum, or the like. The vaginal care composition is preferably non-greasy, but still provides moisturisation and lubrication without negative effects on the user such as stickiness.

[0058] The vaginal care composition may be delivered to the intimate area by any suitable means known for applying such products, including manually with the hands and / or fingers, and / or with a delivery device. The user may dispense the vaginal care composition onto a finger, hand, and / or delivery device and then apply the vaginal care composition to the vaginal tissue. Additionally or alternatively, the user may dispense the vaginal care composition directly onto the target vaginal tissue and subsequently use a finger, hand, and / or delivery device to spread the vaginal care composition. Dispensing the vaginal care composition may include pouring, dipping, squeezing, and / or spraying from a container (e.g. tube, jar, bottle, spray bottle, aerosol). Non-limiting examples of delivery devices for applying a vaginal care composition can include gloves, swabs, wipes, sponges, plunger-type devices, and applicators. In one aspect, it may be preferred to use a delivery device to deliver the vaginal care composition because it can help keep the vaginal care composition from touching the user ’s hands.

[0059] A preferred applicator is one that that includes one or more replaceable composition subportions that can be inserted into and removed from a main applicator body. The applicator and sub-portions can be packaged together as an initial kit and the sub-portions sold separately as previous ones are used and need replacing. A significant rise in the amount of L. acidophilus is observed following the application of the composition and the blend of preservatives used (potassium sorbate / sodium benzoate) show no adverse effects on the bacteria.

[0060] Skin regeneration is a complex process that involves the renewal of skin cells, with keratinocytes and dermal fibroblasts serving vital functions in tissue repair and overall skin health.

[0061] Keratinocytes are the dominant cells in the epidermal layer of the skin and are responsible for synthesizing keratin, a key structural protein that confers strength and waterproofing properties to the skin. Dermal fibroblasts in the dermal or deeper layers of the skin produce collagen and elastin, the proteins that support skin structure and elasticity. These cell types collaborate in a combined manner to ensure effective tissue repair and the regeneration of skin cells.

[0062] Peptides can have an important role in maintaining skin health as some peptides possess the ability to stimulate collagen production. For example, Palmitoyl pentapeptide-4 (Pal-KTTKS) contains 5 amino acids linked to a 16-carbon aliphatic chain for improving the penetration of the molecule through lipid structures of the skin. Pal-KTTKS and similar peptides are recognised for their enhancement of collagen production. Peptides, such as Pal-KTTKS, acetyl tetrapeptide (Ac-PPYL), and copper peptide (GHK-Cu), are known for their regenerative characteristics. Pal-KTTKS is useful in skin revitalization; Ac-PPYL assists in skin hydration; and GHK-Cu has antioxidant properties.

[0063] Peptides play a crucial role in skin hydration through the enhancement of cellular energy (ATP) and the reduction of reactive oxygen species (ROS) responsible for skin damage. By bolstering cellular energy levels, peptides contribute significantly to optimizing skin function and sustaining adequate hydration levels. In this respect, synergism with the phytoglycogen in the composition could have further benefit in skin hydration. Well-hydrated skin functions optimally by supporting essential processes like collagen synthesis and maintaining the skin barrier's integrity. The addition of relevant peptides to the composition may therefore enhance the ability of the composition to restore and / or maintain a genital ecosystem.

[0064] Although the focus has been on describing herein a vaginal microbiome, the composition could also be useful for male users also and thus generally to a genital area.

Claims

CLAIMS1. A method of restoring and / or maintaining a healthy genital ecosystem comprising administering a genital care composition including:-• a postbiotic• plant-based glycogen ,and• plant-based stem cells.

2. A method according to claim 1, wherein the postbiotic is Lactobacillus Ferment Lysate.

3. A method according to claim 1 or 1, wherein the plant-based glycogen is isolated from non-GMO sweet corn.

4. A method according to any preceding claim, wherein the plant-based stem cells are a Lycium barbarum callus culture extract based on a plant stem cell culture of a goji seedling.

5. A method according to any preceding claim, the composition including one or more of:-(a) A prebiotic,(b) Sodium Hyaluronate,(c) At least one preservative,(d) Avina sativa kernel extract,(e) A buffering agent, and(f) A thickening agent.

6. A method according to any preceding claim, wherein the composition comprises a majority of water, and minor amounts of propanediol, Aloe Vera juice, oatmeal extract, hyaluronic acid, Lactobacillus Ferment Lysate, Lactic acid, xanthan gum, hydroxyethylcellulose, potassium sorbate, sodium benzoate, phytoglycogen, and Lycium Barbarum Callus culture extract.

7. A method according to any one of the preceding claims and comprising administering the vaginal care composition once a day.

8. A method according to any preceding claim, wherein the composition further comprises a peptide.

9. A method of restoring and / or maintaining a healthy vaginal ecosystem comprising a female user administering an amount of a vaginal care composition to her vaginal area and, optionally, one or more of her vulva, vestibule, labia majora, labia minora, or external urogenital tract; wherein the vaginal care composition comprises:-• a postbiotic• plant-based glycogen ,and• plant-based stem cells.

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