CN111655232A

CN111655232A - Methods and compositions for reducing vaginal dryness sensation

Info

Publication number: CN111655232A
Application number: CN201980009752.5A
Authority: CN
Inventors: 王诚奕; 拉里·理查德·鲁宾逊; 玛丽亚·A·弗里贝里; 斯科特·布莱恩·宾特里姆; 内里·瓦妮莎·布莱斯林; 凯拉·L·威尔森霍克; 拉斐尔·沃伦
Original assignee: Procter and Gamble Co
Current assignee: Procter and Gamble Co
Priority date: 2018-01-26
Filing date: 2019-01-25
Publication date: 2020-09-11
Also published as: WO2019147875A1; EP3743044A1; WO2019147877A1; CN111655234A; EP3743046A1

Abstract

The present invention provides a method of reducing the sensation of vaginal dryness. The method comprises a female user providing an amount of a vaginal care composition on at least a portion of an outer surface of an applicator and administering the amount of the vaginal care composition to her vaginal opening and optionally to one or more of her vulva, vaginal vestibule, labia majora, labia minora, or urogenital tract while grasping and manipulating the applicator. The vaginal care composition may comprise an oil-in-water emulsion and a thickening agent comprising a polyacrylamide polymer and a fatty alcohol.

Description

Methods and compositions for reducing vaginal dryness sensation

Technical Field

Methods and compositions for reducing the perception of vaginal dryness are described herein.

Background

It is estimated that by 2030, there will be about 12 million menopausal women and postmenopausal women worldwide. Given that the average age at which menopause occurs has remained constant and that women generally have an increased life expectancy, the number of postmenopausal women is expected to increase. Thus, there is an increasing interest in the conditions and symptoms experienced by peri-menopausal, and postmenopausal women, and the need for treatment is increasing.

Menopause is generally defined as the 12 months after the female's last menstruation. However, the process leading to menopause (commonly referred to as perimenopause) can be a progressive process. Peri-and menopause are known to be associated with hot flashes, night sweats, mood changes, stress, fatigue, irritability, and memory difficulties. Furthermore, menopause is associated with a decrease in estrogen production. A decrease in estrogen blood levels can lead to changes in both the internal and external genitalia (i.e., the vulva-vaginal region), including vaginal atrophy and thinning of the vaginal and urethral mucosa, loss of vaginal elasticity, and reduction of glandular secretions, which may be accompanied by a decrease in tissue hydration. It is estimated that up to 57% of perimenopausal and postmenopausal women suffer from vaginal atrophy. Vaginal atrophy can be beneficial for urogenital infections and can also lead to vaginal irritation, burning, dryness, itching, off-tastes, and pain during sexual intercourse (displeasure), thus greatly affecting the quality of life of women.

Various technical approaches have been proposed to address the above-mentioned vaginal conditions and symptoms. Prescription-based treatment regimens include hormone replacement therapy, which may include administering estrogen supplements with or without progesterone deep within the vaginal cavity. Although hormonal therapy has shown a positive effect in the treatment of vaginal atrophy, some women continue to experience menopausal symptoms and for many women such treatment costs have proven to be too high. Hormone replacement therapy is often limited by consumer fear and history of contraindications such as cancer and thromboembolic events. Furthermore, due to the nature of the condition, women may feel uncomfortable and/or embarrassed when discussing the above symptoms and may avoid seeking physician consultation. In addition, many women no longer visit gynecologists every year, making their primary care family physicians a major potential treatment resource, and primary care physicians often fail to address or treat menopausal symptoms, which are considered the "natural" part of aging.

Current over-the-counter routes to relieve the sensation of vaginal dryness include the administration of sexual lubricants (e.g., Rabolan) for reducing discomfort during sexual activity

Silky human body lubricant and mugwort

Gels and lubricants) or vaginal moisturizers (e.g.,

long-acting moisturizer and

a moisturizing topical comfort gel, or HyaloGyn/HyaloFemme, available from feidia pharmaceutical industries (Fidia faceutici SpA) and both provided with a disposable applicator for placement within the vaginal cavity).

While the foregoing over-the-counter techniques may be useful, some forms may not give preference to the female's sexual health or use experience. For example, current products are designed to act quickly to provide short-term relief on an as-needed basis (e.g., prior to sexual intercourse), and may not provide the desired long-lasting moisturization and lubricity. In addition, current methods of application (e.g., with the fingers) and marketing aesthetics (e.g., as a sexual aid) of vaginal moisturizers and sexual lubricants can also be barriers to women seeking treatment.

Moisturizers are known to generally rehydrate dry vaginal epithelial tissue and be absorbed into the epithelial cells, but do not provide the desired lubricity. In addition, current vaginal moisturizer products include mucoadhesive polymers that bind to and retain moisture on the vaginal epithelial cell surface to hydrate the underlying cells and are formulated for deep intravaginal administration. Such administration regimens typically involve depositing 3g to 6g of the vaginal moisturizer product deep in the vaginal cavity every three days. However, the administration of vaginal products in such dosage regimens is not suitable for easy-to-get habits. In addition, the large amount of product administered per dose can result in leakage of the product from the vaginal cavity, which can be undesirable and embarrassing to the consumer, and can affect the efficacy and desired use of the product. Plunger-type devices for delivering such products deep into the vaginal cavity can also be an additional mechanical irritant and can damage delicate tissues. Finally, it is believed that the tissue deep in the vaginal cavity lacks the sensitivity/innervation of the introitus/vulva and that mainly only "pressure" can be detected, without other sensations. As a result, the user may not experience any soothing benefits during or after application deep within the vaginal cavity. Without being limited by theory, it is believed that administration of the vaginal composition to the vaginal orifice and/or extra-vaginal tissue with the highest sensitivity and exhibiting the most signs of atrophy may provide greater relief from symptoms.

The role of the sexual lubricant is to provide rapid action, short term relief from sensation of vaginal dryness and associated pain during intercourse. For example, water and silicone based lubricants are designed to be used shortly before sexual activity, which may affect the overall experience and hinder spontaneity, and may not provide a lasting benefit as they are typically wiped or washed off after use. In addition, typical lubricants have low viscosity, making them difficult to apply to the desired location and prone to leakage from the application site. Silicone-based lubricants are also known to stain fabrics, which may be undesirable to consumers, and may be incompatible with silicone vaginal applicators or devices.

While it is known that vaginal atrophy and sensation of dryness may cause pain and discomfort in sexual life, few discuss vaginal atrophy may also cause discomfort and pain in daily activities such as walking, exercise or sitting/standing. Women suffering from vaginal atrophy reportedly experience vaginal dryness, which may cause vaginal tissue to stick together and/or to clothing, which may be uncomfortable and/or painful and may impede daily activities. Women with vaginal atrophy are limited to the type of clothing they can wear. Even jeans or tights may cause pain and discomfort. Furthermore, many women undergoing perimenopause and menopause are not in partner relationship nor engaged in sexual activity due to pain, lack of partner, self-esteem, or low libido resulting from estrogen deprivation, which makes sexual lubrication unnecessary.

Thus, there remains a need for improved methods and compositions to reduce the sensation of lubricable and soothing vaginal dryness, while simultaneously moisturizing and healing the tissue throughout the day without leaking from the application site or soiling clothing. In particular, there is a need for a daily method of reducing the sensation of vaginal dryness using smaller doses of vaginal compositions deposited on the introitus and optionally the extra-vaginal tissues that can help reduce pain/discomfort during daily activities.

Disclosure of Invention

A method of alleviating a sensation of vaginal dryness, the method comprising: (a) a female user providing an amount of a vaginal care composition onto at least a portion of an exterior surface of an applicator; and (b) administering at least a portion of the amount of the vaginal care composition to her vaginal opening and, optionally, to one or more of her vulva, vaginal vestibule, labia majora, labia minora, or external urogenital tract while grasping and manipulating the applicator; wherein the vaginal care composition comprises an oil-in-water emulsion and a thickening agent comprising a polyacrylamide polymer and a fatty alcohol.

A method of restoring vaginal moisture and lubrication comprising administering a vaginal care composition to a female user in need thereof; wherein the vaginal care composition comprises: (a) an oil-in-water emulsion; (b) a thickener comprising a polyacrylamide polymer; and (c) hyaluronic acid or a salt thereof; wherein the vaginal care composition has a viscosity of from about 20,000cps to about 200,000 cps.

A kit for alleviating the perception of vaginal dryness, the kit comprising: a vaginal care composition, and an applicator for applying the vaginal care composition to the vaginal opening and optionally to extra-vaginal tissue; wherein the vaginal care composition comprises an oil-in-water emulsion and a thickener comprising a polyacrylamide polymer and a fatty alcohol.

A method of alleviating a sensation of vaginal dryness, the method comprising: (a) a female user providing an amount of a vaginal care composition onto at least a portion of an applicator; and (b) administering at least a portion of the amount of the vaginal care composition to her vaginal area while grasping and manipulating the applicator; wherein the vaginal care composition comprises an oil-in-water emulsion and a thickener comprising a polyacrylamide polymer and a fatty alcohol.

Drawings

While the specification concludes with claims particularly pointing out and distinctly claiming the invention, it is believed that the present invention will be better understood from the following description in conjunction with the accompanying drawings, in which:

FIG. 1 is a front view of one embodiment of a kit including a pouch, a dispenser of a vaginal care composition, and an applicator;

FIG. 2 is a perspective top view of the applicator of FIG. 1; and

fig. 3 is a front view of the applicator of fig. 1 standing upright on a surface.

Detailed Description

Consumers are seeking improved methods of reducing vaginal dryness that can provide long lasting moisturization and lubrication using once daily application regimens with products having a non-sticky texture without the need for conventional sexual lubricants used each time symptoms or discomfort are felt. However, it is challenging to formulate a vaginal product that provides long lasting moisturization and lubrication while having a consumer acceptable rheology and feel.

Current vaginal products typically use rheology modifiers (e.g., carbomers and carbopols) that act as mucoadhesives to increase the viscosity of the product and retain water on the epithelial surface. Without wishing to be bound by theory, it is believed that the mucoadhesive rheology modifier derives its adhesion from the large amount of hydrogen bonding to the-COOH, -COOH salts and-OH moieties of the mucosal tissue, and the mostly linear, flexible backbone of the polymer maximizes the interaction between the hydrogen bonding groups and the mucosal tissue. Commonly used rheology modifiers are generally composed of acrylate and/or methacrylate monomers which, when the polymer undergoes hydrolysis, can form salts of-COOH and can further improve the mucoadhesion of the polymer. However, female users have reported that mucoadhesive polymers feel tacky when used in vaginal products, which may be undesirable. This texture may be unacceptable to some consumers, resulting in reduced dose compliance or complete avoidance of the vaginal product.

Hyaluronic acid is a natural lubricating and moisturizing substance found around the skin and joints and is widely used in skin care and medical products due to its biocompatibility, hydration, and mucoadhesiveness. However, commercially available hyaluronic acid undergoes significant degradation in an acidic environment, particularly at body temperature (about 37 ℃). This degradation results in a reduction in the molecular weight of the hyaluronic acid and a corresponding reduction in its viscosity. Thus, the lubricating effect of hyaluronic acid is generally short in duration. Furthermore, it is known that hyaluronic acid vaginal lubricants may degrade upon storage, resulting in a limited shelf life. However, without being limited by theory, it is believed that increasing the concentration of hyaluronic acid may result in poor textural properties and may increase the cost of the product.

It has been surprisingly found that a vaginal care composition comprising an oil-in-water solution, hyaluronic acid or a salt thereof, and a non-mucoadhesive thickener maintains sufficient viscosity even under acidic pH and temperature conditions of the vaginal environment, while still providing long lasting moisturization and lubrication without stickiness. In particular, it has been found that vaginal care compositions comprising an oil-in-water emulsion, hyaluronic acid or a salt thereof, and a thickener comprising a polyacrylamide polymer can be applied daily to the vaginal introitus and optionally the extravaginal tissue to provide a moist and lubricious feel for a full day, even after wiping and/or urination, thereby making daily activity more comfortable.

Without being limited by theory, it is believed that the polyacrylamide polymers defined herein are non-mucoadhesive in that they are substantially free of-COOH, -COOH salts and-OH moieties and are crosslinked using monomers having two or more vinyl moieties. The cross-linking agent may limit the conformational flexibility of the polymer and reduce the possible conformation of interaction with mucosal tissue. In addition, acrylamide monomers are not readily hydrolyzed, and if they do undergo hydrolysis, primary amine groups will be produced that do not readily interact with mucosal tissue. In addition, the thickener may also contain fatty alcohols that can create a lamellar gel network that can thicken the formulation without mucoadhesion. It is believed that fatty alcohols can create asymmetric structures that can bind water and establish rheology.

It was found that the vaginal care compositions described herein can have sufficient viscosity to allow application to the body without mess (i.e., it can stay on the applicator/finger during application without dripping), but can also shear and melt upon application, thus spreading smoothly on the body. Oil-in-water emulsions allow the formulation to have both a humectant in the oil phase and a water soluble vaginal care agent in the same formulation, which can provide acute moisturization and chronic healing. The combination with an aesthetically pleasing acute sensation (smooth application) stimulates daily use, which is important for chronic healing, especially at the most sensitive/innervated vaginal opening/vulva.

Described herein is a vaginal care composition comprising an oil-in-water emulsion, hyaluronic acid or a salt thereof, and a thickener comprising a polyacrylamide polymer, which can be applied to the vaginal orifice and optionally, one or more of the vulva, the vaginal vestibule, the labia majora, the labia minora, and/or the urogenital tract to reduce the sensation of vaginal dryness. In one aspect, the vaginal care composition can provide relief of vaginal dryness sensation for about 3 hours to about 48 hours, alternatively about 4 hours to about 40 hours, alternatively about 6 hours to about 36 hours, alternatively about 12 hours to about 24 hours. Also described herein is a kit comprising a vaginal care composition and a delivery device, such as an applicator, for administering the vaginal care composition.

All percentages are by weight of the vaginal care composition unless otherwise specifically indicated. All ratios are weight ratios unless otherwise specifically noted. All ranges are inclusive and combinable. The upper and lower limits of the ranges described are interchangeable to further form ranges not explicitly described. The number of significant figures indicates that neither a limitation of the indicated quantity nor a limitation of the accuracy of the measurement is expressed. All numerical values should be understood as modified by the word "about" unless otherwise specifically indicated. Unless otherwise indicated, all measurements are understood to be made at about 25 ℃ and at ambient conditions, where "ambient conditions" refers to conditions at about 1 atmosphere of pressure and at about 50% relative humidity.

The compositions of the present disclosure may comprise, consist essentially of, or consist of the components described herein, as well as optional ingredients. As used herein, "consisting essentially of means that the applicator, composition or component may contain additional ingredients or features, but only if the additional ingredients or features do not materially alter the basic and novel characteristics of the claimed applicator, composition or method. As used in the specification and in the claims, the singular form of "a", "an", and "the" are intended to include the plural form as well, unless the context clearly indicates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

As used herein, "aromatic alcohol preservative" includes molecules that contain at least one benzyl moiety, a single hydroxyl moiety, and no carboxylate groups. The hydroxyl moiety is directly bonded to the benzyl moiety or is located on the side chain.

As used herein, "estrogenic agent" means any natural or synthetic estrogen (e.g., estrogen, estradiol, and estriol), metabolite of estrogen, ester of estrogen, analog of estrogen, phytoestrogen (e.g., isoflavone, coumestrol, prenylflavonoid), estrogen precursor (e.g., dehydroepiandrosterone), and/or any compound that binds to an estrogen receptor or otherwise exhibits at least a moderate or weak estrogen-like effect, including selective estrogen receptor modulators ("SERMs") such as, for example: africaxifen (4-hydroxy tamoxifen), arzoxifene (arzoxifene), bazedoxifene, clomiphene, nonmolrey (femarelle) (DT56a), lasofoxifene, oxybenzoxifene, raloxifene, tamoxifen, toremifene, mifepristone (RU486), VA2914, ulipristal, proroelle (Proellex), asolinil (Asoprisnil), and CDB-4124.

As used herein, "graspable portion" means a portion having an external shape and size that can be grasped by 2 or more fingers of a human hand to manipulate the applicator in use.

As used herein, "introitus" means the opening of a human vagina that extends 35 millimeters (mm) from the entrance to the vaginal cavity.

As used herein, "preservative enhancing agent" means any molecule that is not registered by a suitable regulatory agency as a preservative for use in cosmetic compositions, but that exhibits improved antibacterial, antimicrobial or antifungal benefits when included in an oil-in-water vaginal care composition.

As used herein, "mucoadhesion" refers to a phenomenon in which natural or synthetic substances applied to the mucosal epithelium adhere to the mucosal layer (typically creating a new interface). Generally, mucosal adhesion can be achieved via physical or chemical processes, or both.

As used herein, a "perimenopausal" woman refers to a woman who, without hormone replacement therapy or other medical treatment, would experience an alteration in the inter-cycle interval and have symptoms associated with estrogen deficiency such as vasomotor flushing, vaginal dryness and/or increasingly severe premenstrual syndrome. Also included are women who will experience less than 12 months of amenorrhea without hormone replacement therapy or other medical treatment.

As used herein, "pharmacologically effective amount," "therapeutically effective amount," or simply "effective amount" means an amount of a composition or component thereof effective to produce a desired pharmacological, therapeutic, or prophylactic result.

As used herein, a "postmenopausal" woman is one who will experience at least 12 months of amenorrhea without hormone replacement therapy or other medical treatment.

As used herein, "progestin" means any natural or synthetic progestin hormone, metabolite of progestin hormone, analog of progestin hormone, progestin precursor, and/or any compound that binds to progestin receptors or otherwise exhibits at least moderate or weak progestin-like effects, including selective progestin receptor modulators ("SPRMs") such as, for example, telapristone (telapristone).

As used herein, "rotationally symmetric" means that the applicator or a portion thereof, such as the insertion portion or the graspable portion, has an overall shape that appears the same when rotated an angle (e.g., 45 °, 90 °, 135 °, 180 °, 225 °, 270 °, 315 °, or 360 °) about its longitudinal axis. For example, an applicator having an overall shape that appears to be the same when rotated 45 ° is considered rotationally symmetric when rotated 45 °. Also, an applicator having an overall shape that appears the same when rotated one revolution is considered to be 360 ° rotationally symmetric. Unless otherwise indicated, rotational symmetry as referred to herein ignores surface features such as printing, coloring, coatings, text, graphics, drug delivery markings, insertion markings, surface texture, and surface ornamentation.

As used herein, "substantially free" means that a component or material is present in an amount of less than about 0.1%, 0.05%, 0.025%, 0.01%, or 0.001% by weight of the vaginal care composition.

As used herein, "tapered" means becoming smaller toward one end. The applicator or a feature thereof such as the insertion portion may have a taper that is gradual, substantial, intermittent, continuous, and combinations thereof. For example, the taper from the maximum width to the tip is considered only when the body cross-sectional area of the applicator at the tip (e.g., including both the solid cross-sectional area and the void cross-sectional area) is less than the body cross-sectional area at the maximum width, even though, for example, the body cross-sectional area may intermittently increase or remain constant between the maximum width and the tip.

As used herein, "treatment" refers to relief or alleviation.

As used herein, "vaginal region" means the vaginal cavity and vulva (or external genitalia), a generic term for the external female reproductive organs found in the perineal region, including the vulva, introitus, vaginal vestibule, labia majora, labia minora, external urogenital tract, urethral meatus, clitoris, and vulvar skin, said region being bounded longitudinally by the pubic bone and anus and laterally by the genital folds. .

As used herein, "vaginal cavity" refers to tissue adjacent to the introitus.

As used herein, "vaginal care composition" means any composition suitable for application to the introitus and/or vulva, vaginal vestibule, labia majora, labia minora, and/or one or more of the external urogenital tract and useful for treating or reducing vaginal dryness.

Vaginal care composition

The vaginal care compositions described herein are suitable for application to the vaginal orifice and optionally to the extravaginal tissue. The vaginal care composition is preferably non-irritating and substantially free of ingredients that are less suitable for application to these tissues.

The vaginal care composition may comprise a preservative system comprising one or more preservatives and a preservative enhancer. A preservative is understood to be a chemical or natural compound (or combination of compounds) that can help inhibit microbial growth, thus protecting the consumer and/or extending the shelf life of the composition in the intended product use. In one aspect, the preservative may be non-irritating when applied to the introitus/vestibule. The preservative may be selected from the group consisting of aromatic alcohol preservatives, organic acid preservatives, salts thereof, and combinations thereof.

Organic acid preservatives are organic molecules having at least one carboxyl group. In one aspect, the organic acid preservative may be water soluble and may have an ambient water solubility of at least 0.1g/100ml of water, or at least 0.5g/100ml of water, or at least 1g/100ml of water. Non-limiting examples of organic acid preservatives can include glutamic acid, malonic acid, phthalic acid, fumaric acid, formic acid, malic acid, heptanoic acid, ascorbic acid, oxalic acid, succinic acid, glutaric acid, adipic acid, propionic acid, butyric acid, valeric acid, caproic acid, pimelic acid, sebacic acid, acetic acid, carbonic acid, lactic acid, salicylic acid, benzoic acid, sorbic acid, citric acid, 4-hydroxybenzoic acid, dehydroacetic acid, undecylenic acid, salts thereof, and mixtures thereof. Salts of the organic acid preservatives can include any cationic counterion. Non-limiting examples of organic acid preservative salt counterions can include sodium ions, ammonium ions, calcium ions, magnesium ions, potassium ions, and silver ions. In one aspect, the organic acid preservative may be selected from the group consisting of salicylic acid, benzoic acid, sorbic acid, citric acid, propionic acid, 4-hydroxybenzoic acid, dehydroacetic acid, formic acid, undecylenic acid, salts thereof, and mixtures thereof. In one aspect, the organic acid preservative may be selected from the group consisting of benzoic acid, sodium benzoate, citric acid, sodium citrate, sodium salicylate, salicylic acid, sorbic acid, and mixtures thereof. In one approach, a combination of an acid and a salt of the same organic acid preservative may be used, such as citric acid and sodium citrate. In one aspect, a combination of two or more organic acid preservatives may be used, such as citric acid, sodium citrate, and sodium benzoate. Without being limited by theory, it is believed that the combination of acid and salt forms of the same organic acid preservative may render the vaginal care composition acidic while still providing a buffering system.

The preservative may be an aromatic alcohol preservative. Non-limiting examples of aromatic alcohol preservatives can include biphenyl-2-ol, butyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, methyl 4-hydroxybenzoate, triclosan, chloroxylenol, o-methyl isopropylbenzene-5-ol, benzyl chlorophenol, dichlorobenzyl alcohol, phenoxyethanol, benzyl alcohol, phenoxyisopropanol, benzyl hemiformal, and combinations thereof. In one aspect, the aromatic alcohol preservative may be selected from the group consisting of benzyl alcohol, phenoxyethanol, propyl 4-hydroxybenzoate, ethyl 4-hydroxybenzoate, and combinations thereof.

The vaginal care composition may comprise less than about 3%, alternatively less than about 2%, alternatively less than about 1.8%, alternatively less than about 1.6%, by weight of the vaginal care composition, of preservatives. The vaginal care composition may comprise from about 0.1% to about 3%, alternatively from about 0.5% to about 2%, alternatively from about 1.2% to about 1.6%, by weight of the vaginal care composition, of a preservative.

The vaginal care composition may comprise less than about 3%, alternatively less than about 2%, alternatively less than about 1.8%, alternatively less than about 1.6%, by weight of the vaginal care composition, of a preservative system. The vaginal care composition may comprise from about 0.1% to about 3%, alternatively from about 0.5% to about 2%, alternatively from about 1.2% to about 1.6%, by weight of the vaginal care composition, of a preservative system.

In one aspect, the vaginal care composition may comprise a preservative enhancer. The preservative enhancer may comprise sorbitan caprylate. In one aspect, the preservative enhancer consists essentially of sorbitan caprylate. Exemplary sorbitan octanoates are produced by Clariant (Muttenz, Switzerland) and by Clariant (r) of moonton, Switzerland

SC is manufactured under the name SC. The vaginal care composition may comprise from about 0.01% to about 3%, alternatively from about 0.01% to about 1%, alternatively from about 0.05% to about 0.8%, alternatively from about 0.1% to about 0.3%, by weight of the vaginal care composition, of a preservative enhancer.

In one aspect, the preservative enhancer may be substantially free of glycol. Without being limited by theory, it is believed that certain levels of diol may be irritating to the vaginal area, particularly the vaginal orifice.

The preservative system may also comprise additional compounds, for example chelating agents such as ethylenediaminetetraacetic acid (EDTA) and salts thereof, or diethylenetriaminepentaacetic acid (DTPA) and salts thereof.

In one aspect, the vaginal care composition can have a pH of from about 4.0 to about 5.5, preferably from about 4.3 to about 5.0, more preferably from about 4.4 to about 4.8. One advantage of using a pH in this range is that the pH of the vaginal care composition will approach the pH of the vaginal opening. It is believed that if the pH is below this range, the composition will have irritation to the introitus/extravaginal tissue. It is believed that if the pH is above this range, the preservative system may not be sufficiently effective and higher levels of preservative system and/or additional preservatives may be required to prevent microbial growth.

The vaginal care composition may be provided, for example, in the form of a spreadable gel, serum, lotion, paste, or cream. In one aspect, the vaginal care composition may be in the form of an oil-in-water emulsion. Oil-in-water emulsions can provide a light and thin, non-greasy sensory feel, yet deliver moisturization and lubricity without the aesthetic negatives such as stickiness or heavy residue typically associated with oil-based compositions and/or mucoadhesive ingredients. Additionally, the vaginal care composition may further comprise one or more vaginal care agents. The vaginal care composition may comprise one or more water soluble ingredients.

The vaginal care composition may comprise water, one or more oils, and optionally one or more vitamins and/or provitamins (e.g., substances that can be converted to vitamins by metabolic processes), one or more thickeners, one or more emulsifiers, one or more humectants, one or more lubricants (which may also be in the form of oils), one or more moisturizers (which may also be in the form of oils), one or more sensory modifiers (e.g., particulates, powders, and film formers). The vaginal care composition preferably provides suitable viscosity, dry feel, moisturizing/nourishing benefits, suitable lubricity, and/or vaginal health benefits.

The vaginal care composition may comprise water in an amount greater than about 50%, or greater than about 60%, or from about 50% to about 95%, or from about 60% to about 90%, or from about 65% to about 80%, by weight of the vaginal care composition. Water can provide a carrier for water soluble ingredients as well as moisturizing benefits.

The vaginal care composition may comprise one or more moisturizers. Moisturizers help the skin to maintain a soft, smooth appearance. Moisturizers can be deposited on the skin and remain on the surface as a thin protective layer, providing moisturizing and/or lubricating benefits. Non-limiting examples of the moisturizer can include vegetable oils, hydrocarbon oils, fatty acids, esters of mono-and/or di-and/or tri-and/or polycarboxylic acids with mono-and polyhydric alcohols, polyoxyethylene, polyoxypropylene, mixtures of polyoxyethylene and polyoxypropylene ethers of fatty alcohols, and mixtures thereof. The vaginal care composition may comprise less than about 30%, alternatively from about 1% to about 20%, alternatively from about 5% to about 15%, alternatively from about 10% to about 15%, by weight of the vaginal care composition, of a humectant. The vaginal care composition may comprise from about 0.05% to about 5%, alternatively from about 0.1% to about 2%, alternatively from about 0.2% to about 1%, by weight of the vaginal care composition, of a humectant.

In one aspect, the vegetable oil may be derived from one or more plant source materials, such as leaves, roots, bark, stems, flowers or seeds of a plant. The vegetable oil can be seed oil, shell oil, flower oil or leaf oil. The vegetable oil may comprise polyunsaturated fatty acids, preferably omega-3 (e.g., alpha-linolenic acid) and/or omega-6 fatty acids. The vegetable oil can be coconut oil, evening primrose oil, sunflower oil, safflower oil, and combinations thereof, which contain omega-3 and/or omega-6 fatty acids. Other non-limiting examples of suitable vegetable oil materials may include oleic canola (oleic canola) oil (brassica campestris), brassica napus (b.napus), turnip (b.rapa), characterized by having an oleic content of greater than 70%, such as high oleic rapeseed oil, very high oleic rapeseed oil, or partially hydrogenated rapeseed oil), horse-vine nut oil (Sclerocarya birrea), palm oil (Elaeis Guineensis) oil), palm olein, palm stearin, palm super olein, pecan oil, pumpkin seed oil, sesame oil (sesamem indicum), wax (s.oreiantate), soybean oil (soybean (glycmax), such as high oleic soybean oil, low linoleic soybean oil, partially hydrogenated soybean oil), and mixtures thereof. The vaginal care composition may comprise from about 0.05% to about 5%, alternatively from about 0.1% to about 2%, alternatively from about 0.2% to about 1%, by weight of the vaginal care composition, of a vegetable oil.

The vaginal care composition may also comprise one or more silicone oils. Silicone oils are liquids comprising one or more polymeric siloxanes or silicone polymers (e.g., polysiloxanes, Polydimethylsiloxane (PDMS), and combinations thereof). The silicone oil may comprise polydimethylsiloxane, dimethiconol (high molecular weight silicone gum), and combinations thereof, one example being Dow corning (Dow)

)1503 fluid (available from Dow Corning Corp.) which contains a combination of polydimethylsiloxane and dimethiconol. The vaginal care composition may comprise from about 0.1% to about 4%, alternatively from about 0.5% to about 3%, alternatively from about 1% to about 3%, by weight of the vaginal care composition, of silicone oil. One advantage of including silicone oil is that it can provide a lubricating benefit. This may be important because silicone oil may impart acute benefits during sexual activity which may produce pain without lubricating components. Silicone oils may also impart acute benefits during and after application; the lubricating benefit allows the product to slide and smear easily during application and lubricate vaginal tissue during daily activities.

The vaginal care composition may comprise one or more vaginal care agents for providing vaginal health benefits. Vaginal care agents may include vitamins, provitamins, and combinations thereof. Non-limiting examples of vaginal care agents may be niacinamide, panthenol, vitamin B3, vitamin B5, vitamin E, and derivatives thereof. In one aspect, the vaginal care agent is selected from the group consisting of: niacinamide, panthenol, and combinations thereof. The vaginal care composition may comprise from about 0.1% to about 7%, alternatively from about 0.5% to about 6%, alternatively from about 2% to about 5%, by weight of the vaginal care composition, of a vitamin and/or provitamin.

The vaginal care composition may comprise one or more humectants such as glycerol. The humectant may be provided in an amount of from about 0.1% to about 20%, or from about 1% to about 15%, or from about 8% to about 12%, by weight of the vaginal care composition. Alternatively, the humectant may be provided in an amount of from about 0.1% to about 5%, alternatively from about 0.5% to about 1%, by weight of the vaginal care composition. Other wetting agents that may be provided include other polyhydric alcohol polyethylene glycols, any form of aloe vera gel, hyaluronic acid or salts thereof, and combinations thereof. The humectant can provide a moisturizing benefit. Without being limited by theory, it is believed that this moisturizing benefit may be important in vaginal use situations because the moisture in the vaginal tissue must be retained throughout the day, even after urination and wiping. In one aspect, the vaginal care composition can comprise from about 0.1% to about 2%, alternatively from about 0.3% to about 1%, hyaluronic acid or salt thereof, by weight of the vaginal care composition. It has previously been thought that hyaluronic acid or salts thereof in skin care compositions in amounts above about 0.1% may leave an undesirable sticky residue on the skin. However, it has been surprisingly found that hyaluronic acid or a salt thereof can be used in vaginal care compositions at levels greater than about 0.1% without feeling tacky.

In one aspect, the hyaluronic acid or salt thereof may have a weight average molecular weight of about 0.5-1.3 megadaltons (Mda), alternatively about 0.75Mda to about 1 Mda.

The vaginal care composition may also include one or more silicone particles to impart desired sensory characteristics to the vaginal care composition. In some embodiments, the vaginal care composition may comprise silicone particles (e.g., polymethylsilsesquioxane) having an average particle size of from about 1 μm to about 15 μm, alternatively from about 2 μm to about 10 μm, alternatively from about 4 μm to about 8 μm. The particles may be in the form of monodisperse microspheres. Polymethylsilsesquioxane particles are sometimes referred to as silicone resins. Some non-limiting examples of polymethylsilsesquioxanes may include those from the Momentive Performance Materials, Inc. (Waterford, NY) McSt

Series of which comprise

2000、

145、

150、

1320, etc. One advantage of including silicone particles is thatThe particle size and characteristics of the particles can impart a dry feel upon application. Without being limited by theory, it is believed that the silicone particles may also aid in ease of applying, rubbing or otherwise applying the vaginal care composition to the vaginal tissue of interest. The vaginal care composition may comprise from about 0.01% to about 3%, alternatively from about 0.1% to about 1.25%, alternatively from about 0.2% to about 0.75%, by weight of the vaginal care composition, of silicone particles.

The vaginal care composition may also include a silicone wax. Silicone waxes are materials containing at least one silicon atom that are solid or semi-solid at room temperature. In one aspect, the silicone wax may have a melting temperature in the range of about 24 ℃ to about 105 ℃, or about 25 ℃ to about 40 ℃, or about 28 ℃ to 35 ℃. The melting temperature of a silicone wax can be measured according to the drop melting point method of ASTM D127 (1 month and 1 day 2015).

In one aspect, the silicone may be an organopolysiloxane having the following formula (I):

wherein:

R₉、R₁₁and R₁₂Independently of one another from (C)₁-C₃₀) Alkyl moiety, (C)₁-C₃₀) Alkoxy moieties and (C)₆-C₃₀) (ii) an aryl moiety, wherein,

R₁₀is selected from (C)₂-C₃₆) Alkyl moiety, (C)₂-C₃₆) Alkoxy moiety, ester-substituted (C)₂-C₃₆) Alkyl moiety and (C)₂-C₃₆) Alkoxy moiety when Z is (C)₂-C₃₀) Alkyl moiety, (C)₂-C₃₀) Alkoxy moieties and (C)₂-C₃₀) At the time of esterification, R₁₀It is also possible for the moiety to be a methyl group,

z is selected from (C)₁-C₃₀) Alkyl moiety, (C)₁-C₃₀) Alkoxy moiety, (C)₆-C₃₀) Aryl moiety and (C)₁-C₃₀) (ii) an ester, wherein the ester is,

u is 0 or an integer between 1 and 100, and

v is an integer between 3 and 100.

Non-limiting examples of suitable silicon waxes include those from the winning Industrial group of Evonik industries AG (Essen, Germany), Evonik

Alkyl silicones of the Wax series, including ABIL Wax 2434 (stearyloxypolydimethylsiloxane),

Wax 2440 (behenoxy polydimethylsiloxane) and

Wax9810P(C_24-28alkyl polydimethyl siloxane). Additional examples of suitable silicone waxes include Dow Corning corporation (Carrollton, KY), both from Dow Corning Corp

2503 wax (stearyl dimethicone and octadecene), Dow

SW-8005C30 resin wax (C)_30-45Alkyl dimethylsilyl polypropylsilsesquioxane) and Dow

580 waxes (stearyloxytrimethylsilane and stearyl alcohol), VP1622 (stearyloxypolydimethylsiloxane) from Wacker chemical AG (Munich, Germany), Munich, Germany. Preferred silicone waxes include semi-solid waxes such as

L118 (stearyl dimethicone), available from sitateh chemical company, Toronto, Ontario, Canada, has a melting temperature of about 30 ℃.

The vaginal care composition may comprise from about 0% to about 20%, alternatively from about 0.1% to about 10%, alternatively from about 0.5% to about 5%, by weight of the vaginal care composition, of silicone wax. It may be preferred that the temperature of the vaginal region when masked (e.g., under clothing) is generally warmer than the exposed skin, such as hands and face, using a silicone wax that is solid or semi-solid at room temperature but melts when applied to the body, particularly the vaginal region. One advantage of using such silicone waxes is that they can leave a residue on vaginal tissue due to softening or melting during application to provide preferred textural characteristics. It is also believed that the silicone wax provides a smooth coating feel to the vaginal tissue, which reduces the pain caused by friction throughout the day.

The vaginal care composition may further comprise one or more emulsifiers. Some non-limiting examples of emulsifiers may include cationic surfactants, anionic surfactants, nonionic surfactants, polyethylene glycols, polypropylene copolymers, alkyl glucosides, ethoxylated fatty acids, and combinations thereof. The vaginal care composition may comprise from about 0.005% to about 5%, alternatively from about 0.01% to about 3%, alternatively from about 0.1% to about 1%, by weight of the vaginal care composition, of an emulsifier. In one aspect, the emulsifier may be polyethylene glycol (PEG)100 stearate.

The vaginal care composition may comprise one or more thickening agents. The thickener may be provided in combination with other ingredients in amounts that facilitate achieving the desired viscosity. The thickening agent may be provided in an amount of from about 0.5% to about 10%, alternatively from about 1% to about 8%, alternatively from about 1.5% to about 5%, by weight of the vaginal care composition. One advantage of including such a level of thickener is that it may help provide sufficient viscosity to allow the vaginal care composition to be applied to a portion of the outer surface of a delivery device, such as an applicator, and administered to the vaginal orifice and optionally the extra-vaginal tissue. If the viscosity is too low, the vaginal care composition may be difficult to apply to the delivery device and/or to the body, creating a mess on the hands and on the counter, which may not be acceptable to the consumer. Without being limited by theory, it is also believed that a vaginal care composition having this level of thickener will remain on the vaginal tissue, thus providing a longer term moisturization benefit. It is believed that vaginal care compositions with lower levels of thickening agent may dry too quickly after application, thereby hindering the ability of the vaginal care composition to provide the desired vaginal health benefits. Vaginal care compositions with higher levels of thickener may be difficult to drain from the package, difficult to apply with minimal force, or may be difficult to wash off or remove from the delivery device surface and/or hands.

In some instances, it may be desirable for the vaginal care compositions herein to not include thickeners and/or other materials having hydroxyl or carboxyl functional moieties that may impart undesirable sensory properties (e.g., stickiness, heavy residual feel, non-lubricious feel) when applied to the labia and/or vaginal opening. Accordingly, it may be desirable to formulate the vaginal care compositions herein to be substantially free of such materials. Some non-limiting examples of mucoadhesive materials that may not be desired for use herein may include polyacrylates (e.g., Makimouse-21 and-25 brand sodium polyacrylate starch from Kobo), carbomers (e.g., from Lubrizol)

) Polycarbophil (e.g., from Lubrizol)

) Poly (methyl vinyl ether/maleic anhydride) copolymers, acidic synthetically modified natural polymers (e.g., carboxymethylcellulose), basic amine-bearing polymers (e.g., chitosan); acidic polymers obtainable from natural sources (e.g., alginic acid, pectin, tragacanth gum and karaya gum); and neutral synthetic polymers (e.g., polyvinyl alcohol and polyvinyl pyrrolidone).

In one aspect, the thickening agent may be non-mucoadhesive. In one aspect, the thickener may be selected from the group consisting of polyacrylamide polymers, fatty alcohols, and mixtures thereof. In one aspect, the thickener may comprise a polyacrylamide polymer and a fatty alcohol.

As used herein, "polyacrylamide polymer" refers to a polymer derived from at least one acrylamide, methacrylamide, alkylacrylamide, or alkylmethacrylamide monomer. The polyacrylamide polymer may be a homopolymer or a copolymer and is linear, branched or crosslinked. Suitable monomers for synthesizing polyacrylamide polymers may include acrylamide, methacrylamide, alkyl acrylamides, alkyl methacrylamides, anionic acrylamides, N-vinyl pyrrolidone, and mixtures thereof. It may be preferred that the polyacrylamide polymer be synthesized from at least about 50 wt%, or at least about 70 wt%, or at least about 90 wt% acrylamide, methacrylamide, and mixtures thereof.

Alkyl acrylamides and alkyl methacrylamides in which the amide nitrogen is replaced by a C₁To C₂₀Alkyl or two C₁To C₈Alkyl (preferably methyl, ethyl or propyl) substituted monomers including N-methylacrylamide, N-methylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, N-octylacrylamide, N-tert-butylacrylamide, N-phenylacrylamide, N-sec-butylacrylamide, N-dimethylmethacrylamide and N, N-dimethylacrylamide. The polyacrylamide polymer may be synthesized using about 0 wt% to about 25 wt%, alternatively about 0.1 wt% to about 15 wt%, alternatively about 0.5 wt% to about 10 wt% of an alkyl acrylamide or alkyl methacrylamide monomer.

Anionic acrylic monomers may include acrylamidoalkylsulfonic acids and salts thereof. Preferred examples are 2-acrylamido-2-methylpropanesulfonic acid and salts thereof. The polyacrylamide polymer may be synthesized using about 0 wt% to about 10 wt%, alternatively about 0.1 wt% to about 5 wt%, alternatively about 0.25 wt% to about 2 wt% of an acrylamidoalkylsulfonic acid monomer or a salt thereof.

The polyacrylamide polymer may be synthesized using, or substantially free of, less than about 10 wt% or less than about 5 wt% of acrylate, methacrylate, maleic anhydride, and/or vinyl acetate monomers. The polymer synthesis is more preferably free of acrylic and methacrylic monomers. Without being limited by theory, polymers with strong hydrogen bonding groups such as-COOH, -COOH salts and-OH may cause the polymer to behave mucoadheringly. Acrylic and methacrylic acid contain-COOH moieties, while acrylate, methacrylate, maleic anhydride and vinyl acetate monomers, when hydrolyzed, will also contain these hydrogen bonding moieties.

The polyacrylamide polymer may also contain a cross-linking agent. Suitable crosslinkers are molecules having two or more, preferably two to four, vinyl moieties. Suitable crosslinking agents may include N, N' -methylene-bisacrylamide, divinylbenzene, triallylamine, trimethallylamine, allyldimethallylamine, diallylmethallylamine, butadiene, 1, 7-octadiene, allyl-acrylamide, allyl-methacrylamide, bisacrylamide acetic acid, salts thereof, and mixtures thereof. One preferred crosslinking agent is N, N' -methylenebisacrylamide. In one aspect, the crosslinking agent may be present at a level of from about 25 to about 250,000ppm, alternatively from about 50 to about 100,000ppm, alternatively from about 100 to about 50,000 ppm.

The polyacrylamide polymer may have a weight average molecular weight in the range of greater than about 1,000,000g/mol, preferably greater than about 1,5000,000g/mol, and may be up to about 30,000,000 g/mol.

Suitable polyacrylamide polymers may include

EZ 7 and

EZ PFCs (available from The Innovation Company, Dreux Cedex, France, de la, de,

E-5 and

305 (available from California)Custom materials, Inc. (CustomIngredients, Inc., San Clemente, Calif.)) (see FIGS. Saint Palmann, Japan),

ETP305 and

ETP505 (available from south west Coast inc, plantatia, CA) of pleisenia, california), florcare from SNF s.a.s. of france^TMT920 GC (France), Hallgel from the Helsda Company of Chicago, Ill. (Chicago, IL))^TM305. And Sepigel from Sebik Corporation (Fairfield, N.J.) of Filofield, N.J.)^TM305 and Sepigel^TM501. Most preferred among these polyacrylamide polymers are those giving the CTFA designation polyacrylamide and isoparaffin and laureth-7, available under the trade designation Sepigel^TM305 from Saybox Corporation (Seppic Corporation) using acrylamide, 2-acrylamido-2-methylpropanesulfonic acid and crosslinked with N, N-methylenebisacrylamide.

The thickener may be a fatty alcohol. In one aspect, the fatty alcohol can have a melting temperature greater than 30 ℃, or greater than about 37 ℃, or greater than about 50 ℃. The melting temperature of the fatty alcohol can be measured according to the drop melting point method of ASTM D127 (1 month and 1 day 2015). Non-limiting examples of fatty alcohols may include stearyl alcohol, cetyl alcohol, behenyl alcohol, stearic acid, palmitic acid, the polyethylene glycol ether of stearyl alcohol having an average of about 1 to about 5 ethylene oxide units, the polyethylene glycol ether of cetyl alcohol having an average of about 1 to about 5 ethylene oxide units, and mixtures thereof. In one aspect, the vaginal care composition may comprise a fatty alcohol selected from the group consisting of: stearyl alcohol, cetyl alcohol, behenyl alcohol, the stearyl alcohol polyglycol ether having an average of about 2 ethylene oxide units (steareth-2), the cetyl alcohol polyglycol ether having an average of about 2 ethylene oxide units, and mixtures thereof. Even more preferably, the vaginal care composition may comprise a compound selected from the group consisting ofFatty alcohols of group: stearyl alcohol, cetyl alcohol, behenyl alcohol, and mixtures thereof. Alternatively, the fatty alcohol may be selected from saturated C₁₆To C₃₀Fatty alcohol, saturated C containing from about 1 to about 5 moles of ethylene oxide₁₆To C₃₀Ethoxylated fatty alcohols, saturated C₁₆To C₃₀Diol, saturated C₁₆To C₃₀Monoglyceryl ether, saturated C₁₆To C₃₀Hydroxy fatty acids, and mixtures thereof, having a melting temperature of at least about 45 ℃. In one aspect, the vaginal care composition may comprise a mixture of two or more fatty alcohols.

The vaginal care composition may comprise from about 0.1% to about 5%, alternatively from about 0.5% to about 2.5%, alternatively from about 0.75% to about 2%, by weight of the vaginal care composition, of a fatty alcohol. Without being limited by theory, it is believed that these fatty alcohols may aid in the development of rheological properties of the composition, which may contribute to the physical stability of the composition. It is believed that the fatty alcohol may increase the viscosity of the vaginal care composition at room temperature, allowing the vaginal care composition to be applied to a delivery device and administered to the body.

While certain materials such as hyaluronic acid, sodium hyaluronate, and/or other moisturizers can provide desirable moisturizing and/or vaginal tissue health benefits, they can also exhibit undesirable mucoadhesive properties (e.g., stickiness) when included in aqueous vaginal care compositions. Thus, the drawbacks of including mucoadhesive moisturizers may outweigh the lubricity and vaginal health benefits provided by these materials. However, it has now been surprisingly found that selecting low levels of hyaluronic acid and polyacrylamide thickener can provide oil-in-water emulsion vaginal care compositions which are stable and provide lubrication and vaginal health benefits without undesirable sticky feel. In some cases, it may be desirable to provide hyaluronic acid to polyacrylamide polymer in a ratio of about 1:10 to about 1: 1.

The vaginal care composition may be substantially free of retinol, retinyl esters, retinal, peptides, ethanol, sunscreens, parabens, and/or sensates such as warming or cooling agents. The vaginal care composition may be substantially free of perfumes, flavors, and/or pigments. The vaginal care composition may be substantially free of estrogenic agents and/or progestinic agents. The vaginal care composition may be substantially free of particles for exfoliating. In such examples, the excluded particles have an average particle size of about 125 microns to about 700 microns or greater. Examples of such particles include polyethylene terephthalate (PET) microbeads, crushed apricot shells, salt crystals, sugar crystals, and crushed volcanic rock. The aforementioned ingredients are believed to be either irritating or present an unsatisfactory use experience in vaginal care compositions. The vaginal care composition may be substantially free of a combination of carbomer and carbomer, as well as other bioadhesive or mucoadhesive components.

The vaginal care composition may preferably have a viscosity suitable for dispensing the composition without dripping or running when the user applies the vaginal care composition around the vaginal orifice and/or on the extravaginal tissue. The vaginal care composition may also have a viscosity that is beneficial for application to the vaginal tissue of interest using the delivery device without undue effort. The vaginal care composition can exhibit a viscosity of from about 2,000cps to about 200,000cps, alternatively from about 5,000cps to about 150,000cps, alternatively from about 20,000cps to about 90,000cps, alternatively from about 2,000cps to about 200,000cps or any integer value within any range formed by any of the foregoing values. Alternatively, the vaginal care composition can have a viscosity of from about 20,000cps to about 200,000cps, alternatively from about 40,000cps to about 100,000cps, alternatively from about 55,000cps to about 80,000 cps. The viscosity of the vaginal care composition can be measured according to the viscosity test method described hereinafter.

It is to be understood that any given material can be used for a variety of purposes in the vaginal care composition. For example, polyethylene glycol can be used as a wetting agent and/or emulsifier.

Examples

The following examples further describe and demonstrate embodiments within the scope of the present invention. The described embodiments are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope of the invention. All exemplified amounts are concentrations by weight of the total composition, i.e., wt/wt percentages, unless otherwise indicated.

TABLE 1：

¹Available as Sodium Hyaluronate Powder (Bio-Sodium Hyaluronate Powder) from Bairand corporation (SK Bioland (South Korea)) in Korea.

²Can be used as

Na2-S was obtained from Akzo Nobel Functional Chemicals (Chicago, IL) in Chicago, Ill.

³. Can be used as

D118 was obtained from sitake (Toronto, Ontario, Canada) of Toronto, Ontario, Canada.

⁴Can be used as

PL68/50 was obtained from BASF (Cincinnati, OH) in Cincinna, Ohio.

5 is available as CF600 from Momentive Performance materials (Waterford, NY) from the Michmate advanced materials group of Wattford, N.Y..

6 can be used as

100-S was obtained from Lipocon Chemicals (Warren, Inc., Valencon, N.J.)Township, NJ)).

7 can be used as Sepigel^TM305 was obtained from seik corporation (Seppic, Fairfield, n.j.) of felfield, new jersey.

8 available as DC 1503 from Dow Corning Inc. (Dow) of Carrolton, Kentucky

Corp. (Carrollton, KY)).

9 can be used as

SC was obtained from Clariant (Muttenz, Switzerland) of Munity, Switzerland.

A 1.5 kg batch of examples 1-7 can be made gravimetrically according to the following procedure:

the aqueous phase (a) was prepared by combining all the ingredients in a beaker or kettle and heating to about 70 ℃ to 80 ℃ with stirring using an overhead mixer. Oil phase (B) was prepared by combining all the ingredients in oil phase (B) in a separate beaker or kettle with a magnetic stir bar and heating to about 70 ℃ to 80 ℃ with stirring using a magnetic stir plate. The acidic aqueous phase (C) was prepared by combining all the ingredients in a further beaker or kettle with a magnetic stir bar and heating to 40 ℃ with stirring using a magnetic stir plate.

Once oil phase (B) reached about 70 ℃ to 80 ℃, it was poured into water phase (a) and mixed using a Tekmar mixer at about 5,000rpm to 10,000rpm for 5 minutes, creating an oil-in-water emulsion. After mixing, the heating was stopped and the mixture was allowed to cool while stirring using an overhead mixer. When the mixture reached 60 ℃, Sepigel was added with continuous stirring using an overhead mixer^TM305. When the mixture reached 50 ℃, the acidic aqueous phase (C) was added with continuous stirring using an overhead mixer. When the mixture reached about 40 ℃ to 45 ℃, the remaining other ingredients (D) were added and the mixture was mixed for 2 minutes using a Tekmar mixer at about 5,000rpm to 10,000 rpm. The resulting oil-in-water emulsion was transferred to a storage vessel and cooled to room temperature.

Delivery device for vaginal care compositions

The vaginal care compositions herein can be administered by any suitable means known for administering such products, including the use of fingers (i.e., using the hands and/or fingers) and/or using a disposable or reusable delivery device. The user can dispense the vaginal care composition onto the fingers, hands and/or delivery device and then apply the vaginal care composition to the target vaginal tissue. Additionally or alternatively, the user can dispense the vaginal care composition directly to the target vaginal tissue and apply the vaginal care composition using fingers, hands, and/or a delivery device. Dispensing the vaginal care composition can include pouring, dripping, squeezing, and/or spraying from a container (e.g., tube, jar, bottle, spray bottle, aerosol). Non-limiting examples of delivery devices for applying the vaginal care composition may 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 as it may help keep the vaginal care composition out of contact with the user's hands.

A preferred delivery device for applying the vaginal care composition to the vaginal orifice and/or to the extravaginal tissue is an egg-shaped applicator as described hereinafter. In one aspect, the applicator can be packaged with the vaginal care composition as a kit and sold as a packaged unit. Alternatively, the elements may be provided separately.

As shown in fig. 1, the kit 110 may include an applicator 100 comprising an elongated body having a proximal end 114 and an insertion portion 116 comprising a tip 124 opposite the proximal end 114. The applicator 100 may also include a graspable portion 118 adjacent the proximal end 114. The kit 110 may include a single applicator that may be reused, or multiple applicators may be provided. The kit 110 may also include a dispenser 104 or container (not shown). The dispenser 104 may include a reservoir 142 in which the vaginal care composition may be stored, and a hand pump 144 for drawing the vaginal care composition from the reservoir and dispensing a dose of the vaginal care composition from the dispenser 104. Alternatively, the vaginal care composition can be stored in a chamber (not shown) within the applicator 100. The kit 110 may also include a pouch 106 in which the applicator 100 and/or dispenser 104 may be stored before and after use.

Referring now to fig. 2-3, the insertion portion 116 can be shaped and sized to accommodate the anatomical geometry of the vaginal opening and for applying the vaginal care composition to the vaginal opening. The insertion portion 116 may terminate at a longitudinal distance L2 from the tip 124, where the termination point is referred to herein as the base 125 of the insertion portion 116. Although the insertion portion may be described herein as terminating at a base for discussion purposes, the base need not be a distinct physical structure (although it may be in some embodiments), but rather a location along the longitudinal axis a defined by the length L2. In one aspect, the insertion portion 116 can have a generally circular cross-section at the base 125. The insertion portion 116 is preferably rotationally symmetric about the longitudinal axis a, and this symmetry may facilitate easier use and application of the vaginal care composition by female users. In one aspect, the insertion portion 116 has an overall shape that appears the same after being angularly rotated by partially turning it about its longitudinal axis by 45 °, 90 °, 135 °, 180 °, 225 °, 270 °, or 315 °.

In one aspect, the insertion portion may be conical. The tip 124 of the insertion portion 116 may have any shape including, but not limited to, rounded, concave, convex, flat, serrated, angled, or pointed. Although the insertion portion may be provided in a variety of shapes, in some embodiments, the insertion portion has a continuous taper, with a rounded tip, a substantially circular cross-section at the base, and side or lateral surfaces that slightly bulge from the base to the rounded tip. The lateral outer surface (e.g., 120 in fig. 3) of the insertion portion 116 can be substantially smooth to avoid irritation of vaginal tissue during manipulation of the applicator to administer the vaginal care composition to the vaginal tissue of interest.

The size and structural properties of the insertion portion 116 may facilitate its use in the vaginal region described above. Although the vaginal shape, axis and dimensions may vary considerably between women, the size and structural attributes of the insertion portion may be designed to accommodate the vaginal opening, allowing for a wide range of anatomical measurements while also self-limiting the insertion depth of the applicator. Since the applicator may be used by women suffering from vaginal atrophy, its size and shape should also accommodate the anatomical changes that occur when vaginal atrophy is experienced. In one aspect, the length L2 of the insertion portion 116, taken along the longitudinal axis a, may be about 10mm to about 25mm, or about 10mm to about 20 mm. In one aspect, the width of the base 125 may also be the maximum width of the insertion portion 116 in order to limit the distance the applicator 100 is inserted into the vaginal opening (and without experiencing discomfort) using gentle hand pressure, and/or to signal to the user that the proper insertion depth has been achieved during use. In one aspect, it may be desirable for the applicator to be sized to prevent over-insertion of the applicator into the vaginal cavity. For example, insertion portion 116 or other portions of the body may also exhibit dimensions that provide a self-limiting feature with respect to insertion beyond the lower vaginal region, such that in some embodiments, insertion portion 116 is prevented from contacting the mid-or upper vaginal region (including the cervix).

The applicator 100 may also include a graspable portion 118 adjacent the proximal end 114. The grippable portion may be defined by texture or visual indicia. The texture may include a plurality of protrusions, a plurality of depressions, and combinations thereof. The texture may be provided as a plurality of ridges, a plurality of grooves, and combinations of the foregoing. Alternatively or in addition, the graspable portion may be provided with a surface finish (e.g., micro texture) or surface treatment (e.g., dip coating, spray coating, printing) that enhances the graspability of the graspable portion. The texture, surface decoration or surface treatment may partially or completely surround the body. The texture may be provided as a repeating (preferably regularly repeating) pattern, but may also be provided as a random pattern or an irregular pattern. Still further, textures may be provided as the shape of objects, some non-limiting examples being leaf shapes, flower shapes, star shapes, and geometric shapes. The texture may also be provided as repeating closed geometric shapes, some non-limiting examples being circles, diamonds, triangles, rectangles, and combinations thereof. The texture, surface decoration or surface treatment may extend about 10mm or more from the proximal end of the applicator.

Proximal end 114 or a portion thereof may be substantially flat. As shown in the embodiment in fig. 3, the proximal end 114 of the applicator 100 includes a flat portion or bottom that may allow a user to place the applicator 100 in an upright position on a surface before and after use such that the applicator is oriented in a manner that minimizes or prevents contact between the remaining surface and the insertion portion of the applicator 100.

The overall length of the applicator 100 may minimize or prevent contact of the female user's fingers with the vaginal region while providing a suitable insertion depth slightly beyond the vaginal opening. The length of the applicator may be from about 35mm to about 85mm, alternatively from about 40mm to about 70mm, alternatively from about 45mm to about 65mm, alternatively from about 35mm to about 85mm, or any integer value of any range formed by any of the foregoing values.

Although the applicator may be provided in a variety of overall shapes, it may be preferred that the applicator is substantially oval or egg-shaped in profile and rotationally symmetric about its longitudinal axis a through an angular rotation of 360 °. It is believed that such geometry may be desirable for application of the spreadable vaginal care composition to the vaginal orifice and optionally the vulva, the vaginal vestibule, the labia majora, the labia minora, and/or the external urogenital tract. This shape may also be particularly useful in the case of women suffering from vaginal atrophy, given the variability in shape and size of this vaginal tissue between users and the variability in sensitivity of these tissues. It is also believed that this shape may facilitate a user's handling and manipulation of the applicator to easily apply the vaginal care composition in a variety of positions (e.g., sitting, standing, or lying down), and without the need to observe the tissue of interest during use.

The applicator may be free of moving parts, electrical elements (e.g., motors, lights, circuits, buzzers, speakers, etc.), and/or electrical power sources (e.g., batteries) to provide an applicator that is simple to manufacture and also easy to soak in or rinse with water for cleaning. Applicators without batteries and/or electrical elements (e.g., motors, lights, etc.) are referred to as non-electrical applicators. At least 60%, 70%, 80%, 90%, 95% or 100% of the bulk volume may be solids volume. The body may be free of chambers for storing flowable compositions and/or channels, conduits and/or openings or holes for delivering such compositions to the outer surface thereof. Alternatively, the applicator may comprise a chamber for storing flowable compositions and/or a channel, conduit, duct, and/or opening or aperture for delivering such compositions to an outer surface thereof (e.g., the insertion portion or a tip thereof). In one aspect, the applicator includes a chamber in fluid communication with an opening defined on the insertion portion or tip. In one aspect, the body may be free of plungers and other structures that may be used to expel the vaginal care composition from the applicator body. Alternatively, the applicator may include a plunger or other structure that can be used to expel the vaginal care composition from the applicator body. In one aspect, the body of the applicator is not penis-shaped.

The applicator and/or the materials used to form the applicator may exhibit one or more properties suitable for applying the vaginal care composition to the vaginal opening and optionally the extra-vaginal tissue, some of which may be softer, more sensitive or less sensitive to women suffering from vaginal atrophy. The applicator and/or the materials used to form the applicator may also contribute to the grippability, reusability, and cleanliness of the applicator. Examples of suitable materials may include thermoplastic elastomers, natural rubber, synthetic rubber (e.g., silicone elastomer/silicone rubber), polyester (e.g., polyurethane such as available from Hapco, inc

2021-5) and/or a thermoplastic olefin.

The applicator can also include one or more visual indicators to indicate to the user where to hold the applicator, which end of the applicator is "up" or "down," and/or on which surfaces of the applicator the vaginal care composition should be applied, for example. The visual indicia may include colors, micro-textures, patterns, text, graphics, coatings, and combinations thereof. In one aspect, the visual indicia can be an administration indicia that visually indicates to the user the surface of the body to which the vaginal care composition is to be applied, or an insertion indicia that visually indicates to the user how far into the vaginal opening the body should be inserted. The administration marker and/or the insertion marker may form part of the insertion portion. Preferably, the administration marker is visually distinct from the insertion marker. For example, the administration marker may be provided in the form of a first color, while the insertion marker may be provided in a second color different from the first color. Alternatively, the administration marker and the insertion marker may be the same visual marker. The visual indicia may be printed on the body, molded with the body, or applied to the body in the form of a coating.

The vaginal care composition may be stored in a dispenser or container (not shown). The container may be any can, bowl, cup, or any of a variety of suitable containers, which may employ a screw-on lid or closure. In such embodiments, the insertion portion can be submerged in the container to contact the vaginal care composition to transfer the vaginal care composition to the surface of the applicator.

The applicator and the dispenser storing the vaginal care composition may be packaged together and sold to the consumer as a unit. Some suitable packages may include boxes, cartons, and clamshell packages formed from plastic and/or paper materials. The kit may also include a container such as, for example, a drawstring pouch or bag (e.g., 106) for storing one or more applicators and optionally a dispenser between uses by the consumer. However, it will be appreciated that the container may be any of a variety of suitable containers for storing one or more items associated with the kit. In some embodiments, the container may facilitate hygiene by maintaining the applicator clean between uses.

Particularly suitable applicators are further described in U.S. provisional patent application No. 62/622,298 filed on 26.1.2018, which is incorporated herein by reference in its entirety.

Application method

The kit, delivery device and vaginal care composition can be used in a variety of ways. In one aspect, vaginal care compositions can be administered to reduce the sensation of vaginal dryness. Alternatively, vaginal care compositions can be administered to restore vaginal moisture and lubrication.

Also described herein are methods of providing one or more vaginal health benefits comprising administering a vaginal care composition to the vaginal opening and optionally to extra-vaginal tissues such as the vulva, the vaginal vestibule, the labia majora, the labia minora, or the external urogenital tract. The one or more vaginal health benefits may be selected from the group consisting of: providing natural moisture; reduction of vaginal irritation and/or burning; providing natural lubrication; relieving vaginal dryness; supplying water to vagina; supplement the natural lubrication of the body; providing all day vaginal moisture and/or lubrication; reducing pain during sexual activity; alleviating discomfort associated with vaginal dryness; and combinations thereof.

Also described herein are methods of treating vaginal dryness and/or vaginal atrophy.

Although methods of reducing the perception of vaginal dryness are exemplified, it is to be understood that the methods described herein can also be used to restore vaginal moisture and lubrication to provide one or more vaginal health benefits, to treat vaginal dryness, and/or to treat vaginal atrophy.

In one aspect, a method for reducing the perception of vaginal dryness can include a female user grasping a delivery device, depositing an amount of a vaginal care composition on at least a portion of the delivery device, manipulating the delivery device to administer the vaginal care composition using the delivery device to her vaginal opening and optionally one or more of the vulva, vaginal vestibule, labia majora, labia minora, or external genitourinary tract such that at least a portion of the vaginal care composition thereon is transferred to a vaginal tissue of interest.

In one aspect, a method for reducing the perception of vaginal dryness can include a female user grasping a delivery device and manipulating the delivery device to administer a vaginal care composition to her vaginal area.

In one aspect, a method for reducing the perception of vaginal dryness can include a female user holding or grasping an applicator and applying an amount of a vaginal care composition to at least a portion of an insertion portion (preferably a delivery surface) of the applicator, manipulating the applicator to deliver the vaginal care composition to her vaginal opening and optionally to extra-vaginal tissue using the applicator such that at least a portion of the vaginal care composition thereon is transferred to vaginal tissue of interest

In some embodiments in which the applicator includes dosing indicia and/or insertion indicia, the female user can use those indicia as a guide for where to deposit the vaginal care composition on the applicator (e.g., the dosing surface) or how far to insert the body into her vaginal opening during use. In some embodiments, the administration marker may provide two visual cues to the female user (i.e., for the female user, the same visual marker is used as both the administration marker and the insertion marker).

The method can further comprise dispensing the vaginal care composition from the dispenser 104. In such embodiments, the vaginal care composition can be dispensed onto the insert portion. The dispenser 104 may regulate the amount of vaginal care composition released therefrom. The amount of vaginal care composition released by the dispenser 104 can be a single dose or less sufficient to cover the insertion portion such that multiple (e.g., 2-4) actuations of the dispenser are required to provide a suitable amount.

Alternatively, the method may comprise the female user dispensing the vaginal care composition from a chamber within the applicator, for example by squeezing or using a plunger or pump, such that the vaginal care composition is provided on at least a portion of the outer surface of the applicator.

Alternatively, the vaginal care composition may be stored in a container (not shown), such as a jar or can. The insert portion can be submerged within the container to contact the vaginal care composition to apply the vaginal care composition thereto. While the methods have been described in connection with the use of an applicator, it should be appreciated that in some embodiments, a method for reducing the sensation of vaginal dryness may include applying a vaginal care composition to at least one finger (e.g., a finger or thumb) of a female user, and using her at least one finger to administer the vaginal care composition to the vaginal opening and optionally to the extravaginal tissue.

The amount of vaginal care composition applied to the surface of the insertion portion may be sufficient to cover the surface of the insertion portion, but not so much as to cause the vaginal care composition to drip from the insertion portion. The amount of vaginal care composition applied to the insertion portion can be from about 0.1g to about 2g, alternatively from about 0.2g to about 1.5g, alternatively from about 0.5g to about 1 g.

The female user can manipulate the applicator in a variety of modes. A female user may insert the insertion portion into her vaginal opening using gentle handle pressure (e.g., until the user notices slight resistance to insertion) to avoid over-insertion into the body through the vaginal opening. The body of the applicator is preferably inserted only a distance sufficient to treat the vaginal opening without discomfort. The insertion portion is only inserted a comfortable distance to avoid pain or tearing or bleeding of delicate tissue. The female user may insert the body into the vaginal opening a distance of 40mm, 35mm, 30mm, 25mm or less, or from about 30mm to about 5mm, or from about 25mm to about 10 mm. Preferably, the tip of the insertion portion is not inserted as far into the middle or upper region of the vaginal cavity by the female user. In some embodiments, the tip of the insertion portion is inserted no more than the lower region of the vaginal cavity. It is believed that at least some female users may find this approach less intimidating and/or simpler and more convenient, thereby encouraging long-term habit development and adherence. The body of the applicator can then be retracted to administer any vaginal care composition remaining thereon (and/or to apply some vaginal care composition applied to the vaginal orifice) to extra-vaginal tissues such as the labia minora, labia majora, clitoris, perineum, urogenital tract, and the like. In one aspect, a female user may manipulate the applicator by: inserting the body of the applicator into the vaginal opening and rotating the body with her wrist, retracting the body from the vaginal opening, and then wiping the body along the extra-vaginal tissue.

In some embodiments, the female user can administer the vaginal care composition to the vaginal tissue of interest for a duration of time from about 1 second to about 40 seconds, or from about 1 second to about 30 seconds, or from about 1 second to about 15 seconds, or any range formed by any of the foregoing values. Short administration times are desirable in terms of providing a convenient and rapid method of completion.

Since the experience of the applicator and vaginal care composition may help encourage female users to develop long-term habits for acute and chronic treatment of vaginal dryness and/or vaginal atrophy, female users may use the applicator to apply the vaginal care composition on a regular basis, rather than as a mere prophetic preparation for sexual activity. For example, sexual activity may not be performed immediately after the usage method is performed. Furthermore, since the administration of the vaginal care composition need not be associated with sexual intimacy, sexual activity may not occur even within 6 hours, 12 hours, or 24 hours after administration of the vaginal care composition. With respect to dosing frequency, in some embodiments, the methods may be performed by the female user at least twice a week or three, four, five, six, or more times a week for at least 4 weeks or 8 weeks or 12 weeks or more. In other cases, the method may be performed daily for at least 4 weeks, or 8 weeks, or 12 weeks, or more. In some cases, a female user may practice the method for 6 months, 8 months, 10 months, 12 months, or more. To facilitate habit formation and habit compliance, the method may be performed by the female user at about the same time each day, or after each day of routine activity. For example, a female user may practice the method in the morning as part of a routine (e.g., after showering). Likewise, the female user may perform the method prior to getting to bed at night or at any other time convenient to the female user. Alternatively, the method may be performed multiple times per day or as needed.

The method can also include cleaning the applicator such that the applicator can be reused at a later time to repeat the administration of the vaginal care composition. In some embodiments, the applicator can be rinsed, sprayed, or soaked in a liquid and/or wiped with a substrate to remove any residual vaginal care composition or body fluid. The cleaning liquid may comprise water and optionally one or more adjuvants such as, for example, soap or other surfactants. The applicator may be soaked in a container containing a cleaning solution, or merely rinsed or soaked, for example, with tap water. After the rinsing, spraying, or soaking step, the applicator may be dried using a substrate or appliance (e.g., a blower) or placed to air dry and stored in a protective reusable container/package (e.g., a drawstring pouch shown in fig. 1) to remain clean until the next use. The cleaning step can be performed prior to applying the vaginal care composition to the applicator, after administering the vaginal care composition to the desired vaginal tissue, or both. Alternatively, the applicator may be disposable or intended for single use.

The methods described herein may be directed to and/or performed by women who are experiencing vaginal dryness and/or vaginal atrophy and/or are suffering from decreased estrogen levels. Vaginal dryness or irritation can also be caused by, for example, vaginitis, inflammation of vaginal tissue due to thinning and contraction of tissue, sexual arousal disorder, menopause, drug (prescription or non-prescription) induced vaginal dryness, displeasure, sexual pain disorder, pregnancy, lactation, hormonal imbalance, anxiety, and diabetes. In addition, the kits and vaginal care compositions can have non-medical uses for women in need of vaginal lubrication. Vaginal atrophy (sometimes referred to as atrophic vaginitis or vaginitis, vulvovaginal atrophy or urogenital atrophy) may be characterized by tissue thinning and contraction and reduced lubrication, which is usually caused by estrogen deprivation and occurs naturally in perimenopausal, menopausal, and postmenopausal women. Symptoms may include vaginal soreness, itching, and dyspareunia. In some embodiments, the female user is 30, 40, 45, 50, or 55 years of age or older, is experiencing a decline in estrogen levels, is suffering from vaginal atrophy, vaginal dryness, has undergone hysterectomy, and/or is a perimenopausal, menopausal, or postmenopausal female. It is believed that the performance of the methods of using the applicator and vaginal care compositions described herein can provide acute and/or chronic relief to the female user of one or more of: vaginal dryness, pain during intercourse, vaginal itching and vaginal irritation.

An exemplary method of using the implement to administer the vaginal care composition is disclosed in U.S. provisional application serial No. 62/622,298, which is incorporated herein by reference in its entirety.

Viscosity test method

The viscosity of the samples was measured using a Brookfield RV viscometer equipped with a T-C crane T-spindle. The viscometer is leveled, set and calibrated according to the manufacturer's standards. The viscometer speed (RPM) is selected to ensure that the measured viscosity is within the manufacturer's recommended set range.

The samples were stored in sealed glass jars with openings and internal diameters of at least 40mm and filled to a height of at least 50mm, carefully handled to avoid entrapment of air bubbles. Centrifugation is used to help remove entrained air. Prior to measurement, the sample jar was equilibrated at 23 ℃ ± 2 ℃ and a relative humidity of about 50% ± 2 ℃ for at least 24 hours.

The viscosity was measured at 23 ℃ ± 2 ℃ and a relative humidity of about 50% ± 2% by placing the uncapped sample jar under the viscometer and lowering the viscometer until the tip of the T-rotor touched the sample surface. Once the T-rotor touches the sample surface, the downlink crane is turned on and a timer is started. Readings were taken every 10 seconds for 1 minute. Viscosity is the arithmetic mean of the viscosities recorded. Care was taken to ensure that the T-shaped rotor did not touch the glass jar.

Further non-limiting description of the disclosure

The following numbered paragraphs constitute further non-limiting descriptions of the present disclosure in a form suitable for appending to the claims section where later desired.

A. A composition for the treatment of vaginal dryness comprising an oil-in-water emulsion, a thickener comprising a polyacrylamide polymer and a fatty alcohol, and optionally hyaluronic acid or a salt thereof, wherein the composition preferably has a pH of from 4 to 5.5, more preferably from 4.3 to 5.0.

B. The composition for use in treating vaginal dryness according to paragraph a, wherein the composition comprises from about 0.1% to about 2% hyaluronic acid or a salt thereof, by weight of the composition.

C. The composition for use in treating vaginal dryness according to any of the preceding paragraphs, wherein the composition comprises from 0.5% to 10%, preferably from 1% to 8%, more preferably from 1.5% to 5%, by weight of the composition, of a thickening agent.

D. The composition for use in the treatment of vaginal dryness according to any of the preceding paragraphs, wherein the composition further comprises a preservative system comprising a preservative, preferably the preservative comprises an organic acid preservative and a salt of the organic acid preservative, and a preservative enhancer comprising sorbitan caprylate.

E. The composition for use in treating vaginal dryness according to any of the preceding paragraphs, wherein the composition further comprises from 0.05% to 5% of a moisturizing agent, wherein the moisturizing agent is preferably a vegetable oil.

F. Use of a composition comprising an oil-in-water emulsion, a thickener comprising a polyacrylamide polymer and a fatty alcohol, and optionally hyaluronic acid or a salt thereof, wherein the composition preferably has a pH of 4.0 to 5.5, more preferably 4.3 to 5.0, as a vaginal care composition for restoring vaginal moisturization and/or lubrication.

G. The use according to paragraph F, wherein the composition comprises from 0.1% to 2% hyaluronic acid or salt thereof, by weight of the composition.

H. The use according to paragraph F or G, wherein the composition comprises from 0.5% to 10%, preferably from 1% to 8%, more preferably from 1.5% to 5%, by weight of the composition, of a thickening agent.

I. Use according to paragraphs F to H, wherein the composition further comprises a preservative system comprising a preservative, preferably the preservative comprises an organic acid preservative and a salt of the organic acid preservative, and a preservative enhancer comprising sorbitan caprylate.

E. Use according to paragraphs F to I, wherein the composition further comprises from 0.05% to 5% of a humectant, wherein the humectant is preferably a vegetable oil.

K. A method of alleviating the perception of vaginal dryness, the method comprising the steps of: administering a vaginal care composition to a vaginal area of a female user in need thereof; wherein the vaginal care composition comprises an oil-in-water emulsion, a thickener comprising a polyacrylamide polymer and a fatty alcohol, and optionally hyaluronic acid or a salt thereof, wherein the composition preferably has a pH of from 4.0 to 5.5, more preferably from 4.3 to 5.0.

L. the method of paragraph K, comprising the steps of: providing an amount of the vaginal care composition to at least a portion of the outer surface of the applicator, and administering at least a portion of the amount of the vaginal care composition to the vaginal orifice and optionally to one or more of the vulva, the vaginal vestibule, the labia majora, the labia minora, and/or the urogenital tract while holding and manipulating the applicator, preferably inserting a portion of the applicator into the vaginal orifice a distance of about 35mm or less.

M. the method according to paragraph L, wherein the amount of the vaginal care composition applied onto the applicator is from 0.1g to 2 g.

The method according to paragraphs K-M, wherein the vaginal care composition is administered once daily.

A kit for alleviating the perception of vaginal dryness, the kit comprising:

a. an applicator for reducing the perception of vaginal dryness, the applicator comprising a non-electric elongated body including a tapered insertion portion having a tip, a proximal end opposite the insertion portion, a dosing flag delineating a dosing surface, and a graspable portion adjacent the proximal end; and

a. vaginal care composition comprising an oil-in-water emulsion, a thickener comprising a polyacrylamide polymer and a fatty alcohol, and optionally hyaluronic acid or a salt thereof, wherein the composition preferably has a pH of from 4.0 to 5.5, more preferably from 4.3 to 5.0.

Each document cited herein, including any cross-referenced or related patent or application, is hereby incorporated by reference in its entirety unless expressly excluded or otherwise limited. The citation of any document is not an admission that it is prior art with any disclosure of the invention or the claims herein or that it alone, or in combination with any one or more of the references, teaches, suggests or discloses any such invention. Further, to the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the same term in a document incorporated by reference, the meaning or definition assigned to that term in this document shall govern.

While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

1. A method of alleviating a sensation of vaginal dryness, the method comprising:

a. providing an amount of a vaginal care composition by a female user on at least a portion of an exterior surface of an applicator; and

b. administering at least a portion of the amount of the vaginal care composition to her vaginal opening and, optionally, to one or more of her vulva, vaginal vestibule, labia majora, labia minora, or external genitourinary tract while grasping and manipulating the applicator;

wherein the vaginal care composition comprises an oil-in-water emulsion and a thickener comprising a polyacrylamide polymer and a fatty alcohol.

2. The method of claim 1, wherein the vaginal care composition comprises 0.1% to 2% hyaluronic acid, or salt thereof, by weight of the vaginal care composition.

3. The method of any preceding claim, wherein the vaginal care composition comprises from 0.5% to 10% of the thickening agent, by weight of the vaginal care composition.

4. The method of any preceding claim, wherein the vaginal care composition further comprises a preservative system comprising a preservative and a preservative enhancer comprising sorbitan caprylate.

5. The method of any one of the preceding claims, wherein the preservative comprises an organic acid preservative and a salt of the organic acid preservative.

6. The method of any preceding claim, wherein the vaginal care composition has a viscosity of 20,000cps to 200,000 cps.

7. The method of any preceding claim, wherein the vaginal care composition is substantially free of one or more of the following: sensates, flavors, colors, estrogens, and progestins.

8. The method of any preceding claim, wherein the amount of the vaginal care composition provided is from 0.1g to 2 g.

9. The method of any one of the preceding claims, wherein the vaginal dryness is from one or more of the group consisting of: vaginitis, vaginal inflammation due to thinning and contraction of tissue, sexual arousal disorder, menopause, drug-induced vaginal dryness, decreased sexual sensation, dyspareunia, hysterectomy, pregnancy, hormonal imbalance, anxiety, or diabetes.

10. The method of any one of the preceding claims, wherein the female user is 40 years old or older.

11. The method of any preceding claim, wherein the vaginal care composition has a pH of 4.0 to 5.0.

12. The method of any preceding claim, wherein the vaginal care composition further comprises a preservative system comprising an organic acid preservative and a salt of the organic acid preservative.

13. The method of any preceding claim, wherein the vaginal care composition comprises from 0.1% to 5% fatty alcohol, by weight of the vaginal care composition.

14. The method of any preceding claim, wherein the vaginal care composition is administered once daily.

15. The method of any preceding claim, wherein the vaginal care composition further comprises from 0.005% to 5% by weight of the vaginal care composition of an emulsifier.