Oral plant-based oil-in-water emulsions and methods of use

Abstract

The present invention relates to an oral water-in-plant based oil emulsion and methods of use. Specifically, the present invention discloses a composition comprising: from 5 wt% to 30 wt% of one or more plant based oils, based on the total weight of the composition; from 70 wt% to 95 wt% of an aqueous phase, based on the total weight of the composition; from 0.1 wt% to 5 wt% of one or more surfactants, based on the total weight of the composition; and from 0.05 wt% to 3 wt% of a viscosity modifier, wherein the composition has a pH of from 4.5 to 9.5, the composition is an oil-in-water (o / w) emulsion, and the composition is consumable. Also included are methods of using the disclosed compositions.

Description

[0001] This application is a divisional application of Chinese invention patent application filed on November 20, 2018, with application number 201880075121.9 and invention title "Oral Water-in-Packed Plant-Based Oil Emulsion and Method of Use". Technical Field

[0002] This invention relates to a water-in-oil emulsion for oral use and a method of application. Specifically, this disclosure relates to oral compositions, and more specifically to oral compositions and methods for relieving oral dryness and improving oral health in subjects. Background Technology

[0003] Dry mouth, or paresthesia, is a common condition caused by insufficient saliva production. It is increasingly prevalent among the elderly and is a side effect of many medications and cancer treatments. Severe cases of dry mouth are often associated with salivary gland dysfunction, a condition known as Sjögren's Syndrome.

[0004] The lack of moisture and lubrication normally provided by saliva has a range of negative effects on oral tissues (soft tissues), from mild discomfort to extreme pain and infected mouth ulcers. Persistent discomfort and dryness can also lead to greater health problems by disrupting sleep and impairing people's ability to speak (socially, potentially affecting mental health) and eat (potentially affecting nutrition). Dry buccal tissues have a weaker barrier function and are more easily penetrated by physical irritants such as toxins and carcinogens in food, beverages, and tobacco. There remains a need for compositions that can better alleviate dry mouth. Summary of the Invention

[0005] This document discloses an oil-in-water composition comprising: 5% to 30% by weight of one or more vegetable-based oils based on the total weight of the composition; 70% to 95% by weight of an aqueous phase; 0.1% to 5% by weight of one or more surfactants; and 0.05% to 3% by weight of one or more viscosity modifiers. The surfactants include (i) nonionic surfactants free of ethylene oxide / propylene oxide (EO / PO), or (ii) surfactants of Formula I. HOCH2-(CHOH) n -CH2NR 1 R 2 (I) Where R 1 and R 2 Independently selected from hydrogen atoms, alkyl groups, C(O)R 3 and SO2R 4 ;R 3 and R 4The surfactant is independently selected from alkyl groups, aryl groups, and aralkyl groups; wherein n is an integer from about 2 to about 5; or a composition of surfactants from group (i) and group (ii) surfactants. The viscosity modifier is selected from edible polymeric viscosity modifiers, silica-containing viscosity modifiers, and combinations thereof. The composition also has a pH of 4.5 to 9.5 and is edible.

[0006] A composition is also disclosed in which the viscosity modifier comprises pyrolytic silica in an amount equal to or greater than 0.5% by weight based on the total weight of the composition.

[0007] The composition also discloses a composition in which one or more nonionic surfactants that do not contain ethylene oxide / propylene oxide (EO / PO) are polyglycerol ester surfactants.

[0008] Methods for preventing, inhibiting, disrupting, or maintaining biofilms in oral tissues, or any combination thereof, are also disclosed, the methods comprising contacting the oral tissues with the disclosed composition.

[0009] A method for influencing hydration loss in oral tissues is also disclosed, the method comprising contacting the oral tissues with the disclosed composition.

[0010] A method for influencing the lubrication capacity or lubricity in oral tissues is also disclosed, the method comprising contacting the oral tissues with the disclosed composition.

[0011] A method for influencing oral dryness, dry mouth, or both is also disclosed, the method comprising contacting oral tissue with the disclosed composition.

[0012] The foregoing description is not intended to depict every embodiment of this disclosure. Details of one or more embodiments of this disclosure are also set forth in the following description. Other features, objectives, and advantages of this disclosure will become apparent from the description and the claims. Detailed Implementation

[0013] Saliva is the oral cavity's primary defense against tooth decay. A healthy flow of saliva helps prevent cavities by physically removing bacteria from the mouth before they can adhere to tooth and tissue surfaces and form a protective biofilm. Saliva flow also helps dilute sugars and acids introduced by ingested food and beverages. This buffering capacity neutralizes acids and aids in the digestive process. The presence of calcium salts and phosphates provides a continuous opportunity for enamel remineralization, helping to reverse the decay process.

[0014] Many people with dry mouth use separate products to address both hard tissue health and soft tissue comfort. For soft tissue comfort, saliva substitutes are typically designed to provide lubrication and moisture. These products come in a variety of forms and include viscous gels / pastes, sprays, rinses, menthol, and sustained-release tablets. These products are applied daily or as needed for comfort. For hard tissue health, different treatments address cavity prevention directly (antibacterial rinses, fluoride products, calcium / phosphate treatments). "Dry mouth friendly" products, such as toothpaste and mouthwash, are generally recommended. Dry mouth friendly products typically have a neutral pH and are free of alcohol or other irritating ingredients (such as anionic surfactants or emulsifiers).

[0015] The aim is to design a product that effectively addresses the need for relief of dry mouth symptoms (soft tissue comfort) and preventative benefits of oral health (enamel and cavity protection). A fully absorbable two-phase emulsion system is ideally suited for this purpose. It addresses the health concerns of both hard tissues (aqueous phase) and soft tissues (oil phase).

[0016] This document discloses compositions that can be used, for example, in oral compositions. The disclosed compositions are oil-in-water (o / w) emulsions. O / w (oil-in-water) emulsions consist of oil droplets dispersed in a continuous aqueous phase. In some embodiments, the useful compositions can be characterized as crude emulsions. Crude emulsions are kinetically stable mixtures of at least two immiscible liquids, wherein one of the liquids has droplets with a diameter greater than 0.1 µm. Crude emulsions effectively scatter light and therefore appear milky white because their droplets are larger than the wavelength of light.

[0017] The disclosed composition, one or more components in the composition, or both can be characterized as edible. Referring to a component or composition as edible may mean that the specific ingredient or composition is safe for long-term daily intake at recommended levels. In some embodiments, the GRAS (Generally Recognized As Safe) list from the U.S. Food and Drug Administration (FDA) can be used to determine whether a component is edible at the levels used in the composition.

[0018] The disclosed compositions comprise at least water, oil, surfactant, and viscosity modifier. The amount of water in the disclosed compositions can be characterized by the amount of the aqueous phase in the composition. The aqueous phase may include components other than water, for example, it may include water-soluble components (as opposed to the oil phase). In some embodiments, the aqueous phase may be not less than 70% by weight (wt%), not less than 75% by weight, or not less than 78% by weight based on the total weight of the composition. In some embodiments, the aqueous phase may be not more than 95% by weight, not more than 92% by weight, not more than 90% by weight, or not more than 89.5% by weight based on the total weight of the composition.

[0019] The disclosed composition also comprises one or more oils. The useful oil can include any oil, but in some embodiments it can include vegetable-based oils. For example, vegetable-based oils can be extracted from, for example, various plants (e.g., soybeans, low-erucic acid rapeseed, and chili peppers), seeds (e.g., sesame and sunflower), nuts (e.g., walnuts and macadamia nuts), and fruits (e.g., palm, olive, and coconut). In some embodiments, the useful oil can include one or more oils that are liquid at room temperature. The composition can contain a single edible oil, or up to two, three, four, five, or more edible oils. Examples of suitable edible oils may include, but are not limited to, sunflower oil (including high-oleic sunflower oil), safflower oil (including high-oleic safflower oil), olive oil, coconut oil, palm oil, peanut oil, soybean oil, flaxseed oil, rapeseed oil, hemp seed oil, cocoa butter, walnut oil, corn oil, grapeseed oil, sesame oil, peanut oil, wheat germ oil, cottonseed oil, fish oil, watermelon seed oil, lemon oil, orange oil, thistle oil, tomato seed oil, almond oil, perilla seed oil, low-erucic acid rapeseed oil, pistachio oil, hazelnut oil, avocado oil, ozone oil, etc., as well as mixtures or fractions thereof. The disclosed composition may contain not less than 15% by weight of one or more oils, not less than 12% by weight of one or more oils, not less than 10% by weight of one or more oils, or not less than 5% by weight of one or more oils based on the total weight of the composition. The disclosed composition may contain one or more oils, not more than 30% by weight of the total weight of the composition, not more than 25% by weight of the total weight of the composition, or not more than 22% by weight of the total weight of the composition.

[0020] The disclosed compositions also comprise one or more surfactants. In some embodiments, the disclosed compositions comprise nonionic surfactants. In some embodiments, the compositions comprise edible nonionic surfactants. In some embodiments, the surfactant is an ethylene oxide / propylene oxide (EO / PO)-free surfactant. EO / PO-based or EO / PO-containing surfactants and polymers may have 1,4-dioxane contamination, which is therefore unfavorable for ingestion, and particularly unfavorable for long-term consumption.

[0021] In some implementations, useful surfactants may include, for example, glyceryl esters and polyglycerol ester surfactants. Glyceryl esters and polyglycerol ester surfactants can be derived from natural sources, can be 1,4-dioxane-free, and can be renewable. Polyglycerol ester surfactants are a class of ester emulsifiers that can possess a wide range of hydrophilic and lipophilic properties and can be made from 100% plant-derived raw materials. These nonionic emulsifiers are highly compatible with many different chemicals and other co-emulsifiers, thereby contributing to the formation of stable oil-in-water emulsions. Furthermore, polyglycerol esters are ECOCERT approved, making them an advantageous option for natural-concept and PEG-free formulations.

[0022] Polyglycerol ester emulsifiers are chemically formed by esterifying most saturated or monounsaturated fatty acids into one or more hydroxyl groups of polyglycerol. Since glycerol is a trifunctional molecule, it can condense with itself to form oligomers and polymers. These polyglycerols are hydroxyl-containing ethers, the simplest example being diglycerol. If the primary hydroxyl group is the only hydroxyl group involved in the reaction, the product is linear; however, if secondary hydroxyl groups are also involved, branched chains are formed. Thus, several diglycerol molecules can be formed, but if polymerization proceeds to triglycerides, tetraglycerides, and higher hydroxyl groups, the number of possible isomers increases exponentially, resulting in many different linear isomers. Typically, 30% to 50% of the total hydroxyl groups are esterified with fatty acids. These fatty acids are formed from any one substance (such as lauric acid, stearic acid, or oleic acid) or a mixture of these substances derived from oils. Chemically, polyglycerol esters can be formed by base-catalyzed random polymerization of glycerol followed by esterification with isolated fatty acids or triacylglycerols. The resulting mixtures vary in degree of polymerization, type, and position of the esterified fatty acids (mono-diglycerol, mono-triglycerol, mono-tetraglycerol, di-diglycerol, or di-triglycerol). These surfactants, prepared by the esterification of polyglycerol and fatty acids, form molecules containing both hydrophilic head and tail groups. The physical properties and appearance of polyglycerol esters of fatty acids depend primarily on their molecular structure. Generally, those with higher degrees of polymerization and shorter or unsaturated fatty acid chains range in physical form from viscous liquids to plastic pastes, while those with lower degrees of polymerization and longer saturated fatty acid chains are typically in powder, flake, or bead form. The color of the ester depends on the source of the fatty acid, but polyglycerol contributes to the color. The solubility of polyglycerol esters in organic solvents depends on the nature of the solvent and the polarity of the ester, but generally, these esters exhibit optimal solubility in protic solvents and polar aprotic solvents such as lower alcohols and dimethyl sulfoxide. Polyglycerol esters of fatty acids are polar or amphiphilic lipids, and their amphiphilic nature in water exhibits mesocrystalline activity, forming lyotropic liquid crystals. Polyglycerol esters, as polar emulsifiers, form aggregates such as micelles at low concentrations in water. They are important nonionic surfactants with diverse applications in cosmetics, food, pharmaceuticals, and other industries. Their amphiphilic properties make them suitable for stabilizing various suspensions. In the food industry, they are used as emulsifiers to replace fats in the production of refined baked goods. Thus, polyglycerol polyricinoleate, an emulsifier derived from castor seeds, reduces the viscosity of chocolate and similar coatings and compounds.

[0023] Traditional emulsifiers, such as esters based on EO / PO polymers and sorbitol esters, are popular due to their ability to produce stable formulations and ease of use. They are produced when ingredients are made from poorly researched and widely accepted raw materials such as ethylene oxide. Today, consumers are more educated and avoid these types of chemicals due to the use of ethylene oxide and the possibility of residual 1,4-dioxane (a well-studied carcinogen).

[0024] POLYALDO of Lonza Group S.p.A. ® Polyglycerol esters differ from traditional EO / PO-based emulsifiers. POLYALDO ® Polyglycerol esters are 100% plant-based. Polyglycerol ester products manufactured by Lonza have a three-character suffix, beginning with two numerical values ​​and ending with a Roman letter. The first value indicates the degree of polymerization of the polyglycerol molecule. It is the number of glycerol units that have reacted with each other to form polyglycerol chains. The second value indicates the degree of esterification of the polyglycerol ester. It is the number of fatty acid molecules that have reacted with the polyglycerol chains. The last character is a Roman letter. This indicates the type of fatty acid used in the esterification process. POLYALDO polyglycerol esters use stearic acid, oleic acid, palmitic acid, and lauric acid as target fatty acids. Here is POLYALDO, a polyglycerol ester emulsifier from Lonza. ® Example of 6-2-S (INCI: Polyglycerol-6-distearate). The suffix of this product contains “6,” “2,” and the letter “S.” According to the naming guidelines above, these characters represent the following: 6 is polyglycerol composed of six (6) units of glycerol. 2 is the degree of esterification of 2 (2) and is reflected in the fatty acid as “distearate.” S is stearic acid, used as the esterified fatty acid. POLYALDO ® 10-1-S (INCI: Polyglycerol-10-stearate). The suffix of this product contains “10”, “1” and the letter “S”. According to the naming guidelines above, these characters represent the following: 10 is polyglycerol composed of ten (10) units of glycerol. 1 is the degree of esterification (1) and is reflected in the fatty acid as “stearate”. S is stearic acid, which is used to esterify fatty acids. These naturally derived, plant-based emulsifiers provide an EO / PO-free option and an alternative to PEG-based chemicals.

[0025] In some implementations, useful surfactants may include those of formula I: HOCH2-(CHOH) n -CH2NR 1 R 2 (I) Where R1 and R 2 Independently selected from hydrogen atoms, alkyl groups, C(O)R 3 and SO2R 4 ;R 3 and R 4 It is independently selected from alkyl groups, aryl groups, and aralkyl groups; and n is an integer from about 2 to about 5.

[0026] Group R 1 and R 2 Independently selected from hydrogen atoms, alkyl groups, C(O)R 3 and SO2R 4 R 1 and R 2 Each of the atoms in R can be a hydrogen atom. 1 and R 2 Each of them can be an alkyl group, R 1 and R 2 Each of them can be C(O)R 3 , or R 1 and R 2 Each of them can be SO2R 4 In some implementations, R 1 It can be a hydrogen atom, and R 2 It can be an alkyl group, C(O)R 3 or SO2R 4 In other implementations, R 1 It can be an alkyl group, and R 2 It can be C(O)R 3 or SO2R 4 In other implementations, R 1 It can be C(O)R 3 And R 2 It can be SO2R 4 When R 1 and R 2 When any one or both of the following are alkyl groups, the alkyl group may contain about one carbon atom, more than about one carbon atom, more than about two carbon atoms, more than about four carbon atoms, more than about six carbon atoms, more than about eight carbon atoms, more than about ten carbon atoms, more than about twelve carbon atoms, more than about fourteen carbon atoms, more than about sixteen carbon atoms, or more than about eighteen carbon atoms. In some embodiments, the alkyl group contains less than about thirty carbon atoms, less than about twenty-six carbon atoms, or less than about twenty carbon atoms. In some embodiments, the alkyl group includes a straight-chain alkyl group. In other embodiments, the alkyl group includes a branched-chain alkyl group. In other embodiments, the alkyl group includes a cycloalkyl group. When R 1 and R 2When each of the alkyl groups in R is present, 1 and R 2 It can contain the same alkyl group, or R 1 and R 2 It may contain different alkyl groups. Non-limiting examples of alkyl groups include methyl, ethyl, 1-propyl, isopropyl, butyl, isobutyl, sec-butyl, pentyl, isopentyl, neopentyl, hexyl, 2-ethylhexyl, octyl, decyl, undecyl, dodecyl, tetradecyl, pentadecyl, octadecyl, cyclohexyl, 4-methylcyclohexyl, cyclohexylmethyl, cyclopentyl, and cyclooctyl.

[0027] Group R 3 and R 4 Independently selected from alkyl groups, aryl groups, and aralkyl groups. When R 3 or R 4 When any one or both of the following are alkyl groups, the alkyl group may contain about one carbon atom, more than about one carbon atom, more than about two carbon atoms, more than about four carbon atoms, more than about six carbon atoms, more than about eight carbon atoms, more than about ten carbon atoms, more than about twelve carbon atoms, more than about fourteen carbon atoms, more than about sixteen carbon atoms, or more than about eighteen carbon atoms. In some embodiments, the alkyl group contains less than about thirty carbon atoms, less than about twenty-six carbon atoms, or less than about twenty carbon atoms. In some embodiments, the alkyl group includes a straight-chain alkyl group. In other embodiments, the alkyl group includes a branched-chain alkyl group. In other embodiments, the alkyl group includes a cycloalkyl group. In a compound of formula I or a pharmaceutically acceptable salt thereof, when R 3 and R 4 When both groups are present, and when R 3 and R 4 When each of the alkyl groups in R is present, 3 and R 4 It can contain the same alkyl group, or R 3 and R 4 It may contain different alkyl groups. Non-limiting examples of alkyl groups include methyl, ethyl, 1-propyl, isopropyl, butyl, isobutyl, sec-butyl, pentyl, isopentyl, neopentyl, hexyl, 2-ethylhexyl, octyl, decyl, undecyl, dodecyl, tetradecyl, pentadecyl, octadecyl, cyclohexyl, 4-methylcyclohexyl, cyclohexylmethyl, cyclopentyl, and cyclooctyl.

[0028] When R 3 or R 4When any one or both of the following are aryl groups, the aryl group may contain one or more aromatic rings. The aromatic ring may contain up to six, eight, ten, twelve, fourteen, sixteen, or eighteen carbon atoms. The aromatic ring may contain heteroatoms, such as nitrogen, oxygen, or sulfur. If more than one aromatic ring is present, the aromatic rings may be fused together, or they may be linked by chemical bonds. In compounds of formula I or their pharmaceutically acceptable salts, when R... 3 and R 4 When both exist, and when R 3 and R 4 When each of the groups contains an aryl group, R 3 and R 4 It can contain the same aryl group, or R 3 and R 4 It may contain different aryl groups. Non-limiting examples of aryl groups include substituted and unsubstituted phenyl, 1-naphthyl, 2-naphthyl, and 9-anthrayl.

[0029] When R 3 or R 4 When any one or both of the following are aralkyl groups, the aralkyl group may contain one or more aromatic rings. The aralkyl group may contain up to six carbon atoms, up to eight carbon atoms, up to ten carbon atoms, up to twelve carbon atoms, up to fourteen carbon atoms, up to sixteen carbon atoms, up to eighteen carbon atoms, or up to twenty carbon atoms. If more than one aromatic ring is present on the aralkyl group, the aromatic rings may be fused together, or they may be linked by chemical bonds. The aromatic rings may contain heteroatoms, such as nitrogen, oxygen, or sulfur. In compounds of formula I or their pharmaceutically acceptable salts, when R... 3 and R 4 When both groups are present, and when R 3 and R 4 When each of the alkyl groups in R contains an aryl group, 3 and R 4 It can contain the same aralkyl group, or R 3 and R 4 It may contain different aralkyl groups. Non-limiting examples of aralkyl groups include benzyl, 1-phenylethyl, 2-phenylethyl, 3-phenylpropyl, 2-naphthylethyl, and 9-anthramethyl.

[0030] In Formula I, n is an integer from about 2 to about 5. In some embodiments, the dental composition comprises a compound of Formula I or a pharmaceutically acceptable salt thereof, wherein n is an integer having a value of about 5, about 4, about 3, or about 2. In some embodiments, n is an integer having a value of 5, or 4, or 3, or 2. It should be understood that the dental composition may comprise more than one compound of Formula I or a pharmaceutically acceptable salt thereof, and the compounds may be represented by Formula I with different integer values ​​of n. In these embodiments, the average value of n in the composition may be a non-integer.

[0031] It is known that compounds of Formula I contain chiral carbon atoms. For simplicity, no stereochemical configuration is specified for each of the chiral carbon atoms in Formula I. This is intended so that Formula I, as used in this specification and claims, represents every compound having any possible stereochemical configuration. In some embodiments, compounds of Formula I are aminoglycosides and their derivatives, commonly known as D-glucosamine, N-methyl-D-glucosamine, N-ethyl-D-glucosamine, N-octyl-D-glucosamine, and N-methyl-N-octanoyl-D-glucosamine, N-methyl-N-nonanoyl-D-glucosamine, and N-methyl-N-decanoyl-D-glucosamine. Many compounds of Formula I are commercially available. For example, N-methyl-N-nonanoyl-D-glucosamine (“MEGA-9”) is commercially available from EMD Chemicals, Inc., San Diego, CA.

[0032] Pharmaceutically acceptable salts of compounds of Formula I may also be used, and these may include ammonium salts. In some embodiments, the dental compositions of the present invention comprise ammonium salts. Ammonium salts may be represented as reaction products of acids and amines, or as reaction products of amines and alkylating agents such as, for example, iodomethane, bromoethane, or benzyl bromide. Ammonium salts include protonated amine compounds, such as those wherein NR 1 R 2 Compounds of formula I whose groups have been protonated by inorganic or organic acids, wherein R 1 and R 2 The groups are independently selected from hydrogen atoms and alkyl groups. Ammonium salts include alkylated amine compounds, such as those containing NR. 1 R 2 Compound I, in which the group has been alkylated by an alkylating agent, wherein R 1 and R 2 It is independently selected from hydrogen atoms and alkyl groups.

[0033] Ammonium salts contain at least one counter ion, which can be an inorganic anion, an organic anion, or a combination of anions. Combinations of anions include combinations of more than one inorganic anion, combinations of more than one organic anion, or combinations of inorganic and organic anions. Inorganic ions include, for example, halide ions (fluoride, chloride, bromide, and iodide ions), nitrate, sulfate, tetrafluoroborate, and tetra(aryl)borate. Tetra(aryl)borates include those having the formula Z4B. - Compounds in which Z is an aromatic group, such as a substituted or unsubstituted phenyl group. Examples of tetra(aryl)borates include, but are not limited to, tetraphenylborate, tetra(4-methylphenyl)borate, tetra(2-methylphenyl)borate, tetra(1,3,5-trimethylphenyl)borate, tetra(4-fluorophenyl)borate, tetra(pentafluorophenyl)borate, and tetra(4-trifluoromethylphenyl)borate. Organic anions include, for example, alkylates (such as acetate, propionate, and butyrate), benzoate, fumarate, maleate, tartrate, ascorbate, benzenesulfonate, toluenesulfonate, and citrate. In some embodiments, the pharmaceutically acceptable salt does not contain unsubstituted or substituted cycloheptatrienolone.

[0034] In some embodiments, the ammonium salt can be formed by protonating a compound of formula I using an inorganic acid, an organic acid, or a combination of an inorganic acid and an organic acid, wherein R 1 and R 2 The ammonium salt is independently selected from hydrogen atoms and alkyl groups. In another embodiment, the ammonium salt can be formed by alkylating a compound of formula I with an alkylating agent, wherein R... 1 and R 2 The ammonium salt is independently selected from hydrogen atoms and alkyl groups. In another embodiment, the ammonium salt can be formed by ion exchange or metathesis reaction with a previously formed ammonium salt. In some embodiments, R 1 Including alkyl groups, and R 2 It is C(O)R 3 , where R 3 Includes alkyl groups. In some embodiments, R 1 Including alkyl groups having about one to about four carbon atoms, R 3 Includes alkyl groups having about four to about sixteen carbon atoms. In some embodiments, R 1 Includes methyl groups, and R 3 This includes alkyl groups having seven, eight, or nine carbon atoms. In some embodiments, the dental composition comprises a compound of formula III, IV, or V.

[0035]

[0036] The disclosed compositions may contain no more than 5% by weight of one or more surfactants, no more than 4.5% by weight of one or more surfactants, or no more than 4% by weight of one or more surfactants based on the total weight of the composition. In some embodiments, the disclosed compositions may contain no less than 0.5% by weight of one or more surfactants, no less than 0.4% by weight of one or more surfactants, or no less than 0.3% by weight of one or more surfactants based on the total weight of the composition.

[0037] The disclosed compositions further comprise one or more viscosity modifiers. In some embodiments, the disclosed compositions may comprise a polymeric viscosity modifier. Exemplary useful polymeric viscosity modifiers may include, for example, hydroxypropyl guar gum, xanthan gum, I-carrageenan, or combinations thereof. In some embodiments, a composition of at least two of hydroxypropyl guar gum, xanthan gum, and ethyl cellulose may be used. In some embodiments, for example, various molecular weights of any of xanthan gum, hydroxypropyl guar gum, and ethyl cellulose may be utilized. In some embodiments, the disclosed compositions comprising polymeric viscosity modifiers may comprise no more than 3% by weight, no more than 2% by weight, or no more than 1.5% by weight of one or more polymeric viscosity modifiers based on the total weight of the composition. In some embodiments, the disclosed composition comprising a polymer viscosity modifier may contain at least 0.2% by weight, at least 0.1% by weight, or at least 0.05% by weight of one or more polymer viscosity modifiers based on the total weight of the composition. In some embodiments, the disclosed composition may contain a silica-containing viscosity modifier. In some embodiments, such a viscosity modifier may include, for example, pyrolytic silica or precipitated silica. In some embodiments, the disclosed composition comprising a silica-containing viscosity modifier may contain at least 2% by weight, or at least 1.5% by weight of one or more silica-containing viscosity modifiers based on the total weight of the composition.

[0038] The disclosed compositions may optionally contain additional components other than water, one or more oils, one or more surfactants, and one or more viscosity modifiers. Exemplary optional components may include, for example, sweeteners, humectants, mineral salts, buffering components, flavoring agents, preservatives, tooth remineralizers, anti-caries agents, or combinations thereof. Other optional beneficial ingredients may also be included at appropriate levels, such as aloe vera (multiple benefits), folic acid (related to B12), hyaluronic acid (lubricating, healthy skin), ceramides (healthy skin), arginine, betaine or oxidized triglycerides, vitamin E (antioxidant and preservative), vitamin B12 (healthy skin, etc.), EDTA, and hexadecylpyridine chloride. Chlorhexidine, other antibacterial and antiseptic agents, or combinations thereof.

[0039] In some embodiments, the disclosed compositions may contain flavoring agents, including, for example, peppermint, strawberry, butter, vanilla, coconut, almond, bubblegum, berry, fruit juice, caramel, caramel, or combinations thereof. In some embodiments, flavoring agents such as mint, citrus, etc., may also be advantageous because they stimulate saliva production when used in the composition. Artificial sweeteners (e.g., stevia, aspartame, sucralose, neotame, acesulfame potassium (Ace-K), saccharin, and advantame) may also be used. In some embodiments, the disclosed compositions may contain one or more sweeteners, including, for example, non-cariogenic polyols or sugar substitutes (e.g., sucralose). In some embodiments, the disclosed compositions may contain non-cariogenic polyol sweeteners, such as xylitol, sorbitol, maltitol, erythritol, isomaltitol, or combinations thereof. In compositions containing optional sweeteners, the sweetener may be present in an amount of not less than 2.5% by weight or not less than 1% by weight based on the total weight of the composition. In some embodiments, the optional sweetener may be present in an amount of not more than 35% by weight, not more than 20% by weight, or not more than 15% by weight based on the total weight of the composition.

[0040] In some embodiments, the disclosed compositions may contain one or more wetting agents, including, for example, glycerin, propylene glycol, or sucrose, or combinations thereof. In compositions containing optional wetting agents, the one or more wetting agents may be present in an amount of not less than 2.5% by weight, not less than 5% by weight, or not less than 10% by weight based on the total weight of the composition. In compositions containing optional wetting agents, the one or more wetting agents may be present in an amount of not more than 40% by weight, not more than 35% by weight, or not more than 30% by weight based on the total weight of the composition.

[0041] In various embodiments, the disclosed compositions may also comprise one or more tooth remineralizers alone or in combination with one or more minerals that may be useful or beneficial to ingestion or oral health.

[0042] In some embodiments, the disclosed compositions may optionally contain one or more minerals that are useful or beneficial to ingestion or oral health. Exemplary optional minerals that may be included in the disclosed compositions may include calcium (Ca), phosphorus (P), magnesium (Mg), fluorine (F), iron (Fe), strontium (Sr), zinc (Zn), potassium (K), or combinations thereof. In some embodiments, some minerals may be provided by comprising magnesium chloride (MgCl2), calcium chloride (CaCl2), strontium chloride, zinc chloride, zinc gluconate, potassium nitrate, dipotassium hydrogen phosphate (KH2PO4), or combinations thereof. In some embodiments, where fluorine is included, it may be included as fluoride ions (F-) in salt form (MgF2, CaF2, etc.) at a concentration not exceeding 4 mg / L.

[0043] In particular, certain calcium-containing compounds are advantageously included in the disclosed compositions. Such calcium compounds include: calcium chloride, calcium carbonate, calcium caseinate, calcium citrate, calcium gluconate, calcium gluconate, calcium glycerophosphate, calcium gluconate, calcium hydroxide, calcium hydroxyapatite, calcium lactate, calcium oxalate, calcium oxide lime, calcium pantothenate, calcium dihydrogen phosphate and ternary calcium phosphate, polycarboxylic acid calcium, calcium propionate, calcium pyrophosphate and calcium sulfate. These compounds have been found to minimize demineralization of calcium hydroxyapatite on the surface of patients' teeth.

[0044] In some embodiments, the tooth remineralizing agent (compound) includes phosphate compounds. Suitable phosphate compounds include, but are not limited to, aluminum phosphate, bone phosphate, calcium phosphate, calcium orthophosphate, anhydrous dicalcium phosphate, calcium phosphate-bone ash, dicalcium phosphate dihydrate, anhydrous dicalcium phosphate, calcium phosphate dihydrate, dicalcium phosphate, neutral calcium phosphate, calcium orthophosphate, tricalcium phosphate, precipitated calcium phosphate, tricalcium phosphate, white calcium phosphate, magnesium phosphate, potassium phosphate, dipotassium hydrogen phosphate, dipotassium orthophosphate, dipotassium monophosphate, dipotassium hydrogen phosphate, potassium dihydrogen phosphate, potassium acid phosphate, potassium dihydrogen phosphate, potassium dihydrogen phosphate, potassium hydrogen phosphate, sodium phosphate, anhydrous sodium phosphate, disodium hydrogen phosphate, disodium orthophosphate, disodium dodecahydrate, disodium phosphate, and mixtures and combinations thereof.

[0045] In some embodiments, a calcium compound, a phosphate compound, or both are used in a manner sufficient to cause the composition to be coated with Ca. 2+ Ions and PO4 3- At least one of the ions is present in saturated amounts in the compositions of the present invention. In some embodiments, saturation with at least one of calcium ions or phosphate ions can substantially reduce or prevent demineralization on the patient's tooth surface or enhance remineralization, or both.

[0046] In various embodiments, the tooth remineralizer is present in an amount of up to about 1 part by weight, or up to about 2 parts by weight, or up to about 5 parts by weight.

[0047] In some embodiments, the disclosed compositions may contain one or more preservatives to impart microbial stability to the composition, enhance its microbial stability, or some combination thereof. In some embodiments, useful preservatives include those that function at neutral pH, do not adversely affect taste, are edible, are effective against a variety of pathogens, or combinations thereof. Specific exemplary useful preservatives may include GEOGARD. ® Preservatives, which are commercially available from Lonza Group AG in Basel, Switzerland, include, for example, benzyl alcohol, sodium benzoate, potassium sorbate, parabens, natural preservatives, polyglycerol esters, glyceryl monolaurate, 1,2-octanediol, caprylic / capric triglyceride, DHA, aloe vera, potassium sorbate, CPC, PHMB, CHG, vitamin E, triethyl citrate, and EDTA.

[0048] In some embodiments, the disclosed compositions may contain one or more naturally occurring amino acids as agents to help prevent tooth decay. "Tooth decay" is understood as cavities, which cause tooth demineralization. The following amino acids have been found to be useful as anti-caries agents: glycine, leucine, isoleucine, lysine, methionine, phenylalanine, serine, threonine, valine, tryptophan, and mixtures thereof; sometimes the following amino acids are preferred: glycine, phenylalanine, serine, isoleucine, leucine, and methionine; sometimes even more preferred are glycine and phenylalanine. The amino acids may be natural or synthetic. The amino acids may be in the D-configuration or L-configuration. In some embodiments, the L-configuration is preferred.

[0049] In some embodiments, the disclosed composition may contain amino acids present in amounts (by weight % of the total composition): at least 0.1% by weight, at least 1% by weight, or at least 2% by weight. In some embodiments, the disclosed composition may contain amino acids present in amounts (by weight % of the total composition): not more than 15% by weight, not more than 12% by weight, or not more than 10% by weight. In some embodiments, the disclosed composition may contain amino acids present in amounts (by weight % of the total composition): including and in the range of 0.1% by weight to 15% by weight, including and in the range of 1% by weight to 12% by weight, or including and in the range of 2% by weight to 10% by weight.

[0050] In some embodiments, the disclosed composition comprises the following amino acids, alone or in combination with other amino acids: 0.1% to 10% by weight of glycine; or 0.1% to 5% by weight of leucine; or 0.1% to 5% by weight of isoleucine; or 0.1% to 10% by weight of lysine; or 0.1% to 10% by weight of methionine; or 0.1% to 5% by weight of phenylalanine; or 0.1% to 10% by weight of serine; or 0.1% to 10% by weight of threonine; or 0.1% to 8% by weight of valine; or 0.1% to 2% by weight of tryptophan; all of the above are expressed as a percentage by weight relative to the total weight of the composition.

[0051] In some embodiments, the disclosed compositions comprise the following amino acids, alone or in combination with other amino acids: 1% to 10% by weight of glycine; or 1% to 5% by weight of leucine; or 2% to 5% by weight of isoleucine; or 5% to 10% by weight of lysine; or 2% to 10% by weight of methionine; or 1% to 5% by weight of phenylalanine; or 1% to 10% by weight of serine; or 6% to 10% by weight of threonine; or 3% to 8% by weight of valine; or 0.5% to 2% by weight of tryptophan; all of the above are expressed as a percentage by weight relative to the total weight of the composition. In contrast, the following amino acids have been found to be ineffective for caries prevention: proline, arginine, histidine, aspartic acid, glutamine, and tyrosine. Some embodiments of the disclosed compositions do not contain these amino acids: proline, arginine, histidine, aspartic acid, glutamine, and tyrosine. Some embodiments of the disclosed compositions contain these amino acids only in an amount not exceeding 0.5% by weight, or more than 0.3% by weight, or more than 0.1% by weight relative to the total composition.

[0052] In some embodiments, the disclosed compositions do not contain any quaternary antimicrobial compounds.

[0053] The disclosed compositions may have varying properties. In some embodiments, the disclosed compositions can be described by their pH, viscosity, stability, a variety of other properties, or combinations thereof.

[0054] In some embodiments, the disclosed composition may have a pH acceptable for use in the human oral cavity, for example. In some embodiments, the disclosed composition may have a pH of, for example, 4.5 to 9.5. In some embodiments, the pH of the composition may be in a more neutral range, for example, 5.0-8.5 or 5.5-8.5, because patients with dry mouth may be more sensitive to pH. The composition may have such a pH naturally, or it may be buffered to have a pH in a useful, for example, “neutral” range.

[0055] In some embodiments, the disclosed compositions may have a viscosity that allows them to be used as or delivered as a sprayable composition. The compositions can be sprayed, for example, via a non-pressurized dispenser or a pressurized pump dispenser. In some embodiments, the disclosed compositions may have a viscosity not exceeding 80,000 centipoise (cps), not exceeding 50,000 cps, not exceeding 20,000 cps, or not exceeding 10,000 cps. In some embodiments, the disclosed compositions may have more desirable rheological properties, resulting in lower shear thinning. In some embodiments, compositions with lower shear thinning exhibit a more widely dispersed spray pattern when delivered in a non-pressurized dispenser.

[0056] In some embodiments, the disclosed compositions may have desired stability properties. The stability of the composition may include microbial stability, physical stability, or a combination thereof. In some embodiments, the disclosed compositions are microbiologically stable for at least 6 months, in some embodiments for 1 year, and in some embodiments for more than 2 years.

[0057] In some embodiments, for example, the disclosed composition remains physically stable when subjected to normal room temperature conditions, when subjected to temperatures approaching or exceeding the freezing point of the composition and subsequently thawing, or a combination of these conditions. In some embodiments, for example, the composition may be stable if it does indeed remain physically stable when subjected to normal room temperature conditions, when subjected to temperatures approaching or exceeding the freezing point of the composition and subsequently thawing, or a combination of these conditions. In some embodiments, the disclosed composition is physically stable when subjected to temperatures above room temperature, for example, greater than 60°C. In some embodiments, the disclosed composition is physically stable, for example, when subjected to mechanical forces (e.g., gravity) such as centrifugation. In some embodiments, the disclosed composition is physically stable, for example, when subjected to changes in both temperature (such as those discussed above) and mechanical forces (such as those discussed above). In some embodiments, a physically stable composition is one that does not separate into an oil phase and an aqueous phase during the product's service life, during transportation and / or storage, or any combination thereof.

[0058] In some embodiments, sprayable compositions with low viscosity (< 10,000 cps) can be readily remixed to a homogeneous state by shaking. In some embodiments, the disclosed compositions that can be used as sprayable compositions can have relatively high viscosity and are not easily mixed by shaking. The amount of shaking required to restore a separated emulsion to a homogeneous state is subjective and can be difficult to assess, especially in opaque packaging. Improper mixing may result in the dispensing and use of a product that is not the intended composition. In some embodiments, the disclosed compositions do not separate into oil and aqueous phases when subjected to a variety of conditions; in other embodiments, the disclosed compositions do separate into oil and aqueous phases when subjected to a variety of conditions. Physically stable compositions may be advantageous because they can provide a homogeneous composition to the user throughout the product's lifespan.

[0059] In some embodiments, the disclosed composition is physically stable upon undergoing at least one freeze / thaw / centrifugation cycle. A freeze / thaw / centrifugation cycle comprises freezing the composition (e.g., for at least 3 hours), followed by thawing the composition (e.g., for at least 2 hours), and then centrifuging the composition at 1750 RCF (relative centrifugal force) for 15 minutes. In some embodiments, the disclosed composition is physically stable, for example, upon undergoing at least two or at least three freeze / thaw / centrifugation cycles. In some embodiments, the disclosed composition is physically stable upon undergoing temperatures above 60°C (which may be referred to as a thermal cycle). In some embodiments, the disclosed composition is physically stable upon undergoing at least one thermal cycle. In some embodiments, the disclosed composition is physically stable upon undergoing at least one freeze / thaw / centrifugation cycle followed by a heating cycle.

[0060] In some embodiments, the disclosed compositions that can be used as sprayable compositions may have, for example, relatively low viscosity (< 10000 cps). In some such compositions, it may be useful even if the composition is not physically stable, because it can be at least temporarily resuspended in the sprayable composition and sprayed upon shaking (e.g., shaking for 5 to 30 seconds, or 5 to 15 seconds, or 5 to 10 seconds).

[0061] In some embodiments, the disclosed compositions may have desired effects when used. Such effects may include, for example, the effect of the composition on biofilms, the effect of the composition on plaque buildup, the effect of the composition on dehydration, the composition's ability to maintain or provide lubricating properties, resistance to dilution or rinsing by saliva or water, or general drinking and eating abilities, or combinations thereof.

[0062] In some embodiments, the disclosed composition can prevent, inhibit, or disrupt the formation or maintenance of biofilms in areas in contact with the composition. The areas of contact can be in vivo or in vitro. In some embodiments, when the composition is applied to a user's mouth (e.g., by spraying the composition into the mouth) compared to a mouth where no composition is applied, the composition can prevent, inhibit, or disrupt the formation or maintenance of biofilms in the mouth. In some embodiments, when the composition is applied to a container where no composition is applied, the composition can prevent, inhibit, or disrupt the formation or maintenance of biofilms in the container where biofilms are present, compared to a container where no composition is applied, and the composition is applied to the container by pouring, spraying, etc. Some combinations that prevent, inhibit, or disrupt the formation or maintenance of biofilms, or achieve these effects, can be measured using a modified MBEC assay (described in ASTM E2799), which measures the growth of Streptococcus mutans (Streptococcus mutans) on specific nails in a microtiter plate. strep mutans Biofilm disruption. Biofilms growing on the nails are treated by periodically immersing them in test material and then washing them with saliva and water. The biofilm remaining on each nail after treatment can be quantified by measuring the amount of fluorescently labeled bacteria eluted from the nails at the end of the treatment cycle (see Examples). In some embodiments, the disclosed composition can affect plaque accumulation in areas in contact with the composition. The areas in contact can be in vivo or in vitro. In some embodiments, when the composition is applied to a user's mouth (e.g., by spraying the composition into the mouth) compared to a mouth without the composition applied, the composition can reduce plaque accumulation on at least one tooth in the mouth. In some embodiments, when the composition is applied to a container that can form plaque, compared to a container without the composition applied, and the composition is applied to the container by pouring, spraying, etc. The reduction in plaque accumulation can be measured by a variety of in vivo methods, including, for example, plaque scoring, plaque staining, etc.

[0063] In some embodiments, the disclosed composition can affect hydration loss in areas in contact with the composition. The areas in contact can be in vivo or in vitro. In some embodiments, the composition can reduce hydration loss in the mouth when applied to a user's mouth (e.g., by spraying the composition into the mouth) compared to the mouth where no composition is applied. In some embodiments, the composition can reduce hydration loss from tissues where hydration may be lost, compared to tissues where no composition is applied, and the composition is applied to the tissue by pouring, spraying, etc. Hydration loss can be measured by exposing a uniformly sized treated tissue sample to a controlled 37°C environment for a set period of time (4 hours) and recording the % weight loss of the treated tissue sample. The treated tissue is then exposed to high temperatures to remove all water from the sample (95°C / 4 hours and 115°C / 4 hours). The water loss at 4 hours is divided by the total water loss (after the 115°C step) to represent the water lost from the tissue at 4 hours. In some embodiments, the disclosed composition can affect less than 65% or less than 60% of the water loss.

[0064] In some embodiments, the disclosed composition can affect the lubricity or lubricity of areas in contact with the composition. The areas in contact can be internal or external. In some embodiments, when the composition is applied to a user's mouth (e.g., by spraying the composition into the mouth) compared to a mouth without the composition applied, the composition can maintain or increase lubricity in the mouth. In some embodiments, the composition can, for example, provide the same level of lubricating properties to the mouth as saliva can provide. In some embodiments, when applied to a substrate where lubricity might be lost, the composition can maintain or increase lubricity on a substrate without the composition applied, and the composition is applied to the substrate by pouring, spraying, etc. Lubricity or the ability to provide lubricating properties can be measured by the coefficient of friction relative to a suitable substrate. A low coefficient of friction (compared to saliva) is desirable.

[0065] The disclosed compositions combine the benefits of both oil and aqueous phases. In some embodiments, the disclosed compositions can combine many desired benefits, such as lubrication, moisturizing, hard tissue exposure to beneficial minerals, and pH balance. Finding an uptakeable surfactant and thickening system to achieve all the desired benefits requires extensive experimental research, and is not limited to routine optimization. Furthermore, some of the disclosed compositions achieve the desired physical stability. Emulsions without certain physical stability standards may have lower-than-expected product shelf life and commercial usability. Stability during freeze / thaw cycles may be important to ensure the stability of the emulsion during storage and transportation. Commercially, it may not be desirable for the emulsion to separate into aqueous and oil phases prior to oral administration. The unique combination of surfactants and thickeners disclosed produces emulsion compositions that are physically stable for multiple cycles of freeze / thaw / centrifugation challenge tests and may resist separation when exposed to elevated temperatures (>60°C). Surprisingly, some of these formulations also possess anti-plaque properties, such as those against Streptococcus mutans (S. mutagenesis). Streptococcus mutans This was demonstrated in an in vitro anti-biofilm study of (a well-known biofilm-forming bacterium that causes dental plaque).

[0066] This document also discloses methods of using the disclosed compositions. The disclosed methods may include contacting the oral cavity or oral tissues with the disclosed compositions. The step of contacting the oral cavity or oral tissues may be accomplished by applying the compositions in any manner, such as by spraying. The disclosed methods may be used to prevent, inhibit, disrupt, or maintain the formation of or maintenance of biofilms in areas in contact with the compositions, or any combination thereof; to influence hydration loss in areas in contact with the compositions; to influence the lubricity or lubricity of areas in contact with the compositions; or to influence or alleviate dry mouth, slack mouth, or both.

[0067] Unless otherwise specified, all scientific and technical terms used herein have their common meaning in the art. The definitions provided herein will aid in understanding certain terms frequently used herein and are not intended to limit the scope of this disclosure.

[0068] Unless otherwise expressly stated, the singular forms “a,” “an,” and “described” as used in this specification and the appended claims cover embodiments having multiple referents.

[0069] Unless otherwise expressly stated, as used in this specification and the appended claims, the term "or" is generally used in its meaning as including "and / or". The term "and / or" means one or all of the listed elements, or any combination of two or more of the listed elements.

[0070] As used herein, the terms “having,” “including,” and “comprising” are used in their open-ended sense and generally mean “including, but not limited to.” It should be understood that “consistently composed of,” “comprises of,” etc., are included within “including,” etc. For example, a composition “comprising” silver can be a composition “composed of silver” or “consistently composed of silver.”

[0071] As used herein, when “consistently made of” refers to a composition, apparatus, system, method, etc., it means that the constituent elements of such composition, apparatus, system, method, etc. are limited to the enumerated constituent elements and any other constituent elements that do not substantially affect the essential and novel characteristics of such composition, apparatus, system, method, etc.

[0072] The terms "preferred" and "ideally" refer to embodiments that provide certain beneficial effects under certain circumstances. However, other embodiments may also be preferred under the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are unavailable, nor is it intended to exclude other embodiments from the scope of this disclosure (including the claims).

[0073] Additionally, in this document, the numerical range expressed by endpoints includes all values ​​contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc., or 10 or less includes 10, 9.4, 7.6, 5, 4.3, 2.9, 1.62, 0.3, etc.). A value is included in the range if the range "at most" includes a specific value.

[0074] The use of "first," "second," etc., in the above description and the following claims is not necessarily intended to indicate the existence of an enumerated number of objects. For example, the "second" basis is only intended to distinguish it from another basis (such as the "first" basis). The use of "first," "second," etc., in the above description and the following claims is also not necessarily intended to indicate that one is earlier than the other in time.

[0075] Exemplary articles and techniques based on this disclosure will be illustrated by the following non-limiting embodiments.

[0076] Example

[0077] Table 1A: Materials

[0078]

[0079]

[0080] Table 1B: Materials - Thickeners

[0081]

[0082]

[0083] Table 1C: Commercially available products for the treatment of dry mouth

[0084]

[0085] Table 1D: Materials and Composition of Artificial Saliva

[0086]

[0087] Dissolve all components in water. Adjust to pH 7.0. Refrigerate for up to one week. Mix thoroughly before use.

[0088] Table 2: Preparation of phosphate buffer water 1 (pH 7)

[0089]

[0090] Table 3: Phosphate Buffer Water 2 (Prepared from water-in-oil Mg / KCl) pH 7

[0091]

[0092] Example Preparation Process

[0093] The formulations of the examples were prepared as follows. The aqueous phase components were mixed together by dissolving all water-soluble components and adjusting the pH to 6-8 with HCl or NaOH (unless otherwise specified). If necessary, glycerol and thickener were added to the aqueous phase in slurry form last, while stirring the solution to prevent clumping. The aqueous phase was heated to 80°C. Next, the oil phase components were mixed together and heated to 80°C. The aqueous phase was then poured into the oil phase, and the combined mixture was homogenized at medium speed for 3 minutes using a PowerGen1000 homogenizer (Fisher Scientific) with a serrated fine generator probe. Each mixture was rolled and allowed to cool to room temperature; then allowed to stand for at least 24 hours before further evaluation.

[0094] Viscosity test

[0095] The viscosity of the example formulations was measured at room temperature using a parallel plate clamp on an AR-G2 electromagnetic bearing rheometer from TA Instruments Ltd. Approximately 1.4 mL of the example formulation was placed between the plates, with the plate gap set to 1 mm for measurement at room temperature. Viscosities were recorded at shear rates of 1.0, 3.16, and 10 1 / s. Each formulation was measured twice in parallel, and the average value was recorded.

[0096] The effect of stabilizing thickeners on lubrication (the effect of reducing friction).

[0097] Some stable thickener polymers also provide lubrication, improving taste or comfort when used during treatment of dry mouth. This property is evaluated by friction measurement according to the friction test method below.

[0098] Friction test method : Friction / lubrication was measured using a FORCEBOARD universal friction tester (Industrial Dynamics, Sweden AB) equipped with a 10 Newton (N) load sensor. A natural lambskin condom made from sheep cecum (Trojan NATURALAMB) was used. ™ Luxury condoms (Church & Dwight Co., Inc., Ewing, NJ) are used to simulate oral mucosal tissue. Before use and between measurements, the condom should be thoroughly rinsed to remove excess liquid, ensuring no residual lubricant or example test preparation may interfere with subsequent measurements. Place the condom on a glass slide, smoothing it to remove wrinkles, and then secure it to the FORCEBOARD friction tester using a stapler. Using a syringe, meter 0.5 mL of the example test solution (or other comparative sample such as water or human saliva) onto the surface of the condom closest to the front of the FORCEBOARD (farthest from the engine). Then, secure a second layer of condom around a gloved finger and move the covered finger downwards along the surface of the FORCEBOARD (towards the engine) while applying a target vertical force of 3 N. Repeat this movement 6–10 times for each parallel measurement. The coefficient of friction (under vertical forces of 2.9 to 3.1 N) was calculated using FORCEBOARD analyzer software (Industrial Dynamics, Sweden). Unless otherwise stated, three parallel measurements were performed for each example, and the average coefficient of friction is recorded in Tables 4A, 4B, 4C, 4E, 4F, and 4J. Lower coefficients of friction values ​​result in smoother surfaces, which is therefore an ideal property for formulations used to treat dry mouth.

[0099] All tested formulations outperformed water. The addition of polymers such as hydroxypropyl guar gum (JAGUAR), xanthan gum, or carrageenan (or a combination thereof) further improved the lubrication of the emulsions compared to the polymer-free control. Adding more polymers also improved the lubricating properties. Higher oil content also improved the lubricating properties of the formulations tested. Among these polymers, hydroxypropyl guar gum (JAGUAR) provided the greatest lubrication effect for the tested formulations.

[0100] Table 4A: Examples 1-6

[0101]

[0102] Table 4B: Examples 7-10

[0103]

[0104] Table 4C: Comparative Example 1 and Examples 11-15

[0105]

[0106] NT = Untested For friction testing, n (parallel measurements) = 2

[0107] Table 4D: Examples 16-21 (Viscosity test not performed)

[0108]

[0109] Table 4E: Examples 22-27

[0110] For friction testing, n (parallel measurements) = 2

[0111] Table 4F: Examples 28-35

[0112]

[0113] Table 4G: Examples 36-41

[0114]

[0115] Table 4H Examples 42-48

[0116]

[0117] Table 4I Examples 49-50 and the amino acid glycine

[0118]

[0119] Table 4J: Comparative Examples and Commercially Available Examples for Friction Coefficient Testing

[0120] Stability test

[0121] Specific polymeric thickeners are added to provide mucosal adhesion, lubrication, and affinity (durability). Some polymeric thickeners offer improved emulsion compatibility and physical stability. The formulations in the examples did not separate into oil and aqueous phases after heating to temperatures above 60°C or freezing. The absence of phase separation after centrifugal cycles indicates physical stability, suggesting an improved potential for long shelf life. The data shown in Table 5 indicate that room temperature stability does not necessarily guarantee stability to elevated temperatures or freezing / thawing / centrifugation conditions. Formulations that pass through three cycles of freezing / thawing / centrifugation and have high-temperature stability above 60°C are preferred.

[0122] High temperature stability test procedure : Place 10-20 mL of the formulation from the examples into a glass vial and heat from 55°C. After equilibration at the target temperature for at least 30 minutes, record any visually observed phase separation. Then increase the temperature by 5°C and allow the formulation to reequilibrate at the newly increased temperature for 30 minutes before visually assessing phase separation. Increase the temperature to 90°C. The temperature recorded for each example is the temperature at which the formulation exhibits phase separation. Preferably, the formulation can remain stable (without phase separation) at higher temperatures.

[0123] Freezing / thawing / centrifugation stability test procedure : Place 10 mL of the example formulation into a 15 mL conical centrifuge tube. Store the example formulation at -15°C for at least 2 hours (usually overnight). After freezing, thaw the formulation at room temperature for at least 2 hours, then centrifuge at 1750 RCF for 15 minutes. Perform phase separation assessment of the formulation after every 15-minute cycle of centrifugation at 1750 RCF.

[0124] Room temperature stability test procedure : The formulations in this example were stored at room temperature for at least one month, after which phase separation was evaluated. Phase separation indicated instability.

[0125] Table 5: Effect of polymer thickeners on formulation stability

[0126]

[0127] Food-grade pyrolytic silica (Evonik A300) can be used to adjust rheology for use alone or in combination with the aforementioned stabilizing thickeners to achieve a mist spray. When used at higher levels, it can improve emulsion stability, as demonstrated by freeze / thaw / centrifugation cycles, and provides heat resistance (high melt temperature). Refer to Table 6A. At a 1% usage level, Formulation Example 4 is more resistant to freeze / thaw / centrifugation cycles compared to similar formulations such as Example 3, but it uses a low level (0.2%) of the low-MW thickener (xanthan gum 3: KELTROL SF). Formulation Example 5 is stable for 3 freeze / thaw / centrifugation cycles when low molecular weight xanthan gum 3 (KELTROL SF) is mixed with pyrolytic silica. All three formulations allow for mist spray delivery from the aforementioned non-pressurized pump atomizer. Using a higher amount (0.5%) of low molecular weight xanthan gum 3 also produces a stable Formulation Example 6, but results in jet delivery. Comparing Examples 2 and 3, using a low level (0.2%) of high molecular weight xanthan gum 2 (KELTROL Advanced) was more stable in freeze / thaw / centrifugation cycles than using the same amount of low molecular weight xanthan gum, but the higher molecular weight polymer resulted in jet delivery. The preferred combination of thickeners (with different molecular weights) and pyrolytic silica can be optimized to provide stability and more desirable spray application. Comparative Examples 40 and 41 similarly show that adding ethyl cellulose to the formulation yields a formulation with a higher viscosity, but when dispensed from the same simple pump-type spray applicator, it has a wider (mist) spray pattern.

[0128] Table 6A: Spraying Capacity of Selected Examples

[0129]

[0130] Table 6B: Spraying Capacity of Selected Examples

[0131]

[0132] In vitro hydration retention test method (thermogravimetric analysis)

[0133] The percentage of weight loss of the samples was determined using a LECO thermogravimetric analyzer (TGA) to simulate 4 hours of moisture retention in the oral cavity. In this in vitro test, thin slices of roasted raw beef (approximately 6 mm thick) were used to simulate soft tissue. A 1 cm diameter section was taken from the roasted beef slice using a circular biopsy puncturist to obtain disc-shaped tissue section samples. These samples were pre-weighed and then coated by immersion in one of commercially available oral dryness relief products, the formulation of the example, or raw materials (oil only). Uncoated beef samples were also analyzed as a control. Approximately 0.2 g of the test material was weighed into a foil-lined analytical container and placed in the LECO TGA thermogravimetric analyzer. The example was then held at body temperature (37°C) for 4 hours, and the percentage of volatile matter (water) loss (%) after this step was recorded. Next, the temperature was increased to evaporate all volatile substances and the total weight fraction was obtained. The weight loss at the 4-hour step point at 37°C is divided by the total volatiles and expressed as a percentage (%) of the total volatiles lost at 4 hours. The following shows detailed information about the time / temperature profile used to run the program on the LECO TGA thermogravimetric analyzer.

[0134] Table 7: LECO TGA Procedure

[0135]

[0136] Summary of in vitro hydration retention test results

[0137] Table 8 below summarizes data on commercially available products, example formulations, and selected raw materials. All commercially available water-based spray products showed an average water loss greater than 65% after 4 hours at 37°C. Most example formulations exhibited superior performance with a water loss of less than 65% after 4 hours at 37°C. The optimal formulation showed a water loss of less than 60%.

[0138] Table 8: Results of in vitro hydration retention test

[0139]

[0140] Short-term rinse resistance test method

[0141] The following test methods were used to simulate the rinsing of the example formulations from the surface of a human mouth. Test substrates were prepared using transparent rectangular LEXAN resin polycarbonate test specimens (13 cm × 5 cm, 0.74 mm thick; available from AeroMat Plastics, Burnsville, MN, USA). This material was used as the test substrate because its surface properties are similar to human skin. Specimens were prepared by forming a 1 cm × 1 cm grid on the back side (uncoated side) to facilitate endpoint visualization. The staining method for Examples 36, 37, 38, and 39 involved adding 2 drops of blue food coloring (McCormick food coloring and Egg dye) to 20 mL of each example formulation. The surface of the test specimen was coated with the example formulation using a pull-down blade coater with a gap set to 0.5 mm. Excess material was then removed using a foam swab, and precise 2 cm × 2 cm squares of the example formulation coating were aligned on the grid. The sample was held vertically along its upper long side and repeatedly immersed in a large water bath at room temperature (22°C + / - 2°C). Each downward movement ensured complete immersion of the sample. Each upward movement completely removed the sample from the water bath. Each downward or upward movement was performed continuously over a period of 1 second, so that a complete immersion / removal cycle lasted approximately 2 seconds. The rinse resistance of each example formulation was determined by calculating the number of immersions required to remove at least 75% of the coating from the initially coated 2 cm × 2 cm area. Each example formulation was performed in four parallel determinations, and the results are shown in Table 9. The results indicate that increasing the concentration of ethyl cellulose requires more immersions to rinse away the sample (increasing rinse resistance), thus resulting in improved retention in the oral cavity.

[0142] Table 9: Short-term flushing resistance test results

[0143]

[0144] Long-term rinse resistance test method (using artificial saliva)

[0145] The following test method is used to demonstrate the long-term persistence (affinity) of coatings of various compositions after immersion in a large amount of artificial saliva. Weigh or peel a glass microscope slide (VWR part number 48312-002), and then apply a small amount (approximately 0.2 g) of sample material to the end of the glass slide away from the rough end used for marking and holding the slide. Then, using gloved fingers, spread the material evenly over a 1-inch × 1-inch (2.5 cm × 2.5 cm) area along the edge of the slide. The amount of material applied to the slide is then quantified by weighing the coated slide. The amount of material applied should be 0.04 g + / - 0.005 g.

[0146] The coated edge of the slide was then fully immersed in a sufficient amount (50 mL) of artificial saliva (the composition in Table 1D) and held upright undisturbed. The slide was removed from the artificial saliva at 30 minutes, 1 hour, and 2 hours. The presence / absence of the coated sample as observed by the naked eye was recorded at those time points.

[0147] Table 10: Short-term flushing resistance test results

[0148]

[0149] Biofilm damage testing methods

[0150] This method utilizes a high-throughput MBEC assay system (Innovotech, Calgary, Alberta, Canada). The method assesses the efficacy of a treatment in disrupting biofilms by quantifying the amount of fluorescently labeled biofilm remaining on the MBEC inoculator nail after exposure to the relevant treatment conditions. This assay is similar to ASTM E2799-12 (using...). MBEC ™ The standard method for testing the disinfection efficacy of biofilms against Pseudomonas aeruginosa was modified to use Streptococcus mutans as the relevant organism, and an improved protocol was used to expose the biofilm to the test material.

[0151] MBEC Measurement Procedure : Overnight cultures of *Streptococcus mutans* (ATCC 25175) were prepared by introducing a small amount of frozen stock solution into 5 mL of BHI broth in a 15 mL conical tube using a sterile inoculation loop. The tubes were incubated at 37°C (stationary, without shaking) for 12–16 hours. The density of the overnight culture was estimated by turbidity measurement (OD600) and then cultured in a solution supplemented with 1% sucrose and 1 μM Alexa Fluor. ® 488 glucan – 10,000MW (Molecular Probes) ® Dilute PN / D22910 in BHI medium to an appropriate OD600 of 0.01 to obtain an appropriate volume of inoculum for filling the required 96-well plates. Add 150 μL of inoculum to each 96-well MBEC plate. ™ Biofilm inoculant plate (Innovotech) ®P&G plates (polystyrene) were inoculated into appropriate wells. Control wells for fluorescence readings were also filled with 150 μL of PBS or bacteria-free BHI + 1% sucrose medium. MBEC inoculator caps (with nails dipped into each well) were placed on the inoculation plate. The plate was wrapped in paraffin film and incubated in a sealed plastic container, which was humidified by lining the bottom with a damp paper towel (37°C, shaken at 250 RPM). The biofilm was allowed to form on the nails for 4 hours before being exposed to the example formulation. In this modified assay, the biofilm growing on the nails was exposed to the example formulation three times during the assay, at 4, 7, and 24 hours post-inoculation. Exposure to the example formulation was performed as a treatment cycle, with additional washing steps in saliva and water. Treatment was performed by transferring the nails to multiple 96-well plates filled with 150 μL / well of the example formulation or 150 μL / well of artificial saliva or water.

[0152] Process the cycle steps (executed at 4, 7, and 24 hours).

[0153] 1) Expose to test material for 2 minutes (150 μL / well) – RT – do not shake

[0154] 2) Expose to artificial saliva for 7 minutes (150 uL / well) at 37°C, shaking.

[0155] 3) Expose to sterile water for 10 minutes (150 mg / well) at 37°C, and shake.

[0156] After rinsing with water, the nails were placed back into the growth medium (BHI + 1% sucrose + 1 μM Alexa Fluor). ® 488 glucan (10,000 MW) was placed in 96-well plates and returned to the incubator to allow additional biofilm buildup until the next treatment or until the end of the final growth phase. After the last treatment exposure cycle (24 hours post-inoculation), the pins were incubated in growth medium for another 4 hours, then transferred to a final wash plate for 1 minute (150 μL sterile water per well, agitated at 37°C for final rinsing), followed by transfer to 150 μL / well of 50 U / mL glucanase (pH 5.5) (from Penicillum sp., Sigma) filled with 0.2 M acetate. ®The pins were placed in 96-well plates (black plates, suitable for fluorescence quantification in a plate reader) using the D4668-1KU formula. The pins were incubated in the extraction solution wells by shaking at 37°C for 30 minutes at 250 RPM. The plate was then placed in an ultrasonic water bath at room temperature for at least 1 hour to elute the accumulated biofilm from the pins into the dextranase / acetate solution. After sonication, the fluorescence in each well was read in a fluorescence plate reader (excitation = 488 nm, emission = 525 nm). Each treatment was performed in parallel with 4–8 wells.

[0157] Results of biofilm damage test method

[0158] Table 11 shows the mean relative fluorescence readings for each formulation treatment. Lower values ​​indicate higher biofilm disruption activity than higher values. Values ​​are recorded as relative fluorescence (%), normalized relative to the mean fluorescence value of wells containing sterile water as a negative control. For consistency, appropriate parallel determinations were performed in the sterile water treatment wells for each MBEC plate. Data were normalized using a water control group run on the same 96-well plate. The p-value I provided for each sample compared to water was calculated using a Student's t-test (1-tailed, unpaired).

[0159] PERIDEX mouthwash (0.12 wt% chlorhexidine gluconate, 3M Health Care, St. Paul, Minn.) was used as a positive control and was not expected to show biofilm accumulation. BIOTENE oral rinsing solution was used as a commercially available product (comparative example) for treating dry mouth (available from GlaxoSmithKline ConsumerHealthcare LP, Moon Township, PA, USA; ingredients include: purified water, propylene glycol, xylitol, hydrogenated starch hydrolysate, poloxamer 407, hydroxyethylcellulose, sodium benzoate, flavoring (peppermint oil), benzoic acid, disodium hydrogen phosphate, zinc gluconate, lactoferrin, lysozyme, lactoperoxidase, potassium thiocyanate, aloe vera gel, calcium lactate, glucose oxidase).

[0160] Table 11: Results of Biofilm Disruption Test

[0161]

[0162] Methods for measuring the hardness of bovine teeth

[0163] Enamelled flake preparation and polishing process : Cut the enamel from the bovine incisor into thin slices approximately 4.5mm × 4.5mm and encapsulate them in an acrylic resin-filled mold with a 1-inch (2.54cm) diameter ring. The enamel slices should face upwards. Use 120-grit sandpaper to sand the encapsulated enamel slices to expose the enamel. Wet sand the enamel surface with 600-grit sandpaper (counter-clockwise rotation, 150 rpm, 10 psi) for 30 seconds. Reverse the direction on the wheel and repeat polishing for another 30 seconds. Reverse the direction on the wheel again and repeat polishing for another 30 seconds. Before continuing with the polishing steps, inspect the sample to ensure it has been fully sanded (all corners exposed).

[0164] For the polishing step, remove the sandpaper and replace it with a 9-micron polishing plate, adding a few drops of polishing slurry to the plate. Set the polishing time to four minutes at 130 rpm, rotating clockwise with 10 pounds of pressure. Polish the sample by cleaning it with cotton swabs soaked in a mixture of 1:3 MURPHY oil soap (obtained from Colgate Palmolive Company, New York, NY, USA) and deionized water, then rinse the sample thoroughly with deionized water. Inspect the samples to confirm they are adequately polished (a flawless shine, with no visible unpolished areas). If the sample is not fully polished, repeat the polishing step as needed. The next step is to remove the 9-micron polishing plate and replace it with a 3-micron polishing plate, adding a few drops of polishing slurry to the plate. Set the polishing time to four minutes at 130 rpm, rotating counterclockwise with 10 pounds of pressure. Polish the sample by cleaning it with cotton swabs soaked in a mixture of 1:3 MURPHY oil soap and deionized water, then rinse the sample thoroughly with deionized water. Inspect the samples to confirm they have been adequately polished (a flawless shine, with no visible unpolished areas). If the samples are not fully polished, repeat the polishing step as needed. The next step is to remove the 3-micron polishing plate and replace it with the master polishing plate, then add a few drops of 0.02-micron polishing solution and ~50 mL of deionized water to this plate. Set the polishing time to two minutes at 120 rpm, rotating counterclockwise with 8 pounds of pressure. Polish the samples, clean them with cotton swabs soaked in a 1:3 mixture of MURPHY oil soap and deionized water, and then rinse the samples thoroughly with deionized water. Inspect the samples. If the samples have been adequately polished, they will exhibit a near-perfect shine, and the polishing process is complete. If the samples are not fully polished, repeat the polishing step as needed.

[0165] Demineralization process of polished glaze flakes : Prepare the demineralized solution as follows. First, prepare an "aged" DL-lactic acid solution by allowing a 0.1M DL-lactic acid solution to stand at room temperature for at least 50 days or in a steam bath at approximately 90°C for seven hours before use. This is necessary for hydrolyzing the lactate polymer into monomers. Next, with stirring on a magnetic stir bar, add 500 mL of saturated HAP (hydroxyapatite) from the 0.1M aged DL-lactic acid solution to a 1000 mL beaker. Add 200 mL of 1% CARBOPOL 907 solution to the beaker. Add 50 mL of the 0.1M aged DL-lactic acid solution to the beaker. Add 200 mL of deionized water to the beaker. Adjust the pH to 5.0 with 6N NaOH and bring the total volume to 1000 mL with additional deionized water. Adjust the pH if necessary. The final demineralization solution contains: 0.1M DL-lactic acid, 0.2% CARBOPOL 907, saturated 50% relative to hydroxyapatite, and a final pH of 5.0. Transfer 30 mL of the demineralization solution to a 50 mL centrifuge tube and tighten the cap. Place the tube in a treatment oven set to 37°C for at least four hours, or until the solution reaches 37°C. Place the polished bovine sample into the centrifuge tube, ensuring the entire sample is immersed in the demineralization solution. Immerse the sample in the solution at 37°C for twenty-four hours. Remove any air bubbles observed on the sample surface by gently tapping the side of the tube. Periodically check the sample, tapping the tube to remove any air bubbles observed on the enamel surface. After twenty-four hours in the solution, remove the sample and rinse three times with approximately 150 mL of deionized water. Wipe away excess water from the enamel surface using Kim Wipes Delicate TaskWipes paper towels. Store the sample in a humid environment in a refrigerator until ready for use.

[0166] The samples were treated with different liquid materials to demineralize the enamel flakes. All treatments were repeated three times.

[0167] Treatment Group 1 (Deionized Water – Negative Control): Transfer 1 mL of deionized water to a low-speed mixing cup. Place the encapsulated tooth sample into the cup, then transfer 1 mL of deionized water onto the sample (ensuring complete coverage of the bovine slice surface). Cover with a parallel measurement cup and incubate at 37°C for 24 hours. After 24 hours, remove the sample and perform hardness measurement.

[0168] Treatment Group 2 (Artificial Saliva - Positive Control): Transfer 1 mL of artificial saliva (the composition in Table 1D) to a low-speed mixing cup. Place the encapsulated tooth sample into the cup, then transfer 1 mL of artificial saliva onto the sample (ensuring complete coverage of the bovine slice surface). Cover with a parallel test cup and incubate in a 37°C oven for 24 hours. After 24 hours, remove the sample and perform hardness measurements.

[0169] Treatment Group 3 (Example 48): Transfer 1 mL of artificial saliva to a low-speed mixing cup. Place the encapsulated tooth sample into the cup, then transfer 1 mL of Example 48 onto the sample (ensuring complete coverage of the bovine slice surface). Cover with a parallel test cup and incubate at 37°C for 4 hours. After four hours, remove the sample from the container and rinse thoroughly with deionized water. Transfer 1 mL of artificial saliva to each low-speed mixing cup, place the encapsulated tooth sample into the cup, and cover with 1 mL of Example 48. Cover with a parallel test cup and incubate at 37°C for 2 hours. After two hours, remove the sample from the container and rinse thoroughly with deionized water. Transfer 1 mL of artificial saliva to a low-speed mixing cup, and again place the encapsulated tooth sample into the cup and cover with 1 mL of Example 48. Cover with a parallel test cup and incubate at 37°C for 18 hours, then remove and rinse thoroughly with deionized water. After 24 hours, remove the sample and perform hardness measurements. Rinsing is to simulate a full day of drinking.

[0170] Hardness measurement

[0171] The hardness of each sample was measured using a Buehler 5104 microhardness tester with the following parameters: 200 gf (1.96 Newtons), a dwell time of 15 seconds, a Vickers indenter, and a diopter of 20x. The hardness of each slice was measured at four points at different angles after demineralization and remineralization. Ten (10) enamel slices were used for each inventive and comparative sample. The average hardness was recorded in Vickers microhardness (VHN).

[0172] Table 12: Microhardness Results

[0173]

[0174] Exemplary Implementation : 1. A composition comprising: Based on the total weight of the composition, one or more plant-based oils comprising 5% to 30% by weight; The aqueous phase comprises 70% to 95% by weight based on the total weight of the composition; Based on the total weight of the composition, there are 0.1% to 5% by weight of one or more surfactants, wherein the one or more surfactants are selected from: (i) nonionic surfactants that do not contain ethylene oxide / propylene oxide (EO / PO), and (ii) surfactants of Formula I. HOCH2-(CHOH) n -CH2NR 1 R 2 (I) Where R 1 and R 2 Independently selected from hydrogen atoms, alkyl groups, C(O)R 3 and SO2R 4 ;R 3 and R 4 The surfactants are independently selected from alkyl groups, aryl groups, and aralkyl groups; wherein n is an integer from about 2 to about 5; and (iii) a composition of surfactants from group (i) and group (ii) surfactants; Based on the total weight of the composition, there are 0.05% to 3% by weight of one or more viscosity modifiers, wherein the viscosity modifiers are selected from: (i) edible polymer viscosity modifiers, (ii) silica-containing viscosity modifiers; and (iii) a combination of (i) group viscosity modifiers and (ii) group viscosity modifiers. The composition has a pH of 4.5 to 9.5, is an oil-in-water (o / w) emulsion, and is edible.

[0175] 2. The composition according to Clause 1, wherein the viscosity modifier comprises pyrolytic silica in an amount of not less than 0.5% by weight based on the total weight of the composition.

[0176] 3. The composition according to Clause 1, wherein the one or more ethylene oxide / propylene oxide (EO / PO)-free nonionic surfactants are polyglycerol ester surfactants.

[0177] 4. The composition according to Clause 1, wherein the surfactant comprises a surfactant of Formula I, and wherein the viscosity modifier is present in an amount not exceeding 2% by weight based on the total weight of the composition.

[0178] 5. The composition according to Clause 1, wherein the aqueous phase is 75% to 90% by weight based on the total weight of the composition.

[0179] 6. The composition according to Clause 1, wherein the one or more edible vegetable-based oils are selected from: sunflower oil, safflower oil, olive oil, coconut oil, palm oil, peanut oil, soybean oil, flaxseed oil, rapeseed oil, linseed oil, hemp seed oil, cocoa butter, walnut oil, corn oil, grapeseed oil, sesame oil, peanut oil, wheat germ oil, cottonseed oil, fish oil, watermelon seed oil, lemon oil, orange oil, thistle oil, tomato seed oil, almond oil, perilla seed oil, low erucic acid rapeseed oil, pistachio fruit oil, hazelnut oil, and avocado oil.

[0180] 7. The composition according to Clause 1, wherein the one or more edible vegetable base oils are present in an amount of 10% to 25% by weight based on the total weight of the composition.

[0181] 8. The composition according to Clause 7, wherein the one or more edible vegetable-based oils are present in an amount of 15% to 22% by weight based on the total weight of the composition.

[0182] 9. The composition according to Clause 1, wherein the composition comprises ethyl cellulose as a viscosity modifier.

[0183] 10. The composition according to any one of Clauses 1 to 9, wherein the composition further comprises at least one of the following: a sweetener, a humectant, a mineral salt, a remineralizing agent, a cariogenic agent, a buffering component, a flavoring agent, a preservative, or a combination thereof.

[0184] 11. The composition according to any one of clauses 1 to 9, wherein the composition further comprises at least one of: aloe vera, folic acid, hyaluronic acid, ceramide, betaine or oxyglyceride, vitamin E, vitamin B12, EDTA, or hexadecylpyridine chloride. Chlorhexidine, other antibacterial and antiseptic agents, or combinations thereof.

[0185] 12. The composition according to Clause 10, wherein the preservative is a composition of at least CPC, vitamin E, and parabens.

[0186] 13. The composition according to Clause 10, wherein the composition comprises 1% to 35% by weight of a sweetener based on the total weight of the composition.

[0187] 14. The composition according to Clause 10, wherein the composition comprises 2.5% to 40% by weight of a wetting agent based on the total weight of the composition.

[0188] 15. The composition according to Clause 11, wherein the composition does not contain any quaternary antimicrobial compound.

[0189] 16. The composition according to any one of clauses 1 to 9, wherein the composition has a viscosity that allows the composition to be used as a sprayable composition or to be delivered as a sprayable composition.

[0190] 17. The composition according to any one of clauses 1 to 9, wherein the composition remains physically stable and does not separate into an aqueous phase and an oil phase when subjected to normal room temperature conditions, when subjected to a temperature close to or above the freezing point of the composition and subsequently thawed, or when subjected to a combination of these conditions.

[0191] 18. The composition according to any one of Clauses 1 to 9, wherein the composition prevents, inhibits, destroys or maintains a biofilm in the area in contact with the composition, or any combination thereof.

[0192] 19. The composition according to any one of clauses 1 to 9, wherein the composition may affect hydration loss in the area in contact with the composition.

[0193] 20. The composition according to any one of clauses 1 to 9, wherein the composition may increase the lubricity or lubricity of the area in contact with the composition.

[0194] 21. A method for preventing, inhibiting, disrupting, or maintaining biofilms in oral tissues, or any combination thereof, the method comprising contacting the oral tissues with the composition described in Clause 18.

[0195] 22. A method for reducing hydration loss in oral tissues, the method comprising:

[0196] To bring oral tissues into contact with the composition as described in Clause 19.

[0197] 23. A method for affecting the lubrication capacity or lubricity of oral tissues, the method comprising:

[0198] To bring oral tissues into contact with the composition as described in Clause 20.

[0199] 24. A method for influencing the effects of dry mouth, or both, the method comprising contacting oral tissue with a composition according to any one of clauses 1 to 9.

[0200] Therefore, embodiments of the oral composition and method of use are disclosed. The above embodiments and other embodiments are all within the scope of the following claims. Those skilled in the art will recognize that this disclosure can be implemented in ways other than those disclosed. The disclosed embodiments are for illustrative purposes only and are not intended to be limiting.

Claims

1. An oil-in-water emulsion composition, said oil-in-water emulsion composition comprising: The oil phase comprises: One or more plant-based oils are present in an amount of 5% to 30% by weight based on the total weight of the oil-in-water emulsion composition. Ethyl cellulose as the primary viscosity modifier; Polyglycerol-10 esters selected from polyglycerol-10 stearate and polyglycerol-10 dipalmitate; and Polyglycerol-6-distearate; and The aqueous phase comprises: water; Xanthan gum as a second viscosity modifier; Calcium chloride; Potassium dihydrogen phosphate; and dipotassium phosphate; The aqueous phase is present in an amount of 70% to 95% by weight based on the total weight of the oil-in-water emulsion composition; The polyglycerol-10 ester and the polyglycerol-6-distearate are present in a total amount of 0.1% to 5% by weight based on the total weight of the oil-in-water emulsion composition; The first viscosity modifier and the second viscosity modifier are present in a total amount of 0.05% by weight to 3% by weight based on the total weight of the oil-in-water emulsion composition. The oil-in-water emulsion composition has a pH of 4.5 to 9.5, and The oil-in-water emulsion composition described herein is edible.

2. The oil-in-water emulsion composition according to claim 1, wherein the polyglycerol-10 ester is polyglycerol-10 stearate.

3. The oil-in-water emulsion composition according to claim 1, wherein the polyglycerol-10 ester is polyglycerol-10 dipalmitate.

4. The oil-in-water emulsion composition according to claim 1, wherein the total amount of polymer viscosity modifier is not greater than 2% by weight based on the total weight of the oil-in-water emulsion composition.

5. The oil-in-water emulsion composition according to claim 4, wherein the total amount of polymer viscosity modifier is not greater than 1.5% by weight based on the total weight of the oil-in-water emulsion composition.

6. The oil-in-water emulsion composition according to claim 5, wherein the total amount of polymer viscosity modifier is not less than 0.2% by weight based on the total weight of the oil-in-water emulsion composition.

7. The oil-in-water emulsion composition according to claim 1, wherein the amounts of calcium chloride, potassium dihydrogen phosphate, and dipotassium phosphate are sufficient to saturate the oil-in-water emulsion composition with calcium ions, with phosphate ions, or with both calcium ions and phosphate ions.

8. The oil-in-water emulsion composition according to claim 1, wherein the total amount of surfactant is not greater than 4.5% by weight based on the total weight of the oil-in-water emulsion composition.

9. The oil-in-water emulsion composition according to claim 8, wherein the total amount of surfactant is not greater than 4% by weight based on the total weight of the oil-in-water emulsion composition.

10. The oil-in-water emulsion composition according to claim 9, wherein the total amount of surfactant is not less than 0.5% by weight based on the total weight of the oil-in-water emulsion composition.

11. The oil-in-water emulsion composition according to claim 1, wherein the aqueous phase is present in an amount of 75% to 90% by weight based on the total weight of the oil-in-water emulsion composition.

12. The oil-in-water emulsion composition according to claim 1, wherein the one or more edible vegetable base oils are present in an amount of 10% to 25% by weight based on the total weight of the oil-in-water emulsion composition.

13. The oil-in-water emulsion composition of claim 1, wherein the oil-in-water emulsion composition remains phase-free during at least three freeze-thaw-centrifugation cycles, each cycle comprising freezing the oil-in-water composition at -15°C for at least 2 hours, thawing the oil-in-water composition at room temperature for at least 2 hours, and centrifuging the oil-in-water composition at a relative centrifugal force of 1750 for 15 minutes.

14. The oil-in-water emulsion composition according to claim 1, wherein the oil-in-water emulsion composition does not exhibit phase separation after being held at a temperature above 60°C for at least 30 minutes.

15. The oil-in-water emulsion composition according to claim 1, wherein the tissue sample treated with the oil-in-water emulsion composition has a water loss of less than 60% according to the in vitro hydration retention test method.

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