Oral care compositions

Abstract

Oral care compositions and, particularly, oral care compositions in the form of a mouthwash composition having improved stannous ion stability are disclosed herein. In accordance with an aspect of the invention, provided is a mouthwash composition comprising a stannous source; a nitrate source; a phosphate source; water in an amount of about 60 wt.% or more, wherein the mouthwash composition has a pH of less than 5 and all weight percentages are based on the total weight of the oral care composition.

Description

PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OCORAL CARE COMPOSITIONSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority from U.S. Patent Application No. 63 / 695,005, filed September 16, 2024, the contents of which are hereby incorporated herein by reference in their entirety.BACKGROUND

[0002] Dental erosion involves demineralization and damage to the tooth structure due to acid attack from nonbacterial sources. Erosion typically occurs initially in the enamel and, if unchecked, may proceed to the underlying dentin. Dental erosion may be caused by or exacerbated by dental plaque. Dental plaque is a sticky biofdm or mass of bacteria that is commonly found between the teeth, along the gum line, and below the gum line margins. Dental plaque can give rise to dental caries and periodontal problems such as gingivitis and periodontitis. Dental caries, tooth decay, and / or tooth demineralization can be caused or exacerbated by acid produced from the bacterial degradation of fermentable sugar.

[0003] Stannous ion sources, such as stannous fluoride and stannous chloride, are known for use in clinical dentistry with a history of therapeutic benefits over forty years, and can have use in reducing certain bacterial growth in the oral cavity.

[0004] There is an ongoing desire for improved oral care compositions.BRIEF SUMMARY

[0005] This summary is intended merely to introduce a simplified summary of some aspects of one or more implementations of the present disclosure. Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. This summary is not an extensive overview, nor is it intended to identify key or critical elements of the present teachings, nor to delineate the scope of the disclosure. Rather, its purpose is merely to present one or more concepts in simplified form as a prelude to the detailed description below.

[0006] Aspects of the invention are directed to oral care compositions and, particularly, oral care compositions in the form of a mouthwash composition having improved stannous ion stability. In accordance with an aspect of the invention, provided is a mouthwash composition comprising aPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC stannous source; a nitrate source; a phosphate source; water in an amount of about 60 wt.% or more, wherein the mouthwash composition has a pH of less than 5 and all weight percentages are based on the total weight of the oral care composition.

[0007] In accordance with another aspect of the invention, provided is a mouthwash composition comprising a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof; an acid selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate (SAPP), and a combination thereof; water in an amount of about 60 wt.% or more; optionally, a fluoride source, wherein all weight percentages are based on the total weight of the oral care composition.

[0008] In accordance with a further aspect of the invention, provided is a mouthwash composition comprising a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof; an acid selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, and a combination thereof; water in an amount of about 60 wt.% or more; optionally, a fluoride source, wherein the mouthwash composition has a pH of about 3 to 5 and all weight percentages are based on the total weight of the oral care composition.

[0009] A list of non-limiting embodiments in accordance with aspects of the invention is provided below:

[0010] In accordance with an embodiment 1, provided is a mouthwash composition comprising: a stannous source; a nitrate source; a phosphate source; and water in an amount of about 60 wt.% or more, wherein the mouthwash composition has a pH of less than 5 and all weight percentages are based on the total weight of the oral care composition.

[0011] In accordance with an embodiment 2, provided is the mouthwash composition according to embodiment 1, wherein the pH is from about 3 up to but not including 5.

[0012] In accordance with an embodiment 3, provided is the mouthwash composition according to embodiment 1 or embodiment 2, wherein the pH is from about 3 to about 4.5.

[0013] In accordance with an embodiment 4, provided is the mouthwash composition according to embodiment 1, wherein the water is present in an amount from about 70 to about 96 wt.%.

[0014] In accordance with an embodiment 5, provided is the mouthwash composition according to any foregoing embodiment, wherein the stannous source is present in an amount from about 0.01 to about 3 wt.%.

[0015] In accordance with an embodiment 6, provided is the mouthwash composition accordingPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC to any foregoing embodiment, wherein the stannous source is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof.

[0016] In accordance with an embodiment 7, provided is the mouthwash composition according to any foregoing embodiment, wherein the nitrate source is present in an amount from about 0.01 to about 4 wt.%.

[0017] In accordance with an embodiment 8, provided is the mouthwash composition according to any foregoing embodiment, wherein the nitrate source is selected from potassium nitrate, lithium nitrate, sodium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, and a combination two or more thereof.

[0018] In accordance with an embodiment 9, provided is the mouthwash composition according to any foregoing embodiment, wherein the phosphate source is present in an amount from about 0.01 to about 4 wt.%.

[0019] In accordance with an embodiment 10, provided is the mouthwash composition according to any foregoing embodiment, wherein the phosphate source is selected from tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.

[0020] In accordance with an embodiment 11, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash composition has a weight ratio of the stannous source to the phosphate source of about 1:2 to about 1:6.

[0021] In accordance with an embodiment 12, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash composition has a weight ratio of the nitrate source to the phosphate source of about 1:2 to about 1:5.

[0022] In accordance with an embodiment 13, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash composition is substantially free or free of abrasives.

[0023] In accordance with an embodiment 14, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash composition is substantially free or free ofPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC sorbitol.

[0024] In accordance with an embodiment 15, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash composition is substantially free or free of glycerin.

[0025] In accordance with an embodiment 16, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash composition is substantially free or free of glycols.

[0026] In accordance with an embodiment 17, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash composition is substantially free or free of monoalcohols.

[0027] In accordance with an embodiment 18, provided is the mouthwash composition according to any foregoing embodiment further comprising: a fluoride source, optionally, in an amount from about 0.01 to about 3 wt.%.

[0028] In accordance with an embodiment 19, provided is the mouthwash composition according to embodiment 18, wherein the fluoride ion source is selected from stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, and a combination of two or more thereof.

[0029] In accordance with an embodiment 20, provided is the mouthwash composition according to any foregoing embodiment further comprising: an acid.

[0030] In accordance with an embodiment 21, provided is the mouthwash composition according to embodiment 20, wherein the acid is an inorganic acid comprising hydrochloric acid, phosphoric acid, sodium acid pyrophosphate, or a combination thereof.

[0031] In accordance with an embodiment 22, provided is the mouthwash composition according to embodiment 20 or embodiment 21, wherein the acid is an organic acid comprising benzoic acid, malic acid, or a combination thereof.

[0032] In accordance with an embodiment 23, provided is the mouthwash composition according to any foregoing embodiment further comprising: a vitamin C and / or derivative thereof.

[0033] In accordance with an embodiment 24, provided is the mouthwash composition according to embodiment 23, wherein the vitamin C and / or derivative thereof is selected from L-ascorbic acid, calcium ascorbate, calcium L-ascorbate dihydrate, magnesium ascorbate, potassium ascorbate, magnesium L-ascorbyl phosphate, L-ascorbic acid 2-phosphate sesquimagnesium saltPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC hydrate, (+) sodium L-ascorbate, dehydro-l-(+)-ascorbic acid dimer, sodium ascorbyl phosphate, ascorbic acid-2-glucoside, ascorbyl dipalmitate, ascorbyl methylsilanol pectinate, ascorbyl stearate, disodium ascorbyl sulfate, ascorbyl 6-palmitate, calcium ascorbyl phosphate, ascorbyl acetate, ascorbyl propionate, ascorbyl stearate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbyl glucoside, ascorbic acid polypeptide, ethyl ascorbyl ether, ascorbyl ethyl silanol pectinate, and a combination of two or more thereof.

[0034] In accordance with an embodiment 25, provided is the mouthwash composition according to embodiment 23 or embodiment 24, wherein the vitamin C and / or derivative thereof comprises ascorbyl phosphate.

[0035] In accordance with an embodiment 26, provided is the mouthwash composition according to any foregoing embodiment further comprising: a coloring agent, wherein the coloring agent is selected from green coloring agents, yellow coloring agents, and a combination of two or more thereof.

[0036] In accordance with an embodiment 27, provided is a mouthwash composition comprising: a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof; an acid and / or a salt thereof selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, a salt thereof, and a combination thereof; water in an amount of about 60 wt.% or more; and optionally, a fluoride source, wherein all weight percentages are based on the total weight of the oral care composition.

[0037] In accordance with an embodiment 28, provided is a mouthwash composition comprising: a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof; an acid and / or a salt thereof; water in an amount of about 60 wt.% or more; and optionally, a fluoride source, wherein the mouthwash composition has a pH of about 3 to 5 and all weight percentages are based on the total weight of the oral care composition.

[0038] In accordance with an embodiment 23, provided is the mouthwash composition according to any foregoing embodiment, wherein the mouthwash has a reduction of stannous ions after being kept in a controlled environment at a temperature of 40°C for 13 weeks of about 20 mol.% or less.

[0039] In accordance with an embodiment 30, provided is a use of the mouthwash according to any foregoing embodiment to reduce formation of dental caries, promote remineralization of the teeth, and / or reduce levels of acid producing bacteria.PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OCBRIEF DESCRIPTION OF THE DRAWINGS

[0040] The present invention may become more fully understood from the detailed description and the accompanying drawings, wherein like elements are labeled similarly and in which:

[0041] FIG. 1 is a bar graph of the stannous ion stability of compositions according to aspects of the disclosure; and

[0042] FIG. 2 is a bar graph of the antioxidant capacity of compositions according to aspects of the disclosure.

[0043] It should be understood that the various aspects are not limited to the arrangements and instrumentality shown in the drawings.DETAILED DESCRIPTION

[0044] For illustrative purposes, the principles of the present invention are described by referencing various exemplary embodiments thereof. Although certain embodiments of the invention are specifically described herein, one of ordinary skill in the art will readily recognize that the same principles are equally applicable to, and can be employed in other compositions and methods. Before explaining the disclosed embodiments of the present invention in detail, it is to be understood that the invention is not limited in its application to the details of any particular embodiment disclosed herein. The terminology used herein is for the purpose of description and not of limitation.

[0045] As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural references unless the context dictates otherwise. The singular form of any class of the ingredients refers not only to one chemical species within that class, but also to a mixture of those chemical species. The terms “a” (or “an”), “one or more” and “at least one” may be used interchangeably herein. The terms “comprising”, “including”, and “having” may be used interchangeably. The term “include” should be interpreted as “include, but are not limited to”. The term “including” should be interpreted as “including, but are not limited to”.

[0046] As used throughout, ranges are used as shorthand for describing each and every value that is within the range. Any value within the range can be selected as the terminus of the range. Thus, a range from 1-5, includes specifically 1, 2, 3, 4 and 5, as well as subranges such as 2-5, 3-5, 2-3, 2-4, 1-4, etc.PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC

[0047] The term “about” when referring to a number means any number within a range of 10% of the number. For example, the phrase “about 2 wt.%” refers to a number between and including 1.8 wt.% and 2.2 wt.%.

[0048] All references cited herein are hereby incorporated by reference in their entireties. In the event of a conflict in a definition in the present disclosure and that of a cited reference, the present disclosure controls.

[0049] The abbreviations and symbols as used herein, unless indicated otherwise, take their ordinary meaning. The abbreviation “wt.%” means percent by weight with respect to the oral care composition. The symbol “°” refers to a degree, such as a temperature degree or a degree of an angle. The symbols “h”, “min”, “mL”, “nm”, and “pm” refer to hour, minute, milliliter, nanometer, and micrometer, respectively. The abbreviation “UV-VIS” referring to a spectrometer or spectroscopy, means Ultraviolet- Visible. The abbreviation “rpm” means revolutions per minute.

[0050] When referring to chemical structures, and names, the symbols “C”, “H”, and “O” mean carbon, hydrogen, and oxygen, respectively. The symbols “=” and “=” mean single bond, double bond, and triple bond, respectively.

[0051] 4‘Volatile”, as used herein, means having a flash point of less than about 100° C. “Nonvolatile”, as used herein, means having a flash point of greater than about 100° C.

[0052] Any member in a list of species that are used to exemplify or define a genus, may be mutually different from, or overlapping with, or a subset of, or equivalent to, or nearly the same as, or identical to, any other member of the list of species. Further, unless explicitly stated, such as when reciting a Markush group, the list of species that define or exemplify the genus is open, and it is given that other species may exist that define or exemplify the genus just as well as, or better than, any other species listed.

[0053] The phrases, “a mixture thereof,” “a combination thereof,” or a combination of two or more thereof’ do not require that the mixture include all of A, B, C, D, E, and F (although all of A, B,C, D, E, and F may be included). Rather, it indicates that a mixture of any two or more of A, B, C,D, E, and F can be included. In other words, it is equivalent to the phrase “one or more elements selected from the group consisting of A, B, C, D, E, F, and a mixture of any two or more of A, B, C, D, E, and F.” Likewise, the term “a salt thereof” also relates to “salts thereof.” Thus, where the disclosure refers to “an element selected from the group consisting of A, B, C, D, E, F, a salt thereof, and a mixture thereof,” it indicates that that one or more of A, B, C, D, and F may bePCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC included, one or more of a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included, or a mixture of any two of A, B, C, D, E, F, a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included.

[0054] All components and elements positively set forth in this disclosure can be negatively excluded from the claims. In other words, the oral care compositions of the instant disclosure can be free or essentially free of all components and elements positively recited throughout the instant disclosure. In some instances, the oral care compositions of the present disclosure may be substantially free of non-incidental amounts of the ingredient(s) or compound(s) described herein. A non-incidental amount of an ingredient or compound is the amount of that ingredient or compound that is added into the oral care composition by itself. For example, an oral care composition may be substantially free of a non-incidental amount of an ingredient or compound, although such ingredient(s) or compound(s) may be present as part of a raw material that is included as a blend of two or more compounds.

[0055] Some of the various categories of components identified may overlap. In such cases where overlap may exist and the oral care composition includes both components (or the composition includes more than two components that overlap), an overlapping compound does not represent more than one component. For example, certain compounds may be characterized as both a fluoride ion source and a stannous ion source. If a particular oral care composition includes both a fluoride ion source and a stannous ion source, stannous fluoride will serve only as either a fluoride ion source or a stannous ion source — not both.

[0056] For readability purposes, the chemical functional groups are in their adjective form; for each of the adjectives, the word “group” is assumed. For example, the adjective “alkyl” without a noun thereafter, should be read as “an alkyl group.”

[0057] Aspects of the invention are directed to oral care compositions and, particularly, oral care compositions in the form of a mouthwash composition having improved stannous ion stability. Certain embodiments of the mouthwash compositions disclosed herein can unexpectedly achieve a high stannous ion stability of, e.g., about 80 mol.% or more of stannous ions remaining after being kept in a controlled environment at a temperature of 40°C for 13 weeks, even when containing about 60 wt.% or more of water. For example, some embodiments of the oral care composition are formulated to have a stannous ion stability of about 83 mol.% or more, about 85 mol.% or more, about 86 mol.% or more, about 90 mol.% or more, about 92 mol.% or more, orPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC about 94 mol.% or more, of remaining stannous ions (e.g., based on the initial amount stannous ion in the oral care composition) after being kept in a controlled environment at a temperature of 40°C for 13 weeks. In other words, certain oral care compositions achieve a stannous ion stability as measured as a reduction of stannous ions after being kept in a controlled environment at a temperature of 40°C for 13 weeks of about 20 mol.% or less, about 17 mol.% or less, about 15 mol.% or less, about 14 mol.% or less, about 10 mol.% or less, about 8 mol.% or less, or about 6 mol.% or less (e.g., based on the initial amount stannous ion in the oral care composition).

[0058] In accordance with an aspect of the invention, provided is a mouthwash composition comprising a stannous source; a nitrate source; a phosphate source; water in an amount of about 60 wt.% or more, wherein the mouthwash composition has a pH of less than 5 and all weight percentages are based on the total weight of the oral care composition.

[0059] In accordance with another aspect of the invention, provided is a mouthwash composition comprising a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof; an acid selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, and a combination thereof; water in an amount of about 60 wt.% or more; and optionally, a fluoride source, wherein all weight percentages are based on the total weight of the oral care composition.

[0060] In accordance with a further aspect of the invention, provided is a mouthwash composition comprising a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof; an acid selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, and a combination thereof; water in an amount of about 60 wt.% or more; and optionally, a fluoride source, wherein the mouthwash composition has a pH of about 3 to 5 and all weight percentages are based on the total weight of the oral care composition.

[0061] The oral care composition may have a pH of up to and including 5. In some cases, however, the oral care composition has a pH of less than 5 or, in other words, a pH of up to but not including 5. The pH of the oral care composition may specifically be up to about 4.7, up to about 4.5, up to about 4.25, up to about 4; from about 3 to about 5, about 3 to about 4.7, about 3 to about 4.5, about 3 to about 4.25, about 3 to about 4, about 3 to about 3.75; from about 3.4 to about 4.5, about 3.4 to about 4.25, about 3.4 to about 4, from about 3.8 to about 4.5, from about 3.8 to about 4.25, or any range or subrange thereof.

[0062] The oral care composition may, in certain preferred embodiments, have a reduced amount,PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC be substantially free of, or free of abrasives. For example, the oral care composition may have about 5 wt.% or less, about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less of abrasives. In at least one embodiment, the oral care composition has 0 wt.% of abrasives.

[0063] Additionally or alternatively, the oral care composition may have a reduced amount, be substantially free of, or free of monoalcohols, such as ethanol, propanol, butanol, etc. The amount of monoalcohols present in the oral care composition may be about 5 wt.% or less, about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition. In some embodiments, the oral care composition has 0 wt.% of non-incidental or added monoalcohols or 0 wt.% of monoalcohols.

[0064] Preferably, the oral care composition has a reduced amount of oils, such as hydrocarbon oils. For example, the amount of oil (e.g., hydrocarbon oils) present in the oral care composition may be about 5 wt.% or less, about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition. In some embodiments, the oral care composition is substantially free of or free of oils, such as hydrocarbon oils.

[0065] In certain embodiments, the oral care composition a reduced amount, be substantially free of, or free of sorbitol, glycerin, and / or glycols. For instance, the individual amounts of sorbitol, glycerin, and / or glycols may be about 5 wt.% or less, about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition.

[0066] The oral care compositions are typically in the form of a mouthwash. Suitable components, such as those listed below, may be included or excluded from the formulations for the oral care compositions depending on the specific combination of other ingredients and the form of the oral care compositions. Additionally or alternatively, the oral care compositions may in some embodiments have a single phase, which contains that components and / or ingredients of the oral care composition.

[0067] The oral care compositions typically comprise a stannous source. The stannous source preferably comprises or consists of a stannous ion source. The stannous source may be present in the oral care composition in an amount from about 0.01 to about 3 wt.%, based on the total weightPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC of the oral care composition. For example, the total amount of stannous source present in the oral care composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.3 wt.%, about 0.01 to about 0.2 wt.%, about 0.01 to about 0.1 wt.%; from about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%, about 0.05 to about 0.5 wt.%, about 0.05 to about 0.3 wt.%, about 0.05 to about 0.2 wt.%, about 0.05 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%, about 0.1 to about 0.3 wt.%, about 0.1 to about 0.2 wt.%; from about 0.2 to about 3 wt.%, about 0.2 to about 2 wt.%, about 0.2 to about 1 wt.%, about 0.2 to about 0.5 wt.%, about 0.2 to about 0.3 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0068] The stannous source may be selected from the group consisting of: stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof. The stannous source may comprise stannous fluoride, stannous chloride, stannous acetate, and a combination of two or more thereof. The oral care composition may include two or more, three or more, four or more, five or more, or six or more of stannous sources. For instance, oral care composition may comprise 2 to 7, 2 to 6, 2 to 5, 2 to 5, or 2 to 4; 3 to 7, 3 to 6, 2 to 5, or 3 to 5 stannous sources. In some embodiments, the stannous source comprises or consist of stannous fluoride and / or stannous pyrophosphate. Additionally or alternatively, the oral care composition may comprise or consist of stannous fluoride and stannous chloride.

[0069] The oral care compositions typically comprise one or more nitrate source. The one or more nitrate source may comprise or consist of nitrate ion sources. The nitrate source(s) may be present in the oral care composition in an amount from about 0.01 to about 4 wt.%, based on the total weight of the oral care composition. In some instances, the amount of nitrate present in the oral care composition may be from about 0.01 to about 3 wt.%, about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.3 wt.%, about 0.01 to about 0.2 wt.%, about 0.01 to about 0.1 wt.%; from about 0.05 to about 4 wt.%, about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%, about 0.05 to about 0.5 wt.%, about 0.05 to about 0.3 wt.%, about 0.05 to about 0.2 wt.%, about 0.05 to about 0.1 wt.%; from aboutPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%, about 0.1 to about 0.3 wt.%, about 0.1 to about 0.2 wt.%; from about 0.2 to about 4 wt.%, about 0.2 to about 3 wt.%, about 0.2 to about 2 wt.%, about 0.2 to about 1 wt.%, about 0.2 to about 0.5 wt.%, about 0.2 to about 0.3 wt.%; from about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0070] The one or more nitrate source may be in the form of a salt or an ion derived therefrom, including, e.g., nitrate salt is selected from an alkali or alkaline earth metal nitrate. Examples of nitrate sources include lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, or a combination two or more thereof. In at least one embodiment, the nitrate source comprises or consists of potassium nitrate.

[0071] The oral care compositions may be formulated to have a molar ratio of the nitrate source to the stannous source, both measured as free ions, of about 2: 1 or less. For example, the oral care composition may have a molar ratio of the nitrate source to the stannous source, both measured as free ions, of about 0.5:1 to about 2:1, about 0.5:1 to about 1.8:1, about 0.5:1 to about 1.6:1, about 0.5: 1 to about 1.4: 1, about 0.5:1 to about 1.2:1, about 0.5: 1 to about 1: 1; from about 0.7: 1 to about 2:1, about 0.7:1 to about 1.8:1, about 0.7:1 to about 1.6:1, about 0.7:1 to about 1.4:1, about 0.7:1 to about 1.2:1, about 0.7:1 to about 1: 1; from about 0.9:1 to about 2:1, about 0.9: 1 to about 1.8: 1, about 0.9:1 to about 1.6:1, about 0.9:1 to about 1.4:1, about 0.9:1 to about 1.2:1, about 0.9:1 to about 1:1, or any range or subrange thereof. In some embodiments, the oral care composition is formulated to have a molar ratio of the nitrate source to the stannous source, both measured as free ions, of about 1:1.

[0072] The oral care compositions typically comprise one or more phosphate source(s), e.g., in an amount that may range from about 0.01 to about 4 wt.%, based on the total weight of the oral care composition. In some instances, the total amount of phosphate source is present in the oral care composition may be from about 0.01 to about 3 wt.%, about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.3 wt.%, about 0.01 to about 0.2 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%, about 0.1 to about 0.3 wt.%, about 0.1 to about 0.2 wt.%; from about 0.2 to about 4 wt.%, about 0.2 to about 3 wt.%, about 0.2 to about 2 wt.%, about 0.2 to about 1 wt.%, about 0.2 to about 0.5 wt.%, about 0.2PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC to about 0.3 wt.%; from about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%, about 0.3 to about 1 wt.%, about 0.3 to about 0.5 wt.%; from about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 0.7 to about 4 wt.%, about 0.7 to about 3 wt.%, about 0.7 to about 2 wt.%, about 0.7 to about 1.5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0073] The phosphate source may preferably comprise a soluble phosphate compound, such as a phosphate salt. The phosphate source may comprise or consist of phosphate ion source(s). Examples of phosphate sources include tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, or a combination thereof. The phosphate source may be a pyrophosphate salt, such as an alkali metal pyrophosphate salt. In certain embodiments, the alkali metal pyrophosphate is selected from a tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are sodium or potassium. For instance, the phosphate source may include tetrasodium pyrophosphate (TSPP), tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate, or a combination of two or more thereof. The phosphate source may be chosen from orthophosphates, polymetaphosphates, pyrophosphates, and a combination of two or more thereof. In some instances, the phosphate source includes tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), or a combination thereof. In at least one embodiment, the phosphate source comprises tetrasodium pyrophosphate. The phosphate source, when in the form of a salt, maybe in their hydrated and / or unhydrated forms.

[0074] The oral care composition may be formulated to specifically have a weight ratio of the stannous source to the phosphate source of about 1:2 to about 1:6. In some embodiments, the oral care composition has a weight ratio of the stannous source to the phosphate source of about 1:2 to about 1:5, about 1:2 to about 1:4, about 1:2 to about 1 :3; from about 1 :3 to about 1 :6, about 1 :3 to about 1 :5, about 1:3 to about 1 :4; from about 1 :4 to about 1 :6, about 1 :4 to about 1 :5, or any range or subrange thereof. The oral care composition may, additionally or alternatively, be formulated to have a weight ratio of the nitrate source to the phosphate source of about 1:2 to about 1:5. For instance, the oral care composition may have a weight ratio of the nitrate source to the phosphatePCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC source of about 1 :2 to about 1 :4, about 1 :2 to about 1 :3; from about 1 :3 to about 1 :5, about 1 :3 to about 1:4, about 1:4 to about 1:5, or any range or subrange thereof.

[0075] The oral care compositions may include a fluoride source. The fluoride source may comprise or consist of fluoride ion source(s). In some cases, the fluoride source is present in the oral care composition in an amount of about 0.01 to about 3 wt.%, based on the total weight of the oral care composition. For example, the total amount of fluoride source present in the oral care composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.3 wt.%, about 0.01 to about 0.2 wt.%, about 0.01 to about 0.1 wt.%; from about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%, about 0.05 to about 0.5 wt.%, about 0.05 to about 0.3 wt.%, about 0.05 to about 0.2 wt.%, about 0.05 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%, about 0.1 to about 0.3 wt.%, about 0.1 to about 0.2 wt.%; from about 0.2 to about 3 wt.%, about 0.2 to about 2 wt.%, about 0.2 to about 1 wt.%, about 0.2 to about 0.5 wt.%, about 0.2 to about 0.3 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0076] The fluoride source may be selected from soluble fluoride ion salts. In some cases, the fluoride source may comprise sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluoride, stannous fluorozirconate, sodium monofluorophosphate, potassium monofluorophosphate, laurylamine hydrofluoride, diethylaminoethyloctoylamide hydrofluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, amine fluorides or a combination of two or more thereof. In some embodiments, the fluoride source comprises sodium fluoride, sodium monofluorophosphate, or a combination thereof.

[0077] In certain embodiments, the oral care composition of the disclosure may contain stannous fluoride and a source of fluoride ions or fluorine-providing agents in amounts such that the oral care composition delivers from 25 ppm to 25,000 ppm (mass fraction) of fluoride ions, generally at least 500 ppm, e.g., from about 500 to about 2000 ppm, from about 800 to about 1800 ppm, from about 1000 to about 1600 ppm, from about 1200 to about 1550 ppm, or about 1450 ppm, e.g., during application of such oral care composition.PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC

[0078] The oral care composition may include one or more acids. The acid may be an inorganic acid, an organic acid, or a combination of two or more thereof. In some cases, the acid may be in the form of a salt of such acid. Examples of inorganic acids and / or a salt thereof include hydrochloric acid, phosphoric acid, sodium acid pyrophosphate (SAPP), a salt thereof, or a combination of two or more thereof. Examples of organic acids and / or a salt thereof include benzoic acid, citric acid, acetic acid, malic acid, a salt thereof, or a combination of two or more thereof. In some embodiments, the oral care composition includes an acid comprising or selected from the group consisting of hydrochloric acid, phosphoric acid, benzoic acid, citric acid, acetic acid, malic acid, sodium acid pyrophosphate, a salt thereof, and a combination thereof. In at least one embodiment, the oral care composition includes an acid comprising or selected from the group consisting of hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, and a combination thereof.

[0079] The one or more acid(s) in the oral care composition in an amount of about 0.01 to about 4 wt.%, based on the total weight of the oral care composition. For example, amount of one or more acid(s) selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, a salt thereof, or a combination thereof may be from about 0.01 to about 4 wt.%, based on the total weight of the oral care composition. In some embodiments, the total amount of the one or more acid(s) (e.g., such as those selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, a salt thereof, and / or a combination thereof) present in the oral care composition may be from about 0.01 to about 3 wt.%, about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.3 wt.%, about 0.01 to about 0.2 wt.%, about 0.01 to about 0.1 wt.%; from about 0.05 to about 4 wt.%, about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%, about 0.05 to about 0.5 wt.%, about 0.05 to about 0.3 wt.%, about 0.05 to about 0.2 wt.%, about 0.05 to about 0.1 wt.%; from about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%, about 0.1 to about 0.3 wt.%, about 0.1 to about 0.2 wt.%; from about 0.2 to about 4 wt.%, about 0.2 to about 3 wt.%, about 0.2 to about 2 wt.%, about 0.2 to about 1 wt.%, about 0.2 to about 0.5 wt.%, about 0.2 to about 0.3 wt.%; from about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%, about 0.8 to about 1.5 wt.%; from about 1.1 to about 4 wt.%, about 1.1 to about 3 wt.%,PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC about 1.14 to about 2 wt.%, about 1.1 to about 1.5 wt.%; from about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0080] The oral care composition may include a vitamin C and / or a derivative thereof. The total amount of vitamin C and / or a derivative thereof may be present in an amount of about 0.1 to about 6 wt.%, based on the total weight of the oral care composition. In some cases, the total amount of the one or more vitamin C and / or a derivative thereof is from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.3 to about 6 wt.%, about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%, about 0.3 to about 1 wt.%; from about 0.5 to about 6 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1.5 wt.%; from about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 6 wt.%, about 3 to about 5 wt.%, about 4 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0081] Vitamin C and / or derivatives thereof generally refers to ascorbic acid or derivatives thereof. Ascorbic acid exists as two enantiomers commonly denoted “L” (for “levo”) and “D” (for “dextro”). Ascorbic acid is also referred to as L(+)-ascorbic acid or L-ascorbic acid. The ascorbic acid derivatives may be or include, but are not limited to, L-ascorbic acid, calcium ascorbate, calcium L-ascorbate dihydrate, magnesium ascorbate, potassium ascorbate, magnesium L- ascorbyl phosphate (also referred to as: magnesium ascorbate phosphate or ascorbic acid phosphate magnesium salt), L-ascorbic acid 2-phosphate sesquimagnesium salt hydrate, (+) sodium L-ascorbate, dehydro-L-(+)-ascorbic acid dimer, sodium ascorbyl phosphate (also referred to as: ascorbic acid phosphate sodium salt, sodium L-ascorbyl phosphate, 2-phospho-L-ascorbic acid trisodium salt, L-ascorbic acid 2-phosphate trisodium salt or sodium L-ascorbyl-2-phosphate), ascorbic acid-2-glucoside, ascorbyl dipalmitate, ascorbyl methylsilanol pectinate, ascorbyl stearate, disodium ascorbyl sulfate, ascorbyl 6-palmitate, calcium ascorbyl phosphate, ascorbyl acetate, ascorbyl propionate, ascorbyl stearate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbyl glucoside, ascorbic acid polypeptide, ethyl ascorbyl ether, ascorbyl ethyl silanol pectinate, or the like, or combinations thereof.PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC

[0082] In some embodiments, the one or more vitamin C and / or derivative thereof may comprise or consists of L-ascorbic acid, calcium ascorbate, calcium L-ascorbate dihydrate, magnesium ascorbate, potassium ascorbate, magnesium L-ascorbyl phosphate, L-ascorbic acid 2-phosphate sesquimagnesium salt hydrate, (+) sodium L-ascorbate, dehydro-l-(+)-ascorbic acid dimer, sodium ascorbyl phosphate, ascorbic acid-2-glucoside, ascorbyl dipalmitate, ascorbyl methylsilanol pectinate, ascorbyl stearate, disodium ascorbyl sulfate, ascorbyl 6-palmitate, calcium ascorbyl phosphate, ascorbyl acetate, ascorbyl propionate, ascorbyl stearate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbyl glucoside, ascorbic acid polypeptide, ethyl ascorbyl ether, ascorbyl ethyl silanol pectinate, or a combination of two or more thereof. In at least one embodiment, the vitamin C and / or derivative comprises or consists of an ascorbyl phosphate, such as sodium ascorbyl phosphate.

[0083] The oral care composition may include one or more polyol(s), e.g., in a total amount from about 7 to about 35 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition. In some embodiments, the total amount of polyol(s) in the oral care composition is from about 7 to about 35 wt.%, about 7 to about 30 wt.%, about 7 to about 25 wt.%, about 7 to about 21 wt.%, about 7 to about 17 wt.%; from about 12 to about 35 wt.%, about 12 to about 30 wt.%, about 12 to about 25 wt.%, about 12 to about 21 wt.%, about 12 to about 17 wt.%; from about 17 to about 35 wt.%, about 17 to about 30 wt.%, about 17 to about 25 wt.%, about 17 to about 21 wt.%; from about 22 to about 35 wt.%, about 22 to about 30 wt.%, about 22 to about 27 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0084] The oral care composition may be formulated to have one or more of the individual polyols present in an amount from about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 7 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 7 wt.%, about 3 to about 6 wt.%; from about 5 to about 10 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from about 6 to about 10 wt.%, about 6 to about 8 wt.%, about 6 to about 7 wt.%; from about 7 to about 10 wt.%, about 7 to about 8 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0085] The polyol(s) may be chosen from glycols or compounds with numerous hydroxyl groups. The one or more polyols may be liquid at ambient temperature (25°C). The polyol may be a humectant. In some preferred embodiments, the polyol(s) comprises glycerin, glycol, inositol,PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a block copolymer of PPG and PEG, a saccharide (e.g., fructose, glucose, sucrose and mixtures of saccharides, such as honey), or a combination of two or more thereof. For instance, the oral care composition comprises maltitol, mannitol, sorbitol, xylitol, a polypropylene glycol (PPG), a polyethylene glycol (PEG), a block copolymer of PPG and PEG, or a combination or two or more thereof.

[0086] In some cases, the oral care composition includes one or more polyol selected from the group consisting of C2-C32 polyols. The one or more polyols may have from 2 to 32 carbon atoms, from 3 to 16 carbon atoms, or from 3 to 12 carbon atoms. For example, the oral care composition may comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, or a combination of two or more thereof. Additional, non-limiting examples of polyols that may, optionally, be included in the oral care include and / or may be chosen from alkanediols such as glycerin, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-butene-l,4-diol, 2-ethyl-l,3-hexanediol, 2-methyl-2,4-pentanediol, caprylyl glycol, 1,2-hexanediol, 1,2-pentanediol, and 4-methyl-l,2-pentanediol; glycol ethers such as ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, ethylene glycol monomethyl ether acetate, diethylene glycol monomethyl ether, diethylene glycol monoethyl ether, diethylene glycol mono-n-propyl ether, ethylene glycol mono-iso-propyl ether, diethylene glycol mono-iso-propyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-t-butyl ether, diethylene glycol mono-t-butyl ether, 1 -methyl- 1 -methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-t- butyl ether, propylene glycol mono-n-propyl ether, propylene glycol mono-iso-propyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol mono-iso-propyl ether, sorbitol, sorbitan, triacetin, and a mixture thereof.

[0087] In some embodiments, the oral care composition comprises at least two polyols, preferably chosen from propylene glycol, glycerin, sorbitol, and mannitol. For example, the oral care composition may comprise propylene glycol in combination with at least one of glycerin, sorbitol, and mannitol. In some cases, the oral care composition comprises glycerin in combination with atPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC least one of propylene glycol sorbitol, and mannitol. In at least one embodiment, the oral care composition includes propylene glycol, glycerin, and sorbitol.

[0088] In certain embodiments, the oral care composition comprises two or more polyols. In at least one embodiment, the oral care composition comprises propylene glycol and glycerin. In some instances, the polyols consist of propylene glycol and glycerin. The oral care compositions may, in some preferred embodiments, have a polyol system comprising propylene glycol and glycerin in a weight ratio of propylene glycol to glycerin of about 2:1 to about 1:3. For instance, the oral care composition may have a weight ratio of propylene glycol to glycerin of about 2: 1 to about 1:3, about 1 : 1 to about 1 :3; from about 1 :1.25 to about 1 :3, about 1:1.5 to about 1:3, about 1:1.75 to about 1:3, about 1:2 to about 1:3; from about 1 : 1 to about 1 :2.5, about 1 :1.25 to about 1 :2.5, about 1 : 1.5 to about 1 :2.5, about 1 : 1.75 to about 1 :2.5, about 1 :2 to about 1 :2; from about 1 : 1 to about 1:2, about 1:1.25 to about 1 :2, about 1: 1.5 to about 1:2, about 1 : 1.75 to about 1:2; from about 1:1 to about 1:1.5, about 1:1.25 to about 1:1.5, about 1:1 to about 1:1.25, or any range or subrange thereof.

[0089] The oral care composition may include one or more humectants. The humectant(s) may be selected from polyols described above. Examples of humectants that may be incorporated in certain embodiments include triethylene glycol, tripropylene glycol, propylene glycol, caprylyl glycol, glycerin, polyethylene glycols, polypropylene glycol, glycerin, sorbitol, hexylene glycol, butylene glycol, hyaluronic acid and / or a salt thereof, 1,2 hexanediol, saccharide isomerate and a combination of two or more thereof. In at least one embodiment, the humectant comprises hyaluronic acid and / or a salt thereof.

[0090] The humectant(s) may be present in the oral care composition in an amount from about 0.01 to about 4 wt.%, about 0.01 to about 3 wt.%, about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.3 wt.%, about 0.01 to about 0.2 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%, about 0.1 to about 0.3 wt.%, about 0.1 to about 0.2 wt.%; from about 0.2 to about 4 wt.%, about 0.2 to about 3 wt.%, about 0.2 to about 2 wt.%, about 0.2 to about 1 wt.%, about 0.2 to about 0.5 wt.%, about 0.2 to about 0.3 wt.%; from about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%, about 0.3 to about 1 wt.%, about 0.3 to about 0.5 wt.%; from about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 0.7PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC to about 4 wt.%, about 0.7 to about 3 wt.%, about 0.7 to about 2 wt.%, about 0.7 to about 1.5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0091] The oral care compositions may comprise one or more surfactant(s), e.g., in an amount from about 0.1 to about 6 wt.%, based on the total weight of the oral care composition. For instance, the oral care composition may comprise a total amount of surfactant(s) of about 0.1 to about 6 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.3 to about 6 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%, about 0.3 to about 1 wt.%; from about 0.5 to about 6 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 6 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 6 wt.%, about 2 to about 4 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0092] The one or more surfactant(s) may be selected from anionic surfactants, amphoteric surfactants, nonionic surfactants, or combinations of two or more thereof. The one or more surfactant(s) preferably comprises at least one nonionic surfactant. In certain embodiments, the oral care composition is free of surfactants other than nonionic surfactants. The one or more nonionic surfactant(s) may be selected from sorbitan surfactants, poloxamers, fatty alcohol ethoxylates, alkylphenol ethoxylates, tertiary amine oxides, tertiary phosphine oxides, dialkyl sulfoxides, glucosides, and / or compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkylaromatic in nature. For example, the nonionic surfactants may be selected from sorbitan surfactants, poloxamers, or a combination of two or more thereof. In some embodiments, the only surfactants in the oral care composition are nonionic surfactants selected from sorbitan surfactants, poloxamers, or a combination of two or more thereof.

[0093] The sorbitan surfactants may be alkoxylate and / or ethoxylated. In some embodiments, the oral care composition comprises one or more sorbitan surfactants, such as those selected from ethoxylated sorbitan surfactants, polyoxyethylene esters, polyoxyethylene sugar alcohol and dehydrated sugar alcohol esters, or a combination of two or more thereof. In certain embodiments, the oral care composition may include, or in some instances exclude, one or more of polysorbate 80, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 81, or polysorbatePCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00-WO-01-OC85. For example, in certain embodiments, the sorbitan surfactants may comprise, or consist of, polysorbate 80 and / or polysorbate 20.

[0094] The nonionic surfactant may be selected from poloxamers, a triblock copolymer of a central of polypropylene glycol and two flanking locks of polyethylene glycol (PEG). The poloxamer may have an average molecular weight between 7680 and 9510 g / mol and / or have a structure according to the following formula:where a may independently be from 5 to 150, preferably from 60 to 95 or from 70 to 90, and b may be from 15 to 67, preferably 20 to 40 or 24 to 30. Non-limiting examples of poloxamers include poloxamer 188, poloxamer 407, poloxamer 237, poloxamer 338, or a combination thereof. The poloxamer may be poloxamer 407, poloxamer 188, or a combination thereof. In at least one embodiment, the nonionic surfactant comprises or consists of poloxamer 407.

[0095] Examples of glucoside surfactants include decyl glucoside, stearyl glucoside, lauryl glucoside, coco-glucoside, cetearyl glucoside, decyl lauryl glucoside, lauroyl ethyl glucoside, myristoyl ethyl glucoside, oleoyl ethyl glucoside, or a combination of two or more thereof. Additional nonionic surfactants that are worth mentioning include fatty alcohol ethoxylates, alcohol ethoxylate (AEO or AE), carboxylated alcohol ethoxylates, nonylphenol ethoxylate, and alkylphenol ethoxylates.

[0096] Further examples of nonionic surfactants include polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, ethylene oxide condensates of aliphatic alcohols, acids, and esters, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides and mixtures of such materials. Additional examples of nonionic surfactants include polyoxyethylene, polyoxyethylene sorbitan esters, polyoxyl 40 hydrogenated castor oil, fatty alcohol ethoxylates, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, ethylene oxide condensates of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides, or a combination of two or more thereof. In some instances, the nonionic surfactant comprises amine oxides, fatty acid amides, ethoxylatedPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC fatty alcohols, block copolymers of polyethylene glycol and polypropylene glycol, glycerol alkyl esters, polyoxyethylene glycol octylphenol ethers, sorbitan alkyl esters, polyoxyethylene glycol sorbitan alkyl esters, or a combination of two or more thereof. In some embodiments, one or more of the above nonionic surfactants may be excluded from the oral care composition.

[0097] The oral care composition may comprise one or more anionic surfactant, wherein the anionic surfactants consist of non-sulfate based anionic surfactant. Preferably, the oral care compositions may have a reduced amount of sulfate based anionic surfactants. The amount of sulfate based anionic surfactants present in the oral care composition may be about 5 wt.% or less, about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition. In some embodiments, the oral care composition is substantially free of or free of sulfate based anionic surfactants. The oral care composition may be substantially free of or free of anionic surfactants.

[0098] The oral care composition may include, or in some embodiments exclude, one or more amphoteric surfactants, such as those having a substituent containing 8 to 18 carbon atoms and a substituent containing one or more carboxylate, sulfonate, sulfate, phosphate, or phosphonate. Examples of amphoteric surfactants include those having an alkyl group comprising from 8 to 20 carbon atoms, 8 to 16 carbon atoms, 10 to 16 carbon atoms, or 10 to 13 carbon atoms. The amphoteric surfactant(s) may include, but are not limited to, derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain or branched. In some cases, one of the aliphatic substituents of the amphoteric surfactant contains about 8 to about 18 carbon atoms and one of the aliphatic substituents contains an anionic water solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate. The amphoteric surfactants disclosed herein may be present in the oral care composition in a salt form.

[0099] The amphoteric surfactants may be selected from alkyl amphopropionates, betaines, alkyl sultaines, alkyl amphoacetates, or a combination of two or more thereof. In some cases, the amphoteric surfactant is selected from betaine surfactants. Examples of betaine surfactants include, e.g., alkyl betaines, such as coco dimethyl carboxymethyl betaine, lauryl dimethyl carboxy-methyl betaine, lauryl dimethyl alpha-carboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl)carboxy methyl betaine, stearyl bis-(2-hydroxypropyl)carboxymethyl betaine, oleyl dimethyl gamma-carboxypropyl betaine, lauryl bis-(2-hydroxypropyl)alpha-PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC carboxyethyl betaine. In some embodiments, one or more of the above amphoteric surfactants may be excluded from the oral care composition.

[0100] The oral care compositions may include one or more coloring agents. Exemplary coloring agents can include natural or uncertified colors from natural sources or certified colors for the effect of color. In some embodiments, the coloring agents can include dyes, certified aluminum lakes or colors derived from a natural source. The coloring agents may be water-based, oil-based or dry.

[0101] Preferably, the coloring agent(s) comprise or are selected from green coloring agents, yellow coloring agents, and a combination of two or more thereof. In some embodiments the oral care composition has coloring agent(s) consisting of one or more green coloring agents, one or more yellow coloring agents, and a combination of two or more thereof. The coloring agent(s) may comprise or consist of Green 3, Yellow 5, Yellow 6, or a combination thereof.

[0102] The concentrations of the coloring agent(s) in the oral care composition may be from trace amount to about 0.6 wt.%, e.g., from about 0.001 to about 0.5 wt.%, about 0.002 to about 0.4 wt.%, about 0.005 to about 0.4 wt.%, about 0.015 to about 0.35 wt.%, about 0.025 to about 0.35 wt.%, about 0.05 to about 0.35 wt.%; from about 0.001 to about 0.2 wt.%, about 0.002 to about 0.2 wt.%, about 0.005 to about 0.2 wt.%, about 0.015 to about 0.2 wt.%, about 0.025 to about 0.2 wt.%, about 0.05 to about 0.2 wt.%; from about 0.001 to about 0.1 wt.%, about 0.002 to about 0.1 wt.%, about 0.005 to about 0.1 wt.%, about 0.015 to about 0.1 wt.%, about 0.025 to about 0.1 wt.%, about 0.05 to about 0.1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0103] The oral care composition may include one or more pH adjusters to increase or decrease the overall pH of the oral care composition. For example, one or more acids may be included to decrease the pH of the oral care composition. Examples of suitable acids for decreasing the pH of the oral care composition include, but are not limited to, citric acid, acetic acid, and the like. The oral care composition may include one or more bases, such as sodium hydroxide, potassium hydroxide and the like, to increase the pH of the oral care composition. Additional or alternative acids and bases that are suitable for adjusting the pH of the oral care composition are readily known to one of ordinary skill in the art.

[0104] The amount of the pH adjuster in the oral care composition may be based on the desired pH of the final oral care composition and / or product. For example, the total amount of the pHPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC adjuster may range from about 0.05 to about 20 wt.%, based on the total weight of the oral care composition. In some instances, the total amount of pH adjuster is from about 0.05 to about 15 wt.%, about 0.1 to about 10 wt.%, or about 0.12 to about 5 wt.%, including ranges and sub-ranges therebetween, based on the total weight of the oral care composition.

[0105] In some embodiments, the oral care compositions may include one or more sweeteners. The oral care composition may include caloric sweeteners and / or non-caloric sweeteners. Examples of non-caloric sweeteners include saccharin, for example, sodium saccharin, acesulfame, neotame, cyclamate or sucralose; natural high-intensity sweeteners, such as thaumatin, stevioside or glycyrrhizin; or sugar alcohols, such as sorbitol, xylitol, maltitol and mannitol. Examples of caloric sweeteners include sugars, such as fructose, glucose, sucrose, and high fructose syrups.

[0106] The one or more sweetener(s) may be present in the oral care composition in an amount of about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the sweetener(s) may be present in an amount of about 0.1 to about 7 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 7 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 3 wt.%, about 0.4 to about 2 wt.%, about 0.4 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%, about 0.8 to about 1.5 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 7 wt.%, about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0107] In some embodiments, the oral care composition preferably is substantially free or free of caloric sweeteners. For example, the oral care compositions may have about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the weight of the oral care composition. In at least one embodiment, the oral care composition contains about 0 wt.% or 0 wt.% of caloric sweeteners, based on the weight of the oral care composition.

[0108] The oral care compositions of the present disclosure may include a flavoring agent. The flavoring agent is typically incorporated in the oral care composition at a concentration of aboutPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC0.01 to about 3 wt.% by weight of the oral care composition. For example, the amount of flavoring agent(s) present in the oral care composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 3 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0109] Suitable flavoring agents include, but are not limited to, essential oils and various flavoring aldehydes, esters, alcohols, and similar materials. Examples of the essential oils include oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange. Also useful are such chemicals as menthol, carvone, and anethole. Additional flavoring agents may include, but are not limited to menthol, artificial vanilla, cinnamon derivatives, and various fruit flavors, spearmint oil, peppermint oil, cinnamon oil, oil of wintergreen (methylsalicylate), clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leaf oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, and a combination of two or more thereof.

[0110] The oral care compositions typically comprise water, e.g., in an amount of about 60 wt.% or more, based on the total weight of the oral care composition. In some embodiments, the total amount water in the oral care composition is from about 60 to about 96 wt.%, about 60 to about 90 wt.%, about 60 to about 85 wt.%, about 60 to about 81 wt.%, about 60 to about 79 wt.%, about 60 to about 77 wt.%, about 60 to about 75 wt.%, about 60 to about 71 wt.%; from about 65 to about 96 wt.%, about 65 to about 90 wt.%, about 65 to about 85 wt.%, about 65 to about 81 wt.%, about 65 to about 79 wt.%, about 65 to about 77 wt.%, about 65 to about 75 wt.%; from about 70 to about 96 wt.%, about 70 to about 90 wt.%, about 70 to about 85 wt.%, about 70 to about 81 wt.%, about 70 to about 79 wt.%, about 70 to about 77 wt.%; from about 75 to about 96 wt.%, about 75 to about 90 wt.%, about 75 to about 85 wt.%, about 75 to about 81 wt.%; from about 77 to about 96 wt.%, about 77 to about 90 wt.%, about 77 to about 85 wt.%, about 77 to about 81 wt.%; from about 79 to about 96 wt.%, about 79 to about 90 wt.%, about 79 to about 85 wt.%; from about 82 to about 96 wt.%, about 82 to about 90 wt.%, about 86 to about 96 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0111] In another aspect, the present disclosure provides a method of using the oral carePCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC compositions disclosed herein. The methods typically comprise applying any of the oral care compositions as described herein to oral cavity and / or the teeth, e.g., by rinsing, gargling, and / or swishing when the oral care composition is in the form of a mouthwash, or otherwise administering the oral care compositions to the oral cavity of a subject. The oral care compositions can be administered regularly, such as, for example, one or more times per day.

[0112] The methods may comprise applying any of the oral care compositions as described herein to the teeth, e.g., by swishing, gargling, rinsing, and / or otherwise administering the oral care composition to the oral cavity of a subject in need thereof. The oral care composition can be administered regularly, such as, for example, one or more times per day (e.g., twice per day). In various embodiments, administering the compositions of the present disclosure to the oral cavity and / or the teeth may provide one or more of the following specific benefits: (i) reduce or inhibit formation of dental caries, (ii) reduce, repair or inhibit pre-carious lesions of the enamel, e.g., as detected by quantitative light-induced fluorescence (QLF) or electrical caries measurement (ECM), (iii) reduce or inhibit demineralization and promote remineralization of the teeth, (iv) reduce hypersensitivity of the teeth, (v) reduce or inhibit gingivitis, (vi) promote healing of sores or cuts in the mouth, (vii) reduce levels of acid producing and / or malodor producing bacteria, (viii) treat, relieve or reduce dry mouth, (ix) clean the teeth and oral cavity, (x) whiten the teeth, (xi) reduce tartar build-up, and / or (xii) reduce or prevent oral malodor.EXAMPLESExample 1

[0113] Six non-limiting oral care compositions (Composition A-F) were prepared in accordance with the formulations shown in Table 1. Compositions A-F were all in the form of a mouthwash composition.PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OCTable 1Example 2

[0114] Compositions A-F were evaluated to assess the stability of fluoride ions and stannous ions in such mouthwash compositions. Specifically, Compositions A-F underwent an accelerated aging evaluation by being kept in a controlled environment at a temperature of 40°C for 26 weeks. During the 26 weeks accelerated aging evaluation, the stability of the fluoride ions and stannous ions in Compositions A-F were determined at 4 weeks, 8 weeks, 13 weeks, and 26 weeks of being kept in the controlled environment.

[0115] Compositions A-F each had a desirable fluoride ion stability at 4 weeks, 8 weeks, 13 weeks, and 26 weeks. Specifically, none of Compositions A-F had a statistically significant change in fluoride ion concentration. Unexpectedly, Composition A exhibited a stannous ion concentration of 94 mol.% of the initial amount of stannous ions after 26 weeks of accelerated aging. Compositions B-E also unexpectedly had a stannous ion concentration ranging from 83 to 86 mol.% of the initial amount of stannous ions after 26 weeks of accelerated aging. Composition F had a stannous ion concentration of 18 mol.% of the initial amount of stannous ion after 26 weeksPCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC of accelerated aging. A summary of the stannous ion stability for Compositions A-F is presented in FIG. 1.Example 3

[0116] Compositions A-F were evaluated according to procedures understood by one of ordinary skill to assess their respective antioxidant capacity. FIG. 2 provides a bar graph showing the antioxidant capacity for Compositions B-E and G. Composition G had a formulation similar to composition C but did not include vitamin C or ascorbyl phosphate. The placebo mouthwash (Placebo MW) was an active free mouthwash.

Claims

PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OCCLAIMSWhat is Claimed is:

1. A mouthwash composition comprising: a stannous source; a nitrate source; a phosphate source; and water in an amount of about 60 wt.% or more, wherein the mouthwash composition has a pH of less than 5 and all weight percentages are based on the total weight of the oral care composition.

2. The mouthwash composition according to claim 1, wherein the pH is from about 3 to about 4.5.

3. The mouthwash composition according to claim 1 or claim 2, wherein the stannous source is present in an amount from about 0.01 to about 3 wt.%, the the stannous source is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof.

4. The mouthwash composition according to any foregoing claim, wherein the nitrate source is selected from potassium nitrate, lithium nitrate, sodium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, and a combination two or more thereof.

5. The mouthwash composition according to any foregoing claim, wherein the phosphate source is selected from tetrasodium pyrophosphate, sodium tripolyphosphate, sodium hexametaphosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC6. The mouthwash composition according to any foregoing claim, wherein the mouthwash composition has a weight ratio of the stannous source to the phosphate source of about 1:2 to about 1:6.

7. The mouthwash composition according to any foregoing claim, wherein the mouthwash composition is substantially free or free of abrasives.

8. The mouthwash composition according to any foregoing claim, wherein the mouthwash composition is substantially free or free of monoalcohols.

9. The mouthwash composition according to any foregoing claim further comprising: a fluoride source comprising stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, or a combination of two or more thereof, wherein the fluoride source is optionally in an amount from about 0.01 to about 3 wt.%.

10. The mouthwash composition according to any foregoing claim further comprising: an acid.

11. The mouthwash composition according to claim 10, wherein the acid is an inorganic acid comprising hydrochloric acid, phosphoric acid, sodium acid pyrophosphate, or a combination thereof.

12. The mouthwash composition according to claim 10 or claim 11, wherein the acid is an organic acid comprising benzoic acid, malic acid, or a combination thereof.

13. The mouthwash composition according to any foregoing claim further comprising: a vitamin C and / or derivative thereof.

14. The mouthwash composition according to claim 13, wherein the vitamin C and / or derivative thereof is selected from L-ascorbic acid, calcium ascorbate, calcium L-ascorbatePCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC dihydrate, magnesium ascorbate, potassium ascorbate, magnesium L-ascorbyl phosphate, L- ascorbic acid 2-phosphate sesquimagnesium salt hydrate, (+) sodium L-ascorbate, dehydro-l-(+)- ascorbic acid dimer, sodium ascorbyl phosphate, ascorbic acid-2-glucoside, ascorbyl dipalmitate, ascorbyl methylsilanol pectinate, ascorbyl stearate, disodium ascorbyl sulfate, ascorbyl 6- palmitate, calcium ascorbyl phosphate, ascorbyl acetate, ascorbyl propionate, ascorbyl stearate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbyl glucoside, ascorbic acid polypeptide, ethyl ascorbyl ether, ascorbyl ethyl silanol pectinate, and a combination of two or more thereof.

15. The mouthwash composition according to claim 13 or claim 14, wherein the vitamin C and / or derivative thereof comprises ascorbyl phosphate.

16. The mouthwash composition according to any foregoing claim further comprising: a coloring agent, wherein the coloring agent is selected from green coloring agents, yellow coloring agents, and a combination of two or more thereof.

17. A mouthwash composition comprising: a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof; an acid and / or a salt thereof selected from hydrochloric acid, phosphoric acid, benzoic acid, malic acid, sodium acid pyrophosphate, a salt thereof, and a combination thereof; water in an amount of about 60 wt.% or more; and optionally, a fluoride source, wherein all weight percentages are based on the total weight of the oral care composition.

18. A mouthwash composition comprising: a stannous source; a nitrate source; a phosphate source; a vitamin C and / or derivative thereof;PCT / US25 / 46514 16 September 2025 (16.09.2025)Docket No. 1081984-00- WO-Ol-OC an acid and / or a salt thereof; water in an amount of about 60 wt.% or more; and optionally, a fluoride source, wherein the mouthwash composition has a pH of about 3 to 5 and all weight percentages are based on the total weight of the oral care composition.

19. The mouthwash composition according to any foregoing claim, wherein the mouthwash has a reduction of stannous ions after being kept in a controlled environment at a temperature of 40°C for 13 weeks of about 20 mol.% or less.

20. Use of the mouthwash according to any foregoing claim to reduce formation of dental caries, promote remineralization of the teeth, and / or reduce levels of acid producing bacteria.

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