WO2025006606A2

WO2025006606A2 - Oral care compositions

Info

Publication number: WO2025006606A2
Application number: PCT/US2024/035618
Authority: WO
Inventors: Robert D'ambrogio; Jean Denis
Original assignee: Colgate Palmolive Co
Current assignee: Colgate Palmolive Co
Priority date: 2023-06-28
Filing date: 2024-06-26
Publication date: 2025-01-02
Anticipated expiration: 2025-12-28
Also published as: WO2025006606A3

Abstract

Oral care compositions are disclosed herein. In accordance with an aspect, provided is an oral care composition having from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 10 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; a stannous ion source; and optionally a phosphate source, wherein all weight percentages are based on the total weight of the oral care composition.

Description

ORAL CARE COMPOSITIONS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from U.S. Patent Application No. 63/523,694, filed June 28, 2023, titled Oral Care Compositions, the content of which are hereby incorporated herein in their entireties, for all purposes.

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 biofilm 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. In accordance with an aspect, provided is an oral care composition having from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 10 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; and a stannous ion source, wherein all weight percentages arc based on the total weight of the oral care composition.

[0007] In accordance with another aspect of the invention, provided is an oral care composition having from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 5 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; and a stannous ion source, wherein the oral care composition has a weight ratio of the amount of sodium citrate and/or an acid thereof to the total amount of the zinc source and the potassium nitrate of about 1:3 to about 3:1, and 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 an oral care composition comprising from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 10 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; a stannous ion source; and a phosphate source, wherein all weight percentages are based on the total weight of the oral care composition.

[0009] In accordance with yet another aspect of the invention, provided is a method for treating, preventing, or ameliorating a symptom associated with a disease, disorder, or condition of the oral cavity comprising applying an effective amount of a composition according to any foregoing claim to an oral cavity surface of a subject in need thereof.

[0010] A list of certain, non-limiting embodiments in accordance with aspects of the invention are provided below:

[0011] In accordance with embodiment 1, provided is an oral care composition comprising: from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 10 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; and a stannous ion source, wherein all weight percentages are based on the total weight of the oral care composition. [0012] In accordance with embodiment 2, provided is an oral care composition according to embodiment 1 further comprising an amino acid.

[0013] In accordance with embodiment 3, provided is an oral care composition according to claim 2, wherein the amino acid comprises arginine.

[0014] In accordance with embodiment 4, provided is an oral care composition according to claim 2 or claim 3, wherein the amino acid is present in an amount from about 1 to about 10 wt.% [0015] In accordance with embodiment 5, provided is an oral care composition according to any foregoing claim, wherein the zinc source is present in an amount from about 0.5 to about 8 wt.%, optionally from about 0.5 to about 6 wt.%, optionally from about 0.7 to about 6 wt.%, or optionally from about 0.9 to about 5 wt.%.

[0016] In accordance with embodiment 6, provided is an oral care composition according to any foregoing claim, wherein the zinc source is selected from zinc phosphate, zinc lactate, zinc oxide, zinc citrate, zinc stearate, zinc gluconate, and a combination of two or more thereof.

[0017] In accordance with embodiment 7, provided is an oral care composition according to any foregoing claim, wherein the zinc source comprises an insoluble zinc compound.

[0018] In accordance with embodiment 8, provided is an oral care composition according to any foregoing claim, wherein the potassium nitrate is present in an amount from about 0.5 to about 10 wt.%, optionally about 1 to about 10 wt.%, optionally about 0.5 to about 5 wt.%, or optionally about 1 wt.% to about 5 wt.%.

[0019] In accordance with embodiment 9, provided is an oral care composition according to any foregoing claim, wherein the sodium citrate and/or an acid thereof, is present in an amount from about 0.5 to about 10 wt.%, optionally from about 1 to about 8 wt.%, or optionally from about 1 to about 5 wt.%.

[0020] In accordance with embodiment 10, provided is an oral care composition according to any foregoing claim, wherein the oral care composition has a weight ratio of the amount of sodium citrate and/or an acid thereof to the total amount of the zinc source and the potassium nitrate of about 1:3 to about 3:1, optionally about 1:2 to about 2:1, about 1:1.5 to about 1.5:1, or about 1:1.2 to about 1.25:1.

[0021] In accordance with embodiment 11, provided is an oral care composition according to any foregoing claim, wherein the oral care composition has a molar ratio of potassium nitrate to stannous ions, both measured as free ions, of from about 0.5:1 to about 2:1.

[0022] In accordance with embodiment 12, provided is an oral care composition according to any foregoing claim, wherein the stannous ion source is present in an amount from about 0.05 to about 5 wt.%.

[0023] In accordance with embodiment 13, provided is an oral care composition according to any of claim 1 to claim 11, wherein the stannous ion source is present in an amount from about 0.1 to about 2 wt.%.

[0024] In accordance with embodiment 14, provided is an oral care composition according to any foregoing claim, wherein the stannous ion source comprises stannous fluoride.

[0025] In accordance with embodiment 15, provided is an oral care composition according to any foregoing claim, further comprising a phosphate source.

[0026] In accordance with embodiment 16, provided is an oral care composition according to claim 15, wherein the phosphate source is present in an amount from about 0.1 to about 7 wt.%.

[0027] In accordance with embodiment 17, provided is an oral care composition according to any foregoing claim, wherein the phosphate source comprises tetrasodium pyrophosphate.

[0028] In accordance with embodiment 18, provided is an oral care composition according to any foregoing claim further comprising a fluoride ion source, optionally, in an amount from about 0.1 to about 2 wt.%.

[0029] In accordance with embodiment 19, provided is an oral care composition according to claim 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.

[0030] In accordance with embodiment 20, provided is an oral care composition according to any foregoing claim further comprising a polyol, optionally, in an amount from about 5 to about 60 wt.%.

[0031] In accordance with embodiment 21, provided is an oral care composition according to claim 20, wherein the polyol comprises a glycol, sorbitol, glycerin, inositol, maltitol, mannitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a saccharide, polyoxypropylene-polyoxyethylene block copolymer and a combination of two or more thereof.

[0032] In accordance with embodiment 22, provided is an oral care composition according to any foregoing claim further comprising an amount of water up to about 10 wt.%.

[0033] In accordance with embodiment 23, provided is an oral care composition according to one of claim 1 to claim 21 further comprising water present in an amount from about 10 to about 80 wt.%.

[0034] In accordance with embodiment 24, provided is an oral care composition according to any foregoing claim further comprising an anionic surfactant, optionally, in an amount from about 0.5 to about 10 wt.%. [0035] In accordance with embodiment 25, provided is an oral care composition according to claim 24, wherein the anionic surfactant is selected from ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco-sulfate, ammonium coco-sulfate, and a combination of two or more thereof.

[0036] In accordance with embodiment 26, provided is an oral care composition according to any foregoing claim further comprising a sweetener, optionally, in an amount from about 0.1 to about 7 wt.%.

[0037] In accordance with embodiment 27, provided is an oral care composition according to claim 26, wherein the sweetener is selected from sucrose, lactose, maltose, sorbitol, xylitol, sodium cyclamate, perillartine, L-aspartyl-L-phenylalanine methyl ester (aspartame), saccharine, and a combination of two or more thereof.

[0038] In accordance with an embodiment 28, provided is an oral care composition comprising: from about 0.1 to about 8 wt.% of a zinc source; from about 0.1 to 5 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; and a stannous ion source, wherein the oral care composition has a weight ratio of the amount of sodium citrate and/or an acid thereof to the total amount of the zinc source and the potassium nitrate of about 1:3 to about 3:1, and wherein all weight percentages are based on the total weight of the oral care composition.

[0039] In accordance with embodiment 29, provided is an oral care composition according to any foregoing claim further comprising a PVM/MA copolymer.

[0040] In accordance with an embodiment 30, provided is an oral care composition comprising: from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 10 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; a stannous ion source; and a phosphate source; wherein all weight percentages are based on the total weight of the oral care composition. [0041] In according with an embodiment 31, a method is provided for treating, preventing, or ameliorating a symptom associated with a disease, disorder, or condition of the oral cavity comprising applying an effective amount of a composition according to any foregoing claim to an oral cavity surface of a subject in need thereof.

[0042] In accordance with embodiment 32, provided is the method according to embodiment 31, wherein the disease, disorder, or condition of the oral cavity is selected from: gingivitis; caries; hypersensitivity; periodontitis; halitosis; discoloration or staining of the teeth; aberrant biofilm formation; pre-carious lesions of the enamel, demineralization of the teeth; sores or cuts in the oral cavity; acid producing bacteria; plaque accumulation; dry mouth; erosion; cariogenic bacteria; and a combination of two or more thereof.

DETAILED DESCRIPTION

[0043] 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.

[0044] 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”.

[0045] 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. [0046] 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.%.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] “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.

[0051] 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.

[0052] 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 be 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.

[0053] 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.

[0054] 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.

[0055] 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.”

[0056] Aspects of the invention are directed to oral care compositions and, e.g., to oral care compositions providing enhanced oral care benefits. The oral care compositions disclosed herein typically comprise a zinc source, potassium nitrate, a stannous ion source, and sodium citrate and/or an acid thereof. The inventors discovered that certain combinations of a zinc source, potassium nitrate, stannous ion source, and sodium citrate and/or and acid thereof, unexpectedly provide enhanced stability for zinc ions and/or stannous ions. Surprisingly, the oral care compositions achieved an enhanced zinc ion and/or stannous ion availability in oral care compositions having a relatively high amount of potassium nitrate. [0057] The oral care compositions may be in the form of dentifrice, toothpaste, mouthwash, and/or the like. 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. In other embodiments, the oral care composition may include two or more phases, such as two, three, four, or five phases.

[0058] The oral care compositions typically comprise a zinc source, preferably in an effective amount. The amount of zinc source in the oral care composition may be from about 0.1 to about 8 wt.%, based on the total weight of the oral care composition. For example, the amount of zinc source may be present in the oral care composition may be 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 1.5 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.7 wt.%, about 0.1 to about 0.5 wt.%; from about 0.3 to about 8 wt.%, 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 1.5 wt.%, about 0.3 to about 1 wt.%, about 0.3 to about 0.8 wt.%; from about 0.5 to about 8 wt.%, 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.%; from about 0.9 to about 8 wt.%, about 0.9 to about 6 wt.%, about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 8 wt.%, about 1.2 to about 6 wt.%, about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 8 wt.%, about 1.5 to about 6 wt.%, about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 8 wt.%, 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 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0059] The zinc source may be selected from soluble zinc compounds and/or insoluble zinc compounds. Examples of zinc sources include zinc sulfate, zinc chloride, zinc acetate, zinc phenol sulfonate, zinc borate, zinc bromide, zinc nitrate, zinc glycerophosphate, zinc benzoate, zinc carbonate, zinc carnosine, zinc citrate, zinc hexafluorosilicate, zinc diacetate trihydrate, zinc oxide, zinc peroxide, zinc salicylate, zinc silicate, zinc stannate, zinc tannate, zinc titanate, zinc tctrafluoroboratc, zinc gluconate, zinc lactate, zinc glycinate, zinc phosphate, and a combination of two or more thereof. The zinc source may be selected from zinc citrate, zinc oxide, zinc phosphate, zinc lactate, zinc sulfate, zinc silicate, zinc gluconate, and a combination of two or more thereof.

[0060] The oral care composition may include two or more, three or more, four or more, five or more, or six or more zinc 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 zinc sources. In some embodiments, the oral care composition comprises or consists of zinc oxide, zinc citrate, zinc phosphate, or a combination of two or more thereof. In at least one preferred embodiment, the oral care composition comprises zinc phosphate. The oral care composition may have a zinc source that consists of zinc phosphate.

[0061] The oral care compositions typically include potassium nitrate, preferably in an effective amount. The amount of potassium nitrate may be from about 0.5 to 10 wt.%, based on the total weight of the oral care composition. For instance, the oral care composition may include potassium nitrate in an amount from about 0.5 to about 10 wt.%, about 0.5 to about 8 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 4 wt.%, about 1 to about 2 wt.%; from about 2 to about 10 wt.%, about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 4 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 4 wt.%; from about 4 to about 10 wt.%, about 4 to about 8 wt.%, about 4 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.%; from about 7 to about 10 wt.%, about 7 to about 9 wt.%, about 7 to about 8 wt.% or any range or subrange thereof, based on the total weight of the oral care composition.

[0062] The amount of potassium nitrate present in the oral care composition may be in amount from about 0.01 to about 0.5 wt.%, based on the total weight of the oral care composition, e.g., when the oral care composition is in the form of a mouthwash. In some instance, the amount of potassium nitrate may be from 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 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 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 0.5 wt.%, about 0.2 to about 0.3 wt.%; from about 0.3 to about 0.5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0063] The oral care composition may include a nitrate ion source other than potassium nitrate. The one or more nitrate ion source other than potassium nitrate may be in the form of a salt or an ion derived therefrom, including, e.g., a nitrate salt selected from an alkali or alkaline earth metal nitrate. Examples of nitrate ion sources other than potassium nitrate include lithium nitrate, sodium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, or a combination two or more thereof.

[0064] The amount of nitrate ion source other than potassium nitrate may be from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. In some instances, the amount of nitrate ion other than potassium nitrate in the oral care composition may be from about 0.1 to about 4 wt.%, about 0.1 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 1 to about 5 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0065] The oral care composition typically includes sodium citrate and/or an acid thereof in an amount, e.g., from about 0.3 to about 10 wt.%, based on the total weight of the oral care composition. In some instances, the oral care composition includes sodium citrate and/or an acid thereof in an amount from about 0.3 to about 8 wt.%, about 0.3 to about 6 wt.%, about 0.3 to about 5 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 10 wt.%, about 0.6 to about 8 wt.%, about 0.6 to about 6 wt.%, about 0.6 to about 5 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 10 wt.%, about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 3 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%; from about 4 to about 10 wt.%, about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 10 wt.%, about 5 to about 8 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 9 wt.%, about 7 to about 8 wt.%; from about 8 to about 10 wt.%, about 8 to about 9 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0066] The sodium citrate and/or acid thereof may be in the form of citric acid. The sodium citrate and/or acid thereof may be in the form of a salt, such as monosodium citrate, disodium citrate, trisodium citrate, or a combination of two or more thereof.

[0067] Additionally, the oral care compositions typically comprise a stannous ion source, preferably present in an effective amount. The stannous ion source may be present in the oral care composition in an amount from about 0.05 to about 5 wt.%, based on the total weight of the oral care composition. For example, the amount of stannous ion present in the oral care composition may be 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.%; 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.%; from 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.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0068] The stannous ion 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. In at least one embodiment, the stannous ion source comprises stannous fluoride.

[0069] The oral care composition may include two or more, three or more, four or more, five or more, or six or more of stannous ion 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 ion sources. In some embodiments, the oral care composition comprises stannous fluoride and stannous pyrophosphate. Additionally or alternatively, the oral care composition may comprise stannous fluoride and stannous chloride.

[0070] The oral care compositions may, preferably, be formulated to have a weight ratio of the total amount of sodium citrate and/or an acid thereof to the total amount of the zinc source and the potassium nitrate of about 1:3 to about 3:1. In some preferred embodiments, the weight ratio of the total amount of sodium citrate and/or an acid thereof to the total amount of the zinc source and the potassium nitrate is from about 1:2.5 to about 3:1, about 1:2 to about 3:1, about 1:1.7 to about 3:1, about 1:1.5 to about 3:1, about 1:1.3 to about 3:1, about 1:1.2 to about 3:1, about 1:1 to about 3:1; from about 1:3 to about 2.5:1, about 1:2.5 to about 2.5:1, about 1:2 to about 2.5:1, about 1:1.7 to about 2.5:1, about 1:1.5 to about 2.5:1, about 1:1.3 to about 2.5:1, about 1:1.2 to about 2.5:1, about 1:1 to about 2.5:1; from about 1:3 to about 2:1, about 1:2.5 to about 2:1, about 1:2 to about 2:1, about 1:1.7 to about 2:1, about 1:1.5 to about 2:1, about 1:1.3 to about 2:1, about 1:1.2 to about 2:1, about 1:1 to about 2:1; from about 1:3 to about 1.8:1, about 1:2.5 to about 1.8:1, about 1:2 to about 1.8:1, about 1:1.7 to about 1.8:1, about 1:1.5 to about 1.8:1, about 1:1.3 to about 1.8:1, about 1:1.2 to about 1.8:1, about 1:1. to about 1.8:1; from about 1:3 to about 1.6:1, about 1:2.5 to about 1.6:1, about 1:2 to about 1.6:1, about 1:1.7 to about 1.6:1, about 1:1.5 to about 1.6:1, about 1:1.3 to about 1.6:1, about 1:1.2 to about 1.6:1, about 1:1 to about 1.6:1; from about 1:3 to about 1.4:1, about 1:2.5 to about 1.4:1, about 1:2 to about 1.4:1, about 1:1.7 to about 1.4:1, about 1:1.5 to about 1.4:1, about 1 : 1.3 to about 1.4:1, about 1 : 1.2 to about 1.4:1, about 1 : 1 to about 1.4:1; from about 1:3 to about 1.25:1, about 1:2.5 to about 1.25:1, about 1:2 to about 1.25:1, about 1:1.7 to about 1.25:1, about 1:1.5 to about 1.25:1, about 1: 1.3 to about 1.25:1, about 1:1.2 to about 1.25:1, about 1:1 to about 1.25:1; from about 1:3 to about 1:1, about 1:2.5 to about 1:1, about 1:2 to about 1:1, about 1:1.7 to about 1:1, about 1:1.5 to about 1:1, about 1:1.3 to about 1:1, about 1:1.2 to about 1 : 1 ; or any range or subrange thereof.

[0071] Additionally or alternatively, the personal care composition may be adapted to have has a weight ratio of the amount of the zinc source to the amount of potassium nitrate from about 1:1 to about 1:8. For instance, in certain preferred embodiments, the weight ratio of the amount of the zinc source to the amount of potassium nitrate is from about 1:1 to about 1:8, about 1:1 to about 1:6, about 1:1 to about 1:5, about 1:1 to about 1:4, about 1:1 to about 1:3, about 1:1 to about 1:2; from about 1:2 to about 1:8, about 1:2 to about 1:6, 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 1:8, 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 :8, about 1 :4 to about 1 :6, about 1 :4 to about 1 :5, about 1:6 to about 1:8, or any range or subrange thereof.

[0072] The oral care compositions may be formulated to have a molar ratio of potassium nitrate to stannous ions, both measured as free ions, that is about 2:1 or less. For example, the oral care composition may have a molar ratio of potassium nitrate to stannous ions, both measured as free ions, of from 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 potassium nitrate to stannous ions, both measured as free ions, of about 1:1.

[0073] The oral care compositions may comprise one or more amino acid(s) in an effective amount. Without being limited to any particular theory, it was discovered that certain oral care compositions having combinations of zinc source, potassium nitrate, and sodium citrate and/or an acid thereof in the amounts and ratios described herein can unexpectedly be enhanced by including certain amino acids (e.g., arginine and/or lysine). The one or more amino acids may be selected from basic amino acids, neutral amino acids, and combinations thereof. The basic amino acids may be selected from naturally occurring basic amino acids, such as arginine, lysine, and histidine, and non-naturally occurring basic amino acids having a carboxyl group and an amino group in the molecule, which are water-soluble and provide an aqueous solution with a pH of 7 or greater. Examples of basic amino acids include arginine, lysine, serine, citrulline, ornithine, creatine, histidine, diaminobutanoic acid, diaminoproprionic acid, salts thereof or combinations thereof. In some embodiments, the basic amino acids are selected from arginine, citrulline, and ornithine. In certain embodiments, the basic amino acid is arginine, e.g., L-arginine, or a salt thereof. Additionally or alternatively, the one or more amino acid can be chosen from neutral amino acids, which can include, but are not limited to, one or more neutral amino acids selected from the group consisting of alanine, aminobutyrate, asparagine, cysteine, cystine, glutamine, glycine, hydroxyproline, isoleucine, leucine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, and combinations thereof. Tn at least one preferred embodiment, the amino acid(s) is selected from arginine, lysine, and a combination thereof.

[0074] The one or more amino acid(s) may be present in an amount from about 0.5 to about 10 wt.%, based on the total weight of the oral care composition. In some embodiments, the one or more amino acid(s) may be present in the oral care composition in an amount from about 0.5 to about 8 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 4 wt.%, about 1 to about 2 wt.%; from about 2 to about 10 wt.%, about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 4 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 4 wt.%; from about 4 to about 10 wt.%, about 4 to about 8 wt.%, about 4 to about 6 wt.%; from about 6 to about 10 wt.%, about 6 to about 8 wt.%; from about 8 to about 10 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0075] The one or more amino acids may be present in an amount from about 0.1 to about 1 wt.%, e.g., when the oral care composition is in the form of a mouthwash. For example, the amino acids may be present in amount from about 0.1 to about 0.8 wt.%, about 0.1 to about 0.6 wt.%, about 0.1 to about 0.4 wt.%, about 0.1 to about 0.3 wt.%; from about 0.2 to about 1 wt.%, about 0.2 to about 0.8 wt.%, about 0.2 to about 0.6 wt.%, about 0.2 to about 0.4 wt.%; from about 0.4 to about 1 wt.%, about 0.4 to about 0.8 wt.%, about 0.4 to about 0.6 wt.%, about 0.6 to about 1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0076] The oral care compositions may include a fluoride ion source. The fluoride ion source may be present in an effective amount. In some cases, the fluoride ion source is present in the oral care composition in an amount of about 0.01 to about 5 wt.%, based on the total weight of the oral care composition. For example, the fluoride ion source is present in an amount of about 0.01 to about 5 wt.%, 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.%; from about 0.05 to about 5 wt.%, 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.%; from 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.%; from 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.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1 .2 to about 5 wt.%, about 1 .2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0077] The fluoride ion source may be selected from soluble fluoride ion salts. For example, the fluoride ion 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 ion source comprises sodium fluoride, sodium monofluorophosphate, or a combination thereof. Additional examples of fluoride ion source are disclosed in U.S. Patent No. 3,535,421, U.S. Patent No. 4,885,155, and U.S. Patent No. 3,678,154, the disclosure of each of which is hereby incorporated by reference in their entirety.

[0078] 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 sufficient to supply, in total, 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.

[0079] The oral care compositions typically comprises one or more phosphate ion source(s). The phosphate ion source(s) is preferably present in an effective amount. In some instances, the oral care composition may include the one or more phosphate ion source(s) in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the one or more phosphate ion source(s) may be present in the oral care composition in an amount 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 0.4 to about 7 wt.%, about 0.4 to about 6 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 4 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 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, 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 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0080] The phosphate source may preferably comprise a soluble phosphate compound, such as a phosphate salt. The pyrophosphate salts used in the present compositions can be any of the alkali metal pyrophosphate salts. In certain embodiments, salts include tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are sodium or potassium. 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 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.

[0081] In particular examples, the phosphate source is selected from alkali dibasic phosphate and alkali pyrophosphate salts, e.g., selected from sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, and a combination of two or more thereof. For example, the oral care compositions may comprise tetrasodium pyrophosphate (Na4P20?), calcium pyrophosphate (Ca2P20?), sodium phosphate dibasic (Na2HP04), or a combination of two or more thereof. In at least one embodiment, the phosphate source comprises tetrasodium pyrophosphate.

[0082] The oral care compositions may include one or more polyol(s). The one or more polyol(s) may be present in the oral care composition in an amount from about 5 to about 60 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include polyol(s) in an amount from about 5 to about 55 wt.%, about 5 to about 45 wt.%, about 5 to about 37 wt.%, about 5 to about 31 wt.%, about 5 to about 25 wt.%, about 5 to about 15 wt.%; from about 10 to about 55 wt.%, about 10 to about 45 wt.%, about 10 to about 37 wt.%, about 10 to about 31 wt.%, about 10 to about 25 wt.%; from about 15 to about 60 wt.%, about 15 to about 55 wt.%, about 15 to about 45 wt.%, about 15 to about 37 wt.%, about 15 to about 31 wt.%, about 5 to about 25 wt.%; from about 20 to about 55 wt.%, about 20 to about 55 wt.%, about 20 to about 50 wt.%, about 20 to about 45 wt.%, about 20 to about 40 wt.%, about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to about 60 wt.%, about 25 to about 55 wt.%, about 25 to about 50 wt.%, about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 to about 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 60 wt.%, about 28 to about 55 wt.%, about 28 to about 50 wt.%, about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 60 wt.%, about 31 to about 55 wt.%, about 31 to about 50 wt.%, about 31 to about 45 wt.%, about 31 to about 40 wt.%, about 31 to about 37 wt.%; from about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; from about 37 to about 60 wt.%, about 37 to about 55 wt.%, about 37 to about 50 wt.%, about 37 to about 45 wt.%; from about 40 to about 60 wt.%, about 40 to about 55 wt.%, about 40 to about 50 wt.%, about 40 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0083] 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). In some preferred embodiments, the polyol(s) comprises glycerin, glycol, inositol, 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. The polyol may be a humectant including, e.g., glycol, sorbitol, glycerin, inositol, maltitol, mannitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a saccharide, polyoxypropylene-polyoxyethylene block copolymer and a combination of two or more thereof.

[0084] 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 of two or more thereof.

[0085] Additionally or alternatively, the oral care composition may include polyol(s) having a molecular weight of from about 100 to 5000 g/mol. For instance, the polyol may comprise a polyethylene glycol, a polypropylene glycol, a block polymer of polyethylene glycol and polypropylene glycol, or a combination of two or more thereof. In some embodiments, the polyol comprises a polypropylene glycol, a polypropylene glycol, and/or a block polymer of polyethylene glycol and polypropylene glycol having a molecular weight of about 100 to about 900, about 200 to about 800, about 400, about 1500 to about 2500, about 2000 to about 4500 or any range or subrange thereof. In some embodiments, the polyol is a polyethylene glycol, such as polyethylene glycol 600 (CAS-25322-68-3). In some embodiments, the compositions of the disclosure comprise one or more polyethylene glycols, for example, polyethylene glycols in a molecular weight range from 200 to 800. For example, the compositions may comprise one or more of polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol, 600 or polyethylene glycol 800.

[0086] The oral care compositions may be formulated to have an amount of water up to about 80 wt.%, based on the total weight of the oral care composition. For example, the amount of water in the oral care composition may be from about 10 to about 80 wt.%, about 20 to about 80 wt.%, about 30 to about 50 wt.%, about 35 to about 80 wt.%, about 40 to about 80 wt.%; from about 10 to about 70 wt.%, about 20 to about 70 wt.%, about 30 to about 70 wt.%, about 35 to about 70 wt.%, about 40 to about 70 wt.%; from about 10 to about 60 wt.%, about 20 to about 60 wt.%, about 30 to about 60 wt.%, about 35 to about 60 wt.%, about 40 to about 60 wt.%; from about 10 to about 50 wt.%, about 20 to about 50 wt.%, about 30 to about 50 wt.%, about 35 to about 50 wt.%, about 40 to about 50 wt.%; from about 10 to about 40 wt.%, about 20 to about 40 wt.%, about 30 to about 40 wt.%, about 35 to about 40 wt.%; from about 10 to about 35 wt.%, about 20 to about 35 wt.%, about 30 to about 35 wt.%; from about 10 to about 30 wt.%, about 20 to about 30 wt.%; from about 10 to about 25 wt.%, about 20 to about 25 wt.%, about 10 to about 20 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0087] In certain embodiments, the amount of water in the oral care composition is from about 1 to about 10 wt.%, based on the total weight of the oral care composition. For example, the oral care composition have water in an amount of about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 5 to about 10 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%; from about 7 to about 10 wt.%, about 7 to about 9 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0088] Surfactants may be included in the oral care composition. The one or more surfactants may be selected from anionic surfactants, such as sulfate based anionic surfactants, sulfonated monoglycerides of fatty acids, acyl isethionates, acyl sarcosinates, acyl taurate, or combinations thereof. Examples of sulfate based anionic surfactants include ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco-sulfate, ammonium coco- sulfate, or a combination of two or more thereof. The one or more anionic surfactant(s) may be selected from non-sulfate based anionic surfactants, such as sulfonated monoglycerides of fatty acids, acyl isethionates, acyl sarcosinates, acyl taurate, or a combination of two or more thereof. For example, the anionic surfactants may be selected from water-soluble salts of higher fatty acid monoglyccridc monosulfatcs, such as the sodium salt of the monosulfatcd monoglyccridc of hydrogenated coconut oil fatty acids; sodium N- methyl N-cocoyl taurate; sodium cocomo- glyceride sulfate; higher alkyl sulfates, such as sodium lauryl sulfate; higher alkyl-ether sulfates, such as sodium laureth-2 sulfate; higher alkyl aryl sulfonates, such as sodium dodecyl benzene sulfonate (sodium lauryl benzene sulfonate); higher alkyl sulfoacetates, such as sodium lauryl sulfoacetate (dodecyl sodium sulfoacetate), higher fatty acid esters of 1,2 dihydroxy propane sulfonate, sulfocolaurate (N-2- ethyl laurate potassium sulfoacetamide) and sodium lauryl sarcosinate.

[0089] The one or more surfactants may be chosen from non-ionic, amphoteric, and cationic surfactants. Nonionic surfactants useful herein may include those compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkyl-aromatic in nature. Non-limiting examples of suitable nonionic surfactants include polyoxyethylene sorbitan esters (sold under the trade name Tweens), polyoxyl 40 hydrogenated castor oil, fatty alcohol ethoxylates, ethylene oxide condensates of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phosphaine oxides, lauryl glucoside (sold under the trade name Plantaren 1200 UP) and long chain dialkyl sulfoxides. Suitable nonionic surfactants with a HLB of 7 or more include sucrose laurate, sucrose cocoate, sucrose stearate; Steareth 20, 21, or 100, and PEG 20 Sorbitan Monostearate (commercially available as Tween 60). In at least one embodiment, the nonionic surfactants are chosen from polyethoxylated sorbitol esters, in particular poly ethoxylated sorbitol monoesters; polycondensates of ethylene oxide and propylene oxide (poloxamers), for instance the products marketed under the trade name PLURONIC by BASF-Wyandotte; condensates of propylene glycol; polyethoxylated hydrogenated castor oil, for instance, cremophors; and sorbitan fatty esters.

[0090] Non-limiting examples of amphoteric surfactants include, for example, long chain imidazoline derivatives such as the product marketed under the trade name 'Miranol C2M' by Miranol; long chain alkyl betaines, such as the product marketed under the tradename 'Empigen BB' by Albright+Wilson, and long chain alkyl amidoalkyl betaines, such as cocamidopropylbetaine, and mixtures thereof.

[0091] The oral care composition may include amphoteric surfactants chosen from derivatives of aliphatic secondary and tertiary amines, in which the aliphatic radical can be a straight chain or branched and wherein one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic water-solubilizing group, such as carboxylate, sulfonate, sulfate, phosphate, or phosphonate. Other exemplary amphoteric surfactants are betaines, such as cocamidopropyl betaine, lauryl dimethyl betaine (sold under the trade name Macat LB), cetyl dimethyl betaine, and cocoamphodiacetate. Additional amphoteric surfactants and nonionic surfactants can be found in U.S. Pat. No. 4,051,234, which is incorporated herein in its entirety for all purposes.

[0092] Examples of cationic surfactants that may be present in the oral care composition include cetyl pyridinium chloride, coamidopropyl PG dimonium chloride phosphate (Phospholipid CDM), myristylamidopropyl PG dimonium chloride phosphate (Phospholipid PTM), stearamidopropyl PG dimonium chloride phosphate (Phospholipid SV), steapyrium chloride (Catemol WPC), and other suitable cationic materials. The cationic surfactants may be D,L-2-pyrrolidone-5-carbo- xylic acid salt of ethyl-N-cocoyl-L-arginate, marketed under the trade name CAE by Ajinomoto Co. Inc. [0093] One or more polymer may be included in the oral care composition. The polymer may be a carboxylic polymer and/or copolymer in some cases. Examples of suitable carboxylic polymers include PVM/MA copolymers, such as a copolymer of methyl vinyl ether/maleic anhydride. In certain embodiments, the PVM/MA copolymer comprises a 1:4 to 4:1 copolymer of maleic anhydride or acid with a further polymerizable ethylenically unsaturated monomer; for example 1:4 to 4:1, e.g., about 1:1.

[0094] The oral care composition may include the one or more polymer(s) in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the total amount of polymer(s) present in the oral care composition may be 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 0.4 to about 7 wt.%, about 0.4 to about 6 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 4 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 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, 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 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0095] 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.

[0096] The one or more sweetener(s) may be present in the oral care composition in an amount from about 0.1 to about 50 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may have a total amount of sweetener(s) from about 0.1 to about 40 wt.%, about 0.1 to about 30 wt.%, about 0.1 to about 20 wt.%, about 0.1 to about 10 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%; from about 1 to about 50 wt.%, about 1 to about 40 wt.%, about 1 to about 30 wt.%, about 1 to about 20 wt.%, about 1 to about 10 wt.%, about 1 to about 5 wt.%, about 1 to about 3 wt.%; from about 5 to about 50 wt.%, about 5 to about 40 wt.%, about 5 to about 30 wt.%, about 5 to about 20 wt.%, about 5 to about 10 wt.%; from about 10 to about 50 wt.%, about 10 to about 45 wt.%, about 10 to about 40 wt.%, about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%; from about 15 to about 50 wt.%, about 15 to about 45 wt.%, about 15 to about 40 wt.%, about 15 to about 37 wt.%, about 15 to about 34 wt.%, about 15 to about 31 wt.%, about 15 to about 28 wt.%, about 15 to about 25 wt.%; from about 20 to about 50 wt.%, about 20 to about 45 wt.%, about 20 to about 40 wt.%, about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to about 50 wt.%, about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 to about 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 50 wt.%, about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 50 wt.%, about 31 to about 45 wt.%, about 31 to about 40 wt.%, about 31 to about 37 wt.%; from about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; from about 37 to about 50 wt.%, about 37 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition. [0097] 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.

[0098] The oral care compositions may include one or more abrasive(s), e.g., in an amount from about 5 to about 35 wt.%, based on the total weight of the oral care composition. In some embodiments, the one or more abrasive(s) is present in an amount from about 5 to about 30 wt.%, about 5 to about 25 wt.%, about 5 to about 21 wt.%, about 5 to about 17 wt.%, about 5 to about 14 wt.%, about 5 to about 11 wt.%; from about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%, about 10 to about 21 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 15 to about 35 wt.%, about 15 to about 30 wt.%, about 15 to about 25 wt.%, about 15 to about 21 wt.%, about 15 to about 19 wt.%; from about 18 to about 35 wt.%, about 18 to about 30 wt.%, about 18 to about 25 wt.%, about 18 to about 21 wt.%; from about 21 to about 35 wt.%, about 21 to about 30 wt.%, about 21 to about 25 wt.%; from about 24 to about 35 wt.%, about 24 to about 30 wt.%; from about 27 to about 35 wt.%, about 27 to about 30 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0099] The one or more abrasive(s) may include: silica, silicate, silicon, alumina (including calcined aluminum oxide), aluminosilicates, such as bentonite, zeolite, kaolin, and mica, siliceous or diatomaceous earth, pumice, calcium carbonate, cuttlebone, insoluble phosphates, composite resins, such as melamine resin, phenolic resin, and urea-formaldehyde resin, polycarbonate, silicon carbide, boron carbide, microcrystalline wax, microcrystalline cellulose, including combinations of colloidal microcrystalline cellulose and carboxymethylcellulose, and combinations and derivatives thereof.

[00100] As used herein, “mica” refers to any of a group of hydrous aluminum silicate minerals with plate morphology and/or perfect basal (micaceous) cleavage. Mica can be, for example, sheet mica, scrap mica or flake mica, as exemplified by muscovite, biotite or phlogopite type micas. The abrasive may be selected from insoluble phosphates, such as orthophosphates, polymetaphosphates, pyrophosphates, and a combination thereof. Synthetic silicas include both silica gels and precipitated silicas that are prepared by the neutralization of aqueous silicate solutions with a strong mineral acid. Abrasives comprising silica may be useful in certain embodiments of the oral care composition. In certain embodiments, the oral compositions may comprise a particularly efficacious combination of silica abrasive particle species. For example, the abrasive(s) be selected from high cleaning silica.

[00101] The oral care compositions may include an abrasive system comprising two or more abrasives. For example, an abrasive system 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 abrasives. The abrasives may comprise one or more cleaning abrasive and/or one or more polishing abrasives. As appreciated by one of skill in the art, a single abrasive species typically performs at least some cleaning and polishing simultaneously. However, particles are generally categorized in the art by the predominant effect they have on a target oral surface. Typically, “polishing abrasives” are considered to be relatively small particles having high hardness, where abrasives with relatively large particle sizes and low hardness are considered to be “cleaning abrasives.” In certain embodiments, the oral care composition comprises two or more abrasives comprising silica. In some embodiments, the first abrasive is selected to be a harder and smaller abrasive, e.g., a higher cleaning and/or polishing abrasive, and the second abrasive is a typical cleaning abrasive. In some embodiments, the oral care composition includes at least one polishing abrasive and/or at least one cleaning abrasive. Further examples of abrasives are disclosed in U.S. Patent Publication No. 2007/140986, which is incorporated herein in its entirety by reference for all purposes.

[00102] The oral care composition may include one or more thickening agent(s), e.g., in an amount from about 0.5 to about 20 wt.%, based on the total weight of the oral care composition. For example, the amount of thickening agent(s) in the oral care composition may be from about 0.5 to about 17 wt.%, about 0.5 to about 14 wt.%, about 0.5 to about 11 wt.%, about 0.5 to about 9 wt.%, about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%; from about 1 to about 20 wt.%, about 1 to about 17 wt.%, about 1 to about 14 wt.%, about 1 to about 11 wt.%, about 1 to about 9 wt.%, about 1 to about 7 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%; from about 2 to about 20 wt.%, about 2 to about 17 wt.%, about 2 to about 14 wt.%, about 2 to about 11 wt.%, about 2 to about 9 wt.%, about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 4 to about 20 wt.%, about 4 to about 17 wt.%, about 4 to about 14 wt.%, about

4 to about 11 wt.%, about 4 to about 9 wt.%, about 4 to about 7 wt.%; from about 7 to about 20 wt.%, about 7 to about 17 wt.%, about 7 to about 14 wt.%, about 7 to about 11 wt.%; from about 10 to about 20 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 14 to about 20 wt.%, about 14 to about 17 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[00103] Thickening agents may be referred to as “thickeners” or “viscosity modifying agents.” Thickening agents are typically included to increase the viscosity of the oral care compositions. Nonetheless, in some instances, certain thickening agents provide additional, surprising benefits to the oral care compositions.

[00104] The one or more thickening agent(s) may be selected from a polysaccharide, a silica thickener, an acrylate, a polymer, and a combination of two or more thereof. Examples of polysaccharides include cellulose, carboxymethyl hydroxyethylcellulose, cellulose acetate propionate carboxylate, hydroxyethylcellulose, hydroxyethyl ethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium cellulose sulfate, carrageenan, or a combination of two more thereof. Natural gums such as karaya, gum arabic, and gum tragacanth can also be incorporated. Colloidal magnesium aluminum silicate can also be used as a component of the thickening composition to further improve the composition's texture. Silica thickeners, which form polymeric structures or gels in aqueous media, may be present. Silica thickeners are typically physically and functionally distinct from the particulate silica abrasives as the silica thickeners are very finely divided and provide little or no abrasive action.

[00105] In some embodiments, the one or more thickening agent(s) comprises a polymer selected from polysaccharides, acrylates, polyvinyl pyrrolidone, polyitaconates, an acrylamides, and combinations thereof. Polyvinyl pyrrolidone generally refers to a polymer containing vinylpyrrolidone (e.g., N-vinylpyrrolidone, N-vinyl-2-pyrrolidione, and N-vinyl-2-pyrrolidinone) as a monomeric unit. The monomeric unit may include a polar imide group, four non-polar methylene groups, and a non-polar methane group. The polyvinyl pyrrolidone may have an average molecular weight in the range 5,000 to 100,000, preferably in the range 5,000 to 50,000. Polyvinyl pyrrolidones that have average molecular weights of 10,000, 30,000 and 40,000 may be commercially available from Sigma Chemjeal Co., GAF Corporation and Sigma Chemical Co. The polyvinyl pyrrolidone may form a hydrogen peroxide-polyvinyl pyrrolidone polymer complexes. Examples of polyvinyl pyrrolidone complexes include those disclosed in U.S. Pat. No. 5,1 2,370, the contents of which are incorporated herein by reference. In some embodiments, the polymer comprises crosslinked polyvinyl pyrrolidone (crosslinked PVP). In at least one embodiment, the polymer consists of polyvinyl pyrrolidone.

[00106] Examples of acrylates that may be included in the oral care composition include, e.g., isobutyl acrylate, tert-butyl acrylate, 2-ethylhexyl acrylate, lauryl acrylate, lauryl/tridecyl acrylate, cetyl acrylate, stearyl acrylate, cyclohexyl acrylate, benzyl acrylate, isobornyl acrylate, 2-methoxyethyl acrylate, 2-ethoxyethyl acrylate, 2-ethoxyethoxyethyl acrylate, 2-phenoxyethyl acrylate, tetrahydrofurfuryl acrylate, 2-hydroxyethyl acrylate, 2-hydroxypropyl acrylate, 4- hydroxybutyl acrylate, dimethylaminoethyl acrylate, 1,4-butanediol acrylate, or a combination of two or more thereof. The acrylate may be chosen from diacrylates. In some embodiments, the oral care composition includes a diacrylate chosen from 1,4-butanediol, 1,6-hexanediol, tetraethylene glycol, tripropylene glycol, ethoxylated bisphenol-A, and a combination of two or more thereof. Triacrylate monomers include trimethylol propane, ethoxylated, glyceryl propoxy, and pentaerythritol.

[00107] Acrylates further include methacrylates, such as methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, isobutyl methacrylate, tert-butyl methacrylate, 2-ethylhexyl methacrylate, lauryl methacrylate, alkyl methacrylate, tridecyl methacrylate, stearyl methacrylate, cyclohexyl methacrylate, benzyl methacrylate, isobomyl methacrylate, 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, dimethylaminoethyl methacrylate, diethylaminoethyl methacrylate, glycidyl methacrylate, tetrahydrofurfuryl methacrylate, allyl methacrylate, ethylene glycol methacrylate, triethylene glycol methacrylate, tetraethylene glycol methacrylate, 1,3-butyleneglycol methacrylate, 1,6-hexanediol methacrylate, trimethylopropane methacrylate, ethoxyethyl methacrylate, trifluoroethyl methacrylate, or a combination of two or more thereof.

[00108] Examples of acrylamides include, but are not limited to, acrylamide, methacrylamide and di(Ci-C3o) alkyl-acrylamides and -methacrylamides such as those of methyl, ethyl, propyl, butyl, pentyl, hexyl and the like. N-substituted acrylamides that may be suitable include N-ethylacrylamide, N-tert-butylacrylamide, N-tert-octylacrylamide, N-octylacrylamide, N-decylacrylamide, N-dodecylacrylamide and the corresponding N-substituted methacrylamides. Other N-substituted acrylamides include N-hydroxy methyl acrylamide, N-isopropylacrylamide, N-methylacrylamide, N,N'-methylenebisacrylamide, N-isobutoxymethylacrylamide, N,N- dimethylacrylamide, 2-acrylamido-2-methylpropanesulfonic acid, or a combination of two or more thereof.

[00109] 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 about 0.01 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.

[00110] 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.

[00111] The oral care compositions may include one or more pigments, such as whitening pigments, and/or colorants. In some embodiments, the whitening pigments include particles ranging in size from about 0.1 pm to about 10 pm with a refractive index greater than about 1.2. Suitable whitening agents include, without limitation, titanium dioxide particles, zinc oxide particles, aluminum oxide particles, tin oxide particles, calcium oxide particles, magnesium oxide particles, barium oxide particles, silica particles, zirconium silicate particles, mica particles, talc particles, tetracalcium phosphate particles, amorphous calcium phosphate particles, alphatricalcium phosphate particles, beta-tricalcium phosphate particles, hydroxyapatite particles, calcium carbonate particles, zinc phosphate particles, silicon dioxide particles, zirconium silicate particles, or the like, or mixtures and combinations thereof. [00112] Exemplary colorants can include natural or uncertified colors from natural sources or certified colors for the effect of color. In some embodiments, the colorant can include dyes, certified aluminum lakes or colors derived from a natural source. The colorant may be water-based, oil-based or dry. The colorants can be primary colors, blends of colors or discrete mixtures of colors, such as confetti. The concentrations of the colorant in the oral care composition may be from trace amount to about 0.6 wt.%, from about 0.1 to about 0.5 wt.%, about 0.2 to about 0.4 wt.%, or about 0.15 to about 0.35 wt.%, based on the total weight of the oral care composition.

[00113] 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.

[00114] 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 pH 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.

[00115] The oral care compositions may have a pH from 4.5 to about 10, 4.5 to about 9, 4.5 to about 8, 4.5 to about 7, 4.5 to about 6; from about 5 to about 10, about 5 to about 9, about 5 to about 8, about 5 to about 7, about 5 to about 6; from about 6 to about 10, about 6 to about 9, about 6 to about 8, or about 6 to about 7; from about 7 to about 10, about 7 to about 9, or about 7 to about 8, including any ranges and subranges therebetween.

EXAMPLES

Example 1

[00116] Twelve non-limiting, oral care compositions (Comps. A-L) were prepared to elucidate aspects of the invention. The formulations for Compositions A-L are shown in Table 1. Each of the oral care compositions was then evaluated to assess the stability of soluble zinc. Specifically, Compositions A-L were evaluated to determine the amount of soluble zinc before and throughout a period of thirteen weeks at a temperature of 40°C and a relative humidity of 75%.

The amount of soluble zinc for Compositions A-L is also provided below in Table 1.

Table 1

Table 1 cont.

Example 2

[00117] Compositions K and L were evaluated to assess the effect in the difference of soluble zinc. Specifically, an in-vitro adaptation of the Plaque Glycolysis Model See Donald J. White, et. al., Journal of Clinical Dentistry, #6 Special Issue, Pp 69-78, 1995, which is incorporated herein by reference in its entirety for all purposes) was used to indirectly measure the effect of Compositions K and L on biofilm health. The method for the in vitro evaluation of film health quantifies the glycolytic effects of the respective oral care composition on treated in vitro biofilm pool of both anaerobic and aerobic bacteria. The efficacy of each oral care composition is based on biofilm pH change. A lower average pH change indicates reduction of viable bacteria and greater antibacterial performance of the respective test toothpaste. An untreated cell is used as the negative control.

[00118] Compositions K and L were evaluated after 8 weeks storage at a temperature of 40 °C and relative humidity of 75% to represent the approximate midpoint of the product expiry. It can be seen that Composition K, which had about 70% of the zinc in a soluble state, provided a greater reduction in viable bacteria as compared to the Composition L. Composition L also provided an antibacterial performance, which is believed to be due to soluble tin, but the insoluble Zn in the aged formula appears to be unavailable to augment bacteria control. A summary of the results of the vitro evaluation of film health is provided in Table 2

Table 2

* Means that do not share common letter=Sign. Diff @95% CI, Tukey method, N=3 per cell

** Negative Control, untreated biofilm

Example 3

[00119] Four non-limiting, example compositions (Example Compositions M-P) were prepared in accordance with aspects of the invention. Example Compositions M-P were in the form of mouthwashes and had formulations as shown in Table 3.

Table 3

Example 4

[00120] Example Compositions M-P were evaluated for active stannous ion stability and for clarity of the composition. Specifically, samples of Example Compositions M-P were maintained in an environmentally controlled area having a temperature of 60°C for two weeks. The samples were then briefly removed and evaluated after 1 week and after 2 weeks of being kept in the environmentally controlled area.

Table 4

[00121] Example Compositions M-P were each determined to have compositional clarity and stability. Specifically, Examples Compositions M-P were crystal clear during all evaluations, which indicates that there was no precipitation in the mouthwashes.

Example 5 [00122] Example Compositions M-P were evaluated for antibacterial properties. The antibacterial properties of Example Compositions M-P were evaluated by way of an in vitro antibacterial ATP test. A summary of the results of the evaluations is shown in Table 5. Note, the sample of “test 1/0” had no water added to the composition (the formulation was not diluted in the test preparations), whereas the sample of “test 1/3” contained 1 part of the mouthwash and 3 parts of water.

Table 5

Example 6

[00123] Example Composition M was evaluated to determine if there was staining due to the stannous ion source. The stannous staining evaluation was conducted via an in-vitro test on HAP disks. Two comparative mouth wash compositions (Comparative Compositions 1 and 2) were also evaluated. The formulas for Comparative Compositions 1 and 2 are shown in Table 6.

Table 6

[00124] Specifically, artificial saliva was prepared and dosed at 2 ml amounts into an appropriate number of 15 ml falcon tubes such that a statistical analysis can be performed per number of samples in the study (typically a minimum of 6 tubes per test sample). The tubes with artificial saliva were incubated in an auto shaker instrument for approximately 18 hours at a speed of 45 rpm and temperature of 37° C. The tubes were then removed from the shaker and a HAP disc and 2 ml of representative test MW sample is added to the tube.

[00125] As a negative control, one set of tubes having a HAP disk plus 2ml of DI water (no test mouth wash) was added to the incubated artificial saliva. This step was repeated for every evaluated sample of mouthwash. Each tube, which had a HAP disk, 2 ml of artificial saliva, and 2 ml of test solution, was then gently vortexed for 20 seconds and incubated for 10 min at a speed 45 rpm and 37° C before the HAP disc was removed.

[00126] The HAP discs were immediately measured after being removed from the respective tube on both sides (without drying) using a Spectroshade instrument. This provided a minimal of 12 measurements (from the minimal 6 tubes) for statistical evaluations.

[00127] The “whiteness” of the HAP discs was determined by the below calculation and the average value for each test sample was normalized versus the negative (Art. saliva + water) control to determine the stain prevention efficacy of each test sample.

W* = (a*^A2 + b*^A2 + (L*-100)^A2) l/2 value.

[00128] Unexpectedly, there was no stannous staining observed with Example Composition M, which contained stannous fluoride plus zinc ions. Control Samples I and II contained stannous fluoride but contained no zinc ions in their compositions.

Table 6

[00129] Without being limited to any particular theory, it is believed that the zinc ions enhance anti-stannous staining upon brushing (Ex. M) by neutralizing sulfur compounds and preventing formation of stannic sulfide. It is worth noting that zinc ions need to be in a soluble state to prevent stannic sulfur by-product formation upon brushing.

Claims

CLAIMS What Is Claimed Is:

1. An oral care composition comprising: from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 10 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; and a stannous ion source, wherein all weight percentages are based on the total weight of the oral care composition.

2. The oral care composition according to claim 1 further comprising an amino acid.

3. The oral care composition according to claim 2, wherein the amino acid comprises arginine.

4. The oral care composition according to claim 2 or claim 3, wherein the amino acid is present in an amount from about 1 to about 10 wt.%

5. The oral care composition according to any foregoing claim, wherein the zinc source is present in an amount from about 0.5 to about 8 wt.%, optionally from about 0.5 to about 6 wt.%, optionally from about 0.7 to about 6 wt.%, or optionally from about 0.9 to about 5 wt.%.

6. The oral care composition according to any foregoing claim, wherein the zinc source is selected from zinc phosphate, zinc lactate, zinc oxide, zinc citrate, zinc stearate, zinc gluconate, and a combination of two or more thereof.

7. The oral care composition according to any foregoing claim, wherein the zinc source comprises an insoluble zinc compound.

8. The oral care composition according to any foregoing claim, wherein the potassium nitrate is present in an amount from about 0.5 to about 10 wt.%, optionally about 1 to about 10 wt.%, optionally about 0.5 to about 5 wt.%, or optionally about 1 wt.% to about 5 wt.%.

9. The oral care composition according to any foregoing claim, wherein the sodium citrate and/or an acid thereof, is present in an amount from about 0.5 to about 10 wt.%, optionally from about 1 to about 8 wt.%, or optionally from about 1 to about 5 wt.%.

10. The oral care composition according to any foregoing claim, wherein the oral care composition has a weight ratio of the amount of sodium citrate and/or an acid thereof to the total amount of the zinc source and the potassium nitrate of about 1 :3 to about 3:1, optionally about 1 :2 to about 2:1, about 1:1.5 to about 1.5:1, or about 1:1.2 to about 1.25:1.

11. The oral care composition according to any foregoing claim, wherein the oral care composition has a molar ratio of potassium nitrate to stannous ions, both measured as free ions, of from about 0.5:1 to about 2:1.

12. The oral care composition according to any foregoing claim, wherein the stannous ion source is present in an amount from about 0.05 to about 5 wt.%.

13. The oral care composition according to any of claim 1 to claim 11, wherein the stannous ion source is present in an amount from about 0.1 to about 2 wt.%.

14. The oral care composition according to any foregoing claim, wherein the stannous ion source comprises stannous fluoride.

15. The oral care composition according to any foregoing claim, further comprising a phosphate source.

16. The oral care composition according to claim 15, wherein the phosphate source is present in an amount from about 0.1 to about 7 wt.%.

17. The oral care composition according to claim 15 or claim 16, wherein the phosphate source comprises tetrasodium pyrophosphate.

18. The oral care composition according to any foregoing claim further comprising a fluoride ion source, optionally, in an amount from about 0.1 to about 2 wt.%.

19. The oral care composition according to claim 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.

20. The oral care composition according to any foregoing claim further comprising a polyol, optionally, in an amount from about 5 to about 60 wt.%.

21. The oral care composition according to claim 20, wherein the polyol comprises a glycol, sorbitol, glycerin, inositol, maltitol, mannitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a saccharide, polyoxypropylene-polyoxyethylene block copolymer and a combination of two or more thereof.

22. The oral care composition according to any foregoing claim further comprising an amount of water up to about 10 wt.%.

23. The oral care composition according to one of claim 1 to claim 21 further comprising water present in an amount from about 10 to about 80 wt.%.

24. The oral care composition according to any foregoing claim further comprising an anionic surfactant, optionally, in an amount from about 0.5 to about 10 wt.%.

25. The oral care composition according to claim 24, wherein the anionic surfactant is selected from ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco-sulfate, ammonium coco-sulfate, and a combination of two or more thereof.

26. The oral care composition according to any foregoing claim further comprising a sweetener, optionally, in an amount from about 0.1 to about 7 wt.%.

27. The oral care composition according to claim 26, wherein the sweetener is selected from sucrose, lactose, maltose, sorbitol, xylitol, sodium cyclamate, perillartine, L-aspartyl-L- phenylalanine methyl ester (aspartame), saccharine, and a combination of two or more thereof.

28. An oral care composition comprising: from about 0.1 to about 8 wt.% of a zinc source; from about 0.1 to 5 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; and a stannous ion source, wherein the oral care composition has a weight ratio of the amount of sodium citrate and/or an acid thereof to the total amount of the zinc source and the potassium nitrate of about 1:3 to about 3:1, and wherein all weight percentages are based on the total weight of the oral care composition.

29. The oral care composition according to any foregoing claim further comprising a PVM/MA copolymer.

30. An oral care composition comprising: from about 0.1 to about 8 wt.% of a zinc source; from about 0.5 to about 10 wt.% of potassium nitrate; from about 0.3 to about 10 wt.% sodium citrate and/or an acid thereof; a stannous ion source; and a phosphate source; wherein all weight percentages are based on the total weight of the oral care composition.

31. A method for treating, preventing, or ameliorating a symptom associated with a disease, disorder, or condition of the oral cavity comprising applying an effective amount of a composition according to any foregoing claim to an oral cavity surface of a subject in need thereof.

32. The method according to claim 31, wherein the disease, disorder, or condition of the oral cavity is selected from: gingivitis; caries; hypersensitivity; periodontitis; halitosis; discoloration or staining of the teeth; aberrant biofdm formation; pre-carious lesions of the enamel, demineralization of the teeth; sores or cuts in the oral cavity; acid producing bacteria; plaque accumulation; dry mouth; erosion; cariogenic bacteria; and a combination of two or more thereof.