Oral care compositions

Abstract

Oral care compositions and, preferably, oral care compositions having enhanced stannous ion stability are disclosed herein. In accordance with an aspect of the invention, provided is an oral care composition comprising a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

Description

ORAL CARE COMPOSITIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 693,277, filed on September 11, 2024 and titled ORAL CARE COMPOSITIONS, and from U.S. Provisional Patent Application No. 63 / 565,953, filed on March 15, 2024 and titled STABILIZING AGENTS FOR STANNOUS CONTAINING ORAL CARE COMPOSITIONS, the contents from both are incorporated herein by reference 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.

[0003] 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.

[0004] 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. However, until recently, the popularity of stannous ion sources has been limited by the instability in aqueous solutions. The instability of stannous salts in water is primarily due to the reactivity of the stannous ion (Sn2+). Stannous salts readily hydrolyze at a pH of above 4, resulting in precipitation from solution. It has traditionally been thought that this formation of insoluble stannous salts results in a loss of therapeutic properties. One common way to overcome the stability problems that can be associated with stannous ions is to limit the amount of water in the composition to very low levels, or to use a dual phase system.

[0005] Formulation of oral care compositions comprising stannous fluoride or stannous chloride and potassium salts have been particularly challenging because of stability issues between thesetwo ingredients. U.S. Patent Application no. 6,464,963 discloses that attempts to include both stannous fluoride and potassium salts, such as potassium nitrate, in a single-phase oral composition is hampered by the formation of insoluble stannic salts and compounds such as Sn(OH)2 and SnO2. U.S. Patent Application no. 6,464,963 solves this stability problem by resorting to dualcomponent composition in which one component comprises the potassium salt, along with sodium hydroxide to adjust the pH of the component to 8 to 11, and the second component comprises the stannous fluoride or other stannous salts.

[0006] Another ingredient that can be found in oral care compositions is sodium lauryl sulfate. Sodium lauryl sulfate can be useful as it may increase phase stability (e.g., reduces the likelihood of phase separation) of the oral care composition and generally does not impact the stability of the active ingredients in the oral care composition. In some cases, a surfactant substitution — adding another surfactant to replace sodium lauryl sulfate — has a negative impact on the taste or stability of the active ingredients. Moreover, microbiological stability of the formulation can be negatively impacted by the absence of sodium lauryl sulfate. There are also production benefits to having sodium lauryl sulfate in a given formulation. For example, by replacing sodium lauryl sulfate with other surfactants, the oral care composition may become overly aerated during production and it may be more difficult to clean the equipment after the production process.

[0007] There is an ongoing desire for improved oral care compositions.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The features, and advantages of the invention will be apparent from the following more detailed description of certain embodiments of the invention and as illustrated in the accompanying drawings in which:

[0009] FIG. 1 is a graph of stannous stability of oral care compositions undergoing accelerated aging in accordance with aspects of the invention; and

[0010] FIG. 2 is a graph of stannous stability of additional oral care compositions undergoing accelerated aging in accordance with aspects of the invention.

[0011] It should be understood that the various aspects are not limited to the compositions, and arrangements shown in the figures.BRIEF SUMMARY

[0012] 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.

[0013] Aspects of the invention are directed to oral care compositions and, preferably, oral care compositions having enhanced stannous ion stability. It was surprisingly discovered that certain embodiments of the oral care composition disclosed herein can achieve enhanced stannous ion stability while having a reduced amount, be essentially free of, or free of polyphosphates and / or gluconates. It was conventionally recognized that it is difficult to formulate oral care compositions having stannous compounds and water due to the instability of the stannous compounds. One successful way to overcome the instability issues associated with stannous compounds in the presence of water has been to utilize specific combinations of stannous compounds, nitrate compounds, and polyphosphates in certain amounts and ratios thereof. In accordance with certain aspects of the invention, the oral care composition unexpectedly and desirably maintains about 55% or more of stannous ions after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, even with a reduced amount, being substantially free of, or free of polyphosphates.

[0014] In accordance with an aspect of the invention, provided is an oral care composition comprising a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0015] In accordance with another aspect of the invention, provided is an oral care composition comprising a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and wherein all weight percentages are based on the total weight of the oral care composition out 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates, and wherein the oral care composition has areduction in stannous ions (Sn(IT)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and all weight percentages arc based on the total weight of the oral care composition.

[0016] In accordance with a further aspect of the invention, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates, and wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0017] In yet an additional aspect of the invention, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising: from about 5 to about 10 wt.% of a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0018] A list of non-limiting embodiments in accordance with aspects of the invention is provided below:

[0019] In accordance with an embodiment 1, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0020] In accordance with an embodiment 2, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlledroom at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0021] In accordance with an embodiment 3, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates, and wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0022] In accordance with an embodiment 4, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising: from about 5 to about 10 wt.% of a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0023] According to an embodiment 5, provided is an oral care composition according to any foregoing embodiment, wherein the stannous source comprises a stannous ion source selected from stannous fluoride, stannous chloride, stannous pyrophosphate, and a combination of two or more thereof.

[0024] According to an embodiment 6, provided is an oral care composition according to any foregoing embodiment, wherein the stannous ion source is present in an amount from about 0.1 to about 7 wt.%.

[0025] According to an embodiment 7, provided is an oral care composition according to any foregoing embodiment, wherein the nitrate source comprises a nitrate salt, nitric acid, or a combination thereof.

[0026] According to an embodiment 8, provided is an oral care composition according to embodiment 7, wherein the nitrate salt is selected from selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, and a combination of two or more thereof.

[0027] According to an embodiment 9, provided is an oral care composition according toany foregoing embodiment, wherein the nitrate salt is potassium nitrate.

[0028] According to an embodiment 10, provided is an oral care composition according to any foregoing embodiment, wherein the nitrate source is present in an amount from about 0.1 to about 9 wt.%.

[0029] According to an embodiment 11, provided is an oral care composition according to any foregoing embodiment, wherein the oral care composition comprises a molar ratio of the nitrate source to the stannous source of about 0.5:1 to about 2:1.

[0030] According to an embodiment 12, provided is an oral care composition according to any foregoing embodiment, wherein the polymer system comprises phosphate / acrylate copolymer in an amount from about 0.1 to about 10 wt.%.

[0031] According to an embodiment 13, provided is an oral care composition according to any foregoing embodiment, wherein the polymer system comprises a carbomer, the carbomer being a C10-30 alkyl acrylate cross-polymer present in an amount from about 0.1 to about 10 wt.%.

[0032] According to an embodiment 14, provided is an oral care composition according to any foregoing embodiment, wherein the polymer system further comprises a polymer selected from the group consisting of polyethylene glycols; polyvinyl methyl ether maleic acid copolymers; polysaccharides; copolymers of maleic anhydride with ethyl acrylate; hydroxyethyl methacrylate; N-vinyl-2-pyrollidone; copolymers of acrylic acid with methyl or hydroxyethyl methacrylate, methyl or ethyl acrylate, isobutyl vinyl ether or N-vinyl-2-pyrrolidone;homopolymers of substituted acrylamides and / or homopolymers of unsaturated sulfonic acids and salts thereof; and a combination of two or more thereof.

[0033] According to an embodiment 15, provided is an oral care composition according to any foregoing embodiment, wherein the amount of water is about 50 to about 90 wt.%.

[0034] According to an embodiment 16, provided is an oral care composition according to any one of embodiment 1 to embodiment 14, wherein the amount of water is about 10 to about 37 wt.%.

[0035] According to an embodiment 17, provided is an oral care composition according to any foregoing embodiment further comprising a surfactant selected from an anionic surfactant, an amphoteric surfactant, or a combination of two or more thereof.

[0036] According to an embodiment 18, provided is an oral care composition according toembodiment 17, wherein the surfactant comprises a sulfate based anionic surfactant and an amphoteric surfactant.

[0037] According to an embodiment 19, provided is an oral care composition according to embodiment 18, wherein the amphoteric surfactant consists of betaine surfactants.

[0038] According to an embodiment 20, provided is an oral care composition according to any foregoing embodiment further comprising a polyol, optionally, in an amount from about 40 to about 75 wt.%.

[0039] According to an embodiment 21, provided is an oral care composition according to embodiment 20, wherein the polyol comprises a glycol, sorbitol, glycerin, inositol, maltitol, mannitol, xylitol, propylene glycol, polypropylene glycol, polyethylene glycol, a saccharide, polyoxypropylene-polyoxyethylene block copolymer, and a combination of two or more thereof.

[0040] According to an embodiment 22, provided is an oral care composition according to any foregoing embodiment, wherein the oral care composition is a single-phase composition.

[0041] According to an embodiment 23, provided is an oral care composition according to any foregoing embodiment, wherein the oral care composition is free of gluconates.

[0042] According to an embodiment 24, provided is an oral care composition according to any foregoing embodiment, wherein the oral care composition has a viscosity of about 1980 cP or more, e.g., as measured using a Brookfield viscometer and a number v74 spindle.

[0043] According to an embodiment 25, provided is an oral care composition according to any foregoing embodiment, wherein the pH is from about 6 to about 8.

[0044] According to an embodiment 26, provided is an oral care composition according to any foregoing embodiment, wherein the total amount of the polymer system is from about 1 to about 20 wt.%.

[0045] According to an embodiment 27, provided is an oral care composition according to any foregoing embodiment, wherein the stabilizing component comprises a stabilizing agent selected from: a polymer; a water-soluble alkali metal polyphosphate; a gluconate; and a combination of two or more thereof.

[0046] According to an embodiment 28, provided is an oral care composition according to any foregoing embodiment further comprising a gluconate.

[0047] According to an embodiment 29, provided is an oral care composition according to embodiment 27 or embodiment 28, wherein the gluconate comprises sodium gluconate.

[0048] In accordance with an embodiment 30, provided is a polymer system for use in the manufacture of an oral care composition having an enhanced stannous ion stability, the oral care composition comprising a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; a stannous source; a nitrate source; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.DETAILED DESCRIPTION

[0049] 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.

[0050] 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”.

[0051] 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.

[0052] 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.%.

[0053] 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.

[0054] 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” as referring to a spectrometer or spectroscopy, means Ultraviolet-Visible. The abbreviation “rpm” means revolutions per minute.

[0055] 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.

[0056] “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.

[0057] 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.

[0058] 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 beincluded, 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.

[0059] 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.

[0060] 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.

[0061] 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.”

[0062] Aspects of the invention are directed to oral care compositions and, preferably, oral care compositions having enhanced stannous ion stability. For example, the oral care composition may preferably be formulated such that about 55% or more of the initial amount of stannous ions remains after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C. In some embodiments, the oral care composition preferably exhibits a reduction in stannous ions (Sn(II)) of about 40% or less, about 37% or less, about 34% or less, about 30% or less, about 26% or less, about 22% or less, about 18% or less, or about 15% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C.

[0063] Additionally, the inventors surprisingly discovered that certain embodiments of the oral care composition can achieve the enhanced stannous ion stability (including, c.g., the abovedescribed reductions in stannous ions after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C) while having a reduced amount, being essentially free of, or free of tetrasodium pyrophosphate, sodium tripolyphosphate, and / or polyphosphates. For example, the oral care composition may have about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, or about 0.1 wt.% or less of tetrasodium pyrophosphate and / or sodium tripolyphosphate, based on the total weight of the oral care composition. In certain embodiments, the oral care composition has about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, or about 0.1 wt.% or less of tetrasodium pyrophosphate, based on the total weight of the oral care composition. The oral care composition may be prepared with 0 wt.% of tetrasodium pyrophosphate in some cases. In further embodiments, the oral care composition has about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, or about 0.1 wt.% or less of sodium tripolyphosphate, based on the total weight of the oral care composition. The oral care composition may be prepared with 0 wt.% of sodium tripolyphosphate in some cases.

[0064] In some preferred embodiments, the oral care composition may have about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, or about 0.1 wt.% or less of polyphosphates, based on the total weight of the oral care composition. In at least one preferred embodiment, the oral care composition is prepared with 0 wt.% of polyphosphates. For instance, the oral care composition may be free of polyphosphates.

[0065] The oral care composition, also or alternatively, may have a reduced amount, be essentially free of, or free of gluconates. In some embodiments, the oral care composition has about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, or about 0.1 wt.% or less of gluconates. In at least one preferred embodiment, the oral care composition is prepared with 0 wt.% of gluconates. For instance, the oral care composition may be free of gluconates. In at least one embodiment, the oral care composition is essentially free of or free of polyphosphates and / or gluconates.

[0066] In accordance with an aspect of the invention, provided is an oral care composition comprising a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water,wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0067] In accordance with another aspect of the invention, provided is an oral care composition comprising a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and wherein all weight percentages are based on the total weight of the oral care composition out 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates, and wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and all weight percentages are based on the total weight of the oral care composition.

[0068] In accordance with a further aspect of the invention, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates, and wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0069] In yet an additional aspect of the invention, provided is an oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising: from about 5 to about 10 wt.% of a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

[0070] The oral care compositions may be a dentifrice, such as toothpaste, in the form of a paste or a gel. 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 componentsand / or ingredients of the oral care composition. Tn other embodiments, the oral care composition may include two or more phases, such as two, three, four, or five phases.

[0071] The oral care compositions typically have a stannous source, which may be a stannous ion source. The stannous source may, in some embodiments, consist of stannous ion source(s). The stannous source may be present in the oral care composition in an amount from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. For example, the amount of stannous source present in the oral care composition may be from 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. In at least one embodiment, the oral care composition includes about 0.4 to about 0.5 wt.% of stannous ion source, such as about 0.45 wt.% of stannous ion source.

[0072] The stannous source may be selected from the group consisting of: stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof. The stannous source may comprise stannous fluoride, stannous chloride, stannous acetate, and a combination of two or more thereof. In at least one embodiment, the stannous ion source comprises stannous fluoride.

[0073] 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.

[0074] The oral care compositions typically comprise one or more nitrate source, which may comprise or consist of nitrate ion source(s). The nitrate source(s) may be present in the oral carecomposition 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 nitrate sourcc(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.

[0075] The one or more nitrate source 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 sources include lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, or a combination two or more thereof. In at least one embodiment, the nitrate ion source comprises or consists of potassium nitrate, sodium nitrate, or a combination thereof.

[0076] The oral care compositions may be formulated to have a molar ratio of nitrate ions 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 nitrate ions 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 nitrate ions to stannous ions, both measured as free ions, of about 1:1.

[0077] The oral care compositions typically comprise a polymer system comprising a carbomer, a pho sphatc / acry late copolymer, or a combination thereof. The polymer system may be present in the oral care composition in an amount from about 1 to about 20 wt.%, based on the total weight of the oral care composition. For example, the total amount of the polymer system present in the oral care composition may be from about 1 to about 16 wt.%, about 1 to about 12 wt.%, about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 4 wt.%; from about 3 to about 20 wt.%, about 3 to about 16 wt.%, about 3 to about 12 wt.%, about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%; from about 5 to about 20 wt.%, about 5 to about 16 wt.%, about 5 to about 12 wt.%, about 5 to about 10 wt.%, about 5 to about 8 wt.%; from about 7 to about 20 wt.%, about 7 to about 16 wt.%, about 7 to about 12 wt.%, about 7 to about 10 wt.%; from about 10 to about 20 wt.%, about 10 to about 16 wt.%, about 15 to about 20 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0078] The polymer system may comprise one or more carbomer, such as cross-linked polyacrylic acid and / or a salt thereof. Carbomers are long polymeric chains of acrylic acid. An exemplary structure of a monomer of a carbomer is shown below.

[0079] The carbomer may be selected from Carbopols. For instance, the oral care composition may include, or in some cases exclude, a carbomer selected from Carbopol 2984, Carbopol 934, Carbopol Ultrez 10, Carbopol 940, Carbopol 941, Carbopol 956, Carbopol 981, Carbopol 2020, and a combination of two or more thereof. In certain preferred embodiments, the carbomer is Cio- 30 alkyl acrylate cross-polymer. In at least one embodiment, the carbomer comprises or consists of carbopol ETD NF 2020.

[0080] The total amount of carbomer in the oral care composition may, in some cases, be from about 0.1 to about 10 wt.%, based on the total weight of the oral care composition. For example, the total amount of carbomer present in the oral care composition may be from about 0.1 to about 7 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 1 wt.%; from about 0.5 to about 10 wt.%, about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 toabout 3 wt.%, about 0.5 to about 1 .5 wt.%; from about 0.1 to about 10 wt.%, about 0.1 to about 7 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 1 wt.%; from about 1 to about 10 wt.%, about 1 to about 7 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 7 wt.%, about 2 to about 5 wt.%; from about 4 to about 10 wt.%, about 4 to about 7 wt.%; from about 5 to about 10 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%; from about 6 to about 10 wt.%, about 6 to about 8 wt.%, about 7 to about 10 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0081] In certain embodiments, the total amount of carbomer is from about 4.5 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of carbomer is from about 5 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of carbomer is from about 5 to about 9 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of carbomer is from about 6 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of carbomer is from about 7 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of carbomer is from about 8 to about 10 wt.%, based on the total weight of the oral care composition.

[0082] The polymer system may comprise one or more pho sphate / acry late copolymer. The phosphate / acrylate copolymer may be a carboxylic acid polymer having at least one phosphate moiety, wherein the monomeric unit comprises acrylic acid, methacrylic acid, 2-hydroxyethyl methacrylate, or any combinations thereof having at least one phosphate moiety. For example, the phosphate / acrylate copolymer may comprise or be formed of: from about 5 to about 30 mol.%, optionally about 8 to about 14 mol%, of 2-hydroxyethyl methacrylate phosphate monomer; from about 60 to about 90 mol.%, optionally about 65 to about 85 mol.%, optionally about 71 to about 79 mol., of acrylic acid monomer; from about 5 to about 35 mol.%, optionally about 10 to about 25 mol.%, optionally about 10 to about 19 mol.%, of methacrylic acid monomer. Non-limiting examples of phosphate / acrylate copolymers include those according to Table 1.Table 1

[0083] In some embodiments, the phosphate / acrylate copolymer is a copolymerized product of a mixture of acrylic acid, methacrylic acid, and 2-hydroxyethyl methacrylate phosphates, with the copolymerized product having acrylic acid in a molar percentage of about 70 to about 90 mol.%, about 80 to about 90 mol.%, or about 85 mol.%; methacrylic acid in a molar percentage of about 5 to about 20 mol.%, about 5 to about 15 mol.%, or about 11 mol%; and hydroxyethyl methacrylate phosphates in a molar percentage of about 1 about 10 mol.%, about 2 about 6 mol.%, or about 4 mol.%. In at least one embodiment, the phosphate / acrylate copolymer comprises or consists of DV88O1 polymer (which may sometimes be referred to as Mirapol 8801).

[0084] In some embodiments, the phosphate / acrylate copolymer has a weight average molecular weight of from about 10 to about 500 kDa, such as about 10 to about 200 kDa, about 10 to about 40 kDa, about 15 to about 25 kDa, or about 17 to about 23 kDa. In certain embodiments, the weight average molecular weight is about 10 to about 40 kDa. In other embodiments, the weight average molecular weight is about 17 to about 23 kDa. For example, in some embodiments, the phosphate / acrylate copolymer is a random copolymer that is the copolymerized product of amixture of, e.g., acrylic acid, methacrylic acid, and 2-hydroxyethyl methacrylate in the relative amounts discussed above.

[0085] The total amount of phosphate / acrylate copolymer in the oral care composition may in some cases be from about 0.1 to about 10 wt.%, based on the total weight of the oral care composition. For example, the total amount of phosphate / acrylate copolymer present in the oral care composition may be from about 0.1 to about 7 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 1 wt.%; from about 0.5 to about 10 wt.%, about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 1.5 wt.%; from about 0.1 to about 10 wt.%, about 0.1 to about 7 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 1 wt.%; from about 1 to about 10 wt.%, about 1 to about 7 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 7 wt.%, about 2 to about 5 wt.%; from about 4 to about 10 wt.%, about 4 to about 7 wt.%; from about 6 to about 10 wt.%, about 6 to about 8 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0086] In certain embodiments, the total amount of phosphate / acrylate copolymer is from about 4.5 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of phosphate / acrylate copolymer is from about 5 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of phosphate / acrylate copolymer is from about 5 to about 9 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of phosphate / acrylate copolymer is from about 6 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of phosphate / acrylate copolymer is from about 7 to about 10 wt.%, based on the total weight of the oral care composition. In at least one embodiment, the total amount of phosphate / acrylate copolymer is from about 8 to about 10 wt.%, based on the total weight of the oral care composition.

[0087] The polymer system, in some preferred embodiments, comprises one or more phosphate / acrylate copolymer and one or more Cio-30 alkyl acrylate cross-polymer. In at least one embodiment, the polymer system consists of phosphate / acrylate copolymer(s), C10-30 alkyl acrylate cross-polymer(s), or a combination of two or more thereof.

[0088] The polymer system may include an additional polymer other than carbomers and phosphate / acrylate copolymers, such as those selected from polyethylene glycols; polyvinylmethyl ether maleic acid copolymers; polysaccharides; copolymers of maleic anhydride with ethyl acrylate; hydroxycthyl methacrylate; N-vinyl-2-pyrollidonc; copolymers of acrylic acid with methyl or hydroxyethyl methacrylate, methyl or ethyl acrylate, isobutyl vinyl ether or N-vinyl-2- pyrrolidone; homopolymers of substituted acrylamides and / or homopolymers of unsaturated sulfonic acids and salts thereof; and a combination of two or more thereof. In some embodiments, the additional polymer may be selected from: polyethylene glycols, polyvinyl methyl ether maleic acid copolymers, polysaccharides, (e.g., cellulose derivatives, for example carboxymethyl cellulose, or polysaccharide, gums, for example xanthan gum or carrageenan gum); acidic polymers (e.g., polyacrylate gels); copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer; copolymers of maleic anhydride with ethyl acrylate; hydroxyethyl methacrylate; N-vinyl-2-pyrollidone; copolymers of acrylic acid with, methyl or hydroxyethyl methacrylate, methyl or ethyl acrylate, isobutyl vinyl ether or N- vinyl-2- pyrrolidone; polymerized olefinically or ethylenically unsaturated carboxylic acids containing an activated carbon-to-carbon olefinic double bond and at least one carboxyl group, that is, an acid containing an olefinic double bond which readily functions in polymerization because of its presence in the monomer molecule either in the alpha-beta position with respect to a carboxyl group or as part of a terminal methylene grouping (illustrative of such acids are acrylic, methacrylic, ethacrylic, alpha- chloroacrylic, crotonic, beta-acryloxy propionic, sorbic, alphachlorsorbic, cinnamic, beta-styrylacrylic, muconic, itaconic, citraconic, mesaconic, glutaconic, aconitic, alpha- phenylacrylic, 2-benzyl acrylic, 2-cyclohexylacrylic, angelic, umbellic, fumaric, maleic acids and anhydrides); other olefinic monomers copolymerizable with such carboxylic monomers include vinylacetate, vinyl chloride, dimethyl maleate and the like; homopolymers of substituted acrylamides and / or homopolymers of unsaturated sulfonic, acids and salts thereof, in particular where polymers are based on unsaturated sulfonic acids selected from acrylamidoalkane sulfonic acids such as 2-acrylamide 2 methylpropane sulfonic acid; and a combination of two or more thereof.

[0089] Examples of polysaccharides include carrageenan, 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, xanthan gum, andgum tragacanth, can also be incorporated. In at least one embodiment, the personal care composition comprises one or more polysaccharidc(s) comprising or consisting of carrageenan and / or xanthan gum.

[0090] 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 nonpolar methane group. The polyvinyl pyrrolidone may have an average molecular weight in the range about 5,000 to about 100,000, preferably in the range about 5,000 to about 50,000. The polyvinyl pyrrolidone may have an average molecular weight of about 10,000, about 30,000, about 40,000, or a range thereof.

[0091] 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.

[0092] 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.

[0093] 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, isobornyl 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.

[0094] 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, and 2-acrylamido-2-methylpropanesulfonic acid.

[0095] The oral care composition, in some cases, may include one or more non-polymer thickening agent. The amount of non-polymer thickening agent(s) in the oral care composition may be from 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 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 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 11 wt.%, about 4 to about 9 wt.%, about 4 to about 7 wt.%, from about 7 to about 11 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0096] Examples of non-polymer thickening agents include silica thickeners (e.g., fumed silica) and / or colloidal magnesium aluminum silicate. Colloidal magnesium aluminum silicate can also be used as a component of the thickening composition to further improve the composition's texture. 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. In some embodiments, the non-polymer thickening agents comprise or consist of silica thickeners, such as fumed silica.

[0097] The oral care composition may in some preferrable embodiment, have a viscosity of about 1980 cP or more, e.g., as measured using a Brookfield viscometer and a number v74 spindle. For example, viscosity of the oral care composition may be about 1,980 to about 400,000 cP, about 1,980 to about 382,000 cP, about 1,980 to about 300,000 cP, about 1,980 to about 200,000 cP, about 1,980 to about 100,000 cP, about 1,980 to about 75,000 cP, about 1,980 to about 50,000 cP, about 1,980 to about 37,000 cP, about 1,980 to about 33,000 cP, about 1,980 to about 30,000 cP,about 1 ,980 to about 27,5000 cP, about 1 ,980 to about 25,000 cP, about 1 ,980 to about 15,000 cP; from about 5,000 to about 400,000 cP, about 5,000 to about 382,000 cP, about 5,000 to about 300,000 cP, about 5,000 to about 200,000 cP, about 5,000 to about 100,000 cP, about 5,000 to about 75,000 cP, about 5,000 to about 50,000 cP, about 5,000 to about 25,000 cP, about 5,000 to about 15,000 cP; from about 15,000 to about 400,000 cP, about 15,000 to about 382,000 cP, about 15,000 to about 300,000 cP, about 15,000 to about 200,000 cP, about 15,000 to about 100,000 cP, about 15,000 to about 75,000 cP, about 15,000 to about 50,000 cP, about 15,000 to about 25,000 cP; from about 24,000 to about 400,000 cP, about 24,000 to about 382,000 cP, about 24,000 to about 300,000 cP, about 24,000 to about 200,000 cP, about 24,000 to about 100,000 cP, about 24,000 to about 75,000 cP, about 24,000 to about 50,000 cP; from about 50,000 to about 400,000 cP, about 50,000 to about 382,000 cP, about 50,000 to about 300,000 cP, about 50,000 to about 200,000 cP, about 50,000 to about 100,000 cP, about 50,000 to about 75,000 cP; from about 100,000 to about 400,000 cP, about 100,000 to about 382,000 cP, about 100,000 to about 300,000 cP, about 100,000 to about 200,000 cP; from about 200,000 to about 400,000 cP, about 200,000 to about 382,000 cP, about 200,000 to about 300,000 cP; from about 300,000 to about 400,000 cP, about 300,000 to about 382,000 cP, or any range or subrange thereof, e.g., as measured using a Brookfield viscometer and a number v74 spindle (e.g. at 1 rpm). The oral care composition may have a viscosity within any of the foregoing ranges, when measured using a Brookfield viscometer and a number v74 using a home-built program. In certain embodiments, the oral care composition has a viscosity of about 1,980 to about 37,000 cP, about 1,980 to about 33,000 cP, about 1,980 to about 30,000 cP, about 1,980 to about 27,5000 cP, e.g., as measured using a Brookfield viscometer and a number v74 spindle (e.g., at 1 rpm).

[0098] As mentioned above, certain embodiments of the oral care compositions, which include the polymer systems described herein, unexpectedly achieve enhanced stannous ion stability without the need for polyphosphates, such as tetrasodium pyrophosphate (TSPP) or sodium tripolyphosphate (STPP), or gluconates. For instance, in certain embodiments, the oral care compositions have a reduced amount be free of polyphosphates, such as alkali polyphosphates. In some embodiments, the oral composition may be free of TSPP or STPP.

[0099] In other embodiments, however, the oral care compositions comprise one or more polyphosphate source(s), which may comprise or consists of polyphosphate ion source(s), and / or a gluconate. In some instances, the oral care composition may include one or more polyphosphateion 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 polyphosphate ion sourcc(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.

[0100] The polyphosphate source may comprise a soluble polyphosphate compound, such as a polyphosphate salt. Examples of polyphosphate ion 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 polyphosphate source may be a pyrophosphate salt, such as an alkali metal pyrophosphate salt. In certain embodiments, the alkali metal pyrophosphate is selected from a tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are sodium or potassium. For instance, the polyphosphate source may include tetrasodium pyrophosphat, tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate or a combination of two or more thereof. The polyphosphate source may be chosen from orthophosphates, polymetaphosphates, pyrophosphates, and a combination of two or more thereof. In some instances, the polyphosphate source includes tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), or a combination thereof. In at least one embodiment, the polyphosphate source comprises tetrasodium pyrophosphate. The polyphosphate source, when in the form of a salt, may be in their hydrated and / or unhydrated forms.

[0101] In some embodiments, the polyphosphate is a water-soluble alkali metal polyphosphate selected from a pyrophosphate, a tripolyphosphatc, a tctraphosphatc; a hcxamctaphosphatc; and a combination of two or more thereof. In some embodiments, the oral care composition may include a combination of carboxylic acid polymer and a water soluble alkali metal polyphosphate.

[0102] In some instances, the oral care composition may include one or more gluconate(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 gluconate(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.

[0103] Examples of gluconates include sodium gluconate, potassium gluconate, calcium gluconate, and / or ferrous gluconate. Additionally examples of gluconates, which may be incorporated into or excluded from certain embodiments, include magnesium gluconate, zinc gluconate, copper gluconate, sodium gluconate, stannous gluconate, potassium gluconate, calcium gluconate, ferrous gluconate, and / or a combination of two or more thereof. The gluconate may be in the form of gluconic acid. In one embodiment, the personal care composition comprises gluconic acid or a salt form, such as sodium gluconate, potassium gluconate, and / or calcium gluconate. In a further embodiment, the personal care composition comprises sodium gluconate.

[0104] The oral care composition may include one or more surfactants, e.g., in an amount ranging from about 0.5 to about 8 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include one or more surfactant in an amount from about 0.5 to about 7 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 1 to about 9 wt.%, about1 to about 8 wt.%, about 1 to about 7 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 9 wt.%, about 2 to about 8 wt.%, 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 2.5 to about 9 wt.%, about 2.5 to about 8 wt.%, about 2.5 to about 7 wt.%, about 2.5 to about 6 wt.%, about 2.5 to about 5 wt.%, about 2.5 to about 4 wt.%, about 2.5 to about 3.5 wt.%; from about 3 to about 9 wt.%, about 3 to about 8 wt.%, about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%, about 3 to about 3.5 wt.%; from about 4 to about 9 wt.%, about 4 to about 8 wt.%, about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 9 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from 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.

[0105] The oral care composition may comprise a surfactant system comprising of a plurality of surfactants. The surfactant system may comprise a plurality of 2 or more surfactants, e.g., 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, or 9 or more surfactants. In some instances, the oral care composition includes 2, 3 4, 5, 6, 7, 8, 9, 10 surfactants, or a range formed therefrom. For example, the oral care composition may comprise 2 to 4, 2 or 3, 3 or 4, 4 to 9, 4 to 8, 4 to 7, 4 to 6, 4 or 5; 5 to 9, 5 to 8, 5 to 7, 5 or 6; 6 to 9, 6 to 8, 6 or 7 surfactants.

[0106] The surfactant system may comprise one or more anionic surfactant, one or more cationic surfactant, one or more nonionic surfactants, one or more amphoteric surfactants, one or more zwitterionic surfactants, or combinations of two or more thereof. In further embodiments, the surfactant system consists of one or more anionic surfactant and / or one or more amphoteric surfactant.

[0107] The oral care compositions typically comprise one or more anionic surfactant(s). The one or more anionic surfactant(s) may be in an amount that ranges from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. In some instances, the one or more anionic surfactant(s) is present in the surfactant system 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.%, about0.8 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.

[0108] The one or more anionic surfactant(s) may be selected be selected from sulfate based anionic surfactants and / or from non- sulfate based anionic surfactants, such as sulfonated monoglycerides of fatty acids, isethionates, sarcosinates, taurate, and a combination of two or more thereof. Examples of sulfate based anionic surfactants include ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco-sulfate, ammonium coco- sulfate, and a combination of two or more thereof. In at least one embodiment, the oral care composition includes a sulfate based anionic surfactant, wherein the oral care composition is substantially free of or free of sodium lauryl sulfate and / or sodium lauryl ether sulfate.

[0109] The anionic surfactant(s) may have at least one acyl group, preferably, comprising a carbon chain of 8 to 21 carbons. In some instance, the alkyl group(s) of the anionic surfactant(s) comprise a carbon chain of 8 to 19 carbons, 8 to 17 carbons, 8 to 15 carbons, 8 to 13 carbons, 8 to 11 carbons; 9 to 21 carbons, 9 to 19 carbons, 9 to 17 carbons, 9 to 15 carbons, 9 to 13 carbons, 9 to 11 carbons; 11 to 21 carbons, 11 to 19 carbons, 11 to 17 carbons, 11 to 15 carbons, 11 to 13 carbons; 13 to 21 carbons, 13 to 19 carbons, 13 to 17 carbons, or any range or subrange thereof. The anionic surfactants disclosed herein may be incorporated in a salt form. The salt form of the anionic surfactants may have an alkali metal (e.g., sodium or potassium) and / or ammonium group.

[0110] Non-limiting examples of isethionates include sodium isethionate, sodium cocoyl isethionate, sodium lauroyl methyl isethionate, and sodium cocoyl methyl isethionate. Sulfonated monoglycerides of fatty acids include sodium coconut monoglyceride sulfonates and the like. Examples of acyl sarcosinates include potassium lauroyl sarcosinate, potassium cocoyl sarcosinate, sodium cocoyl sarcosinate, sodium lauroyl sarcosinate, sodium myristoyl sarcosinate, sodium oleoyl sarcosinate, sodium palmitoyl sarcosinate, ammonium lauroyl sarcosinate, and combinations of two or more thereof.

[0111] The anionic surfactant may be selected from taurates having a structure according to the following formula:wherein Ri is a saturated or unsaturated, straight or branched alkyl chain with 6 to 18 carbon atoms, R2 is H or methyl, and M+is H, sodium, or potassium (e.g., sodium methyl cocoyl taurate).

[0112] Additional examples of taurate surfactants include sodium cocoyl taurate, potassium cocoyl taurate, potassium methyl cocoyl taurate, sodium caproyl methyl taurate, sodium cocoyl taurate, sodium lauroyl taurate, sodium methyl cocoyl taurate (SMCT), sodium methyl lauroyl taurate, sodium methyl myristoyl taurate, sodium methyl oleoyl taurate, sodium methyl palmitoyl taurate, sodium methyl stearoyl taurate, and combinations of two or more thereof. In some embodiments, the oral care composition comprises sodium lauroyl methyl taurate (or sodium methyl lauroyl taurate), sodium methyl cocoyl taurate (SMCT), or a combination thereof. In at least one preferred embodiment, the surfactant system comprises sodium methyl cocoyl taurate.

[0113] The surfactant system may comprise one or more amphoteric surfactant(s), e.g., in an amount from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. For example, the one or more amphoteric surfactant(s) may be present in the surfactant system in an amount 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.%; 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.%, about 0.3 to about 1 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.%, about 0.6 to about 1 wt.%; from about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 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 3 to about 4 wt.%, about 4 to about 5 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0114] Amphoteric surfactants are typically characterized by a combination of high surfactant activity, lather forming and mildness. The amphoteric surfactant may comprise a substituent containing 8 to 18 carbon atoms and a substituent containing one or more carboxylate, sulfonate, sulfate, phosphate, or phosphonate. For instance, the amphoteric surfactant may have an alkyl group comprising from 8 to 20 carbon atoms, 8 to 16 carbon atoms, 10 to 16 carbon atoms, or 10to 13 carbon atoms. The amphoteric surfactant(s) may include, but are not limited to, derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain or branched. In some cases, one of the aliphatic substituents of the amphoteric surfactant contains about 8 to about 18 carbon atoms and one of the aliphatic substituents contains an anionic water solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate. The amphoteric surfactants disclosed herein may be present in the oral care composition in a salt form.

[0115] The amphoteric surfactants may include alkyl amphopropionates, betaines, alkyl sultaines, alkyl amphoacetates, or a combination of two or more thereof. Preferably, the oral care composition includes an amphoteric surfactant selected from betaine surfactants (also referred to herein as betaines). Examples of betaine surfactants include, e.g., alkyl betaines, such as coco dimethyl carboxymethyl betaine, lauryl dimethyl carboxy-methyl betaine, lauryl dimethyl alphacarboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl)carboxy methyl betaine, stearyl bis-(2-hydroxypropyl)carboxymethyl betaine, oleyl dimethyl gammacarboxypropyl betaine, lauryl bis-(2-hydroxypropyl)alpha-carboxyethyl betaine. In some instances, the betaine surfactant is selected from coca betaine, cocamidopropyl betaine, lauryl betaine, laurylhydroxy sulfobetaine, lauryldimethyl betaine, behenyl betaine, capryl / capramidopropyl betaine, lauryl hydroxysultaine, stearyl betaine, and a combination of two or more thereof. For instance, the betaine surfactant may be coco betaine, cocamidopropyl betaine, behenyl betaine, capryl / capramidopropyl betaine, lauryl betaine, or a combination of two or more thereof. In at least one embodiment, the oral care composition comprises coco betaine, cocamidopropyl betaine, or a combination thereof.

[0116] The surfactant system may comprise one or more nonionic surfactant(s). The one or more nonionic surfactant(s) may be present in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. In some instances, the one or more nonionic surfactant(s) is present in the surfactant system 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 4wt.%, 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.

[0117] The one or more nonionic surfactant(s) may be selected from glucosides, compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkylaromatic in nature. Examples of glucoside surfactants include decyl glucoside, stearyl glucoside, lauryl glucoside, coco-glucoside, cetearyl glucoside, decyl lauryl glucoside, lauroyl ethyl glucoside, myristoyl ethyl glucoside, oleoyl ethyl glucoside, or a combination of two or more thereof. In some embodiments, the surfactant system includes one or more nonionic surfactant(s) chosen from lauryl glucoside, lauroyl ethyl glucoside, myristoyl ethyl glucoside, oleoyl ethyl glucoside, and a combination of two or more thereof. Additionally or alternatively, the glucoside surfactant may be chosen from polyglucosides, such as alkylpolyglucosides.

[0118] Further examples of nonionic surfactants include poloxamers, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, ethylene oxide condensates of aliphatic alcohols, acids, and esters, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides and mixtures of such materials. Additional examples of nonionic surfactants include polyoxyethylene, polyoxyethylene sorbitan esters, polyoxyl 40 hydrogenated castor oil, fatty alcohol ethoxylates, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, ethylene oxide condensates of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides, or a combination of two or more thereof. In some instances, the nonionic surfactant comprises amine oxides, fatty acid amides, ethoxylated fatty alcohols, block copolymers of polyethylene glycol and polypropylene glycol, glycerol alkyl esters, polyoxyethytene glycol octylphenol ethers, sorbitan alkyl esters, polyoxyethylene glycol sorbitan alkyl esters, or a combination of two or more thereof.

[0119] 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 carecomposition 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 about4 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 about5 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.

[0120] 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.

[0121] In certain embodiments, the oral care composition of the disclosure may contain stannous fluoride and / or a source of fluoride ions or fluorine-providing agents in amounts sufficient to deliver, 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] The oral care compositions may include an abrasive system comprising two or more abrasives. For example, the abrasive system may comprise 2 to 7, 2 to 6, 2 to 5, 2 to 5, or 2 to 4; 3to 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.

[0126] 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 1 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 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.

[0127] In other embodiments, the oral care composition may include polyol(s) in an amount 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.%, about 1 to about 2 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.

[0128] The polyol(s) may be chosen from glycols or compounds with numerous hydroxyl groups. The one or more polyols may be liquid at ambient temperature (25 °C). The polyol may be a humectant. In some preferred embodiments, the polyol(s) comprises glycerin, glycol, inositol, 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.

[0129] 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- 1 ,4-diol, 2-ethyl- 1 ,3-hexanediol, 2-methyl-2,4-pentanediol, caprylylglycol, 1 ,2-hexanediol, 1 ,2-pentanediol, and 4-methyl-l ,2-pentanediol; glycol ethers such as ethylene glycol monomcthyl ether, ethylene glycol monocthyl ether, ethylene glycol monobutyl ether, ethylene glycol monomethyl ether acetate, diethylene glycol monomethyl ether, diethylene glycol monoethyl ether, diethylene glycol mono-n-propyl ether, ethylene glycol mono-iso-propyl ether, diethylene glycol mono-iso-propyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-t-butyl ether, diethylene glycol mono-t-butyl ether, 1 -methyl- 1 -methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-t- butyl ether, propylene glycol mono-n-propyl ether, propylene glycol mono-iso-propyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol mono-iso-propyl ether, sorbitol, sorbitan, triacetin, and a mixture thereof.

[0130] 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.

[0131] In some embodiments, the oral care compositions may include one or more sweeteners. The oral care composition may include caloric sweeteners and / or non-caloric sweeteners. Examples of non-caloric sweeteners include saccharin, for example, sodium saccharin, acesulfame, neotame, cyclamate or sucralose; natural high-intensity sweeteners, such as thaumatin, stevioside or glycyrrhizin; or sugar alcohols, such as sorbitol, xylitol, maltitol and mannitol. Examples of caloric sweeteners include sugars, such as fructose, glucose, sucrose, and high fructose syrups.

[0132] 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.

[0133] 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.

[0134] 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 flavoringagent(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.

[0135] 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.

[0136] The oral care compositions may include one or more colorants. 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.

[0137] 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.

[0138] 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.

[0139] The oral care compositions may have a pH from 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 9, about 6 to about 8, or about 6 to about 7; from about 7 to about 9, or about 7 to about 8, including any ranges and subranges therebetween.

[0140] The oral care compositions may include water in some embodiments. For example, the oral care composition may have water in an amount from about 50 to about 90 wt.%, based on the total weight of the oral care composition. In some embodiments, the amount of water in the oral care composition may be from about 50 to about 75 wt.%, about 50 to about 70 wt.%, about 50 to about 60 wt.%; from about 60 to about 90 wt.%, about 60 to about 75 wt.%, about 60 to about 70 wt.%; from about 70 to about 90 wt.%, about 70 to about 80 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0141] In other embodiments, the water may be present in the oral care composition in an amount from about 10 to about 37 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include water in an amount from about 10 to about 34 wt.%, about 10 to about 31 wt.%, about 10 to about 28 wt.%, about 10 to about 25 wt.%; from 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 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 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 37 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.EXAMPLESExample 1

[0142] Five compositions (Compositions A-E) were prepared in the form of simple solutions. The formulations as well as the viscosities for Compositions A-E are shown in Table 2.Table 2Example 2

[0143] Compositions A-E were evaluated to assess the stability of the stannous ions in each of the respective compositions. Specifically, samples from each of Compositions A-E underwent accelerated aging by being placed in an environmentally controlled space at a temperature of 60°C for 2 weeks. The amount of Sn(II) in the respective samples of Compositions A-E before and after the accelerated aging was determined. The change in the amount of Sn(ll) after accelerated aging for each of Compositions A-E is presented in Table 3.Table 3Example 3

[0144] Six compositions (Compositions F-K) were prepared in the form of simple solutions. The formulations for Compositions F-K are shown in Table 4.Table 4

[0145] Compositions F-K were evaluated to assess the stability of the stannous ions in each of the respective compositions. Similar to the procedures described in Example 2, samples from each of Compositions F-K underwent accelerated aging by being placed in an environmentally controlled space at a temperature of 60°C for 2 weeks. The amount of Sn(II) in the respective samples of Compositions F-K was evaluated periodically over the 2 weeks of accelerated aging. A summary of the change in the amount of Sn(II) during the accelerated aging of Compositions F-K is shown in FIG. 1.Example 4

[0146] Six compositions (Compositions L-Q) were prepared in the form of simple solutions. The formulations for Compositions L-Q are shown in Table 5.Table 5

[0147] Compositions L-Q were evaluated to assess the stability of the stannous ions in each of the respective compositions. Similar to the procedures described in Examples 2 and 3, samples from each of Compositions L-Q underwent accelerated aging by being placed in an environmentally controlled space at a temperature of 60°C for 2 weeks. The amount of Sn(II) in the respective samples of Compositions L-Q was evaluated periodically over the 2 weeks of accelerated aging. A summary of the change in the amount of Sn(II) during the accelerated aging of Compositions F- K is shown in FIG. 2.

Claims

CLAIMSWhat is Claimed is:

1. An oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

2. An oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

3. An oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates, andwherein the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

4. An oral care composition comprising: a stannous source; a nitrate source; a polymer system comprising: from about 5 to about 10 wt.% of a carbomer, a pho sphate / acry late copolymer, or a combination thereof; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

5. The oral care composition according to any foregoing claim, wherein the stannous source is present in an amount from about 0.1 to about 7 wt.%, the stannous source comprising stannous fluoride, stannous chloride, stannous pyrophosphate, or a combination of two or more thereof.

6. The oral care composition according to any foregoing claim, wherein the nitrate source is present in an amount from about 0.1 to about 9 wt.%, the nitrate salt being selected from nitric acid, lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, and a combination of two or more thereof.

7. The oral care composition according to any foregoing claim, wherein the oral care composition comprises a molar ratio of the nitrate source to the stannous source of about 0.5:1 to about 2:1.

8. The oral care composition according to any foregoing claim, wherein the total amount of the polymer system is from about 1 to about 20 wt.%.

9. The oral care composition according to any foregoing claim, wherein the polymer system comprises phosphate / acrylate copolymer in an amount from about 0.1 to about 10 wt.%.

10. The oral care composition according to any foregoing claim, wherein the polymer system comprises a carbomer, the carbomer being a Cio-30 alkyl acrylate cross-polymer present in an amount from about 0.1 to about 10 wt.%.

11. The oral care composition according to any foregoing claim, wherein the polymer system further comprises a polymer selected from the group consisting of a polyethylene glycol; a polyvinyl methyl ether maleic acid copolymer; a polysaccharide; a copolymer of maleic anhydride with ethyl acrylate; a hydroxyethyl methacrylate; a N-vinyl-2-pyrollidone; a copolymer of acrylic acid with methyl or hydroxyethyl methacrylate, a methyl or ethyl acrylate, an isobutyl vinyl ether or N-vinyl-2-pyrrolidone; a homopolymer of substituted acrylamides and / or homopolymers of unsaturated sulfonic acids and salts thereof; and a combination of two or more thereof.

12. The oral care composition according to any foregoing claim, wherein the amount of water is about 50 to about 90 wt.%.

13. The oral care composition according to any one of claim 1 to claim 11, wherein the amount of water is about 10 to about 37 wt.%.

14. The oral care composition according to any foregoing claim, further comprising a surfactant selected from an anionic surfactant, an amphoteric surfactant, or a combination of two or more thereof.

15. The oral care composition according to claim 14, wherein the surfactant comprises a sulfate based anionic surfactant and an amphoteric surfactant.

16. The oral care composition according to any foregoing claim, wherein the oral care composition is a single-phase composition.

17. The oral care composition according to any foregoing claim, wherein the oral care composition has a viscosity of about 1980 cP or more, e.g., as measured using a Brookfield viscometer and a number v74 spindle.

18. The oral care composition according to any foregoing claim, wherein the oral care composition is free of gluconates.

19. The oral care composition according to any foregoing claim, wherein the stabilizing component comprises a stabilizing agent selected from: a polymer; a water-soluble alkali metal polyphosphate; a gluconate; and a combination of two or more thereof.

20. A polymer system for use in the manufacture of an oral care composition having an enhanced stannous ion stability, the oral care composition comprising a polymer system comprising a carbomer, a phosphate / acrylate copolymer, or a combination thereof; a stannous source; a nitrate source; and about 10 wt.% or more of water, wherein the oral care composition is free of polyphosphates and the oral care composition has a reduction in stannous ions (Sn(II)) of about 45% or less after 2 weeks of being kept in an environmentally controlled room at a temperature of 60 °C, and wherein all weight percentages are based on the total weight of the oral care composition.

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