Oral care compositions

Abstract

Oral care compositions comprising a stannous ion source and a red dye are disclosed herein. In accordance with an aspect, provided is an oral care composition comprising a stannous ion source; a nitrate ion source; a phosphate source; and red dye consisting of Red 30.

Description

ORAL CARE COMPOSITIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 612,694, filed December 20, 2023, titled Oral Care Compositions, which is hereby incorporated herein by reference in its entirety for all purposes.BACKGROUND

[0002] Dental erosion involves demineralization and damage to the tooth structure due to acid attack from nonbacterial sources. Erosion typically occurs initially in the enamel and, if unchecked, may proceed to the underlying dentin. Dental 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 or tooth demineralization caused by acid produced from the bacterial degradation of fermentable sugar.

[0003] Oral care compositions that contain stannous ion sources exhibit excellent clinical benefits, particularly in the reduction of gingivitis. Stannous ion sources, such as stannous fluoride and stannous chloride, are well known for use in clinical dentistry with a history of therapeutic benefits over forty years. However, its popularity has been limited by its 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 above 4, resulting in precipitation from solution. Additionally stannous salts readily hydrolyze when in the presence of other common components in oral care compositions.

[0004] It has traditionally been thought that this formation of insoluble stannous salts results in a loss of therapeutic properties.BRIEF SUMMARY

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

[0006] Aspects of the invention are directed to oral care compositions. In accordance with an aspect, provided is an oral care composition comprising a stannous ion source; a nitrate ion source; a phosphate source; and red colorant consisting of Red 30.

[0007] In accordance with another aspect, provided is an oral care composition comprising: from about 0.1 to about 5 wt.% of a stannous ion source; from about 0.1 to about 7 wt.% of a nitrate ion source; from about 0.1 to about 7 wt.% of a phosphate source; red colorant comprising Red 30; from about 1 to about 35 wt.% of an abrasive; and from about 1 to about 60 wt.% of a polyol, wherein the red colorant is stable for 2 weeks at a temperature of 60°C and all weight percentages are based on the total weight of the oral care composition.

[0008] In accordance with a further aspect, provided is an oral care composition consisting of: a stannous ion source; a nitrate ion source; a phosphate source; red colorant comprising of Red 30; optionally, a fluoride ion source; optionally, one or more thickening agent; optionally, one or more abrasive; optionally, one or more surfactant; optionally, one or more polyol; optionally water; and optionally, one or more of a flavoring agent, non-red colorant, sweetener, opacifier, or a combination thereof.

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

[0010] In accordance with an embodiment 1, provided is an oral care composition comprising: a stannous ion source; a nitrate ion source; a phosphate source; and a red colorant consisting of Red 30.

[0011] In accordance with an embodiment 2, provided is the oral care composition according to embodiment 1, wherein the stannous ion source is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and a combination of two or more thereof.

[0012] In accordance with an embodiment 3, provided is the oral care composition according to embodiment 1 or embodiment 2, wherein the stannous ion source consists of stannous fluoride.

[0013] In accordance with an embodiment 4, provided is the oral care composition according to any foregoing embodiment, wherein the stannous ion is present in an amount from about 0.1 toabout 5 wt.%, based on the total weight of the oral care composition.

[0014] In accordance with an embodiment 5, provided is the oral care composition according to any foregoing embodiment, wherein the nitrate ion source is selected from an alkali metal nitrate, an alkaline earth metal nitrate, zinc nitrate, silver nitrate, ammonium nitrate, and a combination of two or more thereof.

[0015] In accordance with an embodiment 6, provided is the oral care composition according to any foregoing embodiment, wherein the nitrate ion source comprises potassium nitrate.

[0016] In accordance with an embodiment 7, provided is the oral care composition according to any foregoing embodiment, wherein the nitrate ion is present in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition.

[0017] In accordance with an embodiment 8, provided is the oral care composition according to any foregoing embodiment, wherein the oral care composition has a molar ratio of nitrate ions to stannous ions, both measured as free ions, of from about 0.5: 1 to about 2:1.

[0018] In accordance with an embodiment 9, provided is the oral care composition according to any foregoing embodiment, wherein phosphate ion source is selected from tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.

[0019] In accordance with an embodiment 10, provided is the oral care composition according to any foregoing embodiment, wherein phosphate ion source comprises tetrasodium pyrophosphate.

[0020] In accordance with an embodiment 11, provided is the oral care composition according to any foregoing embodiment, wherein phosphate ion source is present in an amount of about 0.1 to about 7 wt.%, based on the total weight of the oral care composition.

[0021] In accordance with an embodiment 12, provided is the oral care composition according to any foregoing embodiment further comprising: a zinc source, preferably, present in an amount from about 0.5 to about 8 wt.%, based on the total weight of the oral care composition.

[0022] In accordance with an embodiment 13, provided is the oral care composition according to any foregoing embodiment further comprising: an abrasive, preferably, in an amount from about 1 to about 35 wt.%, based on the total weight of the oral care composition.

[0023] In accordance with an embodiment 14, provided is the oral care composition according toembodiment 13, wherein the abrasive comprising one or more of silica, silicate, silicon, bentonite, zeolite, kaolin, mica, pumice, calcium carbonate, cuttlebone, insoluble phosphates, polycarbonate, microcrystalline wax, microcrystalline cellulose, or a combination of two or more thereof.

[0024] In accordance with an embodiment 15, provided is the oral care composition according to embodiment 13, wherein the abrasive is selected from the group consisting of silica, silicate, silicon, bentonite, zeolite, kaolin, mica, pumice, calcium carbonate, cuttlebone, insoluble phosphates, polycarbonate, microcrystalline wax, microcrystalline cellulose, and a combination of two or more thereof.

[0025] In accordance with an embodiment 16, provided is the oral care composition according to one of embodiment 13 to embodiment 15, wherein the abrasive comprises silica.

[0026] In accordance with an embodiment 17, provided is the oral care composition according to any foregoing embodiment further comprising: a thickening agent, preferably, present in an amount from about 0.5 to about 20 wt.%, based on the total weight of the oral care composition.

[0027] In accordance with an embodiment 18, provided is the oral care composition according to any foregoing embodiment, wherein the Red 30 is selected from free D&C Red 30 dye, the red 30 lake, the D&C Red 30 dye adhered to silica, and a mixture thereof.

[0028] In accordance with an embodiment 19, provided is an oral care composition comprising: from about 0.1 to about 5 wt.% of a stannous ion source; from about 0.1 to about 7 wt.% of a nitrate ion source; from about 0.1 to about 7 wt.% of a phosphate source; red colorant comprising Red 30; from about 1 to about 35 wt.% of an abrasive; and from about 1 to about 60 wt.% of a polyol, wherein the red colorant in the oral care composition is stable for 2 weeks at a temperature of 60°C and all weight percentages are based on the total weight of the oral care composition.

[0029] In accordance with an embodiment 20, provided is an oral care composition consisting of: a stannous ion source; a nitrate ion source; a phosphate source; a red colorant comprising Red 30; optionally, a fluoride ion source; optionally, one or more thickening agent; optionally, one or more abrasive; optionally, one or more surfactant; optionally, one or more polyol; optionally water; and optionally, one or more of a flavoring agent, non-red colorant, sweetener, opacifier, or a combination thereof.

[0030] In accordance with an embodiment 21, provided is the oral care composition according to embodiment 19 or embodiment 20, wherein the red colorant consists of Red 30.

[0031] In accordance with an embodiment 22, provided is the oral care composition according toany foregoing embodiment, wherein the red colorant is present in an amount from about 0.0001 to about 2 wt.%, about 0.001 to about 2 wt.%, or about 0.01 to about 2 wt.%, based on the total weight of the oral care composition.

[0032] In accordance with an embodiment 23, provided is the oral care composition according to any foregoing embodiment, wherein the amount of red colorant is about 0.0001 to about 0.5 wt.%, about 0.001 to about 0.5 wt.%, or about 0.01 to about 0.5 wt.%, based on the total weight of the oral care composition.

[0033] In accordance with an embodiment 24, provided is the oral care composition according to any foregoing embodiment, wherein the amount of red colorant is about 0.0001 to about 0.2 wt.%, about 0.001 to about 0.2 wt.%, or about 0.01 to about 0.2 wt.%, based on the total weight of the oral care composition.

[0034] In accordance with an embodiment 25, provided is the oral care composition according to any foregoing embodiment, wherein the amount of red colorant is about 0.0001 to about 0.1 wt.%, about 0.001 to about 0.1 wt.%, or about 0.01 to about 0.1 wt.%, based on the total weight of the oral care composition.

[0035] In accordance with an embodiment 26, provided is the oral care composition according to any foregoing embodiment, wherein the amount of red colorant is about 0.0001 to about 0.05 wt.%, about 0.001 to about 0.05 wt.%, or about 0.001 to about 0.01 wt.%, based on the total weight of the oral care composition.DETAILED DESCRIPTION

[0036] 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.

[0037] 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 thosechemical 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”.

[0038] 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.

[0039] 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.%.

[0040] 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.

[0041] The abbreviations and symbols as used herein, unless indicated otherwise, take their ordinary meaning. The abbreviation “wt.%” means percent by weight with respect to the oral care composition. The symbol “°” refers to a degree, such as a temperature degree or a degree of an angle. The symbols “h”, “min”, “mL”, “nm”, and “pm” refer to hour, minute, milliliter, nanometer, and micrometer, respectively. The abbreviation “UV-VIS” referring to a spectrometer or spectroscopy, means Ultraviolet-Visible. The abbreviation “rpm” means revolutions per minute.

[0042] 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.

[0043] “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.

[0044] 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.

[0045] The phrases, “a mixture thereof,” “a combination thereof,” or a combination of two or more thereof’ do not require that the mixture include all of A, B, C, D, E, and F (although all of A, B,C, D, E, and F may be included). Rather, it indicates that a mixture of any two or more of A, B, C,D, E, and F can be included. In other words, it is equivalent to the phrase “one or more elements selected from the group consisting of A, B, C, D, E, F, and a mixture of any two or more of A, B, C, D, E, and F.” Likewise, the term “a salt thereof’ also relates to “salts thereof.” Thus, where the disclosure refers to “an element selected from the group consisting of A, B, C, D, E, F, a salt thereof, and a mixture thereof,” it indicates that that one or more of A, B, C, D, and F may be included, one or more of a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included, or a mixture of any two of A, B, C, D, E, F, a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included.

[0046] 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-inci dental 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.

[0047] 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.

[0048] 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.”

[0049] Aspects of the invention are directed to oral care compositions comprising a stannous ion source and a red dye. It was unexpectedly discovered oral care compositions have a stannous ion source in the presence of red dye could be produced while maintaining a high level of stannous ion stability and red dye stability. For instances, oral care compositions comprising a stannous ion source; a nitrate ion source; a phosphate source; and red dye consisting of Red 30, in certain amounts and ratios thereof achieve a high level of stannous ion stability and a high level of red dye stability even when the stannous source is in the presence of a red dye.

[0050] In accordance with an aspect, provided is an oral care composition comprising a stannous ion source; a nitrate ion source; a phosphate source; and red colorant consisting of Red 30.

[0051] In accordance with another aspect, provided is an oral care composition comprising: from about 0.1 to about 5 wt.% of a stannous ion source; from about 0.1 to about 7 wt.% of a nitrate ion source; from about 0.1 to about 7 wt.% of a phosphate source; red colorant comprising Red 30; from about 1 to about 35 wt.% of an abrasive; and from about 1 to about 60 wt.% of a polyol, wherein the red colorant is stable for 2 weeks at a temperature of 60°C and all weight percentages are based on the total weight of the oral care composition.

[0052] In accordance with a further aspect, provided is an oral care composition consisting of: a stannous ion source; a nitrate ion source; a phosphate source; red colorant comprising of Red 30; optionally, a fluoride ion source; optionally, one or more thickening agent; optionally, one or more abrasive; optionally, one or more surfactant; optionally, one or more polyol; optionally water; and optionally, one or more of a flavoring agent, non-red colorant, sweetener, opacifier, or a combination thereof.

[0053] The oral care composition preferably is formulated such that the red colorant is stable for 2 weeks at a temperature of 60°C. For instance, in some embodiments, the oral care composition has a red colorant that is stable for about 2 weeks, about 3 weeks, about 4 four weeks, about 5 weeks, about 6 weeks, or any range or subrange thereof, at a temperature of 60°C.

[0054] The oral care compositions may be in the form of dentifrice, toothpaste, mouthwash, gels, varnishes, leave-on products (e.g., in the form of a gel, varnish, etc.), and / or the like. Suitable components, such as those listed below, may be included or excluded from the formulations for the oral care compositions depending on the specific combination of other ingredients and the form of the oral care compositions. Additionally or alternatively, the oral care compositions may in some embodiments have a single phase, which contains that components and / or ingredients of theoral care composition. Tn other embodiments, the oral care composition may include two or more phases, such as two, three, four, or five phases.

[0055] The oral care compositions typically comprise a stannous source (e.g., a stannous ion source), preferably in an effective amount. The stannous source may comprise or consist of stannous ion sources. The stannous source (e.g., stannous ion 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 (e.g., stannous ion 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, oral care composition includes about 0.4 to about 0.5 wt.% of stannous source, such as about 0.45 wt.% of stannous source.

[0056] 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 source comprises stannous fluoride.

[0057] The oral care composition may include two or more, three or more, four or more, five or more, or six or more of stannous sources (e.g., 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 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.

[0058] The oral care compositions also typically comprises a red colorant. A red colorant, as usedherein, may refer to a dye, a pigment, and / or a certified aluminum lake thereof that provides a red color. The red colorant may be water-based, oil-based, or dry. The red colorant may be synthetic or derived from a natural source (e.g., a natural red colorant). Preferably, the red colorant is red dye 30. For example, the red colorant may be selected from free D&C Red 30 dye, red 30 lake, D&C Red 30 dye adhered to silica, and a mixture thereof. Red dye 30 may be the only red colorant in the oral care composition. In some preferred embodiments, the oral care composition comprises red colorant consisting of red dye 30. For instance, in certain preferred embodiments, red dye 30 is the only red colorant in the oral care composition. In some preferred embodiments, the red colorant consists of free D&C Red 30 dye, red 30 lake, D&C Red 30 dye adhered to silica, and a mixture thereof. Red dye 30 may refer to compounds having a structure according to Formula (I), an acid thereof, and / or a salt thereof:

[0059] The red colorant (preferably, red dye 30) may be present in the oral care composition in an amount up to 2 wt.% or, in some cases, up to 0.2 wt.%, based on the total weight of the oral care composition. In some embodiments, the oral care composition includes red colorant in an amount ranging from about 0.0001 to about 2 wt.%, about 0.0002 to about 2 wt.%, about 0.0005 to about 2 wt.%, about 0.001 to about 2 wt.%, about 0.005 to about 2 wt.%, about 0.01 to about 2 wt.%, about 0.05 to about 2 wt.%, about 0.1 to about 2 wt.%, about 0.3 to about 2 wt.%, about 0.5 to about 2 wt.%, about 0.7 to about 2 wt.%, about 0.9 to about 2 wt.%, about 1.2 to about 2 wt.%; from about 0.0001 to about 1.5 wt.%, about 0.0002 to about 1.5 wt.%, about 0.0005 to about 1.5 wt.%, about 0.001 to about 1.5 wt.%, about 0.005 to about 1.5 wt.%, about 0.01 to about 1.5 wt.%, about 0.05 to about 1.5 wt.%, about 0.1 to about 1.5 wt.%, about 0.3 to about 1.5 wt.%, about 0.5 to about 1.5 wt.%, about 0.7 to about 1.5 wt.%, about 0.9 to about 1.5 wt.%, about 1.2 to about 1.5 wt.%; from about 0.0001 to about 1 wt.%, about 0.0002 to about 1 wt.%, about 0.0005 to about 1 wt.%, about 0.001 to about 1 wt.%, about 0.005 to about 1 wt.%, about 0.01 to about 1 wt.%, about 0.05 to about 1 wt.%, about 0.1 to about 1 wt.%, about 0.3 to about 1 wt.%, about 0.5 to about 1 wt.%, about 0.7 to about 1 wt.%; from about 0.0001 to about 0.5 wt.%, about 0.0002 to about 0.5wt.%, about 0.0005 to about 0.5 wt.%, about 0.001 to about 0.5 wt.%, about 0.0025 to about 0.5 wt.%, about 0.005 to about 0.5 wt.%, about 0.0075 to about 0.5 wt.%, about 0.01 to about 0.5 wt.%, about 0.025 to about 0.5 wt.%, about 0.05 to about 0.5 wt.%, about 0.075 to about 0.5 wt.%, about 0.1 to about 0.5 wt.%, about 0.3 to about 0.5 wt.%; from about 0.0001 to about 0.1 wt.%, about 0.0002 to about 0.1 wt.%, about 0.0005 to about 0.1 wt.%, about 0.001 to about 0.1 wt.%, about 0.0025 to about 0.1 wt.%, about 0.005 to about 0.1 wt.%, about 0.0075 to about 0.1 wt.%, about 0.01 to about 0.1 wt.%, about 0.025 to about 0.1 wt.%, about 0.05 to about 0.1 wt.%, about 0.075 to about 0.1 wt.%; from about 0.0001 to about 0.07 wt.%, about 0.0002 to about 0.07 wt.%, about 0.0005 to about 0.07 wt.%, about 0.001 to about 0.07 wt.%, about 0.0025 to about 0.07 wt.%, about 0.005 to about 0.07 wt.%, about 0.0075 to about 0.07 wt.%, about 0.01 to about 0.07 wt.%, about 0.025 to about 0.07 wt.%; from about 0.0001 to about 0.04 wt.%, about 0.0002 to about 0.04 wt.%, about 0.0005 to about 0.04 wt.%, about 0.001 to about 0.04 wt.%, about 0.0025 to about 0.04 wt.%, about 0.005 to about 0.04 wt.%, about 0.0075 to about 0.04 wt.%, about 0.01 to about 0.04 wt.%; from about 0.0001 to about 0.01 wt.%, about 0.0002 to about 0.01 wt.%, about 0.0005 to about 0.01 wt.%, about 0.001 to about 0.01 wt.%, about 0.0025 to about 0.01 wt.%, about 0.005 to about 0.01 wt.%; from about 0.0001 to about 0.007 wt.%, about 0.0002 to about 0.007 wt.%, about 0.0005 to about 0.007 wt.%, about 0.001 to about 0.007 wt.%, about 0.0025 to about 0.007 wt.%; from about 0.0001 to about 0.003 wt.%, about 0.0002 to about 0.003 wt.%, about 0.0005 to about 0.003 wt.%, about 0.001 to about 0.003 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0060] The oral care compositions typically comprise one or more nitrate source (e.g., a nitrate ion source), preferably present in an effective amount. The nitrate source may comprise or consist of nitrate ion source(s). The nitrate source(s) (e.g., nitrate ion source(s)) may be present in the oral care composition 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 amount of nitrate source present in the oral care composition may be from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; 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 7 wt.%, about 1.2 to about 6 wt.%, about 1.2 to about 5wt.%, 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 7 wt.%, about 1.5 to about 6 wt.%, about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 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 4 to about 5 wt.%; from about 5 to about 7 wt.%, about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0061] The one or more nitrate source (e.g., nitrate ion source) may be in the form of a salt or an ion derived therefrom, including, e.g., nitrate salt is selected from an alkali or alkaline earth metal nitrate. Examples of nitrate ion sources include lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, or a combination of two or more thereof. In at least one embodiment, the nitrate ion source comprises or consists of sodium nitrate, potassium nitrate, and / or a combination thereof. In at least one preferred embodiment, the nitrate source comprises or consists of potassium nitrate.

[0062] 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.

[0063] The oral care compositions typically comprise one or more phosphate source, which may comprises or consist of phosphate ion source(s). The phosphate source (e.g., phosphate ion source(s)) is preferably present in an effective amount. In some instances, the oral care composition may include one or more phosphate source (e.g., phosphate ion source(s)) in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the one or more phosphate source (e.g., phosphate ion source(s)) may be present in the oral carecomposition 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.

[0064] The phosphate source may preferably comprise a soluble phosphate compound, such as a phosphate salt. The phosphate source may be a phosphate ion source. Examples of phosphate 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 phosphate source may be a pyrophosphate salt, such as an alkali metal pyrophosphate salt. In certain embodiments, the alkali metal pyrophosphate is selected from a tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are sodium or potassium. For instance, the phosphate source may include tetrasodium pyrophosphate (TSPP), tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate or a combination of two or more thereof. The phosphate source may be chosen from orthophosphates, polymetaphosphates, pyrophosphates, and a combination of two or more thereof. In some preferred instances, the phosphate source includes tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), or a combination thereof. In at least one preferred embodiment, the phosphate source comprises tetrasodium pyrophosphate. The phosphate source, when in the form of a salt, maybe in their hydrated and / or unhydrated forms.

[0065] Additionally or alternatively, the oral care composition may include one or more anticalculus agent. Examples of anti-calculus agents include, but are not limited to: phosphates andpolyphosphates, poly ami nopropane sulfonic acid (AM PS), polyolefin sulfonates, polyolefin phosphates, diphosphonates such as azacycloalkane-2, 2-diphosphonates (e.g., azacycloheptane- 2,2-diphosphonic acid), N-m ethyl azacyclopentane-2,3-diphosphonic acid, ethane- 1 -hydroxy- 1,1- diphosphonic acid (EHDP) and ethane- 1 -amino- 1,1 -diphosphonate, phosphonoalkane carboxylic acids and. Useful inorganic phosphate and polyphosphate salts include monobasic, dibasic and tribasic sodium phosphates. Soluble pyrophosphates, such as those disclosed herein may be useful anticalculus agents. The pyrophosphate salts can be any of the alkali metal pyrophosphate salts. For example, the anti-calculus agents may comprise or consist of tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), and / or a combination thereof.

[0066] The oral care composition may include the anti-calculus agents in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the anticalculus agent(s) may be present in the oral care composition in an amount from about 0.1 to about6 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 about7 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.

[0067] The oral care compositions may include a fluoride ion source. The fluoride ion source may be present in an effective amount. In some cases, the fluoride ion source is present in the oral care composition in an amount of about 0.01 to about 5 wt.%, based on the total weight of the oral care composition. For example, the fluoride ion source is present in an amount of about 0.01 to about 5 wt.%, about 0.01 to about 4 wt.%, about 0.01 to about 3 wt.%, about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%; from about 0.05 to about 5 wt.%, about 0.05 to about 4 wt.%, about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%; from about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0068] The 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 fluor ozirconate, 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.

[0069] In certain embodiments, the oral care composition of the disclosure may contain stannous fluoride and a source of fluoride ions or fluorine-providing agents in amounts sufficient to 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.

[0070] The oral care composition also typically include a zinc source. The zinc source may be a zinc ion source. The zinc source may be present in the oral care composition in an amount from about 0.1 to about 8 wt.%, based on the total weight of the oral care composition. For example, the amount of zinc source present in the oral care composition may be from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.3 to about 8 wt.%, about 0.3 to about 6wt.%, 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 8 wt.%, about 0.6 to about 6 wt.%, 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 8 wt.%, about 0.9 to about 6 wt.%, about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 8 wt.%, about 1.2 to about 6 wt.%, about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 8 wt.%, about 1.5 to about 6 wt.%, about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0071] The zinc source may be in the form of a salt. For example, the zinc source may comprise one or more zinc salt(s) chosen from zinc sulfate, zinc chloride, zinc acetate, zinc phenol sulfonate, zinc borate, zinc bromide, zinc nitrate, zinc glycerophosphate, zinc benzoate, zinc carbonate, zinc carnosine, zinc citrate, zinc hexafluorosilicate, zinc diacetate trihydrate, zinc oxide, zinc peroxide, zinc salicylate, zinc silicate, zinc stannate, zinc tannate, zinc titanate, zinc tetrafluoroborate, zinc gluconate, zinc lactate, zinc glycinate, zinc phosphate, and a combination of two or more thereof. In some embodiments, the zinc source is selected from zinc citrate, zinc oxide, zinc phosphate, zinc lactate, zinc sulfate, zinc silicate, zinc gluconate, and a combination of two or more thereof. In at least one embodiment, the zinc source comprises zinc phosphate, zinc oxide, zinc citrate, or a combination thereof.

[0072] The oral care composition may include two or more, three or more, four or more, five or more, or six or more zinc sources. For instance, oral care composition may comprise 2 to 7, 2 to 6, 2 to 5, 2 to 5, or 2 to 4; 3 to 7, 3 to 6, 2 to 5, or 3 to 5 zinc sources. In some embodiments, the oral care composition comprises zinc oxide, zinc citrate, zinc phosphate, or a combination of two or more thereof. In at least one preferred embodiment, the oral care composition comprises zinc phosphate.

[0073] The oral care compositions may comprise one or more surfactant(s) in an amount that may vary, but typically may be from about 0.1 to about 8 wt.%, based on the total weight of the oral care composition. For example, the amount of one or more surfactant(s) present in the oral carecomposition may be from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.3 to about 8 wt.%, about 0.3 to about 6 wt.%, about 0.3 to about 5 wt.%, about 0.3 to about4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 8 wt.%, about 0.6 to about 6 wt.%, about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 8 wt.%, about 0.9 to about 6 wt.%, about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 8 wt.%, about 1.2 to about 6 wt.%, about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 8 wt.%, about 1.5 to about 6 wt.%, about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition

[0074] The one or more surfactant(s) may comprise an anionic surfactant, such as those selected from water-soluble, water-miscible salts of alkyl sulfate, such as those having from 8 to 20 carbon atoms in the alkyl radical (e.g., sodium alkyl sulfate) and the water-soluble or water-miscible salts of sulfonated monoglycerides of fatty acids having from 8 to 20 carbon atoms. Examples of anionic surfactants, which may be included or excluded in some instances from the oral care composition, include sodium lauryl sulfate, sodium lauryl ether sulfate, potassium lauryl sulfate, potassium lauryl ether sulfate, ammonia lauryl sulfate, ammonia lauryl ether sulfate, sodium lauryl sarcosinate, sodium cocoyl methyl taurate, sodium monoglyceride sulfate, sodium cetaryl sulfate, potassium cocoyl glycinate, sodium lauryl phosphate, sodium lauryl lactylate, sodium lauryl sulfoacetate, sodium lauryl glutamate, sodium lauryl isethionate, sodium laureth carboxylate, sodium dodecyl benzenesulfonate, and combinations thereof. In one embodiment, sodium lauryl sulfate is a preferred surfactant. Additional anionic surfactants are disclosed in U.S. Patent No. 3,959,458, which is incorporated herein by reference in its entirety for all purposes.

[0075] The anionic surfactant may comprise of consist of non-sulfate based anionic surfactants. Examples of non-sulfate based anionic surfactants include isethionate surfactants, taurate surfactants, sarcosinate surfactants, sulfonated monoglycerides of fatty acid surfactants, or acombination of two or more thereof. 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.

[0076] The anionic surfactant may be selected from taurates having a structure according to the following formula:

[0077] 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).

[0078] Further anionic surfactants of mention include long chain alkyl (C6-C22) materials, such as long chain alkyl sulfates, long chain alkyl sulfonates, long chain alkyl phosphates, long chain alkyl ether sulfates, long chain alkyl alpha olefin sulfonates, long chain alkyl taurates, long chain alkyl isethionates (SCI), long chain alkyl glyceryl ether sulfonates (AGES), sulfosuccinates and the like. These anionic surfactants can be alkoxylated, e.g., ethoxylated, although alkoxylation is not required.

[0079] The oral care composition may include a surfactant other than an anionic surfactant, such as a nonionic surfactant, amphoteric surfactant, or cationic surfactant. Examples of amphoteric surfactants include betaine surfactants, such as cocamidopropyl betaine, lauryl dimethyl betaine (sold under the trade name Macat LB), cetyl dimethyl betaine, and cocoamphodiacetate. Examples of nonionic surfactants, which may be included or excluded from the oral are composition, include 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.

[0080] The oral care composition may include one or more thickening agent(s), e.g., in an amount from about 0.5 to about 20 wt.%, based on the total weight of the oral care composition. For example, the amount of thickening agent(s) in the oral care composition may be from about 0.5 to about 17 wt.%, about 0.5 to about 14 wt.%, about 0.5 to about 11 wt.%, about 0.5 to about 9 wt.%,about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%; from about 1 to about 20 wt.%, about 1 to about 17 wt.%, about 1 to about 14 wt.%, about 1 to about 11 wt.%, about 1 to about 9 wt.%, about 1 to about 7 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%; from about 2 to about 20 wt.%, about 2 to about 17 wt.%, about 2 to about 14 wt.%, about 2 to about 11 wt.%, about 2 to about 9 wt.%, about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 4 to about 20 wt.%, about 4 to about 17 wt.%, about 4 to about 14 wt.%, about 4 to about 11 wt.%, about 4 to about 9 wt.%, about 4 to about 7 wt.%; from about 7 to about 20 wt.%, about 7 to about 17 wt.%, about 7 to about 14 wt.%, about 7 to about 11 wt.%; from about 10 to about 20 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 14 to about 20 wt.%, about 14 to about 17 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0081] Thickening agents may be referred to as “thickeners” or “viscosity modifying agents.” Thickening agents are typically included to increase the viscosity of the oral care compositions. Nonetheless, in some instances, certain thickening agents provide additional, surprising benefits to the oral care compositions.

[0082] The one or more thickening agent(s) may be selected from a polysaccharide, a silica thickener, an acrylate, a polymer, and a combination of two or more thereof. Examples of polysaccharides include cellulose, carboxymethyl hydroxyethylcellulose, cellulose acetate propionate carboxylate, hydroxy ethyl cellulose, hydroxyethyl ethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium cellulose sulfate, carrageenan, or a combination of two more thereof. Natural gums such as xanthan gum, karaya, gum arabic, and gum tragacanth can also be incorporated. Colloidal magnesium aluminum silicate can also be used as a component of the thickening composition to further improve the composition's texture. Silica thickeners, which form polymeric structures or gels in aqueous media, may be present. Silica thickeners are typically physically and functionally distinct from the particulate silica abrasives as the silica thickeners are very finely divided and provide little or no abrasive action. In at least one preferred embodiment, the one or more thickening agent(s) comprise or consist of xanthan gum, silica thickener, and / or a combination of two or more thereof.

[0083] In some embodiments, the one or more thickening agent(s) comprises a polymer selected from polysaccharides, acrylates, polyvinyl pyrrolidone, polyitaconates, an acrylamides, and combinations thereof. Polyvinyl pyrrolidone generally refers to a polymer containing vinylpyrrolidone (e.g., N-vinylpyrrolidone, N-vinyl-2-pyrrolidione, and N-vinyl-2-pyrrolidinone) as a monomeric unit. The monomeric unit may include a polar imide group, four non-polar methylene groups, and a non-polar methane group. The polyvinyl pyrrolidone may have an average molecular weight in the range 5,000 to 100,000, preferably in the range 5,000 to 50,000. The polyvinyl pyrrolidones may have average molecular weights of 10,000, 30,000 and 40,000. The polyvinyl pyrrolidone may form a hydrogen peroxide-polyvinyl pyrrolidone polymer complexes. Examples of polyvinyl pyrrolidone complexes include those disclosed in U.S. Patent No. 5,122,370, the contents of which are incorporated herein by reference in its entirety for all purposes. In some embodiments, the polymer comprises crosslinked polyvinyl pyrrolidone (crosslinked PVP). In at least one embodiment, the polymer consists of polyvinyl pyrrolidone.

[0084] 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 / tri decyl 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.

[0085] 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.

[0086] 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 glycolmethacrylate, triethylene glycol methacrylate, tetraethylene glycol methacrylate, 1,3- butyleneglycol methacrylate, 1,6-hexanediol methacrylate, trimethylopropane methacrylate, ethoxy ethyl methacrylate, trifluoroethyl methacrylate, or a combination of two or more thereof.

[0087] 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-butyl acrylamide, N-tert-octylacrylamide, N-octyl acrylamide, N- decyl acrylamide, N-dodecylacrylamide and the corresponding N-substituted methacrylamides. Other N-substituted acrylamides include N-hydroxymethyl acrylamide, N-isopropylacrylamide, N-methylacrylamide, N,N' -methylenebisacrylamide, N-isobutoxymethylacrylamide, N,N- dimethylacrylamide, and 2-acrylamido-2 -methylpropanesulfonic acid.

[0088] 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.

[0089] In other embodiments, the oral care composition may include polyol(s) in an amount from about 0.5 to about 17 wt.%, about 0.5 to about 14 wt.%, about 0.5 to about 11 wt.%, about 0.5 to about 9 wt.%, about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%,about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 20 wt.%, about 1 to about 17 wt.%, about 1 to about 14 wt.%, about 1 to about 11 wt.%, about 1 to about 9 wt.%, about 1 to about 7 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, 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.

[0090] 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.

[0091] In some cases, the oral care composition includes one or more polyol selected from the group consisting of C2-C32 polyols. The one or more polyols may have from 2 to 32 carbon atoms, from 3 to 16 carbon atoms, or from 3 to 12 carbon atoms. For example, the oral care composition may comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, or a combination of two or more thereof. Additional, non-limiting examples of polyols that may, optionally, be included in the oral care include and / or may be chosen from alkanediols such as glycerin, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-butene-l,4-diol, 2-ethyl-l,3-hexanediol, 2-methyl-2,4-pentanediol, caprylylglycol, 1,2-hexanediol, 1,2-pentanediol, and 4-methyl-l ,2-pentanediol; glycol ethers such as ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, ethylene glycol monomethyl ether acetate, diethylene glycol monomethyl ether, diethylene glycol monoethyl ether, diethylene glycol mono-n-propyl ether, ethylene glycol mono-iso-propyl ether, diethylene glycol mono-iso-propyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-t-butyl ether, diethylene glycol mono-t-butyl ether, 1-methyl-l-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.

[0092] 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.

[0093] The oral care compositions may include one or more abrasive(s), e.g., in an amount from about 1 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 1 to about 30 wt.%, about 1 to about 25 wt.%, about 1 to about 21 wt.%, about 1 to about 17 wt.%, about 1 to about 14 wt.%, about 1 to about 11 wt.%; 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 10to 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.

[0094] 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. For example, the one or more abrasive may be selected from silicas including gels and precipitates, calcium carbonate, dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate, insoluble sodium polymetaphosphate, hydrated alumina, resinous abrasive materials such as particulate condensation products of urea and formaldehyde, and combinations thereof.

[0095] 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.

[0096] The oral care compositions may include an abrasive system comprising two or more abrasives. For example, an abrasive system comprise 2 to 7, 2 to 6, 2 to 5, 2 to 5, or 2 to 4; 3 to 7, 3 to 6, 2 to 5, or 3 to 5 abrasives. The abrasives may comprise one or more cleaning abrasive and / orone 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 by reference in its entirety by reference for all purposes.

[0097] In some cases, the abrasive is selected from silica, silicate, silicon, bentonite, zeolite, kaolin, mica, pumice, calcium carbonate, cuttlebone, insoluble phosphates, polycarbonate, microcrystalline wax, microcrystalline cellulose, and a combination of two or more thereof. The oral care composition may have abrasive(s) consisting of silica, silicate, silicon, bentonite, zeolite, kaolin, mica, pumice, calcium carbonate, cuttlebone, insoluble phosphates, polycarbonate, microcrystalline wax, microcrystalline cellulose, and a combination of two or more thereof in certain embodiments. In at least one embodiment, the abrasive is silica.

[0098] 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.

[0099] 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.%, about1 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.

[0100] 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.

[0101] The oral care compositions of the present disclosure may include a flavoring agent. The flavoring agent is typically incorporated in the oral care composition at a concentration of about 0.01 to about 3 wt.% by weight of the oral care composition. For example, the amount of flavoring agent(s) present in the oral care composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about1 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.

[0102] 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.

[0103] The oral care compositions may include one or more colorants other than a red colorant. Exemplary colorants other than red colorant (also referred to herein as non-red colorants) can include natural or uncertified colors from natural sources or certified colors for the effect of color. In some embodiments, the colorant other than the red colorant can include non-red dyes, non-red certified aluminum lakes, or non-red colors derived from a natural source. The colorant other than red colorant may be water-based, oil-based or dry. The colorants other than red colorant can be primary colors, blends of colors or discrete mixtures of colors, such as confetti. The concentrations of the colorant other than red 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.

[0104] The oral care composition may include an opacifier. Non-limiting examples of opacifiers include, without limitation, titanium dioxide particles, zinc oxide particles, aluminum oxide particles, tin oxide particles, calcium oxide particles, magnesium oxide particles, barium oxide particles, silica particles, zirconium silicate particles, mica particles, talc particles, tetracalcium phosphate particles, amorphous calcium phosphate particles, alpha-tricalcium phosphate particles, beta-tricalcium phosphate particles, hydroxyapatite particles, calcium carbonate particles, zinc phosphate particles, silicon dioxide particles, zirconium silicate particles, or the like, or mixtures and combinations thereof. The amount of opacifier(s) present 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.

[0105] 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.

[0106] 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.

[0107] The oral care compositions may have a pH from 4.5 to about 10, 4.5 to about 9, 4.5 to about 8, 4.5 to about 7, 4.5 to about 6; from about 5 to about 10, about 5 to about 9, about 5 to about 8, about 5 to about 7, about 5 to about 6; from about 6 to about 10, about 6 to about 9, about 6 to about 8, or about 6 to about 7; from about 7 to about 10, about 7 to about 9, or about 7 to about 8, including any ranges and subranges therebetween.

[0108] The oral care compositions typically comprise an amount of water. The amount of water present in the oral care compositions may be about 5 to about 64 wt.% of water, based on the total weight of the oral care composition. For example, the amount of water in the oral care composition may be from about 5 to about 60 wt.%, about 5 to about 56 wt.%, about 5 to about 50 wt.%, about 5 to about 45 wt.%, about 5 to about 41 wt.%, about 5 to about 37 wt.%, about 5 to about 33 wt.%; from about 10 to about 64 wt.%, about 10 to about 56 wt.%, about 10 to about 50 wt.%, about 10 to about 45 wt.%, about 10 to about 41 wt.%, about 10 to about 37 wt.%, about 10 to about 33 wt.%; from about 14 to about 64 wt.%, about 14 to about 56 wt.%, about 14 to about 50 wt.%, about 14 to about 45 wt.%, about 14 to about 41 wt.%, about 14 to about 37 wt.%, about 14 to about 33 wt.%; from about 19 to about 64 wt.%, about 19 to about 56 wt.%, about 19 to about 50 wt.%, about 19 to about 45 wt.%, about 19 to about 41 wt.%, about 19 to about 39 wt.%, about 19 to about 37 wt.%, about 19 to about 35 wt.%, about 19 to about 33 wt.%; from about 24 to about64 wt.%, about 24 to about 60 wt.%, about 24 to about 56 wt.%, about 24 to about 53 wt.%, about 24 to about 50 wt.%, about 24 to about 47 wt.%, about 24 to about 45 wt.%, about 24 to about 43 wt.%, about 24 to about 41 wt.%, about 24 to about 39 wt.%, about 24 to about 37 wt.%, about 24 to about 35 wt.%, about 24 to about 33 wt.%; from about 29 to about 64 wt.%, about 29 to about 60 wt.%, about 29 to about 56 wt.%, about 29 to about 53 wt.%, about 29 to about 50 wt.%, about 29 to about 47 wt.%, about 29 to about 45 wt.%, about 29 to about 43 wt.%, about 29 to about 41 wt.%, about 29 to about 39 wt.%, about 29 to about 37 wt.%; from about 32 to about 64 wt.%, about 32 to about 60 wt.%, about 32 to about 56 wt.%, about 32 to about 53 wt.%, about 32 to about 50 wt.%, about 32 to about 47 wt.%, about 32 to about 45 wt.%, about 32 to about 43 wt.%, about 32 to about 41 wt.%, about 32 to about 39 wt.%; from about 34 to about 64 wt.%, about 34 to about 60 wt.%, about 34 to about 56 wt.%, about 34 to about 53 wt.%, about 34 to about 50 wt.%, about 34 to about 47 wt.%, about 34 to about 45 wt.%, about 34 to about 43 wt.%, about 34 to about 41 wt.%; from about 39 to about 64 wt.%, about 39 to about 60 wt.%, about 39 to about 56 wt.%, about 39 to about 53 wt.%, about 39 to about 50 wt.%, about 39 to about 47 wt.%, about 39 to about 45 wt.%, about 39 to about 43 wt.% or any range or subrange thereof, based on the total weight of the oral care composition.EXAMPLESExample 1

[0109] Four non-limiting, example compositions (Example Compositions A-D) were prepared in the form of a dentifrice in accordance with aspects of the invention. The formulations for preparing Example Compositions A-D are shown in Table 1.Table 1Example 2

[0110] Two non-limiting, example compositions (Example Compositions E and F) were prepared in accordance with aspects of the invention. Two comparative compositions (Comparative Compositions 1 and 2) were prepared having an equivalent amount of red dye but having either red dye 40 and or red dye 3 instead of red dye 30. Example Compositions E and F as well as Comparative Compositions 1 and 2 were all in the form of dentifrices and were prepared according to the formulations shown in Table 2.Table 2

[0111] Example Composition E, Example Composition F, Comparative Composition 1, andComparative Composition 2 were evaluated for aging stability. Specifically, samples of Example Compositions E and F and Comparative Compositions 1 and 2 were placed in a controlled environment having a temperature of 60 °C and evaluated after 1 week and after 2 weeks. The samples of Example Compositions E and F passed the accelerated aging stability evaluation after both 1 week and 2 weeks under a temperature 60 °C. Comparative Compositions 1 and 2 each failed both the 1 week and 2 week accelerated aging evaluations at a temperature 60 °C. A sample of Comparative Composition 2, which contained red dye 3 exhibited significant fading over a single night at room temperature.

Claims

CLAIMSWhat Is Claimed Is:

1. An oral care composition comprising: a stannous ion source; a nitrate ion source; a phosphate source; and a red colorant consisting of Red 30.

2. The oral care composition according to claim 1, wherein the stannous ion source is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and a combination of two or more thereof.

3. The oral care composition according to claim 1 or claim 2, wherein the stannous ion source consists of stannous fluoride.

4. The oral care composition according to any foregoing claim, wherein the stannous ion is present in an amount from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition.

5. The oral care composition according to any foregoing claim, wherein the nitrate ion source is selected from an alkali metal nitrate, an alkaline earth metal nitrate, zinc nitrate, silver nitrate, ammonium nitrate, and a combination of two or more thereof.

6. The oral care composition according to any foregoing claim, wherein the nitrate ion source comprises potassium nitrate.

7. The oral care composition according to any foregoing claim, wherein the nitrate ion is present in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition.

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

9. The oral care composition according to any foregoing claim, wherein phosphate ion source is selected from tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.

10. The oral care composition according to any foregoing claim, wherein phosphate ion source comprises tetrasodium pyrophosphate.

11. The oral care composition according to any foregoing claim, wherein phosphate ion source is present in an amount of about 0.1 to about 7 wt.%, based on the total weight of the oral care composition.

12. The oral care composition according to any foregoing claim further comprising: a zinc source, preferably, present in an amount from about 0.5 to about 8 wt.%, based on the total weight of the oral care composition.

13. The oral care composition according to any foregoing claim further comprising: an abrasive, preferably, in an amount from about 1 to about 35 wt.%, based on the total weight of the oral care composition.

14. The oral care composition according to claim 13, wherein the abrasive comprising one or more of silica, silicate, silicon, bentonite, zeolite, kaolin, mica, pumice, calcium carbonate, cuttlebone, insoluble phosphates, polycarbonate, microcrystalline wax, microcrystalline cellulose, or a combination of two or more thereof.

15. The oral care composition according to claim 13, wherein the abrasive is selected from the group consisting of silica, silicate, silicon, bentonite, zeolite, kaolin, mica, pumice, calcium carbonate, cuttlebone, insoluble phosphates, polycarbonate, microcrystalline wax, microcrystalline cellulose, and a combination of two or more thereof.

16. The oral care composition according to one of claim 13 to claim 15, wherein the abrasive comprises silica.

17. The oral care composition according to any foregoing claim further comprising: a thickening agent, preferably, present in an amount from about 0.5 to about 20 wt.%, based on the total weight of the oral care composition.

18. The oral care composition according to any foregoing claim, wherein the Red 30 is selected from free D&C Red 30 dye, the red 30 lake, the D&C Red 30 dye adhered to silica, and a mixture thereof.

19. An oral care composition comprising: from about 0.1 to about 5 wt.% of a stannous ion source; from about 0.1 to about 7 wt.% of a nitrate ion source; from about 0.1 to about 7 wt.% of a phosphate source; a red colorant comprising Red 30; from about 1 to about 35 wt.% of an abrasive; and from about 1 to about 60 wt.% of a polyol, wherein the red colorant in the oral care composition is stable for 2 weeks at a temperature of 60°C and all weight percentages are based on the total weight of the oral care composition.

20. An oral care composition consisting of: a stannous ion source; a nitrate ion source; a phosphate source; a red colorant comprising Red 30;optionally, a fluoride ion source; optionally, one or more thickening agent; optionally, one or more abrasive; optionally, one or more surfactant; optionally, one or more polyol; optionally water; and optionally, one or more of a flavoring agent, non-red colorant, sweetener, opacifier, or a combination thereof.

21. The oral care composition according to claim 19 or claim 20, wherein the red colorant consists of Red 30.

22. The oral care composition according to any foregoing claim, wherein the red colorant is present in an amount from about 0.0001 to about 2 wt.%, about 0.001 to about 2 wt.%, or about 0.01 to about 2 wt.%.

23. The oral care composition according to any foregoing claim, wherein the amount of red colorant is about 0.0001 to about 0.5 wt.%, about 0.001 to about 0.5 wt.%, or about 0.01 to about 0.5 wt.%.

24. The oral care composition according to any foregoing claim, wherein the amount of red colorant is about 0.0001 to about 0.2 wt.%, about 0.001 to about 0.2 wt.%, or about 0.01 to about 0.2 wt.%.

25. The oral care composition according to any foregoing claim, wherein the amount of red colorant is about 0.0001 to about 0.1 wt.%, about 0.001 to about 0.1 wt.%, or about 0.01 to about 0.1 wt.%.

26. The oral care composition according to any foregoing claim, wherein the amount of red colorant is about 0.0001 to about 0.05 wt.%, about 0.001 to about 0.05 wt.%, or about 0.001 to about 0.01 wt.%.