Oral care composition

Abstract

Disclosed herein are oral care compositions, in particular oral care compositions having enhanced stability of stannous ions. According to at least one aspect, there is provided an oral care composition comprising: a source of stannous ions; and crosslinked polyacrylic acid and / or salts thereof, wherein the weight ratio of the source of stannous ions to the crosslinked polyacrylic acid and / or salts thereof of the personal care composition is from about 4: 1 to about 1 :4.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Patent Application No. 63 / 547,757, filed November 8, 2023, entitled “Oral Care Composition,” the contents of which are incorporated herein by reference in their entirety for all purposes. Background Technology

[0002] Dental plaque is a sticky biofilm or clump of bacteria that typically exists between teeth, along the gum line, and below the gum line. Dental plaque can cause tooth decay and periodontal problems such as gingivitis and periodontitis. Tooth decay is caused by acids produced from the degradation of sugars by bacteria, resulting in cavities or demineralization of teeth.

[0003] Oral care compositions containing stannous sources have shown excellent clinical benefits, particularly in reducing gingivitis. Stannous sources such as stannous fluoride and stannous chloride are well-known for their use in clinical dentistry, with over forty years of history of therapeutic benefits. However, until recently, their widespread use was limited by their instability in aqueous solutions. The instability of stannous salts in water is primarily due to the reactivity of stannous ions (Sn2+). Stannous salts readily hydrolyze at pH above 4, leading to precipitation from solution. Traditionally, the formation of this insoluble stannous salt was thought to result in a loss of therapeutic properties.

[0004] A common approach to overcoming stability issues related to stannous ions is to limit the water content in the composition to very low levels or to use a biphasic system. Both of these approaches to addressing the stannous ion problem have drawbacks. Low-water oral care compositions may be difficult to formulate to achieve the desired rheological properties, while biphasic compositions are quite expensive to manufacture and package. Therefore, it is preferable to formulate a high-water-content composition that uses an alternative method to maintain a stable and effective stannous ion concentration. Summary of the Invention

[0005] This invention is intended only to provide a simplified overview of some aspects of one or more embodiments of the present disclosure. Further areas of application of the present disclosure will become apparent from the detailed embodiments provided below. This invention is not a broad review, nor is it intended to identify key or essential elements of the teachings, nor to depict the scope of the disclosure. Rather, its purpose is merely to present one or more concepts in a simplified form as a prelude to the detailed embodiments described below.

[0006] Aspects of the present invention relate to oral care compositions, for example, oral care compositions having enhanced stannous ion stability. According to at least one aspect, an oral care composition is provided comprising: a stannous source; and crosslinked polyacrylic acid and / or its salt, wherein the weight ratio of the stannous source to the crosslinked polyacrylic acid and / or its salt in the personal care composition is from about 4:1 to about 1:4.

[0007] According to another aspect, an oral care composition is provided comprising: a tin oxide source; about 0.2 to about 4 wt.% of crosslinked polyacrylic acid and / or its salts; polyphosphates and / or their salts; a polyol; and about 10 to about 40 wt.% of water, wherein all weight percentages are based on the total weight of the oral care composition.

[0008] According to another aspect, a method for preparing an oral care composition is provided, the method comprising crosslinking polyacrylic acid and / or its salts to form crosslinked polyacrylic acid and / or its salts; and chelating a tin oxide source with the crosslinked polyacrylic acid and / or its salts.

[0009] The following is a list of non-limiting exemplary implementations:

[0010] According to embodiment 1, an oral care composition is provided comprising: a tin oxide source; and crosslinked polyacrylic acid and / or its salt, wherein the weight ratio of the tin oxide source to the crosslinked polyacrylic acid and / or its salt in the personal care composition is from about 4:1 to about 1:4.

[0011] According to embodiment 2, an oral care composition according to claim 1 is provided, which further comprises: about 10 wt.% or more water, based on the total weight of the oral care composition.

[0012] According to embodiment 3, an oral care composition according to embodiment 1 or embodiment 2 is provided, wherein the amount of water present is about 15 wt.% or more, based on the total weight of the oral care composition.

[0013] According to embodiment 4, an oral care composition according to any of the foregoing embodiments is provided, wherein the crosslinked polyacrylic acid and / or its salt is branched polyacrylic acid and / or its salt.

[0014] According to embodiment 5, an oral care composition according to any of the preceding embodiments is provided, wherein the crosslinked polyacrylic acid and / or its salts are crosslinked with allyl sucrose and / or allyl pentaerythritol.

[0015] According to embodiment 6, an oral care composition according to any of the preceding embodiments is provided, wherein the crosslinked polyacrylic acid and / or its salts contain about 56% to about 68% w / w carboxylic acid groups.

[0016] According to embodiment 7, an oral care composition according to any of the preceding embodiments is provided, wherein the crosslinked polyacrylic acid and / or its salts have an average molecular weight of 7 × 10⁻⁶. 5 Up to 4×109 Da.

[0017] According to embodiment 8, an oral care composition according to any of the foregoing embodiments is provided, wherein the crosslinked polyacrylic acid and / or its salts are present in an amount of about 0.2 to about 4 wt.%, based on the total weight of the oral care composition.

[0018] According to embodiment 9, an oral care composition according to any of the foregoing embodiments is provided, wherein the oral care composition comprises about 2 wt.% or less of natural gums and / or polysaccharides.

[0019] According to embodiment 10, an oral care composition according to any of the foregoing embodiments is provided, wherein the stannous source is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethyleneglyoxide, and combinations of two or more thereof.

[0020] According to embodiment 11, an oral care composition according to any of the foregoing embodiments is provided, wherein the stannous source comprises stannous fluoride.

[0021] According to embodiment 12, an oral care composition according to any of the foregoing embodiments is provided, which further comprises: a polyphosphate, optionally in an amount of about 0.1 to about 7 wt.%, based on the total weight of the oral care composition.

[0022] According to embodiment 13, an oral care composition according to embodiment 12 is provided, wherein the polyphosphate is an alkali metal polyphosphate.

[0023] According to embodiment 14, an oral care composition according to embodiment 13 is provided, wherein the alkali metal polyphosphate is selected from pyrophosphate, tripolyphosphate, tetraphosphate, hexametaphosphate, and combinations of two or more thereof.

[0024] According to embodiment 15, an oral care composition according to one of embodiments 12 to 14 is provided, wherein the polyphosphate is selected from sodium pyrophosphate, potassium pyrophosphate, sodium tripolyphosphate, potassium tripolyphosphate, and combinations of two or more thereof.

[0025] According to embodiment 16, an oral care composition according to one of embodiments 12 to 15 is provided, wherein the polyphosphate comprises tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate, or a combination of two or more thereof.

[0026] According to embodiment 17, an oral care composition according to any of the foregoing embodiments is provided, which further comprises: basic amino acids, optionally in an amount of about 0.1 to about 10 wt.%, based on the total weight of the oral care composition.

[0027] According to embodiment 18, an oral care composition according to embodiment 17 is provided, wherein the basic amino acid comprises arginine, lysine, histidine, or a combination thereof.

[0028] According to embodiment 19, an oral care composition according to any of the foregoing embodiments is provided, which further comprises: hydroxide, optionally present in an amount of about 0.1 to about 4 wt.%.

[0029] According to embodiment 20, an oral care composition according to any of the foregoing embodiments is provided, which further comprises: bicarbonate, carbonate or combination thereof, optionally present in an amount of about 0.1 to about 4 wt.%.

[0030] According to embodiment 21, an oral care composition according to any of the foregoing embodiments is provided, which further comprises: a potassium source, optionally in an amount of about 0.1 to about 6 wt.%, based on the total weight of the oral care composition.

[0031] According to embodiment 22, an oral care composition according to embodiment 21 is provided, wherein the potassium source comprises potassium nitrate, potassium citrate, or a combination thereof.

[0032] According to embodiment 23, an oral care composition according to embodiment 21 or embodiment 22 is provided, wherein the potassium source comprises potassium nitrate.

[0033] According to embodiment 24, an oral care composition according to any of the foregoing embodiments is provided, which further comprises: a polyol, optionally in an amount of about 30 to about 68 wt.%, based on the total weight of the oral care composition.

[0034] According to embodiment 25, an oral care composition according to embodiment 24 is provided, wherein the polyol is present in an amount of about 35 to about 58 wt.%, based on the total weight of the oral care composition.

[0035] According to embodiment 26, an oral care composition according to embodiment 24 or embodiment 25 is provided, wherein the polyol comprises glycerol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), block copolymers of PPG and PEG, sugars, or combinations of two or more thereof.

[0036] According to embodiment 27, an oral care composition according to one of embodiments 24 to 26 is provided, wherein the polyol comprises two or more polyols.

[0037] According to embodiment 28, an oral care composition according to embodiment 27 is provided, wherein the two or more polyols comprise sorbitol.

[0038] According to embodiment 29, an oral care composition according to any of the foregoing embodiments is provided, which further comprises: an organic acid buffering system, optionally in an amount of about 0.2 to about 4 wt.%, based on the total weight of the oral care composition.

[0039] According to embodiment 30, an oral care composition according to embodiment 29 is provided, wherein the organic acid buffering system comprises citric acid and trisodium citrate, wherein the weight ratio of citric acid to sodium citrate is from about 1:3 to about 1:8.

[0040] According to embodiment 31, an oral care composition according to any of the foregoing embodiments is provided, wherein the pH of the oral care composition is about 5 or higher, for example, as measured in a 10 wt.% aqueous solution.

[0041] According to embodiment 32, an oral care composition according to the foregoing embodiment is provided, wherein when maintained at a temperature of 60°C for 2 weeks, the reduction of soluble tin II in the oral care composition is less than about 25%.

[0042] According to embodiment 33, an oral care composition according to any of the foregoing embodiments is provided, wherein when maintained at a temperature of 40°C and a relative humidity of 75% for 13 weeks, the reduction of soluble tin II in the oral care composition is less than about 25%.

[0043] According to embodiment 34, an oral care composition according to any of the foregoing embodiments is provided, wherein when maintained at a temperature of 40°C and a relative humidity of 75% for 13 weeks, the reduction in the total amount of soluble tin in the oral care composition is less than about 10%.

[0044] According to embodiment 35, an oral care composition is provided comprising: a tin oxide source; about 0.2 to about 4 wt.% of crosslinked polyacrylic acid and / or its salts; a polyphosphate and / or its salts; a polyol; and about 10 to about 40 wt.% of water, wherein the pH of the oral care composition is about 5 or higher, and all weight percentages are based on the total weight of the oral care composition.

[0045] According to embodiment 36, a method for preparing an oral care composition is provided, comprising: crosslinking polyacrylic acid and / or its salts to form crosslinked polyacrylic acid and / or its salts; and chelating a tin oxide source with the crosslinked polyacrylic acid and / or its salts.

[0046] According to embodiment 37, an oral care composition according to embodiment 36 is provided, which further includes: adding at least one of the following: potassium source, nitrate source, fluoride source, polyol, abrasive, surfactant, thickener other than polyacrylic acid and / or its salts, sweetener, flavoring agent, coloring agent, water, or a combination of two or more thereof.

[0047] According to embodiment 38, an oral care composition is provided comprising a tin oxide source; a polymer system comprising crosslinked polyacrylic acid, a phosphate / acrylate copolymer, a salt thereof, or a combination thereof; and a polyphosphate and / or a salt thereof, wherein the pH of the oral care composition is about 5 or higher, and all weight percentages are based on the total weight of the oral care composition.

[0048] According to embodiment 38, an oral care composition is provided comprising a tin oxide source; a polymer system comprising crosslinked polyacrylic acid, a phosphate ester / acrylate copolymer, a salt thereof, or a combination thereof; a nitrate source; a polyphosphate and / or a salt thereof; and about 10 wt.% or more water, wherein the pH of the oral care composition is about 5 or higher, and all weight percentages are based on the total weight of the oral care composition. Detailed Implementation

[0049] For illustrative purposes, the principles of the invention are described by reference to various exemplary embodiments thereof. Although certain embodiments of the invention have been specifically described herein, those skilled in the art will readily recognize that the same principles apply equally to and can be used in other compositions and methods. Before explaining the embodiments disclosed herein in detail, it should 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 descriptive purposes and not for limiting purposes.

[0050] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context otherwise requires. The singular form of any class of ingredients refers not only to one chemical substance in that class but also to mixtures of such chemical substances. The terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein. The terms “comprising,” “including,” and “having” are used interchangeably. The term “include” should be construed as “including, but not limited to.”

[0051] As used throughout, a range is used as a shorthand to describe the individual values ​​within that range. Any value within the range can be chosen as the endpoint of the range. Therefore, the range 1-5 specifically includes 1, 2, 3, 4, and 5, as well as subranges such as 2-5, 3-5, 2-3, 2-4, 1-4, etc.

[0052] When referring to numbers, the term "about" means any number within the range of 10% of that number. For example, the phrase "about 2 wt.%" refers to a number between 1.8 wt.% and 2.2 wt.%, inclusive.

[0053] All references cited in this document are incorporated herein by reference in their entirety. In the event of any discrepancy between the definitions in this disclosure and those in the cited references, this disclosure shall prevail.

[0054] The abbreviations and symbols used herein have their ordinary meanings unless otherwise stated. The abbreviation "wt.%" refers to a percentage by weight relative to the oral care composition. The symbol "°" refers to degrees, such as temperature or angle. The symbols "h", "min", "mL", "nm", and "μm" refer to hours, minutes, milliliters, nanometers, and micrometers, respectively. The abbreviation "UV-VIS" refers to a spectrometer or spectroscopy, meaning ultraviolet-visible light. The abbreviation "rpm" indicates revolutions per minute.

[0055] When referring to chemical structures and names, the symbols "C", "H", and "O" represent carbon, hydrogen, and oxygen, respectively. The symbols "-", "=", and "≡" represent single, double, and triple bonds, respectively.

[0056] As used in this article, "volatile" means having a flash point of less than about 100°C. As used in this article, "non-volatile" means having a flash point of greater than about 100°C.

[0057] Any member of a species list used to exemplify or define a genus may be distinct from, overlap with, be a subset of, be equivalent to, or be nearly identical to, or be the same as any other member of that genus. Furthermore, for example, when listing the Markush group, the species list defining or defining the genus is open-ended and assumes the existence of other species that define or define the genus as well as, or better than, any other species listed, unless explicitly stated otherwise.

[0058] The phrases “mixtures thereof,” “combinations thereof,” or “combinations of two or more thereof” do not require that the mixture include all of A, B, C, D, E, and F (although it may include all of A, B, C, D, E, and F). Rather, it indicates a mixture that may include any two or more of A, B, C, D, E, and F. 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 mixtures of any two or more of A, B, C, D, E, and F.” Similarly, the term “a salt thereof” also refers to “salts thereof.” Therefore, when this disclosure refers to "an element selected from the group consisting of A, B, C, D, E, F, their salts and mixtures thereof", it means that it may include one or more of A, B, C, D and F, one or more of the salts of A, B, C, D, E and F, or a mixture of any two of the salts of A, B, C, D, E, F, the salts of A, B, C, D, E and F.

[0059] All components and elements positively described in this disclosure may be negatively excluded from the claims. In other words, the oral care compositions of this disclosure may be free of or substantially free of all components and elements positively described throughout this disclosure. In some cases, the oral care compositions of this disclosure may be substantially free of non-accidental amounts of the ingredients or compounds described herein. A non-accidental amount of an ingredient or compound is the amount of an ingredient or compound added alone to the oral care composition. For example, an oral care composition may be substantially free of non-accidental amounts of an ingredient or compound, although such an ingredient or compound may be present as part of a raw material contained as a blend of two or more compounds.

[0060] Some of the components in the defined categories may overlap. In cases where overlap is possible and the oral care composition contains two components (or more than two overlapping components), the overlapping compounds do not represent more than one component. For example, some compounds may be characterized as both a fluoride source and a stannous source. If a particular oral care composition refers to both a fluoride source and a stannous source, then stannous fluoride will act as either a fluoride source or a stannous source only, not both.

[0061] For readability purposes, chemical functional groups are given their adjectival forms; for each adjective, the word "group" is assumed. For example, the adjective "alkyl" without a noun should be read as "alkyl group".

[0062] This invention relates to oral care compositions, such as oral care compositions comprising a stannous source and crosslinked polyacrylic acid and / or its salts. The inventors have found that the oral care compositions disclosed herein can advantageously stabilize stannous ions in compositions containing components that frequently react with, precipitate, or oxidize stannous ions. For example, certain embodiments of the oral care compositions achieve stable stannous ions while having about 10 wt.% or more, or about 15 wt.% or more, of water, based on the total weight of the oral care composition. It has also been found that oral care compositions according to certain embodiments disclosed herein achieve stable stannous ions while having a pH of about 5 or higher.

[0063] Preferably, the oral care composition has enhanced tin II stability, such that when maintained at 60°C for 2 weeks, the reduction of soluble tin II in the oral care composition is less than about 25%, preferably less than about 20%, and more preferably less than about 18%. Additionally or alternatively, when maintained at 40°C and 75% relative humidity for 13 weeks, the reduction of soluble tin II in the oral care composition may be less than about 25%, preferably less than about 23%, and more preferably less than about 21%.

[0064] In some preferred embodiments, the oral care composition has enhanced tin ion stability such that when maintained at 40°C and 75% relative humidity for 13 weeks, the reduction in the total amount of soluble tin in the oral care composition is less than about 10%, preferably less than about 9%, less than about 8%, or less than 7%.

[0065] According to at least one aspect, an oral care composition is provided comprising: a tin oxide source; and crosslinked polyacrylic acid and / or its salt, wherein the weight ratio of the tin oxide source to the crosslinked polyacrylic acid and / or its salt in the personal care composition is from about 4:1 to about 1:4.

[0066] According to another aspect, an oral care composition is provided comprising: a tin oxide source; about 0.2 to about 4 wt.% of crosslinked polyacrylic acid and / or its salts; a polyphosphate and / or its salts; a polyol; and about 10 to about 40 wt.% of water, wherein all weight percentages are based on the total weight of the oral care composition.

[0067] According to another aspect, a method for preparing an oral care composition is provided, the method comprising crosslinking polyacrylic acid and / or its salts to form crosslinked polyacrylic acid and / or its salts; and chelating a tin oxide source with the crosslinked polyacrylic acid and / or its salts.

[0068] In some embodiments, the pH of the oral care composition is about 5 or higher. For example, the pH of the oral care composition may be 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; about 6 to about 10, about 6 to about 9, about 6 to about 8, or about 6 to about 7.

[0069] Additionally or alternatively, the oral care composition may contain reduced amounts of thickeners other than crosslinked polyacrylic acid, phosphate / acrylate copolymers, and / or their salts, such as polysaccharides and / or natural gums. For example, in some preferred embodiments, the oral care composition may contain 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. Additionally or alternatively, in some preferred embodiments, the oral care composition may contain 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, natural gums, based on the weight of the oral care composition. In addition, in some preferred embodiments, the oral care composition 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 of a thickener other than crosslinked polyacrylic acid, phosphate ester / acrylate copolymer and / or its salts, based on the weight of the oral care composition.

[0070] In some preferred embodiments, the oral care composition may contain a thickener other than crosslinked polyacrylic acid, phosphate ester / acrylate copolymers, and / or their salts, in amounts of about 0.1 to about 2.5 wt.%, about 0.3 to about 2.5 wt.%, about 0.6 to about 2 wt.%, about 1 to about 2.5 wt.%; about 0.1 to about 2 wt.%, about 0.3 to about 2 wt.%, about 0.6 to about 2 wt.%, about 1 to about 2 wt.%; about 0.1 to about 1.5 wt.%, about 0.3 to about 1.5 wt.%, about 0.6 to about 1.5 wt.%, or any range or subrange thereof, about 0.1 to about 1 wt.%, about 0.3 to about 1 wt.%, about 0.6 to about 1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition. As described above, in some embodiments, the oral care composition may have a reduced amount of thickener other than polyacrylic acid and / or its salts. For example, the oral care composition may contain a thickener other than polyacrylic acid and / or its salts, in amounts of about 0.1 to about 2.5 wt.%, about 0.3 to about 2.5 wt.%, about 0.6 to about 2 wt.%, about 1 to about 2.5 wt.%; about 0.1 to about 2 wt.%, about 0.3 to about 2 wt.%, about 0.6 to about 2 wt.%, about 1 to about 2 wt.%; about 0.1 to about 1.5 wt.%, about 0.3 to about 1.5 wt.%, about 0.6 to about 1.5 wt.%, or any range or subrange thereof, about 0.1 to about 1 wt.%, about 0.3 to about 1 wt.%, about 0.6 to about 1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0071] Oral care compositions may be in the form of dental floss, toothpaste, mouthwash, gel, varnish, leave-on products (e.g., gel, varnish, etc.) and / or similar forms. The formulation of an oral care composition may or may not contain suitable components, as listed below, depending on the specific combination of other ingredients and the form of the oral care composition. Additionally or alternatively, in some embodiments, the oral care composition may have a single phase comprising components and / or ingredients of the oral care composition. In other embodiments, the oral care composition may comprise two or more phases, such as biphasic, triphasic, tetraphasic, or pentapeptides.

[0072] Oral care compositions typically contain a stannous source, preferably in an effective amount. The stannous source may comprise or consist of a stannous ion source. The amount of the stannous source (e.g., a stannous ion source) in the oral care composition may be from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. For example, the amount of stannous ions present in an oral care composition may be from about 0.1 to about 4 wt.%, from about 0.1 to about 3 wt.%, from about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, from about 0.3 to about 4 wt.%, from about 0.3 to about 3 wt.%, from about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, from about 0.6 to about 4 wt.%, from about 0.6 to about 3 wt.%, from about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, from about 0.9 to about 4 wt.%, from about 0.9 to about 3 wt.%, from about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, from about 1.2 to about 4 wt.%, from about 1.2 to about 3 wt.%, from about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, from about 1.5 to about 4 wt.%, from about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%; from about 1.5 to about 5 wt.%; from about 2 to about 5 wt.%; from about 1.5 to about 4 wt.%, from about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%; from about 1.5 ...4 wt.%, from about 1.5 to about 3 wt.%; from about 2 to about wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%, 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 comprises about 0.4 to about 0.5 wt.% of a tin sub-source (e.g., a tin sub-ion source), such as about 0.45 wt.% of a tin sub-source.

[0073] A stannous source (e.g., a stannous ion source) may comprise, or in some cases consist of, stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous glycol, or combinations of two or more thereof. For example, a stannous source may comprise stannous fluoride, stannous chloride, stannous acetate, stannous pyrophosphate, or combinations of two or more thereof. A stannous source may be selected from stannous fluoride, stannous chloride, stannous acetate, or combinations of two or more thereof. In at least one embodiment, the stannous source comprises stannous fluoride.

[0074] Oral care compositions may contain two or more, three or more, four or more, five or more, or six or more stannous sources (e.g., stannous ion sources). For example, an oral care composition may contain 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 contains stannous fluoride and stannous pyrophosphate. Additionally or alternatively, the oral care composition may contain stannous fluoride and stannous chloride.

[0075] Oral care compositions typically comprise one or more crosslinked polyacrylic acids, phosphate ester / acrylate copolymers, their salts, or combinations thereof. In at least one preferred embodiment, the oral care composition comprises one or more crosslinked polyacrylic acids and / or their salts. In some cases, the total amount of crosslinked acrylic acids and / or their salts in the oral care composition may 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 crosslinked acrylic acid and / or its salts present in the oral care composition may be 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.%; 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.%; 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.%; 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.%; about 2 to about 10 wt.%, about 2 to about 7 wt.%, about 2 to about 5 wt.%; about 4 to about 10 wt.%, about 4 to about 7 wt.%; about 4 to about 7 wt.%; about 4 to about 7 wt.%; about 1 ... wt.%; 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.

[0076] Preferably, the presence of one or more crosslinked acrylic acids and / or their salts can be from about 0.2 to about 4 wt.%, based on the total weight of the oral care composition. In some cases, the amount of the one or more crosslinked acrylic acids and / or salts may be from about 0.2 to about 3 wt.%, from about 0.2 to about 2.5 wt.%, from about 0.2 to about 2 wt.%, from about 0.2 to about 1.5 wt.%, from about 0.2 to about 1.25 wt.%, from about 0.2 to about 1 wt.%, from about 0.2 to about 0.75 wt.%, from about 0.2 to about 0.5 wt.%; from about 0.35 to about 4 wt.%, from about 0.35 to about 3 wt.%, from about 0.35 to about 2.5 wt.%, from about 0.35 to about 2 wt.%, from about 0.35 to about 1.5 wt.%, from about 0.35 to about 1.25 wt.%, from about 0.35 to about 1 wt.%, from about 0.35 to about 0.75 wt.%, from about 0.35 to about 0.5 wt.%; from about 0.5 to about 4 wt.%, from about 0.5 to about 3 wt.%, from about 0.5 to about 2.5 wt. wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1.5 wt.%, about 0.5 to about 1.25 wt.%, about 0.5 to about 1 wt.%, about 0.5 to about 0.75 wt.%; about 0.75 to about 4 wt.%, about 0.75 to about 3 wt.%, about 0.75 to about 2.5 wt.%, about 0.75 to about 2 wt.%, about 0.75 to about 1.5 wt.%, about 0.75 to about 1.25 wt.%, about 0.75 to about 1 wt.%; about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2.5 wt.%, about 1 to about 2 wt.%, about 1 to about 1.5 wt.%, about 1 to about 1.25 wt.%; about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2.5 wt.%, about 1.5 to about 2 wt.%; about 2 to about 4 wt.%, about 2 to about 3 wt.%, about 2 to about 2.5 wt.%; about 2.5 to about 4 wt.%, about 2.5 to about 3 wt.%, about 3 to about 4 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0077] Crosslinked polyacrylic acid and / or its salts may be selected from branched polyacrylic acid and / or its salts. In some cases, the polyacrylic acid and / or its salts consist of branched polyacrylic acid and / or its salts. However, in further cases, the oral care composition comprises at least one linear polyacrylic acid and / or its salt.

[0078] Crosslinked polyacrylic acid and / or its salts can be carbomers. An exemplary structure of a carbomer monomer is shown below.

[0079] The crosslinked polyacrylic acid and / or its salts may be high molecular weight polyacrylic acid. Preferably, the crosslinked polyacrylic acid and / or its salts are crosslinked with allyl sucrose and / or allyl pentaerythritol. Additionally or alternatively, the crosslinked polyacrylic acid and / or its salts may contain about 56% to about 68% w / w carboxylic acid groups. For example, the crosslinked polyacrylic acid and / or its salts may contain about 56% to about 65% w / w, about 56% to about 62% w / w, about 56% to about 59% w / w; about 59% to about 65% w / w, about 59% to about 62% w / w, or about 61% to about 65% w / w carboxylic acid groups. The molecular weight of the carbomer may be 7 × 10⁻⁶. 5 Up to 4×10 9 Da. In some cases, the molecular weight of carbomer is 7 × 10⁻⁶. 5 Up to 1×10 8 Da, 7×10 5 Up to 4×10 7 Da, 7×10 5 Up to 4×10 6 Da; from 1×10 6 Up to 1×10 8 Da, 1×10 6 Up to 4×10 7 Da; 1×10 7 Up to 1×10 8 Da, 7×10 7 Up to 1×10 8 Da, or any range or subrange thereof. Carbomer may be selected from Carbopol. For example, personal care compositions may contain or, in some cases, not contain polyacrylic acid and / or its salts selected from Carbopol 2984, Carbopol 910, Carbopol 934P, Carbopol Ultrez 10, Carbopol 940, Carbopol 941, Carbopol 956, Carbopol 971P, Carbopol 974P, Carbopol 981, Carbopol 2020, and combinations of two or more thereof. Additionally or alternatively, crosslinked polyacrylic acid and / or its salts may be selected from carbomer. In some preferred embodiments, the carbomer is acrylic acid C. 10-30 Alkyl ester crosslinked polymer. In at least one embodiment, the carbomer comprises or is composed of carbopol ETD NF 2020.

[0080] Oral care compositions are preferably formulated having a stannous ion source and crosslinked polyacrylic acid and / or its salts, wherein the weight ratio of the stannous ion source to the crosslinked polyacrylic acid and / or its salts is from about 4:1 to about 1:4. In some cases, the weight ratio of the stannous ion source to the crosslinked polyacrylic acid and / or its salts in the oral care composition is from about 4:1 to about 1:4, from about 4:1 to about 1:3, from about 4:1 to about 1:2, from about 4:1 to about 1:1; from about 3:1 to about 1:4, from about 3:1 to about 1:3, from about 3:1 to about 1:2, from about 3:1 to about 1:1; from about 2:1 to about 1:4, from about 2:1 to about 1:3, from about 2:1 to about 1:2, from about 2:1 to about 1:1; from about 1:1 to about 1:4, from about 1:1 to about 1:3, from about 1:1 to about 1:2, or any range or subrange thereof. In at least one embodiment, the weight ratio of the stannous ion source of the oral care composition to the crosslinked polyacrylic acid and / or its salt is about 1:1.1.

[0081] Polyacrylic acid and / or its salts can be neutralized with a crosslinking agent selected from inorganic or organic bases, such as alkali metal-, ammonium-, or (alkanol)amine compounds, such as sodium hydroxide and potassium hydroxide, or sodium carbonate and potassium carbonate, ammonia, triethanolamine, etc. However, the inventors have unexpectedly discovered that certain crosslinking agents, combined with certain polyacrylic acid and / or its salts, stannous sources, and specific proportions disclosed herein, can yield enhanced benefits. Therefore, certain embodiments of the oral care composition may include, or in some cases exclude, one or more of the aforementioned crosslinking agents for neutralizing polyacrylic acid and / or its salts.

[0082] Without being limited by any particular theory, the inventors have discovered that certain crosslinking agents, when combined with certain polyacrylic acids and / or their salts, and stannous sources, and in specific proportions disclosed herein, promote enhanced stannous stability of certain oral care compositions disclosed herein. The crosslinking agents used herein are generally suitable for crosslinking polyacrylic acids and / or their salts. In some cases, the crosslinking agent may comprise, or in some cases may consist of, those selected from polyphosphates, basic amino acids, bicarbonates, carbonates, hydroxides, or combinations thereof. For example, the crosslinking agent may be selected from polyphosphates, basic amino acids, bicarbonates, carbonates, or combinations thereof. In some cases, the crosslinking agent comprises polyphosphates, basic amino acids, or combinations thereof. Preferably, the crosslinking agent comprises a polyphosphate.

[0083] In some preferred embodiments, the oral care composition comprises a phosphate ester / acrylate copolymer and optionally carbomer. The phosphate ester / acrylate copolymer can be a carboxylic acid polymer having at least one phosphate ester moiety, wherein the monomer unit comprises acrylic acid, methacrylic acid, 2-hydroxyethyl methacrylate, or any combination thereof having at least one phosphate ester moiety. For example, the phosphate ester / acrylate copolymer may comprise or be formed from: about 5 to about 30 mol%, optionally about 8 to about 14 mol%, of 2-hydroxyethyl methacrylate phosphate monomer; about 60 to about 90 mol%, optionally about 65 to about 85 mol%, optionally about 71 to about 79 mol%, of acrylic acid monomer; 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 ester / acrylate copolymers include those according to Table 1. Table 1

[0084] In some embodiments, the phosphate ester / acrylate copolymer is a copolymer of a mixture of acrylic acid, methacrylic acid, and 2-hydroxyethyl methacrylate phosphate, wherein the molar percentage of acrylic acid in the copolymer is about 70 to about 90 mol%, about 80 to about 90 mol%, or about 85 mol%; the molar percentage of methacrylic acid is about 5 to about 20 mol%, about 5 to about 15 mol%, or about 11 mol%; and the molar percentage of hydroxyethyl methacrylate phosphate is about 1 mol% to about 10 mol%, about 2 mol% to about 6 mol%, or about 4 mol%. In at least one embodiment, the phosphate ester / acrylate copolymer comprises or is composed of DV8801 polymer (which may sometimes be referred to as Mirapol 8801).

[0085] In some embodiments, the weight-average molecular weight of the phosphate ester / acrylate copolymer is 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 some 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 ester / acrylate copolymer is a random copolymer, which is a copolymer of, for example, acrylic acid, methacrylic acid, and 2-hydroxyethyl methacrylate in the aforementioned relative amounts.

[0086] In some cases, the total amount of phosphate ester / acrylate copolymer in the oral care composition may 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 ester / acrylate copolymer present in an oral care composition may be 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.%; 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.%; 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.%; 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.%; about 2 to about 10 wt.%, about 2 to about 7 wt.%, about 2 to about 5 wt.%; about 4 to about 10 wt.%, about 4 to about 7 wt.%; about 6 to about 10 wt.%. wt.%, about 6 to about 8 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0087] Oral care compositions may contain an effective amount of polyphosphates. In some embodiments, the amount of polyphosphate in the oral care composition is about 0.1 to about 7 wt.%, 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 2.7 wt.%, about 0.1 to about 2.4 wt.%, about 0.1 to about 2.1 wt.%, about 0.1 to about 1.7 wt.%, about 0.1 to about 1.4 wt.%, about 0.1 to about 1.1 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 2.7 wt.%, about 0.5 to about 2.4 wt.%, about 0.5 to about 2.1 wt.%, about 0.5 to about 1.7 wt.%, about 0.5 to about 1.4 wt.%, about 0.5 to about 1.1 wt.%; about 1 to about 7 wt.%; wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2.7 wt.%, about 1 to about 2.4 wt.%, about 1 to about 2.1 wt.%, about 1 to about 1.7 wt.%; about 1.3 to about 7 wt.%, about 1.3 to about 5 wt.%, about 1.3 to about 4 wt.%, about 1.3 to about 3 wt.%, about 1.3 to about 2.7 wt.%, about 1.3 to about 2.4 wt.%, about 1.3 to about 2.1 wt.%, about 1.3 to about 1.7 wt.%; about 1.6 to about 7 wt.%, about 1.6 to about 5 wt.%, about 1.6 to about 4 wt.%, about 1.6 to about 3 wt.%, about 1.6 to about 2.7 wt.%, about 1.6 to about 2.4 wt.%, about 1.6 to about 2.1 wt.%; about 1.9 to about 7 wt.%, about 1.9 to about 5 wt.%, about 1.9 to about 4 wt.%, about 1.9 to about 3 wt.%, about 1.9 to about 2.7 wt.%, about 1.9 to about 2.4 wt.%; about 2.4 to about 7 wt.%, about 2.4 to about 6 wt.%, about 2.4 to about 5 wt.%, about 2.4 to about 4 wt.%, about 2.4 to about 3 wt.%, about 2.4 to about 2.7 wt.%; about 2.7 to about 7 wt.%, about 2.7 to about 6 wt.%, about 2.7 to about 5 wt.%, about 2.7 to about 4 wt.%; about 3.3 to about 7 wt.%, about 3.3 to about 6 wt.%, about 3.3 to about 5 wt.%, about 3.3 to about 4 wt.%, about 3.9 to about 7 wt.%, about 3.9 to about 6 wt.%, about 3.9 to about 5 wt.%; about 4.6 to about 7 wt.%, about 4.6 to about 6 wt.%, about 4.6 to about 5 wt.%; about 5.5 to about 7 wt.%, about 5.5 to about 6 wt.%.5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0088] Polyphosphates may comprise, or in some cases consist of, polyphosphates selected from pyrophosphates, orthophosphates, polymetaphosphates, and combinations of two or more thereof. Polyphosphates may comprise pyrophosphates, such as alkali metal pyrophosphates selected from tetraalkali metal pyrophosphates, dialkali metal dica pyrophosphates, trialkali metal monoacid pyrophosphates, and mixtures thereof. The alkali metal may be sodium and / or potassium. For example, the polyphosphate may be an alkali metal polyphosphate selected from pyrophosphates, tripolyphosphates, tetraphosphates, hexametaphosphates, and combinations thereof. In some embodiments, the polyphosphate is selected from sodium pyrophosphate, potassium pyrophosphate, sodium tripolyphosphate, potassium tripolyphosphate, or combinations thereof. In further embodiments, the polyphosphate comprises tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate, potassium polyphosphate, sodium polyphosphate, or combinations of two or more thereof.

[0089] In some embodiments, the oral care composition is preferably formulated having a weight ratio of polyacrylic acid and / or its salts to polyphosphate of about 1:3 to about 1:8. For example, the weight ratio of polyacrylic acid and / or its salts to polyphosphate may be about 1:3 to about 1:8, about 1:3 to about 1:7, about 1:3 to about 1:6, about 1:3 to about 1:5, about 1:3 to about 1:4; about 1:4 to about 1:8, about 1:4 to about 1:7, about 1:4 to about 1:6, about 1:4 to about 1:5; about 1:5 to about 1:8, about 1:5 to about 1:7, about 1:5 to about 1:6; about 1:6 to about 1:8, about 1:6 to about 1:7, or about 1:7 to about 1:8, including any range or subrange thereof.

[0090] Oral care compositions may contain one or more basic amino acids, preferably in an effective amount. In some embodiments, the amount of the one or more amino acids present in the oral care composition may be from about 0.1 to about 10 wt.%, from about 0.1 to about 8 wt.%, from about 0.1 to about 6 wt.%, from about 0.1 to about 4 wt.%, from about 0.1 to about 2 wt.%, from about 0.1 to about 1 wt.%, from about 0.1 to about 0.5 wt.%; from about 0.5 to about 10 wt.%, from about 0.5 to about 8 wt.%, from about 0.5 to about 6 wt.%, from about 0.5 to about 4 wt.%, from about 0.5 to about 2 wt.%, from about 0.5 to about 1 wt.%; from about 1 to about 10 wt.%, from about 1 to about 8 wt.%, from about 1 to about 6 wt.%, from about 1 to about 4 wt.%, from about 1 to about 2 wt.%; from about 2 to about 10 wt.%, from about 2 to about 8 wt.%, from about 2 to about 6 wt.%, from about 2 to about 4 wt.%; from about 3 to about 10 wt.%, from about 3 to about 8 wt.%, from about 3 to about 6 wt.%; from about 3 to about 6 wt.%. wt.%, about 3 to about 4 wt.%; about 4 to about 10 wt.%; about 4 to about 8 wt.%; about 4 to about 6 wt.%; about 6 to about 10 wt.%; about 6 to about 8 wt.%; about 8 to about 10 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0091] The one or more basic amino acids may be selected from naturally occurring basic amino acids such as arginine, lysine, and histidine, as well as non-naturally occurring basic amino acids having a carboxyl and amino group in their molecules. These amino acids are water-soluble and provide an aqueous solution with a pH of 7 or higher. The one or more basic amino acids may be selected from lysine, arginine, citrulline, ornithine, and combinations of two or more thereof. For example, a personal care composition may contain one or more of L-lysine, L-arginine, D-lysine, D-glycine, or combinations of two or more thereof. In at least one embodiment, the basic amino acid is selected from L-glycine, L-arginine, and combinations thereof. In some embodiments, the only amino acid in the oral care composition is a basic amino acid, as disclosed herein.

[0092] Examples of additional amino acids that may be incorporated into or excluded from oral care compositions include glycine, serine, citrulline, ornithine, creatine, histidine, diaminobutyric acid, diaminopropionic acid, their salts, or combinations thereof. Additionally or alternatively, oral care compositions may contain neutral amino acids selected from the group consisting of: alanine, aminobutyric acid, asparagine, cysteine, cystine, glutamine, glycine, hydroxyproline, isoleucine, leucine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, and combinations thereof.

[0093] Oral care compositions may contain bicarbonates, carbonates, or combinations thereof. The bicarbonates, carbonates, or combinations thereof may be in the form of salts having cations selected from potassium, sodium, and calcium. Examples of bicarbonates, carbonates, or combinations thereof that may be incorporated into or are not included in oral care compositions include sodium bicarbonate, potassium bicarbonate, potassium carbonate, calcium carbonate, or combinations thereof.

[0094] The total amount of bicarbonate and / or carbonate in the oral care composition may be from about 0.1 to about 4 wt.%, from about 0.1 to about 2.5 wt.%, from about 0.1 to about 2 wt.%, from about 0.1 to about 1.5 wt.%, from about 0.1 to about 1.25 wt.%, from about 0.1 to about 1 wt.%, from about 0.1 to about 0.75 wt.%, from about 0.1 to about 0.5 wt.%, from about 0.1 to about 0.4 wt.%, from about 0.1 to about 0.3 wt.%; from about 0.2 to about 4 wt.%, from about 0.2 to about 2.5 wt.%, from about 0.2 to about 2 wt.%, from about 0.2 to about 1.5 wt.%, from about 0.2 to about 1.25 wt.%, from about 0.2 to about 1 wt.%, from about 0.2 to about 0.75 wt.%, from about 0.2 to about 0.5 wt.%; from about 0.35 to about 4 wt.%, from about 0.35 to about 2.5 wt. wt.%, about 0.35 to about 2 wt.%, about 0.35 to about 1.5 wt.%, about 0.35 to about 1.25 wt.%, about 0.35 to about 1 wt.%, about 0.35 to about 0.75 wt.%, about 0.35 to about 0.5 wt.%; about 0.5 to about 4 wt.%, about 0.5 to about 2.5 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1.5 wt.%, about 0.5 to about 1.25 wt.%, about 0.5 to about 1 wt.%, about 0.5 to about 0.75 wt.%; about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2.5 wt.%, about 1 to about 2 wt.%, about 1 to about 1.5 wt.%, about 1 to about 1.25 wt.%; about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2.5 wt. wt.%, about 1.5 to about 2 wt.%; about 2 to about 4 wt.%; about 2 to about 3 wt.%; about 2 to about 2.5 wt.%; about 2.5 to about 4 wt.%; about 2.5 to about 3 wt.%; about 3 to about 4 wt.%; or any range or subrange thereof, based on the total weight of the oral care composition.

[0095] Oral care compositions may contain hydroxides. Examples of hydroxides that may be included in oral care compositions, or not included in some cases, include sodium hydroxide, calcium hydroxide, magnesium hydroxide, and potassium hydroxide. The total amount of hydroxide in the oral care composition may be from about 0.1 to about 4 wt.%, from about 0.1 to about 2.5 wt.%, from about 0.1 to about 2 wt.%, from about 0.1 to about 1.5 wt.%, from about 0.1 to about 1.25 wt.%, from about 0.1 to about 1 wt.%, from about 0.1 to about 0.75 wt.%, from about 0.1 to about 0.5 wt.%, from about 0.1 to about 0.4 wt.%, from about 0.1 to about 0.3 wt.%; from about 0.2 to about 4 wt.%, from about 0.2 to about 2.5 wt.%, from about 0.2 to about 2 wt.%, from about 0.2 to about 1.5 wt.%, from about 0.2 to about 1.25 wt.%, from about 0.2 to about 1 wt.%, from about 0.2 to about 0.75 wt.%, from about 0.2 to about 0.5 wt.%; from about 0.35 to about 4 wt.%, from about 0.35 to about 2.5 wt. wt.%, about 0.35 to about 2 wt.%, about 0.35 to about 1.5 wt.%, about 0.35 to about 1.25 wt.%, about 0.35 to about 1 wt.%, about 0.35 to about 0.75 wt.%, about 0.35 to about 0.5 wt.%; about 0.5 to about 4 wt.%, about 0.5 to about 2.5 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1.5 wt.%, about 0.5 to about 1.25 wt.%, about 0.5 to about 1 wt.%, about 0.5 to about 0.75 wt.%; about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2.5 wt.%, about 1 to about 2 wt.%, about 1 to about 1.5 wt.%, about 1 to about 1.25 wt.%; about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2.5 wt. wt.%, about 1.5 to about 2 wt.%; about 2 to about 4 wt.%; about 2 to about 3 wt.%; about 2 to about 2.5 wt.%; about 2.5 to about 4 wt.%; about 2.5 to about 3 wt.%; about 3 to about 4 wt.%; or any range or subrange thereof, based on the total weight of the oral care composition.

[0096] Oral care compositions typically contain a certain amount of water. The amount of water present in an oral care composition may be about 10 wt.% or more, about 15 wt.% or more, about 20 wt.% or more, about 25 wt.% or more, about 30 wt.% or more, about 35 wt.% or more, or any range or subrange thereof (e.g., about 10 to 35 wt.%), based on the total weight of the oral care composition. In some embodiments, the oral care composition comprises water, preferably in an amount of, for example, about 10 to about 45 wt.%, about 10 to about 40 wt.%, about 10 to about 35 wt.%, about 10 to about 32 wt.%, about 10 to about 29 wt.%, about 10 to about 26 wt.%, about 10 to about 23 wt.%, about 10 to about 17 wt.%; about 15 to about 45 wt.%, about 15 to about 40 wt.%, about 15 to about 35 wt.%, about 15 to about 32 wt.%, about 15 to about 29 wt.%, about 15 to about 26 wt.%, about 15 to about 23 wt.%, about 15 to about 19 wt.%; about 19 to about 45 wt.%, about 19 to about 40 wt.%, about 19 to about 35 wt.%, about 19 to about 32 wt.%, about 19 to about 29 wt.%, about 19 to about 26 wt.%, about 19 to about 23 wt.%. wt.%; about 22 to about 45 wt.%, about 22 to about 40 wt.%, about 22 to about 35 wt.%, about 22 to about 32 wt.%, about 22 to about 29 wt.%, about 22 to about 26 wt.%; about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 to about 35 wt.%, about 25 to about 32 wt.%, about 25 to about 29 wt.%; about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 35 wt.%, about 28 to about 32 wt.%; about 31 to about 45 wt.%, about 31 to about 40 wt.%, about 31 to about 35 wt.%; about 34 to about 45 wt.%, about 34 to about 40 wt.%, about 37 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0097] The oral care composition may contain a potassium source, preferably in an effective amount. The amount of potassium source may be from about 0.1 to about 6 wt.%, based on the total weight of the oral care composition. For example, oral care compositions may contain a potassium source in the following amounts: about 0.1 to about 6 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1.5 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%, about 0.3 to about 1.5 wt.%, about 0.3 to about 1 wt.%; about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1.5 wt.%, about 0.5 to about 1 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.%. wt.%, about 0.9 to about 1.5 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.%; about 1.5 to about 5 wt.%; about 1.5 to about 4 wt.%; about 1.5 to about 3 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.%; about 3 to about 6 wt.%; about 3 to about 5 wt.%; about 4 to about 6 wt.%; about 4 to about 5 wt.%; about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0098] The potassium source can be a potassium ion source. Potassium sources typically comprise potassium nitrate, potassium citrate, or combinations thereof. Preferably, the oral care composition comprises potassium nitrate. In at least one embodiment, the potassium ion source is substantially composed of potassium nitrate or is composed of potassium nitrate.

[0099] Additionally or alternatively, the oral care composition may contain one or more nitrate sources (e.g., nitrate ion sources), preferably present in an effective amount. The nitrate source may comprise or consist of a nitrate ion source. The amount of nitrate source (e.g., nitrate ion source) present in the oral care composition may be from about 0.1 to about 8 wt.%, based on the total weight of the oral care composition. In some cases, the amount of a nitrate source (e.g., a nitrate ion source) in the oral care composition may be from about 0.1 to about 6 wt.%, from about 0.1 to about 4 wt.%, from about 0.1 to about 3 wt.%, from about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, from about 0.3 to about 4 wt.%, from about 0.3 to about 3 wt.%, from about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, from about 0.6 to about 4 wt.%, from about 0.6 to about 3 wt.%, from about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, from about 0.9 to about 4 wt.%, from about 0.9 to about 3 wt.%, from about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, from about 1.2 to about 4 wt.%, from about 1.2 to about 3 wt.%, from about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, from about 1.5 to about 4 wt.%, from about 1.5 to about 3 wt.%; wt.%; 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.%; about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; about 5 to about 8 wt.%, about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0100] The one or more nitrate sources (e.g., nitrate ion sources) may be in the form of salts or ions derived therefrom, including nitrates, for example, selected from alkali metal or alkaline earth metal nitrates. Examples of nitrate sources (e.g., nitrate ion sources) include lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, or combinations of two or more thereof. In at least one preferred embodiment, the nitrate source comprises potassium nitrate.

[0101] Oral care compositions can be formulated to have a molar ratio of nitrate ions to stannous ions (both measured as free ions) of about 2:1 or less. For example, the molar ratio of nitrate ions to stannous ions (both measured as free ions) in an oral care composition can be 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; about 0.7:1 to about 2:1, about 0.7:1 to about 1.8:1. The ratios are approximately 0.7:1 to approximately 1.6:1, approximately 0.7:1 to approximately 1.4:1, approximately 0.7:1 to approximately 1.2:1, approximately 0.7:1 to approximately 1:1; approximately 0.9:1 to approximately 2:1, approximately 0.9:1 to approximately 1.8:1, approximately 0.9:1 to approximately 1.6:1, approximately 0.9:1 to approximately 1.4:1, approximately 0.9:1 to approximately 1.2:1, approximately 0.9:1 to approximately 1:1, or any range or subrange thereof. In some embodiments, the oral care composition is formulated to have a molar ratio of approximately 1:1 of nitrate ions to stannous ions (both measured as free ions).

[0102] The oral care composition may contain one or more polyols. The amount of said one or more polyols in the oral care composition may be from about 10 to about 58 wt.%, based on the total weight of the oral care composition. For example, the total amount of polyols present in the oral care composition may be about 10 to about 55 wt.%, about 10 to about 45 wt.%, about 10 to about 37 wt.%, about 10 to about 31 wt.%, about 10 to about 25 wt.%; about 15 to about 60 wt.%, about 15 to about 55 wt.%, about 15 to about 45 wt.%, about 15 to about 37 wt.%, about 15 to about 31 wt.%, about 5 to about 25 wt.%; about 20 to about 58 wt.%, about 20 to about 54 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.%; about 25 to about 58 wt.%, about 25 to about 54 wt.%, about 25 to about 50 wt.%, about 25 to about 45 wt.%; 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.%; about 28 to about 58 wt.%, about 28 to about 54 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.%; about 31 to about 58 wt.%, about 31 to about 54 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.%; about 34 to about 58 wt.%, about 34 to about 54 wt.%, about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; about 37 to about 58 wt.%; about 34 to about 58 wt.%; about 34 to about 50 wt.%; about 34 to about 45 wt.%; ...8 wt.%; about 34 to about 50 wt.%; about 34 to about 4 wt.%, about 37 to about 54 wt.%, about 37 to about 50 wt.%, about 37 to about 45 wt.%; about 40 to about 58 wt.%, about 40 to about 54 wt.%, about 40 to about 50 wt.%, about 40 to about 45 wt.%; about 43 to about 58 wt.%, about 43 to about 54 wt.%, about 43 to about 50 wt.%, about 43 to about 48 wt.%; about 45 to about 58 wt.%, about 45 to about 54 wt.%, about 45 to about 50 wt.%, about 45 to about 48 wt.%, about 48 to about 58 wt.%, about 48 to about 54 wt.%, about 48 to about 50 wt.%, about 52 to about 58 wt.%, about 52 to about 56 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0103] The polyol may be selected from glycols or compounds having multiple hydroxyl groups. The one or more polyols may be liquid at ambient temperature (25°C). In some preferred embodiments, the polyol comprises glycerol, glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), block copolymers of PPG and PEG, sugars (e.g., fructose, glucose, sucrose, and mixtures of sugars such as honey), or combinations of two or more thereof. For example, an oral care composition may comprise maltitol, mannitol, sorbitol, xylitol, polypropylene glycol (PPG), polyethylene glycol (PEG), block copolymers of PPG and PEG, or combinations of two or more thereof. Polyols can be humectants, including, for example, glycols, sorbitol, glycerol, inositol, maltitol, mannitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), sugars, polypropylene glycol-polyethylene glycol block copolymers, and combinations of two or more thereof.

[0104] In some cases, oral care compositions contain one or more C2-C derivatives. 32 The polyols in the group consisting of polyols. The one or more polyols may have 2 to 32 carbon atoms, 3 to 16 carbon atoms, or 3 to 12 carbon atoms. For example, an oral care composition may contain ethylene glycol, propylene glycol, butylene glycol, hexanediol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, or combinations of two or more thereof. Other non-limiting examples of polyols that may optionally be included in oral care products include and / or may be selected from alkanediols such as glycerol, 1,2,6-hexanediol, trimethylolpropane, ethylene glycol, propylene glycol, butanediol, pentanediol, hexanediol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-buten-1,4-diol, 2-ethyl-1,3-hexanediol, 2-methyl-2,4-pentanediol, octyl ethylene glycol, 1,2-hexanediol, 1,2-pentanediol, and 4-methyl-1,2-pentanediol; glycol ethers (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 monoisopropyl ether, diethylene glycol monoisopropyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-tert-butyl ether, diethylene glycol mono-tert-butyl ether, 1-methyl-1-methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-tert-butyl ether, propylene glycol mono-n-propyl ether, propylene glycol monoisopropyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol monoisopropyl ether, sorbitol, anhydrosorbitol, triacetin, and mixtures of two or more thereof.

[0105] Additionally or alternatively, the oral care composition may comprise a polyol with a molecular weight of about 100 to 5000 g / mol. For example, the polyol may comprise polyethylene glycol, polypropylene glycol, block polymers of polyethylene glycol and polypropylene glycol, or combinations of two or more thereof. In some embodiments, the polyol comprises polypropylene glycol, polypropylene glycol, and / or block polymers 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 polyethylene glycol, such as polyethylene glycol 600. In some embodiments, the oral care composition comprises one or more polyethylene glycols, such as polyethylene glycol with a molecular weight range of 200 to 800. For example, the composition may contain one or more of polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol 600 or polyethylene glycol 800.

[0106] In some embodiments, the oral care composition comprises two or more polyols. In some cases, at least one polyol is selected from glycerol and sorbitol. In at least one embodiment, the oral care composition comprises glycerol and sorbitol.

[0107] Organic acid buffering systems may be included in certain embodiments of the oral care composition. The organic acid buffering system may contain citric acid and / or its salts. For example, the oral care composition may contain a salt of citric acid, such as sodium citrate. Examples of sodium citrate include trisodium citrate, disodium citrate, and monosodium citrate. In some embodiments, the oral care composition contains citric acid and its salts (e.g., sodium citrate).

[0108] Oral care compositions can be formulated to have an organic acid buffering system comprising citric acid and sodium citrate (such as trisodium citrate, disodium citrate, monosodium citrate, or combinations thereof) in a weight ratio of about 1:3 to about 1:8. For example, the weight ratio of citric acid to sodium citrate can be about 1:3 to about 1:8, about 1:3 to about 1:7, about 1:3 to about 1:6, about 1:3 to about 1:5, about 1:3 to about 1:4; about 1:4 to about 1:8, about 1:4 to about 1:7, about 1:4 to about 1:6, about 1:4 to about 1:5; about 1:5 to about 1:8, about 1:5 to about 1:7, about 1:5 to about 1:6; about 1:6 to about 1:8, about 1:6 to about 1:7, or about 1:7 to about 1:8, including any range or subrange thereof.

[0109] In some embodiments, the amount of sodium citrate in the oral care composition is about 0.1 to about 8 wt.%, about 0.1 to about 6 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; about 0.5 to about 8 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 4 wt.%, about 1 to about 2 wt.%; about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 4 wt.%; about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 4 wt.%; about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 6 to about 8 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0110] Additionally or alternatively, the amount of citric acid in the oral care composition may be from about 0.1 to about 4 wt.%, from about 0.1 to about 3 wt.%, from about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, from about 0.3 to about 4 wt.%, from about 0.3 to about 3 wt.%, from about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, from about 0.6 to about 4 wt.%, from about 0.6 to about 3 wt.%, from about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, from about 0.9 to about 4 wt.%, from about 0.9 to about 3 wt.%, from about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, from about 1.2 to about 4 wt.%, from about 1.2 to about 3 wt.%, from about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, from about 1.5 to about 4 wt.%, from about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%; wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%, about 3 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0111] Oral care compositions may contain one or more thickeners other than polyacrylic acid and / or its salts. The amount of thickener other than polyacrylic acid, phosphate ester / acrylate copolymer and / or its salts 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 thickener in an oral care composition, other than polyacrylic acid, phosphate ester / acrylate copolymer and / or its salts, may be about 0.1 to about 6 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; about 0.3 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 0.6 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 0.9 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.%; 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.%; about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%; about 1.5 to about 4 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.%; about 0.9 to about 5 wt.%, about 1.5 to about 4 wt.%; about 0.6 to about 4 wt.%; about 0.6 to about 3 wt.%; about 0.6 to about 2 wt.%; about 0.9 to about 5 wt.%, about 1.5 to about 4 wt.%; about 0.6 to about 4 wt.%; about 0 wt.%, about 1.5 to about 3 wt.%; 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.%; about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; about 5 to about 8 wt.%, about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0112] As described above, in some embodiments, the oral care composition may have a reduced amount of a thickener other than a thickener selected from polyacrylic acid, phosphate ester / acrylate copolymers, their salts, or combinations thereof. For example, the oral care composition may contain a thickener other than polyacrylic acid, or phosphate ester / acrylate copolymers and / or their salts, in an amount of about 0.1 to about 2.5 wt.%, about 0.3 to about 2.5 wt.%, about 0.6 to about 2 wt.%, about 1 to about 2.5 wt.%; about 0.1 to about 2 wt.%, about 0.3 to about 2 wt.%, about 0.6 to about 2 wt.%, about 1 to about 2 wt.%; about 0.1 to about 1.5 wt.%, about 0.3 to about 1.5 wt.%, about 0.6 to about 1.5 wt.%, or any range or subrange thereof, about 0.1 to about 1 wt.%, about 0.3 to about 1 wt.%, about 0.6 to about 1 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0113] Thickeners can be called "thickening agents" or "viscosity modifiers." They are typically included to increase the viscosity of oral care compositions. However, in some cases, certain thickeners provide additional, surprising benefits to oral care compositions.

[0114] Embodiments of the oral care composition may include or exclude one or more thickeners other than polyacrylic acid, phosphate / acrylate copolymers and / or their salts, including those selected from polysaccharides, silica thickeners, acrylates, polymers other than polyacrylic acid, phosphate / acrylate copolymers and / or their salts, and combinations of two or more thereof. Examples of polysaccharides include cellulose, carboxymethyl hydroxyethyl cellulose, cellulose acetate propionate carboxylate, hydroxyethyl cellulose, hydroxyethyl ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl hydroxyethyl cellulose, microcrystalline cellulose, sodium cellulose sulfate, carrageenan, or combinations of two or more thereof. Some embodiments of the oral care composition may also incorporate or exclude natural gums such as gum arabic, gum arabic, xanthan gum, and tragacanth gum. Colloidal magnesium aluminum silicate may also be used as a component of the thickening composition to further improve the texture of the composition. Silica thickeners that form polymeric structures or gels in aqueous media may be present. Silica thickeners are generally different from particulate silica abrasives in both physical and functional terms because silica thickeners are dispersed very finely and provide little or no abrasive action.

[0115] In some embodiments, one or more thickeners comprise polymers selected from polysaccharides, acrylates, polyvinylpyrrolidone, polyitaconate, acrylamide, and combinations thereof. Polyvinylpyrrolidone generally refers to polymers containing vinylpyrrolidone (e.g., N-vinylpyrrolidone, N-vinyl-2-pyrrolidone, and N-vinyl-2-pyrrolidinone) as monomer units. The monomer unit may include a polar imide group, four nonpolar methylene groups, and a nonpolar methane group. The average molecular weight of polyvinylpyrrolidone can range from 5,000 to 100,000, preferably from 5,000 to 50,000. Polyvinylpyrrolidones with average molecular weights of 10,000, 30,000, and 40,000 are available from Sigma Chemical Co., GAF Corporation, and Sigma Chemical Co. In some embodiments, the polymer comprises cross-linked polyvinylpyrrolidone (cross-linked PVP). In at least one embodiment, the polymer is composed of polyvinylpyrrolidone.

[0116] Examples of acrylates that may be included in oral care compositions include, for example, 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 combinations of two or more thereof.

[0117] The acrylate may be selected from diacrylates. In some embodiments, the oral care composition comprises a diacrylate selected from 1,4-butanediol, 1,6-hexanediol, tetraethylene glycol, tripropylene glycol, ethoxylated bisphenol A, and combinations of two or more thereof. The triacrylate monomers include trimethylolpropane (ethoxylated), glycerylpropoxy, and pentaerythritol.

[0118] Acrylic esters also 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-butanediol methacrylate, 1,6-hexanediol methacrylate, trimethylolpropane methacrylate, ethoxyethyl methacrylate, trifluoroethyl methacrylate, or combinations of two or more thereof.

[0119] Examples of acrylamide include, but are not limited to, acrylamide, methacrylamide, and di(C1-C2)acrylamide. 30 )alkylacrylamide and di(C1-C 30Alkylmethylacrylamides, such as those with methyl, ethyl, propyl, butyl, pentyl, hexyl, etc. Suitable N-substituted acrylamides 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-hydroxymethylacrylamide, N-isopropylacrylamide, N-methacrylamide, N,N'-methylenebisacrylamide, N-isobutoxymethylacrylamide, N,N-dimethylacrylamide, and 2-acrylamido-2-methylpropanesulfonic acid. In some embodiments, the oral care composition does not contain one or more of the thickeners listed above, other than polyacrylic acid and / or its salts.

[0120] Oral care compositions may contain a fluoride source (e.g., a fluoride ion source). The fluoride source may contain or consist of a fluoride ion source. The fluoride source may be present in an effective amount. In some cases, the amount of the fluoride source (e.g., a fluoride ion source) in the oral care composition is from about 0.01 to about 5 wt.%, based on the total weight of the oral care composition. For example, the amount of a fluoride source (e.g., a fluoride ion source) is 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.%; 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.%; 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 0.3 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 0.6 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.%; 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.%; 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.%; about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; 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.

[0121] The fluoride source (e.g., a fluoride ion source) may be selected from soluble fluoride ion salts. For example, the fluoride source may include 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, dialcyldimethylammonium fluoride, hexadecylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine stannous fluoride, potassium glycine fluoride, glycine hydrofluoride, amine fluorides, or combinations of two or more thereof. In some embodiments, the fluoride source (e.g., a fluoride ion source) includes sodium fluoride, sodium monofluorophosphate, or combinations thereof. Further examples of fluoride ion sources are disclosed in U.S. Patent Nos. 3,535,421, 4,885,155 and 3,678,154, the disclosures of which are incorporated herein by reference in their entirety.

[0122] In some embodiments, the oral care composition of this disclosure may contain stannous fluoride and a fluoride ion source or fluoride supplier in an amount sufficient to deliver a total of 25 ppm to 25,000 ppm (mass fraction) of fluoride ions, typically at least 500 ppm, such as about 500 to about 2,000 ppm, about 800 to about 1,800 ppm, about 1,000 to about 1,600 ppm, about 1,200 to about 1,550 ppm, or about 1,450 ppm.

[0123] Oral care compositions may contain one or more abrasives, for example, in amounts of about 5 wt.% to about 35 wt.% based on the total weight of the oral care composition. In some embodiments, the one or more abrasives are present in amounts of 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.%; 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.%; 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.%; about 18 to about 35 wt.%, about 18 to about 30 wt.%, about 18 to about 25 wt.%, about 18 to about 21 wt.%; about 21 to about 35 wt.%, about 21 to about 30 wt.%; about 21 to about 30 wt.%. wt.%, about 21 to about 25 wt.%; about 24 to about 35 wt.%; about 24 to about 30 wt.%; 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.

[0124] The one or more abrasives may include: silica, silicates, silicon, alumina (including calcined aluminum oxide), aluminosilicates such as bentonite, zeolite, kaolin, and mica, siliceous clay 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 carboxymethyl cellulose, and combinations and derivatives thereof. For example, the one or more abrasives may be selected from silica including gels and precipitates, calcium carbonate, dicalcium dihydrate orthophosphate, calcium pyrophosphate, tricalcium phosphate, polymetaphosphate, insoluble sodium polymetaphosphate, hydrated alumina, resin abrasive materials such as particulate condensation products of urea and formaldehyde, and combinations thereof.

[0125] As used herein, “mica” refers to any of a group of hydrated aluminum silicate minerals having a platy morphology and / or perfect matrix (mica-like) cleavage. Mica can be, for example, platy mica, fragmented mica, or fragmented mica, such as muscovite, biotite, or phlogopite-type mica. Abrasives can be selected from insoluble phosphates, such as orthophosphates, polymetaphosphates, pyrophosphates, and combinations thereof. Synthetic silica includes silica gel and precipitated silica, which are prepared by neutralizing aqueous silicate solutions with strong inorganic acids. Abrasives containing silica can be used in certain embodiments of oral care compositions. In some embodiments, the oral composition may contain a particularly effective combination of silica abrasive particle types. For example, the abrasive is selected from high-cleanliness silica.

[0126] Oral care compositions may comprise an abrasive system containing two or more abrasives. For example, an abrasive system may contain 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 abrasives and / or one or more polishing abrasives. As understood by those skilled in the art, a single abrasive species typically performs at least some cleaning and polishing simultaneously. However, particles are generally classified in the art according to their primary effect on the target oral surface. Generally, "polishing abrasives" are considered to be relatively small particles with high hardness, while abrasives with relatively large particle size and low hardness are considered "cleaning abrasives." In some embodiments, the oral care composition comprises two or more silica-containing abrasives. In some embodiments, the first abrasive is selected to be a harder and smaller abrasive, such as a higher-grade cleaning and / or polishing abrasive, and the second abrasive is a typical cleaning abrasive. In some embodiments, the oral care composition comprises 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 for all purposes.

[0127] Oral care compositions may contain surfactants. One or more surfactants may be present in an amount of about 0.5 to about 8 wt.%, based on the total weight of the oral care composition. For example, an oral care composition may comprise one or more surfactants in amounts of 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.%; or about 1 to about 9 wt.%, about 1 to about 8 wt.%, about 1 to about 7 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; 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.%; 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.%; wt.%, about 2.5 to about 4 wt.%, about 2.5 to about 3.5 wt.%; 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.%; 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.%; about 5 to about 9 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; about 7 to about 9 wt.%, about 7 to about 8 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0128] The one or more surfactants may be selected from anionic surfactants, such as sulfate-based anionic surfactants, sulfonated monoglycerides of fatty acids, acylhydroxyethyl sulfonates, acylsarcosinates, acyl taurate, or combinations thereof. Examples of sulfate-based anionic surfactants include ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium cocoyl sulfate, ammonium cocoyl sulfate, or combinations of two or more thereof. The one or more anionic surfactants may be selected from non-sulfate-based anionic surfactants, such as sulfonated monoglycerides of fatty acids, acylhydroxyethyl sulfonates, acylsarcosinates, acyl taurate, or combinations of two or more thereof. For example, anionic surfactants can be selected from water-soluble salts of monoglycerides of higher fatty acids, such as sodium salts of monoglycerides of hydrogenated coconut oil fatty acids; sodium N-methyl N-cocoyl taurate; sodium cococo-glyceride sulfate; higher alkyl sulfates, such as sodium lauryl sulfate; higher alkyl ether sulfates, such as sodium lauryl ether-2 sulfate; higher alkyl aryl sulfonates, such as sodium dodecylbenzene sulfonate; higher alkyl sulfoacetates, such as sodium lauryl sulfoacetate; higher fatty acid esters of 1,2-dihydroxypropane sulfonate; sulfocolaurate (N-2-ethyl laurate potassium sulfoacetamide); and sodium lauryl sarcosinate.

[0129] The one or more surfactants may be selected from nonionic, amphoteric, and cationic surfactants. Nonionic surfactants used herein may include those compounds produced by the condensation of an epoxy alkyl group (which is inherently hydrophilic) with an organic hydrophobic compound, which may inherently be aliphatic or alkyl aromatic. Non-limiting examples of suitable nonionic surfactants include polyethylene glycol sorbitan ester (sold under the trade name Tween), polyethylene glycol 40 hydrogenated castor oil, fatty alcohol polyethylene glycol ethers, ethylene oxide condensates of fatty alcohols, long-chain tertiary amine oxides, long-chain tertiary phosphaine oxides, lauryl glucoside (sold under the trade name Plantaren 1200 UP), and long-chain dialkyl sulfoxides. Suitable nonionic surfactants with an HLB of 7 or greater include sucrose laurate, sucrose cocoate, sucrose stearate; stearyl alcohol polyether 20, 21, or 100, and PEG 20 sorbitan monostearate (commercially available Tween 60). In at least one embodiment, the nonionic surfactant is selected from polyethoxylated sorbitol esters, particularly polyethoxylated sorbitol monoesters; condensates of ethylene oxide and propylene oxide (poloxamers), such as those sold by BASF-Wyandotte under the trade name PLURONIC; condensates of propylene glycol; polyethoxylated hydrogenated castor oil, such as cremophors; and dehydrated sorbitol fatty acid esters.

[0130] Non-limiting examples of amphoteric surfactants include, for example, long-chain imidazoline derivatives, such as products marketed by Miranol under the trade name “Miranol C2M”; long-chain alkyl betaines, such as products marketed by Albright+Wilson under the trade name “EmpigenBB”; and long-chain alkyl amide alkyl betaines, such as cocamidopropyl betaine, and mixtures thereof.

[0131] Oral care compositions may comprise an amphoteric surfactant selected from derivatives of aliphatic secondary and tertiary amines, wherein the aliphatic group may be linear or branched, and one of the aliphatic substituents contains about 8 to about 18 carbon atoms, and one contains an anionic water-solubilizing group, such as a carboxylate, sulfonate, sulfate, phosphate, or phosphonate group. Other exemplary amphoteric surfactants are betaines, such as cocamidopropyl betaine, lauryl dimethyl betaine (sold under the trade name MacatLB), cetyl dimethyl betaine, and coacromamphodiacetate. Further amphoteric and nonionic surfactants can be found in U.S. Patent No. 4,051,234, which is incorporated herein by reference in its entirety for all purposes.

[0132] Examples of cationic surfactants that may be present in oral care compositions include hexadecylpyridinium chloride, cocamidopropyl PG dimethylammonium chloride phosphate (Phospholipid CDM), myristamidopropyl PG dimethylammonium chloride phosphate (Phospholipid PTM), stearamidopropyl PG dimethylammonium chloride phosphate (Phospholipid SV), cetyl chloride (Catemol WPC), and other suitable cationic materials. The cationic surfactant may also be D,L-2-pyrrolidone-5-carboxylic acid.

[0133] The oral care composition may contain a zinc source. The zinc source may be a zinc ion source. The amount of zinc source present in the oral care composition may be from about 0.1 to about 8 wt.%, based on the total weight of the oral care composition. For example, the amount of zinc source present in the oral care composition may be from about 0.1 to about 6 wt.%, from about 0.1 to about 5 wt.%, from about 0.1 to about 4 wt.%, from about 0.1 to about 3 wt.%, from about 0.1 to about 2 wt.%, from about 0.1 to about 1 wt.%; from about 0.3 to about 8 wt.%, from about 0.3 to about 6 wt.%, from about 0.3 to about 5 wt.%, from about 0.3 to about 4 wt.%, from about 0.3 to about 3 wt.%, from about 0.3 to about 2 wt.%; from about 0.6 to about 8 wt.%, from about 0.6 to about 6 wt.%, from about 0.6 to about 5 wt.%, from about 0.6 to about 4 wt.%, from about 0.6 to about 3 wt.%, from about 0.6 to about 2 wt.%; from about 0.9 to about 8 wt.%, from about 0.9 to about 6 wt.%, from about 0.9 to about 5 wt.%, from about 0.9 to about 4 wt.%, from about 0.9 to about 3 wt.%, from about 0.9 to about 2 wt.%; wt.%; 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.%; 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.%; 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.%; about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; 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.

[0134] The zinc source can be in the form of a salt. For example, the zinc source may comprise one or more zinc salts selected from: zinc sulfate, zinc chloride, zinc acetate, zinc phenolsulfonate, 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 combinations 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 combinations of two or more thereof.

[0135] Oral care compositions may contain two or more, three or more, four or more, five or more, or six or more zinc sources. For example, an oral care composition may contain 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 contains zinc oxide, zinc citrate, zinc phosphate, or a combination of two or more thereof.

[0136] Oral care compositions can be formulated in a weight ratio of zinc oxide to zinc citrate of about 1.5:1 to about 4.5:1. For example, the weight ratio of zinc oxide to zinc citrate can be about 1.5:1 to about 4.5:1, about 1.5:1 to about 4:1, about 1.5:1 to about 3.5:1, about 1.5:1 to about 3:1, about 1.5:1 to about 2.5:1; about 2:1 to about 4.5:1, about 2:1 to about 4:1, about 2:1 to about 3.5:1, about 2:1 to about 3:1; about 2.5:1 to about 4.5:1, about 2.5:1 to about 4:1, about 2.5:1 to about 3.5:1; about 3:1 to about 4.5:1, about 3:1 to about 4:1, or any range or subrange thereof. In some embodiments, the weight ratio of zinc oxide to zinc citrate is about 2:1, about 2.5:1, about 3:1, about 3.5:1, about 4:1, or a range thereof.

[0137] In some embodiments, the oral care composition may contain one or more sweeteners. The oral care composition may contain calorie sweeteners and / or calorie-free sweeteners. Examples of calorie-free sweeteners include saccharin, such as sodium saccharin, acesulfame potassium, neotame, cyclohexylsulfamic acid, or sucralose; naturally occurring high-sweetness sweeteners, such as kiwifruit protein, steviol, or glycyrrhizin; or sugar alcohols, such as sorbitol, xylitol, maltitol, and mannitol. Examples of calorie sweeteners include sugars, such as fructose, glucose, sucrose, and high-fructose corn syrup.

[0138] The amount of one or more sweeteners in the oral care composition may be from about 0.1 to about 50 wt.%, based on the total weight of the oral care composition. For example, the total amount of sweetener in an oral care composition may be from about 0.1 to about 40 wt.%, from about 0.1 to about 30 wt.%, from about 0.1 to about 20 wt.%, from about 0.1 to about 10 wt.%, from about 0.1 to about 5 wt.%, from about 0.1 to about 3 wt.%; from about 1 to about 50 wt.%, from about 1 to about 40 wt.%, from about 1 to about 30 wt.%, from about 1 to about 20 wt.%, from about 1 to about 10 wt.%, from about 1 to about 5 wt.%, from about 1 to about 3 wt.%; from about 5 to about 50 wt.%, from about 5 to about 40 wt.%, from about 5 to about 30 wt.%, from about 5 to about 20 wt.%, from about 5 to about 10 wt.%; from about 10 to about 50 wt.%, from about 10 to about 45 wt.%, from about 10 to about 40 wt.%, from about 10 to about 35 wt.%, from about 10 to about 30 wt.%, from about 10 to about 25 wt.%; from about 15 to about 50 wt.%. 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.%; 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.%; 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.%; about 28 to about 50 wt.%, about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 37 wt.%; wt.%, about 28 to about 34 wt.%, about 28 to about 31 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.%; about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; 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.

[0139] In some embodiments, the oral care composition is preferably substantially free of or free of calorie sweeteners. For example, the oral care composition 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 of calorie sweeteners, 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 calorie sweeteners, based on the weight of the oral care composition.

[0140] The oral care compositions disclosed herein may include flavoring agents. Flavoring agents are typically incorporated into the oral care composition at a concentration of about 0.01 to about 3 wt.% of the oral care composition by weight. For example, the amount of flavoring agent present in the oral care composition may be 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.%; about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%; about 0.5 to about 1 wt.%; about 1 to about 3 wt.%, about 1 to about 2 wt.%; about 2 to about 3 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0141] Suitable flavoring agents include, but are not limited to, essential oils and various flavoring aldehydes, esters, alcohols, and similar substances. Examples of essential oils include spearmint oil, peppermint oil, wintergreen oil, sassafras oil, clove oil, sage oil, eucalyptus oil, marjoram oil, cinnamon oil, lemon oil, lime oil, grapefruit oil, and orange oil. Also useful chemicals are menthol, carvone, and anethole. Other flavoring agents may include, but are not limited to, menthol, artificial vanilla, cinnamon derivatives, and various fruit spices, spearmint oil, peppermint oil, cinnamon oil, wintergreen oil (methyl salicylate), clove oil, laurel oil, anise oil, eucalyptus oil, thyme oil, cedarwood leaf oil, nutmeg oil, sage oil, bitter almond oil, cassia oil, and combinations of two or more thereof.

[0142] Oral care compositions may contain one or more colorants. Exemplary colorants may include natural or uncertified colors from natural sources, or colors with certified color effects. In some embodiments, colorants may include dyes, certified aluminum lakes, or colors derived from natural sources. Colorants may be water-based, oil-based, or dry. Colorants may be primary colors, mixed colors, or discontinuous mixed colors, such as confetti. The concentration of colorants in an oral care composition may be trace to about 0.6 wt.%, 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.

[0143] Oral care compositions may contain 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 contained to decrease the pH of the oral care composition. Examples of suitable acids for decreasing the pH of an oral care composition include, but are not limited to, citric acid, acetic acid, etc. Oral care compositions may contain one or more bases, such as sodium hydroxide, potassium hydroxide, etc., to increase the pH of the oral care composition. Additional or alternative acids and bases suitable for adjusting the pH of oral care compositions are readily known to those skilled in the art.

[0144] The amount of pH adjuster in an 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 pH adjuster may be from about 0.05 to about 20 wt.%, based on the total weight of the oral care composition. In some cases, the total amount of pH adjuster may be from about 0.05 to about 15 wt.%, from about 0.1 to about 10 wt.%, or from about 0.12 to about 5 wt.%, including ranges and subranges therein, based on the total weight of the oral care composition.

[0145] The pH of the oral care composition may be 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; 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; about 6 to about 10, about 6 to about 9, about 6 to about 8, or about 6 to about 7; about 7 to about 10, about 7 to about 9, or about 7 to about 8, including any range and subrange therein, for example, measured as a 10 wt.% solution. The pH of the solution (e.g., any of the aforementioned pH ranges) may be measured as a 10 wt.% solution, wherein the solution contains 10 wt.% of the oral care composition, the remainder being water.

[0146] According to another aspect, a method for preparing an oral care composition is provided, the method comprising crosslinking polyacrylic acid and / or its salts to form crosslinked polyacrylic acid and / or its salts; and chelating a stannous ion source with the crosslinked polyacrylic acid and / or its salts. The method may include crosslinking the polyacrylic acid and / or its salts with any of the polyphosphates, basic amino acids, bicarbonates, carbonates, and / or hydroxides disclosed herein, and for example, in the amounts disclosed herein. In some cases, the polyacrylic acid and / or its salts are crosslinked with polyphosphates, basic amino acids, or combinations thereof (as disclosed above). The step of crosslinking the polyacrylic acid and / or its salts may include neutralizing the polyacrylic acid and / or its salts.

[0147] The method includes chelating a stannous ion source with crosslinked polyacrylic acid and / or its salts. In some embodiments, the stannous ion source is mixed with crosslinked polyacrylic acid and / or its salts, followed by the addition of a metal ion source (such as from a fluoride ion source), a surfactant, a potassium source, a nitrate source, and / or a zinc source, including those disclosed herein. For example, the stannous ion source may be the first component mixed with the crosslinked polyacrylic acid and / or its salts.

[0148] The method may further include adding one or more additional components to the crosslinked polyacrylic acid and / or its salts (e.g., after the stannous ion source is mixed and / or chelated with the crosslinked polyacrylic acid and / or its salts). The additional components may be selected from any of the aforementioned potassium sources, nitrate sources (e.g., nitrate ion sources), fluoride sources (e.g., fluoride ion sources), polyols, abrasives, surfactants, thickeners other than polyacrylic acid and / or its salts, zinc sources, sweeteners, flavorings, colorings, and / or water. Example Example 1

[0149] Two non-limiting example compositions (Example A and Example B) and two comparative compositions (Comparative 1 and Comparative 2) were prepared in the form of dental cleaning agents. The formulations of Example Compositions A and B and Comparative Compositions 1 and 2 are shown in Table 1 (below). Table 1

[0150] Example 2

[0151] Examples A and B, as well as comparative compositions 1 and 2, were evaluated to assess the amount of soluble tin(II) under accelerated aging conditions. Samples from examples A and B, and comparative compositions 1 and 2 were stored in an environmentally controlled zone at 60°C for 2 weeks. The amount of soluble tin(II) in each sample was measured before placement in the environmentally controlled zone, after 1 week in the environmentally controlled zone, and after 2 weeks in the environmentally controlled zone. The results of accelerated aging according to this example are summarized in Table 2 (below). Table 2

[0152]

[0153] According to the ICH accelerated aging / stress guidelines, additional samples from Example Compositions A and B, as well as Comparative Compositions 1 and 2, were collected and stored for 13 weeks in an environmentally controlled zone at 40°C and 75% relative humidity (RH). The amount of soluble tin(II) in each sample was measured before placement in the environmentally controlled zone, after 4 weeks, after 8 weeks, and after 13 weeks. Samples of each composition were sealed in representative toothpaste tubes. The results of accelerated aging to assess the stability of soluble tin(II) at 40°C and 75% relative humidity, according to this example, are summarized in Table 3 below. Table 3

[0154] Example 3

[0155] Examples A and B, as well as comparative compositions 1 and 2, were evaluated to assess the amount of soluble tin under different accelerated aging conditions. Specifically, samples from examples A and B, and comparative compositions 1 and 2, were stored for 13 weeks in an environmentally controlled zone at a temperature of 40°C and a relative humidity (RH) of 75%. The amount of soluble tin in each sample was measured before placement in the environmentally controlled zone, after 4 weeks, after 8 weeks, and after 13 weeks. The results of accelerated aging according to this example are summarized in Table 4. Table 4

[0156]

[0157] Without being bound by any particular theory, it is believed that tin preparations with a pH greater than 5 typically exhibit high levels of oxidation and precipitation of soluble tin. Surprisingly advantageously, compositions A and B of the examples maintained high levels of soluble tin and tin(II). Example 4

[0158] Three non-limiting example compositions (Examples CE) were prepared as dental cleaning agents. The formulations of Example Compositions CE are shown in Table 5 below. Table 5

[0159] Example 5

[0160] The Example Composition CE was evaluated to assess the amount of soluble tin(II) under accelerated aging conditions. Samples from each Example Composition CE were stored in an environmentally controlled zone at 60°C for 2 weeks. The amount of soluble tin(II) in each sample was measured before placement in the environmentally controlled zone, after 1 week in the environmentally controlled zone, and after 2 weeks in the environmentally controlled zone. The results of accelerated aging according to this example are summarized in Table 6 below. Table 6

[0161]

[0162] Additional samples from each of the example compositions CE were collected and stored in an environmentally controlled zone at 40°C and 75% relative humidity (RH) for 13 weeks. The amount of soluble tin(II) in each sample was measured before placement in the environmentally controlled zone, after 4 weeks, after 8 weeks, and after 13 weeks. The results of accelerated aging to evaluate the stability of soluble tin(II) according to this example are summarized in Table 7 below. Table 7

[0163] Example 6

[0164] The Example Composition CE was evaluated to assess the amount of soluble tin under different accelerated aging conditions. Specifically, samples from each Example Composition CE were stored for 13 weeks in an environmentally controlled zone at a temperature of 40°C and a relative humidity (RH) of 75%. The amount of soluble tin in each sample was measured before placement in the environmentally controlled zone, after 4 weeks, after 8 weeks, and after 13 weeks. The results of accelerated aging according to this example are summarized in Table 8 (below). Table 8

[0165]

Claims

1. An oral care composition comprising: Yaxiyuan; and Crosslinked polyacrylic acid and / or its salts, The weight ratio of the stannous source in the personal care composition to the crosslinked polyacrylic acid and / or its salt is from about 4:1 to about 1:

4.

2. The oral care composition according to claim 1, further comprising: Approximately 10 wt.% or more water, based on the total weight of the oral care composition.

3. The oral care composition according to any one of the preceding claims, wherein the crosslinked polyacrylic acid and / or its salt is branched polyacrylic acid and / or its salt.

4. The oral care composition according to any one of the preceding claims, wherein the crosslinked polyacrylic acid and / or its salt are crosslinked with allyl sucrose and / or allyl pentaerythritol.

5. The oral care composition according to any one of the preceding claims, wherein the crosslinked polyacrylic acid and / or its salts contain about 56% to about 68% w / w of carboxylic acid groups.

6. The oral care composition according to any one of the preceding claims, wherein the crosslinked polyacrylic acid and / or its salts have an average molecular weight of 7 × 10⁻⁶. 5 Up to 4×10 9 Da.

7. The oral care composition according to any one of the preceding claims, wherein the oral care composition comprises about 2 wt.% or less of natural gums and / or polysaccharides.

8. The oral care composition according to any one of the preceding claims, wherein the stannous source is selected from stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous glycol, and combinations of two or more thereof.

9. The oral care composition according to any one of the preceding claims, further comprising: An alkali metal polyphosphate, selected from pyrophosphate, tripolyphosphate, tetraphosphate, hexametaphosphate, and combinations of two or more thereof, optionally wherein the amount of said alkali metal polyphosphate is from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition.

10. The oral care composition according to any one of the preceding claims, further comprising: The basic amino acid, optionally, is present in an amount of about 0.1 to about 10 wt.%, based on the total weight of the oral care composition.

11. The oral care composition according to any one of the preceding claims, further comprising: The potassium source comprises potassium nitrate, potassium citrate, or a combination thereof, optionally wherein the potassium source is present in an amount of about 0.1 to about 6 wt.%, based on the total weight of the oral care composition.

12. The oral care composition according to any one of the preceding claims, further comprising: The polyol comprises glycerol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), block copolymers of PPG and PEG, sugars, or combinations of two or more thereof, optionally wherein the polyol is present in an amount of about 30 to about 68 wt.%, based on the total weight of the oral care composition.

13. The oral care composition according to any one of the preceding claims, further comprising: An organic acid buffer system, optionally, is used in an amount of about 0.2 to about 4 wt.%, based on the total weight of the oral care composition.

14. The oral care composition of claim 13, wherein the organic acid buffering system comprises citric acid and trisodium citrate, wherein the weight ratio of citric acid to trisodium citrate is from about 1:3 to about 1:

8.

15. The oral care composition according to any one of the preceding claims, wherein when maintained at a temperature of 60°C for 2 weeks, the reduction of soluble tin II in the oral care composition is less than about 25%.

16. The oral care composition according to any one of the preceding claims, wherein when maintained at a temperature of 40°C and a relative humidity of 75% for 13 weeks, the reduction of soluble tin II in the oral care composition is less than about 25%.

17. The oral care composition according to any one of the preceding claims, wherein when maintained at a temperature of 40°C and a relative humidity of 75% for 13 weeks, the reduction in the total amount of soluble tin in the oral care composition is less than about 10%.

18. An oral care composition comprising: Yaxiyuan; About 0.2 to about 4 wt.% of crosslinked polyacrylic acid and / or its salts; Polyphosphates and / or their salts; Polyols; and Approximately 10 to approximately 40 wt.% water, The oral care composition has a pH of about 5 or higher, and all weight percentages are based on the total weight of the oral care composition.

19. An oral care composition comprising: Yaxiyuan; Polymer systems comprising crosslinked polyacrylic acid, phosphate ester / acrylate copolymers, their salts, or combinations thereof; and Polyphosphates and / or their salts, The oral care composition has a pH of about 5 or higher, and all weight percentages are based on the total weight of the oral care composition.

20. An oral care composition comprising: Yaxiyuan; A polymer system comprising crosslinked polyacrylic acid, phosphate ester / acrylate copolymer, salts thereof, or combinations thereof; Nitrate source; Polyphosphates and / or their salts; and Approximately 10 wt.% or more water, The oral care composition has a pH of about 5 or higher, and all weight percentages are based on the total weight of the oral care composition.

21. A method for preparing an oral care composition, comprising: Crosslinking polyacrylic acid and / or its salts to form crosslinked polyacrylic acid and / or its salts; and The stannous ion source is chelated with the crosslinked polyacrylic acid and / or its salt.

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