Oral care composition

Abstract

The present application relates to novel aqueous oral care compositions that can be used to combine and deliver incompatible stannous fluoride or stannous chloride and potassium salts in high water compositions, for example, to provide effective dental caries prevention, prevention of dental erosion, and mitigation of tooth hypersensitivity. The composition comprises stannous fluoride or stannous chloride, nitric acid or a water-soluble nitrate, a water-soluble alkali metal polyphosphate, a taurine salt surfactant (e.g., sodium methyl cocoyl taurate), and greater than 10% water by weight of the composition.

Description

[0001] Cross - reference to related patent applications

[0002] This application claims priority to U.S. Application No. 63 / 427,129, filed November 22, 2022, titled Oral Care Compositions; U.S. Application No. 63 / 427,124, filed November 22, 2022, titled Oral Care Compositions; and U.S. Application No. 63 / 427,135, filed November 22, 2022, titled Oral Care Compositions, the entire contents of which are incorporated herein by reference in their entirety for all purposes. Background of the Invention

[0003] This application relates to novel aqueous oral care compositions that can be used to combine and deliver incompatible stannous fluoride or stannous chloride and potassium salts in high - water compositions, for example to provide effective caries prevention, prevent dental erosion, and relieve tooth hypersensitivity.

[0004] Dental plaque is a sticky biofilm or mass of bacteria that is commonly present between teeth, along the gum line, and beneath the margin of the gum line. Dental plaque can cause dental caries and periodontal problems such as gingivitis and periodontitis. Dental caries or tooth demineralization is caused by acids produced by the bacterial degradation of fermentable sugars.

[0005] Oral care compositions containing a source of stannous ions exhibit excellent clinical benefits, particularly in reducing gingivitis. Sources of stannous ions such as stannous fluoride and stannous chloride are well - known in clinical dentistry and have a history of therapeutic benefits spanning over four decades. However, until recently, their popularity has been limited due to their instability in aqueous solutions. The instability of stannous salts in water is mainly due to the reactivity of stannous ions (Sn 2+ ). Stannous salts are prone to hydrolysis at pH values above 4, resulting in precipitation from the solution. Traditionally, it has been thought that the formation of insoluble stannous salts leads to the loss of therapeutic properties.

[0006] One common way to overcome the stability problems associated with stannous ions is to limit the amount of water in the composition to very low levels or to use a biphasic system. Both of these solutions to the stannous ion problem have drawbacks. Low - water oral care compositions can be difficult to formulate with desired rheological properties, while biphasic compositions are significantly more expensive in terms of manufacturing and packaging. Therefore, it is preferred to formulate high - water compositions that use alternative means to maintain a stable and effective concentration of stannous ions.

[0007] Dentin hypersensitivity (i.e., sensitivity) is a painful condition caused by the movement of fluid in exposed dentinal tubules in response to external stimuli such as pressure and temperature.

[0008] In many parts of the world, consumers prefer highly foaming toothpastes compared to products with poor foaming ability. Conventional levels of surfactants typically produce an acceptable volume of foam when tested in pure water. However, when the test is conducted in a solution simulating the composition of human saliva, it is difficult to achieve a foam level exceeding a certain volume because human saliva has defoaming properties.

[0009] The formulation of oral care compositions containing stannous fluoride or stannous chloride and potassium salts is particularly challenging due to stability issues between these two components. Gambogi et al., US 6,464,963 (Colgate-Palmolive Co.) disclose that attempts to simultaneously include stannous fluoride and a potassium salt (such as potassium nitrate) in a single-phase desensitizing dental composition are hindered by the formation of insoluble tin salts and compounds such as Sn(OH)2 and SnO2. Gambogi solved this problem by employing a two-component composition, where one component contains the potassium salt and sodium hydroxide to adjust the pH of the component to 8 to 11, and the second component contains stannous fluoride or other stannous salts. Other suggestions in the prior art for formulations combining fluoride and stannous salts similarly require a very low water content, such as less than 10% water.

[0010] It has also been reported that aqueous oral care compositions containing both unstable stannous ions and nitrate ions may form potentially toxic substances, such as nitrite ions and nitrosamines, due to the reduction of nitrate ions by stannous ions. See, for example, Strand, US2011 / 0020247 (Procter & Gamble Co.); Heckendorn et al., U.S. 8,926,950 (GABA Int’l Holding). Strand also reports a further difficulty that fluoride ions in the oral care composition tend to precipitate out of the solution when potassium nitrate is present, due to the low solubility of the ionic fluoride source.

[0011] Although it is generally suggested that oral care compositions containing stannous salts, fluoride salts, and polyphosphates can be prepared, many references do not address or seemingly recognize the unique formulation difficulties that may be encountered. See, for example, Yu et al., U.S. 5,811,079 (Warner-Lambert Co.); Midha et al., US2017 / 0281486 (Procter & Gamble Co.). Other references disclosing similar compositions avoid the problem by employing two-component manufacturing.

[0012] Another ingredient that can be present in an oral care composition is sodium lauryl sulfate. Sodium lauryl sulfate can be useful as it can improve the phase stability of the oral care composition (e.g., reduce the likelihood of phase separation) and generally does not affect the stability of the active ingredients in the oral care composition. In some cases, surfactant substitution (adding another surfactant to replace sodium lauryl sulfate) has a negative impact on the taste or stability of the active ingredients. Additionally, the microbial stability of the formulation may be negatively affected by the lack of sodium lauryl sulfate. There are also production benefits to having sodium lauryl sulfate in a given formulation. For example, by replacing sodium lauryl sulfate with other surfactants, the oral care composition may become over-aerated during production and may be more difficult to clean the equipment after the production process.

[0013] There is a continuing desire for improved oral care compositions. SUMMARY OF THE INVENTION

[0014] The present disclosure provides a combination of stannous fluoride or stannous chloride, nitric acid or soluble nitrate, an effective amount of a taurate surfactant (e.g., sodium methyl cocoyl taurate), and an alkali metal polyphosphate in a high-water oral care composition, which results in the stability of stannous, fluoride, and nitrate. Preferably, the nitrate is an alkali metal nitrate (e.g., potassium nitrate), and the alkali metal polyphosphate is pyrophosphate, tripolyphosphate, tetraphosphate, or hexametaphosphate (e.g., sodium pyrophosphate or potassium pyrophosphate). In some embodiments, the composition comprises at least 10% water, such as at least 20%, at least 50%, or at least 75% w / w water. In some embodiments, the composition has a pH above 6.0, such as about 7.

[0015] The present disclosure also provides a method for stabilizing stannous ions in an aqueous oral care composition, the method formulating the composition with a source of nitrate ions (e.g., potassium nitrate) and a source of polyphosphate ions (e.g., sodium pyrophosphate or potassium pyrophosphate) in a high-water composition (e.g., at least 10% w / w water), optionally wherein the solution has a pH above 6.0 (e.g., about 7).

[0016] It has also unexpectedly been found that, according to the present disclosure, stabilizing stannous using nitrate and polyphosphate can result in clear and translucent toothpaste and gel compositions.

[0017] The present disclosure also provides a single-component oral care composition package comprising the composition disclosed herein.

[0018] Based on the detailed description provided hereinafter, further applicable fields of the present invention will become apparent. It should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. Detailed Embodiments

[0019] The following description of the preferred embodiments is exemplary in nature and is in no way intended to limit the invention, its application, or uses.

[0020] As used throughout, ranges are used as shorthand for describing each and every value within the range. Any value within the range can be selected as the endpoint of the range. Additionally, all references cited herein are hereby incorporated by reference in their entirety. In the event of a conflict in definitions between those in the present disclosure and those in the cited references, the present disclosure shall control.

[0021] Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in the specification are to be understood as being weight percentages relative to the total composition. The amounts given are based on the active weight of the materials.

[0022] As is common in the art, the compositions described herein are sometimes described in terms of their ingredients, although the ingredients may dissociate, associate, or react in the formulation. For example, ions are typically provided to the formulation in the form of salts, which may dissolve and dissociate in an aqueous solution. It is understood that the present invention encompasses both the mixtures of the described ingredients and the products obtained therefrom.

[0023] In a first aspect, the present disclosure provides an oral care composition having a single phase (Composition 1), wherein the oral care composition comprises:

[0024] (i) Stannous fluoride or stannous chloride;

[0025] (ii) Nitric acid or a water-soluble nitrate (e.g., potassium nitrate);

[0026] (iii) A water-soluble alkali metal polyphosphate (e.g., sodium pyrophosphate or potassium pyrophosphate or sodium tripolyphosphate or potassium tripolyphosphate);

[0027] (iv) An effective amount of a taurate surfactant represented by formula (1):

[0028]

[0029] wherein R1 is a saturated or unsaturated, straight-chain or branched alkyl chain having 6 to 18 carbon atoms, R2 is H or methyl, and M + is H, sodium, or potassium (e.g., wherein the taurate surfactant is sodium methyl cocoyl taurate); and

[0030] (v) Greater than 10% water by weight of the composition.

[0031] For example, the present disclosure provides the following embodiments of Composition 1:

[0032] 1.1 Composition 1, wherein the water-soluble nitrate is selected from alkali metal nitrates or alkaline earth metal nitrates, or zinc nitrate, silver nitrate, or ammonium nitrate.

[0033] 1.2 Composition 1.1, wherein the water-soluble nitrate is an alkali metal nitrate or an alkaline earth metal nitrate.

[0034] 1.3 Composition 1.2, wherein the nitrate is selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, and calcium nitrate.

[0035] 1.4 Composition 1.3, wherein the nitrate is potassium nitrate.

[0036] 1.5 Any of the foregoing compositions, wherein the water-soluble alkali metal polyphosphate is selected from pyrophosphates, tripolyphosphates, tetraphosphates, or hexametaphosphates.

[0037] 1.6 Any of the foregoing compositions, wherein the water-soluble alkali metal polyphosphate is sodium polyphosphate or potassium polyphosphate.

[0038] 1.7 Any of the foregoing compositions, wherein the water-soluble alkali metal polyphosphate is selected from sodium pyrophosphate, potassium pyrophosphate, sodium tripolyphosphate, and potassium tripolyphosphate.

[0039] 1.8 Composition 1.7, wherein the sodium pyrophosphate salts are selected from acid sodium pyrophosphate (i.e., disodium pyrophosphate) and tetrasodium pyrophosphate.

[0040] 1.9 Any of the foregoing compositions, wherein the water-soluble nitrate is potassium nitrate, and the water-soluble alkali metal polyphosphate is tetrasodium pyrophosphate.

[0041] 1.10 Any of the foregoing compositions, wherein the composition comprises at least a 1:1, such as a 1:1 to 5:1, or 1:1 to 4:1, or 1:1 to 3:1, or 1:1 to 2:1, or 1.5:1 to 5:1, or 2:1 to 5:1, or 2:1 to 4:1, or 2:1 to 3:1, or about 1:1 molar ratio of an alkali metal polyphosphate (e.g., tetrasodium pyrophosphate) to stannous fluoride or stannous chloride.

[0042] 1.11 Any of the foregoing compositions, wherein the composition comprises at least a 0.3:1, such as a 0.3:1 to 20:1, or 0.5:1 to 20:1, or 1:1 to 20:1, or 1:1 to 15:1, or 1:1 to 10:1, or 1:1 to 5:1, or 1:1 to 3:1, or about 1:1 molar ratio of nitric acid or a water-soluble nitrate (e.g., potassium nitrate) to stannous fluoride or stannous chloride.

[0043] 1.12 Any of the foregoing compositions, wherein the composition comprises stannous fluoride or stannous chloride in an amount of 0.1% to 2%, such as 0.1% to 1%, or 0.25% to 0.75%, or about 0.45% by weight of the composition.

[0044] 1.13 Any of the foregoing compositions, wherein the composition comprises nitric acid or a water-soluble nitrate (e.g., potassium nitrate) in an amount of 0.1% to 5%, such as 0.1% to 2%, or 0.1% to 1%, or 0.1% to 0.5%, or 0.2% to 0.4%, or 0.25% to 0.75%, about 0.3%, or about 0.5% by weight of the composition.

[0045] 1.14 Any of the foregoing compositions, wherein the composition comprises an alkali metal polyphosphate (e.g., tetrasodium pyrophosphate or sodium tripolyphosphate) in an amount of 0.1% to 5%, such as 0.8% to 5%, or 0.8% to 4%, or 0.8% to 3%, or 0.8% to 2%, or 0.8% to 1.0%, or 1.0% to 1.5%, or about 0.8%, or about 1.2% by weight of the composition.

[0046] 1.15 Any of the foregoing compositions, wherein the composition comprises at least 10% water, such as at least 20%, at least 30%, or at least 40%, or at least 50%, or at least 60%, or at least 65%, up to 95%, or about 20%, or about 30%, or about 40%, or about 60%, or about 80% water by weight of the composition.

[0047] 1.16 Any of the foregoing compositions, wherein the composition comprises 70% to 95% water, such as 75% to 95%, or 75% to 90%, or 75% to 85%, or 75% to 80% by weight of the composition; or wherein the composition comprises 10% to 50% water, such as 10% to 40%, or 10% to 30%, or about 20%, or about 25% by weight.

[0048] 1.17 Any of the foregoing oral care compositions, wherein the composition comprises 10% to 40% (e.g., about 25%) water by weight.

[0049] 1.18 Any of the foregoing compositions, wherein the composition comprises one or more humectants (e.g., glycerol, sorbitol, propylene glycol, or mixtures thereof) in a net amount of 5% to 70%, such as 5% to 25%, or 10% to 25%, or 15% to 25%, or about 20%, or 30% to 70%, or 35% to 60%, or 40% to 60%, or 60% to 70% by weight of the composition.

[0050] 1.19 Any of the foregoing compositions, wherein the composition is single-phase, i.e., it does not form two phases when standing still.

[0051] 1.20 Any of the foregoing compositions, wherein the composition is two-phase, i.e., it forms two phases when standing still.

[0052] 1.21 Composition 1.19, wherein the composition forms an emulsion immediately after mixing and separates into two phases within 10 minutes (e.g., within 5 minutes, or within 3 minutes, or within 1 minute) after standing still.

[0053] 1.22 Any of the foregoing compositions, wherein the composition is a clear (e.g., non-opaque or non-turbid) solution (e.g., non-suspension) or a clear (e.g., translucent, non-opaque) semi-solid or gel.

[0054] 1.23 Any of the foregoing compositions, wherein the composition is physically and chemically stable, e.g., wherein no color change or precipitation occurs when stored under ambient conditions for 3 months or longer (e.g., 6 months or longer, or 1 year or longer).

[0055] 1.24 Composition 1.22, wherein the stannous ion concentration remains substantially stable for at least three months during storage, e.g., the concentration of stannous ions is at least 80%, or at least 85%, or at least 90% of the original concentration.

[0056] 1.25 Any of the foregoing compositions, wherein the composition has a pH of 5 to 9, or 6 to 8, or 6.5 to 7.5, or 6.9 to 7.1, or about 7.

[0057] 1.26 Any of the foregoing compositions, wherein the composition contains less than 10% by weight of any hydrophobic liquid or mixture of hydrophobic liquids (e.g., alkyl fatty acid esters (e.g., isopropyl myristate), vegetable oils, mineral oils, or combinations thereof), e.g., less than 5% by weight, or less than 3% by weight, or less than 1% by weight of such hydrophobic liquids.

[0058] 1.27 Any of the foregoing compositions, wherein the composition does not contain or is substantially free of any hydrophobic liquid or mixture of hydrophobic liquids (e.g., less than 0.1% by weight of the composition).

[0059] 1.28 Composition 1 or any one of 1.1 to 1.24, wherein the composition comprises at least 10% by weight of any hydrophobic liquid or mixture of hydrophobic liquids (e.g., alkyl fatty acid esters (e.g., isopropyl myristate), vegetable oils, mineral oils, or combinations thereof), e.g., 10% to 90% by weight, or 20% to 80% by weight, or 30% to 70% by weight, or 30% to 50% by weight, or 10% to 50% by weight, or 10% to 30% by weight of such a hydrophobic liquid.

[0060] 1.29 Any of the foregoing compositions, further comprising a nonionic surfactant, e.g., a hydrophilic nonionic surfactant.

[0061] 1.30 Composition 1.28, wherein the nonionic surfactant is a copolymer of ethylene oxide and propylene oxide, e.g., a block copolymer (e.g., a triblock copolymer).

[0062] 1.31 Composition 1.29, wherein the nonionic surfactant is a poloxamer, e.g., a triblock copolymer with hydrophobic polypropylene glycol blocks flanked by hydrophilic polyethylene glycol blocks.

[0063] 1.32 Composition 1.30, wherein the poloxamer has a polyethylene glycol block length of about 75 to 125 (e.g., about 100 to 101) units and a polypropylene block length of about 25 to 75 (e.g., about 55 to 56) units, e.g., poloxamer 407 or Pluronic F127.

[0064] 1.33 Any of the foregoing compositions, comprising the nonionic surfactant in an amount of 0.01% to 5.0% by weight of the composition, e.g., 0.1% to 1.0%, 0.2% to 0.7%, 0.3% to 0.5%, about 0.4%.

[0065] 1.34 Any of the foregoing compositions, wherein the composition further comprises one or more of the following: thickening agents (e.g., xanthan gum or carboxymethyl cellulose, e.g., the sodium salt), buffering agents, sweetening agents, flavoring agents, pigments, dyes, anticaries agents, antibacterial agents, whitening agents, desensitizing agents, preservatives, or mixtures thereof.

[0066] 1.35 Any of the foregoing compositions, wherein the composition further comprises an additional source of fluoride ions.

[0067] 1.36 Composition 1.35, wherein the additional source of fluoride ions is selected from sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, fluorinated amines (e.g., N'-octadecyltrimethylenediamine-N,N,N'-tris(2-ethanol)-dihydrofluoride), ammonium fluoride, titanium fluoride, hexafluorosulfates, or mixtures thereof.

[0068] 1.37 Any of the foregoing compositions, wherein the composition comprises a whitening agent.

[0069] 1.38 Any of the foregoing compositions, wherein the composition comprises a whitening agent, and wherein the whitening agent is hydrogen peroxide.

[0070] 1.39 Any of the foregoing compositions, wherein the composition is a mouthwash.

[0071] 1.40 Any of the foregoing compositions, wherein the composition is a dentifrice (e.g., toothpaste or tooth gel).

[0072] 1.41 Any of the foregoing compositions, wherein the composition does not contain an abrasive (e.g., the composition does not contain silica).

[0073] 1.42 Any of the foregoing compositions, wherein the composition comprises an abrasive (e.g., silica) in an amount of 1% to 30% by weight of the composition, such as 10% to 30%, or 20% to 25%, or 15% to 20%. One or more abrasives may include: silica, silicate, silicon, alumina (including calcined alumina), aluminosilicate (e.g., bentonite, zeolite, kaolin, and mica), silica or diatomaceous earth, pumice, calcium carbonate, cuttlebone, insoluble phosphate, composite resin (e.g., melamine resin, phenolic resin, and urea resin), polycarbonate, silicon carbide, boron carbide, microcrystalline wax, microcrystalline cellulose (including a combination of colloidal microcrystalline cellulose and carboxymethyl cellulose), and combinations and derivatives thereof.

[0074] 1.43 Any of the foregoing compositions, wherein when applied to the oral cavity, e.g., by rinsing and / or brushing, the composition effectively (i) reduces or inhibits the formation of dental caries, (ii) reduces, repairs, or inhibits pre-carious lesions of tooth enamel, e.g., as detected by quantitative light-induced fluorescence (QLF) or electrical caries measurement (ECM), (iii) reduces or inhibits tooth demineralization and promotes tooth remineralization, (iv) reduces tooth hypersensitivity, (v) reduces or inhibits gingivitis, (vi) promotes the healing of ulcers or wounds in the mouth, (vii) reduces the levels of acid-producing and / or malodor-producing bacteria, (viii) treats, alleviates, or reduces dry mouth, (ix) cleans teeth and the oral cavity, (x) whitens teeth, (xi) reduces tartar accumulation, (xii) reduces or prevents oral malodor, and / or (xiii) promotes systemic health, including cardiovascular health, e.g., by reducing the likelihood of systemic infections caused by oral tissues.

[0075] 1.44 Any of the foregoing compositions, wherein the composition has enhanced stannous ion stability (e.g., compared to a composition comprising stannous fluoride or stannous chloride without both a nitrate ion source and polyphosphate).

[0076] 1.45 Any of the foregoing compositions, wherein the composition is packaged in a container comprising: a single storage compartment that houses the composition; and a closure (e.g., a screw cap closure) that seals the compartment.

[0077] 1.46 Any of the foregoing compositions, further comprising one or more of an amphoteric surfactant (e.g., betaine) and / or a nonionic polymer (e.g., polyethylene glycol, such as PEG-600).

[0078] 1.47 The foregoing composition, wherein the nonionic polymer comprises polyethylene glycol (e.g., from about 0.5% to about 5% by weight) (e.g., about 2% by weight of the total weight of the oral care composition).

[0079] 1.48 The composition of 1.47, wherein the oral care composition comprises an amphoteric surfactant (e.g., cocamidopropyl betaine).

[0080] 1.49 The foregoing composition, wherein the amphoteric surfactant comprises cocamidopropyl betaine (e.g., from about 0.5% to about 5% by weight of the total weight of the oral care composition) (e.g., about 1.25% by weight).

[0081] 1.50 Any of the foregoing compositions, wherein, based on the total weight of the oral care composition, the composition has less than 20% by weight, such as less than 15% by weight, or less than 10% by weight, or less than 5% by weight, or less than 1% by weight, or from 0.05% to 1% by weight, or from 0.05% to 0.5% by weight, or from 0.25% to 0.75% by weight, or about 0.5% by weight of any polymer thickener (e.g., xanthan gum, carrageenan, carboxymethyl cellulose, such as sodium CMC).

[0082] 1.51 The foregoing composition, wherein the composition comprises xanthan gum (e.g., from about 0.1% to about 1% by weight of the total oral care composition).

[0083] 1.52 Any of the foregoing compositions, wherein the composition has less than 40% by weight, such as from 5% to 40% by weight, or from 5% to 30% by weight, or from 5% to 25% by weight, or about 23% by weight of any silica (e.g., thickening silica).

[0084] 1.53 Any of the foregoing compositions, wherein the composition is translucent or transparent. As used herein, translucent means the property of an oral care composition that allows light to pass through but does not necessarily allow fine objects to be discerned through a 1 cm thickness of the oral care composition. With respect to the oral care compositions of the present disclosure, the term "transparent" means that the visible light transmittance of the oral care composition is at least 65%, for example, measured using a Lambda 40 UV-Vis or Lambda 25 UV-Vis spectrometer. For example, the transmittance of the oral care composition at a wavelength of 600 nm can be at least 70%, at least 75%, at least 80%, at least 85%, at least 88%, at least 90%, or at least 95%, for example, measured using a Lambda 40 UV-Vis spectrometer or a Lambda 25 UV-Vis spectrometer.

[0085] 1.54 Any of the foregoing compositions, in the form of a gel having a cylindrical cross-section (e.g., a diameter of 5 mm to 15 mm, or 8 mm to 10 mm).

[0086] 1.55 Any of the foregoing compositions, in the form of a gel having a flat ribbon cross-section (e.g., a thickness of 2 mm to 15 mm, 5 mm to 10 mm).

[0087] 1.56 Any of the foregoing oral care compositions, wherein the R1 is a saturated or unsaturated, straight-chain or branched alkyl chain having 8 to 14 carbon atoms.

[0088] 1.57 Any of the foregoing oral care compositions, wherein the taurate surfactant comprises one or more surfactants selected from the group consisting of potassium cocoyl taurate, potassium methyl cocoyl taurate, sodium caproyl methyl taurate, sodium cocoyl taurate, sodium lauroyl taurate, sodium methyl cocoyl taurate, sodium methyl lauroyl taurate, sodium methyl myristoyl taurate, sodium methyl oleoyl taurate, sodium methyl palmitoyl taurate, sodium methyl stearoyl taurate, and combinations thereof.

[0089] 1.58 Any of the foregoing oral care compositions, wherein the taurate surfactant comprises one or more surfactants selected from the group consisting of sodium lauroyl methyl taurate (or sodium methyl lauroyl taurate), sodium methyl cocoyl taurate, and combinations thereof.

[0090] Any one of the foregoing oral care compositions, wherein the taurate surfactant comprises sodium methyl cocoyl taurate (e.g., from about 0.5% to about 10% by weight of sodium methyl cocoyl taurate, based on the total weight of the oral care composition) (e.g., from 1% to 5% by weight of sodium methyl cocoyl taurate) (e.g., about 2.5% by weight of sodium methyl cocoyl taurate, based on the total weight of the oral care composition).

[0091] Any one of the foregoing oral care compositions, wherein the taurate surfactant is present in an amount of from about 0.25% to about 5% by weight of the oral care composition, such as from about 0.4% to about 3%, such as from about 0.4% to about 2.75%, such as from about 0.4% to about 2.5%, such as from about 0.5% to about 3%, such as from about 0.8% to about 3%, such as from about 1% to about 3%, such as from about 1.2% to about 2.7%, such as from about 1.5% to about 3%, such as from about 2% to about 3%, such as from about 1% to about 2.8%, such as from about 1% to about 2.7%, such as from about 1% to about 2.5%, such as from about 1.5% to about 2.8%, such as from about 1.5% to about 2.5%, such as from about 1.8% to about 3%, such as from about 1.8% to about 2.8%, such as from about 1.8% to about 2.7%, such as from about 1.8% to about 2.5%, such as about 2.5%.

[0092] Any one of the foregoing oral care compositions, wherein the taurate surfactant comprises sodium methyl cocoyl taurate in an amount of from 0.25% to 5% by weight of the total composition (e.g., about 1% by weight of the total composition).

[0093] Any one of the foregoing oral care compositions, wherein the oral care composition comprises hyaluronic acid (e.g., high molecular weight hyaluronic acid (HA)) or sodium hyaluronate (e.g., average MW > 100,000 Da, such as 300 kDa to 1 MDa).

[0094] Any one of the foregoing oral care compositions, wherein the composition comprises:

[0095] · from 0.1% to 2% of stannous fluoride;

[0096] · from 0.1% to 2% by weight of potassium nitrate;

[0097] · from 0.1% to 5% by weight of sodium pyrophosphate;

[0098] · from 0.25% to 5% by weight of sodium methyl cocoyl taurate; and

[0099] · from 15% to 30% by weight (e.g., about 24% by weight) of water.

[0100] 1.64 Any of the foregoing oral care compositions, wherein the composition comprises:

[0101] · 0.1% to 2% stannous fluoride;

[0102] · 0.1% to 2% by weight of potassium nitrate;

[0103] · 0.1% to 5% by weight of sodium tripolyphosphate;

[0104] · 0.25% to 5% by weight of sodium methyl cocoyl taurate; and

[0105] · 15% to 30% by weight (e.g., about 24% by weight) of water.

[0106] The composition may optionally comprise additional ingredients suitable for oral care compositions. The compositions of the present disclosure (e.g., any of Composition 1.0 and the like or Composition 2.0 and the like) may be formulated in a suitable dentifrice base, which may include, for example, an abrasive (e.g., a silica abrasive), a surfactant, a foaming agent, a vitamin, a polymer, an enzyme, a humectant, a thickening agent, additional antimicrobial agents, a preservative, a flavoring agent, a coloring agent, and / or a combination thereof. Examples of suitable additional ingredients that may be used in the compositions of the present disclosure are discussed in more detail below.

[0107] In a second aspect, the present disclosure also provides a method (Method 1) for stabilizing stannous ions in an aqueous oral care composition, the method comprising the steps of: (1) providing an aqueous carrier, (2) adding a source of stannous ions to the aqueous carrier, (3) adding a source of nitrate ions to the aqueous carrier, and (4) incorporating a source of polyphosphate ions and a taurate surfactant into the aqueous carrier, wherein the final composition is a single-phase high-water composition.

[0108] For example, the present disclosure provides the following embodiments of Method 1:

[0109] 1.1 Method 1, wherein the source of stannous ions is a water-soluble stannous salt.

[0110] 1.2 Method 1 or 1.1, wherein the stannous salt is selected from stannous chloride and stannous fluoride.

[0111] 1.3 Method 1.2, wherein the stannous salt is stannous fluoride.

[0112] 1.4 Any of the foregoing methods, wherein the source of nitrate ions is nitric acid or a water-soluble nitrate.

[0113] 1.5 Method 1.4, wherein the water-soluble nitrate is selected from alkali metal nitrates or alkaline earth metal nitrates, or zinc nitrate, silver nitrate, or ammonium nitrate.

[0114] 1.6 Method 1.4, wherein the water-soluble nitrate is an alkali metal nitrate or an alkaline earth metal nitrate.

[0115] 1.7 Method 1.6, wherein the nitrate is selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, and calcium nitrate.

[0116] 1.8 Method 1.7, wherein the nitrate is potassium nitrate.

[0117] 1.9 Any of the foregoing methods, wherein the polyphosphate ion source is a water-soluble alkali metal polyphosphate.

[0118] 1.10 Method 1.9, wherein the water-soluble alkali metal polyphosphate is selected from pyrophosphates, tripolyphosphates, tetraphosphates, or hexametaphosphates.

[0119] 1.11 Method 1.10, wherein the water-soluble alkali metal polyphosphate is sodium polyphosphate or potassium polyphosphate.

[0120] 1.12 Method 1.11, wherein the water-soluble alkali metal polyphosphate is selected from sodium pyrophosphate, potassium pyrophosphate, sodium tripolyphosphate, and potassium tripolyphosphate.

[0121] 1.13 Method 1.12, wherein the sodium pyrophosphate salt is selected from acid sodium pyrophosphate (i.e., disodium pyrophosphate) and tetrasodium pyrophosphate.

[0122] 1.14 Any of the foregoing methods, wherein the stannous salt is stannous fluoride, the nitrate is potassium nitrate, and the polyphosphate is tetrasodium pyrophosphate.

[0123] 1.15 Any of the foregoing methods, wherein the composition is formulated to have at least a 1:1, such as a 1:1 to 5:1, or 1:1 to 4:1, or 1:1 to 3:1, or 1:1 to 2:1, or 1.5:1 to 5:1, or 2:1 to 5:1, or 2:1 to 4:1, or 2:1 to 3:1, or about 1:1 molar ratio of a polyphosphate source (e.g., tetrasodium pyrophosphate or sodium tripolyphosphate) to a stannous source (e.g., stannous fluoride).

[0124] 1.16 Any of the foregoing methods, wherein the composition is formulated to have at least a 0.3:1, such as a 0.3:1 to 20:1, or 0.5:1 to 20:1, or 1:1 to 20:1, or 1:1 to 15:1, or 1:1 to 10:1, or 1:1 to 5:1, or 1:1 to 3:1, or about 1:1 molar ratio of nitric acid or a nitrate source (e.g., potassium nitrate) to a stannous source (e.g., stannous fluoride).

[0125] 1.17 Any of the foregoing methods, wherein based on the total weight of the oral care composition, the composition is formulated to comprise from 0.1% to 2% by weight of the composition, such as from 0.1% to 1% by weight, or from 0.25% to 0.75% by weight, or about 0.45% by weight, of a stannous ion source (e.g., stannous fluoride).

[0126] 1.18 Any of the foregoing methods, wherein based on the total weight of the oral care composition, the composition is formulated to comprise from 0.1% to 5% by weight of the composition, such as from about 0.1% to about 2% by weight, or from about 0.1% to about 1% by weight, or from about 0.1% to about 0.5% by weight, or from about 0.2% to about 0.4% by weight, or from about 0.25% to about 0.75% by weight, about 0.3% by weight, or about 0.5% by weight, of a nitrate ion source (e.g., potassium nitrate, nitric acid, etc.).

[0127] 1.19 Any of the foregoing methods, wherein the composition is formulated to comprise from about 0.1% to about 5% by weight of the composition, such as from about 0.8% to about 5% by weight, or from about 0.8% to about 4% by weight, or from about 0.8% to about 3% by weight, or from about 0.8% to about 2% by weight, or from about 0.8% to about 1% by weight, or from about 1% to about 1.5% by weight, or about 0.8% by weight, or about 1.2% by weight, of a polyphosphate ion source (e.g., tetrasodium pyrophosphate).

[0128] 1.20 Any of the foregoing methods, wherein the aqueous carrier comprises water and optionally one or more humectants (e.g., glycerol, sorbitol, propylene glycol, or mixtures thereof).

[0129] 1.21 Any of the foregoing methods, wherein the composition is formulated to comprise from about 10% to about 95% by weight of the composition, such as from about 20% to about 95% by weight of the composition, or from about 30% to about 95% by weight of the composition, or from about 40% to about 95% by weight of the composition, or from about 50% to about 95% by weight of the composition, or from about 60% to about 95% by weight of the composition, or from about 65% to about 95% by weight of the composition, or about 20% by weight, or about 40% by weight, or about 60% by weight, or about 80% by weight, of water.

[0130] 1.22 Any of the foregoing methods, wherein the composition is formulated to comprise from about 70% to about 95%, such as from about 75% to about 95%, or from about 75% to about 90%, or from about 75% to about 85%, or from about 75% to about 80% water by weight of the composition; or wherein the composition is formulated to comprise from about 10% to about 50%, such as from about 10% to about 40%, or from about 10% to about 30%, or about 20% water. In some cases, based on the total weight of the oral care composition, the oral care composition comprises water in an amount of from about 70% by weight to about 95% by weight, from about 70% by weight to about 90% by weight, from about 70% by weight to about 85% by weight, from about 70% by weight to about 80% by weight; from about 75% by weight to about 95% by weight, from about 75% by weight to about 90% by weight, from about 75% by weight to about 85% by weight; from about 80% by weight to about 95% by weight, from about 80% by weight to about 90% by weight, or any range or sub-range thereof. In other cases, based on the total weight of the oral care composition, the amount of water in the oral care composition is from about 10% by weight to about 50% by weight, from about 15% by weight to about 50% by weight, from about 20% by weight to about 50% by weight, from about 30% by weight to about 50% by weight; from about 10% by weight to about 45% by weight, from about 15% by weight to about 45% by weight, from about 20% by weight to about 45% by weight, from about 30% by weight to about 45% by weight; from about 10% by weight to about 40% by weight, from about 15% by weight to about 40% by weight, from about 20% by weight to about 40% by weight, from about 30% by weight to about 40% by weight, or any range or sub-range thereof.

[0131] 1.23 Any of the foregoing methods, wherein the composition is formulated to comprise a net amount of one or more humectants (such as glycerol, sorbitol, propylene glycol, or mixtures thereof) from about 5% to about 75%, such as from about 5% to about 25% by weight of the composition, or from about 10% to about 25% by weight of the composition, or from about 15% to about 25% by weight of the composition, or about 20% by weight of the composition, or from about 30% to about 70% by weight of the composition, or from about 35% to about 60% by weight of the composition, or from about 40% to about 60% by weight of the composition, or from about 60% to about 70% by weight of the composition.

[0132] 1.24 Any of the foregoing methods, wherein the composition is formulated as a clear (such as non-opaque or non-turbid) solution (such as non-suspension) or a clear (such as translucent, non-opaque) semi-solid or gel.

[0133] 1.25 Any of the foregoing methods, wherein the composition is physically and chemically stable, for example, wherein no color change or precipitation occurs upon storage for 3 months or longer (such as 6 months or longer, or 1 year or longer) under ambient conditions.

[0134] 1.26 Method 1.27, wherein the concentration of stannous ions remains substantially stable for at least three months during storage. For example, the concentration of stannous ions is at least 80%, or at least 85%, or at least 90% of the original concentration.

[0135] 1.27 Any of the foregoing methods, wherein the composition has a pH of 5 to 9, or 6 to 8, or 6.5 to 7.5, or 6.9 to 7.1, or about 7.

[0136] 1.28 Any of the foregoing methods, wherein based on the total weight of the oral care composition, the composition is formulated to contain less than 10% by weight of any hydrophobic liquid or mixture of hydrophobic liquids (e.g., alkyl fatty acid esters (e.g., isopropyl myristate), vegetable oils, mineral oils, or combinations thereof), such as less than 5% by weight, or less than 3% by weight, or less than 1% by weight of such hydrophobic liquids.

[0137] 1.29 Any of the foregoing methods, wherein the composition is formulated to be free or substantially free of any hydrophobic liquid or mixture of hydrophobic liquids (e.g., less than 0.1% by weight of the oral care composition), i.e., the method does not include any step of adding any hydrophobic liquid to the aqueous carrier.

[0138] 1.30 Any of the foregoing methods, wherein the composition is formulated to contain a nonionic surfactant, such as a hydrophilic nonionic surfactant, i.e., the method further includes step (5) of adding a nonionic surfactant to the aqueous carrier.

[0139] 1.31 Method 1.31, wherein the nonionic surfactant is a copolymer of ethylene oxide and propylene oxide, such as a block copolymer (e.g., a triblock copolymer).

[0140] 1.32 Method 1.31, wherein the nonionic surfactant is poloxamer, such as a triblock copolymer with a hydrophobic polypropylene glycol block flanked by hydrophilic polyethylene glycol blocks.

[0141] 1.33 Method 1.33, wherein the poloxamer has a polyethylene glycol block length of about 75 to 125 units (e.g., about 100 to 101 units) and a polypropylene block length of about 25 to 75 units (e.g., about 55 to 56 units), such as poloxamer 407 or Pluronic F127.

[0142] 1.34 Any one of methods 1.31 to 1.34, wherein the composition is formulated to contain the nonionic surfactant in an amount of 0.01% to 5.0% by weight of the composition, such as 0.1% to 1.0%, 0.2% to 0.7%, 0.3% to 0.5%, about 0.4% by weight based on the total oral care composition.

[0143] 1.35 Any of the foregoing methods, wherein the composition is a dentifrice (e.g., toothpaste or tooth gel).

[0144] 1.36 Any of the foregoing methods, wherein the composition is formulated to contain an abrasive (e.g., silica) in an amount of about 1% to about 30% by weight of the composition, such as about 10% to about 30%, or about 20% to about 25% by weight based on the oral care composition.

[0145] 1.37 Any of the foregoing methods, wherein the composition is formulated to be free of an abrasive (e.g., the composition is formulated to be free of silica).

[0146] 1.38 Any of the foregoing methods, wherein step (1) occurs first, and steps (2) to (5) occur in any order.

[0147] 1.39 Any of the foregoing methods, further comprising a final step (6) of packaging the composition in a container, the container comprising: a single storage compartment that houses the composition; and a closure (e.g., a screw cap closure) that seals the compartment.

[0148] 1.40 Any of the foregoing methods, wherein the method produces a composition according to Composition 1 or any one of its 1.1 to 1.64.

[0149] 1.41 Any of the foregoing methods, wherein the method comprises adding an effective amount of a taurate surfactant represented by formula (1):

[0150]

[0151] wherein R1 is a saturated or unsaturated, straight-chain or branched alkyl chain having 6 to 18 carbon atoms, R2 is H or methyl, and M + is H, sodium or potassium (e.g., wherein the taurate surfactant is sodium methyl cocoyl taurate).

[0152] 1.42 The foregoing method, wherein the R1 is a saturated or unsaturated, straight-chain or branched alkyl chain having 8 to 14 carbon atoms.

[0153] 1.43 Any one of the foregoing methods, wherein the taurate surfactant comprises one or more surfactants selected from the group consisting of potassium cocoyl taurate, potassium methyl cocoyl taurate, sodium caproyl methyl taurate, sodium cocoyl taurate, sodium lauroyl taurate, sodium methyl cocoyl taurate, sodium methyl lauroyl taurate, sodium methyl myristoyl taurate, sodium methyl oleoyl taurate, sodium methyl palmitoyl taurate, sodium methyl stearoyl taurate, and combinations of two or more thereof.

[0154] 1.44 Any one of the foregoing methods, wherein the taurate surfactant comprises one or more surfactants selected from the group consisting of sodium lauroyl methyl taurate (or sodium methyl lauroyl taurate), sodium methyl cocoyl taurate, and combinations thereof.

[0155] 1.45 Any one of the foregoing methods, wherein the taurate surfactant comprises sodium methyl cocoyl taurate (e.g., from about 0.5% to about 10% by weight of sodium methyl cocoyl taurate) (e.g., from about 1% to about 5% by weight of sodium methyl cocoyl taurate) (e.g., about 2.5% by weight of sodium methyl cocoyl taurate).

[0156] 1.46 Any one of the foregoing methods, wherein the taurate surfactant is present in an amount of from about 0.25% to about 5%, such as from about 0.4% to about 3%, such as from about 0.4% to about 2.75%, such as from about 0.4% to about 2.5%, such as from about 0.5% to about 3%, such as from about 0.8% to about 3%, such as from about 1% to about 3%, such as from about 1.2% to about 2.7%, such as from about 1.5% to about 3%, such as from about 2% to about 3%, such as from about 1% to about 2.8%, such as from about 1% to about 2.7%, such as from about 1% to about 2.5%, such as from about 1.5% to about 2.8%, such as from about 1.5% to about 2.5%, such as from about 1.8% to about 3%, such as from about 1.8% to about 2.8%, such as from about 1.8% to about 2.7%, such as from about 1.8% to about 2.5%, such as about 2.5% by weight of the composition.

[0157] 1.47 Any one of the foregoing methods, wherein the taurate surfactant comprises sodium methyl cocoyl taurate in an amount of from about 0.25% to about 5% (e.g., about 2.5% by weight of the total composition).

[0158] In a third aspect, the present disclosure provides an oral care package comprising a composition according to any one of Composition 1 or 1.1 to 1.66. The oral care package may include a container comprising: a single storage compartment that houses the composition; and a closure (e.g., a screw cap closure) that seals the compartment. In some embodiments, where the composition is a toothpaste or a gel, the package includes a closure that dispenses a strip of toothpaste or gel having a circular cross-section, an oval cross-section, or a flat ribbon cross-section. In some embodiments, such a strip is dispensed to have a diameter or thickness of 5 mm to 25 mm, such as 5 mm to 10 mm, or 10 mm to 15 mm, or 15 mm to 20 mm, or 20 mm to 25 mm.

[0159] In a fourth aspect, the present disclosure provides a method of treating or preventing gingivitis, dental plaque, dental caries, and / or tooth hypersensitivity, the method comprising applying to the oral cavity of a person in need thereof a composition according to the present invention (e.g., Composition 1 and the like), such as by brushing, e.g., once or more times per day.

[0160] Alternatively, the present disclosure provides Composition 1 and the like for use in treating or preventing gingivitis, dental plaque, dental caries, and / or tooth hypersensitivity.

[0161] The method of the fourth aspect includes applying any one of the compositions as described herein to the teeth, such as by brushing, rinsing, or irrigating, or otherwise applying the composition to the oral cavity of a subject in need thereof. The composition may be applied regularly, such as once or more times per day (e.g., twice per day). In various embodiments, applying the composition of the present disclosure to the teeth may provide one or more of the following specific benefits: (i) reducing or inhibiting the formation of dental caries, (ii) reducing, repairing, or inhibiting pre-carious lesions of tooth enamel, e.g., as detected by quantitative light-induced fluorescence (QLF) or electrical caries measurement (ECM), (iii) reducing or inhibiting tooth demineralization and promoting tooth remineralization, (iv) reducing tooth hypersensitivity, (v) reducing or inhibiting gingivitis, (vi) promoting the healing of ulcers or wounds in the mouth, (vii) reducing the levels of acid-producing and / or malodor-producing bacteria, (viii) treating, alleviating, or reducing dry mouth, (ix) cleaning the teeth and oral cavity, (x) whitening the teeth, (xi) reducing tartar accumulation, (xii) reducing or preventing oral malodor, and / or (xiii) promoting overall health, including cardiovascular health, e.g., by reducing the likelihood of systemic infections caused by oral tissues.

[0162] Oral care compositions can be applicable to oral care, oral hygiene, and / or oral appearance, or their intended method of use includes application to the oral cavity, and refers to palatable and safe compositions for topical application to the oral cavity and providing benefits to teeth and / or the oral cavity. The term "oral care composition" thus clearly excludes compositions that are highly toxic, unpalatable, or otherwise unsuitable for application to the oral cavity. In some embodiments, the oral care composition is not intended to be swallowed, but rather remains in the oral cavity for a time sufficient to affect the intended utility. In some embodiments, the oral care compositions disclosed herein are for human use. Oral care compositions include, for example, dentifrices and mouthwashes. In some embodiments, the present disclosure provides mouthwash formulations.

[0163] As used herein, "orally acceptable" refers to materials that are safe and palatable at relevant concentrations for use in oral care formulations such as mouthwashes or dentifrices.

[0164] As used herein, "orally acceptable carrier" refers to any carrier that can be used to formulate the oral care compositions disclosed herein. When an orally acceptable carrier is retained in the mouth without being swallowed for a time sufficient to allow effective contact with the tooth surface as required herein, it is harmless to mammals in the amounts disclosed herein. Generally, an orally acceptable carrier is harmless even if not intended to be swallowed. Suitable orally acceptable carriers include, for example, one or more of the following: water, thickening agents, buffering agents, humectants, surfactants, abrasives, sweeteners, flavoring agents, pigments, dyes, anticariogenic agents, antibacterial agents, whitening agents, desensitizing agents, vitamins, preservatives, enzymes, and mixtures thereof.

[0165] A two-component toothpaste can be packaged in a tube including two parallel compartments and discharged via a common nozzle such that when the user squeezes the toothpaste from the package, the two components are mixed just prior to application to the oral cavity. Similarly, a two-component mouthwash is typically packaged in a bottle including two compartments such that when in use, a measured amount of liquid from each compartment is dispensed and mixed. Two-component compositions are generally used to keep in separate component and compartment ingredients that are incompatible with each other such that if kept in the same component, they would react adversely with each other or interfere with each other.

[0166] In contrast, a biphasic composition (such as a mouthwash) is a single-component composition containing two immiscible liquids that settle into two phases when at rest. Such a composition does not require separate storage compartments because the natural tendency for the two phases to separate helps ensure that the ingredients in one phase do not remain in close contact with the ingredients in the other phase. However, when vigorously mixed, the two phases become closely combined (e.g., to form an emulsion), which may or may not separate back into two phases when at rest.

[0167] The oral care compositions of the present disclosure (e.g., any of Composition 1.0 and the like or Composition 2.0 and the like) may comprise an anionic surfactant that is not sodium lauryl sulfate. For example, in one aspect, any of Composition 1.0 and the like may additionally comprise any of the following surfactants:

[0168] i. water-soluble salts of monoglyceride monosulfates of higher fatty acids, such as sodium salt of monosulfated monoglyceride of hydrogenated coconut oil fatty acid, sodium cocomonoglyceride sulfate,

[0169] ii. higher alkyl ether sulfates, such as having the formula CH3(CH2) m CH2(OCH2CH2) n OSO3X, where m is from 6 to 16, such as 10, n is from 1 to 6, such as 2, 3 or 4, and X is Na or K, such as sodium laureth-2 sulfate (CH3(CH2) 10 CH2(OCH2CH2)2OSO3Na),

[0170] iii. higher alkyl aryl sulfonates, such as sodium dodecylbenzenesulfonate (sodium laurylbenzenesulfonate),

[0171] iv. higher alkyl sulfoglucuronates, such as sodium lauryl sulfoglucuronate (sodium dodecyl sulfoglucuronate), higher fatty acid esters of 1,2-dihydroxypropane sulfonate, sulfocolaurate (N-2-ethyl potassium laurate sulfoglucuronamide), and sodium lauroyl sarcosinate.

[0172] "Higher alkyl" means, for example, C 6-30Alkyl. In certain embodiments, anionic surfactants useful herein include water-soluble salts of alkyl sulfates having from 10 to 18 carbon atoms in the alkyl group and water-soluble salts of sulfonated monoglycerides of fatty acids having from 10 to 18 carbon atoms. Sodium lauroyl sarcosinate and sodium cocomonoglyceride sulfonate are examples of anionic surfactants of this type. The anionic surfactant may be present in an effective amount (e.g., > 0.01% by weight of the formulation), but not at a concentration that will irritate oral tissues (e.g., < 10%), and the optimal concentration depends on the particular formulation and the particular surfactant. In one embodiment, the anionic surfactant is present in the toothpaste at from 0.3% to 4.5% by weight, such as about 1.5%. The compositions of the present disclosure may optionally contain a mixture of surfactants, such as a mixture comprising an anionic surfactant and other surfactants that may be anionic, cationic, zwitterionic, or nonionic. Generally, suitable surfactants are those that are reasonably stable over a wide pH range. Surfactants are described more fully, for example, in U.S. Patent No. 3,959,458 to Agricola et al.; U.S. Patent No. 3,937,807 to Haefele; and U.S. Patent No. 4,051,234 to Gieske et al., the disclosures of which are incorporated herein by reference in their entirety.

[0173] As used herein, "nonionic surfactant" generally refers to a compound produced by the condensation of an alkylene oxide group (essentially hydrophilic) with an organic hydrophobic compound that may be aliphatic or alkyl-aromatic in nature. Examples of suitable nonionic surfactants include poloxamers (sold under the trade name ), polyoxyethylene, polyoxyethylene sorbitan esters (sold under the trade name ), polyoxyethylene 40 hydrogenated castor oil, fatty alcohol ethoxylates, poly(ethylene oxide) condensates of alkylphenols, condensation products derived from the reaction product of ethylene oxide with propylene oxide and ethylenediamine, ethylene oxide condensates of aliphatic alcohols, alkyl polyglycosides (e.g., fatty alcohol ethers of polyglycosides, e.g., decyl ethers of glucose and polyglucoside polymers, lauryl ethers, octyl ethers, octanoyl ethers, myristyl ethers, stearyl ethers, and other ethers, including mixed ethers such as octyl / octanoyl (C 8-10 ) glucoside, cocoalkyl (C 8-16 ) glucoside, and lauryl (C 12-16 ) glucoside), long-chain tertiary amine oxides, long-chain tertiary phosphine oxides, long-chain dialkyl sulfoxides, and mixtures of such substances.

[0174] In some embodiments, the nonionic surfactant includes amine oxides, fatty acid amides, ethoxylated fatty alcohols, block copolymers of polyethylene glycol and polypropylene glycol, glycerol alkyl esters, polyoxyethylene octylphenol ethers, sorbitan alkyl esters, polyoxyethylene sorbitan alkyl esters, and mixtures thereof. Examples of amine oxides include, but are not limited to, lauramidopropyl dimethylamine oxide, myristamidopropyl dimethylamine oxide, and mixtures thereof. Examples of fatty acid amides include, but are not limited to, coconut monoethanolamide, lauramide monoethanolamide, coconut diethanolamide, and mixtures thereof. In certain embodiments, the nonionic surfactant is a combination of an amine oxide and a fatty acid amide. In certain embodiments, the amine oxide is a mixture of lauramidopropyl dimethylamine oxide and myristamidopropyl dimethylamine oxide. In certain embodiments, the nonionic surfactant is a combination of lauryl / myristamidopropyl dimethylamine oxide and coconut monoethanolamide. In certain embodiments, based on the total weight of the oral care composition, the nonionic surfactant is present in an amount of from 0.01% to 5.0%, 0.1% to 2.0%, 0.1% to 0.6%, 0.2% to 0.4%, about 0.2%, or about 0.5% by weight.

[0175] Mouthwashes typically contain significant levels of ethanol, which is generally required to dissolve essential oils and prevent bacterial contamination. High levels of ethanol may be undesirable because, in addition to the possibility of abuse by ingestion, ethanol can also exacerbate conditions such as dry mouth. Thus, in some embodiments, the oral care compositions of the present invention are substantially free of ethanol, e.g., contain less than 1% by weight ethanol based on the total weight of the oral care composition.

[0176] Humectants can increase the viscosity, mouthfeel, and sweetness of the product, and can also help preserve the product from deterioration or microbial contamination. Suitable humectants include edible polyols such as glycerol, sorbitol, xylitol, propylene glycol, and other polyols and mixtures of these humectants. Sorbitol can in some cases be provided as a hydrogenated starch hydrolysate in the form of a syrup, which mainly contains sorbitol (the product when starch is completely hydrolyzed to glucose and then hydrogenated), but may also contain other sugar alcohols such as mannitol, maltitol, and long-chain hydrogenated saccharides due to incomplete hydrolysis and / or the presence of sugars other than glucose, and in such cases these other sugar alcohols also serve as humectants. In some embodiments, based on the total weight of the oral care composition, the humectant is present at a level of from 5% to 25%, e.g., 15% to 20% by weight.

[0177] Flavoring agents for use in the present invention may include: extracts or oils from flavoring plants such as mint, spearmint, cinnamon, wintergreen, and combinations thereof; cooling agents such as menthol, methyl salicylate, and commercially available products; and sweeteners, which may include polyols (which also serve as humectants), saccharin, acesulfame potassium, aspartame, neotame, stevia, and sucralose.

[0178] Other ingredients that may optionally be included in the compositions according to the present invention include hyaluronic acid, green tea, ginger, sea salt, coconut oil, turmeric, white turmeric (curcumin), grape seed oil, ginseng, monk fruit, vitamin E, basil, chamomile, pomegranate, aloe vera, and charcoal. Any one of such ingredients may be present in an amount of 0.01% to 2%, such as 0.01% to 1%, or 0.01% to 0.5%, or 0.01% to 0.1% by weight of the composition, based on the total weight of the oral care composition.

[0179] Examples

[0180] Unless otherwise specified, the pH of all solutions described in the examples is about 7. Unless otherwise specified, all numbers for stannous ion concentration refer to soluble stannous, rather than total stannous (total stannous is a combination of soluble stannous and insoluble stannous).

[0181] Example 1 - Dentifrice formulation

[0182] Exemplary dentifrice compositions according to the present disclosure may be formulated as follows (amounts are shown as % by weight of the composition):

[0183]

[0184] Although the present disclosure has been described with respect to specific examples, including the presently preferred modes of carrying out the present disclosure, those skilled in the art will understand that there are many variations and permutations of the systems and techniques described above. It should be understood that other embodiments may be utilized and structural and functional modifications may be made without departing from the scope of the present disclosure.

Claims

1. An oral care composition comprising: (i) Stannous fluoride or stannous chloride; (ii) Nitric acid or a water-soluble nitrate; (iii) A water-soluble alkali metal polyphosphate; (iv) An effective amount of a taurate surfactant represented by formula (1): wherein R1 is a saturated or unsaturated, straight-chain or branched alkyl chain having 6 to 18 C atoms, R2 is H or methyl, and M + is H, sodium or potassium; and (v) Greater than 10% water by weight of the oral care composition.

2. The oral care composition according to claim 1, wherein the water-soluble nitrate is selected from alkali metal nitrates, alkaline earth metal nitrates, zinc nitrate, silver nitrate, ammonium nitrate, and combinations of two or more thereof.

3. The oral care composition according to claim 1, wherein the water-soluble nitrate is selected from lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, and combinations of two or more thereof.

4. The oral care composition according to claim 1, wherein the water-soluble nitrate is potassium nitrate.

5. The oral care composition according to any one of claims 1 to 4, wherein the water-soluble alkali metal polyphosphate is selected from pyrophosphates, tripolyphosphates, tetraphosphates, hexametaphosphates, and combinations of two or more thereof.

6. The oral care composition according to claim 5, wherein the water-soluble alkali metal polyphosphate is selected from sodium pyrophosphate, potassium pyrophosphate, sodium tripolyphosphate, potassium tripolyphosphate, and combinations of two or more thereof.

7. The oral care composition according to claim 1, wherein the water-soluble nitrate is potassium nitrate and the water-soluble alkali metal polyphosphate is sodium pyrophosphate.

8. The oral care composition according to any one of claims 1 to 7, wherein the oral care composition comprises at least a 1:1, such as a 1:1 to 5:1, or 1:1 to 4:1, or 1:1 to 3:1, or 1:1 to 2:1, or 1.5:1 to 5:1, or 2:1 to 5:1, or 2:1 to 4:1, or 2:1 to 3:1, or about 1:1 molar ratio of the alkali metal polyphosphate to stannous fluoride or stannous chloride.

9. The oral care composition according to any one of claims 1 to 8, wherein the oral care composition comprises at least a 0.3:1, such as a 0.3:1 to 20:1, 0.5:1 to 20:1, 1:1 to 20:1, 1:1 to 15:1, 1:1 to 10:1, 1:1 to 5:1, 1:1 to 3:1, or about 1:1 molar ratio of nitric acid or the water-soluble nitrate to stannous fluoride or stannous chloride.

10. The oral care composition according to any one of claims 1 to 9, wherein the oral care composition comprises stannous fluoride or stannous chloride in an amount of 0.1% to 2% by weight, such as 0.1% to 1% by weight, or 0.25% to 0.75% by weight, or about 0.45% by weight, based on the weight of the oral care composition; and wherein the oral care composition comprises nitric acid or a water-soluble nitrate (such as potassium nitrate) in an amount of 0.1% to 5% by weight, such as 0.1% to 2% by weight, or 0.1% to 1% by weight, or 0.1% to 0.5% by weight, or 0.2% to 0.4% by weight, or about 0.3% by weight, based on the weight of the oral care composition; and wherein the oral care composition comprises an alkali metal polyphosphate (such as sodium pyrophosphate) in an amount of 0.1% to 5% by weight, such as 0.8% to 5% by weight, or 0.8% to 4% by weight, or 0.8% to 3% by weight, or 0.8% to 2% by weight, or 0.8% to 1.0% by weight, or about 0.8% by weight, based on the weight of the oral care composition.

11. The oral care composition according to any one of claims 1 to 10, wherein the oral care composition comprises about 50% to about 95% by weight of water, based on the weight of the oral care composition.

12. The oral care composition according to claim 11, wherein the oral care composition comprises about 70% to about 95% by weight, such as about 75% to about 95% by weight, or about 75% to about 90% by weight, or about 75% to about 85% by weight, or about 75% to about 80% by weight of water, based on the weight of the oral care composition.

13. The oral care composition according to any one of claims 1 to 10, wherein the oral care composition comprises about 10% to about 50% by weight, such as about 10% to about 40% by weight, or about 10% to about 30% by weight of water, based on the weight of the oral care composition.

14. The oral care composition according to any one of claims 1 to 13, wherein the oral care composition comprises one or more humectants in a total amount of not more than 25% by weight, such as 5% to 25% by weight, or 10% to 25% by weight, or 15% to 25% by weight, or about 20% by weight, based on the weight of the oral care composition.

15. The oral care composition according to any one of claims 1 to 14, wherein the oral care composition is a single-phase composition.

16. The oral care composition according to any one of claims 1 to 14, wherein the oral care composition is a two-phase composition.

17. The oral care composition according to any one of claims 1 to 16, wherein the oral care composition is toothpaste.

18. The oral care composition according to any one of claims 1 to 17, wherein R1 is a saturated or unsaturated, straight-chain or branched alkyl chain having 8 to 14 carbon atoms.

19. The oral care composition according to any one of claims 1 to 18, wherein the taurate surfactant comprises one or more surfactants selected from the group consisting of potassium cocoyl taurate, potassium methyl cocoyl taurate, sodium hexanoyl methyl taurate, sodium cocoyl taurate, sodium lauroyl taurate, sodium methyl cocoyl taurate, sodium methyl lauroyl taurate, sodium methyl myristoyl taurate, sodium methyl oleoyl taurate, sodium methyl palmitoyl taurate, sodium methyl stearoyl taurate, and combinations of two or more thereof.

20. The oral care composition according to any one of claims 1 to 19, wherein the taurate surfactant comprises one or more surfactants selected from the group consisting of sodium lauroyl methyl taurate (or sodium methyl lauroyl taurate), sodium methyl cocoyl taurate, and combinations thereof.

21. The oral care composition according to any one of claims 1 to 20, wherein the taurate surfactant comprises sodium methyl cocoyl taurate.

22. The oral care composition according to any one of claims 1 to 21, wherein the taurate surfactant is present in an amount of about 0.25 wt% to about 5 wt% based on the weight of the oral care composition.

23. The oral care composition according to any one of claims 1 to 22, wherein the taurate surfactant comprises sodium methyl cocoyl taurate in an amount of about 0.25 wt% to 5 wt% (e.g., about 2.5 wt% based on the weight of the total composition).

24. The oral care composition according to any one of claims 1 to 23, wherein the oral care composition comprises hyaluronic acid (e.g., high molecular weight hyaluronic acid (HA)) or sodium hyaluronate.

25. The oral care composition according to any one of claims 1 to 24, wherein the oral care composition comprises: · about 0.1 wt% to about 2 wt% of stannous fluoride; · about 0.1 wt% to about 2 wt% of potassium nitrate; · about 0.1 wt% to about 5 wt% of sodium pyrophosphate; · about 0.25 wt% to 5 wt% of sodium methyl cocoyl taurate; and · about 15 wt% to about 30 wt% of water, wherein all weight percentages are based on the total weight of the oral care composition.

26. The oral care composition according to any one of claims 1 to 25, wherein the oral care composition comprises: · about 0.1 wt% to about 2 wt% of stannous fluoride; · about 0.1 wt% to about 2 wt% of potassium nitrate; · about 0.1 wt% to about 5 wt% of sodium tripolyphosphate; · about 0.25 wt% to about 5 wt% of sodium methyl cocoyl taurate; and · about 15 wt% to about 30 wt% of water, wherein all weight percentages are based on the total weight of the oral care composition.

27. An oral care kit comprising the composition according to any one of claims 1 to 26, wherein the kit comprises: A container, said container comprising a single storage compartment, said compartment containing said oral care composition; and a closure for sealing said compartment.

28. A method of treating or preventing gingivitis, dental plaque, dental caries and / or tooth hypersensitivity, said method comprising applying a composition according to any one of claims 1 to 26 to the oral cavity of a person in need thereof by brushing once or more times daily.

29. A method for stabilizing stannous ions in an aqueous oral care composition, comprising the following steps: (1) Providing an aqueous carrier, (2) adding a source of stannous ions to said aqueous carrier, (3) adding a source of nitrate ions to said aqueous carrier, (4) adding a source of polyphosphate ions and a taurate surfactant to said aqueous carrier, wherein the final composition is a single-component high-water composition.

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