Stable dentifrice compositions containing highly loaded sodium bicarbonate

Abstract

The present technology generally relates to stable dentifrice compositions containing a large amount of sodium bicarbonate. More specifically, the disclosed technology relates to stable dentifrice compositions containing a) at least 40% by weight sodium bicarbonate, b) at least one stannous ion anticaries component, c) stabilizer components including i) carboxyvinyl polymers and / or copolymers, ii) polyvinylpyrrolidone, and iii) xanthan gum, and d) at least one humectant component.

Description

[Technical field]

[0001] The present technology generally relates to a stable dentifrice composition that contains a large amount of sodium bicarbonate. More specifically, the present disclosure relates to a stable dentifrice composition that contains a) at least 40% by weight of sodium bicarbonate, b) at least one stannous ion anticaries component, c) a stabilizer component that includes i) a carboxyvinyl polymer and / or copolymer, ii) polyvinylpyrrolidone, and iii) xanthan gum, and d) at least one humectant component. In one embodiment, the dentifrice composition of the present technology is anhydrous. [Background technology]

[0002] Many different dentifrice compositions are known to provide cleaning, whitening, and better gingival health to keep teeth clean. Many of these known dentifrices contain a high content of water-insoluble abrasives that help remove plaque and stains that have built up on the teeth. The use of bicarbonate (baking soda) as a dentifrice or the incorporation of such salts into dentifrice compositions is well known in the art of oral care. The addition of bicarbonate to dentifrices is beneficial for several reasons, including providing good plaque removal capabilities. Sodium bicarbonate is known to penetrate the plaque layer, disrupt the sticky polysaccharide matrix, loosen the structural integrity of the biofilm, and enhance the physical removal of plaque. In addition, sodium bicarbonate is well known to enhance the whitening properties of dentifrices by removing stains that have built up on the tooth surface. Importantly, bicarbonate provides a clean and fresh feeling in the oral cavity after brushing and rinsing with water.

[0003] Sodium bicarbonate particles are generally a desirable abrasive for dentifrice compositions because they are relatively soft compared to most conventional abrasive materials used in dentifrice compositions. The American Dental Association recommends that only a small degree of abrasion is sufficient to avoid staining of tooth enamel surfaces. However, due to its softness, high levels of sodium bicarbonate or secondary abrasives are required to achieve maximum cleaning effectiveness.

[0004] However, high levels of conventional bicarbonate abrasives in toothpaste formulations impart excessively high viscosity, making the product difficult to mix during formulation. The high viscosity of the product makes it difficult for consumers to dispense or squeeze from the container. Furthermore, as the product ages, stability issues such as unacceptable hardening or phase separation occur.

[0005] In addition to incorporating sodium bicarbonate abrasives into dentifrice compositions, it is known to incorporate stannous-containing compounds (e.g., stannous fluoride) into sodium bicarbonate-containing dentifrices. Stannous fluoride is a common active ingredient in dentifrices and is recognized as an effective anticaries agent. In addition, stannous fluoride has been proven to be an effective agent for treating various conditions and diseases in the oral cavity, such as plaque, gingivitis, hypersensitivity, enamel demineralization, and periodontitis. Maintaining the amount of tin in the stannous state (stannous II) is essential to provide these oral hygiene benefits over the shelf life of the product. However, stannous ions are unstable and rapidly oxidize and / or hydrolyze to stannous ions (stannous IV), which are not bioactive and also cause discoloration and staining problems. Furthermore, stannous compounds are known to reduce or inhibit fluoridation of enamel. Maximizing and maintaining the amount of tin in the stannous state (stannous II) is essential to provide these oral hygiene benefits over the shelf life of the product.

[0006] Therefore, stannous-containing formulations typically contain a stabilization system designed to maintain stannous ions in the stannous (II) state.The most effective means of stabilizing stannous compounds is to reduce or eliminate the amount of water present in the composition.However, reducing the level of water, and optionally replacing some or all of the removed water with anhydrous humectants, can cause problems in obtaining acceptable rheology in the composition and can hinder the physical stability of the product.

[0007] To date, attempts to achieve acceptable abrasive cleaning power and desirable anti-caries efficacy by incorporating high levels of sodium bicarbonate and conventional amounts of stannous fluoride into dentifrice compositions have not been satisfactory from a stability standpoint. Stabilizer ingredients in dentifrices are known to be critical to maintaining the physical stability of dentifrices, such as toothpastes. Thus, an aspect of the present technology is the provision of stabilizer ingredients that stabilize dentifrice compositions that contain high levels of sodium bicarbonate abrasives and stannous-containing anti-caries agents. Summary of the Invention

[0008] The present technology is based on the discovery that stabilizer ingredients including i) carboxyvinyl polymer, ii) polyvinylpyrrolidone, and iii) xanthan gum stabilize dentifrice compositions containing high levels of sodium bicarbonate and stannous-containing anticaries agents against poor stability, dispersibility, texture consistency, and discoloration.

[0009] Another aspect of the present technology is the provision of a sodium bicarbonate-based anhydrous toothpaste formulation containing stannous fluoride that is stabilized by stabilizer components comprising i) carboxyvinyl polymer, ii) polyvinylpyrrolidone, and iii) xanthan gum, and is effective in removing plaque and retarding the accumulation of stains on teeth without deleterious abrasion of tooth enamel, cementum, or dentin, wherein the toothpaste exhibits good physical stability and substantially overcomes formulation problems caused by high viscosity.

[0010] In one aspect, the present technology comprises: a) about 40 to about 70 wt. %, or about 45 to about 65 wt. %, or about 50 to about 60 wt. % of an abrasive component comprising sodium bicarbonate; b) about 0.15 to about 2.5 wt. %, or about 0.2 to about 2.45 wt. %, or about 0.25 to about 2.4 wt. %, or about 0.5 to about 2.25 wt. %, or about 0.75 to about 2 wt. %, or about 1 to about 1.5 wt. % of a caries prevention component selected from a stannous ion source; c) a stabilizer component, i) about 0.3 to about 1 weight percent of a carboxyvinyl polymer; ii) about 0.2 to about 1 weight percent polyvinylpyrrolidone, and iii) about 0.2 to about 1% by weight of xanthan gum; A stabilizer component comprising: d) about 15 to about 50% by weight, or about 20 to about 45% by weight, or about 25 to about 40% by weight of at least one moisturizing agent component; wherein all weight percentages are based on the weight of the total composition, The present invention relates to dentifrice compositions. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] In all aspects of the present disclosure, all percentages are calculated by weight of the total composition. All ratios are expressed as weight ratios. All numerical ranges of amounts are inclusive and combinable unless otherwise stated.

[0012] For selected embodiments and aspects of the disclosed technology, overlapping weight ranges are expressed for the various components and ingredients that may be included in the disclosed compositions, but the amount of each component in the disclosed compositions is selected from its disclosed range such that the sum of all components or ingredients in the composition totals 100 weight percent. The amounts used will vary depending on the purpose and characteristics of the desired product and can be readily determined by one of ordinary skill in the art.

[0013] All percentages, ratios and levels of ingredients referred to herein are based on 100 percent active material unless otherwise specified.

[0014] The dentifrice compositions of the disclosed technology may suitably comprise, consist essentially of, or consist of the ingredients, elements, and process delineations described herein. The disclosed technology illustratively disclosed herein may suitably be practiced in the absence of any element not specifically disclosed herein.

[0015] As defined herein, "stable" and "stability" mean that no visible phase separation is observed under accelerated aging conditions at 40°C±2°C and 75%±5% relative humidity (RH) for a period of at least about 1 week of storage, or at least about 1 month of storage, or at least about 3 months of storage. In another aspect, the products of the disclosed technology do not exhibit visible phase separation or syneresis after accelerated storage conditions of 40°C±2°C and 75%RH±5%RH for at least about 6 months and long-term (LT) conditions of 25°C±2°C and 60%RH±5%RH for 12 months.

[0016] The prefix "(meth)acrylic" includes "acrylic" as well as "methacrylic." For example, the term "(meth)acrylic acid" includes both acrylic acid and methacrylic acid.

[0017] As used herein, unless otherwise specified, the term "dentifrice" means a paste, gel, powder, tablet, or liquid preparation used to clean the surfaces of the oral cavity and may be in the form of toothpaste, tooth gel, powder, tablet, foam, strip, and rinse. In one embodiment, the dentifrice is a toothpaste or tooth gel.

[0018] The components of the dentifrice compositions of the present technology are described in the following sections.

[0019] Abrasive ingredients In one embodiment of the present technology, the dentifrice of the present technology uses sodium bicarbonate as an abrasive component. As previously recognized, sodium bicarbonate provides plaque removal capabilities and leaves the mouth feeling clean and fresh after brushing and rinsing with water. In one embodiment, the sodium bicarbonate is provided in a particulate form having an average particle size ranging from 5 μm to about 200 μm, or from about 20 μm to 120 μm in diameter. The bicarbonate particles are incorporated into the dentifrice composition in an amount ranging from about 40 to about 70% by weight, or from about 45 to about 65% by weight, or from about 50 to about 60% by weight, based on the weight of the total dentifrice.

[0020] Stannous ion component In one embodiment, the dentifrice of the present technology comprises stannous ions. Stannous ions are generally derived from stannous salts added to the dentifrice. Stannous ions have been found to be useful in reducing gingivitis, plaque, sensitivity, and improving breath benefits. In one embodiment, the stannous salt is selected from stannous fluoride and stannous chloride dihydrate. Other stannous salts include stannous acetate, stannous fluoride chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethyleneglyoxide, and combinations thereof. Combinations of two or more of the aforementioned stannous salts may also be used. The stannous salt is present in an amount of from about 0.15% to about 2.5%, or from about 0.2 to about 2.45%, or from about 0.25 to about 2.4%, or from about 0.5 to about 2.25%, or from about 0.75 to about 2%, or from about 1 to about 1.5% by weight based on the weight of the total dentifrice composition.

[0021] Stabilizer ingredients In one embodiment, the stabilizer component comprises i) a carboxyvinyl polymer, ii) polyvinylpyrrolidone, and iii) xanthan gum. The stabilizer component improves the processability of dentifrice compositions containing high levels of bicarbonate during manufacture by reducing the formulation viscosity during mixing, as well as improving the long-term stability (shelf life) of the final product against phase separation and hardening. Additionally, the stabilizer component stabilizes the stannous ion component against oxidation and / or hydrolysis to the stannic state, thereby maintaining the efficacy of the stannous ion for the oral health benefits mentioned above, mitigating enamel fluoridation inhibition, and lightening dental enamel stains.

[0022] In one embodiment, component i) of the stabilizer component is a carboxyvinyl polymer. Examples of carboxyvinyl polymers include carbomers (e.g., polyacrylic acid homopolymers crosslinked with allyl pentaerythritol, allyl ethers of sucrose, or allyl ethers of propylene), polycarbophils (e.g., polyacrylic acid homopolymers crosslinked with divinyl glycol), and (meth)acrylic acid and C(meth)acrylic acid. 10 ~C 30 Crosslinked copolymers with alkyl esters (e.g., copolymers crosslinked with allyl pentaerythritol, allyl ether of sucrose, or allyl ether of propylene, INCI: Acrylates / C10-30 alkyl acrylate crosspolymer), and C of (meth)acrylic acid. 10 ~C 30 Crosslinked interpolymers of acrylic acid, optionally in combination with alkyl esters, are also included. Crosslinked interpolymers of acrylic acid and (meth)acrylic acid and C interpolymers of (meth)acrylic acid. 10 ~C 30 The crosslinked copolymers with alkyl esters are polymerized in the presence of a steric stabilizer and / or a wetting agent.

[0023] U.S. Pat. No. 5,288,814, incorporated herein by reference, describes copolymers of (meth)acrylic acid alone or in the presence of a steric stabilizer comprising at least one hydrophilic moiety and at least one hydrophobic moiety arranged in a linear block copolymer configuration or a random comb copolymer configuration. 10 ~C 30 Crosslinked interpolymers, optionally combined with alkyl ester comonomers, are described. Both of these steric stabilizer configurations contain hydrophilic moieties that include polyoxyethylene ether groups. U.S. Pat. No. 5,373,044, incorporated herein by reference, describes crosslinked interpolymers of (meth)acrylic acid and optional (meth)acrylic acid C10 copolymers polymerized in the presence of steric stabilizers and wetting agents described in U.S. Pat. No. 5,288,814 above. 10 ~C 30Interpolymers with alkyl ester comonomers are disclosed. The wetting agent is selected from low surface tension surfactants, glycols, polyhydric alcohols, and mixtures thereof.

[0024] Suitable carbomers as described above are commercially available under the Carbopol™ trade name sold by Lubrizol Advanced Materials, Inc. under the product names 956, 971P NF, 974P NF, and 980 NF.

[0025] A suitable polycarbophil polymer is sold by Lubrizol Advanced Materials under the trade name Noveon™, product name AA-1 USP.

[0026] (Meth)acrylic acid and C of (meth)acrylic acid 10 ~C 30 Copolymers with alkyl esters are commercially available under the trade name Pemulen™, sold by Lubrizol Advanced Materials, Inc., under the product names TR-1 NF and TR-2 NF.

[0027] (Meth)acrylic acid C 10 ~C 30 Interpolymers of (meth)acrylic acid, optionally in combination with alkyl esters, are commercially available under the trade name Carbopol™, sold by Lubrizol Advanced Materials, Inc., under the product names ETD 2020 NF and Ultrez 10 NF.

[0028] In one embodiment of the present technology, component ii) of the stabilizer component comprises polyvinylpyrrolidone (PVP). Polyvinylpyrrolidone is a linear polymer obtained by radical polymerization of N-vinylpyrrolidone. Polyvinylpyrrolidone can be characterized by its K value, which is a viscosity index directly related to its molecular weight. Commercially available polyvinylpyrrolidone is classified into several viscosity grades according to its K value, such as K-12, K-17, K-25, K-29 / 32, or K-90, with weight average molecular weights of 4000, 10,000, 34,000, 58,000, and 1,300,000, which are described in Ashland Pharmaceutical and Technology Report entitled Plasticizer Compatibility and Thermal and Rheological Properties of Plasdone™ Povidone and Copovidone Polymer for Hot-Melt Extrusion Applications; Mohammed Rhaman, Seher Ozkan, James Lester, Ishrathe Farzana, Vivian Bi and Thomas Durig. The K value is a calculated value obtained by substituting viscosity measurements into the Fikentscher formula.

[0029] In one embodiment, medium to high K values, such as K-25, K-29 / 32, K-90, and mixtures thereof, are suitable for use as the polyvinylpyrrolidone component of the stabilizer component. Pharmaceutical grade polyvinylpyrrolidone is commercially available from Ashland Global Specialties Inc. under the trade name Plasdone™ and from BASF Corporation under the trade name Kollidon™.

[0030] In one embodiment, component iii) of the stabilizer component of the present technology comprises xanthan gum. Xanthan gum is a natural gum polysaccharide commonly used as a food additive and is also widely used in the cosmetics and personal care industries as a rheology control agent. It is produced by a biotechnological process involving the fermentation of glucose or sucrose by the bacterium Xanthomonas campestris. Xanthan gum is a high molecular weight extracellular heteropolysaccharide ranging from about 1,000,000 Dalton units to more than about 50,000,000 Dalton units per polymer molecule. Xanthan gum is commercially available under the trade name Keldent™ from CPKelco. Xanthan gum is also available from many other commercial sources such as Sigma-Aldrich.

[0031] In one embodiment, the stabilizer component comprises, based on the weight of the total composition, i) from about 0.3 to about 1 weight percent carboxyvinyl polymer, ii) from about 0.2 to about 1 weight percent polyvinylpyrrolidone, and iii) from about 0.2 to about 1 weight percent xanthan gum.

[0032] Moisturizer In one aspect, humectants suitable for use in the present technology include polyhydric alcohols such as glycerin, sorbitol, xylitol, propylene glycol, polyethylene glycol (PEG), and other polyols, as well as mixtures of these humectants.

[0033] In one embodiment, low to medium molecular weight polyethylene glycols, such as PEG 300, PEG 400, PEG 600, PEG 800, PEG 1000, PEG 1500, and mixtures thereof, are useful as the humectant component.

[0034] In one embodiment, the humectant component is present in an amount ranging from about 15 to about 50 wt.%, or from about 20 to about 45 wt.%, or from about 25 to about 40 wt.%, based on the total weight of the composition.

[0035] Auxiliary dental abrasives Optionally, auxiliary dental abrasives may be used together with the sodium bicarbonate abrasive of the present technology.The auxiliary abrasive selected must be compatible with the sodium bicarbonate abrasive and other components in the target composition, and not excessively abrasive to dentin.Suitable auxiliary abrasives include, for example, silica, including silica gel and precipitated silica; insoluble sodium polymetaphosphate; hydrated alumina; calcium-containing compounds, including calcium carbonate, sodium carbonate, sodium bicarbonate, dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate, calcium oxyapatite; resinous abrasives, such as particulate condensation products of urea and formaldehyde; and mixtures thereof.

[0036] In one embodiment, the auxiliary dental abrasive is selected from calcium carbonate. Suitable sources include finely ground natural chalk (FGNC), ground calcium carbonate, precipitated calcium carbonate, and combinations thereof. Calcium carbonate abrasives are generally used in dentifrice compositions such as toothpastes that do not require a translucent to transparent appearance, i.e., are opaque.

[0037] In one embodiment, the calcium carbonate is selected from FGNC obtained from limestone or marble. Furthermore, the FGNC can be chemically or physically modified by coating during or after grinding with heat treatment. Typical coating materials include magnesium stearate or magnesium oleate. The morphology of the FGNC can also be modified during the grinding process by using various grinding techniques, such as ball mill grinding, air classifier grinding, or spiral jet grinding. Medium particle sizes of 1-15 microns and fine particles of 0.5-3 m are available. 2 An example of a natural chalk having a BET (Brunauer, Emmett and Teller) surface area of ​​100 nm / g is described in WO 03 / 030850.

[0038] In one aspect, the supplemental dental abrasive is selected from abrasive silica. Various types of silica dental abrasives are known in the art and have unique advantages such as excellent tooth cleaning and polishing performance without excessively abrading tooth enamel or dentin.

[0039] The silica dental abrasive polishing materials herein, as well as other auxiliary abrasives, generally have an average particle size ranging from about 0.1 to about 30 microns, or from about 5 to about 20 microns. The abrasives may be precipitated silicas or silica gels, such as the silica xerogels described in U.S. Pat. Nos. 3,538,230 and 3,862,307. Commercially available examples include the silica xerogels sold under the trade name Syloid™ by W.R. Grace and Co., and the precipitated silica abrasive materials sold under the trade name Zeodent™ by Evonik Corporation, particularly silicas bearing the names Zeodent™ 103, Zeodent™ 113, Zeodent™ 115, Zeodent™ 124, and Zeodent™ 623. Another oral care abrasive silica manufactured by Evonik is sold under the trade name Spherilex™ 145 and Spherilex™ 148. The types of silica dental abrasives useful in toothpastes of the present technology are described in more detail in U.S. Pat. Nos. 4,340,583, 5,603,920, 5,589,160, 5,658,553, 5,651,958, and 6,740,311.

[0040] It should be noted that there are two types of silica that can be used in toothpaste and tooth gel compositions. As mentioned above, silica is used as a dental abrasive. However, certain silicas can also be used as thickeners. The difference between the two types of silica is discussed in U.S. Pat. No. 6,342,205 (see Tables B and C and the accompanying disclosure), the disclosure of which is incorporated herein by reference in its entirety. Generally, abrasive silicas have a particle size of about 50 to about 125 cm. 3Oil absorption value in the range of about 1.5 to about 3 cm / 100 g 3 / g, about 0.2 to about 0.3 g / cm 3 and about 0.35 to about 0.45 g / cm 3 In contrast, thickening silicas have higher oil absorption values, higher pore volumes, lower pore densities, and lower packing densities than abrasive silicas, where the oil absorption values, pore volumes, pore densities, and packing densities are measured as described in columns 3-5 of the aforementioned U.S. Patent No. 6,342,205.

[0041] Mixtures of abrasives can be used, such as mixtures of the various grades of Zeodent™ silica abrasives listed above. In one embodiment, the total amount of auxiliary abrasive components in the dentifrice compositions of the present technology typically ranges from about 5% to about 30% by weight, or from about 10 to about 25% by weight, or from about 15 to about 20% by weight, based on the total weight of the composition.

[0042] Co-thickener Optional auxiliary thickeners provide desirable consistency and / or enhance the performance of the dentifrice composition. The optional auxiliary thickeners used in the compositions of the present technology are limited only to the extent that they can be added to compositions suitable for use in the oral cavity and provide the desired release of active ingredients to the oral cavity. Suitable thickeners include cellulose derivatives ("cellulose gums"), such as carboxymethyl cellulose (CMC) and its salts (e.g., sodium CMC), methylcellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, fermentation derived cellulose (FDC), microfibrous cellulose (MFC), and mixtures thereof, carrageenans, such as iota carrageenan, kappa carrageenan, kappa-2-carrageenan, lambda carrageenan, and mixtures thereof, guar gum, tara gum, locust bean gum, cassia gum, karaya gum, gum arabic, tragacanth gum, and mixtures thereof, and silica.

[0043] FDC can be obtained from Sphingomonas culture extract (commercially available as Kelco Care™ Diutan gum). Kelco Care™ Diutan gum is a natural high molecular weight polysaccharide with low anionic charge density produced by fermentation of the microorganism Sphingomonas sp. ATCC 53159. It is composed of six sugar units: d-glucose, d-glucuronic acid, d-glucose (with two l-rhamnoses in the side chains), and l-rhamnose, forming a linear backbone with repeating side chains. Diutan gum has a high molecular weight (typically several million kD) and therefore a long molecular chain length. This causes the Diutan gum polymer chains to become entangled at relatively low concentrations in solution. The structured network of entangled rigid molecules creates a high viscosity at low shear rates, resulting in excellent suspension properties. The molecules in the complex network of Diutan gum formulations are weakly associated. This network is gradually destroyed under the influence of applied shear stress, and the diutan gum solution becomes highly pseudoplastic. This rheological behavior makes Sphingomonas culture extract (Kelco Care™ Diutan gum) a robust candidate as a thickener and stabilizer in challenging dentifrice formulations, such as low or high pH, ​​high ionic content, or natural formulations.

[0044] Microfiber cellulose can be prepared by mechanically disrupting / modifying cereal, wood, or cotton-based cellulose fibers and is commercially available from a variety of commercial sources.

[0045] As previously mentioned, thickening silicas are distinguished from abrasive silicas by having higher oil absorption values, higher pore volumes, lower pore densities, and lower packing densities than abrasive silicas. In one embodiment, thickening silicas have a viscosity of about 150 to about 225 cm 3 Oil absorption value in the range of 100g, approx. 3.5 to approx. 6.5 cm 3 / g, about 0.1 to about 0.15 g / cm 3 and about 0.1 to about 0.25 g / cm 3As previously mentioned, the oil absorption value, pore volume, pore density, and packing density are measured as described in columns 3-5 of the above-mentioned U.S. Patent No. 6,342,205. Silica thickener materials are silicas sold under the trade name Zeodent™ by Evonik Corporation, specifically having the names Zeodent™ 153, Zeodent™ 163, and Zeodent™ 165.

[0046] In one embodiment, the optional auxiliary thickening agent can be selected from the individual thickening agents listed above, or a mixture of two or more thickening agents selected from the list above can be used in the composition of the present technology. In one embodiment, the auxiliary thickening agent component is present in the dentifrice composition of the present technology in an amount ranging from about 0.1 to about 10% by weight, or from about 0.5 to about 8% by weight, or from about 0.75 to about 7.5% by weight, or from about 1 to about 5% by weight, based on the total weight of the composition.

[0047] Surfactants In one embodiment, the dentifrice composition of the present technology comprises at least one orally acceptable cleansing surfactant.The surfactant improves the stability of the dentifrice composition, aids in cleaning oral surfaces with cleaning power, and provides foam when agitated, for example, during brushing with the oral care products of the present disclosure, such as toothpastes and tooth gels.The surfactant promotes the efficacy of dentifrice active ingredients, such as anti-caries agents and whitening agents, by dispersing these substances thoroughly throughout the oral cavity.The cleansing surfactant component can be selected from anionic surfactants, amphoteric surfactants, nonionic surfactants, and mixtures thereof.

[0048] In one embodiment, the surfactant may include an anionic surfactant. Suitable anionic surfactants include C8 to C 20 Water-soluble salts of alkyl sulfates, C8-C 20These include, but are not limited to, sulfonated monoglycerides of fatty acids, sarcosinates, taurates, etc. Illustrative examples include, but are not limited to, sodium lauryl sulfate, sodium cocoyl monoglyceride sulfonate, sodium lauryl sarcosinate, sodium lauryl isoethionate, sodium laureth carboxylate, and sodium dodecylbenzenesulfonate.

[0049] In one embodiment, the surfactant may include an amphoteric surfactant.Suitable amphoteric surfactants include alkyl betaines such as lauryl betaine, coco betaine; alkyl amido betaines such as cocamidopropyl betaine and cocohexadecyl dimethyl betaine; alkyl amido sultaines such as cocamidopropyl hydroxysultaine; (mono- and di-) amphocarboxylates such as sodium cocoamphoacetate, sodium lauroamphoacetate, sodium capryloamphoacetate, disodium cocoamphodiacetate, disodium lauroamphodiacetate, disodium caprylamphodiacetate, disodium capryloamphodiacetate, disodium cocoamphodipropionate, disodium lauroamphodipropionate, disodium caprylamphodipropionate, disodium capryloamphodipropionate, C8-C 22 Alkyl amine oxides, such as, but not limited to, octyl dimethylamine oxide, decyl dimethylamine oxide, dodecyl dimethylamine oxide, iso-dodecyl dimethylamine oxide, myristyl dimethylamine oxide, myristyl / cetyl dimethylamine oxide, myristyl dimethylamine oxide, coco dimethylamine oxide; and mixtures thereof.

[0050] In one embodiment, the surfactant may include a non-ionic surfactant. Suitable non-ionic surfactants include, but are not limited to, poloxamers, polyoxyethylene sorbitan esters, polysorbates, fatty alcohol ethoxylates, alkylphenol ethoxylates, tertiary amine oxides, tertiary phosphine oxides, dialkyl sulfoxides, and the like.

[0051] In one embodiment, surfactant can include cationic surfactant.Suitable cationic surfactant includes but is not limited to stearyl dimethyl benzyl ammonium chloride, dodecyl trimethyl ammonium chloride, nonyl benzyl ethyl dimethyl ammonium nitrate, tetradecyl pyridinium bromide, lauryl pyridinium chloride, cetyl pyridinium chloride, lauryl pyridinium chloride, lauryl isoquinolinium bromide, ditallow (hydrogenated) dimethyl ammonium chloride, dilauryl dimethyl ammonium chloride and stearalkonium chloride, and mixtures thereof.

[0052] In one embodiment, the surfactant includes anionic surfactants, amphoteric surfactants, and nonionic surfactants.

[0053] In one embodiment, the amount of surfactant present in the dentifrice composition of the present technology ranges from about 0.1 to about 5% by weight, or from about 0.25 to about 4.0% by weight, or from about 0.4 to about 4% by weight, or from about 1 to 3% by weight, based on the weight of the total composition.

[0054] Fluoride ion source The dentifrice composition of the present technology may also contain a fluoride ion source to reduce calcium loss.Suitable fluoride ion sources include, but are not limited to, sodium fluoride, potassium fluoride, barium fluoride, potassium monofluorophosphate, sodium monofluorophosphate, ammonium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluorides such as Olafur (N'-octadecyltrimethylenediamine-N,N,N'-tris(2-ethanol)-dihydrofluoride), ammonium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium fluorozirconate, sodium monofluorophosphate, aluminum monofluorophosphate, aluminum difluorophosphate, and combinations thereof.In one embodiment, one or more fluoride ion sources are included in the dentifrice composition.

[0055] In one embodiment, the dentifrice composition of the present technology comprises a fluoride ion source in an amount ranging from about 0.01 to about 10% by weight, or from about 0.1 to about 7% by weight, or from about 0.2 to about 5% by weight, or from about 0.25 to about 1.75% by weight, or from about 0.5 to about 1.5% by weight, or from about 0.75 to about 1.25% by weight, based on the total weight of the composition.

[0056] In one embodiment, the amount of fluoride in the dentifrice composition can be expressed in terms of active fluoride ion present in the composition. The active fluoride ion can be present in an amount ranging from about 500 to about 20,000 ppm, or from about 850 to about 15,000 ppm, or from about 1,500 to about 10,000 ppm, or from about 2,500 to about 8,000 ppm, or from about 3,000 to about 5,000 ppm.

[0057] water Water is an optional component of the dentifrice composition of the present technology. The water used in preparing the dentifrice composition should preferably be deionized and free of organic impurities. In one embodiment, the dentifrice composition comprises about 0 to about 50% by weight, or about 1 to about 45% by weight, or about 5% to about 40% by weight, or about 10 to about 35% by weight, or about 15 to about 25% by weight of water, where all percentages are based on the weight of the total composition. Free water in these ranges is in addition to the water introduced with the other ingredients in the composition.

[0058] Other Ingredients In addition to the above ingredients, the compositions of the present technology may contain various other conventional ingredients typically used in dentifrice compositions, such as toothpaste and tooth gel compositions, including, but not limited to, flavoring agents, sweetening agents, sensates, pH adjusting and buffering agents, coloring agents, anti-tartar agents, antibacterial agents, preservatives, whitening agents, desensitizing agents, and mixtures thereof.

[0059] In some embodiments, the composition of the present technology comprises at least one flavoring agent.Suitable flavoring agents include, but are not limited to, essential oils, various flavoring aldehydes, esters, alcohols, and similar materials, as well as menthol, carvone, and anethole, and mixtures thereof.Examples of essential oils include spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange oil.In some embodiments, a mixture of peppermint oil and spearmint oil is used as flavoring agent in the composition disclosed herein.

[0060] If a flavoring is used, the amount of flavoring is in the range of about 0.1 to about 5 wt.%, or about 0.2 to 4 wt.%, or about 0.3 to about 3 wt.%, or about 0.4 to about 2 wt.%, or about 0.5 to 2 wt.%, or about 0.6 to about 2 wt.%, or about 0.7 to about 2 wt.%, or about 0.8 to about 2 wt.%, or about 0.9 to about 2 wt.%, or about 1 to about 2 wt.%, based on the total weight of the composition.

[0061] In some embodiments, the composition of the present technology comprises at least one sweetener.Any food grade or pharma- ceutically acceptable sweetener may be used.Suitable sweeteners include, for example, sucrose, glucose, saccharin, sucralose, dextrose, levulose, lactose, mannitol, sorbitol, fructose, maltose, xylitol, saccharin salts (e.g., sodium saccharin), thaumatin, aspartame, D-tryptophan, dihydrochalcone, acesulfame, cyclamate salts, and mixtures thereof.

[0062] When a sweetener is used, the amount of the sweetener ranges from about 0.005 to about 10% by weight, or from about 0.01 to 9% by weight, or from about 0.1 to 7% by weight, or from about 0.1% to 5% by weight, or from about 0.3 to about 3% by weight, or from about 0.5 to 2% by weight, or from about 0.6 to about 1% by weight, based on the total weight of the composition.

[0063] Sensates, such as cooling agents, warming agents, and tingling agents, are useful for delivering signals to consumers. The best known cooling agent is menthol, particularly 1-menthol, which is found naturally in peppermint oil. Among the synthetic cooling agents, many are derivatives of menthol or structurally related to menthol, i.e., contain a cyclohexane moiety and are derivatized with functional groups such as carboxamides, ketals, esters, ethers, and alcohols. Examples include p-menthane carboxamide compounds, such as N-ethyl-p-methane-3-carboxamide or N-(4-cyanomethylphenyl)-p-menthane carboxamide. An example of a synthetic carboxamide cooling agent that is structurally unrelated to menthol is N,2,3-trimethyl-2-isopropylbutanamide. Further exemplary synthetic cooling agents include alcohol derivatives such as 3-1-menthoxy-propane-1,2-diol, isopulegol, p-menthane-3,8-diol, menthone glycerol acetal, menthyl esters such as menthyl acetate, menthyl acetoacetate, menthyl lactate, and monomenthyl succinate.

[0064] Additional agents structurally unrelated to menthol but reported to have similar physiological cooling effects include α-ketoenamine derivatives described in U.S. Pat. No. 6,592,884, including 3-methyl-2-(1-pyrrolidinyl)-2-cyclopenten-1-one (3-MPC), 5-methyl-2-(1-pyrrolidinyl)-2-cyclopenten-1-one (5-MPC), 2,5-dimethyl-4-(1-pyrrolidinyl)-3(2H)-furanone (DMPF), and icilin (also known as AG-3-5, chemical name 142-hydroxyphenyl]-4-[2-nitrophenyl]-1,2,3,6-tetrahydropyrimidin-2-one).

[0065] Examples of warming agents include ethanol, nicotinic acid esters such as benzyl nicotinate, polyhydric alcohols, nonanoyl vanillylamide, vanillyl ether nonanoate, vanillyl alcohol alkyl ether derivatives such as vanillyl ethyl ether, vanillyl butyl ether, vanillyl pentyl ether, and vanillyl hexyl ether, isovanillyl alcohol alkyl ethers, ethyl vanillyl alcohol alkyl ethers, veratryl alcohol derivatives, substituted benzyl alcohol derivatives, substituted benzyl alcohol alkyl ethers, vanillin propylene glycol acetal, ethyl vanillin propylene glycol acetal, ginger extract, ginger oil, gingerol, zingerone, or combinations thereof.

[0066] Examples of pungent agents include capsaicin, homocapsaicin, jambu oleoresin, zanthoxylum peperitum, sanshool-I, sanshool II, sanshoamide, piperine, piperidine, spilanthol, 4-(1-methoxymethyl)-2-phenyl-1,3-dioxolane, or combinations thereof.

[0067] In one embodiment, the amount of sensate ranges from about 0.001 to about 5 wt.%, or from about 0.01 to about 4 wt.%, or from about 0.1 to about 3 wt.%, or from about 0.5 to about 2 wt.%, or from about 1 to about 1.5 wt.%, based on the total weight of the composition.

[0068] The dentifrice composition of the present technology may contain an effective amount of pH adjusting agent and / or pH buffering agent.As used herein, pH adjusting agent means an agent that can be used to adjust or maintain the pH of dentifrice composition in a desired pH range based on formulation requirements.Such agents include acidifying agents that lower the pH, basifying agents that raise the pH, and buffering agents that maintain the pH within a desired range.pH adjusting agents and buffering agents can include alkali metal hydroxides, ammonium hydroxide, organic ammonium compounds, amino alcohols, carbonates, sesquicarbonates, borates, silicates, phosphates, imidazoles, and mixtures thereof. Specific pH adjusters and buffers include monosodium phosphate (monobasic sodium phosphate), trisodium phosphate (sodium phosphate tribasic dodecahydrate or TSP), sodium benzoate, benzoic acid, sodium hydroxide, potassium hydroxide, alkali metal carbonates, sodium carbonate, imidazole, pyrophosphate, sodium gluconate, lactic acid, sodium lactate, citric acid, sodium citrate, tris(hydroxymethyl)aminomethane, and / or phosphoric acid.

[0069] In one embodiment, the amount of pH adjusting agent and / or buffering agent used is the amount necessary to adjust and maintain the pH of the dentifrice composition in the range of from about pH 7.5 to about pH 10, or from about pH 7.5 to about pH 8.5, for example, or from about pH 7.6 to about pH 8.4, or from about pH 7.7 to about pH 8.3, or a pH of about 8.

[0070] In some embodiments, the dentifrice composition may include at least one coloring agent. Coloring agents include pigments, dyes, lakes, and agents that impart luster or reflectivity, such as pearlescent agents. Any orally acceptable coloring agent may be used, including, but not limited to, talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, magnesium aluminum silicate, silica, titanium dioxide, zinc oxide, red, yellow, brown, and black iron oxide, ferric ammonium ferrocyanide, manganese violet, ultramarine, titanated mica, bismuth oxychloride, and the like. Food, Drug, and Cosmetic Act (FD&C) colorants such as primary FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 3, FD&C Red No. 33, and FD&C Red No. 40 and lake FD&C Blue No. 1, FD&C Blue No. 2, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 2, FD&C Red No. 3, FD&C Red No. 33, FD&C Red No. 40, and combinations thereof.

[0071] One or more colorants are optionally present in a total amount of from about 0.001 to about 20 wt. %, or from about 0.01 to about 10 wt. %, or from about 0.1 to about 5 wt. %, based on the total weight of the composition.

[0072] The dentifrice composition may include an anti-calculus agent. In one embodiment, the anti-calculus agent is a phosphorus-containing compound. Non-limiting examples include pyrophosphate salts as a source of pyrophosphate ions. In one embodiment, the composition includes sodium pyrophosphate (SPP), sodium acid pyrophosphate (SAPP), sodium tripolyphosphate (STPP), tetrasodium pyrophosphate (TSPP), sodium hexametaphosphate (SHMP), and combinations thereof. Other useful anti-calculus agents include polycarboxylate polymers and polyvinyl methyl ether / maleic anhydride (PVME / MA) copolymers.

[0073] In one embodiment, the amount of anticalculus agent ranges from about 0.01 to about 10% by weight, or from about 0.1 to about 6% by weight of pyrophosphate based on the weight of the total composition.

[0074] In one aspect, the composition of the present technology can contain antimicrobial (e.g., antibacterial) agents and / or preservatives. Antimicrobial agents and preservatives improve the antimicrobial properties and shelf-life stability of dentifrice compositions. Non-limiting examples of antimicrobial agents and preservatives are triclosan, chlorhexidine, cetylpyridinium chloride, benzalkonium chloride, stannous salts, essential oils, zinc oxide, zinc citrate, benzyl alcohol, sodium benzoate, isobutyl paraben, isopropyl paraben, ethyl paraben, methylparaben, ethylparaben, propylparaben, and mixtures thereof. Other useful antimicrobial agents are disclosed in U.S. Patent No. 5,776,435.

[0075] The antimicrobial agent and / or preservative is optionally present in an antimicrobially effective amount, typically in an amount ranging from about 0.05 to about 10% by weight, or from about 0.1 to about 3% by weight, or from about 0.5 to about 1% by weight, based on the total weight of the composition.

[0076] In one aspect, the dentifrice composition of the present technology can contain a whitening agent.Non-limiting examples of whitening agents that can be used include, for example, peroxide, metal chlorite, perborate, percarbonate, peracid, hypochlorite, and mixtures thereof.In some embodiments, the whitening agent is hydrogen peroxide or a hydrogen peroxide source, for example, urea peroxide or a peroxide salt or complex (for example, peroxyphosphate, peroxycarbonate, perborate, peroxysilicate, or persulfate, for example, calcium peroxyphosphate, sodium perborate, sodium carbonate perhydrogenate, sodium peroxyphosphate, and potassium persulfate), or a hydrogen peroxide polymer complex (for example, peroxide-polyvinylpyrrolidone polymer complex).

[0077] In one embodiment, the amount of whitening agent in the dentifrice composition of the present technology ranges from about 1 to about 10% by weight, or from about 0.25 to about 7.5% by weight, or from about 0.4 to 5% by weight, or from about 0.6 to about 3% by weight, based on the total weight of the composition.

[0078] In one embodiment, the dentifrice composition of the present technology optionally comprises a desensitizing agent or tooth sensitivity protection agent. There can be one or more of such agents. Suitable desensitizing agents include, but are not limited to, potassium salts, such as potassium citrate, potassium tartrate, potassium chloride, potassium sulfate, and potassium nitrate. Other suitable desensitizing agents include sodium nitrate and stannous and strontium salts. Alternatively, local or systemic analgesics such as aspirin, codeine, acetaminophen, sodium salicylate, or triethanolamine salicylate can be used alone or in combination with the desensitizing agents described above.

[0079] In one embodiment, the desensitizing agent is used in an amount ranging from about 0.1 to about 10 wt.%, or from about 0.5 to about 7 wt.%, or from about 1 to about 5 wt.%, based on the total weight of the composition.

[0080] The dentifrice composition of the present technology is prepared by the conventional method for making dentifrice formulations.In one embodiment, the dentifrice is formulated into toothpaste or tooth gel, which can be prepared by high temperature process or ambient temperature process (low temperature process).The process can be batch process or continuous process.In one embodiment, the dentifrice can be prepared by the process described in U.S. Patent No. 4,353,890 and U.S. Patent No. 6,187,293.

[0081] In one embodiment, the dentifrice composition of the present technology is manufactured according to standard toothpaste formulation procedures well known in the art. For example, the composition can be manufactured as follows: The polymer is dispersed in a pre-dispersion solvent (polyethylene glycol or propylene glycol or mixtures thereof) to obtain a pre-dispersed polymer mixture. The pre-dispersed polymer mixture is added to glycerin and placed in a planetary mixer (Ross VersaMix, Model VMC-1) and mixed under heat (about 50°C) for 1 hour under full vacuum to obtain a homogenous gel phase. Heat is removed and salts such as fluoride, sodium saccharin, phosphate salts, and pH adjusters are added to the gel phase and mixed under full vacuum for 30 minutes. Sodium bicarbonate and other solids are added to the mixture and mixed at a planetary speed of 20-30 rpm for 3-5 minutes until the sodium bicarbonate is completely wetted. The mixture is then mixed under vacuum for 45-60 minutes with planetary speed increased to 80-100 rpm and disperser speed of 2500-3500 rpm to obtain a smooth dentifrice. Surfactants and flavorings are then added to the dentifrice and mixed under vacuum for 20-30 minutes at a planetary speed of 80-100 rpm and a disperser speed of 1500-2500 rpm to obtain a homogenous composition.

[0082] In toothpaste or gel form, the composition can be packaged in conventional plastic laminated metal tubes, pump dispensers, squeezable plastic containers, and other conventional toothpaste and tooth gel dispensers.Toothpaste and gel formulations can be conveniently dispensed in ribbon-like form with good body and texture.The formulation does not hang excessively into toothbrush bristles, and is not clumpy or excessively sticky.

[0083] The toothpaste and tooth gel compositions of the present technology are used in a conventional manner. The composition is brushed onto the tooth surface and then rinsed off. The composition generally contacts the tooth surface during brushing for at least about 30 seconds, or at least about 60 seconds, or at least about 120 seconds.

[0084] The present technology is illustrated by the following examples, which are for illustrative purposes only and should not be construed as limiting the scope of the technology or the manner in which it may be practiced. Unless otherwise specified, all weight percentages are expressed as 100 percent active material. EXAMPLES

[0085] Examples 1 to 6 Dentifrice compositions were prepared from the ingredients listed in Table 1. All compositions contained 0.45% stannous fluoride and 50% sodium bicarbonate and were manufactured at 4 kg scale by using a Ross mixer (Model #VMC-1). Carboxyvinyl polymer and polyvinylpyrrolidone (PVP) K30 were separately dispersed in polyethylene glycol and xanthan gum was dispersed in glycerin to obtain individual pre-dispersed polymer mixtures. The pre-dispersed polymer mixtures and the remainder of the glycerin from the formulation were added to the Ross mixer and mixed for 1 hour under full vacuum with heat (about 50°C) to obtain a homogenous gel phase. Heating was stopped and salts such as fluoride, sodium saccharin, phosphate salts, and pH adjusters were added to the gel phase and mixed for 30 minutes under full vacuum with planetary speed of 80-100 rpm and disperser speed of 2500-3500 rpm. Sodium bicarbonate and other solids were added to the mixture and mixed under vacuum for 45-60 minutes at increased planetary speeds of 80-100 rpm and disperser speeds of 2500-3500 rpm to obtain a smooth dentifrice. Surfactants and flavors were added to the dentifrice and mixed under vacuum for 20-30 minutes until homogenous. Three dentifrice compositions (Examples 1-3) were prepared with a stabilizer comprising a carboxyvinyl polymer along with PVP and xanthan gum. Three comparative dentifrice compositions (Examples 4-6) were prepared with xanthan, PVP, or xanthan / PVP stabilizer systems, respectively, in the absence of carboxyvinyl polymer.

[0086] [Table 1] 1 Comparative Example 2 Carbopol® 974P NF Polymer 3 Sodium Lauryl Sulfate

[0087] The toothpaste samples listed in Table 1, along with two commercially available anhydrous sodium bicarbonate toothpastes, were packaged in 8 ounce glass jars and stored in an ESPEC humidity chamber (Model No. ESL-3CA) at 40±2° C. and 75%±5% RH for the Accelerated Stability Test (ACC Test) according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), (ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2), Current Step 4, version dated 6 February 2003), and at 25±2° C. and 60±5% RH for the Long Term Stability Test (LT Test) according to the ICH protocol mentioned above. Toothpaste viscosity (Helipath viscosity was measured in a Brookfield Viscometer (Model No. DV-I+) at 5 rpm and ambient room temperature (20-25 °C)) was measured and recorded once per month over a 3-month period in accordance with the ISO 11609:2017(E) stability testing protocol (Table 2). Toothpaste performance and appearance observations (syneresis / separation and discoloration) are summarized in Table 2.

[0088] [Table 2-1]

[0089] [Table 2-2] 1 Commercially available anhydrous toothpaste containing 40-60% by weight sodium bicarbonate (based on the total weight of the composition)

[0090] Two commercial anhydrous sodium bicarbonate toothpastes (A) and (B) failed stability testing under ACC and LT test conditions, exhibiting severe syneresis and hardening (poor dispensability / extrusion). All commercial samples had a viscosity increase of about 100% even in the first month when tested under accelerated test conditions. A viscosity change of about 100% is known to indicate that the formulation tested has a tendency to fail stability testing, giving unacceptable or unsatisfactory physical stability test results.

[0091] Three compositions prepared with the stabilizer of the present technology (Examples 1, 2, and 3) exhibited good physical stability and showed no signs of syneresis / separation, hardening, and discoloration (yellowing effect) when aged for three months under accelerated storage conditions according to the ACC and LT tests. Three comparative dentifrice compositions (Examples 4, 5, and 6) using only two components of the stabilizer composition (PVP and xanthan) in the absence of the carboxyvinyl polymer component exhibited syneresis under accelerated aging conditions and also had a tendency to discolor (severe yellow appearance on the surface), which is indicative of oxidation of stannous ion from the stannous (II) form to its inactive form stannous (IV).

Claims

1. 1. A dentifrice composition comprising: a) about 40 to about 70 wt. %, or about 45 to about 65 wt. %, or about 50 to about 60 wt. % of an abrasive component comprising sodium bicarbonate; b) about 0.15 to about 2.5 wt. %, or about 0.2 to about 2.45 wt. %, or about 0.25 to about 2.4 wt. %, or about 0.5 to about 2.25 wt. %, or about 0.75 to about 2 wt. %, or about 1 to about 1.5 wt. % of an anticaries component selected from a stannous ion source; c) a stabilizer component, i) about 0.3 to about 1 weight percent of a carboxyvinyl polymer; ii) about 0.2 to about 1 weight percent polyvinylpyrrolidone, and iii) about 0.2 to about 1% by weight of xanthan gum; A stabilizer component comprising: d) from about 15 to about 50%, or from about 20 to about 45%, or from about 25 to about 40% by weight of at least one humectant component; all percentages being based on weight of the total composition; Dentifrice compositions.

2. 2. The dentifrice composition of claim 1, wherein the stannous ion source is selected from stannous fluoride, stannous chloride dihydrate, stannous chlorofluoride, stannous pyrophosphate, stannous sulfate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations thereof.

3. 3. The dentifrice composition of claim 1 or 2 further comprising a source of fluoride ions.

4. 4. The dentifrice composition of any one of claims 1 to 3, wherein the fluoride ion source is selected from sodium fluoride, potassium fluoride, barium fluoride, potassium monofluorophosphate, sodium monofluorophosphate, ammonium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluorides such as Olaflur (N'-octadecyltrimethylenediamine-N,N,N'-tris(2-ethanol)-dihydrofluoride), ammonium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium fluorozirconate, sodium monofluorophosphate, aluminum monofluorophosphate, aluminum difluorophosphate, and combinations thereof.

5. 5. The method of any one of claims 1 to 4, wherein the fluoride ion source is present in an amount ranging from about 0.01 to about 10 wt.%, or from about 0.1 to about 7 wt.%, or from about 0.2 to about 5 wt.%, or from about 0.25 to about 1.75 wt.%, or from about 0.5 to about 1.5 wt.%, or from about 0.75 to about 1.25 wt.%, based on the total weight of the composition.

6. The carboxyvinyl polymer is a crosslinked homopolymer of acrylic acid, a crosslinked homopolymer of (meth)acrylic acid and a C １０ ~C ３０ The dentifrice composition of any one of claims 1 to 5, selected from cross-linked copolymers with alkyl esters, interpolymers thereof, and combinations thereof.

7. The crosslinked copolymer of (meth)acrylic acid is a copolymer of acrylic acid and C １０ ~C ３０ A dentifrice composition according to any one of claims 1 to 6 prepared from alkyl esters.

8. 8. The dentifrice composition of any one of claims 1 to 7, wherein the at least one anhydrous humectant component is selected from glycerol, sorbitol, xylitol, polyethylene glycol, propylene glycol, and combinations thereof.

9. The abrasive component is abrasive silica, tricalcium phosphate (Ca ３ (P.O. ４ ) ２ ), dicalcium phosphate dihydrate (CaHPO ４・ 2H ２ O), hydroxyapatite (Ca １０ (P.O. ４ ) ６ (OH) ２ 9. The dentifrice composition of claim 1, further comprising an auxiliary abrasive selected from calcium carbonate abrasives, or an abrasive such as sodium metaphosphate, potassium metaphosphate, aluminum silicate, calcined alumina, bentonite, and combinations thereof.

10. 10. The dentifrice composition of any one of claims 1 to 9, wherein the auxiliary abrasive component is present in an amount ranging from about 5 to about 30 wt.%, or from about 10 to about 25 wt.%, or from about 15 to about 20 wt.%, based on the total weight of the composition.

11. 11. The dentifrice composition of any one of claims 1 to 10, further comprising a surfactant selected from anionic surfactants, cationic surfactants, zwitterionic surfactants, amphoteric surfactants, nonionic surfactants, and mixtures thereof.

12. 12. A dentifrice composition according to any one of claims 1 to 11, wherein the surfactant is present in an amount ranging from about 0.1 to about 5% by weight, or from about 0.25 to about 4.0% by weight, or from about 0.4 to about 4% by weight, or from about 1 to about 3% by weight, based on the weight of the total composition.

13. 13. A dentifrice composition according to any one of claims 1 to 12, further comprising a thickener component selected from cellulose based thickeners, non-xanthan gums, seaweed extracts, thickening silicas, and mixtures thereof.

14. 14. The dentifrice composition of claim 13, wherein the cellulosic thickener is selected from carboxymethylcellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, cellulose derived from bacterial fermentation, fine fibrous cellulose, and mixtures thereof; or the non-xanthan gum thickener is selected from guar gum, tara gum, locust bean, gum arabic, gum tragacanth, gum karaya, gum cassia, and mixtures thereof; or the seaweed extract thickener is selected from kappa carrageenan, kappa-2-carrageenan, iota carrageenan, lambda carrageenan, alginates, and mixtures thereof.

15. 15. A dentifrice composition according to any one of claims 13 or 14, wherein the thickening agent is present in an amount ranging from about 0.1 to about 10% by weight, or from about 1.5 to about 9% by weight, or from about 2.5 to about 8.5% by weight, or from about 4 to about 7.5% by weight, based on the weight of the total composition.

16. 16. The dentifrice composition of any one of claims 1 to 15, further comprising flavoring agents, sweetening agents, sensates, pH adjusting and buffering agents, colorants, anti-tartar agents, anti-bacterial agents, preservatives, whitening agents, desensitizing agents, and combinations thereof.

17. A dentifrice composition according to any one of claims 1 to 16, wherein the composition is anhydrous.

18. A dentifrice composition according to any one of claims 1 to 17, wherein the dentifrice is a toothpaste or a tooth gel.

19. As a stabilizer for highly loaded sodium bicarbonate dentifrice compositions i) about 0.3 to about 1 weight percent of a carboxyvinyl polymer; ii) about 0.2 to about 1 weight percent polyvinylpyrrolidone; iii) about 0.2 to about 1 weight percent xanthan gum; 5. Use of a composition comprising: wherein the dentifrice composition comprises at least about 40% by weight, or at least about 45% by weight, or at least about 50% by weight, or at least about 60% by weight, or at least about 65% by weight, or at least about 70% by weight sodium bicarbonate.

20. 20. The use of claim 19, wherein the dentifrice composition further comprises from about 0.15% to about 2.5%, or from about 0.2 to about 2.45%, or from about 0.25 to about 2.4%, or from about 0.5 to about 2.25%, or from about 0.75 to about 2%, or from about 1 to about 1.5% by weight of an anticaries ingredient selected from a source of stannous ions.

21. 21. The use of claim 19 or 20, wherein the dentifrice composition further comprises from about 15 to about 50%, or from about 20 to about 45%, or from about 25 to about 40% by weight of at least one humectant ingredient, all percentages being based on the weight of the total composition.

22. Use according to any one of claims 19 to 21, wherein the dentifrice composition further comprises an ingredient according to any one of claims 2 to 16.

23. 20. The use of claim 19, wherein the dentifrice composition is anhydrous.

Images