Solid oral care compositions comprising PVP and HEC as a binder system

Abstract

The present invention relates to solid oral care compositions, such as tablets, comprising a binder system. In certain aspects, the present invention relates to solid oral care compositions comprising a binder system, wherein the binder system comprises polyvinylpyrrolidone and hydroxyethylcellulose, as well as tablets, to the use of these compositions and to methods of manufacturing these compositions.

Description

Technical Field

[0001] This invention relates to solid oral care compositions, such as tablets, comprising an adhesive system. In some aspects, the invention relates to solid oral care compositions comprising an adhesive system for tablets, wherein the adhesive system comprises polyvinylpyrrolidone and hydroxyethyl cellulose, and to methods of using these compositions and of manufacturing these compositions. Background Technology

[0002] An acceptable dental cleaning composition should remove residue, effectively clean the oral cavity, and efficiently deliver any possible active ingredients contained in the composition. This mode of action is intended to help prevent cavities and promote gum health. Typically, brushing is required with a dental cleaning agent containing various detergents, active substances, and abrasives. Paste form is a common and prevalent form of dental cleaning products and is usually provided via paste-filled laminated tubes; the rheological properties of these types of products make them desirable for delivering active ingredients. Problems may arise in dispensing this type of product and in effectively using all the product provided in the tube. For example, the viscosity of the paste may make it difficult to fully squeeze out the last drop of toothpaste from the tube. Transportation may also cause tube deformation, which in turn may affect product dispensing.

[0003] A large number of dental cleaning agents on the market are in paste or gel form and packaged in tubes, squeeze bottles, pressurized cans, or pump dispensers. While these dental cleaning agents have been used traditionally, the market demands products that can be used on the go, require less packaging, can be stored for longer periods, and require less water. However, the types of oral care products that address these needs appear to be relatively limited. Tablets are available, but some of these products may have issues such as brittleness and may break or crumble during transport or sometime before the consumer uses them. Other issues with these products may include the ability to deliver the various active ingredients to the consumer's teeth or gums at the same level as toothpaste and gels.

[0004] Therefore, there is a need for oral care products that can potentially replace the ointments and gels currently on the market. Summary of the Invention

[0005] This invention relates to solid compositions comprising a binder system, such as tablets, wherein the binder system comprises polyvinylpyrrolidone (PVP) and hydroxyethyl cellulose (HEC). In one aspect, the weight ratio of PVP to HEC is from 0.5:1 to 2.5:1 (PVP:HEC) (e.g., a PVP:HEC weight ratio of 1.5:1). In another aspect, the solid composition (e.g., a single-use tablet) is capable of delivering one or more active ingredients (e.g., fluoride) at least as equivalent to a toothpaste or gel having a similar amount / concentration of active substances. It is not desired to be bound by theory, but it is considered that a specific ratio of PVP to HEC is important for suitable friability and active substance delivery characteristics, and that the components of the solid oral care composition are present in amounts in which the active substance (e.g.) can be released more effectively. In some embodiments, this disclosure relates to storage-stable solid compositions comprising a binder system, wherein the binder system comprises polyvinylpyrrolidone (PVP) and hydroxyethyl cellulose (HEC) and an active ingredient, wherein the components remain stable in the solid composition.

[0006] Further applicability of this disclosure will become apparent from the detailed description provided below. It should be understood that while the detailed description and specific examples indicate preferred embodiments of the invention, they are intended for illustrative purposes only and not for limiting the scope of the invention. Detailed Implementation

[0007] The following description of preferred embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or its uses.

[0008] As used throughout, "range" serves as a shorthand for describing the individual values ​​within a range. Any value within a range can be chosen as an end value of the range. Furthermore, all references cited herein are incorporated herein by reference in their entirety. In the event of any conflict between definitions in this disclosure and those in the cited references, the definitions in this disclosure shall prevail.

[0009] Unless otherwise specified, all percentages and quantities expressed herein and elsewhere in this specification shall be understood as weight percentages relative to the total composition. Given quantities are based on the weight of the active material in the material.

[0010] Open-ended terms such as "include / including" and "contain / containing" mean "including / containing". In this description, unless otherwise stated, the singular is used, including the plural.

[0011] As used herein, "oral care composition" means a composition whose intended use includes oral care, oral hygiene, and / or oral appearance, or whose intended method of use includes application to the oral cavity, and refers to a composition that is palatable and safe for topical application to the oral cavity and provides benefits to the teeth and / or oral cavity. Therefore, the term "oral care composition" specifically 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 is retained in the oral cavity for a duration sufficient to affect the intended efficacy. Oral care compositions disclosed herein can be used in non-human mammals such as companion animals (e.g., dogs and cats) as well as for human use. In some embodiments, oral care compositions disclosed herein are for human use. Solid oral care compositions include, for example, powders (e.g., free-flowing granules), tablets, capsules (tablet type), granules, pellets, round tablets, films, and beads.

[0012] As used herein, “effective amount” means an amount of compound or composition sufficient to cause positive benefits, functional benefits (e.g., providing suitable fragility and active substance delivery characteristics) and / or oral health benefits (e.g., acceptable delivery of fluoride) of the oral care composition.

[0013] As used herein, "unit dose" refers to the amount of oral care composition to be applied to a patient or consumer for a single use. A unit dose of oral care composition can be a unit dose of powder (e.g., free-flowing particles), a unit dose of tablet, a unit dose of capsule (tablet type), a unit dose of granules, a unit dose of pellets, a unit dose of round tablets, a unit dose of film, a unit dose of beads, or any other suitable unit dose of oral care composition that can remain in the oral cavity for a duration sufficient to contact some or all of the tooth surfaces and / or oral tissues for oral health purposes.

[0014] In some aspects, the solid oral care compositions of this disclosure can be stored in airtight, moisture-proof packaging (e.g., pouches, sealed foil pouches, blister packs, and desiccant-sealed tubes). Useful packaging materials include polymer packaging (e.g., polyethylene and polypropylene), foil packaging (e.g., aluminum), and combinations thereof.

[0015] The solid oral care compositions disclosed herein are water-free or have a low water content. As used herein, the term "low water content" means the total concentration of water, including any free water and all water contained in any component. In various embodiments of the compositions, the amount of water is less than 4% by weight, or less than 3% by weight, or less than 2% by weight, or less than 1% by weight, or less than 0.5% by weight, or less than 0.1% by weight, or from about 0.0001% to about 4% by weight, or from about 0.0001% to about 0.5% by weight, or from about 0.0001% to about 0.1% by weight.

[0016] The solid oral care compositions disclosed herein (such as composition 1 and any of the following) may be in various forms, including, for example, powders (e.g., free-flowing particles), tablets, capsules (tablet type), granules, pellets, flakes, films, and beads.

[0017] In some aspects, the solid oral care compositions disclosed herein (e.g., any of Composition 1 and below, etc.) comprise one or more desiccants, such as moisture-absorbing materials. Examples of desiccants include, but are not limited to, phosphates, pyrophosphates and other polyphosphates, calcium lactate, calcium lactate phosphate, double salts of calcium lactate, and mixtures thereof. Other desiccants include silica gel and precipitates (e.g., non-abrasive silica), alumina, and mixtures thereof. Specific examples include, but are not limited to, dicalcium phosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, polymetaphosphate, insoluble sodium polymetaphosphate, potassium metaphosphate, tricalcium phosphate, trimagnesium phosphate and magnesium orthophosphate, hydrated alumina, aluminum silicate, zirconium silicate, bentonite, β-calcium pyrophosphate, or calcium carbonate. Pyrophosphates may also be used in this invention as anti-tartar agents or as buffers. Pyrophosphates suitable for use in the compositions of this invention include dialkali metal pyrophosphates, tetraalkali metal pyrophosphates, and mixtures thereof. Disodium dihydrogen pyrophosphate, tetrasodium pyrophosphate, and tetrapotassium pyrophosphate are preferred in their unhydrated and hydrated forms. In several embodiments, the desiccant comprises, by weight of the total composition, about 0.1% to about 60%, about 1% to about 30%, about 1% to about 10%, or about 1% to about 5%, or about 2%, about 3%, about 4%, or about 5%.

[0018] In some aspects, the solid oral care compositions disclosed herein (e.g., any of Composition 1 and the following, etc.) comprise a buffer. Examples of buffers include anhydrous carbonates (e.g., sodium carbonate), sesquicarbonates, bicarbonates (e.g., sodium bicarbonate), silicates, bisulfates, phosphates (e.g., potassium dihydrogen phosphate and dipotassium hydrogen phosphate), citrates, pyrophosphates (sodium and potassium salts), and combinations thereof.

[0019] In some aspects, the solid oral care compositions disclosed in this invention (e.g., any of Composition 1 and below, etc.) further comprise a disintegrant. Disintegrants include natural starches (e.g., corn starch, potato starch, etc.), directly compressible starches (e.g., starch 1500), and modified starches (e.g., carboxymethyl starch and sodium glycolate starch, which can be...) and and (Obtained) and starch derivatives (such as amylose). Other examples are cross-linked polyvinylpyrrolidone, such as POLYPLASDONE. and KOLLIDON The obtained cross-polvinone; modified cellulose, for example, in the form of... PHARMACEL and NYMCEL The obtained cross-linked carboxymethyl cellulose sodium; alginate and sodium alginate; microcrystalline cellulose, for example And for example The methacrylic acid-divinylbenzene copolymer salt obtained by IRP-88. Other examples of disintegrants are light silicic anhydride, calcium silicate, magnesium aluminosilicate, and carboxymethyl cellulose. In this invention, each of them may be used alone or in combination of two or more of them. The typical amount of disintegrant by weight of the total composition is from about 0.5% to about 20%, from about 1% to about 5% in one embodiment, and from about 1% to about 3% in another embodiment.

[0020] In some aspects, the binder system of the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) further comprises a polymer binder that increases the volume of the composition and helps to hold the components of the composition together when the composition is in tablet form. Examples of suitable polymer binders include, for example, starch, natural gums (e.g., xanthan gum), cellulose gum, microcrystalline cellulose, maltodextrin, methylcellulose, cellulose ethers, sodium carboxymethyl cellulose, ethylcellulose, gelatin, polyethylene glycol, pectin, alginate, polyacrylamide, and polyvinyl alcohol. Zolpidemone, polyvinyl alcohol, and mixtures thereof. In some aspects, the adhesive system may also contain one or more non-polymeric adhesives, such as dextrose, lactose, sucrose, sorbitol, mannitol, and xylitol.

[0021] In some aspects, the solid oral care compositions disclosed in this invention (e.g., any of Composition 1 and the following, etc.) may contain acid buffers. For example, these acids may include citric acid, ascorbic acid, malic acid, adipic acid, tartaric acid, fumaric acid, succinic acid, sodium pyrophosphate, lactic acid, hexanoic acid, their acid salts and anhydrides, and mixtures thereof. Examples of useful anhydrides include citrate anhydride, glucono-D-lactone, and succinic anhydride. Examples of useful acid salts include potassium hydrogen tartrate, acid citrate, sodium dihydrogen phosphate, disodium dihydrogen phosphate, sodium acid sulfite, and combinations thereof.

[0022] In some aspects, the solid oral care compositions disclosed in this invention (e.g., any of Composition 1 and the following, etc.) may contain a carbonate base. Examples of suitable carbonate bases include sodium bicarbonate, sodium carbonate, sodium sesquicarbonate, potassium carbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, magnesium oxide, sodium glycinate carbonate, L-lysine carbonate, arginine carbonate, zinc carbonate, zinc oxide, and mixtures thereof. In some aspects, the base is present in the composition in an amount of 5% to 60% by weight, about 7% to 50% by weight, or about 8% to about 15% by weight.

[0023] In some aspects, the solid oral care compositions disclosed in this invention (e.g., any of Composition 1 and the following, etc.) comprise a lubricant. Various lubricants are suitable for use in this composition, including water-dispersible lubricants, water-soluble lubricants, water-insoluble lubricants, and combinations thereof. Examples of useful water-soluble lubricants include sodium benzoate, polyethylene glycol, L-leucine, adipic acid, and combinations thereof. The composition may also comprise water-insoluble lubricants, including, for example, stearates (e.g., magnesium stearate, calcium stearate, and zinc stearate), oils (e.g., mineral oil, hydrogenated and partially hydrogenated vegetable oils, and cottonseed oil), and combinations thereof. Other water-insoluble lubricants include, for example, animal fats, polyoxyethylene monostearate, talc, and combinations thereof. When the composition is in tablet form, the composition preferably comprises a sufficient amount of lubricant to enable the composition to be formed into tablets and released in tablet form from a high-speed tablet press. In some aspects, the amount of lubricant in the composition is 1% to about 15% by weight, 1% to about 12% by weight, 2% to about 10% by weight, or 3% to about 8% by weight (e.g., about 4%).

[0024] In some aspects, the solid oral care compositions of this disclosure described herein (e.g., any of Composition 1 and below, etc.) may also contain additional ingredients such as flavoring agents; fillers; surfactants; preservatives such as sodium benzoate and potassium sorbate; dyes and pigments; and sweeteners.

[0025] In some aspects, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below) may comprise anionic surfactants (e.g., components of Composition 1 and below), such as water-soluble salts of higher fatty acid monoglyceride monosulfates, such as sodium salts of hydrogenated coconut fatty acid monosulfates, such as sodium cocoyl glutamate, sodium N-methyl-N-cocoyl taurate, sodium cocoyl monoglyceride sulfate; higher alkyl sulfates, such as sodium lauryl sulfate; higher alkyl-ether sulfates, such as CH3(CH2). m CH2(OCH2CH2) n OS03X is a higher alkyl-ether sulfate, wherein m is 6 to 16 (e.g., 10), n is 1 to 6 (e.g., 2, 3, or 4), and X is Na, or, for example, sodium lauryl ether-2 sulfate (CH3(CH2)). 10 CH2(OCH2CH2)2OSO3Na); higher alkyl aryl sulfonates, such as sodium dodecylbenzenesulfonate (sodium laurylbenzenesulfonate); higher alkyl sulfonates, such as sodium lauryl sulfonate (sodium dodecyl sulfonate), higher fatty acid esters of 1,2-dihydroxypropane sulfonate, sulfocolaurate (N-2-ethyllaurate potassium sulfoacetamide), and sodium lauryl sarcosinate. "Higher alkyl" means, for example, C 6-3 o-alkyl. In a particular embodiment, the anionic surfactant (if present) is selected from sodium lauryl sulfate and sodium lauryl ether sulfate. When present, the anionic surfactant is present in an effective amount (e.g., greater than 0.001% by weight of the formulation) but not at a concentration (e.g., 1%) that would irritate oral tissues, and the optimal concentration depends on the specific formulation and the specific surfactant. In one embodiment, the anionic surfactant is present at 0.03% to 5% by weight, for example, 1.5%.

[0026] In another aspect, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) may comprise one or more cationic surfactants. Cationic surfactants useful in this invention can be broadly defined as derivatives of aliphatic quaternary ammonium compounds having a long alkyl chain containing 8 to 18 carbon atoms, such as lauryltrimethylammonium chloride and cetylpyridine chloride. Cetyltrimethylammonium bromide, diisobutylphenoxyethyl dimethylbenzylammonium chloride, nitrite coconutylalkyltrimethylammonium, fluorinated cetylpyridine and mixtures thereof. Exemplary cationic surfactants are quaternary ammonium fluorides described in U.S. Patent No. 3,535,421 to Briner et al., which is incorporated herein by reference. Some cationic surfactants may also act as bactericides in compositions.

[0027] The exemplary nonionic surfactants of this disclosure (e.g., any of Composition 1 and below, etc.) that can be used in the compositions of this disclosure can be broadly defined as compounds produced by condensing an oxidized olefinic group (which is inherently hydrophilic) with an organic hydrophobic compound that may be inherently aliphatic or alkyl aromatic. Examples of suitable nonionic surfactants include, but are not limited to, pluronics, polyethylene oxide condensates of alkylphenols, products derived from the condensation of ethylene oxide with the reaction products of propylene oxide and ethylenediamine, ethylene oxide condensates of aliphatic alcohols, long-chain tertiary amine oxides, long-chain tertiary phosphine oxides, long-chain dialkyl sulfoxides, and mixtures of such materials. In a particular embodiment, the compositions of the present invention comprise a nonionic surfactant selected from poloxamer (e.g., poloxamer 407), polysorbates (e.g., polysorbate 20), polyoxyethylene hydrogenated castor oil (e.g., polyoxyethylene 40 hydrogenated castor oil), and mixtures thereof.

[0028] The surfactant or a mixture of compatible surfactants may be present in the composition of the invention at a weight of 0.1% to 5%, in another embodiment 0.3% to 3%, and in yet another embodiment 0.5% to 2.5%.

[0029] In some aspects, the solid oral care compositions disclosed herein (e.g., any of Composition 1 and the following, etc.) may comprise one or more fillers. For example, the filler may be selected from one or more of the following: crystalline cellulose, ethyl cellulose, dextrin, various cyclodextrins (α-cyclodextrin, β-cyclodextrin and γ-cyclodextrin), sodium sulfate and its derivatives, and amylopectin.

[0030] In some aspects, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) may also contain one or more flavoring agents. Useful flavoring agents include natural and synthetic flavoring sources, including, for example, volatile oils, synthetic flavoring oils, flavoring fragrances, oils, liquids, oleoresins, and extracts derived from plants, leaves, flowers, fruits, stems, and combinations thereof. Suitable flavoring agents include, for example, lemon oil, such as lemon, orange, grape, lime, and grapefruit; fruit flavorings, including, for example, apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot, and other fruit flavorings. Other useful flavoring agents include, for example, aldehydes and esters (e.g., benzaldehyde (cherry, almond)), citral (α-citral (lemon, lime), neraldehyde (β-citral (lemon, lime), decanal (orange, lemon), C-8 aldehyde (citrus fruits), C-9 aldehyde (citrus fruits), C-12 aldehyde (citrus fruits), tolualdehyde (cherry, almond), 2,6-dimethyloctanal (unripe fruit), 2-dodecenal (citrus, orange), and mixtures thereof.

[0031] In some aspects, the solid oral care compositions disclosed herein (e.g., any of Composition 1 and below, etc.) may contain one or more dyes or lakes. Useful lakes include dyes absorbed on aluminum hydroxide and other suitable carriers.

[0032] In some aspects, the solid oral care compositions disclosed herein (e.g., any of Composition 1 and the following, etc.) may contain one or more sweeteners, such as those selected from: stevia, sugars (e.g., sucrose, glucose, invert sugar, fructose, ribose, tagag-ketose, sucralose, maltitol, erythritol, xylitol, and mixtures thereof), saccharin and various salts thereof (e.g., sodium and calcium salts of saccharin), cyclohexanesulfonic acid and various salts thereof, dipeptide sweeteners (e.g., aspartame), acesulfame potassium, dihydrochalcone, glycyrrhizin, and sugar alcohols (including, for example, sorbitol, sorbitol syrup, mannitol, and xylitol), and combinations thereof.

[0033] In some aspects, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) may comprise calcium phosphate abrasives, such as tricalcium phosphate (Ca3(PO4)2) or hydroxyapatite (Ca2PO4). 10 (PO4)6(OH)2), or dicalcium phosphate dihydrate (CaHPO4·2H2O, sometimes referred to as DiCal in this text) or calcium pyrophosphate. Alternatively, calcium carbonate, and especially natural or precipitated calcium carbonate, can be used as the abrasive.

[0034] In some aspects, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) may comprise one or more additional particulate materials, such as silica abrasives, such as precipitated silica with an average particle size up to about 20 micrometers, such as Zeodent sold by JMHuber. Other useful abrasives include sodium metaphosphate, potassium metaphosphate, aluminum silicate, calcined alumina, bentonite or other siliceous materials, or combinations thereof.

[0035] The silica abrasive polishing materials and other abrasives used herein typically range in average particle size from about 0.1 micrometers to about 30 micrometers, and from about 5 micrometers to about 15 micrometers. Silica abrasives can be derived from precipitated silica or silica gel, such as the silica desiccant described in U.S. Patent No. 3,538,230 to Pader et al. and U.S. Patent No. 3,862,307 to Digiulio (both incorporated herein by reference). Specific silica desiccants are marketed under trade names. Sold by WRGrace & Co., Davison Chemical Division. Precipitated silica materials include those marketed under trade names. Those sold by JMHuber Corp. include silica bearing the names Zeodent 115 and Zeodent 119. These silica abrasives are described in U.S. Patent No. 4,340,583, granted to Wason, which is incorporated herein by reference.

[0036] In some aspects, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) comprise abrasives. For example, the abrasives may comprise precipitated amorphous silica and silica gel with an oil absorption value of less than about 100 cc / 100g silica and ranging from about 45 cc / 100g silica to about 70 cc / 100g silica. The oil absorption value is measured using the ASTARub-Out Method D281. In some embodiments, the silica is in the form of colloidal particles with an average particle size of about 3 micrometers to about 12 micrometers, and about 5 micrometers to about 10 micrometers.

[0037] In some respects, microparticles or abrasive materials contain mostly very small particles, such as particles with a d50 of less than about 5 micrometers, or small particles of silica (SPS) with a d50 of about 3 to about 4 micrometers, such as Sorbosil. (Ineos). Such small particles are particularly useful in formulations targeting the reduction of hypersensitivity. The small particle component can be present in combination with a second, larger abrasive particle. In some embodiments, for example, the formulation comprises about 3% to about 8% SPS and about 25% to about 45% conventional abrasive.

[0038] Low-oil-absorption silica abrasives, traded under the name Sylodent, are particularly useful in the practice of this invention. Sold by Davison Chemical Division, WRGrace & Co., Baltimore, Md. 21203. Sylodent 650 (A silica hydrogel consisting of particles of colloidal silica with a water content of about 29% by weight, an average diameter of about 7 to about 10 micrometers, and an oil absorption of less than about 70 cc / 100g silica) is an example of a low-oil-absorption silica abrasive useful in the practice of the present invention. The total abrasive contents are present in the oral care composition of the present invention at a concentration of about 10% to about 60% by weight, in another embodiment about 15% to about 35% by weight, and in yet another embodiment about 15% to about 25% by weight.

[0039] Natural calcium carbonate is found in rocks such as chalk, limestone, marble, and travertine. It is also a major component of eggshells and mollusk shells. The natural calcium carbonate abrasive of the present invention is typically finely ground limestone, which may optionally be refined or partially refined to remove impurities. For use in the present invention, the average particle size of the material is less than 10 micrometers, for example, from 3 to 7 micrometers, for example, about 5.5 micrometers. Since natural calcium carbonate may contain a high proportion of relatively large, uncontrolled particles, which can unacceptably increase abrasiveness, it is preferred that no more than 0.01%, preferably no more than 0.004%, by weight of particles will not pass through 325 mesh. This material has a strong crystalline structure and is therefore much harder and more abrasive than precipitated calcium carbonate. The tap density of natural calcium carbonate is, for example, from 1 g / cc to 1.5 g / cc, for example, about 1.2 g / cc, for example, about 1.19 g / cc. Natural calcium carbonate exists in various polymorphs, such as calcite, aragonite, and spherulite; for the purposes of this invention, calcite is preferred. Examples of commercially available products suitable for use in this invention include those from GMZ. 25-11FG.

[0040] Precipitated calcium carbonate is typically produced by calcining limestone to produce calcium oxide (lime), which can then be converted back to calcium carbonate by reacting it with carbon dioxide in water. Precipitated calcium carbonate has a different crystal structure than natural calcium carbonate. It is generally more brittle and porous, thus exhibiting lower abrasiveness and higher water absorption. For use in this invention, the particles are small, for example, with an average particle size of 1 to 5 micrometers, and, for example, no more than 0.1%, preferably no more than 0.05%, of particles by weight will not pass through a 325-mesh sieve. The particles may, for example, have a density of 3 to 6 micrometers, for example, 3.8 = 4.9, or, for example, a density of about 4.3. 90 ; 1 micrometer to 4 micrometers, for example 2.2 micrometers to 2.6 micrometers, for example approximately 2.4 micrometers of D 50 ; and 1 micrometer to 2 micrometers, for example 1.2 micrometers to 1.4 micrometers, for example about 1.3 micrometers of D 10The granules have relatively high water absorption, for example, at least 25 g / 100 g, such as 30 g / 100 g to 70 g / 100 g. Examples of commercially available products suitable for use in this invention include, for example, those from Lagos Industria Quimica. 15Plus.

[0041] In some aspects, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) may comprise one or more polymers, such as polyethylene glycol, polyvinyl methyl ether maleic acid copolymers, polysaccharides (e.g., cellulose derivatives such as carboxymethyl cellulose, or polysaccharide gums such as xanthan gum or carrageenan). Acidic polymers such as polyacrylate gels may be provided in the form of their free acid or partially or completely neutralized water-soluble alkali metals (e.g., potassium or sodium) or ammonium salts. Some embodiments include maleic anhydride or maleic acid copolymers with another polymerizable olefinically unsaturated monomer (e.g., methyl vinyl ether (methoxyethylene)) in a ratio of about 1:4 to about 4:1, having a molecular weight (MW) of about 30,000 to about 1,000,000. These copolymers are available, for example, as GAF Chemicals' Gantrez AN 139 (MW 500,000), AN 119 (MW 250,000), and S-97 pharmaceutical grade (MW 70,000).

[0042] Other active polymers include, for example, 1:1 copolymers of maleic anhydride with ethyl acrylate, hydroxyethyl methacrylate, N-vinyl-2-pyrrolidone, or ethylene, the latter being available, for example, as Monsanto EMA number 1103, MW 10,000, and EMA class 61; and those that are 1:1 copolymers of acrylic acid with methyl methacrylate or hydroxyethyl methacrylate, methyl acrylate or ethyl acrylate, isobutyl vinyl ether, or N-vinyl-2-pyrrolidone.

[0043] Generally, suitable copolymers are olefinic or olefinically unsaturated carboxylic acids containing an active carbon-carbon olefinic double bond and at least one carboxyl group, i.e., acids containing an olefinic double bond that readily functions in polymerization due to its presence in the monomer molecule at the α-β position relative to the carboxyl group or as part of the terminal methylene group. Examples of such acids are acrylic acid, methacrylic acid, ethylacrylic acid, α-chloroacrylic acid, crotonic acid, β-acryloyloxypropionic acid, sorbic acid, α-chlorosorbic acid, cinnamic acid, β-styrylacrylic acid, mucoacrylic acid, itacrylic acid, citracic acid, mesoconic acid, pentenepic acid, aconitic acid, α-phenylacrylic acid, 2-phenylmethylacrylic acid, 2-cyclohexylacrylic acid, angelic acid, umbelliferous acid, fumaric acid, maleic acid, and acid anhydrides. Other different olefinic monomers that can copolymerize with such carboxylic acid monomers include vinyl acetate, vinyl chloride, dimethyl maleate, etc. The copolymer contains a sufficient amount of carboxylate groups for water solubility.

[0044] Another class of polymerizing agents includes compositions containing homopolymers of substituted acrylamides and / or homopolymers of unsaturated sulfonic acids and their salts, particularly wherein the polymer is an unsaturated sulfonic acid based on acrylamide-based alkyl sulfonic acids (e.g., 2-acrylamido-2-methylpropane sulfonic acid) with a molecular weight of about 1,000 to about 2,000,000, as described in U.S. Patent No. 4,842,847 to Zahid, dated June 27, 1989, which is incorporated herein by reference.

[0045] Another class of available polymerizers includes polyamino acids, particularly those containing proportionate anionic surfactant amino acids, such as aspartic acid, glutamic acid, and phosphoserine, as disclosed in U.S. Patent No. 4,866,161 to Sikes et al., which is incorporated herein by reference.

[0046] In some aspects, the solid oral care compositions of this disclosure (e.g., any of Composition 1 and below, etc.) may also contain one or more fluoride ion sources, such as soluble fluoride salts. A wide variety of fluoride-generating materials can be used as sources of soluble fluoride in the compositions of the present invention. Examples of suitable fluoride-generating materials are found in U.S. Patent No. 3,535,421 to Briner et al.; U.S. Patent No. 4,885,155 to Parran, Jr. et al.; and U.S. Patent No. 3,678,154 to Widder et al., which are incorporated herein by reference.

[0047] Representative fluoride ion sources include, but are not limited to, stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, and combinations thereof. In some embodiments, the fluoride ion source includes stannous fluoride, sodium fluoride, sodium monofluorophosphate, and mixtures thereof.

[0048] In some embodiments, the solid oral care compositions of this disclosure (e.g., compositions 1 and below, etc.) may contain a source of fluoride ions or a component providing fluoride in an amount sufficient to supply from about 25 ppm to 25,000 ppm, typically at least about 500 ppm, for example from about 500 ppm to about 2000 ppm, for example from about 1000 ppm to about 1600 ppm, for example from about 1450 ppm. The appropriate level of fluoride will depend on the specific application.

[0049] The fluoride ion source may be added to the composition of the invention at a level of about 0.01 wt% to about 10 wt% in one embodiment, or about 0.03 wt% to about 5 wt% in another embodiment, and about 0.1 wt% to about 1 wt% in yet another embodiment, based on the weight of the fluoride salt used to provide an appropriate level of fluoride ions. The weight of the fluoride salt used to provide an appropriate level of fluoride ions will vary significantly based on the weight of the counterion in the salt.

[0050] In the preparation of oral care compositions, it is sometimes necessary to add thickening materials to provide a desired consistency or to stabilize or enhance the properties of the formulation. In some aspects, solid oral care compositions (e.g., any of Composition 1 and the following, etc.) may contain one or more thickeners selected from carboxyvinyl polymers, carrageenan, and water-soluble salts of cellulose ethers (e.g., sodium carboxymethyl cellulose and sodium carboxymethyl hydroxyethyl cellulose). Natural gums, such as gum arabic, gum arabic, and gum astragalus, may also be incorporated. Colloidal magnesium aluminum silicate or fine silica may be used as a component of the thickening composition to further improve the texture of the composition. In some embodiments, a thickener is used in an amount of about 0.5% to about 10.0% by weight of the total composition.

[0051] It should be understood that while the general properties of each of the materials in the above categories may differ, there may be some common properties among two or more of the materials in such categories, and any given material can be used for multiple purposes. All components in a composition can have functions beyond their primary function and can contribute to the overall properties of the composition, including its stability, efficacy, consistency, mouthfeel, taste, odor, etc. For example, a binder can also act as a disintegrant, and vice versa.

[0052] In some aspects, the solid compositions of this disclosure can be manufactured using techniques known in the art. Documents disclosing techniques that can be used to prepare the solid compositions of this disclosure include U.S. Patents 4,886,669; 6,106,861; 6,596,311; 6,743,443; 6,811,793; 7,501,409; 7,815,897; 8,377,995; and U.S. Patent Application 2005 / 0169986, all of which are incorporated herein by reference in their entirety. Typically, the components and optional ingredients can be kneaded with an organic solvent, filled into a mold, and subjected to compression molding. The organic solvent can be an alcohol such as methanol, ethanol, propanol, or isopropanol. The kneading and granulation operations, performed by adding such adjuvants for the preparation of the formulation and by adding such a solvent, can be carried out using conventionally used equipment. For example, a fluidized bed granulator, a roller granulator, an extrusion granulator, or a spray dryer can be used. Solid compositions can also be prepared by freeze drying.

[0053] In some respects, granules can be prepared by any of the known methods for preparing granules (e.g., dry granulation, layered granulation, impregnation granulation, etc.). For dry granulation, the mixture of components and optional additives is subjected to granulation using a roller press, roller granulator, etc.

[0054] For layered granulation, a mixture similar to that described above is added to a rolling inactive carrier, while a binder solution is sprayed using a centrifugal fluidized bed granulator or similar device to cause the mixture to adhere to the carrier. Examples of inactive carriers used in this method include crystals of sugars or inorganic salts such as crystalline lactose, crystalline cellulose, crystalline sodium chloride, etc., and spherical particles such as spherical particles of crystalline cellulose (brand name: Avicel SP, Asahi Kasei Corporation), spherical particles of crystalline cellulose and lactose (brand names: Nonpareil-NP-5 and NP-7, Freund Co., Ltd.), spherical particles of purified white sugar (brand name: Nonpareil-103, Freund Co., Ltd.), spherical particles of lactose and α-starch, etc.

[0055] For impregnation granulation, a solution containing potassium persulfate and other components of appropriate concentration is mixed with a porous support, ensuring a sufficient amount of solution remains within the cavities of the support. The mixture is then dried to remove the solvent. Examples of porous supports that can be used include magnesium aluminum silicate (brand name: Neusiline, Fuji Chemical Industry Co., Ltd.) and calcium silicate (Florite, Eisai Co., Ltd.). Examples of solvents include ethanol and methanol.

[0056] In one aspect, this disclosure relates to a solid oral care composition (composition 1) (e.g., a tablet) comprising an adhesive system, wherein the adhesive system comprises polyvinylpyrrolidone (PVP) and hydroxyethyl cellulose (HEC).

[0057] For example, the present invention covers any of the following compositions (unless otherwise indicated, values ​​are given as a percentage of the total weight of the composition):

[0058] 1.1. A solid oral care composition of composition 1, wherein the adhesive system comprises PVP and HEC in a weight ratio of 0.5:1 to 2.5:1 (PVP:HEC) (e.g., 0.75:1 to 2:1) (e.g., 1:1 to 1.75:1) (e.g., 1.25:1 to 1.75:1) (e.g., 0.75:1 or 1:1 or 1.25:1 or 1.5:1 or 1.75:1 or 2:1), wherein the weight is relative to the total weight of the composition.

[0059] 1.2. Composition 1 or 1.1, wherein the weight ratio of PVP to HEC is 1.5:1 (PVP:HEC), wherein the weight is relative to the total weight of the composition.

[0060] 1.3. Any of the foregoing compositions, wherein the amount of PVP is 1% to 15% by weight of the total composition.

[0061] 1.4. Any of the foregoing compositions, wherein the amount of PVP is 3% to 8% (e.g., about 6%) of the total composition by weight.

[0062] 1.5. Any of the foregoing compositions, wherein the amount of PVP is 6% by weight of the total composition.

[0063] 1.6. Any of the foregoing compositions, wherein the amount of HEC is 0.5% to 10% by weight of the total composition.

[0064] 1.7. Any of the foregoing compositions, wherein the amount of HEC is 1% to 5% (e.g., 2% to 5% by weight) (e.g., about 4%) of the total composition.

[0065] 1.8. Any of the foregoing compositions, wherein the amount of HEC is 4% by weight of the total composition.

[0066] 1.9. Any of the foregoing compositions, comprising about 6% PVP and about 4% HEC by weight relative to the total weight of the composition.

[0067] 1.10. Any of the foregoing compositions, wherein the PVP is cross-linked polyvinylpyrrolidone (e.g., crosspovidone).

[0068] 1.11. Any of the foregoing compositions, wherein the composition further comprises a desiccant, and wherein the desiccant is selected from calcium lactate, calcium lactate phosphate, double salts of calcium lactate, phosphates, pyrophosphates, polyphosphates, orthophosphates, metaphosphates, silica, alumina, bicarbonates, polymetaphosphates, aluminum silicate, zirconium silicate, bentonite, and combinations thereof.

[0069] 1.12. Any of the foregoing compositions, wherein the desiccant is selected from pyrophosphate, alumina, sodium bicarbonate, and combinations thereof.

[0070] 1.13. Any of the foregoing compositions, wherein the composition is in the form of tablets, powders or granules.

[0071] 1.14. Any of the foregoing compositions, wherein the composition is a single unit dose of an oral care composition.

[0072] 1.15. Any of the foregoing compositions, wherein the composition does not contain water or contains water in an amount of less than 4%, or less than 3%, or less than 2%, or less than 1%, or less than 0.5%, or 0.0001% to 4%, or 0.0001% to 0.5%, or 0.0001% to 0.1%, or 0.001% to 4% by weight.

[0073] 1.16. Any of the foregoing compositions, wherein the desiccant is present in an amount of 0.1% to 60%, 1% to 30%, or 1% to 11% by weight (e.g., about 10% sodium bicarbonate by weight).

[0074] 1.17. Any of the foregoing compositions further comprises a disintegrant selected from: natural starch (e.g., corn starch, potato starch), directly compressible starch, modified starch (e.g., carboxymethyl starch and sodium glycolate starch), starch derivatives (e.g., amylose), modified cellulose (e.g., croscarmellose sodium), alginate, sodium alginate, microcrystalline cellulose, methacrylic acid-divinylbenzene copolymer salt, light silicic anhydride, calcium silicate, magnesium metasilicate, carboxymethyl cellulose, and mixtures thereof.

[0075] 1.18. In any of the foregoing compositions, the adhesive system further comprises a polymeric adhesive that increases the volume of the composition and, when the composition is in tablet form, helps to hold the components of the composition together.

[0076] 1.19. Composition 1.18, wherein the polymer binder is selected from starch, natural gum (e.g., xanthan gum), cellulose gum, microcrystalline cellulose, maltodextrin, methylcellulose, cellulose ether, sodium carboxymethyl cellulose, ethylcellulose, gelatin, polyethylene glycol, cross-linked polyvinylpyrrolidone, pectin, alginate, polyacrylamide, and polyvinyl alcohol. Zolpidemone, polyvinyl alcohol, and mixtures thereof.

[0077] 1.20. Any of the foregoing compositions, wherein the adhesive further comprises a non-polymer adhesive.

[0078] 1.21. The composition according to 1.20, wherein the non-polymer binder is xylitol.

[0079] 1.22. Any of the foregoing compositions, wherein the adhesive system is present in the composition in an amount of 5% to about 20% by weight, or about 7% to about 15% by weight (e.g., 8% to 12% by weight) (e.g., 9% to 11% by weight) (e.g., about 10% by weight).

[0080] 1.23. The composition according to 1.22, wherein the adhesive system is present in an amount of 10% by weight relative to the total composition.

[0081] 1.24. Any of the foregoing compositions further comprises a buffer selected from anhydrous carbonates (e.g., sodium carbonate), sesquicarbonates, bicarbonates (e.g., sodium bicarbonate), silicates, bisulfates, citrates, phosphates (e.g., potassium dihydrogen phosphate), dipotassium hydrogen phosphate, and combinations thereof.

[0082] 1.25. The composition according to 1.24, wherein the amount of said buffer is from 5.0% to about 20%, or from about 7% to about 15%, or about 10% by weight of the total composition.

[0083] 1.26. The composition according to 1.25, wherein the buffer is sodium bicarbonate.

[0084] 1.27. Any of the foregoing compositions comprises an acid buffer selected from the group consisting of: citric acid, ascorbic acid, malic acid, adipic acid, tartaric acid, fumaric acid, succinic acid, sodium pyrophosphate, lactic acid, cyclohexanesulfonic acid, citrate anhydride, gluconate-D-lactone, succinic anhydride, potassium hydrogen tartrate, acid citrate, sodium dihydrogen phosphate, disodium dihydrogen phosphate, and sodium acid sulfite.

[0085] 1.28. Any of the foregoing compositions further comprises a lubricant (e.g., an insoluble lubricant), wherein the lubricant is selected from: stearates (e.g., magnesium stearate, calcium stearate, and zinc stearate), oils (e.g., mineral oils, hydrogenated and partially hydrogenated vegetable oils and cottonseed oils), animal fats, polyoxyethylene monostearate, talc, and combinations thereof.

[0086] 1.29. The composition according to 1.28, wherein the lubricant is magnesium stearate.

[0087] 1.30. Any of the foregoing compositions further comprises one or more flavoring agents, one or more fillers, one or more surfactants, one or more dyes or lakes, or any combination thereof.

[0088] 1.31. Any of the foregoing compositions, wherein the solid oral care composition comprises abrasives and / or microparticles selected from calcium phosphate, calcium sulfate, natural calcium carbonate, precipitated calcium carbonate, silica (e.g., synthetic silica), and combinations thereof (e.g., 10% to 30% by weight) (15% to 25% by weight) (e.g., about 20% by weight).

[0089] 1.32. The composition according to any one of the preceding claims, wherein the abrasive and / or particles are selected from dicalcium phosphate dihydrate, precipitated calcium carbonate, synthetic silica, and combinations thereof (e.g., 10% to 30% by weight) (e.g., 15% to 25% by weight) (e.g., about 20% by weight).

[0090] 1.33. The composition according to any one of the preceding claims, wherein the solid oral care composition comprises 2% to 6% (e.g., about 4% by weight) calcium carbonate (e.g., precipitated calcium carbonate) and 8% to 12% (e.g., about 10% by weight) dicalcium phosphate (e.g., dicalcium phosphate dihydrate) by weight.

[0091] 1.34. Any of the foregoing compositions, wherein the solid oral care composition comprises anionic surfactant (e.g., 1% to 5% by weight) (e.g., about 2.5% by weight).

[0092] 1.35. Any of the foregoing compositions, wherein the solid oral care composition comprises an anionic surfactant selected from: sodium cocoyl glutamate, sodium lauryl sulfate, sorbitol fatty acid esters, polyoxyethylene (20) sorbitol monooleate (polysorbate 80 or Tween 80), polyethylene glycol fatty acid esters, polyoxyethylene sorbitol fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene polyoxypropylene alkyl ethers, polyoxyethylene polyoxypropylene block copolymers, polyoxyethylene alkylphenyl ethers, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitol fatty acid esters, polyoxyethylene glycerol fatty acid esters, and combinations thereof (e.g., 1% to 5% by weight) (e.g., about 2.5% by weight).

[0093] 1.36. The aforementioned composition, wherein the surfactant is sodium cocoyl glutamate.

[0094] 1.37. Any of the aforementioned solid oral care compositions, wherein the composition comprises a nonionic surfactant.

[0095] 1.38. The aforementioned composition, wherein the solid oral care composition comprises a nonionic surfactant selected from poloxamer (e.g., poloxamer 407), polysorbate (e.g., polysorbate 20), polyoxyethylene hydrogenated castor oil (e.g., polyoxyethylene 40 hydrogenated castor oil), and mixtures thereof (e.g., 1% to 5% by weight) (e.g., about 2% by weight).

[0096] 1.39. Any of the foregoing compositions, wherein the solid oral care composition comprises a fluoride source.

[0097] 1.40. The aforementioned composition, wherein the fluoride source is selected from stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, and combinations thereof.

[0098] 1.41. The aforementioned composition, wherein the fluoride source is sodium monofluorophosphate.

[0099] 1.42. Any of the foregoing compositions, wherein the amount of the fluoride source is 0.5% to 2% (e.g., about 0.76%) of the total composition by weight.

[0100] 1.43. Any of the foregoing compositions, wherein the solid oral care composition is a tablet comprising:

[0101] • An adhesive system comprising 8% to 12% (e.g., about 10% by weight) of polyvinylpyrrolidone (PVP) and hydroxyethyl cellulose (HEC), wherein the amount of PVP is 3% to 8% (e.g., 6%) by weight relative to the total composition, and the amount of HEC is 2% to 6% (e.g., 4%) relative to the total composition.

[0102] • 15% to 25% of the abrasive source, said abrasive source comprising: silica, calcium carbonate (e.g., precipitated calcium carbonate), and dicalcium phosphate; and

[0103] • 0.5% to 2% (e.g., about 0.76%) sodium monofluorophosphate by weight, wherein all weights are relative to the total weight of the composition.

[0104] 1.44. Any of the foregoing solid oral care compositions, wherein the solid oral care composition comprises a fluoride source, wherein the fluoride source is provided in an amount (e.g., 500 ppm to about 2000 ppm) (e.g., 1000 ppm to 1600 ppm) (e.g., 1000 ppm) (e.g., about 1450 ppm) to effectively supply 25 ppm to 25,000 ppm of fluoride ions to the oral cavity.

[0105] 1.45. Any of the foregoing compositions, wherein the adhesive system comprises polyvinylpyrrolidone (PVP) and hydroxyethyl cellulose (HEC) (e.g., wherein the amount of PVP is 3% to 8% (e.g., 6%) relative to the total composition by weight, and the amount of HEC is 2% to 6% (e.g., 4%) relative to the total composition).

[0106] 1.46. Any of the foregoing compositions, wherein the solid oral care composition is selected from: powders (e.g., free-flowing particles), tablets, granules, pellets, sheets, films, and beads.

[0107] 1.47. Any of the foregoing compositions, wherein the solid oral care composition is a tablet or granules.

[0108] 1.48. Any of the foregoing compositions, wherein the solid oral care composition is a tablet.

[0109] Therefore, the present invention also covers methods of using any of Composition 1 and the following to (i) reduce or inhibit the formation of dental caries, (ii) alleviate, repair or inhibit early enamel damage, for example, as detected by quantitative light-induced fluorescence (QLF) or electrical caries measurement (ECM), (iii) alleviate or inhibit tooth demineralization and promote tooth remineralization, (iv) reduce tooth hypersensitivity, (v) alleviate or inhibit gingivitis, (vi) promote the healing of ulcers or wounds in the mouth, (vii) reduce the level of acid-producing bacteria, (viii) inhibit the formation of oral microbial biofilms, (ix) raise and / or maintain the pH of dental plaque at a level of at least pH 5.5 after a sugar challenge, (x) reduce dental plaque accumulation, (xi) treat dry mouth, and / or (xii) clean teeth and oral cavity, said methods comprising applying the composition of the present invention to the oral cavity, for example by applying the composition of the present invention (e.g., any of Composition 1 and the following) to the oral cavity of a patient in need of such treatment.

[0110] Example

[0111] Exemplary embodiments of the present disclosure will be illustrated by referring to the following examples, which are included to illustrate but do not limit the scope of the invention.

[0112] Example 1

[0113] The following are representative tablets of the present invention (e.g., solid oral care compositions):

[0114] Table 1 - Representative Formulation A (Tablets)

[0115] Material quantity

[0116] (by weight %)

[0117] silicon dioxide 6.2 Xylitol 26.0 dicalcium phosphate dihydrate 10.3 Anionic surfactants 2.5 Precipitated calcium carbonate 4.0 Sodium bicarbonate 10.35 Insoluble lubricant 4.0 Hydroxyethyl cellulose 4.0 Nonionic surfactants 2.0 D-Mannitol 20.2 Polyvinylpyrrolidone 6.0 Sodium monofluorophosphate 0.76 Flavoring agents and sweeteners 3.65 total ～100

[0118] Example 2

[0119] It is anticipated that in the assay to measure fluoride delivery, the solid oral care composition tablet of representative formulation A will likely deliver the same or similar concentration of fluoride as a toothpaste formulation containing sodium monofluorophosphate and containing a similar concentration of fluoride.

[0120] The invention has been described above with reference to illustrative embodiments, but it should be understood that the invention is not limited to the disclosed embodiments. Changes and modifications that will be made by those skilled in the art after reading this specification are also within the scope of the invention, which is defined in the appended claims.

Claims

1. A solid oral care composition comprising: a binder system, wherein the binder system comprises polyvinylpyrrolidone (PVP) in an amount of 3% to 8% by weight of the total composition, hydroxyethylcellulose (HEC) in an amount of 2% to 5% by weight of the total composition, and one or more non-polymeric binders including xylitol, wherein the binder system comprises PVP and HEC in a weight ratio of 0.5: 1 to 2.5: 1 (PVP:HEC), wherein the weights are relative to the total weight of the composition; 15% to 25% by weight of an abrasive, the abrasive comprising a mixture of dicalcium phosphate, precipitated calcium carbonate, and silica; and 0.5% to 2% by weight of sodium monofluorophosphate; and an anionic surfactant selected from the group consisting of sodium cocoyl glutamate, sodium N-methyl-N-cocoyl taurate, and sodium cocoyl monoglyceride sulfate, wherein the composition comprises less than 4% by weight of water, and wherein the solid oral care composition is a tablet.

2. The solid oral care composition of claim 1, wherein the binder system comprises PVP and HEC in a weight ratio of 1.25: 1 to 1.75: 1 (PVP:HEC), wherein the weights are relative to the total weight of the composition.

3. The solid oral care composition of claim 1, wherein the weight ratio of PVP and HEC is 1.5: 1 (PVP:HEC), wherein the weights are relative to the total weight of the composition.

4. The solid oral care composition of claim 1, wherein the composition comprises PVP in an amount of 6% by weight and HEC in an amount of 4% by weight relative to the total weight of the composition.

5. The solid oral care composition of claim 1, wherein the composition does not comprise water.

6. The solid oral care composition of claim 1, wherein the composition comprises water in an amount of less than 1% by weight.

7. The solid oral care composition of claim 1, wherein the anionic surfactant is sodium cocoyl glutamate.

8. The solid oral care composition of claim 1, wherein the anionic surfactant is sodium N-methyl-N-cocoyl taurate.

9. The solid oral care composition of claim 1, wherein the solid oral care composition further comprises a non-ionic surfactant selected from the group consisting of poloxamers, polysorbates, polyoxyethylene hydrogenated castor oil, and mixtures thereof.

10. The solid oral care composition of claim 9, wherein the non-ionic surfactant is a poloxamer.

11. The solid oral care composition of claim 1, wherein the sodium monofluorophosphate is provided in an amount effective to supply 25 ppm to 25,000 ppm of fluoride ions to the oral cavity.

12. The solid oral care composition of claim 11, wherein the sodium monofluorophosphate is provided in an amount effective to supply 1000 ppm to 1600 ppm of fluoride ions to the oral cavity.

13. The solid oral care composition of claim 1, wherein the anionic surfactant is sodium cocoyl glutamate; and the solid oral care composition further comprises poloxamer 407.

14. The solid oral care composition of claim 1, wherein the solid oral care composition comprises 8% to 12% of the binder system.

15. A solid oral care composition comprising: 6% by weight of polyvinylpyrrolidone (PVP); 4% by weight of hydroxyethylcellulose (HEC); xylitol; mannitol; 15% to 25% by weight of an abrasive comprising a mixture of dicalcium phosphate, precipitated calcium carbonate, and silica; 0.5% to 2% by weight of sodium monofluorophosphate; an anionic surfactant selected from the group consisting of sodium cocoyl glutamate, sodium N-methyl-N-cocoyl taurate, and sodium cocoyl monoglyceride sulfate; 1% to 5% by weight of a nonionic surfactant selected from the group consisting of poloxamers, polysorbates, polyoxyethylene hydrogenated castor oil, and mixtures thereof; and less than 4% by weight of water, wherein the oral care composition is a tablet, and wherein all percentages are by weight relative to the total weight of the composition.

16. The solid oral care composition of claim 15, wherein the composition comprises 26% by weight of xylitol.

17. The solid oral care composition of claim 15, wherein the anionic surfactant is sodium cocoyl glutamate.

18. Use of the composition of any one of claims 1 to 17 in the manufacture of an oral care product for: (i) reducing or inhibiting the formation of dental caries; (ii) reducing, repairing, or inhibiting early enamel lesions; (iii) reducing or inhibiting demineralization of the teeth and promoting remineralization of the teeth; (iv) reducing hypersensitivity of the teeth; (v) reducing or inhibiting gingivitis; (vi) promoting healing of sores or wounds in the mouth; (vii) reducing levels of acid producing bacteria; (viii) inhibiting microbial biofilm formation in the oral cavity; (ix) increasing and / or maintaining plaque pH at levels of at least pH 5.5 after a sugar challenge; (x) reducing plaque accumulation; (xi) treating dry mouth; and / or (xii) cleaning the teeth and oral cavity.

19. Use of the composition of any one of claims 1 to 17 in the manufacture of an oral care product for reducing or inhibiting the formation of dental caries, promoting remineralization of the teeth, or treating dry mouth.