Oral care compositions
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-06-26
- Publication Date
- 2026-03-18
Smart Images
Figure US2024035624_02012025_PF_FP_ABST
Abstract
Description
ORAL CARE COMPOSITIONSCROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority from U.S. Patent Application No. 63 / 524,013, filed June 29, 2023, titled Oral Care Compositions, the content of which are hereby incorporated herein in their entireties, for all purposes.BACKGROUND
[0002] Dentin is a portion of the tooth internal to the enamel and cementum that has a radially striated appearance owing to a large number of fine canals or tubules known as the dentinal tubules. Tubules run from the pulp cavity to the periphery of the dentin and are generally about two microns in diameter at their base and somewhat narrower at their periphery. Tubules are not usually exposed to the environment in the oral cavity, as they are usually covered by enamel or cementum. The cementum in turn is often covered by the gums.
[0003] It is commonly understood that partially or fully exposed tubules can lead to tooth sensitivity, an irritating and painful condition. Recession of the gum line exposes the cementum and may lead to erosion of the cementum and exposure of the dentinal tubules. It is believed that the exposed tubules cause nerves within the tooth to be affected excessively by external oral stimuli because material and energy transfer between the exterior and interior of the tooth is accelerated through the tubules. For instance, fluid movements in the dentinal tubules that activate pulpal nerve endings may irritate the nerve through the open dentin tubules, thereby creating pain.
[0004] There is an ongoing need for oral care compositions that can reduce the sensitivity of teeth.BRIEF SUMMARY
[0005] This summary is intended merely to introduce a simplified summary of some aspects of one or more implementations of the present disclosure. Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. This summary is not an extensive overview, nor is it intended to identify key or critical elements of the present teachings, nor to delineate the scope of the disclosure. Rather, its purpose is merely to present one or more concepts in simplified form as a prelude to the detailed description below.
[0006] Aspects of the invention are directed to oral care compositions. In accordance with an aspect of the invention, provided is an oral care composition having from about 2 to about 10 wt.% of a potassium source selected from potassium nitrate, potassium citrate, potassium oxalate, and a combination thereof; an abrasive comprising calcium carbonate, calcium bicarbonate or a combination thereof; a fluoride source; and a polyol, wherein all weight percentages are based on the total weight of the oral care composition.
[0007] In accordance with another aspect, provided is an oral care composition from about 2 to about 11 wt.% of a potassium source selected from potassium nitrate, potassium citrate, potassium oxalate, and a combination thereof; about 30 wt.% or more of an abrasive comprising calcium carbonate, wherein the abrasive is free of silica; a fluoride source; and a polyol comprising from about 9 to 32 wt.% of glycerin, wherein all weight percentages arc based on the total weight of the oral care composition.
[0008] A list of non-limiting exemplary embodiments in accordance with certain aspects of the invention are provided below:
[0009] In accordance with embodiment 1, provided is an oral care composition comprising: from about 2 to about 10 wt.% of a potassium source comprising potassium nitrate, potassium citrate, potassium oxalate, or a combination thereof; an abrasive system comprising a calcium based abrasive; a fluoride source; and a polyol, wherein all weight percentages are based on the total weight of the oral care composition.
[0010] In accordance with embodiment 2, provided is an oral care composition comprising: from about 2 to about 10 wt.% of a potassium source comprising potassium nitrate, potassium citrate, potassium oxalate, or a combination thereof; an abrasive comprising calcium carbonate, calcium bicarbonate or a combination thereof; a fluoride source; and a polyol, wherein all weight percentages are based on the total weight of the oral care composition.
[0011] In accordance with embodiment 3, provided is the oral care composition according to embodiment 1 or embodiment 2, wherein the abrasive system is substantially free, or free, of a silica abrasive.
[0012] In accordance with embodiment 4, provided is the oral care composition according to any foregoing embodiment, wherein the oral care composition is substantially free, or free, of a silica compound.
[0013] In accordance with embodiment 5, provided is the oral care composition according to anyforegoing embodiment, wherein the potassium source comprises potassium nitrate.
[0014] In accordance with embodiment 6, provided is the oral care composition according to any foregoing embodiment, wherein the abrasive system is present in an amount of about 30 wt.% or more.
[0015] In accordance with embodiment 7, provided is the oral care composition according to any foregoing embodiment, wherein the abrasive system comprises from about 30 to about 55 wt.% of calcium carbonate, calcium pyrophosphate, calcium bicarbonate, or a combination of two or more thereof.
[0016] In accordance with embodiment 8, provided is the oral care composition according to any foregoing embodiment, wherein the fluoride source is selected from sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, and a combination of two or more thereof.
[0017] In accordance with embodiment 9, provided is the oral care composition according to any foregoing embodiment further comprising a basic amino acid.
[0018] In accordance with embodiment 10, provided is the oral care composition according to embodiment 9, wherein the basic amino acid is selected from arginine, lysine, citrulline, ornithine, creatine, histidine, and a combination of two or more thereof.
[0019] In accordance with embodiment 11, provided is the oral care composition according to embodiment 9 or embodiment 10, wherein the basic amino acid comprises arginine.
[0020] In accordance with embodiment 12, provided is the oral care composition according to any foregoing embodiment, wherein the polyol is selected from a C2-C32 glycol, glycerin, and a combination of two or more thereof.
[0021] In accordance with embodiment 13, provided is the oral care composition according to any foregoing embodiment, wherein the polyol comprises glycerin.
[0022] In accordance with embodiment 14, provided is the oral care composition according to any foregoing embodiment, wherein the polyol is present in an amount from about 7 to about 32 wt.%.
[0023] In accordance with embodiment 15, provided is the oral care composition according to any foregoing embodiment, wherein the oral care composition comprises about 5 wt.% or less of sorbitol.
[0024] In accordance with embodiment 16, provided is the oral care composition according to any foregoing embodiment, wherein the oral care composition comprises about 5 wt.% or less of asugar alcohol.
[0025] In accordance with embodiment 17, provided is the oral care composition according to any foregoing embodiment, wherein the oral care composition is substantially free, or free, of a sugar alcohol.
[0026] In accordance with embodiment 18, provided is the oral care composition according to any foregoing embodiment, wherein the oral care composition is substantially free, or free, of a hops beta acid.
[0027] In accordance with embodiment 19, provided is the oral care composition according to any foregoing embodiment further comprising from about 0.1 to about 7 wt.% of a phosphate source.
[0028] In accordance with embodiment 20, provided is the oral care composition according to embodiment 19, wherein the phosphate source is selected from sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrasodium pyrophosphate, sodium tripolyphosphate, and a combination thereof.
[0029] In accordance with embodiment 21, provided is the oral care composition according to any foregoing embodiment further comprising from about 10 to about 50 wt.% of water.
[0030] In accordance with embodiment 22, provided is the oral care composition according to any foregoing embodiment further comprising an anionic surfactant, optionally, present in an amount from about 0.5 to about 7 wt.%.
[0031] In accordance with embodiment 23, provided is the oral care composition according to embodiment 22, wherein the anionic surfactant is selected from sodium lauryl sulfate, sodium lauryl ether sulfate, ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco-sulfate, ammonium coco-sulfate, or a combination of two or more thereof.
[0032] In accordance with embodiment 24, provided is an oral care composition comprising: from about 2 to about 11 wt.% of a potassium source selected from potassium nitrate, potassium citrate, potassium oxalate, and a combination thereof; about 30 wt.% or more of an abrasive comprising calcium carbonate, wherein the abrasive is free of silica; a fluoride source; and a polyol comprising from about 9 to about 32 wt.% of glycerin, wherein all weight percentages are based on the total weight of the oral care composition.BRIEF DESCRIPTION OF THE DRAWINGS
[0033] The features, and advantages of the invention will be apparent from the following more detailed description of certain embodiments of the invention and as illustrated in the accompanying drawings in which:
[0034] FIGURE is a bar graph of the potassium availability for three non-limiting example oral care compositions in accordance with aspects of the invention.
[0035] It should be understood that the various aspects are not limited to the compositions, arrangements, and instrumentality shown in the figures.DETAILED DESCRIPTION
[0036] For illustrative purposes, the principles of the present invention are described by referencing various exemplary embodiments thereof. Although certain embodiments of the invention are specifically described herein, one of ordinary skill in the art will readily recognize that the same principles are equally applicable to, and can be employed in other compositions and methods. Before explaining the disclosed embodiments of the present invention in detail, it is to be understood that the invention is not limited in its application to the details of any particular embodiment disclosed herein. The terminology used herein is for the purpose of description and not of limitation.
[0037] As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural references unless the context dictates otherwise. The singular form of any class of the ingredients refers not only to one chemical species within that class, but also to a mixture of those chemical species. The terms “a” (or “an”), “one or more” and “at least one” may be used interchangeably herein. The terms “comprising”, “including”, and “having” may be used interchangeably. The term “include” should be interpreted as “include, but are not limited to”. The term “including” should be interpreted as “including, but are not limited to”.
[0038] As used throughout, ranges are used as shorthand for describing each and every value that is within the range. Any value within the range can be selected as the terminus of the range. Thus, a range from 1-5, includes specifically 1, 2, 3, 4 and 5, as well as subranges such as 2-5, 3-5, 2-3, 2-4, 1-4, etc.
[0039] The term “about” when referring to a number means any number within a range of 10% of the number. For example, the phrase “about 2 wt.%” refers to a number between and including 1.8 wt.% and 2.2 wt.%.
[0040] All references cited herein are hereby incorporated by reference in their entireties. In the event of a conflict in a definition in the present disclosure and that of a cited reference, the present disclosure controls.
[0041] The abbreviations and symbols as used herein, unless indicated otherwise, take their ordinary meaning. The abbreviation “wt.%” means percent by weight with respect to the oral care composition. The symbol “°” refers to a degree, such as a temperature degree or a degree of an angle. The symbols “h”, “min”, “mL”, “nm”, and “pm” refer to hour, minute, milliliter, nanometer, and micrometer, respectively. The abbreviation “UV-VIS” referring to a spectrometer or spectroscopy, means Ultraviolet-Visible. The abbreviation “rpm” means revolutions per minute.
[0042] When referring to chemical structures, and names, the symbols “C”, “H”, and “O” mean carbon, hydrogen, and oxygen, respectively. The symbols “=” and “=” mean single bond, double bond, and triple bond, respectively.
[0043] “Volatile”, as used herein, means having a flash point of less than about 100° C. “Nonvolatile”, as used herein, means having a flash point of greater than about 100° C.
[0044] Any member in a list of species that are used to exemplify or define a genus, may be mutually different from, or overlapping with, or a subset of, or equivalent to, or nearly the same as, or identical to, any other member of the list of species. Further, unless explicitly stated, such as when reciting a Markush group, the list of species that define or exemplify the genus is open, and it is given that other species may exist that define or exemplify the genus just as well as, or better than, any other species listed.
[0045] The phrases, “a mixture thereof,” “a combination thereof,” or a combination of two or more thereof’ do not require that the mixture include all of A, B, C, D, E, and F (although all of A, B,C, D, E, and F may be included). Rather, it indicates that a mixture of any two or more of A, B, C,D, E, and F can be included. In other words, it is equivalent to the phrase “one or more elements selected from the group consisting of A, B, C, D, E, F, and a mixture of any two or more of A, B, C, D, E, and F.” Likewise, the term “a salt thereof” also relates to “salts thereof.” Thus, where the disclosure refers to “an element selected from the group consisting of A, B, C, D, E, F, a salt thereof, and a mixture thereof,” it indicates that that one or more of A, B, C, D, and F may beincluded, one or more of a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included, or a mixture of any two of A, B, C, D, E, F, a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included.
[0046] All components and elements positively set forth in this disclosure can be negatively excluded from the claims. In other words, the oral care compositions of the instant disclosure can be free or essentially free of all components and elements positively recited throughout the instant disclosure. In some instances, the oral care compositions of the present disclosure may be substantially free of non-incidental amounts of the ingredient(s) or compound(s) described herein. A non-incidental amount of an ingredient or compound is the amount of that ingredient or compound that is added into the oral care composition by itself. For example, an oral care composition may be substantially free of a non-incidental amount of an ingredient or compound, although such ingredient(s) or compound(s) may be present as part of a raw material that is included as a blend of two or more compounds.
[0047] Some of the various categories of components identified may overlap. In such cases where overlap may exist and the oral care composition includes both components (or the composition includes more than two components that overlap), an overlapping compound does not represent more than one component. For example, certain compounds may be characterized as both a fluoride source and a stannous ion source. If a particular oral care composition includes both a fluoride source and a stannous ion source, stannous fluoride will serve only as either a fluoride source or a stannous source — not both.
[0048] For readability purposes, the chemical functional groups are in their adjective form; for each of the adjectives, the word “group” is assumed. For example, the adjective “alkyl” without a noun thereafter, should be read as “an alkyl group.”
[0049] Aspects of the invention are directed to oral care compositions and, e.g., oral care composition comprising an anti- sensitivity agent selection from a potassium source. Without being limited to any particular theory, it is difficult to obtain stable oral care compositions that are free of silica abrasive or have a reduced amount of silica abrasive and that include a potassium source. The inventors surprisingly discovered that certain oral care compositions disclosed herein achieve superior potassium stability and superior potassium availability.
[0050] In accordance with an aspect of the invention, provided is an oral care composition having from about 2 to about 10 wt.% of a potassium source comprising potassium nitrate, potassiumcitrate, potassium oxalate, or a combination thereof; an abrasive comprising calcium carbonate, calcium bicarbonate or a combination thereof; a fluoride source; and a polyol, wherein all weight percentages are based on the total weight of the oral care composition.
[0051] In accordance with another aspect, provided is an oral care composition from about 2 to about 11 wt.% of a potassium source selected from potassium nitrate, potassium citrate, potassium oxalate, and a combination thereof; about 30 wt.% or more of an abrasive comprising calcium carbonate, wherein the abrasive is free of silica; a fluoride source; and a polyol comprising from about 9 to about 32 wt.% of glycerin, wherein all weight percentages are based on the total weight of the oral care composition.
[0052] The oral care compositions may, preferably, contain silica abrasive in an amount of about 4 wt.% or less, based on the total weight of the oral care composition. For example, the oral care composition may have a total amount of silica abrasive of about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition. In some preferred embodiments, the oral care composition is substantially free or free of silica abrasive.
[0053] Additionally, certain embodiments of the oral care composition are formulated to have a total amount of silica or silica compounds of about 4 wt.% or less, based on the total weight of the oral care composition. For instance, the oral care composition may be formulated to have a total amount of silica and / or silica compounds of about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition. In at least one preferred embodiment, the oral care composition is substantially free or free of silica and / or silica compounds.
[0054] The oral care compositions may, also or alternatively, be formulated to have about 5 wt.% or less of sugar alcohol (e.g., sorbitol, xylitol, inositol, and / or maltitol). In some embodiments, the total amount of sorbitol, xylitol, inositol, maltitol, and / or sugar alcohol (as a whole) is about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition. The oral care composition, in at least one embodiment, is substantially free or free of sorbitol, xylitol, inositol, maltitol, and / or sugar alcohol (as a whole).
[0055] Additionally or alternatively, the oral care composition may preferably be formulated to be substantially free or free of hops beta acids and / or salts thereof. In some embodiments, the oralcare composition has hops beta acids and / or salts thereof in an amount of about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the total weight of the oral care composition.
[0056] The oral care compositions may be in the form of dentifrice, toothpaste, mouthwash, and / or the like. Suitable components, such as those listed below, may be included or excluded from the formulations for the oral care compositions depending on the specific combination of other ingredients and the form of the oral care compositions. Additionally or alternatively, the oral care compositions may in some embodiments have a single phase, which contains that components and / or ingredients of the oral care composition. In other embodiments, the oral care composition may include two or more phases, such as two, three, four, or five phases.
[0057] The oral care compositions typically include a potassium source, preferably in an effective amount for an anti- sensitizing agent. The amount of potassium source may be from about 2 to about 10 wt.%, based on the total weight of the oral care composition. For instance, the oral care composition may include a potassium source (such as, potassium nitrate) in an amount from about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 4 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 4 wt.%; from about 4 to about 10 wt.%, about 4 to about 8 wt.%, about 4 to about 6 wt.%; from about 5 to about 10 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from about 6 to about 10 wt.%, about 6 to about 8 wt.%; from about 7 to about 10 wt.%, about 7 to about 9 wt.%, about 7 to about 8 wt.% or any range or subrange thereof, based on the total weight of the oral care composition.
[0058] The potassium source may be a potassium ion source. The potassium source typically comprises potassium nitrate, potassium citrate, potassium oxalate, or a combination thereof. Preferably, the oral care composition comprises potassium nitrate. The potassium source may consist of potassium nitrate, potassium citrate, potassium oxalate, and a combination thereof. In at least one embodiment, the potassium ion source consists essentially of or consists of potassium nitrate.
[0059] The oral care compositions typically include an abrasive comprising calcium carbonate, calcium bicarbonate or a combination thereof. The oral care compositions may include about 30 wt.% or more of an abrasive, based on the total weight of the oral care composition. For example, the total amount of abrasive present in the oral care composition may be from about 30 to about55 wt.%, about 30 to about 51 wt.%, about 30 to about 47 wt.%, about 30 to about 44 wt.%, about 30 to about 41 wt.%, about 30 to about 38 wt.%, about 30 to about 36 wt.%, about 30 to about 34 wt.%; from about 33 to about 55 wt.%, about 33 to about 51 wt.%, about 33 to about 47 wt.%, about 33 to about 44 wt.%, about 33 to about 41 wt.%, about 33 to about 38 wt.%, about 33 to about 36 wt.%; from about 36 to about 55 wt.%, about 36 to about 51 wt.%, about 36 to about 47 wt.%, about 36 to about 44 wt.%, about 36 to about 41 wt.%; from about 39 to about 55 wt.%, about 39 to about 51 wt.%, about 39 to about 47 wt.%, about 39 to about 44 wt.%, about 39 to about 41 wt.%; from about 43 to about 55 wt.%, about 43 to about 51 wt.%; from about 47 to about 55 wt.%, about 47 to about 51 wt.%, about 51 to about 55 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0060] The abrasive typically comprises a calcium based abrasive, such as calcium carbonate, calcium bicarbonate, or a combination thereof. In certain preferred embodiments, the oral care composition comprises calcium carbonate. The amount of calcium carbonate, calcium bicarbonate, or a combination thereof may be any of the foregoing amounts disclosed for the abrasive. For instance, the abrasive may consist of calcium carbonate, calcium bicarbonate, and a combination thereof. In at least one embodiment, the abrasive consists of calcium carbonate.
[0061] The abrasive may also comprise one or more of phosphate compounds, such as an insoluble phosphate compound; alumina compounds, such as calcined aluminum oxide; pumice; cuttlebone; composite resins, such as melamine resin, phenolic resin, and urea-formaldehyde resin; polycarbonate; boron carbide; microcrystalline wax; microcrystalline cellulose, including combinations of colloidal microcrystalline cellulose and carboxymethylcellulose, and combinations and derivatives thereof. Phosphate abrasives may include calcium phosphate, dicalcium phosphate, calcium pyrophosphate, dicalcium orthophosphate, tricalcium phosphate, p- calcium pyrophosphate, calcium metaphosphate, or a combination thereof.
[0062] The oral care compositions may include an abrasive system comprising two or more abrasives. For example, an abrasive system may comprise 2 to 7, 2 to 6, 2 to 5, 2 to 5, or 2 to 4; 3 to 7, 3 to 6, 2 to 5, or 3 to 5 abrasives. The abrasive system may include one or more cleaning abrasive and / or one or more polishing abrasives. As appreciated by one of skill in the art, a single abrasive species typically performs at least some cleaning and polishing simultaneously. However, particles are generally categorized in the art by the predominant effect they have on a target oral surface. Typically, “polishing abrasives” are considered to be relatively small particleshaving high hardness, where abrasives with relatively large particle sizes and low hardness are considered to be “cleaning abrasives.” In some embodiments, the first abrasive is selected to be a harder and smaller abrasive, e.g., a higher cleaning and / or polishing abrasive, and the second abrasive is a cleaning abrasive. In some embodiments, the oral care composition includes at least one polishing abrasive and / or at least one cleaning abrasive. Further examples of abrasives are disclosed in U.S. Patent Publication No. 2007 / 140986, which is incorporated herein in its entirety by reference for all purposes.
[0063] The oral care compositions typically include a fluoride source. The fluoride source may be a fluoride ion source and is preferably present in an effective amount. In some cases, the fluoride source is present in the oral care composition in an amount from about 0.01 to about 5 wt.%, based on the total weight of the oral care composition. For example, the fluoride source may be present in an amount from about 0.01 to about 4 wt.%, about 0.01 to about 3 wt.%, about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%; from about 0.05 to about 5 wt.%, about 0.05 to about 4 wt.%, about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%; from about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0064] The fluoride source may be selected from soluble fluoride ion salts. For example, the fluoride source may comprise sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluoride, stannous fluorozirconate, sodium monofluorophosphate, potassium monofluorophosphate, laurylamine hydrofluoride, diethylaminoethyloctoylamide hydrofluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, amine fluorides, or a combination of two or more thereof. In some embodiments, the fluoride source comprises sodium fluoride, sodiummonofluorophosphate, stannous fluoride, or a combination thereof. Additional examples of fluoride ion source arc disclosed in U.S. Patent No. 3,535,421, U.S. Patent No. 4,885,155, and U.S. Patent No. 3,678,154, the disclosure of each of which is hereby incorporated by reference in its entirety.
[0065] The oral care compositions may include one or more polyol(s). The one or more polyol(s) may be present in the oral care composition in an amount from about 7 to about 32 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include polyol(s) in an amount from about 7 to about 27 wt.%, about 7 to about 24 wt.%, about 7 to about 22 wt.%, about 7 to about 20 wt.%, about 7 to about 18 wt.%, about 7 to about 16 wt.%, about 7 to about 14 wt.%; from about 10 to about 32 wt.%, about 10 to about 27 wt.%, about 10 to about 24 wt.%, about 10 to about 22 wt.%, about 10 to about 20 wt.%, about 10 to about 18 wt.%, about 10 to about 16 wt.%, about 10 to about 14 wt.%; from about 13 to about 32 wt.%, about 13 to about 27 wt.%, about 13 to about 24 wt.%, about 13 to about 22 wt.%, about 13 to about 20 wt.%, about 13 to about 18 wt.%; from about 16 to about 32 wt.%, about 16 to about 27 wt.%, about 16 to about 24 wt.%, about 16 to about 22 wt.%, about 16 to about 20 wt.%; from about 18 to about 32 wt.%, about 18 to about 27 wt.%, about 18 to about 24 wt.%, about 18 to about 22 wt.%; from about 20 to about 32 wt.%, about 20 to about 27 wt.%; from about 22 to about 32 wt.%, about 22 to about 27 wt.%, about 24 to about 32 wt.%, about 26 to about 32 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0066] The polyol(s) may be chosen from glycols or compounds with numerous hydroxyl groups. The one or more polyols may be liquid at ambient temperature (25 °C). In some preferred embodiments, the polyol comprises or consists of glycerin, glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a block copolymer of PPG and PEG, a saccharide (e.g., fructose, glucose, sucrose and mixtures of saccharides, such as honey), or a combination of two or more thereof. For instance, the oral care composition may comprise maltitol, mannitol, sorbitol, xylitol, a polypropylene glycol (PPG), a polyethylene glycol (PEG), a block copolymer of PPG and PEG, or a combination or two or more thereof. The polyol may be a humectant including, e.g., glycol, sorbitol, glycerin, inositol, maltitol, mannitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a saccharide, polyoxypropylene-polyoxyethylene block copolymer and a combination of two or more thereof.
[0067] In some cases, the oral care composition includes one or more polyol selected from the group consisting of C2-C32 polyols. The one or more polyols may have from 2 to 32 carbon atoms, from 3 to 16 carbon atoms, or from 3 to 12 carbon atoms. For example, the oral care composition may comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, or a combination of two or more thereof. Additional, non-limiting examples of polyols that may, optionally, be included in the oral care include and / or may be chosen from alkanediols such as glycerin, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-butene-l,4-diol, 2-ethyl-l,3-hexanediol, 2-methyl-2,4-pentanediol, caprylyl glycol, 1,2-hexanediol, 1,2-pentanediol, and 4-methyl-l,2-pentanediol; glycol ethers, such as ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutyl ether, ethylene glycol monomethyl ether acetate, diethylene glycol monomethyl ether, diethylene glycol monoethyl ether, diethylene glycol mono-n-propyl ether, ethylene glycol mono-iso-propyl ether, diethylene glycol mono-iso-propyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-t-butyl ether, diethylene glycol mono-t-butyl ether, 1 -methyl- 1-methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-t- butyl ether, propylene glycol mono-n-propyl ether, propylene glycol mono-iso-propyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol mono-iso-propyl ether, sorbitol, sorbitan, triacetin, and a mixture of two or more thereof. One or more of the foregoing polyols may be excluded from certain embodiments of oral care composition.
[0068] Additionally or alternatively, the oral care composition may include polyol(s) having a molecular weight of about 100 to 5000 g / mol. For instance, the polyol may comprise a polyethylene glycol, a polypropylene glycol, a block polymer of polyethylene glycol and polypropylene glycol, or a combination of two or more thereof. In some embodiments, the polyol comprises a polyethylene glycols, a polypropylene glycol, and / or a block polymer of polyethylene glycol and polypropylene glycol having a molecular weight of about 100 to about 900, about 200 to about 800, about 400, about 1500 to about 2500, about 2000 to about 4500, or any range or subrange thereof. In some embodiments, the oral care composition includes one or more polyethylene glycols, for example, polyethylene glycols in a molecular weight range from 200 to800. For example, the oral care compositions may comprise one or more of polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol, 600 or polyethylene glycol 800. In at least one embodiment, glycerin is the only polyol in the oral care composition. One or more of the foregoing polyols may be excluded from certain embodiments of oral care composition.
[0069] The oral care compositions may, in some embodiments, include one or more amino acid(s), e.g., in an amount of about 0.1 to about 10 wt.%, based on the total weight of the oral care composition. In some embodiments, the one or more amino acid(s) may be present in the oral care composition in an amount from about 0.1 to about 8 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.5 to about 10 wt.%, about 0.5 to about 8 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 4 wt.%, about 1 to about 2 wt.%; from about 2 to about 10 wt.%, about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 4 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 4 wt.%; from about 4 to about 10 wt.%, about 4 to about 8 wt.%, about 4 to about 6 wt.%; from about 6 to about 10 wt.%, about 6 to about 8 wt.%; from about 8 to about 10 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.
[0070] The one or more amino acids may be selected from basic amino acids, neutral amino acids, and combinations thereof. The basic amino acids may be selected from naturally occurring basic amino acids, such as arginine, lysine, and histidine, and non-naturally occurring basic amino acids having a carboxyl group and an amino group in the molecule, which are water-soluble and provide an aqueous solution with a pH of 7 or greater. Examples of basic amino acids include arginine, lysine, serine, citrulline, ornithine, creatine, histidine, diaminobutanoic acid, diaminoproprionic acid, salts thereof or combinations thereof. In some embodiments, the basic amino acids are selected from arginine, citrulline, and ornithine. In certain embodiments, the basic amino acid is arginine, e.g., L-arginine, or a salt thereof. Additionally or alternatively, the one or more amino acid can be chosen from neutral amino acids, which can include, but are not limited to, one or more neutral amino acids selected from the group consisting of alanine, aminobutyrate, asparagine, cysteine, cystine, glutamine, glycine, hydroxyproline, isoleucine, leucine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, and combinationsthereof. For instance, the oral care composition may have one or more amino acid(s) selected from arginine, lysine, citrullinc, ornithine, creatine, histidine, and a combination thereof. In at least one preferred embodiment, the amino acid(s) is selected from arginine, lysine, and a combination thereof.
[0071] The oral care compositions may comprise one or more phosphate source(s). The phosphate source(s) is preferably present in an effective amount. In some instances, the oral care composition may include one or more phosphate source(s) in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the one or more phosphate source(s) may be present in the oral care composition in an amount from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 7 wt.%, about 0.4 to about 6 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 4 wt.%, about 0.4 to about 3 wt.%, about 0.4 to about 2 wt.%, about 0.4 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition. The phosphate source may be a phosphate ion source.
[0072] The phosphate source may preferably comprise a soluble phosphate compound, such as a phosphate salt. The pyrophosphate salts used in the oral care compositions can be any of the alkali metal pyrophosphate salts. In certain embodiments, alkali metal pyrophosphate salts include tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate, and mixtures thereof, wherein the alkali metals are sodium or potassium. Examples of phosphate sources include tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, or a combination thereof. The phosphate source may be chosen from orthophosphates, polymetaphosphates, pyrophosphates, and a combination of two or more thereof. In some instances, the phosphate source includes tetrasodium pyrophosphate (TSPP), sodiumtripolyphosphate (STPP), or a combination thereof. In at least one embodiment, the oral care composition includes a phosphate compound selected from calcium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, and a combination of two or more thereof.
[0073] In particular examples, the phosphate source is selected from alkali dibasic phosphate and alkali pyrophosphate salts, e.g., selected from sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, and a combination of two or more thereof. For example, the oral care compositions may comprise tetrasodium pyrophosphate (Nad^Ch), calcium pyrophosphate (Ca2P20?), sodium phosphate dibasic (Na2HP04), or a combination of two or more thereof. In at least one embodiment, the phosphate source comprises tetrasodium pyrophosphate.
[0074] Surfactants may be included in the oral care composition. The one or more surfactants may be selected from anionic surfactants, such as sulfate based anionic surfactants, sulfonated monoglycerides of fatty acids, acyl isethionates, acyl sarcosinates, acyl taurate, or combinations thereof. Examples of sulfate based anionic surfactants include sodium lauryl sulfate, sodium lauryl ether sulfate, ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco- sulfate, ammonium coco- sulfate, or a combination of two or more thereof. The one or more anionic surfactant(s) may be selected from non-sulfate based anionic surfactants, such as sulfonated monoglycerides of fatty acids, acyl isethionates, acyl sarcosinates, acyl taurate, or a combination of two or more thereof. For example, the anionic surfactants may be selected from water-soluble salts of higher fatty acid monoglyceride monosulfates, such as the sodium salt of the monosulfated monoglyceride of hydrogenated coconut oil fatty acids; sodium N- methyl N-cocoyl taurate; sodium cocomo-glyceride sulfate; higher alkyl sulfates, such as sodium lauryl sulfate; higher alkyl-ether sulfates, such as sodium laureth-2 sulfate; higher alkyl aryl sulfonates, such as sodium dodecyl benzene sulfonate (sodium lauryl benzene sulfonate); higher alkyl sulfoacetates, such as sodium lauryl sulfoacetate (dodecyl sodium sulfoacetate), higher fatty acid esters of 1,2 dihydroxy propane sulfonate, sulfocolaurate (N-2- ethyl laurate potassium sulfoacetamide), and sodium lauryl sarcosinate; and a combination of two or more thereof.
[0075] The total amount of anionic surfactants in the oral care composition may be from about 0.5to about 7 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include anionic surfactant(s) in an amount from about 0.5 to about 7 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0076] The one or more surfactants may, also or alternatively, be chosen from non-ionic, amphoteric, and cationic surfactants. Nonionic surfactants useful herein may include those compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkyl-aromatic in nature. Nonlimiting examples of suitable nonionic surfactants include polyoxyethylene sorbitan esters (sold under the trade name Tweens), polyoxyl 40 hydrogenated castor oil, fatty alcohol ethoxylates, ethylene oxide condensates of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phosphaine oxides, lauryl glucoside (sold under the trade name Plantaren 1200 UP) and long chain dialkyl sulfoxides. Suitable nonionic surfactants with a HLB of 7 or more include sucrose laurate, sucrose cocoate, sucrose stearate; Steareth 20, 21, or 100, and PEG 20 Sorbitan Monostearate (commercially available as Tween 60). In at least one embodiment, the nonionic surfactants are chosen from poly ethoxylated sorbitol esters, in particular poly ethoxylated sorbitol monoesters; polycondensates of ethylene oxide and propylene oxide (poloxamers), for instance, the products marketed under the trade name PLURONIC by BASF-Wyandotte; condensates of propylene glycol; polyethoxylated hydrogenated castor oil, for instance, cremophors; and sorbitan fatty esters.
[0077] The total amount of nonionic surfactants in the oral care composition may be from about 0.5 to about 7 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include nonionic surfactant(s) in an amount from about 0.5 to about 7 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0078] Non-limiting examples of amphoteric surfactants include, for example, long chain imidazoline derivatives, such as the product marketed under the trade name 'Miranol C2M' by Miranol; long chain alkyl betaines, such as the product marketed under the tradename 'Empigen BB' by Albright+Wilson, and long chain alkyl amidoalkyl betaines, such as cocamidopropylbetaine, and mixtures thereof.
[0079] The oral care composition may include amphoteric surfactants chosen from derivatives of aliphatic secondary and tertiary amines, in which the aliphatic radical can be a straight chain or branched and wherein one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic water-solubilizing group, such as carboxylate, sulfonate, sulfate, phosphate, or phosphonate. Other exemplary amphoteric surfactants are betaines, such as cocamidopropyl betaine, lauryl dimethyl betaine (sold under the trade name Macat LB), cetyl dimethyl betaine, and cocoamphodiacetate. Additional amphoteric surfactants and nonionic surfactants can be found in U.S. Pat. No. 4,051,234, which is incorporated herein in its entirety for all purposes.
[0080] The oral care compositions may include amphoteric surfactants in an amount from about 0.5 to about 7 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include amphoteric surfactant(s) in an amount from about 0.5 to about 7 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%,about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0081] Examples of cationic surfactants that may be present in the oral care composition include cetyl pyridinium chloride, coamidopropyl PG dimonium chloride phosphate (Phospholipid CDM), myristylamidopropyl PG dimonium chloride phosphate (Phospholipid PTM), stearamidopropyl PG dimonium chloride phosphate (Phospholipid SV), steapyrium chloride (Catemol WPC), and other suitable cationic materials. The cationic surfactants may be D,L-2-pyrrolidone-5-carbo- xylic acid salt of ethyl-N-cocoyl-L-arginate, marketed under the trade name CAE by Ajinomoto Co. Inc.
[0082] The total amount of cationic surfactants in the oral care composition may be from about 0.5 to about 7 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include cationic surfactant(s) in an amount from about 0.5 to about 7 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0083] The oral care compositions may include one or more sweeteners. The oral care composition may include caloric sweeteners and / or non-caloric sweeteners. Examples of non-caloric sweeteners include saccharin, e.g., sodium saccharin, acesulfame, neotame, cyclamate or sucralose; natural high-intensity sweeteners, such as thaumatin, stevioside or glycyrrhizin; or sugar alcohols, such as sorbitol, xylitol, maltitol and mannitol. Examples of caloric sweeteners include sugars, such as fructose, glucose, sucrose, and high fructose syrups.
[0084] The one or more sweetener(s) may be present in the oral care composition in an amount from about 0.1 to about 50 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may have a total amount of sweetener(s) from about 0.1 to about 40 wt.%, about 0.1 to about 30 wt.%, about 0.1 to about 20 wt.%, about 0.1 to about 10wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%; from about 1 to about 50 wt.%, about 1 to about 40 wt.%, about 1 to about 30 wt.%, about 1 to about 20 wt.%, about 1 to about 10 wt.%, about 1 to about 5 wt.%, about 1 to about 3 wt.%; from about 5 to about 50 wt.%, about 5 to about 40 wt.%, about 5 to about 30 wt.%, about 5 to about 20 wt.%, about 5 to about 10 wt.%; from about 10 to about 50 wt.%, about 10 to about 45 wt.%, about 10 to about 40 wt.%, about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%; from about 15 to about 50 wt.%, about 15 to about 45 wt.%, about 15 to about 40 wt.%, about 15 to about 37 wt.%, about 15 to about 34 wt.%, about 15 to about 31 wt.%, about 15 to about 28 wt.%, about 15 to about 25 wt.%; from about 20 to about 50 wt.%, about 20 to about 45 wt.%, about 20 to about 40 wt.%, about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to about 50 wt.%, about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 to about 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 50 wt.%, about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 50 wt.%, about 31 to about 45 wt.%, about 31 to about 40 wt.%, about 31 to about 37 wt.%; from about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; from about 37 to about 50 wt.%, about 37 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.
[0085] In some embodiments, the oral care composition preferably is substantially free or free of caloric sweeteners. For example, the oral care compositions may have about 4 wt.% or less, about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, or about 0.1 wt.% or less, based on the weight of the oral care composition. In at least one embodiment, the oral care composition contains about 0 wt.% or 0 wt.% of caloric sweeteners, based on the weight of the oral care composition.
[0086] The oral care composition may include water, e.g., in an amount from about 10 to about 50 wt.%, based on the total weight of the oral care composition. In some instances, the amount of water in the oral care composition is from about 10 to about 50 wt.%, about 10 to about 45 wt.%, about 10 to about 40 wt.%, about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%, about 10 to about 20 wt.%; from about 20 to about 50 wt.%, about 20 to about 45 wt.%, about 20 to about 40 wt.%, about 20 to about 35 wt.%, about 20 to about 30 wt.%; from about 25 to about 50 wt.%, about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 toabout 35 wt.%, about 25 to about 30 wt.%; from about 30 to about 50 wt.%, about 30 to about 45 wt.%, about 30 to about 40 wt.%, about 30 to about 35 wt.%; from about 35 to about 50 wt.%, about 35 to about 45 wt.%, about 35 to about 40 wt.%, about 40 to about 50 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.EXAMPLESExample 1
[0087] Three non-limiting example oral care composition (Example Compositions A-C) were prepared in accordance with aspects of the invention. The formulas for Example Compositions A- C are provided in Table 1.Table 1
[0088] A comparative composition having the following ingredients was also evaluated: potassium nitrate 5%, sodium fluoride 0.25% (0.15% w / v fluoride ion)Inactive ingredients - water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, and blue 1.Example 2
[0089] Example Compositions A-C and Comparative Composition were evaluated to assess the availability of potassium ions during the brushing of teeth. Example Composition A was also evaluated to assess the stability of the potassium source. To measure the availability of potassium ion during teeth brushing, volunteers were used to collect data for each oral care composition. The volunteers were instructed to brush their teeth with a massed quantity of one of Example Compositions A-C or Comparative Composition for two minutes. Stimulated saliva was collected before brushing and five minutes after brushing with one of Example Compositions A-C or Comparative Composition. After brushing, the volunteers expectorated into a collection vial. The expectorated slurry was then centrifuged and filtered before diluting in a 10% nitric acid solution. Samples were then submitted for soluble potassium analysis. The results were used to calculate soluble potassium content based on the various dilution factors.
[0090] The stability of the potassium source was evaluated by placing a sample of Example Composition A in a controlled environment having a temperature of 40°C and a relative humidity of 75% for 13 weeks. After the 13 weeks, approximately 1 gram of Example Compositions A was diluted with 120 mL of water and stirred for 15 minutes or until complete dispersion to form a dispersed solution. 50 mL of a 1 .3 wt.% of cesium chloride solution was added to the dispersed solution. The mixture was diluted to 500 mL and stirred for 15 minutes. Approximately 13 mL of this solution was transferred to a centrifuge tube and centrifuged for 15 minutes. After centrifugation, the solution was measured to determine the soluble potassium content using an atomic absorption spectrophotometer fitted with an air-acetylene burner head (e.g., Agilent 240 AA).
[0091] The availability of the potassium ions yielded by Example Compositions A-C and Comparative Composition during brushing is shown in FIGURE. The amount of potassium source of Example Composition A after being in the controlled environment for 13 weeks was 1.97 wt.%.
[0092] This unexpected potassium stability correlates with an unexpected sensitivity benefit provided by exemplary compositions of the present invention.Example 3
[0093] The viscosity of Example Compositions A-C was evaluated. Specifically, samples of Example Compositions A-C were maintained in a controlled environment and evaluated at certain times. A summary of the evaluation of the viscosity of Example Compositions A-C is provided in Table 2 (below).Table 2
Claims
CLAIMSWhat Is Claimed Is:
1. An oral care composition comprising: from about 2 to about 10 wt.% of a potassium source comprising potassium nitrate, potassium citrate, potassium oxalate, or a combination thereof; an abrasive system comprising a calcium based abrasive; a fluoride source; and a polyol; wherein all weight percentages are based on the total weight of the oral care composition.
2. An oral care composition comprising: from about 2 to about 10 wt.% of a potassium source comprising potassium nitrate, potassium citrate, potassium oxalate, or a combination thereof; an abrasive comprising calcium carbonate, calcium bicarbonate or a combination thereof; a fluoride source; and a polyol; wherein all weight percentages are based on the total weight of the oral care composition.
3. The oral care composition according to claim 1 or claim 2, wherein the abrasive system is substantially free, or free, of a silica abrasive.
4. The oral care composition according to any foregoing claim, wherein the oral care composition is substantially free, or free, of a silica compound.
5. The oral care composition according to any foregoing claim, wherein the potassium source comprises potassium nitrate.
6. The oral care composition according to any foregoing claim, wherein the abrasive system is present in an amount of about 30 wt.% or more.
7. The oral care composition according to any foregoing claim, wherein the abrasive system comprises from about 30 to about 55 wt.% of calcium carbonate, calcium pyrophosphate, calcium bicarbonate, or a combination of two or more thereof.
8. The oral care composition according to any foregoing claim, wherein the fluoride source is selected from sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, and a combination of two or more thereof.
9. The oral care composition according to any foregoing claim further comprising a basic amino acid.
10. The oral care composition according to claim 9, wherein the basic amino acid is selected from arginine, lysine, citrulline, ornithine, creatine, histidine, and a combination of two or more thereof.
11. The oral care composition according to claim 9 or claim 10, wherein the basic amino acid comprises arginine.
12. The oral care composition according to any foregoing claim, wherein the polyol is selected from a C2-C32 glycol, glycerin, and a combination of two or more thereof.
13. The oral care composition according to any foregoing claim, wherein the polyol comprises glycerin.
14. The oral care composition according to any foregoing claim, wherein the polyol is present in an amount from about 7 to about 32 wt.%.
15. The oral care composition according to any foregoing claim, wherein the oral care composition comprises about 5 wt.% or less of sorbitol.The oral care composition according to any foregoing claim, wherein the oral care composition comprises about 5 wt.% or less of a sugar alcohol.
17. The oral care composition according to any foregoing claim, wherein the oral care composition is substantially free, or free, of a sugar alcohol.
18. The oral care composition according to any foregoing claim, wherein the oral care composition is substantially free, or free, of a hops beta acid.
19. The oral care composition according to any foregoing claim further comprising from about 0.1 to about 7 wt.% of a phosphate source.
20. The oral care composition according to claim 19, wherein the phosphate source is selected from sodium phosphate dibasic, potassium phosphate dibasic, dicalcium phosphate dihydrate, calcium pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrasodium pyrophosphate, sodium tripolyphosphate, and a combination thereof.
21. The oral care composition according to any foregoing claim further comprising from about10 to about 50 wt.% of water.
22. The oral care composition according to any foregoing claim further comprising an anionic surfactant, optionally, present in an amount from about 0.5 to about 7 wt.%.
23. The oral care composition according to claim 22, wherein the anionic surfactant is selected from sodium lauryl sulfate, sodium lauryl ether sulfate, ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco-sulfate, ammonium coco-sulfate, or a combination of two or more thereof.
24. An oral care composition comprising:from about 2 to about 11 wt.% of a potassium source selected from potassium nitrate, potassium citrate, potassium oxalate, and a combination thereof; about 30 wt.% or more of an abrasive comprising calcium carbonate, wherein the abrasive is free of silica; a fluoride source; and a polyol comprising from about 9 to about 32 wt.% of glycerin, wherein all weight percentages are based on the total weight of the oral care composition.