Oral care compositions comprising chitosan and silica

Abstract

Oral care compositions and, particularly, oral care compositions providing enhanced oral care benefits are disclosed herein. In accordance with an aspect, provided is an oral care composition comprising from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof; an amine fluoride compound; from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of 1 µm to about 100 µm; from about 27 to about 49 wt.% of polyol; and from about 0.5 to about 7 wt.% of a surfactant, wherein all weight percentages are based on the total weight of the oral care composition.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from U.S. Provisional Patent Application No. 63 / 640,646, filed April 30, 2024, titled Oral Care Compositions, which is hereby incorporated herein by reference in its entirety 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 arc 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 believed that in certain cases tooth sensitivity may be due to the exposure of dentin, which covers the nerve, either through loss of the enamel layer or recession of the gums. The dentin contains a large number of microtubules that run from the outside of the tooth to the nerve in the center of the tooth. When the dentin is exposed, the microtubules can transmit stimuli, e.g., from changes in temperature or from certain foods (acidic or sweet) to the nerve, causing the tooth or teeth to perceive pain. The pain usually subsides after a short period of time.

[0004] It is commonly understood that partially or fully exposed tubules can lead to tooth sensitivity, an irritating and painful condition. In this theory, recession of the gum line exposes cementum to erosion. The eroded cementum in turn exposes the hollow dentinal tubules. 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. Common environmental stimuli, such as heat, cold, chemicals and physical and mechanical pressure or stimuli, such as brushing, are able to irritate the nerve through the open dentin tubules and thereby create pain. The pain of sensitive teeth appears to result from these stimuli, which apparently cause fluid movements in the dentinal tubules that activate pulpal nerve endings.

[0005] There is a need in the art for a dentifrice that, upon use, prevents or reduces tooth sensitivity. Despite the many products on the market and the many efforts to address this problem over the years, there still remains a need for safe and effective oral care products to address the problem of dental hypersensitivity. BRIEF SUMMARY

[0006] 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.

[0007] Aspects of the invention are directed to oral care compositions and, particularly, oral care compositions providing enhanced oral care benefits. In accordance with an aspect of the invention, provided is an oral care composition comprising from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof; an amine fluoride compound; from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm; from about 27 to about 49 wt.% of a polyol; and from about 0.5 to about 7 wt.% of a surfactant, wherein all weight percentages are based on the total weight of the oral care composition.

[0008] In accordance with further aspects, provided is an oral care composition comprising from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof; a fluoride ion source (e.g., a fluoride source other than an amine fluoride compound); from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm; from about 27 to about 49 wt.% of a polyol; from about 0.5 to about 7 wt.% of a surfactant, wherein all weight percentages are based on the total weight of the oral care composition.

[0009] In accordance with yet further aspects, provided is the use of a silica comprising an average dio particle size of about 1 to about 10 pm, an average dso particle size of about 4 to about 16 pm, and an average dgo particle size of about 6 to about 20 pm in combination with chitosan and / or a derivative thereof, a fluoride source, a polyol, and a surfactant to manufacture an oral care composition.

[0010] A list of non-limiting example embodiments in accordance with aspects of the invention are provided below:

[0011] In accordance with an embodiment 1, provided is an oral care composition comprising: from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof; an amine fluoride compound; from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm; from about 27 to about 49 wt.% of a polyol; and from about 0.5 to about 7 wt.% of a surfactant, wherein all weight percentages arc based on the total weight of the oral care composition.

[0012] In accordance with an embodiment 2, provided is an oral care composition according to embodiment 1, wherein the oral care composition is free of phosphate compounds.

[0013] In accordance with an embodiment 3, provided is an oral care composition according to embodiment 1 or embodiment 2, wherein the chitosan is a fungal based chitosan.

[0014] In accordance with an embodiment 4, provided is an oral care composition according to any foregoing embodiment, wherein the chitosan comprises bleached fungal based chitosan.

[0015] In accordance with an embodiment 5, provided is an oral care composition according to any one of embodiment 1 to embodiment 3, wherein the chitosan consists of bleached fungal based chitosan.

[0016] In accordance with an embodiment 6, provided is an oral care composition according to any foregoing embodiment, wherein the amine fluoride compounds are formed from a fluoride ion source and an amine compound.

[0017] In accordance with an embodiment 7, provided is an oral care composition according to any foregoing embodiment, wherein the amine compound is selected from rapeseed oil, rice bran, soybean oil, tallow, and a combination of two or more thereof.

[0018] In accordance with an embodiment 8, provided is an oral care composition according to embodiment 6 or embodiment 7, wherein the fluoride ion source comprises sodium fluoride.

[0019] In accordance with an embodiment 9, provided is an oral care composition according to any foregoing embodiment, wherein the one or more silica comprises a silica that is a non-abrasive silica having an average diameter of about 1 pm to about 10 pm.

[0020] In accordance with an embodiment 10, provided is an oral care composition according to any foregoing embodiment, wherein the polyol comprises glycerin, sorbitol, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, a polyethylene glycol, a polypropylene glycol, a polyethylene glycol, a polypropylene glycol, or a combination of two or more thereof.

[0021] In accordance with an embodiment 11, provided is an oral care composition according to embodiment 10, wherein the polyol comprises glycerin and sorbitol.

[0022] In accordance with an embodiment 12, provided is an oral care composition according to any foregoing embodiment, wherein the surfactant comprises an amphoteric surfactant.

[0023] In accordance with an embodiment 13, provided is an oral care composition according to embodiment 12, wherein the amphoteric surfactant comprises a betaine surfactant.

[0024] In accordance with an embodiment 14, provided is an oral care composition according to embodiment 12 or embodiment 13, wherein the surfactant is selected from the group consisting of amphoteric surfactants.

[0025] In accordance with an embodiment 15, provided is an oral care composition according to any foregoing embodiment further comprising an organic acid and / or a salt thereof.

[0026] In accordance with an embodiment 16, provided is an oral care composition according to any foregoing embodiment, wherein the organic acid and / or salt thereof are selected from citric acid, malic acid, gluconic acid, a salt thereof, or a combination thereof.

[0027] In accordance with an embodiment 17, provided is an oral care composition according to any foregoing embodiment, wherein the oral care composition is substantially free or free of titanium dioxide.

[0028] In accordance with an embodiment 18, provided is an oral care composition according to any foregoing embodiment, wherein the oral care composition is substantially free or free of whitening pigments.

[0029] In accordance with an embodiment 19, provided is an oral care composition according to any foregoing embodiment, wherein the oral care composition is substantially free or free of antisensitivity agents selected from potassium salts, strontium salts, and chloride salts.

[0030] In accordance with an embodiment 20, provided is an oral care composition according to any foregoing embodiment further comprising one or more thickening agent.

[0031] In accordance with an embodiment 21, provided is an oral care composition according to embodiment 20, wherein the one or more thickening agent comprises a silica thickener.

[0032] In accordance with an embodiment 22, provided is an oral care composition according to embodiment 20 or embodiment 21, wherein the one or more thickening agent comprises a cellulose ether.

[0033] In accordance with an embodiment 23, provided is oral care composition comprising: from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof; a fluoride ion source; from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm; from about 27 to about 49 wt.% of a polyol; and from about 0.5 to about 7 wt.% of a surfactant; wherein all weight percentages are based on the total weight of the oral care composition.

[0034] In accordance with an embodiment 24, provided is an oral care composition according to embodiment 23 further comprising a phosphate compound.

[0035] In accordance with an embodiment 25, provided is an oral care composition according to embodiment 24, wherein the phosphate compound comprises zinc phosphate.

[0036] In accordance with an embodiment 26, provided is an oral care composition according to any foregoing embodiment, wherein the one or more silica comprises a silica having an average oil absorption of about 210 to about 360 g / lOOg.

[0037] In accordance with an embodiment 27, provided is an oral care composition according to any foregoing embodiment, wherein the one or more silica comprises a silica having a BET surface of 180 to 270 m2 / g.

[0038] In accordance with an embodiment 28, provided is an oral care composition according to any foregoing embodiment, wherein the one or more silica comprises a silica having a micropore volume of about 0.01 to about 0.1 m2 / g.

[0039] In accordance with an embodiment 29, disclosed is a use of a silica comprising an average dio particle size of about 0.1 to about 3 pm, an average dso particle size of about 1 to about 4.5 pm, and an average doo particle size of about 2 to about 10 pm in combination with chitosan and / or a derivative thereof, a fluoride source, a polyol, and a surfactant to manufacture an oral care composition.

[0040] In accordance with an embodiment 30, disclosed is a use of a silica comprising an average dio particle size of about 0.1 to about 3 pm, an average dso particle size of about 1 to about 4.5 pm, an average dgo particle size of about 2 to about 10 pm, an average oil absorption of about 210 to about 360 g / lOOg, a BET surface of 180 to 270 m2 / g, and a micropore volume of about 0.01 to about 0.1 m2 / g in combination with chitosan and / or a derivative thereof, a fluoride source, a polyol, and a surfactant to manufacture an oral care composition. DETAILED DESCRIPTION

[0041] 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 arc 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.

[0042] 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”.

[0043] 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.

[0044] 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.%.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] “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.

[0049] 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.

[0050] 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 be included, 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.

[0051] 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.

[0052] 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 polyol and a humectant. If a particular claim to an oral care composition includes both a polyol and a humectant, glycerin will serve only as either a polyol or a humectant—not both.

[0053] 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.”

[0054] Aspects of the invention are directed to oral care compositions and, particularly, oral care compositions providing enhanced oral care benefits. In accordance with an aspect of the invention, provided is an oral care composition comprising from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof; an amine fluoride compound; from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm; from about 27 to about 49 wt.% of a polyol; and from about 0.5 to about 7 wt.% of a surfactant, wherein all weight percentages are based on the total weight of the oral care composition.

[0055] In certain embodiments, the oral care composition has a reduced amount, is substantially free of, or free of phosphate compounds. Without being limited to any particular theory, certain embodiments of the oral care compositions disclosed herein, which include one or more amine fluoride compound(s) have a reduced amount or are preferably substantially free of or free of phosphate compounds. In some embodiments, the oral care composition may have about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, based on the total weight of the oral care compositions, of phosphate compounds.

[0056] In accordance with further aspects of the invention, provided is an oral care composition comprising from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof; a fluoride ion source (e.g., a fluoride source other than an amine fluoride compound); from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm; from about 27 to about 49 wt.% of a polyol; from about 0.5 to about 7 wt.% of a surfactant, wherein all weight percentages are based on the total weight of the oral care composition.

[0057] In certain embodiments, such as those that arc substantially free of or free of amine fluoride compounds, the oral care composition may comprise a phosphate compound, such as a zinc phosphate. For example, in certain embodiments, the oral care composition comprises one or more phosphate compound in an amount from about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1.5 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%, about 1 to about 1.5 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%, about 3 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0058] Preferably, the oral care compositions are adapted to provide an anti-sensitivity effect. In some cases, the oral care composition achieves the anti-sensitivity effect while having a reduced amount, being substantially free of, or free of anti-sensitivity agents selected from potassium salts, strontium salts, and chloride salts. For example, the oral care composition may have about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, based on the total weight of the oral care compositions, of anti-sensitivity agents selected from potassium salts, strontium salts, and chloride salts. Examples of anti-sensitivity agents selected from potassium salts, strontium salts, and chloride salts that may be limited or excluded from certain preferred embodiments include potassium nitrate, potassium bicarbonate, and / or potassium chloride.

[0059] The oral care compositions may, in some cases, have a reduced amount, be substantially free of, or be free of titanium dioxide. For example, the oral care composition may have about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, based on the total weight of the oral care compositions, of titanium dioxide. In some embodiments, the oral care composition may have a total amount of whitening pigments of about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, based on the total weight of the oral care composition. In at least one embodiment, the oral care composition is substantially free of or free of whitening pigments.

[0060] In accordance with yet further aspects, provided is the use of a silica comprising an average dio particle size of about 1 to about 10 pm, an average dso particle size of about 4 to about 16 pm, and an average dgo particle size of about 6 to about 20 pm in combination with chitosan and / or a derivative thereof, a fluoride source, a polyol, and a surfactant to manufacture an oral care composition.

[0061] The oral care compositions may be in the form of a dentifrice, a toothpaste, a gel, and / or the like. Suitable components, such as those listed below, may be included or excluded from the formulations for the oral care compositions disclosed herein depending on the specific combination of other ingredients and / or the form of the oral care compositions. Additionally or alternatively, the oral care compositions may in some embodiments have a single phase, which contains all of the 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.

[0062] The oral care compositions typically comprise a chitosan and / or a derivative thereof. The total amount of chitosan and / or derivatives thereof in the oral care composition may be from about 0.5 to about 5 wt.%, based on the total weight of the oral care composition. For example, the total amount of chitosan and / or derivatives thereof present in the oral care composition may be from about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1.5 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%, about 1 to about 1.5 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%, about 3 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0063] Chitosan is a linear polysaccharide that is composed of randomly distributed P-(l-4)-linked D-glucosamines (deacetylated units) and N-acetyl-D-glucosamines (acetylated units). In certain embodiments, the oral care compositions disclosed herein may comprise chitosan and / or derivatives thereof selected from chitosans of crustacean origin (also referred herein as crustacean based chitosan) or chitosans of fungal origin (also referred to herein as fungal based chitosan). For example, shrimp based chitosans and / or derivatives thereof, Aspergillus based chitosan and / or derivatives thereof, Agaricus bisporu based chitosan and / or derivatives thereof, or a combination of two or more thereof may be used in certain embodiments. In certain preferred embodiments, however, the oral care composition is free of crustacean based chitosan and / or derivatives thereof.

[0064] Preferably, the chitosan and / or chitosan derivative comprises one or more fungal based chitosan(s). In some instances, the chitosan and / or chitosan derivative consists of fungal based chitosan(s). Additionally, in certain preferred embodiments, the oral care composition comprises or, in some cases, consists of bleached chitosan and / or derivatives thereof. The chitosan and / or derivative thereof preparations may include, for example, glucan. The chitosan and / or derivatives thereof may be synthesized from chitin by the deacetylation of chitin using sodium hydroxide.

[0065] In addition to the chitosan and / or a derivative thereof, the oral care compositions typically include a silica, preferably, in an amount from about 3 to about 35 wt.%, based on the total weight of the oral care composition. In some cases, the oral care composition comprises silica in an amount from about 11 to about 35 wt.%, about 11 to about 30 wt.%, about 11 to about 25 wt.%, about 11 to about 22 wt.%, about 11 to about 20 wt.%, about 11 to about 18 wt.%, about 11 to about 16 wt.%, about 11 to about 14 wt.%; from about 14 to about 35 wt.%, about 14 to about 30 wt.%, about 14 to about 25 wt.%, about 14 to about 22 wt.%, about 14 to about 20 wt.%, about 14 to about 18 wt.%, about 14 to about 16 wt.%; from about 16 to about 35 wt.%, about 16 to about 30 wt.%, about 16 to about 25 wt.%, about 16 to about 22 wt.%, about 16 to about 20 wt.%, about 16 to about 18 wt.%; from about 18 to about 35 wt.%, about 18 to about 30 wt.%, about 18 to about 25 wt.%, about 18 to about 22 wt.%, about 18 to about 20 wt.%; from about 25 to about 30 wt.%, about 20 to about 30 wt.%, about 20 to about 25 wt.%, about 20 to about 23 wt.%; from about 25 to about 35 wt.%, about 25 to about 30 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition. Additionally or alternatively, one or more silica may be present in the oral care composition in an amount from about 3 to about 15 wt.%, about 3 to about 12 wt.%, about 3 to about 9 wt.%, about 3 to about 6 wt.%; from about 5 to about 15 wt.%, about 5 to about 12 wt.%, about 5 to about 9 wt.%, about 5 to about 7 wt.%; from about 7 to about 15 wt.%, about 7 to about 12 wt.%, about 7 to about 9 wt.%; from about 9 to about 15 wt.%, about 9 to about 12 wt.%, from about 11 to about 15 wt.%, about 13 to about 15 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0066] The oral care composition may comprise a plurality of silica. The plurality of silica may comprise one or more silica that is a non-abrasive silica and / or one or more non-thickening silica. The oral care composition may comprise at least one silica having an average maximum diameter of about 1 pm to about 100 pm. In some instances, the oral care composition may comprise a plurality of silica, with at least one of the silica having an average maximum diameter of about 1 pm to about 20 pm and, optionally, one or more silica having an average maximum diameter of about 21 pm to about 100 pm.

[0067] In certain embodiments, the oral care composition comprises one or more silica having an average maximum diameter of about 1 pm to about 20 pm, about 1 pm to about 16 pm, about 1 pm to about 12 pm, about 1 pm to about 8 pm, about 1 pm to about 6 pm, about 1 pm to about 5 pm, about 1 pm to about 4 pm, about 1 pm to about 3 pm; from about 2 pm to about 20 pm, about 2 pm to about 16 pm, about 2 pm to about 12 pm, about 2 pm to about 8 pm, about 2 pm to about 6 pm, about 2 pm to about 5 pm, about 2 pm to about 4 pm; from about 3 pm to about 20 pm, about 3 pm to about 16 pm, about 3 pm to about 12 pm, about 3 pm to about 8 pm, about 3 pm to about 6 pm; from about 4 pm to about 20 pm, about 4 pm to about 16 pm, about 4 pm to about 12 pm, about 4 pm to about 8 pm, about 4 pm to about 6 pm; from about 5 pm to about 20 pm, about 5 pm to about 16 pm, about 5 pm to about 12 pm, about 5 pm to about 8 pm; from about 7 pm to about 20 pm, about 7 pm to about 16 pm, about 7 pm to about 12 pm; from about 9 pm to about 20 pm, about 9 pm to about 16 pm, about 9 pm to about 13 pm, or any range or subrange thereof.

[0068] The silica having an average maximum diameter of about 1 pm to about 20 pm may be specifically adapted to have a particle distribution comprising an average dio particle size of about 0.1 to about 3 pm, an average dso particle size of about 1 to about 4.5 pm, and an average dgo particle size of about 2 to about 10 pm. For example, the average dio particle size of the silica may be from about 0.1 to about 3 pm, about 0.1 to about 2 pm, about 0.1 to about 1.5 pm, about 0.1 to about 1 pm, about 0.1 to about 0.8 pm, about 0.1 to about 0.6 pm; from about 0.5 to about 3 pm, about 0.5 to about 2 pm, about 0.5 to about 1.5 pm, about 0.5 to about 1 pm, about 0.5 to about 0.8 pm; from about 1 to about 3 pm, about 1 to about 2 pm, about 1 to about 1.5 pm; from about 1.5 to about 3 pm, about 1.5 to about 2 pm, about 2 to about 3 pm, or any range or subrange thereof. Additionally and / or alternatively, the average dso particle size of the silica may be from about 1 to about 4.5 pm, about 1 to about 4 pm, about 1 to about 3.5 pm, about 1 to about 3 pm, about 1 to about 2.5 pm, about 1 to about 2 pm; from about 2 to about 4.5 pm, about 2 to about 4 pm, about 2 to about 3.5 pm, about 2 to about 3 pm; from about 2.5 to about 4.5 pm, about 2.5 to about 4 pm, about 2.5 to about 3.5 pm; from about 3 to about 4.5 pm, about 3 to about 4 pm, about 3.5 to about 4.5 pm, or any range or subrange thereof. Additionally and / or alternatively, the average doo particle size of the silica may be from about 2 to about 10 pm, about 2 to about 8 pm, about 2 to about 6 pm, about 2 to about 5 pm, about 2 to about 4 pm; from about 4 to about 10 pm, about 4 to about 8 pim, about 4 to about 6 pim, about 4 to about 5 pim; from about 5 to about 10 pm, about 5 to about 8 pim, about 5 to about 6 pim; from about 6 to about 10 pim, about 6 to about 8 pim, about 7 to about 10 pim, or any range or subrange thereof.

[0069] As discussed above, the oral care composition may comprise a silica having an average maximum diameter of about 21 pim to about 100 pm. In some cases, the silica may have an average diameter of about 21 pm to about 100 pm, about 21 pm to about 90 pm, about 21 pm to about 80 pm, about 21 pm to about 70 pm, about 21 pm to about 60 pm, about 21 pm to about 50 pm about 21 pm to about 40 pm; from about 30 pm to about 100 pm, about 30 pm to about 90 pm, about 30 pm to about 80 pm, about 30 pm to about 70 pm, about 30 pm to about 60 pm, about 30 pm to about 50 pm about 30 pm to about 40 pm; from about 40 pm to about 100 pm, about 40 pm to about 90 pm, about 40 pm to about 80 pm, about 40 pm to about 70 pm, about 40 pm to about 60 pm; from about 60 pm to about 100 pm, about 60 pm to about 90 pm, about 60 pm to about 80 pm; from about 80 pm to about 100 pm, about 80 pm to about 90 pm, or any range or subrange thereof. The silica having an average maximum diameter of about 21 pm to about 100 pm may be in addition to or alternative to the silica having an average maximum diameter of about 1 pm to about 20 pm.

[0070] The average particle size of the silica may be measured using a Malvern Particle Size Analyzer, such as a Model Mastersizer 2000 (or comparable model) (Malvern Instruments, Inc., Southborough, Mass.), wherein a helium-neon gas laser beam is projected through a transparent cell which contains silica, such as, e.g., silica hydrogel particles suspended in an aqueous solution. Light rays that strike the particles are scattered through angles that are inversely proportional to the particle size. The photodetector arrant measures the quantity of light at several predetermined angles. Electrical signals proportional to the measured light flux values are then processed by a microcomputer system, against a scatter pattern predicted from theoretical particles as defined by the refractive indices of the sample and aqueous dispersant to determine the particle size distribution of the silica hydrogel, for example. It will be understood that other methods of measuring particle size are known in the art, and based on the disclosure set forth herein, the skilled artisan will understand how to calculate median particle size, mean particle size, and / or particle size distribution of silica particles of the present invention.

[0071] The silica may have an average oil absorption of about 210 to about 360 grams of oil per 100 grams of silica (referred herein as “g / 100g”). For example, the oral care composition may have one or more silica having an average oil adsorption of, preferably, about 210 to about 360 g / lOOg, about 230 to about 360 g / lOOg, about 250 to about 360 g / lOOg, about 260 to about 360 g / lOOg, about 270 to about 360 g / lOOg, about 280 to about 360 g / lOOg; preferably from about 210 to about 340 g / lOOg, about 230 to about 340 g / lOOg, about 250 to about 340 g / lOOg, about 260 to about 340 g / lOOg, about 270 to about 340 g / lOOg, about 280 to about 340 g / lOOg; preferably from about 210 to about 320 g / lOOg, about 230 to about 320 g / lOOg, about 250 to about 320 g / lOOg, about 260 to about 320 g / lOOg, about 270 to about 320 g / lOOg, about 280 to about 320 g / lOOg; preferably from about 210 to about 300 g / lOOg, about 230 to about 300 g / lOOg, about 250 to about 300 g / lOOg, about 260 to about 300 g / lOOg, about 270 to about 300 g / lOOg; preferably from about 210 to about 280 g / lOOg, about 230 to about 280 g / lOOg, about 250 to about 280 g / lOOg, about 260 to about 280 g / lOOg, about 270 to about 280 g / lOOg; preferably from about 210 to about 270 g / lOOg, about 230 to about 270 g / lOOg, about 250 to about 270 g / lOOg, about 260 to about 270 g / lOOg; preferably from about 210 to about 260 g / lOOg, about 230 to about 260 g / lOOg, or any range or subrange thereof. The silica having the average oil absorption of about 210 to about 360 grams of oil per 100 grams of silica, or any subrange provided herein, may be the silica having an average maximum diameter of about 1 pm to about 20 pm and / or the silica having an average maximum diameter of about 21 pm to about 100 pm.

[0072] The silica may have a BET surface of 180 to 270 m2 / g, preferably from about 195 to about 270 m2 / g, about 205 to about 270 m2 / g, about 215 to about 270 m2 / g, about 225 to about 270 m2 / g, about 235 to about 270 m2 / g; preferably from about 180 to about 255 m2 / g, about 195 to about 255 m2 / g, about 205 to about 255 m2 / g, about 215 to about 255 m2 / g, about 225 to about 255 m2 / g, about 235 to about 255 m2 / g; preferably from about 180 to about 240 m2 / g, about 195 to about 240 m2 / g, about 205 to about 240 m2 / g, about 215 to about 240 m2 / g, about 225 to about 240 m2 / g, about 235 to about 240 m2 / g; preferably from about 180 to about 230 m2 / g, about 195 to about 230 m2 / g, about 205 to about 230 m2 / g, about 215 to about 230 m2 / g, about 225 to about 230 m2 / g, or any range or subrange thereof. The silica having the BET surface of 180 to 270 m2 / g, or any subrange provided herein, may be the silica having an average maximum diameter of about 1 pm to about 20 pm and / or the silica having an average maximum diameter of about 21 pm to about 100 pm.

[0073] The silica may have a micropore volume of about 0.01 to about 0.1 cm2 / g, preferably from about 0.01 to about 0.08 cm2 / g, about 0.01 to about 0.07 cm2 / g, about 0.01 to about 0.06 cm2 / g, about 0.01 to about 0.05 cm2 / g, about 0.01 to about 0.04 cm2 / g, about 0.01 to about 0.03 cm2 / g; preferably about 0.02 to about 0.1 cm2 / g, about 0.02 to about 0.08 cm2 / g, about 0.02 to about 0.07 cm2 / g, about 0.02 to about 0.06 cm2 / g, about 0.02 to about 0.05 cm2 / g, about 0.02 to about 0.04 cm2 / g; preferably about 0.03 to about 0.1 cm2 / g, about 0.03 to about 0.08 cm2 / g, about 0.03 to about 0.07 cm2 / g, about 0.03 to about 0.06 cm2 / g, about 0.03 to about 0.05 cm2 / g, about 0.03 to about 0.04 cm2 / g; preferably about 0.04 to about 0.1 cm2 / g, about 0.04 to about 0.08 cm2 / g, about 0.04 to about 0.07 cm2 / g, about 0.04 to about 0.06 cm2 / g, about 0.04 to about 0.05 cm2 / g, or any range thereof. The silica having the micropore volume of about 0.01 to about 0.1 cm2 / g, or any subrange provided herein, may be the silica having an average maximum diameter of about 1 pm to about 20 pm and / or the silica having an average maximum diameter of about 21 pm to about 100 pm.

[0074] The silica may have a total pore of about 1 to about 1.3. For example, the total pore of the silica may be from about 1 to about 1.3, about 1 to about 1.2, about 1 to about 1.1; from about 1.05 to about 1.3, about 1.05 to about 1.2; from about 1.1 to about 1.3, about 1.1 to about 1.2, about 1.2 to about 1.3, or any range or subrange thereof. The silica having the total pore of about 1 to about 1.3, or any subrange provided herein, may be the silica having an average maximum diameter of about 1 pm to about 20 pm and / or the silica having an average maximum diameter of about 21 pm to about 100 pm.

[0075] In some embodiments, the oral care composition may comprise a plurality of silica, with at least one of the silica having an average maximum diameter of about 1 pm to about 20 pm (or a subrange disclosed above), an average dio particle size of about 0.1 to about 3 pm (or a subrange disclosed above), an average dso particle size of the silica may be from about 1 to about 4.5 pm (or a subrange disclosed above), an average dgo particle size of the silica may be from about 2 to about 10 pm (or a subrange disclosed above), an average oil absorption of about 210 to about 360 grams of oil per 100 grams of silica (or a subrange disclosed above), a BET surface of 180 to 270 m2 / g (or a subrange disclosed above), a micropore volume of about 0.01 to about 0.1 cm2 / g (or a subrange disclosed above), and / or a total pore of about 1 to about 1.3 (or a subrange disclosed above); and, optionally, one or more silica having an average maximum diameter of about 21 pm to about 100 pm. In at least one embodiment, the oral care composition may comprise a plurality of silica, with at least one of the silica having an average maximum diameter of about 1 pm to about 20 pm (or a subrange disclosed above), an average dio particle size of about 0.1 to about 3 pm (or a subrange disclosed above), an average dso particle size of the silica may be from about 1 to about 4.5 pm (or a subrange disclosed above), an average dgo particle size of the silica may be from about 2 to about 10 pm (or a subrange disclosed above), an average oil absorption of about 210 to about 360 grams of oil per 100 grams of silica (or a subrange disclosed above), a BET surface of 180 to 270 nr / g (or a subrange disclosed above), a micropore volume of about 0.01 to about 0.1 cm2 / g (or a subrange disclosed above), and a total pore of about 1 to about 1.3 (or a subrange disclosed above); and, optionally, one or more silica having an average maximum diameter of about 21 pm to about 100 pm.

[0076] In some cases, the total amount of abrasive in the oral care composition is from about 11 to about 25 wt.%, about 11 to about 22 wt.%, about 11 to about 20 wt.%, about 11 to about 18 wt.%, about 11 to about 16 wt.%, about 11 to about 14 wt.%; from about 14 to about 30 wt.%, about 14 to about 25 wt.%, about 14 to about 22 wt.%, about 14 to about 20 wt.%, about 14 to about 18 wt.%, about 14 to about 16 wt.%; from about 16 to about 30 wt.%, about 16 to about 25 wt.%, about 16 to about 22 wt.%, about 16 to about 20 wt.%, about 16 to about 18 wt.%; from about 18 to about 30 wt.%, about 18 to about 25 wt.%, about 18 to about 22 wt.%, about 18 to about 20 wt.%; from about 20 to about 30 wt.%, about 20 to about 25 wt.%, about 20 to about 23 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0077] Additionally, the oral care composition may include one or more abrasive, such as a silica abrasive. The total amount of abrasive in the oral care composition may be from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the total amount of abrasive in the oral care composition may be from about 0.1 to about 5 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 5 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 5 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%, about 0.8 to about 1.5 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 7 wt.%, about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0078] The one or more abrasive may be selected from silica abrasives and / or from abrasives other than silica abrasives. For instance, the oral care composition may include an abrasive chosen from silica abrasive, alumina (including calcined aluminum oxide), aluminosilicates, bentonite, zeolite, kaolin, mica, siliceous or diatomaceous earth, pumice, calcium compounds, calcium carbonate, cuttlebone, composite resins (such as melamine resin, phenolic resin, and urea-formaldehyde resin), polycarbonate, silicon carbide, boron carbide, microcrystalline wax, microcrystalline cellulose (e.g., combinations of colloidal microcrystalline cellulose and carboxymethylcellulose) dicalcium phosphate, calcium pyrophosphate, dicalcium orthophosphate dihydrate, tricalcium phosphate, calcium polymetaphosphate, calcium carbonate, calcium bicarbonate, and a combination of two or more thereof. In some embodiments, the oral care composition includes one or more of abrasives chosen from dicalcium phosphate, calcium pyrophosphate, dicalcium orthophosphate dihydrate, tricalcium phosphate, calcium polymetaphosphate, calcium carbonate, calcium bicarbonate, or a combination of two or more thereof. In further embodiments, the oral care composition comprises an abrasive selected from silica abrasive, calcium carbonate, dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate, insoluble sodium polymetaphosphate, hydrated alumina, resinous abrasive materials such as particulate condensation products of urea and formaldehyde, and combinations thereof.

[0079] The abrasive in some cases may be an insoluble phosphate salt, such as calcium pyrophosphate, dicalcium orthophosphate dihydrate, tricalcium phosphate, and calcium polymetaphosphate. As used herein, “mica” refers to any of a group of hydrous aluminum silicate minerals with plate morphology and / or perfect basal (micaceous) cleavage. Mica can be, for example, sheet mica, scrap mica or flake mica, as exemplified by muscovite, biotite or phlogopite type micas.

[0080] The oral care composition may comprise a fluoride source. The total amount of fluoride source present in the oral care composition may be in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the fluoride ion source may be present in an amount of about 0.1 to about 5 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 5 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 5 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%, about 0.8 to about 1.5 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 7 wt.%, about 5 to about 6 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0081] In certain embodiments, the fluoride source comprises one or more amine fluoride compound(s). The amine fluoride compound(s) is generally formed from a fluoride ion source and an amine compound. The amine fluoride compound may be formed in situ in the oral care composition or may be formed in situ in a composition used in the preparation of the oral care composition. The amine compound may be selected from plant based amine compounds and / or animal based amine compounds. Examples of animal based amine compounds include, e.g., tallow and / or fish oils. Examples of plant based amine compounds include rapeseed oil, rice bran, soybean oil, mustard seed oil, sunflower oil, com oil, peanut oil, linseed oil, castor oil, palm oil, coconut oil, and combinations of two or more thereof.

[0082] The oral care composition may, additionally or alternatively, include a fluoride source other than an amine fluoride compound. For example, the fluoride source other than an amine fluoride compound may be selected from fluoride ions sources, such as soluble fluoride ion salts. Examples of fluoride ion sources include sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, lithium fluoride, sodium monofluorophosphate, potassium monofluorophosphate, or a combination of two or more thereof. In some embodiments, the fluoride ion source comprises sodium fluoride, sodium monofluorophosphate, or a combination thereof.

[0083] In certain embodiments, the oral care composition has a fluoride source selected from the group consisting of fluoride sources other than an amine fluoride compounds. In other words, in certain embodiments, the oral care composition may be substantially free or free of amine fluoride compounds. For example, the oral care composition may comprise amine fluoride compound(s) in amount of about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, or about 0.001 wt.% or less, based on the total weight of the oral care compositions. In at least one embodiment, the oral care composition has about 0.001 wt.% or less or 0 wt.% of amine fluoride compound, based on the total weight of the oral care compositions.

[0084] The oral care compositions may comprise a stannous source (e.g., a stannous ion source), preferably in an effective amount. The stannous source may comprise or consists of stannous ion source(s). The stannous source (e.g., stannous ion source) may be present in the oral care composition in an amount from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. For example, the amount of stannous source (e.g., stannous ion) present in the oral care composition may be from 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. In at least one embodiment, oral care composition includes about 0.4 to about 0.5 wt.% of stannous ion source, such as about 0.45 wt.% of stannous ion source.

[0085] The stannous source (e.g., stannous ion source) may be selected from the group consisting of: stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof. The stannous source may comprise stannous fluoride, stannous chloride, stannous acetate, and a combination of two or more thereof. In at least one embodiment, the stannous source (e.g., stannous ion source) comprises stannous fluoride.

[0086] The oral care composition may comprise polyol(s) typically in an amount of about 27 to about 49 wt.%, based on the total weight of the oral care composition. For example, the amount of polyol(s) in the oral care composition may be from about 27 to about 49 wt.%, about 27 to about 45 wt.%, about 27 to about 41 wt.%, about 27 to about 38 wt.%, about 27 to about 35 wt.%, about 27 to about 32 wt.%; from about 31 to about 49 wt.%, about 31 to about 45 wt.%, about 31 to about 41 wt.%, about 31 to about 38 wt.%, about 31 to about 35 wt.%; from about 34 to about 49 wt.%, about 34 to about 45 wt.%, about 34 to about 41 wt.%, about 34 to about 38 wt.%; from about 37 to about 49 wt.%, about 37 to about 45 wt.%, about 37 to about 41 wt.%; from about 40 to about 49 wt.%, about 40 to about 45 wt.%; about 43 to about 49 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0087] 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 cases, the oral care composition includes or excludes 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. Examples of polyols that may be included in, or in some embodiments excluded from, the oral care composition include glycerin, glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), or a combination of two or more thereof. In some preferred embodiments, the one or more polyol(s) comprises ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, a polyethylene glycol, a polypropylene glycol, a polyethylene glycol, a polypropylene glycol, or a combination of two or more thereof.

[0088] 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.

[0089] Additionally or alternatively, the oral care composition may include polyol(s) having a molecular weight of from 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, a polyethylene glycol-polypropylene glycol copolymer, or a combination of two or more thereof. In some embodiments, the polyol comprises a polypropylene glycol, 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.

[0090] The oral care composition may comprise an organic acid and / or salt thereof. In certain preferred embodiments, the organic acid and / or salt thereof is selected from citric acid, malic acid, gluconic acid, a salt thereof, or a combination thereof. For example, the oral care composition may include one or more organic acid and / or salt thereof selected from citric acid, sodium citrate (e.g., trisodium citrate dihydrate), malic acid, sodium malate, potassium maleate, gluconic acid, sodium gluconate, and a combination of two or more thereof. In some embodiments, the oral care composition comprises citric acid and / or a salt thereof as well as malic acid and / or a salt thereof. For example, in at least one instance, the oral care composition includes a sodium citrate (e.g., trisodium citrate dihydrate) and malic acid.

[0091] The oral care composition may be formulated to specifically have citric acid and / or a salt thereof and malic acid and / or a salt thereof in a weight ratio of a total amount of citric acid and / or a salt thereof to a total amount of malic acid and / or a salt thereof of about 15:1 to about 2:1. In some instances, the weight ratio of the total amount of citric acid and / or a salt thereof to the total amount of malic acid and / or a salt thereof is from about 15:1 to about 2:1, about 12:1 to about 2:1, about 10:1 to about 2:1, about 8:1 to about 2:1, about 6:1 to about 2:1, about 4:1 to about 2:1; from about 15:1 to about 4:1, about 12:1 to about 4:1, about 10:1 to about 4:1, about 8:1 to about 4:1, about 6:1 to about 4:1; from about 15:1 to about 6:1, about 12:1 to about 6:1, about 10:1 to about 6:1, about 8:1 to about 6:1; from about 15:1 to about 8:1, about 12:1 to about 8:1, about 10:1 to about 8:1; from about 15:1 to about 10:1, about 12:1 to about 10:1, or any range or subrange thereof.

[0092] The amount of organic acid and / or a salt thereof may be present in an amount from about 0.1 to about 4 wt.%, based on the total weight of the oral care composition. For instance, the amount of organic acid and / or a salt thereof may be from 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 0.5 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 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2 wt.%; from about 2 to about 4 wt.%, about 2 to about 3 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0093] Surfactants may be included in the oral care composition. The one or more surfactant(s) may be present in an amount ranging from about 0.5 to about 8 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include one or more surfactant 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.%; from about 1 to about 9 wt.%, about 1 to about 8 wt.%, about 1 to about 7 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 9 wt.%, about 2 to about 8 wt.%, about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 2.5 to about 9 wt.%, about 2.5 to about 8 wt.%, about 2.5 to about 7 wt.%, about 2.5 to about 6 wt.%, about 2.5 to about 5 wt.%, about 2.5 to about 4 wt.%, about 2.5 to about 3.5 wt.%; from about 3 to about 9 wt.%, about 3 to about 8 wt.%, about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%, about 3 to about 3.5 wt.%; from about 4 to about 9 wt.%, about 4 to about 8 wt.%, about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 9 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from 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.

[0094] The one or more surfactants may be chosen from anionic, nonionic, amphoteric, and / or cationic surfactants. In at least one preferred embodiment, the one or more surfactants comprises an amphoteric surfactant. The amphoteric surfactants may be 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 include betaine surfactants, such as cocamidopropyl betaine, lauryl dimethyl betaine, cetyl dimethyl betaine, and cocoamphodiacetate. Non-limiting examples of amphoteric surfactants include, for example, long chain imidazoline derivatives; long chain alkyl betaines and long chain alkyl amidoalkyl betaines, such as cocamidopropylbetaine, and mixtures thereof. Additional amphoteric surfactants and nonionic surfactants can be found in U.S. Patent No. 4,051,234, which is incorporated herein in its entirety for all purposes.

[0095] Nonionic surfactants may be chosen from 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. Non-limiting examples of suitable nonionic surfactants include polyoxyethylene sorbitan esters, hydrogenated castor oil, fatty alcohol ethoxylates, ethylene oxide condensates of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phosphaine oxides, glucosides, and long chain dialkyl sulfoxides.

[0096] 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 ammonium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium cocosulfate, 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.

[0097] In some embodiments, the oral care composition has a reduced amount, is substantially free of, or free of anionic surfactants. For example, the oral care composition may have anionic surfactants in amount of about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, based on the total weight of the oral care compositions. In at least one embodiment, the oral care composition is substantially free of or free of anionic surfactants.

[0098] In further embodiments, the oral care composition has a reduced amount, is substantially free of, or free of cationic surfactants. For example, the oral care composition may have cationic surfactants in an amount of about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, based on the total weight of the oral care compositions. In at least one embodiment, the oral care composition is substantially free of or free of cationic surfactants.

[0099] In certain embodiments, the oral care composition have a reduced amount, are substantially free of, or free of nonionic surfactants. For example, the oral care composition may have nonionic surfactants in an amount of about 0.5 wt.% or less, about 0.2 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, about 0.01 wt.% or less, about 0.005 wt.% or less, based on the total weight of the oral care compositions. In at least one embodiment, the oral care composition is substantially free of or free of nonionic surfactants.

[0100] The oral care composition may comprise a thickening system comprising one or more thickening agent(s), such as those selected from a polysaccharide, a silica thickener, an acrylate, a polyacrylic acid, a polyvinyl pyrrolidone, polyitaconates, cellulose ether, an acrylamides, a salt thereof, and a combination of two or more thereof. The amount of thickening agent(s) present in the oral care composition may be from about 0.1 to about 15 wt.%, based on the total weight of the oral care composition. For instance, the amount thickening agent(s) in the oral care composition may be from about 0.1 to about 15 wt.%, about 0.1 to about 12 wt.%, about 0.1 to about 9 wt.%, about 0.1 to about 7 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 15 wt.%, about 0.4 to about 12 wt.%, about 0.4 to about 9 wt.%, about 0.4 to about 7 wt.%, about 0.4 to about 5 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 15 wt.%, about 0.8 to about 12 wt.%, about 0.8 to about 9 wt.%, about 0.8 to about 7 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%, about 0.8 to about 1.5 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%; from about 4 to about 15 wt.%, about 4 to about 12 wt.%, about 4 to about 9 wt.%, about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 15 wt.%, about 5 to about 12 wt.%, about 5 to about 9 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from about 7 to about 15 wt.%, about 7 to about 12 wt.%, about 7 to about 9 wt.%; from about 9 to about 15 wt.%, about 9 to about 12 wt.%, about 11 to about 15 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0101] The oral care composition may preferably comprise at least one thickening agent selected from cellulose ethers. The cellulose ether may be selected from cellulose polymers, for example one or more hydroxyalkyl cellulose polymers, such as hydroxypropylmethyl cellulose (HPMC), hydroxyethylpropyl cellulose (HEPC), hydroxybutylmethyl cellulose (HBMC), carboxymethyl cellulose (CMC), hydroxyl propyl cellulose, hydroxycthyl cellulose, methyl cellulose, and combinations of two or more thereof. In at least one embodiment, the one or more thickening agent comprises a mixture of cellulose materials such as, for example, a mixture of two hydroxyalkyl cellulose materials having different molecular weight.

[0102] Additional examples of thickening agents, which may be included or excluded from embodiments of the oral care composition include polysaccharides, such as cellulose, carboxymethyl hydroxyethylcellulose, cellulose acetate propionate carboxylate, hydroxyethylcellulose, hydroxyethyl ethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium cellulose sulfate, carrageenan, or a combination of two more thereof. Natural gums such as karaya, gum arabic, xanthan gum, and gum tragacanth can also be incorporated.

[0103] Silica thickeners, which form polymeric structures or gels in aqueous media, may be present. Silica thickeners are typically physically and functionally distinct from the particulate silica abrasives as the silica thickeners are very finely divided and provide little or no abrasive action.

[0104] Examples of acrylates that may, optionally, be included or excluded from the oral care composition, include methacrylates, isobutyl acrylate, tert-butyl acrylate, 2-ethylhexyl acrylate, lauryl acrylate, lauryl / tridecyl acrylate, cetyl acrylate, stearyl acrylate, cyclohexyl acrylate, benzyl acrylate, isobomyl acrylate, 2-methoxyethyl acrylate, 2-ethoxyethyl acrylate, 2-ethoxyethoxyethyl acrylate, 2-phenoxyethyl acrylate, tetrahydrofurfuryl acrylate, 2-hydroxyethyl acrylate, 2-hydroxypropyl acrylate, 4-hydroxybutyl acrylate, dimethylaminoethyl acrylate, 1,4-butanediol acrylate, or a combination of two or more thereof. The acrylate may be chosen from diacrylates. In some embodiments, the diacrylate is chosen from 1,4-butanediol, 1,6-hexanediol, tetraethylene glycol, tripropylene glycol, ethoxylated bisphenol-A, or a combination of two or more thereof. Triacrylate monomers include trimethylol propane, ethoxylated, glyceryl propoxy, and pentaerythritol.

[0105] Examples of acrylamides that may, optionally, be included or excluded from the oral care composition, include acrylamide, methacrylamide and di(Ci-C3o) alkyl-acrylamides and -methacrylamides such as those of methyl, ethyl, propyl, butyl, pentyl, hexyl, and the like. N-substituted acrylamides that may be suitable include N-ethylacrylamide, N-tert-butylacrylamide, N-tert-octylacrylamide, N-octylacrylamide, N-decylacrylamide, N-dodecylacrylamide, and the corresponding N-substitutcd methacrylamides. Other N-substitutcd acrylamides include N-hydroxymethyl acrylamide, N-isopropylacrylamide, N-methylacrylamide, N,N'-methylenebisacrylamide, N-isobutoxymethylacrylamide, N,N-dimethylacrylamide, and 2-acrylamido-2-methylpropanesulfonic acid.

[0106] The oral care compositions may include an anti-calculus agent in certain embodiments. The amount of anti-calculus agent(s) present in the oral care composition may be from about 0.5 to about 10 wt.%, based on the total weight of the oral care composition. In some instances, the anti-calculus agent(s) is present in the oral care composition in an amount from about 0.5 to about 8 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.%; from about 1 to about 10 wt.%, about 1 to about 8 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 10 wt.%, about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 10 wt.%, about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%; from about 5 to about 10 wt.%, about 5 to about 8 wt.%, about 5 to about 6 wt.%; from about 7 to about 10 wt.%, about 7 to about 8 wt.%, about 8 to about 10 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0107] The anti-calculus agent(s) may be chosen from phosphates and polyphosphates (e.g., pyrophosphates), polyaminopropanesulfonic acid (AMPS), hexametaphosphate salts, zinc citrate trihydrate, polypeptides, polyolefin sulfonates, polyolefin phosphates, diphosphonates, and combinations of two or more thereof. Examples of anti-calculus agents include tetrasodium pyrophosphate, ammonium tripolyphosphate, hexametaphosphate salt, polycarboxylate polymers, polyvinyl methyl ether / maleic anhydride (PVME / MA) copolymers, or combinations of two or more thereof. In some embodiments, the oral care composition includes one or more alkali metal polyphosphate, e.g., as tetrasodium pyrophosphate.

[0108] 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, for example, 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.

[0109] The one or more sweetener(s) may be present in the oral care composition in an amount from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. For example, the total amount of sweetener(s) in the oral care composition may be from 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 0.5 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 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 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 3 to about 4 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0110] In some embodiments, the oral care composition preferably has a reduced amount, is substantially free, or is 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 of caloric sweeteners, based on the weight of the oral care composition. In at least one embodiment, the oral care composition is free substantially free or free of caloric sweeteners. For instance, in certain cases, the oral care composition contains about 0 wt.% or 0 wt.% of caloric sweeteners, based on the weight of the oral care composition.

[0111] The oral care compositions of the present disclosure may include a flavoring agent. The flavoring agent is typically incorporated in the oral care composition at a concentration of about 0.01 to about 3 wt.% by weight of the oral care composition. For example, the amount of flavoring agent(s) present in the oral care composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 3 wt.%, about 1 to about 2 wt.%; about 2 to about 3 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0112] Suitable flavoring agents include, but are not limited to, essential oils and various flavoring aldehydes, esters, alcohols, and similar materials. Examples of the essential oils include oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange. Also useful are such chemicals as menthol, carvone, and anethole. Additional flavoring agents may include, but arc not limited to menthol, artificial vanilla, cinnamon derivatives, and various fruit flavors, spearmint oil, peppermint oil, cinnamon oil, oil of wintergreen (methylsalicylate), clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leaf oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, and a combination of two or more thereof.

[0113] The oral care compositions may include one or more colorants. Exemplary colorants can include natural or uncertified colors from natural sources or certified colors for the effect of color. In some embodiments, the colorant can include dyes, certified aluminum lakes or colors derived from a natural source. The colorant may be water-based, oil-based or dry. The colorants can be primary colors, blends of colors or discrete mixtures of colors, such as confetti. The concentrations of the colorant in the oral care composition may be from trace amount to about 0.6 wt.%, from about 0.1 to about 0.5 wt.%, about 0.2 to about 0.4 wt.%, or about 0.15 to about 0.35 wt.%, based on the total weight of the oral care composition.

[0114] The oral care composition may include one or more pH adjusters to increase or decrease the overall pH of the oral care composition. For example, one or more acids may be included to decrease the pH of the oral care composition. Examples of suitable acids for decreasing the pH of the oral care composition include, but are not limited to, citric acid, acetic acid, sodium acid pyrophosphate, and the like. The oral care composition may include one or more bases, such as sodium hydroxide, potassium hydroxide and the like, to increase the pH of the oral care composition. Additional or alternative acids and bases that are suitable for adjusting the pH of the oral care composition are readily known to one of ordinary skill in the art.

[0115] The amount of the pH adjuster in the oral care composition may be based on the desired pH of the final oral care composition and / or product. For example, the total amount of the pH adjuster may range from about 0.05 to about 20 wt.%, based on the total weight of the oral care composition. In some instances, the total amount of pH adjuster is from about 0.05 to about 15 wt.%, about 0.1 to about 10 wt.%, or about 0.12 to about 5 wt.%, including ranges and sub-ranges therebetween, based on the total weight of the oral care composition.

[0116] The oral care compositions may have a pH from about 3 to about 7, about 3 to about 7, about 3 to about 6, about 3 to about 5.5, about 3 to about 5, about 4 to about 7, about 4 to about 6, about 4 to about 5.5, about 4 to about 5, about 4.5 to about 7, about 4.5 to about 6, about 4.5 to about 5.5, about 4.5 to about 5, about 5 to about 7, about 5 to about 6, any range or subrange thereof, c.g., as measured as a 10 wt.% solution. The pH of the solution (c.g., any of the foregoing pH ranges) may be measured as a 10 wt.% solution, whereby the solution comprises 10 wt.% of the oral care composition with the remainder being water.

[0117] Water is typically present in the oral care composition. For example, the oral care composition may comprise water in an amount from about 15 to about 40 wt.%, based on the total weight of the oral care composition. In some embodiments, the amount of water in the oral care composition is from about 15 to about 40 wt.%, about 15 to about 35 wt.%, about 15 to about 32 wt.%, about 15 to about 29 wt.%, about 15 to about 26 wt.%, about 15 to about 23 wt.%; from about 19 to about 40 wt.%, about 19 to about 35 wt.%, about 19 to about 32 wt.%, about 19 to about 29 wt.%, about 19 to about 26 wt.%; from about 22 to about 40 wt.%, about 22 to about 35 wt.%, about 22 to about 32 wt.%, about 22 to about 29 wt.%, about 22 to about 26 wt.%; from about 25 to about 40 wt.%, about 25 to about 35 wt.%, about 25 to about 32 wt.%; from about 28 to about 40 wt.%, about 28 to about 35 wt.%, about 28 to about 32 wt.%; from about 31 to about 40 wt.%, about 31 to about 35 wt.%; from about 34 to about 40 wt.%, about 34 to about 38 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition. EXAMPLES Example 1

[0118] Seven non-limiting, example oral care compositions (Example Compositions A-G) were prepared in accordance with aspects of the invention. The formulations used for preparing Example Compositions A-G and a comparative composition (Comparative composition 1) are shown in Table 1. Table 1 Compound Name Comp. 1 (wt.%) Ex. A (wt.%) Ex. B (wt.%) Ex. C (wt.%) Water Q.S. to 100 Q.S. to 100 Q.S. to 100 Q.S. to 100 Glycerin 28-33 28-33 28-33 28-33 Sorbitol 6-9 6-9 6-9 6-9 Synthetic Amorphous High Cleaning Silica having oil absorption of 60-100 g / lOOg and total pore of 0.1-0.3. (VP5 and AC-43) 23 13.5 16 16 Precipitated Synthetic Amorphous Silica having oil absorption of about 260 to about 280 g / lOOg and total pore of about 1 to about 1.2 5 5 5 Aminefluoride Solution Comprising Alkyl trihydroxyethyl Propylenediamine and Hydrofluoric Acid, and Aminefluoride Compounds formed therefrom (17 wt.% Alkyl trihydroxyethyl Propylenediamine and 1.5 wt.% of Hydrofluoric Acid) 0.9-1.2 Sodium Fluoride 0.2 0.3 0.3 0.3 Stannous Chloride 0.6 0.6 0.6 0.6 Malic Acid 0.2 0.2 Trisodium Citrate Dihydrate 1 Sodium Gluconate 0.8 0.8 1.5 Cocamidopropyl Betaine Solution 3-5 3-5 3-5 3-5 Amine Chloride Solution Comprising Rapeseed Oleaminopropylamineth-3 and Hydrochloric Acid, and Amine Chloride Compounds Thereof (28 wt.% of Rapeseed Oleaminopropylamineth-3 and 14 wt.% of Hydrochloric Acid) 0.9-1.2 0.9-1.2 0.9-1.2 Hydroxyethlycellulose 1.6 1.6 1.4 1.4 Chito s an / Glucan-bleached 1-1.3 1-1.3 1-1.3 1-1.3 Flavoring Agents and Sweeteners (Sodium Saccharin and Sucralose) 2 2 2 2 Coloring Agents 0.04 0.04 0.04 0.04 Hydrochloric Acid 0-0.01 0-0.01 0-0.01 0-0.01 Table 1 Continued Compound Name Ex. D (wt.%) Ex. E (wt.%) Ex. F (wt.%) Ex. G (wt.%) Water Q.S. to 100 Q.S. to 100 Q.S. to 100 Q.S. to 100 Glycerin 28-33 28-33 28-33 28-33 Sorbitol 6-9 6-9 6-9 6-9 Synthetic Amorphous High Cleaning Silica having Oil Absorption of 60-100 g / lOOg and total pore of 0.1-0.3 (VP5 and AC-43) 13.5 13.5 13.5 13.5 Precipitated Synthetic Amorphous Silica having oil absorption of about 260 to about 280 g / lOOg and total pore of about 1 to about 1.2 5 5 5 5 Sodium Fluoride 0.3 0.3 0.3 0.3 Stannous chloride 0.6 0.6 0.6 0.6 Zinc Phosphate 1 1 Malic Acid 0.15 0.15 Trisodium Citrate Dihydrate 1.1 1.1 Hydrochloric Acid 0.08 0.06 Sodium Gluconate 0.8 0.8 Cocamidopropyl Betaine Solution 3-5 3-5 3.5 3-5 Amine Chloride Solution Comprising Rapeseed Olcaminopropylamincth-3 and Hydrochloric Acid, and Amine Chloride Compounds Thereof (28 wt.% of Rapeseed Oleaminopropylamineth-3 and 14 wt.% of Hydrochloric Acid) 0.9-1.2 0.9-1.2 0.9-1.2 0.9-1.2 Hydroxyethlycellulose 1.5 1.5 1.6 1.6 Chitosan / Glucan-bleached 1-1.3 1-1.3 1-1.3 1-1.3 Flavoring Agents and Sweeteners (Sodium Saccharin and Sucralose) 2 2 2 2 Coloring Agents 0.04 0.04 0.04 0.04 Hydrochloric Acid 0-0.01 0-0.01 0-0.01 0-0.01 Example 2

[0119] A sensitivity evaluation of Example Composition A and Comparative Composition 1 is conducted to compare the anti-sensitivity benefit of Example Composition A and Comparative Composition 1. It is believed that Example Composition A provides an anti-sensitivity benefit while Comparative Composition 1 does not provide a statistically significant anti-sensitivity benefit.

Claims

1. An oral care composition comprising:from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof;an amine fluoride compound;from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm;from about 27 to about 49 wt.% of a polyol; andfrom about 0.5 to about 7 wt.% of a surfactant,wherein all weight percentages are based on the total weight of the oral care composition.

2. The oral care composition according to claim 1, wherein the oral care composition is free of phosphate compounds.

3. The oral care composition according to claim 1 or claim 2, wherein the chitosan is a fungal based chitosan.

4. The oral care composition according to any foregoing claim, wherein the chitosan consists of bleached fungal based chitosan.

5. The oral care composition according to any foregoing claim, wherein the amine fluoride compounds are formed from a fluoride ion source and an amine compound.

6. The oral care composition according to any foregoing claim, wherein the amine compound is selected from rapeseed oil, rice bran, soybean oil, tallow, and a combination of two or more thereof.

7. The oral care composition according to claim 5 or claim 6, wherein the fluoride ionsource comprises sodium fluoride.

8. The oral care composition according to any foregoing claim, wherein the one or more silica comprises a silica that is a non-abrasivc silica having an average diameter of about 1 pm to about 10 pm.

9. The oral care composition according to any foregoing claim, wherein the polyol comprises glycerin, sorbitol, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, a polyethylene glycol, a polypropylene glycol, a polyethylene glycol, a polypropylene glycol, or a combination of two or more thereof.

10. The oral care composition according to any foregoing claim, wherein the surfactant comprises an amphoteric surfactant, the amphoteric surfactant comprising a betaine surfactant.

11. The oral care composition according to any one of claims 1 to 9, wherein the surfactant is selected from the group consisting of amphoteric surfactants.

12. The oral care composition according to any foregoing claim further comprising: an organic acid and / or a salt thereof, wherein the organic acid and / or the salt thereof comprises citric acid, malic acid, gluconic acid, a salt thereof, or a combination thereof.

13. The oral care composition according to any foregoing claim, wherein the oral care composition is substantially free or free of titanium dioxide.

14. The oral care composition according to any foregoing claim, wherein the oral care composition is substantially free or free of anti-sensitivity agents selected from potassium salts, strontium salts, and chloride salts.

15. The oral care composition according to any foregoing claim further comprising:one or more thickening agent comprising a silica thickener, a cellulose ether, or a combination of two or more thereof.

16. An oral care composition comprising:from about 0.5 to about 5 wt.% of chitosan and / or a derivative thereof;a fluoride ion source;from about 11 to about 25 wt.% of one or more silica having an average maximum diameter of about 1 pm to about 100 pm;from about 27 to about 49 wt.% of a polyol; andfrom about 0.5 to about 7 wt.% of a surfactant;wherein all weight percentages are based on the total weight of the oral care composition.

17. The oral care composition according to claim 16 further comprising: one or more phosphate compound comprising zinc phosphate.

18. The oral care composition according to any foregoing claim, wherein the one or more silica has an average oil absorption of about 210 to about 360 g / lOOg, a BET surface of 180 to 270 m2 / g, and / or a micropore volume of about 0.01 to about 0.1 m2 / g.

19. Use of a silica comprising an average dw particle size of about 0.1 to about 3 pm, an average dso particle size of about 1 to about 4.5 pm, and an average dyo particle size of about 2 to about 10 pm in combination with chitosan and / or a derivative thereof, a fluoride source, a polyol, and a surfactant to manufacture an oral care composition.

20. Use of a silica comprising an average dw particle size of about 0.1 to about 3 pm, an average dso particle size of about 1 to about 4.5 pm, an average dyo particle size of about 2 to about 10 pm, an average oil absorption of about 210 to about 360 g / lOOg, a BET surface of 180 to 270 m2 / g, and a micropore volume of about 0.01 to about 0.1 nr / g in combination with chitosan and / or a derivative thereof, a fluoride source, a polyol, and a surfactant to manufacture an oral care composition.