Oral care strip and composition thereof

Abstract

Disclosed herein are oral care films and oral care compositions comprising such oral care films. An oral care film may comprise: from about 5% to about 19% by weight, based on the total weight of the oral care film, of oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a nonionic surfactant; and starch.

Description

Background Art

[0001] Bleeding gums are associated with many common oral conditions, such as gingivitis. Bleeding gums can be caused by the accumulation of plaque, a soft, sticky, colorless film of bacteria that forms on teeth and gums and produces toxins that can inflame or infect gum tissue, leading to gingivitis. Gingivitis is the initial stage of gum disease and, if left untreated, can lead to periodontitis.

[0002] Antibacterial agents have been used in oral care products to reduce dental plaque and gingivitis, and therefore reduce bleeding gums. Similarly, hemostatic agents have also been used in oral care products to reduce bleeding gums. Oleanolic acid is considered to have both antibacterial and hemostatic properties, and then it is desired to produce an oral care composition incorporating oleanolic acid. However, due to its hydrophobic properties, oleanolic acid is often dissolved in solvents such as ethanol or dimethyl sulfoxide (DMSO) to promote its use. The use of such solvents limits the incorporation of oleanolic acid in the oral care compositions that wish to avoid or limit the use of these ingredients. Summary of the Invention

[0003] This disclosure is intended only to provide a brief overview of some aspects of one or more embodiments of the present disclosure. Other applicable areas of the present disclosure will become apparent based on the specific embodiments provided below. This disclosure is not intended to be an exhaustive overview, nor is it intended to point out the key elements or important elements of this teaching, nor is it intended to define the scope of the present disclosure. On the contrary, its purpose is merely to present one or more concepts in a simplified form as a preface to the following specific embodiments.

[0004] Aspects of the present invention relate to oral care films and oral care compositions comprising such films. According to one aspect of the present invention, an oral care film for an oral care composition is provided, the oral care film comprising: from about 5% to about 19% by weight of oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a nonionic surfactant; and starch, wherein all weight percentages are based on the total weight of the oral care film.

[0005] According to another aspect of the present invention, there is provided an oral care film for an oral care composition, the oral care film comprising: oleanolic acid; a hydroxide; a polyol; a hydroxide; a polyol; and a nonionic surfactant, wherein the weight ratio of oleanolic acid to hydroxide of the oral care film is from about 90:1 to about 80:1, and the weight ratio of polyol to nonionic surfactant of the oral care film is from about 27:1 to about 18:1.

[0006] According to another aspect of the present invention, an oral care film for an oral care composition is provided, the oral care film comprising: from about 5 wt % to about 19 wt % oleanolic acid; a hydroxide; a glycol; a nonionic surfactant; from about 25 wt % to about 80 wt % cellulose; and from about 10 wt % to about 30 wt % corn starch, wherein all weight percentages are based on the total weight of the oral care film.

[0007] According to yet another aspect of the present invention, there is provided an oral care film for an oral care composition, the oral care film consisting of: oleanolic acid and / or its salt; hydroxide; polyol; nonionic surfactant; starch; optionally, a thickener; optionally, an opacifier; and optionally, a colorant.

[0008] According to another aspect of the present invention, a method for producing an oral care film is provided. The method generally comprises forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and a nonionic surfactant; and evaporating water from the aqueous solution to form an oral care film. DETAILED DESCRIPTION

[0009] For the purpose of illustration, the principle of the present invention is described by reference to a plurality of exemplary embodiments of the present invention. Although certain embodiments of the present invention are specifically described herein, it will be readily appreciated by those of ordinary skill in the art that the same principles are equally applicable to and can be used in other compositions and methods. Before describing the disclosed embodiments of the present invention in detail, it should be understood that the present invention is not limited to the details of any particular embodiment disclosed herein in its application. The terms used herein are for the purpose of description rather than limitation.

[0010] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context indicates otherwise. The singular form of any class of components refers not only to one chemical substance within that class, but also to mixtures of these chemical substances. The terms "a" (or "an"), "one / kind or more / kind," and "at least one / kind" may be used interchangeably herein. The terms "comprising," "including," and "having" may be used interchangeably. The term "including" should be interpreted as "including, but not limited to." The term "including" should be interpreted as "including, but not limited to."

[0011] As used throughout, ranges are used as shorthand for describing each and every value within the range. Any value within a range can be selected as the endpoint of the range. Thus, a range of 1 to 5 specifically includes 1, 2, 3, 4, and 5, as well as subranges such as 2 to 5, 3 to 5, 2 to 3, 2 to 4, 1 to 4, etc.

[0012] When referring to a number, the term "about" means any number within 10% of that number. For example, the phrase "about 2 weight %" means a number between and including 1.8 weight % and 2.2 weight %.

[0013] All references cited herein are hereby incorporated by reference in their entirety. In the event of a conflict in a definition in the present disclosure and that in a cited reference, the present disclosure controls.

[0014] Unless otherwise indicated, the abbreviations and symbols used herein have their ordinary meanings. The abbreviation "wt%" means the percentage by weight relative to the oral care composition. The symbol "°" refers to degrees, such as temperature or angle. The symbols "h," "min," "mL," "nm," and "μm" refer to hours, minutes, milliliters, nanometers, and micrometers, respectively. When referring to a spectrometer or spectroscopy, the abbreviation "UV-VIS" means ultraviolet-visible. The abbreviation "rpm" means revolutions per minute.

[0015] When referring to chemical structures and names, the symbols "C", "H" and "O" refer to carbon, hydrogen and oxygen, respectively. The symbols "-", "=" and "≡" refer to a single bond, a double bond and a triple bond, respectively.

[0016] As used herein, "volatile" means having a flash point below about 100°C. As used herein, "non-volatile" means having a flash point above about 100°C.

[0017] Any member of a species list used to exemplify or define a genus may be mutually distinct from, overlap with, be a subset of, be equivalent to, be nearly identical to, or be identical to any other member of the species list. Furthermore, unless explicitly stated, for example when reciting Markush groups, a species list defining or exemplifying a genus is open-ended and gives the possibility that there may be other species that define or exemplify the genus as well as or better than any other species listed.

[0018] The phrase "a mixture thereof," "a combination thereof," or a combination of two or more thereof" does not require that the mixture include all of A, B, C, D, E, and F (although it may include all of A, B, C, D, E, and F). Rather, it means that a mixture may include any two or more of A, B, C, D, E, and F. In other words, it is equivalent to the phrase "one or more elements selected from A, B, C, D, E, F, and a mixture of any two or more of A, B, C, D, E, and F." . Similarly, the term "salts thereof" also relates to "salts thereof". Therefore, when the present disclosure refers to "an element selected from A, B, C, D, E, F, salts thereof, and mixtures thereof", it means that it may contain one or more of A, B, C, D and F, may contain one or more of the salts of A, B, C, D, E and F, or may contain a mixture of any two of the salts of A, B, C, D, E, F, the salts of A, B, C, D, E and F.

[0019] All components and elements affirmatively set forth in the present disclosure may be negatively excluded from the claims. In other words, the oral care films and / or oral care compositions of the present disclosure may be free of or substantially free of all components and elements affirmatively recited throughout the present disclosure. In some cases, the oral care films and / or oral care compositions of the present disclosure may be substantially free of unincidental amounts of ingredients or compounds described herein. An unincidental amount of an ingredient or compound is the amount of that ingredient or compound that is added to the oral care film and / or oral care composition alone. For example, the oral care film and / or oral care composition may be substantially free of unincidental amounts of an ingredient or compound, although such an ingredient or compound may be present as part of a raw material included in a blend of two or more compounds.

[0020] Some of the components of the different categories identified may overlap. In the event that there may be overlap and the oral care film and / or oral care composition contains two components (or the oral care film and / or oral care composition contains more than two overlapping components), the overlapping compounds do not represent more than one component. For example, certain compounds may be characterized as both a polyol and a sweetener. If a particular oral care film and / or oral care composition specifies both a polyol and a sweetener, xylitol will only be used as one of the polyols or the sweetener—not as both.

[0021] For readability purposes, chemical functional groups are presented in their adjective form; for each adjective, the word "group" is assumed. For example, the adjective "alkyl" without a noun following it should be read as "alkyl group."

[0022] Aspects of the present invention relate to oral care films and oral care compositions comprising such films. According to one aspect of the present invention, an oral care film for an oral care composition is provided, the oral care film comprising: from about 5% to about 19% by weight of oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a nonionic surfactant; and starch, wherein all weight percentages are based on the total weight of the oral care film.

[0023] According to another aspect of the present invention, there is provided an oral care film for an oral care composition, the oral care film comprising: oleanolic acid; a hydroxide; a polyol; a hydroxide; a polyol; and a nonionic surfactant, wherein the weight ratio of oleanolic acid to hydroxide of the oral care film is from about 90:1 to about 80:1, and the weight ratio of polyol to nonionic surfactant of the oral care film is from about 27:1 to about 18:1.

[0024] According to another aspect of the present invention, an oral care film for an oral care composition is provided, the oral care film comprising: from about 5 wt % to about 19 wt % oleanolic acid; a hydroxide; a glycol; a nonionic surfactant; from about 25 wt % to about 80 wt % cellulose; and from about 10 wt % to about 30 wt % corn starch, wherein all weight percentages are based on the total weight of the oral care film.

[0025] According to yet another aspect of the present invention, there is provided an oral care film for an oral care composition, the oral care film consisting of: oleanolic acid and / or its salt; hydroxide; polyol; nonionic surfactant; starch; optionally, a thickener; optionally, an opacifier; and optionally, a colorant.

[0026] According to another aspect of the present invention, a method for producing an oral care film is provided. The method generally comprises forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and a nonionic surfactant; and evaporating water from the aqueous solution to form an oral care film.

[0027] According to another aspect of the present invention, a method for producing an oral care film is provided. The method generally comprises forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and a nonionic surfactant; and evaporating water from the aqueous solution to form an oral care film.

[0028] The oral care film can be a solid film and / or a pseudo-solid film. Although the oral care film can be in the form of a single layer, in some embodiments, the oral care film is in the form of a multilayer oral care film, wherein at least two of the adjacent layers of the oral care film have different formulations.

[0029] The oral care film can be configured to have a smooth texture and be ductile. For example, the oral care film can be configured to have a roughness of about 0.1 μm to about 20 μm, for example as measured according to JIS-B-0601. For example, the roughness of the oral care composition can be about 0.1 μm to about 20 μm, about 0.1 μm to about 16 μm, about 0.1 μm to about 14 μm, about 0.1 μm to about 10 μm, about 0.1 μm to about 6 μm, about 0.1 μm to about 4 μm, about 0.1 μm to about 2 μm, about 0.1 μm to about 1 μm, about 0.1 μm to about 0.5 μm; about 1 μm to about 20 μm, about 1 μm to about 16 μm, about 1 μm to about 14 μm, about 1 μm to about 10 μm, about 1 μm to about 6 μm, about 1 μm to about 4 μm, about 1 μm to about 2 μm; about 2 μm to about 20 μm m, about 2 μm to about 16 μm, about 2 μm to about 14 μm, about 2 μm to about 10 μm, about 2 μm to about 6 μm; about 4 μm to about 20 μm, about 4 μm to about 16 μm, about 4 μm to about 14 μm, about 4 μm to about 10 μm, about 4 μm to about 8 μm; about 8 μm to about 20 μm, about 8 μm to about 16 μm, about 8 μm to about 14 μm, about 8 μm to about 12 μm; about 10 μm to about 20 μm, about 10 μm to about 16 μm, about 10 μm to about 14 μm; about 14 μm to about 20 μm, about 14 μm to about 17 μm, or any range or sub-range thereof.

[0030] In certain embodiments, the oral care film is configured to dissolve within about 2 minutes of brushing teeth with an oral care composition comprising the oral care film. For example, the oral care film can dissolve within about 1.7 minutes, about 1.4 minutes, about 1.1 minutes, about 0.9 minutes, about 0.7 minutes, about 0.5 minutes, or about 0.3 minutes of starting brushing teeth with an oral care composition comprising the oral care film. In some embodiments, the oral care film dissolves within about 3 minutes, about 2.5 minutes, about 2 minutes, about 0.7 minutes, about 0.5 minutes, or about 0.3 minutes of immersion in water without stirring.

[0031] The formulation of the oral care film can include or exclude suitable components and / or ingredients, such as those listed below, depending on the specific combination of other components, the characteristics of the oral care film, and / or the use of the oral care film.

[0032] The oral care film typically contains oleanolic acid and / or its salts. Oleanolic acid (3β-hydroxy-oleanolic-12-ene-28-acid) is a pentacyclic triterpenoid compound that can be obtained from plants. For example, oleanolic acid can be extracted from many medicinal plants such as marigold (marigold), Ligustrum lucidum (Oleaceae) and Chinese snow calendula. In some embodiments, oleanolic acid and / or its salts are incorporated into the oral care film in the form of a salt. In other embodiments, oleanolic acid and / or its salts are incorporated into the oral care film in the form of oleanolic acid.

[0033] The amount of oleanolic acid and / or its salt present in the oral care film can be from about 5 wt % to about 19 wt %, based on the total weight of the oral care film. For example, the oral care film can include oleanolic acid and / or its salt in the following amounts, based on the total weight of the oral care film: from about 5 wt % to about 17 wt %, from about 5 wt % to about 15 wt %, from about 5 wt % to about 13 wt %, from about 5 wt % to about 11 wt %, from about 5 wt % to about 9 wt %; from about 7 wt % to about 19 wt %, from about 7 wt % to about 17 wt %, from about 7 wt % to about 15 wt %, from about 7 wt % to about 13 wt %, from about 7 wt % to about 11 wt %, from about 7 wt % to about 9 wt %; % to about 17 wt %, about 9 wt % to about 15 wt %, about 9 wt % to about 13 wt %, about 9 wt % to about 11 wt %; about 11 wt % to about 19 wt %, about 11 wt % to about 17 wt %, about 11 wt % to about 15 wt %, about 11 wt % to about 13 wt %; about 13 wt % to about 19 wt %, about 13 wt % to about 17 wt %, about 13 wt % to about 15 wt %; about 15 wt % to about 19 wt %, about 15 wt % to about 17 wt %, about 17 wt % to about 19 wt %, or any range or sub-range thereof.

[0034] The oral care film typically includes the hydroxide in an amount that can vary, but in some cases is from about 0.05% to about 2% by weight, based on the total weight of the oral care film. For example, the hydroxide can be present in an amount of from about 0.05% to about 1.6% by weight, from about 0.05% to about 1.2% by weight, from about 0.05% to about 1% by weight, from about 0.05% to about 0.8% by weight, from about 0.05% to about 0.7% by weight, from about 0.05% to about 0.6% by weight, from about 0.05% to about 0.5% by weight, from about 0.05% to about 0.4% by weight, from about 0.05% to about 0.2% by weight, from about 0.05% to about 0.1% by weight; from about 0.1% to about 0.6% by weight, from about 0.05% to about 0.5% by weight, from about 0.05% to about 0.4% by weight, from about 0.05% to about 0.2% by weight, from about 0.05% to about 0.1% by weight; about 1.6 wt %, about 0.1 wt % to about 1.2 wt %, about 0.1 wt % to about 1 wt %, about 0.1 wt % to about 0.8 wt %, about 0.1 wt % to about 0.7 wt %, about 0.1 wt % to about 0.6 wt %, about 0.1 wt % to about 0.5 wt %, about 0.1 wt % to about 0.4 wt %; about 0.3 wt % to about 2 wt %, about 0.3 wt % to about 1.6 wt %, about 0.3 wt % to about 1.2 wt %, about 0.3 wt % to about 1 wt %, about 0.3 wt % to about 0.8 wt %, about 0.3 wt % to about 0. 7 wt %, about 0.3 wt % to about 0.6 wt %; about 0.5 wt % to about 2 wt %, about 0.5 wt % to about 1.6 wt %, about 0.5 wt % to about 1.2 wt %, about 0.5 wt % to about 1 wt %, about 0.5 wt % to about 0.8 wt %, about 0.5 wt % to about 0.7 wt %; about 0.6 wt % to about 2 wt %, about 0.6 wt % to about 1.6 wt %, about 0.6 wt % to about 1.2 wt %, about 0.6 wt % to about 1 wt %, about 0.6 wt % to about 0.8 wt %; about 0.7 wt % to about 2 wt %, about 0 .7 wt % to about 1.6 wt %, about 0.7 wt % to about 1.2 wt %, about 0.7 wt % to about 1 wt %; about 0.9 wt % to about 2 wt %, about 0.9 wt % to about 1.6 wt %, about 0.9 wt % to about 1.2 wt %; about 1.1 wt % to about 2 wt %, about 1.1 wt % to about 1.6 wt %, about 1.1 wt % to about 1.3 wt %; about 1.4 wt % to about 2 wt %, about 1.4 wt % to about 1.8 wt %, about 1.4 wt % to about 1.6 wt %, about 1.7 wt % to about 2 wt %, or ranges or sub-ranges thereof.

[0035] The hydroxide can be selected from alkali metal hydroxides, such as sodium hydroxide and potassium hydroxide. Non-limiting examples of hydroxides include sodium hydroxide, potassium hydroxide, calcium hydroxide, ammonium hydroxide, magnesium hydroxide, or a combination of two or more thereof. In certain embodiments, the hydroxide is selected from sodium hydroxide, potassium hydroxide, calcium hydroxide, or a combination thereof.

[0036] The oral care film typically comprises the polyol, for example, in an amount that can vary from about 4 weight percent to about 25 weight percent, based on the total weight of the oral care film. In some cases, the polyol is present in the oral care film in the following amounts, based on the total weight of the oral care film: from about 4 wt % to about 25 wt %, from about 4 wt % to about 21 wt %, from about 4 wt % to about 19 wt %, from about 4 wt % to about 17 wt %, from about 4 wt % to about 15 wt %, from about 4 wt % to about 13 wt %, from about 4 wt % to about 11 wt %, from about 4 wt % to about 9 wt %; from about 6 wt % to about 25 wt %, from about 6 wt % to about 21 wt %, from about 6 wt % to about 19 wt %, from about 6 wt % to about 17 wt %, from about 6 wt % to about 15 wt %, from about 6 wt % to about 13 wt %, from about 6 wt % to about 11 wt %, from about 6 wt % to about 9 wt %; from about 8 wt % to about 25 wt %, from about 8 wt % to about 21 wt %, from about 8 wt % to about 19 wt %, from about 8 wt % to about 17 wt %. % to about 19 wt %, about 10 wt % to about 17 wt %, about 10 wt % to about 15 wt %, about 10 wt % to about 13 wt %; about 12 wt % to about 25 wt %, about 12 wt % to about 21 wt %, about 12 wt % to about 19 wt %, about 12 wt % to about 17 wt %, about 12 wt % to about 15 wt %; about 15 wt % to about 25 wt %, about 15 wt % to about 21 wt %, about 15 wt % to about 19 wt %, about 15 wt % to about 17 wt %; about 18 wt % to about 25 wt %, about 18 wt % to about 21 wt %, or any range or sub-range thereof.

[0037] In at least one embodiment, the polyol is present in the oral care film in an amount of about 10% to about 40% by weight, about 10% to about 35% by weight, about 10% to about 30% by weight, about 10% to about 25% by weight, about 10% to about 20% by weight; about 15% to about 45% by weight, about 15% to about 40% by weight, about 15% to about 35% by weight, about 15% to about 30% by weight, about 15% to about 25% by weight; about 18% to about 45% by weight, about 18% to about 40% by weight, about 18% to about 35% by weight, about 18% to about 30% by weight, about 18% to about 25% by weight; about 21% to about 45% by weight, about 21% to about 40% by weight, about 21% to about 35% by weight, about 21% to about % to about 32 weight %, about 21 weight % to about 29 weight %, about 21 weight % to about 26 weight %, about 24 weight % to about 45 weight %, about 24 weight % to about 40 weight %, about 24 weight % to about 35 weight %, about 24 weight % to about 32 weight %, about 24 weight % to about 29 weight %; about 27 weight % to about 45 weight %, about 27 weight % to about 40 weight %, about 27 weight % to about 35 weight %, about 27 weight % to about 32 weight %; about 30 weight % to about 45 weight %, about 30 weight % to about 40 weight %, about 30 weight % to about 35 weight %, about 30 weight % to about 33 weight %; about 34 weight % to about 45 weight %, about 34 weight % to about 40 weight %, about 34 weight % to about 38 weight %; about 38 weight % to about 45 weight %, about 38 weight % to about 42 weight %, or any range or sub-range thereof.

[0038] The polyol may be selected from a diol or a compound having multiple hydroxyl groups, such as glycerol. One or more polyols may be liquid at ambient temperature (25°C). The polyol may be a humectant. In some cases, the oral care film comprises one or more selected from C2-C 32The polyol of the polyol. The one or more polyols can have 2 to 32 carbon atoms, 3 to 16 carbon atoms, or 3 to 12 carbon atoms. For example, the oral care film can include ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerol, diglycerol, diethylene glycol, and dipropylene glycol, or a combination of two or more thereof. Additional non-limiting examples of polyols that can be optionally included in the oral care include and / or can be selected from alkanediols such as glycerol, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentanediol, hexanediol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-butene-1,4-diol, 2-ethyl-1,3-hexanediol, 2-methyl-2,4-pentanediol, octanediol, 1,2-hexanediol, 1,2-pentanediol, and 4-methyl-1,2-pentanediol; glycol ethers such as ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, and 1,2-hexanediol; 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 monoisopropyl ether, diethylene glycol monoisopropyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-tert-butyl ether, diethylene glycol mono-tert-butyl ether, 1-methyl-1-methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-tert-butyl ether, propylene glycol mono-n-propyl ether, propylene glycol monoisopropyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol monoisopropyl ether, sorbitol, sorbitan, glyceryl triacetate, and mixtures thereof.

[0039] In certain embodiments, the polyol is composed of one or more diols. The diol can be selected from propylene glycol, ethylene glycol, butylene glycol, octanediol, or a combination of two or more thereof.

[0040] In addition, the oral care film typically includes one or more surfactants. Based on the total weight of the oral care film, the total amount of surfactant present in the oral care film can be from about 0.1 wt % to about 5 wt %. For example, based on the total weight of the oral care film, the oral care film can include the following total amounts of surfactants: from about 0.1 wt % to about 5 wt %, from about 0.1 wt % to about 4 wt %, from about 0.1 wt % to about 3 wt %, from about 0.1 wt % to about 2 wt %, from about 0.1 wt % to about 1 wt %, from about 0.1 wt % to about 0.75 wt %, from about 0.1 wt % to about 0.5 wt %; from about 0.25 wt % to about 5 wt %, from about 0.25 wt % to about 4 wt %, from about 0.25 wt % to about 3 wt %, from about 0.25 wt % to about 2 wt %, from about 0.25 wt % to about 1 wt %, from about 0.25 wt % to about 0.75 wt %, from about 0.1 wt % to about 0.5 wt %; % to about 4 wt %, about 0.5 wt % to about 3 wt %, about 0.5 wt % to about 2 wt %, about 0.5 wt % to about 1 wt %, about 0.5 wt % to about 0.75 wt %; about 0.75 wt % to about 5 wt %, about 0.75 wt % to about 4 wt %, about 0.75 wt % to about 3 wt %, about 0.75 wt % to about 2 wt %, about 0.75 wt % to about 1 wt %; about 1 wt % to about 5 wt %, about 1 wt % to about 4 wt %, about 1 wt % to about 3 wt %, about 1 wt % to about 2 wt %, or any range or sub-range thereof.

[0041] In at least one embodiment, the oral care film can include the following total amounts of surfactant, based on the total weight of the oral care film: from about 2 wt% to about 10 wt%, from about 2 wt% to about 8 wt%, from about 2 wt% to about 7 wt%, from about 2 wt% to about 6 wt%, from about 2 wt% to about 5 wt%, from about 2 wt% to about 4 wt%; from about 4 wt% to about 12 wt%, from about 4 wt% to about 10 wt%, from about 4 wt% to about 8 wt%, from about 4 wt% to about 7 wt%, from about 4 wt% to about 6 wt%, from about 2 wt% to about 5 wt%, from about 2 wt% to about 4 wt%; % to about 5 weight %; about 5 weight % to about 12 weight %, about 5 weight % to about 10 weight %, about 5 weight % to about 8 weight %, about 5 weight % to about 7 weight %, about 5 weight % to about 6 weight %; about 6 weight % to about 12 weight %, about 6 weight % to about 10 weight %, about 6 weight % to about 8 weight %; about 7 weight % to about 12 weight %, about 7 weight % to about 10 weight %, about 7 weight % to about 9 weight %; about 9 weight % to about 12 weight %, about 9 weight % to about 11 weight %, or any range or sub-range thereof.

[0042] One or more surfactants can be selected from anionic surfactants, amphoteric surfactants, nonionic surfactants or a combination of two or more thereof. One or more surfactants preferably include at least one nonionic surfactant. In certain embodiments, the oral care film does not contain a surfactant other than a nonionic surfactant. One or more nonionic surfactants can be selected from sorbitan surfactants, poloxamers, fatty alcohol ethoxylates, alkylphenol ethoxylates, tertiary amine oxides, tertiary phosphine oxides, dialkyl sulfoxides, glucosides and / or compounds produced by condensation of alkylene oxide groups (hydrophilic in nature) with organic hydrophobic compounds (which can be aliphatic or alkyl aromatic in nature).

[0043] The sorbitan surfactant may be an alkoxylate and / or ethoxylated. In some embodiments, the oral care film comprises one or more sorbitan surfactants, such as those selected from the group consisting of ethoxylated sorbitan surfactants, polyoxyethylene esters, polyoxyethylene sugar alcohols, and anhydrosugar alcohol esters, or a combination of two or more thereof. In certain embodiments, the oral care film may comprise, or in some cases exclude, one or more of polysorbate 80, polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65, polysorbate 81, or polysorbate 85. For example, in certain embodiments, the sorbitan surfactant may comprise, or consist of, polysorbate 80 and / or polysorbate 20.

[0044] Examples of glucoside surfactants include decyl glucoside, stearyl glucoside, lauryl glucoside, cocoyl glucoside, cetearyl glucoside, decyl lauryl glucoside, lauroyl ethyl glucoside, myristoyl ethyl glucoside, oleoyl ethyl glucoside, or a combination of two or more thereof. The poloxamer may be poloxamer 407, poloxamer 188, or a combination thereof. Other nonionic surfactants worth mentioning include fatty alcohol ethoxylates, alcohol ethoxylates (AEO or AE), carboxylated alcohol ethoxylates, nonylphenol ethoxylates, and alkylphenol ethoxylates.

[0045] Other examples of nonionic surfactants include polyethylene oxide condensates of alkylphenols; products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylenediamine; ethylene oxide condensates of aliphatic alcohols, acids and esters; long-chain tertiary amine oxides; long-chain tertiary phosphine oxides; long-chain dialkyl sulfoxides; and mixtures of such substances. Other examples of nonionic surfactants include polyoxyethylene, polyoxyethylene sorbitan esters, polyoxyethylene 40 hydrogenated castor oil, fatty alcohol ethoxylates, polyethylene oxide condensates of alkylphenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylenediamine, ethylene oxide condensates of aliphatic alcohols, long-chain tertiary amine oxides, long-chain tertiary phosphine oxides, long-chain dialkyl sulfoxides, or a combination of two or more thereof. In some cases, the nonionic surfactant comprises an amine oxide, a fatty acid amide, an ethoxylated fatty alcohol, a block copolymer of polyethylene glycol and polypropylene glycol, a glycerol alkyl ester, a polyoxyethylene glycol octylphenol ether, a sorbitan alkyl ester, a polyoxyethylene glycol sorbitan alkyl ester, or a combination of two or more thereof. In some embodiments, the oral care film may not contain one or more of the above nonionic surfactants.

[0046] In at least one preferred embodiment, the nonionic surfactant is the only surfactant present in the oral care film, wherein the nonionic surfactant can be selected from sorbitan surfactants (e.g., polysorbate 80). In at least one embodiment, polysorbate 80 is the only surfactant present in the oral care film.

[0047] The oral care film may comprise one or more anionic surfactants, wherein the anionic surfactants are comprised of non-sulfate-based anionic surfactants. Preferably, the oral care film has a reduced amount of sodium lauryl sulfate and / or sodium lauryl ether sulfate. For example, the amount of sodium lauryl sulfate and / or sodium lauryl ether sulfate present in the oral care film may be about 5 wt % or less, 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 total weight of the oral care film. In some embodiments, the oral care film is substantially free of or free of sodium lauryl sulfate and / or sodium lauryl ether sulfate.

[0048] Additionally, the oral care film can include a reduced amount of sulfate-based anionic surfactants. The amount of sulfate-based anionic surfactants present in the oral care film can be about 5 wt % or less, 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 total weight of the oral care film. In some embodiments, the oral care film is substantially free of or free of sulfate-based anionic surfactants.

[0049] Oral care film may include or in some embodiments do not include one or more amphoteric surfactants, such as those with substituents containing 8 to 18 carbon atoms and substituents containing one or more carboxylates, sulfonates, sulfates, phosphates or phosphonates. Examples of amphoteric surfactants include those with alkyl groups containing 8 to 20 carbon atoms, 8 to 16 carbon atoms, 10 to 16 carbon atoms or 10 to 13 carbon atoms. Amphoteric surfactants may include but are not limited to derivatives of aliphatic secondary amines and tertiary amines wherein the aliphatic group can be straight or branched. In some cases, one of the aliphatic substituents of the amphoteric surfactant contains about 8 to about 18 carbon atoms and one of the aliphatic substituents contains an anionic water solubilizing group, such as carboxyl, sulfonate, sulfate, phosphate or phosphonate. Amphoteric surfactants disclosed herein may be present in the oral care film in the form of salts.

[0050] The amphoteric surfactant can be selected from alkyl amphopropionates, betaines, alkyl sulfobetaines, alkyl amphoacetates or a combination of two or more thereof. In some cases, the amphoteric surfactant is selected from betaine surfactants. Examples of betaine surfactants include, for example, alkyl betaines, such as cocodimethyl carboxymethyl betaine, lauryl dimethyl carboxymethyl betaine, lauryl dimethyl α-carboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl) carboxymethyl betaine, stearyl bis-(2-hydroxypropyl) carboxymethyl betaine, oleyl dimethyl γ-carboxypropyl betaine, lauryl bis-(2-hydroxypropyl) α-carboxyethyl betaine. In some embodiments, the oral care film may not include one or more of the above-mentioned amphoteric surfactants.

[0051] The oral care film can be configured to have a weight ratio of oleanolic acid to hydroxide of about 105:1 to about 65:1. In some preferred embodiments, the weight ratio of oleanolic acid to hydroxide is about 105:1 to about 65:1, about 100:1 to about 65:1, about 95:1 to about 65:1, about 90:1 to about 65:1, about 86:1 to about 65:1, about 82:1 to about 65:1, about 78:1 to about 65:1, about 72:1 to about 65:1, about 70:1 to about 65:1; about 105:1 to about 70:1, about 100:1 to about 70:1, about 95:1 to about 70:1, about 90:1 to about 70:1, about 86:1 to about 70:1, about 82:1 to about 70:1, about 78:1 to about 70:1, about 75:1 to about 70:1; about 105:1 to about 75:1, about 100:1 to about 75:1, about 95:1 to about 75:1, about 90:1 to about 75:1 , about 86:1 to about 75:1, about 82:1 to about 75:1, about 78:1 to about 75:1; about 105:1 to about 80:1, about 100:1 to about 80:1, about 95:1 to about 80:1, about 90:1 to about 80:1, about 86:1 to about 80:1; about 105:1 to about 83:1, about 100:1 to about 83:1, about 95:1 to about 83:1, about 90:1 to about 80:1 1 to about 83:1, about 86:1 to about 83:1; about 105:1 to about 86:1, about 100:1 to about 86:1, about 95:1 to about 86:1, about 90:1 to about 86:1, about 86:1 to about 86:1, about 82:1 to about 86:1, about 78:1 to about 86:1, about 72:1 to about 86:1, about 70:1 to about 86:1, or any range or subrange thereof.

[0052] Additionally or alternatively, the oral care film can be formulated to have a weight ratio of polyol to nonionic surfactant of from about 29: 1 to about 16: 1. For example, in some preferred embodiments, the weight ratio of polyol to nonionic surfactant is from about 26: 1 to about 16: 1, from about 26: 1 to about 18: 1, from about 26: 1 to about 20: 1, from about 26: 1 to about 22: 1, from about 26: 1 to about 24: 1; from about 23: 1 to about 16: 1, from about 23: 1 to about 18: 1, from about 23: 1 to about 20: 1; from about 21: 1 to about 16: 1, from about 21: 1 to about 18: 1, from about 21: 1 to about 20: 1, from about 19: 1 to about 16: 1, or any range or sub-range thereof.

[0053] The oral care film can be specifically formulated to have a weight ratio of oleanolic acid to the total amount of polyol and nonionic surfactant of about 4:1 to about 1:3. For example, the oral care film can have a weight ratio of oleanolic acid to the total amount of polyol and nonionic surfactant of about 4:1 to about 1:3, about 3:1 to about 1:3, about 2:1 to about 1:3, about 1:1 to about 1:3; about 4:1 to about 1:2, about 3:1 to about 1:2, about 2:1 to about 1:2, about 1:1 to about 1:2; about 4:1 to about 1:1, about 3:1 to about 1:1, about 2:1 to about 1:1, or any range or sub-range thereof.

[0054] The oral care film can also include starch, for example, in an amount of about 10% to about 30% by weight, based on the total weight of the oral care film. In some cases, the oral care film includes starch in the following amounts, based on the total weight of the oral care composition: about 10% to about 27%, about 10% to about 24%, about 10% to about 21%, about 10% to about 19%, about 10% to about 17%, about 10% to about 15%; about 13% to about 30%, about 13% to about 27%, about 13% to about 24%, about 13% to about 21%, about 13% to about 19%, about 13% to about 17%; about 16% to about 30%, about 1 % to about 27 wt %, about 16 wt % to about 24 wt %, about 16 wt % to about 21 wt %, about 16 wt % to about 19 wt %; about 18 wt % to about 30 wt %, about 18 wt % to about 27 wt %, about 18 wt % to about 24 wt %, about 18 wt % to about 21 wt %, about 18 wt % to about 19 wt %; about 20 wt % to about 30 wt %, about 20 wt % to about 27 wt %, about 20 wt % to about 24 wt %; about 22 wt % to about 30 wt %, about 22 wt % to about 27 wt %, about 22 wt % to about 25 wt %, or any range or sub-range thereof.

[0055] Cold water swellable physically modified pregelatinized starch is particularly useful as a texture modifier to increase the hardness of oral care films. In certain embodiments, the starch can be prepared by cooking the starch in the presence of water and, optionally, an organic solvent at a temperature not exceeding 10° C. above the gelatinization temperature. After cooking the starch, the resulting starch can then be dried to obtain the final starch component.

[0056] In some embodiments, the starch is a pregelatinized stable cross-linked waxy corn starch. In its dry form, the pregelatinized starch may have an average flake size of no greater than 180 microns, with 85% of the flakes being less than 75 microns. The bulk density of the pregelatinized starch may be about 20 pounds per square foot.3 About 70 lbs / ft 3 , about 30 lb / ft 3 About 60 lbs / ft 3 , about 30 lb / ft 3 About 55 lbs / ft 3 , about 35 lb / ft 3 About 55 lbs / ft 3 , about 40 lb / ft 3 About 55 lbs / ft 3 , about 35 lb / ft 3 About 50 lbs / ft 3 , about 40 lb / ft 3 About 50 lbs / ft 3 , about 42 lb / ft 3 About 48 lbs / ft 3 , or about 44 lb / ft 3 .

[0057] Additionally or alternatively, the oral care film can include one or more thickening agents, for example, in an amount from about 25% to about 80% by weight, based on the total weight of the oral care film. For example, the oral care film can include a total amount of thickening agent from about 25% to about 80% by weight, from about 25% to about 75% by weight, from about 25% to about 70% by weight, from about 25% to about 66% by weight, from about 25% to about 63% by weight, from about 25% to about 60% by weight, from about 25% to about 57% by weight, from about 25% to about 54% by weight, from about 25% to about 51% by weight, from about 25% to about 46% by weight, from about 25% to about 41% by weight, from about 30% to about 80% by weight, from about 30% to about 75% by weight, from about 30% to about 70% by weight, based on the total weight of the oral care film. %, about 30 wt % to about 66 wt %, about 30 wt % to about 63 wt %, about 30 wt % to about 60 wt %, about 30 wt % to about 57 wt %, about 30 wt % to about 54 wt %, about 30 wt % to about 51 wt %, about 30 wt % to about 46 wt %, about 30 wt % to about 41 wt %; about 35 wt % to about 80 wt %, about 35 wt % to about 75 wt %, about 35 wt % to about 70 wt %, about 35 wt % to about 66 wt %, about 35 wt % to about 63 wt %, about 35 wt % to about 60 wt %, about 35 wt % to about 57 wt %, about 35 wt % to about 54 wt %, about 35 wt % to about % to about 51 wt %, about 35 wt % to about 46 wt %; about 40 wt % to about 80 wt %, about 40 wt % to about 75 wt %, about 40 wt % to about 70 wt %, about 40 wt % to about 66 wt %, about 40 wt % to about 63 wt %, about 40 wt % to about 60 wt %, about 40 wt % to about 57 wt %, about 40 wt % to about 54 wt %, about 40 wt % to about 51 wt %; about 45 wt % to about 80 wt %, about 45 wt % to about 75 wt %, about 45 wt % to about 70 wt %, about 45 wt % to about 66 wt %, about 45 wt % to about 63 wt %, about 45 wt % to about 6 0 wt %, about 45 wt % to about 57 wt %, about 45 wt % to about 54 wt %; about 48 wt % to about 80 wt %, about 48 wt % to about 75 wt %, about 48 wt % to about 70 wt %, about 48 wt % to about 66 wt %, about 48 wt % to about 63 wt %, about 48 wt % to about 60 wt %, about 48 wt % to about 57 wt %; about 51 wt % to about 80 wt %, about 51 wt % to about 75 wt %, about 51 wt % to about 70 wt %, about 51 wt % to about 66 wt %; about 54 wt % to about 80 wt %, about 54 wt % to about 75 wt %, about 54 wt % to about 70 wt %;From about 57% to about 80% by weight, from about 57% to about 75% by weight, from about 57% to about 70% by weight, from about 57% to about 66% by weight, from about 57% to about 63% by weight; from about 60% to about 80% by weight, from about 60% to about 75% by weight, from about 60% to about 70% by weight, from about 60% to about 66% by weight; from about 63% to about 80% by weight, from about 63% to about 75% by weight, from about 68% to about 80% by weight, from about 68% to about 75% by weight, or any range or sub-range thereof.

[0058] Preferably, one or more thickeners include cellulose. In certain embodiments, the oral care film includes at least two celluloses. The thickener may be composed of one or more celluloses, or in certain embodiments, of at least two celluloses. Non-limiting examples of cellulose include hydroxyalkyl celluloses, such as hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxyethyl propyl cellulose, hydroxybutyl methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, carboxymethyl hydroxyethyl cellulose, hydroxypropyl methylcellulose, and methyl hydroxyethyl cellulose. Microcrystalline cellulose is another cellulose worth mentioning. The cellulose polymer may be a low-viscosity hydroxypropyl methylcellulose polymer (HPMC). In some embodiments, HPMC preferably has a viscosity in the range of about 1 millipascal second (mPa·s) to about 40 millipascal seconds, as determined using an Ubbelohde viscometer at a temperature of 20°C with a 2 wt % HPMC aqueous solution. In some cases, HPMC has a viscosity of about 3 mPa·s to about 20 mPa·s at 20°C.

[0059] In at least one embodiment, the HPMC is a low viscosity HPMC having about 29.1% methoxy and about 9% hydroxypropyl substitutions and, for example, a viscosity of about 5.1 mPa·s at a temperature of 20° C. (as measured as a 2 wt % aqueous solution using an Ubbelohde viscometer). In another embodiment, the oral care film comprises an HPMC having a viscosity of 40 to 60 cps (e.g., HPMC E50).

[0060] Additional thickeners that may or may not be included in the oral care film include polysaccharides, acrylates, thickening polymers, or combinations of two or more thereof. Examples of additional polysaccharides include cellulose acetate propionate carboxylate, sodium cellulose sulfate, carrageenan, or combinations of two or more thereof. Natural gums such as xanthan gum, karaya gum, gum arabic, and tragacanth gum may also be incorporated.

[0061] In certain embodiments, the oral care film may comprise a salt. The salt may be an alkali metal and / or alkaline earth metal salt. For example, the oral care composition may comprise a salt selected from the group consisting of sodium chloride, potassium chloride, sodium bromide, sodium iodide, sodium hypochlorite, sodium chlorate, sodium perchlorate, sodium bromate, sodium iodate, sodium nitrate, sodium sulfate, sodium thiosulfate, or a combination thereof. In at least one embodiment, the oral care composition comprises a salt selected from the group consisting of sodium chloride, potassium chloride, sodium bromide, or a combination thereof.

[0062] The salt (e.g., a salt of an alkali metal and / or an alkaline earth metal) can be present in an amount from about 0.2% to about 4% by weight, based on the total weight of the oral care film. In some cases, the salt can be present in an amount from about 0.2% to about 4% by weight, from about 0.2% to about 3% by weight, from about 0.2% to about 2% by weight, from about 0.2% to about 1% by weight, from about 0.2% to about 0.75% by weight, from about 0.2% to about 0.5% by weight; from about 0.5% to about 5% by weight, from about 0.5% to about 4% by weight, from about 0.5% to about 3% by weight, from about 0.2% to about 2% by weight, from about 0.2% to about 1% by weight, from about 0.2% to about 0.75% by weight, from about 0.2% to about 0.5% by weight; From about 1 weight % to about 1.5 weight %; from about 1.5 weight % to about 4 weight %, from about 1.5 weight % to about 3 weight %, from about 1.5 weight % to about 2 weight %; from about 2 weight % to about 4 weight %, from about 2 weight % to about 3 weight %; from about 2.5 weight % to about 4 weight %, from about 2.5 weight % to about 3.5 weight %, or any range or sub-range thereof.

[0063] In some cases, the oral care film may include one or more opacifiers and / or one or more colorants. The opacifier may be present in an amount of about 10 wt % to about 30 wt %, based on the total weight of the oral care film. For example, the oral care film may include the following total amounts of opacifiers: about 10 wt % to about 27 wt %, about 10 wt % to about 24 wt %, about 10 wt % to about 21 wt %, about 10 wt % to about 19 wt %, about 10 wt % to about 17 wt %, about 10 wt % to about 15 wt %; about 13 wt % to about 30 wt %, about 13 wt % to about 27 wt %, about 13 wt % to about 24 wt %, about 13 wt % to about 21 wt %, about 13 wt % to about 19 wt %, about 13 wt % to about 17 wt %; about 16 wt % to about 30 wt %, about 16 % to about 27 wt %, about 16 wt % to about 24 wt %, about 16 wt % to about 21 wt %, about 16 wt % to about 19 wt %; about 18 wt % to about 30 wt %, about 18 wt % to about 27 wt %, about 18 wt % to about 24 wt %, about 18 wt % to about 21 wt %, about 18 wt % to about 19 wt %; about 20 wt % to about 30 wt %, about 20 wt % to about 27 wt %, about 20 wt % to about 24 wt %; about 22 wt % to about 30 wt %, about 22 wt % to about 27 wt %, about 22 wt % to about 25 wt %, or any range or subrange thereof.

[0064] Sunscreens can include one or more stannous oxides, tin oxides, titanium oxides, iron oxides, zinc oxides, kaolin, mica, or a combination of two or more thereof. The iron oxide can be selected from yellow iron oxide, red iron oxide, and / or iron (II, III) oxide. In at least one preferred embodiment, the sunscreen comprises or consists of tin oxide. The oral care film can reduce the amount of titanium-based sunscreens, such as titanium dioxide. For example, the amount of titanium-based sunscreens present in the oral care film can be about 5% by weight or less, about 4% by weight or less, about 3% by weight or less, about 2% by weight or less, about 1% by weight or less, about 0.5% by weight or less, or about 0.1% by weight or less, based on the total weight of the oral care film. In some cases, the oral care film is substantially free of or free of titanium oxide and / or titanium-based sunscreens.

[0065] Additionally or alternatively, the oral care film can include one or more colorants in an amount ranging from about 1 wt % to about 3 wt %, based on the total weight of the oral care film. For example, the oral care film can include the following total amounts of opacifiers: from about 1 wt % to about 3 wt %, from about 1 wt % to about 2.5 wt %, from about 1 wt % to about 2 wt %, from about 1 wt % to about 1.5 wt %; from about 1.5 wt % to about 3 wt %, from about 1.5 wt % to about 2.5 wt %, from about 1.5 wt % to about 2 wt %; from about 2 wt % to about 3 wt %, from about 2 wt % to about 2.5 wt %, from about 2.5 wt % to about 3 wt %, or any range or subrange thereof, based on the total weight of the oral care film.

[0066] One or more coloring agents can comprise dyestuff, aluminum lake through certification or be derived from the pigment of natural origin.Coloring agent can be water-based, oil-based or dry.Coloring agent can be original pigment, pigment blend or discrete pigment mixture, for example five-color pigment (confetti).The limiting examples of dyestuff comprises the food dye and composition thereof that is applicable to food, medicine and cosmetic application.Some pigment reagents (coloring agent) are called as FD&C dyestuff.

[0067] According to another aspect of the present disclosure, a method for producing an oral care film (e.g., an oral care film disclosed herein) is provided. The method for producing an oral care film generally comprises forming a solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and a nonionic surfactant to form an aqueous solution. The solution may further comprise one or more of the ingredients / components described herein with respect to the oral care film.

[0068] Additionally, the method generally includes evaporating water from the aqueous solution to form the oral care film. For example, water can be removed from the aqueous solution by heating the slurry to a temperature of about 60° C. to about 85° C. until sufficient water is removed (e.g., in some cases, for about 5 to 20 minutes).

[0069] Aspects of the present invention also relate to oral care compositions, such as dentifrices, toothpastes, gels, and the like, comprising at least one oral care film disclosed herein. In some preferred embodiments, the oral care composition, in the absence of the oral care film, is translucent and / or transparent. As used herein, translucent refers to the property of an oral care composition that allows light to pass through, but does not necessarily allow fine objects to be discerned through a 1 cm thickness of the oral care composition. The term "transparent" with respect to the oral care compositions of the present disclosure means that the oral care composition has a visible light transmittance of at least 65%, for example, as measured using a Lambda 40 UV-Visible or Lambda 25 UV-Visible spectrometer. For example, the transmittance of the oral care composition at a wavelength of 600 nm can be at least 70%, at least 75%, at least 80%, at least 85%, at least 88%, at least 90%, or at least 95%, for example, as measured using a Lambda 40 UV-Visible spectrometer or a Lambda 25 UV-Visible spectrometer.

[0070] The oral care composition can be formulated such that a majority of the oleanolic acid is present in the oral care film. For example, the amount of oleanolic acid in the oral care composition, excluding the oleanolic acid present in the oral care film, can be about 3% by weight or less, about 2% by weight or less, about 1% by weight or less, about 0.5% by weight or less, about 0.1% by weight or less, or about 0.05% by weight or less. In some cases, the oral care composition is substantially free of or free of oleanolic acid, excluding the oleanolic acid present in the oral care film.

[0071] The oral care composition can include a fluoride ion source, a stannous source, a nitrate ion source, a phosphate source, an anticalculus agent, one or more surfactants, a zinc source, one or more polyols, one or more abrasives, one or more thickeners, and / or water. The oral care composition can optionally include a stannous ion source, for example, in an effective amount. The stannous ion source can be present in the oral care composition in an amount of about 0.1 wt % to about 5 wt %, based on the total weight of the oral care composition. For example, the amount of stannous ions present in the oral care composition can be from about 0.1% to about 4%, from about 0.1% to about 3%, from about 0.1% to about 2%, based on the total weight of the oral care composition; from about 0.3% to about 5%, from about 0.3% to about 4%, from about 0.3% to about 3%, from about 0.3% to about 2%, from about 0.6% to about 5%, from about 0.6% to about 4%, from about 0.6% to about 3%, from about 0.6% to about 2%, from about 0.9% to about 5%, from about 0.9% to about 4%, from about 0.9% to about 5 ... % to about 3 wt %; about 2 wt % to about 5 wt %, about 2 wt % to about 4 wt %, about 2 wt % to about 3 wt %; about 3 wt % to about 5 wt %, about 4 wt % to about 5 wt %, or any range or subrange thereof. In at least one embodiment, the oral care composition comprises from about 0.4 wt % to about 0.5 wt % of a stannous ion source, for example, about 0.45 wt % of a stannous ion source.

[0072] The stannous ion source can be selected from: 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 a combination of two or more thereof. The stannous source can include stannous fluoride, stannous chloride, stannous acetate, and a combination of two or more thereof. In at least one embodiment, the stannous ion source includes stannous fluoride.

[0073] The oral care composition may optionally include one or more nitrate ion sources. The nitrate ion source may be present in the oral care composition in an amount of from about 0.1 wt % to about 5 wt %, based on the total weight of the oral care composition. In some cases, the amount of nitrate ions present in the oral care composition may be from about 0.1 wt % to about 4 wt %, from about 0.1 wt % to about 3 wt %, from about 0.1 wt % to about 2 wt %; from about 0.3 wt % to about 5 wt %, from about 0.3 wt % to about 4 wt %, from about 0.3 wt % to about 3 wt %, from about 0.3 wt % to about 2 wt %; from about 0.6 wt % to about 5 wt %, from about 0.6 wt % to about 4 wt %, from about 0.6 wt % to about 3 wt %, from about 0.6 wt % to about 2 wt %; from about 0.9 wt % to about 5 wt %, from about % to about 4 wt %, about 2 wt % to about 3 wt %; about 3 wt % to about 5 wt %, about 4 wt % to about 5 wt %, about 0.9 wt % to about 2 wt %; about 1.2 wt % to about 5 wt %, about 1.2 wt % to about 4 wt %, about 1.2 wt % to about 3 wt %, about 1.2 wt % to about 2 wt %; about 1.5 wt % to about 5 wt %, about 1.5 wt % to about 4 wt %, about 1.5 wt % to about 3 wt %; about 2 wt % to about 5 wt %, about 2 wt % to about 4 wt %, about 2 wt % to about 3 wt %; about 3 wt % to about 5 wt %, about 4 wt % to about 5 wt %, or any range or subrange thereof.

[0074] One or more nitrate ion sources can be in the form of a salt or an ion derived therefrom, including, for example, a nitrate selected from an alkali metal or alkaline earth metal nitrate. Examples of nitrate ion sources include lithium nitrate, sodium nitrate, potassium nitrate, magnesium nitrate, calcium nitrate, zinc nitrate, silver nitrate, ammonium nitrate, or a combination of two or more thereof. In at least one embodiment, the nitrate ion source includes potassium nitrate.

[0075] The oral care composition may optionally include one or more phosphate ion sources. The phosphate ion source is preferably present in an effective amount. In some cases, the oral care composition may include one or more phosphate ion sources in an amount of about 0.1 wt % to about 7 wt %, based on the total weight of the oral care composition. For example, based on the total weight of the oral care composition, the one or more phosphate ion sources can be present in the oral care composition in the following amounts: from about 0.1 wt % to about 6 wt %, from about 0.1 wt % to about 5 wt %, from about 0.1 wt % to about 4 wt %, from about 0.1 wt % to about 3 wt %, from about 0.1 wt % to about 2 wt %, from about 0.1 wt % to about 1 wt %; from about 0.4 wt % to about 7 wt %, from about 0.4 wt % to about 6 wt %, from about 0.4 wt % to about 5 wt %, from about 0.4 wt % to about 4 wt %, from about 0.4 wt % to about 3 wt %, from about 0.4 wt % to about 2 wt %, from about 0.4 wt % to about 1 wt %; from about 0.8 wt % to about 7 wt %, from about 0.8 wt % to about 6 wt %, from about 0.8 wt % to about 1 wt %. % to about 5 weight %, about 0.8 weight % to about 4 weight %, about 0.8 weight % to about 3 weight %, about 0.8 weight % to about 2 weight %; about 1.4 weight % to about 7 weight %, about 1.4 weight % to about 6 weight %, about 1.4 weight % to about 5 weight %, about 1.4 weight % to about 4 weight %, about 1.4 weight % to about 3 weight %; about 2 weight % to about 7 weight %, about 2 weight % to about 6 weight %, about 2 weight % to about 5 weight %, about 2 weight % to about 4 weight %, about 2 weight % to about 3 weight %; about 3 weight % to about 7 weight %, about 3 weight % to about 6 weight %, about 3 weight % to about 5 weight %; about 4 weight % to about 7 weight %, about 4 weight % to about 6 weight %, about 5 weight % to about 7 weight %, or any range or subrange thereof.

[0076] The phosphate source can preferably include a soluble phosphate compound, such as phosphate. The phosphate source can be a phosphate ion source. Examples of phosphate ion sources include tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate (calcium pyrophosphate), p-calcium pyrophosphate (p-calciumpyrophosphate), tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate or a combination thereof. The phosphate source can be a pyrophosphate, such as an alkali metal pyrophosphate. In certain embodiments, the alkali metal pyrophosphate is selected from tetraalkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and a mixture thereof, wherein the alkali metal is sodium or potassium. For example, the phosphate source can include tetrasodium pyrophosphate (TSPP), tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate or a combination thereof of two or more. The phosphate source can be selected from orthophosphate, polymetaphosphate, pyrophosphate and a combination thereof of two or more. In some cases, the phosphate source comprises tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), or a combination thereof. In at least one embodiment, the phosphate source comprises tetrasodium pyrophosphate. The phosphate source, when in salt form, may be in a hydrated and / or unhydrated form.

[0077] Oral care compositions can optionally include one or more anticalculus agents. Examples of anticalculus agents include, but are not limited to, phosphates and polyphosphates, polyaminopropanesulfonic acid (AMPS), polyolefin sulfonates, polyolefin phosphates, diphosphonates such as azacycloalkane-2,2-diphosphonates (e.g., azacycloheptane-2,2-diphosphonic acid), N-methylazacyclopentane-2,3-diphosphonic acid, ethane-1-hydroxy-1,1-diphosphonic acid (EHDP) and ethane-1-amino-1,1-diphosphonates, phosphonoalkane carboxylic acid and. Useful inorganic phosphates and polyphosphates include sodium dihydrogen phosphate, disodium hydrogen phosphate, and trisodium phosphate. Soluble pyrophosphates such as those disclosed herein can be useful anticalculus agents. Pyrophosphate can be any one of alkali metal pyrophosphates.

[0078] The oral care composition can include an anticalculus agent in an amount of about 0.1% to about 7% by weight, based on the total weight of the oral care composition. For example, the anticalculus agent can be present in the oral care composition in the following amounts: from about 0.1% to about 6% by weight, from about 0.1% to about 5% by weight, from about 0.1% to about 4% by weight, from about 0.1% to about 3% by weight, from about 0.1% to about 2% by weight, from about 0.1% to about 1% by weight; from about 0.4% to about 7% by weight, from about 0.4% to about 6% by weight, from about 0.4% to about 5% by weight, from about 0.4% to about 4% by weight, from about 0.4% to about 3% by weight, from about 0.4% to about 2% by weight, from about 0.4% to about 1% by weight; from about 0.8% to about 7% by weight, from about 0.8% to about 6% by weight, from about 0.8% to about 5% by weight % to about 4 wt %, about 2 wt % to about 3 wt %; about 3 wt % to about 7 wt %, about 3 wt % to about 6 wt %, about 3 wt % to about 5 wt %; about 4 wt % to about 7 wt %, about 4 wt % to about 6 wt %, about 5 wt % to about 7 wt %, or any range or subrange thereof.

[0079] Oral care compositions can optionally include a zinc source. When present, the zinc ion source is preferably an effective amount. The zinc source can be a zinc ion source. Based on the gross weight of the oral care composition, the zinc source (e.g., a zinc ion source) can be present in the oral care composition in an amount of about 0.1 wt % to about 8 wt %. For example, based on the gross weight of the oral care composition, the amount of the zinc source (e.g., a zinc ion source) present in the oral care composition can be about 0.1 wt % to about 6 wt %, about 0.1 wt % to about 5 wt %, about 0.1 wt % to about 4 wt %, about 0.1 wt % to about 3 wt %, about 0.1 wt % to about 2 wt %, about 0.1 wt % to about 1 wt %; about 0.3 wt % to about 8 wt %, about 0.3 wt % to about 6 wt %, about 0.3 wt % to about 5 wt %, about 0.3 wt % to about 4 wt %, about 0.3 wt % to about 3 wt %, about 0.3 wt % to about 2 wt %; about 0.6 wt % to about 8 wt %, about 0.6 wt % to about 6 wt %, about 0.6 wt % to about 5 wt %, about 0.6 wt % to about 4 wt %, about 0.6 wt % to about 3 wt %, about 0.6 wt % to about 2 wt %; about 0.9 wt % to about 8 wt %, about 0.9 wt % to about 6 wt %, about 0.9 wt % to about 5 wt %, about 0 .9 wt % to about 4 wt %, about 0.9 wt % to about 3 wt %, about 0.9 wt % to about 2 wt %; about 1.2 wt % to about 8 wt %, about 1.2 wt % to about 6 wt %, about 1.2 wt % to about 5 wt %, about 1.2 wt % to about 4 wt %, about 1.2 wt % to about 3 wt %, about 1.2 wt % to about 2 wt %; about 1.5 wt % to about 8 wt %, about 1.5 wt % to about 6 wt %, about 1.5 wt % to about 5 wt %, about 1.5 % to about 4 wt %, about 1.5 wt % to about 3 wt %; about 2 wt % to about 8 wt %, about 2 wt % to about 6 wt %, about 2 wt % to about 5 wt %, about 2 wt % to about 4 wt %, about 2 wt % to about 3 wt %; about 3 wt % to about 8 wt %, about 3 wt % to about 6 wt %, about 3 wt % to about 5 wt %; about 4 wt % to about 8 wt %, about 4 wt % to about 6 wt %, about 4 wt % to about 5 wt %, or any range or subrange thereof.

[0080] The zinc source can be in the form of a salt. For example, the zinc source can include one or more zinc salts selected from the group consisting of zinc sulfate, zinc chloride, zinc acetate, zinc phenolsulfonate, zinc borate, zinc bromide, zinc nitrate, zinc glycerophosphate, zinc benzoate, zinc carbonate, zinc carnosine, zinc citrate, zinc hexafluorosilicate, zinc diacetate trihydrate, zinc oxide, zinc peroxide, zinc salicylate, zinc silicate, zinc stannate, zinc tannate, zinc titanate, zinc tetrafluoroborate, zinc gluconate, zinc lactate, zinc glycinate, zinc phosphate, and a combination of two or more thereof. In some embodiments, the zinc source is selected from the group consisting of zinc citrate, zinc oxide, zinc phosphate, zinc lactate, zinc sulfate, zinc silicate, zinc gluconate, and a combination of two or more thereof.

[0081] The oral care composition can optionally include one or more surfactants, for example, in an amount ranging from about 0.5 weight % to about 8 weight % based on the total weight of the oral care composition. For example, the oral care composition can include one or more surfactants in amounts of about 0.5% to about 7%, about 0.5% to about 6%, about 0.5% to about 5%, about 0.5% to about 4%, about 0.5% to about 3%, about 0.5% to about 2%; about 1% to about 9%, about 1% to about 8%, about 1% to about 7%, about 1% to about 6%, about 1% to about 5%, about 1% to about 4%, about 1% to about 3%, about 1% to about 2%; about 2% to about 9%, about 2% to about 8%, about 2% to about 7%, about 2% to about 6%, about 2% to about 5%, about 2% to about 4%, about 2% to about 3%; about 2.5% to about 9% % to about 4 wt %, about 3 wt % to about 8 wt %, about 3 wt % to about 7 wt %, about 3 wt % to about 6 wt %, about 3 wt % to about 5 wt %, about 3 wt % to about 4 wt %, about 3 wt % to about 3.5 wt %; about 4 wt % to about 9 wt %, about 4 wt % to about 8 wt %, about 4 wt % to about 7 wt %, about 4 wt % to about 6 wt %, about 4 wt % to about 5 wt %; about 5 wt % to about 9 wt %, about 5 wt % to about 8 wt %, about 5 wt % to about 7 wt %, about 5 wt % to about 6 wt %; about 7 wt % to about 9 wt %, about 7 wt % to about 8 wt %, or any range or subrange thereof.

[0082] One or more surfactants can be selected from one or more anionic surfactants, one or more cationic surfactants, one or more nonionic surfactants, one or more amphoteric surfactants, one or more zwitterionic surfactants, one or more bacterial surfactants or a combination of two or more thereof. One or more anionic surfactants can be selected from anionic surfactants based on sulfate and / or anionic surfactants based on non-sulfate, such as sulfonated monoglycerides of fatty acids, isethionates, sarcosinates, taurates and a combination of two or more thereof. Examples of anionic surfactants based on sulfate include sodium lauryl sulfate, ammonium lauryl ether sulfate, sodium lauryl sulfate, ammonium lauryl ether sulfate, sodium lauryl sulfate, sodium cocoyl sulfate, ammonium cocoyl sulfate and a combination of two or more thereof. In at least one embodiment, the oral care composition comprises an anionic surfactant based on sulfate, wherein the oral care composition is substantially free of or free of sodium lauryl sulfate and / or sodium lauryl ether sulfate.

[0083] The feature of amphoteric surfactant is generally a combination of high surfactant activity, foam formation and mildness. Amphoteric surfactant can include a substituent containing 8 to 18 carbon atoms and a substituent containing one or more carboxylate, sulfonate, sulfate, phosphate or phosphonate. For example, amphoteric surfactant can have an alkyl group containing 8 to 20 carbon atoms, 8 to 16 carbon atoms, 10 to 16 carbon atoms or 10 to 13 carbon atoms. Amphoteric surfactant can include but is not limited to derivatives of aliphatic secondary amines and aliphatic tertiary amines wherein the aliphatic group can be straight or branched. In some cases, one of the aliphatic substituents of the amphoteric surfactant includes approximately 8 to approximately 18 carbon atoms, and one of the aliphatic substituents includes an anionic water solubilizing group, such as carboxyl, sulfonate, sulfate, phosphate or phosphonate. Amphoteric surfactant disclosed herein can be present in the oral care composition in the form of a salt.

[0084] Amphoteric surfactants can include alkyl amphoteric propionates, betaines, alkyl sulfobetaines, alkyl amphoteric acetates or a combination of two or more thereof. Preferably, the oral care composition comprises an amphoteric surfactant selected from betaine surfactants (also referred to herein as betaines). One or more nonionic surfactants can be selected from glucosides, compounds produced by condensation of alkylene oxide groups (hydrophilic in nature) with organic hydrophobic compounds that can be aliphatic or alkyl aromatic in nature. Other examples of nonionic surfactants include poloxamers; polyethylene oxide condensates of alkylphenols; products derived from the condensation of ethylene oxide with the reaction products of propylene oxide and ethylenediamine; ethylene oxide condensates of aliphatic alcohols, acids and esters; long-chain tertiary amine oxides; long-chain tertiary phosphine oxides; long-chain dialkyl sulfoxides; and mixtures of such substances.

[0085] The oral care composition may optionally include a fluoride ion source. The fluoride ion source may be present in an effective amount. In some cases, the fluoride ion source is present in the oral care composition in an amount of about 0.01 wt % to about 5 wt %, based on the total weight of the oral care composition. For example, the fluoride ion source is present in the following amounts, based on the total weight of the oral care composition: from about 0.01% to about 5%, from about 0.01% to about 4%, from about 0.01% to about 3%, from about 0.01% to about 2%, from about 0.01% to about 1%; from about 0.05% to about 5%, from about 0.05% to about 4%, from about 0.05% to about 3%, from about 0.05% to about 2%, from about 0.05% to about 1%; from about 0.1% to about 5%, from about 0.1% to about 4%, from about 0.1% to about 3%, from about 0.1% to about 2%; from about 0.3% to about 5%, from about 0.3% to about 4%, from about 0.3% to about 3%, from about 0.3% to about 2%. % by weight; about 0.6 % to about 5 % by weight, about 0.6 % to about 4 % by weight, about 0.6 % to about 3 % by weight, about 0.6 % to about 2 % by weight; about 0.9 % to about 5 % by weight, about 0.9 % to about 4 % by weight, about 0.9 % to about 3 % by weight, about 0.9 % to about 2 % by weight; about 1.2 % to about 5 % by weight, about 1.2 % to about 4 % by weight, about 1.2 % to about 3 % by weight, about 1.2 % to about 2 % by weight; about 1.5 % to about 5 % by weight, about 1.5 % to about 4 % by weight, about 1.5 % to about 3 % by weight; about 2 % to about 5 % by weight, about 2 % to about 4 % by weight, about 2 % to about 3 % by weight; about 3 % to about 5 % by weight, about 4 % to about 5 % by weight, or any range or subrange thereof.

[0086] The fluoride ion source can be selected from soluble fluoride ion salts. For example, the fluoride ion source can include: sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, ammonium zinc fluoride, lithium fluoride, ammonium fluoride, stannous fluoride, stannous fluorozirconate, sodium monofluorophosphate, potassium monofluorophosphate, laurylamine hydrofluoride, diethylaminoethyloctylamide hydrofluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride Dilaurylmorpholine fluoride Sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, amine fluoride, or a combination of two or more thereof. In some embodiments, the fluoride ion source comprises sodium fluoride, sodium monofluorophosphate, or a combination thereof. Additional examples of fluoride ion sources are disclosed in U.S. Pat. No. 3,535,421, U.S. Pat. No. 4,885,155, and U.S. Pat. No. 3,678,154, the disclosures of each of which are hereby incorporated by reference in their entirety.

[0087] In certain embodiments, the oral care compositions of the present disclosure may include a fluoride ion source or a fluoride-providing agent in an amount sufficient to deliver a total of 25 ppm to 25,000 ppm (mass fraction) of fluoride ions, typically at least 500 ppm, e.g., from about 500 ppm to about 2000 ppm, from about 800 ppm to about 1800 ppm, from about 1000 ppm to about 1600 ppm, from about 1200 ppm to about 1550 ppm, or about 1450 ppm.

[0088] The oral care composition can optionally include one or more abrasives, for example, in an amount of about 5% to about 35% by weight based on the total weight of the oral care composition. In some embodiments, the one or more abrasives are present in the following amounts based on the total weight of the oral care composition: about 5% to about 30% by weight, about 5% to about 25% by weight, about 5% to about 21% by weight, about 5% to about 17% by weight, about 5% to about 14% by weight, about 5% to about 11% by weight; about 10% to about 35% by weight, about 10% to about 30% by weight, about 10% to about 25% by weight, about 10% to about 21% by weight, about 10% to about 17% by weight, about 10% to about 14% by weight; about 15% to about 35% by weight, about 15% to about 35% by weight, about 15% to about 15% by weight. % to about 30 weight %, about 15 weight % to about 25 weight %, about 15 weight % to about 21 weight %, about 15 weight % to about 19 weight %; about 18 weight % to about 35 weight %, about 18 weight % to about 30 weight %, about 18 weight % to about 25 weight %, about 18 weight % to about 21 weight %; about 21 weight % to about 35 weight %, about 21 weight % to about 30 weight %, about 21 weight % to about 25 weight %; about 24 weight % to about 35 weight %, about 24 weight % to about 30 weight %; about 27 weight % to about 35 weight %, about 27 weight % to about 30 weight %, or any range or subrange thereof.

[0089] The one or more abrasives may include silica, silicates, silicon, alumina (including calcined alumina), aluminosilicates (e.g., bentonite, zeolite, kaolin, and mica), silica or diatomaceous earth, pumice, calcium carbonate, cuttlebone, insoluble phosphates, composite resins (e.g., melamine resins, phenolic resins, and urea-formaldehyde resins), polycarbonates, silicon carbide, boron carbide, microcrystalline wax, microcrystalline cellulose (including combinations of colloidal microcrystalline cellulose and carboxymethyl cellulose), and combinations and derivatives thereof.

[0090] As used herein, "mica" refers to any one of the hydrous aluminosilicate mineral group having a flaky morphology and / or perfect substrate (mica-like) cleavage. Mica can be, for example, flaky mica, crushed mica or thin-sheet mica, as illustrated by muscovite, biotite or phlogopite-type mica. Abrasives can be selected from insoluble phosphates, such as orthophosphates, polymetaphosphates, pyrophosphates, and combinations thereof. Synthetic silica includes both silica gel and precipitated silica, which are prepared by neutralizing an aqueous silicate solution with a strong mineral acid. Abrasives comprising silica can be used in certain embodiments of oral care compositions. In certain embodiments, oral compositions can include a particularly effective combination of silica abrasive particulate matter. For example, abrasives are selected from high-cleaning silica, tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), and a combination of two or more thereof.

[0091] The oral care composition can optionally include one or more thickeners, for example, in an amount of about 0.5 weight percent to about 20 weight percent based on the total weight of the oral care composition. For example, the amount of thickener in the oral care composition can be from about 0.5% to about 17% by weight, from about 0.5% to about 14% by weight, from about 0.5% to about 11% by weight, from about 0.5% to about 9% by weight, from about 0.5% to about 7% by weight, from about 0.5% to about 5% by weight, from about 0.5% to about 4% by weight, from about 0.5% to about 3% by weight; from about 1% to about 20% by weight, from about 1% to about 17% by weight, from about 1% to about 14% by weight, from about 1% to about 11% by weight, from about 1% to about 9% by weight, from about 1% to about 7% by weight, from about 1% to about 5% by weight, from about 1% to about 4% by weight, from about 1% to about 3% by weight; from about 2% to about 20% by weight, from about 2% to about 17% by weight, from about 2% to about 14% by weight % to about 14 wt %, about 2 wt % to about 11 wt %, about 2 wt % to about 9 wt %, about 2 wt % to about 7 wt %, about 2 wt % to about 5 wt %, about 2 wt % to about 4 wt %, about 2 wt % to about 3 wt %; about 4 wt % to about 20 wt %, about 4 wt % to about 17 wt %, about 4 wt % to about 14 wt %, about 4 wt % to about 11 wt %, about 4 wt % to about 9 wt %, about 4 wt % to about 7 wt %; about 7 wt % to about 20 wt %, about 7 wt % to about 17 wt %, about 7 wt % to about 14 wt %, about 7 wt % to about 11 wt %; about 10 wt % to about 20 wt %, about 10 wt % to about 17 wt %, about 10 wt % to about 14 wt %; about 14 wt % to about 20 wt %, about 14 wt % to about 17 wt %, or any range or subrange thereof.

[0092] Thickening agents may be referred to as "thickeners" or "viscosity modifiers." Thickening agents are typically included to increase the viscosity of oral care compositions. Nevertheless, in some cases, certain thickening agents provide additional, unexpected benefits to oral care compositions.

[0093] One or more thickening agents can be selected from polysaccharides, silica thickeners, acrylates, polymers, and combinations of two or more thereof. Examples of polysaccharides include cellulose, carboxymethyl hydroxyethyl cellulose, cellulose acetate propionate carboxylate, hydroxyethyl cellulose, hydroxyethyl ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl hydroxyethyl cellulose, microcrystalline cellulose, sodium cellulose sulfate, carrageenan, or combinations of two or more thereof. Natural gums such as karaya gum, gum arabic, and tragacanth gum can also be incorporated. Colloidal magnesium aluminum silicate can also be used as a component of the thickening composition to further improve the texture of the composition. Silica thickeners can be present, which form a polymeric structure or gel in an aqueous medium. Silica thickeners are generally different from granular silica abrasives physically and functionally because silica thickeners are very finely divided and provide almost no grinding action.

[0094] The oral care composition can optionally include one or more polyols.The one or more polyols can be present in the oral care composition in an amount of about 1 wt % to about 60 wt %, based on the total weight of the oral care composition. For example, the oral care composition can include the polyol in the following amounts, based on the total weight of the oral care composition: from about 20% to about 55%, from about 20% to about 50%, from about 20% to about 45%, from about 20% to about 40%, from about 20% to about 37%, from about 20% to about 34%, from about 20% to about 31%, from about 20% to about 28%; from about 25% to about 60%, from about 25% to about 55%, from about 25% to about 50%, from about 25% to about 45%, from about 25% to about 40%, from about 25% to about 37%, from about 25% to about 34%, from about 25% to about 31%, from about 20% to about 28%; % to about 45 wt %, about 31 wt % to about 40 wt %, about 31 wt % to about 50 wt %, about 31 wt % to about 45 wt %, about 31 wt % to about 40 wt %, about 31 wt % to about 37 wt %; about 34 wt % to about 50 wt %, about 34 wt % to about 45 wt %, about 34 wt % to about 40 wt %; about 37 wt % to about 60 wt %, about 37 wt % to about 55 wt %, about 37 wt % to about 50 wt %, about 37 wt % to about 45 wt %; about 40 wt % to about 60 wt %, about 40 wt % to about 55 wt %, about 40 wt % to about 50 wt %, about 40 wt % to about 45 wt %, or any range or subrange thereof.

[0095] In other embodiments, the oral care composition can include a polyol in an amount of from about 0.5% to about 17% by weight, from about 0.5% to about 14% by weight, from about 0.5% to about 11% by weight, from about 0.5% to about 9% by weight, from about 0.5% to about 7% by weight, from about 0.5% to about 5% by weight, from about 0.5% to about 4% by weight, from about 0.5% to about 3% by weight, from about 0.5% to about 2% by weight, from about 0.5% to about 1% by weight; from about 1% to about 20% by weight, from about 1% to about 17% by weight, from about 1% to about 14% by weight, from about 1% to about 11% by weight, from about 1% to about 9% by weight, from about 1% to about 7% by weight, from about 1% to about 5% by weight, from about 1% to about 4% by weight, from about 1% to about 3% by weight, from about 1% to about 2% by weight; about 20 wt %, about 2 wt % to about 17 wt %, about 2 wt % to about 14 wt %, about 2 wt % to about 11 wt %, about 2 wt % to about 9 wt %, about 2 wt % to about 7 wt %, about 2 wt % to about 5 wt %, about 2 wt % to about 4 wt %, about 2 wt % to about 3 wt %; about 4 wt % to about 20 wt %, about 4 wt % to about 17 wt %, about 4 wt % to about 14 wt %, about 4 wt % to about 11 wt %, about 4 wt % to about 9 wt %, about 4 wt % to about 7 wt %; about 7 wt % to about 20 wt %, about 7 wt % to about 17 wt %, about 7 wt % to about 14 wt %, about 7 wt % to about 11 wt %; about 10 wt % to about 20 wt %, about 10 wt % to about 17 wt %, about 10 wt % to about 14 wt %; about 14 wt % to about 20 wt %, about 14 wt % to about 17 wt %, or any range or subrange thereof.

[0096] Polyol can be selected from ethylene glycol or a compound with too many hydroxyl groups. One or more polyols can be liquid at ambient temperature (25 DEG C). Polyol can be a humectant. In some preferred embodiments, polyol includes glycerol, glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a block copolymer of PPG and PEG, sugar (such as a mixture of fructose, glucose, sucrose and sugar such as honey) or a combination of two or more thereof. For example, the oral care composition includes maltitol, mannitol, sorbitol, xylitol, polypropylene glycol (PPG), polyethylene glycol (PEG), a block copolymer of PPG and PEG or a combination of two or more thereof.

[0097] In some cases, the oral care composition comprises a compound selected from C2-C 32One or more polyols in polyol.One or more polyols can have 2 to 32 carbon atoms, 3 to 16 carbon atoms or 3 to 12 carbon atoms.For example, oral care composition can comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerine, diglycerine, diethylene glycol and dipropylene glycol, sorbitol or its two or more combination.In addition, the limiting examples that can optionally be included in the polyol in oral care comprises and / or can be selected from glycerine, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentanediol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, octyl glycol, 1,2-hexylene glycol, 1,2-pentanediol and 4-methyl-1,2-pentanediol sorbitol, sorbitan, triacetin and its composition.

[0098] The oral care composition of the present disclosure can include flavoring agents. By the weight of the oral care composition, flavoring agents are usually incorporated into the oral care composition with a concentration of about 0.01 % by weight to about 3 % by weight. For example, based on the gross weight of the oral care composition, the amount of the flavoring agents present in the oral care composition can be about 0.01 % by weight to about 2 % by weight, about 0.01 % by weight to about 1 % by weight, about 0.01 % by weight to about 0.5 % by weight, about 0.01 % by weight to about 0.1 % by weight; about 0.1 % by weight to about 3 % by weight, about 0.1 % by weight to about 2 % by weight, about 0.1 % by weight to about 1 % by weight, about 0.1 % by weight to about 0.5 % by weight; about 0.5 % by weight to about 3 % by weight, about 0.5 % by weight to about 2 % by weight, about 0.5 % by weight to about 1 % by weight; about 1 % by weight to about 3 % by weight, about 1 % by weight to about 2 % by weight; about 2 % by weight to about 3 % by weight, including any scope or sub-range thereof.

[0099] The present invention also can be used to prepare the flavoring agent of the present invention.Suitable flavoring agent includes but is not limited to aldehyde, ester, alcohol and the similar material of essential oil and various flavoring.The example of essential oil comprises the oil of spearmint, peppermint, wintergreen, yellow sassafras, cloves, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit and orange.Chemical substances such as menthol, carvone and anethole are also useful.Other flavoring agent can include but is not limited to menthol, artificial vanilla, cinnamon derivative and various fruit flavors, spearmint oil, peppermint oil, cinnamon oil, wintergreen oil (methyl salicylate), clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leaf oil, nutmeg oil, sage oil, bitter almond oil, cinnamon oil and the combination of both or more thereof.

[0100] Oral care compositions can comprise one or more coloring agents.Exemplary coloring agents can comprise natural or uncertified pigments or color effect certified pigments from natural sources.In some embodiments, coloring agent can comprise dye, certified aluminum lake or pigment derived from natural sources.Coloring agent can be water-based, oil-based or dry.Coloring agent can be original pigment, pigment blend or discrete pigment mixture, for example five-color pigment.Based on the gross weight of oral care compositions, the concentration of coloring agent in oral care compositions can be trace amount to about 0.6 weight %, about 0.1 weight % to about 0.5 weight %, about 0.2 weight % to about 0.4 weight % or about 0.15 weight % to about 0.35 weight %.

[0101] The oral care composition may include one or more pH adjusting agents 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, 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. One of ordinary skill in the art will readily recognize additional or alternative acids and bases suitable for adjusting the pH of an oral care composition.

[0102] The amount of pH adjusting agent in the oral care composition can be based on the desired pH of the final oral care composition and / or product. For example, the total amount of pH adjusting agent can be in the range of about 0.05 wt % to about 20 wt %, based on the total weight of the oral care composition. In some cases, the total amount of pH adjusting agent is from about 0.05 wt % to about 15 wt %, from about 0.1 wt % to about 10 wt %, or from about 0.12 wt % to about 5 wt %, based on the total weight of the oral care composition, including ranges and subranges therebetween.

[0103] The pH of the oral care composition can be 4.5 to about 10, 4.5 to about 9, 4.5 to about 8, 4.5 to about 7, 4.5 to about 6; about 5 to about 10, about 5 to about 9, about 5 to about 8, about 5 to about 7, about 5 to about 6; about 6 to about 10, about 6 to about 9, about 6 to about 8, or about 6 to about 7; about 7 to about 10, about 7 to about 9, or about 7 to about 8, including ranges and subranges therebetween.

[0104] In some embodiments, the oral care composition may include water. Water may be present in the oral care composition in an amount of about 5% to about 37% by weight, based on the total weight of the oral care composition. For example, based on the total weight of the oral care composition, the oral care composition may include water in the following amounts: about 5% to about 34% by weight, about 5% to about 31% by weight, about 5% to about 28% by weight, about 5% to about 25% by weight, about 5% to about 20% by weight; about 10% to about 37% by weight, about 10% to about 34% by weight, about 10% to about 31% by weight, about 10% to about 28% by weight, about 10% to about 25% by weight; about 15% to about 37% by weight, about 15% to about 34% by weight, about 15% to about 31% by weight, about 15% to about 28% by weight, about 10% to about 25% by weight. % to about 28 weight %, about 15 weight % to about 25 weight %; about 20 weight % to about 37 weight %, about 20 weight % to about 34 weight %, about 20 weight % to about 31 weight %, about 20 weight % to about 28 weight %; about 25 weight % to about 37 weight %, about 25 weight % to about 34 weight %, about 25 weight % to about 31 weight %; about 28 weight % to about 37 weight %, about 28 weight % to about 34 weight %, about 28 weight % to about 31 weight %; about 31 weight % to about 37 weight %; about 37 weight % to about 50 weight %, about 37 weight % to about 45 weight %, or any range or subrange thereof.

[0105] Example

[0106] Example 1

[0107] Four non-limiting example oral care films (Example Films A through D) were prepared according to aspects of the present invention. A comparative oral care film (Comparative Film 1) was also prepared. The formulations of Example Films A through D and Comparative Film 1 are shown in Table 1.

[0108] Table 1

[0109]

Claims

1. An oral care film for an oral care composition, the oral care film comprising: about 5 wt % to about 19 wt % of oleanolic acid and / or a salt thereof, based on the total weight of the oral care film; hydroxide; a polyol, optionally in an amount from about 4 wt % to about 25 wt % based on the total weight of the oral care film; Nonionic surfactants; starch, optionally in an amount from about 10 wt % to about 30 wt % based on the total weight of the oral care film; and Optionally, from about 25 wt% to about 80 wt% cellulose based on the total weight of the oral care film. 2 . The oral care film according to claim 1 , wherein the polyol is a glycol selected from propylene glycol, ethylene glycol, butylene glycol, octanediol, or a combination of two or more thereof.

3. The oral care film of claim 1 or claim 2, wherein the hydroxide comprises sodium hydroxide, potassium hydroxide, calcium hydroxide, ammonium hydroxide, magnesium hydroxide, or a combination of two or more thereof.

4. The oral care film of any preceding claim, wherein the nonionic surfactant comprises an ethoxylated sorbitan surfactant.

5. The oral care film of claim 4, wherein the ethoxylated sorbitan surfactant comprises polysorbate 80, polysorbate 20, or a combination thereof.

6. The oral care film of any preceding claim, wherein the oral care film is free of surfactants other than non-ionic surfactants.

7. The oral care film of any preceding claim, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of from about 90:1 to about 80:

1.

8. The oral care film of any preceding claim, wherein the oral care film has a weight ratio of the polyol to the nonionic surfactant of from about 27:1 to about 18:

1.

9. The oral care film of any preceding claim, wherein the oral care film has a weight ratio of the oleanolic acid to the total amount of the polyol and the nonionic surfactant of about 3:1 to 1:

2.

10. The oral care film of any preceding claim, further comprising an opacifier comprising stannous oxide, titanium oxide, iron oxide, or a combination thereof.

11. The oral care film of any preceding claim further comprising a colorant.

12. An oral care film for an oral care composition, the oral care film comprising: Oleanolic acid; hydroxide; polyols; and nonionic surfactants, The weight ratio of the oleanolic acid to the hydroxide of the oral care film is about 90:1 to about 80:1, and the weight ratio of the polyol to the nonionic surfactant of the oral care film is about 27:1 to about 18:

1.

13. An oral care film for an oral care composition, the oral care film comprising: Oleanolic acid and / or its salts; hydroxide; polyols; Nonionic surfactants; starch; Optionally, salt; Optionally, a sunscreen, and Optionally, a colorant.

14. An oral care composition comprising the oral care film of any preceding claim, wherein the oral care composition in the absence of the oral care film is translucent.

15. An oral care composition comprising the oral care film of any preceding claim, wherein the oral care composition is substantially free of or free of oleanolic acid other than that present in the oral care film.

16. A method for producing an oral care film, the method comprising: An aqueous solution is formed by mixing water, oleanolic acid and / or its salt, hydroxide, polyol, and nonionic surfactant; Water is evaporated from the aqueous solution to form the oral care film.

Images