Oral care compositions comprising oleanolic acid

Abstract

Oral care films and oral care compositions containing such oral care films are disclosed herein. The oral care films may comprise from about 5 to about 19 wt.%, based on the total weight of the oral care film, of oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; and a starch.

Description

ORAL CARE COMPOSITIONS COMPRISING OLEANOLIC ACIDCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from Chinese Patent Application No. 202410269338.0, filed March 8, 2024, titled ORAL CARE STRIPS AND COMPOSITIONS THEREOF, which is hereby incorporated herein by reference in its entirety for all purposes.BACKGROUND

[0002] Gum bleeding is associated with many common oral conditions, such as gingivitis. Gum bleeding may be caused by a buildup of plaque, a soft, sticky, colorless film of bacteria that forms on the teeth and gums, and produces toxins that may inflame or infect the gum tissue to cause gingivitis. Gingivitis is the initial stage of gum disease and, if left untreated, may cause periodontitis.

[0003] Antibacterial agents have been used in oral care products to reduce plaque and gingivitis, and hence reduce gum bleeding. Similarly, hemostatic agents have also been used in oral care products to reduce gum bleeding. Oleanolic acid is believed to have both antibacterial and hemostatic properties, and there is a desire to create oral care compositions incorporating oleanolic acid. However, due to its hydrophobic properties, oleanolic acid is often dissolved in solvents, such as ethanol or dimethyl sulfoxide (DMSO), to facilitate its use. The use of such solvents limits the incorporation of oleanolic acid in oral care compositions which wish to avoid or limit the use of those ingredients.BRIEF SUMMARY

[0004] This summary is intended merely to introduce a simplified summary of some aspects of one or more implementations of the present disclosure. Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. This summary is not an extensive overview, nor is it intended to identify key or critical elements of the present teachings, nor to delineate the scope of the disclosure. Rather, its purpose is merely to present one or more concepts in simplified form as a prelude to the detailed description below.

[0005] Aspects of the invention are directed to oral care films and oral care compositions containing such oral care films. In accordance with an aspect of the invention, provided is an oralcare film for an oral care composition, the oral care film including from about 5 to about 19 wt.% of olcanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; and a starch, wherein all weight percentages based on the total weight of the oral care film.

[0006] According to another aspect of the invention, provided is an oral care film for an oral care composition, the oral care film including oleanolic acid; a hydroxide; a polyol; a hydroxide; a polyol; and a non-ionic surfactant, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of about 90:1 to about 80:1, and the oral care film has a weight ratio of the polyol to the nonionic surfactant of about 27:1 to about 18:1.

[0007] In accordance with a further aspect of the invention, provided is an oral care film for an oral care composition, the oral care film including from about 5 to about 19 wt.% of oleanolic acid; a hydroxide; a glycol; a non-ionic surfactant; from about 25 to about 80 wt.% of cellulose; and from about 10 to about 30 wt.% of a cornstarch, wherein all weight percentages based on the total weight of the oral care film.

[0008] According to yet another aspect of the invention, provided is an oral care film for an oral care composition, the oral care film consisting of oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; a starch; optionally a thickening agent, optionally, an opacifying agent, and optionally, a colorant.

[0009] In accordance with yet a further aspect of the invention, a method for producing an oral care film is provided. The method typically includes forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and non-ionic surfactant; evaporating water from the aqueous solution to form the oral care film.

[0010] A list of non-limiting example embodiments according to certain aspects of the invention is provided below:

[0011] In accordance with an embodiment 1, provided is an oral care film for an oral care composition, the oral care film comprising: from about 5 to about 19 wt.% of oleanolic acid and / or a salt thereof, based on the total weight of the oral care film; a hydroxide; a polyol optionally in an amount from about 4 to about 25 wt.%, based on the total weight of the oral care film; a non- ionic surfactant; a starch optionally in an amount from about 10 to about 30 wt.%, based on the total weight of the oral care film; and optionally, from about 25 to about 80 wt.% of cellulose, based on the total weight of the oral care film.

[0012] According to an embodiment 2, provided is the oral care film of embodiment 1, whereinthe polyol is a glycol selected from propylene glycol, ethylene glycol, butylene glycol, capryl glycol, or a combination of two or more thereof.

[0013] According to an embodiment , provided is the oral care film of embodiment 1 or embodiment 2, wherein the hydroxide comprises sodium hydroxide, potassium hydroxide, calcium hydroxide, ammonium hydroxide, magnesium hydroxide, or a combination of two or more thereof.

[0014] According to an embodiment 4, provided is the oral care film of any foregoing embodiment, wherein the nonionic surfactant comprises an ethoxylated sorbitan surfactants.

[0015] According to an embodiment 5, provided is the oral care film of embodiment 4, wherein the ethoxylated sorbitan surfactant comprises polysorbate 80, polysorbate 20, or a combination thereof.

[0016] According to an embodiment 6, provided is the oral care film of any foregoing embodiment, wherein the oral care film is free of surfactants other than nonionic surfactants.

[0017] According to an embodiment 7, provided is the oral care film of any foregoing embodiment, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of about 90:1 to about 80:1.

[0018] According to an embodiment 8, provided is the oral care film of any foregoing embodiment, wherein the oral care film has a weight ratio of the polyol to the nonionic surfactant of about 27:1 to about 18:1.

[0019] According to an embodiment 9, provided is the oral care film of any foregoing embodiment, 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.

[0020] According to an embodiment 10, provided is the oral care film of any foregoing embodiment further comprising an opacifying agent comprising stannous oxide, a titanium oxide, an iron oxide, or a combination thereof.

[0021] According to an embodiment 11, provided is the oral care film of any foregoing embodiment further comprising a colorant.

[0022] In accordance with an embodiment 12, provided is an oral care film for an oral care composition, the oral care film comprising: oleanolic acid; a hydroxide; a polyol; and a non-ionic surfactant, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of about 90:1 to about 80:1, and the oral care film has a weight ratio of the polyol to the nonionic surfactant of about 27:1 to about 18:1.

[0023] According to an embodiment 13, provided is the oral care film of any foregoing embodiment, wherein the oral care film has about 2 wt.% or less of water.

[0024] According to an embodiment 14, provided is the oral care film of any foregoing embodiment, wherein the oral care film is substantially free or free of water.

[0025] In accordance with an embodiment 15, provided is an oral care film for an oral care composition, the oral care film consisting of: oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; a starch; optionally, a salt; optionally, an opacifying agent, and optionally, a colorant.

[0026] In accordance with an embodiment 16, provided is an oral care composition comprising the oral care film according to any foregoing embodiment, wherein the oral care composition absent the oral care film is translucent.

[0027] In accordance with an embodiment 17, provided is an oral care composition comprising the oral care film according to any foregoing embodiment, wherein the oral care composition is substantially free or free of oleanolic acid other than the oleanolic acid present in the oral care film.

[0028] In accordance with an embodiment 18, provided is a method of producing an oral care film, the method comprising: forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and a non-ionic surfactant; evaporating water from the aqueous solution to form the oral care film.

[0029] In accordance with an embodiment 19, provided is an oral care film for an oral care composition, the oral care film consisting of: oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; a starch; a salt; optionally, an opacifying agent; and optionally, a colorant, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of about 90:1 to about 80:1, and the oral care film has a weight ratio of the polyol to the nonionic surfactant of about 27:1 to about 18.

[0030] According to an embodiment 20, provided is the oral care film of any foregoing embodiment, wherein the oral care film is configured to have a roughness of about 0.1 to about 20 pm, e.g., as measured in accordance with accordance with JIS-B-0601.

[0031] According to an embodiment 21, provided is the oral care film of any foregoing embodiment, wherein the oral care film is adapted to dissolve within about 2 minutes of brushing (e.g., teeth) using an oral care composition containing the oral care film.DETAILED DESCRIPTION

[0032] For illustrative purposes, the principles of the present invention arc described by referencing various exemplary embodiments thereof. Although certain embodiments of the invention are specifically described herein, one of ordinary skill in the art will readily recognize that the same principles are equally applicable to, and can be employed in other compositions and methods. Before explaining the disclosed embodiments of the present invention in detail, it is to be understood that the invention is not limited in its application to the details of any particular embodiment disclosed herein. The terminology used herein is for the purpose of description and not of limitation.

[0033] As used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural references unless the context dictates otherwise. The singular form of any class of the ingredients refers not only to one chemical species within that class, but also to a mixture of those chemical species. The terms “a” (or “an”), “one or more” and “at least one” may be used interchangeably herein. The terms “comprising”, “including”, and “having” may be used interchangeably. The term “include” should be interpreted as “include, but are not limited to”. The term “including” should be interpreted as “including, but are not limited to”.

[0034] As used throughout, ranges are used as shorthand for describing each and every value that is within the range. Any value within the range can be selected as the terminus of the range. Thus, a range from 1-5, includes specifically 1, 2, 3, 4 and 5, as well as subranges such as 2-5, 3-5, 2-3, 2-4, 1-4, etc.

[0035] The term “about” when referring to a number means any number within a range of 10% of the number. For example, the phrase “about 2 wt.%” refers to a number between and including 1.8 wt.% and 2.2 wt.%.

[0036] All references cited herein are hereby incorporated by reference in their entireties. In the event of a conflict in a definition in the present disclosure and that of a cited reference, the present disclosure controls.

[0037] The abbreviations and symbols as used herein, unless indicated otherwise, take their ordinary meaning. The abbreviation “wt.%” means percent by weight with respect to the oral care composition. The symbol “°” refers to a degree, such as a temperature degree or a degree of an angle. The symbols “h”, “min”, “mL”, “nm”, and “pm” refer to hour, minute, milliliter, nanometer,and micrometer, respectively. The abbreviation “UV-VIS” as referring to a spectrometer or spectroscopy, means Ultraviolet-Visible. The abbreviation “rpm” means revolutions per minute.

[0038] When referring to chemical structures, and names, the symbols “C”, “H”, and “O” mean carbon, hydrogen, and oxygen, respectively. The symbols“=” and “=” mean single bond, double bond, and triple bond, respectively.

[0039] “ Volatile”, as used herein, means having a flash point of less than about 100° C. “Nonvolatile”, as used herein, means having a flash point of greater than about 100° C.

[0040] Any member in a list of species that are used to exemplify or define a genus, may be mutually different from, or overlapping with, or a subset of, or equivalent to, or nearly the same as, or identical to, any other member of the list of species. Further, unless explicitly stated, such as when reciting a Markush group, the list of species that define or exemplify the genus is open, and it is given that other species may exist that define or exemplify the genus just as well as, or better than, any other species listed.

[0041] The phrases, “a mixture thereof,” “a combination thereof,” or a combination of two or more thereof’ do not require that the mixture include all of A, B, C, D, E, and F (although all of A, B,C, D, E, and F may be included). Rather, it indicates that a mixture of any two or more of A, B, C,D, E, and F can be included. In other words, it is equivalent to the phrase “one or more elements selected from the group consisting of A, B, C, D, E, F, and a mixture of any two or more of A, B, C, D, E, and F.” Likewise, the term “a salt thereof” also relates to “salts thereof.” Thus, where the disclosure refers to “an element selected from the group consisting of A, B, C, D, E, F, a salt thereof, and a mixture thereof,” it indicates that that one or more of A, B, C, D, and F may be included, one or more of a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included, or a mixture of any two of A, B, C, D, E, F, a salt of A, a salt of B, a salt of C, a salt of D, a salt of E, and a salt of F may be included.

[0042] All components and elements positively set forth in this disclosure can be negatively excluded from the claims. In other words, the oral care films and / or the oral care compositions of the instant disclosure can be free or essentially free of all components and elements positively recited throughout the instant disclosure. In some instances, the oral care films and / or oral care compositions of the present disclosure may be substantially free of non-incidental amounts of the ingredient(s) or compound(s) described herein. A non-incidental amount of an ingredient or compound is the amount of that ingredient or compound that is added into the oral care films and / orthe oral care composition by itself. For example, an oral care film and / or an oral care composition may be substantially free of a non-incidcntal amount of an ingredient or compound, although such ingredient(s) or compound(s) may be present as pail of a raw material that is included as a blend of two or more compounds.

[0043] Some of the various categories of components identified may overlap. In such cases where overlap may exist and the oral care film and / or the oral care composition includes both components (or the oral care film and / or the oral care composition includes more than two components that overlap), an overlapping compound does not represent more than one component. For example, certain compounds may be characterized as both a polyol and a sweetener. If a particular the oral care film and / or oral care composition recites both a polyol and a sweetener, xylitol will serve only as either a polyol or a sweetener — not both.

[0044] For readability purposes, the chemical functional groups are in their adjective form; for each of the adjectives, the word “group” is assumed. For example, the adjective “alkyl” without a noun thereafter, should be read as “an alkyl group.”

[0045] Aspects of the invention are directed to oral care films and oral care compositions containing such oral care films. In accordance with an aspect of the invention, provided is an oral care film for an oral care composition, the oral care film including from about 5 to about 19 wt.% of oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; and a starch, wherein all weight percentages based on the total weight of the oral care film.

[0046] According to another aspect of the invention, provided is an oral care film for an oral care composition, the oral care film including oleanolic acid; a hydroxide; a polyol; a hydroxide; a polyol; and a non-ionic surfactant, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of about 90:1 to about 80:1, and the oral care film has a weight ratio of the polyol to the nonionic surfactant of about 27:1 to about 18:1.

[0047] In accordance with a further aspect of the invention, provided is an oral care film for an oral care composition, the oral care film including from about 5 to about 19 wt.% of oleanolic acid; a hydroxide; a glycol; a non-ionic surfactant; from about 25 to about 80 wt.% of cellulose; and from about 10 to about 30 wt.% of a cornstarch, wherein all weight percentages based on the total weight of the oral care film.

[0048] According to yet another aspect of the invention, provided is an oral care film for an oral care composition, the oral care film consisting of oleanolic acid and / or a salt thereof; a hydroxide;a polyol; a non-ionic surfactant; a starch; optionally a thickening agent, optionally, an opacifying agent, and optionally, a colorant.

[0049] In accordance with yet a further aspect of the invention, a method for producing an oral care film is provided. The method typically includes forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and non-ionic surfactant; evaporating water from the aqueous solution to form the oral care film.

[0050] In accordance with yet a further aspect of the invention, a method for producing an oral care film is provided. The method typically includes forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and non-ionic surfactant; evaporating water from the aqueous solution to form the oral care film.

[0051] The oral care film may be a solid film and / or a pseudo solid film. Although the oral care film may be in the form of a monolayer, in some embodiments the oral care film is in the form of a multi-layer oral care film, where at least two of adjacent layers of the oral care film have distinct formulations.

[0052] The oral care film may be configured to have a smooth texture and are ductile. For example, the oral care film may be configured to have a roughness of about 0.1 to about 20 pm, e.g., as measured in accordance with accordance with JIS-B-0601. For example, the oral care composition may have a roughness of about 0.1 to about 20 pm, about 0.1 to about 16 pm, about 0.1 to about 14 pm, about 0.1 to about 10 pm, about 0.1 to about 6 pm, about 0.1 to about 4 pm, about 0.1 to about 2 pm, about 0.1 to about 1 pm, about 0.1 to about 0.5 pm; from about 1 to about 20 pm, about 1 to about 16 pm, about 1 to about 14 pm, about 1 to about 10 pm, about 1 to about 6 pm, about 1 to about 4 pm, about 1 to about 2 pm; from about 2 to about 20 pm, about 2 to about 16 pm, about 2 to about 14 pm, about 2 to about 10 pm, about 2 to about 6 pm; from about 4 to about 20 pm, about 4 to about 16 pm, about 4 to about 14 pm, about 4 to about 10 pm, about 4 to about 8 pm; from about 8 to about 20 pm, about 8 to about 16 pm, about 8 to about 14 pm, about 8 to about 12 pm; from about 10 to about 20 pm, about 10 to about 16 pm, about 10 to about 14 pm; from about 14 to about 20 pm, about 14 to about 17 pm, or any range or subrange thereof, e.g., as measured in accordance with accordance with JIS-B-0601.

[0053] In certain embodiments, the oral care film is configured to dissolve within about 2 minutes of brushing teeth using an oral care composition containing the oral care film. For instance, the oral care film may dissolve within about 1.7 minutes, about 1.4 minutes, about 1.1 minutes, about0.9 minutes, about 0.7 minutes, about 0.5 minutes, or about 0.3 minutes from the start of brushing teeth using an oral care composition containing 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 being submerged in water without agitation.

[0054] Suitable components and / or ingredients, such as those listed below, may be included or excluded from the formulations for the oral care film depending on the specific combination of other components, the properties of the oral care film, and / or the use of the oral care film.

[0055] The oral care film typically comprises oleanolic acid and / or a salt thereof. Oleanic or oleanolic acid (3|3-hydroxy-olea-12-en-28-oic) is a pentacyclic triterpenoid, which may be obtained from plants. For example, oleanolic acid can be extracted from a number of medicinal plants, such as Calendula officinalis L. (marigold), Ligustrum lucidum Ait (oleaceae), and Hemsleya Chinensis Cogn. In some embodiments, the oleanolic acid and / or a salt thereof is incorporated into the oral care film in the form of a salt. In further embodiments, the oleanolic acid and / or a salt thereof is incorporated into the oral care film in the form of oleanolic acid.

[0056] The amount of oleanolic acid and / or a salt thereof present in the oral care film may be from about 5 to about 19 wt.%, based on the total weight of the oral care film. For example, the oral care film may comprise oleanolic acid and / or a salt thereof in an amount from about 5 to about 17 wt.%, about 5 to about 15 wt.%, about 5 to about 13 wt.%, about 5 to about 11 wt.%, about 5 to about 9 wt.%; from about 7 to about 19 wt.%, about 7 to about 17 wt.%, about 7 to about 15 wt.%, about 7 to about 13 wt.%, about 7 to about 11 wt.%, about 7 to about 9 wt.%; from about 9 to about 19 wt.%, about 9 to about 17 wt.%, about 9 to about 15 wt.%, about 9 to about 13 wt.%, about 9 to about 11 wt.%; from about 11 to about 19 wt.%, about 11 to about 17 wt.%, about 11 to about 15 wt.%, about 11 to about 13 wt.%; from about 13 to about 19 wt.%, about 13 to about 17 wt.%, about 13 to about 15 wt.%; from about 15 to about 19 wt.%, about 15 to about 17 wt.%, about 17 to about 19 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0057] The oral care films typically comprise a hydroxide in an amount that may vary, but in some cases is from about 0.05 to about 2 wt.%, based on the total weight of the oral care film. For instance, the hydroxide may be present in an amount from about 0.05 to about 1.6 wt.%, about 0.05 to about 1.2 wt.%, about 0.05 to about 1 wt.%, about 0.05 to about 0.8 wt.%, about 0.05 to about 0.7 wt.%, about 0.05 to about 0.6 wt.%, about 0.05 to about 0.5 wt.%, about 0.05 to about0.4 wt.%, about 0.05 to about 0.2 wt.%, about 0.05 to about 0.1 wt.%; about 0.1 to about 1 .6 wt.%, about 0.1 to about 1.2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.8 wt.%, about 0.1 to about 0.7 wt.%, about 0.1 to about 0.6 wt.%, about 0.1 to about 0.5 wt.%, about 0.1 to about 0.4 wt.%; from about 0.3 to about 2 wt.%, about 0.3 to about 1.6 wt.%, about 0.3 to about 1.2 wt.%, about 0.3 to about 1 wt.%, about 0.3 to about 0.8 wt.%, about 0.3 to about 0.7 wt.%, about 0.3 to about 0.6 wt.%; from about 0.5 to about 2 wt.%, about 0.5 to about 1.6 wt.%, about 0.5 to about 1.2 wt.%, about 0.5 to about 1 wt.%, about 0.5 to about 0.8 wt.%, about 0.5 to about 0.7 wt.%; from about 0.6 to about 2 wt.%, about 0.6 to about 1.6 wt.%, about 0.6 to about 1.2 wt.%, about 0.6 to about 1 wt.%, about 0.6 to about 0.8 wt.%; from about 0.7 to about 2 wt.%, about 0.7 to about 1.6 wt.%, about 0.7 to about 1.2 wt.%, about 0.7 to about 1 wt.%; from about 0.9 to about 2 wt.%, about 0.9 to about 1.6 wt.%, about 0.9 to about 1.2 wt.%; from about 1.1 to about 2 wt.%, about 1.1 to about 1.6 wt.%, about 1.1 to about 1.3 wt.%; from about 1.4 to about 2 wt.%, about 1.4 to about 1.8 wt.%, about 1.4 to about 1.6 wt.%, about 1.7 to about 2 wt.%, or a range or subrange thereof, based on the total weight of the oral care film.

[0058] The hydroxide may 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 combinations of two or more thereof. In certain embodiments, the hydroxide is selected from sodium hydroxide, potassium hydroxide, calcium hydroxide, or a combination thereof.

[0059] The oral care films typically include a polyol, e.g., in an amount that may vary from about 4 to about 25 wt.%, based on the total weight of the oral care film. In some instances, the polyol(s) is present in the oral care film in an amount of about 4 to about 25 wt.%, about 4 to about 21 wt.%, about 4 to about 19 wt.%, about 4 to about 17 wt.%, about 4 to about 15 wt.%, about 4 to about 13 wt.%, about 4 to about 11 wt.%, about 4 to about 9 wt.%; from about 6 to about 25 wt.%, about 6 to about 21 wt.%, about 6 to about 19 wt.%, about 6 to about 17 wt.%, about 6 to about 15 wt.%, about 6 to about 13 wt.%, about 6 to about 11 wt.%, about 6 to about 9 wt.%; from about 8 to about 25 wt.%, about 8 to about 21 wt.%, about 8 to about 19 wt.%, about 8 to about 17 wt.%, about 8 to about 15 wt.%, about 8 to about 13 wt.%, about 8 to about 11 wt.%; from about 10 to about 25 wt.%, about 10 to about 21 wt.%, about 10 to about 19 wt.%, about 10 to about 17 wt.%, about 10 to about 15 wt.%, about 10 to about 13 wt.%; from about 12 to about 25 wt.%, about 12 to about 21 wt.%, about 12 to about 19 wt.%, about 12 to about 17 wt.%, about 12 to about 15wt.%; from about 15 to about 25 wt.%, about 15 to about 21 wt.%, about 15 to about 19 wt.%, about 15 to about 17 wt.%; from about 18 to about 25 wt.%, about 18 to about 21 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0060] In at least one embodiment, the polyol(s) is present in the oral care film in an amount from about 10 to about 40 wt.%, about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%, about 10 to about 20 wt.%; from about 15 to about 45 wt.%, about 15 to about 40 wt.%, about 15 to about 35 wt.%, about 15 to about 30 wt.%, about 15 to about 25 wt.%; from about 18 to about 45 wt.%, about 18 to about 40 wt.%, about 18 to about 35 wt.%, about 18 to about 30 wt.%, about 18 to about 25 wt.%; from about 21 to about 45 wt.%, about 21 to about 40 wt.%, about 21 to about 35 wt.%, about 21 to about 32 wt.%, about 21 to about 29 wt.%, about 21 to about 26 wt.%; from about 24 to about 45 wt.%, about 24 to about 40 wt.%, about 24 to about 35 wt.%, about 24 to about 32 wt.%, about 24 to about 29 wt.%; from about 27 to about 45 wt.%, about 27 to about 40 wt.%, about 27 to about 35 wt.%, about 27 to about 32 wt.%; from about 30 to about 45 wt.%, about 30 to about 40 wt.%, about 30 to about 35 wt.%, about 30 to about 33 wt.%; from about 34 to about 45 wt.%, about 34 to about 40 wt.%, about 34 to about 38 wt.%; from about 38 to about 45 wt.%, about 38 to about 42 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0061] The polyol(s) may be chosen from glycols or compounds with numerous hydroxyl groups, such as glycerin. The 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 includes one or more polyol selected from the group consisting of C2-C32 polyols. The one or more polyols may have from 2 to 32 carbon atoms, from 3 to 16 carbon atoms, or from 3 to 12 carbon atoms. For example, the oral care films may comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, or a combination of two or more thereof. Additional, non-limiting examples of polyols that may, optionally, be included in the oral care include and / or may be chosen from alkanediols such as glycerin, 1,2,6-hexanetriol, trimethylolpropane, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, 2-butene-l,4-diol, 2-ethyl-l,3-hexanediol, 2-methyl-2,4-pentanediol, caprylyl glycol, 1,2-hexanediol, 1,2-pentanediol, and 4-methyl-l,2-pentanediol; glycol ethers such as ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monobutylether, ethylene glycol monomethyl ether acetate, diethylene glycol monomethyl ether, diethylene glycol monocthyl ether, dicthylcnc glycol mono-n-propyl ether, ethylene glycol mono-iso-propyl ether, diethylene glycol mono-iso-propyl ether, ethylene glycol mono-n-butyl ether, ethylene glycol mono-t-butyl ether, diethylene glycol mono-t-butyl ether, 1 -methyl- 1-methoxybutanol, propylene glycol monomethyl ether, propylene glycol monoethyl ether, propylene glycol mono-t- butyl ether, propylene glycol mono-n-propyl ether, propylene glycol mono-iso-propyl ether, dipropylene glycol monomethyl ether, dipropylene glycol monoethyl ether, dipropylene glycol mono-n-propyl ether, dipropylene glycol mono-iso-propyl ether, sorbitol, sorbitan, triacetin, and a mixture thereof.

[0062] In certain embodiments, the polyol consists of one or more glycols. The glycols may be selected from propylene glycol, ethylene glycol, butylene glycol, capryl glycol, or a combination of two or more thereof.

[0063] Additionally, the oral care films typically comprise one or more surfactant(s). The total amount of surfactant(s) present in the oral care film may be from about 0.1 to about 5 wt.%, based on the total weight of the oral care film. For instance, the oral care film may comprise a total amount of surfactant(s) of from about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.75 wt.%, about 0.1 to about 0.5 wt.%; from about 0.25 to about 5 wt.%, about 0.25 to about 4 wt.%, about 0.25 to about 3 wt.%, about 0.25 to about 2 wt.%, about 0.25 to about 1 wt.%, about 0.25 to about 0.75 wt.%, about 0.25 to about 0.5 wt.%; from about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%, about 0.5 to about 0.75 wt.%; from about 0.75 to about 5 wt.%, about 0.75 to about 4 wt.%, about 0.75 to about 3 wt.%, about 0.75 to about 2 wt.%, about 0.75 to about 1 wt.%; from about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0064] In at least one embodiment, the oral care film may comprise a total amount of surfactant(s) of about 2 to about 10 wt.%, about 2 to about 8 wt.%, about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%; from about 4 to about 12 wt.%, about 4 to about 10 wt.%, about 4 to about 8 wt.%, about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 12 wt.%, about 5 to about 10 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from about 6 to about 12 wt.%, about 6to about 10 wt.%, about 6 to about 8 wt.%; from about 7 to about 12 wt.%, about 7 to about 10 wt.%, about 7 to about 9 wt.%; from about 9 to about 12 wt.%, about 9 to about 11 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0065] The one or more surfactant(s) may be selected from anionic surfactants, amphoteric surfactants, nonionic surfactants, or combinations of two or more thereof. The one or more surfactant(s) preferably comprises at least one nonionic surfactant. In certain embodiments, the oral care film is free of surfactants other than nonionic surfactants. The one or more nonionic surfactant(s) may 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 the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkylaromatic in nature.

[0066] The sorbitan surfactants may be alkoxylate and / or ethoxylated. In some embodiments, the oral care film comprises one or more sorbitan surfactants, such as those selected from ethoxylated sorbitan surfactants, polyoxyethylene esters, polyoxyethylene sugar alcohol and dehydrated sugar alcohol esters, or a combination of two or more thereof. In certain embodiments, the oral care film may include, or in some instances 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 surfactants may comprise, or consist of, polysorbate 80 and / or polysorbate 20.

[0067] Examples of glucoside surfactants include decyl glucoside, stearyl glucoside, lauryl glucoside, coco-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. Additional nonionic surfactants that are worth mentioning include fatty alcohol ethoxylates, alcohol ethoxylate (AEO or AE), carboxylated alcohol ethoxylates, nonylphenol ethoxylate, and alkylphenol ethoxylates.

[0068] Further examples of nonionic surfactants include polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, ethylene oxide condensates of aliphatic alcohols, acids, and esters, long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkylsulfoxides and mixtures of such materials. Additional examples of nonionic surfactants include polyoxyethylene, polyoxyethylene sorbitan esters, polyoxyl 40 hydrogenated castor oil, fatty alcohol ethoxylates, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, 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 instances, the nonionic surfactant comprises amine oxides, fatty acid amides, ethoxylated fatty alcohols, block copolymers of polyethylene glycol and polypropylene glycol, glycerol alkyl esters, polyoxyethytene glycol octylphenol ethers, sorbitan alkyl esters, polyoxyethylene glycol sorbitan alkyl esters, or a combination of two or more thereof. In some embodiments, one or more of the above nonionic surfactants may be excluded from the oral care film.

[0069] In at least one preferred embodiment, nonionic surfactants are the only surfactants present in the oral care film, wherein the nonionic surfactants may 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.

[0070] The oral care film may comprise one or more anionic surfactant, wherein the anionic surfactants consist of non-sulfate based anionic surfactant. Preferably, the oral care film has a reduced amount of sodium lauryl sulfate and / or sodium lauryl ether sulfate. For instance, 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.

[0071] Additionally, the oral care films may a reduced amount of sulfate based anionic surfactants. The amount of sulfate based anionic surfactants 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 sulfate based anionic surfactants.

[0072] The oral care film may include, or in some embodiments exclude, one or more amphoteric surfactants, such as those having a substituent containing 8 to 18 carbon atoms and a substituentcontaining one or more carboxylate, sulfonate, sulfate, phosphate, or phosphonate. Examples of amphoteric surfactants include those having an alkyl group comprising from 8 to 20 carbon atoms, 8 to 16 carbon atoms, 10 to 16 carbon atoms, or 10 to 13 carbon atoms. The amphoteric surfactant(s) may include, but are not limited to, derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain 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, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate. The amphoteric surfactants disclosed herein may be present in the oral care film in a salt form.

[0073] The amphoteric surfactants may be selected from alkyl amphopropionates, betaines, alkyl sultaines, 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, e.g., alkyl betaines, such as coco dimethyl carboxymethyl betaine, lauryl dimethyl carboxy-methyl betaine, lauryl dimethyl alpha-carboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl)carboxy methyl betaine, stearyl bis-(2-hydroxypropyl)carboxymethyl betaine, oleyl dimethyl gamma-carboxypropyl betaine, lauryl bis-(2-hydroxypropyl)alpha- carboxyethyl betaine. In some embodiments, one or more of the above amphoteric surfactants may be excluded from the oral care film.

[0074] The oral care films may be formulated to have a weight ratio of the oleanolic acid to the hydroxide of about 105:1 to about 65:1. In some preferred embodiments, the weight ratio of the oleanolic acid to the hydroxide is from 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; from 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; from 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; from 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; from 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 83:1, about 86:1 to about 83:1; from 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 toabout 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. .

[0075] Additionally or alternatively, the oral care films may be formulated to have a weight ratio of the polyol to the nonionic surfactant of about 29: 1 to about 16:1. For instance, in some preferable embodiments, the weight ratio of the polyol to the nonionic surfactant is from about 26:1 to about 16:1, about 26:1 to about 18:1, about 26:1 to about 20:1, about 26:1 to about 22:1, about 26:1 to about 24:1; about 23:1 to about 16:1, about 23:1 to about 18:1, about 23:1 to about 20:1; about 21:1 to about 16:1, about 21:1 to about 18:1, about 21:1 to about 20:1 about 19:1 to about 16:1, or any range or subrange thereof.

[0076] The oral care film may be specifically formulated to have a weight ratio of the of the oleanolic acid to the total amount of the polyol and the nonionic surfactant of about 4: 1 to about 1:3. For instance, the oral care film may have a weight ratio of the of the oleanolic acid to the total amount of the polyol and the 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; from 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; from 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 subrange thereof.

[0077] The oral care film may also include a starch, e.g., in an amount from about 10 to about 30 wt.%, based on the total weight of the oral care film. In some instances, the oral care film includes starch in an amount from about 10 to about 27 wt.%, about 10 to about 24 wt.%, about 10 to about 21 wt.%, about 10 to about 19 wt.%, about 10 to about 17 wt.%, about 10 to about 15 wt.%; from about 13 to about 30 wt.%, about 13 to about 27 wt.%, about 13 to about 24 wt.%, about 13 to about 21 wt.%, about 13 to about 19 wt.%, about 13 to about 17 wt.%; from about 16 to about 30 wt.%, about 16 to about 27 wt.%, about 16 to about 24 wt.%, about 16 to about 21 wt.%, about 16 to about 19 wt.%; from about 18 to about 30 wt.%, about 18 to about 27 wt.%, about 18 to about 24 wt.%, about 18 to about 21 wt.%, about 18 to about 19 wt.%; from about 20 to about 30 wt.%, about 20 to about 27 wt.%, about 20 to about 24 wt.%; from about 22 to about 30 wt.%, about 22 to about 27 wt.%, about 22 to about 25 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0078] Cold water swellable, physically modified and pregelatenized starches are particularly useful as texture modifier to increase the stiffness of the oral care film. The starch, in certain embodiments, may be prepared by cooking the starch in the presence of water and optionally anorganic solvent at a temperature not more than 10 °C higher than the gelatinization temperature. After cooking the starch, the obtained starch may then be dried to obtain the final starch ingredient.

[0079] In some embodiments, the starch is a pregelanterized, stabilized and crosslinked waxy maize starch. In its dry form, the pregelanterized starch may have an average flake size no greater than 180 micrometers with 85% of the flakes being smaller than 75 micrometers. The bulk density of the pregelanterized maybe from about 20 to about 70 lbs / ft3, about 30 to about 60 lbs / ft3, about 30 to about 55 lbs / ft3, about 35 to about 55 lbs / ft3, about 40 to about 55 lbs / ft3, about 35 to about 50 lbs / ft3, about 40 to about 50 lbs / ft3, about 42 to about 48 lbs / ft3, or about 44 lbs / ft3.

[0080] Additionally or alternatively, the oral care film may include one or more thickening agent(s), e.g., in an amount from about 25 to about 80 wt.%, based on the total weight of the oral care film. For example, the oral care film may include a total amount of thickening(s) may be from about 25 to about 80 wt.%, about 25 to about 75 wt.%, about 25 to about 70 wt.%, about 25 to about 66 wt.%, about 25 to about 63 wt.%, about 25 to about 60 wt.%, about 25 to about 57 wt.%, about 25 to about 54 wt.%, about 25 to about 51 wt.%, about 25 to about 46 wt.%, about 25 to about 41 wt.%; from about 30 to about 80 wt.%, about 30 to about 75 wt.%, about 30 to about 70 wt.%, about 30 to about 66 wt.%, about 30 to about 63 wt.%, about 30 to about 60 wt.%, about 30 to about 57 wt.%, about 30 to about 54 wt.%, about 30 to about 51 wt.%, about 30 to about 46 wt.%, about 30 to about 41 wt.%; from about 35 to about 80 wt.%, about 35 to about 75 wt.%, about 35 to about 70 wt.%, about 35 to about 66 wt.%, about 35 to about 63 wt.%, about 35 to about 60 wt.%, about 35 to about 57 wt.%, about 35 to about 54 wt.%, about 35 to about 51 wt.%, about 35 to about 46 wt.%; from about 40 to about 80 wt.%, about 40 to about 75 wt.%, about 40 to about 70 wt.%, about 40 to about 66 wt.%, about 40 to about 63 wt.%, about 40 to about 60 wt.%, about 40 to about 57 wt.%, about 40 to about 54 wt.%, about 40 to about 51 wt.%; from about 45 to about 80 wt.%, about 45 to about 75 wt.%, about 45 to about 70 wt.%, about 45 to about 66 wt.%, about 45 to about 63 wt.%, about 45 to about 60 wt.%, about 45 to about 57 wt.%, about 45 to about 54 wt.%; from about 48 to about 80 wt.%, about 48 to about 75 wt.%, about 48 to about 70 wt.%, about 48 to about 66 wt.%, about 48 to about 63 wt.%, about 48 to about 60 wt.%, about 48 to about 57 wt.%; from about 51 to about 80 wt.%, about 51 to about 75 wt.%, about 51 to about 70 wt.%, about 51 to about 66 wt.%; from about 54 to about 80 wt.%, about 54 to about 75 wt.%, about 54 to about 70 wt.%; from about 57 to about 80 wt.%, about 57 to about 75 wt.%, about 57 to about 70 wt.%, about 57 to about 66 wt.%, about 57 to about 63 wt.%; fromabout 60 to about 80 wt.%, about 60 to about 75 wt.%, about 60 to about 70 wt.%, about 60 to about 66 wt.%; from about 63 to about 80 wt.%, about 63 to about 75 wt.%, from about 68 to about 80 wt.%, about 68 to about 75 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0081] Preferably, the one or more thickening agent comprises a cellulose. In certain embodiments, the oral care film comprises at least two celluloses. The thickening agents may consists of one or more celluloses or, in certain embodiments, at least two cellulose. Non-limiting examples of celluloses include hydroxyalkyl celluloses, such as hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxyethylpropyl cellulose, hydroxybutyl methyl cellulose, hydroxy propyl methyl cellulose, carboxymethyl cellulose, carboxymethyl hydroxyethylcellulose, hydroxypropyl methylcellulose, and methyl hydroxyethylcellulose. Microcrystalline cellulose is another cellulose that is worth mentioning. The cellulose polymer may be a low viscosity hydropropylmethyl cellulose polymer (HPMC). In some embodiments, it is preferable that the HPMC has a viscosity in the range of about 1 to about 40 millipascal seconds (mPa- s), as determined as a 2 wt.% aqueous solution of the HPMC at a temperature of 20 °C using a Ubbelohde tube viscometer. In some cases, the HPMC has a viscosity of about 3 to about 20 mPa- s at 20° C.

[0082] In at least one embodiments, the HPMC is a low viscosity HPMC having about 29.1% methoxyl groups and about 9% hydroxyproxyl group substitution and, e.g., has a viscosity of about 5.1 mPa- s at a temperature of 20 °C, measured as a 2 wt. % solution in water using a Ubbelohde tube viscometer. In another embodiment, the oral care film includes an HPMC (e.g., HPMC E50) having a viscosity from 40 to 60 cps.

[0083] Additional thickening agents, which may be included or excluded from 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 a combination of two more thereof. Natural gums such as xanthan gum, karaya, gum arabic, and gum tragacanth can also be incorporated.

[0084] In certain embodiments, the oral care film may comprise a salt. The salt may be a salt of an alkali metal and / or an alkali earth metal. For example, the oral care composition may include a salt selected from sodium chloride, potassium chloride, sodium bromide, sodium iodide, sodium hypochlorite, sodium chlorate, sodium perchlorate, sodium bromate, sodium iodate, sodiumnitrate, sodium sulphate, sodium thiosulfate, or a combination thereof. Tn at least one embodiment, the oral care composition includes a salt selected from sodium chloride, potassium chloride, sodium bromide, or a combination thereof.

[0085] The salt (e.g., salt of alkali metal and / or alkali earth metal) may be present in an amount from about 0.2 to about 4 wt.%, based on the total weight of the oral care film. In some cases, the salt may be present in an amount from about 0.2 to about 4 wt.%, about 0.2 to about 3 wt.%, about 0.2 to about 2 wt.%, about 0.2 to about 1 wt.%, about 0.2 to about 0.75 wt.%, about 0.2 to about 0.5 wt.%; from about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%, about 0.5 to about 0.75 wt.%; from about 1 to about 4 wt.%, about Ito about 3 wt.%, about 1 to about 2 wt.%, about 1 to about 1.5 wt.%; from about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%, about 1.5 to about 2 wt.%; from about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 2.5 to about 4 wt.%, about 2.5 to about 3.5 wt.%, or any range or subrange thereof, based on the total weight of the oral care film. The salt may be selected from the group consisting of salt of alkali metal and / or alkali earth metal. In at least one embodiment, the salt comprises or consists of sodium chloride.

[0086] The oral care film, in some cases, may include one or more opacifying agent and / or one or more colorant. The opacifying agent(s) may be present in an amount from about 10 to about 30 wt.%, based on the total weight of the oral care film. For example, the oral care film may include a total amount of opacifying agent(s) of about 10 to about 27 wt.%, about 10 to about 24 wt.%, about 10 to about 21 wt.%, about 10 to about 19 wt.%, about 10 to about 17 wt.%, about 10 to about 15 wt.%; from about 13 to about 30 wt.%, about 13 to about 27 wt.%, about 13 to about 24 wt.%, about 13 to about 21 wt.%, about 13 to about 19 wt.%, about 13 to about 17 wt.%; from about 16 to about 30 wt.%, about 16 to about 27 wt.%, about 16 to about 24 wt.%, about 16 to about 21 wt.%, about 16 to about 19 wt.%; from about 18 to about 30 wt.%, about 18 to about 27 wt.%, about 18 to about 24 wt.%, about 18 to about 21 wt.%, about 18 to about 19 wt.%; from about 20 to about 30 wt.%, about 20 to about 27 wt.%, about 20 to about 24 wt.%; from about 22 to about 30 wt.%, about 22 to about 27 wt.%, about 22 to about 25 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0087] The opacifying agents may comprise one or more a stannous oxide, stannic oxide, a titanium oxide, an iron oxide, zinc oxide, kaolin, mica, or a combination of two or more thereof. The iron oxide may be chosen from yellow iron oxide, red iron oxide, and / or iron(II,III) oxide. Inat least one preferred embodiment, the opacifying agent comprises or consisting of stannic oxide. The oral care films may have a reduced amount of titanium based opacifiers, such as titanium dioxide. For example, the amount of titanium based opacifiers 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 cases, the oral care film is substantially free of or free of titanium oxides and / or titanium based opacifiers.

[0088] Additionally or alternatively, the oral care film may comprise one or more colorants in an amount ranging from about 1 to about 3 wt.%, based on the total weight of the oral care film. For example, the oral care film may include a total amount of opacifying agent(s) of about 1 to about 3 wt.%, about 1 to about 2.5 wt.%, about 1 to about 2 wt.%, about 1 to about 1.5 wt.%; from about 1.5 to about 3 wt.%, about 1.5 to about 2.5 wt.%, about 1.5 to about 2 wt.%; from about 2 to about 3 wt.%, about 2 to about 2.5 wt.%, about 2.5 to about 3 wt.%, or any range or subrange thereof, based on the total weight of the oral care film.

[0089] The one or more colorants may comprise dyes, certified aluminum lakes or colors derived from a natural source. The colorant may be water-based, oil-based or dry. The colorants can be primary colors, blends of colors or discrete mixtures of colors, such as confetti. Non-limiting examples of dyes include food dyes suitable for food, drug and cosmetic applications, and mixtures thereof. Some color agents (colorants) are known as FD&C dyes.

[0090] The oral care films may include a reduced amount, be substantially free of, or free of water. For example, the oral care composition may include water in an amount of about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, about 0.05 wt.% or less, or about 0.01 wt.% or less. In certain embodiments, the oral care films are substantially free of water. In at least one preferred embodiment, the oral care film is free of water.

[0091] In accordance with further aspects of the disclosure, provided are methods for producing an oral care film, such as the oral care films disclosed herein. The method for producing the oral care film typically comprises forming a solution forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and non-ionic surfactant. The solution may also include one or more ingredients / components described herein with regard to the oral care films.

[0092] Additionally, the method typically comprises evaporating water from the aqueous solution to form the oral care film. For example, water may be removed from the aqueous solution by heating the slurry to a temperature about 60 to about 85 °C until the sufficient water has been removed (e.g., about 5 to 20 minutes in some instances).

[0093] Aspects of the present invention are also directed to oral care compositions, such as dentifrices, toothpastes, gels, or the like, containing at least one oral care film disclosed herein. In some preferred embodiments, the wherein the oral care composition absent the oral care film is translucent and / or transparent. Translucent, as used herein, refers to the characteristic of an oral care composition to permit the passage of light but does not necessarily allow for detailed objects to be distinguished through a thickness of 1 cm of the oral care composition. The term “transparent” with respect to oral care compositions of the present disclosure indicates that the oral care composition has transmittance of visible light of at least 65%, for example measured using a Lambda 40 UV-visible or Lambda 25 UV-visible spectrometer. The oral care compositions may have, for example, a transmittance of at least 70%, at least 75%, at least 80%, at least 85%, at least 88%, at least 90%, or at least 95% at a wavelength of 600 nm, measured, for example, using a Lambda 40 UV-visible spectrometer or Lambda 25 UV-visible spectrometer.

[0094] The oral care compositions may be formulated such that the majority of the oleanolic acid is present in the oral care film. For example, the oral care composition may have an amount of oleanolic acid other than the oleanolic acid present in the oral care film of about 3 wt.% or less, about 2 wt.% or less, about 1 wt.% or less, about 0.5 wt.% or less, about 0.1 wt.% or less, or about 0.05 wt.% or less. In some instances, the oral care composition is substantially free or free of oleanolic acid other than the oleanolic acid present in the oral care films in the oral care composition.

[0095] The oral care composition may comprise a fluoride ion source, a stannous source, a nitrate ion source, a phosphate source, an anti-calculus agent, one or more surfactant, a zinc source, one or more polyol, one or more abrasive, one or more thickening agent, and / or water. The oral care compositions may optionally comprise a stannous ion source, e.g., in an effective amount. The stannous ion source may be present in the oral care composition in an amount from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. For example, the amount of stannous ion present in the oral care composition may be from about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, about 0.3 to about4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition. In at least one embodiment, oral care composition includes about 0.4 to about 0.5 wt.% of stannous ion source, such as about 0.45 wt.% of stannous ion source.

[0096] The stannous ion source may be selected from the group consisting of: stannous fluoride, stannous chloride, stannous pyrophosphate, stannous formate, stannous acetate, stannous gluconate, stannous lactate, stannous tartrate, stannous oxalate, stannous malonate, stannous citrate, stannous ethylene glyoxide, and combinations of two or more thereof. The stannous source may comprise stannous fluoride, stannous chloride, stannous acetate, and a combination of two or more thereof. In at least one embodiment, the stannous ion source comprises stannous fluoride.

[0097] The oral care compositions may optionally comprise one or more nitrate ion source. The nitrate ion source(s) may be present in the oral care composition in an amount from about 0.1 to about 5 wt.%, based on the total weight of the oral care composition. In some instances, the amount of nitrate ion present in the oral care composition may be from about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, about 0.3 to about4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0098] The one or more nitrate ion source may be in the form of a salt or an ion derived therefrom, including, e.g., nitrate salt is selected from an alkali 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 two or more thereof. In at least one embodiment, the nitrate ion source comprises potassium nitrate.

[0099] The oral care composition may optionally comprise one or more phosphate ion source(s). The phosphate ion source(s) is preferably present in an effective amount. In some instances, the oral care composition may include one or more phosphate ion source(s) in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the one or more phosphate ion source(s) may be present in the oral care composition in an amount from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 7 wt.%, about 0.4 to about 6 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 4 wt.%, about 0.4 to about 3 wt.%, about 0.4 to about 2 wt.%, about 0.4 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0100] The phosphate source may preferably comprise a soluble phosphate compound, such as a phosphate salt. The phosphate source may be a phosphate ion source. Examples of phosphate ion sources include tetrasodium pyrophosphate, dicalcium orthophosphate dihydrate, dicalcium phosphate dihydrate, calcium hydrogen phosphate, calcium pyrophosphate, p-calcium pyrophosphate, tricalcium phosphate, calcium metaphosphate, potassium metaphosphate, sodium metaphosphate, or a combination thereof. The phosphate source may be a pyrophosphate salt, such as an alkali metal pyrophosphate salt. In certain embodiments, the alkali metal pyrophosphate is selected from a tetra alkali metal pyrophosphate, dialkali metal diacid pyrophosphate, trialkali metal monoacid pyrophosphate and mixtures thereof, wherein the alkali metals are sodium or potassium. For instance, the phosphate source may include tetrasodium pyrophosphate (TSPP), tetrapotassium pyrophosphate, sodium tripolyphosphate, tetrapolyphosphate, sodium trimetaphosphate, sodium hexametaphosphate or a combination of two or more thereof. The phosphate source may be chosen from orthophosphates, polymetaphosphates, pyrophosphates, anda combination of two or more thereof. In some instances, the phosphate source includes tetrasodium pyrophosphate (TSPP), sodium tripolyphosphatc (STPP), or a combination thereof. In at least one embodiment, the phosphate source comprises tetrasodium pyrophosphate. The phosphate source, when in the form of a salt, maybe in their hydrated and / or unhydrated forms.

[0101] The oral care composition may optionally include one or more anti-calculus agent. Examples of anti-calculus agents include, but are not limited to: phosphates and polyphosphates, polyaminopropane sulfonic acid (AM PS), polyolefin sulfonates, polyolefin phosphates, diphosphonates such as azacycloalkane-2, 2-diphosphonates (e.g., azacycloheptane-2,2- diphosphonic acid), N-methyl azacyclopentane-2,3-diphosphonic acid, ethane- 1 -hydroxy- 1,1- diphosphonic acid (EHDP) and ethane- 1 -amino- 1,1 -diphosphonate, phosphonoalkane carboxylic acids and. Useful inorganic phosphate and polyphosphate salts include monobasic, dibasic and tribasic sodium phosphates. Soluble pyrophosphates, such as those disclosed herein may be useful anticalculus agents. The pyrophosphate salts can be any of the alkali metal pyrophosphate salts.

[0102] The oral care composition may include the anti-calculus agents in an amount from about 0.1 to about 7 wt.%, based on the total weight of the oral care composition. For example, the anticalculus agent(s) may be present in the oral care composition in an amount from about 0.1 to about6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.4 to about 7 wt.%, about 0.4 to about 6 wt.%, about 0.4 to about 5 wt.%, about 0.4 to about 4 wt.%, about 0.4 to about 3 wt.%, about 0.4 to about 2 wt.%, about 0.4 to about 1 wt.%; from about 0.8 to about 7 wt.%, about 0.8 to about 6 wt.%, about 0.8 to about 5 wt.%, about 0.8 to about 4 wt.%, about 0.8 to about 3 wt.%, about 0.8 to about 2 wt.%; from about 1.4 to about 7 wt.%, about 1.4 to about 6 wt.%, about 1.4 to about 5 wt.%, about 1.4 to about 4 wt.%, about 1.4 to about 3 wt.%; from about 2 to about 7 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about7 wt.%, about 4 to about 6 wt.%, about 5 to about 7 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0103] The oral care composition may optionally include a zinc source. When present, the zinc ion source is preferably in an effective amount. The zinc source may be a zinc ion source. The zinc source (e.g., zinc ion source) may be present in the oral care composition in an amount from about 0.1 to about 8 wt.%, based on the total weight of the oral care composition. For example, theamount of zinc source (e.g., zinc ion source) present in the oral care composition may be from about 0.1 to about 6 wt.%, about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%; from about 0.3 to about 8 wt.%, about 0.3 to about 6 wt.%, about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 8 wt.%, about 0.6 to about 6 wt.%, about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about 3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 8 wt.%, about 0.9 to about 6 wt.%, about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 8 wt.%, about 1.2 to about 6 wt.%, about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 8 wt.%, about 1.5 to about 6 wt.%, about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 8 wt.%, about 2 to about 6 wt.%, about 2 to about 5 wt.%, about 2 to about4 wt.%, about 2 to about 3 wt.%; from about 3 to about 8 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%; from about 4 to about 8 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0104] The zinc source may be in the form of a salt. For example, the zinc source may comprise one or more zinc salt(s) chosen from zinc sulfate, zinc chloride, zinc acetate, zinc phenol sulfonate, zinc borate, zinc bromide, zinc nitrate, zinc glycerophosphate, zinc benzoate, zinc carbonate, zinc camosine, 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 zinc citrate, zinc oxide, zinc phosphate, zinc lactate, zinc sulfate, zinc silicate, zinc gluconate, and a combination of two or more thereof.

[0105] The oral care composition may optionally include one or more surfactants, e.g., in an amount ranging from about 0.5 to about 8 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include one or more surfactant in an amount from about 0.5 to about 7 wt.%, about 0.5 to about 6 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%; from about 1 to about 9 wt.%, about 1 to about 8 wt.%, about 1 to about 7 wt.%, about 1 to about 6 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 9 wt.%, about 2 to about 8 wt.%, about 2 to about 7 wt.%, about 2 to about 6wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 2.5 to about 9 wt.%, about 2.5 to about 8 wt.%, about 2.5 to about 7 wt.%, about 2.5 to about 6 wt.%, about 2.5 to about 5 wt.%, about 2.5 to about 4 wt.%, about 2.5 to about 3.5 wt.%; from about 3 to about 9 wt.%, about 3 to about 8 wt.%, about 3 to about 7 wt.%, about 3 to about 6 wt.%, about 3 to about 5 wt.%, about 3 to about 4 wt.%, about 3 to about 3.5 wt.%; from about 4 to about 9 wt.%, about 4 to about 8 wt.%, about 4 to about 7 wt.%, about 4 to about 6 wt.%, about 4 to about 5 wt.%; from about 5 to about 9 wt.%, about 5 to about 8 wt.%, about 5 to about 7 wt.%, about 5 to about 6 wt.%; from about 7 to about 9 wt.%, about 7 to about 8 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0106] The one or more surfactants may be selected from one or more anionic surfactant, one or more cationic surfactant, one or more nonionic surfactants, one or more amphoteric surfactants, one or more zwitterionic surfactants, one or more bacterial surfactant, or combinations of two or more thereof. The one or more anionic surfactant(s) may be selected be selected from sulfate based anionic surfactants and / or from non-sulfate based anionic surfactants, such as sulfonated monoglycerides of fatty acids, isethionates, sarcosinates, taurate, and a combination of two or more thereof. Examples of sulfate based anionic surfactants include sodium lauryl sulfate, ammonium lauryl ether sulfate, sodium lauryl sulfate, ammonium lauryl ether sulfate, sodium dodecyl sulfate, sodium coco- sulfate, ammonium coco- sulfate, and a combination of two or more thereof. In at least one embodiment, the oral care composition includes a sulfate based anionic surfactant, wherein the oral care composition is substantially free of or free of sodium lauryl sulfate and / or sodium lauryl ether sulfate.

[0107] Amphoteric surfactants are typically characterized by a combination of high surfactant activity, lather forming and mildness. The amphoteric surfactant may comprise a substituent containing 8 to 18 carbon atoms and a substituent containing one or more carboxylate, sulfonate, sulfate, phosphate, or phosphonate. For instance, the amphoteric surfactant may have an alkyl group comprising from 8 to 20 carbon atoms, 8 to 16 carbon atoms, 10 to 16 carbon atoms, or 10 to 13 carbon atoms. The amphoteric surfactant(s) may include, but are not limited to, derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain 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 watersolubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate. The amphoteric surfactants disclosed herein may be present in the oral care composition in a salt form.

[0108] The amphoteric surfactants may include alkyl amphopropionates, betaines, alkyl sultaines, alkyl amphoacetates, or a combination of two or more thereof. Preferably, the oral care composition includes an amphoteric surfactant selected from betaine surfactants (also referred to herein as betaines). The one or more nonionic surfactant(s) may be selected from glucosides, compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkylaromatic in nature. Further examples of nonionic surfactants include poloxamers, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, 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 materials.

[0109] The oral care compositions 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 to about 5 wt.%, based on the total weight of the oral care composition. For example, the fluoride ion source is present in an amount of about 0.01 to about 5 wt.%, about 0.01 to about 4 wt.%, about 0.01 to about 3 wt.%, about 0.01 to about2 wt.%, about 0.01 to about 1 wt.%; from about 0.05 to about 5 wt.%, about 0.05 to about 4 wt.%, about 0.05 to about 3 wt.%, about 0.05 to about 2 wt.%, about 0.05 to about 1 wt.%; from about 0.1 to about 5 wt.%, about 0.1 to about 4 wt.%, about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%; from about 0.3 to about 5 wt.%, about 0.3 to about 4 wt.%, about 0.3 to about 3 wt.%, about 0.3 to about 2 wt.%; from about 0.6 to about 5 wt.%, about 0.6 to about 4 wt.%, about 0.6 to about3 wt.%, about 0.6 to about 2 wt.%; from about 0.9 to about 5 wt.%, about 0.9 to about 4 wt.%, about 0.9 to about 3 wt.%, about 0.9 to about 2 wt.%; from about 1.2 to about 5 wt.%, about 1.2 to about 4 wt.%, about 1.2 to about 3 wt.%, about 1.2 to about 2 wt.%; from about 1.5 to about 5 wt.%, about 1.5 to about 4 wt.%, about 1.5 to about 3 wt.%; from about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 3 to about 5 wt.%, about 4 to about 5 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0110] The fluoride ion source may be selected from soluble fluoride ion salts. For example, the fluoride ion source may comprise sodium fluoride, potassium fluoride, calcium fluoride, zincfluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluoride, stannous fluorozirconatc, sodium monofluoropho sphatc, potassium monofluoropho sphatc, laurylamine hydrofluoride, diethylaminoethyloctoylamide hydrofluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, amine fluorides or a combination of two or more thereof. In some embodiments, the fluoride ion source comprises sodium fluoride, sodium monofluorophosphate, or a combination thereof. Additional examples of fluoride ion source are disclosed in U.S. Patent No. 3,535,421, U.S. Patent No.4,885,155, and U.S. Patent No. 3,678,154, the disclosure of each of which is hereby incorporated by reference in their entirety.

[0111] In certain embodiments, the oral care composition of the disclosure may contain a source of fluoride ions or fluorine-providing agents in amounts sufficient to deliver, in total, from 25 ppm to 25,000 ppm (mass fraction) of fluoride ions, generally at least 500 ppm, e.g., from about 500 to about 2000 ppm, from about 800 to about 1800 ppm, from about 1000 to about 1600 ppm, from about 1200 to about 1550 ppm, or about 1450 ppm.

[0112] The oral care compositions may optionally include one or more abrasive(s), e.g., in an amount from about 5 to about 35 wt.%, based on the total weight of the oral care composition. In some embodiments, the one or more abrasive(s) is present in an amount from about 5 to about 30 wt.%, about 5 to about 25 wt.%, about 5 to about 21 wt.%, about 5 to about 17 wt.%, about 5 to about 14 wt.%, about 5 to about 11 wt.%; from about 10 to about 35 wt.%, about 10 to about 30 wt.%, about 10 to about 25 wt.%, about 10 to about 21 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 15 to about 35 wt.%, about 15 to about 30 wt.%, about 15 to about 25 wt.%, about 15 to about 21 wt.%, about 15 to about 19 wt.%; from about 18 to about 35 wt.%, about 18 to about 30 wt.%, about 18 to about 25 wt.%, about 18 to about 21 wt.%; from about 21 to about 35 wt.%, about 21 to about 30 wt.%, about 21 to about 25 wt.%; from about 24 to about 35 wt.%, about 24 to about 30 wt.%; from about 27 to about 35 wt.%, about 27 to about 30 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0113] The one or more abrasive(s) may include: silica, silicate, silicon, alumina (including calcined aluminum oxide), aluminosilicates, such as bentonite, zeolite, kaolin, and mica, siliceous or diatomaceous earth, pumice, calcium carbonate, cuttlebone, insoluble phosphates, composite resins, such as melamine resin, phenolic resin, and urea-formaldehyde resin, polycarbonate, siliconcarbide, boron carbide, microcrystalline wax, microcrystalline cellulose, including combinations of colloidal microcrystallinc cellulose and carboxymcthylccllulosc, and combinations and derivatives thereof.

[0114] As used herein, “mica” refers to any of a group of hydrous aluminum silicate minerals with plate morphology and / or perfect basal (micaceous) cleavage. Mica can be, for example, sheet mica, scrap mica or flake mica, as exemplified by muscovite, biotite or phlogopite type micas. The abrasive may be selected from insoluble phosphates, such as orthophosphates, polymetaphosphates, pyrophosphates, and a combination thereof. Synthetic silicas include both silica gels and precipitated silicas that are prepared by the neutralization of aqueous silicate solutions with a strong mineral acid. Abrasives comprising silica may be useful in certain embodiments of the oral care composition. In certain embodiments, the oral care compositions may comprise a particularly efficacious combination of silica abrasive particle species. For example, the abrasive(s) be selected from high cleaning silica, tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), and a combination of two or more thereof.

[0115] The oral care composition may optionally include one or more thickening agent(s), e.g., in an amount from about 0.5 to about 20 wt.%, based on the total weight of the oral care composition. For example, the amount of thickening agent(s) in the oral care composition may be from about 0.5 to about 17 wt.%, about 0.5 to about 14 wt.%, about 0.5 to about 11 wt.%, about 0.5 to about9 wt.%, about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%; from about 1 to about 20 wt.%, about 1 to about 17 wt.%, about 1 to about 14 wt.%, about 1 to about 11 wt.%, about 1 to about 9 wt.%, about 1 to about 7 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%; from about 2 to about 20 wt.%, about 2 to about 17 wt.%, about 2 to about 14 wt.%, about 2 to about 11 wt.%, about 2 to about 9 wt.%, about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 4 to about 20 wt.%, about 4 to about 17 wt.%, about 4 to about 14 wt.%, about 4 to about 11 wt.%, about 4 to about 9 wt.%, about 4 to about 7 wt.%; from about 7 to about 20 wt.%, about 7 to about 17 wt.%, about 7 to about 14 wt.%, about 7 to about 11 wt.%; from about10 to about 20 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 14 to about 20 wt.%, about 14 to about 17 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0116] Thickening agents may be referred to as “thickeners” or “viscosity modifying agents.” Thickening agents arc typically included to increase the viscosity of the oral care compositions. Nonetheless, in some instances, certain thickening agents provide additional, surprising benefits to the oral care compositions.

[0117] The one or more thickening agent(s) may be selected from a polysaccharide, a silica thickener, an acrylate, a polymer, and a combination of two or more thereof. Examples of polysaccharides include cellulose, carboxymethyl hydroxyethylcellulose, cellulose acetate propionate carboxylate, hydroxyethylcellulose, hydroxyethyl ethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium cellulose sulfate, carrageenan, or a combination of two more thereof. Natural gums such as karaya, gum arabic, and gum tragacanth can also be incorporated. Colloidal magnesium aluminum silicate can also be used as a component of the thickening composition to further improve the composition's texture. Silica thickeners, which form polymeric structures or gels in aqueous media, may be present. Silica thickeners are typically physically and functionally distinct from the particulate silica abrasives as the silica thickeners are very finely divided and provide little or no abrasive action.

[0118] The oral care compositions may optionally include one or more polyol(s). The one or more polyol(s) may be present in the oral care composition in an amount from about 1 to about 60 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include polyol(s) in an amount from about 20 to about 55 wt.%, about 20 to about 50 wt.%, about 20 to about 45 wt.%, about 20 to about 40 wt.%, about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to about 60 wt.%, about 25 to about 55 wt.%, about 25 to about 50 wt.%, about 25 to about 45 wt.%, about 25 to about 40 wt.%, about 25 to about 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 60 wt.%, about 28 to about 55 wt.%, about 28 to about 50 wt.%, about 28 to about 45 wt.%, about 28 to about 40 wt.%, about 28 to about 37 wt.%, about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 60 wt.%, about 31 to about 55 wt.%, about 31 to about 50 wt.%, about 31 to about 45 wt.%, about 31 to about 40 wt.%, about 31 to about 37 wt.%; from about 34 to about 50 wt.%, about 34 to about 45 wt.%, about 34 to about 40 wt.%; from about 37 to about 60 wt.%, about 37 to about 55 wt.%, about 37 to about 50 wt.%, about 37 to about 45 wt.%; from about 40 to about 60 wt.%, about 40 to about 55 wt.%, about 40to about 50 wt.%, about 40 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0119] In other embodiments, the oral care composition may include polyol(s) in an amount from about 0.5 to about 17 wt.%, about 0.5 to about 14 wt.%, about 0.5 to about 11 wt.%, about 0.5 to about 9 wt.%, about 0.5 to about 7 wt.%, about 0.5 to about 5 wt.%, about 0.5 to about 4 wt.%, about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 20 wt.%, about 1 to about 17 wt.%, about 1 to about 14 wt.%, about 1 to about 11 wt.%, about 1 to about 9 wt.%, about 1 to about 7 wt.%, about 1 to about 5 wt.%, about 1 to about 4 wt.%, about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 20 wt.%, about 2 to about 17 wt.%, about 2 to about 14 wt.%, about 2 to about 11 wt.%, about 2 to about 9 wt.%, about 2 to about 7 wt.%, about 2 to about 5 wt.%, about 2 to about 4 wt.%, about 2 to about 3 wt.%; from about 4 to about 20 wt.%, about 4 to about 17 wt.%, about 4 to about 14 wt.%, about 4 to about 11 wt.%, about 4 to about 9 wt.%, about 4 to about 7 wt.%; from about 7 to about 20 wt.%, about 7 to about 17 wt.%, about 7 to about 14 wt.%, about 7 to about 11 wt.%; from about 10 to about 20 wt.%, about 10 to about 17 wt.%, about 10 to about 14 wt.%; from about 14 to about 20 wt.%, about 14 to about 17 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.

[0120] The polyol(s) may be chosen from glycols or compounds with numerous hydroxyl groups. The one or more polyols may be liquid at ambient temperature (25 °C). The polyol may be a humectant. In some preferred embodiments, the polyol(s) comprises glycerin, glycol, inositol, maltitol, mannitol, sorbitol, xylitol, propylene glycol, polypropylene glycol (PPG), polyethylene glycol (PEG), a block copolymer of PPG and PEG, a saccharide (e.g., fructose, glucose, sucrose and mixtures of saccharides, such as honey), or a combination of two or more thereof. For instance, the oral care composition comprises maltitol, mannitol, sorbitol, xylitol, a polypropylene glycol (PPG), a polyethylene glycol (PEG), a block copolymer of PPG and PEG, or a combination or two or more thereof.

[0121] In some cases, the oral care composition includes one or more polyol selected from the group consisting of C2-C32 polyols. The one or more polyols may have from 2 to 32 carbon atoms, from 3 to 16 carbon atoms, or from 3 to 12 carbon atoms. For example, the oral care composition may comprise ethylene glycol, propylene glycol, butylene glycol, hexylene glycol, glycerin, diglycerin, diethylene glycol, and dipropylene glycol, sorbitol, or a combination of two or morethereof. Additional, non-limiting examples of polyols that may, optionally, be included in the oral care include and / or may be chosen from glycerin, 1,2,6-hcxanctriol, trimcthylolpropanc, ethylene glycol, propylene glycol, butylene glycol, pentylene glycol, hexylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, pentaethylene glycol, dipropylene glycol, caprylyl glycol, 1 ,2-hexanediol, 1 ,2-pentanediol, and 4-methyl- 1 ,2-pentanediol sorbitol, sorbitan, triacetin, and a mixture thereof.

[0122] The oral care compositions of the present disclosure may include a flavoring agent. The flavoring agent is typically incorporated in the oral care composition at a concentration of about 0.01 to about 3 wt.%, by weight of the oral care composition. For example, the amount of flavoring agent(s) present in the oral care composition may be from about 0.01 to about 2 wt.%, about 0.01 to about 1 wt.%, about 0.01 to about 0.5 wt.%, about 0.01 to about 0.1 wt.%; from about 0.1 to about 3 wt.%, about 0.1 to about 2 wt.%, about 0.1 to about 1 wt.%, about 0.1 to about 0.5 wt.%; from about 0.5 to about 3 wt.%, about 0.5 to about 2 wt.%, about 0.5 to about 1 wt.%; from about 1 to about 3 wt.%, about 1 to about 2 wt.%; from about 2 to about 3 wt.%, including any range or subrange thereof, based on the total weight of the oral care composition.

[0123] Suitable flavoring agents include, but are not limited to, essential oils and various flavoring aldehydes, esters, alcohols, and similar materials. Examples of the essential oils include oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange. Also useful are chemicals such as menthol, carvone, and anethole. Additional flavoring agents may include, but are not limited to menthol, artificial vanilla, cinnamon derivatives, and various fruit flavors, spearmint oil, peppermint oil, cinnamon oil, oil of wintergreen (methylsalicylate), clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leaf oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, and a combination of two or more thereof.

[0124] The oral care compositions may include one or more colorants. Exemplary colorants can include natural or uncertified colors from natural sources or certified colors for the effect of color. In some embodiments, the colorant can include dyes, certified aluminum lakes or colors derived from a natural source. The colorant may be water-based, oil-based or dry. The colorants can be primary colors, blends of colors or discrete mixtures of colors, such as confetti. The concentrations of the colorant in the oral care composition may be from trace amount to about 0.6 wt.%, fromabout 0.1 to about 0.5 wt.%, about 0.2 to about 0.4 wt.%, or about 0.15 to about 0.35 wt.%, based on the total weight of the oral care composition.

[0125] The oral care composition may include one or more pH adjusters to increase or decrease the overall pH of the oral care composition. For example, one or more acids may be included to decrease the pH of the oral care composition. Examples of suitable acids for decreasing the pH of the oral care composition include, but are not limited to, citric acid, acetic acid, and the like. The oral care composition may include one or more bases, such as sodium hydroxide, potassium hydroxide and the like, to increase the pH of the oral care composition. Additional or alternative acids and bases that are suitable for adjusting the pH of the oral care composition are readily known to one of ordinary skill in the art.

[0126] The amount of the pH adjuster in the oral care composition may be based on the desired pH of the final oral care composition and / or product. For example, the total amount of the pH adjuster may range from about 0.05 to about 20 wt.%, based on the total weight of the oral care composition. In some instances, the total amount of pH adjuster is from about 0.05 to about 15 wt.%, about 0.1 to about 10 wt.%, or about 0.12 to about 5 wt.%, including ranges and sub-ranges therebetween, based on the total weight of the oral care composition.

[0127] The oral care compositions may have a pH from 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; from 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; from about 6 to about 10, about 6 to about 9, about 6 to about 8, or about 6 to about 7; from about 7 to about 10, about 7 to about 9, or about 7 to about 8, including any ranges and subranges therebetween.

[0128] The oral care compositions may include water in some embodiments. The water may be present in the oral care composition in an amount from about 5 to about 37 wt.%, based on the total weight of the oral care composition. For example, the oral care composition may include water in an amount from about 5 to about 34 wt.%, about 5 to about 31 wt.%, about 5 to about 28 wt.%, about 5 to about 25 wt.%, about 5 to about 20 wt.%; from about 10 to about 37 wt.%, about 10 to about 34 wt.%, about 10 to about 31 wt.%, about 10 to about 28 wt.%, about 10 to about 25 wt.%; from about 15 to about 37 wt.%, about 15 to about 34 wt.%, about 15 to about 31 wt.%, about 15 to about 28 wt.%, about 15 to about 25 wt.%; from about 20 to about 37 wt.%, about 20 to about 34 wt.%, about 20 to about 31 wt.%, about 20 to about 28 wt.%; from about 25 to about 37 wt.%, about 25 to about 34 wt.%, about 25 to about 31 wt.%; from about 28 to about 37 wt.%,about 28 to about 34 wt.%, about 28 to about 31 wt.%; from about 31 to about 37 wt.%; from about 37 to about 50 wt.%, about 37 to about 45 wt.%, or any range or subrange thereof, based on the total weight of the oral care composition.EXAMPLESExample 1

[0129] Four non-limiting example oral care films (Exame Films A-D) were prepared in accordance with aspects of the invention. A comparative oral care film (Comparative Film 1) was also prepared. The formulation for Example Films A-D and Comparative Film 1 is shown in Table 1.Table 1

Claims

CLAIMSWhat is Claimed is:

1. An oral care film for an oral care composition, the oral care film comprising: from about 5 to about 19 wt.% of oleanolic acid and / or a salt thereof, based on the total weight of the oral care film; a hydroxide; a polyol optionally in an amount from about 4 to about 25 wt.%, based on the total weight of the oral care film; a non-ionic surfactant; a starch optionally in an amount from about 10 to about 30 wt.%, based on the total weight of the oral care film; and optionally, from about 25 to about 80 wt.% of 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, capryl glycol, and a combination of two or more thereof.

3. The oral care film according to 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 according to any foregoing claim, wherein the nonionic surfactant comprises an ethoxylated sorbitan surfactants.

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

6. The oral care film according to any foregoing claim, wherein the oral care film is free of surfactants other than nonionic surfactants.

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

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

9. The oral care film according to any foregoing 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 according to any foregoing claim, further comprising an opacifying agent comprising stannous oxide, a titanium oxide, an iron oxide, or a combination thereof.

11. The oral care film according to any foregoing claim, further comprising a colorant.

12. An oral care film for an oral care composition, the oral care film comprising: oleanolic acid; a hydroxide; a polyol; and a non-ionic surfactant, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of about 90: 1 to about 80: 1, and the oral care film has a weight ratio of the polyol to the nonionic surfactant of about 27:1 to about 18:1.

13. The oral care film according to any foregoing claim, wherein the oral care film has about 2 wt.% or less of water.

14. The oral care film, according to any foregoing claim, wherein the oral care film is substantially free or free of water.

15. An oral care film for an oral care composition, the oral care film consisting of: oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; a starch; optionally, a salt; optionally, an opacifying agent, and optionally, a colorant.

16. An oral care composition comprising the oral care film according to any foregoing claim, wherein the oral care composition absent the oral care film is translucent.

17. An oral care composition comprising the oral care film according to any foregoing claim, wherein the oral care composition is substantially free or free of oleanolic acid other than the oleanolic acid present in the oral care film.

18. A method of producing an oral care film, the method comprising: forming an aqueous solution by mixing water, oleanolic acid and / or a salt thereof, a hydroxide, a polyol, and a non-ionic surfactant; evaporating water from the aqueous solution to form the oral care film.

19. An oral care film for an oral care composition, the oral care film consisting of: oleanolic acid and / or a salt thereof; a hydroxide; a polyol; a non-ionic surfactant; a starch;a salt; optionally, an opacifying agent; and optionally, a colorant, wherein the oral care film has a weight ratio of the oleanolic acid to the hydroxide of about 90:1 to about 80:1, and wherein the oral care film has a weight ratio of the polyol to the nonionic surfactant of about 27:1 to about 18.

20. The oral care film according to claim 6, wherein the nonionic surfactants are selected from the group consisting of ethoxylated sorbitan surfactants.

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