Oral care compositions and methods for whitening teeth

Abstract

Disclosed herein are oral care compositions comprising one or more water-soluble polymers and whitening agents comprising one or more acyl donors and one or more perhydrolase enzymes, wherein the oral care composition is in the form of a solid film. Further disclosed herein are methods of making and using the oral care composition, as well as kits comprising the oral care composition and a dentifrice comprising at least one source of hydrogen peroxide.

Description

ORAL CARE COMPOSITIONS AND METHODS FOR WHITENING TEETH CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of priority from U.S. Provisional Patent Application No.63 / 609,489, filed 13 December 2023, the contents of which are hereby incorporated herein by reference in their entirety. BACKGROUND

[0002] Conventional oral care products such as toothpastes and gels may include oral care whitening agents and are often used to whiten teeth. For example, conventional toothpastes including hydrogen peroxide may be used to oxidize chromophores bound to surfaces of teeth to thereby whiten the teeth. While toothpastes including hydrogen peroxide have proven effective for whitening teeth, different chromophores on the surfaces are often oxidized at varying rates and / or via varying mechanisms. Accordingly, toothpastes including a single whitening agent (e.g., hydrogen peroxide) may require relatively longer periods of treatment to appreciably whiten the teeth and may generally be less effective.

[0003] In view of the foregoing, oral care products incorporating hydrogen peroxide often include an additional oral care whitening agent or agents to facilitate the oxidation of the different chromophores and thereby shorten the periods of treatment. However, the incorporation of multiple whitening agents in novel oral care products has proven to be difficult due to the general instability and / or degradation of the whitening agents. For example, oral cleansing and whitening compositions in the form of solid films have been developed. However, incorporation of stable whitening agents in these solid films has presented challenges due to the instability and / or the degradation of the whitening agents.

[0004] Therefore, improved oral care whitening compositions and methods for whitening teeth are needed. BRIEF SUMMARY

[0005] This summary is intended merely to introduce a simplified summary of some aspects of one or more implementations of the present disclosure. Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. This summaryis not an extensive overview, nor is it intended to identify key or critical elements of the present teachings, nor to delineate the scope of the disclosure. Rather, its purpose is merely to present one or more concepts in simplified form as a prelude to the detailed description below.

[0006] In certain embodiments of the disclosure, there is provided an oral care composition that may be used to enhance whitening efficacy of the teeth, for example when used together with a dentifrice comprising at least one source of hydrogen peroxide. In certain embodiments, the oral care composition comprises one or more water-soluble polymers and a whitening agent comprising one or more acyl donor and one or more perhydrolase enzymes, wherein the oral care composition is in the form of a solid film.

[0007] In certain embodiments, the oral care composition is free of or substantially free of hydrogen peroxide.

[0008] In certain embodiments, the one or more perhydrolase enzymes are present in the oral care composition in an amount ranging from about 0.001 wt% to about 2 wt%, about 0.001 wt% to about 1 wt%, about 0.005 wt% to about 0.5 wt%, about 0.01 wt% to about 0.05 wt%, or about 0.01 wt%, based on the total weight of the oral care composition. In certain embodiments, the one or more acyl donor is triacetin, and in certain embodiments, the one or more acyl donor is present in the oral care composition in an amount ranging from about 1 wt% to about 20 wt%, about 3 wt% to about 17 wt%, about 4 wt% to about 15 wt%, about 10 wt% to about 15 wt%, or about 14 wt% to about 15 wt%, based on the total weight of the oral care composition.

[0009] According to certain embodiments, the one or more water-soluble polymers selected from carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), cetyl hydroxyethylcellulose, hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinylpyrrolidone (PVP), polyvinylpyrrolidone / vinyl acetate (PVP / VA), cellulose ethers, or a combination thereof. In one embodiment, the water soluble polymer is PVP, and in one embodiments, the water-soluble polymer in HPMC. In certain embodiments, the one or more water-soluble polymers are present in an amount ranging from about 60 wt% to about 90 wt%, about 70 wt% to about 80 wt%, about 71 wt% to about 75 wt%, or about 71 wt% to about 72 wt%, based on the total weight of the oral care composition.

[0010] In certain embodiments of the disclosure, the oral care composition further comprises a sugar or sweetener, such as sucralose. In certain embodiments, the sugar or sweetener is present in an amount ranging from about 0.01 wt% to about 10 wt%, about 0.1 wt% to about 5%, about0.9 wt%, or about 5 wt%, based on the total weight of the oral care composition.

[0011] In certain embodiments, the oral care composition further comprises water, for example water present in an amount ranging from about 1 wt% to about 10 wt%, about 5 wt% to about 9 wt%, or about 7 wt% to about 8 wt%, based on the total weight of the oral care composition.

[0012] In certain embodiments disclosed herein, the solid film of the oral care composition is dissolvable and / or disintegrable, for example in water and / or in saliva.

[0013] In accordance with another aspect of the disclosure, provided is a method for preparing the oral care composition disclosed herein, the method comprising contacting the one or more water- soluble polymers and the whitening agents comprising one or more acyl donor and one or more perhydrolase enzymes with water to prepare a slurry; casting the slurry onto a surface to form a layer; and drying the layer to form the solid film.

[0014] In certain embodiments of the method for preparing the oral compositions disclosed herein, the layer is dried at about 20oC to about 100oC for about 5 minutes to about 24 hours, such as from about 60oC to about 70oC for about 30 minutes to about 60 minutes. In certain embodiments of the method, the water is added to the slurry in an amount ranging from about 60 wt% to about 90 wt%, about 70 wt% to about 80 wt%, about 71 wt% to about 75 wt%, or about 73 wt% to about 74 wt%, based on the total weight of the slurry, and in certain embodiments, water is present in the solid film in an amount ranging from about 1 wt% to about 10 wt%, about 5 wt% to about 9 wt%, or about 7 wt% to about 8 wt%, based on the total weight of the oral care composition.

[0015] Also disclosed herein are methods of whitening teeth, the methods comprising applying the oral care composition as disclosed herein to the teeth and contacting the teeth with a dentifrice comprising at least one source of hydrogen peroxide. In certain embodiments, the dentifrice comprising at least one source of hydrogen peroxide is a toothpaste, and in certain embodiments, the hydrogen peroxide is present in the dentifrice comprising hydrogen peroxide in an amount ranging from about 0.01 wt% to about 5.0 wt%, about 0.01 wt% to about 1.0 wt%, about 0.05 wt% to about 0.5 wt %, or about 0.1 wt%, based on the total weight of the dentifrice.

[0016] In accordance with another aspect of the disclosure, there is provided a kit comprising the oral care composition as disclosed herein and a dentifrice comprising at least one source of hydrogen peroxide, wherein the oral care composition and the dentifrice are separate until the time of use.BRIEF DESCRIPTION OF THE DRAWING

[0017] The features, and advantages of the disclosure will be apparent from the following more detailed description of certain embodiments and as illustrated in the accompanying drawing in which:

[0018] FIG. 1 is a graph showing the whitening efficacy of a 0.1% hydrogen peroxide toothpaste used alone and a 0.1% hydrogen peroxide toothpaste used in conjunction with an enzyme film, as described in Example 2.

[0019] It should be understood that the various aspects are not limited to the compositions, arrangements, and instrumentality shown in the figure. DETAILED DESCRIPTION

[0020] For illustrative purposes, the principles of the present disclosure are described by referencing various exemplary embodiments thereof. Although certain embodiments 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 in detail, it is to be understood that the disclosure 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.

[0021] 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 not limited to”.

[0022] As used throughout, ranges are used as shorthand for describing each and every value that is within the range. It should be appreciated and understood that the description in a range format is merely for convenience and brevity, and should not be construed as an inflexible limitation on the scope of any embodiments or implementations disclosed herein. Accordingly, the disclosed range should be construed to have specifically disclosed all the possible subranges as well as individual numerical values within that range. As such, any value within the range may be selectedas the terminus of the range. For example, description of a range such as from 1 to 5 should be considered to have specifically disclosed subranges such as from 1.5 to 3, from 1 to 4.5, from 2 to 5, from 3.1 to 5, etc., as well as individual numbers within that range, for example, 1, 2, 3, 3.2, 4, 5, etc. This applies regardless of the breadth of the range.

[0023] Unless otherwise specified, all percentages and amounts expressed herein and elsewhere in the specification should be understood to refer to percentages by weight. The amounts given are based on the active weight of the material.

[0024] Additionally, all numerical values are “about” or “approximately” the indicated value, and take into account experimental error and variations that would be expected by a person having ordinary skill in the art. It should be appreciated that all numerical values and ranges disclosed herein are approximate values and ranges, whether “about” is used in conjunction therewith. It should also be appreciated that the term “about,” as used herein, in conjunction with a numeral refers to a value that may be ± 0.01% (inclusive), ± 0.1% (inclusive), ± 0.5% (inclusive), ± 1% (inclusive) of that numeral, ± 2% (inclusive) of that numeral, ± 3% (inclusive) of that numeral, ± 5% (inclusive) of that numeral, ± 10% (inclusive) of that numeral, or ± 15% (inclusive) of that numeral. It should further be appreciated that when a numerical range is disclosed herein, any numerical value falling within the range is also specifically disclosed.

[0025] As used herein, “free” or “substantially free” of a material may refer to a composition, component, or phase where the material is present in an amount of less than 10.0 weight %, less than 5.0 weight %, less than 3.0 weight %, less than 1.0 weight %, less than 0.1 weight %, less than 0.05 weight %, less than 0.01 weight %, less than 0.005 weight %, or less than 0.0001 weight % based on a total weight of the composition, component, or phase. In certain embodiments, if a composition is free or substantially free of a material, the material is not present in detectable quantities in the composition.

[0026] 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.

[0027] Peracetic acid is a strong bleaching agent that rapidly targets a broad range of tough stains. Hydrogen peroxide and triacetin can be converted to peracetic acid via the perhydrolase enzyme. Disclosed herein is an oral care composition, such as a solid oral care composition (e.g., a film) for use in teeth whitening that comprises both the perhydrolase enzyme and triacetin. The oral carecomposition disclosed herein may be used together with a separate source of hydrogen peroxide, e.g., a dentifrice such as a toothpaste comprising hydrogen peroxide, in order to enhance the whitening efficacy of the hydrogen peroxide.

[0028] In certain embodiments, the oral care composition disclosed herein is a solid intended to contact the oral cavity and / or one or more surfaces of the oral cavity, e.g., the teeth. In an exemplary implementation, the oral care composition is a tooth whitening composition, similar to a toothpaste, but in the form of a solid film, ribbon, tape, strip, or the like. In certain embodiments, the oral care composition is intended to be used together with a toothpaste or other dentifrice for enhancing the whitening efficacy of the toothpaste or other dentifrice. For simplicity, the terms “dentifrice” or “toothpaste” are used herein to refer to an oral cleansing and / or whitening composition, and do not otherwise refer to the oral care composition (e.g., solid film) disclosed herein. The term “toothpaste” as used herein, however, does not limit the oral cleansing and / or whitening composition to a “paste,” but is used to refer to conventional uses for a “toothpaste.”

[0029] The oral care compositions disclosed herein may be a toothpaste in the form of a film, such as a ribbon, strip, or tape. Each of the ribbons, strips, or tape, may be packaged as a single dose (e.g., single use strip) or a multi-dose (e.g., roll, stack, etc.) that may be separated by the user / consumer. The oral care composition may be disposed of or packaged in a container, such as an airtight container. Illustrative containers may include, but are not limited to, a retort pouch, a sachet, a TETRA PAK®, a bottle, a tray, a metal can (e.g., tin can), or the like, or combinations thereof. In a preferred implementation, the oral care composition may be disposed in a retort pouch or a sachet that is portable and / or disposable. It should be appreciated that each of the containers may include any number of servings or doses of the oral care composition. For example, each container may include a single dose or multiple doses.

[0030] As noted above, the oral care composition disclosed herein may be a toothpaste in the form of a ribbon, strip, or tape, such as a solid film. The solid film may be dissolvable and / or disintegrable. As used herein, the term or expression “dissolvable” may refer to the ability to disperse into a liquid. For example, a dissolvable solid film may disperse into a liquid, such as saliva. As used herein, the term or expression “disintegrable” may refer to the ability to decompose into constituent elements, parts, and / or small particles. It should be appreciated that the ability of the solid film to be dissolvable and / or disintegrable may be provided by one or more components of the oral care composition. For example, an orally acceptable vehicle and / or water-solublepolymer incorporated into the oral care composition may at least partially contribute to the dissolvable and / or disintegrable properties of the oral care composition. In at least one implementation, the solid film may be dissolvable and / or disintegrable in water, saliva, or a combination thereof. The solid film may be dissolvable and / or disintegrable in a predetermined amount of time and / or rate. For example, the solid film may be completely dissolvable and / or disintegrable in about 30 seconds or less, about 1 min or less, about 2 min or less, about 3 min or less, about 5 min or less, about 10 min or less. In another example, the solid film may dissolve or disintegrate at a rate of about 0.5 gram / minute (g / min) or less, about 1 g / min or less, about 1.5 g / min or less, about 2 g / min or less, about 3 g / min or less, about 5 g / min or less, about 10 g / min or less, about 15 g / min or less, or about 30 g / min or less. It should be appreciated that conventional oral care compositions in the form of a solid film are often not dissolvable or disintegrable; and thus, need to be physically removed (e.g., peeling, abrading, etc.) after a predetermined period of time.

[0031] In at least one implementation, contacting the oral care composition with a hydrogen- peroxide containing dentifrice (e.g., toothpaste) may initiate a whitening effect. For example, contacting the whitening agents of the oral care composition with the hydrogen peroxide of the dentifrice composition may initiate the release of peracetic acid. As noted above, the oral care composition may be in the form of a solid film or ribbon. As such, water may be provided by saliva when contacting the solid film with surfaces of the oral cavity. The water may also be provided by water utilized in the cleaning of the oral cavity (e.g., during brushing). For example, the oral care composition may be applied to the surfaces of the oral cavity, e.g., the teeth, and added water and / or saliva acts to dissolve or disintegrate the film to release the whitening agents in the oral care composition so that it reacts with the hydrogen peroxide in the dentifrice composition, creating peracetic acid and initiating a whitening effect. Similarly, the action of brushing or agitation with a toothbrush may facilitate the initiation of the whitening effect. Whitening agents

[0032] The one or more whitening agents may be or include materials or substances that are effective to, capable of, or configured to provide whitening of a tooth surface to which it is applied. In certain embodiments, the one or more whitening agents are non-peroxide whitening agents. By way of non-limiting example, the one or more whitening agents may include at least one enzyme, e.g., a perhydrolase enzyme, and at least one acyl donor, e.g., triacetin. In addition, the one or morewhitening agents may further include, but are not limited to, one or more sources of non-peroxide bleaching agents. A. Acyl Donor

[0033] The oral care composition may include one or more acyl donors. The one or more acyl donors may be any compound or material configured to react with any one or more of the sources of hydrogen peroxide and / or any one or more of the enzymes having perhydrolytic activity to form an oral care whitening enhancer. The acyl donors may be or include, but are not limited to, C2-18 carboxylic acids, including lower linear or branched alkyl carboxylic acids, hydrolysable esters of C2-18 carboxylic acids, and the like, and mixtures or combinations thereof. In at least one example, the C2-18carboxylic acids may be unsubstituted. In another example, the C2-18carboxylic acids may be substituted with a hydroxyl and / or a C1-4alkoxy group.

[0034] In certain embodiments, the one or more acyl donors may be an ester represented by formula (1), [X]mR5(1), wherein X is an ester group represented by formula (2), R6C(O)O (2), and wherein R5is a C1-6linear, branched, or cyclic hydrocarbyl moiety, a five-member cyclic heteroaromatic moiety, or a six-member cyclic aromatic or heteroaromatic moiety, optionally substituted with hydroxyl groups, where each individual carbon atom in R5 includes no more than one hydroxyl group, no more than one ester group, no more than one ester group or carboxylic acid group, where R5optionally includes one or more ether linkages, where m is an integer from 1 to the number of carbon atoms in R5, and where the esters have a solubility in water of at least 5 ppm at 25 °C; where R6 is a C1 to C7 linear, branched or cyclic hydrocarbyl moiety, optionally substituted with a hydroxyl group or C1to C4alkoxy group, wherein R6optionally includes one or more ether linkages where R6 is C2 to C7.

[0035] In one embodiment, the one or more acyl donor may be glyceride represented by the formula (3), ,where R1is a C1-7straight or branch chain alkyl, optionally substituted with a hydroxyl or a C1-4 alkoxy group, and R3 and R4 are individually an H or an R1C(O).

[0036] In another example, the one or more acyl donors may be an ester represented by the formula (4), , where R1 is a C1-7 straight or with a hydroxyl or a C1-4alkoxy group, R2is a C1-10or alkynyl, aryl, alkylaryl, alkylheteroaryl, heteroaryl, (CH2CH2O)n, or (CH2CH(CH3)—O)nH, and n is an integer from 1 to 10.

[0037] In yet another example, one or more of the acyl donors may be an acetylated saccharide. Illustrated acetylated saccharides may be or include, but are not limited to, acetylated monosaccharides, acetylated disaccharides, acetylated polysaccharide, and the like, and combinations thereof.

[0038] The one or more acyl donors may be or include, but are not limited to, C2-18carboxylic acids, C2-6 carboxylic acids (e.g., acetic acid), including lower linear or branched alkyl carboxylic acids, optionally substituted with hydroxy and / or C1-4 alkoxy groups, hydrolysable and acceptable esters thereof (e.g., mono-, di-, and tri-glycerides, and acylated saccharides), and mixtures thereof. In at least one example, the one or more acyl donors may be or include, but are not limited to 1,2,3- triacetoxypropane or triacetin or glycerin triacetate, acylated saccharides, and the like, and combinations thereof. In at least one implementation, the at least one acyl donor may have a water solubility of at least 5 ppm at 25 °C. In certain embodiments, the acyl donor is 1,2,3- triacetoxypropane or triacetin.

[0039] In at least one implementation, the one or more acyl donors may be or include, but are not limited to, one or more acylated saccharides selected from acylated mono-, di-, and polysaccharides. In another implementation, the acylated saccharides are selected from acetylated xylan, fragments of acetylated xylan, acetylated xylose (e.g., xylose tetraacetate), acetylated glucose (e.g., α-D-glucose pentaacetate, β-D-glucose pentaacetate, 1-thio-β-D-glucose-2,3,4,6- tetraacetate), β-D-galactose pentaacetate, sorbitol hexaacetate, sucrose octaacetate, β-D- ribofuranose-1,2,3,5-tetraacetate. β-D-ribofuranose-1,2,3,4-tetraacetate, tri-O-acetyl-D-galactal, tri-O-acetyl-D-glucal, β-D-xylofuranose tetraacetate, β-D-glucopyranose pentaacetate, β-D-glucopyranose-1,2,3,4-tetraacetate, β-D-glucopyranose-2,3,4,6-tetraacetate, 2-acetamido-2- deoxy-1,3,4,6-tetracetyl-3-D-glucopyranose, 2-acetamido-2-deoxy-3,4,6-triacetyl-1-chloride-α- D-glucopyranose, β-D-mannopyranose pentaacetate, and acetylated cellulose. In a typical implementation, the acetylated saccharide is selected from β-D-ribofuranose-1,2,3,5-tetraacetate, tri-O-acetyl-D-galactal, tri-O-acetyl-D-glucal, sucrose octaacetate, and acetylated cellulose. In another implementation, the acyl donors may include 5-acetoxymethyl-2-furaldehyde, 3,4- diacetoxy-1-butene, 4-acetoxybenezoic acid, vanillin acetate, propylene glycol methyl ether acetate, methyl lactate, ethyl lactate, methyl glycolate, ethyl glycolate, methyl methoxyacetate, ethyl methoxyacetate, methyl 3-hydroxybutyrate, ethyl 3-hydroxybutyrate, and triethyl 2-acetyl citrate.

[0040] In yet another implementation, the one or more acyl donors are selected from monoacetin, diacetin, triacetin, monopropionin, dipropionin, tripropionin, monobutyrin, dibutyrin, tributyrin, glucose pentaacetate, xylose tetraacetate, acetylated xylan, acetylated xylan fragments, 3-D- ribofuranose-1,2,3,5-tetraacetate, tri-O-acetyl-D-galactal, tri-O-acetyl-D-glucal, monoesters or diesters of 1,2-ethanediol, 1,2-propanediol, 1,3-propanediol, 1,2-butanediol, 1,3-butanediol, 2,3- butanediol, 1,4-butanediol, 1,2-pentanediol, 2,5-pentanediol, 1,5-pentanediol, 1,6-pentanediol, 1,2-hexanediol, 2,5-hexanediol, 1,6-hexanediol, and mixtures thereof. In a further implementation, the acyl donor is propylene glycol diacetate (PGDA), ethylene glycol diacetate (EGDA), or a mixture thereof. In yet another implementation, the one or more acyl donors are selected from monoacetin, diacetin, triacetin, monopropionin, dipropionin, tripropionin, monobutyrin, dibutyrin, and tributyrin. In yet another aspect, the acyl donor is selected from diacetin and triacetin.

[0041] The amount or concentration of the one or more acyl donors may vary widely. In at least one implementation, the amount of the one or more acyl donors may be at least partially determined by a target or desired concentration of peroxyacid or peracetic acid to be generated via enzyme-catalyzed perhydrolysis. For example, the target or desired concentration of peroxyacid or peracetic acid to be generated via enzyme-catalyzed perhydrolysis may be less than or equal to about 2,000 ppm, and the amount of the one or more acyl donors present in the oral care composition may be greater than or equal to 0.05 wt% and less than or equal to 40 wt% based on a total weight of the oral care composition. For example, the amount of the one or more acyl donors present in the oral care whitening composition may be from about 0.05 wt%, about 5 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, or about 40wt%. In another implementation, the amount of the one or more acyl donors present in the oral care composition may be less than about 20 wt%. For example, the amount of the one or more acyl donors present in the oral care composition may be less than about 19 wt%, less than about 18 wt%, less than about 17 wt%, less than about 16 wt%, less than about 15 wt%, less than about 14 wt%, less than about 13 wt%, less than about 12 wt%, less than about 11 wt%, less than about 10 wt%, less than about 9 wt%, less than about 8 wt%, less than about 7 wt%, less than about 6 wt%, less than about 5 wt%, less than about 4 wt%, less than about 2 wt%, less than about 1.5 wt%, less than about 1.0 wt%, less than about 0.9 wt%, less than about 0.8 wt%, less than about 0.7 wt%, less than about 0.6 wt%, less than about 0.5 wt%, less than about 0.4 wt%, less than about 0.3 wt%, less than about 0.2 wt%, or less than about 0.1 wt%. In certain embodiments, the amount of the one or more acyl donors may present in the oral care composition may range from about 1 wt% to about 20 wt%, about 3 wt% to about 17 wt%, about 4 wt% to about 15 wt%, about 10 wt% to about 15 wt%, about 14 wt% to about 15 wt%, about 15 wt%, or about 14.8 wt%. In certain embodiments, the amount of the one or more acyl donors may present in the oral care composition may range from about 1 wt% to about 10 wt%, about 2 wt% to about 6 wt%, about 4 wt% to about 5 wt%, about 4 wt%, or about 4.3 wt%.

[0042] In certain embodiments, the acyl donor is triacetin, and the triacetin is present in the oral care composition in an amount ranging from about 1 wt% to about 20 wt%, such as from about 2 wt% to about 5 wt% or from about 12 wt% to about 15 wt%. It is noted that the weight percent of the one or more acyl donors may increase when the oral care composition is in the form of a solid as compared to a liquid (e.g., slurry) form, where a higher amount of water is present in the oral care composition. B. Enzymes having Perhydrolytic activity

[0043] The oral care composition of the present disclosure may include one or more enzymes having perhydrolytic activity. The one or more enzymes having perhydolytic activity include any enzyme capable of catalyzing a reaction between the one or more sources of hydrogen peroxide or the hydrogen peroxide generated therefrom as described herein and a suitable substrate, i.e., an acyl donor of the present disclosure, to generate an oral care whitening enhancer, i.e., peracetic acid. In certain embodiments, the enzyme having perhydrolytic activity is a perhydrolyase. Perhydrolases are enzymes that generate peroxyacid via perhydrolysis. In enzyme-catalyzed perhydrolysis reactions, the acyl donor substrate (a peroxyacid precursor) is combined with asource of hydrogen peroxide and water. The perhydrolase enzyme catalyzes the formation of a peroxyacid, such as peracetic acid.

[0044] Enzymes having perhydrolytic activity include certain lipases, proteases, esterases, acyl transferases, aryl esterases, carbohydrate esterases, and combinations thereof. Examples include the perhydrolytic proteases disclosed in U.S. Pat. No. 7,510,859, which is herein incorporated by reference in its entirety, the perhydrolytic aryl esterases disclosed in U.S. Pat. No. 8,663,616, which is herein incorporated by reference in its entirety and the perhydrolytic aryl esterase / acyl transferase from Mycobacterium smegmatis, which is disclosed in U.S. Pat. No. 8,663,616. In certain embodiments, the perhydrolase is a perhydrolase carbohydrate esterase.

[0045] In certain embodiments of the disclosure, the perhydrolase carbohydrate esterase suitable for inclusion in the present oral care compositions is a member of the carbohydrate esterase family 7 (CE-7). Enzymes from the CE-7 family are well known in the art (see Coutinho, P. M., Henrissat, B. “Carbohydrate-active enzymes: an integrated database approach” in Recent Advances in Carbohydrate Bioengineering, H. J. Gilbert, G. Davies, B. Henrissat and B. Svensson eds., (1999) The Royal Society of Chemistry, Cambridge, pp. 3-12, which is herein incorporated by reference in its entirety). The CE-7 family of enzymes has been demonstrated to be particularly effective for producing peroxyacids acids from a variety of acyl donor substrates when combined with a source of peroxygen, e.g., hydrogen peroxide (U.S. Pat. Nos. 7,794,378; 7,951,566; 7,723,083; and 7,964,378 and U.S. Patent Application Publication Nos. 2008 / 0176299, 2010 / 0087529, 2011 / 0081693, and 2011 / 0236335 to DiCosimo et al.; each incorporated herein by reference in its entirety).

[0046] Members of the CE-7 family, which include, e.g., cephalosporin C deacetylases (CAHs; E.C.3.1.1.41) and acetyl xylan esterases (AXEs; E.C.3.1.1.72), share a conserved signature motif (Vincent et. al., J. Mol. Biol., 330:593-606 (2003), which is herein incorporated by reference in its entirety). The signature motif for CE-7 family members comprises three conserved motifs as follows (residue position numbering relative to reference sequence SEQ ID NO: 2; the CE-7 perhydrolase from B. subtilis ATCC® 31954™). The relative numbering accounts for small insertions or deletions (for example, typically five amino acids of less) within the aligned sequence. The CE-7 signature motifs are disclosed, for example, in U.S. Patent Publication No. 2018 / 0168981 to Gronlund et al., which is herein incorporated by reference in its entirety.

[0047] The enzyme may be provided in the form of a powder, an enzyme powder, or a stabilizedenzyme powder. Methods for making and stabilizing the enzyme powder are described, for example, in U.S. Patent Application Publication Nos. 2010 / 0086534 and 2010 / 0086535, the disclosures of which are incorporated herein by reference. The enzyme may be present in the enzyme powder in an amount of about 0.5 wt% to about 75 wt%, based on a dry weight of the enzyme powder. In a typical implementation, the enzyme may be present in the enzyme powder in an amount of about 10 wt% to about 50 wt%, or more typically in an amount of about 20 wt% to about 33 wt%, based on a dry weight of the enzyme powder.

[0048] The enzyme powder may have a particle size median diameter (D50) from about 100 μm to about 300 μm. For example, the particle size median diameter (D50) of the enzyme may be from about 100 μm, about 110 μm, about 120 μm, about 130 μm, about 140 μm, about 150 μm, about 160 μm, about 170 μm, about 180 μm, about 190 μm, or about 200 μm to about 210 μm, about 220 μm, about 230 μm, about 240 μm, about 250 μm, about 260 μm, about 270 μm, about 280 μm, about 290 μm, or about 300 μm. In another example, the enzyme may have a particle size median diameter (D50) from about 100 μm to about 300 μm, about 110 μm to about 290 μm, about 120 μm to about 280 μm, about 130 μm to about 270 μm, about 140 μm to about 260 μm, about 150 μm to about 250 μm, about 160 μm to about 240 μm, about 170 μm to about 230 μm, about 180 μm to about 220 μm, or about 190 μm to about 210 μm.

[0049] The enzyme powder may include an excipient. The excipient may be or provide the balance of the enzyme powder. Accordingly, in at least one example, the enzyme powder may include only the enzyme and the excipient. In another example, the enzyme powder may include the enzyme, the excipient, and at least one additional component. The excipient may be an oligosaccharide having a number average molecular weight of at least about 1,250 and a weight average molecular weight of at least about 9,000. The oligosaccharide excipient may have a number average molecular weight of at least about 1,700 and a weight average molecular weight of at least about 15,000. Illustrative oligosaccharides may be or include, but are not limited to, maltodextrin, xylan, mannan, fucoidan, galactomannan, chitosan, raffinose, stachyose, pectin, insulin, levan, graminan, amylopectin, sucrose, lactulose, lactose, maltose, trehalose, cellobiose, nigerotriose, maltotriose, melezitose, maltotriulose, raffinose, kestose, and the like, and cominations or mixtures thereof. The oligosaccharides may also include, but are not limited to, water-soluble non-ionic cellulose ethers, such as hydroxymethyl-cellulose and hydroxypropylmethylcellulose, and mixtures thereof. The one or more excipients may be or include, but are not limited to, trehalose, lactose, sucrose,mannitol, sorbitol, glucose, cellobiose, α-cyclodextrin, carboxymethylcellulose, and the like, and combinations thereof. In a typical implementation, the oligosaccharide excipient is maltodextrin.

[0050] In certain embodiments, the one or more perhydrolase enzymes may be present in the oral care composition in an amount ranging from about 0.001 wt% to about 10 wt%, depending on whether the oral care composition is in the form of a solid (e.g., film) or a liquid (e.g., slurry). In certain embodiments wherein the oral care composition is in the form of a solid, the at least one perhydrolase enzyme may present in the oral care composition in an amount ranging from about 0.001 wt% to about 5 wt%, about 0.005 wt% to about 1 wt%, about 0.01 wt% to about 0.1 wt%, about 0.01 wt% to about 0.05 wt%, about 1 wt% to about 3 wt%, about 0.01 wt%, or about 1 wt%. In certain embodiments wherein the oral care composition is in the form of a liquid, the at least one perhydrolase enzyme may present in the oral care composition in an amount ranging from about 0.001 wt% to about 5 wt%, about 0.001 wt% to about 2 wt%, about 0.005 wt% to about 2 wt%, about 0.01 wt% to about 0.1 wt%, about 0.01 wt% to about 0.05 wt%, about 1 wt% to about 3 wt%, about 0.01 wt%, or about 1.7 wt%.

[0051] As discussed above, the one or more enzymes having perhydrolytic activity may catalyze, be capable of catalyzing, or be configured to catalyze a reaction between the one or more sources of hydrogen peroxide and the one or more acyl donors to generate the oral care whitening enhancer. In at least one implementation, the oral care whitening enhancer is peroxyacid or peracetic acid. The amount or concentration of the peracetic acid generated by perhydrolysis may vary widely. In at least one implementation, the amount of the peracetic acid generated may be from about 0.1 ppm to about 10,000 ppm based on a total weight of the oral care composition. For example, the amount of the peracetic acid generated may be from about 0.1 ppm, about 0.5 ppm, about 1 ppm, about 5 ppm, about 10 ppm, about 15 ppm, about 20 ppm, about 50 ppm, about 100 ppm, about 150 ppm, about 200 ppm, about 300 ppm, about 500 ppm, about 600 ppm, about 700 ppm, about 800 ppm, or about 900 ppm to about 1,000 ppm, about 1,200 ppm, about 1,400 ppm, about 1,600 ppm, about 1,800 ppm, about 2,000 ppm, about 2,500 ppm, about 3,000 ppm, about 3,500 ppm, about 4,000 ppm, about 5,000 ppm, about 6,000 ppm, about 7,000 ppm, about 8,000 ppm, about 9,000 ppm, or about 10,000 ppm. In another example, the amount of the peracetic acid generated may be less than 0.1 ppm, less than 0.5 ppm, less than 1 ppm, less than 5 ppm, less than 10 ppm, less than 15 ppm, less than 20 ppm, less than 50 ppm, less than 100 ppm, less than 150 ppm, less than 200 ppm, less than 300 ppm, less than 500 ppm, less than 600 ppm, less than 700 ppm, lessthan 800 ppm, less than 900 ppm, less than 1,000 ppm, less than 1,200 ppm, less than 1,400 ppm, less than 1,600 ppm, less than 1,800 ppm, less than 2,000 ppm, less than 2,500 ppm, less than 3,000 ppm, less than 3,500 ppm, less than 4,000 ppm, less than 5,000 ppm, less than 6,000 ppm, less than 7,000 ppm, less than 8,000 ppm, less than 9,000 ppm, or less than 10,000 ppm. In a typical implementation, the amount of the peracetic acid generated is less than 2000 ppm based on a total weight of the oral care composition. C. Optional non-peroxide bleaching agents

[0052] In certain embodiments, the oral care compositions disclosed herein may optionally comprise one or more non-peroxide bleaching agents, in addition to the one or more acyl donors and the one or more perhydrolysis enzymes. The one or more non-peroxide bleaching agents may be or include, but are not limited to, a salt of a peroxymonosulfate or a salt of monopersulfate (MPS). For example, the non-peroxide bleaching agent may be or include, but is not limited to, an alkali metal salt of MPS, such as a potassium MPS, sodium MPS, ammonium MPS, or the like, or any combination thereof. MPS may be provided as a single molecule, a compound, such as a monopersulfate compound or MPS compound, a complex, such as a monopersulfate complex, or any combination thereof. In at least one implementation, the non-peroxide bleaching agents may be or include an MPS compound or a mixture of two or more salts of peroxymonosulfate. The MPS compound may be or include a mixed salt or triple salt, such as 2KHSO5·KHSO4·K2SO4. The MPS may be utilized as a solid, such as a solid powder. The MPS may also be utilized as a liquid, such as an aqueous liquid, that may be subsequently dried. In certain embodiments, the oral care composition disclosed herein is free of or substantially free of non-peroxide bleaching agents in addition to the one or more acyl donors and the one or more perhydrolysis enzymes. For example, in certain embodiments, the oral care composition is free of or substantially free of an MPS compound or a mixture of two or more salts of peroxymonosulfate. Water-soluble polymers

[0053] The oral care composition disclosed herein comprises an orally-acceptable vehicle. The orally acceptable vehicle may be or include a polymer base. The polymer base may be or include one or more water soluble polymers. The water soluble polymers may be capable of or configured to form a polymer matrix. Illustrative water soluble polymers may be or include, but are not limited to, one or more of carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), cetyl hydroxyethylcellulose, hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC),polyvinylpyrrolidone (PVP), polyvinylpyrrolidone / vinyl acetate (PVP / VA), cellulose ethers, or the like, or combinations thereof. Illustrative cellulose ethers may be or include, but are not limited to, hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), water soluble ethylhydroxyethyl cellulose (EHEC), carboxymethyl cellulose (CMC), carboxymethylhydroxyethyl cellulose (CMHEC), hydroxypropylhydroxyethyl cellulose (HPHEC), methyl cellulose (MC), methylhydroxypropyl cellulose (MHPC), methylhydroxyethyl cellulose (MHEC), carboxymethylmethyl cellulose (CMMC), hydrophobically modified carboxymethyl cellulose (HMCMC), hydrophobically modified hydroxyethyl cellulose (HMHEC), hydrophobically modified hydroxypropyl cellulose (HMHPC), hydrophobically modified ethylhydroxyethyl cellulose (HMEHEC), hydrophobically modified carboxymethylhydroxyethyl cellulose (HMCMHEC), hydrophobically modified hydroxypropylhydroxyethyl cellulose (HMHPHEC), hydrophobically modified methyl cellulose (HMMC), hydrophobically modified methylhydroxypropyl cellulose (HMMHPC), hydrophobically modified methylhydroxyethyl cellulose (HMMHEC), hydrophobically modified carboxymethylmethyl cellulose (HMCMMC), cationic hydroxyethyl cellulose (cationic HEC) and cationic hydrophobically modified hydroxyethyl cellulose (cationic HMHEC), a 2-pyrrolidinone,1 ethenyl-, homopolymer (CAS No. 9003-39-8), FLEXITHIX™, which is commercially available from Ashland of Kennedy, TX, an ammonium acryloyldimethyltaurate / vinylpyrrolidone copolymer, or copolymer of ammonium acryloyldimethyltaurate and vinylpyrrolidone monomers (CAS No. 91081-14-0), polyacrylate crosspolymer-6 (CAS No. 1439374-06-7), or the like, or combinations thereof.

[0054] In certain embodiments, the one or more water-soluble polymer may comprise hydroxypropylmethyl cellulose (HPMC). In certain embodiments, the one or more water-soluble polymer may comprise polyvinylpyrrolidone (PVP).

[0055] In certain embodiments, the PVP may be low molecular weight PVP, high molecular weight PVP, or a combination thereof. As used herein, “low molecular weight PVP” may refer to PVP having a molecular weight of from about 10,000 Da or less to about 100,000 Da. As used herein, “high molecular weight PVP” may refer to PVP having a molecular weight of from about 200,000 Da to about 1,500,000 Da.

[0056] The polymer base may be present in an amount of from about 5 wt% to about 90 wt%, based on the total weight of the oral care composition, depending on whether the oral carecomposition is in a solid form (e.g., film) or a liquid form (e.g., slurry). For example, when the oral care composition is in a solid form, the polymer base may be present in an amount of from about 50 wt%, about 90 wt%, about 55 wt%, about 60 wt%, about 65 wt%, about 70 wt%, about 75 wt%, about 80 wt%, about 85 wt%, or about 90 wt%, based on the total weight of the oral care composition. When the oral care composition is in a liquid form, the polymer base may be present in an amount of from about 5 wt%, about 50 wt%, about 10 wt%, about 15 wt%, about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, or about 50 wt%, based on the total weight of the oral care composition.

[0057] In certain embodiments, the oral care composition may be substantially clear. As used herein, the expression “substantially clear” may refer to the oral care composition or the carrier that is translucent or transparent.

[0058] In certain embodiments, the orally acceptable vehicle may include one or more plasticizers and / or polymers capable of or configured to improve flexibility of the oral care product (e.g., solid film oral cleansing and whitening composition). Illustrative plasticizers may be or include, but are not limited to, glycerin, sorbitol, an alkylene glycol, poloxamers, block co-polymers, or combinations thereof. Illustrative alkylene glycol may be or include, but are not limited to polyethylene glycol (PEG) or propylene glycol (PPG). In an exemplary implementation, the plasticizer may include polyethylene glycol, propylene glycol, or a combination thereof. Illustrative polyethylene glycol may be or include, but are not limited to, PEG-400, PEG-600, PEG-1000, or a combination thereof. The poloxamers may be a liquid or a paste. The poloxamer may have an average molecular weight of less than or equal to about 12,000 Dalton (Da), less than or equal to about 11,000 Da, less than or equal to about 10,000 Da, less than or equal to about 9,000 Da, less than or equal to about 8,000 Da, less than or equal to about 7,000 Da, or less than or equal to about 6,000 Da. Illustrative poloxamers may be or include, but are not limited to, one or more of PLURONIC® L35 (poly(ethylene glycol)-block-poly(propylene glycol)-block- poly(ethylene glycol)), PLURONIC® L43, PLURONIC® L64, PLURONIC® L10, PLURONIC® L44, PLURONIC® L62, PLURONIC® 10R5, PLURONIC® 17R4, PLURONIC® L25R4, PLURONIC® P84, PLURONIC® P65, PLURONIC® P104, and PLURONIC® P105, or the like, or any mixture or combination thereof, each of which or commercially available from BASF Corp. of Florham Park, NJ. In a preferred implementation, the orally acceptable vehicle includes a poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol)polymer, such as PLURONIC® L35. The block co-polymers may be or include one or more block co-polymers of polyethylene glycol and polyethylene glycol (e.g., molecular weight of at least 5000 Da), polypropylene glycol and polyethylene glycol, and the like, and combinations thereof. The block co-polymer of ethylene oxide and propylene oxide may be represented by the formula (ethylene oxide)x−(propylene oxide)y, where x is an integer from about 80 to about 150 (e.g., x=100-130, or about 116 or about 118), and y is an integer from about 30 to about 80 (e.g., y=60- 70, or about 66). The block co-polymer of ethylene oxide and propylene oxide may have an average molecular weight greater than or equal to about 5,000 Da and less than or equal to about 20,000 Da. For example, the molecular weight of the block co-polymer of ethylene oxide and propylene oxide may be from about 8,000 Da to about 13,000 Da. In another example, the molecular weight of the block co-polymer of ethylene oxide and propylene oxide may be from about 9,800 Da or about 10,000 Da. In yet another example, the molecular weight of the block co- polymer of ethylene oxide and propylene oxide may be from about 8,000 Da to about 10,000 Da. In at least one implementation, the block copolymer, if included in the composition, may be or include PLURAFLO® L4370, PLURAFLO® L1220, and PLURACARE® L1220, each of which are commercially available from BASF of Wyandotte, MI.

[0059] The one or more plasticizers may be present in an amount of from about 1 wt% to about 40 wt%, based on the total weight of the oral care composition. For example, the one or more plasticizers may be present in an amount of from about 1 wt%, about 5 wt%, or about 10 wt% to about 15 wt%, about 20 wt%, about 30 wt%, or about 40 wt%, based on the total weight of the oral care product or the oral cleansing and whitening composition thereof. In at least one implementation, the plasticizers include propylene glycol in an amount greater than 6 wt%, greater than 7 wt%, greater than 8 wt%, or greater than 9 wt%, based on the total weight of the oral care composition.

[0060] The oral care product or the oral care composition thereof may also include one or more flavorants and / or sweeteners. Illustrative flavorants and / or sweeteners may include, but are not limited to, essential oils and various flavoring aldehydes, esters, alcohols, or the like. The flavorants and / or sweeteners may also include, but are not limited to, sweeteners, sucralose, maltodextrin, dextrose, polydextrose, sucrose, maltose, dextrin, dried invert sugar, mannose, xylose, ribose, fructose, levulose, galactose, sugar alcohols, such as sorbitol, mannitol, xylitol, maltitol, and isomalt, aspartame, neotame, saccharin and salts thereof (e.g., sodium saccharin),gum arabic, dipeptide-based intense sweeteners, cyclamates, dihydrochalcones, or the like, or mixtures thereof. Examples of the essential oils include oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange. In another example, the flavoring agents may include menthol, carvone, and anethole. In a preferred implementation, the oral care composition is a sugarless composition to prevent or inhibit tooth decay. For example, the sweeteners may include one or more of isomalt, maltitol, xylitol, sorbitol, sucralose, or any combination thereof.

[0061] It should be appreciated by one having ordinary skill in the art that the oral care compositions disclosed herein may include other additional ingredients / components. For example, the oral care compositions may include any one or more of the following: anti-caries agents, anticalculus agents, diluents, surface active agents or surfactants, mouth feel agents, sweetening agents, colorants or coloring agents, preservatives, antifoam agents (e.g., benzoic acid, sulfuric acid, glyceryl monostearate, etc.), abrasives, or the like, or a combination thereof. It should further be appreciated by one having ordinary skill in the art that while general attributes of each of the above categories of materials may differ, there may be some common attributes and any given material may serve multiple purposes within two or more of such categories of materials. For example, clove oil may be capable of or configured to provide a flavor property as well as a therapeutic function. In at least one implementation, the oral care composition may be free or substantially free of fluoride containing components.

[0062] For example, the oral care compositions disclosed herein may further include one or more fluoride ion sources (e.g., soluble fluoride salts). A wide variety of fluoride ion-yielding materials may be employed as sources of soluble fluoride. Examples of suitable fluoride ion-yielding materials may be found in U.S. Pat. No. 3,535,421 to Briner et al., U.S. Pat. No. 4,885,155 to Parran, Jr. et al., and U.S. Pat. No. 3,678,154 to Widder et al., the disclosures of which are incorporated herein by reference. Illustrative fluoride ion sources include, but are not limited to, stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride, ammonium fluoride, and combinations thereof. In a typical implementation, the fluoride ion source includes sodium fluoride. The amount of the fluoride ion source in the oral care composition may be less than 0.08 wt%, less than 0.07 wt %, less than 0.06 wt %, less than 0.05 wt%, or less than 0.04 wt%. For example, the amount of the fluoride ion source may be about 0.05 wt%. In another implementation, the fluoride ion sourceis present in an amount to provide a total of about 100 to about 20,000 ppm, about 200 to about 5,000 ppm, or about 500 to about 2,500 ppm, fluoride ions.

[0063] In an exemplary implementation, the oral care composition thereof may one or more anticalculus agents. Illustrative anticalculus agents may include, but are not limited to, phosphates and polyphosphates (e.g., pyrophosphates), polyaminopropanesulfonic acid (AMPS), hexametaphosphate salts, zinc citrate trihydrate, polypeptides, polyolefin sulfonates, polyolefin phosphates, diphosphonates. In a typical implementation, the anticalculus agents includes tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), tetrapotassium pyrophosphate (TKPP), or a combination thereof.

[0064] In certain embodiments, the additional components of the oral care composition may include one or more abrasives or abrasive compounds. As used herein, the term “abrasive” may refer to materials commonly referred to as “polishing agents.” The one or more abrasives may be mixed, combined, dispersed, suspended, or otherwise contacted with the orally acceptable vehicle. In at least one implementation, the oral care composition includes a single abrasive. In another implementation, the oral care composition includes a mixture or combination of at least two abrasives. Illustrative abrasives may be or include, but are not limited to, metaphosphate compounds, phosphate salts (e.g., insoluble phosphate salts), such as sodium metaphosphate, potassium metaphosphate, calcium pyrophosphate, magnesium orthophosphate, trimagnesium orthophosphate, tricalcium phosphate, dicalcium phosphate dihydrate, anhydrous dicalcium phosphate, calcium carbonate, magnesium carbonate, hydrated alumina, abrasive silicas, silica, silicates, zirconium silicate, aluminum silicate, calcined aluminum silicate, polymethyl methacrylate, or the like, or a combination thereof. In an exemplary implementation, the abrasives include at least the silica abrasives, such as those available under the trade designation ZEODENT® 115, which are commercially available from Evonic Industries, AG of Essen Germany. Any one or more of the abrasives may be present in an amount of from 0 wt % to about 20 wt %, based on the total weight of the oral care composition. For example, the one or more abrasives may be present in an amount of from 0 wt %, about 0.1 wt % about 0.5 wt %, about 1 wt %, or about 2 wt % to less than or equal to about 5 wt %, less than or equal to about 8 wt %, less than or equal to about 10 wt %, less than or equal to about 15 wt %, or less than or equal to about 20 wt %, based on the total weight of the oral care composition.

[0065] The oral care composition may include one or more antimicrobial agents and / or one ormore preservatives such as, methylisothiazolinone (MIT), sodium benzoate, potassium sorbate, benzyl alcohol, and combinations thereof. In another example, the oral care composition may include one or more antibacterial agents selected from halogenated diphenyl ether (e.g. triclosan), herbal extracts and essential oils (e.g., rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitol, catechol, methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswak extract, sea-buckthorn extract), bisguanide antiseptics (e.g., chlorhexidine, alexidine or octenidine), quaternary ammonium compounds (e.g., cetylpyridinium chloride (CPC), benzalkonium chloride, tetradecylpyridinium chloride (TPC), N-tetradecyl-4-ethylpyridinium chloride (TDEPC)), phenolic antiseptics, hexetidine, octenidine, sanguinarine, povidone iodine, delmopinol, salifluor, other metal ions (e.g., stannous salts, copper salts, iron salts), sanguinarine, propolis and oxygenating agents (e.g., hydrogen peroxide, buffered sodium peroxyborate or peroxycarbonate), phthalic acid and its salts, monoperthalic acid and its salts and esters, ascorbyl stearate, oleoyl sarcosine, alkyl sulfate, dioctyl sulfosuccinate, salicylanilide, domiphen bromide, delmopinol, octapinol, and other piperidino derivatives, nicin preparations, chlorite salts; and mixtures of any of the foregoing. In a typical implementation, the antibacterial agent includes cetylpyridinium chloride (CPC). For example, all of the dual-phase mouthwash compositions disclosed herein may include CPC as an antibacterial agent.

[0066] The oral care products and / or the oral care composition thereof may include an antioxidant. Any orally acceptable antioxidant may be used, including, but not limited to, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants, chlorophyll, melatonin, and the like, and combinations and mixtures thereof.

[0067] All ingredients for use in the compositions described herein should be orally acceptable. As used herein, “orally acceptable” may refer any ingredient that is present in a composition as described in an amount and form which does not render the composition unsafe for use in the oral cavity. Methods of Preparing an Oral Care Composition

[0068] The present disclosure may provide a method for preparing the oral care compositions disclosed herein. The method may include preparing a slurry of the orally acceptable vehicle and the one or more whitening agents. The slurry may be prepared by mixing, stirring, combining, orotherwise contacting the orally acceptable vehicle, the one or more whitening agents, and water with one another. The water may be present in an amount sufficient to prepare a slurry. For example, the water may be present in an amount greater than or equal to about 40 wt %, greater than or equal to about 45%, greater than or equal to about 50%, greater than or equal to about 55%, greater than or equal to about 60%, greater than or equal to about 65%, greater than or equal to about 70%, or more. The method may also include preparing solid films of the oral care product with the slurry. Preparing the solid films of the oral care product with the slurry may include at least partially evaporating water from the slurry with heat and / or reduced pressure.

[0069] Preparing the solid films of the oral care product may include casting the slurry on a substrate (e.g., stainless steel surface) prior to evaporating the water therefrom. Casting may refer to the application or disposition of the slurry to the substrate at an appropriate, sufficient, or predetermined thickness. The substrate may be a metallic substrate, such as a stainless steel substrate, a non-stick substrate, such as a mylar or TEFLON surface, or the like. The casting may be conducted at temperatures of from room temperature or about 25 °C to about 60 °C or more, such as up to about 75 °C, about 80 °C, or more. The casting may be conducted for a predetermined amount of time (i.e., casting time), which may be at least partially determined by the amount of water present in the slurry. The casing time may be from about 15 minutes, about 20 minutes, about 30 minutes, about 40 minutes, about 45 minutes, about 50 minutes, about 1 hour, about 2 hours, about 5 hours, about 10 hours, about 12 hours, about 1 day, about 2 days, about 4 days, about 1 week, or more. As used herein, the expression “casting time” may refer to the amount of time for drying the slurry.

[0070] In at least one implementation, a releasing agent may be utilized to facilitate the formation of the solid films during casting. For example, the releasing agent (e.g., betaines) may be incorporated into the slurry or the oral care composition to facilitate the separation of the solid films from the substrate. In another example, the releasing agent may be disposed or coated on the substrate prior to casting the slurry on the substrate to facilitate the separation of the solid films from the substrate. In yet another example, the releasing agent may be disposed or coated on the substrate and incorporated into the slurry or the oral care composition. The amount of the releasing agent utilized may be limited. For example, the amount of the releasing agent may be limited to prevent the degradation or instability of the one or more whitening agents. Kits and Methods of Using an Oral Care Composition

[0071] In certain embodiments disclosed herein, the oral care composition may be used together with a dentifrice comprising at least one source of hydrogen peroxide. The dentifrice may be available from a different source or may be packaged together with the oral care composition as a kit. Accordingly, disclosed herein are kits comprising the oral care composition disclosed herein and a dentifrice comprising at least one source of hydrogen peroxide.

[0072] The dentifrice and the oral care composition may be maintained separate from one another until the time of use, where they may be combined, mixed, or otherwise contacted with one another. For example, the dentifrice and the oral care composition may be maintained in separate vessels or containers. The dentifrice and the oral care composition may also be combined with one another in a single vessel. As further described herein, the one or more enzymes having perhydrolytic activity catalyze a reaction between the one or more sources of hydrogen peroxide and the one or more acyl donors to generate an oral care whitening enhancer (e.g., peracetic acid). In at least one implementation, the sources of hydrogen peroxide may be maintained in a dentifrice (e.g., toothpaste) and the acyl donors and / or the enzymes having perhydrolytic activity may be maintained in the oral care composition, including a solid oral care composition (e.g., a film, ribbon, tape, etc.).

[0073] The weight ratio of the dentifrice, including the source of hydrogen peroxide, to the oral care composition, including the acyl donors and / or the enzymes having perhydrolytic activity, may be greater than or equal to about 1:1 and less than or equal to about 8:1. For example, the weight ratio of the dentifrice to the oral care composition may be from about 1:1, about 1.5:1, about 2:1, about 2.5:1, about 3:1, about 3.5:1, or about 4:1 to about 4.5:1, about 5:1, about 5.5:1, about 6:1, about 6.5:1, about 7:1, about 7.5:1, or about 8:1. In another example, the weight ratio of the dentifrice to the oral care composition may be from about 1:1 to about 8:1, about 1.5:1 to about 7.5:1, about 2:1 to about 7:1, about 2.5:1 to about 6.5:1, about 3:1 to about 6:1, about 3.5:1 to about 5.5:1, about 4:1 to about 5:1, or about 3.8:1 to about 4.2:1. In yet another example, the weight ratio of the dentifrice to the oral care composition may be greater than 0 and less than 1:1, less than 1.5:1, less than 2:1, less than 2.5:1, less than 3:1, less than 3.5:1, less than 4:1, less than 4.5:1, less than 5:1, less than 5.5:1, less than 6:1, less than 6.5:1, less than 7:1, less than 7.5:1, or less than 8:1. In a typical implementation, the weight ratio of the dentifrice to the oral care composition is about 4:1.

[0074] The dentifrice may include one or more sources of hydrogen peroxide. The one or moresources of hydrogen peroxide may be any compound or material configured to react with any one or more of the acyl donors and / or any one or more of the enzymes having perhydrolytic activity to form the whitening enhancer. Illustrative sources of hydrogen peroxide may be or include, but are not limited to, hydrogen peroxide, urea peroxide, calcium peroxide, cross-linked polyvinylpyrrolidone (PVP) hydrogen peroxide complex, sodium percarbonate, and the like, and combinations thereof. The sources of hydrogen peroxide may also be or include, but are not limited to, PEROXYDONE™ XL 10 complex, POLYPLASDONE® XL 10F, which are commercially available from Ashland Inc. of Covington, Ky.

[0075] The amount or concentration of the source of hydrogen peroxide in the dentifrice may vary widely. In at least one example, the amount of hydrogen peroxide may be greater than or equal to 0.01 wt% and less than or equal to 10 wt% based on a total weight of the dentifrice. For example, the amount of the hydrogen peroxide in the whitening composition may be from about 0.01 wt% to about 5.0 wt%, about 0.01 wt% to about 1.0 wt%, about 0.05 wt% to about 0.5 wt %, or about 0.1 wt%. In another example, the amount of the source of hydrogen peroxide in the dentifrice may be from about 0.5 wt% to about 10.5 wt%, about 1.0 wt% to about 10.0 wt%, about 1.5 wt% to about 9.5 wt%, about 2.0 wt% to about 9.0 wt%, about 2.5 wt% to about 8.5 wt%, about 2.0 wt% to about 8.0 wt%, about 2.5 wt% to about 7.5 wt%, about 3.0 wt% to about 7.0 wt%, about 3.5 wt% to about 6.5 wt%, about 4.0 wt% to about 6.0 wt%, about 4.5 wt% to about 5.5 wt%, about 5.0 wt% to about 6.0 wt%, or about 5.5 wt%. In yet another example, the amount of the source of hydrogen peroxide in the oral care whitening composition may be less than or equal to 0.5 wt%, less than or equal to 1.0 wt%, less than or equal to 1.5 wt%, less than or equal to 2.0 wt%, less than or equal to 2.5 wt%, less than or equal to 2.0 wt%, less than or equal to 2.5 wt%, less than or equal to 3.0 wt%, less than or equal to 3.5 wt%, less than or equal to 4.0 wt%, less than or equal to 4.5 wt%, less than or equal to 5.0 wt%, less than or equal to 5.5 wt%, less than or equal to 6.0 wt%, less than or equal to 6.5 wt%, less than or equal to 7.0 wt%, less than or equal to 7.5 wt%, less than or equal to 8.0 wt%, less than or equal to 8.5 wt%, less than or equal to 9.0 wt%, less than or equal to 9.5 wt%, less than or equal to 10.0 wt%, or less than or equal to 10.5 wt%. In a typical implementation, the hydrogen peroxide is present in the dentifrice in an amount of about 0.1 wt%.

[0076] The whitening enhancer (e.g., peracetic acid) of the oral care composition may be generated within at least 3 minutes from contacting the one or more sources of hydrogen peroxide,the one or more acyl donors, and / or the one or more enzymes having perhydrolytic activity with one another or initiation of the perhydrolysis reaction. For example, the whitening enhancer of the oral care composition may be generated in less than or equal to 3 minutes, less than or equal to 2.8 minutes, less than or equal to 2.6 minutes, less than or equal to 2.4 minutes, less than or equal to 2.2 minutes, less than or equal to 2.0 minutes, less than or equal to 1.8 minutes, less than or equal to 1.6 minutes, less than or equal to 1.4 minutes, less than or equal to 1.2 minutes, less than or equal to 1.0 minute, less than or equal to 0.8 minutes, less than or equal to 0.6 minutes, or less than or equal to 0.4 minutes.

[0077] The present disclosure further provides methods for whitening the surfaces of teeth in a human or animal subject with the oral care composition disclosed herein. As used herein “animal subject” may include higher order non-human mammals such as canines, felines, and horses.

[0078] The method may include storing the oral care composition in a stable form until the time of use. The method may also include contacting the perhydrolase enzyme and the acyl donor of the oral care composition with the source of hydrogen peroxide, to initiate the generation of peracetic acid. In at least one implementation, contacting the perhydrolase enzyme and the acyl donor of the oral care composition with the source of hydrogen peroxide to initiate the generation of peracetic acid may include admixing, stirring, or otherwise contacting a dentifrice comprising the source of hydrogen peroxide with oral care composition comprising the acyl donor and the enzyme having perhydrolytic activity. In at least one implementation, the method may comprise, in a first step, affixing or applying the oral care composition, for example a solid oral care composition in the form of a film to a surface of the oral cavity, e.g., the teeth. In a second step, the method mat comprise contacting the dentifrice comprising a source of hydrogen peroxide with the surface of the oral cavity, e.g., the teeth, to which the oral care composition has been affixed or applied. Optionally, the method further comprises using an implement, such as a toothbrush, to agitate or mix the dentifrice together with the oral care composition, e.g., by brushing the teeth. In certain embodiments of the methods disclosed herein, the oral care composition may generate the peracetic acid within less than 2 minutes, less than 1.5 minutes, less than 1 minutes, less than 45 seconds, or less than 30 seconds.

[0079] The oral care composition may be applied and / or contacted with the surfaces of the teeth at predetermined intervals. For example, the oral care composition may be applied and / or contacted with the surfaces of the teeth on a daily basis, such as once, twice, or three times a day,at least one time a day for multiple days, multiple times a day for multiple days, or alternatively every other day. The oral care composition may be utilized for up to 2 weeks, up to 3 weeks, up to 4 weeks, up to 6 weeks, up to 8 weeks, or greater. In certain embodiments, the oral care composition may be used as needed for any period of time.

[0080] The oral care composition disclosed herein may be used together with a dentifrice comprising a source of hydrogen peroxide to whiten teeth. In certain embodiments, the methods disclosed herein enhance tooth whitening as compared to the use of the dentifrice comprising a source of hydrogen peroxide alone, within use of the oral care composition comprising one or more acyl donors and one or more perhydrolase enzymes. In certain embodiments, the use of the oral care composition in the form of a solid, e.g., a film, enhances tooth whitening as compared to the use of an oral care composition in the form of a liquid or a gel. While not wishing to be bound by theory, it is believed that the use of a solid oral care composition, in addition to providing a more user-friendly experience, provides enhanced whitening efficacy over the use of a gel composition because a solid oral care composition may provide, inter alia, superior adhesion to the surface of the teeth.

[0081] Whitening efficacy may be measured by any means know to those of ordinary skill in the art. In certain embodiments, whitening efficacy may be measure using the L*, a*, b* color scale, e.g., using a SpectroShade comprising a spectrophotometer and a camera. In certain embodiments, whitening efficacy may be evaluated using the following formula, wherein ΔW indicates the change in whiteness of a surface (e.g., the teeth) as compared to an initial starting value. A negative ΔW value indicates whiter teeth as compared to the initial starting value. The ΔW value may be calculated using the following formula: ∗ ^ ^= (^∗^ + ^∗^ + (^∗ − 100)^)^where a*represents greenness to redness, b*represents blueness to yellowness, and L*represents lightness.

[0082] Accordingly, disclosed herein are methods of whitening teeth using the oral care compositions disclosed herein. In certain embodiments, the methods of whitening teeth as disclosed herein have a ΔW value that is lower than about -1.0, such as lower than about -1.5, lower than about -2, lower than about -2.5, lower than about -3.0, lower than about -3.5, lower than about -4.0, lower than about -5, lower than about -5.5, or lower than about -6.0. In certainembodiments, the methods of whitening teeth as disclosed herein provide enhanced whitening efficacy as compared to a method that does not use the oral care composition disclosed herein, providing a ΔW value that is at least 0.2 lower than the ΔW value of the method that does not use the oral care compositions, such as a ΔW value that is at least 0.3 lower, at least 0.4 lower, at least 0.5 lower, at least 0.6 lower, at 0.7 lower, at least 0.8 lower, at least 0.9 lower, at least 1.0 lower, at least 1.1 lower, at least 1.2 lower, at least 1.3 lower, at least 1.4 lower, or at least 1.5 lower. In certain embodiments, the methods of whitening teeth as disclosed herein with a solid oral care composition provide enhanced whitening efficacy as compared to a method using a liquid or gel oral care composition as disclosed herein, providing a ΔW value that is at least 0.2 lower than the ΔW value of the method that uses a liquid or gel oral care composition, such as a ΔW value that is at least 0.3 lower, at least 0.4 lower, at least 0.5 lower, at least 0.6 lower, at 0.7 lower, at least 0.8 lower, at least 0.9 lower, at least 1.0 lower, at least 1.1 lower, at least 1.2 lower, at least 1.3 lower, at least 1.4 lower, or at least 1.5 lower. EXAMPLES

[0083] The examples and other implementations described herein are exemplary and not intended to be limiting in describing the full scope of compositions and methods of this disclosure. Equivalent changes, modifications and variations of specific implementations, materials, compositions and methods may be made within the scope of the present disclosure, with substantially similar results. Example 1 – Preparation of whitening strips

[0084] Formulations containing 60-90% purified water, 10-30% hydroxypropylmethyl cellulose (HPMC), 1-10% triacetin, and 1-3% perhydrolase enzyme were made into a slurry. The slurry was then dried to produce a thin film. An exemplary formulation is disclosed in Table 1 below.

[0085] Table 1 – Exemplary enzyme film formulation Ingredient Wt % in Solution Solids (g) Wt % in

[0086] Films were prepared by first preparing a homogenous slurry of the formulation. The slurrywas cast onto a coated stainless steel surface, using a casting bar to evenly cast the slurry on to the surface. The slurry was then heated at 60-75oC for 30-60 minutes until the film was dried. Example 2 – Efficacy of whitening strips

[0087] Artificially stained bovine teeth mounted in resin were purchased from the Dental Product Testing Division of Therametric Technologies, Inc. Pre-brushed bovine teeth with L*values between 58 – 62 were placed into 3D-printed teeth holders, and their baseline L*, a*, and b*values were measured using a SpectroShade. The bovine teeth were then wet, and a film prepared as discussed above in Example 1 was placed on the wet teeth for 1 minute. Upon completion of the 1 minute, a dilute slurry of the film followed immediately by a dilute slurry of 0.1% hydrogen peroxide toothpaste was placed on the teeth. The teeth were then brushed for 2 minutes in a brushing machine. At the conclusion of the 2 minutes of brushing, the teeth were rinsed with water and the process was completed a second time, thus completing 1 cycle. The process was repeated for a total of 3 cycles.

[0088] Three control cycles were performed using only a 0.1% hydrogen peroxide toothpaste alone without the use of a film.

[0089] The whitening performance was reported as the change in W after treatment as compared to a baseline. A more negative ΔW translated to whiter teeth compared to the baseline measurement. The ΔW value was calculated by: ∗∗^ ∗^^ ^= (^ + ^ + (^∗ − 100)^)^where a*represents greenness to redness, b*represents blueness to yellowness, and L*represents lightness. The results are shown below in Table 2 and Figure 1.

[0090] Table 2 – Whitening efficacy (ΔW) of H2O2toothpaste together with an enzyme film 0.1% H2O2 toothpaste 0.1% H2O2 toothpaste +

[0091] As shown in Figure 1, the whitening efficacy of 0.1% hydrogen peroxide toothpaste used in conjunction with an enzyme film as disclosed herein can enhance the whitening efficacy ascompared to the use of a 0.1% hydrogen peroxide toothpaste alone.

[0092] The present disclosure has been described with reference to exemplary implementations. Although a limited number of implementations have been shown and described, it will be appreciated by those skilled in the art that changes may be made in these implementations without departing from the principles and spirit of the preceding detailed description. It is intended that the present disclosure be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

CLAIMS What Is Claimed Is:

1. An oral care composition comprising: one or more water-soluble polymers, and a whitening agent comprising one or more acyl donors and one or more perhydrolase enzymes, wherein the oral care composition is in the form of a solid film.

2. The oral care composition according to claim 1, wherein the composition is free of or substantially free of hydrogen peroxide.

3. The oral care composition according to claim 1 or 2, wherein the one or more perhydrolase enzymes are present in the oral care composition in an amount ranging from about 0.001 wt% to about 2 wt%, about 0.001 wt% to about 1 wt%, about 0.005 wt% to about 0.5 wt%, about 0.01 wt% to about 0.05 wt%, or about 0.01 wt%, based on the total weight of the oral care composition.

4. The oral care composition according to any of the preceding claims, wherein the one or more acyl donors comprise triacetin.

5. The oral care composition according to any of the preceding claims, wherein the one or more acyl donor is present in the oral care composition in an amount ranging from about 1 wt% to about 20 wt%, about 3 wt% to about 17 wt%, about 4 wt% to about 15 wt%, about 10 wt% to about 15 wt%, or about 14 wt% to about 15 wt%, based on the total weight of the oral care composition.

6. The oral care composition according to any of the preceding claims, wherein the one or more water-soluble polymers is selected from carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), cetyl hydroxyethylcellulose, hydroxypropyl methylcellulose (HPMC),hydroxypropyl cellulose (HPC), polyvinylpyrrolidone (PVP), polyvinylpyrrolidone / vinyl acetate (PVP / VA), cellulose ethers, or a combination thereof.

7. The oral care composition according to claim 6, wherein the one or more water-soluble polymer is PVP.

8. The oral care composition according to claim 6, wherein the one or more water-soluble polymer is HPMC.

9. The oral care composition according to any of the preceding claims, wherein the one or more water-soluble polymers are present in an amount ranging from about 60 wt% to about 90 wt%, about 70 wt% to about 80 wt%, about 71 wt% to about 75 wt%, or about 71 wt% to about 72 wt%, based on the total weight of the oral care composition.

10. The oral care composition according to any of the preceding claims, further comprising a sugar or sweetener.

11. The oral care composition according to claim 10, wherein the sugar or sweetener comprises sucralose.

12. The oral care composition according to claim 10 or 11, wherein the sugar or sweetener is present in an amount ranging from about 0.01 wt% to about 10 wt%, about 0.1 wt% to about 5%, about 0.9 wt%, or about 5 wt%, based on the total weight of the oral care composition.

13. The oral care composition according to any of the preceding claims, further comprising water in an amount ranging from about 1 wt% to about 10 wt%, about 5 wt% to about 9 wt%, or about 7 wt% to about 8 wt%, based on the total weight of the oral care composition.

14. The oral care composition according to any of the preceding claims, wherein the solid film is dissolvable and / or disintegrable.

15. A method for preparing the oral care composition according to any one of claims 1-14, the method comprising: contacting the one or more water-soluble polymers and the whitening agents comprising one or more acyl donor and one or more perhydrolase enzymes with water to prepare a slurry; casting the slurry onto a surface to form a layer; and drying the layer to form the solid film.

16. The method according to claim 15, wherein the layer is dried at about 20oC to about 100oC for about 5 minutes to about 24 hours, such as from about 60oC to about 70oC for about 30 minutes to about 60 minutes.

17. The method according to claim 15 or 16, wherein the water is added to the slurry in an amount ranging from about 60 wt% to about 90 wt%, about 70 wt% to about 80 wt%, about 71 wt% to about 75 wt%, or about 73 wt% to about 74 wt%, based on the total weight of the slurry.

18. The method according to any one of claims 15-17, wherein water is present in the solid film in an amount ranging from about 1 wt% to about 10 wt%, about 5 wt% to about 9 wt%, or about 7 wt% to about 8 wt%, based on the total weight of the oral care composition.

19. A method of whitening teeth, the method comprising: applying the oral care composition of any one of claims 1-14 to the teeth; and contacting the teeth with a dentifrice comprising at least one source of hydrogen peroxide.

20. The method according to claim 19, wherein the dentifrice comprising at least one source of hydrogen peroxide is a toothpaste.

21. The method according to claim 19 or 20, wherein the hydrogen peroxide is present in the dentifrice comprising hydrogen peroxide in an amount ranging from about 0.01 wt% to about 5.0 wt%, about 0.01 wt%, to about 1 wt%, about 0.05 wt% to about 0.5 wt %, or about 0.1 wt%, based on the total weight of the dentifrice.

22. A kit comprising the oral care composition of any one of claims 1-14 and dentifrice comprising at least one source of hydrogen peroxide, wherein the oral care composition and the dentifrice are separate until the time of use.

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