Oral care compositions and methods for whitening teeth

Abstract

Disclosed herein are oral care compositions comprising one or more water-soluble polymers and a whitening agent comprising one or more acyl donors and one or more perhydrolytic 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 compositions, as well as kits comprising the oral care compositions and a dentifrice comprising at least one source of hydrogen peroxide.

Description

[0001] Cross-references to related applications This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 609,489, filed December 13, 2023, the contents of which are incorporated herein by reference in their entirety. Background Technology

[0002] Conventional oral care products, such as toothpaste and gel, may include oral whitening agents and are frequently used to whiten teeth. For example, conventional toothpaste containing hydrogen peroxide can be used to oxidize chromophores bound to the tooth surface, thereby whitening the teeth. Although toothpaste containing hydrogen peroxide has been shown to be effective for whitening teeth, different chromophores on the surface are often oxidized at different rates and / or through different mechanisms. Therefore, toothpaste containing a single whitening agent (e.g., hydrogen peroxide) may require a relatively long treatment period to produce noticeable whitening and may generally be less effective.

[0003] In light of the foregoing, oral care products incorporating hydrogen peroxide typically include one or more additional oral whitening agents to promote the oxidation of different chromophores and thereby shorten treatment time. However, incorporating multiple whitening agents into novel oral care products has proven difficult due to the general instability and / or degradation of whitening agents. For example, oral cleaning and whitening compositions in solid film form have been developed. However, incorporating stable whitening agents into these solid films has been challenging due to the instability and / or degradation of whitening agents.

[0004] Therefore, there is a need for improved oral care whitening compositions and methods for whitening teeth. Summary of the Invention

[0005] This summary is intended only to provide a simplified overview of some aspects of one or more embodiments of the present disclosure. Other applicable areas of this disclosure will become apparent from the detailed description provided below. This summary is not an exhaustive overview, nor is it intended to identify key or essential elements of the teachings, nor is it intended to define the scope of the disclosure. Rather, its purpose is merely to present one or more ideas in a simplified form as a prelude to the following detailed description.

[0006] In some embodiments of this disclosure, an oral care composition is provided that, for example, when used with a dental cleaning agent containing at least one source of hydrogen peroxide, can be used to enhance teeth whitening efficacy. In some embodiments, the oral care composition comprises one or more water-soluble polymers and a whitening agent containing one or more acyl donors and one or more hydrolytic enzymes, wherein the oral care composition is in the form of a solid film.

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

[0008] In some embodiments, the one or more hydrolytic enzymes are present in the oral care composition in amounts of 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 some embodiments, the one or more acyl donors are triacetin, and in some embodiments, the one or more acyl donors are present in the oral care composition in amounts of 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 some embodiments, the one or more water-soluble polymers are selected from carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), hexadecyl hydroxyethyl cellulose, hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinylpyrrolidone (PVP), polyvinylpyrrolidone / vinyl acetate (PVP / VA), cellulose ethers, or combinations thereof. In one embodiment, the water-soluble polymer is PVP, and in one embodiment, the water-soluble polymer is in HPMC. In some embodiments, based on the total weight of the oral care composition, the one or more water-soluble polymers are present in amounts of 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%.

[0010] In some embodiments of this disclosure, the oral care composition further comprises a sugar or sweetener, such as sucralose. In some embodiments, the sugar or sweetener is present in amounts of about 0.01 wt% to about 10 wt%, about 0.1 wt% to about 5 wt%, about 0.9 wt%, or about 5 wt% based on the total weight of the oral care composition.

[0011] In some embodiments, the oral care composition further comprises water, for example, water present in an amount of 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 some embodiments disclosed herein, the solid film of the oral care composition is soluble and / or disintegrable, for example, in water and / or saliva.

[0013] According to another aspect of this disclosure, a method for preparing the oral care composition disclosed herein is provided, the method comprising contacting the one or more water-soluble polymers and the whitening agent comprising one or more acyl donors and one or more perhydrolysin 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 some embodiments of the method for preparing the oral composition disclosed herein, the layer is dried at about 20°C to about 100°C for about 5 minutes to about 24 hours, such as at about 60°C to about 70°C for about 30 minutes to about 60 minutes. In some embodiments of the method, water is added to the slurry in an amount of 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 some embodiments, water is present in the solid film in an amount of 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] This document also discloses a method for whitening teeth, the method comprising applying an oral care composition as disclosed herein to the teeth and contacting the teeth with a dental cleaning agent containing at least one source of hydrogen peroxide. In some embodiments, the dental cleaning agent containing at least one source of hydrogen peroxide is toothpaste, and in some embodiments, hydrogen peroxide is present in the dental cleaning agent containing hydrogen peroxide in amounts of 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 dental cleaning agent.

[0016] According to another aspect of this disclosure, a kit is provided comprising an oral care composition as disclosed herein and a dental floss containing at least one source of hydrogen peroxide, wherein the oral care composition and the dental floss are separate before use. Attached Figure Description

[0017] Features and advantages of this disclosure will become apparent from the following more detailed description of certain embodiments and as illustrated in the accompanying drawings, in which: Figure 1 The figure shows the whitening efficacy of 0.1% hydrogen peroxide toothpaste used alone and 0.1% hydrogen peroxide toothpaste used in combination with an enzyme membrane as described in Example 2.

[0018] It should be understood that the aspects are not limited to the components, arrangements, and tools shown in the diagram. Detailed Implementation

[0019] For illustrative purposes, the principles of this disclosure are described with reference to various exemplary embodiments. Although certain embodiments are specifically described herein, those skilled in the art will readily recognize that the same principles apply equally to other compositions and methods and can be employed in other systems and methods. Before explaining the disclosed embodiments in detail, it should be understood that this disclosure is not limited in its application to the details of any particular embodiment disclosed herein. The terminology used herein is for descriptive purposes and not for limitation.

[0020] As used herein and in the appended claims, the singular forms “a / an” and “the” include plural references unless the context clearly indicates otherwise. The singular form of any class of ingredients refers not only to a single chemical species of that class but also to mixtures of such chemical species. The terms “a” (or “an”), “one or more”, and “at least one” are used interchangeably herein. The terms “comprising,” “including,” and “having” are used interchangeably. The term “comprising” should be construed as “including, but not limited to”.

[0021] The ranges used throughout are intended as a concise way of describing each value within the range. It should be understood that the range format is for convenience and brevity only and should not be construed as a rigid limitation on the scope of any embodiment or implementation disclosed herein. Accordingly, the disclosed ranges should be interpreted as specifically disclosing all possible subranges and individual values ​​within the ranges. Therefore, any value within the range can be chosen as an endpoint of the range. For example, a description of a range such as 1 to 5 should be considered as specifically disclosing subranges such as 1.5 to 3, 1 to 4.5, 2 to 5, 3.1 to 5, etc., and individual numbers within the range, such as 1, 2, 3, 3.2, 4, 5, etc. This applies regardless of the width of the range.

[0022] Unless otherwise specified, all percentages and quantities expressed herein and elsewhere in this specification shall be understood as weight percentages. Given quantities are based on the effective weight of the material.

[0023] Furthermore, all numerical values ​​are specified as “about” or “approximately”, and experimental errors and variations anticipated by one of ordinary skill in the art are taken into account. It should be understood that all numerical values ​​and ranges disclosed herein are approximate values ​​and ranges, whether or not the term “about” is used in conjunction with them. It should also be understood that, as used herein, the term “about” in conjunction with a number means a value that can be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive), ±2% (inclusive), ±3% (inclusive), ±5% (inclusive), ±10% (inclusive), or ±15% (inclusive). It should also be understood that when a numerical range is disclosed herein, any numerical value falling within that range is also specifically disclosed.

[0024] As used herein, "free from" or "substantially free from" a material can mean a composition, component, or phase in which the material is present in an amount less than 10.0 wt%, less than 5.0 wt%, less than 3.0 wt%, less than 1.0 wt%, less than 0.1 wt%, less than 0.05 wt%, less than 0.01 wt%, less than 0.005 wt%, or less than 0.0001 wt% based on the total weight of the composition, component, or phase. In some embodiments, if the composition is free from or substantially free from the material, then the material is not present in a detectable amount in the composition.

[0025] All references cited in this document are incorporated herein by reference in their entirety. In the event of any conflict between the definitions in this disclosure and those in the cited references, this disclosure shall prevail.

[0026] Peracetic acid is a powerful bleaching agent that rapidly removes a wide range of stubborn stains. Hydrogen peroxide and triacetin can be converted into peracetic acid by a hydrolytic enzyme. This document discloses an oral care composition, such as a solid oral care composition (e.g., a film) for teeth whitening, comprising a hydrolytic enzyme and triacetin. The oral care composition disclosed herein can be used in conjunction with a separate hydrogen peroxide source (e.g., a dental floss, such as a toothpaste containing hydrogen peroxide) to enhance the whitening efficacy of hydrogen peroxide.

[0027] In some embodiments, the oral care compositions disclosed herein are solids intended to contact the oral cavity and / or one or more surfaces of the oral cavity, such as teeth. In exemplary embodiments, the oral care composition is a teeth whitening composition, similar to toothpaste, but in the form of a solid film, strip, tape, bar, etc. In some embodiments, the oral care composition is intended to be used in conjunction with toothpaste or other dental cleaning agents to enhance the whitening efficacy of the toothpaste or other dental cleaning agents. For simplicity, the terms "dental cleaning agent" or "toothpaste" as used herein refer to oral cleaning and / or whitening compositions, and not to the oral care compositions disclosed herein (e.g., solid films). However, the term "toothpaste" as used herein does not limit the oral cleaning and / or whitening composition to a "paste," but is used to refer to the conventional use of "toothpaste."

[0028] The oral care compositions disclosed herein may be toothpaste in film form, such as strips, bars, or tapes. Each strip, bar, or tape may be packaged as a single dose (e.g., a single-use strip) or multiple doses (e.g., rolls, stacks, etc.) that can be separated by the user / consumer. The oral care compositions may be contained or packaged in containers, such as airtight containers. Illustrative containers may include, but are not limited to, retort pouches, sachets, TETRA PAK®, bottles, trays, metal cans (e.g., tin cans), and combinations thereof. In a preferred embodiment, the oral care compositions may be contained in portable and / or single-use retort pouches or sachets. It should be understood that each container may include any number of portions or doses of the oral care compositions. For example, each container may include single or multiple doses.

[0029] As described above, the oral care compositions disclosed herein can be toothpaste in the form of strips, bars, or tapes (such as solid films). The solid film can be soluble and / or disintegratable. As used herein, the term or expression "soluble" can refer to the ability to disperse in a liquid. For example, a soluble solid film can be dispersed in a liquid (such as saliva). As used herein, the term or expression "disintegratable" can refer to the ability to break down into constituent elements, portions, and / or small particles. It should be understood that the soluble and / or disintegratable ability of the solid film can be provided by one or more components of the oral care composition. For example, orally acceptable mediators and / or water-soluble polymers incorporated into the oral care composition can at least partially contribute to the soluble and / or disintegratable properties of the oral care composition. In at least one embodiment, the solid film can dissolve and / or disintegrate in water, saliva, or a combination thereof. The solid film can dissolve and / or disintegrate within a predetermined time amount and / or rate. For example, a solid film can completely dissolve and / or disintegrate within about 30 seconds or less, about 1 minute or less, about 2 minutes or less, about 3 minutes or less, about 5 minutes or less, or about 10 minutes or less. In another example, a solid film can dissolve or disintegrate at a rate of about 0.5 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 understood that conventional oral care compositions in the form of solid films are generally insoluble or disintegratable; therefore, physical removal (e.g., peeling, grinding, etc.) is required after a predetermined period of time.

[0030] In at least one embodiment, contacting the oral care composition with a dental cleaning agent (e.g., toothpaste) containing hydrogen peroxide can induce a whitening effect. For example, contacting the whitening agent in the oral care composition with the hydrogen peroxide in the dental cleaning agent composition can induce the release of peracetic acid. As described above, the oral care composition can be in the form of a solid film or strip. Thus, when the solid film comes into contact with the oral surface, water can be provided by saliva. Water can also be provided by water used in oral hygiene (e.g., during brushing). For example, the oral care composition can be applied to the oral surface, such as teeth, and added water and / or saliva can be used to dissolve or disintegrate the film to release the whitening agent in the oral care composition, causing it to react with the hydrogen peroxide in the dental cleaning agent composition to produce peracetic acid and induce a whitening effect. Similarly, the action of brushing or agitating with a toothbrush can promote the induction of a whitening effect.

[0031] whitening agent One or more whitening agents may be or include materials or substances that are effective, capable of, or can be configured to provide whitening to the tooth surface to which they are applied. In some embodiments, one or more whitening agents are non-peroxide whitening agents. As a non-limiting example, one or more whitening agents may include at least one enzyme (e.g., a hydrolase) and at least one acyl donor (e.g., triacetin). Additionally, one or more whitening agents may further include, but are not limited to, one or more non-peroxide bleaching agent sources.

[0032] A. Acyl donor Oral care compositions 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 hydrogen peroxide sources and / or any one or more enzymes having perhydrolytic activity to form an oral care whitening enhancer. Acyl donors may be, or include, C... 2-18 Carboxylic acids, including lower linear or branched alkyl carboxylic acids, C 2-18 Hydrolyzable esters of carboxylic acids, etc., and mixtures or combinations thereof. In at least one instance, C 2-18 Carboxylic acids can be unsubstituted. In another example, C... 2-18 Carboxylic acids can be hydroxyl and / or C 1-4 Alkyl-substituted.

[0033] In some embodiments, the one or more acyl donors may be esters represented by formula (1). [X] m R5(1), Where X is an ester group represented by formula (2), R6C(O)O(2) And R5 is a C that is optionally substituted with a hydroxyl group. 1-6 The ester comprises a straight-chain, branched, or cyclic hydrocarbon moiety, a five-membered cyclic heteroaromatic moiety, or a six-membered cyclic aromatic or heteroaromatic moiety, wherein each individual carbon atom in R5 comprises no more than one hydroxyl group, no more than one ester group, no more than one ester group, or a carboxylic acid group, wherein R5 optionally comprises one or more ether bonds, wherein m is an integer from 1 to the number of carbon atoms in R5, and wherein the ester has a solubility in water of at least 5 ppm at 25°C; wherein R6 is a C1 to C7 straight-chain, branched, or cyclic hydrocarbon moiety optionally substituted with a hydroxyl group or a C1 to C4 alkoxy group, wherein R6 optionally comprises one or more ether bonds, and wherein R6 is C2 to C7.

[0034] In one embodiment, one or more acyl donors may be glycerides represented by formula (3), (3), Wherein R1 is optionally represented by a hydroxyl group or C. 1-4alkoxy-substituted C 1-7 Straight-chain or branched alkyl groups, and R3 and R4 are individually H or R1C(O).

[0035] In another instance, one or more acyl donors may be esters represented by formula (4), (4), Wherein R1 is optionally represented by a hydroxyl group or C. 1-4 alkoxy-substituted C 1-7 Straight-chain or branched alkyl group, R2 is C 1-10 Straight-chain or branched alkyl, alkenyl, alkynyl, aryl, alkylaryl, alkyl heteroaryl, heteroaryl, (CH2CH2O) n Or (CH2CH(CH3)—O) n H, and n is an integer from 1 to 10.

[0036] In another example, one or more of the acyl donors may be acetylated sugars. The acetylated sugars shown may be, but are not limited to, acetylated monosaccharides, acetylated disaccharides, acetylated polysaccharides, and combinations thereof.

[0037] One or more acyl donors may be, or include but are not limited to, C. 2-18 Carboxylic acid, C 2-6 Carboxylic acids (e.g., acetic acid), including those optionally marked with a hydroxyl group and / or C 1-4 Alkoxy-substituted lower linear or branched alkyl carboxylic acids, their hydrolyzable and acceptable esters (e.g., monoglycerides, diglycerides, and triglycerides, as well as acylated sugars), and mixtures thereof. In at least one example, one or more acyl donors may be, or include but are not limited to, 1,2,3-triacetoxypropane or triacetin or triacetylglycerol, acylated sugars, and combinations thereof. In at least one embodiment, at least one acyl donor has a water solubility of at least 5 ppm at 25°C. In some embodiments, the acyl donor is 1,2,3-triacetoxypropane or triacetin.

[0038] In at least one embodiment, one or more acyl donors may be, or include, one or more acyl sugars selected from acylated monosaccharides, disaccharides, and polysaccharides. In another embodiment, the acyl sugar is 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-furanose-1,2,3,5-tetraacetate, β-D-furanose-1,2,3,4-tetraacetate, tri-O-acetyl The acetylated sugars are selected from β-D-ribofurano-1,2,3,4-tetraacetate, β-D-xylfuranose 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-tetraacetyl-3-D-glucopyranose, 2-acetamido-2-deoxy-3,4,6-triacetyl-1-chloro-α-D-glucopyranose, β-D-mannose pentaacetate, and acetylated cellulose. In typical embodiments, the acetylated sugar is selected from β-D-ribofurano-1,2,3,5-tetraacetate, β-D-acetyl-D-galactal, β-O-acetyl-D-glucopyranose, sucrose octaacetate, and acetylated cellulose. In another embodiment, the acyl donor may include 5-acetoxymethyl-2-furfural, 3,4-diacetoxy-1-butene, 4-acetoxybenzoic acid, vanillyl 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.

[0039] In yet another embodiment, one or more acyl donors are selected from monoacetate, diacetate, triacetate, monopropionate, dipropionate, tripropionate, monobutyrate, dibutyrate, tributyrate, glucose pentaacetate, xylose tetraacetate, acetylated xylan, acetylated xylan fragments, 3-D-ribofurano-1,2,3,5-tetraacetate, and tri-O-acetyl-D-galactoside. Aldehydes, tri-O-acetyl-D-glucuronide, 1,2-ethylene glycol, 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, monoesters or diesters thereof. In another embodiment, the acyl donor is propylene glycol diacetate (PGDA), ethylene glycol diacetate (EGDA), or mixtures thereof. In yet another embodiment, one or more acyl donors are selected from monoacetate, diacetate, triacetate, monopropionic acid glyceride, dipropionic acid glyceride, tripropionic acid glyceride, monobutyric acid glyceride, dibutyric acid glyceride, and tributyric acid glyceride. On the other hand, the acyl donor is selected from diacetate and triacetate.

[0040] The amount or concentration of one or more acyl donors can vary considerably. In at least one embodiment, the amount of one or more acyl donors can be determined at least in part by a target or desired concentration of peroxyacid or peracetic acid generated by enzymatic hydrolysis. For example, based on the total weight of the oral care composition, the target or desired concentration of peroxyacid or peracetic acid generated by enzymatic hydrolysis can be less than or equal to about 2,000 ppm, and the amount of one or more acyl donors present in the oral care composition can be greater than or equal to 0.05 wt% and less than or equal to 40 wt%. For example, the amount of one or more acyl donors present in an oral care whitening composition can be 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 40 wt%. In another embodiment, the amount of one or more acyl donors present in the oral care composition can be less than about 20 wt%. For example, the amount of 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 some embodiments, the amount of one or more acyl donors present in the oral care composition may be from about 1 wt% to about 20 wt%, from about 3 wt% to about 17 wt%, from about 4 wt% to about 15 wt%, from about 10 wt% to about 15 wt%, from about 14 wt% to about 15 wt%, from about 15 wt%, or from about 14.8 wt%. In some embodiments, the amount of one or more acyl donors present in the oral care composition may be from about 1 wt% to about 10 wt%, from about 2 wt% to about 6 wt%, from about 4 wt% to about 5 wt%, from about 4 wt%, or from about 4.3 wt%.

[0041] In some embodiments, the acyl donor is triacetin, and triacetin is present in the oral care composition in an amount of about 1 wt% to about 20 wt%, such as about 2 wt% to about 5 wt%, or about 12 wt% to about 15 wt%. It should be noted that when the oral care composition is in solid form, the weight percentage of one or more acyl donors may increase compared to a liquid (e.g., slurry) form, in which a higher amount of water is present in the oral care composition.

[0042] B. Enzymes with perhydrolytic activity The oral care compositions disclosed herein may include one or more enzymes having perhydrolyzable activity. One or more enzymes having perhydrolyzable activity include any enzyme capable of catalyzing a reaction between one or more hydrogen peroxide sources, or hydrogen peroxide generated therefrom as described herein, and a suitable substrate (i.e., the acyl donor of this disclosure) to generate an oral care whitening enhancer (i.e., peracetic acid). In some embodiments, the enzyme having perhydrolyzable activity is a perhydrolase. A perhydrolase is an enzyme that generates peroxyacids through perhydrolysis. In an enzyme-catalyzed perhydrolysis reaction, the acyl donor substrate (peroxyacid precursor) is combined with a hydrogen peroxide source and water. The perhydrolase catalyzes the formation of peroxyacids such as peracetic acid.

[0043] Enzymes with perhydrolytic activity include certain lipases, proteases, esterases, acyltransferases, aryl esterases, carbohydrate esterases, and combinations thereof. Examples include the perhydrolytic protease disclosed in U.S. Patent No. 7,510,859, which is incorporated herein by reference in its entirety; the perhydrolytic aryl esterase disclosed in U.S. Patent No. 8,663,616, which is incorporated herein by reference in its entirety; and the perhydrolytic aryl esterase / acyltransferase from Mycobacterium smegma disclosed in U.S. Patent No. 8,663,616. In some embodiments, the perhydrolase is a perhydrolytic carbohydrate esterase.

[0044] In some embodiments of this disclosure, the perhydrolyzing carbohydrate esterase suitable for inclusion in the oral care compositions of the present invention is a member of the carbohydrate esterase family 7 (CE-7). Enzymes of the CE-7 family are well known in the art (see Coutinho, PM, Henrissat, B. “Carbohydrate-active enzymes: an integrated database approach”, Recent Advances in Carbohydrate Bioengineering, edited by HJ Gilbert, G. Davies, B. Henrissat and B. Svensson, (1999), The Royal Society of Chemistry, Cambridge, pp. 3-12, which is incorporated herein by reference in its entirety). When combined with a peroxide source (e.g., hydrogen peroxide), enzymes of the CE-7 family have been shown to be particularly effective in producing peroxyacids from a variety of acyl donor substrates (U.S. Patent Nos. 7,794,378, 7,951,566, 7,723,083, and 7,964,378, and U.S. Patent Application Publications Nos. 2008 / 0176299, 2010 / 0087529, 2011 / 0081693, and 2011 / 0236335, granted to DiCosimo et al.; each of which is incorporated herein by reference in its entirety).

[0045] Members of the CE-7 family, including, for example, cephalosporin C deacetylase (CAH; EC3.1.1.41) and acetylxylan esterase (AXE; EC3.1.1.72), share conserved characteristic motifs (Vincent et al., Journal of Molecular Biology). J. Mol. Biol. ) , 330:593-606 (2003), which is incorporated herein by reference in its entirety. The characteristic motifs of the CE-7 family members comprise three conserved motifs (residue position numbers relative to the reference sequence SEQ ID NO: 2; CE-7 perhydrolase from Bacillus subtilis ATCC® 31954TM). The relative numbers indicate small insertions or deletions within the aligned sequence (e.g., typically less than five amino acids). The CE-7 characteristic motifs are disclosed, for example, in U.S. Patent Publication No. 2018 / 0168981 to Grolund et al., which is incorporated herein by reference in its entirety.

[0046] Enzymes can be provided in the form of powder, enzyme powder, or stabilized enzyme powder. Methods for preparing and stabilizing enzyme powders are described, for example, in U.S. Patent Application Publications Nos. 2010 / 0086534 and 2010 / 0086535, the disclosures of which are incorporated herein by reference. Based on the dry weight of the enzyme powder, the enzyme can be present in the enzyme powder in an amount of about 0.5 wt% to about 75 wt%. In a typical embodiment, based on the dry weight of the enzyme powder, the enzyme can 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%.

[0047] The median particle diameter (D50) of the enzyme powder can be from about 100 μm to about 300 μm. For example, the median particle diameter (D50) of the enzyme can 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 median diameter (D50) of the enzyme can be 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.

[0048] Enzyme powder may include excipients. Excipients may be or provide the remainder of the enzyme powder. Accordingly, in at least one example, the enzyme powder may consist only of 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 with 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. Oligosaccharides may include, or are not limited to, maltodextrin, xylan, mannan, fucoidan, galactomannan, chitosan, raffinose, stachyose, pectin, insulin, fructan, graminan, amylopectin, sucrose, lactulose, lactose, maltose, trehalose, cellobiose, aspergillus triose, maltotriose, pinotriose, maltotriose, raffinose, sucrose triose, and combinations or mixtures thereof. Oligosaccharides may also include, but are not limited to, water-soluble nonionic cellulose ethers, such as hydroxymethylcellulose and hydroxypropyl methylcellulose, and mixtures thereof. One or more excipients may be, or include but are not limited to, trehalose, lactose, sucrose, mannitol, sorbitol, glucose, cellobiose, α-cyclodextrin, carboxymethyl cellulose, and combinations thereof. In a typical embodiment, the oligosaccharide excipient is maltodextrin.

[0049] In some embodiments, one or more perhydrolysins may be present in the oral care composition in an amount from about 0.001 wt% to about 10 wt%, depending on whether the oral care composition is in solid (e.g., film) or liquid (e.g., slurry) form. In some embodiments where the oral care composition is in solid form, the at least one perhydrolysin may be present in the oral care composition in an amount from about 0.001 wt% to about 5 wt%, from about 0.005 wt% to about 1 wt%, from about 0.01 wt% to about 0.1 wt%, from about 0.01 wt% to about 0.05 wt%, from about 1 wt% to about 3 wt%, from about 0.01 wt%, or from about 1 wt%. In some embodiments in which the oral care composition is in liquid form, the at least one perhydrolyzing enzyme may be present in the oral care composition in amounts of 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%.

[0050] As discussed above, one or more enzymes with perhydrolytic activity can catalyze, are capable of catalyzing, or are configured to catalyze the reaction between one or more hydrogen peroxide sources and one or more acyl donors to generate an oral care whitening enhancer. In at least one embodiment, the oral care whitening enhancer is a peroxyacid or peracetic acid. The amount or concentration of peracetic acid generated by perhydrolysis can vary widely. In at least one embodiment, the amount of peracetic acid generated can be from about 0.1 ppm to about 10,000 ppm based on the total weight of the oral care composition. For example, the amount of peracetic acid produced can be approximately 0.1 ppm, approximately 0.5 ppm, approximately 1 ppm, approximately 5 ppm, approximately 10 ppm, approximately 15 ppm, approximately 20 ppm, approximately 50 ppm, approximately 100 ppm, approximately 150 ppm, approximately 200 ppm, approximately 300 ppm, approximately 500 ppm, approximately 600 ppm, approximately 700 ppm, approximately 800 ppm, or approximately 900 ppm to approximately 1,000 ppm, approximately 1,200 ppm, approximately 1,400 ppm, approximately 1,600 ppm, approximately 1,800 ppm, approximately 2,000 ppm, approximately 2,500 ppm, approximately 3,000 ppm, approximately 3,500 ppm, approximately 4,000 ppm, approximately 5,000 ppm, approximately 6,000 ppm, approximately 7,000 ppm, approximately 8,000 ppm, or approximately 1,000 ppm. ppm, approximately 9,000 ppm or approximately 10,000 ppm. In another example, the amount of peracetic acid produced can 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, less than 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. ppm, less than 9,000 ppm, or less than 10,000 ppm. In a typical embodiment, the amount of peracetic acid generated is less than 2,000 ppm based on the total weight of the oral care composition.

[0051] C. Optional non-peroxide bleach In some embodiments, in addition to one or more acyl donors and one or more perhydrolases, the oral care compositions disclosed herein may optionally comprise one or more non-peroxide bleaching agents. One or more non-peroxide bleaching agents may be, or include, peroxymonosulfate or monopersulfate (MPS). For example, non-peroxide bleaching agents may be, or include, alkali metal salts of MPS, such as potassium MPS, sodium MPS, ammonium MPS, etc., 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 embodiment, the non-peroxide bleaching agent may be or comprise an MPS compound or a mixture of two or more peroxymonosulfates. MPS compounds may be or comprise mixed salts or ternary salts, such as 2KHSO5·KHSO4·K2SO4. MPS may be used as a solid (e.g., a solid powder). MPS may also be used as a liquid (e.g., an aqueous liquid), which may subsequently be dried. In some embodiments, the oral care compositions disclosed herein contain no or substantially no non-peroxide bleaching agents, except for one or more acyl donors and one or more perhydrolases. For example, in some embodiments, the oral care compositions contain no or substantially no MPS compounds or mixtures of two or more peroxide monosulfates.

[0052] Water-soluble polymers The oral care compositions disclosed herein comprise an oral-acceptable mediator. An oral-acceptable mediator may be or includes a polymer matrix. The polymer matrix may be or includes one or more water-soluble polymers. Water-soluble polymers may be able to or can be configured to form a polymer matrix. Illustrative water-soluble polymers may be, but are not limited to, one or more of the following: carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), cetyl hydroxyethyl cellulose, hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinylpyrrolidone (PVP), polyvinylpyrrolidone / vinyl acetate (PVP / VA), cellulose ethers, and combinations thereof. The cellulose ether described herein may be, or is not limited to, hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), water-soluble ethyl hydroxyethyl cellulose (EHEC), carboxymethyl cellulose (CMC), carboxymethyl hydroxyethyl cellulose (CMHEC), hydroxypropyl hydroxyethyl cellulose (HPHEC), methyl cellulose (MC), methyl hydroxypropyl cellulose (MHPC), methyl hydroxyethyl cellulose (MHEC), carboxymethyl methyl cellulose (CMMC), hydrophobically modified carboxymethyl cellulose (HMCMC), hydrophobically modified hydroxyethyl cellulose (HMHEC), hydrophobically modified hydroxypropyl hydroxyethyl cellulose (HMHPC), hydrophobically modified ethyl hydroxyethyl cellulose (HMEHEC), hydrophobically modified carboxymethyl hydroxyethyl cellulose (HMCMHEC), and hydrophobically modified hydroxypropyl hydroxyethyl cellulose (HMHPHEC). Water-modified methylcellulose (HMMC), hydrophobically modified methyl hydroxypropyl cellulose (HMMHPC), hydrophobically modified methyl hydroxyethyl cellulose (HMMHEC), hydrophobically modified carboxymethyl methyl cellulose (HMCMMC), cationic hydroxyethyl cellulose (cationic HEC) and cationic hydrophobically modified hydroxyethyl cellulose (cationic HMHEC), 2-pyrrolidone, 1-vinyl homopolymer (CAS No. 9003-39-8), FLEXITHIX™ available commercially from Ashland Corporation, Kennedy, Texas, ammonium acryloyl dimethyl taurate / vinyl pyrrolidone copolymer, or copolymer of ammonium acryloyl dimethyl taurate and vinyl pyrrolidone monomers (CAS No. 91081-14-0), polyacrylate crosspolymer-6 (CAS No. 1439374-06-7), etc., or combinations thereof.

[0053] In some embodiments, one or more water-soluble polymers may comprise hydroxypropyl methylcellulose (HPMC). In some embodiments, one or more water-soluble polymers may comprise polyvinylpyrrolidone (PVP).

[0054] In some embodiments, the PVP may be a low molecular weight PVP, a high molecular weight PVP, or a combination thereof. As used herein, “low molecular weight PVP” may refer to a PVP with a molecular weight of about 10,000 Da or less to about 100,000 Da. As used herein, “high molecular weight PVP” may refer to a PVP with a molecular weight of about 200,000 Da to about 1,500,000 Da.

[0055] Based on the total weight of the oral care composition, the polymer matrix may be present in amounts from about 5 wt% to about 90 wt%, depending on whether the oral care composition is in solid form (e.g., a film) or liquid form (e.g., a slurry). For example, when the oral care composition is in solid form, the polymer matrix may be present in amounts 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 liquid form, the polymer matrix may be present in amounts 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.

[0056] In some embodiments, the oral care composition may be substantially transparent. As used herein, the term "substantially transparent" may refer to a translucent or transparent oral care composition or carrier.

[0057] In some embodiments, an orally acceptable mediator may include one or more plasticizers and / or polymers capable of or configured to improve the flexibility of oral care products (e.g., solid film oral cleaning and whitening compositions). Illustrative plasticizers may be, or include, glycerol, sorbitol, alkylene glycols, poloxamer, block copolymers, or combinations thereof. Illustrative alkylene glycols may be, or include, polyethylene glycol (PEG) or propylene glycol (PPG). In exemplary embodiments, the plasticizer may include polyethylene glycol, propylene glycol, or combinations thereof. Illustrative polyethylene glycols may be, or include, PEG-400, PEG-600, PEG-1000, or combinations thereof. Poloxamer may be a liquid or a paste. The average molecular weight of poloxamer can be less than or equal to about 12,000 Daltons (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. The illustrative poloxamer may be, or includes but is not limited to, 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 any mixture or combination thereof, each of which may be available from BASF Corp., Florham Park, NJ. In a preferred embodiment, the oral mediator acceptable to the oral cavity comprises a poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) polymer, such as PLURONIC® L35. The block copolymer can be or includes one or more block copolymers of polyethylene glycol and polyethylene glycol (e.g., with a molecular weight of at least 5000 Da), polypropylene glycol and polyethylene glycol, and combinations thereof. Block copolymers of ethylene oxide and propylene oxide can be derived from the formula (ethylene oxide). x -(propylene oxide) yThe expression indicates that 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 average molecular weight of the block copolymer of ethylene oxide and propylene oxide can be 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 copolymer of ethylene oxide and propylene oxide can be from about 8,000 Da to about 13,000 Da. In another example, the molecular weight of the block copolymer of ethylene oxide and propylene oxide can be about 9,800 Da or about 10,000 Da. In yet another example, the molecular weight of the block copolymer of ethylene oxide and propylene oxide can be from about 8,000 Da to about 10,000 Da. In at least one embodiment, the block copolymer (if included in the composition) may be or include PLURAFLO® L4370, PLURAFLO® L1220 and PLURACARE® L1220, each of which is commercially available from BASF in Wayne-Dort, Michigan.

[0058] Based on the total weight of the oral care composition, one or more plasticizers may be present in amounts from about 1 wt% to about 40 wt%. For example, based on the total weight of the oral care product or its oral cleaning and whitening composition, one or more plasticizers may be present in amounts 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%. In at least one embodiment, based on the total weight of the oral care composition, the plasticizer comprises propylene glycol in amounts greater than 6 wt%, greater than 7 wt%, greater than 8 wt%, or greater than 9 wt%.

[0059] Oral care products or their oral care compositions may also include one or more flavoring agents and / or sweeteners. Illustrated flavoring agents and / or sweeteners may include, but are not limited to, essential oils and various flavoring aldehydes, esters, alcohols, etc. Flavoring agents 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 isomaltulose, aspartame, neotame, saccharin and its salts (e.g., sodium saccharin), gum arabic, dipeptide-based potent sweeteners, cyclamate, dihydrochalcone, etc., or mixtures thereof. Examples of essential oils include spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange oils. In another example, the flavoring agent may include menthol, carvone, and anethole. In a preferred embodiment, the oral care composition is a sugar-free composition to prevent or inhibit tooth decay. For example, the sweetener may include one or more of isomaltitol, maltitol, xylitol, sorbitol, sucralose, or any combination thereof.

[0060] Those skilled in the art will understand that the oral care compositions disclosed herein may include other additional ingredients / components. For example, an oral care composition may include any one or more of the following: anti-caries agents, anti-tartar agents, diluents, surface active agents or surfactants, mouthwashes, sweeteners, colorants or coloring agents, preservatives, defoamers (e.g., benzoic acid, sulfuric acid, glyceryl monostearate, etc.), abrasives, or combinations thereof. Those skilled in the art will further understand that while the general properties of materials in each of the above categories may differ, there may be some common properties within two or more categories of materials in such categories, and any given material can be used for multiple purposes. For example, clove oil can or may be configured to provide flavor properties as well as therapeutic functions. In at least one embodiment, the oral care composition may be free of or substantially free of fluoride components.

[0061] For example, the oral care compositions disclosed herein may further include one or more fluoride ion sources (e.g., soluble fluoride salts). A variety of fluoride-generating materials can be used as soluble fluoride sources. Examples of suitable fluoride-generating materials can be found in U.S. Patent No. 3,535,421 to Briner et al.; U.S. Patent No. 4,885,155 to Parran, Jr. et al.; and U.S. Patent 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 embodiment, the fluoride ion source comprises 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 fluoride ion source may be about 0.05 wt%. In another embodiment, the fluoride ion source is present in an amount providing 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 of fluoride ions.

[0062] In exemplary embodiments, the oral care composition may be one or more anti-tartar agents. Illustrative anti-tartar agents may include, but are not limited to, phosphates and polyphosphates (e.g., pyrophosphates), polyaminopropanesulfonic acid (AMPS), hexametaphosphate, zinc citrate trihydrate, peptides, polyolefin sulfonates, polyolefin phosphates, and bisphosphonates. In typical embodiments, anti-tartar agents include tetrasodium pyrophosphate (TSPP), sodium tripolyphosphate (STPP), tetrapotassium pyrophosphate (TKPP), or combinations thereof.

[0063] In some embodiments, 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 a material commonly referred to as a "polishing agent." One or more abrasives may be mixed, combined, dispersed, suspended, or otherwise contacted with an oral-acceptable mediator. In at least one embodiment, the oral care composition comprises a single abrasive. In another embodiment, the oral care composition comprises a mixture or combination of at least two abrasives. Illustrative abrasives may be, or include, metaphosphate compounds, phosphates (e.g., insoluble phosphates), 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 silica, silica, silicates, zirconium silicate, aluminum silicate, calcined aluminum silicate, polymethyl methacrylate, etc., or combinations thereof. In an exemplary embodiment, the abrasive comprises at least a silica abrasive, such as the commercially available abrasive under the trade name ZEODENT® 115 from Evonic Industries, AG of Essen, Germany. Based on the total weight of the oral care composition, any one or more abrasives may be present in amounts from 0 wt% to about 20 wt%. For example, based on the total weight of the oral care composition, one or more abrasives may be present in amounts 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%.

[0064] Oral care compositions may include one or more antimicrobial agents and / or one or more preservatives, such as methylisothiazolinone (MIT), sodium benzoate, potassium sorbate, benzyl alcohol, and combinations thereof. In another example, an oral care composition may include one or more antimicrobial agents selected from halogenated diphenyl ethers (e.g., triclosan), herbal extracts and essential oils (e.g., rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, saprol, catechin, methyl salicylate, epigallocatechin gallate, epigallocatechin gallate, gallic acid, miswak extract, sea buckthorn extract), biguanide preservatives (e.g., chlorhexidine, alexiconidine, or oteninidine), and quaternary ammonium compounds (e.g., cetylpyridine chloride (CPC), benzalkonium chloride, tetradecylpyridine chloride (TPC)). N-Tetradecyl-4-ethylpyridine chloride (TDEPC), phenolic preservatives, heexetidine, octenidine, sanguisorbine, povidone-iodine, delmopinol, salifluor, other metal ions (e.g., stannous, copper, iron salts), sanguisorbine, propolis, and oxidizing agents (e.g., hydrogen peroxide, buffered sodium perborate or sodium percarbonate), phthalic acid and its salts, monoperoxyphthalic acid and its salts and esters, ascorbic acid stearate, oleoylsarcosine, alkyl sulfates, dioctyl sulfosuccinate, salicylaniline, domiphen bromide, delmopinol, octopiol and other piperidinyl derivatives, nicotinic acid preparations, chlorites; and mixtures of any of the foregoing. In a typical embodiment, the antimicrobial agent includes hexadecylpyridine chloride (CPC). For example, all biphasic mouthwash compositions disclosed herein may include CPC as an antibacterial agent.

[0065] Oral care products and / or their oral care compositions may include antioxidants. Any oral-acceptable antioxidants 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 combinations thereof.

[0066] All ingredients used in the compositions described herein shall be orally acceptable. As used herein, “orally acceptable” can mean any ingredient present in the compositions as described in an amount and form that will not make the use of the composition in the oral cavity unsafe.

[0067] Method for preparing oral care compositions This disclosure provides a method for preparing the oral care compositions disclosed herein. The method may include preparing a slurry of an orally acceptable mordant and one or more whitening agents. The slurry may be prepared by mixing, stirring, combining, or otherwise contacting the orally acceptable mordant, one or more whitening agents, and water with each other. Water may be present in an amount sufficient to prepare the slurry. For example, 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 a solid film of the oral care product from the slurry. Preparing a solid film of the oral care product from the slurry may include at least partially evaporating water from the slurry by heating and / or reducing pressure.

[0068] Preparing a solid film for oral care products may include casting a slurry onto a substrate (e.g., a stainless steel surface) before evaporating water therefrom. Casting can refer to applying or distributing the slurry to the substrate to an appropriate, sufficient, or predetermined thickness. The substrate may be a metallic substrate, such as a stainless steel substrate, a non-adhesive substrate, such as a polyester film or a TEFLON surface, etc. Casting may be performed at room temperature or at temperatures from about 25°C to about 60°C or higher (e.g., up to about 75°C, about 80°C or higher). Casting may be performed for a predetermined amount of time (i.e., casting time), which may be determined at least in part by the amount of water present in the slurry. Casting time may be 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 longer. As used herein, the expression "casting time" may refer to the amount of time it takes for the slurry to dry.

[0069] In at least one embodiment, a release agent can be used to promote the formation of a solid film during casting. For example, a release agent (e.g., betaine) can be incorporated into the slurry or oral care composition to promote the separation of the solid film from the substrate. In another example, a release agent can be placed or coated onto the substrate before the slurry is cast onto it to promote the separation of the solid film from the substrate. In yet another embodiment, the release agent can be placed or coated onto the substrate and incorporated into the slurry or oral care composition. The amount of release agent used may be limited. For example, the amount of release agent can be limited to prevent degradation or instability of one or more whitening agents.

[0070] Kits and methods of using oral care compositions In some embodiments disclosed herein, the oral care composition may be used in conjunction with a dental flosser containing at least one source of hydrogen peroxide. The dental flosser may be obtained from various sources or may be packaged together with the oral care composition in a kit. Therefore, a kit comprising the oral care composition disclosed herein and a dental flosser containing at least one source of hydrogen peroxide is disclosed herein.

[0071] Dental cleaning agents and oral care compositions can remain separate from each other until the time of use, during which time they can be combined, mixed, or otherwise come into contact with each other. For example, dental cleaning agents and oral care compositions can be maintained in separate dishes or containers. Dental cleaning agents and oral care compositions can also be combined with each other in a single dish. As further described herein, one or more enzymes with perhydrolyzable activity catalyze a reaction between one or more hydrogen peroxide sources and one or more acyl donors to generate an oral care whitening enhancer (e.g., peracetic acid). In at least one embodiment, the hydrogen peroxide source can be maintained in the dental cleaning agent (e.g., toothpaste), and the acyl donor and / or the enzyme with perhydrolyzable activity can be maintained in the oral care composition, including solid oral care compositions (e.g., films, strips, tapes, etc.).

[0072] The weight ratio of a dental cleaning agent comprising a hydrogen peroxide source to an oral care composition comprising an acyl donor and / or an enzyme having perhydrolyzable activity can 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 dental cleaning agent to the oral care composition can be 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 dental cleaning agent to the oral care composition can be from about 1:1 to about 8:1, from about 1.5:1 to about 7.5:1, from about 2:1 to about 7:1, from about 2.5:1 to about 6.5:1, from about 3:1 to about 6:1, from about 3.5:1 to about 5.5:1, from about 4:1 to about 5:1, or from about 3.8:1 to about 4.2:1. In yet another example, the weight ratio of the dental cleaning agent to the oral care composition can 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 embodiment, the weight ratio of the dental cleaning agent to the oral care composition is about 4:1.

[0073] Dental cleaning agents may include one or more sources of hydrogen peroxide. These sources may be any compound or material formulated to react with any one or more acyl donors and / or any one or more enzymes having perhydrolytic activity to form a whitening enhancer. Illustrative sources of hydrogen peroxide may include, but are not limited to, hydrogen peroxide, urea peroxide, calcium peroxide, cross-linked polyvinylpyrrolidone (PVP) hydrogen peroxide complex, sodium percarbonate, and combinations thereof. Sources of hydrogen peroxide may also include, but are not limited to, PEROXYDONETM XL 10 complex and POLYPLASDONE® XL 10F, which are commercially available from Ashland Inc. of Covington, Kentucky.

[0074] The amount or concentration of hydrogen peroxide source in a dental cleaning agent can vary considerably. In at least one embodiment, the amount of hydrogen peroxide, based on the total weight of the dental cleaning agent, can be greater than or equal to 0.01 wt% and less than or equal to 10 wt%. For example, the amount of hydrogen peroxide in a whitening composition can be from about 0.01 wt% to about 5.0 wt%, from about 0.01 wt% to about 1.0 wt%, from about 0.05 wt% to about 0.5 wt%, or about 0.1 wt%. In another example, the amount of hydrogen peroxide source in the dental cleaning agent may be from about 0.5 wt% to about 10.5 wt%, from about 1.0 wt% to about 10.0 wt%, from about 1.5 wt% to about 9.5 wt%, from about 2.0 wt% to about 9.0 wt%, from about 2.5 wt% to about 8.5 wt%, from about 2.0 wt% to about 8.0 wt%, from about 2.5 wt% to about 7.5 wt%, from about 3.0 wt% to about 7.0 wt%, from about 3.5 wt% to about 6.5 wt%, from about 4.0 wt% to about 6.0 wt%, from about 4.5 wt% to about 5.5 wt%, from about 5.0 wt% to about 6.0 wt%, or from about 5.5 wt%. In yet another embodiment, the amount of hydrogen peroxide source 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, hydrogen peroxide is present in the dental cleaning agent at an amount of about 0.1 wt%.

[0075] The whitening enhancer (e.g., peracetic acid) of the oral care composition can be generated within at least 3 minutes after the contact of one or more hydrogen peroxide sources, one or more acyl donors, and / or one or more enzymes with perhydrolytic activity or after the start of a perhydrolysis reaction. For example, the whitening enhancer of the oral care composition can be generated within 3 minutes or less, 2.8 minutes or less, 2.6 minutes or less, 2.4 minutes or less, 2.2 minutes or less, 2.0 minutes or less, 1.8 minutes or less, 1.6 minutes or less, 1.4 minutes or less, 1.2 minutes or less, 1.0 minutes or less, 0.8 minutes or less, 0.6 minutes or less, or 0.4 minutes.

[0076] This disclosure further provides a method for whitening the tooth surface of a human or animal subject using the oral care compositions disclosed herein. As used herein, "animal subject" may include higher non-human mammals such as canines, felines, and horses.

[0077] The method may include storing the oral care composition in a stable form until its intended use. The method may also include contacting the perhydrolyzed enzyme and acyl donor of the oral care composition with a hydrogen peroxide source to initiate the formation of peracetic acid. In at least one embodiment, contacting the perhydrolyzed enzyme and acyl donor of the oral care composition with a hydrogen peroxide source to initiate the formation of peracetic acid may include mixing, stirring, or otherwise contacting an oral care composition containing a hydrogen peroxide source with an oral care composition containing an acyl donor and an enzyme having perhydrolyzed activity. In at least one embodiment, the method may include, in a first step, attaching or applying the oral care composition, such as a solid oral care composition in film form, to an oral cavity surface, such as teeth. In a second step, the method may include contacting the dental cleaning agent containing a hydrogen peroxide source with an oral cavity surface (e.g., teeth) to which the oral care composition has been attached or applied. Optionally, the method further includes using a tool such as a toothbrush, for example by brushing teeth, to agitate or mix the dental cleaning agent with the oral care composition. In some embodiments of the methods disclosed herein, the oral care composition can generate peracetic acid in less than 2 minutes, less than 1.5 minutes, less than 1 minute, less than 45 seconds, or less than 30 seconds.

[0078] The oral care composition can be applied and / or contacted with the surface of teeth at predetermined time intervals. For example, the oral care composition can be applied and / or contacted with the tooth surface daily, such as once, twice, or three times a day, at least once a day for several days, multiple times a day for several days, or alternatively every other day. The oral care composition can be used for up to 2 weeks, up to 3 weeks, up to 4 weeks, up to 6 weeks, up to 8 weeks, or longer. In some embodiments, the oral care composition can be used for any period of time as needed.

[0079] The oral care compositions disclosed herein can be used in conjunction with dental cleaning agents containing a hydrogen peroxide source to whiten teeth. In some embodiments, the methods disclosed herein enhance tooth whitening when using oral care compositions containing one or more acyl donors and one or more perhydrolysins compared to using dental cleaning agents containing only a hydrogen peroxide source. In some embodiments, the use of oral care compositions in solid (e.g., film) form enhances tooth whitening compared to using oral care compositions in liquid or gel form. While not wishing to be bound by theory, it is believed that the use of solid oral care compositions provides superior whitening efficacy compared to the use of gel compositions, in addition to offering a more user-friendly experience, because solid oral care compositions, in particular, provide excellent adhesion to the tooth surface.

[0080] Whitening efficacy can be measured in any manner known to those skilled in the art. In some embodiments, whitening efficacy can be measured using L*, a*, b* color scales, for example, using a SpectroShade device that includes a spectrophotometer and a camera. In some embodiments, whitening efficacy can be evaluated using the following formula, where ΔW indicates the change in surface (e.g., teeth) whiteness compared to an initial starting value. A negative ΔW value indicates whiter teeth compared to the initial starting value. The ΔW value can be calculated using the following formula: Where a * Indicates the range from green to red, b * Indicates blue to yellow, and L * Indicates brightness.

[0081] Therefore, this document discloses a method for whitening teeth using the oral care composition disclosed herein. In some embodiments, the ΔW value of the method for whitening teeth as disclosed herein is less than about -1.0, such as less than about -1.5, less than about -2, less than about -2.5, less than about -3.0, less than about -3.5, less than about -4.0, less than about -5, less than about -5.5, or less than about -6.0. In some embodiments, the method for whitening teeth as disclosed herein provides enhanced whitening efficacy compared to a method without using the oral care composition disclosed herein, providing a ΔW value that is at least 0.2 lower than the ΔW value of the method without using the oral care composition, such as at least 0.3, at least 0.4, at least 0.5, at least 0.6, at least 0.7, at least 0.8, at least 0.9, at least 1.0, at least 1.1, at least 1.2, at least 1.3, at least 1.4, or at least 1.5 lower. In some embodiments, the method of whitening teeth with a solid oral care composition as disclosed herein provides enhanced whitening efficacy compared to the 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 using a liquid or gel oral care composition, such as at least 0.3, at least 0.4, at least 0.5, at least 0.6, at least 0.7, at least 0.8, at least 0.9, at least 1.0, at least 1.1, at least 1.2, at least 1.3, at least 1.4, or at least 1.5 lower.

[0082] Example The examples and other embodiments described herein are exemplary and are not intended to limit the scope of the compositions and methods described herein. Equivalent changes, modifications, and variations in specific embodiments, materials, compositions, and methods can be made within the scope of this disclosure to obtain substantially similar results.

[0083] Example 1 - Preparation of Whitening Strips A slurry containing 60-90% purified water, 10-30% hydroxypropyl methylcellulose (HPMC), 1-10% triacetin, and 1-3% hydrolytic enzyme is prepared. The slurry is then dried to produce a film. Exemplary formulations are disclosed in Table 1 below.

[0084] Table 1 - Exemplary Enzyme Membrane Formulations The film is prepared by first making a homogeneous slurry of the formulation. The slurry is then uniformly cast onto the surface using a casting rod, specifically onto the coated stainless steel surface. The slurry is then heated at 60-75°C for 30-60 minutes until the film is dry.

[0085] Example 2 - The Efficacy of Whitening Strips Purchase artificially stained bovine teeth, mounted in resin, from the dental product testing division of Therametric Technologies, Inc. (L) * Brushed cow teeth with values ​​between 58 and 62 were placed in 3D-printed dental trays, and their baseline L was measured using SpectroShade. * a * and b * The cow's teeth were then moistened, and the membrane prepared as described in Example 1 above was placed on the moistened teeth for 1 minute. After 1 minute, a thin slurry of the membrane, followed by a thin slurry of 0.1% hydrogen peroxide toothpaste, was placed on the teeth. The teeth were then brushed in a brushing machine for 2 minutes. After brushing for 2 minutes, the teeth were rinsed with water, and the process was repeated a second time, thus completing one cycle. The process was repeated for a total of 3 cycles.

[0086] Three control cycles were performed using only 0.1% hydrogen peroxide toothpaste, without the use of a membrane.

[0087] The whitening performance report shows the change in W after treatment compared to baseline. A larger negative ΔW value compared to baseline measurement indicates whiter teeth. The ΔW value is calculated using the following formula: Where a * Indicates the range from green to red, b * Indicates blue to yellow, and L * Indicates brightness. See Table 2 below. Figure 1 The results are shown in the figure.

[0088] Table 2 - Whitening efficacy of H2O2 toothpaste along with enzyme membrane (ΔW) like Figure 1 As shown, compared with using 0.1% hydrogen peroxide toothpaste alone, the whitening effect of using 0.1% hydrogen peroxide toothpaste in combination with the enzyme membrane disclosed herein can be enhanced.

[0089] This disclosure has been described with reference to exemplary embodiments. While a limited number of embodiments have been shown and described, those skilled in the art will understand that changes may be made to these embodiments without departing from the principles and spirit of the prior art. This disclosure is intended to be interpreted in a manner that includes all such modifications and changes, provided they fall within the scope of the appended claims or their equivalents.

Claims

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

2. The oral care composition of 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 perhydrolyzing enzymes are present in the oral care composition in amounts of 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 one of the preceding claims, wherein the one or more acyl donors comprise triacetin.

5. The oral care composition according to any one of the preceding claims, wherein the one or more acyl donors are present in the oral care composition in an amount of 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 one of the preceding claims, wherein the one or more water-soluble polymers are selected from carboxymethyl cellulose (CMC), hydroxyethyl cellulose (HEC), cetyl hydroxyethyl cellulose, hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinylpyrrolidone (PVP), polyvinylpyrrolidone / vinyl acetate (PVP / VA), cellulose ethers, or combinations thereof.

7. The oral care composition of claim 6, wherein one or more water-soluble polymers are PVP.

8. The oral care composition of claim 6, wherein one or more water-soluble polymers are HPMC.

9. The oral care composition according to any one of the preceding claims, wherein the one or more water-soluble polymers are present in an amount of 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 one of the preceding claims, further comprising sugar or a sweetener.

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

12. The oral care composition of claim 10 or 11, wherein the sugar or sweetener is present in an amount of about 0.01 wt% to about 10 wt%, about 0.1 wt% to about 5 wt%, 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 one of the preceding claims, further comprising water in an amount of 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 one of the preceding claims, wherein the solid film is soluble and / or disintegrable.

15. A method for preparing an oral care composition according to any one of claims 1 to 14, the method comprising: To prepare a slurry, one or more water-soluble polymers and a whitening agent containing one or more acyl donors and one or more hydrolytic enzymes are contacted with water. The slurry is cast onto a surface to form a layer; and The layer is dried to form the solid film.

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

17. The method of claim 15 or 16, wherein the water is added to the slurry in an amount of 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 to 17, wherein water is present in the solid membrane in an amount of 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 for whitening teeth, the method comprising: Apply the oral care composition according to any one of claims 1 to 14 to the teeth; and The teeth are brought into contact with a dental cleaning agent containing at least one source of hydrogen peroxide.

20. The method of claim 19, wherein the dental cleaning agent comprising at least one source of hydrogen peroxide is toothpaste.

21. The method of claim 19 or 20, wherein the hydrogen peroxide is present in the dental cleaning agent containing hydrogen peroxide in an amount of 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 dental cleaning agent.

22. A kit comprising an oral care composition according to any one of claims 1 to 14 and a dental cleaning agent containing at least one source of hydrogen peroxide, wherein the oral care composition and the dental cleaning agent are separate before use.

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