CN112912146A

CN112912146A - Oral care compositions and methods

Info

Publication number: CN112912146A
Application number: CN201880098278.3A
Authority: CN
Inventors: 迈克尔·诺思; 董蓉; 帕洛马·皮门塔; 希拉·皮尔希
Original assignee: Colgate Palmolive Co
Current assignee: Colgate Palmolive Co
Priority date: 2018-10-16
Filing date: 2018-10-16
Publication date: 2021-06-04
Also published as: BR112021006653A2; BR112021006653B1; CA3113777A1; EP3849670A1; MX2021004165A; AU2018446162A1; WO2020081050A1; AU2018446162B2

Abstract

Film forming compositions and methods for preventing stains on teeth and increasing shine and gloss of teeth. The film-forming composition can include a polymer, such as a hydrophobic polymer, and an orally acceptable solvent. The hydrophobic polymer may include an acrylate component and a hydrophobic group coupled to each other. The hydrophobic groups may include alkyl chains, polyethylene glycol, polypropylene, polyesters, polyorthoesters, phospholipids, long chain fatty acids, vinyl chloride, vinyl fluoride, silicones, urethanes, octylacrylamide, butylaminoethyl, styrene, and combinations thereof.

Description

Oral care compositions and methods

Background

Conventional oral care products, such as dentifrices, typically incorporate abrasives to clean plaque and stains from the surfaces of the teeth. In addition to removing plaque and stains, abrasives can polish teeth, thereby increasing their luster and shine. While conventional oral care products incorporating abrasives have proven effective in removing plaque and stains and increasing shine and brightness, the continued use of these oral care products often results in excessive abrasion of the enamel on the tooth surface.

Thus, there is a need for improved oral care products and film-forming compositions, and methods for protecting teeth from stains and/or improving tooth gloss and shine without abrasives.

Disclosure of Invention

This summary is intended merely to introduce a simplified summary of some aspects of one or more embodiments of the disclosure. Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. This summary is not an extensive overview, is not intended to identify key or critical elements of the teachings or to delineate the scope of the disclosure. Rather, its sole purpose is to present one or more concepts in a simplified form as a prelude to the more detailed description that is presented later.

The foregoing and/or other aspects and utilities embodied in the present disclosure may be achieved by providing a film-forming composition for preventing stains or increasing shine and gloss of teeth. The film-forming composition can include a polymer, such as a hydrophobic polymer, and an orally acceptable solvent.

In at least one embodiment, the hydrophobic polymer may include an acrylate component and a hydrophobic group coupled to each other. The hydrophobic groups may include one or more of alkyl chains, polyethylene glycol, polypropylene, polyesters, polyorthoesters, phospholipids, long chain fatty acids, vinyl chloride, vinyl fluoride, silicones, urethanes, octylacrylamide, butylaminoethyl, and styrene.

In at least one embodiment, the acrylate component may be provided by an acrylate monomer. The acrylate monomers may include one or more of methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, and trimethylolpropane triacrylate. The acrylate component may be configured to promote, maintain, or increase the adhesion of a film formed from the film-forming composition to a tooth surface.

In at least one embodiment, the polymer may be a carboxylated acrylic copolymer.

In at least one embodiment, the polymer can be a copolymer of octylacrylamide and one or more monomers. The one or more monomers may include one or more of acrylic acid, methacrylic acid, and any simple esters thereof. In at least one embodiment, the polymer may be

The foregoing and/or other aspects and utilities embodied in the present disclosure may be achieved by providing a film-forming composition for increasing shine and gloss of teeth, which may include a polycarboxylate polymer and an orally acceptable solvent. In at least one embodiment, the polycarboxylate polymer may be a copolymer of methyl vinyl ether and maleic anhydride.

The foregoing and/or other aspects and utilities embodied in the present disclosure may be achieved by providing a film-forming composition for increasing shine and gloss of teeth. The film-forming composition can include ethylcellulose having a degree of ethoxylation of from about 45% to about 55% or from about 48% to about 52%.

In at least one embodiment, the film-forming composition can further comprise a fluorine compound. The fluorine compound may be a soluble salt of fluorine ions. In at least one embodiment, the fluoride compound may include one or more of sodium fluoride, potassium fluoride, calcium fluoride, zinc ammonium fluoride (zinc ammonium fluoride), lithium fluoride, ammonium fluoride, stannous fluoride, and stannous fluorozirconate. In a preferred embodiment, the fluorine compound comprises sodium fluoride.

In at least one embodiment, the orally acceptable solvent can include one or more of ethanol, methanol, isopropanol, butanol, water, acetone, methyl ethyl ketone, ethyl acetate, butyl acetate, cyclohexanone, cyclohexane, methylene chloride, chloroform, carbon tetrachloride, trichloroethylene, perchloroethylene, methyl glycol acetate, toluene, benzene, diethyl ether, and benzyl alcohol. In a preferred embodiment, the orally acceptable solvent comprises ethanol.

In at least one embodiment, the film-forming composition may further comprise a binder. The binder may include one or more of polyvinyl acetal (polyvinylacetaldehyde), polyvinyl alcohol, polyvinyl acetate, poly (ethylene oxide), polyacrylate, polyvinylpyrrolidone/vinyl acetate copolymer, polyoxyethylene/polyoxypropylene block copolymer, and silicone resin.

In at least one embodiment, the film-forming composition can further include one or more of a therapeutic agent, an antimicrobial agent, a desensitizing agent, a sweetener, and a whitening agent.

In at least one embodiment, the whitening agent includes an oxidizing agent, optionally, the oxidizing agent includes one or more of a peroxide, a chlorite, and a hypochlorite. In at least one embodiment, the whitening agent includes a peroxy compound.

The foregoing and/or other aspects and utilities embodied in the present disclosure may be achieved by providing a method for preventing stains on teeth. The method can comprise applying any of the film-forming compositions disclosed herein to a tooth surface or to a tooth surface. The method may further comprise evaporating at least a portion of the orally acceptable solvent to form a film on the tooth surface.

The foregoing and/or other aspects and utilities embodied in the present disclosure may be achieved by providing a method for increasing shine and gloss of teeth. The method can comprise applying any of the film-forming compositions disclosed herein to a tooth surface or to a tooth surface. The method may further comprise evaporating at least a portion of the orally acceptable solvent to form a film on the tooth surface.

Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating some exemplary aspects of the disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure.

Detailed Description

The following description of various exemplary aspects is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses.

As used throughout this disclosure, ranges are used as a shorthand way of describing each and every value that is within the range. It is to be understood and appreciated that the description in range format is merely for convenience and brevity and should not be construed as a rigid limitation on the scope of any embodiments or implementations disclosed herein. Accordingly, the disclosed range should be interpreted as having specifically disclosed all the possible sub-ranges as well as individual numerical values within the range. Thus, any value within the range can be selected as the terminus of the range. For example, description of a range such as 1 to 5 should be considered to have specifically disclosed sub-ranges such as 1.5 to 3, 1 to 4.5, 2 to 5, 3.1 to 5, etc., as well as individual numbers within the range such as 1, 2, 3, 3.2, 4, 5, etc. This applies regardless of the breadth of the range.

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

Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in this specification are to be understood as referring to weight percentages. The amounts given are based on the effective weight of the material.

Moreover, all numerical values are "about" or "approximately" the stated value, and take into account experimental error and deviation as would be expected by one of ordinary skill in the art. It should be understood that all numbers and ranges disclosed herein are approximations and approximate ranges, regardless of whether "about" is used in connection therewith. It is also to be understood that the term "about" in connection with a numerical value, as used herein, refers to a value that can be ± 0.01% (inclusive), ± 0.1% (inclusive), ± 0.5% (inclusive), ± 1% (inclusive), ± 2% (inclusive) of the numerical value, ± 3% (inclusive) of the numerical value, ± 5% (inclusive) of the numerical value, ± 10% (inclusive) of the numerical value, or ± 15% (inclusive) of the numerical value. It should also be understood that when numerical ranges are disclosed herein, any number falling within the range is also specifically disclosed.

The present inventors have surprisingly and unexpectedly discovered that films formed from polymers comprising an acrylate component and bulky hydrophobic groups exhibit relatively greater efficacy in stain prevention and acting as a stain barrier than polymers without these features or characteristics. In some examples, a relatively large volume of hydrophobic groups may be coupled with the acrylate. For example, films formed from copolymers of acrylate monomers with monomers having relatively bulky hydrophobic functional groups (e.g., octylacrylamide, butylaminoethyl, and/or styrene) exhibit relatively greater efficacy in stain prevention and acting as a stain barrier than films formed from polymers lacking these characteristics. It has also been unexpectedly and unexpectedly found that films formed from polymers incorporating or including acrylic or acrylate groups exhibit relatively greater bonding to tooth surfaces than films formed from polymers without acrylic groups. It has also been unexpectedly and unexpectedly found that films formed from polymers incorporating or including acrylic groups exhibit relatively greater and more reproducible or consistent gloss and shine than films formed from polymers without acrylic groups.

Composition comprising a metal oxide and a metal oxide

The compositions disclosed herein may be or may include an oral care product or film-forming composition thereof. For example, the compositions disclosed herein can be oral care products comprising a film-forming composition or a film-forming composition thereof. In at least one embodiment, the film-forming composition can include one or more polymers having a hydrophilic component or functional group and a hydrophobic component or functional group. For example, the film-forming composition can include a polymer having an acrylate or acrylic component (i.e., a hydrophilic component) and a bulky hydrophobic component (e.g., t-octyl acrylamide, butylaminoethyl methacrylate, and/or styrene). As further described herein, the film-forming compositions disclosed herein or films formed therefrom can be or are configured to provide stain barrier and stain prevention properties to oral surfaces (e.g., tooth surfaces). The film-forming compositions disclosed herein or films formed therefrom can also or be configured to enhance, maintain, or otherwise provide gloss and shine to the tooth surface.

Polymer and method of making same

The one or more polymers of the film-forming composition may be or include, but are not limited to, one or more film-forming polymers. As used herein, the expression "film-forming polymer" may refer to or encompass polymers, prepolymers, and/or monomers that are capable of or configured to form a continuous film on a substrate, such as an oral surface (e.g., a tooth surface), alone or in the presence of at least one additional agent.

The film-forming polymer may include one or more hydrophilic components or functional groups and/or one or more hydrophobic components or functional groups. The hydrophilic component or functional group can be or is configured to promote, maintain, or increase the adhesion of the film-forming polymer to the oral surface. Illustrative hydrophilic components or functional groups can be or include, but are not limited to, acrylate or acrylic groups, carboxyl groups, carbonyl groups, mercapto groups, phosphate groups, hydroxyl groups, amines, disulfides, nitro groups, and the like, and combinations thereof. The hydrophilic component may be provided by one or more acrylate monomers. Illustrative acrylate monomers can include, but are not limited to, methacrylate, methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, trimethylolpropane triacrylate, and the like, as well as mixtures or combinations thereof.

The hydrophobic component or functional group can be or be configured to provide one or more benefits or characteristics to a film formed from the film-forming polymer. For example, the hydrophobic component can be or be configured to provide, maintain, or increase the effectiveness of the film for preventing stains. In another example, the hydrophobic component can be or be configured to provide, maintain, or increase the efficacy of the film as a stain barrier. Illustrative hydrophobic components or functional groups can be or include, but are not limited to, alkyl chains, polyethylene glycols, polypropylenes, polyesters, polyorthoesters, phospholipids, long chain fatty acids, vinyl chlorides, vinyl fluorides, silicones, urethanes, octylacrylamides, butylaminoethyl, styrene, and the like, as well as mixtures or combinations thereof.

In at least one embodiment, the film-forming polymer can be or include a homopolymer. In another embodiment, the film-forming polymer may be or include a copolymer made or produced from two or more different monomers. For example, the film-forming polymer may be or include a copolymer composed of a first monomer capable of or configured to provide a hydrophilic component or functional group and a second monomer capable of or configured to provide a hydrophobic component or functional group.

In at least one embodiment, the film-forming polymer may be or include a carboxylated acrylic copolymer. For example, the film-forming polymer can be a copolymer of octylacrylamide and one or more monomers, wherein the one or more monomers can include one or more of acrylic acid, methacrylic acid, and any one or more simple esters thereof. In another example, the film-forming polymer can be a polymer formed from one or more monomers of octylacrylamide, t-butylaminoethyl methacrylate, and monomers of acrylic acid, methacrylic acid, or any one or more simple esters thereof.

Exemplary film-forming polymers can be or include, but are not limited to, those under the trade name

And

those sold commercially, these are available from Akzo Nobel Company (Surface Chemistry of Amsterdam, Netherlands). For example, the film-forming polymer can be or include, but is not limited to

4961、

HC、

2.0、RESYN^TMXP, film-forming polymers selected from octylacrylamide/acrylates/butylaminoethyl methacrylate copolymers, e.g.

LV-71、

EDGE^TM、

47, and the like, as well as combinations thereof, all available from Akzo Nobel Company (Surface Chemistry, Amsterdam, the Netherlands). The film-forming polymer may be selected from vinyl acetate/butyl maleate/isobornyl acrylate copolymers such as ADVANTAGE from Ashland Global Specialty Chemicals Inc. of Calkengton, Kyon (Kyongton, KY)^TMPLUS. The film-forming polymers can also be selected from acrylate/tert-butylacrylamide copolymers, for example from BASF SE of Ludwigshafen, Germany

STRONG and

the film-forming polymer may also be chosen from acrylate/dimethylaminoethyl methacrylate copolymers, for example from Evonik Industries of Essen, Germany

Polymers of the series, e.g.

E PO(CAS：24938-16-7)、

RS 100、

RS PO、

RL PO、

RL 100, and the like, as well as combinations thereof. For example, the film-forming polymer may be poly (butyl methacrylate-co- (2-dimethylaminoethyl) methacrylate-co-methyl methacrylate) 1: 2: 1. The film-forming polymer may be selected from polyvinylpyrrolidone/vinyl acetate, e.g. PVP/VA series polymers, and triacontyl PVP, e.g. GANEX^TMWP-660, both commercially available from Ashland Global Specialty Chemicals Inc., Calwaton, Kentucky. The film-forming polymer may be selected from at least one of the following: octylacrylamide/acrylate/butylaminoethyl methacrylate copolymers, Vinyl Acetate (VA)/butyl maleate/isobornyl acrylate copolymers, acrylate/t-butylacrylamide copolymers, polyvinylpyrrolidone/vinyl acetate copolymers, triacontyl PVP copolymers, acrylate/dimethylaminoethyl methacrylate copolymers, and the like, as well as mixtures or combinations thereof. In a preferred embodiment, the film-forming polymer may be a copolymer of an acrylate and octylacrylamide. For example, the film-forming polymer can be or include a copolymer of 2-methyl-2-propenoic acid 2-methylpropyl ester and 2-propenoic acid with N- (1, 1, 3, 3-tetramethylbutyl) -2-propenamide or a copolymer of 2-methyl-2-propenoic acid 2-methylpropyl ester, 2-propenoic acid, N- (1, 1, 3, 3-tetramethylbutyl) -2-propenamide (CAS 129702-02-9). For example, the film-forming polymer can be or include, but is not limited to

79 available from Akzo Nobel Company (Surface Chemistry, Amsterdam, Netherlands). In another preferred embodiment, the film-forming polymer may be an octylacrylamide/acrylate/butylaminoethyl methacrylate copolymer. For example, the film-forming polymer can be or include a polymer of 2-methyl-2-acrylic acid 2- (1, 1-dimethylethyl) aminoethyl ester with 2-methyl-2-acrylic acid methyl ester, 1, 2-propanediol mono (2-methyl-2-acrylate), a copolymer of 2-acrylic acid and N- (1, 1, 3, 3-tetramethylbutyl) -2-acrylamide (CAS 70801-07-09). For example, the film-forming polymer can be or include, but is not limited to

LV-71, available from Akzo Nobel Company (Surface Chemistry). In a further preferred embodiment, the film-forming polymer may be

E PO(CAS：24938-16-7)。

In at least one embodiment, the film-forming polymer may be or include, but is not limited to, a polycarboxylate, such as a copolymer of methyl vinyl ether and maleic anhydride. For example, the film-forming polymer may be or include an anionic polycarboxylate polymer, e.g.

S-97, available from Ashland Specialty Chemicals of Bound Brook, N.J.).

In another embodiment, the film-forming polymer may be or include, but is not limited to, a styrene copolymer, such as poly (styrene-co-maleic acid) partially isobutyl ester copolymer (CAS 28571-95-1).

In at least one embodiment, the film-forming polymer may be or include, but is not limited to, cellulose or derivatives of cellulose derivatives, such as alkyl cellulose ethers. As used herein, the expression "alkyl cellulose ether" may refer to a lower alkyl ether of cellulose, such as ethyl cellulose. In a preferred embodiment, the cellulose derivative is ethyl cellulose. The degree of ethoxylation and/or the viscosity of the ethylcellulose can vary. For example, ethyl cellulose mayHas a degree of ethoxylation of from about 45% to about 55% or from about 48% to about 52%. In another example, the ethylcellulose can have a viscosity of from about 3cP to about 70cP or from about 80cP to about 105cP (a 5% 80: 20 toluene: ethanol solution measured at 25 ℃). In another example, the ethylcellulose can have an average substitution value of from about 2.3 to about 2.60 ethoxy groups per anhydroglucose unit. In yet another example, the ethylcellulose can have an average substitution value of from about 2.46 to about 2.58 ethoxy groups per anhydroglucose unit, corresponding to an ethoxy content of from about 48% to about 49.5%. Illustrative ethylcellulose can be or include, but is not limited to

EC N100 ethylcellulose, commercially available from Hercules inc, Wilmington, DE;

Standard 100、ETHOCEL^TME7、ETHOCEL^TME22、ETHOCEL^TMe50, and the like, and mixtures thereof, are commercially available from the Dow Corning Company.

The amount or concentration of any one or more of the film-forming polymers present in the oral care product or film-forming composition thereof can vary widely. In at least one embodiment, the amount of any one or more of the film-forming polymers present can be an amount effective to form a film capable of or configured to prevent the transmission of stains and/or an amount effective to form a film capable of or configured to provide a stain barrier. In another embodiment, the amount of any one or more of the film-forming polymers present can be an amount effective to form a film that is capable of or configured to provide a relatively greater gloss and shine than the substrate (e.g., tooth surface) alone. In at least one embodiment, any one or more of the film-forming polymers may be present in an amount of from about 1% to about 50% by weight, based on the total weight of the oral care product or film-forming composition thereof. For example, any one or more of the film-forming polymers may be present in an amount of about 1, about 2, about 4, about 6, about 8, about 10, about 12, about 14, about 16, about 18, about 20, about 22, or about 24 to about 26, about 28, about 30, about 32, about 34, about 36, about 38, about 40, about 42, about 44, about 46, about 48, or about 50 weight percent, based on the total weight of the oral care product or film-forming composition thereof. In another example, any one or more of the film-forming polymers may be present in an amount of about 1 wt% to about 50 wt%, about 5 wt% to about 45 wt%, about 10 wt% to about 40 wt%, about 15 wt% to about 35 wt%, about 20 wt% to about 30 wt%, or about 22.5 to about 28.5 or about 25 wt%. In another embodiment, any one or more of the film-forming polymers may be present in an amount of about 1% to about 30% by weight, based on the total weight of the oral care product or film-forming composition thereof. For example, any one or more of the film-forming polymers may be present in an amount of about 1, about 2, about 4, about 6, about 8, about 10, about 12, or about 14 to about 16, about 18, about 20, about 22, about 24, about 26, about 28, or about 30 weight percent, based on the total weight of the oral care product or film-forming composition thereof. In another example, any one or more of the film-forming polymers may be present in an amount of about 1 wt% to about 30 wt%, about 2 wt% to about 28 wt%, about 4 wt% to about 26 wt%, about 6 wt% to about 24 wt%, about 8 wt% to about 22 wt%, about 10 wt% to about 20 wt%, about 12 wt% to about 18 wt%, or about 14 wt% to about 16 wt%.

Fluoride or fluorine compounds

The oral care product or film-forming composition thereof may include one or more fluoride or fluorine compounds. As used herein, the expression "fluoride" or "fluorine compound" may refer to a fluoride source and/or a compound capable of or configured to provide fluoride ions. Illustrative fluorides can be or include, but are not limited to, soluble salts of fluoride ions such as sodium fluoride, potassium fluoride, calcium fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluorozirconate, complex fluorides, monofluorophosphate esters and salts thereof (e.g., sodium monofluorophosphate or potassium monofluorophosphate), dodecylamine hydrofluoride, diethylaminoethyl octanoamide hydrofluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, amine fluoride, and the like, as well as mixtures or combinations thereof. In a preferred embodiment, the fluoride is sodium fluoride.

The amount or concentration of the one or more fluorine compounds present in the oral care product or film-forming composition thereof can vary widely. In at least one embodiment, the fluorine compound may be present in an amount capable of or configured to provide fluoride ions in an amount of from about 100ppm to about 50,000 ppm. For example, the fluorine compound may be present in an amount capable of or configured to provide an amount of fluoride ions of about 100ppm, about 500ppm, about 1,000ppm, about 5,000ppm, or about 10,000ppm to about 15,000ppm, about 20,000ppm, about 25,000ppm, about 30,000ppm, about 35,000ppm, about 40,000ppm, about 45,000ppm, or about 50,000 ppm. In another example, the fluorine compound can be present in an amount capable of or configured to provide an amount of fluoride ion of at least 100ppm, at least 500ppm, at least 1,000ppm, at least 5,000ppm, at least 10,000ppm, at least 15,000ppm, at least 20,000ppm, at least 25,000ppm, or at least 30,000 ppm. In preferred embodiments, the fluorine compound is present in an amount sufficient to provide from about 500ppm to about 30,000ppm, more preferably from about 1,000ppm to about 23,000ppm or from about 1,100ppm to about 22,600 ppm. It will be appreciated that the exact weight percent of the fluorine compound in the film-forming composition can be determined, at least in part, by varying the stoichiometric characteristics of the fluorine compound. In exemplary embodiments, the fluorine compound is sodium fluoride and is present in an amount of about 0.5 wt.%, about 1 wt.%, about 1.5 wt.%, about 2 wt.%, about 2.5 wt.%, about 3 wt.%, about 3.5 wt.%, about 4 wt.%, or about 4.5 wt.% to about 5 wt.%, about 6.5 wt.%, about 7 wt.%, about 7.5 wt.%, about 8 wt.%, or about 8.5 wt.%. In preferred embodiments, sodium fluoride is present in an amount of about 4% to about 6% or about 5% by weight. In another embodiment, sodium fluoride is present in an amount of about 0.5 wt.% to about 1.5 wt.%, about 1 wt.%, or about 1.11 wt.%.

Adhesives or adhesion enhancers

In at least one embodiment, the oral care product or film-forming composition thereof can optionally include one or more binders configured to improve, maintain, and/or promote adhesion of a film formed from the film-forming composition to an oral surface. The one or more binders may also be configured to increase the hydrophobicity of a film formed from the film-forming composition, thereby allowing the film to withstand external challenges, such as grinding, rubbing, or brushing.

Illustrative binders can be or include, but are not limited to, alkyd resins, polyvinyl acetal, polyvinyl alcohol, polyvinyl acetate, poly (ethylene oxide), polyacrylates, ketone resins, polyvinyl pyrrolidone/vinyl acetate copolymers, polyethylene glycol having a molecular weight of 200 to 1000, polyoxyethylene/polyoxypropylene block copolymers (Polyox), silicone resins, and the like, and mixtures or combinations thereof. In at least one embodiment, the one or more adhesives may include a siloxane polymer, which is also commonly referred to in the art as a "silicone" polymer. Illustrative silicone-based hydrophobic polymers can be or include, but are not limited to, polyorganosiloxanes, polydiorganosiloxanes, and the like, as well as combinations thereof. In at least one embodiment, the adhesion enhancing agent comprises at least one silicon Pressure Sensitive Adhesive (PSA). Such PSAs may be pressure sensitive hydrophobic polymers specifically designed for pharmaceutical use, and are permeable to many pharmaceutical compounds, and are useful for transdermal applications of various compounds. In some embodiments, the silicone polymer is a copolymer product of mixing a silanol-terminated polydiorganosiloxane (such as polydimethylsiloxane) with a silanol-containing silicone resin, whereby the silanol groups of the polydiorganosiloxane undergo a condensation reaction with the silanol groups of the silicone resin, causing the polydiorganosiloxane to be lightly crosslinked by the silicone resin (i.e., the polydiorganosiloxane chains are bonded together through the resin molecules to create chain branching and entanglement and/or a small amount of network character) to form the silicone hydrophobic polymer. In at least one embodiment, the adhesion enhancing agent is available from the Dow Corning Company of Midland, Mich under the trade name BIO-PSA. Varying the ratio of silicone resin to polydiorganosiloxane will vary the tackiness of the polymer. This ratio may be in the range of about 70: 30 to about 50: 50. For example, BIO-PSA silicones available from Dow-Corning are available in different silicone resin to silicone polymer ratios, namely 65/35 (low tack), 60/40 (medium tack), 55/45 (high tack). Such polyorganosiloxane PSAs are available in the form of a solution in ethyl acetate solvent or dimethylsilicone oil. In at least one embodiment, the adhesion enhancing agent may include silicone adhesives 8-7016 available from Dow Corning Corporation of Midland, Mich.

In some embodiments, the binder is a natural resin. Illustrative natural resins can be or include, but are not limited to, shellac, rosin, and the like, as well as mixtures or combinations thereof. Shellac is commercially available and may be provided along with a solvent (e.g., ethanol). One such commercially available shellac (known as "Refined Pharmaceutical Glaze") is available from Mantrose-Haeuser Co., Inc. of Westport, CT.

The amount or concentration of adhesion enhancing agent present in the oral care product or film-forming composition thereof can vary widely. The adhesion enhancer may be present in the film-forming composition in an amount of from about 1% to about 5% by weight. For example, the adhesion enhancer may be present in the film-forming composition in an amount of about 1.0 wt.%, about 1.5 wt.%, about 2.0 wt.%, about 2.5 wt.%, or about 3.0 wt.% to about 3.5 wt.%, about 4.0 wt.%, about 4.5 wt.%, or about 5.0 wt.%. In another example, the adhesion enhancer may be present in the film-forming composition in an amount of from about 1.0% to about 5.0%, from about 1.5% to about 4.5%, from about 2.0% to about 4.0%, or from about 2.5% to about 3.5% by weight. In yet another example, the adhesion enhancer may be present in the film-forming composition in an amount greater than or equal to 1.0 wt%, greater than or equal to 1.5 wt%, greater than or equal to 2.0 wt%, greater than or equal to 2.5 wt%, greater than or equal to 3.0 wt%, greater than or equal to 3.5 wt%, greater than or equal to 4.0 wt%, or greater than or equal to 4.5 wt%. In another example, the adhesion enhancer may be present in the film-forming composition in an amount 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 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.%, or less than or equal to 5.0 wt.%. In typical embodiments, the adhesion enhancer is present in the film-forming composition in an amount of about 3.0% by weight.

Thickening system

In at least one embodiment, the oral care product or film-forming composition thereof can optionally include a thickening system having one or more thickening agents. The one or more thickening agents may be any orally acceptable thickening or thickening agent. Illustrative thickening agents can be or include, but are not limited to, colloidal silica, fumed silica, crosslinked polyvinylpyrrolidone (PVP) polymers, crosslinked polyvinylpyrrolidone (PVP), and the like, as well as mixtures or combinations thereof. The thickening system may include a crosslinked polyvinylpyrrolidone (PVP) polymer. The thickening system may also include that available from Ashland Inc. of Calwenton, Kentucky (Covington, KY)

XL 10F. Additional illustrative thickeners may include, but are not limited to, carbomers (e.g., carboxyvinyl polymers), carrageenans (e.g., Irish moss, carrageenan, iota carrageenan, etc.), high molecular weight polyethylene glycols (e.g., commercially available from The Dow Chemical Company of Midland, Mich.)

) Cellulose polymers, hydroxyethylcellulose, carboxymethylcellulose and salts thereof (e.g., CMC sodium), natural gums (e.g., karaya, xanthan, acacia, and tragacanth), colloidal magnesium aluminum silicate, hydrophilic polymers, e.g., carbomers, e.g., carboxymethylene polymers, examplesSuch as acrylic polymers and acrylic copolymers, and the like, as well as mixtures or combinations thereof. Carboxypolymethylene is a slightly acidic vinyl polymer having active carboxyl groups. One such carboxypolymethylene is commercially available from Noveon, inc, of Cleveland (Cleveland, OH), OH

974 and/or 980. In at least one embodiment, the one or more thickening agents may be or include a cellulose ether selected from one or more of: hydroxyalkyl cellulose polymers such as hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose, hydroxyethyl cellulose, methyl cellulose, ethyl cellulose, carboxymethyl cellulose, and mixtures or combinations thereof.

In at least one embodiment, the thickening system may include a single thickener. For example, the thickening system may include a crosslinked polyvinylpyrrolidone (PVP) polymer. In another embodiment, the thickening system may include a plurality of thickeners. For example, the thickening system may include a crosslinked PVP polymer and a silica thickener. In another example, the thickening system may include a plurality of silica thickeners.

The amount or concentration of the thickening system and/or thickening agent thereof present in the oral care product or film-forming composition thereof can vary widely. The thickening system and/or thickening agent thereof may be present in the oral care product or film-forming composition thereof in an amount of from about 10 wt% to about 30 wt%, based on the total weight of the oral care product or film-forming composition thereof. For example, the thickening system and/or thickening agent may be present in the oral care product or film-forming composition thereof in an amount of about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, or about 21 to about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, or about 30 weight percent. In another example, the thickening system and/or thickening agent may be present in the oral care product or film-forming composition thereof in an amount of from about 12% to about 30%, from about 13% to about 29%, from about 14% to about 28%, from about 15% to about 27%, from about 16% to about 26%, from about 17% to about 25%, from about 18% to about 24%, from about 19% to about 23%, or from about 20% to about 22% by weight. In typical embodiments, the thickening system and/or thickening agent may be present in the oral care product or film-forming composition thereof in an amount of from about 20% to about 22% by weight, more typically about 21% by weight.

Flavoring agent

The film-forming composition may also include one or more flavoring agents. Illustrative flavoring agents that may be used in the film-forming composition may be or include, but are not limited to, essential oils and various flavoring aldehydes, esters, alcohols, and the like, as well as sweetening agents such as saccharin sodium and the like, as well as mixtures or combinations thereof. Illustrative essential oils can include, but are not limited to, oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange. Also suitable are chemicals such as menthol, carvone, anethole, and the like, as well as mixtures or combinations thereof. In a preferred embodiment, the flavoring agent comprises oils of peppermint and spearmint.

The amount or concentration of the one or more flavoring agents present in the oral care product or film-forming composition thereof can vary widely. In at least one embodiment, the one or more flavoring agents may be present in an amount from about 0.01% to about 50% by weight, based on the total weight of the oral care product or film-forming composition thereof. For example, the one or more flavoring agents may be present in an amount of about 0.01, about 1, about 5, about 10, about 15, about 20, or about 25 to about 30, about 35, about 40, about 45, or about 50 weight percent.

Orally acceptable vehicle

In at least one embodiment, the film-forming composition can be dispersed or dissolved in an orally acceptable vehicle. As used herein, the expression "orally acceptable vehicle" can refer to a suitable vehicle, ingredient, or combination of ingredients that can be used to form and/or apply the film-forming composition or one or more components thereof to the surfaces of the oral cavity in a safe and effective manner. For example, an orally acceptable vehicle can be a suitable solvent, and the film-forming composition can be dispersed, dissolved, mixed, or otherwise contacted with a suitable solvent to prepare or form an oral care product. Illustrative solvents can be or include, but are not limited to, ethanol, methanol, isopropanol, butanol, water, acetone, methyl ethyl ketone, ethyl acetate, butyl acetate, cyclohexanone, cyclohexane, methylene chloride, chloroform, carbon tetrachloride, trichloroethylene, perchloroethylene, methyl glycol acetate, toluene, benzene, diethyl ether, benzyl alcohol, and the like, as well as mixtures or combinations thereof. In a preferred embodiment, the orally acceptable vehicle is ethanol.

The orally acceptable vehicle can form the remainder of the oral care product. In at least one embodiment, the orally acceptable vehicle (e.g., ethanol) can be present in an amount of at least 60 weight%, at least 62 weight%, at least 64 weight%, at least 66 weight%, at least 68 weight%, at least 70 weight%, at least 72 weight%, at least 74 weight%, at least 76 weight%, at least 78 weight%, at least 80 weight%, at least 82 weight%, at least 84 weight%, at least 86 weight%, at least 88 weight%, at least 90 weight%, at least 92 weight%, at least 94 weight%, at least 96 weight%, at least 98 weight%, or at least 99 weight%, based on the total weight of the oral care product.

Additional ingredients

One of ordinary skill in the art will appreciate that the oral care product and/or film-forming composition thereof may include other additional ingredients/components. For example, the oral care products and/or film-forming compositions thereof can include one or more anticaries agents, desensitizing agents, viscosity modifiers, diluents, surfactants (e.g., emulsifiers, foam modulators, and the like), pH modifying agents (e.g., acids and bases), therapeutic agents, humectants, mouth feel agents, sweeteners, flavorants, whitening agents, colorants, preservatives, and the like, as well as combinations and mixtures thereof. It will be further appreciated by those of ordinary skill in the art that while the 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 the categories of materials.

As discussed above, the film-forming composition may include one or more therapeutic agents. Illustrative therapeutic agents may be or include, but are not limited to, stannous ions or stannous ion sources to mitigate calcium loss. Suitable stannous ion sources include, but are not limited to, stannous fluoride, other stannous halides (e.g., stannous chloride dihydrate), stannous pyrophosphate, organic stannous carboxylates such as stannous formate, acetate, gluconate, lactate, tartrate, oxalate, malonate and citrate, glyoxylate, and the like. One or more stannous ion sources are optionally and illustratively present in a total amount of from about 0.01% to about 10%, for example from about 0.1% to about 7% or from about 1% to about 5%.

The therapeutic agent may also be or include, but is not limited to, an antimicrobial agent (e.g., an antibacterial agent), such as triclosan (triclosan). An illustrative list of suitable antimicrobial agents is provided in U.S. Pat. No. 5,776,435 to Gaffar et al, the contents of which are incorporated herein by reference. One or more antimicrobial agents may be present in an antibacterially effective total amount of from about 0.05% to about 10%, for example from about 0.1% to about 3%.

Other therapeutic agents include, but are not limited to, a source of calcium ions (e.g., calcium carbonate), a source of zinc ions (e.g., zinc citrate), a source of potassium ions (e.g., potassium chloride), or combinations thereof. The amount of ion source in the compositions of the present invention, if present, is in the range of about 0.1% to 5% by weight, typically about 1% by weight. Basic amino acids such as arginine, in free or salt form, may also be used as therapeutic agents.

As discussed above, the film-forming composition may include one or more whitening agents. As used herein, the expression "whitening agent" may refer to a material that affects the whitening of the tooth surface to which it is applied. Any whitening agent known or developed in the art may be used in the film-forming composition of the present invention.

For example, in some embodiments, the film-forming composition may include a whitening pigment. In some embodiments, the whitening pigment includes particles having a size in the range of about 0.1 μm to about 10 μm and a refractive index greater than about 1.2. Suitable whitening agents include, but are not limited to, titanium dioxide particles, zinc oxide particles, aluminum oxide particles, tin oxide particles, calcium oxide particles, magnesium oxide particles, barium oxide particles, silica particles, zirconium silicate particles, mica particles, talc particles, tetracalcium phosphate particles, amorphous calcium phosphate particles, alpha-tricalcium phosphate particles, beta-tricalcium phosphate particles, hydroxyapatite particles, calcium carbonate particles, zinc phosphate particles, silica particles, zirconium silicate particles, and combinations thereof. The amount of whitening pigment such as titanium dioxide particles may be sufficient to whiten teeth.

In some embodiments, the whitening agent may be an oxidizing agent, a reducing agent, or a combination thereof. As used herein, the expression "oxidizing agent" may refer to a material and/or compound that can accept electrons from another material and/or compound (e.g., a molecule) in the oral environment during normal and approved use without deleterious or unacceptable injurious effects on the oral cavity. Illustrative oxidizing agents suitable for use with the film-forming composition can include, but are not limited to, peroxides, chlorites, and hypochlorites. Examples of suitable chlorites and hypochlorites include those having alkali or alkali metal cations, and include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, calcium hypochlorite, barium hypochlorite, magnesium hypochlorite, lithium hypochlorite, and sodium hypochlorite.

In at least one embodiment, the whitening agent includes a peroxy compound. As used herein, the expression "peroxy compound" may refer to any compound that includes a divalent oxy-oxy group. Peroxy compounds include peroxides and hydroperoxides such as hydrogen peroxide, peroxides of alkali and alkaline earth metals, organic peroxy compounds, peroxy acids, pharmaceutically-acceptable salts thereof, and mixtures thereof. Peroxides of alkali and alkaline earth metals include lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof. Organic peroxy compounds include urea peroxide (also known as urea hydrogen peroxide), glyceryl hydroperoxide, alkyl hydroperoxides, dialkyl peroxides, alkyl peroxyacids, peroxyesters, diacyl peroxides, benzoyl peroxide, monoperoxyphthalate, and mixtures thereof. Peroxy acids and salts thereof include organic peroxy acids such as alkyl peroxy acids, and monoperoxyphthalate and mixtures thereof, and inorganic peroxy acid salts such as persulfates, dipersulfates, percarbonates, perphosphates, perborates and persilicates of alkali and alkaline earth metals such as lithium, potassium, sodium, magnesium, calcium and barium, and mixtures thereof. Typically, the peroxy compound comprises hydrogen peroxide, carbamide peroxide, sodium percarbonate or mixtures thereof.

In at least one embodiment, the film forming composition includes a whitening complex. As used herein, the expression "whitening complex" may refer to a whitening agent as described herein complexed with a polymer or copolymer, which is capable of or configured to release the whitening agent upon exposure to a highly aqueous environment, such as in the oral cavity. As used herein, a "complex" is an entity formed by a loose association involving two or more molecular entities (ionic or uncharged), such as whitening agents and polymers.

All ingredients used in the compositions described herein should be orally acceptable. As used herein, "orally acceptable" may refer to any ingredient present in a composition as described in an amount and in a form that does not render the use of the composition unsafe in the oral cavity.

Method

The present disclosure can provide methods for increasing shine and gloss, preventing stains, and/or providing a stain barrier on an oral surface in a human or animal subject. As used herein, "animal subject" can include higher non-human mammals, such as canines, felines, and horses. The method can comprise contacting any of the film-forming compositions disclosed herein with an oral surface, such as a dental surface. Contacting the tooth surface with the film-forming composition can include applying the film-forming composition directly to the tooth using a delivery device, such as a pen (e.g., a pen)

Whitening pen or

ACTIS^TMWhitening pens, Colgate-Palmolive Company, New York City, N.Y. (NY); liquid sticks with applicators such as felt tips, brushes, sprays, balls or non-woven pads, etc. Contacting the tooth surface with the film-forming composition can further comprise disposing the film-forming composition in a dental tray (e.g., a reservoir of a dental tray) and disposing the dental tray about the tooth.

The method can further comprise evaporating the solvent or orally acceptable vehicle from the film-forming composition to form a film on the tooth surface. The resulting film formed in situ can increase or feel shine and luster of the tooth surface, prevent stains on the tooth surface, and/or provide a stain barrier on the tooth surface. The method can include holding the film on the tooth surface for at least 12 hours, at least one day, at least two days, at least three days, at least four days, or more.

The method can include applying or contacting the oral care product and/or film-forming composition thereof to the tooth surface at predetermined time intervals. For example, the method may comprise applying or contacting the oral care product and/or film-forming composition thereof to the tooth surface daily, every other day, once or twice a week, or once a month. In another example, the method can comprise applying or contacting the oral care product and/or film-forming composition thereof to the tooth surface at least once a day, at least once every two days, at least once every three days, at least once every five days, at least once a week, at least once every two weeks, or at least once a month. The oral care product and/or film-forming composition thereof may be used for up to 2 weeks, up to 3 weeks, up to 4 weeks, up to 6 weeks, up to 8 weeks, or more.

All ingredients used in the compositions described herein should be orally acceptable. As used herein, "orally acceptable" can refer to any ingredient present in the composition as described, in an amount and in a form that does not render the composition unsafe for use in the oral cavity.

Examples of the invention

The examples and other embodiments described herein are exemplary and are not intended to limit the overall scope of the compositions and methods described herein. Equivalent changes, modifications and variations of specific embodiments, materials, compositions and methods may be made within the scope of the present disclosure, with substantially similar results.

Example 1

Films formed from the different test film-forming compositions (1) - (9) were evaluated for the ability or efficacy to prevent stains. Test film-forming compositions (1) - (9) were prepared by combining about 80 wt% pure ethanol (200 proof) with about 20 wt% of each of the following polymers: (1) anionic linear polycarboxylate polymers

(2) Poly (ethyl acrylate/acrylic acid) (P (EA/AA)); (3) poly (styrene-co-maleic acid) partially isobutyl ester copolymer (Sty/Mal); (4) acrylate/octylacrylamide copolymer (C)

79) (ii) a (5) Octylacrylamide/acrylate/butylaminoethyl methacrylate copolymer

(6) Acrylate/dimethylaminoethyl methacrylate copolymer (A)

E PO) copolymer; (7) polyurethane-64 (

C2000) (ii) a (8) Polymethyl vinyl ether solution (PVME); and (9) polydimethylsiloxane/dimethicone (Dow)

Q7-9120 silicone oil). Specifically, about 20% by weight of each polymer was mixed with about 80% by weight of ethanol in a vialCombined and vortexed or agitated for about 5 minutes to prepare a corresponding solution of each polymer. The solution was then allowed to stand overnight, then vortexed or agitated again for about 5 minutes.

To evaluate stain prevention, 36 artificially stained bovine incisors were obtained from Therametric Technologies inc, Noblesville, indiana, mounted separately to the resin block and having an L value between 64 and 74. Each of the artificially stained bovine incisors was cleaned and dried, and the baseline L of each of the 36 bovine incisors was recorded with a spectrophotometer (SPECTROSHADE Micro instrument manufactured by Medical High Technology of Verona, Italy)^*、a^*、b^*The value is obtained. At measurement of L^*、a^*、b^*After the values, each bovine incisor was incubated overnight at about 37 ℃ in a well plate containing simulated saliva with stirring (about 100 rpm). After incubation, each bovine incisor was rinsed three times with deionized water and L was measured with a spectrophotometer^*、a^*、b^*The value is obtained.

Test film-forming compositions (1) - (9) were each applied to three individual bovine incisors in triplicate to assess stain prevention, with the remaining nine bovine incisors uncoated to provide negative controls. To coat bovine incisors, each of the test film-forming compositions (1) - (9) was applied to the corresponding bovine incisors and allowed to air dry for about 2 minutes.

Filtering the liquor through a fine mesh filter

The black tea bag was immersed in 50g of hot deionized water for at least 15 minutes, and 1g of instant coffee was dissolved in 50g of hot deionized water for at least 15 minutes to prepare a coloring broth. The wine, tea and coffee solutions were then combined with each other in equal parts by volume and stirred to prepare a staining broth. The coated bovine incisors and uncoated bovine incisors (control) were then immersed in the staining broth and incubated at about 37 ℃ for about 24 hours with stirring (about 100 rpm).

Each bovine incisor was then removed from the staining broth and rinsed three times with deionized water. Should be takenIt is understood that rinsing bovine incisors with deionized water leaves intact the corresponding film formed from each of the film-forming compositions (1) - (9). L of each bovine incisor after treatment was then measured^*、a^*、b^*The value is obtained. After the measurement, each bovine incisor was then rinsed three times with ethanol to remove the corresponding film therefrom, and L was measured again after removing the corresponding film^*、a^*、b^*The value is obtained.

L after treatment^*、a^*、b^*The values were compared to baseline values to calculate the change in whiteness for each bovine incisor. It is understood that the whiteness index (W)^*) Is a measure of the overall color change relative to pure white, given by equation (1), the change in whiteness index (AW)^*) Measured by equation (2). It should also be understood that Δ W^*The lower, the whiter the teeth.

The results for stain prevention (Δ W) are summarized in Table 1^*) And as a stain barrier (Δ W)^*) The efficacy of each of the film-forming compositions (1) to (9) and the control. Stain Barrier (Δ W)^*) The value corresponds to L measured after washing with deionized water (the membrane is still intact)^*、a^*、b^*Values and indicate the efficacy of the film as a stain barrier. It will be appreciated that the stain barrier (Δ W)^*) A relatively low value compared to the control indicates the ability to partially or completely repel stain. Stain prevention (Δ W)^*) Corresponding to L measured after washing off the membrane with ethanol^*、a^*、b^*And represents the efficacy of the film to capture or retain any stain it cannot repel.

W^*＝((L^*-100)²+(a^*)²+(b^*)²)^1/2 (1)

ΔW^*＝W^* _{Treatment of}-W^* _{Base line} (2)

Table 1 film-forming compositions (1) - (9) for stain prevention and whitening efficacy of stain barrier (aw)^＊)

As shown in table 1, the test film-forming compositions (4) and (5) provided complete stain barrier, and the test film-forming compositions (1), (3), and (6) were able to resist most stains. It will be appreciated that the test film-forming compositions (1) and (3) - (6) that exhibited relatively greater stain barrier properties each had a combination of hydrophilicity and hydrophobicity. It should be noted that poly (ethyl acrylate/acrylic acid) (P (EA/AA)) also exhibits both hydrophilicity and hydrophobicity, however, the film-forming composition (2) exhibits relatively poor stain barrier properties. However, the deviation of the observed results for the film-forming composition (2) is due to the fact that the dried film is colored and false positives are generated. As further shown in table 1, all three remaining test film-forming compositions (7) - (9) were hydrophobic polymers; and thus exhibit relatively poor efficacy as a stain barrier. It should be noted that the film formed from polyurethane-64 exhibited a color that produced false positives similar to poly (ethyl acrylate/acrylic acid) (P (EA/AA)).

To evaluate the efficacy of the membrane in trapping or retaining the fraction of the staining broth that the membrane cannot repel, the stain prevention value (aw) was set^*) And stain barrier value (Δ W)^*) A comparison is made. In particular, equivalent or substantially identical stain prevention and stain barrier values indicate relatively poor efficacy in stains that the entrapment membrane cannot repel. As shown in table 1, the films formed from film-forming compositions (6) and (9) exhibited relatively poor efficacy in trapping stains, indicating that these films allowed stains to pass directly to the surface of bovine incisors. However, the remaining film exhibited relatively greater efficacy in preventing the penetration of stains into the surface of bovine incisors.

Example 2

Evaluation of the composition from acrylate/octylacrylamide copolymer (

79) And octylacrylamide/acrylate/butylaminoethyl methacrylate copolymer

Film-forming composition ofThe film formed by the product has the effect of preventing stains at different concentrations. Specifically, film-forming compositions (10) to (14) were prepared at concentrations including

79 and pure ethanol as solvents: 1 wt%, 5 wt%, 10 wt%, 20 wt% and 30 wt%. Similarly prepared to include the same concentration

The film-forming compositions (15) to (19) of (1).

To evaluate stain prevention, 33 artificially stained bovine incisors were obtained from Therametric Technologies Inc, mounted alone to a resin block and having an L value between 66 and 78. Each of the artificially stained bovine incisors was cleaned and dried, and the baseline L of each of the 33 bovine incisors was recorded with a spectrophotometer (SPECTROSHADE Micro instrument manufactured by Medical High Technology of Verona, Italy)^*、a^*、b^*The value is obtained. At measurement of L^*、a^*、b^*After the values, each bovine incisor was incubated overnight at about 37 ℃ in a well plate containing simulated saliva with stirring (about 100 rpm). After incubation, each bovine incisor was rinsed three times with deionized water and L was measured with a spectrophotometer^*、a^*、b^*The value is obtained.

Will have different concentrations

79 test film-forming compositions (10) - (14) and with different concentrations

Each of test film-forming compositions (15) - (19) was applied in triplicate to three individual bovine incisors to assess stain prevention, with the remaining nine bovine incisors being uncoated to provide negative controls. To coat bovine incisors, each of the test film-forming compositions (10) - (19) was applied to the corresponding bovine incisors and allowed to air dry for about 2 minutes.

Then will be coatedCoated and uncoated bovine incisors (control) were immersed in the staining broth of example 1 and incubated at about 37 ℃ for about 24 hours with stirring (about 100 rpm). Bovine incisors were then removed from the staining broth and rinsed three times with deionized water. As discussed above, rinsing bovine incisors with deionized water left the corresponding films formed intact. Then, L of bovine incisors after treatment was measured^*、a^*、b^*The value is obtained. After the measurement, bovine incisors were then rinsed three times with ethanol to remove the respective films therefrom, and L was measured again after the respective films were removed^*、a^*、b^*The value is obtained. The results for stain prevention (Δ W) are summarized in Table 2^*) And as a stain barrier (Δ W)^*) The efficacy of each of the film-forming compositions (10) to (19) and the control.

Table 2 film-forming compositions (10) - (19) whitening efficacy (aw) for stain prevention^＊)

As shown in table 2, including relatively low concentrations (about 1% to about 5% by weight)

79 or

Exhibit a lower efficacy against staining compared to higher concentrations (about 10% to about 30% by weight).

In view of the foregoing, it has been unexpectedly and unexpectedly discovered that polymers comprising an acrylate component and a relatively large volume of hydrophobic groups coupled to the acrylate component exhibit relatively greater efficacy in stain prevention and as a stain barrier than polymers without these characteristics. For example, the polymer may be a copolymer formed from an acrylate monomer and a monomer having a relatively bulky hydrophobic functional group (e.g., octylacrylamide, butylaminoethyl, and/or styrene).

Example 3

Films formed from different film-forming compositions were evaluated for their ability or efficacy to provide shine and/or shine on a dental treatment surface. Specifically, the evaluation included an acrylate/octylacrylamide copolymer (C:)

79) Octylacrylamide/acrylate/butylaminoethyl methacrylate copolymer

Poly (ethyl acrylate/acrylic acid) (P (EA/AA)) or ethylcellulose (AQUALON)^TMN100Pharm) provides gloss and/or shine on the surface of bleached bovine incisors obtained from thermetric Technologies, Inc. Film-forming compositions (20) - (22) were prepared at concentrations including

79 and pure ethanol as solvents: 1 wt%, 10 wt% and 20 wt%. Similarly prepared to include the same concentrations (i.e., 1 wt%, 10 wt%, and 20 wt%)

The film-forming compositions (23) to (25), the film-forming compositions (26) to (28) comprising the same concentration of P (EA/AA), and the film-forming compositions comprising the same concentration of AQUALON^TMN100Pharm film-forming compositions (29) to (31).

Baseline gloss and shine measurements or Gloss Units (GU) were obtained on each bleached bovine incisors. To measure the baseline GU, each bovine incisor was placed facing down toward the instrument (Novo-Curve gloss meter manufactured by Rhopoint Instruments of East sassex, UK) and covered to block ambient light. After the initial measurement of the GU, the bovine incisors were repositioned, retrieved and measured again. This process was repeated for a total of three measurements and averaged to provide the baseline GU.

After measuring the baseline GU of each bovine incisor, each film-forming composition was applied to the corresponding bleached bovine incisor and dried for about 25 minutes. After application of the film-forming composition, the GU is measured as discussed above. The change in GU, or Δ GU, is a measure of the change in Gloss Units (GU) and is calculated according to equation (3). It will be appreciated that a positive Δ GU indicates an increase in gloss and shine and a decrease in Δ GU indicates a decrease in gloss and shine. Each sample was processed on six separate bovine incisors and averaged. The calculated Δ GU is summarized in table 3.

Δ GU ═ GU (after application of the film-forming composition) -GU (baseline) (3)

TABLE 3 gloss and shine (. DELTA.GU) of film-forming compositions (20) to (31)

As shown in Table 3, comprises

The film-forming compositions (23) to (25) in

A significant increase in Δ GU was exhibited with increasing concentration. As indicated, including 1% by weight

The film-forming composition (23) of (1) has little remarkable effect on gloss and luster; however, films prepared from 10 and 20 wt% film-forming compositions (24) and (25), respectively, exhibited a significant increase in Δ GU. It should be understood that the various embodiments described herein,

is ionic or has an ionic charge provided by the carboxylate functionality of the acrylic or acrylate group, which promotes or maintains the bonding of the polymer to oral surfaces (e.g., tooth surfaces), while bulky hydrophobic groups such as t-octyl acrylamide andbutylaminoethyl methacrylate can provide other benefits (e.g., stain prevention) as discussed above.

Also as shown in Table 3, consisting of

79 film-forming compositions (20) to (22) form films exhibiting gloss and shine characteristics independent of weight percent. Although significant differences in gloss and shine were observed at all concentrations evaluated, 1% by weight was included

79 provides the most consistent and reproducible results. It should be understood that the various embodiments described herein,

79 has a chemical structure similar to that of

The inclusion may promote or maintain the binding of the polymer to oral surfaces (e.g., tooth surfaces), while bulky hydrophobic groups, such as t-octyl acrylamide, may provide other benefits (e.g., stain prevention) as discussed above.

Films formed from film-forming compositions (26) - (28) including poly (ethyl acrylate-co-acrylic acid) (P (EA/AA)) exhibited gloss and shine depending on the concentration (% by weight) of the polymer. For example, polymers at concentrations of about 10 wt% to about 20 wt% exhibit significantly greater gloss and shine. It will be appreciated that the chemical structure of P (EA/AA) is similar to that of

79 and

both because P (EA/AA) has functional groups capable of binding to tooth surfaces and hydrophobic functional groups, such as ethyl acrylate, that provide additional benefits as discussed above.

Comprises ethyl cellulose AQUALON^TMCompositions of EC N100The film formed from the film compositions (29) - (31) unexpectedly and unexpectedly exhibited changes in gloss and shine characteristics. As shown in Table 3, the film formed from 10 wt% of the film-forming composition (30) exhibited

Compared to significantly less gloss and shine. In addition, no significant change in gloss and shine characteristics was observed for films formed from 1 and 20 weight percent of the film forming compositions (29) and (31), respectively. It is understood that unlike other polymers, the chemical structure of ethylcellulose does not include any functional groups that can promote or maintain the binding of the polymer to oral surfaces, such as tooth surfaces.

In view of the foregoing, it has been unexpectedly and unexpectedly discovered that polymers incorporating or including acrylic groups that can facilitate or maintain the polymer's binding to the tooth surface exhibit relatively greater and more reproducible or consistent shine and brightness characteristics.

The disclosure has been described with reference to exemplary embodiments. While a limited number of embodiments have been shown and described, it will be appreciated by those skilled in the art that changes may be made in these embodiments without departing from the principles and spirit of the embodiments described previously. It is intended that the 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

1. A film-forming composition for preventing stains or increasing shine and gloss of teeth, the film-forming composition comprising:

a polymer, wherein the polymer is a hydrophobic polymer; and

an orally acceptable solvent.

2. The film-forming composition of claim 1, wherein the hydrophobic polymer comprises an acrylate component and a hydrophobic group coupled to each other, optionally wherein the hydrophobic group comprises one or more of an alkyl chain, polyethylene glycol, polypropylene, polyester, polyorthoester, phospholipid, long chain fatty acid, vinyl chloride, vinyl fluoride, siloxane, urethane, octylacrylamide, butylaminoethyl, and styrene.

3. The film-forming composition of claim 1 or 2, wherein the acrylate component is provided by an acrylate monomer, optionally the acrylate monomer comprises one or more of methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, and trimethylolpropane triacrylate, further optionally wherein the acrylate component is configured to promote, maintain, or increase adhesion of a film formed from the film-forming composition to the surface of the tooth.

4. The film-forming composition of any preceding claim, wherein the polymer is a carboxylated acrylic copolymer.

5. The film-forming composition of any preceding claim, wherein the polymer is a copolymer of octylacrylamide and one or more monomers, wherein the one or more monomers comprise one or more of acrylic acid, methacrylic acid, and any simple esters thereof, optionally the polymer is

6. A film-forming composition for increasing the shine and gloss of teeth, the film-forming composition comprising:

a polycarboxylate polymer, wherein the polycarboxylate polymer is a copolymer of methyl vinyl ether and maleic anhydride; and

an orally acceptable solvent.

7. A film-forming composition for increasing the shine and gloss of teeth, the film-forming composition comprising:

ethylcellulose having a degree of ethoxylation of from about 45% to about 55% or from about 48% to about 52%.

8. The film-forming composition of any preceding claim, further comprising a fluorochemical, wherein the fluorochemical is a soluble salt of a fluoride ion, optionally wherein the fluorochemical comprises one or more of sodium fluoride, potassium fluoride, calcium fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluoride, and stannous fluorozirconate, preferably the fluorochemical comprises sodium fluoride.

9. The film-forming composition of any preceding claim, wherein the orally acceptable solvent comprises one or more of ethanol, methanol, isopropanol, butanol, water, acetone, methyl ethyl ketone, ethyl acetate, butyl acetate, cyclohexanone, cyclohexane, dichloromethane, chloroform, carbon tetrachloride, trichloroethylene, perchloroethylene, methyl glycol acetate, toluene, benzene, diethyl ether, and benzyl alcohol, preferably the orally acceptable solvent comprises ethanol.

10. The film-forming composition of any one of the preceding claims, further comprising a binder.

11. The film forming composition of claim 10, wherein the binder comprises one or more of a polyvinyl acetal, a polyvinyl alcohol, a polyvinyl acetate, a poly (ethylene oxide), a polyacrylate, a polyvinyl pyrrolidone/vinyl acetate copolymer, a polyoxyethylene/polyoxypropylene block copolymer, and a silicone resin.

12. The film forming composition of any one of the preceding claims, further comprising one or more of a therapeutic agent, an antimicrobial agent, a desensitizing agent, a sweetener, and a whitening agent.

13. The film forming composition of claim 12, wherein the whitening agent comprises an oxidizing agent, optionally the oxidizing agent comprises one or more of a peroxide, a chlorite, and a hypochlorite, further optionally the whitening agent comprises a peroxy compound.

14. A method for preventing stains on teeth, the method comprising:

applying the film-forming composition of any one of the preceding claims to the surface of the tooth; and

evaporating at least a portion of the orally acceptable solvent to form a film on the surface of the tooth.

15. A method for increasing the shine and gloss of teeth, comprising:

applying the film-forming composition of any one of claims 1 to 13 to the surface of the tooth; and