BR112021006653B1 - Film-forming compositions and method for preventing stains or increasing the polish and shine of teeth - Google Patents

Abstract

ORAL HYGIENE COMPOSITIONS AND METHODS FOR THE SAME. Film-forming compositions and methods to prevent stains and increase tooth polish and shine. Film-forming compositions may 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 group may include an alkyl chain, a polyethylene glycol, a polypropylene, a polyester, a polyorthester, a phospholipid, a long chain fatty acid, a vinyl chloride, fluorethylene, a siloxane, a urethane, an octylacrylamide, a butylaminoethyl , a styrene and combinations thereof.

Description

[001] Conventional oral care products, such as toothpastes, can often incorporate abrasives to clean plaque and stains from the surface of teeth. In addition to removing plaque and stains, abrasives may also be able to polish teeth to increase their polish and shine. Although conventional oral care products that incorporate abrasives have been shown to be effective in removing plaque and stains and increasing polish and shine, prolonged use of these oral care products can often result in excessive abrasion of enamel on tooth surfaces.

[002] What is needed, then, are improved oral hygiene products and film-forming compositions and methods for protecting teeth from stains and/or improving the polishing and shine of teeth without abrasives.

BRIEF SUMMARY

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

[004] The foregoing and/or other aspects and utilities embodied in the present disclosure can be achieved by providing a film-forming composition to prevent stains or increase the polish and shine of teeth. The film-forming composition may include a polymer, such as a hydrophobic polymer, and an orally acceptable solvent.

[005] In at least one implementation, the hydrophobic polymer can include an acrylate component and a hydrophobic group coupled to each other. The hydrophobic group may include one or more of an alkyl chain, a polyethylene glycol, a polypropylene, a polyester, a polyorthother, a phospholipid, a long chain fatty acid, a vinyl chloride, fluorethylene, a siloxane, a urethane, an octylacrylamide , a butylaminoethyl and a styrene.

[006] In at least one implementation, the acrylate component may be provided by an acrylate monomer. The acrylate monomer 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 facilitate, maintain or enhance adhesion of a film formed from the film-forming composition to tooth surfaces.

[007] In at least one implementation, the polymer can be a carboxylated acrylic copolymer.

[008] In at least one implementation, 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 ester thereof. In at least one implementation, the polymer may be DERMACRYL®.

[009] The foregoing and/or other aspects and utilities embodied in the present disclosure can be achieved by providing a film-forming composition to increase the polish and shine of teeth, the film-forming composition can include a polycarboxylate polymer and an orally solvent acceptable. In at least one implementation, the polycarboxylate polymer may be a copolymer of methyl vinyl ether and maleic anhydride.

[0010] The foregoing aspects and/or other aspects and utilities incorporated in the present disclosure can be achieved by providing a film-forming composition to increase the polishing and shine of teeth. The film-forming composition may include an ethylcellulose having a degree of ethoxylation of about 45% to about 55% or about 48% to about 52%.

[0011] In at least one implementation, the film-forming composition may further include a fluoride compound. The fluoride compound may be a soluble salt of a fluoride ion. In at least one implementation, the fluoride compound may include one or more of sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluoride, and fluorozirconate. stannous. In a preferred implementation, the fluoride compound includes sodium fluoride.

[0012] In at least one implementation, the orally acceptable solvent may 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 implementation, the orally acceptable solvent includes ethanol.

[0013] In at least one implementation, the film-forming composition may further include an adhesive. The adhesive may include one or more of a polyvinyl acetaldehyde, a polyvinyl alcohol, a polyvinyl acetate, a poly(ethylene oxide), a polyacrylate, a polyvinylpyrolidone, a polyvinylpyrolidone/vinyl acetate copolymer, a polyoxyethylene/vinyl acetate block copolymer, polyoxopropylene and a silicone resin.

[0014] In at least one implementation, the film-forming composition may further include one or more of a therapeutic agent, an antimicrobial agent, a desensitizing agent, a sweetener and a bleaching agent.

[0015] In at least one implementation, the bleaching agent includes an oxidizing agent, optionally, the oxidizing agent includes one or more peroxides, chlorites and hypochlorites. In at least one implementation, the bleaching agent includes a peroxide compound.

[0016] The foregoing and/or other aspects and utilities embodied in the present disclosure can be achieved by providing a method for preventing tooth stains. The method may include applying any of the film-forming compositions disclosed herein to or on the surfaces of the teeth. The method may also include evaporating at least a portion of the orally acceptable solvent to form a film on tooth surfaces.

[0017] The foregoing aspects and/or other aspects and utilities embodied in the present disclosure can be achieved by providing a method for increasing the polishing and shine of teeth. The method may include applying any of the film-forming compositions disclosed herein to or on the surfaces of the teeth. The method may also include evaporating at least a portion of the orally acceptable solvent to form a film on tooth surfaces.

[0018] Other areas of applicability of the present disclosure will become apparent from the detailed description provided below. It should be understood that the detailed description and specific examples, while indicating some typical aspects of the disclosure, are intended for illustration purposes only and are not intended to limit the scope of the disclosure.

DETAILED DESCRIPTION

[0019] The following description of various typical aspect(s) is merely exemplary in nature and is in no way intended to limit the disclosure, its application or uses.

[0020] As used throughout this disclosure, ranges are used as shorthand to describe each and every value that falls within the range. It should be appreciated and understood that the description in a range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of any embodiments or implementations disclosed herein. Therefore, the disclosed range should be interpreted as having specifically disclosed all possible subranges as well as individual numerical values within that range. As such, any value within the range can be selected as the end of the range. For example, describing a range as 1 to 5 should be considered to have specifically disclosed subranges such as 1.5 to 3, 1 to 4.5, 2 to 5, 3.1 to 5, etc. ., as well as individual numbers within that range, e.g. 1, 2, 3, 3,2, 4, 5, etc. This applies regardless of the range width

[0021] All references cited in this document are incorporated in full through this application by reference. In the event of a conflict in a definition in this disclosure and the one cited by reference, the definition in this disclosure will control.

[0022] Unless otherwise specified, all percentages and quantities expressed in this document and elsewhere in the specification should be understood as referring to percentages by weight. The quantities provided are based on the active weight of the material.

[0023] Additionally, all numerical values are "about" or "approximately" the indicated value and take into account errors and experimental variations that would be expected by a person skilled in the art. It should be appreciated that all numerical values and ranges disclosed in this document are approximate values and ranges, regardless of the use of "about" in conjunction therewith. It should also be appreciated that the term "about", as used herein, in conjunction with a numeral, refers to a value that may be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive) of that numeral, ±2% (inclusive) of that numeral, ±3% (inclusive) of that numeral, ±5% (inclusive) of that numeral, ±10% (inclusive ) of that numeral or ± 15% (inclusive) of that numeral. It should further be recognized that when a numerical range is disclosed in this document, any numerical value that falls within the range is also specifically disclosed.

[0024] The present inventors have surprisingly and unexpectedly discovered that films formed from polymers including an acrylate component and a bulky hydrophobic group exhibit relatively greater effectiveness for stain prevention and as a stain barrier compared to polymers without these characteristics or properties. In some examples, the relatively bulky hydrophobic group may be coupled to the acrylate. For example, films formed from a copolymer of an acrylate monomer and a monomer with a relatively bulky hydrophobic functional group, such as an octylacrylamide, a butylaminoethyl and/or a styrene exhibit relatively greater effectiveness for stain prevention and as a barrier. against stains as compared to films formed from a polymer without these properties. It has also been surprisingly and unexpectedly discovered that films formed from polymers incorporating or including acrylic acid or acrylate groups exhibit relatively greater binding to tooth surfaces compared to films formed from polymers without acrylic acid groups. It has further surprisingly and unexpectedly been discovered that films formed from polymers incorporating or including acrylic acid groups exhibit relatively greater and more reproducible or consistent gloss and gloss properties compared to films formed from polymers without acrylic acid groups.

COMPOSITIONS

[0025] The compositions disclosed herein may be or include an oral hygiene product or a film-forming composition thereof. For example, the compositions disclosed herein may be an oral care product including the film-forming composition or the film-forming composition thereof. In at least one implementation, the film-forming composition may 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 may include a polymer with an acrylate or acrylic acid component (i.e., hydrophilic component) and a bulky hydrophobic component, such as a tert-octylacrylamide, a butylaminoethyl methacrylate and/or a styrene. As further described herein, the film-forming compositions disclosed herein or films formed therefrom may be capable of or configured to provide stain barrier and stain prevention properties to surfaces of the oral cavity, such as tooth surfaces. The film-forming compositions disclosed herein or films formed therefrom may also be capable of or configured to enhance, maintain or otherwise provide polish and shine to tooth surfaces.

Polymers

[0026] 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 term "film-forming polymer" may refer to or encompass polymers, prepolymers and/or monomers capable of or configured to form, alone or in the presence of at least one additional agent, a continuous film on a substrate, such as the surfaces of the oral cavity (e.g. surface of teeth).

[0027] 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 components or functional groups may be capable of or configured to facilitate, maintain or increase adhesion of the film-forming polymer to the surfaces of the oral cavity. Illustrative hydrophilic components or functional groups may be or include, but are not limited to, acrylate or acrylic acid groups, carboxyl groups, carbonyl groups, sulfhydryl groups, phosphate groups, hydroxyl groups, amines, disulfides, nitro groups or the like, and combinations of the same. The hydrophilic components may be provided by one or more acrylate monomers. Illustrative acrylate monomers may include, but are not limited to, methacrylates, methyl acrylate, ethyl acrylate, 2-chloroethyl vinyl ether, 2-ethylhexyl acrylate, hydroxyethyl methacrylate, butyl acrylate, butyl methacrylate, trimethylolpropane triacrylate or the like, and mixtures or the like or combinations thereof.

[0028] The hydrophobic components or functional groups may be capable of or configured to provide one or more benefits or properties to the film formed by the film-forming polymer. For example, the hydrophobic components may be capable or configured to provide, maintain, or increase the effectiveness of the stain prevention film. In another example, the hydrophobic component may be capable of or configured to provide, maintain or increase the effectiveness of the film as a stain barrier. Illustrative hydrophobic components or functional groups may be or include, but are not limited to, an alkyl chain, a polyethylene glycol, a polypropylene, a polyester, a polyorthester, a phospholipid, a long chain fatty acid, a vinyl chloride, fluorethylene , a siloxane, a urethane, an octylacrylamide, a butylaminoethyl, a styrene or the like, and mixtures or combinations thereof.

[0029] In at least one implementation, the film-forming polymer may be or include a homopolymer. In another implementation, the film-forming polymer may be or include a copolymer composed of or produced by 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 the hydrophilic component or functional group and a second monomer capable of or configured to provide the hydrophobic component or functional group.

[0030] In at least one implementation, the film-forming polymer may be or include a carboxylated acrylic copolymer. For example, the film-forming polymer may be a copolymer of octylacrylamide and one or more monomers, where the one or more monomers may include one or more of acrylic acid, methacrylic acid and any one or more simple esters thereof. In another example, the film-forming polymer may be a polymer formed from octylacrylamide, t-butylaminoethyl methacrylate and one or more monomers of acrylic acid, methacrylic acid or any one or more simple esters thereof.

[0031] The illustrative film-forming polymer may be or include, but is not limited to, those sold under the trade names DERMACRYL®, AMPHOMER®, BALANCE® and VERSACRYL®, which are commercially available from AkzoNobel Company, Surface Chemistry, of Amsterdam, Netherlands. For example, the film-forming polymer may be or include, but is not limited to, AMPHOMER® 4961, AMPHOMER® HC, DERMACRYL® 2.0, RESYN™ XP, a film-forming polymer selected from octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer , such as AMPHOMER® LV-71, AMPHOMER®, AMPHOMER® EDGE™, BALANCE® 47 or the like, and combinations thereof, all of which are commercially available from AkzoNobel Company, Surface Chemistry, of Amsterdam, The Netherlands. The film-forming polymer may be selected from vinyl acetate/butyl maleate/isobornyl acrylate copolymers, such as ADVANTAGE™ PLUS, from Ashland Global Specialty Chemicals Inc., of Covington, KY. The film-forming polymer can also be selected from acrylates/t-butylacrylamide copolymers such as ULTRAHOLD® STRONG and ULTRAHOLD®8 from BASF SE of Ludwigshafen, Germany. The film-forming polymer can also be selected from acrylates/dimethylaminoethyl methacrylate copolymers, such as the EUDRAGIT® range of polymers from Evonik Industries of Essen, Germany, such as EUDRAGIT®E100, EUDRAGIT® E PO (CAS: 24938 -16-7), EUDRAGIT® RS 100, EUDRAGIT® RS PO, EUDRAGIT® RL PO, EUDRAGIT® RL 100 or similar, and 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, such as the PVP/VA series of polymers, and triacontanyl PVP, such as GANEX™ WP-660, both of which are commercially available from Ashland Global Specialty Chemicals Inc., of Covington, KY. The film-forming polymer can be selected from at least one of octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, vinyl acetate (VA)/butyl maleate/isobornyl acrylate copolymer, acrylates/t-butylacrylamide copolymer, polyvinylpyrrolidone, polyvinylpyrrolidone copolymer/vinyl acetate copolymer, acrylates/dimethylaminoethyl methacrylate copolymer and the like, and mixtures or combinations thereof. In a preferred implementation, the film-forming polymer may be a copolymer of acrylates and octylacrylamide. For example, the film-forming polymer may be or include 2-propenoic acid, 2-methyl-, 2-methylpropylester copolymer, polymer with 2-propenoic acid and N-(1,1,3,3-tetramethylbutyl)-2- propenamide or 2-propenoic acid, 2-methyl-, 2-methylpropyl ester, 2-propenoic acid, N-(1,1,3,3-tetramethylbutyl)-2-propenamide (CAS 129702-02-9). For example, the film-forming polymer may be or include, but is not limited to, DERMACRYL® 79, which is commercially available from AkzoNobel Company, Surface Chemistry, of Amsterdam, The Netherlands. In another preferred implementation, the film-forming polymer may be an oxtylacrylamide/acrylates/butylaminoethyl methacrylate copolymer. For example, the film-forming polymer may be or include 2-propenoic acid, 2-methyl-, 2-(1,1-dimethylethyl)aminoethyl ester copolymer, polymer with methyl 2-methyl-2-propenoate, 1,2- propanediol mono(2-methyl-2-propenoate), 2-propenoic acid and N-(1,1,3,3-tetramethylbutyl)-2-propenamide (CAS 70801-07-09). For example, the film-forming polymer may be or include, but is not limited to, AMPHOMER® LV-71, commercially available from AkzoNobel Company, Surface Chemistry. In yet another preferred implementation, the film-forming polymer may be EUDRAGIT® E PO (CAS: 24938-16-7).

[0032] In at least one implementation, 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, such as GANTREZ® S-97, commercially available from Ashland Specialty Chemicals, of Bound Brook, NJ.

[0033] In another implementation, the film-forming polymer may be or include, but is not limited to, a styrene copolymer, such as poly(styrene-co-maleic acid) partial isobutyl ester copolymer (CAS 28571-95 -1).

[0034] In at least one implementation, the film-forming polymer may be or include, but is not limited to, a cellulose derivative, such as an alkyl cellulose ether. As used herein, the term "alkyl cellulose ether" may refer to a lower alkyl cellulose ether, such as an ethyl cellulose. In a preferred implementation, the cellulose derivative is ethylcellulose. The degree of ethoxylation and/or viscosity of ethylcellulose may vary. For example, ethylcellulose may have a degree of ethoxylation of about 45% to about 55%, or about 48% to about 52%. In another example, ethylcellulose may have a viscosity of about 3 cP to about 70 cP or about 80 cP to about 105 cP (5% 80:20 toluene:ethanol solution measured at 25°C). In another example, ethylcellulose may have an average substitution value of about 2.3 to about 2.60 ethoxyl groups per anhydroglucose unit. In yet another example, ethylcellulose may have an average substitution value of about 2.46 to about 2.58 ethoxyl groups per anhydroglucose unit, corresponding to an ethoxyl content of about 48% to about 49.5%. %. Illustrative ethylcelluloses may be or include, but are not limited to, AQUALON® EC N100 ethylcellulose, commercially available from Hercules Inc., of Wilmington, DE., ETHOCEL® Standard 100, ETHOCEL™ E7, ETHOCEL™ E22, ETHOCEL™ E50, or the like, and mixtures thereof, all commercially available from Dow Corning Company.

[0035] The amount or concentration of any one or more of the film-forming polymers present in the oral care product or the film-forming composition thereof can vary widely. In at least one implementation, the amount of any one or more of the film-forming polymers present may be an amount effective to form a film capable of or configured to prevent penetration of stains therethrough and/or an amount effective to form a film capable of or configured to provide a barrier against stains. In another implementation, the amount of any one or more of the film-forming polymers present may be an effective amount to form a film capable of or configured to provide relatively greater polish and shine to a substrate (e.g., tooth surfaces) compared to with the substrate alone. In at least one implementation, the amount of any one or more of the film-forming polymers present may be from about 1% by weight to about 50% by weight, based on the total weight of the oral care product or forming composition. film of the same. For example, the amount of any one or more of the film-forming polymers present may be about 1 wt%, about 2 wt%, about 4 wt%, about 6 wt%, about 8 % by weight, about 10% by weight, about 12% by weight, about 14% by weight, about 16% by weight, about 18% by weight, about 20% by weight, about 22% by weight, or about 24% by weight to about 26% by weight, about 28% by weight, about 30% by weight, about 32% by weight, about 34% by weight, about 36% by weight, about 38% by weight, about 40% by weight, about 42% by weight, about 44% by weight, about 46% by weight, about 48% by weight or about 50% by weight weight, based on the total weight of the oral care product or its film-forming composition. In another example, the amount of any one or more of the film-forming polymers present may be from about 1% by weight to about 50% by weight, about 5% by weight to about 45% by weight, about 10% by weight to about 40% by weight, about 15% by weight to about 35% by weight, about 20% by weight to about 30% by weight or about 22.5 to about 28, 5 or about 25% by weight. In another implementation, the amount of any one or more of the film-forming polymers present may be from about 1% by weight to about 30% by weight, based on the total weight of the oral care product or film-forming composition. the same. For example, the amount of any one or more of the film-forming polymers present may be about 1 wt%, about 2 wt%, about 4 wt%, about 6 wt%, about 8 % by weight, about 10% by weight, about 12% by weight, or about 14% by weight, about 16% by weight, about 18% by weight, about 20% by weight, about 22 % by weight, about 24% by weight, about 26% by weight, about 28% by weight, or about 30% by weight, based on the total weight of the oral care product or the film-forming composition thereof . In another example, the amount of any one or more of the film-forming polymers present may be from about 1 wt% to about 30 wt%, about 2 wt% to about 28 wt%, about 4% by weight to about 26% by weight, about 6% by weight to about 24% by weight, about 8% by weight to about 22% by weight, about 10% by weight to about 20 % by weight, about 12% by weight to about 18% by weight or about 14% by weight to about 16% by weight.

Fluoride or Fluoride Compounds

[0036] The oral hygiene product or film-forming composition thereof may include one or more fluorides or fluoride compounds. As used herein, the term "fluoride" or "fluoride compound" may refer to a source of fluoride and/or compounds capable of or configured to provide fluoride ions. The illustrated fluorides may be or include, but are not limited to, soluble salts of the fluoride ion, such as sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride , stannous fluoride, stannous fluorozirconate, complex fluorides, monofluorophosphates and their salts (e.g., sodium monofluorophosphate or potassium monofluorophosphate), laurylamine fluoride, diethylaminoethylctoylamide fluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, sarcosine stannous fluoride, glycine fluoride potassium, glycine hydrofluoride, amine fluorides, or the like, and mixtures or combinations thereof. In a preferred implementation, the fluoride is sodium fluoride.

[0037] The amount or concentration of one or more fluoride compounds present in the oral hygiene product or its film-forming composition can vary widely. In at least one implementation, the fluoride compounds may be presented in an amount capable of or configured to provide fluoride ions in an amount of from about 100 ppm to about 50,000 ppm. For example, the fluoride compounds may be present in an amount capable of or configured to provide fluoride ions in an amount of about 100 ppm, about 500 ppm, about 1,000 ppm, about 5,000 ppm, or about 10,000 ppm to about 15,000 ppm, about 20,000 ppm, about 25,000 ppm, about 30,000 ppm, about 35,000 ppm, about 40,000 ppm, about 45,000 ppm or about 50,000 ppm. In another example, the fluoride compounds may be presented in an amount capable or configured to provide fluoride ions in an amount of at least 100 ppm, at least 500 ppm, at least 1,000 ppm, at least 5,000 ppm, at least 10,000 ppm , at least 15,000 ppm, at least 20,000 ppm, at least 25,000 ppm or at least 30,000 ppm. In a preferred implementation, the fluoride compounds are present in an amount sufficient to provide from about 500 ppm to about 30,000 ppm, more preferably about 1,000 ppm to about 23,000 ppm, or about 1,100 ppm to about 22,600 ppm. . It should be appreciated that the exact weight percentage of the fluoride compound in the film-forming composition can be at least partially determined by the stoichiometric properties of the various fluoride compounds. In an exemplary implementation, the fluoride compound is sodium fluoride and is present in an amount of about 0.5% by weight, about 1% by weight, about 1.5% by weight, about 2% by weight. weight, about 2.5% by weight, about 3% by weight, about 3.5% by weight, about 4% by weight or about 4.5% by weight to about 5% by weight, about 6.5% by weight, about 7% by weight, about 7.5% by weight, about 8% by weight or about 8.5% by weight. In a preferred implementation, sodium fluoride is present in an amount of about 4% by weight to about 6% by weight, or about 5% by weight. In another preferred implementation, sodium fluoride is present in an amount of about 0.5% by weight to about 1.5% by weight, about 1% by weight, or about 1.11% by weight.

Adhesive Agent or Adhesion Enhancer

[0038] In at least one implementation, the oral care product or film-forming composition thereof may optionally include one or more adhesives configured to improve, maintain and/or facilitate adhesion of the film formed from the film-forming composition. to the surfaces of the oral cavity. One or more adhesives may also be configured to increase the hydrophobicity of the film formed from the film-forming composition, thereby allowing the film to withstand external challenges such as abrasion, rubbing or brushing.

[0039] Illustrative adhesives may be or include, but are not limited to, alkyd resins, polyvinyl acetaldehydes, polyvinyl alcohols, polyvinyl acetates, poly(ethylene oxide), polyacrylates, ketone resins, polyvinylpyrolidone, polyvinylpyrolidone/vinyl acetate copolymer, polyethylene glycols of 200 to 1000 molecular weight, polyoxyethylene/polyoxyethylene block copolymer (polyoxyethylene/polyoxopropylene), resins, or the like, and mixtures or combinations thereof. In at least one implementation, one or more adhesives may include siloxane polymers, which are also generally known in the art as "silicone" polymers. Illustrative silicone-based hydrophobic polymers may be or include, but are not limited to, polyorganosiloxane, polydiorganosiloxane, and the like, and combinations thereof. In at least one implementation, the adhesion enhancing agent includes at least one pressure-sensitive silicon adhesive (PSA). Such PSAs can be pressure-sensitive hydrophobic polymers designed specifically for pharmaceutical use and are permeable to many drug compounds and can be applied for transdermal delivery of various compounds. In some implementations, silicone polymers are the 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 so that the polydiorganosiloxane is lightly cross-linked by the silicone resin (i.e., the polydiorganosiloxane chains are linked together through the resin molecules to give chain branching and entanglement and/or a small amount of network character ) to form hydrophobic silicone polymers. In at least one implementation, the adhesion enhancing agents are available under the trade name BIO-PSA, from Dow Corning Company, of Midland, MI. Changing a ratio of silicone resin to polydiorganosiloxane modifies the tackiness of the polymer. This ratio may vary between 70:30 and 50:50. For example, BIO-PSA silicone commercially available from Dow-Corning is available in various ratios of silicone resin to silicone polymer, namely 65/35 (low tack), 60/40 (medium tack), and 55/45 (high adhesion). Such polyorganosiloxane PSA is available dissolved in ethyl acetate or dimethicone solvent. In at least one implementation, the adhesion enhancing agent may include Silicone Adhesive 8-7016, commercially available from Dow Corning Corporation of Midland, MI.

[0040] In some implementations, the adhesive is a natural resin. Illustrative natural resins may be or include, but are not limited to, shellac, rosin or the like and mixtures or combinations thereof. Shellac is commercially available and can be supplied with a solvent (e.g. ethanol). Said commercially available shellac, known as Refined Pharmaceutical Glaze, is available from Mantrose-Haeuser Co., Inc., of Westport, CT.

[0041] The amount or concentration of adhesion-enhancing agents present in the oral hygiene product or its film-forming composition can vary widely. The amount of adhesion enhancing agents present in the film-forming composition can be from about 1% by weight to about 5% by weight. For example, the amount of adhesion enhancing agents present in the film-forming composition may be about 1.0% by weight, about 1.5% by weight, about 2.0% by weight, about 2. .5% by weight or about 3.0% by weight to about 3.5% by weight, about 4.0% by weight, about 4.5% by weight or about 5.0% by weight . In another example, the amount of the adhesion enhancing agents present in the film-forming composition may be from about 1.0 wt% to about 5.0 wt%, about 1.5 wt% to about 4.5% by weight, about 2.0% by weight to about 4.0% by weight, or about 2.5% by weight to about 3.5% by weight. In yet another example, the amount of adhesion enhancing agents present in the film-forming composition may be greater than or equal to greater than or equal to 1.0% by weight, greater than or equal to 1.5% by weight, greater than or equal to to 2.0%, greater than or equal to 2.5% by weight, greater than or equal to 3.0% by weight, greater than or equal to 3.5% by weight, greater than or equal to 4.0% by weight, or greater than or equal to 4.5% by weight. In another example, the amount of adhesion enhancing agents present in the film-forming composition may be less than or equal to 1.0% by weight, less than or equal to 1.5% by weight, less than or equal to 2.0% by weight, less than or equal to 2.5% by weight, less than or equal to 3.0% by weight, less than or equal to 3.5% by weight, less than or equal to 4.0% by weight, less than or equal to 4.5% by weight, or less than or equal to 5.0% by weight. In a typical implementation, the amount of adhesion enhancing agents present in the film-forming composition is about 3.0% by weight.

Thickening system

[0042] In at least one implementation, the oral care product or film-forming composition thereof may optionally include a thickening system having one or more thickeners. The one or more thickeners may be any orally acceptable thickener or thickening agent. Illustrative thickeners may be or include, but are not limited to, colloidal silica, fumed silica, a cross-linked polyvinylpyrrolidone (PVP) polymer, cross-linked polyvinylpyrrolidone (PVP) and the like, and mixtures or combinations thereof. The thickening system may include a cross-linked polyvinylpyrrolidone (PVP) polymer. The thickening system may also include POLIPASDONA® XL 10F, which is commercially available from Ashland Inc. of Covington, KY. 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., CARBOWAX ®, which is commercially available from The Dow Chemical Company of Midland, MI), cellulosic polymers, hydroxyethylcellulose, carboxymethylcellulose and their salts (e.g., sodium CMC), natural gums (e.g., karaya, xanthan, gum arabic, and tragacanth ), magnesium colloidal aluminum silicate, hydrophilic polymers such as carbomers such as carboxymethylene polymers such as acrylic acid polymers and acrylic acid copolymers and the like, and mixtures or combinations thereof. Carboxypolymethylene is a slightly acidic vinyl polymer with active carboxyl groups. An example of carboxypolymethylene is CARBOPOL® 974 and/or 980, available commercially from Noveon, Inc. of Cleveland, OH. In at least one implementation, one or more thickeners may be or include a cellulose ether, selected from one or more of hydroxyalkyl cellulose polymers, such as hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose, hydroxyethylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose and mixtures thereof. or combinations.

[0043] In at least one implementation, the thickening system may include a single thickener. For example, the thickening system may include cross-linked polyvinylpyrrolidone (PVP) polymer. In another implementation, the thickening system may include a plurality of thickeners. For example, the thickening system may include cross-linked PVP polymer and a silica thickener. In another example, the thickening system may include a plurality of silica thickeners.

[0044] The amount or concentration of the thickening system and/or its thickeners present in the oral hygiene product or its film-forming composition can vary widely. The amount of the thickening system and/or its thickeners present in the oral hygiene product or film-forming composition thereof may be from about 10% by weight to about 30% by weight based on the total weight of the hygiene product. oral or in the film-forming composition thereof. For example, the amount of the thickening system and/or its thickeners present in the oral care product or film-forming composition thereof may be about 10% by weight, about 11% by weight, about 12% by weight. weight, about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight , about 20% by weight or about 21% by weight to about 22% by weight, about 23% by weight, about 24% by weight, about 25% by weight, about 26% by weight, about 27% by weight, about 28% by weight, about 29% by weight or about 30% by weight. In another example, the amount of the thickening system and/or its thickeners present in the oral care product or film-forming composition thereof may be from about 12% by weight to about 30% by weight, about 13%. by weight to about 29% by weight, about 14% by weight to about 28% by weight, about 15% by weight to about 27% by weight, about 16% by weight to about 26% by weight weight, about 17% by weight to about 25% by weight, about 18% by weight to about 24% by weight, about 19% by weight to about 23% by weight, or about 20% by weight. weight to about 22% by weight. In a typical implementation, the amount of the thickening system and/or its thickeners present in the oral care product or film-forming composition thereof may be from about 20% by weight to about 22% by weight, more typically about 21% by weight.

Flavoring Agents

[0045] 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 similar materials, as well as sweeteners, such as sodium saccharin and the like, and their mixtures or combinations. Illustrative essential oils may include, but are not limited to, spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit and orange oils. Also useful are chemicals such as menthol, carvone, anethole and the like, and mixtures or combinations thereof. In a preferred implementation, the flavoring agents include peppermint and spearmint oils.

[0046] The amount or concentration of one or more flavoring agents present in the oral care product or film-forming composition thereof can vary widely. In at least one implementation, the amount of one or more flavoring agents present may be from about 0.01% by weight to about 50% by weight, based on the total weight of the oral care product or film-forming composition. the same. For example, the amount of one or more flavoring agents present may be about 0.01% by weight, about 1% by weight, about 5% by weight, about 10% by weight, about 15% by weight. weight, about 20% by weight or about 25% by weight % to about 30% by weight, about 35% by weight, about 40% by weight, about 45% by weight or about 50% by weight Weight.

Oral Acceptable Vehicle

[0047] In at least one implementation, the film-forming composition can be dispersed or dissolved in an orally acceptable carrier. As used herein, the term "orally acceptable carrier" may refer to a suitable carrier, ingredient or combination of ingredients, which may be used to form and/or apply the film-forming composition or one or more components thereof to surfaces of the oral cavity safely and effectively. For example, the orally acceptable carrier may be a suitable solvent and the film-forming composition may be dispersed, dissolved, mixed or otherwise contacted with the suitable solvent to prepare or form the oral care product. Illustrative solvents may 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, methylene tetrachloride. carbon, trichloroethylene, perchloroethylene, methyl glycol acetate, toluene, benzene, diethyl ether, benzyl alcohol or the like, and mixtures or combinations thereof. In a preferred implementation, the orally acceptable carrier is ethanol.

[0048] The orally acceptable vehicle can constitute the balance of the oral hygiene product. In at least one implementation, the orally acceptable carrier (e.g., ethanol) may be present in an amount of at least 60% by weight, at least 62% by weight, at least 64% by weight, at least 66% by weight. , at least 68 wt%, at least 70 wt%, at least 72 wt%, at least 74 wt%, at least 76 wt%, at least 78 wt%, at least 80 wt% , at least 82% by weight, at least 84% by weight, at least 86% by weight, at least 88% by weight, at least 90% by weight, at least 92% by weight, at least 94% by weight, at least 96% by weight, at least 98% by weight or at least 99% by weight, based on the total weight of the oral care product.

Additional Ingredients

[0049] It should be appreciated by those skilled in the art that oral hygiene products and/or film-forming compositions thereof may include other additional ingredients/components. For example, oral care products and/or film-forming compositions thereof may include one or more anti-caries agents, desensitizing agents, viscosity modifiers, diluents, surfactants (e.g., emulsifiers, foam modulators, etc.) , pH modifying agents (e.g., acids and bases), therapeutic agents, humectants, mouthfeel agents, sweetening agents, flavoring agents, bleaching agents, colorants, preservatives and the like, and combinations and mixtures thereof. It should further be appreciated by those commonly skilled in the art that, although general attributes of each of the above categories of materials may be different, there may be some common attributes and any given material may serve multiple purposes within two or more of such categories of material. materials.

[0050] 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, a stannous ion or a source of stannous ion to mitigate calcium loss. Suitable stannous ion sources include but are not limited to stannous fluoride, other stannous halides such as tin chloride dihydrate, tin pyrophosphate, organic tin carboxylate salts such as stannous formate, acetate, gluconate, lactate, tartrate. , oxalate, malonate and citrate, ethylene tin glyoxide 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%, e.g., about 0.1% to about 7%, or about 1% to around 5%.

[0051] The therapeutic agent may also be or include, but is not limited to, an antimicrobial (e.g., antibacterial) agent, such as triclosan. An illustrative list of suitable antibacterial agents is provided in US Patent 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 a total antimicrobial effective amount of from about 0.05% to about 10%, for example, about 0.1% to about 3%.

[0052] Other therapeutic agents include, without limitation, sources of calcium ions, e.g., calcium carbonate, a source of zinc ions, e.g., zinc citrate, a source of potassium ions, e.g., zinc chloride. potassium or its combinations. If present, the amount of ion source in the present composition ranges from about 0.1% to 5%, typically about 1% by weight. A basic amino acid, for example arginine in free form or in salt form, can also be used as a therapeutic agent.

[0053] As discussed above, the film-forming composition may include one or more bleaching agents. As used herein, the term "whitening agent" may refer to a material that affects the whitening of the surface of the tooth to which it is applied. Any bleaching agent known or developed in the art can be used in the present film-forming composition.

[0054] For example, in some implementations, the film-forming composition may include a lightening pigment. In some implementations, the whitening pigments include particles ranging in size from about 0.1 μm to about 10 μm with a refractive index greater than about 1.2. Suitable bleaching agents include, without limitation, titanium dioxide particles, zinc oxide particles, aluminum oxide particles, tin oxide particles, calcium oxide particles, magnesium oxide particles, barium, silica particles, zirconium silicate particles, mica particles, talc particles, tetracalcium phosphate particles, amorphous calcium phosphate particles, alpha-tricalcium phosphate particles, beta-tricalcium phosphate particles, hydroxylapatite particles , calcium carbonate particles, zinc phosphate particles, silicon dioxide particles, zirconium silicate particles and combinations thereof. The whitening pigment, such as titanium dioxide particles, can be in an amount that is sufficient to whiten teeth.

[0055] In some implementations, the bleaching agent may be an oxidizing agent, a reducing agent or combinations thereof. As used herein, the term "oxidizing agent" may refer to material and/or compounds that can accept an electron from another material and/or compound (e.g., molecule) in the environment of the oral cavity without having a deleterious effect or unacceptably harmful to the oral cavity in normal and accepted use. Illustrative oxidizing agents suitable for use with the film-forming composition may 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, sodium hypochlorite. barium, magnesium hypochlorite, lithium hypochlorite and sodium hypochlorite.

[0056] In at least one implementation, the bleaching agent includes a peroxide compound. As used herein, the term "peroxide compound" may refer to any compound including an oxygen-oxygen bivalent group. Peroxide compounds include peroxides and hydroperoxides, such as hydrogen peroxide, alkali metal and alkaline earth metal peroxides, organic peroxide compounds, peroxide acids, pharmaceutically acceptable salts thereof, and mixtures thereof. Alkali metal and alkaline earth metal peroxides include lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof. Organic peroxide compounds include carbamide peroxide (also known as urea and hydrogen peroxide), glyceryl hydrogen peroxide, alkyl hydrogen peroxides, dialkyl peroxides, alkyl peroxide acids, peroxide esters, diacyl peroxide, benzoyl peroxide , monoperoxyphthalate and mixtures thereof. Peroxide acids and their organic peroxide acid salts, such as alkyl peroxide acids and monoperoxyphthalate and mixtures thereof, as well as inorganic peroxide acid salts, such as persulfate, dipersulfate, percarbonate, perphosphate, alkali metal perborate and persilicate salts and alkaline earths, such as lithium, sodium, potassium, magnesium, calcium and barium and mixtures thereof. Typically, the peroxide compound comprises hydrogen peroxide, urea peroxide, sodium percarbonate or mixtures thereof.

[0057] In at least one implementation, the film-forming compositions include a bleaching complex. As used herein, the term "bleaching complex" may refer to a bleaching agent as described herein complexed with a polymer or copolymer that is capable of or configured to release the bleaching agent upon exposure to highly aqueous environments, 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 discharged), for example, a bleaching agent and a polymer.

[0058] All ingredients for use in the compositions described in this document must be acceptable orally. As used herein, "orally acceptable" may refer to any ingredient that is present in a composition as described in an amount and form that does not render the composition unsafe for use in the oral cavity.

METHODS

[0059] The present disclosure may provide methods for increasing gloss and shine, preventing stains, and/or providing a stain barrier on the surfaces of an oral cavity in a human or animal subject. As used herein, "animal subject" may include higher order non-human mammals such as canines, felines, and horses. The method may include contacting any of the film-forming compositions disclosed herein with surfaces of the oral cavity, such as tooth surfaces. Contacting the surface of the teeth with the film-forming composition may include applying the film-forming composition directly to the teeth using a delivery device, such as a pen, (e.g., a COLGATE® Whitening Pen or a COLGATE Whitening Pen ® ACTIS™, Colgate-Palmolive Company, New York, NY), a liquid stick with an applicator such as a felt tip, brush, spray, roller ball or non-woven pad, or the like. Contacting the surface of the teeth with the film-forming composition may also include disposing the film-forming composition in a dental tray (e.g., reservoir of a dental tray) and disposing the dental tray over the teeth.

[0060] The method may also include evaporating an orally acceptable solvent or carrier from the film-forming composition to form a film on the surfaces of the teeth. The resulting film, formed in situ, can increase the polish and shine or perceived polish and shine of tooth surfaces, prevent staining of tooth surfaces, and/or provide a barrier against staining of tooth surfaces. The method may include keeping the film on the surfaces of the teeth for at least 12 hours, at least one day, at least two days, at least three days, at least four days or more.

[0061] The method may include applying or contacting the oral hygiene product and/or the film-forming composition thereof with the surfaces of the teeth at predetermined intervals. For example, the method may include applying or contacting the oral care product and/or the film-forming composition thereof with the surfaces of the teeth on a daily basis, every other day, once or twice a week or once. once a month. In another example, the method may include applying or contacting the oral hygiene product and/or the film-forming composition thereof with the surfaces of the teeth 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 hygiene product and/or the film-forming composition thereof 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 more.

[0062] All ingredients for use in the compositions described in this document must be acceptable orally. As used herein, "orally acceptable" may refer to any ingredient that is present in a composition as described in an amount and form that does not render the composition unsafe for use in the oral cavity.

EXAMPLES

[0063] The examples and other implementations described herein are exemplary and are not intended to be limiting in describing the full scope of the compositions and methods of this disclosure. Equivalent changes, modifications, and variations of the specific implementations, materials, compositions, and methods may be made within the scope of the present disclosure, with substantially similar results.

Example 1

[0064] The ability or effectiveness of films formed from various test film-forming compositions (1) - (9) was evaluated for stain prevention. Test film-forming compositions (1) - (9) were prepared by combining about 80% by weight of absolute ethanol (200 proof) with about 20% by weight of each of the following polymers: (1) Polycarboxylate polymer anionic linear (GANTREZ®); (2) Poly(ethyl acrylate/acrylic acid) (P(EA/AA)); (3) Poly(styrene-co-maleic acid) partial isobutylester copolymer (Sty/Mal); (4) Acrylates/octylacrylamide copolymer (DERMACRYL® 79); (5) Octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer (AMPHOMER®); (6) Dimethylaminoethyl acrylate/methacrylate copolymer (EUDRAGIT® E PO); (7) Polyurethane-64 (BAYCUSAN® C 2000); (8) Polymethyl vinyl ether (PVME) solution; and (9) Polydimethylsiloxane/Dimethicone (Dow Corning® Q7-9120 Silicone Fluid). Particularly, about 20% by weight of each of the polymers was combined with about 80% by weight of ethanol in a flask and vortexed for about 5 minutes to prepare respective solutions of each of the polymers. The solutions were then left to stand overnight and subsequently vortexed or shaken again for about 5 minutes.

[0065] To evaluate stain prevention, 36 artificially colored bovine incisors individually mounted in resin blocks and with L values between 64 and 74 were obtained from Therametric Technologies Inc. from Noblesville, IN. Each of the artificially stained bovine incisors was cleaned and dried, and the baseline L*, a*, b* values of each of the 36 bovine incisors were recorded with a spectrophotometer (SPECTROSHADE micro instrument, manufactured by Medical High Technology, from Verona, Italy). After measuring the L*, a*, b* values, each of the bovine incisors was incubated overnight in well plates containing simulated saliva at about 37°C under shaking (about 100 rpm). After incubation, each of the bovine incisors was washed three times with deionized water and the L*, a*, b* values were measured with the spectrophotometer.

[0066] Each of the test film-forming compositions (1)-(9) was applied to three separate bovine incisors to evaluate stain prevention in triplicate, and the remaining nine bovine incisors were left uncoated to provide a negative control. . To coat bovine incisors, each of the test film-forming compositions (1)-(9) was applied to a respective bovine incisor and allowed to air dry for about 2 minutes.

[0067] A coloring broth was prepared by filtering wine through a fine mesh filter, dipping a bag of LIPTON® black tea in 50 g of hot deionized water for at least 15 minutes and dissolving 1 g of instant coffee in 50 g of hot deionized water for at least 15 minutes. The wine, tea and coffee solutions were then combined with each other in equal parts by volume and stirred to prepare the coloring broth. Each of the coated bovine incisors and the uncoated bovine incisors (Control) were then submerged in the staining broth and incubated at about 37°C for about 24 hours under shaking (about 100 rpm).

[0068] Each of the bovine incisors was then removed from the staining broth and washed three times with DI water. It should be appreciated that rinsing the bovine incisors with DI water allowed the respective film formed from each of the film-forming compositions (1)-(9) to remain intact. The L*, a*, b* values of each of the bovine incisors after treatment were measured. After measurement, each of the bovine incisors was then washed three times with ethanol to remove the respective films and the L*, a*, b* values were measured again after removing the respective films.

[0069] The L*, a*, b* values after treatment were compared with the baseline values to calculate the change in whiteness of each of the bovine incisors. It should be considered that the whiteness index (W*) is a measure of the general color change in relation to pure white, and is given by formula (1), and the change in the whiteness index (ΔW*) is measured by formula (2). It should also be noted that the lower the ΔW*, the whiter the tooth.

[0070] The effectiveness of each of the film-forming compositions (1)(9) and control for stain prevention (ΔW*) and as a stain barrier (ΔW*) is summarized in Table 1. Barrier values against stains (ΔW*) correspond to the L*, a*, b* values measured after rinsing with DI water (film still intact) and represent the effectiveness of the films as a barrier to stains. It should be appreciated that relatively lower stain barrier values (ΔW*) than the control indicate the ability to partially or completely repel stains. Stain prevention (ΔW*) corresponds to the L*, a*, b* values measured after the film has been removed with the ethanol rinse and represents the effectiveness of the films in capturing or retaining any stains that it was unable to repel. Table 1 Whitening Efficacy (ΔW*) for Stain Prevention and Stain Barrier for Film-Forming Compositions (1)-(9)

[0071] As illustrated in Table 1, the test film-forming compositions (4) and (5) provided a complete stain barrier, and the test film-forming compositions (1), (3) and (6) were capable of repelling a significant portion of the stain. It should be appreciated that each of the test film-forming compositions (1) and (3)-(6) that exhibited relatively greater stain barrier properties has a combination of hydrophilic and hydrophobic properties. It should be noted that poly(ethyl acrylate/acrylic acid) (P(EA/AA)) also exhibits hydrophilic and hydrophobic properties, however, the film-forming composition (2) exhibited relatively weak stain barrier properties. The discrepancy in the results observed from the film-forming composition (2), however, was due to the fact that the dried film was colored and gave false positives. As further illustrated in Table 1, the remaining three test film-forming compositions. (7)-(9) are all hydrophobic polymers; and therefore exhibited relatively poor efficacy as a stain barrier. It is noteworthy that the film formed from polyurethane-64, similar to poly(ethyl acrylate/acrylic acid) (P(EA/AA)), exhibited a color that yielded a false positive.

[0072] To evaluate the effectiveness of the films in capturing or retaining portions of the staining broth that the films were unable to repel, the stain prevention values (ΔW*) were compared with the stain barrier values (ΔW*). In particular, substantially equal parity or stain prevention and stain barrier values indicate relatively low effectiveness in capturing stains that the films failed to repel. As illustrated in Table 1, the films formed from the film-forming compositions (6) and (9) exhibited relatively poor effectiveness in retaining stains, indicating that these films allowed the stain to pass directly to the surfaces of bovine incisors. The remaining films, however, exhibited relatively greater effectiveness in preventing stains from penetrating the surfaces of bovine incisors.

Example 2

[0073] The effectiveness of films formed from film-forming compositions of acrylates/octylacrylamide copolymer (DERMACRYL® 79) and octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer (AMPHOMER®) was evaluated for stain prevention at varying concentrations. Particularly, film-forming compositions (10)-(14) including DERMACRYL® 79 and absolute ethanol as a solvent were prepared in the following concentrations: 1 wt%, 5 wt%, 10 wt%, 20 wt% and 30% by weight. Film-forming compositions (15)-(19) including AMPHOMER® in the same concentrations were prepared in a similar way.

[0074] To evaluate stain prevention, 33 artificially stained bovine incisors individually mounted in resin blocks and with L values between 66 and 78 were obtained from Therametric Technologies Inc. Each of the artificially stained bovine incisors was cleaned and dried, and The baseline L*, a*, b* values of each of the 33 bovine incisors were recorded with a spectrophotometer (SPECTROSHADE micro instrument, manufactured by Medical High Technology, Verona, Italy). After measuring the L*, a*, b* values, each of the bovine incisors was incubated overnight in well plates containing simulated saliva at about 37°C under shaking (|about 100 rpm). After incubation, each of the bovine incisors was washed three times with deionized water and the L*, a*, b* values were measured with the spectrophotometer.

[0075] Each of the test film-forming compositions (10)(14), having varying concentrations of DERMACRYL® 79, and the test film-forming compositions (15)-(19), having varying concentrations of AMPHOMER®, was applied to three separate bovine incisors to evaluate stain prevention in triplicate, and the remaining nine bovine incisors were left uncoated to provide a negative control. To coat bovine incisors, each of the test film-forming compositions (10)-(19) was applied to a respective bovine incisor and allowed to air dry for about 2 minutes.

[0076] The coated bovine incisors and the uncoated bovine incisors (Control) were then submerged in the staining broth of Example 1 and incubated at about 37°C for about 24 hours under agitation (about 100 rpm). Bovine incisors were then removed from the staining broth and rinsed three times with DI water. As discussed above, rinsing bovine incisors with DI water allowed the film to remain intact. The L*, a*, b* values of bovine incisors after treatment were measured. After measurement, the bovine incisors were washed three times with ethanol to remove the respective films, and the L*, a*, b* values were measured again after removing the respective films. The effectiveness of each of the film-forming compositions (10)-(19) and the control for stain prevention (ΔW*) and as a stain barrier (ΔW*) is summarized in Table 2. Table 2 Whitening Efficacy ( ΔW*) for Stain Prevention for Film-Forming Compositions (10)-(19)

[0077] As illustrated in Table 2, film-forming compositions including DEMACRYL®79 or AMPHOMER® in relatively low concentrations (about 1% by weight to about 5% by weight) exhibited lower effectiveness to resist staining compared to the highest concentrations (about 10% by weight to about 30% by weight).

[0078] In view of the foregoing, it has been surprisingly and unexpectedly discovered that polymers including an acrylate component and a relatively bulky hydrophobic group coupled to the acrylate component exhibit relatively greater effectiveness for stain prevention and as a stain barrier compared to polymers that do not have these properties. For example, the polymer may be a copolymer formed from an acrylate monomer and a monomer with a relatively bulky hydrophobic functional group, such as an octylacrylamide, a butylaminoethyl and/or a styrene.

Example 3

[0079] The ability or effectiveness of films formed from various film-forming compositions to provide shine and/or shine on treated tooth surfaces was evaluated. Particularly, film-forming compositions including acrylates/octylacrylamide copolymer (DERMACRYL® 79), octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer (AMPHOMER®), poly(ethyl acrylate/acrylic acid) (P(EA/AA)) or ethyl cellulose (AQUALON)TM N100 Pharm) were evaluated for their ability to provide polish and/or shine on bleached bovine incisor surfaces obtained from Therametric Technologies, Inc. Film-forming compositions (20)-(22) including DERMACRYL® 79 and ethanol absolute as solvent were prepared in the following concentrations: 1% by weight, 10% by weight and 20% by weight. Film-forming compositions (23)-(25) including AMPHOMER®, film-forming compositions (26)-(28) including P(EA/AA), and film-forming compositions (29)-(31) including AQUALONTM N100 Pharm at the same concentrations (i.e., 1 wt%, 10 wt%, and 20 wt%) were prepared in a similar way.

[0080] Baseline polishing and brightness measurements or brightness units (GU) were obtained on each of the whitened bovine incisors. To measure baseline GU, each of the bovine incisors was placed face down towards the instrument (Novo-Curve Glossmeter manufactured by Rhopoint Instruments, of East Sussex, UK) and covered to block ambient light. After an initial GU measurement, the bovine incisor was repositioned, retrieved and measured again. This process was repeated for a total of three measurements, which were averaged to provide the GU baseline.

[0081] After the baseline GU of each of the bovine incisors was measured, each of the film-forming compositions was applied to a respective bleached bovine incisor and dried for about 25 minutes. After application of the film-forming composition, GU was measured as discussed above. The change in GU or ΔGU is a measure of the change in brightness units (GU) and is calculated according to formula (3). It should be appreciated that a positive ΔGU indicates an increase in polish and shine, and a decrease in ΔGU indicates a decrease in polish and shine. Each sample was treated on six separate bovine incisors and averaged. The calculated ΔGU is summarized in Table 3. ΔGU = GU (after application of film-forming composition) - GU (baseline) (3) Table 3 Polishing and Shine (ΔGU) for Film-Forming Compositions (20)-( 31)

[0082] As illustrated in Table 3, films formed from film-forming compositions (23)-(25) including AMPHOMER® exhibited a significant increase in ΔGU as the concentration of AMPHOMER® increased. As indicated, the film-forming composition (23) including 1% by weight of AMPHOMER® exhibited little or no significant effect on polishing and gloss; however, films prepared from 10 wt % and 20 wt % film-forming compositions (24) and (25), respectively, exhibited a significant increase in ΔGU. It should be appreciated that the chemical structure of AMPHOMER® is ionic or has ionic charges provided by an acrylic acid carboxylate functional group or acrylate group, which may facilitate or maintain the binding of the polymer to surfaces in the oral cavity, such as tooth surfaces, while bulky hydrophobic groups such as tert-octylacrylamide and butylaminoethyl methacrylate may provide other benefits (e.g., stain prevention) as discussed above.

[0083] As also illustrated in Table 3, films formed from film-forming compositions (20)-(22) including DERMACRYL® 79 exhibited polishing and gloss properties independent of weight percentage. Although a significant difference in polish and shine was observed at all concentrations evaluated, the film-forming composition (20), including 1 wt% DERMACRYL® 79, provided the most consistent and reproducible results. It should be appreciated that the chemical structure of DERMACRYL® 79, similar to AMPHOMER®, includes acrylate groups that can facilitate or maintain the binding of the polymer to surfaces in the oral cavity, such as tooth surfaces, while bulky hydrophobic groups, such as tert -octylacrylamide, may provide other benefits (e.g., spot prevention) as discussed above.

[0084] Films formed from film-forming compositions (26)-(28) including poly(ethyl acrylate-co-acrylic acid) (P(EA/AA)) exhibited polish and shine that was concentration dependent (% by weight) of the polymer. For example, concentrations of about 10 wt% to about 20 wt% of the polymer exhibited significantly greater polish and shine. It should be appreciated that the chemical structure of P(EA/AA) is similar to DEMACRYL® 79 and AMPHOMER®, as P(EA/AA) has functional groups capable of binding to tooth surfaces and hydrophobic functional groups, such as ethyl acrylate, which provide additional benefits as discussed above.

[0085] Films formed from film-forming compositions (29)-(31) including AQUALONTM EC N100 ethylcellulose surprisingly and unexpectedly exhibited variability in polishing and gloss properties. As illustrated in Table 3, the film formed from the 10 wt% film-forming compositions (30) exhibited significantly less polish and shine compared to AMPHOMER®. Furthermore, no significant changes in polishing and gloss properties were observed for the film formed from the 1 wt % and 20 wt % film-forming compositions (29) and (31), respectively. It should be appreciated that the chemical structure of ethylcellulose, unlike other polymers, does not include any functional groups that could facilitate or maintain the binding of the polymer to surfaces in the oral cavity, such as tooth surfaces.

[0086] In view of the foregoing, it has been surprisingly and unexpectedly discovered that polymers that incorporate or include acrylic acid groups, which can facilitate or maintain the binding of the polymer to tooth surfaces, exhibit relatively greater and more reproducible or consistent gloss and properties of shine.

[0087] The present disclosure has been described with reference to exemplary implementations. Although a limited number of implementations have been described and shown, it will be appreciated by those skilled in the art that modifications can be made to these implementations without departing from the principles and scope of the previous detailed description. This disclosure is intended to be construed as including all such modifications and changes to the extent that they are within the scope of the appended claims or equivalents thereto.

Claims (10)

1. Film-forming composition for preventing stains or increasing the polish and shine of teeth, characterized by comprising: a polymer, wherein the polymer is a hydrophobic polymer; wherein the hydrophobic copolymer is an acrylate/octylacrylamide copolymer; an orally acceptable solvent; a bleaching agent comprising an oxidizing agent; and a fluoride compound. 2. Film-forming composition according to claim 1, characterized by the fact that: 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 one alkyl chain, a polyethylene glycol, a polypropylene, a polyester, a polyorthoester, a phospholipid, a long chain fatty acid, a vinyl chloride, fluorethylene, a siloxane, a urethane, an octylacrylamide, a butylaminoethyl and a styrene; and 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 and trimethylolpropane triacrylate, more optionally, wherein the acrylate component is configured to facilitate, maintain or enhance adhesion of a film formed from the film-forming composition to tooth surfaces. 3. Film-forming composition according to claim 1 or 2, characterized in that the polymer is a carboxylated acrylic copolymer. 4. Film-forming composition according to any one of claims 1 to 3, characterized in that the polymer is a copolymer of octylacrylamide and one or more monomers, wherein the one or more monomers comprises one or more of acrylic acid , methacrylic acid and any simple ester thereof, optionally, the polymer is 2-propenoic acid, 2-methyl-, 2-methylpropylester, polymer with 2-propenoic acid and N-(1,1,3,3-tetramethylbutyl)- 2- propenamide. 5. Film-forming composition for increasing the polish and shine of teeth characterized by comprising: a polycarboxylate polymer, wherein the polycarboxylate polymer is a copolymer of methyl vinyl ether and maleic anhydride; and an orally acceptable solvent. 6. Film-forming composition for increasing the polishing and shine of teeth characterized by comprising: an ethylcellulose having a degree of ethoxylation of 45% to 55% or 48% to 52%. 7. Film-forming composition according to any one of claims 1 to 6, characterized in that the fluoride compound is a soluble salt of a fluoride ion, optionally, wherein the fluoride compound includes one or more of sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, ammonium zinc fluoride, lithium fluoride, ammonium fluoride, stannous fluoride and stannous fluorozirconate, preferably the fluoride compound comprises sodium fluoride; an adhesive comprising one or more of a polyvinyl acetaldehyde, a polyvinyl alcohol, a polyvinyl acetate, a poly(ethylene oxide), a polyacrylate, a polyvinylpyrolidone, a polyvinylpyrolidone/vinyl acetate copolymer, a polyoxyethylene/polyoxopropylene block copolymer and a silicone resin; a therapeutic agent; an antimicrobial agent; a desensitizing agent; a sweetener; and wherein the oxidizing agent comprises one or more of peroxides, chlorites and hypochlorites, optionally, the bleaching agent comprises a peroxide compound. 8. Film-forming composition according to any one of claims 1 to 7, characterized in that the orally acceptable solvent comprises 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, perchlorethylene, methyl glycol acetate, toluene, benzene, diethyl ether and benzyl alcohol, preferably the orally acceptable solvent comprises ethanol. 9. Method for preventing tooth stains characterized by: applying the film-forming composition, as defined in any one of claims 1 to 8, to the surfaces of the teeth; and evaporating at least a portion of the orally acceptable solvent to form a film on tooth surfaces. 10. Method for increasing the polish and shine of teeth, characterized in that it comprises: applying the film-forming composition, as defined in any one of claims 1 to 8, to the surfaces of the teeth; and evaporating at least a portion of the orally acceptable solvent to form a film on tooth surfaces.