BR112021006649A2 - compositions for oral hygiene and methods for the same - Google Patents

Abstract

compositions for oral hygiene and methods therefor background of the invention. Disclosed is a film-forming composition and methods for preventing acid erosion of teeth and preventing tooth decay. the film-forming composition can include a hydrophobic copolymer, a fluoride compound and an orally acceptable solvent. the film-forming composition can also include a cellulose derivative, a rosin, a fluoride compound and an orally acceptable solvent.

Description

descriptive report of the invention patent for "COMPOSITIONS FOR ORAL HYGIENE AND METHODS FOR THEM"

FUNDAMENTALS OF THE INVENTION

[0001] Conventional oral care products are often used to distribute fluoride to the surfaces of the oral cavity to thus prevent the formation of caries. For example, fluoride-containing toothpastes and mouthwashes are often used to distribute or apply fluoride to tooth surfaces, thus preventing the formation of cavities. The effectiveness of fluoride in preventing tooth decay, however, is partially determined by the ability of fluoride to maintain contact with tooth surfaces. Thus, the effectiveness of fluoride delivered to tooth surfaces through conventional oral care products (eg, mouthwashes and toothpastes) is generally unsatisfactory, as fluoride is often easily removed from teeth by physical or chemical processes. For example, fluoride on tooth surfaces can be physically removed by chewing and/or chemically removed by prolonged exposure to varying temperatures and the pH levels of the foods and beverages we consume.

[0002] In view of the above, dental varnish compositions including fluoride have been developed to provide relatively longer contact between the fluoride and tooth surfaces. Although conventional dental varnish compositions that incorporate fluoride demonstrate relatively greater effectiveness in preventing caries formation compared to conventional oral care products, they are often highly viscous and take a long time to dry, resulting in the formation of a coating. slimy or sticky, which is unpleasant and undesirable. Furthermore, conventional dental varnish compositions can often use natural resins which tend to form relatively thick films with a yellowish tint,

which can make your teeth look stained.

[0003] What is needed, then, are improved oral care products and film-forming compositions thereof, and methods for preventing caries formation that address these and other disadvantages of conventional film-forming compositions.

BRIEF SUMMARY

[0004] This summary is merely intended 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 evident 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 delineate the scope of the disclosure. Rather, its purpose is merely to present one or more concepts in a simplified form as an introduction to the detailed description below.

[0005] The foregoing and/or other aspects and utilities incorporated in the present disclosure can be achieved by providing a film-forming composition to prevent the formation of tooth decay. The film-forming composition can include a hydrophobic copolymer, a fluoride compound and an orally acceptable solvent.

[0006] In at least one implementation, the hydrophobic copolymer may include an acrylate, optionally the hydrophobic copolymer is an acrylate/octylacrylamide copolymer. In another implementation, the acrylate/octylacrylamide copolymer is 2-propenoic acid, 2-methyl ester, 2-methylpropyl, polymer with 2-propenoic acid and N-(1,1,3,3-tetramethylbutyl)-2-propenamide.

[0007] In at least one implementation, the fluoride compound can be or include a soluble salt of a fluoride ion.

[0008] 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, fluoride stannous and stannous fluorozirconate. In at least one implementation, the fluoride compound includes sodium fluoride.

[0009] 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, cyclo -hexane, methylene chloride, chloroform, carbon tetrachloride, trichlorethylene, tetrachlorethylene, perchlorethylene, methylglycol acetate, toluene, benzene, diethyl ether and benzyl alcohol. In a preferred embodiment, the orally acceptable solvent includes ethanol.

[0010] In at least one implementation, the film-forming composition can further include an adhesive. In at least one implementation, the adhesive can include one or more of a polyvinyl acetaldehyde, a polyvinyl alcohol, a polyvinyl acetate, a poly(ethylene oxide), a polyacrylate, a polyvinylpyrrolidone, a polyvinylpyrrolidone/vinyl acetate copolymer , a polyoxyethylene/polyoxopropylene polymer block and a silicone resin. In at least one implementation, the adhesive is a rosin.

[0011] The foregoing and/or other aspects and utilities incorporated in the present disclosure can be achieved by providing a film-forming composition to prevent the formation of tooth decay. The film-forming composition can include a cellulose derivative, a rosin, a fluoride compound and an orally acceptable solvent.

[0012] In at least one implementation, the cellulose derivative can include an alkyl ether of cellulose, preferably, the cellulose derivative includes ethylcellulose.

[0013] In at least one implementation, the cellulose derivative is ethylcellulose, and ethylcellulose includes an average substitution value of about 2.25 to about 2.60 ethoxy groups per anhydroglucose unit.

[0014] In at least one implementation, the rosin is at least partially hydrogenated. In another implementation, the rosin is fully hydrogenated.

[0015] In at least one implementation, the fluoride compound can be a soluble salt of a fluoride ion.

[0016] 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, fluoride stannous and stannous fluorozirconate. In another implementation, the fluoride compound can include sodium fluoride.

[0017] The foregoing and/or other aspects and utilities incorporated in the present disclosure may be obtained by providing a method for preparing any of the film-forming composition disclosed herein, the method may include contacting the acrylate/octylacrylamide copolymer of the fluoride compound and the orally acceptable solvent with each other.

[0018] The foregoing and/or other aspects and utilities incorporated in the present disclosure may be obtained by providing a method for preparing any of the film-forming composition disclosed herein, the method may include contacting the cellulose derivative, rosin, of the fluoride compound and the orally acceptable solvent together.

[0019] The foregoing and/or other aspects and utilities incorporated in the present disclosure can also be achieved by providing a method to prevent acid erosion on tooth surfaces, the method includes contacting tooth surfaces with any of the tooth-forming compositions. film disclosed in this document.

[0020] The foregoing and/or other aspects and utilities incorporated in the present disclosure can also be achieved by providing a method to prevent tooth decay, the method may include contacting the teeth with any of the tooth-forming compositions. film disclosed in this document.

[0021] Other areas of applicability of the present disclosure will become evident 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 illustrative purposes only and are not intended to limit the scope of the disclosure.

DETAILED DESCRIPTION

[0022] The following description of various typical aspect(s) is merely exemplary in nature and is in no way intended to limit disclosure, application or uses.

[0023] As used throughout this document, ranges are used to include and describe each and every value that falls within the range. It should be appreciated and understood that the description in a ranged format is for convenience and brevity only, and should not be construed as an inflexible limitation on the scope of any modalities or implementations disclosed herein. Consequently, the disclosed range should be interpreted as having specifically disclosed all possible subranges as well as individual numerical values within that range. Thus, any value within the range can be selected as the end of the range. For example, the description of a range, such 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, eg 1, 2, 3, 3,2, 4, 5, etc. This applies regardless of the span of the range.

[0024] All references cited in this document are hereby incorporated in their entirety by reference. In the event of a conflict in a definition in this disclosure and that cited by reference, the definition in this disclosure will control.

[0025] Unless otherwise specified, all percentages and quantities expressed in this document and elsewhere in the specification shall be understood to refer to percentages by weight. Quantities delivered are based on the active weight of the material.

[0026] 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.

The present inventors have surprisingly and unexpectedly found that film-forming compositions including a fluoride compound and a hydrophobic polymer (eg an acrylate/octylacrylamide copolymer) or a combination of a rosin and a cellulose derivative (eg , an alkyl ether of cellulose) exhibit relatively more durable film-forming compositions than those commercially available. It was also surprisingly and unexpectedly found that film-forming compositions including a fluoride compound and a hydrophobic polymer (eg an acrylate/octylacrylamide copolymer) or a combination of a rosin and a cellulose derivative (eg a cellulose alkyl ether) exhibit relatively greater anticaries effect or relatively greater efficacy for preventing caries formation than commercially available film-forming compositions.

Without being bound by theory, the present inventors believe that the balance between hydrophilicity and hydrophobicity of the film-forming composition or the film formed therefrom can provide surprisingly unexpected results.

For example, films formed from the film-forming compositions disclosed herein exhibit sufficient hydrophilicity to allow aqueous solutions, such as saliva, to pass through to deliver fluoride ions to tooth surfaces, exhibiting sufficient hydrophobicity to maintain durability for periods prolonged (eg at least 5 min, at least 10 min, at least 30 min, at least 45 min, at least 1 hour, at least 2 hours, at least 5 hours, at least 10 hours, at least 15 hours, at least 20 hours, at least 1 day, etc.). As further demonstrated in this document, the balance of hydrophilicity and hydrophobicity allows films formed from film-forming compositions to exhibit relatively greater durability compared to conventional films.

Furthermore, the balance of hydrophilicity and hydrophobicity allows films formed from film-forming compositions to exhibit a relatively greater distribution of fluoride than conventional films, even when they include lower concentrations of fluoride.

COMPOSITIONS

[0028] The compositions disclosed herein may be or include an oral care product or a film-forming composition thereof. For example, the compositions disclosed herein can 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 can include one or more hydrophobic polymers and one or more fluoride or fluoride compounds. For example, the film-forming composition can include an acrylate/octylacrylamide copolymer and a fluoride compound. In another implementation, the film-forming composition can include a fluoride compound and a combination of a rosin and a cellulose derivative. For example, the film-forming composition can include a fluoride compound and a combination of a rosin and an alkyl ether of a cellulose (e.g., ethylcellulose). As further described herein, the film-forming compositions and/or one or more components thereof may be capable or configured to deliver fluoride to surfaces of the oral cavity. For example, the film-forming compositions and/or one or more components thereof can be configured to deliver fluoride to tooth surfaces in a sustained manner to thereby provide an anti-caries effect on teeth. Hydrophobic Polymers

[0029] One or more hydrophobic polymers of the film-forming composition may be or include, but are not limited to hydrophobic film-forming polymers, such as hydrophobic film-forming polymers having functional groups with properties that provide relatively greater adhesion to surfaces of the oral cavity (eg tooth surfaces). Illustrative functional groups may include, but are not limited to, carboxyl groups, phosphate groups,

hydroxyl groups, amines, disulfides, nitro groups or the like, and combinations thereof.

[0030] In at least one implementation, the hydrophobic polymer can be or include a copolymer. For example, the hydrophobic polymer can be or include a carboxylated acrylic copolymer. In another example, the hydrophobic polymer can be a copolymer of octylacrylamide and one or more monomers, where the one or more monomers can include one or more of acrylic acid, methacrylic acid and any one or more simple esters thereof. In yet another example, the hydrophobic polymer can 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. Illustrative carboxylated acrylic copolymers may be or include, without limitation, those sold under the trade names DERMACRYL®, AMPHOMER®, BALANCE® and VERSACRYL®, which are commercially available from AkzoNobel Company, Surface Chemistry of Amsterdam, The Netherlands. For example, carboxylated acrylic copolymers can be or include, but are not limited to, AMPHOMER® 4961, AMPHOMER® HC, DERMACRYL® 2.0, RESYN™ XP, a hydrophobic copolymer selected from octylacrylamide/acrylates/butylaminoethyl, such as AMPHOMER® LV-71, AMPHOMER®, AMPHOMER® EDGE™, BALANCE® 47, or the like, and combinations thereof, all commercially available from AkzoNobel Company, Surface Chemistry of Amsterdam, The Netherlands. The hydrophobic copolymer can also be selected from VA/butyl maleate/isobornyl acrylate copolymer, such as ADVANTAGE™ PLUS from Ashland Global Specialty Chemicals Inc. (Covington, KY). The hydrophobic copolymer can also be selected from acrylates/t-butylacrylamide copolymer such as ULTRAHOLD® STRONG and ULTRAHOLD®8 from BASF SE of Ludwigshafen, Germany. The hydrophobic copolymer can be selected from acrylates/dimethylaminoethyl methacrylate copolymer, such as the range of EUDRAGIT® polymers from Evonik Industries of Essen, Germany, such as EUDRAGIT®E100, EUDRAGIT® E PO, EUDRAGIT® RS 100, EUDRAGIT® RS PO, EUDRAGIT® RL PO, EUDRAGIT® RL 100, or the like, and combinations thereof. The hydrophobic copolymer can be selected from polyvinylpyrrolidone/vinyl acetate, such as the PVP/VA series of polymers from Ashland Global Specialty Chemicals Inc. of Covington, KY. The hydrophobic copolymer can be selected from triacotanil PVP, such as GANEX™ WP-660 from Ashland Global Specialty Chemicals Inc. of Covington, KY. The hydrophobic copolymer can be selected from at least one of octylacrylamide/acrylates/butylaminoethyl methacrylate copolymer, VA/butyl maleate/isobornyl acrylate copolymer, acrylates/t-butylacrylamide copolymer, polyvinylpyrrolidone/vinyl acetate copolymer, copolymer triacotanil PVP, acrylates/dimethylaminoethyl copolymer, acrylates/dimethylaminoethyl methacrylate copolymer or mixtures thereof. In a preferred implementation, the hydrophobic polymer can be a copolymer of 2-propenoic acid, 2-methyl ether, 2-methylpropyl, polymer with 2-propenoic acid and N-(1,1,3,3-tetramethylbutyl)-2- propenamide or 2-propenoic acid, 2-methyl ester, 2-methylpropyl, 2-propenoic acid, N-(1,1,3,3-tetramethylbutyl)-2-propenamide copolymer (CAS 129702-02-9). For example, the hydrophobic polymer can be or include, but is not limited to, DERMACRYL® 79, which is commercially available from AkzoNobel Company, Surface Chemistry of Amsterdam, The Netherlands.

[0031] The amount or concentration of one or more hydrophobic polymers present in the oral care product or in the film-forming composition thereof can vary widely. In at least one implementation, the amount of one or more hydrophobic polymers present can be from about 1% by weight to about 50% by weight, based on the total weight of the oral care product or film-forming composition of the product. same. For example, the amount of one or more hydrophobic polymers present can be about 1% by weight, about 5% by weight, about 10% by weight, about 15% by 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.

In another example, the amount of one or more hydrophobic polymers present can 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 at least one implementation, the amount of one or more hydrophobic polymers present can be from about 10% by weight to about 30% by weight, based on the total weight of the oral care product or film-forming composition of the product. same.

For example, the amount of one or more hydrophobic polymers present can be about 10% by weight, about 12% by weight, about 14% by weight, about 16% by weight, about 18% by weight, about 19% by weight, or about 19.5% by weight to about 20.5% by weight, about 21% 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 film-forming composition thereof.

In another example, the amount of one or more hydrophobic polymers present can be from about 10% by weight to about 30% by weight, about 12% by weight to about 28% by weight, about 14% by weight to about 26% by weight, about 16% by weight to about 24% by weight, about 18% by weight to about 22% by weight, about 19% by weight to about 21% by weight, or about 19.5% by weight to about 20.5% by weight, based on the total weight of the oral care product or its film-forming composition.

In a preferred embodiment, the amount of one or more hydrophobic polymers present can be from about 19% by weight to about 21% by weight, about 19.5% by weight to about 20.5% by weight, or about 20% by weight, based on a total weight of the oral care product or the film-forming composition thereof. Fluoride or Fluoride Compounds

[0032] The oral care product or the film-forming composition thereof may include one or more fluorides or fluoride compounds. As used herein, the term "fluoride" or "fluoride compound" can refer to a source of fluoride and/or compounds capable or configured to provide fluoride ions. Illustrated fluorides can be or include, but are not limited to, soluble fluoride ion salts 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 (eg, sodium monofluorophosphate or potassium monofluorophosphate), laurylamine hydrochloride, diethylaminoethyloctoylamide hydrochloride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dimorphoyl fluoride, fluoride stannous sarcosine, potassium and glycine fluoride, glycine hydrochloride, amine fluorides, or the like, and mixtures or combinations thereof. In a preferred implementation, the fluoride ion source includes sodium fluoride.

[0033] The amount or concentration of one or more fluoride compounds present in the oral care product or in the film-forming composition thereof can vary widely. In at least one implementation, the fluoride compounds can be presented in an amount capable or configured to deliver fluoride ions in an amount from about 100ppm to about 50,000ppm. For example, the fluoride compounds can be presented in an amount capable or configured to provide fluoride ions in an amount of about 100ppm, about 500ppm, about 1000ppm, about 5,000ppm, or about 10,000ppm 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 can be presented in an amount capable or configured to provide fluoride ions in an amount of at least 100ppm, at least 500ppm, 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 embodiment, the fluoride compounds are present in an amount sufficient to provide 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 variable 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, 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 embodiment, sodium fluoride is present in an amount from about 4% by weight to about 6% by weight, or about 5% by weight. In another preferred embodiment, sodium fluoride is present in an amount of from about 0.5% by weight to about 1.5% by weight, about 1% by weight or about 1.11% by weight.

Rosin

The oral care product or the film-forming composition thereof may include one or more rosins. In at least one implementation, one or more rosins can be at least partially hydrogenated. One or more rosins can be completely or fully hydrogenated. The hydrogenated rosins can be rosin acids or resin acids that have at least some of their carbon-carbon double bonds hydrogenated. It should be appreciated that the relatively greater degree to which rosins are hydrogenated, the more colorless they appear to the human eye. Accordingly, in at least one implementation, the oral care product or film-forming composition thereof can include a fully hydrogenated rosin that can be transparent or substantially transparent.

[0035] Illustrative rosins may be or include, but are not limited to rosins of the class of rosins known in the art as the rosin class. Members of the rosin class are non-synthetic naturally derived adhesive resins (eg, typically derived from various species of pine). Rosin may include a substantial fraction of resin acid components that are isomeric with abietic acid (C20H30O2). Examples of rosin may also include dihydrobietic acid (C20H32O2) and/or dehydroabietic acid (C20H28O2). Rosin can range from black to substantially colorless, although resins in this class may typically be pale yellow to amber in color and have a density of about 1.07 to about 1.09 g/cm3. Various materials that are individually referred to as “rosin” include Canadian balm, frankincense balm, Elemi resin, Opopanax resin, Tolu balm, Peruvian balm, and POLY-PALE™ resin, which is a partially dimerized rosin commercially available from Eastman Chemical Company, Kingsport, TN. Illustrative rosins can also be or include, but are not limited to, wood rosin, gum rosin, tall oil rosin and mixtures thereof. Rosins can be raw or refined.

[0036] In a preferred implementation, one or more rosins of the film-forming composition, when present, may be or include, but is not limited to, FORALTM AX-E, a fully hydrogenated tree rosin that has been distilled and dimerized, which is commercially available from Eastman Chemical Company. FORAL™ AX-E is nearly colorless and in some implementations is more stable than rosin components. FORAL™ AX-E resists oxidation and retains its substantially colorless characteristics over time. Other suitable commercially available rosins include STAYBELITE™ Resins-E, a partially hydrogenated rosin available from Eastman Chemical Company, which also exhibits good oxidation resistance and light color. Additional suitable commercially available rosins include PAMITE™ (pine resin rosin), DYMEREX™ (dimerized rosin), POLYSTIX® 90 (partially dimerized rosin), DRESINATE™ (rosin soap) and PERMALYN™ NC-11 (non-crystalline rosin ), all of which are commercially available from Eastman Chemical Company.

[0037] The amount or concentration of one or more rosins present in the oral care product or in the film-forming composition thereof can vary widely. In at least one implementation, the amount of resins present in the film-forming composition can be from about 1% by weight to about 9% by weight, based on the total weight of the oral care product or skin-forming composition. film of it. For example, the amount of rosins present in the film-forming composition can be about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, or about 4.5% by weight to about 5.5% by weight, about 6% by weight, about 7% by weight, about 8% by weight or about

9% by weight, based on the total weight of the oral care product or film-forming composition thereof. In another example, the amount of rosins present in the film-forming composition can be from about 1% by weight to about 9% by weight, about 2% by weight to about 8% by weight, about 3% by weight to about 7% by weight, about 4% by weight to about 6% by weight, or about 4.5% by weight to about 5.5% by weight. In a preferred embodiment, the amount of rosins present can be from about 4% by weight to about 6% by weight, about 4.5% by weight to about 5.5% by weight, or more preferably about 5% by weight. Cellulose Derivatives

The oral care product or the film-forming composition thereof may include one or more cellulose derivatives or cellulose derivatives. Cellulose derivatives can be or include, but are not limited to, an alkyl ether of cellulose. As used herein, the term "cellulose alkyl ether" may refer to a cellulose lower alkyl ether, such as ethylcellulose. In a preferred implementation, the cellulose derivative is ethylcellulose. The degree of ethoxylation and/or viscosity of ethylcellulose can vary. For example, ethylcellulose can have a degree of ethoxylation of about 45% to about 50% and a viscosity of about 3 cP to about 70 cP (5% solution at 25°C measured on an Ubbelohde viscometer). In another example, ethylcellulose can have an average substitution value of from about 2.25 to about 2.60 ethoxy groups per anhydroglucose unit, or from about 44% to about 52% ethoxyl content. In yet another example, ethylcellulose may 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 ethylcelluloses can be or include, but are not limited to AQUALON® N100 ethylcellulose, commercially available from Hercules Inc. of Wilmington, DE.,

ETHOCEL® Standard 100, ETHOCELTM E7, ETHOCELTM E22, ETHOCELTM E50, or the like, and mixtures thereof, all of which are commercially available from the Dow Corning Company.

[0039] The amount or concentration of cellulose derivatives present in the oral care product or in the film-forming composition thereof can vary widely. In at least one implementation, the amount of cellulose derivatives present in the film-forming composition can be from about 1% by weight to about 50% by weight, based on the total weight of the oral care product or skin composition. film formation thereof. For example, the amount of cellulose derivatives present in the film-forming composition can be about 1% by weight, about 5% by weight, about 10% by weight, about 15% by 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. In another example, the amount of cellulose derivatives present in the film-forming composition can 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 cellulose derivatives present in the film-forming composition can be from about 10% by weight to about 16% by weight. For example, the amount of cellulose derivatives present in the film-forming composition can be about 10% by weight, about 11% by weight, about 12% by weight, or about 12.5% by weight a about 13.5% by weight, about 14% by weight, about 15% by weight, or about 16% by weight, based on the total weight of the oral care product or film-forming composition thereof . In another example, the amount of cellulose derivatives present in the film-forming composition can be from about 10% by weight to about 16% by weight, about 11% by weight to about 15% by weight, about 12% by weight to about 14% by weight, or about 12.5% by weight to about 13.5% by weight. In a preferred embodiment, the amount of the cellulose derivative, such as ethyl cellulose, present in the film-forming composition can be from about 12% by weight to about 14% by weight, or about 13% by weight. Adhesive or Adhesion Boosting Agent

[0040] In at least one implementation, the oral care product or the 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 forming composition. of film to the surfaces of the oral cavity. One or more adhesives can 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, friction or brushing.

[0041] 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, polyvinylpyrrolidone, polyvinylpyrrolidone acetate copolymer /vinyl, polyethylene glycols of 200 to 1000 molecular weight, and polyoxyethylene/polyoxopropylene (Polyox) block copolymers, silicon resins, or the like, and mixtures or combinations thereof. In at least one implementation, the one or more adhesives can include siloxane polymers, which are also generally known in the art as "silicone" polymers. Illustrative silicone-based hydrophobic polymers can 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 the transdermal application of various compounds.

In some implementations, silicone polymers are the copolymer product of mixing a silanol-terminated polydiorganosiloxane, such as polydimethyl siloxane, 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 such that the polydiorganosiloxane is lightly cross-linked by the silicone resin (i.e. the polydiorganosiloxane chains are linked together via the resin molecules to obtain branching and tangling of chains and/or a small amount of network characteristics) to form the hydrophobic silicone polymers.

In at least one implementation, adhesion enhancing agents are available under the tradename BIO-PSA from the Dow Corning Company of Midland, MI.

Changing a silicone resin to polydiorganosiloxane ratio modifies the tackiness of the polymer.

This ratio can range from about 70:30 to about 50:50. For example, the BIO-PSA silicone commercially available from Dow-Corning is available in varying silicone resin to silicone polymer ratios, specifically, 65/35 (low tack), 60/40 (medium tack) and 55/45 ( high stickiness). Such polyorganosiloxane PSA is available dissolved in ethyl acetate or dimethicone solvent.

In at least one implementation, the adhesion enhancing agent can include Silicone Adhesive 8-7016, commercially available from Dow Corning Corporation of Midland, MI.

[0042] In some embodiments, the adhesive is a natural resin. Illustrative natural resins can be or include, but are not limited to, shellac, rosins or the like, and mixtures or combinations thereof. Shellac is commercially available and can be supplied with a solvent (eg ethanol). A commercially available shellac, known as Refined Pharmaceutical Glaze, is available from Mantrose-Haeuser Co., Inc. of Westport, CT.

[0043] The amount or concentration of adhesion enhancing agents present in the oral care product or in the film-forming composition thereof 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 can 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 adhesion enhancing agents present in the film-forming composition can be from about 1.0% by weight to about 5.0% by weight, about 1.5% by weight 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 or greater than 1.0% by weight, greater than or equal to 1.5% by weight, greater than or equal to to 2.0% by weight, 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 at 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.

[0044] In an exemplary implementation, the oral care product or the film-forming composition thereof is free or substantially free of any adhesives and/or rosins. For example, the oral care product or the film-forming composition thereof may explicitly exclude any additional adhesives and/or rosins. As used herein, "free" or "substantially free" may refer to a composition, component or phase that contains less than 10.0% by weight, less than 5.0% by weight, less than 3.0% by weight. weight, less than 1.0% by weight, less than 0.1% by weight, less than 0.05% by weight, less than 0.01% by weight, less than 0.005% by weight, or less than 0. 0001% by weight based on the total weight of the oral care product or film-forming composition thereof. In at least one implementation, the oral care product or film-forming composition thereof may exclude any one or more components capable or configured to enhance adhesion of the oral care product or film-forming composition to tooth surfaces. . For example, the film-forming composition can consist essentially of the hydrophobic polymer, the fluoride compound and an orally acceptable solvent. Thickening System

[0045] 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 can be any orally acceptable thickener or thickening agent.

Illustrative thickeners can be or include, but are not limited to, colloidal silica, fumed silica, a crosslinked polyvinylpyrrolidone (PVP) polymer, crosslinked polyvinylpyrrolidone (PVP) and the like, and mixtures or combinations thereof.

The thickening system can include a cross-linked polyvinylpyrrolidone (PVP) polymer.

The thickening system can 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 Dow Chemical Company of Midland, MI), cellulosic polymers, hydroxyethylcellulose, carboxymethylcellulose and its salts (eg, CMC sodium), natural gums (eg, karaya, xanthan, gum arabic and tragacanth), colloidal magnesium 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, commercially available from Noveon, Inc. of Cleveland, OH.

In at least one implementation, one or more thickeners can be or include a cellulose ether, selected from one or more hydroxyalkylcellulose polymers, such as hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose, hydroxyethylcellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, and mixtures or combinations thereof .

[0046] In at least one implementation, the thickening system can include a single thickener. For example, the thickening system can include cross-linked polyvinylpyrrolidone (PVP) polymer. In another implementation, the thickening system can include a plurality of thickeners. For example, the thickening system can include cross-linked PVP polymer and a silica thickener. In another example, the thickening system can include a plurality of silica thickeners.

[0047] The amount or concentration of the thickening system and/or its thickeners present in the oral care product or film-forming composition can vary widely. The amount of the thickening system and/or its thickeners present in the oral care product or film-forming composition can be from about 10% by weight to about 30% by weight based on the total weight of the oral care product. buccal or 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 can be about 10% by weight, about 11% by weight, about 12 % by 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, about 21% by weight, about 22% by weight, about 23% by weight, about 24% by weight, about 25% by weight, about 26% by weight 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, about 17% by weight to about 25% by weight, about 18% by weight to about 24% by weight weight, about 19% by weight to about 23% by weight or about 20% by weight to about 22% by weight. In a typical implementation, the amount of thickening system and/or thickeners thereof present in the oral care product or film-forming composition thereof may be about 20% by weight to about 22% by weight, plus typically about 21% by weight. Flavoring Agents

[0048] The film-forming composition can also include one or more flavoring agents. Illustrative flavoring agents that can be used in the film-forming composition can 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 saccharin sodium and the like, and mixtures or combinations thereof. Examples of essential oils include oils of spearmint, peppermint, wintergreen, sassafras, clover, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit and orange. Chemicals such as menthol, carvone, anethole and the like, and mixtures or combinations thereof, are also useful. In a preferred implementation, flavoring agents include oils of spearmint and peppermint.

[0049] The amount or concentration of one or more flavoring agents present in the oral care product or film-forming composition can vary widely. In at least one implementation, the amount of one or more flavoring agents present can be from about 0.01% by weight to about 50% by weight, based on a total weight of the oral care product or builder composition. of film of the same. For example, the amount of one or more flavoring agents present can be about

0.01% by weight, about 1% by weight, about 5% by weight, about 10% by weight, about 15% by weight, about 20% by weight, or about 25% by weight a about 30% by weight, about 35% by weight, about 40% by weight, about 45% by weight or about 50% by weight. Oral Acceptable Vehicle

[0050] In at least one implementation, the film-forming composition can be dispersed or dissolved in an orally acceptable vehicle. As used herein, "orally acceptable carrier" can refer to a suitable vehicle, ingredient or combination of ingredients, which can 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 vehicle can be a suitable solvent and the film-forming composition can be dispersed, dissolved, mixed or otherwise contacted with the appropriate solvent to prepare or form the oral care product. . Illustrative solvents can be or include, without limitation, ethanol, methanol, isopropanol, butanol, water, acetone, methyl ethyl ketone, ethyl acetate, butyl acetate, cyclohexanone, cyclohexane, methylene chloride, chloroform, tetrachloride carbon, trichlorethylene, tetrachlorethylene, perchlorethylene, methyl glycol acetate, toluene, benzene, diethyl ether, benzyl alcohol or the like and mixtures or combinations thereof. In a preferred implementation, the orally acceptable vehicle is ethanol.

[0051] The vehicle acceptable orally can compose the balance of the product for oral hygiene. In at least one implementation, the orally acceptable vehicle (e.g. ethanol) can 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% by weight, at least 70% by weight, at least 72% by weight, at least 74% by weight, at least 76% by weight, at least 78% by weight, at least 80% by weight weight, 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 a total weight of the oral care product. Polar solvent

[0052] In various implementations, the film-forming composition disclosed in this document can include one more solvent, such as a polar solvent. The polar solvent is selected so that it has the ability to at least partially dissolve the hydrophobic polymers disclosed herein. The polar solvent can include glycerine, propylene glycol, alcohol or water.

[0053] In a preferred implementation, the polar solvent includes ethanol, for example, in an amount sufficient to dissolve the ingredients of the film-forming composition, in particular, the hydrophobic polymer. In various implementations, the polar solvent can be present in the film-forming composition in an amount of up to about 99%, including greater than about 0% to about 99%, more preferably about 10% to about 95% or from about 20% to about 80%, more preferably including an amount of about 79% by weight relative to the total weight of the film-forming composition. Additional Ingredients

[0054] It should be appreciated by those of ordinary skill in the art that oral care products and/or the film-forming composition thereof may include other additional ingredients/components. For example, oral care products and/or the film-forming composition thereof may include anticaries agents, desensitizing agents, viscosity modifiers, diluents, surface active agents (e.g., emulsifiers, foam modulators, etc.) , pH modifying agents (eg, acids and bases), humectants, mouthfeel agents, sweetening agents, flavoring agents, colorants, preservatives, and the like, and combinations and mixtures thereof. It should further be appreciated by those of ordinary skill in the art that while 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 such categories of materials. materials.

[0055] All ingredients for use in the compositions described herein must be orally acceptable. As used herein, "orally acceptable" can refer to any ingredient that is present in a composition, as described in an amount and form that does not make the composition unsafe for use in the oral cavity.

METHODS

[0056] The present disclosure can provide methods for preventing the formation of caries on surfaces of the oral cavity in a human or animal subject. As used herein, "animal subject" can 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 in contact with oral cavity surfaces, such as tooth surfaces. Contacting the surface of teeth with the film-forming composition may include applying the film-forming composition directly to the teeth using an administration device, such as a pen, (eg, a COLGATE® whitening pen or a pen. ® ACTIS™ bleaching agent, Colgate-Palmolive Company, New York, NY), a liquid stick with an applicator, such as a felt tip, brush, spray, swivel 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 mold (e.g., dental mold reservoir) and disposing the dental mold to the teeth.

[0057] The method may also include evaporating an orally acceptable solvent or vehicle from the film-forming composition to form a film on tooth surfaces. The resulting film, formed in situ, can allow the suspended fluoride to remain in contact with tooth surfaces. The method can further include the sustained release of fluoride from the film to tooth surfaces. Sustained release of fluoride from the film to tooth surfaces may include solubilizing the fluoride compound disposed in the film to provide fluoride ions. Fluoride ions can migrate or be distributed to tooth surfaces. The method may also include maintaining the film on tooth surfaces for at least 12 hours, at least one day, at least two days, at least three days, at least four days or more.

[0058] The method may include applying or contacting the oral care product and/or the film-forming composition thereof with the tooth surfaces 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 tooth surfaces daily, every other day, once or twice a week, or once a week. month. In another example, the method may include applying or contacting the oral care product and/or the film-forming composition thereof with the tooth surfaces at least once a day, at least once every other day, 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 the skin-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.

[0059] The present disclosure can also provide methods for preparing a film-forming composition. The method can include mixing, dissolving, combining or otherwise bringing each component of the film-forming composition into contact with one another. For example, the method can include putting an acrylate/octylacrylamide copolymer, a fluoride compound and an orally acceptable solvent in contact with each other. In another example, the method may include bringing a cellulose derivative, a rosin and a fluoride compound into contact with each other.

[0060] All ingredients for use in the compositions described herein must be orally acceptable. As used herein, "orally acceptable" can refer to any ingredient that is present in a composition, as described in an amount and form that does not make the composition unsafe for use in the oral cavity.

EXAMPLES

[0061] The examples and other implementations described in this document are exemplary and are not intended to be limiting in describing the full scope of the compositions and methods of this disclosure. Changes, modifications and equivalent variations of specific implementations, materials, compositions and methods may be made within the scope of this disclosure, with substantially similar results.

[0062] Example 1

[0063] The effectiveness of exemplary film-forming compositions (1)-(5) to prevent the formation of caries or dental decay was evaluated in vitro by pH cycling. Particularly, the effectiveness of the film-forming compositions (1)-(5) on loss of surface microhardness or loss of surface microhardness (SMHL) was evaluated. The test film-forming compositions (1)-(5) were prepared by combining the ingredients/components according to Table 1. Particularly, the ingredients/components of each of the test film-forming compositions (1)- (5) were combined or otherwise brought into contact with each other in a rotating mixing bottle and were mixed at about 3540 rpm for about 5 minutes until a homogeneous suspension was obtained. Table 1 Test Film Formation Compositions (1)-(5) INGREDIENT/COMPONENT (1) (2) (3) (4) (5) Acrylates/Copolymer 20% 20% -- -- -- Octylacrylamide Ethylcellulose -- -- 13% 13% 13% Hydrogenated Rosin -- -- 5% 5% 5% Sodium Fluoride 5% 1.11% 5% 1.11% 0.26% Ethanol 75% 78.89% 77% 80.89% 81.74% Total 100.0 100.0 100.0 100.0 100.0

[0064] To assess the effectiveness of the film-forming compositions (1)-(5), a thin layer of each of the film-forming compositions (1)-(5) was brushed onto a respective enamel block and set aside long enough to allow the ethanol to evaporate. The film-forming compositions (1)-(5) were evaluated along with a negative control (N1) and two positive controls (P1) and (P2). The negative control (N1) was an untreated enamel block, and the positive controls (P1) and (P2) were DURAPHAT® and PREVIDENT®, respectively, which are commercially available from Colgate-Palmolive Company of New York, NY, USA. It should be appreciated that DURAPHAT® and PREVIDENT® include or contain about 5% sodium fluoride. Each of the film-forming compositions (1)-(5) and the controls (N1), (P1) and (P2) were evaluated in triplicate. Thus, three separate enamel blocks were used for each of the film-forming compositions (1)-(5) and each of the controls (N1), (P1) and (P2).

[0065] After the ethanol was allowed to evaporate, each of the enamel blocks was transferred to a well plate containing 2 mL of a demineralization solution (pH of about 4), which was prepared by combining the ingredients/components according to with Table 2 and was incubated at about 37°C for about 55 minutes. Each of the enamel blocks was then washed once in deionized (DI) water and transferred to a well plate containing 2 mL of a remineralization solution (pH about 7), which was prepared by combining the ingredients/components according to Table 3 and was incubated at about 37°C for about 3 hours. After incubation for 3 hours, each of the enamel blocks was removed from the well plate including the remineralization solution and was cleaned twice with cotton swabs dipped in ethanol and subsequently dipped in ethanol once. Each of the enamel blocks was then transferred to a new well plate containing 2 ml of the remineralization solution and incubated at about 37°C overnight for about 16 hours. After incubation, each of the enamel blocks was removed from the remineralization solution, washed in DI water and transferred to a new well plate containing 2 mL of the demineralization solution and incubated at approximately 37°C for approximately 55 minutes . After demineralization, each of the enamel blocks was washed once with DI water and transferred to a new well plate containing 2 mL of the remineralization solution and incubated at about 37°C for about 36 hours. After incubation, each of the enamel blocks was removed from the remineralization solution, washed and then dried on the bench top.

Table 2 Demineralization Solution (pH about 4) INGREDIENT/COMPONENT Mass Calcium Nitrate Tetrahydrate 0.4723 g/L (Ca(NO3)2 • 4H2O) Potassium Phosphate Monobasic 0.2722 g/L (KH2PO4) Acetic acid 4.5083 g/L (CH3COOH) Table 3 Remineralization Solution (pH about 7) INGREDIENT/COMPONENT Mass Calcium Nitrate Tetrahydrate 0.3542 g/L (Ca(NO3)2 • 4H2O) Phosphate Monobasic Potassium 0.1225 g/L (KH2PO4) Potassium Chloride 9.6915 g/L (KCl) Phosphate Buffered Saline 100 mL/L (PBS)

[0066] After drying, the mechanical properties of each of the enamel blocks were evaluated using a MICROMET® 5010 Microindentation Hardness Tester, which is commercially available from Thermo Fisher Scientific of Waltham, MA. The MICROMET® 5010 Microindentation Hardness Tester was prepared with a Knoop Diamond indenter at a load of 25 g and 5 indentations were taken for each of the enamel blocks. The surface microhardness loss (SMHS) of each of the enamel blocks was calculated according to Formula 1. The calculated % SMHS are summarized in Table 4. It should be appreciated that the lower the % SMHL value, the higher the anticaries effect or greater the effectiveness to prevent decay or tooth decay. % 𝑑𝑒 𝑆𝑀𝐻𝐿 = @ ó @ (1)

Table 4% SMHL of Test Film Formation Compositions (1)-(5) and Controls (N1), (P1) and (P2) (N1) (P1) (P2) (1) (2) (3 ) (4) (5) SMHL (%) 56.23 29.23 25.45 17.74 16.67 22.29 12.60 18.71 Standard Deviation 5.86 0.12 1.33 5.68 4 .54 3.83 3.75 1.45

[0067] As indicated in Table 4, each of the test film-forming compositions (1)-(5) exhibited comparable or relatively greater anticaries effect; and thus exhibited comparable or greater efficacy in preventing caries or dental decay. It was surprisingly and unexpectedly found that test film-forming compositions (1)-(5) exhibited a relatively greater anticaries effect even at lower concentrations of sodium fluoride.

[0068] Example 2

[0069] The ability or effectiveness of films formed from variable film-forming compositions to resist acid erosion on oral cavity surfaces (eg tooth surfaces) was evaluated in vitro. Particularly, the effectiveness of a film-forming composition (6) in loss of surface microhardness or loss of surface microhardness (SMHL) was evaluated. The test film forming composition (6) was prepared by combining the ingredients/components according to Table 5. Specifically, the ingredients/components were combined or otherwise brought into contact with each other in a rotating mixing bottle and were mixed at about 3540 rpm for about 5 minutes until a homogeneous suspension was obtained. Table 5 Test Film Formation Compositions (1)-(5) INGREDIENT/COMPONENT (6) Acrylates/Octylacrylamide Copolymer 20% Ethanol 80% Total 100.0

[0070] To assess the effectiveness of the film-forming composition (6), a thin layer of the film-forming composition (6) was brushed onto an enamel block and set aside for a sufficient time to allow the ethanol to evaporate . A negative control was provided by an uncoated enamel block. After the ethanol was allowed to evaporate, each of the enamel blocks was transferred to a well plate containing 2 ml of the demineralization solution prepared in Example 1 and incubated at about 37°C for about 30 minutes. Each of the enamel blocks was then washed thoroughly with DI water and allowed to dry.

[0071] After drying, the mechanical properties of each of the enamel blocks were evaluated using a MICROMET® 5010 Microindentation Hardness Tester, which is commercially available from Thermo Fisher Scientific of Waltham, MA. The MICROMET® 5010 Microindentation Hardness Tester was prepared with a Knoop Diamond indenter at a load of 25 g and 5 indentations were taken for each of the enamel blocks. The surface microhardness loss (SMHS) of each of the enamel blocks was calculated according to Formula 1. The calculated % SMHS are summarized in Table 6. It should be appreciated that the lower the % SMHL value, the higher the anti-erosion effectiveness of the film. Table 6 % SMHL of Test (6) and Control (N2) (N2) Film Formation Composition (6) SMHL (%) 92% 0%

[0072] As illustrated in Table 6, the film formed from the film-forming composition (6) completely protected the enamel block, or tooth surfaces, from acid erosion.

[0073] 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 spirit of the foregoing detailed description.

It is intended that this disclosure be interpreted to include all such modifications and changes as they come within the scope of the appended claims or equivalents thereto.

Claims (18)

1. A film-forming composition for preventing the formation of tooth decay, the film-forming composition being characterized in that it comprises: a hydrophobic copolymer; a fluoride compound; and an orally acceptable solvent. 2. Film-forming composition according to claim 1, characterized in that the hydrophobic copolymer comprises an acrylate, optionally, wherein the hydrophobic copolymer is an acrylate/octylacrylamide copolymer, optionally further, wherein the copolymer of acrylate/octylacrylamide is 2-propenoic acid, 2-methyl ester, 2-methylpropyl, polymer with 2-propenoic acid and N-(1,1,3,3-tetramethylbutyl)-2-propenamide. 3. Film-forming composition according to claim 1 or 2, characterized in that the fluoride compound is a soluble salt of a fluoride ion. 4. Film-forming composition according to claim 3, characterized in that the fluoride compound comprises one or more of sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc fluoride and ammonium , lithium fluoride, ammonium fluoride, stannous fluoride and stannous fluorozirconate, preferably, the fluoride compound comprises sodium fluoride. 5. Film-forming composition according to any one of the preceding claims, 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, trichlorethylene, perchlorethylene, methylglycol acetate, toluene, benzene, diethyl ether and benzyl alcohol, preferably, the orally acceptable solvent comprises ethanol. 6. Film-forming composition according to any one of the preceding claims, characterized in that it further comprises an adhesive. 7. A film-forming composition according to claim 6, characterized in that the adhesive comprises 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. 8. Film-forming composition according to claim 6, characterized in that the adhesive is a rosin. 9. Film-forming composition to prevent tooth decay, the film-forming composition being characterized in that it comprises: a cellulose derivative; a resin; a fluoride compound; and an orally acceptable solvent. 10. Film-forming composition according to claim 9, characterized in that the cellulose derivative comprises an alkyl ether of cellulose, preferably, the cellulose derivative comprises ethylcellulose. 11. A film-forming composition according to claim 10, characterized in that the cellulose derivative is ethylcellulose, and the ethylcellulose comprises an average substitution value of from about 2.25 to about 2.60 groups ethoxyl per anhydroglucose unit. 12. Film-forming composition according to any one of claims 9 to 11, characterized in that the rosin is at least partially hydrogenated, preferably the rosin is fully hydrogenated. 13. A film-forming composition according to any one of claims 9 to 12, characterized in that the fluoride compound is a soluble salt of a fluoride ion. 14. Film-forming composition according to any one of claims 9 to 13, characterized in that the fluoride compound comprises one or more of sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, zinc ammonium fluoride, lithium fluoride, ammonium fluoride, stannous fluoride and stannous fluorozirconate, preferably the fluoride compound comprises sodium fluoride. 15. Method for preparing the film-forming composition according to any one of claims 1 to 8, characterized in that it comprises contacting the acrylate/octylacrylamide copolymer, the fluoride compound and the orally acceptable solvent together. 16. Method for preparing the film-forming composition according to any one of claims 9 to 14, characterized in that it comprises contacting the cellulose derivative, rosin, the fluoride compound and the acceptable solvent via oral with each other. 17. Method to prevent acid erosion on tooth surfaces, the method characterized by the fact that it comprises: placing tooth surfaces in contact with the film-forming composition, according to any one of claims 1 to 14. 18. Method to prevent the formation of tooth decay, the method characterized by the fact that it comprises: placing the teeth in contact with the film-forming composition, according to any one of claims 1 to 14.