Oral care composition comprising peroxide and ethylene oxide / propylene oxide block copolymer

Abstract

An oral care composition is described herein. The oral care composition comprises an ethylene oxide / propylene oxide block copolymer having the formula HO (C2H4O) a (C3H6O) b (C2H4O) aH wherein per mole of such copolymer has a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units wherein a is from 50 to 400, b is from 50 to 400, and wherein the copolymer has a molecular weight of about 1250 to about 15000. The oral care composition further comprises a peroxide and an emulsifier. The oral care composition comprises the ethylene oxide / propylene oxide block copolymer in an amount of at least about 20 wt% based on the total weight of the composition.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 388,052, filed on July 11, 2022, the entire contents of which are incorporated herein in their entirety. Technical Field

[0003] The present invention relates to an oral care composition. Background Art

[0004] Peroxides are commonly found in compositions for tooth whitening treatments in both professional and home applications. However, it is difficult to formulate with high levels of peroxides because peroxides may be unstable. For example, the oxidative properties of peroxides have brought many challenges to oral care compositions such as toothpastes, gels, and mouthwashes. That is, when peroxide decomposes, it releases oxygen, water, and free radicals. Excessive gas can cause product packaging to swell and burst, and free radicals can cause the entire composition (comprising active substances and flavorings) to decompose into a composition with water-like viscosity and reduced efficacy.

[0005] In order to solve this problem, a kind of strategy that makes peroxide stable is to reduce the amount of water and use the solid form of peroxide.However, there are some limitations in low water / anhydrous composition.For example, conventional thickeners (such as xanthan gum) need the hydration of water to reach complete gelling ability.Another limitation is that the solid content of low water / anhydrous composition is high.Increasing solid peroxide content is very challenging, because higher amount of solid peroxide means more solids, higher viscosity and lower fluidity.

[0006] Therefore, there is a need for improved oral care compositions containing high levels of peroxide. Summary of the invention

[0007] It has been discovered that the use of ethylene oxide / propylene oxide block copolymers, and an emulsifier in combination with a peroxide enables the use of liquid peroxides and eliminates the restriction to anhydrous formulations.

[0008] In an embodiment, an oral care composition is provided. The oral care composition comprises:

[0009] An ethylene oxide / propylene oxide block copolymer having the formula:

[0010] HO(C2H4O) a (C3H6O) b (C2H4O) a H

[0011] wherein each mole of such copolymer has a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, wherein a is 50 to 400, b is about 50 to 400, and the copolymer has a molecular weight of about 1250 to 15000 kg / mol; a peroxide and an emulsifier, wherein the amount of ethylene oxide / propylene oxide block copolymer is at least 20 wt % based on the total weight of the composition.

[0012] In another embodiment, a method of whitening comprises applying an oral care composition to the surface of a mammal's teeth. DETAILED DESCRIPTION

[0013] Oral care compositions may contain fluoride, peroxide, abrasives, flavoring agents and other ingredients to provide benefits such as reducing plaque and tartar, preventing tooth decay, preventing and treating gingivitis, establishing anti-sensitivity protection, freshening bad breath and whitening teeth. Some consumers are particularly interested in products that contain relatively high levels (e.g., greater than 1%) of peroxide to enhance the removal of both intrinsic and extrinsic stains.

[0014] However, oral care compositions, especially those containing a peroxide source, may be unstable and difficult to formulate. For example, peroxides are prone to decomposition, such as hydrogen peroxide, which decomposes to form water and oxygen. As peroxide decomposes, its effectiveness is reduced, generating excess gas that may cause primary packaging to swell and rupture, and may affect the structural stability and efficacy of other components in the oral care composition, including flavoring agents. To address this problem, many oral care compositions containing peroxides in solid form are anhydrous or have a low water content. However, due to the high solids content, such formulations have limitations when high concentrations of peroxide are used.

[0015] Embodiments of the present invention advantageously provide a kind of oral care composition, it comprises aqueous peroxide, so that oral care composition is applied more easily, and cost is saved in manufacturing process.Embodiments further advantageously utilize the component in oral care composition, and this component can help stabilize peroxide and maintain original viscosity.In an embodiment, oral care composition can comprise ethylene oxide / propylene oxide block copolymer, surfactant and peroxide.The viscosity of said composition can be about 1,000cP to about 1,000,000cP.

[0016] In one embodiment, the oral care composition may include an ethylene oxide / propylene oxide block copolymer having the formula:

[0017] HO(C2H4O) a (C3H6O) b (C2H4O) a H

[0018] wherein each mole of such copolymer has a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, and the copolymer has a molecular weight of about 1250 to 15000 kg / mol; an emulsifier and a peroxide. In the formula of the ethylene oxide / propylene oxide block copolymer, a and b may be 50 to 400.

[0019] Various embodiments are described below. It should be noted that the specific embodiments are not intended to be exhaustive descriptions or limitations of the broader aspects discussed herein. An aspect described in conjunction with a particular embodiment is not necessarily limited to that embodiment and may be practiced with any other embodiment or embodiments.

[0020] As used herein, "about" will be understood by one of ordinary skill in the art and will vary to some extent depending on the context in which it is used. If a term is used that is not clear to one of ordinary skill in the art, then in the context in which the term is used, "about" will mean up to plus or minus 10% of the particular term.

[0021] The articles "a", "an" and "the" are used herein to refer to one or more than one (ie, at least one) of the grammatical object of the article. For example, "a filter" means one filter or more than one filters.

[0022] Unless expressly stated otherwise, all percentages stated in connection with the compositions described herein refer to percentages by weight based on the mixture or composition in question, respectively.

[0023] Recitation of ranges of values ​​herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or clearly contradicted by context.

[0024] The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended only to illustrate certain materials and methods and is not intended to limit the scope. No language in this specification should be construed as indicating that any non-claimed element is essential to practicing the disclosed materials and methods.

[0025] The composition can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise useful in oral care compositions.

[0026] As used herein, "oral care composition" means a product that, during routine use, is not intentionally swallowed for the purpose of systemic administration of a particular therapeutic agent, but is retained in the oral cavity for a sufficient time to contact tooth surfaces or oral tissues. Examples of oral care compositions include dentifrices, mouthwashes, mousses, foams, oral sprays, lozenges, chewable tablets, chewing gums, teeth whitening strips, whitening gels, toothpastes, dental floss and dental floss coatings, breath freshening soluble strips, denture care or adhesive products. Oral care compositions may also be incorporated into strips or films for direct application or attachment to oral surfaces.

[0027] As used herein, unless otherwise indicated, the term "dentifrices" includes pastes, gels or liquid formulations for use under teeth or gums. Dentifrice compositions can be single-phase compositions, or can be a combination of two or more independent dentifrice compositions. Dentifrice compositions can be in any desired form, such as deep stripes, surface stripes, multi-layers, gels around pastes or any combination thereof. Each dentifrice composition in a dentifrice comprising two or more independent dentifrice compositions can be contained in physically separated compartments of a dispenser and distributed side by side.

[0028] As used herein, the term "dispenser" refers to any pump, tube, or container suitable for dispensing a composition such as a dentifrice.

[0029] As used herein, the term "tooth" refers to a natural tooth, an artificial tooth, or a dental prosthesis.

[0030] In an embodiment of the present disclosure, an oral care composition is provided. The oral care composition may include an ethylene oxide / propylene oxide block copolymer. The oral care composition may include an ethylene oxide / propylene oxide block copolymer having the following formula:

[0031] HO(C2H4O) a (C3H6O) b (C2H4O) a H

[0032] wherein each mole of the copolymer has a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, and the copolymer has a molecular weight of about 1250 to 15000 kg / mol; an emulsifier and a peroxide. In some embodiments, the copolymer can have about 1500 to about 14500 kg / mol, about 1750 to about 14000 kg / mol, about 2000 to about 13500 kg / mol, about 2250 to about 13000 kg / mol, about 2500 to about 12500 kg / mol, about 2750 to about 12000 kg / mol, about 3000 kg / mol to about 11500 kg / mol, about 3500 to about 11000 kg / mol, about 4000 kg / mol to about 10500 kg / mol, about 4500 to about 10000 kg / mol, about 5000 to about 9500 kg / mol, about 5500 to about 9000 kg / mol, about 6000 to about 8500 kg / mol, or about 7500 to about 8000 kg / mol, or any range or subvalue described herein. The ethylene oxide / propylene oxide block copolymer may be included in the oral care composition in an amount of at least about 20 wt % based on the total weight of the composition. It has been found that when the amount of ethylene oxide / propylene oxide block copolymer is less than about 20 wt %, the oral care composition does not form a stable structure.

[0033] In some embodiments, the emulsifier may include an anionic emulsifier, a nonionic emulsifier, or a combination thereof. The emulsifier may be stearyl alcohol, cetearyl alcohol, cetyl alcohol, stearyl and sodium lauryl sulfate, sodium lauryl sulfate, sodium lauryl glucose carboxylate, lauryl glucoside, or a combination thereof.

[0034] The inclusion of an emulsifier in an oral care composition has been found to balance the viscosity and texture of the composition.

[0035] In embodiments of the present disclosure, peroxides may include, but are not limited to, hydrogen peroxide, carbamide peroxide, calcium peroxide, sodium peroxide, zinc peroxide, or a combination thereof. In one embodiment of the oral care composition, the peroxide may include hydrogen peroxide. In some embodiments, the amount of peroxide in the oral care composition may be about 0.01 wt%, about 0.5 w%, at least about 0.75%, about 1%, about 1.25%, about 1.5%, about 1.75%, about 2%, about 2.25%, about 2.5%, about 2.75%, about 3%, about 3.25%, about 3.5%, about 3.75%, about 4%, about 4.25%, about 4.5%, about 4.75%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, about 20%, about 21%, about 22%, about 23%, about 24%, about 25%, about 26%, about 27%, about 28%, about 29%, about 30%, about 31%, about 32%, about 33%, about 34%, about 35%, about 36%, about 37%, about 38%, about 39%, about 40%, about 41%, about 42%, about 43%, about 44%, about 45%, about 46%, about 47%, about 48%, about 49%, about 50%, about 51%, about 52%, about 53%, about 54%, about 55%, about 56%, about 57%, about 58%, about 59%, about 60%, about 61%, about 62%, about 63%, about 64%, about 65%, about 66%, about 67%, In some embodiments, the amount of peroxide in the oral composition is about 0.5% to about 10%, about 1% to about 9%, about 2% to about 8%, about 3% to about 7%, or about 4% to about 6%.

[0036] In some embodiments, the peroxide can be a liquid formulation. The concentration of the peroxide in the liquid formulation can be about 20wt%, about 25wt%, about 30wt%, about 35wt%, about 40wt%, about 45wt%, or about 50wt%, or in any range defined therein (e.g., about 20wt% to about 40wt%).

[0037] In some embodiments, the oral care composition may further include water. The oral care composition may have a water concentration of about 5% to about 20%. In some embodiments, the water concentration may be about 5%, about 7%, about 10%, about 12%, about 15%, about 17%, or about 20%. In other embodiments, the water concentration may be about 1% to about 25%, about 5% to about 20%, about 7% to about 18%, or about 10% to about 15%, or any value or sub-range herein.

[0038] In some embodiments, the oral care composition may include at least one excipient. Excipients suitable for use include any compound conventionally used in oral care compositions. Suitable excipients for oral compositions may be selected from preservatives, abrasives (lubricants), antibacterial agents, inflammation inhibitors, irritation preventers, irritation inhibitors, antimicrobial agents, antioxidants, binders, (mineral) fillers, buffers, carrier materials, chelating agents, cleaning agents, care agents, surface-active substances, enzymes, foam formers, foam stabilizers, foam boosters, gelling agents, gel formers, bleaching agents, odor and / or taste regulators, odor and / or taste reducers, odor and / or taste enhancers, plasticizers, skin cooling agents, skin soothing agents, skin cleansers, skin care agents, skin healing agents, mucosal protective agents, stabilizers, suspending agents, vitamins, colorants, color protectants, pigments, surfactants, electrolytes, silicone derivatives, polyols, calcium carbonate, calcium hydrogen phosphate, aluminum oxide, fluoride, zinc salts, tin salts, potassium salts, sodium salts and strontium salts, pyrophosphates or hydroxyapatite.

[0039] In some embodiments, the oral care composition according to the present invention comprises at least one excipient, wherein the at least one excipient is selected from: surfactants, desensitizing agents, whitening agents, tartar control agents, antibacterial agents, abrasives, chelating agents (including silica), binders and thickeners, detergents, adhesives, foam regulators, pH regulators, mouthfeel agents, sweeteners, flavoring agents, colorants, preservatives, combinations thereof, and the like.

[0040] In some embodiments, the oral care composition may further include a surfactant. In some embodiments of the present disclosure, the surfactant may be an anionic surfactant, a nonionic surfactant, or a combination thereof. In some embodiments, the surfactant may also include a zwitterionic surfactant, an amphoteric surfactant, or a cationic surfactant. In some embodiments, the anionic surfactant may be sodium lauryl sulfate, sodium lauryl glucose carboxylate, lauryl glucoside, or a combination thereof. In some embodiments, the nonionic surfactant may include alkyl polyglucoside or lauryl glucoside. In some embodiments, the surfactant may be sodium lauryl glucose carboxylate and lauryl glucoside.

[0041] The surfactant can be prepared in a solvent. The solvent can include water, an edible polyol, such as glycerol, diglycerol, triglycerol, sorbitol, xylitol, butylene glycol, erythritol, polyethylene glycol, propylene glycol, or a combination thereof.

[0042] In some embodiments, the surfactant may include anionic surfactants such as organic phosphates (including alkyl phosphates, alkyl or alkenyl phosphates). Organic phosphate surfactants have a strong affinity for the enamel surface and have sufficient surface binding tendency to desorb the surface membrane protein and remain attached to the enamel surface. Examples of suitable surfactants include alkyl and alkyl (poly) alkoxy phosphates, such as lauryl phosphate; PPG5 ceteareth-10 phosphate; laureth-1 phosphate; laureth-3 phosphate; laureth-9 phosphate; trilaureth-4 phosphate; C 12 -C 18 PEG9 phosphate; sodium laureth-10 phosphate. In one example, the alkyl phosphate is polymerized. Examples of polymerized alkyl phosphates include alkyl phosphates containing repeating alkoxy groups, particularly 3 or more ethoxy, propoxy, isopropoxy or butoxy groups as polymeric moieties.

[0043] Zwitterionic or amphoteric surfactants may include derivatives of aliphatic quaternary ammonium, phosphonium and sulfonium compounds, wherein the aliphatic radical may be straight chain or branched, and wherein one of the aliphatic substituents contains from about 8 to 18 carbon atoms and one contains an anionic water solubilizing group (e.g., carboxyl, sulfonate, sulfate, phosphate or phosphonate). Amphoteric surfactants may include amine oxide surfactants.

[0044] Other suitable polymeric organic phosphates can include dextran phosphate, polyglucosidic phosphate, alkyl polyglucosidic phosphate, polyglyceryl phosphate, alkyl polyglyceryl phosphate, polyether phosphate and alkoxylated polyol phosphate. Some examples include polyethylene glycol (PEG) PEG phosphate, polypropylene glycol (PPG) phosphate, alkyl PPG phosphate, PEG / PPG phosphate, alkyl PEG / PPG phosphate, PEG / PPG / PEG phosphate, dipropylene glycol phosphate, PEG glyceryl phosphate, polybutylene glycol (PBG) phosphate, PEG cyclodextrin phosphate, PEG sorbitan phosphate, PEG alkyl sorbitan phosphate and PEG methyl glucoside phosphate. Suitable non-polymeric phosphates include alkyl monoglyceride phosphate, alkyl sorbitan phosphate, alkyl methyl glucoside phosphate and alkyl sucrose phosphate.

[0045] In some embodiments, the oral care composition may further include an abrasive. The abrasive may include silicon dioxide (such as a gel or precipitate), aluminum oxide, phosphate (including orthophosphate, polymetaphosphate, pyrophosphate), or a combination thereof. Specific examples may include silicone microspheres (such as polyorganosilsesquioxane particles), dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate, insoluble sodium polymetaphosphate, rice husk silica, hydrated aluminum oxide, beta calcium pyrophosphate, calcium carbonate, and resin abrasive materials (such as microparticle condensation products of urea and formaldehyde). In some embodiments, the abrasive may be silicon dioxide, polyorganosilsesquioxane, calcium pyrophosphate, poly(methyl methacrylate), calcium carbonate, dicalcium phosphate, barium sulfate, or a combination thereof.

[0046] In some embodiments, the amount of abrasive included in the oral care composition can be about 20wt% based on the total weight of the oral care composition. In some embodiments, the amount of abrasive included can be about 10wt% to about 30wt%, about 12wt% to about 28wt%, about 15wt% to about 25wt%, or about 17wt% to about 22wt%.

[0047] The oral care composition may have a viscosity of about 1,000 to about 1,000,000 cP. The viscosity can be measured using a viscometer HA (spindle V75, measuring speed 5 rpm). In some embodiments, the viscosity can be about 1,000 cP, about 10,000 cP, about 25,000 cP, about 50,000 cP, about 75,000 cP, about 100,000 cP, about 125,000 cP, about 150,000 cP, about 175,000 cP, about 200,000 cP, about 250,000 cP, about 275,000 cP, about 300,000 cP, about 325,000 cP, about 350,000 cP, about 375,000 cP, about 400,000 cP, about 425,000 cP, about 450,000 cP, about 475,000 cP, about 50 cP, about 800,000 cP, about 825,000 cP, about 850,000 cP, about 875,000 cP, about 900,000 cP, about 925,000 cP, about 950,000 cP, about 975,000 cP, or about 1,000,000 cP.

[0048] In some embodiments of the oral care composition, at least about 80% of the peroxide remains, at least about 85% of the peroxide remains, at least about 90% of the peroxide remains, at least about 91% of the peroxide remains, at least about 92% of the peroxide remains, at least about 93% of the peroxide remains, at least about 94% of the peroxide remains, at least about 95% of the peroxide remains, at least about 96% of the peroxide remains, at least about 97% of the peroxide remains, at least about 98% of the peroxide remains, or at least about 99% of the peroxide remains according to the Peroxide Stability Test after 4 weeks at 40°C.

[0049] The following method was used to perform a peroxide stability test to determine the stability of peroxides in oral care compositions. First, add 0.4000 g (+ / - 0.02 g) of oral care sample to a 250 ml plastic beaker. This procedure was performed in duplicate. Then, 100 mL of 0.04 N H2SO4 (sulfuric acid) was added to the beaker. A stir bar was added and the beaker was covered with a plastic paraffin film such as Parafilm. (From Bemis Flexible Packaging, Oshkosh, Wisconsin) FlexiblePackaging) is available) covered, and the solution is stirred for at least ten minutes (or longer) until the sample appears to be uniform. After stirring, 25 mL of 10% KI (potassium iodide) solution and 3 drops of NH4-molybdate are added to the beaker, the beaker is covered with plastic paraffin film, and the solution is stirred for another 3-20 minutes. The resulting solution is analyzed by automatic titration with 0.1N sodium thiosulfate solution. The hydrogen peroxide % is calculated using the following formula:

[0050]

[0051] The measurements are taken after the formulation is initially prepared and then again after the formulation has been stored for a given period of time at 40°C in a non-reactive container. Peroxide stability is calculated as the percent peroxide measured after a given period of time at 40°C divided by the initial percent peroxide measured and then multiplied by 100. Products placed at 40°C represent accelerated stability and can be used to determine the reactions that may occur to the oral care composition throughout its shelf life. The given time can be any suitable amount of time. For example, four weeks, eight weeks, 13 weeks, or 26 weeks.

[0052] In other embodiments, the oral care composition may further comprise at least one ingredient from the group consisting of a desensitizing agent, a chelating agent, a whitening agent, a tartar control agent, a detergent, an adhesive, a foam regulator, a pH regulator, a mouthfeel agent, a sweetener, a flavoring agent, a coloring agent, a preservative, a humectant, and combinations thereof.

[0053] In some embodiments, the oral care composition may include a flavoring agent. The flavoring agent is a member selected from the following: mucosal coolants, mucosal warming agents, substances with pungent taste, sweeteners, sugar substitutes, organic or inorganic acidulants (e.g., malic acid, acetic acid, citric acid, tartaric acid, phosphoric acid), bitter substances (e.g., quinine, caffeine, limonin, gentian glycosides, humulone, lupulone, catechol, tannin), edible mineral salts (e.g., sodium chloride, potassium chloride, magnesium chloride, and sodium phosphate), essential oils (e.g., spearmint, peppermint, wintergreen, sassafras, cloves, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, and orange oils), menthol, carvone, anethole, and combinations thereof.

[0054] Antimicrobial agents may include nonionic antibacterial agents, including halogenated diphenyl ether compounds, such as 2,4,4'-trichloro-2'-hydroxydiphenyl ether (triclosan) and 2,2'-dihydroxy-5,5'-dibromodiphenyl ether. Other useful nonionic antibacterial agents may include phenolic compounds (including phenol and its homologues, monoalkyl and polyalkyl and aromatic halogenated phenols, resorcinol and its derivatives) and bisphenolic compounds, which are more fully disclosed in U.S. Pat. No. 5,368,844, the disclosure of which is incorporated herein by reference.

[0055] In some embodiments, the oral care composition according to the present disclosure comprises an antimicrobial agent. In some embodiments, the antimicrobial agent is a member selected from the following: triclosan, chlorhexidine and its salts (e.g., acetate, gluconate or hydrochloride thereof), peroxide, phenol and its salts, domiphen bromide (phenododecinium bromide), bromochlorophene, Zn salts, stannous fluoride, chlorophyll, Cu salts, Cu gluconate, Cu chlorophyll, sodium lauryl sulfate, polylysine, quaternary monoammonium salts (such as coconut oil fatty benzyl dimethyl ammonium chloride), homopolymers of arginine, arginine salts or complexes, or also pyridinium salts (such as cetylpyridinium chloride), and combinations thereof.

[0056] Thymol, menthol, methyl salicylate and eucalyptol and mixtures thereof are well known as antimicrobial agents and are active against dental plaque.

[0057] In some embodiments, the antimicrobial agent is a nonionic antibacterial agent. In some embodiments, the nonionic antibacterial agent is included in the oral care composition at a concentration of about 0.001 wt.% to about 5 wt.%. In some embodiments, the nonionic antibacterial agent is present in an amount of about 0.01 wt.% to about 1.5 wt.%.

[0058] Antimicrobial agents of particular interest are quaternary monoammonium salts (such as coco-fatty benzyldimethylammonium chloride), or also pyridinium salts (such as cetylpyridinium chloride), polylysine, thymol, menthol, methyl salicylate and eucalyptol, triclosan, chlorhexidine and its salts (e.g., its acetate, gluconate or hydrochloride) and combinations thereof.

[0059] In some embodiments, the oral care composition may include an anticaries agent. In some embodiments, the anticaries agent is a fluoride ion source selected from the following: inorganic fluoride salts, such as soluble alkali metal salts, alkaline earth metal salts (e.g., sodium fluoride, stannous fluoride, potassium fluoride, ammonium fluoride, calcium fluoride), copper fluoride (e.g., cuprous fluoride), zinc fluoride, barium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium fluorozirconate, ammonium fluorozirconate, sodium monofluorophosphate, aluminum monofluorophosphate and aluminum difluorophosphate, sodium calcium pyrophosphate fluoride, and combinations thereof.

[0060] In some embodiments, the oral care composition may include an anti-tartar agent. In some embodiments, the anti-tartar agent is selected from: pyrophosphate (including dialkali metal or tetraalkali metal pyrophosphate, such as Na4P2O7, K4P2O7, Na2K2P2O7, Na2H2P2O7 and K2H2P2O7, sodium tripolyphosphate); long chain polyphosphate (such as sodium hexametaphosphate); and cyclic phosphate (such as sodium trimetaphosphate). In some embodiments, the anti-tartar agent is present in the oral care composition at a concentration of about 1wt.% to about 5wt.%.

[0061] In some embodiments, the oral care composition may further contain a desensitizing agent, such as nitrate, bicarbonate, potassium nitrate, arg / 'n / 'ne-bicarbonate-phytate complex, potassium citrate or potassium oxalate, and arginine.

[0062] In some embodiments, the oral care composition may include a thickener. In some embodiments, the thickener is selected from, but not limited to, the group consisting of calcium carbonate, titanium dioxide, silicon dioxide, talc, aluminum oxide, dicalcium phosphate, tricalcium phosphate, magnesium hydroxide, cellulosic thickeners (such as carboxymethyl cellulose), hydroxyalkyl celluloses (such as hydroxypropyl cellulose, hydroxyethyl cellulose), gums (such as xanthan gum), polyglycols and polyethylene glycols, inorganic thickeners (e.g., amorphous silica compounds, natural and synthetic clays, lithium magnesium silicate and magnesium aluminum silicate), and combinations thereof.

[0063] In some embodiments, the thickener is an organic thickener selected from the group consisting of natural and synthetic gums and colloids (including cellulosic thickeners such as carboxymethyl cellulose); hydroxyalkyl celluloses (such as hydroxypropyl cellulose, hydroxyethyl cellulose); gums (such as xanthan gum); polyglycols with different molecular weights sold under the trade name Polyox.TM.; and polyethylene glycol. In some embodiments, the thickener is an inorganic thickener selected from the group consisting of amorphous silica compounds such as those sold under the trade name Available colloidal silica compounds (manufactured by Cabot Corporation and distributed by Lenape Chemical, Bound Brook, NJ); 165 (JM Huber Chemicals Division, Havre de Grace, MD 21078); 15 (Davison Chemical Division of WR Grace Corporation, Baltimore, MD, 21203); natural and synthetic clays; lithium magnesium silicate (Laponite); and magnesium aluminum silicate (Veegum). In some embodiments, the thickener is present in the oral care composition in an amount from about 0.1 wt.% to about 10 wt.%. In some embodiments, the thickener is present in an amount from about 0.5 wt.% to about 4.0 wt.%.

[0064] In some embodiments, the oral care composition may include an antioxidant. In some embodiments, the antioxidant is selected from: naturally occurring tocopherol and its derivatives (e.g., vitamin E acetate), vitamin C and its salts and derivatives (e.g., ascorbyl palmitate, ascorbyl phosphate Mg, ascorbyl acetate), vitamin A and derivatives (vitamin A palmitate), tocotrienols, flavonoids, α-hydroxy acids (e.g., citric acid, lactic acid, malic acid, tartaric acid) and their Na salts, Ka salts and Ca salts, flavonoids, quercetin, phenol benzylamine, propyl gallate, octyl gallate, dodecyl gallate, butylated hydroxyanisole (BHA, E320), butylated hydroxytoluene (BHT, 2,6-di-tert-butyl-4-methylphenol, E 321), lecithin, mono- and di-glycerides of edible fatty acids esterified with citrate, carotenoids, carotenes (e.g., o-carotene, β-carotene, lycopene) and their derivatives, phytic acid, lactoferrin, EDTA, EGTA), folic acid and its derivatives, ubiquinone and ubiquinol and their derivatives, ferulic acid and its derivatives, zinc and its derivatives (e.g., ZnO, ZnS04), selenium and its derivatives (e.g., selenium methionine), orthophosphate and Na, K and Ca salts of monophosphate, and components, extracts and fractions thereof isolated from plants (e.g., tea, green tea, seaweed, grape seed, wheat germ, chamomile, rosemary, oregano), and combinations thereof.

[0065] Antioxidants of particular interest are octadecyl 3-(2,5-di-tert-butyl-4-hydroxyphenyl) propionate, tetrabutylethylene bisphenol and tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate.

[0066] Photostabilizers may also be included in the oral care composition.A good example of a benzotriazole photostabilizer is 2-(5-chloro-2H-benzotriazol-2-yl)-6-(1,1 dimethylethyl)-4-methylphenol.

[0067] The oral care composition of the present disclosure may be a product selected from the group consisting of a mouth-dissolving film, a whitening strip, a whitening gel, a mouthwash, a toothpaste or a dentifrice.

[0068] In an embodiment of the present disclosure, a method for whitening is also provided, which comprises applying the oral care composition as described herein to the surface of mammalian teeth.

[0069] Examples

[0070] The present invention will now be described more fully with reference to the accompanying examples. However, it should be understood that the following description is illustrative only and should not be construed as limiting the present invention in any way.

[0071] Example 1

[0072] Prepare an oral care composition according to the present disclosure. Melt and then add to 65°C water. Mix the mixture until it becomes a viscous white paste. Add tetrasodium pyrophosphate (TSPP), sodium saccharin and sodium monofluorophosphate to 142g hydrogen peroxide and mix until dissolved to form a peroxide solution. The surfactant paste was added to a Ross mixer and mixed. The peroxide solution was then added to the Ross mixer and mixed. Next, calcium pyrophosphate was added to the mixture, which was then mixed. Additional excipients were then added and mixed to form the final formulation, shown in Table 1 below.

[0073] Table 1 Oral care composition formulation

[0074]

[0075]

[0076] The initial viscosity of the oral care composition was measured to be 521,400 cP and had an initial pH of 7.75. A visual inspection was performed and the paste was smooth.

[0077] Example 2

[0078] Peroxide stability testing was also performed. To determine peroxide stability, add sample to a 150 mL beaker and weigh (to the nearest 0.1 mg) for (w / w) analysis, or use a volumetric pipette to measure the volume with a target of approximately 8 mL of titrant according to the following formula for (w / v) analysis. The sample weight should be no less than approximately 0.1 g and no more than approximately 12 g of sample.

[0079]

[0080] For rinses, add approximately 50 mL of water. For gels, dentifrices, tooth whiteners, and other samples containing high levels of surfactants or high organic content, add 50 mL of ethanol / water (1:1 v / v) solution. Mix until the sample is dispersed. For samples that do not disperse in water, i.e., polymer-based formulations, add approximately 30 mL of chloroform to disperse the polymer matrix. Then continue to add approximately 50 mL of ethanol / water (1:1 v / v) solution.

[0081] Slowly add 25 mL of glacial acetic acid to the mixture, followed immediately by 5 mL of 20% potassium iodide solution and 4 drops of ammonium molybdate solution. Mix the solution for 5 minutes. Add 2 mL of starch indicator solution and a dark blue-black color appears, then titrate the solution with sodium thiosulfate 0.1N solution while mixing the sample until the dark blue-black color disappears. Some residual color may still remain. If so, the titration should be continued slowly until the endpoint is reached and no color is present. The percentage of oxidant is then calculated according to the following formula.

[0082]

[0083] Where: N = equivalent concentration of sodium thiosulfate solution

[0084] meq = 0.00800 (active oxygen)

[0085] meq = 0.04704 (carbamide peroxide)

[0086] meq = 0.01701 (hydrogen peroxide)

[0087] meq = 0.03604 (calcium peroxide)

[0088] A 5% peroxide toothpaste formulation containing a high level of surfactant was prepared according to the oral care composition of the present disclosure. A peroxide stability test was then conducted under the following conditions in Table 2. The results are also presented in Table 2.

[0089] Table 2. Peroxide stability test

[0090]

[0091] From this testing it can be seen that the peroxide stability of the toothpaste formulations of the present disclosure has similar stability to the benchmark comparisons of the Aqueous Comparative Example 4% and Anhydrous Comparative Example 5% formulations.

[0092] In an embodiment, an oral care composition is provided. The oral care composition may include:

[0093] An ethylene oxide / propylene oxide block copolymer having the formula:

[0094] HO(C2H4O) a (C3H6O) b (C2H4O) a H

[0095] wherein each mole of this copolymer has a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, wherein a is from 50 to 400, b is from about 50 to 400, and the copolymer has a molecular weight of about 1250 to 15000 kg / mol,

[0096] Peroxides and emulsifiers;

[0097] The amount of the ethylene oxide / propylene oxide block copolymer is at least 20 wt % based on the total weight of the composition.

[0098] In certain embodiments, the emulsifier of the oral care composition can include an anionic emulsifier or a nonionic emulsifier.

[0099] In certain embodiments, the emulsifier may include stearyl alcohol, cetearyl alcohol, cetyl alcohol, stearyl alcohol, and sodium lauryl sulfate, sodium lauryl glucose carboxylate, lauryl glucoside, or combinations thereof.

[0100] In certain embodiments, peroxide may be included in the oral care composition in an amount of about 0.01 wt % to about 10 wt %.

[0101] In certain embodiments, the oral care composition can further comprise an abrasive. In certain embodiments, the abrasive can include silica, polyorganosilsesquioxane, calcium pyrophosphate, poly(methyl methacrylate), calcium carbonate, dicalcium phosphate, barium sulfate, or a combination thereof.

[0102] In certain embodiments, the oral care composition may further include a surfactant. In certain embodiments, the surfactant may include an anionic surfactant, a nonionic surfactant, or a combination thereof. In certain embodiments, wherein the nonionic surfactant includes an alkyl polyglucoside surfactant. In certain embodiments, the anionic surfactant may include sodium lauryl glucose carboxylate and lauryl glucoside.

[0103] In certain embodiments, the oral care composition can further comprise water.In certain embodiments, the composition can have a water concentration of about 5% to about 20%.

[0104] In certain embodiments of the oral care composition, wherein at least about 80% of the peroxide remains, at least about 85% of the peroxide remains, at least about 90% of the peroxide remains, at least about 91% of the peroxide remains, at least about 92% of the peroxide remains, at least about 93% of the peroxide remains, at least about 94% of the peroxide remains, at least about 95% of the peroxide remains, at least about 96% of the peroxide remains, at least about 97% of the peroxide remains, at least about 98% of the peroxide remains, or at least about 99% of the peroxide remains according to the Peroxide Stability Test after 4 weeks at 40°C.

[0105] In certain embodiments, the oral care composition may be a product selected from the group consisting of an orodissolving film, a whitening strip, a whitening gel, a mouthwash, a toothpaste, or a dentifrice.

[0106] In certain embodiments, the composition may have a viscosity of about 1,000 to about 250,000 cP.

[0107] In certain embodiments of the oral care composition, the peroxide can include hydrogen peroxide, urea peroxide, calcium peroxide, sodium peroxide, zinc peroxide, or combinations thereof.

[0108] In certain embodiments of the oral care compositions, the peroxide may be hydrogen peroxide.

[0109] In certain embodiments, the oral care composition may include at least one ingredient selected from the group consisting of: desensitizing agents, chelating agents, whitening agents, tartar control agents, detergents, adhesives, foam regulators, pH regulators, mouthfeel agents, sweeteners, flavoring agents, colorants, preservatives, humectants, and combinations thereof.

[0110] In certain embodiments, the oral care composition can include a humectant. In certain embodiments, the humectant can include glycerin.

[0111] In certain embodiments of the oral care composition, the peroxide can be a liquid formulation. In certain embodiments, the liquid formulation can have a peroxide concentration of about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, or about 50 wt%.

[0112] In certain embodiments, a whitening method is provided. The whitening method may include applying an oral care composition according to the present disclosure to the surface of a mammal's teeth.

[0113] The ranges and values ​​disclosed herein should not be understood as being strictly limited to the exact numerical values ​​recited. Instead, unless otherwise specified, each such range is intended to mean both the recited value and a functionally equivalent range around that value. For example, a value disclosed as "5 wt %" is intended to mean "about 5 wt %".

[0114] Although specific embodiments of the present invention have been illustrated and described, it will be apparent to those skilled in the art that various other changes and modifications may be made without departing from the spirit and scope of the present invention. Therefore, it is intended that all such changes and modifications within the scope of the present invention be covered in the appended claims.

Claims

1. An oral care composition comprising: An ethylene oxide / propylene oxide block copolymer having the formula: <h2 style=";text-align:left;direction:ltr">HO(C2H4O)<h2 style=";text-align:left;direction:ltr"> a <h2 style=";text-align:left;direction:ltr"> (C3H6O)<h2 style=";text-align:left;direction:ltr"> b <h2 style=";text-align:left;direction:ltr"> (C2H4O)<h2 style=";text-align:left;direction:ltr"> a <h2 style=";text-align:left;direction:ltr"> H wherein each mole of this copolymer has a total of about 25 to about 50 moles of ethylene oxide units and about 5 to about 11 moles of propylene oxide units, wherein a is from 50 to 400, b is from about 50 to 400, and the copolymer has a molecular weight of about 1250 to 15000 kg / mol, Peroxide, and Emulsifiers; The amount of the ethylene oxide / propylene oxide block copolymer is at least 20 wt % based on the total weight of the composition.

2. The oral care composition according to claim 1, wherein The emulsifier includes an anionic emulsifier or a nonionic emulsifier.

3. The oral care composition according to claim 1, wherein The emulsifier includes stearyl alcohol, cetearyl alcohol, cetyl alcohol, stearyl alcohol and sodium lauryl sulfate, sodium lauryl glucose carboxylate, lauryl glucoside, or a combination thereof.

4. An oral care composition according to one of the preceding claims, wherein The peroxide is included in an amount of about 0.01 wt % to about 10 wt %.

5. The oral care composition according to one of the preceding claims, further comprising an abrasive.

6. The oral care composition according to claim 5, wherein The abrasive includes silica, polyorganosilsesquioxane, calcium pyrophosphate, poly(methyl methacrylate), calcium carbonate, dicalcium phosphate, barium sulfate, or a combination thereof.

7. The oral care composition according to one of the preceding claims, further comprising a surfactant.

8. The oral care composition according to claim 7, wherein The surfactant includes an anionic surfactant, a nonionic surfactant or a combination thereof.

9. The oral care composition according to claim 8, wherein The nonionic surfactant includes an alkyl polyglucoside surfactant.

10. The oral care composition according to claim 9, wherein The anionic surfactants include sodium lauryl glucose carboxylate and lauryl glucoside.

11. The oral care composition according to one of the preceding claims, further comprising water.

12. The oral care composition according to claim 11, wherein The composition has a water concentration of about 5% to about 20%.

13. The oral care composition according to one of the preceding claims, wherein According to the Peroxide Stability Test, after 4 weeks at 40°C, at least about 80% of the peroxide remains, at least about 85% of the peroxide remains, at least about 90% of the peroxide remains, at least about 91% of the peroxide remains, at least about 92% of the peroxide remains, at least about 93% of the peroxide remains, at least about 94% of the peroxide remains, at least about 95% of the peroxide remains, at least about 96% of the peroxide remains, at least about 97% of the peroxide remains, at least about 98% of the peroxide remains, or at least about 99% of the peroxide remains.

14. The oral care composition according to one of the preceding claims, wherein The composition is a product selected from the group consisting of an orodissolving film, a whitening strip, a whitening gel, a mouthwash, a toothpaste or a dentifrice.

15. The oral care composition according to one of the preceding claims, wherein The composition has a viscosity of about 1,000 to about 250,000 cP.

16. The oral care composition according to one of the preceding claims, wherein The peroxide includes hydrogen peroxide, urea peroxide, calcium peroxide, sodium peroxide, zinc peroxide, or a combination thereof.

17. A composition as claimed in one of the preceding claims, wherein The peroxide is hydrogen peroxide.

18. A composition as claimed in one of the preceding claims, wherein The oral care composition comprises at least one ingredient selected from the group consisting of desensitizing agents, chelating agents, whitening agents, tartar control agents, detergents, adhesives, foam regulators, pH regulators, mouthfeel agents, sweeteners, flavoring agents, colorants, preservatives, humectants, and combinations thereof.

19. The composition of claim 18, wherein The oral care composition comprises the humectant.

20. The composition of claim 19, wherein The humectant includes glycerin.

21. A composition as claimed in one of the preceding claims, wherein The peroxide is a liquid formulation.

22. The composition of claim 21, wherein The liquid formulation has a concentration of the peroxide of about 20 wt%, about 25 wt%, about 30 wt%, about 35 wt%, about 40 wt%, about 45 wt%, or about 50 wt%.

23. A whitening method comprising applying an oral care composition according to one of claims 1 to 22 to the surface of mammalian teeth.

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