CN116648228A - Per-sulfate oral whitening compositions - Google Patents
Per-sulfate oral whitening compositions Download PDFInfo
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- CN116648228A CN116648228A CN202280006362.4A CN202280006362A CN116648228A CN 116648228 A CN116648228 A CN 116648228A CN 202280006362 A CN202280006362 A CN 202280006362A CN 116648228 A CN116648228 A CN 116648228A
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Abstract
The present disclosure provides tooth whitening oral care compositions comprising potassium monopersulfate having improved stability and methods of using the same.
Description
Cross Reference to Related Applications
The present application claims priority and benefit from U.S. provisional application No. 63/293,345, filed on month 12, 23 of 2021, and U.S. provisional application No. 63/293,355, filed on month 12, 23 of 2021, each of which is incorporated herein by reference in its entirety.
Background
Consumer products that provide tooth whitening are numerous and take many forms, but one of the more popular forms is as a dentifrice, such as toothpaste. Toothpaste must generally have a semi-solid form that will hold well enough shape to be dispensed from the tube and rest on the bristles of the toothbrush, but also a fluid that is sufficiently easy to squeeze out of the tube. The toothpaste must also be sufficiently tacky to adhere to the teeth to some extent, and must be sufficiently soluble to disperse in the mouth. These various objectives are generally met by formulating a toothpaste with a mixture of liquid polar humectants (e.g., glycerin, polypropylene glycol, and sorbitol) in a high water base (e.g., 10% to 40% water). Various polymers are commonly used to provide the gel-like consistency required for toothpaste.
Unfortunately, many brighteners present stability problems in the presence of water, humectants, and some polymers. Other inorganic materials (e.g., fluoride sources and surfactants) may also interact negatively, resulting in instability and loss of activity of the active whitening agent. Thus, there is a need for a whitening toothpaste formulated with various ingredients that aim to improve the stability and activity of the active whitening agent.
Abrasives can be particularly difficult to formulate into whitening toothpastes due to the high surface area, hygroscopicity and acidity of many abrasives. However, abrasives can be a critical component of whitening compositions because many stains adhere firmly but superficially to the tooth surface, and abrasives aid in the removal of such stains by their inherent abrasive action and by providing better access to the stains by the whitening agent.
The products currently available for whitening teeth include a variety of different ingredients, and the main active ingredient is most commonly a peroxide source, such as hydrogen peroxide. The use of peroxide agents generally presents a number of difficulties in the formulation and long-term stability of the resulting compositions. In addition, hydrogen peroxide may cause strong irritation to teeth and gums at high concentrations or in the case of prolonged contact with the oral mucosa. Accordingly, there is a need for alternative oxidizing agents with improved stability, especially for whitening products that provide long-term contact with oral tissue.
Persulfuric acid (H) 2 SO 5 Also known as peroxomonosulphuric acid) And salts thereof (peroxomonosulphates) are powerful oxidants and detergents. They are currently used for a variety of industrial and consumer purposes, including swimming pool handling and denture cleaning. Compared with having anions [ HS ] 2 O 8 ] – The peroxodisulfates of (2) generally have an anion [ HSO ] 5 ]-. Peroxymonosulfate whitening products have been explored for use in several oral care applications, including whitening strips, mouthwashes, and toothpastes. One common persulfate oxidizer is potassium persulfate (KHSO 5 ) Also known as potassium monopersulfate, abbreviated as KMPS or MPS, and as a compositionAnd->Is sold (each of them is a potassium monopersulfate trisalt having about 45% to 50% by weight potassium monopersulfate).
The use of potassium peroxymonosulfate in oral care applications is very limited due to its instability in aqueous solutions, particularly in aqueous solutions near or above neutral pH. Potassium monopersulfate is known to degrade even in the presence of small amounts of water and heat. Thus, potassium monopersulfate whitening compositions are subject to particular difficulties in formulation.
Potassium monopersulfate can also react and decompose when combined with other common oral care excipients (especially polar compounds such as humectants, anionic or neutral hydroxyl polymers, and surfactants). These excipients can destabilize the potassium monopersulfate, resulting in a loss of whitening efficacy. Thus, it is necessary to adjust the formulation with potassium monopersulfate to avoid or reduce the amount of such ingredients, which makes it challenging to formulate compositions having desirable mouthfeel (e.g., foaming), appearance, viscosity, and other important characteristics. In addition, potassium monopersulfate can also interact negatively with any common flavoring agent that tends to have unstable or oxidizable functional groups. This can make formulating flavoring agents into such compositions challenging.
There remains a need for a peroxymonosulfate whitening dentifrice product based on a tooth whitening agent having improved stability, mouthfeel, appearance, viscosity, flavor, and consumer acceptability.
Disclosure of Invention
The present disclosure provides tooth whitening oral care compositions comprising from 0.01% to 10% potassium monopersulfate by weight of the composition, the composition prepared by mixing from 21% to 60% calcium pyrophosphate (Ca 2 P 2 O 7 ) And/or insoluble sodium metaphosphate ([ NaPO) 3 ] n ) And 20% to 60% by weight of the composition of a poloxamer (polyoxyethylene/polyoxypropylene triblock copolymer). In other embodiments, the composition may further comprise one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, alkali metal polyphosphate, anionic surfactant, zwitterionic surfactant, cationic surfactant, and amphoteric surfactant. In at least one aspect, the tooth whitening oral care compositions of the present disclosure are low water or anhydrous.
Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
Detailed Description
The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.
As used throughout, ranges are used as shorthand expressions for describing the respective values and each value that are within the range. Any value within the range can be selected as the terminus of the range. In addition, all references cited herein are incorporated by reference in their entirety. In the event of a conflict between a definition in the present disclosure and a definition of a cited reference, the present disclosure controls.
Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in the specification are to be understood as referring to weight percentages. The amounts given are based on the effective weight of the material.
Open terms such as "comprising," including, "" containing, "" having, "and the like mean" including/comprising. In this specification, the use of the singular also includes the plural unless specifically stated otherwise. For example, "a lubricant" also includes the case of using more than one lubricant.
"about" means plus or minus 20% of the stated value. Thus, for example, "about 5%" means 80% to 120% of 5%, or 4.0% to 6.0%, inclusive of the range.
The inventors have unexpectedly found that from 21% to 60% calcium pyrophosphate (Ca 2 P 2 O 7 ) And/or insoluble sodium metaphosphate ([ NaPO) 3 ] n ) And 20% to 60% polyoxyethylene/polyoxypropylene triblock copolymer are very effective in stabilizing potassium monopersulfate against degradation while also providing advantageous rheological properties.
In a first aspect, the present disclosure provides a tooth whitening oral care composition (composition 1) comprising from 0.01% to 10% by weight of potassium monopersulfate, the composition being prepared by mixing from 21% to 60% by weight of the composition of calcium pyrophosphate (Ca 2 P 2 O 7 ) And/or insoluble sodium metaphosphate ([ NaPO) 3 ] n ) And from 20% to 60% by weight of the composition of a polyoxyethylene/polyoxypropylene triblock copolymer. In other embodiments, the present disclosure provides:
1.1. composition 1, wherein potassium peroxymonosulfate is provided as a triple salt of potassium peroxymonosulfate, potassium bisulfate, and potassium sulfate, optionally wherein the triple salt comprises about 45 wt.% to 50 wt.% potassium peroxymonosulfate, e.g., 47 wt.% or 49 wt.% potassium peroxymonosulfate;
1.2. composition 1 or 1.1, wherein the composition comprises potassium peroxymonosulfate in an amount of 0.01% to 5%, or 0.05% to 5%, or 0.1% to 5%, or 0.5% to 3%, or 0.5% to 2.5%, or 0.5% to 2%, or 0.5% to 1.5%, or 0.75% to 1.25%, or 1% to 5%, or 1% to 4%, or 1% to 3%, or 1% to 2%, or 1.5% to 3%, or 2% to 3%, or 1.5% to 2%, or 2% to 2.5%, or about 0.5%, or about 1%, or about 1.5%, or about 2%, or about 2.5% by weight of the composition.
1.3. Any of the foregoing compositions, wherein the inorganic peroxymonosulfate is not granulated (e.g., not granulated);
1.4. any of the foregoing compositions, wherein the composition does not comprise hydrogen peroxide;
1.5. any of the foregoing compositions, wherein the composition does not comprise any of hydrogen peroxide, urea peroxide, a peroxide salt (e.g., sodium peroxide, potassium peroxide, lithium peroxide, calcium peroxide), a peroxyacid (e.g., peracetic acid, peroxybenzoic acid, or a salt or derivative thereof), an organic peroxide (e.g., urea hydrogen peroxide, glyceryl hydrogen peroxide, peroxyesters, diacyl peroxides, monoperoxyphthalate, or a salt thereof), perborate, persilicate, percarbonate, chlorinated oxidant (e.g., hypochlorite, chlorite, perchlorate, chlorine dioxide), or peroxodisulphuric acid or peroxodisulphate;
1.6. any of the foregoing compositions, wherein potassium monopersulfate is the only oxidizing agent present in the composition;
1.7. composition 1 or any one of 1.1 to 1.6, wherein the composition is prepared by mixing 21% to 60% by weight of the composition of calcium pyrophosphate (Ca 2 P 2 O 7 ) To stabilize;
1.8. composition 1 or any one of 1.1 to 1.6, wherein the composition is prepared by 21% to 60% by weight of the composition of insoluble sodium metaphosphate ([ NaPO 3 ] n ) To stabilize;
1.9. composition 1 or any one of 1.1 to 1.6, wherein the composition is prepared by mixing 21% to 60% by weight of the composition of calcium pyrophosphate (Ca 2 P 2 O 7 ) And insoluble sodium metaphosphate ([ NaPO) 3 ] n ) To stabilize;
1.10. the composition of any one of compositions 1 or 1.1 to 1.9, wherein the composition comprises calcium pyrophosphate and/or insoluble sodium metaphosphate in an amount of 22% to 60%, or 22% to 50%, or 22% to 40%, or 22% to 35%, or 25% to 60%, or 25% to 50%, or 25% to 40%, or 25% to 35%, or 25% to 30%, or 21% to 30%, or 22% to 30%, or 22.5% to 27.5%, or 23% to 27%, or 24% to 26%, or about 25% by weight of the composition.
1.11. The composition 1 or any one of 1.1 to 1.10, wherein the polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula:
HO-[CH 2 CH 2 O] a [-CH(CH 3 )CH 2 O-] b [CH 2 CH 2 O] a -H，
wherein a is an integer from 1 to 30 and b is an integer from 10 to 60;
1.12. composition 1.11 wherein in the formula a is an integer from 5 to 20 and b is an integer from 10 to 40;
1.13. composition 1.11 wherein in the formula a is an integer from 10 to 15 and b is an integer from 10 to 20;
1.14. composition 1.11 wherein in the formula a is an integer from 10 to 12 (e.g. 11) and b is an integer from 15 to 20 (e.g. 16);
1.15. The composition 1 or any one of 1.1 to 1.14, wherein the polyoxyethylene/polyoxypropylene triblock copolymer has an average molecular weight of 1000 daltons to 7000 daltons, such as 1000 daltons to 6000 daltons, or 1000 daltons to 5000 daltons, or 1000 daltons to 4000 daltons, or 1000 daltons to 3000 daltons, or 1000 daltons to 2000 daltons, or 1500 daltons to 3000 daltons, or 1500 daltons to 2000 daltons, or 1800 daltons to 2000 daltons, or about 1900 daltons, optionally wherein the average molecular weight is a number average molecular weight or a weight average molecular weight;
1.16. composition 1.11 wherein the polyoxyethylene/polyoxypropylene triblock copolymer is Pluronic L35;
1.17. any of composition 1 or 1.1 to 1.16, wherein the composition comprises the polyoxyethylene/polyoxypropylene triblock copolymer in an amount of 22% to 60%, or 22% to 50%, or 22% to 40%, or 22% to 35%, or 25% to 60%, or 25% to 50%, or 25% to 40%, or 25% to 35%, or 27% to 33%, or 28% to 32%, or 30% to 32%, or about 30%, or about 31% by weight of the composition;
1.18. Any of the foregoing compositions, wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, polyphosphate (e.g., alkali metal polyphosphate), and surfactant (e.g., anionic surfactant and/or zwitterionic surfactant);
1.19. composition 1.18, wherein the composition further comprises polyvinylpyrrolidone;
1.20. composition 1.19, wherein the polyvinylpyrrolidone is crosslinked polyvinylpyrrolidone;
1.21. composition 1.19 or 1.20, wherein the polyvinylpyrrolidone is not complexed or bound to hydrogen peroxide;
1.22. any of compositions 1.19 to 1.21, wherein the composition comprises polyvinylpyrrolidone in an amount of 1% to 50%, or 1% to 40%, or 1% to 30%, or 1% to 25%, or 1% to 22%, or 1% to 20%, or 1% to 18%, or 1% to 15%, or 1% to 12%, or 1% to 10%, or 1% to 8%, or 1% to 6%, or 3% to 15%, or 3% to 12%, or 3% to 10%, or 3% to 8%, or 3% to 6%, or 4% to 8%, or 4% to 6%, or about 5% by weight of the composition.
1.23. Any of compositions 1.18 to 1.22, wherein the composition further comprises a polyethylene glycol/polypropylene glycol random copolymer (PEG/PPG copolymer);
1.24. composition 1.23 wherein the average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of the PEG/PPG random copolymer is about 75 to 150EG to 45 to 95PG, or about 95 to 135EG to 50 to 80PG, or about 105 to 125EG to 55 to 75PG, or about 110 to 120EG to 60 to 70PG, or about 116EG to 66PG (i.e., PEG/PPG 116/66);
1.25. composition 1.23, wherein the PEG/PPG random copolymer is pluracore L1220;
1.26. any of compositions 1.23 to 1.25, wherein the composition comprises PEG/PPG random copolymer in an amount of 1% to 50%, or 1% to 40%, or 1% to 30%, or 1% to 25%, or 1% to 20%, or 1% to 18%, or 1% to 15%, or 1% to 12%, or 1% to 10%, or 6% to 40%, or 6% to 30%, or 6% to 25%, or 6% to 20%, or 6% to 15%, or 6% to 10%, or 8% to 30%, or 8% to 25%, or 8% to 20%, or 8% to 15%, or 8% to 12%, or 10% to 30%, or 10% to 25%, or 10% to 20%, or 10% to 15%, or 10% to 12%, or about 10% by weight of the composition.
1.27. Any one of compositions 1.18 to 1.26, wherein the composition further comprises polyethylene glycol;
1.28. composition 1.27, wherein the polyethylene glycol is selected from the group consisting of PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, and PEG-2000;
1.29. composition 1.27, wherein the polyethylene glycol is PEG 600;
1.30. any of compositions 1.27 to 1.29, wherein the composition comprises polyethylene glycol in an amount of 1% to 50%, or 1% to 40%, or 1% to 30%, or 1% to 25%, or 1% to 20%, or 1% to 18%, or 1% to 15%, or 5% to 40%, or 5% to 30%, or 5% to 25%, or 5% to 20%, or 5% to 15%, or 8% to 40%, or 8% to 30%, or 8% to 25%, or 8% to 20%, or 8% to 15%, or 10% to 30%, or 10% to 25%, or 10% to 20%, or 10% to 15%, or 12% to 25%, or 12% to 15%, or about 12% (e.g., about 12.5%) by weight of the composition.
1.31. Any of the foregoing compositions, wherein the composition further comprises one or more additional polymers, such as any one or more of the following: polypropylene (PP) two Alcohols, polysaccharides (e.g., cellulose derivatives such as carboxymethyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, microcrystalline cellulose, or polysaccharide gums such as xanthan gum, guar gum or carrageenan, pectin, karaya gum); a chitosan; dextran; hyaluronic acid and sodium hyaluronate; synthetic anionic polymeric polycarboxylates, such as copolymers of maleic anhydride or maleic acid with additional polymerizable ethylenically unsaturated monomers, preferably methyl vinyl ether (e.g., 1:4 to 4:1 maleic anhydride/maleic acid to methyl vinyl ether ratio); polyphosphonic acids and polyphosphonates (i.e., polyphosphonates); a crosslinked carboxyvinyl copolymer; polyacrylic acid or polyacrylate polymers (e.g., carbomers); polyacrylamides, such as (2-hydroxypropyl) methacrylamide; other polyoxyethylene-polyoxypropylene copolymer (PEG-PPG) triblock copolymers, such as poloxamers 105, 108, 122, 123, 124, 182, 183, 184, 185, 188, 212, 215, 217, 234, 235, 237, 238, 288, 333, 334, 335, 338, 402, 403 or 407); PEG-PPG tetrablock copolymers; other PEG/PPG random copolymers, such as PEG/PPG-38/8; a polyamine; polyvinyl alcohol; aggregation Oxazolines, for example poly (2-alkyl-2->Oxazolines), for example poly +.o-substituted by methyl, ethyl or isopropyl>An oxazoline; and a quaternary ammonium polymer;
1.32. composition 1 or any of compositions 1.1 to 1.31, wherein the composition does not comprise any one or more of the following: polyacrylic acid or polyacrylate Polymer (PAA), polyvinylpyrrolidone-vinyl acetate copolymer (PVP-VA), and poly (ethylene oxide)Oxazoline Polymers (PO) and mixtures thereof;
1.33. composition 1 or any of compositions 1.1 to 1.31, wherein the composition comprises 30 wt% to 70 wt% of a polymer (e.g., PEG/PPG random copolymer, PEG/PPG triblock copolymer, PVP, and PEG), such as 30 wt% to 60 wt%, or 40 wt% to 60 wt%, or 50 wt% to 60 wt%, or 55 wt% to 59 wt%, or 58 wt% to 59 wt%;
1.34. any of the foregoing compositions, wherein the composition further comprises a polyphosphate or an organic cyclic polyphosphate, such as an alkali metal pyrophosphate, alkali metal tripolyphosphate, alkali metal tetraphosphate, alkali metal hexametaphosphate, alkali metal insoluble metaphosphate, alkali metal phytate, or mixtures thereof;
1.35. Composition 1.34, wherein the composition comprises sodium or potassium pyrophosphate, sodium or potassium tripolyphosphate, sodium or potassium tetraphosphate, sodium or potassium phytate, or a mixture thereof;
1.36. composition 1.34, wherein the composition comprises a tetra-alkali metal pyrophosphate salt, such as tetra sodium pyrophosphate or tetra potassium pyrophosphate;
1.37. composition 1.34, wherein the composition comprises a dialkali metal pyrophosphate salt, such as disodium pyrophosphate or dipotassium pyrophosphate;
1.38. composition 1.34, wherein the composition comprises a tetra-and a di-alkali metal pyrophosphate salt, such as tetra-and disodium pyrophosphate;
1.39. any of compositions 1.34 to 1.38, wherein the composition comprises 0.1 to 5 wt% polyphosphate, such as 0.5 to 5 wt%, or 1 to 5 wt%, or 2 to 5 wt%, or 3 to 5 wt%, or 3.5 to 5 wt%, or 4 to 5 wt%, or 3.5 to 4.5 wt%, or about 4 wt% polyphosphate, optionally 1 to 5% or 2 to 4% tetra alkali metal pyrophosphate and 0.5 to 2% dialkali metal pyrophosphate, such as about 3% tetrasodium pyrophosphate and about 1% disodium pyrophosphate;
1.40. Any of the foregoing compositions, wherein the composition further comprises one or more surfactants, such as anionic surfactants, cationic surfactants, amphoteric surfactants, nonionic surfactants, and/or zwitterionic surfactants;
1.41. composition 1.40, wherein the composition comprises a mixture of anionic surfactants and/or zwitterionic surfactants;
1.42. composition 1.40 or 1.41, wherein the anionic surfactant is selected from the group consisting of: sodium lauryl sulfate, sodium laureth sulfate, sodium myristyl polyether sulfate, sodium lauroyl sarcosinate, sodium cocoyl monoglyceride sulfonate, sodium laurylbenzenesulfonate, sodium laurylsulfonate, sodium N-methyl N-cocoyl taurate, sodium cocoyl isethionate, sodium dioctylsulfosuccinate and sodium cocoyl monoglyceride sulfate and ammonium analogues thereof;
1.43. composition 1.40 or 1.41, wherein the zwitterionic surfactant is selected from the group consisting of: cocamidopropyl betaine (CAPB), cocamidopropyl sulfobetaine, cocamidopropyl hydroxysulfobetaine, lauramidopropyl betaine, lauramidopropyl sulfobetaine, lauramidopropyl hydroxysulfobetaine, oleamidopropyl betaine, oleamidopropyl sulfobetaine, oleamidopropyl hydroxysulfobetaine, tallow amidopropyl betaine, tallow amidopropyl sulfobetaine, tallow amidopropyl hydroxysulfobetaine, lauryl betaine, lauryl sulfobetaine, lauryl hydroxysulfobetaine, lauryl dimethyl amine oxide, and myristyl amine oxide;
1.44. Composition 1.40, wherein the cationic surfactant is selected from the group consisting of: cetyl pyridinium chloride(CPC), cetrimide, benzalkonium chloride, benzethonium chloride (1-hexadecylcarbamoyl-ethyl) -trimethylammonium halide, (1-hexadecylcarbamoyl-2-phenyl-ethyl) -trimethylammonium halide, 1-hexadecylcarbamoyl-1, 1-dimethyl-pyrrolidineHalides and [2- (1H-indol-3-yl) -1-hexadecylcarbamoyl-ethyl)]-trimethylammonium halide, wherein the halide is optionally chloride, fluoride or bromide, or lauroyl arginine, ethyl lauroyl arginine ester hydrochloride, or sebacoyl bis-lauroyl amino lysine disodium;
1.45. composition 1.40, wherein the nonionic surfactant is selected from the group consisting of: cocomonoethanolamide, cocodiethanolamide, lauramidopropyl dimethylamine oxide, myristamidopropyl dimethylamine oxide, and decyl glucoside;
1.46 composition any one of 1.40 to 1.45, wherein the composition comprises sodium lauryl sulfate;
1.47. any one of compositions 1.40 to 1.45, wherein the composition comprises cocamidopropyl betaine;
1.48. composition 1.39 or 1.40, wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine;
1.49. Any of compositions 1.40 to 1.48, wherein the composition comprises a total amount of surfactant of 0.1% to 5%, such as 0.5% to 5%, or 1% to 5%, or 1.5% to 5%, or 2% to 5%, or 3% to 5%, or 4% to 5%, or 1% to 4%, or 2% to 4%, or 3% to 4%, or 2% to 5%, or 3% to 5%, or 1% to 3%, or 2% to 2.5%, or 2.5% to 3%, or 2.25% to 2.75%, or 2.25% to 2.5%, or about 2.3% surfactant, by weight of the composition;
1.50 composition any one of 1.40 to 1.49, wherein the composition comprises any one or more surfactants in an individual amount of 0.1% to 5%, such as 0.1% to 4%, or 0.1% to 3%, or 0.1% to 2.5%, or 0.1% to 2%, or 0.1% to 1.5%, or 0.1% to 1%, or 0.1% to 0.5%, or 1% to 4%, or 2% to 4%, or 1% to 3%, or 2% to 3%, or 1.5% to 2.5%, or 2% to 2.5%, or about 0.3%, or about 2% by weight of the composition;
1.51. any of compositions 1.40 to 1.50, wherein the composition comprises 0.1% to 5%, or 1% to 5%, or 2% to 4%, or 1% to 3%, or 2% to 3%, or 1.5% to 2.5%, or 2% to 2.5%, or about 2% sodium lauryl sulfate, and 0.1% to 1%, or 0.1% to 0.5%, or about 0.3% cocamidopropyl betaine, by weight of the composition;
1.52. Any of compositions 1.40 to 1.51, wherein the composition comprises an anionic surfactant (e.g., sodium lauryl sulfate) and a zwitterionic surfactant (e.g., cocamidopropyl betaine) in a weight ratio of about 20:1 to 1:1, such as about 20:1 to 2:1, or about 15:1 to 3:1, or about 12:1 to 4:1, or about 10:1 to 5:1, or about 8:1 to 5:1, or about 7:1 to 5:1, or about 6:1;
1.53. any of the foregoing compositions, wherein the composition further comprises an antioxidant, for example selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, vitamin a, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures thereof;
1.54. composition 1.53 wherein the antioxidant is butylated hydroxyanisole or butylated hydroxytoluene;
1.55. composition 1.53 wherein the antioxidant is butylated hydroxytoluene;
1.56. any of compositions 1.52 to 1.55, wherein the composition comprises any one or more antioxidants in an individual amount of 0.001% to 1%, such as 0.01% to 0.5%, or 0.01% to 0.3%, or 0.01% to 0.1%, or 0.01% to 0.05%, or about 0.03% by weight of the composition;
1.57. Any of the foregoing compositions, wherein the composition further comprises a thickening agent, such as magnesium aluminum silicate or fumed silica, optionally in an amount of 0.1% to 10% by weight of the composition, such as 1% to 10%, or 2.5% to 10%, or 3% to 10%, or 2.5% to 7.5%, or 3% to 8%, or 3% to 6%, or 3% to 5%, or about 4% by weight of the composition;
1.58. any of the foregoing compositions, wherein the composition further comprises a fluoride source;
1.59. composition 1.58 wherein the fluoride source is selected from sodium fluoride, sodium monofluorophosphate, and stannous fluoride, or mixtures thereof;
1.60. composition 1.58 or 1.59, wherein the composition comprises from 0.1% to 5% by weight of the composition of a fluoride source, for example from 0.5% to 5%, or from 0.5% to 3%, or from 0.5% to 2%, or from 0.5% to 1%, or about 0.75% by weight of the composition of a fluoride source;
1.61. any of the foregoing compositions, wherein the composition further comprises an additional abrasive (i.e., in addition to the calcium pyrophosphate and/or the insoluble sodium metaphosphate), optionally wherein the composition does not comprise a hydrated silica or precipitated silica abrasive (e.g., synthetic Gao Qingjie force silica);
1.62. Composition 1.61, wherein the additional abrasive is selected from the group consisting of silica (e.g., hydrated silica, precipitated silica), calcium carbonate, calcium orthophosphate, dicalcium orthophosphate, tricalcium phosphate, and arginine carbonate, e.g., in an amount of 0.1% to 10%, or 0.1% to 5%, or 1% to 5%, or 2.5% to 5%;
1.63. any of the foregoing compositions, wherein the composition further comprises a desensitizing agent, e.g., in an amount of 0.1 to 5 wt%, such as potassium nitrate;
1.64. any of the foregoing compositions, wherein the composition further comprises an enamel enhancer, e.g., zinc phosphate, in an amount of 0.1 to 5 wt.%;
1.65. any of the foregoing compositions, wherein the composition further comprises one or more flavoring and sweetening agents, e.g., in an amount of 0.1% to 5%, or 0.5% to 5%, or 1% to 5%, or 2% to 3%;
1.66. any of the foregoing compositions, wherein the composition is substantially anhydrous (e.g., less than 4%, or less than 3%, or less than 2%, or less than 1% water, by weight of the composition);
1.67. Any of the foregoing compositions, wherein the composition does not comprise any acetate, e.g., wherein the composition does not comprise any of the following: glyceryl triacetate, glyceryl acetate, propylene glycol diacetate, ethylene glycol diacetate, and diethylene glycol diacetate;
1.68. any of the foregoing compositions, wherein the composition does not comprise any humectant, e.g., wherein the composition does not comprise any of glycerin, propylene glycol, sorbitol, or xylitol;
1.69. the composition of any one of composition 1 or 1.1 to 1.68, wherein the composition comprises 1% to 3% sodium lauryl sulfate and 0.1% to 0.5% cocamidopropyl betaine, by weight of the composition;
1.70. the composition of any one of composition 1 or 1.1 to 1.68, wherein the composition comprises 1.5% to 2.5% sodium lauryl sulfate and 0.2% to 0.4% cocamidopropyl betaine, by weight of the composition;
1.71. the composition of any one of composition 1 or 1.1 to 1.68, wherein the composition comprises about 2% sodium lauryl sulfate and about 0.3% cocamidopropyl betaine, by weight of the composition;
1.72. composition 1 or any one of compositions 1.1 to 1.71, wherein the composition comprises sodium lauryl sulfate and cocamidopropyl betaine in a weight ratio of about 8:1 to 5:1, e.g., about 6:1;
1.73. Any of the foregoing compositions, wherein the composition comprises potassium monopersulfate in an amount of from 1% to 5%, and the composition is stabilized by a combination of from 20% to 40% calcium pyrophosphate and from 25% to 50% polyoxyethylene/polyoxypropylene triblock copolymer, each having the formula HO- [ CH 2 CH 2 O] a [-CH(CH 3 )CH 2 O-] b [CH 2 CH 2 O] a -H, wherein an integer of 10 to 12 (e.g. 11), and b is an integer of 15 to 20 (e.g. 16), for example the polymer is Pluronic L35;
1.74. any of the foregoing compositions, wherein the composition comprises potassium peroxymonosulfate in an amount of 1% to 3%,and the composition is stabilized by a combination of 20% to 30% calcium pyrophosphate and 25% to 35% polyoxyethylene/polyoxypropylene triblock copolymer, each having the formula HO- [ CH 2 CH 2 O] a [-CH(CH 3 )CH 2 O-] b [CH 2 CH 2 O] a -H, wherein an integer of 10 to 12 (e.g. 11), and b is an integer of 15 to 20 (e.g. 16), for example the polymer is Pluronic L35;
1.75. any of the foregoing compositions, wherein the composition further comprises polyvinylpyrrolidone in an amount of from 1% to 10% and a PEG/PPG random copolymer (e.g., pluracore L1220 polymer) having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of from about 105 to 125EG to 55 to 75PG in an amount of from 6% to 15% and polyethylene glycol 600 in an amount of from 5% to 20% each by weight of the composition;
1.76. Any of the foregoing compositions, wherein the composition further comprises from 2% to 5% tetrasodium pyrophosphate and from 0.5% to 1.5% disodium pyrophosphate, by weight of the composition;
1.77. any of the foregoing compositions, wherein the composition further comprises a Blue dye or pigment, such as a Blue 15 pigment (also known as CI 74160), optionally in an amount of 0.001% to 0.1% by weight of the composition, such as 0.01% to 0.08%, or 0.03% to 0.07%, or about 0.05% by weight of the composition;
1.78. the composition 1 or any one of 1.1 to 1.77, wherein the composition comprises or consists of:
| composition of the components | Weight percent |
| Potassium monopersulfate | 0.1% to 5% (e.g., about 1%) |
| Calcium pyrophosphate | 21% to 30% (e.g., about 25%) |
| PEG/PPG triblock copolymers (e.g. Pluronic L35) | 25% to 35% (e.g., 30% to 32% or about 31%) |
| Polyvinylpyrrolidone | 1% to 15% (e.g., about 5%) |
| PEG-PPG random copolymer (e.g. PEG/PPG-116/66) | 6% to 15% (e.g., about 10%) |
| Polyethylene glycol (e.g., PEG 600) | 10% to 20% (e.g., about 12.5%) |
| Polyphosphates (e.g. tetrasodium pyrophosphate and disodium pyrophosphate) | 2.5% to 5% (e.g., about 4%) |
| Anionic surfactants (e.g., sodium lauryl sulfate) | 1% to 5% (e.g., about 2%) |
| Zwitterionic surfactants (e.g. cocamidopropyl betaine) | 0.1% to 1% (e.g., about 0.3%) |
| Fluoride sources (e.g., sodium monofluorophosphate) | 0.1% to 2% (e.g., about 0.76% or 1.1%) |
| Antioxidants (e.g., BHT) | 0% to 0.3% (e.g., 0% or about 0.03%) |
| Thickeners (e.g. fumed silica) | 2.5% to 5% (e.g., about 4%) |
| Sweetener and flavoring agent | 0.5% to 5% (e.g., 3% to 3.5%) |
| Blue pigment or dye (e.g., blue 15) | 0.001% to 0.1% (e.g., about 0.05%) |
| Totals to | About 100 |
1.79. Any of the foregoing compositions, wherein the composition is a dentifrice, such as toothpaste or tooth gel;
1.80. any of the foregoing compositions, wherein the composition has the consistency of a paste or gel (e.g., is not a free flowing liquid nor is it a solid, such as a solid powder or pellet);
1.81. any of the foregoing compositions, wherein the composition has an extrusion pressure of from 0.03 bar to 0.2 bar, such as from 0.03 bar to 0.15 bar, or from 0.03 bar to 0.10 bar, or from 0.03 bar to 0.07 bar, or from 0.04 bar to 0.06 bar, or about 0.05 bar;
1.82. any of the foregoing compositions, wherein the composition has a viscosity (measured at 1 rpm) of 50,000cp to 300,000cp, such as a viscosity of 100,000cp to 300,000cp, or 150,000cp to 250,000cp, or 175,000cp to 225,000cp, or about 200,000 cp;
1.83. Any of the foregoing compositions, wherein the composition maintains an extrusion pressure of less than 0.1 bar and/or a viscosity (at 1 rpm) of less than 300,000cp after aging at 40 ℃/65% relative humidity for up to 3 months;
1.84. any of the foregoing compositions, wherein the composition loses no more than 10% of its initial Active Oxygen (AO) content after aging at 60 ℃/75% relative humidity for up to 3 months.
Potassium monopersulfate (also known as MPS, KMPS, potassium monopersulfate or Potassium monopersulfate)Or (b)Commercially available, both of which are the trisalts of potassium monopersulfate, potassium bisulfate and potassium sulfate (2 KHSO 5 ·KHSO 4 ·K 2 SO 4 )。
Potassium monopersulfate has limited stability in aqueous solutions and can be unstable due to other common toothpaste ingredients (even small amounts of water). Thus, contact with water should be avoided or minimized during processing and storage. The composition is preferably packaged in a moisture free environment.
As used herein, the term "insoluble sodium metaphosphate" is used to refer to the insoluble polymer sodium metaphosphate having the empirical formula [ NaPO ] 3 ] n Also known as "Maddrell salt". This is a very useful abrasive that is insoluble in water and has a low ability to release phosphate ions into solution. It has a high molecular weight, where n has a value of up to 2000. It is different from, for example, trisodium orthophosphate (Na 3 PO 4 ) Tetra sodium pyrophosphate (Na) 4 P 2 O 7 ) Pentasodium tripolyphosphate (Na) 5 P 3 O 10 ) Hexasodium tetraphosphate (Na) 6 P 4 O 13 ) Sodium trimetaphosphate (Na) 3 [(PO 3 ) 3 )]) Or sodium hexametaphosphate (Na) 6 [(PO 3 ) 6 )]) Such soluble materials, all of which are water soluble and tend to hydrolyze under aqueous conditions to provide orthophosphate anions.
The compositions of the present disclosure contain no water or have a low water content. As used herein, the term "low water content" means the total concentration of water, including any free water and all water contained in any ingredient. In various embodiments of the composition, the amount of water is an amount of less than 4 wt%, or less than 3 wt%, or less than 2 wt%, or less than 1 wt%, or less than 0.5 wt%, or less than 0.1 wt%, or about 0.0001 wt% to about 4 wt%, or about 0.0001 wt% to about 0.5 wt%, or about 0.0001 wt% to about 0.1 wt%.
The amount of potassium peroxymonosulfate in the compositions of the present invention is effective to produce improved tooth whitening when used once or twice a day for about three months as compared to a control composition without peroxymonosulfate. The amount of peroxymonosulfate is generally from about 0.1% to about 10%, preferably about 1% or 2% by weight of the composition.
In some embodiments, the compositions of the present disclosure comprise a buffer. Examples of buffers include anhydrous carbonates such as sodium carbonate, sesquicarbonates, bicarbonates such as sodium bicarbonate, silicates, bisulfate, phosphates such as potassium dihydrogen phosphate and dipotassium hydrogen phosphate, citrates, pyrophosphates (sodium and potassium salts), and combinations thereof. When the strip is hydrated, the amount of buffer is sufficient to provide a pH of about 5 to about 9, preferably about 6 to about 8, and more preferably about 7. Typical amounts of buffer are from about 0.1% to about 5%, in one embodiment from about 1% to about 3%, and in another embodiment from about 0.5% to about 1% by weight of the total composition.
The compositions of the present disclosure comprise polyoxyethylene-polyoxypropylene triblock copolymers, also known as poloxamers. The term "poloxamer" or "poloxamer copolymer" refers to a nonionic triblock copolymer comprised of a central polyoxypropylene unit (also known as a poly (oxypropylene) unit) hydrophobic chain flanked by two polyoxyethylene units (such as poly (oxypropylene) units) hydrophilic chains. Poloxamers have the following chemical structure:
HO-[CH 2 CH 2 O] a [-CH(CH 3 )CH 2 O-]b[CH 2 CH 2 O] a -H，
where a and b are integers, each typically between 10 and 200. Poloxamers are named according to conventional convention based on their molecular weight and ethoxy content and include poloxamer 407, poloxamer 338, poloxamer 237, poloxamer 188 and poloxamer 124.Pluronic is the name of a series of poloxamer polymers manufactured by BASF. For example, pluronic F-127 is poloxamer 407. Poloxamers are different from other polyethylene glycol/polypropylene glycol copolymers (PEG/PPG copolymers or EO/PO copolymers) having a structure other than a triblock structure (e.g., a random copolymer structure). Such copolymers, unlike poloxamers, include those made by BASF And->PEG/PPG copolymers sold as series polymers are random PEG/PPG copolymers.
For example, suitable poloxamers may includeL35、/>L43、/>L64、/>L10、/>L44、/>L62、/>10R5、/>17R4、/>L25R4、/>P84、/>P65、/>PI 04、andOne or more of PI 05. />Card dispersants are commercially available from BASF, florban park, new jersey.
In some embodiments, the compositions of the present disclosure may comprise polyvinylpyrrolidone (optionally crosslinked), also known as poly-N-vinyl-poly-2-pyrrolidone, and commonly abbreviated as "PVP" (optionally crosslinked PVP). PVP generally refers to polymers that contain vinylpyrrolidone (also known as N-vinylpyrrolidone, N-vinyl-2-pyrrolidone, and N-vinyl-2-pyrrolidone) as a monomer unit. The monomer units may include a polar imide group, four nonpolar methylene groups, and a nonpolar methyl group. Crosslinked PVP is included as sold by Mirabilite Aoshima Li Fu BASF, N.J., U.S.And->And sold by Ashland, kawenton, kentucky, U.S.AINF-10 are commercially available.
In addition to potassium monopersulfate, the compositions of the present disclosure may optionally include a whitening (oxidizing) agent, but preferably do not include other whitening agents. Whitening agents are materials that are effective to provide whitening to the tooth surface to which they are applied, typically via oxidation, as well as agents including agents such as hydrogen peroxide and carbamide peroxide. In various embodiments, the compositions of the present disclosure may optionally comprise a peroxide whitening agent (including a peroxide compound), but preferably do not comprise a peroxide whitening agent or do not comprise a peroxide compound. Peroxide compounds are oxidizing compounds containing divalent oxygen-oxygen groups. Peroxide compounds include peroxides and hydroperoxides, such as hydrogen peroxide, alkali metal and alkaline earth metal peroxides, organic peroxy compounds, peroxy acids, pharmaceutically-acceptable salts thereof, and mixtures thereof. Peroxides of alkali metals and alkaline earth metals include lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof. Organic peroxy compounds include carbamide peroxide (also known as urea hydrogen peroxide), glyceryl hydrogen peroxide, alkyl hydrogen peroxide, dialkyl peroxide, alkyl peroxy acids, peroxy esters, diacyl peroxides, benzoyl peroxide and monoperoxyphthalate and mixtures thereof. Peroxy acids and salts thereof include organic peroxy acids such as alkyl peroxy acids and monoperoxyphthalate esters and mixtures thereof, and inorganic peroxy acid salts such as persulfates of alkali and alkaline earth metals (e.g., lithium, potassium, sodium, magnesium, calcium, and barium), dipersulfates, percarbonates, perphosphates, perborates, and persilicates, and mixtures thereof. In various embodiments, the peroxide compound includes hydrogen peroxide, carbamide peroxide, sodium percarbonate, and mixtures thereof. In some embodiments, the peroxide compound comprises hydrogen peroxide. In some embodiments, the peroxide compound consists essentially of hydrogen peroxide. In some embodiments, the composition may comprise a non-peroxide whitening agent. Whitening agents suitable for use in those herein include non-peroxy compounds such as chlorine dioxide, chlorites and hypochlorites. Chlorites and hypochlorites include those of alkali metals and alkaline earth metals such as lithium, potassium, sodium, magnesium, calcium, and barium. One or more additional whitening agents are optionally present in a tooth whitening effective total amount. In some embodiments, the composition additionally comprises an activator, such as tetraacetylethylene diamine. In some embodiments, the compositions of the present invention do not contain all of the additional whitening agents listed above.
In some embodiments, the composition may comprise a non-oxidative whitening agent. Non-oxidative brighteners include colorants (e.g., titanium dioxide and blue pigments or dyes) and hydroxyapatite. These agents make the tooth whiter in appearance by masking or covering the stain, rather than chemically removing or destroying the stain.
The compositions of the present disclosure may optionally further comprise other ingredients, such as flavoring agents; a filler; a surfactant; preservatives, such as sodium benzoate and potassium sorbate; colorants, including, for example, dyes and pigments; and a sweetener. In some embodiments, the compositions of the present disclosure comprise one or more surfactants, such as anionic surfactants, cationic surfactants, zwitterionic surfactants, or nonionic surfactants.
As used herein, "anionic surfactants" means those surface-active compounds or detergent compounds which contain in their molecular structure an organic hydrophobic group, typically containing from 8 to 26 carbon atoms or typically containing from 10 to 18 carbon atoms, and at least one water-solubilizing group selected from sulfonate, sulfate and carboxylate groups to form water-soluble detergents. Typically, the hydrophobic group will comprise C 8 -C 22 Alkyl or acyl. Such surfactants are used in the form of water-soluble salts, and the salt-forming cations are generally selected from sodium, potassium, ammonium, magnesium and mono-, di-or tri-C 2 -C 3 Ammonium alkoxides, in which sodium, magnesium and ammonium cations are again the most preferred cations. Some examples of suitable anionic surfactants include, but are not limited to, linear C 8 -C 18 Alkyl ether sulphates, ether sulphates and salts thereofSodium, potassium, ammonium and ethanolammonium salts. Suitable anionic ether sulphates have the formula R (OC 2 H 4 ) n OSO 3 M, wherein n is 1 to 12, or 1 to 5, and R is an alkyl, alkylaryl, acyl or alkenyl group having 8 to 18 carbon atoms, e.g. C 12 -C 14 Or C 12 -C 16 And M is a solubilizing cation selected from the group consisting of sodium ion, potassium ion, ammonium ion, magnesium ion, and mono-, di-, and triethanolamine ion. Exemplary alkyl ether sulfates contain 12 to 15 carbon atoms in their alkyl group, such as sodium laureth (2 EO) sulfate. Some preferred exemplary anionic surfactants that can be used in the compositions of the present disclosure include Sodium Lauryl Ether Sulfate (SLES), sodium lauryl sulfate, and ammonium lauryl sulfate. In certain embodiments, the anionic surfactant is present in an amount of 0.01% to 5.0%, 0.1% to 2.0%, 0.2% to 0.4%, or about 0.33%.
As used herein, "nonionic surfactant" generally refers to compounds produced by the condensation of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be aliphatic or alkyl aromatic in nature. Examples of suitable nonionic surfactants include poloxamers (under the trade nameSold), polyoxyethylene sorbitan esters (under the trade name +.>Sales), polyethylene glycol 40 hydrogenated castor oil, fatty alcohol ethoxylates, polyethylene oxide condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylenediamine, ethylene oxide condensates of aliphatic alcohols, alkyl polyglycosides (e.g., fatty alcohol ethers of polyglucosides, such as decyl ether, lauryl ether, octyl ether, caprylyl ether, myristyl ether, stearyl ether and other ethers of glucose and polyglucoside polymers, including, for example, octyl/caprylyl (C) 8-10 ) Glucoside, coco (C) 8-16 ) Glucoside and laurelRadical (C) 12-16 ) Mixed ethers of glucosides), long chain tertiary amine oxides, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides, and mixtures of such materials.
In some embodiments, the nonionic surfactant includes amine oxides, fatty acid amides, ethoxylated fatty alcohols, block copolymers of polyethylene glycol and polypropylene glycol, alkyl glycerides, polyoxyethylene glycol octylphenol ether, alkyl sorbitan esters, polyoxyethylene glycol alkyl sorbitan esters, and mixtures thereof. Examples of amine oxides include, but are not limited to, lauramidopropyl dimethyl amine oxide, myristamidopropyl dimethyl amine oxide, and mixtures thereof. Examples of fatty acid amides include, but are not limited to, coco monoethanolamide, lauramide monoethanolamide, coco diethanolamide, and mixtures thereof. In certain embodiments, the nonionic surfactant is a combination of an amine oxide and a fatty acid amide. In certain embodiments, the amine oxide is a mixture of lauramidopropyl dimethyl amine oxide and myristamidopropyl dimethyl amine oxide. In certain embodiments, the nonionic surfactant is a combination of lauryl/myristamidopropyl dimethyl amine oxide and cocomonoethanolamide. In certain embodiments, the nonionic surfactant is present in an amount of 0.01% to 5.0%, 0.1% to 2.0%, 0.1% to 0.6%, 0.2% to 0.4%, about 0.2%, or about 0.5%.
As used herein, the term "cationic surfactant" includes the cationic surfactants disclosed in WO 2007/01552 A2, the contents of which are incorporated herein by reference in their entirety.
Examples of surfactants that can be used are sodium lauryl sulfate, sorbitan fatty acid esters, polyoxyethylene (20) sorbitan monooleate (polysorbate 80 or tween 80), polyethylene glycol fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene alkyl ethers, polyoxyethylene polyoxypropylene block copolymers, polyoxyethylene alkylphenyl ethers, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitol fatty acid esters, and polyoxyethylene glycerol fatty acid esters. In the present invention, each of them may be used alone, or two or more of them may be used in combination. Typical amounts of surfactant are from about 0.1% to about 3%, in one embodiment from about 0.1% to about 2%, and in another embodiment from about 0.1% to about 1% by weight of the total composition.
Examples of fillers are crystalline cellulose, ethylcellulose, dextrins, various cyclodextrins (α -cyclodextrin, β -cyclodextrin and γ -cyclodextrin), sodium sulfate and derivatives thereof and amylopectin.
Useful flavoring agents include natural and synthetic flavoring sources including, for example, volatile oils, synthetic flavoring oils, flavoring aromatics, oils, liquids, oleoresins, and extracts derived from plants, leaves, flowers, fruits, stems, and combinations thereof. Suitable flavoring agents include, for example, lemon oil, such as lemon, orange, grape, lime and grapefruit, fruit flavors, including, for example, apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot and other fruit flavoring agents. Additional useful flavoring agents include, for example, aldehydes and esters (e.g., benzaldehyde (cherry, almond)); citral, i.e. alpha-citral (lemon, lime); neral, i.e. beta-citral (lemon, lime); decanal (orange, lemon); aldehyde C-8 (citrus fruit); aldehyde C-9 (citrus fruit); aldehyde C-12 (citrus fruit); tolualdehyde (cherry, almond); 2, 6-dimethyloctanal (immature fruit); 2-dodecenal (citrus, orange); and mixtures thereof.
Suitable colorants include, for example, food, pharmaceutical and cosmetic (FD & C) colorants, including, for example, dyes, lakes, and certain natural and derived colorants. Useful lakes include dyes absorbed on aluminum hydroxide and other suitable carriers.
Suitable sweeteners include stevia; sugars such as sucrose, glucose, invert sugar, fructose, ribose, tagatose, sucralose, maltitol, erythritol, xylitol, and mixtures thereof; saccharin and its various salts (e.g., sodium and calcium salts of saccharin); cyclohexanesulfuric acid and various salts thereof; dipeptide sweeteners (e.g., aspartame); potassium acesulfame; dihydrochalcones; glycyrrhizin; and sugar alcohols including, for example, sorbitol syrup, mannitol, and xylitol, and combinations thereof.
It should be appreciated that while the general properties of each of the above-mentioned classes of materials may be different, there may be some common properties, and any given material may be used for multiple purposes in two or more of such classes of materials. All ingredients in the composition may have functions other than their primary functions and may contribute to the overall characteristics of the composition, including its stability, efficacy, consistency, mouthfeel, taste, smell, and the like. For example, the binder may also act as a disintegrant, and vice versa.
In a second aspect, the present disclosure provides a method for whitening teeth comprising the steps of: (a) Applying composition 1 or 1.1 and any of the following to teeth, and (b) maintaining the composition in contact with teeth for a sufficient period of time (e.g., 0.1 minutes to 60 minutes, or 0.1 minutes to 30 minutes, or 0.1 minutes to 10 minutes, or 0.1 minutes to 5 minutes, or 0.1 minutes to 2 minutes, or 0.1 minutes to 1 minute) to effect whitening of teeth contacted by the composition. In some embodiments, a toothbrush may be used to apply the composition and to maintain the composition in contact with the teeth by utilizing a brushing action. In some embodiments, the composition may be applied to the teeth using a tray and the composition is held in contact with the teeth by placing the tray in the mouth until whitening is complete.
In further embodiments, the present disclosure provides the use of composition 1, or 1.1, and any one of the following, or any other embodiment thereof, for whitening teeth.
Examples
Exemplary embodiments of the present disclosure will be illustrated by reference to the following examples, which are included to illustrate and not limit the scope of the invention.
In the examples and elsewhere in the description of the invention, chemical symbols and terms have their usual and customary meaning. Unless otherwise indicated, temperatures are in degrees celsius. The amounts of the components are weight percentages based on the described criteria; if no other criteria are described, this refers to the total weight of the composition. Various names of chemical components include those listed in CTFA international cosmetic ingredient dictionary (International Cosmetic Ingredient Dictionary) (Cosmetics, toiletry and Fragrance Association, inc., 7 th edition 1997).
Example 1: exemplary MPS-based whitening dentifrice
Potassium monopersulfate is combined and mixed with calcium pyrophosphate and other excipients to provide a homogeneous product.
The composition may have the following formulation:
| composition of the components | Weight percent |
| Potassium monopersulfate | 0.1% to 5% (e.g. 1%) |
| Calcium pyrophosphate | 20% to 30% (e.g. 25%) |
| PEG/PPG triblock copolymers (e.g. Pluronic L35) | 25% to 35% (e.g. 31%) |
| Polyvinylpyrrolidone | 1% to 15% (e.g. 5%) |
| PEG-PPG random copolymer (e.g. PEG/PPG-116/66) | 6% to 15% (e.g. 10%) |
| Polyethylene glycol (e.g., PEG 600) | 10% to 20% (e.g. 12.5%) |
| Polyphosphates (e.g. sodium pyrophosphate) | 2.5% to 5% (e.g. 4%) |
| Anionic surfactants (e.g., sodium lauryl sulfate) | 1% to 5% (e.g. 2%) |
| Zwitterionic surfactants (e.g. cocamidopropyl betaine) | 0.1% to 1% (e.g., 0.3%) |
| Fluoride sources (e.g. sodium monofluorophosphate) | 0.1% to 2% (e.g. 0.75%) |
| Antioxidants (e.g., BHT) | 0.01% to 0.3% (e.g., 0.03%) |
| Thickeners (e.g. fumed silica) | 2.5% to 5% (e.g. 4%) |
| Sweetener and flavoring agent | 0.5 to 5% |
| Blue pigment or dye (e.g. blue 15) | 0.001% to 0.1% (e.g., about 0.05%) |
| Totals to | About 100 |
Tests on formulations within the scope of the present disclosure show that they provide improved stability and retained active oxygen activity compared to comparative formulations that are not within the scope of the present disclosure.
Example 2: MPS stability
To evaluate the effect of replacing the calcium pyrophosphate abrasive with a high-cleaning silica abrasive, four compositions were prepared according to the following table:
compositions A, B, C and D were compared in an accelerated aging study. Samples were placed in test tubes and stored at 60 ℃/75% RH (relative humidity) for 2 weeks. The initial and at 1 and 2 weeks Active Oxygen (AO) levels were determined by iodometric titration. The results are shown in the following table (expressed as a percentage of the initial theoretical AO):
| formulations | Initial AO | AO at 1 week | AO at 2 weeks |
| Composition A | 100％ | 94％ | 94％ |
| Composition B | 100％ | 95％ | 92.3％ |
| Composition C | 95％ | 53％ | 41％ |
| Composition D | 110％ | 44％ | 26％ |
The results demonstrate that compositions a and B stabilized by the calcium pyrophosphate abrasive and PEG/PPG triblock copolymer maintained almost all active oxygen in the 2 week study. In contrast, with the high cleaning silica abrasive (composition F, G), active oxygen is rapidly lost due to the decomposition of potassium peroxymonosulfate. Without being bound by theory, it is believed that trace amounts of heavy metals in precipitated silica (e.g., gao Qingjie force silica) promote catalytic decomposition of MPS (unlike fumed silica which lacks such impurities). It is also noted that Gao Qingjie force silica is a more effective abrasive than calcium pyrophosphate (e.g., gao Qingjie force silica has an RDA (relative dentin abrasion) of about 160, but for calcium pyrophosphate it is about 90). Thus, this loss of abrasiveness is a result of improving MPS stability.
Example 3: rheology of rheology
Compositions a and B were compared during the aging study using a Brookfield programmable viscometer. All tests were performed with toothpaste in a solid container (120 ml sample cup). Samples were stored at 40 ℃/65% rh (relative humidity) for 2 or 3 months. A new position is selected at least 1cm from the wall of the bottle and from the previously tested position. The viscometer rotor slowly descends into the sample vial, as little as possible to disturb the sample. The vane v74 rotor on the shaft of the viscometer is then slowly lowered into the sample. Thixotropic ring testing was performed according to programmed software. Extrusion pressure (bar) is a measure used to evaluate the ability of toothpaste or gel to be extruded from a tube. Acceptable extrusion pressures range from 0.03 bar to 0.1 bar, with about 0.05 bar being desirable. If the squeezing pressure is too low, the toothpaste may ooze out of the tube or be expelled from the tube too vigorously under slight pressure. If the squeezing pressure is too high, the toothpaste will be difficult to squeeze out of the tube. The viscosity was measured at 1rpm (in centipoise (cP)). The viscosity of the toothpaste is preferably maintained at 70,000cp to 300,000cp, most preferably at about 200,000cp during aging.
The results are shown in the following table (n.m. =not measurable because toothpaste cannot be extruded from the tube):
The results demonstrate that the compositions of the present invention maintain stable rheological properties compared to similar compositions outside the scope of the present disclosure.
Example 4: whitening efficacy
Comparative composition E the whitening efficacy of composition a was tested. Composition E is a commercial whitening toothpaste composition having high cleaning power silica. Composition E contained (in decreasing order of concentration): glycerol, hydrated silica, sodium hexametaphosphate, water, PEG-6, perfume, silica, sodium lauryl sulfate, cocamidopropyl betaine, trisodium phosphate, mica, corrugated carrageenan powder (chondrus crispus powder), PEG-20M, sodium fluoride, xanthan gum and sodium chloride, and small amounts of flavoring, coloring and preservative agents.
The head of the soft bristle toothbrush was cut from the handle and mounted on a brushing machine for use. Bovine teeth were fitted and stained with coffee and tea. The toothpaste slurry was poured onto each tray and brushing of the teeth was started immediately. The teeth were brushed for 2 minutes under an applied pressure of 250 grams. The brushing machine was set at 120 times per minute. After 2 minutes, the brushing was stopped, the slurry was removed, the teeth rinsed with deionized water, and then dried. The brushing treatment was repeated a total of 14 times to simulate twice daily use of each product for 7 days.
Values of L, a, and b were measured for each tooth before and after treatment using software from Medical High Technology (MHT). Values L, a, and b were used to calculate the change in whiteness index from baseline for each tooth after 14 treatments. Whiteness index is reported as Δw, where:
W*＝(a* 2 +b* 2 +(L*-100) 2 ) 1/2
ΔW*＝W* treated with –W* Base line
Absolute values of aw are reported. It should be noted that the more positive the value of Δw, the closer the tooth color is to white.
Analysis of variance testing was used to compare the average aw values after 14 treatments for each product. Subsequent Tukey multiple comparison tests were performed to evaluate the pairwise comparisons of products. A p-value of less than 0.05 indicates a statistically significant difference between the products.
The results are shown in the following table:
the whitening results for composition a were statistically significantly improved over that for composition E (p-value 0.0023) over 14 treatments. The results demonstrate that the whitening compositions according to the present disclosure are very effective, being more pronounced than the current commercial whitening compositions.
Example 5: whitening efficacy enhancement with blue pigments
Abrasives (e.g., gao Qingjie force silica) are commonly used to remove stain molecules from tooth surfaces, or oxidizing agents are used to bleach the color of the stain molecules on teeth, or both. The inventors have further found that the use of blue pigments can mask the presence of stains by making the teeth appear whiter. This is important because both the abrasive and the oxidizing agent take a period of time (typically 1 to 2 weeks) to begin to exhibit a significant whitening effect, while the masking effect of the blue pigment is much more immediate.
These compositions were compared in a whitening study. Composition a from example 1, composition a with 0.05% Blue 15 pigment (CI 74160) added, and a commercial whitening composition (composition F) comprising 0.1% hydrogen peroxide and 0.05% Blue 15 pigment.
Complete human molar teeth were obtained from Therametric Technologies, inc. The crowns were separated from the roots and the separated crowns were bisected longitudinally using a Buehler IsoMet low speed saw. The bisected crown portion was installed in a methacrylate resin so that only the enamel was exposed. 27 teeth were selected and three teeth were mounted on each tray using the heat set impression compound. All nine trays were used to evaluate each product in a random order.
All measurements were made using a Spectroshade Micro instrument manufactured by Medical High Technology (MHT). Before measuring the baseline optical properties of the teeth, the instrument is calibrated according to the manufacturer's instructions. For measurement, the instrument is positioned such that one tooth is in the field of view of the instrument, and then an image is captured. This procedure was repeated for each measurement in the study.
A slurry of 1:2 (weight/weight) toothpaste and artificial saliva (e.g., about 250g toothpaste and 500g artificial saliva) was prepared for each sample. The slurry was mixed by hand to completely homogenize the solution prior to addition to the tray.
The head of the soft bristle toothbrush was cut from the handle and mounted on a brushing machine for use. 9mL of standard toothpaste slurry was poured onto each tray and brushing was started immediately. The teeth were brushed for 10 minutes under an applied pressure of 250 grams. The brushing machine was set to 120 times per minute. After 10 minutes, the brushing was stopped, the slurry was removed, the teeth rinsed with deionized water, and then dried. Baseline spectrophotometric measurements were then performed. The teeth were then immersed in artificial saliva (9 mL/tray) and aged for 15 minutes at 37 ℃ with stirring. The test toothpaste slurry was then added to the tray and the teeth were brushed for 2 minutes with 250 grams of pressure applied. The brushing machine was set to 120 times per minute. After 2 minutes, the brushing was stopped, the slurry was removed, the teeth rinsed with deionized water, and then dried. Post-treatment spectrophotometric measurements were then performed. The data analysis was as described in example 4.
The results are shown in the following table.
| Average DeltaW | |
| Composition A (1% MPS) | 7.20 |
| Composition A (1% MPS) +Blue 15 | 15.83 |
| Composition F (0.1% HP) +Blue 15 | 12.01 |
The results demonstrate that the addition of Blue 15 pigment improves the instant whitening effect (1 brush cycle) of MPS toothpaste according to the present disclosure. In addition, the whitening effect of MPS in combination with Blue 15 was greater than the whitening effect of an equivalent amount of Blue 15 added to an equivalent hydrogen peroxide-based toothpaste composition (0.1% HP having an active oxygen content equivalent to 1% MPS).
The invention has been described above with reference to illustrative examples, but it is to be understood that the invention is not limited to the disclosed embodiments. Variations and modifications that may occur to one skilled in the art upon reading the specification are also within the scope of the invention, which is defined in the appended claims.
Claims (19)
1. A tooth whitening oral care composition comprising 0.01% to 10% by weight of potassium monopersulfate, the composition being prepared by mixing 21% to 60% calcium pyrophosphate (Ca 2 P 2 O 7 ) And/or insoluble sodium metaphosphate ([ NaPO) 3 ] n ) And from 20% to 60% by weight of the composition of a polyoxyethylene/polyoxypropylene triblock copolymer.
2. The composition of claim 1, wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition.
3. The composition according to claim 1 or 2, wherein the composition is prepared by mixing 21% to 60% calcium pyrophosphate (Ca 2 P 2 O 7 ) To stabilize.
4. The composition of claim 3, wherein the composition comprises the calcium pyrophosphate in an amount of 22% to 60%, or 22% to 50%, or 22% to 40%, or 22% to 35%, or 25% to 60%, or 25% to 50%, or 25% to 40%, or 25% to 35%, or 25% to 30%, or 21% to 30%, or 22% to 30%, or 22.5% to 27.5%, or 23% to 27%, or 24% to 26%, or about 25% by weight of the composition.
5. The composition of any one of claims 1 to 4, wherein the polyoxyethylene/polyoxypropylene triblock copolymer is a triblock copolymer having the formula:
HO-[CH 2 CH 2 O] a [-CH(CH 3 )CH 2 O-] b [CH 2 CH 2 O] a -H，
wherein a is an integer of 1 to 30 and b is an integer of 10 to 60.
6. The composition of any one of claims 1 to 5, wherein the composition further comprises one or more of polyvinylpyrrolidone, polyethylene glycol/polypropylene glycol random copolymer, polyethylene glycol, polyphosphate (e.g., alkali metal polyphosphate), and surfactant (e.g., anionic surfactant and/or zwitterionic surfactant).
7. The composition of any one of claims 1 to 6, wherein the composition comprises a mixture of anionic surfactant and zwitterionic surfactant.
8. The composition of claim 7, wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine.
9. The composition of claim 8, wherein the composition comprises from 2% to 4%, or from 1% to 3%, or from 2% to 3%, or from 1.5% to 2.5%, or from 2% to 2.5%, or about 2% sodium lauryl sulfate, and from 0.1% to 1%, or from 0.1% to 0.5%, or about 0.3% cocamidopropyl betaine, by weight of the composition.
10. The composition according to any one of claims 1 to 9, wherein the composition further comprises an antioxidant, for example the antioxidant is selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, vitamin a, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid and mixtures thereof.
11. The composition of any one of claims 1 to 10, wherein the composition comprises the potassium peroxymonosulfate in an amount of from 1% to 5%, and the composition is stabilized by a combination of from 20% to 40% calcium pyrophosphate and from 25% to 50% polyoxyethylene/polyoxypropylene triblock copolymer, each by weight of the composition, the polyoxyethylene/polyoxypropylene triblock copolymer having the formulaHO-[CH 2 CH 2 O] a [-CH(CH 3 )CH 2 O-] b [CH 2 CH 2 O] a -H, wherein an integer of 10 to 12 (e.g. 11), and b is an integer of 15 to 20 (e.g. 16), for example the polymer is Pluronic L35.
12. The composition of any of claims 1-11, wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, and the composition is stabilized by a combination of 20% to 30% calcium pyrophosphate and 25% to 35% polyoxyethylene/polyoxypropylene triblock copolymer, each by weight of the composition, having the formula HO- [ CH 2 CH 2 O] a [-CH(CH 3 )CH 2 O-] b [CH 2 CH 2 O] a -H, wherein an integer of 10 to 12 (e.g. 11), and b is an integer of 15 to 20 (e.g. 16), for example the polymer is Pluronic L35.
13. The composition of any one of claims 1 to 12, wherein the composition further comprises polyvinylpyrrolidone in an amount of 1% to 10%, a PEG/PPG random copolymer (e.g., pluracure L1220 polymer) having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105 to 125EG to 55 to 75PG in an amount of 6% to 15%, and polyethylene glycol 600 in an amount of 5% to 20%, each by weight of the composition.
14. The composition of any one of claims 1 to 13, wherein the composition further comprises from 2% to 5% tetrasodium pyrophosphate and from 0.5% to 1.5% disodium pyrophosphate, by weight of the composition.
15. The composition according to any one of claims 1 to 14, wherein the composition further comprises a Blue dye or pigment, such as Blue 15 pigment (also known as CI 74160), optionally in an amount of 0.001% to 0.1% by weight of the composition, such as 0.01% to 0.08%, or 0.03% to 0.07%, or about 0.05% by weight of the composition.
16. The composition of any one of claims 1 to 15, wherein the composition comprises:
。
17. The composition according to any one of claims 1 to 16, wherein the composition is a dentifrice, such as a toothpaste or a tooth gel.
18. A method for whitening teeth comprising the steps of: (a) Applying the composition according to any one of claims 1 to 17 to the teeth, and (b) maintaining the composition in contact with the teeth for a sufficient period of time (e.g., 0.1 to 60 minutes, or 0.1 to 30 minutes, or 0.1 to 10 minutes, or 0.1 to 5 minutes, or 0.1 to 2 minutes, or 0.1 to 1 minute) to effect whitening of the teeth contacted by the composition.
19. Use of a composition according to any one of claims 1 to 17 in a method for whitening teeth.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163293355P | 2021-12-23 | 2021-12-23 | |
| US63/293,345 | 2021-12-23 | ||
| US63/293,355 | 2021-12-23 | ||
| PCT/US2022/053991 WO2023122342A1 (en) | 2021-12-23 | 2022-12-23 | Peroxymonosulfate oral compositions for tooth whitening |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116648228A true CN116648228A (en) | 2023-08-25 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202280006362.4A Pending CN116648228A (en) | 2021-12-23 | 2022-12-23 | Per-sulfate oral whitening compositions |
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| Country | Link |
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| CN (1) | CN116648228A (en) |
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- 2022-12-23 CN CN202280006362.4A patent/CN116648228A/en active Pending
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