Peroxymonosulfate oral whitening compositions

Abstract

The present disclosure provides tooth whitening oral care compositions comprising potassium peroxymonosulfate having improved stability and methods of using the same.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is an international application claiming priority to and the benefit of U.S. Provisional Application Serial No. 63 / 436,350, filed on December 30, 2022, the contents of which are hereby incorporated by reference in their entirety. Background Art

[0003] Consumer products that provide teeth whitening are numerous and come in many forms, but one of the more popular forms is as a dentifrice, such as toothpaste. Toothpaste typically must have a semi-solid form that is able to hold its shape well enough to be dispensed from a tube and rest on the bristles of a toothbrush, but also fluid enough to be easily squeezed out of the tube. Toothpaste must also be viscous enough to adhere to the teeth to some extent, yet soluble enough to disperse in the mouth. These various objectives are typically met by formulating 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 typically used to provide the gel-like consistency required for toothpaste.

[0004] Unfortunately, many whitening agents have stability issues in the presence of water, humectants, and some polymers. Other inorganic substances (such as fluoride sources and surfactants) may also interact negatively, leading to instability and loss of activity of the active whitening agent. Therefore, it has become necessary to formulate whitening toothpastes with various ingredients designed to improve the stability and activity of the whitening agent active.

[0005] Abrasives can be particularly difficult to formulate into whitening toothpastes due to their high surface area, hygroscopicity, and acidic nature. However, abrasives can be a key component of whitening compositions because many stains adhere firmly but superficially to tooth surfaces, and abrasives help remove such stains both through their inherent abrasive action and by providing better access of the whitening agent to the stain.

[0006] Products currently available for teeth whitening include a variety of ingredients, with the primary active ingredient most often being a peroxide source, such as hydrogen peroxide. The use of peroxide agents often presents numerous difficulties in both the formulation and long-term stability of the resulting compositions. Furthermore, hydrogen peroxide can be highly irritating to teeth and gums at high concentrations or when in contact with the oral mucosa for extended periods. Therefore, there is a need for alternative oxidizing agents with improved stability, particularly for whitening products intended for prolonged contact with oral tissues.

[0007] Persulfate (H2SO5, also known as peroxymonosulfuric acid) and its salts (peroxymonosulfates) are powerful oxidants and detergents. They are currently used for a variety of industrial and consumer purposes, including swimming pool treatment and denture cleaning. Compared to the anion [HS2O8] –Related peroxydisulfates, peroxymonosulfates typically have an anion [HSO5] – Permonosulfate whitening products have been explored for use in several oral care applications, including whitening strips, mouthwashes, and toothpastes. A common permonosulfate oxidant is potassium permonosulfate (KHSO5), also known as potassium monoperoxysulfate and abbreviated as KMPS or MPS, and is used as a composition and (each of which is a potassium peroxymonosulfate triple salt having about 45% to 50% by weight of potassium peroxymonosulfate).

[0008] The use of potassium peroxymonosulfate in oral care applications is very limited due to its instability in aqueous solutions, especially at or above neutral pH. Potassium peroxymonosulfate is known to degrade even in the presence of small amounts of water and heat. Therefore, potassium peroxymonosulfate whitening compositions face special difficulties in formulation.

[0009] When combined with other common oral care excipients (especially polar compounds, such as wetting agents, and anionic or neutral hydroxy polymers and surfactants), potassium permonosulfate may also react and decompose. These excipients may make potassium permonosulfate unstable, causing the loss of whitening efficacy. Therefore, it is necessary to adjust the preparation with potassium permonosulfate to avoid or reduce the amount of such composition, which makes it still challenging to prepare the composition with desired mouthfeel (such as, foaming), outward appearance, viscosity and other important characteristics. In addition, potassium permonosulfate may also interact negatively with any common flavoring agent that tends to have unstable or oxidizable functional groups. This may make it challenging to formulate flavoring agents into such compositions.

[0010] As mentioned above, in order to solve the above peroxymonosulfate stability problem, non-aqueous formulations have been studied. However, such formulations may face their own formulation difficulties, such as maintaining appropriate viscosity during aging, ensuring sufficient foaming in the absence of water, and the interaction between the ingredients introduced in place of water. For example, formulation scientists use a combination of polyol humectants, polar and non-polar polymers to replace water in toothpaste or gel, and add different surfactants to ensure sufficient stability, viscosity and foaming. The present inventors and others have found that polyol humectants commonly used as water substitutes generally promote peroxymonosulfate degradation. For example, propylene glycol, sorbitol, glycerol and xylitol are very common oral care moisturizers, but their high polarity and hygroscopicity (due to their hydroxyl functional groups) promote MPS degradation both directly and indirectly (by retaining water). In addition, the present inventors have unexpectedly found that some anhydrous toothpaste compositions in which potassium peroxymonosulfate is stabilized by calcium pyrophosphate in a poloxamer / polyethylene glycol / PEG-PPG random copolymer vehicle have an abnormally low freezing point. Such compositions may solidify at temperatures of 20°C and below (68°F and below), or if they do not solidify themselves, may have an unacceptably low viscosity and, therefore, insufficient extrudability (squeezability).

[0011] There remains a need for tooth whitening dentifrice products based on peroxymonosulfate whitening agents having improved stability, mouthfeel, appearance, viscosity, flavor, and consumer acceptability without adversely affecting the setting point (eg, improved extrudability or squeezability). Summary of the Invention

[0012] The present disclosure provides a tooth whitening oral care composition comprising potassium permonosulfate by weight of the composition, stabilized by a combination of calcium pyrophosphate (Ca2P2O7) by weight of the composition and 10% to 60% of a poloxamer (polyoxyethylene / polyoxypropylene triblock copolymer) by weight of the composition and 5% to 20% of polyethylene glycol-400 (PEG-400) by weight of the composition. In other embodiments, the composition may further comprise one or more of the following: polyvinyl pyrrolidone, a polyethylene glycol / polypropylene glycol random copolymer, an alkali metal polyphosphate, an anionic surfactant, a zwitterionic surfactant, a cationic surfactant, and an amphoteric surfactant. In at least one aspect, the tooth whitening oral care composition of the present disclosure is low in water or anhydrous. Compared to prior art compositions, the compositions of the present disclosure provide a higher freezing point and, therefore, improved extrudability.

[0013] 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

[0014] 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.

[0015] As used throughout, ranges are used as shorthand for describing individual values ​​and each value within a range. Any value within a range can be selected as the endpoint of the range. In addition, all references cited herein are hereby incorporated by reference in their entirety. In the event of a conflict between a definition in the present disclosure and a definition in the cited reference, the present disclosure shall prevail.

[0016] Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in the specification are to be understood as referring to percentages by weight. The amounts given are based on the active weight of the material.

[0017] Open-ended terms such as "include," "comprising," "containing," and "having" mean "including." In this specification, unless otherwise specified, the singular also includes the plural. For example, "a lubricant" also includes the case where more than one lubricant is used.

[0018] "About" means plus or minus 20% of the stated value. Thus, for example, "about 5%" means 80% to 120%, or 4.0% to 6.0%, of 5%, inclusive.

[0019] It has been previously discovered that a combination of calcium pyrophosphate (Ca2P2O7) and poloxamer (a polyoxyethylene / polyoxypropylene triblock copolymer) is very effective in stabilizing potassium permonosulfate against degradation while also providing favorable rheological properties. Preferably, such a composition also contains anionic and zwitterionic surfactants (e.g., sodium lauryl sulfate and cocamidopropyl betaine) to optimize the foaming properties of the composition. However, the present inventors have unexpectedly discovered that such a composition (which is stable in aging studies and has good whitening and foaming properties) has a freezing point that is too high. At temperatures that consumers may encounter or during product transportation, the composition may solidify or become too viscous. As a result, the composition has insufficient extrudability, which seriously affects consumer acceptance. Without being bound by theory, it is believed that a higher content of poloxamer can lower the freezing point of the composition. Therefore, it is necessary to find different components to replace all or part of the poloxamer to provide a composition with a freezing point below 15°C, preferably above 10°C.

[0020] While many different polyethylene glycol polymers have been seen used in the formulation of various oral care compositions, PEG-400, in amounts of 5% to 20% by weight of the composition as described herein, has not been reported to provide such compositions with good stability and an acceptable freezing point, resulting in improved extrudability (squeezability).

[0021] In a first aspect, the present disclosure provides a tooth whitening oral care composition (Composition 1) comprising potassium permonosulfate, calcium pyrophosphate (Ca2P2O7), 5% to 20% polyethylene glycol-400 (PEG-400), and 10% to 60% polyoxyethylene / polyoxypropylene triblock copolymer (poloxamer), by weight of the composition. In other embodiments, the present disclosure provides:

[0022] 1.1. Composition 1, wherein the potassium peroxymonosulfate is provided as a triple salt of potassium peroxymonosulfate, potassium hydrogen sulfate, and potassium sulfate, optionally wherein the triple salt comprises about 45% to 50% by weight of potassium peroxymonosulfate, e.g., 47% or 49% by weight of potassium peroxymonosulfate;

[0023] 1.2. Composition 1 or 1.1, wherein the composition comprises the potassium peroxymonosulfate in an amount of 0.01% to 10% by weight of the composition, e.g., 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;

[0024] 1.3. Any of the preceding compositions, wherein the inorganic peroxymonosulfate salt is not granulated (eg, not pelletized);

[0025] 1.4. Any of the preceding compositions, wherein the composition does not contain hydrogen peroxide;

[0026] 1.5. Any of the preceding compositions, wherein the composition does not comprise any of the following: hydrogen peroxide, urea peroxide, peroxide salts (e.g., sodium peroxide, potassium peroxide, lithium peroxide, calcium peroxide), peroxyacids (e.g., peroxyacetic acid, peroxybenzoic acid, or salts or derivatives thereof), organic peroxides (e.g., urea hydroperoxide, glyceryl hydroperoxide, peroxyesters, diacyl peroxides, monoperoxyphthalates or salts thereof), perborates, persilicates, percarbonates, chlorinated oxidants (e.g., hypochlorites, chlorites, chlorates, perchlorates, chlorine dioxide), or peroxodisulfuric acid or peroxodisulfate salts;

[0027] 1.6. Any of the preceding compositions, wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition;

[0028] 1.7. Composition 1 or any one of 1.1 to 1.6, wherein the composition comprises 5% to 60% calcium pyrophosphate (Ca2P2O7) by weight of the composition;

[0029] 1.8. Composition 1 or any one of 1.1 to 1.6, wherein the composition is stabilized by 10% to 40% calcium pyrophosphate (Ca2P2O7) by weight of the composition;

[0030] 1.9. Composition 1 or any one of 1.1 to 1.6, wherein the composition is stabilized by 20% to 30% calcium pyrophosphate (Ca2P2O7) by weight of the composition;

[0031] 1.10. Composition 1 or any of 1.1 to 1.9, wherein the composition comprises the calcium pyrophosphate in an amount of 1% to 60% by weight of the composition, e.g., 5% to 60%, or 5% to 50%, or 10% to 60%, or 10% to 50%, or 10% to 40%, or 15% to 60%, or 15% to 40%, or 20% to 60%, or 20% to 40%, or 21% to 40%, 22% to 40%, or 22% to 35%, 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;

[0032] 1.11. Composition 1 or any of 1.1 to 1.10, wherein the polyoxyethylene / polyoxypropylene triblock copolymer is a triblock copolymer having the formula:

[0033] HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O]a -H,

[0034] wherein a is an integer from 1 to 30, and b is an integer from 10 to 60;

[0035] 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;

[0036] 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;

[0037] 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);

[0038] 1.15. Composition 1 or any of 1.1 to 1.14, wherein the polyoxyethylene / polyoxypropylene triblock copolymer has an average molecular weight of 1000 to 7000 Daltons, e.g., 1000 to 6000 Daltons, or 1000 to 5000 Daltons, or 1000 to 4000 Daltons, or 1000 to 3000 Daltons, or 1000 to 2000 Daltons, or 1500 to 3000 Daltons, or 1500 to 2000 Daltons, or 1800 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;

[0039] 1.16. Composition 1.11, wherein the polyoxyethylene / polyoxypropylene triblock copolymer is Pluronic L35;

[0040] 1.17. Composition 1 or any of 1.1 to 1.16, wherein the composition comprises the polyoxyethylene / polyoxypropylene triblock copolymer in an amount of 10% to 60%, or 10% to 50%, 10% to 45%, 10% to 40%, 10% to 35%, 10% to 30% to 25%, 10% to 20%, 10% to 15%, 15% to 50%, 15% to 45%, 15% to 40%, 15% to 35%, 15% to 30%, 15% to 25%, 15% to 20%, 20% to 50%, 20% to 45%, 20% to 40%, 20% to 35%, 20% to 30%, 20% to 25%, or about 23%, or about 24%, by weight of the composition;

[0041] 1.18. Any of the preceding compositions, wherein the composition further comprises one or more of the following: polyvinylpyrrolidone, polyethylene glycol / polypropylene glycol random copolymer, additional polyethylene glycol, a polyphosphate (e.g., an alkali metal polyphosphate), and a surfactant (e.g., an anionic surfactant and / or a zwitterionic surfactant);

[0042] 1.19. Composition 1.18, wherein the composition further comprises polyvinylpyrrolidone;

[0043] 1.20. Composition 1.19, wherein the polyvinyl pyrrolidone is a cross-linked polyvinyl pyrrolidone;

[0044] 1.21. Composition 1.19 or 1.20, wherein the polyvinylpyrrolidone is not complexed or bound to hydrogen peroxide;

[0045] 1.22. Any of compositions 1.19 to 1.21, wherein the composition comprises the 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;

[0046] 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);

[0047] 1.24. Composition 1.23, wherein the PEG / PPG random copolymer has an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 75 to 150 EG to 45 to 95 PG, or about 95 to 135 EG to 50 to 80 PG, or about 105 to 125 EG to 55 to 75 PG, or about 110 to 120 EG to 60 to 70 PG, or about 116 EG to 66 PG (i.e., PEG / PPG 116 / 66);

[0048] 1.25. Composition 1.23, wherein the PEG / PPG random copolymer is Pluracare L1220;

[0049] 1.26. Any of compositions 1.23 to 1.25, wherein the composition comprises 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%, by weight of the composition. %, 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% of the PEG / PPG random copolymer;

[0050] 1.27. Any of compositions 1.18 to 1.26, wherein the composition further comprises a polyethylene glycol selected from PEG-200, PEG-300, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, and PEG-2000, optionally selected from PEG-200, PEG-300, and PEG-500;

[0051] 1.28. Composition 1 or any of compositions 1.1 to 1.27, wherein the composition does not comprise any one or more of polyethylene glycols selected from PEG-200, PEG-300, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, and PEG-2000;

[0052] 1.29. Composition 1.28, wherein the composition does not contain PEG 600;

[0053] 1.30. Composition 1.27 wherein the composition comprises additional polyethylene glycol in a total 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 20%, or 12% to 15%, or about 12% (e.g., about 12.5%), by weight of the composition;

[0054] 1.31. Any of the preceding compositions, wherein the composition further comprises one or more additional polymers, such as any one or more of the following: polypropylene glycol, polysaccharides (e.g., cellulose derivatives such as carboxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, ethylcellulose, microcrystalline cellulose; or polysaccharide gums such as xanthan gum, guar gum, or carrageenan, pectin, karaya gum); chitosan; dextran; hyaluronic acid and sodium hyaluronate; synthetic anionic polymeric polycarboxylates such as copolymers of maleic anhydride or maleic acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether (e.g., copolymers having a ratio of maleic anhydride / maleic acid to methyl vinyl ether of 1:4 to 4:1); polyphosphonic acids and polyphosphonates (i.e., polyphosphates); cross-linked carboxyvinyl copolymers; polyacrylic acid or polyacrylate polymers (e.g., carbomers); polyacrylamides, such as (2-hydroxypropyl) methacrylamide; other polyoxyethylene-polyoxypropylene copolymers (PEG-PPG) triblock copolymers, such as poloxamer 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; polyamines; polyvinyl alcohol; poly Oxazolines, such as poly(2-alkyl-2- oxazoline), for example, methyl, ethyl or isopropyl substituted poly oxazoline; and quaternary ammonium polymer;

[0055] 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 polymers (PAA), polyvinyl pyrrolidone-vinyl acetate copolymers (PVP-VA), poly Oxazoline polymers (PO) and mixtures thereof;

[0056] 1.33. Composition 1 or any of compositions 1.1 to 1.31, wherein the composition comprises 30% to 70% by weight of a polymer (e.g., a PEG / PPG random copolymer, a PEG / PPG triblock copolymer, PVP, and PEG), e.g., 30% to 60%, or 40% to 60%, or 50% to 60%, or 55% to 60%, or 55% to 59%, or 58% to 59% by weight;

[0057] 1.34. Any of the preceding compositions, wherein the composition further comprises a polyphosphate or an organic cyclic polyphosphate, such as an alkali metal pyrophosphate, an alkali metal tripolyphosphate, an alkali metal tetraphosphate, an alkali metal hexametaphosphate, an alkali metal insoluble metaphosphate, an alkali metal phytate, or a mixture thereof;

[0058] 1.35. Composition 1.34, wherein the composition comprises sodium or potassium pyrophosphate, sodium or potassium tripolyphosphate, sodium or potassium tetraphosphate, sodium or potassium phytic acid, or a mixture thereof;

[0059] 1.36. Composition 1.34, wherein the composition comprises a tetraalkali metal pyrophosphate, such as tetrasodium pyrophosphate or tetrapotassium pyrophosphate;

[0060] 1.37. Composition 1.34, wherein the composition comprises a dialkali metal pyrophosphate, such as disodium pyrophosphate or dipotassium pyrophosphate;

[0061] 1.38. Composition 1.34, wherein the composition comprises a tetraalkali metal pyrophosphate and a dialkali metal pyrophosphate, such as tetrasodium pyrophosphate and disodium pyrophosphate;

[0062] 1.39. Any of compositions 1.34 to 1.38, wherein the composition comprises 0.1% to 5% by weight of a polyphosphate, e.g., 0.5% to 5%, or 1% to 5%, or 2% to 5%, or 3% to 5%, or 3.5% to 5%, or 4% to 5%, or 3.5% to 4.5%, or about 4% by weight of a polyphosphate, optionally 1% to 5% or 2% to 4% tetraalkali metal pyrophosphate and 0.5% to 2% dialkali metal pyrophosphate, e.g., about 3% tetrasodium pyrophosphate and about 1% disodium pyrophosphate;

[0063] 1.40. Any of the preceding compositions, wherein the composition further comprises one or more surfactants, such as anionic surfactants, cationic surfactants, amphoteric surfactants, nonionic surfactants, and / or zwitterionic surfactants;

[0064] 1.41. Composition 1.40, wherein the composition comprises a mixture of anionic surfactant and zwitterionic surfactant;

[0065] 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 myreth sulfate, sodium lauroyl sarcosinate, sodium cocomonoglyceride sulfonate, sodium laurylbenzenesulfonate, sodium lauryl sulfoacetate, sodium N-methyl N-cocoyl taurate, sodium cocoyl isethionate, sodium dioctyl sulfosuccinate, and sodium cocomonoglyceride sulfate and ammonium analogs thereof;

[0066] 1.43. Composition 1.40 or 1.41 wherein the zwitterionic surfactant is selected from the group consisting of: cocamidopropyl betaine (CAPB), cocamidopropyl sultaine, cocamidopropyl hydroxysultaine, lauramidopropyl betaine, lauramidopropyl sultaine, lauramidopropyl hydroxysultaine, oleamidopropyl betaine, oleamidopropyl sultaine, oleamidopropyl hydroxysultaine, tallowamidopropyl betaine, tallowamidopropyl sultaine, tallowamidopropyl hydroxysultaine, lauryl betaine, lauryl sultaine, lauryl hydroxysultaine, lauryl dimethylamine oxide, and myristylamine oxide;

[0067] 1.44. Composition 1.40, wherein the cationic surfactant is selected from: cetylpyridinium chloride (CPC), cetrimonium bromide, benzalkonium chloride, benzethonium chloride (1-hexadecylcarbamoyl-ethyl)-trimethylammonium halide, (1-hexadecylcarbamoyl-2-phenyl-ethyl)-trimethylammonium halide, 1-hexadecylcarbamoyl-1,1-dimethyl-pyrrolidine Halides 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 disodium sebacoyl bislauramidolysine;

[0068] 1.45. Composition 1.40, wherein the nonionic surfactant is selected from the group consisting of: coco monoethanolamide, coco diethanolamide, lauroyl propyl dimethylamine oxide, myristyl propyl dimethylamine oxide, and decyl glucoside;

[0069] 1.46. Any of compositions 1.40 to 1.45, wherein the composition comprises sodium lauryl sulfate;

[0070] 1.47. Any of compositions 1.40 to 1.45, wherein the composition comprises cocamidopropyl betaine;

[0071] 1.48. Composition 1.39 or 1.40, wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine;

[0072] 1.49. Any of compositions 1.40 to 1.48, wherein the composition comprises 0.1% to 5% of a surfactant, e.g., 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 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% of a surfactant, by weight of the composition;

[0073] 1.50. Any of compositions 1.40 to 1.49, wherein the composition comprises any one or more surfactants in an individual amount of 0.1% to 5%, e.g., 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;

[0074] 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;

[0075] 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, e.g., 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;

[0076] 1.53. Any of the preceding compositions, wherein the composition further comprises an antioxidant, such as an antioxidant selected from the group consisting of butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures thereof;

[0077] 1.54. Composition 1.53, wherein the antioxidant is butylated hydroxyanisole or butylated hydroxytoluene;

[0078] 1.55. Composition 1.53, wherein the antioxidant is butylated hydroxytoluene;

[0079] 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%, e.g., 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;

[0080] 1.57. Any of the preceding compositions, further comprising a thickener, 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;

[0081] 1.58. Any of the preceding compositions, wherein the composition further comprises a fluoride source;

[0082] 1.59. Composition 1.58, wherein the fluoride source is selected from sodium fluoride, sodium monofluorophosphate, and stannous fluoride, or mixtures thereof;

[0083] 1.60. Composition 1.58 or 1.59, wherein the composition comprises 0.1% to 5% of a fluoride source, by weight of the composition, e.g., 0.5% to 5%, or 0.5% to 3%, or 0.5% to 2%, or 0.5% to 1%, or about 0.75% of a fluoride source, by weight of the composition;

[0084] 1.61. Any of the preceding compositions, wherein the composition further comprises an additional abrasive (i.e., in addition to the calcium pyrophosphate and / or insoluble sodium metaphosphate), optionally wherein the composition does not comprise a hydrated silica or precipitated silica abrasive (e.g., a synthetic high-cleaning silica);

[0085] 1.62. Composition 1.61 wherein the additional abrasive is selected from 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%;

[0086] 1.63. Any of the preceding compositions, wherein the composition further comprises a desensitizing agent, e.g., a desensitizing agent such as potassium nitrate, in an amount of 0.1% to 5% by weight;

[0087] 1.64. Any of the preceding compositions, wherein the composition further comprises a tooth enamel strengthening agent, eg, a tooth enamel strengthening agent such as zinc phosphate, in an amount of 0.1% to 5% by weight;

[0088] 1.65. Any of the preceding compositions, further comprising one or more flavoring agents and sweeteners, e.g., in an amount of 0.1% to 5%, or 0.5% to 5%, or 1% to 5%, or 2% to 5%, or 2% to 3%;

[0089] 1.66. Any of the preceding 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);

[0090] 1.67. Any of the preceding compositions, wherein the composition does not comprise any acetate, for example, wherein the composition does not comprise any of: triacetin, acetin, propylene glycol diacetate, ethylene glycol diacetate, and diethylene glycol diacetate;

[0091] 1.68. Any of the preceding compositions, wherein the composition comprises PEG-400 in an amount of 6% to 18%, or 7% to 15%, or 8% to 14%, or 9% to 13%, or 10% to 15%, or 10% to 13%, or 11% to 15%, or 11% to 13%, or 12% to 14%, or 12% to 13%, or about 12.5%, by weight of the composition;

[0092] 1.69. Any of the preceding compositions, wherein the composition does not comprise any humectant, for example, wherein the composition does not comprise any of glycerin, propylene glycol, sorbitol, or xylitol;

[0093] 1.70. Composition 1 or any of 1.1 to 1.69, wherein the composition comprises 1% to 3% sodium lauryl sulfate and 0.1% to 0.5% cocamidopropyl betaine, by weight of the composition;

[0094] 1.71. Composition 1 or any of 1.1 to 1.69, 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;

[0095] 1.72. Composition 1 or any of 1.1 to 1.69, wherein the composition comprises about 2% sodium lauryl sulfate and about 0.3% cocamidopropyl betaine, by weight of the composition;

[0096] 1.73. Composition 1 or any of compositions 1.1 to 1.72, 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;

[0097] 1.74. Any of the preceding compositions, wherein the composition comprises potassium permonosulfate in an amount of 1% to 5%, calcium pyrophosphate in an amount of 20% to 40%, PEG-400 in an amount of 10% to 15%, and a polyoxyethylene / polyoxypropylene triblock copolymer in an amount of 25% to 50%, each by weight of the composition, wherein the polyoxyethylene / polyoxypropylene triblock copolymer has the formula HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H, wherein b is an integer from 10 to 12 (e.g., 11), and b is an integer from 15 to 20 (e.g., 16), for example, the polymer is Pluronic L35;

[0098] 1.75. Any of the preceding compositions, wherein the composition comprises potassium permonosulfate in an amount of 1% to 3%, calcium pyrophosphate in an amount of 20% to 30%, PEG-400 in an amount of 12% to 13%, and a polyoxyethylene / polyoxypropylene triblock copolymer in an amount of 25% to 35%, each by weight of the composition, wherein the polyoxyethylene / polyoxypropylene triblock copolymer has the formula HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H, wherein b is an integer from 10 to 12 (e.g., 11), and b is an integer from 15 to 20 (e.g., 16), for example, the polymer is Pluronic L35;

[0099] 1.76. Any of the preceding compositions, wherein the composition further comprises polyvinylpyrrolidone in an amount of 1% to 10%, a PEG / PPG random copolymer having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105 to 125 EG to 55 to 75 PG (e.g., Pluracare L1220 polymer) in an amount of 6% to 15%, and polyethylene glycol 600 in an amount of 5% to 20%, each by weight of the composition;

[0100] 1.77. Any of the preceding compositions, wherein the composition further comprises 2% to 5% tetrasodium pyrophosphate and 0.5% to 1.5% disodium pyrophosphate, by weight of the composition;

[0101] 1.78. Any of the preceding compositions, further comprising 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;

[0102] 1.79. Any of the preceding compositions, further comprising 1% to 15% propylene glycol, e.g., 5% to 15%, or 5% to 10%, or about 7.5%, by weight of the composition;

[0103] 1.80. Any of the preceding compositions, wherein the composition further comprises 2% to 10% by weight of the composition of one or more of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate, e.g., 5% to 10%, or 10% to 15%, or 2% to 5%, or 3% to 8%, or about 5% (e.g., potassium nitrate or zinc nitrate);

[0104] 1.81. Composition 1 or any of 1.1 to 1.80, wherein the composition comprises or consists of:

[0105]

[0106] or

[0107]

[0108] 1.82. Any of the preceding compositions, wherein the composition is a dentifrice, such as a toothpaste or tooth gel;

[0109] 1.83. Any of the preceding compositions, wherein the composition has the consistency of a paste or gel (e.g., not a free-flowing liquid, nor a solid, such as a solid powder or pellets);

[0110] 1.84. Any of the preceding compositions, wherein the composition is extruded at a pressure of 0.03 bar to 0.2 bar, e.g., 0.03 bar to 0.15 bar, or 0.03 bar to 0.10 bar, or 0.03 bar to 0.07 bar, or 0.04 bar to 0.06 bar, or about 0.05 bar;

[0111] 1.85. Any of the preceding compositions, wherein the composition has a viscosity (measured at 1 rpm) of 50,000 cP to 300,000 cP, e.g., 100,000 cP to 300,000 cP, or 150,000 cP to 250,000 cP, or 175,000 cP to 225,000 cP, or about 200,000 cP;

[0112] 1.86. Any of the preceding compositions, wherein after aging for up to 3 months at 40°C / 65% relative humidity, the composition maintains an extrusion pressure of less than 0.1 bar and / or a viscosity of less than 300,000 cP (at 1 rpm);

[0113] 1.87. Any of the preceding compositions, wherein the composition loses no more than 10% of its initial active oxygen (AO) content after aging at 60°C / 75% relative humidity for 1 week, or 2 weeks, or 3 weeks, or 1 month, or 2 months, or 3 months;

[0114] 1.88. Any of the preceding compositions, wherein the composition loses no more than 5% of its initial active oxygen (AO) content after aging at 60°C / 75% relative humidity for up to 1 week, or 2 weeks, or 3 weeks, or 1 month, or 2 months, or 3 months;

[0115] 1.89. Any of the preceding compositions, wherein the composition loses no more than 15% of its initial active oxygen (AO) content after aging at 40°C / 60% relative humidity for up to 1 month, or 2 months, or 3 months;

[0116] 1.90. Any of the preceding compositions, wherein the composition loses no more than 10% of its initial active oxygen (AO) content after aging at 40°C / 60% relative humidity for up to 1 month, or 2 months, or 3 months;

[0117] 1.91. Any of the preceding compositions, wherein the composition loses no more than 5% of its initial active oxygen (AO) content after aging at 40°C / 60% relative humidity for up to 1 month, or 2 months, or 3 months;

[0118] 1.92. Any of the preceding compositions, wherein the composition has a foam volume of at least 100 mL, e.g., at least 120 mL, or at least 130 mL, or at least 140 mL, after stirring at 4000 rpm for 120 seconds;

[0119] 1.93. Any of the preceding compositions, wherein the composition forms bubbles of size (R 32 ) Foam not larger than 50 μm, for example, less than 45 μm;

[0120] 1.94. Any of the preceding compositions, wherein the composition has a freezing point below 15°C, e.g., below 10°C, or below 5°C, or below 0°C, e.g., between 0°C and 15°C, or between 0°C and 10°C, or between 0°C and 5°C;

[0121] 1.95. Any of the preceding compositions, wherein the composition has an extrudability greater than 0.1 mL / sec, e.g., as measured using a Texture-Analyzer with tube extrusion (TA-TR), e.g., as described in Example 7 herein, e.g., 0.1 ml / sec to 5 ml / sec, 0.1 ml / sec to 4 ml / sec, or 0.1 ml / sec to 3 ml / sec, or 0.1 ml / sec to 2 ml / sec, or 0.5 ml / sec to 5 ml / sec, or 0.5 ml / sec to 4 ml / sec, or 0.5 ml / sec to 3 ml / sec, or 0.5 ml / sec to 2 ml / sec, or 1 ml / sec to 5 mL / sec, or 1 mL / sec to 4 mL / sec, or 1 mL / sec to 3 mL / sec, or 1 mL / sec to 2 mL / sec, or 1.5 mL / sec to 2 mL / sec, or 2 mL / sec to 5 mL / sec, or 3 mL / sec to 5 mL / sec, or 4 mL / sec to 5 mL / sec, or greater than 0.5 mL / sec, or greater than 1 mL / sec, or greater than 2 mL / sec, or greater than 3 mL / sec, or greater than 4 mL / sec, or greater than 5 mL / sec;

[0122] 1.96. Any of the preceding compositions, wherein the composition has an extrusion pressure of less than 0.1 bar, e.g., as measured using the "Extrusion Pressure" method as described in Example 7 herein, e.g., less than 0.07 bar, less than 0.06 bar, less than 0.05 bar, less than 0.04 bar, less than 0.03 bar, less than 0.02 bar, less than 0.01 bar, 0.001 bar to 0.1 bar, 0.001 bar to 0.07 bar, 0.001 bar to 0.06 ... an extrusion pressure of 0.001 bar to 0.05 bar, 0.001 bar to 0.04 bar, 0.001 bar to 0.03 bar, 0.001 bar to 0.02 bar, 0.001 bar to 0.01 bar, 0.005 bar to 0.07 bar, 0.005 bar to 0.06 bar, 0.005 bar to 0.05 bar, 0.005 bar to 0.04 bar, 0.005 bar to 0.03 bar, 0.005 bar to 0.02 bar, or 0.005 bar to 0.001 bar;

[0123] 1.97. Any of the foregoing compositions, wherein the composition has a static viscosity (e.g., at 1 second) of less than 300 Pa*s. -1s, less than 100 Pa*s, less than 50 Pa*s, from 1 Pa*s to 300 Pa*s, from 1 Pa*s to 250 Pa*s, from 1 Pa*s to 200 Pa*s, from 1 Pa*s to 150 Pa*s, from 1 Pa*s to 100 Pa*s, from 1 Pa*s to 50 Pa*s, from 10 Pa*s to 50 Pa*s, from 10 Pa*s to 50 Pa*s, as measured using the low shear rate viscosity method as described in Example 7 herein. a static viscosity of from 10 Pa*s to 300 Pa*s, from 10 Pa*s to 250 Pa*s, from 10 Pa*s to 200 Pa*s, from 10 Pa*s to 150 Pa*s, from 10 Pa*s to 100 Pa*s, from 10 Pa*s to 50 Pa*s, from 20 Pa*s to 300 Pa*s, from 20 Pa*s to 250 Pa*s, from 20 Pa*s to 200 Pa*s, from 20 Pa*s to 150 Pa*s, from 20 Pa*s to 100 Pa*s, or from 20 Pa*s to 50 Pa*s;

[0124] 1.98. Any of the preceding compositions, wherein the composition has a hardening point of less than 13°C, e.g., as measured using a method as described in Example 7 herein, e.g., less than 12°C, less than 10°C, less than 8°C, less than 6°C, less than 4°C, less than 2°C, less than 1°C, less than 0°C, -10°C to 13°C, -10°C to 12°C, -10°C to 10°C, -10°C to 8°C, -10°C to 6°C, -10°C to 4°C, -10°C to 2°C, -10°C to 1°C, -10°C to 0°C, -5°C to 13°C, -5°C to 12°C, -5°C to 10°C , a hardening point of -5°C to 8°C, -5°C to 6°C, -5°C to 4°C, -5°C to 2°C, -5°C to 1°C, -5°C to 0°C, 0°C to 13°C, 0°C to 12°C, 0°C to 10°C, 0°C to 8°C, 0°C to 6°C, 0°C to 4°C, 0°C to 2°C, 0°C to 1°C, 2°C to 13°C, 2°C to 12°C, 2°C to 10°C, 2°C to 8°C, 2°C to 6°C, 2°C to 4°C, 4°C to 13°C, 4°C to 12°C, 4°C to 10°C, 4°C to 8°C, 4°C to 6°C, 6°C to 13°C, 6°C to 12°C, 6°C to 10°C, or 6°C to 8°C.

[0125] Potassium monopersulfate (also known as MPS, KMPS, potassium monopersulfate or potassium monooxysulfate) is used as or Commercially available, both are triple salts of potassium peroxymonosulfate, potassium bisulfate, and potassium sulfate (2KHSO5·KHSO4·K2SO4).

[0126] Potassium peroxymonosulfate has limited stability in aqueous solution and may be unstable due to other common toothpaste ingredients (even small amounts of water). Therefore, contact with water should be avoided or minimized during processing and storage. The composition is preferably packaged in a moisture-free environment.

[0127] The composition of the present disclosure does not comprise water or has low water content.As used herein, term " low water content " means the total concentration of water, comprises the whole water comprising in any free water and any composition.In the various embodiments of composition, the amount of water is less than 4 % by weight, or less than 3 % by weight, or less than 2 % by weight, or less than 1 % by weight, or less than 0.5 % by weight, or less than 0.1 % by weight, or about 0.0001 % by weight to about 4 % by weight, or about 0.0001 % by weight to about 0.5 % by weight, or about 0.0001 % by weight to about 0.1 % by weight.Preferably, composition does not have the water added.

[0128] The amount of potassium peroxomonosulfate in the compositions of the present invention is effective to produce improved tooth whitening when used once or twice daily for about three months, compared to a control composition not containing peroxomonosulfate. The amount of peroxomonosulfate is typically from about 0.1% to about 10%, preferably about 1% or 2% by weight, of the composition.

[0129] In some embodiments, the compositions of the present disclosure include a buffer. Examples of buffers include anhydrous carbonates such as sodium carbonate, sesquicarbonates, bicarbonates such as sodium bicarbonate, silicates, bisulfates, 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. A typical amount of buffer is about 0.1% to about 5%, in one embodiment about 1% to about 3%, and in another embodiment about 0.5% to about 1%, by weight of the total composition.

[0130] 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 composed of a central hydrophobic chain of polyoxypropylene units (also known as poly(propylene oxide) units) flanked by two hydrophilic chains of polyoxyethylene units (e.g., poly(ethylene oxide) units). Poloxamers have the following chemical structure:

[0131] HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H,

[0132] wherein a and b are integers, each typically ranging from 10 to 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 different from poloxamers include those manufactured by BASF as and PEG / PPG copolymers are sold in the PEGYLATE series of polymers, which are random PEG / PPG copolymers.

[0133] For example, suitable poloxamers may include one or more of the following: L35, L43, L64, L10, L44, L62, 10R5, 17R4, L25R4, P84, P65, PI 04 and PI 05. The BASF(R) brand of dispersants are commercially available from BASF, Florham Park, New Jersey.

[0134] In some embodiments, the compositions of the present disclosure may include polyvinylpyrrolidone (optionally cross-linked), also known as poly-N-vinyl-poly-2-pyrrolidone, and often abbreviated as "PVP" (optionally cross-linked PVP). PVP generally refers to a polymer comprising vinylpyrrolidone (also known as N-vinylpyrrolidone, N-vinyl-2-pyrrolidone, and N-vinyl-2-pyrrolidone) as a monomer unit. The monomer unit may include a polar imide group, four non-polar methylene groups, and a non-polar methane group. Cross-linked PVP includes those commercially available as follows: and and POLYPLASDO sold by Ashland, Covington, Kentucky, USA INF-10.

[0135] The compositions of the present disclosure may optionally include a whitening (oxidizing) agent in addition to potassium permonosulfate, but preferably do not include another whitening agent. Whitening agents are typically materials that effectively provide whitening to the tooth surface to which they are applied via oxidation, and include reagents such as hydrogen peroxide and urea peroxide. In various embodiments, the compositions of the present disclosure may optionally include peroxide whitening agents (including peroxide compounds), but preferably do not include peroxide whitening agents or do not include peroxide compounds. Peroxide compounds are oxidizing compounds that include 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. Alkali metal and alkaline earth metal peroxides include lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof. Organic peroxide compounds include urea peroxide (also known as urea hydrogen peroxide), glyceryl hydrogen peroxide, alkyl hydrogen peroxide, dialkyl peroxide, alkyl peroxyacid, peroxyester, diacyl peroxide, benzoyl peroxide and monoperoxyphthalate and mixtures thereof. Peroxyacids and their salts include organic peroxyacids such as alkyl peroxyacid and monoperoxyphthalate and mixtures thereof, and inorganic peroxyacid salts such as persulfates, dipersulfates, percarbonates, perphosphates, perborates and persilicates of alkali metals and alkaline earth metals (such as lithium, potassium, sodium, magnesium, calcium and barium), and mixtures thereof. In various embodiments, peroxide compounds include hydrogen peroxide, urea peroxide, sodium percarbonate and mixtures thereof. In some embodiments, peroxide compounds include hydrogen peroxide. In some embodiments, peroxide compounds consist essentially of hydrogen peroxide. In some embodiments, the composition may include non-peroxide whitening agents. Whitening agents in those available herein include non-peroxide compounds, such as chlorine dioxide, chlorite and hypochlorite. Chlorites and hypochlorites include those of alkali metals and alkaline earth metals (e.g., lithium, potassium, sodium, magnesium, calcium, and barium). One or more additional whitening agents are optionally present in a total amount effective for tooth whitening. In some embodiments, the composition additionally comprises an activator, such as tetraacetylethylenediamine. In some embodiments, the compositions of the present invention are free of all of the additional whitening agents listed above.

[0136] In some embodiments, the composition may include a non-oxidative whitening agent. Non-oxidative whitening agents include colorants (e.g., titanium dioxide and blue pigments or dyes) and hydroxyapatite. These agents make the teeth appear whiter by masking or covering the stains rather than chemically removing or destroying them.

[0137] The compositions of the present disclosure may optionally further comprise other ingredients, such as flavoring agents; fillers; surfactants; preservatives, such as sodium benzoate and potassium sorbate; colorants, including, for example, dyes and pigments; and sweeteners. 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.

[0138] As used herein, "anionic surfactants" means those surface active compounds or detergent compounds that contain in their molecular structure an organic hydrophobic group, typically containing 8 to 26 carbon atoms or typically containing 10 to 18 carbon atoms, and at least one water solubilizing group selected from sulfonate, sulfate and carboxylate groups to form a water-soluble detergent. Typically, the hydrophobic group will include C8-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-C2-C3 alkanolammonium, di-C2-C3 alkanolammonium or tri-C2-C3 alkanolammonium, wherein sodium cations, magnesium cations and ammonium cations are generally selected cations. Some examples of suitable anionic surfactants include, but are not limited to, linear C8-C 18 Alkyl ether sulfates, sodium, potassium, ammonium and ethanolammonium salts of ether sulfates and their salts. Suitable anionic ether sulfates have the formula R(OC2H4) n OSO3M, 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, such as C 12 -C 14 or C 12 -C 16 wherein the alkyl group is selected from the group consisting of sodium, potassium, ammonium, magnesium, monoethanolammonium, diethanolammonium, and triethanolammonium. Exemplary alkyl ether sulfates (e.g., sodium laureth (2EO) sulfate) contain 12 to 15 carbon atoms in their alkyl groups. 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%.

[0139] 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 (trade names Sold), polyoxyethylene, polyoxyethylene sorbitan esters (trade name sold), polyoxyethylene 40 hydrogenated castor oil, fatty alcohol ethoxylates, polyethylene oxide condensates of alkylphenols, products derived from the condensation of ethylene oxide with the reaction products of propylene oxide and ethylenediamine, ethylene oxide condensates of aliphatic alcohols, alkylpolyglycosides (e.g., fatty alcohol ethers of polyglycosides, such as fatty alcohol ethers of polyglucosides, such as decyl, lauryl, octyl, octyl, myristyl, stearyl and other ethers of glucose and polyglucosidic polymers, including, for example, octyl / octyl (C 8-10 ) Glucoside, Cocoyl (C 8-16 ) Glucoside and Lauryl (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 substances.

[0140] In some embodiments, nonionic surfactants include amine oxides, fatty acid amides, ethoxylated fatty alcohols, block copolymers of polyethylene glycol and polypropylene glycol, glycerol alkyl esters, polyoxyethylene glycol octylphenol ethers, sorbitan alkyl esters, polyoxyethylene glycol sorbitan alkyl esters, and mixtures thereof. Examples of amine oxides include, but are not limited to, lauramidopropyl dimethylamine oxide, myristamidopropyl dimethylamine oxide, and mixtures thereof. Examples of fatty acid amides include, but are not limited to, coconut oil monoethanolamide, lauramide monoethanolamide, coconut oil diethanolamide, and mixtures thereof. In certain embodiments, the nonionic surfactant is a combination of amine oxide and fatty acid amide. In certain embodiments, the amine oxide is a mixture of lauramidopropyl dimethylamine oxide and myristamidopropyl dimethylamine oxide. In certain embodiments, the nonionic surfactant is a combination of lauryl / myristamidopropyl dimethylamine oxide and coconut oil monoethanolamide. 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%.

[0141] As used herein, the term "cationic surfactant" includes the cationic surfactants disclosed in WO 2007 / 011552 A2, the contents of which are incorporated herein by reference in their entirety.

[0142] 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 alkyl ethers, polyoxyethylene polyoxypropylene block copolymers, polyoxyethylene alkylphenyl ethers, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid esters, and polyoxyethylene glycerol fatty acid esters. In the present invention, each of these can be used alone, or two or more of them can be used in combination. Typical amounts of surfactants 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.

[0143] Examples of fillers are crystalline cellulose, ethyl cellulose, dextrin, various cyclodextrins (α-cyclodextrin, β-cyclodextrin and γ-cyclodextrin), sodium sulfate and its derivatives, and pullulan.

[0144] Available flavoring agents include natural and synthetic flavor 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 oils, such as lemon, orange, grape, lime, and grapefruit; fruit essences, including, for example, apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot, and other fruit flavors. Other flavoring agents that may be used include, for example, aldehydes and esters (e.g., benzaldehyde (cherry, almond)); citral, i.e., α-citral (lemon, lime); neral, i.e., β-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 (unripe fruit); 2-dodedenal (citrus, tangerine); and mixtures thereof.

[0145] Suitable colorants include, for example, food, drug, and cosmetic (FD&C) colors, including, for example, dyes, lakes, and certain natural and derived colorants. Useful lakes include dyes absorbed on aluminum hydroxide and other suitable carriers.

[0146] Suitable sweeteners include stevia; sugars such as sucrose, glucose, invert sugar, fructose, ribose, tagalose, sucralose, maltitol, erythritol, xylitol, and mixtures thereof; saccharin and its various salts (e.g., sodium and calcium salts of saccharin); cyclamate and its various salts; dipeptide sweeteners (e.g., aspartame); acesulfame potassium; dihydrochalcone; glycyrrhizin; and sugar alcohols, including, for example, sorbitol, sorbitol syrup, mannitol, and xylitol, and combinations thereof.

[0147] It will be understood that while the general properties of each of the above classes of materials may differ, within two or more of such classes of materials, there may be some common properties, and any given material may be used for multiple purposes. All ingredients in a composition may have functions other than their primary function and may contribute to the overall properties of the composition, including its stability, efficacy, consistency, mouthfeel, taste, smell, etc. For example, a binder may also act as a disintegrant, and vice versa.

[0148] In a second aspect, the present disclosure provides a method for whitening teeth comprising the steps of: (a) applying any of composition 1, or 1.1, et seq. to 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 achieve whitening of the teeth contacted by the composition. In some embodiments, the composition can be applied using a toothbrush and maintained in contact with the teeth by utilizing a brushing action. In some embodiments, the composition can be applied to the teeth using a dental tray and maintained in contact with the teeth by placing the dental tray in the mouth until whitening is complete.

[0149] In other embodiments, the present disclosure provides use of any of Composition 1, or 1.1 et seq., or any other embodiment thereof for whitening teeth.

[0150] Example

[0151] Illustrative embodiments of the present disclosure will be described with reference to the following examples, which are included for purposes of illustration and not to limit the scope of the invention.

[0152] In the examples and elsewhere in the specification of the present invention, chemical symbols and terms have their usual and customary meanings. Unless otherwise indicated, temperatures are in degrees Celsius. The amount of the component is the weight percentage based on the described standard; if no other standard is described, it will be inferred to be the total weight of the composition. The various names of chemical components include those listed in the CTFA International Cosmetic Ingredient Dictionary (Cosmetics, Toiletry and Fragrance Association, Inc., 7th Edition. 1997).

[0153] Example 1: Exemplary MPS-Based Whitening Dentifrice

[0154] Potassium peroxymonosulfate is combined with calcium pyrophosphate and other excipients and mixed to provide a homogenous product.

[0155] The composition may have the following formulation:

[0156]

[0157] Testing of formulations within the scope of the present disclosure showed that they provided improved stability and retained active oxygen activity compared to comparative formulations not within the scope of the present disclosure.

[0158] Example 2: MPS stability

[0159] To evaluate the effect of replacing calcium pyrophosphate abrasive with a high cleaning silica abrasive, four compositions were prepared according to the following table:

[0160]

[0161] Compositions A, B, C, and D were compared in an accelerated aging study. Samples were placed in tubes and stored at 60°C / 75% RH (relative humidity) for 2 weeks. Active oxygen (AO) levels were determined initially and at 1 and 2 weeks by iodine titration. The results are shown in the following table (expressed as a percentage of the initial theoretical AO):

[0162] formula 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％

[0163] The results show that compositions A and B stabilized by calcium pyrophosphate abrasives and PEG / PPG triblock copolymers retained almost all of the active oxygen species over the 2-week study. In contrast, using high-cleaning silica abrasives (compositions F, G), there was a rapid loss of active oxygen species due to the decomposition of potassium monopersulfate. Without being bound by theory, it is believed that trace heavy metals in precipitated silica (e.g., high-cleaning silica) promote the catalytic decomposition of MPS (unlike fumed silica, which lacks such impurities). It is also noted that high-cleaning silica is a more effective abrasive than calcium pyrophosphate (e.g., the RDA (realtive dentin abrasivity, relative dentin abrasivity) of high-cleaning silica is about 160, but the RDA of calcium pyrophosphate is about 90). Therefore, this loss of abrasiveness is a result of improved MPS stability.

[0164] Example 3: Rheology

[0165] During the aging study, compositions A and B were compared using a Brookfield programmable viscometer. All tests were performed with toothpaste in a solid container (120 ml sample cup). The samples were stored at 40°C / 65% RH (relative humidity) for 2 or 3 months. A new location was selected at least 1 cm from the wall of the jar and from the previously tested location. The viscometer rotor was slowly lowered into the sample jar, disturbing the sample as little as possible. The blade v74 rotor on the viscometer shaft was then slowly lowered into the sample. The thixotropy ring test was performed according to the programmed software. Extrusion pressure (bar) is a measure used to assess the ability of a toothpaste or gel to be squeezed out of a tube. Acceptable squeeze pressures range from 0.03 bar to 0.1 bar, with approximately 0.05 bar being ideal. If the squeeze pressure is too low, the toothpaste will seep out of the tube or be expelled too vigorously from the tube under slight pressure. If the squeeze pressure is too high, the toothpaste will be difficult to squeeze out of the tube. Viscosity is measured at 1 rpm (in centipoise (cP)). The viscosity of the toothpaste is preferably maintained at 70,000 cP to 300,000 cP, and most preferably at about 200,000 cP during aging.

[0166] The results are shown in the table below (NM = Not Measurable, as the toothpaste could not be squeezed out of the tube):

[0167] Extrusion pressure initial 1 month 2 months 3 months Composition A 0.048 0.052 0.052 0.057 Composition B 0.080 NM (>0.2 bar) NM (>0.2 bar) NM (>0.2 bar)

[0168] Viscosity (1rpm) initial 1 month 2 months 3 months Composition A 205,883 258,726 282,788 298,990 Composition B 368,676 NM NM NM

[0169] 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.

[0170] Example 4: Whitening effect

[0171] The whitening efficacy of composition A was tested against composition E. Composition E is a commercial whitening toothpaste composition with high-cleansing silica. Composition E contains (in decreasing order of concentration): glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, fragrance, silica, sodium lauryl sulfate, cocamidopropyl betaine, trisodium phosphate, mica, chondrus crispus powder, PEG-20M, sodium fluoride, xanthan gum, and sodium chloride, as well as minor amounts of flavorings, colors, and preservatives.

[0172] The head of a soft-bristled toothbrush was cut from the handle and mounted on a brushing machine for use. Cow teeth were mounted and dyed with coffee and tea. Each toothpaste slurry was poured onto each tray and the teeth immediately began to be brushed. The teeth were brushed for 2 minutes under an applied pressure of 250 grams. The brushing machine was set to 120 strokes per minute. After 2 minutes, the brushing was stopped, the slurry was removed, and the teeth were rinsed with deionized water and then dried. The brushing process was repeated a total of 14 times to simulate using each product twice a day for 7 days.

[0173] Software from Medical High Technology (MHT) was used to measure the L*, a*, and b* values ​​of each tooth before and after treatment. The L*, a*, and b* values ​​were used to calculate the change in whiteness index for each tooth after 14 treatments compared to baseline. The whiteness index is reported as ΔW*, where:

[0174] W*=(a* 2 +b* 2 +(L*-100) 2 ) 1 / 2

[0175] ΔW*=W* 经处理的 –W* 基线

[0176] The absolute value of ΔW* is reported. It should be noted that the more positive the value of ΔW*, the closer the tooth color is to white.

[0177] The mean ΔW* values ​​of each product after 14 treatments were compared using an analysis of variance test. A subsequent Tukey's multiple comparison test was performed to evaluate pairwise comparisons of the products. A p-value of less than 0.05 indicated a statistically significant difference between the products.

[0178] The results are shown in the table below:

[0179]

[0180] At treatment 14, the whitening results of Composition A were statistically significantly improved (p-value 0.0023) over the whitening results of Composition E. The results demonstrate that the whitening compositions according to the present disclosure are highly effective, significantly more so than current commercial whitening compositions.

[0181] Example 5: Using blue pigment to improve whitening effect

[0182] Typically, teeth whitening is performed using an abrasive (e.g., high-cleaning silica) to remove stain molecules from the tooth surface, or an oxidizing agent to bleach the color of the stain molecules on the teeth, or both. The inventors have further discovered that the use of a blue pigment can mask the presence of stains by making the teeth appear whiter. This is important because both abrasives and oxidizing agents require a period of time (typically 1 to 2 weeks) to begin to show a significant whitening effect, while the masking effect of a blue pigment is much more immediate.

[0183] These compositions were compared in a whitening study: Composition A from Example 1, Composition A with the addition of 0.05% Blue 15 pigment (CI 74160), and a commercial whitening composition comprising 0.1% hydrogen peroxide and 0.05% Blue 15 pigment (Composition F).

[0184] Complete human molars were obtained from Therametric Technologies, Inc. The crown and root were separated, and the separated crown was bisected longitudinally using a Buehler IsoMet low-speed saw. The bisected crown sections were mounted in methacrylate resin, exposing only the enamel. Twenty-seven teeth were selected and three teeth per tray were mounted using heat-setting impression compound. All nine trays were used to evaluate each product in a randomized order.

[0185] All measurements were performed using a Spectroshade Micro instrument manufactured by Medical High Technology (MHT). Prior to measuring baseline optical properties of teeth, the instrument was calibrated according to the manufacturer's instructions. To perform a measurement, the instrument was positioned so that a tooth was within its field of view, and an image was captured. This process was repeated for each measurement in the study.

[0186] A 1:2 (weight / weight) slurry of toothpaste to artificial saliva was prepared for each sample (eg, approximately 250 g of toothpaste and 500 g of artificial saliva). The slurry was mixed by hand to fully homogenize the solution before adding to the tray.

[0187] The head of a soft-bristled toothbrush was cut from the handle and mounted on a brushing machine for use. 9 mL of standard toothpaste slurry was poured onto each tray and brushing started immediately. The teeth were brushed for 10 minutes under an applied pressure of 250 grams. The brushing machine was set to 120 strokes per minute. After 10 minutes, brushing was stopped, the slurry was removed, and the teeth were rinsed with deionized water and then dried. Baseline spectrophotometry was then performed. The teeth were then immersed in artificial saliva (9 mL / tray) and aged for 15 minutes at 37°C under stirring. The test toothpaste slurry was then added to the tray and the teeth were brushed for 2 minutes under an applied pressure of 250 grams. The brushing machine was set to 120 strokes per minute. After 2 minutes, brushing was stopped, the slurry was removed, and the teeth were rinsed with deionized water and then dried. Spectrophotometry was then performed after treatment. Data analysis is as described in Example 4.

[0188] The results are shown in the following table.

[0189] Average ΔW Composition A (1% MPS) 7.20 Composition A (1% MPS) + Blue 15 15.83 Composition F (0.1% HP) + Blue 15 12.01

[0190] The results show that the addition of Blue 15 pigment enhances the immediate whitening effect (1 brushing cycle) of the MPS toothpaste according to the present disclosure. Furthermore, the whitening effect of MPS in combination with Blue 15 is greater than the same amount of Blue 15 added to a comparable hydrogen peroxide-based toothpaste composition (0.1% HP has an active oxygen content comparable to 1% MPS).

[0191] Example 6: Synergistic effect of SLS and CAPB on foaming properties

[0192] Foaming properties were measured using a dynamic foam analyzer (DFA) from Kruss. DFA is equipped with a cylinder with a prism attached to one side, which allows the bubble size and bubble count on the cylinder surface to be measured. Before the test, 50 mL of each toothpaste slurry was made by mixing toothpaste sample and water in a 1:3 weight ratio. The slurry was delivered to the DFA cylinder. In order to measure the foaming rate, a flash foam test was performed. In this test, since the foam height could not be measured during stirring, stirring was occasionally stopped midway during foam growth to measure the foam height. In detail, the slurry was stirred at 4000 rpm for 10 seconds, and stirring was stopped for 15 seconds, during which time the foam height was measured. This stirring-stop procedure was repeated 12 times. After the flash foam test, the slurry was kept unstirred for another 20 seconds, and final foam height, bubble size and bubble count were measured. Bubble count was determined as both area count (bubbles per square millimeter on a flat surface) and volume count (bubbles per cubic millimeter). For each composition tested, the test was repeated three times. Analysis was performed using Kruss's Advance software.

[0193] Composition A is the MPS whitening toothpaste described above, and for comparison, compositions G and H were prepared, which correspond to composition A except that they do not contain CAPB (composition G) or SLS (composition H). Composition J is a commercial fluoride tooth cream for comparison. The formulations of the compositions are shown in the table below (all values ​​are weight percentages of the composition):

[0194]

[0195] The test results are shown in the table below:

[0196]

[0197]

[0198] These results show that the use of a combination of anionic surfactants (SLS) and zwitterionic surfactants (CAPB) in an MPS-based anhydrous toothpaste provides significantly improved foaming properties compared to using either anionic surfactants (SLS) or zwitterionic surfactants (CAPB) alone. For this synergistic combination, total foam volume increased at all time points, and the increase in foam volume was faster and more significant. For example, between 10 and 110 seconds, the foam volume of composition G increased by only 25%, and the foam volume of composition H increased by only 14%, but the foam volume of composition A increased by 45%. Moreover, most of this increase was achieved quickly, with the foam volume of composition A increasing by 35% from 10 to 40 seconds. In contrast, during this time period, the foam volumes of compositions G and H increased by only 11% and 6%, respectively. The results for composition A were also greatly improved compared to commercial toothpaste composition J.

[0199] Furthermore, the individual bubble size of the SLS / CAPB surfactant combination was found to be significantly smaller, resulting in a greater number of bubbles formed per unit area and per unit volume. These results lead to an improved mouthfeel when brushing teeth with the composition.

[0200] Example 7: Effect of PEG-400 on Extrudability

[0201] Extrudability Measurements Using a Texture Analyzer

[0202] A texture analyzer (TA) measures the response of a material when subjected to a force (e.g., compression or tension). Due to its adaptability, texture analysis has become commonplace in many industries and is used to measure a specific range of characteristics or properties related to material behavior, fracture, flow, adhesion, or bending. There are many fixtures that allow a texture analyzer to be used for various tests that simulate specific processes. One of them is the tube extrusion fixture (TA-TR), which can be used to test the extrusion of a material from a package (e.g., a toothpaste tube). See, for example, Ahuja et al., “Rheological measurements for prediction of pumping and squeezing pressures of toothpaste”, Journal of Non-Newtonian Fluid Mechanics, 258: 1-9 (2018).

[0203] In a typical experiment, the TA probe traveled downward at a speed of 20 mm / s and applied a constant force of 1.5 kg to the toothpaste tube for 5 seconds. During the experiment, the amount of paste discharged was collected and weighed. All pastes tested had similar densities (approximately 1.3 g / mL), and the mass was converted to volume and reported as flow rate in mL / s ("squeezability"). The force of 1.5 kg was chosen because it closely represents the typical force applied to a toothpaste tube by a human hand, based on recent studies on toothpaste tubes. See, e.g., J. Cepriá-Bernal et al., “Grip force and force sharing in two different manipulation tasks with bottles”, Ergonomics, 60:957-966 (2017); J. Cepriá-Bernal and A. Pérez González, “Dataset of Tactile Signatures of the Human Right Hand in Twenty-One Activities of Daily Living Using a High Spatial Resolution PressureSensor”, Sensors(Basel), 21:2594(2021).

[0204] The squeezability results determined using this TA-TR method were found to correlate closely with data from a panel of human testers. Preferred compositions were found to have squeezabilities greater than 0.1 mL / sec, typically in the range of 0.1 mL / sec to 2 mL / sec, although compositions with higher squeezability are achievable.

[0205] Extrudability based on rheological characterization

[0206] Rheological measurements were performed using a DHR rheometer. A standard 15 mm diameter, 4-paddle blade was used in a standard rheometer cup, with the shear rate swept from 0.1 to 30 s / s in logarithmic mode with 10 points per decade and 10 seconds per point. This corresponds roughly to an RPM range of 0.5 to 200.

[0207] Two parameters were extracted from these rheological measurements: the “squeeze pressure” as calculated by FitFlow; and the specific shear rate 1 s -1 The "resting" viscosity at 100° is obtained by integrating the flow curve and represents the pressure required to push the paste through a tapered tube (roughly simulating a toothpaste tube). This measurement and data analysis can be performed on a rheometer or on a Brookfield viscometer using the FitFlow method, but using a rheometer is preferred. For viscosity measurements, a low shear rate (e.g., 1 s -1 ) The test is performed from rest, as this best represents normal toothpaste tube squeezing conditions. This measurement is distinct from the typical Brookfield "viscosity" measurement, which is typically performed at 1 RPM after subjecting the sample to high shear at 200 RPM.

[0208] It was found that extrudability (both "extrusion pressure" and "rest" viscosity measurements) correlated well with the TA-TR results. Preferred compositions were found to have an extrusion pressure of less than 0.1 bar, typically in the range of 0.001 bar to 0.07 bar (more preferably 0.001 bar to 0.04 bar), and a "rest" viscosity of less than 400 Pa*s (Pascal*seconds), typically in the range of 10 Pa*s to 200 Pa*s (more preferably 10 Pa*s to 150 Pa*s).

[0209] Extrudability inferred from the hardening point

[0210] Another way to estimate extrudability is by determining the "hardening point" of the composition, which is the temperature at which the viscosity derivative curve (i.e., the slope of the viscosity curve) of the composition reaches a minimum. -1 By cooling the composition at a constant shear rate of 100°F (0.1°C), a viscosity curve (viscosity in Pa*s versus temperature, e.g., between 0°C and 20°C) can be quickly and easily determined using a rheometer. From this graph, a first derivative can be derived, providing a plot of the viscosity slope (Pa*s / °C) versus temperature (°C), with the hardening point being the minimum of the graph. Generally, the lower the hardening point (the temperature around which the viscosity increases sharply), the more extrudable the paste is at low temperatures.

[0211] The above method was applied to the following toothpaste composition:

[0212]

[0213] The results show that the formulation with PEG-400 provides a significant improvement in extrudability, especially at low temperatures, and that extrudability is further improved by adding propylene glycol to the formulation. For example, the results of the hardening point measurements are as follows:

[0214]

[0215] For the MPS / PEG-400 / PG formulation, the viscosity slope plotted against temperature shows a decrease starting at approximately 5°C, but the minimum value is not reached at the lowest temperature measured (0°C). The results obtained from the texture analyzer and rheological characterization are comparable. A hardening point value of less than 13°C, especially less than 10°C, is preferred to ensure adequate extrudability at lower temperatures.

[0216] Additional data indicate that the inclusion of salt additives (e.g., potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, aluminum nitrate) also provides significant reductions in hardening temperature, freezing point, and improved extrudability.

[0217] The present invention has been described above with reference to illustrative embodiments, but it should be understood that the present invention is not limited to the disclosed embodiments. Changes and modifications that occur to those skilled in the art when reading this specification are also within the scope of the present invention, and the scope of the present invention is defined in the appended claims.

Claims

1. A tooth whitening oral care composition comprising potassium permonosulfate, calcium pyrophosphate (Ca2P2O7), 5% to 20% polyethylene glycol-400 (PEG-400), and 10% to 60% of a polyoxyethylene / polyoxypropylene triblock copolymer, based on the weight of the composition.

2. The composition of claim 1, wherein the potassium peroxymonosulfate is the only oxidizing agent present in the composition.

3. A composition according to claim 1 or 2, wherein the composition comprises 10% to 40% calcium pyrophosphate (Ca2P2O7) by weight of the composition.

4. The composition of any one of claims 1 to 3, wherein the composition comprises the PEG-400 in an amount of 6% to 18%, or 7% to 15%, or 8% to 14%, or 9% to 13%, or 10% to 15%, or 10% to 13%, or 11% to 15%, or 11% to 13%, or 12% to 14%, or 12% to 13%, or about 12.5%, by weight of the composition.

5. The composition according to any one of claims 1 to 4, wherein the polyoxyethylene / polyoxypropylene triblock copolymer is a triblock copolymer having the formula: HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H, wherein a is an integer from 1 to 30, and b is an integer from 10 to 60.

6. The composition of any one of claims 1 to 5, wherein the composition further comprises one or more of the following: polyvinyl pyrrolidone, polyethylene glycol / polypropylene glycol random copolymer, polyethylene glycol, a polyphosphate (e.g., an alkali metal polyphosphate), and a surfactant (e.g., an anionic surfactant and / or a zwitterionic surfactant).

7. The composition of any one of claims 1 to 6, wherein the composition comprises a mixture of anionic and zwitterionic surfactants.

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 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.

10. The composition according to any one of claims 1 to 9, wherein the composition further comprises an antioxidant, for example an antioxidant selected from 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 1% to 5%, calcium pyrophosphate 20% to 40%, PEG-400 10% to 15% and a polyoxyethylene / polyoxypropylene triblock copolymer 25% to 50%, each by weight of the composition, the polyoxyethylene / polyoxypropylene triblock copolymer having the formula HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H, wherein b is an integer from 10 to 12 (eg, 11), and b is an integer from 15 to 20 (eg, 16), for example, the polymer is Pluronic L35.

12. The composition of any one of claims 1 to 11, wherein the composition comprises the potassium peroxymonosulfate in an amount of 1% to 3%, and the composition comprises 20% to 30% calcium pyrophosphate, 12% to 13% PEG-400, and 25% to 35% polyoxyethylene / polyoxypropylene triblock copolymer, each by weight of the composition, the polyoxyethylene / polyoxypropylene triblock copolymer having the formula HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H, wherein b is an integer from 10 to 12 (eg, 11), and b is an integer from 15 to 20 (eg, 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 having an average molar ratio of ethylene glycol units (EG) to propylene glycol units (PG) of about 105 to 125 EG to 55 to 75 PG (e.g., Pluracare L1220 polymer) 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. A composition according to 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. A 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. A composition according to any one of claims 1 to 15, wherein the composition further comprises from 1% to 15% propylene glycol, for example from 5% to 15%, or from 5% to 10%, or about 7.5% propylene glycol by weight of the composition.

17. The composition of any one of claims 1 to 16, wherein the composition further comprises 2% to 10% by weight of the composition of one or more of potassium nitrate, zinc nitrate, potassium sulfate, potassium chloride, calcium chloride, sodium chloride, or aluminum nitrate, such as 5% to 10%, or 10% to 15%, or 2% to 5%, or 3% to 8%, or about 5% (e.g., potassium nitrate or zinc nitrate).

18. The composition according to any one of claims 1 to 17, wherein the composition comprises: or 19. A composition according to any one of claims 1 to 18, wherein the composition is a dentifrice, such as a toothpaste or tooth gel.

20. A method for whitening teeth, comprising the steps of: (a) applying a composition according to any one of claims 1 to 19 to the teeth, and (b) maintaining the composition in contact with the teeth for a sufficient period of time (e.g., 0.1 minute to 60 minutes, or 0.1 minute to 30 minutes, or 0.1 minute to 10 minutes, or 0.1 minute to 5 minutes, or 0.1 minute to 2 minutes, or 0.1 minute to 1 minute) to achieve whitening of the teeth contacted by the composition.

21. Use of a composition according to any one of claims 1 to 19 in a method for whitening teeth.

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