Oral compositions and methods

By combining potassium persulfate and hydrogen peroxide and improving stability through specific formulation strategies and additives, the problems of low stability of active ingredients and low consumer acceptance in existing dental whitening products are solved, achieving higher whitening effects.

CN119836283APending Publication Date: 2025-04-15COLGATE PALMOLIVE CO
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Patent Information

Application Number
CN202380064283.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-09-09
Filing Date
2023-09-08
Publication Date
2025-04-15

AI Technical Summary

Technical Problem

In existing dental whitening products, active ingredients such as hydrogen peroxide and potassium persulfate are prone to lose stability in the presence of water and other ingredients, resulting in poor whitening effect and great irritation to teeth and gums, which is low in consumer acceptance.

Method used

An improved dental whitening and cleansing agent is formed by combining potassium persulfate and hydrogen peroxide and improving the stability of the biactive agent through specific formulation strategies and additives such as polymers and surfactants.

Benefits of technology

It achieves a higher whitening effect compared to toothpaste preparations using hydrogen peroxide or potassium persulfate alone, while avoiding the problems of stability and consumer acceptance.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure provides tooth whitening oral care compositions comprising potassium peroxymonosulfate and a source of hydrogen peroxide with improved stability and methods of using the same.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is an international patent application claiming priority to and the benefit of U.S. Provisional Application Serial No. 63 / 405,153, filed on September 9, 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 take many forms, but one of the more popular forms is as a dentifrice, such as toothpaste. Toothpaste must have a semi-solid form that can hold its shape well enough to be dispensed from a tube and rest on the bristles of a toothbrush, but is 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, and must be soluble enough to be dispersed in the mouth. These various objectives are usually met by formulating toothpaste with a mixture of liquid polar humectants (e.g., glycerol, polypropylene glycol, and sorbitol) in a high water base (e.g., 10% to 40% water). Various polymers are often 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 (e.g., fluoride sources and surfactants) may also interact negatively, resulting in instability and loss of activity of the active whitening agent. Therefore, it is 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 the high surface area, hygroscopicity, and acidic nature of many abrasives. However, abrasives can be a key component of whitening compositions because many stains are firmly but superficially attached 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 whitening teeth include a variety of ingredients, and the most common primary active whitening ingredient is a peroxide source, such as hydrogen peroxide. The use of peroxide reagents is generally difficult in terms of both the formulation and long-term stability of the resulting composition. In addition, at high concentrations or in prolonged contact with the oral mucosa, hydrogen peroxide may produce strong irritation to teeth and gums. Therefore, although hydrogen peroxide does have teeth whitening benefits, it may be difficult to use it in oral care products due to formulation, stability and consumer acceptability issues.

[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 usually have an anion [HSO5] - Permonosulfate whitening products have been explored for use in a number of oral care applications, including whitening strips, mouthwashes, and toothpastes. One common permonosulfate oxidant is potassium permonosulfate (KHSO5), also known as potassium monopersulfate and abbreviated as KMPS or MPS, and sold as part of the compositions Oxone and Caroat.

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

[0009] There remains a need for permonosulfate and hydrogen peroxide based teeth whitening dentifrice products that overcome stability, formulation and consumer acceptability issues that may arise. Summary of the invention

[0010] The present disclosure relates to oral care compositions (e.g., toothpastes) that combine potassium permonosulfate ("MPS") and hydrogen peroxide ("HP") to unexpectedly provide improved whitening efficacy relative to MPS or HP alone. In one aspect, disclosed herein is at least one formulation strategy to stabilize dual active agents (MPS and HP) that pass accelerated aging stability screening tests. The present disclosure also provides that selected combinations of MPS and HP (e.g., at 1% MPS and 2% HP) exhibit better whitening efficacy than toothpastes with even higher levels of hydrogen peroxide (e.g., 5% weight / volume). Thus, in one aspect, the present disclosure provides toothpaste formulations that can provide MPS in combination with a small amount of hydrogen peroxide, which provide improved whitening efficacy relative to formulations with large amounts of hydrogen peroxide alone (e.g., 5% hydrogen peroxide), and which avoid potential problems with stability and consumer acceptance.

[0011] The present disclosure provides a tooth whitening oral care composition comprising: 0.01% to 10% by weight of potassium permonosulfate (MPS); 5% to 60% by weight of an abrasive selected from calcium pyrophosphate (Ca2P2O7), insoluble sodium metaphosphate ([NaPO3] n), anhydrous calcium hydrogen phosphate (CaHPO4), or a mixture thereof; and 0.25% to 25% by weight of a source of hydrogen peroxide, by weight of the composition, wherein the source of hydrogen peroxide provides an amount of hydrogen peroxide (e.g., free hydrogen peroxide) of 0.05% to 4.5% by weight of the total composition. In some embodiments, the tooth whitening oral care composition comprises: about 1% potassium permonosulfate (MPS) by weight of the total composition, and an amount of a source of hydrogen peroxide that provides an approximate efficacy equivalent to 3% hydrogen peroxide (e.g., free hydrogen peroxide). In other embodiments, the composition may also include 20% to 60% by weight of a poloxamer (e.g., a polyoxyethylene / polyoxypropylene triblock copolymer). In other embodiments, the composition may further comprise one or more of the following: polyvinyl pyrrolidone, sodium stearate, abrasive silica (e.g., up to 10% by weight), polyethylene glycol / polypropylene glycol random copolymer, polyethylene glycol, propylene glycol, alkali metal polyphosphates, anionic surfactants, and amphoteric surfactants. In at least one aspect, the teeth whitening oral care composition of the present disclosure is a low water or anhydrous composition.

[0012] 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 preferred embodiments of the invention, are intended for illustrative purposes only and are not intended to limit the scope of the invention. DETAILED DESCRIPTION

[0013] The following description of the preferred embodiment is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

[0014] As used throughout, ranges are used as shorthand for describing each and every value within a range. Any value within a range may 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 the limitations in the present disclosure and the limitations of the cited references, the present disclosure shall prevail.

[0015] 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.

[0016] Open terms such as "include / including", "contain / containing" and the like mean "including / comprising". In this specification, unless otherwise specified, the use of the singular also includes the plural. For example, "a lubricant" also includes the case of using more than one lubricant.

[0017] "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%, including the end values ​​of the range.

[0018] In a first aspect, the present disclosure provides a tooth whitening oral care composition (Composition 1) comprising: (a) 0.01% to 10% by weight of potassium permonosulfate (e.g., about 1% by weight), (b) 5% to 60% by weight of an abrasive selected from calcium pyrophosphate (Ca2P2O7), insoluble sodium metaphosphate ([NaPO3] n ), anhydrous calcium hydrogen phosphate (CaHPO4), or a mixture thereof; and (c) 0.25% to 25% by weight of the composition of a source of hydrogen peroxide, wherein the source of hydrogen peroxide provides an amount of hydrogen peroxide (e.g., free hydrogen peroxide) of 0.05% to 4.5% (e.g., about 0.1%, about 1%, or about 2%, or about 3%, or about 4% by weight) of the total composition. In other embodiments, the present disclosure provides:

[0019] 1.1. Composition 1, wherein potassium permonosulfate is provided as a triple salt of potassium permonosulfate, potassium hydrogen sulfate and potassium sulfate, optionally wherein the triple salt comprises about 45% to 50% by weight of potassium permonosulfate, such as 47% or 49% by weight of potassium permonosulfate;

[0020] 1.2. Composition 1 or 1.1, wherein the composition comprises the potassium permonosulfate 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;

[0021] 1.3. Any of the preceding compositions, wherein the inorganic peroxymonosulfate salt is not granulated (eg, not granulated);

[0022] 1.4. Any of the preceding compositions, wherein the potassium permonosulfate and the hydrogen peroxide source are the only oxidizing agents present in the composition and / or the only whitening agents present in the composition;

[0023] 1.5. Composition 1 or any of 1.1 to 1.4, wherein the composition comprises 5% to 60% (e.g., 5% to 30%) calcium pyrophosphate (Ca2P2O7) by weight of the composition;

[0024] 1.6. Composition 1 or any one of 1.1 to 1.4, wherein the composition comprises 5% to 60% (e.g., 5% to 30%) of insoluble sodium metaphosphate ([NaPO3] n );

[0025] 1.7. Composition 1 or any one of 1.1 to 1.4, wherein the composition comprises 5% to 60% (e.g., 5% to 30%) of calcium pyrophosphate (Ca2P2O7) and insoluble sodium metaphosphate ([NaPO3] n );

[0026] 1.8. Composition 1 or any of 1.1 to 1.4, wherein the composition comprises 5% to 60% (e.g., 5% to 30%) of anhydrous calcium hydrogen phosphate (CaHPO4) by weight of the composition;

[0027] 1.9. Composition 1 or any of 1.1 to 1.4, wherein the composition comprises 5% to 60% (e.g., 5% to 30%) of calcium pyrophosphate (Ca2P2O7) and anhydrous calcium hydrogen phosphate (CaHPO4), by weight of the composition;

[0028] 1.10. Composition 1 or any of 1.1 to 1.9, wherein the composition comprises a total amount of the calcium pyrophosphate and / or the insoluble sodium metaphosphate and / or the anhydrous calcium hydrogen phosphate (CaHPO4) of 10% to 60%, or 10% to 50%, or 10% to 40%, or 10% to 35%, or 10% to 60%, or 10% to 50%, or 10% to 40%, or 10% to 35%, or 10% to 30%, or 10% to 30%, or 10% to 30%, or 10% to 27.5%, or 12% to 27%, or 12% to 26%, or about 15%, or about 20%, by weight of the composition;

[0029] 1.11. Composition 1 or any one of 1.1 to 1.10, wherein the composition comprises calcium pyrophosphate and / or insoluble sodium metaphosphate and / or anhydrous calcium hydrogen phosphate (CaHPO4) 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 10%, or 1% to 5%, or 10% to 35%, or 10% to 30%, or 10% to 20%, or 20% to 40%, or 20% to 30%, or 30% to 50%, or 30% to 40%, or 10% to 27.5%, or 15% to 25%, or 12% to 27%, or 12% to 26%, or about 10%, or about 15%, or about 20%, each independently by weight of the composition;

[0030] 1.12. Composition 1 or any of 1.1 to 1.10, wherein the hydrogen peroxide source is selected from a polymer-linked hydrogen peroxide complex, a silica-hydrogen peroxide complex (e.g., 20% to 50% HP by weight, e.g., HP complexed with fumed silica), and liquid aqueous hydrogen peroxide (e.g., 35% aqueous hydrogen peroxide or 50% aqueous hydrogen peroxide);

[0031] 1.13. Composition 1.13, wherein the hydrogen peroxide source is a polymer-linked hydrogen peroxide complex; 1.14. Composition 1.13, wherein the hydrogen peroxide source is a polyvinylpyrrolidone-hydrogen peroxide complex;

[0032] 1.15. Composition 1.13, wherein the hydrogen peroxide source is a cross-linked polyvinyl pyrrolidone-hydrogen peroxide complex;

[0033] 1.16. Composition 1.14 or 1.15, wherein the polyvinylpyrrolidone-hydrogen complex comprises 15% to 25% by weight of hydrogen peroxide, such as about 18% to 20% by weight of hydrogen peroxide, or about 18% or about 20% by weight of hydrogen peroxide;

[0034] 1.17. Composition 1 or any of 1.1 to 1.16, wherein the composition comprises 0.5% to 25% of a source of hydrogen peroxide (e.g., cPVP-HP complex), by weight of the composition, for example, 1% to 25%, or 1% to 20%, or 1% to 15%, or 1% to 10%, or 1% to 5%, or 5% to 25%, or 5% to 20%, or 5% to 15%, or 5% to 10%, or 10% to 25%, or 10% to 20%, or 10% to 15%, or 15% to 25%, or 15% to 20%, or 6% to 12%, 8% to 12%, or 16% to 17%, or about 5%, or about 10%, or about 15%, or about 16%, or about 17%, by weight of the composition;

[0035] 1.18. Composition 1 or any of 1.1 to 1.17, wherein the source of hydrogen peroxide provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.05% to 4.5% by weight of the total composition, e.g., 0.1% to 4.5%, or 0.5% to 4.5%, or 1 to 4.5%, or 1 to 4%, or 2% to 4%, or 3% to 4%, or 0.1% to 3.5%, or 0.5% to 3.5%, or 1% to 3.5%, or 2% to 3.5%, or 0.1% to 2.5%, or 0.5% to 2.5%, or 1% to 2.5%, or 1.5% to 2.5%, or 0.1% to 1%, or 0.1% to 0.5%, or about 0.1%, or about 1%, or about 2%, or about 3%, or about 4% by weight of the composition;

[0036] 1.19. Composition 1 or any of 1.1 to 1.18, wherein the composition further comprises a poloxamer (eg, a polyoxyethylene / polyoxypropylene triblock copolymer);

[0037] 1.20. Composition 1.19, wherein the polyoxyethylene / polyoxypropylene triblock copolymer is a triblock copolymer having the formula:

[0038] HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H,

[0039] wherein a is an integer from 1 to 30, and b is an integer from 10 to 60;

[0040] 1.21. Composition 1.20, wherein in the formula, a is an integer from 5 to 20, and b is an integer from 10 to 40;

[0041] 1.22. Composition 1.21, wherein in the formula, a is an integer from 10 to 15, and b is an integer from 10 to 20;

[0042] 1.23. Composition 1.22, 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);

[0043] 1.24. Composition 1 or any of 1.19 to 1.23, 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;

[0044] 1.25. Composition 1.24, wherein the polyoxyethylene / polyoxypropylene triblock copolymer is L35 (i.e., poloxamer 407);

[0045] 1.26. Composition 1 or any of 1.19 to 1.25, wherein the composition comprises the polyoxyethylene / polyoxypropylene triblock copolymer in an amount of 20% to 60%, for example 22% to 60%, or 22% to 50%, or 22% to 40%, or 22% to 35%, or 22% to 30%, or 25% to 60%, or 25% to 50%, or 25% to 40%, or 25% to 35%, or 25% to 30%, or 27% to 35%, or 28% to 35%, or about 26%, or about 30%, or about 31%, or about 32%, or about 33%, or about 34%, by weight of the composition;

[0046] 1.27. Any of the preceding compositions, wherein the composition further comprises one or more of: polyvinylpyrrolidone (e.g., 0.5% to 20% by weight), polyethylene glycol / polypropylene glycol random copolymer (e.g., 0.5% to 50% by weight), polyethylene glycol (e.g., 0.5% to 50% by weight), a humectant (e.g., polypropylene glycol, e.g., 1% to 20% by weight), a polyphosphate (e.g., an alkali metal polyphosphate, e.g., 0.1% to 5% by weight), a surfactant (e.g., an anionic surfactant and / or a zwitterionic surfactant, e.g., 0.1% to 6% by weight), and a thickener (e.g., fumed silica and / or sodium stearate, e.g., 0.1% to 10% by weight);

[0047] 1.28. Composition 1.27, wherein the composition further comprises polyvinylpyrrolidone;

[0048] 1.29. Composition 1.28, wherein the polyvinyl pyrrolidone is a cross-linked polyvinyl pyrrolidone;

[0049] 1.30. Composition 1.28 or 1.29, wherein the polyvinylpyrrolidone is not complexed or combined with hydrogen peroxide (e.g., the polyvinylpyrrolidone is not added to the composition in the form of a PVP-hydrogen peroxide complex);

[0050] 1.31. Composition 1.28 or 1.29, wherein the polyvinylpyrrolidone is complexed or associated with hydrogen peroxide (eg, cross-linked PVP complexed with hydrogen peroxide);

[0051] 1.32. Composition 1.28, wherein the polyvinyl pyrrolidone is linear polyvinyl pyrrolidone;

[0052] 1.33. Any of compositions 1.28 to 1.32, 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 5% to 10%, or 6% to 8%, or about 5%, or about 7.5%, by weight of the composition;

[0053] 1.34. Any of the preceding compositions, wherein the composition further comprises a polyethylene glycol / polypropylene glycol random copolymer (PEG / PPG copolymer, e.g., PEG / PPG 116 / 66 or PEG / PPG 38 / 8);

[0054] 1.35. Composition 1.34, 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);

[0055] 1.36. Composition 1.34, wherein the PEG / PPG random copolymer is L1220 (PEG / PPG 116 / 66);

[0056] 1.37. Any of compositions 1.34 to 1.36, wherein the composition comprises, by weight of the composition, 0.5% to 50%, or 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 PEG / PPG random copolymer in an amount of 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%;

[0057] 1.38. Any of the preceding compositions, wherein the composition further comprises polyethylene glycol;

[0058] 1.39. Composition 1.38, wherein the polyethylene glycol is selected from PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600 and PEG-2000;

[0059] 1.40. Composition 1.39, wherein the polyethylene glycol is PEG 600;

[0060] 1.41. Any of compositions 1.38 to 1.40, wherein the composition comprises, by weight of the composition, 0.5% to 50%, or 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 50%. % 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 10%, or about 12% (e.g., about 12.5%) of the polyethylene glycol in an amount of 15% 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 10%, or about 12% (e.g., about 12.5%);

[0061] 1.42. Any of the preceding compositions further comprising a humectant (eg, glycerin, sorbitol, xylitol, propylene glycol, or mixtures thereof).

[0062] 1.43. Composition 1.42, wherein the humectant comprises or consists of propylene glycol;

[0063] 1.44. Composition 1.42 or 1.43, wherein the composition comprises the humectant (e.g., propylene glycol) in an amount of 1% to 20%, or 2% to 18%, or 5% to 15%, or 5% to 12%, or 5% to 10%, or about 7.5%, by weight of the composition.

[0064] 1.45. 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 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 polymer polycarboxylates such as maleic anhydride or copolymers of maleic acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether (e.g., copolymers of maleic anhydride / maleic acid with methyl vinyl ether in a ratio of 1:4 to 4:1); polyphosphonic acids and polyphosphonates (i.e., 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 oxazoline; and quaternary ammonium polymer;

[0065] 1.46. Any of the preceding compositions, 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;

[0066] 1.47. Any of the preceding compositions, wherein the composition comprises 30% to 70% by weight of the polymer, e.g., 30% to 60% by weight, or 40% to 60% by weight, or 50% to 60% by weight, or 55% to 60% by weight, or 55% to 59% by weight, or 58% to 59% by weight of the polymer;

[0067] 1.48. 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;

[0068] 1.49. Composition 1.48, wherein the composition comprises sodium or potassium pyrophosphate, sodium or potassium tripolyphosphate, sodium or potassium tetraphosphate, sodium or potassium phytate, or a mixture thereof;

[0069] 1.50. Composition 1.49, wherein the composition comprises tetrasodium pyrophosphate or tetrapotassium pyrophosphate;

[0070] 1.51. Composition 1.49, wherein the composition comprises disodium dihydrogen pyrophosphate or dipotassium dihydrogen pyrophosphate;

[0071] 1.52. Composition 1.49, wherein the composition comprises tetrasodium pyrophosphate and disodium dihydrogen pyrophosphate;

[0072] 1.53. Any of compositions 1.48 to 1.52, 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 2.5% to 5%, or 3% to 5%, or 3.5% to 5%, or 4% to 5%, or 2.5% to 4.5%, or 3% to 4.5%, or 3.5% to 4.5%, or 2% to 4%, or 2.5% to 4%, or about 3%, or about 3.5%, or about 4% polyphosphate (e.g., about 3% tetrasodium pyrophosphate and about 1% disodium dihydrogen pyrophosphate);

[0073] 1.54. Any of the preceding compositions, wherein the composition further comprises one or more surfactants, for example, anionic surfactants, cationic surfactants, nonionic surfactants and / or zwitterionic surfactants;

[0074] 1.55. Composition 1.54, wherein the composition comprises a mixture of anionic surfactant and zwitterionic surfactant;

[0075] 1.56. Composition 1.54 or 1.55, 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 lauryl benzene sulfonate, sodium lauryl sulfoacetate, sodium N-methyl N-cocoyl taurate, sodium cocoyl isethionate, sodium dioctyl sulfosuccinate, and sodium cocomonoglyceride sulfate and its ammonium analogs;

[0076] 1.57. Composition 1.54 or 1.55, wherein the zwitterionic surfactant is selected from the group consisting of: cocamidopropyl betaine, 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 myristicamine oxide;

[0077] 1.58. Composition 1.54, 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 halide 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 dilauroyl acyl lysine;

[0078] 1.59. Composition 1.54, wherein the nonionic surfactant is selected from the group consisting of: coconut monoethanolamide, coconut diethanolamide, lauramidopropyl dimethylamine oxide, myristamidopropyl dimethylamine oxide, and decyl glucoside;

[0079] 1.60. Any of the preceding compositions wherein the composition comprises sodium lauryl sulfate.

[0080] 1.61. Any of the preceding compositions wherein the composition comprises cocamidopropyl betaine.

[0081] 1.62. Any of the preceding compositions, wherein the composition comprises a mixture of sodium lauryl sulfate and cocamidopropyl betaine;

[0082] 1.63. Any of the preceding compositions, wherein the composition comprises from 0.1% to 6% of a surfactant, e.g., from 0.1% to 5%, or from 0.5% to 5%, or from 1% to 5%, or from 1.5% to 5%, or from 2% to 5%, or from 3% to 5%, or from 4% to 5%, or from 1% to 4%, or from 2% to 4%, or from 3% to 4%, or from 2% to 5%, or from 3% to 5%, or from 1% to 3%, or from 1% to 2%, or from 2% to 3%, or from 2% to 2.5%, or from 1.5% to 2.5%, or from 2.5% to 3%, or from 2.25% to 2.75%, or from 2.25% to 2.5%, or about 2%, or about 2.3% of a surfactant, by weight of the composition;

[0083] 1.64. Any of the preceding compositions, wherein the composition comprises from 0.1% to 5% of a surfactant, for example from 0.1% to 4%, or from 0.1% to 3%, or from 0.1% to 2.5%, or from 0.1% to 2%, or from 0.1% to 1.5%, or from 0.1% to 1%, or from 0.1% to 0.5%, or from 1% to 4%, or 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 0.3%, or about 2% of any one or more surfactants in individual amounts, by weight of the composition;

[0084] 1.65. Any of the preceding compositions, wherein the composition comprises from 0.1% to 5%, or from 1% to 5%, or 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%, of sodium lauryl sulfate, and / or from 0.1% to 1%, or from 0.1% to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition;

[0085] 1.66. Any of the preceding compositions, 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;

[0086] 1.67. Any of the preceding compositions, wherein the composition further comprises an antioxidant selected from, for example, butylated hydroxyanisole, butylated hydroxytoluene, vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, and mixtures thereof;

[0087] 1.68. The aforementioned composition, wherein the antioxidant is butylated hydroxyanisole (BHA) or butylated hydroxytoluene (BHT);

[0088] 1.69. The aforementioned composition, wherein the antioxidant is butylated hydroxytoluene;

[0089] 1.70. Any of the preceding compositions, 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;

[0090] 1.71. Any of the preceding compositions, wherein the composition further comprises one or more thickeners, such as sodium stearate, 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 3% to 4%, or about 3%, or about 3.5%, or about 4%, or about 5%, by weight of the composition;

[0091] 1.72. Composition 1.71, wherein the thickener comprises sodium stearate;

[0092] 1.73. Composition 1.71 or 1.72, wherein the thickener comprises fumed silica;

[0093] 1.74. Any of the preceding compositions, wherein the composition further comprises a fluoride source;

[0094] 1.75. Composition 1.74, wherein the fluoride source is selected from sodium fluoride, sodium monofluorophosphate and stannous fluoride, or mixtures thereof;

[0095] 1.76. Composition 1.74 or 1.75, wherein the composition comprises 0.1% to 5% of a fluoride source by weight of the composition, for example 0.5% to 5%, or 0.5% to 3%, or 0.5% to 2%, or 0.5% to 1%, or about 1%, or about 0.75%, or about 0.45% of a fluoride source by weight of the composition;

[0096] 1.77. Any of the preceding compositions, wherein the composition further comprises an additional abrasive (ie, in addition to the calcium pyrophosphate and / or the insoluble sodium metaphosphate and / or the anhydrous calcium hydrogen phosphate);

[0097] 1.78. Composition 1.77 wherein the additional abrasive is selected from abrasive silica (e.g., hydrated silica, precipitated silica), calcium carbonate, calcium orthophosphate, calcium hydrogen 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%;

[0098] 1.79. Any of the preceding compositions, wherein the composition further comprises abrasive silica (e.g., in an amount up to 10% by weight of the composition);

[0099] 1.80. Composition 1.79, wherein the composition comprises the abrasive silica in an amount of 0.1% to 10%, or 1% to 8%, or 1% to 5%, or 1% to 3%, or 1% to 2%, or 2% to 8%, or 3% to 7%, or 5% to 10%, or 8% to 10%, by weight of the composition;

[0100] 1.81. Any of the preceding compositions, wherein the composition further comprises a desensitizing agent, for example, in an amount of 0.1% to 5% by weight, such as potassium nitrate;

[0101] 1.82. Any of the preceding compositions, wherein the composition further comprises an enamel strengthening agent, such as in an amount of 0.1% to 5% by weight, such as zinc phosphate (e.g., about 1% by weight);

[0102] 1.83. Any of the preceding compositions, wherein the composition further comprises one or more of a flavoring agent, a sweetener and / or a coloring agent, for example, 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%;

[0103] 1.84. 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);

[0104] 1.85. Any of the preceding compositions, wherein the composition has no added water;

[0105] 1.86. 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;

[0106] 1.87. Composition 1 or any of 1.1 to 1.86, wherein the composition comprises or consists of potassium permonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG / PPG triblock copolymer (e.g., poloxamer 408), polyvinylpyrrolidone, PEG-PPG random copolymer (e.g., PEG / PPG-116 / 66), polyethylene glycol (e.g., PEG-600), polyphosphate (e.g., sodium pyrophosphate), anionic surfactant (e.g., sodium lauryl sulfate), zwitterionic surfactant (e.g., cocamidopropyl betaine), fluoride source (e.g., sodium monofluorophosphate), thickener (e.g., fumed silica or sodium stearate), and one or more sweeteners, flavoring agents and / or colors, and optionally propylene glycol, and optionally an antioxidant (e.g., BHT);

[0107] 1.88. Composition 1 or any of 1.1 to 1.86, wherein the composition comprises or consists of potassium permonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG / PPG triblock copolymer (e.g., poloxamer 408), polyvinylpyrrolidone, PEG-PPG random copolymer (e.g., PEG / PPG-116 / 66), polyethylene glycol (e.g., PEG-600), polyphosphate (e.g., sodium pyrophosphate), anionic surfactant (e.g., sodium lauryl sulfate), fluoride source (e.g., sodium monofluorophosphate), thickener (e.g., fumed silica), and one or more sweeteners, flavoring agents and / or colors, and optionally propylene glycol, and optionally an antioxidant (e.g., BHT);

[0108] 1.89. Composition 1 or any of 1.1 to 1.86, wherein the composition comprises or consists of potassium permonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG / PPG triblock copolymer (e.g., poloxamer 408), PEG-PPG random copolymer (e.g., PEG / PPG-116 / 66), polyethylene glycol (e.g., PEG-600), propylene glycol, polyphosphate (e.g., sodium pyrophosphate), anionic surfactant (e.g., sodium lauryl sulfate), fluoride source (e.g., sodium monofluorophosphate), thickener (e.g., fumed silica), and one or more sweeteners, flavorants and / or colors, and optionally an antioxidant (e.g., BHT);

[0109] 1.90. Any of the preceding compositions, wherein the composition comprises from 20% to 60% by weight of one or more poloxamers (eg, polyoxyethylene / polyoxypropylene triblock copolymers), based on the weight of the composition;

[0110] 1.91. The aforementioned composition, wherein the composition comprises 20 wt% to 60 wt% of the polyoxyethylene / polyoxypropylene triblock copolymer based on the weight of the composition;

[0111] 1.92. Any of the preceding compositions, wherein the hydrogen peroxide source is selected from the group consisting of: hydrogen peroxide, cross-linked polyvinylpyrrolidone (PVP) hydrogen peroxide complex, polyvinylpyrrolidone (PVP) hydrogen peroxide complex, and combinations thereof;

[0112] 1.93. The aforementioned composition, wherein the hydrogen peroxide source comprises cross-linked PVP complexed with hydrogen peroxide;

[0113] 1.94. Any of the preceding compositions, wherein the composition is a dentifrice, such as a toothpaste or tooth gel;

[0114] 1.95. Any of the preceding compositions, wherein the composition has the consistency of a paste or gel (eg, not a free-flowing liquid, nor a solid, such as a solid powder or granules);

[0115] 1.96. Any of the preceding compositions, wherein the hydrogen peroxide source and / or the potassium peroxymonosulfate is or can be kept in separate containers until use (eg, a two-component composition);

[0116] 1.97. Composition 1 or any of compositions 1.1 to 1.96 wherein the hydrogen peroxide source and / or the potassium peroxymonosulfate is or can be maintained in the same container until use (e.g., a one-component composition), optionally wherein the one-component is a single-phase or two-phase component.

[0117] 1.98. Any of the preceding compositions, wherein the source of hydrogen peroxide is present in an amount to provide the following amount of hydrogen peroxide (e.g., free hydrogen peroxide), based on the total weight of the oral care product or whitening composition thereof: 0.05 wt. % to 4 wt. % (e.g., 0.075 wt. % to 3.5 wt. %, or 0.075 wt. % to 3 wt. %, or 0.075 wt. % to 2.5 wt. %, or 0.075 wt. % to 2.25 wt. %, or 0.075 wt. % to 2 wt. %, or about 0.1 %, or about 0.5%, or about 1 %, or about 2%, or about 3%, or about 4%, or about 4.5%, all by weight of the total composition);

[0118] 1.99. Any of the preceding compositions, wherein the composition comprises the potassium permonosulfate 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. , and wherein the composition further comprises a source of hydrogen peroxide in an amount providing the following amount of hydrogen peroxide (e.g., free hydrogen peroxide) based on the total weight of the oral care product or the whitening composition thereof: 0.05 wt % to 4 wt % (e.g., 0.075 wt % to 3.5 wt %, or 0.075 wt % to 3 wt %, or 0.075 wt % to 2.5 wt %, or 0.075 wt % to 2.25 wt %, or 0.075 wt % to 2 wt %, or about 0.1 %, or about 0.5%, or about 1 %, or about 2%, or about 3%, or about 4%, or about 4.5%, all by weight of the total composition);

[0119] 1.100. Any of the preceding compositions, wherein the composition comprises potassium permonosulfate in an amount of 0.01% to 5% (e.g., 0.1% to 2.5%, or about 1%), by weight of the total composition, and a source of hydrogen peroxide in an amount to provide hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.05% to 4% by weight (e.g., 0.075% to 3%, or 0.075% to 2%, or about 0.5%, or about 1%, or about 2%, or about 3%, or about 4%, or about 4.5%, all by weight of the total composition);

[0120] 1.101. Any of the preceding compositions, wherein the composition comprises the potassium permonosulfate in an amount of about 1% by weight of the total composition, and the source of hydrogen peroxide in an amount to provide hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of about 2% or 3% by weight of the total composition;

[0121] 1.102. Any of the preceding compositions, wherein the source of hydrogen peroxide comprises cross-linked PVP complexed with hydrogen peroxide in an amount of 1% to 25%, or 1% to 20%, or 2% to 15%, or 3% to 12%, or about 5.5%, or about 11%, or about 16% to 17%, and wherein the cross-linked PVP complexed with hydrogen peroxide provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.05% to 4.5%, e.g., 0.075% to 3.5%, or 0.075% to 3%, or 0.075% to 2.5%, or about 0.1%, or about 1%, or about 2%, or about 3%, or about 4%;

[0122] 1.103. Any of the preceding compositions, wherein the composition comprises:

[0123] 0.01% to 10% potassium peroxymonosulfate by weight of the composition; 5% to 60% calcium pyrophosphate (Ca2P2O7) and / or insoluble sodium metaphosphate ([NaPO3] n ); 3% to 20% by weight of a hydrogen peroxide source, by weight of the composition, wherein the hydrogen peroxide source provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.5% to 3.5% by weight, by weight of the composition); and 20% to 60% by weight of one or more poloxamers (e.g., polyoxyethylene / polyoxypropylene triblock copolymers), wherein the weights are relative to the total composition;

[0124] 1.104. Any of the preceding compositions, wherein the composition comprises:

[0125] 0.01% to 10% potassium permonosulfate (e.g., about 1% by weight, or about 2% by weight) by weight of the composition; 5% to 60% calcium pyrophosphate (Ca2P2O7) and / or insoluble sodium metaphosphate ([NaPO3] n ) (e.g., 27 wt % to 35 wt %); 0.5% to 25% by weight of the composition of a cross-linked PVP complexed with hydrogen peroxide, wherein the cross-linked PVP complexed with hydrogen peroxide provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.05 wt % to 4.5 wt % (e.g., about 0.1 wt %, or about 1 wt %, or about 2 wt %, or about 3 wt %, or about 4 wt %, or about 4.5 wt %); and 20% to 60% by weight of the composition of a PEG / PPG triblock copolymer (e.g., L35) (e.g., 27 wt % to 34 wt %);

[0126] 1.105. Any of the preceding compositions, wherein the amount of the source of hydrogen peroxide, based on the weight of the composition, is from 0.25% to 25% by weight (e.g., from 0.5% to 15%, or from 10% to 20%, or from 3% to 7%, or from 8% to 12%, or about 5.5%, or about 11%, or about 16% to 17% by weight) of the composition;

[0127] 1.106. Any of the preceding compositions, wherein the hydrogen peroxide source is selected from the group consisting of hydrogen peroxide, urea peroxide, sodium perborate, calcium peroxide, cross-linked polyvinylpyrrolidone (PVP) hydrogen peroxide complex, polyvinylpyrrolidone (PVP) hydrogen peroxide complex, sodium percarbonate, and combinations thereof;

[0128] 1.107. Any of the preceding compositions, wherein the composition comprises or consists of:

[0129]

[0130] 1.108. Any of the preceding compositions, wherein the composition comprises or consists of:

[0131]

[0132] 1.109. Any of the preceding compositions, wherein the composition comprises or consists of:

[0133]

[0134] 1.110. Any of the preceding compositions, wherein the composition comprises or consists of:

[0135]

[0136] 1.111. Any of the preceding compositions, wherein the composition comprises a total amount of water (including any water contained in additional ingredients) of less than 4%, e.g., less than 3%, or less than 2%, or less than 1%, or less than 0.5%, or less than 0.1%, or from about 0.0001% to about 4%, or from about 0.0001% to about 0.5%, or from about 0.0001% to about 0.1%, by weight of the composition;

[0137] 1.112. Any of the preceding compositions, wherein the composition is a dentifrice, such as a toothpaste or tooth gel;

[0138] Potassium monopersulfate (also known as MPS, KMPS, potassium monopersulfate or potassium monooxysulfate) is used as or Commercially available, both are triple salts of potassium persulfate, potassium hydrogen sulfate and potassium sulfate (2KHSO5·KHSO4·K2SO4) (ie, "MPS triple salt").

[0139] Potassium permonosulfate has limited stability in aqueous solutions and may require additional stabilizing ingredients. Therefore, contact with water should be avoided or minimized during processing and storage. The composition is preferably packaged in a moisture-free environment.

[0140] As used herein, the term "insoluble sodium metaphosphate" is used to refer to insoluble polymeric sodium metaphosphate having the empirical formula [NaPO3] n , also known as "Maddrell's salt". This is a very useful abrasive which is insoluble in water and has a low ability to release phosphate ions into solution. It has a high molecular weight with values ​​of n up to 2000. It is different from other abrasives such as trisodium orthophosphate (Na3PO4), tetrasodium pyrophosphate (Na4P2O7), pentasodium tripolyphosphate (Na5P3O 10 ), hexasodium tetraphosphate (Na6P4O 13 ), sodium trimetaphosphate (Na3[(PO3)3)]) or sodium hexametaphosphate (Na6[(PO3)6)]), all of which are water-soluble and readily hydrolyze under aqueous conditions to provide orthophosphate anions.

[0141] The composition of the present disclosure does not include water or has low water content. As used herein, the term "low water content" means the total concentration of water, including all water contained in any free water and any component. In a plurality of embodiments of the 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 %, 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.

[0142] The amount of potassium permonosulfate or hydrogen peroxide source in the composition 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 without a permonosulfate or hydrogen peroxide source. The amount of permonosulfate is generally from about 0.1% to about 10% by weight of the composition, and the amount of hydrogen peroxide source is sufficient to provide about 0.5% to 5% hydrogen peroxide by weight of the composition.

[0143] 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 the buffer is sufficient to provide a pH of about 5 to about 9, preferably about 6 to about 8, and more preferably about 7. The typical amount of buffer is about 0.1% to about 5%, about 1% to about 3% in one embodiment, and about 0.5% to about 1% in another embodiment by weight of the total composition.

[0144] In certain embodiments, the compositions of the present disclosure (e.g., any of Composition 1 et seq.) comprise a poloxamer, which is a polyoxyethylene-polyoxypropylene triblock copolymer. The term "poloxamer" or "poloxamer copolymer" refers to a nonionic triblock copolymer consisting of a central polyoxypropylene unit (also known as a poly(oxypropylene) unit) hydrophobic chain flanked by two polyoxyethylene units (e.g., poly(oxyethylene) units) hydrophilic chains. Poloxamer has the following chemical structure: HO-[CH2CH2O] a [-CH(CH3)CH2O-] b [CH2CH2O] a -H, 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. is the name of a series of poloxamer polymers manufactured by BASF. For example, F-127 is poloxamer 407. Poloxamer is 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 Poloxamer 407 manufactured by BASF under the trade name and PEG / PPG copolymers are sold in the SUPERTRAX series of polymers, which are random PEG / PPG copolymers.

[0145] 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 PI05. HYDRADE(R) brand dispersants are commercially available from BASF, Florham Park, NJ.

[0146] 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 cross-linked "PVP". PVP generally refers to a polymer comprising vinylpyrrolidone (also known as N-vinylpyrrolidone, N-vinyl-2-pyrrolidone, and N-vinyl-2-pyrrolidinone) 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 PVP sold as BASF, Mount Olive, New Jersey, USA. and and sold in Ashland, Covington, Kentucky, USA INF-10 is commercially available.

[0147] The hydrogen peroxide source can be any compound or substance capable of or configured to provide or release hydrogen peroxide, or can include any compound or material capable of or configured to provide or release hydrogen peroxide. In one aspect, the hydrogen peroxide source can be configured to release hydrogen peroxide when in contact with water. In certain aspects, exemplary hydrogen peroxide sources can be or include, but are not limited to, hydrogen peroxide (aqueous hydrogen peroxide), peroxyurea, sodium perborate, calcium peroxide, cross-linked polyvinyl pyrrolidone (PVP) hydrogen peroxide complex, polyvinyl pyrrolidone (PVP) hydrogen peroxide complex, silicon dioxide-hydrogen peroxide complex, sodium percarbonate, and combinations thereof. The hydrogen peroxide source can also be or include, but are not limited to, commercially available from Ashland Inc., Covington, Kentucky XL 10F complex. In a typical embodiment, the hydrogen peroxide source is aqueous hydrogen peroxide or a cross-linked PVP-hydrogen peroxide complex.

[0148] The amount or concentration of the hydrogen peroxide source may depend on the amount of hydrogen peroxide provided or otherwise delivered by the hydrogen peroxide source. In some embodiments, the hydrogen peroxide source may be present in an amount (e.g., 0.25% to 25% by weight) to provide 0.5% to 4.5% by weight of hydrogen peroxide (e.g., free hydrogen peroxide) based on the total weight of the oral care composition. For example, the hydrogen peroxide source may be present in an amount (e.g., 0.5% to 20% by weight, or about 5.5% by weight, or about 11% by weight, or about 16% to 17% by weight) to provide 0.05% to 4% by weight of hydrogen peroxide (e.g., free hydrogen peroxide) based on the total weight of the oral care product or its whitening composition. In some embodiments, the oral care composition of the present disclosure (e.g., any of Composition 1 et seq.) comprises a source of hydrogen peroxide in an amount (e.g., 0.5 wt. % to 20 wt. %, or about 5.5 wt. %, or about 11 wt. %, or about 16 wt. % to 17 wt. %) to provide 0.075 wt. % to 3 wt. % of hydrogen peroxide (e.g., free hydrogen peroxide) based on the total weight of the oral care composition. In some embodiments, the oral care composition of the present disclosure (e.g., any of Composition 1 et seq.) comprises a source of hydrogen peroxide in an amount (e.g., 0.5 wt. % to 15 wt. %, or about 5.5 wt. %, or about 11 wt. %) to provide 0.075 wt. % to 2.5 wt. % of hydrogen peroxide (e.g., free hydrogen peroxide) based on the total weight of the oral care composition. In some embodiments, the oral care composition of the present disclosure (e.g., any of Composition 1 et seq.) comprises a source of hydrogen peroxide in an amount (e.g., 0.5 wt. % to 15 wt. %, or about 5.5 wt. %, or about 11 wt. %) to provide hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.075 wt. % to 2.25 wt. % based on the total weight of the oral care composition. In some embodiments, the oral care composition of the present disclosure (e.g., any of Composition 1 et seq.) comprises a source of hydrogen peroxide in an amount (e.g., 0.5 wt. % to 15 wt. %, or about 5.5 wt. %, or about 11 wt. %) to provide hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.075 wt. % to 2 wt. % based on the total weight of the oral care composition. In some embodiments, an oral care composition of the present disclosure (e.g., any of Composition 1 et seq.) comprises a source of hydrogen peroxide in an amount providing about 0.05%, or about 0.1%, or about 1%, or about 2%, or about 3%, or about 4%, or about 4.5% by weight of hydrogen peroxide (e.g., 0.5 wt. % to 25 wt. %, or about 5.5 wt. %, or about 11 wt. %, or about 16 wt. % to 17 wt. %, or about 20 wt. % to 22 wt. %, or about 25 wt. %), wherein the weight is based on the total weight of the oral care composition.

[0149] In some embodiments, the composition of the present disclosure (e.g., any one of composition 1 and the like) may optionally include a whitening (oxidizing) agent in addition to potassium permonosulfate and a hydrogen peroxide source. Whitening agents are generally substances that effectively provide whitening of the tooth surface to which they are applied, and include agents such as urea peroxide. In multiple embodiments, the composition of the present disclosure (e.g., any one of composition 1 and the like) includes a hydrogen peroxide source, wherein the hydrogen peroxide source includes a divalent oxygen-oxygen group. In multiple embodiments, the composition of the present disclosure (e.g., any one of composition 1 and the like) may also include peroxides of alkali metals and alkaline earth metals, 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 urea peroxide (also known as urea hydrogen peroxide), glyceryl hydrogen peroxide, alkyl hydrogen peroxide, dialkyl peroxide, alkyl peroxy acid, peroxy ester, diacyl peroxide, benzoyl peroxide, and monoperoxy phthalate, and mixtures thereof. Peroxy acid and its salt include organic peroxy acid such as alkyl peroxy acid and monoperoxy phthalate and mixtures thereof, and inorganic peroxy acid salts such as persulfate, dipersulfate, percarbonate, perphosphate, perborate and persilicate of alkali metal and alkaline earth metal (such as lithium, potassium, sodium, magnesium, calcium and barium), and mixtures thereof. In certain embodiments, the oral care composition of the present disclosure (e.g., any one of composition 1 and the like) also includes peroxy urea and / or sodium percarbonate in addition to a hydrogen peroxide source. In some embodiments, the composition of the present disclosure (e.g., any one of composition 1 and the like) may also include a non-peroxide whitening agent. Whitening agents suitable for use herein include non-peroxide 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. Non-peroxide whitening agents also include colorants, such as titanium dioxide and hydroxyapatite. One or more additional whitening agents are optionally present in a total amount effective for tooth whitening. In some embodiments, the composition additionally includes an activator, such as tetraacetylethylenediamine. In some embodiments, the composition of the present invention may include a non-oxidative whitening agent, which is an agent that achieves a whitening effect without oxidizing stains in teeth, such as titanium dioxide or a blue dye or pigment (e.g., FD&C blue pigment or blue 15 pigment (CI 74160)). In some embodiments, the composition of the present invention does not contain all of the additional whitening agents listed above.

[0150] The compositions of the present disclosure may optionally further include 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 include one or more surfactants, such as anionic surfactants, cationic surfactants, zwitterionic surfactants, or nonionic surfactants.

[0151] As used herein, "anionic surfactants" means those surface active compounds or detergent compounds which contain in their molecular structure an organic hydrophobic group usually containing 8 to 26 carbon atoms or usually containing 10 to 18 carbon atoms and at least one water solubilizing group selected from sulfonate, sulfate and carboxylate 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 usually selected from sodium, potassium, ammonium, magnesium and mono-C2-C3 alkanolammonium, di-C2-C3 alkanolammonium or tri-C2-C3 alkanolammonium, wherein sodium, magnesium and ammonium cations are also commonly 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 The alkyl group of the present invention is alkyl, and M is a solubilizing cation selected from sodium, potassium, ammonium, magnesium, and monoethanolammonium, diethanolammonium, and triethanolammonium. Exemplary alkyl ether sulfates contain 12 to 15 carbon atoms in their alkyl groups, such as sodium laureth (2EO) 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%.

[0152] As used herein, "nonionic surfactant" generally refers to compounds produced by the condensation of oxyalkylene 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 (under the trade name ethylene oxide condensates, products derived from the condensation of ethylene oxide with the reaction products of propylene oxide and ethylenediamine, ethylene oxide condensates of aliphatic alcohols, alkyl polyglycosides (e.g., fatty alcohol ethers of polyglycosides such as fatty alcohol ethers of polyglucosides, such as decyl ether, lauryl ether, caprylyl ether, caprylyl ether, myristic ether, stearyl ether and other ethers of glucose and polyglucosidic polymers, including, for example, capryl / octyl (C 8-10 ) Glucoside, Coconut oil base (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.

[0153] 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, polyethylene glycol octylphenol ethers, sorbitan alkyl esters, polyethylene glycol sorbitan alkyl esters and mixtures thereof. Examples of amine oxides include, but are not limited to, lauramide propyl dimethyl amine oxide, myristamide propyl dimethyl amine 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, nonionic surfactants are combinations of amine oxides and fatty acid amides. In certain embodiments, amine oxides are mixtures of lauramide propyl dimethyl amine oxide and myristamide propyl dimethyl amine oxide. In certain embodiments, nonionic surfactants are combinations of laurel / myristamide propyl dimethyl amine 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%.

[0154] As used herein, the term "cationic surfactant" includes cationic surfactants disclosed in WO 2007 / 011552A2, the contents of which are incorporated herein by reference in their entirety. Examples of such compounds include benzalkonium chloride, dodecyltrimethylammonium chloride, benzyldimethylstearylammonium chloride, hexadecyltrimethylammonium bromide, benzethonium chloride (diisobutylphenoxyethoxyethyldimethylbenzylammonium chloride), methylbenzethonium chloride, hexadecylpyridinium chloride, Chloride, Alkylisoquinoline Bromide, hexetidine, hexamidine isethionate, octenidine, octenidine dihydrochloride, monobiguanides (e.g., p-chlorobenzyl biguanide and N'-(4-chlorobenzyl)-N"-(2,4-dichlorobenzyl) biguanide), poly(biguanides) (e.g., polyhexamethylene biguanide hydrochloride), bisbiguanides, cetylpyridinium chloride , chlorhexidine, Alexidine and N-α-acyl arginine alkyl ester salts (such as ethyl lauroyl arginine ester hydrochloride (ELAH)).

[0155] As used herein, the term "zwitterionic surfactant" is generally a linear compound having both anionic and cationic groups in the polar portion of the molecule, such as a carboxylic acid group or a sulfonic acid group and a quaternary amine group or an amine oxide group, respectively. Suitable zwitterionic surfactants include betaines and sultaines. Betaines are characterized by having a quaternary α-aminomethylcarboxylic acid group, while sultaines are characterized by having a quaternary γ-aminopropylsulfonic acid group or a γ-amino-β-hydroxysulfonic acid group. Suitable zwitterionic surfactants include, for example, cocamidopropyl betaine, 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 myristicamine oxide.

[0156] Examples of surfactants that can be used in the compositions of the present disclosure include 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 sorbitol fatty acid esters and polyoxyethylene glycerol fatty acid esters and cocamidopropyl betaine. In the present invention, each of them can be used alone or two or more of them can be used in combination. The typical amount of surfactant is about 0.1% to about 3% by weight of the total composition, about 0.1% to about 2% in one embodiment, and about 0.1% to about 1% in another embodiment.

[0157] Examples of fillers are crystalline cellulose, ethyl cellulose, dextrin, various cyclodextrins (ie, α-cyclodextrin, β-cyclodextrin, and γ-cyclodextrin), sodium sulfate, and derivatives thereof, and pullulan.

[0158] Available flavoring agents include natural and synthetic flavor sources, including, for example, volatile oils, synthetic flavor oils, flavor 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, sour orange, and grapefruit; Fruit essences include, for example, apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot, and other fruit flavoring agents. Other useful flavoring agents include, for example, aldehydes and esters such as benzaldehyde (cherry, almond); citral, i.e., α-citral (lemon, lime); neral, i.e., β-citral (lemon, lime); decanal (orange, lemon); aldehyde C-8 (citrus fruits); aldehyde C-9 (citrus fruits); aldehyde C-12 (citrus fruits); tolualdehyde (cherry, almond); 2,6-dimethyloctanal (unripe fruits); 2-dodecenal (citrus, tangerine); and mixtures thereof.

[0159] 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.

[0160] 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.

[0161] It should be understood that while the general properties of each of the above-mentioned classes of materials may differ, there may be some common properties among two or more of such classes of materials, and any given material may be used for multiple purposes. All ingredients in the 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 function as a disintegrant and vice versa.

[0162] 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 the composition is 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 the composition is maintained in contact with the teeth by placing the dental tray in the mouth until whitening is complete.

[0163] In other embodiments, the present disclosure provides use of any of Compositions 1 or 1.1 et seq., or any other embodiment thereof, for whitening teeth.

[0164] Example

[0165] Exemplary embodiments of the present disclosure will be described by reference to the following examples, which are included to illustrate but not to limit the scope of the invention.

[0166] In the examples of the present invention and elsewhere in the specification, chemical symbols and terms have their usual and customary meanings. Unless otherwise indicated, temperatures are in degrees Celsius. The amount of the component is in weight percentage based on the described standard; if no other standard is described, it refers to 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).

[0167] Example 1: Exemplary HP / MPS-Based Whitening Dentifrice

[0168] Potassium permonosulfate is combined with calcium pyrophosphate and cross-linked PVP-hydrogen peroxide complex and other excipients and mixed to provide a homogeneous product.

[0169] The composition may have the following formulation:

[0170] General composition A

[0171]

[0172] General composition B

[0173]

[0174] For example, a MPS / HP dentifrice composition (e.g., 1% MPS / 3% HP) can be formulated according to the present disclosure:

[0175]

[0176] 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.

[0177] Example 2a: Formulation of MPS and HP toothpaste

[0178] To utilize dual active agents, a combination of potassium permonosulfate ("MPS") and hydrogen peroxide in a toothpaste formulation was developed to unexpectedly enhance whitening efficacy relative to toothpastes containing greater amounts of hydrogen peroxide.

[0179] First, the level of MPS is selected to be 1% by weight of the oral care composition tested. Then, the level of HP is changed from 2 wt %, 3 wt %, or 4 wt % to be combined with MPS to evaluate the whitening efficacy. A challenge is to develop a formulation strategy to provide a stable dual-active agent product. Without being bound by theory, the challenges involved in developing a formulation strategy may be related to the understanding that due to poor compatibility, formulating MPS or HP alone in toothpaste will bring limited ingredient selection to those skilled in the art. For example, some commonly used humectants in market-based peroxide-containing toothpastes and non-whitening toothpastes may include propylene glycol, glycerol, and sorbitol. However, due to incompatibility with MPS, some of these humectants cannot be formulated in toothpastes containing MPS and HP. Therefore, the humectants used to formulate general compositions A and B (as described in Example 1) are L35 (Poloxamer 407), PEG (PEG-600), and propylene glycol (0% to 20%).

[0180] Secondly, a series of peroxide sources, including cross-linked PVP-hydrogen peroxide complexes and silica-hydrogen peroxide complexes, were also evaluated in the accelerated aging study. The compatibility test of MPS with HP was designed as follows: 1% MPS (provided as 2% by weight of Caroat triple salt) and 2% HP (amount of PVP-HP complex or silica-HP complex providing 2% by weight of hydrogen peroxide) were distributed into a gel matrix containing 95% Pluronic L35 (Poloxamer 407) and 5% sodium stearate. The samples were subjected to accelerated aging at 60°C for 1 week, and the active oxygen content was measured at the initial and 1 week. As expected, when combined with MPS, the compatibility of PVP-HP was improved relative to the composition containing silica-HP. As shown in Table 1, it was found that the initial active oxygen content of the two compositions was similar, but after aging for 1 week, significantly higher active oxygen was retained in the composition made using the PVP-HP complex compared to the composition made using the silica-HP complex.

[0181]

[0182] In addition, the thickeners fumed silica, cross-linked PVP and sodium stearate were evaluated in a complete toothpaste formulation with respect to viscosity and stability. The test formulation was as follows:

[0183]

[0184] The samples were subjected to accelerated aging at 40°C for 13 weeks, and the viscosity, pH and active oxygen content were measured at the initial and 13 weeks. It was found that each thickener could provide sufficient thickening efficacy, as well as compatibility with 1% MPS (provided by 2% Caroat) and 2% HP (11% cPVP-HP complex). In addition, the combination of fumed silica plus cross-linked PVP or fumed silica plus sodium stearate can also provide sufficient thickening efficacy and compatibility with MPS and HP. The results of the combined tests are shown in Table 2 below. As shown below, both thickening systems provide stable pH and good stability, with only a small amount and similar reduction in active oxygen after aging for 13 weeks. Both thickening systems also provide acceptable viscosity, with the fumed silica plus cPVP system providing a slightly higher viscosity.

[0185]

[0186] Example 2b: Formulation stability and enamel whitening efficacy relative to hydrogen peroxide-only toothpaste

[0187] To evaluate stability, variations of Formulation A shown below, with 1% MPS and HP in amounts ranging from 2% to 4%, were subjected to accelerated aging studies at 40°C for 13 weeks. Viscosity, pH, and active oxygen content were measured initially and at 13 weeks. The composition of Formulation A is shown in the table below:

[0188] Recipe A

[0189]

[0190] All data collected from the study met the specifications and no swelling or phase separation was observed throughout the aging process, indicating that the combination of 1% MPS and 2% to 4% HP maintained good stability throughout the aging process. The results are shown in Table 3.

[0191]

[0192] Formula A with 2% hydrogen peroxide was tested against a commercial 5% hydrogen peroxide based whitening toothpaste. The test used a standard in vitro brushing protocol incorporating stained bovine teeth. The composition of the 5% HP toothpaste is as follows:

[0193] Element weight% Cross-linked PVP complexed with hydrogen peroxide 22 Calcium pyrophosphate 15 Polyethylene glycol / polypropylene glycol random copolymer 116 / 66 copolymer 7.5 Polyoxypropylene-polyoxyethylene triblock copolymer 45 Fumed Silica 3.0 Polyphosphate 1.7 Butylated Hydroxytoluene 0.03 Sodium monofluorophosphate 0.76 Sodium lauryl sulfate 2 Sweeteners and flavoring agents 2.98

[0194] The bovine central incisor was artificially stained (in coffee and tea soup) and fixed in resin. The teeth were pre-brushed so that the initial L* value was 58 to 62. 10g of toothpaste was dispersed in 10g of DI water, and the slurry was used to brush the bovine incisor for 2 minutes at 120 back and forth / minutes under 250g force. A hyperspectral camera (Middleton Spectral Vision) was used to measure L*, a*, and b* values. L*, a*, and b* values ​​were measured after each brushing twice, and 14 brushings were performed to evaluate the whitening performance of the toothpaste for 7 days of use. The whitening performance is reported as the change in W value after treatment compared to the baseline value, and the results are shown in Tables 1 and 2 below. The equation for calculating ΔW from L*, a*, and b* values ​​is shown below. In Tables 1 and 2, the absolute value ΔW takes a positive value. The higher the absolute ΔW value, the whiter the teeth compared to the baseline measurement.

[0195] W*=(a* 2 +b* 2 +(L*-100) 2 ) 1 / 2

[0196] ΔW=W* 经处理的 –W* 基线

[0197] The results of the test are shown below in Table 4. The results show that the composition according to the present invention with 1% MPS and 2% HP provides better whitening than a commercial toothpaste product with 5% HP.

[0198]

[0199] 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 may be made by those skilled in the art after 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: (a) 0.01% to 10% potassium permonosulfate by weight of the composition; 5% to 60% abrasive by weight of the composition, the abrasive being selected from calcium pyrophosphate (Ca2P2O7), insoluble sodium metaphosphate ([NaPO3] n ), anhydrous calcium hydrogen phosphate (CaHPO4), or a mixture thereof; and (c) 0.25% to 25% by weight of a source of hydrogen peroxide, wherein the source of hydrogen peroxide provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.05% to 4.5% (e.g., about 0.1%, about 1%, or about 2%, or about 3%, or about 4% by weight) of the total composition.

2. The composition of claim 1, wherein the composition comprises the potassium permonosulfate 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.

3. A composition according to any one of the preceding claims, wherein the potassium permonosulfate and the source of hydrogen peroxide are the only oxidizing agents present in the composition and / or the only whitening agents present in the composition.

4. A composition according to any one of the preceding claims, wherein the composition comprises 5% to 60% calcium pyrophosphate (Ca2P2O7) by weight of the composition.

5. The composition of any of the preceding claims, wherein the hydrogen peroxide source is selected from polymer-linked hydrogen peroxide complexes, silica-hydrogen peroxide complexes (e.g., 20% to 50% HP by weight, e.g., HP complexed with fumed silica), and liquid aqueous hydrogen peroxide (e.g., 35% aqueous hydrogen peroxide or 50% aqueous hydrogen peroxide).

6. The composition according to claim 5, wherein the hydrogen peroxide source is a cross-linked polyvinylpyrrolidone-hydrogen peroxide complex.

7. A composition according to any one of the preceding claims, wherein the composition comprises a polyoxyethylene / polyoxypropylene triblock copolymer, and wherein the triblock copolymer has 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.

8. A composition according to any of the preceding claims, wherein the composition further comprises one or more of the following: polyvinylpyrrolidone (e.g., 1% to 50% by weight), polyethylene glycol (e.g., 0.5% to 50% by weight), a humectant (e.g., polypropylene glycol, e.g., 1% to 20% by weight), a polyphosphate (e.g., an alkali metal polyphosphate, e.g., 0.1% to 5% by weight), a surfactant (e.g., an anionic surfactant and / or a zwitterionic surfactant, e.g., 0.1% to 6% by weight), and a thickener (e.g., fumed silica and / or sodium stearate, e.g., 0.1% to 10% by weight).

9. The composition of claim 8, wherein the composition comprises sodium lauryl sulfate and / or cocamidopropyl betaine.

10. A composition according to claim 9, 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%, of sodium lauryl sulfate, and / or from 0.1% to 1%, or from 0.1% to 0.5%, or about 0.3%, of cocamidopropyl betaine, by weight of the composition.

11. A composition according to any one of claims 1 to 10, wherein the composition further comprises a polyethylene glycol / polypropylene glycol random copolymer (PEG / PPG copolymer, such as PEG / PPG 116 / 66 or PEG / PPG 38 / 8), for example, in an amount of 0.5% to 50% by weight of the composition.

12. A composition according to any one of claims 1 to 11, wherein the composition further comprises a humectant (e.g., glycerol, sorbitol, xylitol, propylene glycol, or mixtures thereof), optionally wherein the humectant comprises propylene glycol in an amount of 1% to 20% by weight of the composition.

13. A composition according to any one of claims 1 to 12, wherein the composition further comprises one or more thickeners, for example sodium stearate, magnesium aluminum silicate or fumed silica, optionally in an amount of 0.1% to 10% by weight of the composition, for example 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 3% to 4%, or about 3%, or about 3.5%, or about 4%, or about 5% by weight of the composition.

14. The composition of claim 13, wherein the composition comprises cross-linked polyvinyl pyrrolidone and fumed silica, or sodium stearate and fumed silica.

15. A composition according to any one of claims 1 to 14, wherein the composition comprises or consists of: (A) potassium permonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG / PPG triblock copolymer (e.g., poloxamer 408), polyvinylpyrrolidone, PEG-PPG random copolymer (e.g., PEG / PPG-116 / 66), polyethylene glycol (e.g., PEG-600), polyphosphate (e.g., sodium pyrophosphate), anionic surfactant (e.g., sodium lauryl sulfate), zwitterionic surfactant (e.g., cocamidopropyl betaine), fluoride source (e.g., sodium monofluorophosphate), thickener (e.g., fumed silica or sodium stearate), and one or more sweeteners, flavoring agents and / or colors, and optionally propylene glycol, and optionally an antioxidant (e.g., BHT); or (B) potassium permonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG / PPG triblock copolymer (e.g., poloxamer 408), polyvinylpyrrolidone, PEG-PPG random copolymer (e.g., PEG / PPG-116 / 66), polyethylene glycol (e.g., PEG-600), polyphosphate (e.g., sodium pyrophosphate), anionic surfactant (e.g., sodium lauryl sulfate), fluoride source (e.g., sodium monofluorophosphate), thickener (e.g., fumed silica), and one or more sweeteners, flavoring agents and / or colors, and optionally propylene glycol, and optionally an antioxidant (e.g., BHT); or (C) potassium permonosulfate (e.g., as MPS triple salt), cross-linked PVP-hydrogen peroxide complex, calcium pyrophosphate, PEG / PPG triblock copolymer (e.g., poloxamer 408), PEG-PPG random copolymer (e.g., PEG / PPG-116 / 66), polyethylene glycol (e.g., PEG-600), propylene glycol, polyphosphate (e.g., sodium pyrophosphate), anionic surfactant (e.g., sodium lauryl sulfate), fluoride source (e.g., sodium monofluorophosphate), thickener (e.g., fumed silica), and one or more sweeteners, flavorants and / or colors, and optionally an antioxidant (e.g., BHT).

16. The composition of any of the preceding claims, wherein the hydrogen peroxide source comprises cross-linked PVP complexed with hydrogen peroxide in an amount of 1% to 25% by weight, and wherein the cross-linked PVP complexed with hydrogen peroxide provides hydrogen peroxide (e.g., free hydrogen peroxide) in an amount of 0.05% to 4.5% by weight.

17. A composition according to any one of the preceding claims, wherein the composition comprises or consists of: or or or 18. A composition according to any preceding claim, wherein the composition is a dentifrice.

19. A method for whitening teeth comprising the steps of: (a) applying the composition according to any one of claims 1 to 18 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 with which the composition is contacted.

Citation Information

Patent Citations

  • Oral coompositions having cationic active ingredients

    WO2007011552A2