Compositions and related methods

Abstract

The present disclosure provides an intermediate composition (e.g., an aqueous slurry) for formulating a dental leucorrhea comprising a hydratable adhesive film, where the intermediate composition comprises an inorganic salt of peroxymonosulfate, preferably an alkali metal salt or an alkaline earth metal salt, or a mixture thereof, and methods of using the same and making a dental leucorrhea.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is an international application claiming priority and benefits of Chinese application No. 202210985240.6 filed on August 17, 2022, the contents of which are hereby incorporated by reference in their entirety. Background Art

[0003] Consumer products that provide tooth whitening are numerous and come in a variety of forms, and one of the more popular forms is tooth whitening strips. These strips, which typically have an adhesive material, are typically adhered to the front surface of the teeth for a long period of time, such as 10 minutes or more, during which time the entrapped whitening agent diffuses into the tooth enamel to bleach away stains. Due to the extended contact provided between the teeth and the whitening composition, such strips are often more convenient and more effective than alternative home whitening treatments such as toothpastes and mouthwashes.

[0004] Products currently available for whitening teeth contain a variety of different ingredients, and the main active ingredient is most often a peroxide source, such as hydrogen peroxide. The use of peroxide agents generally presents many difficulties in terms of both the formulation and long-term stability of the resulting composition. In addition, hydrogen peroxide may be highly irritating to teeth and gums at high concentrations or when in contact with the oral mucosa for a long time. Therefore, there is a need for alternative oxidants with improved stability, especially for whitening products that provide long-term contact with oral tissues.

[0005] Persulfate and its salts (persulfates) are powerful oxidants and detergents. They are currently used for a variety of industrial and consumer applications, including swimming pool treatment and denture cleaning. For some oral care applications such as mouthwashes and toothpastes, persulfate whitening products have been developed. The most common permonosulfate oxidant is potassium permonosulfate, commonly known as MPS, and sold as part of the composition Oxone or Caroat.

[0006] 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. Thus, potassium permonosulfate whitening compositions face particular difficulties in formulations intended for more than brief or transient use in the oral cavity.

[0007]

[0006] Therefore, there is a need for a teeth whitening product that provides the convenience and durability of strips with the improved properties of persulfate whitening agents. Summary of the invention

[0008] In a first aspect, the present disclosure provides an intermediate composition (Composition 1) (eg, an aqueous slurry) for formulating a tooth whitening strip including a hydratable adhesive film, wherein the intermediate composition comprises an inorganic peroxymonosulfate salt, preferably an alkali metal salt or an alkaline earth metal salt, or a mixture thereof.

[0009] In a second aspect, the present disclosure provides a tooth whitening strip (Strip 1), for example, comprising or made using an intermediate composition (Composition 1).

[0010] 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

[0011] 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.

[0012] As used throughout, ranges are used as shorthand for describing individual values ​​and each value within the 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.

[0013] Unless otherwise indicated, all percentages and amounts expressed herein and elsewhere in the specification should be understood to refer to percentages by weight. The amounts given are based on the effective weight of the material.

[0014] Open terms such as "include", "comprising", "containing", "with", etc. mean "including". In this specification, unless otherwise specified, the use of the singular form also includes the plural form. For example, "lubricant" also covers the case where more than one lubricant is used.

[0015] In a first aspect, the present disclosure provides an intermediate composition (Composition 1) (e.g., an aqueous slurry) for formulating a tooth whitening strip comprising a hydratable adhesive film, wherein the intermediate composition comprises an inorganic peroxymonosulfate salt, preferably an alkali metal salt or an alkaline earth metal salt, or a mixture thereof. In additional embodiments, the present disclosure provides (all weight percentages provided below are measured by weight of the intermediate composition):

[0016] 1.1. Composition 1, wherein the inorganic peroxymonosulfate salt is sodium peroxymonosulfate, potassium peroxymonosulfate or lithium peroxymonosulfate, or a combination thereof;

[0017] 1.2. Composition 1 or 1.1, wherein the peroxymonosulfate is potassium peroxymonosulfate;

[0018] 1.3. Composition 1.2, wherein the potassium peroxymonosulfate is a triple salt of potassium peroxymonosulfate, potassium hydrogen sulfate and potassium sulfate (e.g. ) is provided, optionally wherein the triple salt comprises about 45 wt % to 50 wt % potassium permonosulfate (MPS), such as 47 wt % or 49 wt % potassium permonosulfate;

[0019] 1.4. Any of the preceding compositions, wherein the composition comprises an effective amount of peroxymonosulfate, the effective amount being 0.01% to 5% by weight of the composition, for example 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 1.2% by weight of the composition. 5%, or 0.9% to 1.2%, or 0.6% to 1.2%, or 0.4% to 2%, or 0.4% to 1.5%, or 0.4% to 1.2%, or 0.4% to 1%, or 0.4% to 0.8%, or 0.3% to 2.0%, or 0.3% to 1.5%, or 0.3% to 1.2%, or 0.3% to 0.9%, or about 1%, or about 0.8%, or about 0.6%;

[0020] 1.5. Any of the preceding compositions, wherein the composition further comprises a second inorganic permonosulfate salt;

[0021] 1.6. Any of the preceding compositions, wherein the inorganic peroxymonosulfate salt is not particulate (eg, not granular);

[0022] 1.7. Any of the preceding compositions, wherein the composition does not comprise hydrogen peroxide;

[0023] 1.8. Any of the foregoing 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., peracetic acid, perbenzoic 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);

[0024] 1.9. Any of the preceding compositions, wherein the inorganic peroxymonosulfate salt is the only oxidizing agent present in the composition;

[0025] 1.10. Composition 1.9, wherein potassium permonosulfate (e.g., as part of a triple salt mixture) is the only oxidant present in the composition;

[0026] 1.11. Composition 1 or any one of 1.1 to 1.10, wherein the composition comprises one or more water-soluble or water-swellable polymers, wherein the one or more water-soluble or water-swellable polymers include anionic polymers and / or neutral polymers;

[0027] 1.12. Composition 1.11, wherein the composition comprises 5% to 50% by weight of a water-soluble or water-swellable polymer or humectant, such as 5% to 30%, or 10% to 30%, or 10% to 25%, or 15% to 25%, or 20% to 30%, or 25% to 30% (e.g., about 20%, or about 25%, or about 30%, or about 27%) of a water-soluble or water-swellable polymer or humectant;

[0028] 1.13. Composition 1 or any one of 1.1 to 1.12, wherein the composition comprises one or more humectants selected from the group consisting of polyethylene glycol (e.g., PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, PEG-2000); polypropylene glycol; polyoxyethylene-polyoxypropylene copolymers (PEG-PPG, including block copolymers, triblock copolymers (poloxamers, such as poloxamer 407); and random copolymers, such as PEG / PPG-116 / 66 and PEG / PPG-38 / 8); ethanol; glycerol; propylene glycol; sorbitol and xylitol;

[0029] 1.14. Composition 1.13, wherein the composition comprises one or more humectants selected from polyethylene glycol, PEG-PPG copolymer, glycerin and propylene glycol;

[0030] 1.15. Composition 1.14, wherein the composition comprises one or more humectants selected from polyethylene glycol, PEG-PPG copolymer and glycerin;

[0031] 1.16. Composition 1.14, wherein the composition comprises at least one polyethylene glycol, for example selected from PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600 and PEG-2000;

[0032] 1.17. Composition 1.16, wherein the composition comprises PEG-600;

[0033] 1.18. Any of compositions 1.13 to 1.17, wherein the composition comprises at least one PEG-PPG copolymer;

[0034] 1.19. Composition 1.18, wherein the PEG-PPG copolymer is a random copolymer, for example, PEG / PPG-116 / 66 to PEG / PPG-38 / 8;

[0035] 1.20. Composition 1.18, wherein the PEG-PPG copolymer is a triblock copolymer, i.e., poloxamer;

[0036] 1.21. Composition 1.20, wherein the poloxamer is selected from poloxamer 101, poloxamer 105, poloxamer 108, poloxamer 122, poloxamer 123, poloxamer 124, poloxamer 181, poloxamer 182, poloxamer 183, poloxamer 184, poloxamer 185, poloxamer 188, poloxamer 212, poloxamer 215, poloxamer 217, Poloxamer 231, Poloxamer 234, Poloxamer 235, Poloxamer 237, Poloxamer 238, Poloxamer 282, Poloxamer 284, Poloxamer 288, Poloxamer 331, Poloxamer 333, Poloxamer 334, Poloxamer 335, Poloxamer 338, Poloxamer 401, Poloxamer 402, Poloxamer 403, and Poloxamer 407;

[0037] 1.22. Composition 1.21, wherein the poloxamer is selected from poloxamer 105 and poloxamer 407;

[0038] 1.23. Composition 1.22, wherein the poloxamer is poloxamer 105;

[0039] 1.24. Any of compositions 1.13 to 1.23, wherein the composition comprises no more than 10% by weight total of the humectant, e.g., no more than 8%, no more than 7%, no more than 6%, no more than 5%, no more than 4%, or no more than 3%, or no more than 2.5%, or no more than 2%, or no more than 1% by weight of the humectant;

[0040] 1.25. Any of compositions 1.13 to 1.24, wherein the composition comprises 0.5% to 10% by weight of the humectant, e.g., 0.5% to 8%, or 0.5% to 7%, or 0.5% to 6%, or 0.5% to 5%, 0.5% to 4%, or 0.5% to 3%, or 0.5% to 2.5%, or 0.5% to 2%, or 1% to 5%, or 1% to 4%, or 1% to 3%, or 1% to 2.5%, or 1% to 2%, or 1.5% to 5%, or 1.5% to 4%, or 1.5% to 3%, or 1.5% to 2.5%, or about 2% by weight of the humectant;

[0041] 1.26. Composition 1.25 wherein the composition comprises 0.5% to 10% polyethylene glycol (e.g., PEG-600), e.g., 0.5% to 8%, or 0.5% to 7%, or 0.5% to 6%, or 0.5% to 5%, 0.5% to 4%, or 0.5% to 3%, or 0.5% to 2.5%, or 0.5% to 2%, or 1% to 10%, or 1% to 8%, or 1% to 6%, or 1% to 5%, or 1% to 4%, or 1% to 3%, or 1% to 2.5%, or 1% to 2%, or 1.5% to 3%, or 1.5% to 2.5%, or 1.5% to 2%, or 3% to 8%, or about 2% polyethylene glycol.

[0042] 1.27. Composition 1.26, wherein the polyethylene glycol comprises PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800 or a combination thereof;

[0043] 1.28. Composition 1.27, wherein the polyethylene glycol comprises PEG-600;

[0044] 1.29. Any of compositions 1.13 to 1.28, wherein the composition does not contain ethanol;

[0045] 1.30. Any of compositions 1.13 to 1.29, wherein the composition does not contain sorbitol or xylitol;

[0046] 1.31. Any of compositions 1.13 to 1.30, wherein the composition does not contain glycerol or propylene glycol;

[0047] 1.32. Any of compositions 1.13 to 1.31, wherein the composition does not contain propylene glycol;

[0048] 1.33. Any of compositions 1.13 to 1.32, wherein the composition does not comprise a PEG-PPG copolymer;

[0049] 1.34. Any of compositions 1.13 to 1.33 wherein polyethylene glycol (eg, PEG-600) is the sole humectant;

[0050] 1.35. Composition 1 or any one of 1.1 to 1.34, wherein the composition further comprises one or more polymers selected from the group consisting of: polysaccharides (e.g., cellulose derivatives such as carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, microcrystalline cellulose; or polysaccharide gums such as xanthan gum, guar gum, or carrageenan, pectin, karaya gum); chitosan; dextran; polyvinyl pyrrolidone (PVP), such as cross-linked PVP; hyaluronic acid and sodium hyaluronate; synthetic anions Polymeric polycarboxylates, such as copolymers of maleic anhydride or 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., polyphosphates); crosslinked carboxyvinyl copolymers; polyacrylic acid or polyacrylate polymers; polyacrylamides, such as (2-hydroxypropyl) methacrylamide; polyamines; polyvinyl alcohol; polyvinyl pyrrolidine-polyvinyl acetate copolymer (PVP-VA); poly Oxazolines, such as poly(2-alkyl-2- oxazoline), for example, methyl, ethyl or isopropyl substituted oxazoline; and quaternary ammonium polymer;

[0051] 1.36. Composition 1 or any one of 1.1 to 1.35, wherein the composition comprises one or more of the following: polyethylene glycol polymer (PEG), polyacrylic acid or polyacrylate polymer (PAA), polyvinyl pyrrolidone polymer (PVP), polyvinyl pyrrolidone-vinyl acetate copolymer (PVP-VA), poly Oxazoline polymers (PO), polyoxyethylene-polyoxypropylene (PEG-PPG) block copolymers and mixtures thereof;

[0052] 1.37. Composition 1.36, wherein the composition comprises at least one of the following: a polyethylene glycol polymer, a polyacrylic acid or polyacrylate polymer, a polyvinyl pyrrolidone polymer, a polyvinyl pyrrolidone-vinyl acetate copolymer, a poly Oxazoline polymers and polyoxyethylene-polyoxypropylene copolymers;

[0053] 1.38. Composition 1 or any one of 1.1 to 1.37, wherein the composition comprises at least one of the following: a cellulose derivative (e.g., carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, or ethyl cellulose), a polyethylene glycol polymer (PEG), a polyacrylic acid or polyacrylate polymer (PAA), a polyvinyl pyrrolidone polymer (PVP), a polyvinyl pyrrolidone-vinyl acetate copolymer (PVP-VA), a poly Oxazoline polymer (PO), polyoxyethylene-polyoxypropylene (PEG-PPG) block copolymer or a mixture thereof;

[0054] 1.39. Composition 1 or any of 1.28 to 1.38, wherein the composition comprises less than 30% by weight of any of the polymers or mixtures of polymers, for example, 1% to 30%, or 1% to 20%, or 1% to 15%, or 1% to 10%, or 1% to 7%, or 5% to 30%, or 5% to 25%, or 5% to 20%, or 5% to 15%, or 10% to 30%, or 10% to 25%, or 10% to 20%, or 15% to 30%, or 15% to 25%, or 15% to 20%, or about 25%, or about 20%, or about 15%, or about 12.5%, or about 10%, or about 6%, or about 5% of any of the polymers or mixtures of polymers;

[0055] 1.40. Composition 1 or any of 1.1 to 1.39, wherein the composition comprises one or more polyvinylpyrrolidone (PVP) polymers, such as linear and / or cross-linked PVP polymers;

[0056] 1.41. Composition 1.40, wherein the composition comprises a linear PVP polymer, for example, one or two linear PVP polymers;

[0057] 1.42. Composition 1.41, wherein the linear PVP polymer is selected from PVP K90 and PVP K29 / 32 or a combination thereof;

[0058] 1.43. Any of compositions 1.40 to 1.42, wherein the composition comprises 10% to 40% by weight of the PVP polymer, e.g., 10% to 35%, or 10% to 30%, or 10% to 25%, or 15% to 40%, or 15% to 35%, or 15% to 30%, or 15% to 25%, or 20% to 40%, or 20% to 35%, or 20% to 30%, or about 25% by weight of the PVP polymer;

[0059] 1.44. Composition 1 or any one of 1.1 to 1.43, wherein the composition does not comprise a polysaccharide polymer or a derivative thereof;

[0060] 1.45. Composition 1 or any one of 1.1 to 1.43, wherein the composition does not contain carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose;

[0061] 1.46. Composition 1 or any of 1.1 to 1.43, wherein the composition does not contain hydroxypropyl methylcellulose;

[0062] 1.47. Composition 1 or any one of 1.1 to 1.43, wherein the composition does not contain carboxymethyl cellulose;

[0063] 1.48. Composition 1 or any one of 1.1 to 1.47, 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;

[0064] 1.49. Composition 1.48, wherein the composition comprises sodium or potassium pyrophosphate (e.g., tetrasodium or tetrapotassium pyrophosphate and / or disodium or dipotassium pyrophosphate and / or sodium acid pyrophosphate), sodium or potassium tripolyphosphate, sodium or potassium tetraphosphate, sodium or potassium phytate, or a mixture thereof;

[0065] 1.50. Composition 1.48 or 1.49, wherein the composition comprises 0.05% to 5% by weight of polyphosphate, for example 0.05% to 2%, or 0.05% to 1%, or 0.05% to 0.5% or about 0.2% by weight of polyphosphate;

[0066] 1.51. Composition 1 or any of 1.1 to 1.50, wherein the composition further comprises a desensitizing agent, for example, in an amount of 0.1% to 5% by weight, such as potassium nitrate;

[0067] 1.52. Composition 1 or any of 1.1 to 1.51, wherein the composition further comprises an enamel strengthening agent, such as an amount of 0.1% to 5% by weight, such as zinc phosphate;

[0068] 1.53. Composition 1 or any of 1.1 to 1.52, wherein the composition further comprises one or more of a flavoring agent and a sweetener;

[0069] 1.54. Composition 1 or any of 1.1 to 1.53, wherein the composition comprises water, e.g., 25% to 85% by weight of the composition (e.g., an aqueous slurry);

[0070] 1.55. Composition 1 or any one of 1.1 to 1.54, wherein the composition consists of water, PVP, potassium peroxymonosulfate triple salt (e.g., ), and one or more of polyethylene glycol (e.g., PEG-600), PEG-PPG copolymer (e.g., poloxamer 105), and glycerol;

[0071] 1.56. Composition 1 or any one of 1.1 to 1.54, wherein the composition consists of water, PVP, potassium peroxymonosulfate triple salt (e.g., ) and polyethylene glycol (e.g., PEG-600);

[0072] 1.57. Composition 1 or any of 1.1 to 1.56, wherein the composition is an aqueous slurry comprising or consisting of:

[0073]

[0074] 1.58. Composition 1 or any of 1.1 to 1.56, wherein the composition is an aqueous slurry comprising or consisting of:

[0075]

[0076]

[0077] or

[0078]

[0079] 1.59. Composition 1 or any of 1.1 to 1.58, wherein the composition is prepared as an aqueous suspension or an aqueous / alcoholic suspension and subsequently dried onto a backing layer to form a tooth whitening strip;

[0080] 1.60. Composition 1 or any of 1.1 to 1.58, wherein the composition is prepared as an aqueous suspension or an aqueous / alcoholic suspension and subsequently dried onto a backing layer to form a tooth whitening strip, and wherein the tooth whitening strip further comprises an inert removable paper or plastic protective film and / or an attached inert paper or plastic backing composition, and wherein the protective film or backing composition is adhered to the hydratable adhesive film, optionally wherein the protective film and / or the backing composition comprises wax paper, coated paper, treated paper, polyethylene, polystyrene, polypropylene, polyvinyl chloride, polyvinyl acetate, polymethyl methacrylate, polytetrafluoroethylene, polyester (e.g., polyethylene terephthalate), polyimide, polycarbonate, or any combination thereof;

[0081] 1.61. Composition 1.60, wherein the protective film and / or the backing layer of the tooth whitening strip comprises polypropylene, polyethylene, polyethylene terephthalate and / or polystyrene;

[0082] 1.62. Composition 1.60 or 1.61, wherein the backing layer comprises polyethylene;

[0083] 1.63. Composition 1 or any of 1.1 to 1.62, wherein the composition provides whitening of the teeth for a period of at least 10 minutes, such as 10 minutes to 30 minutes, or 10 minutes to 60 minutes;

[0084] 1.64. Composition 1 and any of 1.1 to 1.6 or 1.10 to 1.54, wherein the composition comprises a whitening agent other than an inorganic permonosulfate salt;

[0085] 1.65. Composition 1.64 wherein the additional whitening agent comprises a peroxide whitening agent comprising a peroxide compound;

[0086] 1.66. Composition 1.64, wherein the peroxide compound is an oxidizing compound comprising a divalent oxygen-oxyl group;

[0087] 1.67. Composition 1.65 or 1.66, wherein the peroxide compound is selected from the group consisting of hydrogen peroxide, alkali metal and alkaline earth metal peroxides, organic peroxide compounds, peroxyacids, pharmaceutically acceptable salts thereof, and mixtures thereof;

[0088] 1.68. Composition 1.67, wherein the alkali metal and alkaline earth metal peroxides are selected from the group consisting of lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof;

[0089] 1.69. Composition 1.68 wherein the organic peroxy compound is selected from the group consisting of urea peroxide (also known as urea hydroperoxide), glyceryl hydroperoxide, alkyl hydroperoxides, dialkyl peroxides, alkyl peroxyacids, peroxyesters, diacyl peroxides, benzoyl peroxide, and monoperoxyphthalates, and mixtures thereof;

[0090] 1.70. Composition 1.67 in which the peroxyacid and its salts are selected from organic peroxyacids such as alkyl peroxyacids and monoperoxyphthalates, and mixtures thereof, and inorganic peroxyacid salts such as persulfates, dipersulfates, percarbonates, perphosphates, perborates and persilicates of alkali metals and alkaline earth metals (e.g., lithium, potassium, sodium, magnesium, calcium and barium), and mixtures thereof;

[0091] 1.71. Composition 1.67, wherein the whitening agent comprises hydrogen peroxide, or urea peroxide, or sodium percarbonate and mixtures thereof;

[0092] 1.72. Composition 1.67, wherein the peroxide compound comprises hydrogen peroxide;

[0093] 1.73. Composition 1.67, wherein the whitening agent is a non-peroxide whitening agent;

[0094] 1.74. Composition 1.73, wherein the non-peroxide whitening agent comprises a member selected from the group consisting of: non-peroxy compounds (e.g., chlorine dioxide), chlorites, hypochlorites, and colorants (e.g., titanium dioxide and hydroxyapatite);

[0095] 1.75. Any of the foregoing compositions, further comprising a pH adjuster selected from the group consisting of lactic acid, citric acid, hydrochloric acid, glycolic acid, sodium hydroxide, potassium chloride, monosodium citrate, disodium citrate, monosodium malate, sodium carbonate, bicarbonate, sesquicarbonate, borate, silicate, monosodium phosphate, trisodium phosphate, pyrophosphate, imidazole, or a combination thereof; e.g., citric acid;

[0096] 1.76. Any of the foregoing compositions, comprising a pH adjuster in an amount of 0.01% to 5% (e.g., about 1.5% by weight);

[0097] 1.77. Composition 1.73 or 1.74, wherein the pH adjuster is citric acid;

[0098] 1.78. Composition 1.73 or 1.74, wherein the pH adjuster is sodium hydroxide, such as an aqueous sodium hydroxide solution (e.g., a 10% aqueous NaOH solution);

[0099] 1.79. Any of the preceding compositions, wherein the pH of the composition after any pH adjustment is about 1 to 7, such as about 3 to 7, or about 4 to 6, or about 4 to 5.5, or about 4.5 to 5.5, or about 5 to 6, such as or about 4, or about 5, or about 6, or about 7;

[0100] 1.80. Any of the foregoing compositions, further comprising a chelating agent selected from alkali metal stannates (e.g., sodium stannate and potassium stannate) and ethylenediaminetetraacetic acid (EDTA) and its salts;

[0101] 1.81. Any of the preceding compositions, wherein the composition is an aqueous slurry;

[0102] 1.82. Any of the preceding compositions, wherein the composition comprises greater than 30% by weight water, e.g., from 30% to 90%, or from 30% to 80%, or from 30% to 70%, or from 30% to 60%, or from 40% to 90%, or from 40% to 80%, or from 40% to 70%, or from 40% to 60%, or from 50% to 90%, or from 50% to 80%, or from 50% to 70%, or from 50% to 60%, or from 60% to 90%, or from 60% to 80%, or from 60% to 70%, or from 70% to 90%, or from 70% to 80%, or from 80% to 90% water by weight.

[0103] In another aspect, the present disclosure encompasses a tooth whitening strip (Strip 1) comprising a hydratable adhesive film, for example, wherein the hydratable adhesive film of the strip comprises or is prepared from an intermediate composition of any of Compositions 1 et seq.

[0104] For example, in other embodiments, the present disclosure provides (all weight percentages provided below are measured by weight of the hydratable adhesive film of the tooth whitening strip, e.g., after drying to remove volatile components such as water or alcohol, and does not include any backing layer or protective film):

[0105] 1.1. Tape 1, wherein the hydratable adhesive film of the tape comprises an inorganic permonosulfate salt, the inorganic permonosulfate salt being sodium permonosulfate, potassium permonosulfate or lithium permonosulfate, or a combination thereof;

[0106] 1.2. Band 1 or 1.1, wherein the peroxymonosulfate is potassium peroxymonosulfate;

[0107] 1.3. In 1.2, the potassium peroxymonosulfate is a triple salt of potassium peroxymonosulfate, potassium hydrogen sulfate and potassium sulfate (e.g., ) is provided, optionally wherein the triple salt comprises about 45 wt % to 50 wt % potassium permonosulfate (MPS), for example, 47 wt % or 49 wt % potassium permonosulfate;

[0108] 1.4. Any of the foregoing tapes, wherein the hydratable adhesive film of the tape comprises an effective amount of a peroxymonosulfate salt, the effective amount being from 0.01% to 10% by weight, for example, from 0.01% to 5%, from 0.05% to 5%, or from 0.1% to 5%, or from 0.5% to 5%, or from 0.5% to 3%, or from 0.5% to 2.5%, or from 0.5 to 2%, or from 0.5% to 1.5%, or from 0.75% to 5%, or from 0.75% to 4%, or from 0.75% to 3%, or from 0.75% to 2.5%, or from 0.5 to 2%, or from 0.5% to 1.5%, or from 0.75% to 5%, or from 0.75% to 4%, or from 0.75% to 3%, or from 0.75% to 2%, or 0.75% to 1.25%, or 0.8% to 1.2%, or 0.85% to 1.15%, or 0.9% to 1.1%, or 1% to 5%, or 1% to 4%, or 1% to 3%, or 1% to 2%, or 1% to 1.5%, or 2% to 5%, or 2% to 4%, or 2% to 3%, or 3% to 5%, or 3% to 4%, or 2.5% to 3.5%, or about 1%, or about 1.35%, or about 1.5%, or about 1.65%, or about 2%, or about 2.5%, or about 3%;

[0109] 1.5. Any of the preceding tapes, wherein the hydratable adhesive film of the tape further comprises a second inorganic permonosulfate salt;

[0110] 1.6. Any of the preceding bands, wherein the inorganic peroxymonosulfate salt is not granulated (eg, not granular);

[0111] 1.7. Any of the preceding tapes, wherein the tape does not contain hydrogen peroxide;

[0112] 1.8. Any of the foregoing tapes, wherein the tape does not contain any of the following: hydrogen peroxide, urea peroxide, peroxide salts (e.g., sodium peroxide, potassium peroxide, lithium peroxide, calcium peroxide), peroxyacids (e.g., peracetic acid, perbenzoic 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);

[0113] 1.9. Any of the preceding bands, wherein the inorganic peroxymonosulfate salt is the only oxidant present in the band;

[0114] 1.10. Zone 1.9, wherein potassium permonosulfate (e.g., as part of a triple salt mixture) is the only oxidant present in the zone;

[0115] 1.11. Tape 1 or any one of 1.1 to 1.10, wherein the hydratable adhesive film of the tape comprises one or more water-soluble or water-swellable polymers, wherein the one or more water-soluble or water-swellable polymers include anionic polymers and / or neutral polymers;

[0116] 1.12. Tape 1.11, wherein the hydratable adhesive film of the tape comprises from 5% to 95% by weight of a water-soluble or water-swellable polymer or humectant, for example, from 5% to 90% by weight, or from 5% to 85% by weight, or from 5% to 80% by weight, or from 5% to 70% by weight, or from 5% to 60% by weight, or from 5% to 30% by weight, or from 10% to 95% by weight, or from 10% to 90% by weight, or from 10% to 85% by weight, or from 10% to 80% by weight, or from 10% to 70% by weight, or from 10% to 150% by weight. % to 95 wt %, or 15 wt % to 90 wt %, or 15 wt % to 85 wt %, or 15 wt % to 80 wt %, or 15 wt % to 70 wt %, or 15 wt % to 60 wt %, or 15 wt % to 25 wt %, or 20 wt % to 95 wt %, or 20 wt % to 90 wt %, or 20 wt % to 85 wt %, or 20 wt % to 80 wt %, or 20 wt % to 70 wt %, or 15 wt % to 60 wt %, or 15 wt % to 25 wt %, or 20 wt % to 95 wt %, or 20 wt % to 90 wt %, or 20 wt % to 85 wt %, or 20 wt % to 80 wt %, or 20 wt % to 70 wt %, or 30 wt %. % to 95% by weight, or 30% to 90% by weight, or 30% to 85% by weight, or 30% to 80% by weight, or 30% to 70% by weight, or 40% to 95% by weight, or 40% to 90% by weight, or 40% to 85% by weight, or 40% to 80% by weight, or 40% to 70% by weight, or 50% to 95% by weight, or 50% to 90% by weight, or 50% to 85% by weight, or 50% to 80% by weight, or 50% to 70% by weight, or 6 ... % to 95 wt%, or 60 wt% to 90 wt%, or 60 wt% to 85 wt%, or 60 wt% to 80 wt%, or 60 wt% to 70 wt%, or 70 wt% to 95 wt%, or 70 wt% to 85 wt%, or 70 wt% to 80 wt%, or 80 wt% to 95 wt%, or 80 wt% to 90 wt%, or 85 wt% to 95 wt% (e.g., about 20 wt%, or about 65 wt%, or about 80 wt%, or about 90 wt%, or about 95 wt%) of a water-soluble or water-swellable polymer or humectant;

[0117] 1.13. Any one of tape 1 or 1.1 to 1.12, wherein the hydratable adhesive film of the tape comprises one or more humectants selected from the group consisting of polyethylene glycol (e.g., PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, PEG-2000); polypropylene glycol; polyoxyethylene-polyoxypropylene copolymers (PEG-PPG; including block copolymers, triblock copolymers (poloxamers; e.g., poloxamer 407) and random copolymers, e.g., PEG / PPG-116 / 66 and PEG / PPG-38 / 8); ethanol; glycerol; propylene glycol; sorbitol and xylitol;

[0118] 1.14. Tape 1.13, wherein the hydratable adhesive film of the tape comprises one or more humectants selected from the group consisting of polyethylene glycol, PEG-PPG copolymer, glycerin and propylene glycol;

[0119] 1.15. Tape 1.14, wherein the hydratable adhesive film of the tape comprises one or more humectants selected from polyethylene glycol, PEG-PPG copolymer and glycerin;

[0120] 1.16. Tape 1.14, wherein the hydratable adhesive film of the tape comprises at least one polyethylene glycol, for example selected from PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600 and PEG-2000;

[0121] 1.17. Tape 1.16, wherein said hydratable adhesive film of said tape comprises PEG-600;

[0122] 1.18. Any of Tapes 1.13 to 1.17, wherein the hydratable adhesive film of the tape comprises at least one PEG-PPG copolymer;

[0123] 1.19. Band 1.18, wherein the PEG-PPG copolymer is a random copolymer, for example, PEG / PPG-116 / 66 or PEG / PPG-38 / 8;

[0124] 1.20. Band 1.18, wherein the PEG-PPG copolymer is a triblock copolymer, i.e., poloxamer;

[0125] 1.21. Band 1.20, wherein the poloxamer is selected from poloxamer 101, poloxamer 105, poloxamer 108, poloxamer 122, poloxamer 123, poloxamer 124, poloxamer 181, poloxamer 182, poloxamer 183, poloxamer 184, poloxamer 185, poloxamer 188, poloxamer 212, poloxamer 215, poloxamer 2 17, Poloxamer 231, Poloxamer 234, Poloxamer 235, Poloxamer 237, Poloxamer 238, Poloxamer 282, Poloxamer 284, Poloxamer 288, Poloxamer 331, Poloxamer 333, Poloxamer 334, Poloxamer 335, Poloxamer 338, Poloxamer 401, Poloxamer 402, Poloxamer 403, and Poloxamer 407;

[0126] 1.22. Band 1.21, wherein the poloxamer is selected from poloxamer 105 and poloxamer 407;

[0127] 1.23. Band 1.22, wherein the poloxamer is poloxamer 105;

[0128] 1.24. Any of Tapes 1.13 to 1.23, wherein the hydratable adhesive film of the tape comprises no more than 30 wt% of the humectant in total, for example, no more than 24 wt%, no more than 21 wt%, no more than 18 wt%, no more than 15 wt%, no more than 12 wt%, or no more than 9 wt%, or no more than 7.5 wt%, or no more than 6 wt%, or no more than 3 wt%, or no more than 2 wt% of the humectant;

[0129] 1.25. Any of Tapes 1.13 to 1.24, wherein the hydratable adhesive film of the tape comprises 0.5% to 30% by weight of the humectant, for example, 0.5% to 24% by weight, or 0.5% to 21% by weight, or 0.5% to 18% by weight, or 0.5% to 15% by weight, 0.5% to 12% by weight, or 0.5% to 10% by weight, or 0.5% to 9% by weight, or 2% to 30% by weight, or 2% to 24% by weight, or 2% to 21% by weight, or 2% to 18% by weight, or 2% to 15% by weight, or 2% to 12% by weight, or 2% to 9% by weight, or 4% to 30% by weight, or 4% to 24% by weight, or 4% to 21% by weight. %, or 4 to 18%, or 4 to 15%, or 4 to 12%, or 4 to 9%, or 6 to 30%, or 6 to 24%, or 6 to 21%, or 6 to 18%, or 6 to 15%, or 6 to 12%, or 8 to 30%, or 8 to 24%, or 8 to 21%, or 8 to 18%, or 10 to 30%, or 10 to 24%, or 10 to 21%, or 10 to 18%, or about 6%, or about 9%, or about 12%, or about 15%, or about 18%, or about 21% of the humectant;

[0130] 1.26. Tape 1.25, wherein the hydratable adhesive film of the tape comprises 1 wt % to 10 wt % polyethylene glycol, for example, 2 wt % to 10 wt %, or 2 wt % to 8 wt %, or 2 wt % to 7 wt %, or 2 wt % to 6 wt %, or 2 wt % to 5 wt %, or 2 wt % to 4 wt %, or 2 wt % to 3 wt %, or 3 wt % to 10 wt %, or 3 wt % to 8 wt %, or 3 wt % to 7 wt % %, or 3 wt % to 6 wt %, or 3 wt % to 5 wt %, or 3 wt % to 4 wt %, or 4 wt % to 10 wt %, or 4 wt % to 8 wt %, or 4 wt % to 7 wt %, or 4 wt % to 6 wt %, or 5 wt % to 10 wt %, or 5 wt % to 8 wt %, or 5 wt % to 7 wt %, or 5 wt % to 6 wt %, or about 3 wt %, or about 4 wt %, or about 5 wt %, or about 6 wt % of polyethylene glycol.

[0131] 1.27. Band 1.26, wherein the polyethylene glycol comprises PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800 or a combination thereof;

[0132] 1.28. Band 1.27, wherein the polyethylene glycol comprises PEG-600;

[0133] 1.29. Any of bands 1.13 to 1.28, wherein the band does not contain ethanol;

[0134] 1.30. Any of bands 1.13 to 1.29, wherein the band does not contain sorbitol or xylitol;

[0135] 1.31. Any of bands 1.13 to 1.30, wherein the band does not contain glycerol or propylene glycol;

[0136] 1.32. Any of bands 1.13 to 1.31, wherein the band does not contain propylene glycol;

[0137] 1.33. Any of bands 1.13 to 1.32, wherein the band does not contain a PEG-PPG copolymer;

[0138] 1.34. Any of Subclauses 1.13 to 1.33, wherein polyethylene glycol (e.g., PEG-600) is the only humectant;

[0139] 1.35. Any one of tapes 1 or 1.1 to 1.34, wherein the hydratable adhesive film of the tape further comprises one or more polymers selected from the group consisting of: polysaccharides (e.g., cellulose derivatives such as carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, microcrystalline cellulose; or polysaccharide gums such as xanthan gum, guar gum, or carrageenan, pectin, karaya gum); chitosan; dextran; polyvinyl pyrrolidone (PVP), such as cross-linked PVP; 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 of maleic anhydride / maleic acid with methyl vinyl ether in a ratio of 1:4 to 4:1); polyphosphonic acids and polyphosphonates (i.e., polyphosphates); crosslinked carboxyvinyl copolymers; polyacrylic acid or polyacrylate polymers; polyacrylamides, such as (2-hydroxypropyl) methacrylamide; polyamines; polyvinyl alcohol; polyvinyl pyrrolidine-polyvinyl acetate copolymer (PVP-VA); poly Oxazolines, such as poly(2-alkyl-2- oxazoline), for example, methyl, ethyl or isopropyl substituted oxazoline; and quaternary ammonium polymer;

[0140] 1.36. Any one of tape 1 or 1.1 to 1.35, wherein the hydratable adhesive film of the tape comprises one or more of the following: polyethylene glycol polymer (PEG), polyacrylic acid or polyacrylate polymer (PAA), polyvinyl pyrrolidone polymer (PVP), polyvinyl pyrrolidone-vinyl acetate copolymer (PVP-VA), poly Oxazoline polymers (PO), polyoxyethylene-polyoxypropylene (PEG-PPG) block copolymers and mixtures thereof;

[0141] 1.37. Band 1.36, wherein the hydratable adhesive film of the band comprises at least one of the following: a polyethylene glycol polymer, a polyacrylic acid or polyacrylate polymer, a polyvinyl pyrrolidone polymer, a polyvinyl pyrrolidone-vinyl acetate copolymer, a polyvinyl Oxazoline polymers and polyoxyethylene-polyoxypropylene copolymers;

[0142] 1.38. Any one of Band 1 or 1.1 to 1.37, wherein the hydratable adhesive film of the band comprises at least one of the following: a cellulose derivative (e.g., carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, or ethyl cellulose), a polyethylene glycol polymer (PEG), a polyacrylic acid or polyacrylate polymer (PAA), a polyvinyl pyrrolidone polymer (PVP), a polyvinyl pyrrolidone-vinyl acetate copolymer (PVP-VA), a polyvinyl acetate copolymer (PVP-V ... Oxazoline polymer (PO), polyoxyethylene-polyoxypropylene (PEG-PPG) block copolymer or a mixture thereof;

[0143] 1.39. Tape 1 or any of 1.1 to 1.38, wherein the hydratable adhesive film of the tape comprises less than 80% by weight of any of the polymers or mixtures of polymers, for example, 1% to 80%, or 1% to 70%, or 1% to 60%, or 1% to 50%, or 1% to 40%, or 5% to 80%, or 5% to 70%, or 5% to 60%, or 5% to 50%, or 10% to 80%, or 10% to 70%, or 10% to 60%, or 10% to 50%, or 20% to 80% by weight %, or 20% to 70%, or 20% to 60%, or 20% to 50%, or 30% to 80%, or 30% to 70%, or 30% to 60%, or 30% to 50%, or 40% to 80%, or 40% to 70%, or 40% to 60%, or 50% to 80%, or 50% to 70%, or 50% to 60%, or 55% to 65%, or 60% to 80%, or 60% to 70%, or about 50%, or about 60%, or about 70%, or about 80% of any of the above polymers or mixtures of polymers;

[0144] 1.40. Tape 1 or any one of 1.1 to 1.39, wherein the hydratable adhesive film of the tape comprises one or more polyvinylpyrrolidone (PVP) polymers, such as linear and / or cross-linked PVP polymers;

[0145] 1.41. Tape 1.40, wherein the hydratable adhesive film of the tape comprises a linear PVP polymer, for example, one or two linear PVP polymers;

[0146] 1.42. Band 1.41, wherein the linear PVP polymer is selected from PVP K90 and PVP K29 / 32, or a combination thereof;

[0147] 1.43. Any of Tapes 1.40 to 1.42, wherein the hydratable adhesive film of the tape comprises 40% to 90% by weight of a PVP polymer, for example, 40% to 80% by weight, or 40% to 75% by weight, or 40% to 70% by weight, or 40% to 65% by weight, or 50% to 90% by weight, or 50% to 80% by weight, or 50% to 75% by weight, or 50% to 70% by weight, or 50% to 65% by weight, or 55% to 90% by weight. %, or 55 to 80 wt%, or 55 to 75 wt%, or 55 to 70 wt%, or 55 to 65 wt%, or 60 to 90 wt%, or 60 to 80 wt%, or 60 to 70 wt%, or 70 to 90 wt%, or 70 to 80 wt%, or 80 to 90 wt%, or 85 to 90 wt%, or about 60 wt%, or about 70 wt%, or about 75 wt%, or about 80 wt%, or about 85 wt% to 90 wt%, or about 60 wt%, or about 70 wt%, or about 75 wt%, or about 80 wt%, or about 85 wt% PVP polymer;

[0148] 1.44. Any one of bands 1 or 1.1 to 1.43, wherein the band does not contain a polysaccharide polymer or a derivative thereof;

[0149] 1.45. Any one of bands 1 or 1.1 to 1.43, wherein the band does not contain carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose;

[0150] 1.46. Any one of bands 1 or 1.1 to 1.43, wherein the band does not contain hydroxypropyl methylcellulose;

[0151] 1.47. Any one of tape 1 or 1.1 to 1.43, wherein the tape does not contain carboxymethyl cellulose;

[0152] 1.48. Tape 1 or any one of 1.1 to 1.47, wherein the hydratable adhesive film of the tape 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;

[0153] 1.49. Tape 1.48, wherein the hydratable adhesive film of the tape comprises sodium or potassium pyrophosphate (e.g., tetrasodium or tetrapotassium pyrophosphate and / or disodium or dipotassium pyrophosphate and / or sodium acid pyrophosphate), sodium or potassium tripolyphosphate, sodium or potassium tetraphosphate, sodium or potassium phytate, or mixtures thereof;

[0154] 1.50. Tape 1.48 or 1.49, wherein the hydratable adhesive film of the tape comprises 0.05 wt % to 5 wt % polyphosphate, e.g., 0.05 wt % to 2 wt %, or 0.05 wt % to 1 wt %, or 0.05 wt % to 0.5 wt %, or about 0.2 wt % polyphosphate;

[0155] 1.51. Tape 1 or any of 1.1 to 1.50, wherein the hydratable adhesive film of the tape further comprises a desensitizing agent, for example in an amount of 0.1 wt % to 5 wt %, such as potassium nitrate;

[0156] 1.52. Tape 1 or any of 1.1 to 1.51, wherein the hydratable adhesive film of the tape further comprises an enamel strengthening agent, such as in an amount of 0.1 wt % to 5 wt %, such as zinc phosphate;

[0157] 1.53. Tape 1 or any of 1.1 to 1.52, wherein the hydratable adhesive film of the tape further comprises one or more of a flavoring agent and a sweetener;

[0158] 1.54. Tape 1 or any one of 1.1 to 1.53, wherein the hydratable adhesive film of the tape is composed of PVP, potassium permonosulfate triple salt (e.g., ), and one or more of polyethylene glycol (e.g., PEG-600), PEG-PPG copolymer (e.g., poloxamer 105), glycerol, and optionally water;

[0159] 1.55. Tape 1 or any one of 1.1 to 1.53, wherein the hydratable adhesive film of the tape is composed of water, PVP, potassium permonosulfate triple salt (e.g., ) and polyethylene glycol (e.g., PEG-600);

[0160] 1.56. Tape 1 or any one of 1.1 to 1.55, wherein the hydratable adhesive film of the tape comprises or is prepared from an intermediate composition of any one of Compositions 1 et seq.;

[0161] 1.57. Band 1.56, wherein the intermediate composition is an aqueous slurry comprising or consisting of:

[0162]

[0163] 1.58. Band 1.56, wherein the intermediate composition is an aqueous slurry comprising or consisting of:

[0164]

[0165]

[0166] or

[0167]

[0168] 1.59. Tape 1 or any of 1.1 to 1.58, wherein the hydratable adhesive film of the tape comprises 40 wt% to 90 wt% PVP, 1 wt% to 6 wt% potassium permonosulfate triple salt (e.g., or about 0.5 wt % to 2 wt % potassium permonosulfate (MPS), and 2% to 20% of one or more of polyethylene glycol (e.g., PEG-600), PEG-PPG copolymer (e.g., poloxamer 105), glycerol, and water;

[0169] 1.60. Tape 1 or any one of 1.1 to 1.58, wherein the hydratable adhesive film of the tape comprises 40 wt% to 90 wt% PVP, 1 wt% to 6 wt% potassium permonosulfate triple salt (e.g., or about 0.5 wt % to 2 wt % potassium permonosulfate (MPS), and 2 % to 10 % of one or more of polyethylene glycol (e.g., PEG-600), PEG-PPG copolymer (e.g., poloxamer 105), and glycerol, and 0 % to 15 % water;

[0170] 1.61. Tape 1 or any of 1.1 to 1.58, wherein the hydratable adhesive film of the tape comprises 40 wt% to 90 wt% PVP, 1 wt% to 6 wt% potassium permonosulfate triple salt (e.g., or about 0.5% to 2% by weight of potassium permonosulfate (MPS)) and 2% to 10% of polyethylene glycol (e.g., PEG-600); and 0% to 15% of water;

[0171] 1.62. Tape 1 or any of 1.1 to 1.58, wherein the hydratable adhesive film of the tape comprises 40 wt% to 90 wt% PVP, 1 wt% to 6 wt% potassium permonosulfate triple salt (e.g., or about 0.5 wt % to 2 wt % potassium permonosulfate (MPS), and 2 % to 10 % of one or more of polyethylene glycol (e.g., PEG-600), PEG-PPG copolymer (e.g., poloxamer 105), and glycerol; and 0 % to 15 % water;

[0172] 1.63. Tape 1 or any one of 1.1 to 1.62, wherein the hydratable adhesive film of the tape contains 0% to 20% water (i.e., after drying), for example, 0% to 16%, or 0% to 14%, or 0% to 12%, or 0% to 10%, or 0% to 5%, or 5% to 15%, or 8% to 12%, or about 11% water (i.e., after drying), based on the weight of the tape.

[0173] 1.64. Tape 1 or any of 1.1 to 1.63, wherein the hydratable adhesive film of the tape comprises or consists of:

[0174]

[0175]

[0176] or

[0177]

[0178] 1.65. Tape 1 or any of 1.1 to 1.64, wherein the tape further comprises an inert paper or plastic backing layer to which the hydratable adhesive film is adhered or attached, and / or an inert removable paper or plastic protective film adhered to the hydratable adhesive film, optionally wherein the protective film and / or the backing tape comprises wax paper, coated paper, treated paper, polyethylene, polystyrene, polypropylene, polyvinyl chloride, polyvinyl acetate, polymethyl methacrylate, polytetrafluoroethylene, polyester (e.g., polyethylene terephthalate), polyimide, polycarbonate, or any combination thereof;

[0179] 1.66. Tape 1 or any of 1.1 to 1.65, wherein the intermediate tape is prepared as an aqueous suspension or an aqueous / alcoholic suspension and subsequently dried onto a backing layer of the teeth whitening tape;

[0180] 1.67. Tape 1 or any of 1.1 to 1.66, wherein the tape is prepared from any of Intermediate Compositions 1 et seq., and wherein the intermediate composition is prepared as an aqueous suspension or aqueous / alcoholic suspension and subsequently dried onto a backing layer of the teeth whitening tape, and wherein the tape further comprises an inert removable paper or plastic protective film and / or an attached inert paper or plastic backing tape, and wherein the protective film or backing tape is adhered to the hydratable adhesive film, optionally wherein the protective film and / or the backing tape comprises wax paper, coated paper, treated paper, polyethylene, polystyrene, polypropylene, polyvinyl chloride, polyvinyl acetate, polymethyl methacrylate, polytetrafluoroethylene, polyesters (e.g., polyethylene terephthalate), polyimides, polycarbonates, or any combination thereof;

[0181] 1.68. Any of tapes 1.65 to 1.67, wherein the protective film and / or the backing tape comprises polypropylene, polyethylene, polyethylene terephthalate and / or polystyrene;

[0182] 1.69. Tape 1.67, wherein the backing layer comprises polyethylene and / or the protective film comprises polyethylene or polypropylene;

[0183] 1.70. Strip 1 or any of 1.1 to 1.69, wherein the strip provides whitening of the teeth for a period of at least 10 minutes, such as 10 minutes to 30 minutes, or 10 minutes to 60 minutes;

[0184] 1.71. Any one of tapes 1 and 1.1 to 1.6 or 1.10 to 1.70, wherein the tape comprises a whitening agent other than the inorganic peroxymonosulfate salt;

[0185] 1.72. Band 1.71, wherein the additional whitening agent comprises a peroxide whitening agent, wherein the peroxide whitening agent comprises a peroxide compound;

[0186] 1.73. Band 1.71, wherein the peroxide compound is an oxidizing compound containing a divalent oxygen-oxygen group;

[0187] 1.74. Band 1.72 or 1.73, wherein the peroxide compound is selected from: hydrogen peroxide, alkali metal and alkaline earth metal peroxides, organic peroxide compounds, peroxyacids, pharmaceutically acceptable salts thereof, and mixtures thereof;

[0188] 1.75. Band 1.74, wherein the alkali metal and alkaline earth metal peroxides are selected from: lithium peroxide, potassium peroxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide and mixtures thereof;

[0189] 1.76. Band 1.75, wherein the organic peroxy compound is selected from: urea peroxide (also known as urea hydroperoxide), glyceryl hydroperoxide, alkyl hydroperoxides, dialkyl peroxides, alkyl peroxyacids, peroxyesters, diacyl peroxides, benzoyl peroxide, and monoperoxyphthalates and mixtures thereof;

[0190] 1.77. Band 1.75, wherein the peroxyacid and its salt are selected from: organic peroxyacids such as alkyl peroxyacids and monoperoxyphthalates and mixtures thereof, and inorganic peroxyacid salts such as persulfates, dipersulfates, percarbonates, perphosphates, perborates and persilicates of alkali metals and alkaline earth metals (e.g., lithium, potassium, sodium, magnesium, calcium and barium), and mixtures thereof;

[0191] 1.78. Band 1.75, wherein the whitening agent comprises hydrogen peroxide, or urea peroxide, or sodium percarbonate and mixtures thereof;

[0192] 1.79. Band 1.75, wherein the peroxide compound comprises hydrogen peroxide;

[0193] 1.80. Band 1.75, wherein the whitening agent is a non-peroxide whitening agent;

[0194] 1.81. Band 1.75, wherein the non-peroxide whitening agent comprises a member selected from the group consisting of: non-peroxide compounds (e.g., chlorine dioxide), chlorites, hypochlorites, and colorants (e.g., titanium dioxide and hydroxyapatite);

[0195] 1.82. Any of the foregoing tapes, further comprising a pH adjuster selected from the group consisting of lactic acid, citric acid, hydrochloric acid, glycolic acid, sodium hydroxide, potassium chloride, monosodium citrate, disodium citrate, monosodium malate, sodium carbonate, bicarbonate, sesquicarbonate, borate, silicate, monosodium phosphate, trisodium phosphate, pyrophosphate, imidazole, or a combination thereof; e.g., citric acid;

[0196] 1.83. Any of the foregoing tapes, comprising a pH adjuster in an amount of 0.01% to 5% (e.g., about 1.5% by weight);

[0197] 1.84. Band 1.82 or 1.83, wherein the pH adjuster is citric acid;

[0198] 1.85. Band 1.82 or 1.83, wherein the pH adjusting agent is sodium hydroxide, for example, an aqueous sodium hydroxide solution (for example, a 10% NaOH solution in water);

[0199] 1.86. Any of the preceding tapes, wherein the pH of the tape measured before drying the tape or after hydrating the tape is about 1 to 7, such as about 3 to 7, or about 4 to 6, or about 4 to 5.5, or about 4.5 to 5.5, or about 5 to 6, such as about 4, about 5, or about 6;

[0200] 1.87. Any of the preceding tapes, further comprising a chelating agent selected from the group consisting of alkali metal stannates (e.g., sodium and potassium stannate) and ethylenediaminetetraacetic acid (EDTA) and its salts;

[0201] 1.88. Any of the preceding tapes, wherein the intermediate tape is an aqueous slurry;

[0202] 1.89. Any of the preceding tapes wherein the tape is free or substantially free (eg, less than 0.005 wt %) of water.

[0203] 1.90. Any of the preceding tapes wherein the tape is free or substantially free of glycerin, sorbitol, xylitol, propylene glycol, and / or ethanol, eg, less than 0.5% by weight of each, or less than 0.1% by weight of each.

[0204] 1.91. Use of any of the foregoing strips in a method for whitening teeth.

[0205] 1.92. A method of whitening teeth comprising applying a tape of 1 or any one of 1.1 to 1.90 to one or more teeth.

[0206] As used herein, the term "strip" refers to a solid, pliable, adherent material comprising a single layer hydratable film comprising an inorganic permonosulfate salt entrapped or dispersed in a polymer matrix and optionally a backing for the front and / or rear surfaces of the film. The film, after wetting with water or saliva or a secondary solvent and after adhering to the surface of the teeth, provides an aqueous vehicle that allows the inorganic permonosulfate salt to diffuse toward the surface of the teeth, thereby providing an oxidative whitening effect to the teeth.

[0207] As used herein, the term "oral care composition" means the total composition delivered to the oral cavity surface. The composition is further defined as a product that, during the normal course of use, is not intended to be swallowed for the purpose of systemic administration of a specific therapeutic agent, but is retained in the oral cavity for a time sufficient to contact substantially all tooth surfaces and / or oral tissues for the purpose of oral activity. Examples of such compositions include, but are not limited to, toothpaste or dentifrice, mouthwash or mouthwash, topical oral gel, denture cleanser, spray, toothpaste powder, tablet, mousse, foam, lozenge, ribbon, chewing gum, etc.

[0208] As used herein, "slurry" or "aqueous slurry" refers to a semi-liquid mixture comprising water and at least one other component suspended in the mixture. In one aspect, the intermediate composition of the present disclosure is an aqueous slurry, which is then incorporated into a tooth whitening strip comprising a hydratable adhesive film. In one aspect, the slurry is incorporated into the strip, followed by a drying process that can remove water and other volatile components used as solvents.

[0209] In one embodiment, the peroxymonosulfate salt is potassium peroxymonosulfate (also known as MPS, potassium monopersulfate). Potassium peroxymonosulfate (an example of which is or An oxidizing agent) is combined to form a triple salt of potassium permonosulfate, potassium hydrogen sulfate and potassium sulfate (2KHSO5·KHSO4·K2SO4), or exists as a triple salt of potassium permonosulfate, potassium hydrogen sulfate and potassium sulfate (2KHSO5·KHSO4·K2SO4).

[0210] Potassium permonosulfate has limited stability in aqueous solution and can be stabilized by other common toothpaste ingredients. Therefore, contact with water should be avoided or minimized during processing and storage. The band is preferably packaged in a moisture-free environment. Preferably, the band is individually packaged and sealed in a unit dose package. The band is usually stored in an airtight, waterproof package, such as a pouch, a sealed foil bag, a blister package, and a desiccant-capped tube. Useful packaging materials include polymeric packaging materials (e.g., polyethylene and polypropylene), metal foil packaging materials (e.g., aluminum), and combinations thereof.

[0211] The resulting tapes incorporating the intermediate compositions of the present disclosure contain no water or have a low water content. As used herein, the term "low water content" means the total concentration of water, including any free water and all water contained in any component. In various embodiments of the compositions, the amount of water in the final resulting tape is less than 4 wt %, or less than 3 wt %, or less than 2 wt %, or less than 1 wt %, or less than 0.5 wt %, or less than 0.1 %, or an amount of about 0.0001 wt % to about 4 wt %, or about 0.0001 wt % to about 0.5 wt %, or about 0.0001 wt % to about 0.1 wt %.

[0212] 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 monopotassium phosphate and dipotassium phosphate, citrates, pyrophosphates (sodium and potassium salts) and combinations thereof. When hydrated, the amount of the buffer is sufficient to provide a pH of about 3 to about 9, preferably about 6 to about 8, more preferably at about 7. The typical amount of buffer is about 0.1% to about 5% by weight of the total composition, about 1% to about 3% in one embodiment, and about 0.5% to about 1% in another embodiment.

[0213] The compositions and bands of the present disclosure optionally include a binder, preferably a polymeric binder, which is compatible with the oxidant, increases the volume of the hydratable film, and helps to hold the components of the film together in the form of a band. Examples of suitable polymeric binders include, for example, starch, natural gums (e.g., xanthan gum), cellulose gum, microcrystalline cellulose, maltodextrin, methylcellulose, cellulose ethers, sodium carboxymethylcellulose, ethylcellulose, gelatin, polyethylene glycol, polyvinyl pyrrolidone, pectin, alginate, polyacrylamide, polyethylene glycol, polyvinylpyrrolidone ... The binder may also include one or more non-polymer binders, such as dextrose, lactose, sucrose, sorbitol, mannitol, xylitol, etc. Typically, the binder is present in the composition in an amount of about 0.1% to about 80% by weight, about 1% to about 10% by weight, or about 1% to about 5% by weight.

[0214] In some embodiments, the intermediate composition comprises a poloxamer, which is a polyoxyethylene-polyoxypropylene triblock copolymer. For example, a suitable poloxamer 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 HYDRADE(R) brand dispersants are commercially available from BASF, Florham Park, NJ.

[0215] In some embodiments, the intermediate composition of the present disclosure may include cross-linked polyvinyl pyrrolidone, also known as poly-N-vinyl-poly-2-pyrrolidone, and often abbreviated as cross-linked "PVP". PVP generally refers to a polymer comprising vinyl pyrrolidone (also known as N-vinyl pyrrolidone, 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 PVP sold as BASF, Mount Olive, New Jersey, USA. and and POLYPLASDO sold by Ashland in Covington, Kentucky, USA INF-10 is one of those commercially available.

[0216] In some embodiments, a PVP copolymer is used, such as a polyvinylpyrrolidone-vinyl acetate copolymer (PVP-VA) (e.g., commercially available as Plasdone S-630 from Ashland Inc.), a polyvinylpyrrolidone-co-polyvinyl butyrate copolymer (PVP-VB), or a polyvinylpyrrolidone-co-polyvinyl propionate copolymer (PVP-VP), or a mixture thereof.

[0217] The intermediate composition of the present disclosure may optionally include a whitening agent other than permonosulfate. Whitening agents are generally materials that effectively provide whitening of the tooth surface to which they are applied, and include agents such as hydrogen peroxide and urea peroxide. In a plurality of embodiments, the composition of the present disclosure may optionally include a peroxide whitening agent, and the peroxide whitening agent includes a peroxide compound. A peroxide compound is an oxidizing compound that includes a divalent oxygen-oxygen group. 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 peroxy compounds include urea peroxide (also referred to as urea hydrogen peroxide), glyceryl hydroperoxide, alkyl hydroperoxides, dialkyl peroxides, alkyl peroxy acids, peroxy esters, diacyl peroxides, benzoyl peroxide, and monoperoxyphthalate, and mixtures thereof. Peroxyacids and their salts include organic peroxyacids such as alkyl peroxyacids, and monoperoxyphthalates and mixtures thereof, and inorganic peroxyacid salts, such as persulfates, dipersulfates, percarbonates, perphosphates, perborates and persilicates of alkali metals and alkaline earth metals (e.g., lithium, potassium, sodium, magnesium, calcium and barium), and mixtures thereof. In multiple 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, non-peroxide brighteners may be provided. Brighteners that may be used in those herein include non-peroxide compounds, such as chlorine dioxide, chlorites and hypochlorites. Chlorites and hypochlorites include chlorites and hypochlorites of alkali metals and alkaline earth metals such as lithium, potassium, sodium, magnesium, calcium and barium. Non-peroxide brighteners also include colorants, such as titanium dioxide and hydroxyapatite. One or more additional whitening agents are optionally present in a tooth whitening effective total amount. In some embodiments, the composition further comprises an activator, such as tetraacetylethylenediamine. In some embodiments, the tapes of the present invention are free of all of the additional whitening agents listed above.

[0218] The intermediate 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.

[0219] 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 sorbitol fatty acid esters, and polyoxyethylene glycerol fatty acid esters. In the present disclosure, each of them 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%, from about 0.1% to about 2%, and from about 0.1% to about 1% by weight of the total composition.

[0220] 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.

[0221] Useful flavoring agents include natural and synthetic flavoring sources, including, for example, volatile oils, synthetic flavoring oils, flavoring aromatics, oils, liquids, oleoresins, and extracts derived from plants, leaves, flowers, fruits, stems, and combinations thereof. Suitable flavoring agents include, for example, lemon oils, such as lemon, orange, grape, lime, and grapefruit; fruit flavors, including, for example, apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot, and other fruit flavoring agents. Other useful flavoring agents 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 fruits); aldehyde C-9 (citrus fruits); aldehyde C-12 (citrus fruits); tolualdehyde (cherry, almond); 2,6-dimethyloctanal (immature fruit); 2-dodecene aldehyde (2-dodedenal) (citrus, tangerine); and mixtures thereof.

[0222] 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.

[0223] 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); cyclamic acid 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.

[0224] It should be understood that while the general properties of each of the above material classes may differ, there may be some common properties within two or more such material classes, 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, potency, consistency, mouthfeel, taste, smell, etc. For example, a binder may also function as a disintegrant, and vice versa.

[0225] In a second aspect, the present disclosure provides a method for making a tooth whitening strip, the method comprising the steps of: (a) applying any of Compositions 1 et seq. (e.g., an aqueous slurry comprising MPS) to a backing layer, and (b) drying Composition 1 et seq. onto the backing layer to form a hydratable adhesive layer of the strip (e.g., by removing water and other volatile components, e.g., where the components serve as solvents).

[0226] In other embodiments, the present disclosure provides the use of Composition 1 et seq. or any of its other embodiments in the manufacture of a tooth whitening strip comprising a hydratable adhesive film, wherein the tooth whitening strip is further applied to a subject in need thereof as part of a method for whitening teeth.

[0227] Example

[0228] Exemplary 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.

[0229] In the embodiments and elsewhere in the description 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 based on the described standard in weight percentage; if no additional standard is described, the total weight of the composition is to be inferred. 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).

[0230] Embodiment 1:

[0231] Different MPS slurries were prepared and applied to polystyrene petri dishes to form dry tapes after a drying process. After the dry tapes were formed, the active oxygen in the tapes was monitored initially and at 8 days under room temperature storage.

[0232] The formulation of the MPS slurry is listed in Table 2.

[0233] Table 1. Formulations of MPS slurries containing different types and levels of humectants:

[0234]

[0235] The retention rate of reactive oxygen species in the dry strips was calculated and used to evaluate MPS stability.

[0236]

[0237] In general, the level of humectant added to the MPS slurry can affect the stability of the MPS in the dry tape. Comparing the results of 0%, 2%, and 6.5% humectants, the higher the level of humectant added to the MPS slurry, the lower the retention of active oxygen in the dry tape achieved. However, humectants are believed to be necessary to provide certain properties (such as stretch) in the tape, which are important for practical applications of the tape.

[0238] The type of humectant also had an effect on the MPS stability in the dry tape when the addition level of humectant was relatively high. When the humectant level in the slurry was 2%, the difference in MPS stability in the tape was small between glycerol, PEG 600 and EO-PO copolymer. However, when the humectant level in the slurry was 6.5%, the difference in MPS stability in the tape became larger between the three humectant types. Again, without being bound by theory, the extent of the effect appears to be consistent with the number of hydroxyl groups in the humectant molecular structure: glycerol>PEG 600>EO-PO polymer. These results are listed in Table 2 below.

[0239] Retention rate of active oxygen in MPS strips with different moisturizer types and levels after 8 days at room temperature

[0240] Table 2

[0241]

[0242] As shown in Table 3, when the moisturizer level increases from 2% to 6.5%, this difference is greatly magnified in the dry tape after water evaporation. After drying, the slurry with 2% moisturizer can be converted into a dry tape with 6% residual moisturizer. This residual moisturizer level is relatively safe for MPS. However, the slurry with 6.5% moisturizer is converted into a dry tape with 26% residual moisturizer. This residual moisturizer level in the dry tape is considered too high for the incorporation of MPS.

[0243] Table 3. Formulations of MPS slurries containing different types and levels of humectants:

[0244]

[0245] Example 2

[0246] Method for preparing MPS slurry

[0247] In certain aspects, the preparation of dry or wet oral strips generally begins with the preparation of a slurry, followed by a drying process to remove water and other volatile components used as solvents. Once the subsequent drying process is completed, whitening actives that have limited stability in the slurry may still retain their effectiveness. Therefore, it is beneficial to develop a suitable working slurry that allows the MPS to be stable in the final dry strip for effective teeth whitening treatment.

[0248] Film formers are essential for preparing oral strips and can be made using water-soluble polymers such as, for example, polyvinyl pyrrolidone (PVP), polyvinyl alcohol (PVA), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), methyl cellulose (MC), hydroxypropyl methyl cellulose (HPEC). The solvents used in the slurry are thought to be problematic when combined with MPS. Glycerol is thought to help prevent the film from becoming too dry and provide elasticity to the strip. However, glycerol is thought to affect the stability of MPS, which may depend on the concentration of glycerol.

[0249] Table 4 lists the results of the stability of MPS for up to two days in some experimental compositions containing glycerol and MPS. In these experimental formulations, Caroat (United Initiator) was used as the source of potassium permonosulfate compound and dosed at 2.2 wt% (45% MPS) to deliver a theoretical active oxygen level (AO) of 0.105% for 1% MPS. The AO level in the formulation was monitored once a day for two days using iodine titration. As shown in Table 4 below, the stability of MPS in the experimental formulations decreased rapidly in a short period of time in the slurry containing glycerol.

[0250] Table 4. Experimental formulations with glycerol and MPS

[0251]

[0252] *Caroat (45% MPS)

[0253] As seen in formulation #8, which contains only glycerol and MPS, glycerol has an immediate negative impact on MPS stability. The initial active oxygen ("AO") level measured only a few hours after formulation preparation was 0.088%, indicating a loss of nearly 16% in a very short period of time. After two days, the AO level dropped to 0.07%, indicating a loss of about 34% of MPS. When the glycerol content is reduced to the 50% to 60% range, such as 57.8% in formulation #9, there is no significant immediate loss of MPS because the AO level is 0.103%.

[0254] After one day, there was still a large loss of about 35% MPS. As in formulation #10, further reducing the glycerol content to 30% appears to reduce the degradation of MPS over time. After one day, the experimental formulation still had 82% MPS, and after two days, more than 75% MPS remained. The total loss of AO was 18% and 25% loss from 1 day and 2 days, respectively, which is lower than the other experimental formulations. Similar results were seen in formulation #11, in which water was used as the main solvent and the glycerol content was significantly reduced to 2%. It shows that formulations with 30% or less glycerol are able to maintain up to 75% MPS within two days. In addition, neither water nor L35 has a negative impact on MPS stability. The study proves that formulations #10 and #11 have the potential to be used as base components of MPS tape slurries.

[0255] When MPS is dissolved in water, it makes the solution very acidic (pH < 3). Experimental formulations #9, #10, and #11 were measured to have a pH of about 2 to 3. Although saliva has buffering capacity, the use of these formulations to prepare the strips may result in a drop in pH near the enamel after wetting in the mouth. Further studies were conducted to determine whether MPS could be stabilized in films with a higher initial pH in the slurry. The compositions and corresponding test results are listed in Table 5.

[0256] Table 5. Experimental formulations with higher pH

[0257]

[0258] The steps for preparing the experimental formulation at a higher pH were as follows:

[0259] 1. Premix A: Prepare 11% MPS aqueous solution by dissolving Caroat in deionized water 2. Premix B: Prepare glycerin / water base with film former

[0260] 3. Mix the above two premixes thoroughly

[0261] 4. Add 10% NaOH to the formulation to adjust pH

[0262] 5. Test the Initial AO of the Experimental Preparation Slurry

[0263] 6. Spread a small amount of the experimental preparation into a thin layer in a petri dish and leave it in the open air overnight to naturally turn into a dry film

[0264] 7. Test the AO of the dry film on the second day and after 5 days

[0265] The results show that the pH of the experimental formulations can be effectively increased to greater than 6 using an aqueous NaOH solution. The addition of NaOH resulted in some degradation of the MPS, for example, the active oxygen in both formulations was reduced to half of the theoretical formulation level of 0.105%, to nearly 0.05%. However, after the experimental formulations were converted to membranes by air drying, the AO levels increased. Without being bound by theory, it is believed that this increase may be due to the loss of water during the drying process. Once the membranes were dried, it was found that the MPS was stable over the course of 5 days as the AO of the membranes did not decrease. Without being bound by theory, the increased AO levels over time may be due to further water evaporation, which further concentrated the MPS in the membranes.

[0266] Example 3

[0267] A representative formulation of MPS slurry is provided below:

[0268] Table 6. Formulation of MPS slurry

[0269] Components Amount by weight % Caroat (45% MPS) 2.2 water Appropriate amount (e.g., about 75%) PVP 10% to 20% PEG 600 3% to 8% EDTA 0.1% to 1% 10% NaOH 0.5% to 3% Alkali metal pyrophosphate 0.1% to 1%

[0270] Example 4

[0271] MPS wet slurry was applied to different packaging materials to form dry tapes after a drying process. After the dry tapes were formed, active oxygen in the tapes was monitored at room temperature at initial, 5 days, 9 days and 16 days.

[0272] The formulations of MPS slurries are listed in Table 7. The packaging materials used were polyethylene terephthalate (PET), polystyrene (PS) and polyethylene (PE).

[0273] Table 7. Formulation of MPS slurry:

[0274] Components Amount by weight % Caroat (45% MPS) 2.2 water Appropriate amount (e.g., about 75%) PVP 10% to 20% PEG 600 3% to 8% Chelating agents 0.1% to 1% pH Adjusters 0.5% to 3% Alkali metal pyrophosphate 0.1% to 1%

[0275] The retention rate of reactive oxygen species in the dry strips was calculated and used to evaluate MPS stability.

[0276]

[0277] While all three packaging material options showed a consistent decrease in reactive oxygen species, the PET option showed a greater decrease compared to the PE and PS options. Without being bound by theory, it is believed that this is because the unsaturated carbonyl groups in PET may react with the MPS and consume more reactive oxygen species in the band. The reaction between PET and MPS was confirmed by FTIR analysis (data not shown). Compared to untreated PET, the MPS-treated PET showed a higher peak at 1710 cm -1 and 723cm -1 The absorption decreases at 800 cm -1 The absorption at 1470 nm showed an increase, which was considered to prove that the C=O structure in PET was destroyed by MPS.

[0278] Example 5

[0279] Further studies were conducted to evaluate the effect of humectants in slurry compositions. Five slurry formulations were prepared according to the following table and dried to form tapes:

[0280]

[0281] Each slurry formulation contained 2% or 6.5% PEG-600 or glycerin as a humectant, while the formulations were otherwise identical. Each formulation was dried to form a tape. The stability of the tape was determined by measuring the active oxygen content of the tape at the initial formulation, after 5 days of storage at room temperature, and after 8 days. The results are shown in the following table (expressed as a percentage of the initial active oxygen content):

[0282]

[0283] The results show that the tapes prepared from the slurry formulations with 2% of each humectant have better stability than the tapes prepared from the slurry formulations with 6.5% of the same humectant. In addition, with the same percentage of humectant in the slurry formulation, the tapes with PEG-600 as the humectant have better stability than the tapes with glycerol as the humectant. Although lower amounts of humectant are therefore preferred, it was found in other experiments that no humectant at all resulted in dry tapes that were too brittle to use. The data show that the total amount of humectant is most important, with amounts less than 6% being preferred, and amounts less than 4% or less than 2% being more preferred, while the choice of humectant is less important, but PEG-type humectants (e.g., PEG-600) are more preferred than polyol humectants (e.g., glycerol).

[0284] Example 6

[0285] Further studies were conducted to investigate the stability of MPS tapes protected by backing layers made of different materials, including polyethylene terephthalate (PET), polystyrene (PS) and polyethylene (PE). An aqueous slurry according to Example 4 was prepared and coated onto a backing layer of PET, PS or PE, and the product was then dried. The slurry was dried to become a hydratable adhesive film. Product stability was determined by measuring the active oxygen content of the tape after 5 days, 9 days and 16 days of storage at room temperature during the initial formulation. Unexpectedly, it was found that the tape was significantly more stable when prepared on a PS or PE backing compared to a PET backing. Without being bound by theory, it is believed that the functional groups in the PET polymer react with potassium permonosulfate during aging. In addition, it is believed that PS may be a polymer that is difficult to use as a backing layer because it does not form flakes as easily as other polymers.

[0286] The present invention has been described above with reference to illustrative embodiments, but it should be understood that the invention is not limited to the disclosed embodiments. Changes and modifications that would occur to a person skilled in the art after reading the specification are also within the scope of the invention defined in the appended claims.

Claims

1. An intermediate composition (eg, aqueous slurry) for formulating a tooth whitening strip including a hydratable adhesive film, wherein the intermediate composition comprises an inorganic peroxymonosulfate salt.

2. The composition according to claim 1, wherein the peroxymonosulfate salt is potassium peroxymonosulfate.

3. The composition according to any one of claims 1 to 2, wherein the 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.

4. A composition according to any one of claims 1 to 3, wherein the composition comprises a peroxymonosulfate salt in an effective amount of from 0.01% to 5% by weight of the composition.

5. A composition according to any one of the preceding claims, wherein the inorganic peroxymonosulfate salt is the only oxidizing agent present in the composition.

6. A composition according to any one of the preceding claims, wherein the composition comprises one or more water-soluble or water-swellable polymers, the one or more water-soluble or water-swellable polymers comprising anionic polymers and / or neutral polymers.

7. A composition according to any one of the preceding claims, wherein the composition comprises one or more humectants selected from the group consisting of polyethylene glycol (e.g., PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600, PEG-2000); polypropylene glycol; polyoxyethylene-polyoxypropylene copolymers (PEG-PPG, including block copolymers, triblock copolymers (poloxamers, such as poloxamer 407) and random copolymers, such as PEG / PPG-116 / 66 and PEG / PPG-38 / 8); ethanol; glycerol; propylene glycol; sorbitol and xylitol.

8. The composition of claim 7, wherein the composition comprises one or more humectants selected from polyethylene glycol, PEG-PPG copolymer and glycerin.

9. The composition according to claim 7 or 8, wherein the composition comprises at least one polyethylene glycol, for example selected from PEG-200, PEG-300, PEG-400, PEG-500, PEG-600, PEG-800, PEG-1000, PEG-1600 and PEG-2000.

10. The composition of claim 9, wherein the composition comprises PEG-600.

11. A composition according to any preceding claim, wherein the composition further comprises one or more polymers selected from the group consisting of: polysaccharides (e.g. cellulose derivatives such as carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, ethylcellulose, microcrystalline cellulose; or polysaccharide gums such as xanthan gum, guar gum, or carrageenan, pectin, karaya gum); chitosan; dextran; polyvinylpyrrolidone (PVP), such as cross-linked PVP; 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 of maleic anhydride / maleic acid with methyl vinyl ether in a ratio of 1:4 to 4:1); polyphosphonic acids and polyphosphonates; cross-linked carboxyvinyl copolymers; polyacrylic acid or polyacrylate polymers; polyacrylamides such as (2-hydroxypropyl)methacrylamide; polyamines; polyvinyl alcohol; polyvinylpyrrolidine-polyvinyl acetate copolymer (PVP-VA); poly Oxazolines, such as poly(2-alkyl-2- oxazoline), isopropyl substituted poly oxazolines; and quaternary ammonium polymers.

12. A composition according to any one of the preceding claims, wherein the composition comprises one or more polyvinylpyrrolidone (PVP) polymers, such as linear and / or cross-linked PVP polymers.

13. A composition according to any one of the preceding claims, wherein the composition consists of water; PVP; potassium peroxymonosulfate triple salt (e.g., ); and one or more of polyethylene glycol (e.g., PEG-600), PEG-PPG copolymer (e.g., poloxamer 105), and glycerol.

14. A composition according to any one of the preceding claims, wherein the composition is an aqueous slurry comprising or consisting of: Or wherein the composition is an aqueous slurry comprising or consisting of: or 15. The composition of any preceding claim, wherein the composition is an aqueous slurry.

16. A tooth whitening strip comprising a hydratable adhesive film, wherein the strip comprises or is prepared from the intermediate composition of any one of claims 1 to 15.

17. The tooth whitening strip of claim 16, wherein the hydratable adhesive film of the strip comprises or consists of:

18. A tooth whitening tape according to claim 17, wherein the tape further comprises an inert paper or plastic backing layer to which the hydratable adhesive film is adhered or attached, and / or an inert removable paper or plastic protective film adhered to the hydratable adhesive film, optionally wherein the protective film and / or the backing tape comprises wax paper, coated paper, treated paper, polyethylene, polystyrene, polypropylene, polyvinyl chloride, polyvinyl acetate, polymethyl methacrylate, polytetrafluoroethylene, polyester (e.g., polyethylene terephthalate), polyimide, polycarbonate, or any combination thereof.

19. A method for manufacturing a teeth whitening strip, comprising the steps of: (a) applying a composition according to any one of claims 1 to 17 to a backing layer, and (b) drying the composition onto the backing layer to form a hydratable adhesive layer of the tape (e.g., by removing water and other volatile components).

20. Use of a composition according to any one of claims 1 to 17 in the manufacture of a tooth whitening strip comprising a hydratable adhesive film, wherein the tooth whitening strip is further applied as part of a method for whitening teeth.

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