Mucoadhesive whitener composition, and a device for delivering the composition thereof

Abstract

The present disclosure provides a mucoadhesive whitener composition, comprising: (a) from about 1 to about 40 wt.% of at least one primary adhesive polymer, (b) from about 1 to about 40 wt.% of at least one secondary adhesive polymer, (c) from about 0.5 to about 10 wt.% of at least one rheology modifier, (d) from about 1 to about 30 wt.% of at least one whitening agent, (e) from about 1 to about 20 wt.% of at least one neutralizer, (f) from about 0.1 to about 90 wt.% of at least one oral care acceptable anhydrous carrier (g) from about 0.1 to about 30 wt.% of at least one oral care ingredient and (h) optionally, from about 0.25 to about 10 wt.% of at least one divalent cationic donor. The present disclosure also provides a device for delivering a mucoadhesive whitener composition.

Description

MUCOADHESIVE WHITENER COMPOSITION, AND A DEVICE FOR DELIVERING THE COMPOSITION THEREOFFIELD OF THE INVENTION

[0001] The presently disclosed process(es), procedure(s), method(s), product(s), result(s), and / or concept(s) (collectively referred to hereinafter as the “present application, present disclosure or invention”) relates generally to a mucoadhesive whitener compositions. The present invention relates to a mucoadhesive whitener composition with at least one primary adhesive polymer, at least one secondary adhesive polymer, at least one rheology modifier, at least one whitening agent, at least one neutralizer, at least one oral care acceptable anhydrous carrier, at least one oral care ingredient and optionally at least one divalent cationic donor.BACKGROUND OF THE INVENTION

[0002] This invention relates to mucoadhesive whitener compositions, and, more particularly, a mucoadhesive whitener composition for effective delivery of a tooth whitening ingredient onto teeth, which exhibits excellent bioadhesion and retention thereon, advantageous penetration through tooth enamel, superior whitening of stained teeth, and a predetermined viscosity which provides for multiple methods of delivery of the tooth whitening composition on to teeth.

[0003] Since the early 1980s, the tooth whitening industry has evolved from the dental office to multiple over-the-counter tooth whitening systems. This includes delivery systems such that the average consumer can whiten their teeth on their own at home without medical supervision.

[0004] Some examples of delivery systems include strips coated with the tooth whitening substance, trays filled with tooth whitener, tooth whiteners incorporated into toothpaste, and painton applicators such as those analogous to felt tip pens, and others using brushes with bristles and foam-type brush applicators. Over-the-counter whiteners generally fall into three categories — trays with gels, strips and paint-on whiteners.

[0005] Tray and gel systems are designed for the user to fill the flexible tray with the whitening formulation and this is placed on the teeth. The gel extrudes out of the tray on the gingival and the mucosa with a great chance of soft tissue irritation. Strips are placed on the teeth with a portion of the strip lying on the gingival area, also causing irritation. Paint-on whiteners tend to leave a persistent insoluble and often visibly opaque film on the teeth after the whitening active is exhausted. Consumers need to brush their teeth to remove the persistent insoluble polymer residual film left behind from the paint-on composition after every use.

[0006] A successful tooth whitening composition requires that the following parameters be favorable: a) a sufficient amount of activated active ingredient, e.g. whitening agent present in and delivered by the composition; b) an enhanced degree of retention of the composition onto teeth; i.e. its bio-adhesion, which is determined by the ratio of its cohesive energy to surface energy; c) a favorable degree of penetration of the composition into the tooth enamel; d) a suitable viscosity to deliver the composition by selected desirable means; and e) efficacy of bleaching of stained teeth enamel by the composition.

[0007] Accordingly, the present invention provides a tooth whitener composition having the advantages of:(1) a predetermined concentration of active H2O2 in a film-forming complex; ;(2) effective bioadhesion / retention of the composition on teeth;(3) penetration of the composition into the tooth enamel;(4) a predeterminable viscosity to deliver the composition onto teeth by one or more suitable delivery means;(5) excellent bleaching or whitening action on stained teeth; and(6) does not leave behind a persistent insoluble opaque polymer coating after application and use.SUMMARY OF THE INVENTION

[0008] One aspect of the present application is to provide a mucoadhesive whitener composition, comprising: (a) from about 1 to about 40 wt.% of at least one primary adhesive polymer, (b) from about 1 to about 40 wt.% of at least one secondary adhesive polymer, (c) from about 0.5 to about 10 wt.% of at least one rheology modifier, (d) from about 1 to about 30 wt.% of at least one whitening agent, (e) from about 1 to about 20 wt.% of at least one neutralizer, (f) from about 0.1 to about 90 wt.% of at least one oral care acceptable anhydrous carrier (g) from about 0.1 to about 30 wt.% of at least one oral care ingredient and (h) optionally, from about 0.25 to about 10 wt.% of at least one divalent cationic donor.

[0009] Another aspect of the present application is to provide a device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition; b) a reservoir to store the composition; c) a channel configured to receive the composition of a) dispensed from the reservoir device to an applicator; and d) applying the dispensed quantity of the composition on a user's tooth by using the applicator, wherein the device is configured to held by a user and to dispense the composition from the reservoir to the applicator on subjecting a force.

[0010] One more aspect of the present application is to provide a device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition ; b) an actuator; c) a reservoir located between the applicator and the actuator and configured to store the composition; d) a channel configured to receive the whitener composition dispensed from the reservoir device to an applicator; and e) applying the dispensed quantity of the composition on a user's tooth by using the applicator, wherein the actuator is configured to dispense the composition from the reservoir to the applicator on subjecting a mechanical force; wherein the device is configured to held by a user and configured actuator to dispense the composition from the reservoir to the applicator on subjecting a force.

[0011] One more aspect of the present application is to provide a method for whitening of teeth.BRIEF DESCRIPTION OF THE DRAWINGSFIG. l is a photograph of treated and untreated bovine enamels embedded in plastic coupons.FIG. 2 is Pre-stained bovine enamels before and after 5-cycle treatment with mucoadhesive whitener formula of Table 5.DETAILED DESCRIPTION OF THE INVENTION

[0012] It is to be understood that the disclosed and / or claimed inventive concept(s) is not limited in its application to the details of construction and the arrangement of the components or steps or methodologies set forth in the following description or illustrated in the drawings. The disclosed and / or claimed inventive concept(s) is capable of other aspects or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0013] As utilized in accordance with the disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings.

[0014] Unless otherwise defined herein, technical terms used in connection with the disclosed and / or claimed inventive concept(s) shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0015] The singular forms “a”, “an”, and “the” include plural forms unless the context clearly dictates otherwise specified or clearly implied to the contrary by the context in which the reference is made.

[0016] For purposes of the following detailed description, other than in any operating examples, or where otherwise indicated, numbers that express, for example, quantities of ingredients used in the specification and claims are to be understood as being modified in all instances by the term "about". The numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties to be obtained in carrying out the invention.

[0017] As used herein, the term “mono-valent cation” refers to a cation having a valency of one (M+). Accordingly, the term "di-valent cation" refers to a cation having a valency of two (M++). The mono-valent cation is selected from the group consisting of sodium, potassium, lithium and combinations thereof. The mono-valent cation is sodium. The di-valent cation is selected from the group consisting of calcium, magnesium, strontium, iron, zinc, tin, copper, and combinationsthereof. More preferably, the di-valent cation is calcium, magnesium, zinc, and combinations thereof.

[0018] All percentages, parts, proportions and ratios as used herein, are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore; do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.

[0019] As used herein, the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0020] The term “each independently selected from the group consisting of’ means when a group appears more than once in a structure, that group may be selected independently each time it appears.

[0021] As used herein, “lower alkyl vinyl ether-maleic acid copolymer” refers to a predetermined weight average molecular weight of from about 500,000 to 3,000, 000 suitable for denture adhesives made by: copolymerizing about 50 mole percent of maleic anhydride, about 50 mole percent of a C1-C4 alkyl vinyl ether, in the presence of a free radical initiator, at about 50° C to 150°C with solvent or solvent-free process to produce as a uniform, fine powder having substantially no residual maleic anhydride.

[0022] The terms “denture fixative" or “mucoadhesive” or “denture adhesive” are used interchangeably to refer to an adhesive that sticks to or adheres to the skin or mucus or mucosal cell or dental surfaces.

[0023] As used herein, the term “in situ" is a specific buccal cavity site of skin or mucosa or mucosal cell or denture surfaces.

[0024] The composition should retain its characteristics and properties in the powder and cream forms during storage under various climatic conditions, such as temperature and humidity; be readily and easily capable of application to the denture surface; not be irritating or uncomfortable to the user; be safe and nontoxic; have no disagreeable odor or color; have no unpalatable taste;should not facilitate growth of harmful organisms or microbes usually found in mouth; and should not facilitate putrefaction: or malodorous decomposition of foods or secretions lodging beneath or adjacent to the denture.

[0025] One embodiment the present invention is a mucoadhesive whitener composition, comprising: (a) from about 1 to about 40 wt.% of at least one primary adhesive polymer, (b) from about 1 to about 40 wt.% of at least one secondary adhesive polymer, (c) from about 0.5 to about 10 wt.% of at least one rheology modifier, (d) from about 1 to about 30 wt.% of at least one whitening agent, (e) from about 1 to about 20 wt.% of at least one neutralizer, (f) from about 0.1 to about 90 wt.% of at least one oral care acceptable anhydrous carrier (g) from about 0.1 to about 30 wt.% of at least one oral care ingredient and (h) optionally, from about 0.25 to about 10 wt.% of at least one divalent cationic donor.

[0026] In another non-limiting embodiment, the primary adhesive polymer is selected from the group consisting of polyvinyl methyl ether / maleic acid copolymer; sodium, calcium or mixed salt of polyvinyl methyl ether / maleic acid and combinations thereof.

[0027] In another non-limiting embodiment, the primary adhesive polymer is selected from the group consisting of lower alkyl vinyl ether-maleic acid copolymer; sodium, calcium or mixed salt of lower alkyl vinyl ether / maleic acid copolymers and combinations thereof.

[0028] In another non-limiting embodiment, the mixed salt of lower alkyl vinyl ether / maleic acid copolymers is having sodium to calcium ratio from 0.01% to 99.99%.

[0029] The alkyl vinyl ether maleic anhydride copolymers are obtained by co-polymerizing an alkyl vinyl ether monomer, such as methyl vinyl ether, ethyl vinyl ether, divinyl ether, propyl vinyl ether and isobutyl vinyl ether, with maleic anhydride to yield the corresponding alkyl vinyl ethermaleic anhydride copolymer which is readily hydrolysable to the acid copolymer. Both anhydride and acid forms are also available from commercial suppliers. For example, Ashland Inc. provides both the polymeric free acid form and the corresponding anhydride form under its "GANTREZ" trademark as the "GANTREZ S Series".

[0030] In another non-limiting embodiment, the present application provides a mucoadhesive whitener composition, wherein the lower alkyl maleic acid copolymer comprises maleic acid and a lower alkyl (C3-C12) vinyl ether having a predetermined weight average molecular weight ofabout 500,000 to 3,000,000 Daltons, suitable for denture adhesives made by copolymerizing about 50 mole percent of maleic anhydride, about 50 mole percent of a C1-C12 alkyl vinyl ether, in the presence of a free radical initiator, at about 50° to 150° C, in a solvent or solvent free process to produce a uniform, fine powder having substantially no residual maleic anhydride.

[0031] In another non-limiting embodiment, the lower alkyl group of vinyl ether-maleic acid copolymer has carbons atoms from 1 to 12 carbon atoms, from 1 to 8 carbon atoms, from 1 to 6 carbon atoms, or from 3 to 6 carbon atoms.

[0032] In another non-limiting embodiment, the primary adhesive polymer is selected from methyl vinyl ether-maleic acid copolymer; sodium, calcium or mixed salt of methyl vinyl ether / maleic acid copolymers and combinations thereof.

[0033] In another non-limiting embodiment, the lower alkyl group of vinyl ether-maleic acid copolymer is methyl vinyl ether-maleic acid (MVE-MA) copolymer.

[0034] In another non-limiting embodiment, the lower alkyl group of vinyl ether-maleic acid copolymer has an average molecular weight of between about 50,000 and about 3,000,000 Daltons.

[0035] In another non-limiting embodiment, the lower alkyl group of vinyl ether-maleic acid copolymer has a number average molecular weight (in Daltons) from about 50,000 to about 100,000, from about 300,000 to about 500,000, from about 500,000 to about 600,000, from about 600,000 to about 900,000, from about 900,000 to about 1,200,000, from about 1,200,000 to about 1,500,000, from about 1,500,000 to about 1,800,000, from about 1,800,000 to about 2,100,000, from about 2, 100,000 to about 2,500,000, from about 2,500,000 to about 2,800,000, or from about 2,800,000 to about 3,000,000.

[0036] In another non-limiting embodiment, the salts of copolymer of alkyl vinyl ether-maleic acid has a specific viscosity of from about 2.5 to about 5.0 when measured as a 1% w / v solution in methyl ethyl ketone (MEK) solution at 25° C.

[0037] In another non-limiting embodiment, the lower alkyl group of vinyl ether-maleic acid copolymer has a specific viscosity of from about 2.5 to about 3.0, from about 3.0 to about 3.5, from about 3.5 to about 4.0, from about 4.0 to about 4.5, and from about 4.5 to about 5.0 when measured as a 1% w / v solution in methyl ethyl ketone (MEK) solution at 25° C.

[0038] In another non-limiting embodiment, the lower alkyl group of vinyl ether-maleic acid copolymer is present in an amount from about 1 to 40 wt.% of the total composition. Further, the lower alkyl group of vinyl ether-maleic acid copolymer is present in an amount of from about 1 to 10 wt.%, from about 10 to about 15 wt.%, from about 15 to about 20 wt.%, from about 20 to 25 wt.%, from about 25 to about 30 wt.%, from about 30 to about 35 wt.%, from about 35 to about 40 wt.% of the total composition.

[0039] In another non-limiting embodiment, the secondary adhesive polymer is selected from the group consisting of carboxymethyl cellulose, carboxymethyl cellulose with at least one monovalent (sodium, potassium, and lithium), carboxymethyl cellulose with at least one divalent (calcium, strontium, zinc, magnesium and iron), alkyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, divalent cation modified carboxymethyl cellulose and combinations thereof.

[0040] In another non-limiting embodiment, the alkyl cellulose is selected from the group consisting of methyl cellulose and ethyl cellulose.

[0041] In another non-limiting embodiment, the secondary adhesive polymer is sodium salt of carboxymethyl cellulose (Na-CMC). The cellulose ether useful herein including but not limited to Aquaion or Blaanose 7H series of sodium carboxymethyl cellulose available from Ashland Inc. having a molecular weight of about 700,000 Daltons. Other examples of useful carboxymethylcellulose include 7H3 SX8F and 7H3 SXF both commercially available from Ashland Inc. In some embodiments, the sodium carboxymethyl cellulose used in the described compositions is 7H3SXF.

[0042] In another non-limiting embodiment, the present application discloses medium to high molecular weight sodium carboxymethyl cellulose. In some embodiments, the medium to high weight average molecular weight is in the range of about 2000 to about 1,500,000 Daltons. In some embodiments, the medium molecular weight ranges from about 10,000 to about 15,000 Daltons; or from about 15,000 to about 20,000 Daltons; or from about 20,000 to about 300,000; or from about 30,000 to about 40,000 Daltons; or from about 40,000 to about 50,000 Daltons; or from about 50,000 to about 60,000 Daltons; or from about 60,000 to about 70,000 Daltons; or from about 70,000 to about 80,000 Daltons. In some embodiments, the high molecular weight ranges from about 80,000 to about 90,000 Daltons; or from about 90,000 to about 100,000 Daltons; orfrom about 100,000 to about 200,000 Daltons; or from about 200,000 to about 300,000 Daltons; or from about 300,000 to about 400,000 Daltons, or from about 400,000 to about 500,000 Daltons, or from about 500,000 to about 600,000 Daltons, or from about 600,000 to about 700,000 Daltons, or from about 700,000 to about 800,000 Daltons, or from about 800,000 to about 900,000 Daltons, or from about 900,000 to about 1,000,000 Daltons, or from about 1,000,000 to about 1,100,000 Daltons.

[0043] In another non-limiting embodiment, the secondary adhesive polymer is present in an amount from about 1 to about 10 wt.%, from about 11 to about 20 wt.%, from about 21 to about 30 wt%, from about 31 to about 40 wt% of the total composition.

[0044] In another non-limiting embodiment, the sodium carboxymethyl cellulose (Na-CMC) is present in an amount of from about 1 to about 40 wt.% of the total composition. Further, the sodium carboxymethyl cellulose (Na-CMC) is present in an amount of from about 5 to about 10 wt.%, from about 10 to about 15 wt.%, from about 15 to about 20 wt.%, from about 20 to about 25 wt.%, from about 25 to about 30 wt.%, from about 30 to about 35 wt.%, from about 35 to about 40 wt.% of the total composition.

[0045] In another non-limiting embodiment, the rheology modifier is selected from the group consisting of linear polyvinyl pyrrolidone, crosslinked polyvinyl pyrrolidone and combinations thereof.

[0046] According to one of the embodiments, the rheology modifier is present in an amount from about 0.5 to about 10 wt.%.

[0047] According to one of the embodiments, the rheology modifier is present in an amount from about 0.5 to about 2 wt.%, from about 2 to about 4 wt.%, from about 4 to about 6 wt.%, from about 6 to about 8 wt.%, and from about 8 to about 10 wt.% of the total composition.

[0048] In another non-limiting embodiment, the whitening agent includes solid whitening agents and bound whitening agents which are substantially anhydrous oxygen generating compounds. Solid whitening agents useful herein include peroxides, metal chlorites, persulfate. Exemplary peroxide phases include hydroperoxides, hydrogen peroxide, peroxides of alkali and alkaline earth metals, organic peroxy compounds, peroxy acids, pharmaceutically-acceptable salts thereof, and mixtures thereof. Peroxides of alkali and alkaline earth metals include lithium peroxide, potassiumperoxide, sodium peroxide, magnesium peroxide, calcium peroxide, barium peroxide, and mixtures thereof. Organic peroxy compounds include urea peroxide, glyceryl hydrogen peroxide, alkyl hydrogen peroxides, dialkyl peroxides, alkyl peroxy acids, peroxy esters, diacyl peroxides, benzoyl peroxide, and monoperoxyphthalate, and mixtures thereof. Peroxy acids and their salts include organic peroxy acids such as alkyl peroxy acids, and monoperoxyphthalate and mixtures thereof, as well as inorganic peroxy acid salts such as and perborate salts of alkali and alkaline earth metals such as lithium, potassium, sodium, magnesium, calcium and barium, and mixtures thereof. Preferred solid peroxides are sodium perborate, urea peroxide, and mixtures thereof. Suitable metal chlorites includes calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite.

[0049] According to one of the embodiments, the whitening agent is bound peroxide based whitening agent. For example, peroxide may be bound to a polymer such as PVP (poly(N- vinylpyrrolidone). Suitable PVP complexes, including Peroxy done XL- 10 (crosslinked PVP-H2O2 complex) or Peroxydone K-30 (PVP K-30 - H2O2 complex are disclosed in U.S. Pat. No. 5,122,370, U.S. Pat. No. 6,893,629B2, U.S. Pat. No. 5,312,619A, U.S. Pat. No. 5,206,385A, U.S. Pat. No. 5,130,124A, U.S. Pat. No. 5,108,742A, and U.S. Pat. No. 5,077,047A are incorporated herein by reference.

[0050] According to one of the embodiments, the whitening agent is selected from the group consisting of PVP-H2O2 complex and crosslinked PVP-H2O2 complex and combinations thereof.

[0051] According to one of the embodiments, the amount of PVP bound peroxide complexes is present in an amount from about 1 to about 30 wt% of the total composition.

[0052] In another non-limiting embodiment, the neutralizer is a salt selected from the group consisting of hydroxides of mono-valent (M+) cation or divalent (M++) cation, phosphate salt of mono-valent (M+) cation or di-valent (M++) cation, pyrophosphate salt of mono-valent cation or di-valent cation, hydrogen phosphate salt of mono-valent cation or di-valent cation, carbonate or bicarbonate salt of mono-valent cation or di-valent cation, tripolyphosphate or orthometaphosphate salt of mono-valent cation or di-valent cation, hydroxide salts of monovalent cation or divalent cation and combinations thereof.

[0053] In various embodiments of this invention, the neutralizer is selected from the group consisting of phosphate salt of mono-valent (M+) cation or di-valent (M++) cation, pyrophosphatesalt of mono-valent cation or di-valent cation, hydrogen phosphate salt of mono-valent cation or di-valent cation, carbonate or bicarbonate salt of mono-valent cation or di-valent cation, orthometaphosphate salt of mono-valent cation or di-valent and combinations thereof.

[0054] Accordingly, the neutralizer is selected from the group consisting of sodium tripolyphosphate, tetrasodium pyrophosphate, sodium hexametaphosphate, sodium hydroxide, sodium carbonate calcium hydroxide, calcium carbonate and combinations thereof.

[0055] In another non-limiting embodiment, the neutralizer is present in an amount of from about 1 to about 20 wt.% of the total composition.

[0056] In one more non-limiting embodiment, the neutralizer is present in an amount of from about 1 to 5 wt.%, from about 5 to about 10 wt.%, from about 10 to about 15 wt.%, or from about 15 to about 20 wt.% of the total composition.

[0057] In another non-limiting embodiment, the oral care acceptable anhydrous carrier is selected from the group consisting of propylene glycol, polyethylene glycol, glycerin, petrolatum, mineral oil, vegetable oils and combinations thereof.

[0058] In one more non-limiting embodiment, the oral care acceptable anhydrous carrier is present in an amount of from about 1 to 5 wt.%, from about 5 to about 10 wt.%, from about 10 to about 15 wt.%, or from about 15 to about 20 wt.% of the total composition.

[0059] In another non-limiting embodiment, the present mucoadhesive whitener composition provides one or more oral care ingredient is selected from the group consisting of colorants, flavoring agents, antibacterial compounds, pain relieving agents, antioxidants, enzymes, cooling agents, sweeteners, adhesion promoters, anti-caking agents, anti-fungal agents, anti-microbial agents, anti-gingivitis agents, anesthetic agents, anti-biotics, anti-inflammatory agents, binder, buffers, colors, dentinal desensitizing agents, dispersants, emollients, fillers, fragrances, gelling agent, humectants, hydrophilic non-oil components, oil carriers, ooze control polymers, preservatives, pigments, plasticizers, thickening agents, viscosity modifiers, therapeutics, vehicles, surfactants, stabilizers, sensates and combinations thereof.

[0060] In another embodiment, the oral care acceptable ingredient is present in an amount from about 0. 1 to about 90 wt.% of the total composition. Further, the oral care ingredient is present in an amount from about 0. 1 to about 10 wt.%, from about 10 to about 20 wt.%, from about 20 toabout 30 wt.%, from about 30 to about 40 wt.%, from about 40 to about 50 wt.%, from about 50 to about 60 wt.%, from about 60 to about 70 wt.%, from about 70 to about 80 wt.%, from about 80 to about 90 wt.% of the total composition.

[0061] Non-limiting examples of colorants are selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, brown iron oxide, yellow iron oxide, black iron oxide, ferric ammonium ferrocyanide, manganese violet, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, titanated mica, iron oxide titanated mica, bismuth oxychloride, and mixtures thereof.

[0062] Non-limiting examples of flavoring agent include (i) synthetic flavoring liquid and / or oil derived from plants leaves, flowers, and fruits, including vanillin, sage, marjoram, parsley oil, spearmint oil, cinnamon oil, oil of wintergreen (methyl salicylate), peppermint oils, clove oil, bay oil, anise oil, and eucalyptus oil; (ii) artificial, natural, or synthetic fruit flavor extracted from lemon, orange, banana, grape, lime, apricot, and grapefruit; (iii) fruit essence prepared from apple, strawberry, cherry, orange, and pineapple; (iv) bean and nut derived flavors including coffee, cocoa, cola, peanut, almond; (v) flavors adsorbed onto a hydrophilic matrix such as “spray-dried” flavors, and (vi) encapsulated flavors.

[0063] The amount of flavoring agent employed is normally a matter of preference subject to such factors as flavor type and strength of flavor desired. Flavoring agent may be present in amounts up to about 4%, in one embodiment about 0.05% to about 3.0%, in another embodiment about 0.8% to about 2.5%, by weight of the total composition.

[0064] Non-limiting examples of antibacterial compounds used in the present composition can be selected from the group consisting of halogenated diphenyl ether (e.g. triclosan), herbal extracts and essential oils (e.g., rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitol, catechol, methyl salicylate, epigallocatechin gallate, epigallocatechin, gallic acid, miswak extract, sea-buckthorn extract), biguanide antiseptics (e.g., chlorhexidine, alexidine or octenidine), quaternary ammonium compounds (e.g., cetylpyridinium chloride (CPC), benzalkonium chloride, tetradecylpyridinium chloride (TPC), N- tetradecyl-4-ethylpyridinium chloride (TDEPC)), phenolic antiseptics, hexetidine, octenidine, sanguinarine, povidone iodine, delmopinol, salifluor, metal ions (e.g., zinc salts, for example, ZincChloride, Zinc Lactate, Zinc Sulfate, stannous salts, copper salts, iron salts), sanguinarine, propolis a stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride and ammonium fluoride. The antiinflammatory compounds of the present application can be selected from the group including but not limited to triamcinolone (trade name: Kenalog), fluocinonide (trade name: Vanos), dexamethasone (trade name: decadron), herpes, amlexanox (aphthasol), ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, aspirin, ketoprofen, piroxicam and meclofenamic acid.

[0065] Non-limiting examples of pain relieving compounds of the present application can be selected from the group including but not limited to benzocaine, lidocaine, procaine, prilocaine, mepivacaine, aspirin, ibuprofen, diclofenac, methyl salicylate, naproxen, acetaminophen, paracetamol and other similar NS AIDS.

[0066] Non-limiting examples of anti-oxidants of the present application can be selected from the group including but not limited to vitamin E, ascorbic acid, uric acid, carotenoids, vitamin A, flavonoids, polyphenols, herbal antioxidants, melatonin, amino-indoles, lipoic acids, caffeic acid, beta-carotene, ellagic acid, epicatechin, epicatechin gallate, ferulic add, genistein, kojic acid, alpha-lipoic acid, lycopene, resveratrol, resorcinol, rosmarinic acid, silibinin, theaflavin, tocopherols, tocotrienols, trolox and ubiquinone- 10.

[0067] Non-limiting examples of enzymes of the present application can be selected from the group including but not limited to Proteases; papain, bromelain, chymotrypsin, ficin and alcalase; Carbohydrases: glucoamylase, alpha-amylase, beta-amylase, dextranase and mutanas; Lipases: plant lipase, gastric lipase and pancreatic lipase and Glucoamylase, a Saccharifying glucoamylase of Aspergillus niger origin.

[0068] Non-limiting examples of cooling agents of the present application can be selected from the group including but not limited to menthol, menthyl lactate, monomenthyl succinate, menthol ethylene glycol carbonate, menthol propylene glycol carbonate, menthone glycerol ketal, 3-(l- menthoxy) propane- 1,2-diol, (-)-isopulegol, WS-3 1 [N-ethyl-p-menthane-3 -carboxamide], WS-23 (2-isopropyl-N-2,3-trimethylbutyramide), and WS-5 [ethyl 3p-menthane-3-carboxamido)acetate].

[0069] Non-limiting examples of sweeteners of the present application can be selected from the group including but not limited to acesulfame K, aspartame, neotame, saccharin, sucralose, stevia, advantame cyclamate, sorbitol, xylitol and erythritol.

[0070] According to one of the embodiments of the present application, the oral care ingredient is present in amount from about 0.1 to about 5 wt.%, from about 6 to about 10 wt.%, from about 11 to about 15 wt.%, from about 16 to about 20wt.%, from about 21 to about 25wt.%, and from about 26 to about 30wt.% based on the total weight of the mucoadhesive whitener composition including denture adhesive and denture fixative composition.

[0071] In some embodiments, an antibacterial, an anti-inflammatory, a pain reliving agent, an antioxidant, an enzyme, a flavoring agent, a cooling agent, and a sweetener is / are present in suitable amounts ranging from about 0.01 wt. % to about 0.1 wt. %, or from about 0.1 wt. % to about 1 wt. %, or from about 1 wt. % to about 10 wt. %, or from about 10 wt. % to about 20 wt. % based on the total weight of the mucoadhesive whitener composition including denture adhesive and denture fixative composition.

[0072] According to another embodiment of the present application, it is contemplated to employ at least one excipient. Suitable excipients for the purposes of this application is a oral care ingredient selected from the group consisting of a preservative, a flavoring agent, a colorant, a sweetening agent, a plasticizer, a binder, a thickener, vehicles, colorant, carrier, flavoring agent, fragrance, sensate, arid mixtures thereof.

[0073] In another non-limiting embodiment, the present application provides a di-valent (M++) cation donor selected from the group consisting of calcium (Ca++), strontium (Sr++), zinc(Zn++), magnesium (Mg++), iron (Fe++), vanadium (V++), chromium (Cr++), manganese (Mn++), nickel (Ni++), copper (Cu++), yttrium (Y++) and mixtures thereof.

[0074] In another non-limiting embodiment, the di-valent (M++) cation donor is a salt selected from the group consisting of acetate salt of di-valent cations, carboxylate salt of di-valent cations, gluconate salt of di-valent cations, halide salt of di-valent cations, hydroxide salt of di-valent cations, carbonate salts of di-valent cations, lactate salt of di-valent cations, oxide salt of di-valent cations, phosphate salt of di-valent cations, sulphate salt of di-valent cations, and combinations thereof.

[0075] In another non-limiting embodiment, the di-valent (M++) cation salt is selected from the group consisting of calcium acetate, calcium carbonate, calcium chloride, calcium 2- ethylbutanoate, calcium gluconate, calcium hydroxide, calcium lactate, calcium oxide, calciumpropionate, calcium sulphate, calcium magnesium acetate, magnesium acetate, magnesium chloride, magnesium propionate, zinc chloride, zinc acetate, and combinations thereof.

[0076] In another non-limiting embodiment, the di-valent (M++) cation donor is present in an amount of from about 0.25 to about 10 wt.% of the total composition. Further, di-valent (M++) cation donor is present in an amount of from about 1 to about 5 wt.%, and from about 5 to about 10 wt.% of the total composition.

[0077] In another non-limiting embodiment, the present application discloses making mucoadhesive whitener composition and of using such formulations for sustained release of active ingredients selected from the group including but not limited to an antibacterial, an antiinflammatory, a pain reliving agent, an antioxidant, an enzyme, a flavoring agent, a cooling agent and a sweetener.

[0078] In one embodiment, the mucoadhesive whitener composition is a an oral gel, an oral ointments, buccal composition, a sublingual composition, a palatal composition, and a denture adhesive composition in the form of a dentifrice, denture cleanser, lozenge, mouth, dental implement tooth powder, topical oral gel, denture product, dissolvable film, strip, oral tablet, wafer, and chewing gum.

[0079] In one embodiment, it is contemplated to use a material that is suitable for mucoadhesive whitener composition applied directly on teeth, particularly, it is safe and palatable at relevant concentrations for use in a hygiene composition, such as, paste, cream, gel, thermoplastic solid, hydrogel or combinations thereof.

[0080] In another non-limiting embodiment, the present mucoadhesive whitener composition has a pH of from about 5 to about 8.

[0081] In another non-limiting embodiment, the mucoadhesive whitener composition is a denture whitening composition.

[0082] In another non-limiting embodiment the present invention relates to a device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition; b) a reservoir to store the composition; c) a channel configured to receive the composition dispensed from the reservoir device to an applicator; and d) applying the dispensed quantity of the composition on a user's tooth by using the applicator, wherein the device isconfigured to held by a user and to dispense the composition from the reservoir to the applicator on subjecting a force.

[0083] In another non-limiting embodiment the present invention relates to a device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition; b) an actuator; c) a reservoir located between the applicator and the actuator and configured to store the composition; d) a channel configured to receive tooth whitening composition dispensed from the reservoir device to an applicator; and e) applying the dispensed quantity of the composition on a user's tooth by using the applicator, wherein the actuator is configured to dispense the composition from the reservoir to the applicator on subjecting a mechanical force; wherein the device is configured to held by a user and configured actuator to dispense the composition from the reservoir to the applicator on subjecting a force. For example, devices suitable for delivering the composition of the present invention are disclosed in the following U.S. patents and publications, which are incorporated herein by reference: U.S. Patent No. 10,821,221 B2; U.S. Patent No. 6,893,629 B2; U.S. Patent No. 5,989,569 A; and U.S. Patent Publication No. 2004 / 0241110 A.

[0084] In another non-limiting embodiment, wherein the actuator is a slide switch, a touch pad, a knob, a capacitive sensor, or any component that upon actuation causes a force on the reservoir and release of the composition from the device.

[0085] In another non-limiting embodiment, wherein the reservoir is a flexible body.

[0086] In another non-limiting embodiment, wherein the reservoir is a non-flexible body.

[0087] In one more non-limiting embodiment, the composition is a non-newtonian fluid, gel, or paste.

[0088] In a non-limiting embodiment, the present invention discloses a method of whitening a tooth, comprising: a) applying an amount of mucoadhesive whitener composition on a tooth, b) allowing mucoadhesive whitener composition to bleach intrinsic and extrinsic stains by release and delivery of bound hydrogen peroxide from whitening agent to the tooth, and c) washing the tooth after two hours of applying the composition.

[0089] In another non-limiting embodiment, the amount of mucoadhesive whitener composition applied on tooth is from about 0.1 to about 1 milligram per millimeter of tooth.

[0090] Further, certain aspects of the present application are illustrated in detail by way of the following examples. The examples are given herein for illustration of the application and are not intended to be limiting thereof.EXAMPLES

[0091] Examples 1: Preparation of mucoadhesive whiteners:

[0092] Mucoadhesive whitener creams were made in a KitchenAid mixer equipped with a heating jacket. The mixing bowl was pre-heated to around 80°C, or 50°C or maintained at room temperature. Orally acceptable carriers were first added to the mixing bowl and mixed at low speed till uniform clear liquid was obtained. If rheology modifier was used, it was added at this point of time and mixed at moderate high speed for 20-30 minutes till a uniform gel if formed. Secondary adhesive polymer(s) were then added to the mixing bowl and mixed at medium speed for 10 minutes to obtain a homogeneous mixture. Whitening agent(s) were then added to the mixing bowl and mixed at medium speed for 10 minutes or till homogeneous. Neutralizers were added to the mixing bowl and mixed for 10 minutes at medium speed till homogeneous. Finally primary adhesive polymer(s) were added to the mixing bowl and mixed at medium-high speed for 15 minutes. Other ingredients (flavour, sweeteners, preservatives, etc) were added last and mixed at slow-medium speed till homogeneous. Samples were then cooled to room temperature gradually with continuous slow mixing and then packaged.

[0093] Test method - visual assessment:

[0094] Tests were performed on bovine enamels embedded in plastic coupons and pre-stained with a modified Stookey stains. Half of the enamel was protected with nail polish and adhesive tape to preserve an untreated stained area for reference. The exposed other half of the stained enamel was treated with the mucoadhesive whitening composition by applying a thin layer (0.1- Img cream / mm2) of the whitening composition. The enamel was exposed to a continuous dropwise addition of artificial saliva at approximately 1ml. min flow rate for 2 hours. After 2 hours the enamel was washed thoroughly under running water to remove any whitening composition remaining on the enamel surface, and wiped dry with paper towels. This treatment-rinse routine was repeated for a total of 5 times for each enamel sample (total treatment time = 5 x 2 hours). After the final rinse the tape and nail polish cover was removed exposing the untreated stained partof the enamel. The enamel with half of it treated with the whitening composition and other half untreated was then photographed for a visual comparison as shown in Figure 1.

[0095] Test method - Instrumental assessment:

[0096] Color balances set (3-4 teeth per set) of bovine enamels embedded in plastic coupons and pre-stained with a modified Stookey stain were used. Enamels were blotted dry with paper towels and lowed to stand in air for 1 hour after which baseline color of the enamels were measured using a Minolta spectrophotometer. Measurements were done in replicates of 3 per enamel sample and average of measured color and luminosity of respective enamel samples were used as baseline. Whitening compositions were applied on the enamel samples in thin layers (0.1-lmg cream / mm2). The enamel was exposed to a continuous dropwise addition of artificial saliva at approximately 1ml. min flow rate for 2 hours. After 2 hours the enamel was washed thoroughly under running water to remove any whitening composition remaining on the enamel surface and wiped dry with paper towels. This treatment-rinse routine was repeated for a total of 5 times for each enamel sample (total treatment time = 5 x 2 hours). After final treatment and rinse, the enamels were thoroughly washed with D.I. water and wiped dry with paper towel. The enamels were allowed to dry completely for 1 hour at room temperature and color and luminosity values were measured using Minolta spectrophotometer in triplicates for each enamel sample as described before. The difference in color luminosity before and after treatment with whitening composition were compared against that of a standard white control surface and the differences in whiteness and luminosity of the bovine enamel samples before and after treatment were expressed as AE* values. Higher values of AE* would represent greater deviation from the absolute white and therefore darker or more stained enamels while lower AE* would represent lesser deviation from the absolute white and therefore lighter or less stained or stain removed from enamel samples. Spectroscopic data for treatment of pre-stained bovine enamel samples with the mucoadhesive formula of Table 5 are shown in Figure 2.

[0097] Example 1: Oil-free mucoadhesive whitener (with PVM / MA - Na / Ca mixed salt):

[0098] Oil-free mucoadhesive whitener (with PVM / MA - Na / Ca mixed salt) composition was prepared as described in Example 1 by using ingredients in Table 1.

[0099] Table 1: Oil-free mucoadhesive whitener (with PVM / MA - Na / Ca mixed salt):

[0100] Example 2: Oil-free mucoadhesive whitener (with PVM / MA diacid) Placebo

[0101] Oil-free mucoadhesive whitener (with PVM / MA diacid) Placebo composition was prepared as described in Example 1 by using the ingredients in Table 2.

[0102] Table 2: Oil-free mucoadhesive whitener (with PVM / MA diacid) Placebo:

[0103] Example 3: Oil-free mucoadhesive whitener (with PVM / MA diacid)

[0104] Oil-free mucoadhesive whitener (with PVM / MA diacid) composition was prepared as described in Example 1 by using the ingredients in Table 3.

[0105] Table 3: Oil-free mucoadhesive whitener (with PVM / MA diacid):

[0106] Example 4: Oil-free mucoadhesive whitener (with PVM / MA diacid)

[0107] Oil-free mucoadhesive whitener (with PVM / MA diacid) composition was prepared as described in Example 1 by using the ingredients in Table 4.

[0108] Table 4: Oil-free mucoadhesive whitener (with PVM / MA diacid):

[0109] Example 5: Oil-free mucoadhesive whitener (with PVM / MA diacid)

[0110] Oil-free mucoadhesive whitener (with PVM / MA diacid) composition was prepared as described in Example 1 by using the ingredients in Table 5.

[0111] Table 5: Oil-free mucoadhesive whitener (with PVM / MA diacid):

[0112] Embodiment 1 : A mucoadhesive whitener composition, comprising: (a) from about 1 to about 40 wt.% of at least one primary adhesive polymer, (b) from about 1 to about 40 wt.% of at least one secondary adhesive polymer, (c) from about 0.5 to about 10 wt.% of at least one rheology modifier, (d) from about 1 to about 30 wt.% of at least one whitening agent, (e) from about 1 to about 20 wt.% of at least one neutralizer, (f) from about 0.1 to about 90 wt.% of at least one oral care acceptable anhydrous carrier, (g) from about 0.1 to about 30 wt.% of at least one oral care ingredient, and (h) optionally, from about 0.25 to about 10 wt.% of at least one divalent cationic donor.

[0113] Embodiment 2: The mucoadhesive whitener composition of embodiment 1 , wherein the primary adhesive polymer is selected from the group consisting of polyvinyl methyl ether / maleic acid copolymer; sodium, calcium or mixed salt of polyvinyl methyl ether / maleic acid and combinations thereof.

[0114] Embodiment 3: The mucoadhesive whitener composition of embodiment 1, wherein the primary adhesive polymer is lower alkyl vinyl ether-maleic acid copolymer; sodium, calcium or their mixed salt of lower alkyl vinyl ether / maleic acid copolymers and combinations thereof.

[0115] Embodiment 4: The mucoadhesive whitener composition of embodiment 1, wherein the secondary adhesive polymer is selected from the group consisting of carboxymethyl cellulose, carboxymethyl cellulose with at least one monovalent (sodium, potassium, and lithium), carboxymethyl cellulose with at least one divalent (calcium, strontium, zinc, magnesium and iron), alkyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, divalent cation modified carboxymethyl cellulose and combinations thereof.

[0116] Embodiment 5: The mucoadhesive whitener composition of embodiment 1, wherein the rheology modifier is selected from the group consisting of linear polyvinyl pyrrolidone, crosslinked polyvinyl pyrrolidone and combinations thereof.

[0117] Embodiment 6: The mucoadhesive whitener composition of embodiment 1, wherein the whitening agent is selected from the group consisting of PVP-H2O2 complex and crosslinked PVP- H2O2 complex and combinations thereof.

[0118] Embodiment 7: The mucoadhesive whitener composition of embodiment 1, wherein the neutralizer is selected from the group consisting of sodium tripolyphosphate, tetrasodium pyrophosphate, sodium hexametaphosphate, sodium hydroxide, sodium carbonate calcium hydroxide, calcium carbonate and combinations thereof.

[0119] Embodiment 8: The mucoadhesive whitener composition of embodiment 1, wherein the oral care acceptable anhydrous carrier is selected from the group consisting of propylene glycol, polyethylene glycol, glycerin, petrolatum, mineral oil, vegetable oils and combinations thereof.

[0120] Embodiment 9: The mucoadhesive whitener composition of embodiment 1, wherein the one or more oral care ingredient is selected from the group consisting of colorants, flavoring agents, antibacterial compounds, pain relieving agents, antioxidants, enzymes, cooling agents, sweeteners, adhesion promoters, anti-caking agents, anti-fungal agents, anti-microbial agents, antigingivitis agents, anesthetic agents, anti-biotics, anti-inflammatory agents, binder, buffers, colors, dentinal desensitizing agents, dispersants, emollients, fdlers, fragrances, gelling agent, humectants, hydrophilic non-oil components, oil carriers, ooze control polymers, preservatives, pigments, plasticizers, thickening agents, viscosity modifiers, therapeutics, vehicles, surfactants, stabilizers, sensates and combinations thereof.

[0121] Embodiment 10: A device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition of embodiment 1; b) a reservoir to store the composition of a); c) a channel configured to receive the composition of a) dispensed from thereservoir to an applicator; d) applying the dispensed quantity of the composition on a user's tooth by using the applicator; and wherein the device is configured to held by a user and to dispense the composition from the reservoir to the applicator on subjecting a force.

[0122] Embodiment 11 : A device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition of embodiment 1; b) an actuator; c) a reservoir located between the applicator and the actuator and configured to store the composition of a); d) a channel configured to receive tooth whitener composition dispensed from the reservoir device to an applicator; and e) applying the dispensed quantity of the composition on a user's tooth by using the applicator, wherein the actuator is configured to dispense the composition from the reservoir to the applicator on subjecting a mechanical force; wherein the device is configured to held by a user and configured actuator to dispense the composition from the reservoir to the applicator on subjecting a force.

[0123] Embodiment 12: The device of embodiment 11, wherein the actuator is a slide switch, a touch pad, a knob, a capacitive sensor, or any component that upon actuation causes a force on the reservoir and release of the composition from the device.

[0124] Embodiment 13. The device of embodiment 11, wherein the reservoir is a flexible body.

[0125] Embodiment 14. The device of embodiment 11, wherein the reservoir is a non- flexible body.

[0126] Embodiment 15. The device of embodiment 11, wherein the mucoadhesive whitener composition is a non-Newtonian fluid, gel, or paste.

[0127] Embodiment 16. A method of whitening a tooth, comprising: a) applying an amount of mucoadhesive whitener composition of embodiment 1 on a tooth, b) allowing mucoadhesive whitener composition to bleach intrinsic and extrinsic stains by release and delivery of bound hydrogen peroxide from whitening agent to the tooth, and c) washing the tooth after two hours of applying the composition on the tooth.

[0128] Embodiment 17. The method of whitening a tooth of embodiment 17, the amount of mucoadhesive whitener composition is from about 0.1 to about 1 milligram per millimeter of tooth.

[0129] The above description fully discloses the invention including preferred embodiments thereof. Modifications and improvements of the embodiments specifically disclosed herein are within the scope of the following claims. Without further elaboration it is believed that one skilledin the art can, given the preceding description, utilize the present invention to its fullest extent. The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.

Claims

What is claimed is:1 . A mucoadhesive whitener composition, comprising:(a) from about 1 to about 40 wt.% of at least one primary adhesive polymer, based on the total weight of the mucoadhesive whitener composition;(b) from about 1 to about 40 wt.% of at least one secondary adhesive polymer, based on the total weight of the mucoadhesive whitener composition;(c) from about 0.5 to about 10 wt.% of at least one rheology modifier, based on the total weight of the mucoadhesive whitener composition;(d) from about 1 to about 30 wt.% of at least one whitening agent, based on the total weight of the mucoadhesive whitener composition;(e) from about 1 to about 20 wt.% of at least one neutralizer, based on the total weight of the mucoadhesive whitener composition;(f) from about 0.1 to about 90 wt.% of at least one oral care acceptable anhydrous carrier, based on the total weight of the mucoadhesive whitener composition;(g) from about 0.1 to about 30 wt.% of at least one oral care ingredient, based on the total weight of the mucoadhesive whitener composition; and(h) optionally, from about 0.25 to about 10 wt.% of at least one divalent cationic donor, based on the total weight of the mucoadhesive whitener composition; preferably being a salt selected from the group consisting of acetate salt of di-valent cations, carboxylate salt of di-valent cations, gluconate salt of di-valent cations, halide salt of di-valent cations, hydroxide salt of di-valent cations, carbonate salts of di-valent cations, lactate salt of di-valent cations, oxide salt of di-valent cations, phosphate salt of di-valent cations, sulphate salt of di-valent cations, and combinations thereof.

2. The mucoadhesive whitener composition according to claim 1, wherein the primary adhesive polymer isselected from the group consisting of polyvinyl methyl ether / maleic acid copolymer; sodium, calcium or mixed salt of polyvinyl methyl ether / maleic acid and combinations thereof; and / or is present in an amount of from 3.0 to 25.0 wt.%, preferably of from 3.0 to 15.0 wt.%, more preferably of from 3.0 to 8.0 wt.%, in each case based on the total weight of the mucoadhesive whitener composition.

3. The mucoadhesive whitener composition according to claim 1 or claim 2, wherein the secondary adhesive polymer is selected from the group consisting of sodium carboxymethyl cellulose, carboxymethyl cellulose with at least one monovalent (sodium, potassium, and lithium) and one divalent (calcium, strontium, zinc, magnesium and iron), ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose and combinations thereof; and / or is present in an amount of from 3.0 to 23.0 wt.%, preferably of from 3.0 to 15.0 wt.%, more preferably of from 3.0 to 10.0 wt.%, in each case based on the total weight of the mucoadhesive whitener composition.

4. The mucoadhesive whitener composition according to any of the preceding claims, wherein the rheology modifier is selected from the group consisting of linear polyvinyl pyrrolidone, crosslinked polyvinyl pyrrolidone and combinations thereof; and / or is present in an amount of from 1.0 to 3.0 wt.%, based on the total weight of the mucoadhesive whitener composition.

5. The mucoadhesive whitener composition according to any of the preceding claims, wherein the whitening agent is selected from the group consisting of PVP-H2O2 complex and crosslinked PVP-H2O2 complex and combinations thereof; and / oris present in an amount of from 12.0 to 23.0 wt.%, based on the total weight of the mucoadhesive whitener composition.

6. The mucoadhesive whitener composition according to any of the preceding claims, wherein the neutralizer is selected from the group consisting of sodium tripolyphosphate, tetrasodium pyrophosphate, sodium hexametaphosphate, sodium hydroxide, sodium carbonate calcium hydroxide, calcium carbonate and combinations thereof; and / or is present in an amount of from 1.0 to 10.0 wt.%, preferably of from 1.0 to 7.0 wt.%, in each case based on the total weight of the mucoadhesive whitener composition.

7. The mucoadhesive whitener composition according to any of the preceding claims, wherein the oral care acceptable anhydrous carrier is selected from the group consisting of propylene glycol, polyethylene glycol, glycerin, petrolatum, mineral oil, vegetable oils and combinations thereof; and / or is present in an amount of from 40.0 to 90.0 wt.%, preferably of from 60 to 90.0 wt.%, in each case based on the total weight of the mucoadhesive whitener composition.

8. The mucoadhesive whitener composition according to any of the preceding claims, wherein the oral care ingredient- is selected from the group consisting of flavoring agents, therapeutics, sweeteners, fillers, colorants, coolants, preservatives, or combinations; and / or- is present in an amount of from 1.0 to 10.0 wt.%, based on the total weight of the mucoadhesive whitener composition.

9. A device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition according to any of the preceding claims; b) a reservoir to store the composition;c) a channel configured to receive the composition dispensed from the reservoir device to an applicator; d) means for applying the dispensed quantity of the composition on a user's tooth by using the applicator; and wherein the device is configured to be held by a user and to dispense the composition from the reservoir to the applicator on subjecting a force.

10. A device for delivering a mucoadhesive whitener composition, comprising: a) a mucoadhesive whitener composition according to any of claims 1 to 8; b) an actuator; c) a reservoir located between the applicator and the actuator and configured to store the composition; d) a channel configured to receive tooth whitening composition dispensed from the reservoir device to an applicator; and e) means for applying the dispensed quantity of the composition on a user's tooth by using the applicator, wherein the actuator is configured to dispense the composition from the reservoir to the applicator on subjecting a mechanical force; wherein the device is configured to held by a user and configured actuator to dispense the composition from the reservoir to the applicator on subjecting a force.

11. The mucoadhesive whitener composition delivery device according to claim 10, wherein the actuator is a slide switch, a touch pad, a knob, a capacitive sensor, or any component that upon actuation causes a force on the reservoir and release of the composition from the device.

12. The device for delivering a mucoadhesive whitener composition according to any of claims 9 to 11, wherein the reservoir is a flexible body.

13. The mucoadhesive whitener composition delivery device according to any of claims 9 to 11, wherein the reservoir is a non-flexible body.

14. The mucoadhesive whitener composition delivery device according to any of claims 9 to 13, wherein the composition is a non-Newtonian fluid, gel, or paste.

15. A non-therapeutically method for whitening of teeth comprising the step of- applying the mucoadhesive whitener composition according to any of claims 1 to 8 to teeth, preferably via the device according to any of claims 9 to 14.

16. Use of the mucoadhesive whitener composition according to any of claims 1 to 8 for whitening of teeth comprising the step of- applying the mucoadhesive whitener composition according to any of claims 1 to 8 to teeth, preferably via the device according to any of claims 9 to 14.

17. A method of whitening a tooth, comprising: a) applying an amount of mucoadhesive whitener composition of claim 1 on a tooth, b) allowing mucoadhesive whitener composition to bleach intrinsic and extrinsic stains by release and delivery of bound hydrogen peroxide from whitening agent to the tooth, and c) washing the tooth after two hours of applying the composition on the tooth.

18. The method of any of the preceding claims, the applying amount of mucoadhesive whitener composition is from about 0.1 to about 1 milligram per millimeter of tooth.

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