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WO2005072692A1 - Procedes et compositions de blanchiment dentaire presentant une concentration reduite en peroxyde - Google Patents

Procedes et compositions de blanchiment dentaire presentant une concentration reduite en peroxyde Download PDF

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Publication number
WO2005072692A1
WO2005072692A1 PCT/US2005/002332 US2005002332W WO2005072692A1 WO 2005072692 A1 WO2005072692 A1 WO 2005072692A1 US 2005002332 W US2005002332 W US 2005002332W WO 2005072692 A1 WO2005072692 A1 WO 2005072692A1
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WO
WIPO (PCT)
Prior art keywords
peroxide
compound
composition
calcium
tooth
Prior art date
Application number
PCT/US2005/002332
Other languages
English (en)
Inventor
Lynette Anne Zaidel
Nora Chila Lin
David Viscio
Original Assignee
Colgate-Palmolive Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Colgate-Palmolive Company filed Critical Colgate-Palmolive Company
Priority to EP05711997A priority Critical patent/EP1718368A1/fr
Priority to CA002553672A priority patent/CA2553672A1/fr
Priority to BRPI0507098-8A priority patent/BRPI0507098A/pt
Priority to AU2005209271A priority patent/AU2005209271A1/en
Publication of WO2005072692A1 publication Critical patent/WO2005072692A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/40—Peroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/22—Peroxides; Oxygen; Ozone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/24—Phosphorous; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/38—Percompounds, e.g. peracids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/88—Two- or multipart kits

Definitions

  • Tooth whitening methods currently offered in dental practices often involve the use of take-home whitening kits containing a peroxide gel or paste. In one type of kit, the peroxide product is placed in a pre-fabricated tray and worn by the patient for 1-2 weeks in daily application times ranging from 30 minutes to overnight. In an attempt to obtain faster whitening, products containing high concentrations up to 22% carbamide peroxide are now available.
  • any one or more of an increased rate of tooth-whitening, increased effectiveness of tooth-whitening and decreased oral irritation are produced in comparison to that produced by a tooth-whitening composition containing the same or greater concentration of the peroxide compound at a pH of 7.0 or less in absence of the one or more abrasive compounds.
  • the methods can involve increasing the pH of the peroxide-containing tooth-whitening composition from a pH of 7.0 or less to a pH to 9.0 or greater by combining, in a dual component system, a first component comprising the peroxide compound in an aqueous vehicle at a pH of about 7 or less and adding a second component comprising an alkaline compound produce a mixture having a pH of about 9 or greater.
  • the present invention can involve a dual component dentifrice system comprising first and second components.
  • the first component can comprise a peroxide compound and a peroxide-compatible abrasive compound.
  • the second component can comprise an alkaline compound. Combining the first and second components in a mixture produces a dentifrice composition having a pH of about 9 or greater is produced.
  • a dentifrice composition having a pH of about 9 or greater is produced.
  • the pH of the first component can be in a range of from about 4 to about 7 and the pH of the second component can be in a pH range of from at least about 9 to about 13.
  • the peroxide compound in the dentifrice composition can be at a hydrogen-peroxide-equivalent concentration of not greater than about 5% by weight or at a hydrogen-peroxide-equivalent concentration of not greater than about 3.5% by weight.
  • the present invention can also include dentifrice compositions comprising a peroxide compound and a peroxide-compatible abrasive compound.
  • the pH of the composition can be 9.0 or greater and the concentration of the peroxide compound can be at a hydrogen-peroxide-equivalent concentration of not greater than about 5% by weight or at a hydrogen-peroxide-equivalent concentration of not greater than about 3.5% by weight.
  • the composition can produces a tooth-whitening effect equal to or greater than that of a comparative tooth-whitening composition having a hydrogen peroxide concentration of about 7% or greater by weight.
  • the present invention can also include methods for whitening a tooth in a mammal.
  • the methods can comprise contacting the tooth for an effective tooth-whitening period with a tooth-whitening composition.
  • the tooth-whitening composition can comprises a peroxide compound and a peroxide-compatible abrasive compound.
  • the pH of the tooth-whitening composition can be at least about 9 and the peroxide compound can be at a hydrogen-peroxide-equivalent concentration of not greater than about 5% by weight or at a hydrogen-peroxide-equivalent concentration of not greater than about 3.5% by weight.
  • the composition can be prepared from a dual component system comprising a first component comprising a peroxide compound and a peroxide-compatible abrasive compound and a second component comprising an alkaline compound.
  • the contacting is for a period of time which is effective in whitening the tooth, i.e. an effective tooth-whitening period, which is less than that required for a comparative composition comprising hydrogen peroxide at a concentration of about 7% by weight or greater and a pH of about 7.0 or less.
  • Such effective tooth-whitening period of the tooth- whitening compositions of the present invention can be not more than about 15 minutes or not more than about 20 minutes and that of comparative composition can be about 30 minutes or greater.
  • the present invention in various embodiments, can also include methods for decreasing whitening time, increasing whitening effectiveness or decreasing oral irritation in a tooth-whitening process.
  • the methods can comprise contacting a tooth for an effective tooth-whitening period with a tooth-whitening composition comprising a peroxide compound and a peroxide-compatible abrasive compound.
  • the pH of the tooth-whitening composition can be at least about 9 and the peroxide compound can be present at a hydrogen-peroxide- equivalent concentration of not greater than about 5% by weight or at a hydrogen-peroxide- equivalent concentration of not greater than about 3.5% by weight.
  • the tooth-whitening composition produces a decrease in whitening time, an increase in whitening effectiveness or a decrease in oral irritation or any combination thereof in comparison to a reference composition having a peroxide compound concentration of about 7% by weight or greater and a pH of about 7.0 or less.
  • the contacting can be for an effective tooth-whitening period which is less than that required for a comparative composition comprising hydrogen peroxide at a concentration of about 7% by weight or greater and a pH of about 7.0 or less.
  • the effective tooth-whitening period of the tooth-whitening composition can be not more than about 15 minutes or not more than about 20 minutes and that of comparative composition can be about 30 minutes or greater.
  • the tooth-whitening composition can be prepared from a dual component system comprising first and second components in which the first component can comprise a peroxide compound and a peroxide-compatible abrasive compound and the second component can comprise an alkaline compound.
  • the first and second components can combine not more than about 15 minutes, not more than about 10 minutes, not more than about 5 minutes or not more than about 2 minutes prior contacting a tooth with the composition to produce tooth whitening.
  • the peroxide compound can be hydrogen peroxide, an organic peroxide compound, a hydrogen peroxide generating compound or combinations thereof.
  • Such organic peroxide compound can be, for example, urea hydrogen peroxide, glyceryl peroxide, benzoyl peroxide, monoperoxyphthalate or combinations thereof.
  • the hydrogen peroxide generating compound can be, for example, sodium persulfate, sodium dipersulfate, sodium percarbonate, sodium perphosphate, sodium perborate, sodium persilicate, potassium persulfate, potassium dipersulfate, potassium percarbonate, potassium perphosphate, potassium perborate, potassium persilicate, calcium persulfate, calcium dipersulfate, calcium percarbonate, calcium perphosphate, calcium perborate, calcium persilicate, sodium peroxide, potassium peroxide and calcium peroxide or combinations thereof.
  • the peroxide- compatible abrasive comprises one or more calcium phosphate salts including, for example calcium pyrophosophate.
  • the peroxide-compatible abrasive can be present in the tooth- whitening composition or in the dentifrice composition at a concentration of at least about 10% by weight or at a concentration of at least about 20% by weight.
  • an alkaline compound can be present.
  • Such alkaline compound can be, for example, sodium hydroxide, potassium hydroxide, ammonium hydroxide, calcium hydroxide, magnesium hydroxide, sodium carbonate, potassium carbonate, ammonium carbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate, potassium bicarbonate, ammonium bicarbonate, calcium bicarbonate, magnesium bicarbonate, urea, monoethanolamine, diethanolamine, triethanolamine, mono(iso)propanolamine, di(iso)propanolamine, tri(iso)propanolamine, 2- amino-2-methylpropanol, 2-amino-2-methyl-l,3-propanediol, 2-amino-2-ethyl-l,3- propanediol, tris(hydroxymethyl)aminomethane, N,N,N'N'-tetrakis(2- hydroxypropyl)ethylenediamine, di(2-ethylhexyl)amine, triamylamine, dodecylamine,
  • the second component can also comprise an abrasive compound.
  • the abrasive compound in the second component can be one or more peroxide-incompatible abrasive compounds, such as, for example a silica compound or an alumina compound or one or more peroxide-compatible abrasive compounds, such as, for example one or more calcium phosphate salts including calcium pyrophosphate as well as a combination of one or more peroxide-incompatible and/or peroxide-compatible abrasive compounds.
  • the total concentration of abrasive compounds in the tooth-whitening compositions or the dentifrice compositions can be at least 10% by weight or at least 20% by weight.
  • the second component can also comprise a color indicator such as, for example, group consisting of FD&C Red No. 3, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Green No. 3, FD&C Blue No. 1 and combinations thereof.
  • a color indicator such as, for example, group consisting of FD&C Red No. 3, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Green No. 3, FD&C Blue No. 1 and combinations thereof.
  • a tooth-desensitizing compound such as, for example, a potassium salt of a weak acid or eugenol.
  • Figure 1 illustrates the in vitro treatment of extracted human teeth for 28 treatment periods using the composition of Example 1 for 20 minute treatment periods; comparative example Cl for 30 minute treatment periods; and comparative example C2 for 30 minute treatment periods.
  • Figure 2 illustrates the in vitro treatment of extracted human teeth for 14 or greater treatments using the compositions of Example 1 for 20 minute treatment periods; the composition of Example 5 for 15 minute treatment periods; comparative example Cl for 30 minute treatment periods; and comparative example C2 for 30 minute treatment periods.
  • the present invention in various embodiments, can involve methods and compositions for enhancing tooth-whitening with compositions containing one or more peroxide compounds and one or more abrasive compounds, wherein the compositions can have a pH of at least about 9.0.
  • Such compositions can accelerate the tooth-whitening process, increase the whitening activity of the peroxide compounds and decrease oral irritation.
  • Reference herein to "a tooth” is intended to include the singular (tooth) and the plural (teeth).
  • the tooth-whitening effect of the compositions is detectable by visual observation or by measurement using any of various instruments following a given application period or following successive application periods of the same duration.
  • the enhanced whitening effect of the compositions of the present invention can be achieved at a reduced concentration of peroxide compounds compared to concentrations normally used.
  • Concentrations of peroxide compounds normally used can be, for example, 7% hydrogen peroxide by weight or 7.5% hydrogen peroxide by weight or an amount of a peroxide compound other than hydrogen peroxide in which the peroxide compound delivers a hydrogen peroxide ion or an organic peroxide ion in an amount equivalent to the hydrogen peroxide ion delivered by 7% by weight hydrogen peroxide or 7.5% by weight hydrogen peroxide under the same conditions of temperature, exposure to light or other radiation, agitation and the like.
  • concentrations of peroxide compounds as used herein refer concentrations that deliver the amount of bleaching activity equal to that delivered by hydrogen peroxide at the stated concentration.
  • the compounds deliver an amount of peroxide ion equal to that delivered by hydrogen peroxide at the stated concentration.
  • carbamide peroxide at a concentration of 10% by weight in an aqueous solution is generally considered to deliver the same amount of hydrogen peroxide ion as an aqueous solution of hydrogen peroxide at a concentration of about 3% by weight.
  • a hydrogen-peroxide-equivalent concentration of 3.5% by weight is intended to mean a carbamide peroxide concentration of about 12% by weight
  • a hydrogen-peroxide-equivalent concentration of 5% by weight is intended to mean a carbamide peroxide concentration of about 17% by weight
  • a hydrogen-peroxide- equivalent concentration of 7% by weight is intended to mean a carbamide peroxide concentration of about 22% by weight.
  • compositions and “reference composition” are used interchangeably herein.
  • Concentrations of the comparative or reference compositions as used herein is intended to mean the concentrations that deliver an amount of peroxide ion equal to that delivered by hydrogen peroxide at the stated concentration.
  • the reference or comparative composition can be hydrogen peroxide.
  • Other comparative compositions can, however, be used and in such instances, the concentrations of the comparative compositions are intended to mean the hydrogen-peroxide-equivalent concentrations of the comparative compositions.
  • the comparative compositions can be at a hydrogen-peroxide-equivalent concentration of about 3.5% by weight or greater, about 5% by weight or greater, about 7% by weight or greater, about 7.5% by weight or greater, about 10% by weight or greater, or about 13% by weight or greater.
  • the hydrogen-peroxide-equivalent concentrations of the peroxide compounds of the present invention show an enhanced whitening effect at hydrogen-peroxide-equivalent concentrations of not more than 3% by weight, not more than 3.5% by weight, not more than 4% by weight, not more than 4.5% by weight, not more than 5% by weight, not more than 5.5% by weight, not more than 6% by weight, and not more than 6.5% by weight.
  • the concentration of the peroxide compound can be viewed as a reduced concentration compared to the reference composition, i.e. the methods in certain embodiments, can involve a reduction in the concentration of the peroxide compound necessary to achieve the same whitening effect in duration of whitening period, effectiveness of whitening and degree of absence of oral irritation.
  • the peroxide compound can be any of a variety of peroxide-based bleaching agents, which deliver a hydrogen peroxide ion or an organic peroxide ion.
  • Such compound include, for example, hydrogen peroxide, organic peroxide compounds, hydrogen peroxide generating compounds, organic peroxide generating compounds and combinations thereof.
  • Organic peroxide compounds include, for example, urea hydrogen peroxide (carbamide peroxide), glyceryl hydrogen peroxide as well as groups of peroxides classified according to the number and kind of organic functional groups attached to the oxygen atoms, such as, for example, alkyl hydrogen peroxide (R-O-O-H), dialkyl hydrogen peroxide (R-O- O-R') peroxy acids (RCO-O-O-H), peroxy esters (RCO-OOR'), and diacyl peroxides (R-CO- O-O-CO-R').
  • urea hydrogen peroxide carbamide peroxide
  • glyceryl hydrogen peroxide as well as groups of peroxides classified according to the number and kind of organic functional groups attached to the oxygen atoms, such as, for example, alkyl hydrogen peroxide (R-O-O-H), dialkyl hydrogen peroxide (R-O- O-R') peroxy acids (RCO-O-O-H),
  • the hydrogen peroxide generating compound can be, for example, alkali metal and alkaline-earth metal persulfate, dipersulfate, percarbonate, perphosphate, perborate, and persilicate salts such as, for example, sodium persulfate, sodium dipersulfate, sodium percarbonate, sodium perphosphate, sodium perborate, sodium persilicate, potassium persulfate, potassium dipersulfate, potassium percarbonate, potassium perphosphate, potassium perborate, potassium persilicate, calcium persulfate, calcium dipersulfate, calcium percarbonate, calcium perphosphate, calcium perborate, calcium persilicate salts as well as sodium peroxide, potassium peroxide and calcium peroxide and combinations of all of the above hydrogen peroxide generating compounds.
  • persilicate salts such as, for example, sodium persulfate, sodium dipersulfate, sodium percarbonate, sodium perphosphate, sodium perborate, sodium persilicate, potassium persul
  • the enhanced whitening effect is achieved at least in part due to the high pH of the tooth- whitening composition which is, in turn achieved by the presence of at least one alkaline compound in the composition.
  • the alkaline compound can be present in one component and the peroxide compound, in the other component such that upon combination prior to use, the tooth-whitening mixture has a pH of at least about 9 or greater.
  • the alkaline compound can be, for example, an alkali metal, ammonium or alkaline earth metal compound such as, for example, sodium hydroxide, potassium hydroxide, ammonium hydroxide, calcium hydroxide, magnesium hydroxide, sodium carbonate, potassium carbonate, ammonium carbonate, calcium carbonate, magnesium carbonate, sodium bicarbonate, potassium bicarbonate, ammonium bicarbonate, calcium bicarbonate, magnesium bicarbonate or combinations thereof; an organic amine such as urea, alkanolamines such as monoethanolamine, diethanolamine, triethanolamine, mono(iso)propanolamine, di(iso)propanolamine, tri(iso)propanolamine or 2-amino-2- methylpropanol; alkanediolamines such as 2-amino-2-methyl-l,3-propanediol or 2-amino-2- ethyl-l,3-propanediol; alkanepolyamines such as tri
  • the alkaline compound can be at a concentration of from about 0.1% by weight to about 30% by weight, from about 0.2% by weight to about 10% by weight, from about 0.5% by weight to about 2% by weight or from about 0.5% by weight to about 0.75% by weight.
  • One or more abrasive compounds can be included in the tooth-whitening compositions of the present invention. Such compounds impart cleaning and polishing -functions to the composition. In addition to such actions, the abrasive compounds can enhance the whitening effect of peroxide compounds.
  • the method of incorporating the abrasive compound into the tooth-whitening composition can depend upon the type of abrasive compound.
  • abrasive compounds can be considered incompatible with peroxide based bleaching compounds because they tend to produce a decomposition of the peroxide compound. This can result not only in a reduced efficacy, but also in premature gas evolution resulting in swelling and/or bursting of tubes containing products made up of a peroxide compound and a peroxide- incompatible abrasive.
  • Peroxide-compatible abrasives i.e. abrasive compounds not considered to cause substantial decomposition of peroxide compounds, include calcium phosphate abrasive compounds (see for example, U.S. Patent No. 5,171,564, which is incorporated in its entirety by reference).
  • Peroxide compatible abrasives include dicalcium phosphate dihydrate, anhydrous dicalcium phosphate, calcium pyrophosphate and mixtures thereof.
  • Peroxide-incompatible abrasives include silica compounds and alumina compounds.
  • silica compounds include for example, hydrated silica, such as Sorbosil AC-35, marketed by PNEOS Silicas Ltd (Warrington, UK; formerly Crosfield Chemicals), or Zeodent 115 from Huber Company (Edison, N.J.).
  • Alumina compounds can include, for example, alumina trihyhydrate, aluminum silicate, calcined alumina and mixtures thereof.
  • abrasives can also be included in the compositions of the present invention, such as, for example, hydroxyapatite, sodium metaphosphate, potassium metaphosphate, tricalcium phosphate, calcium carbonate, sodium bicarbonate, bentonite, and mixtures thereof.
  • Peroxide-incompatible abrasives can be combined with peroxide compounds immediately prior to use without producing substantial decomposition of the peroxide compounds. Such mixtures can produce an enhanced whitening activity of the peroxide compound (see for example, U.S. Patent No. 5,766,574 which is incorporated in its entirety by reference).
  • the tooth-whitening compositions of the present invention can be in the form of a dual component system.
  • the first component can comprise the peroxide compound and the second component can comprise the alkaline compound.
  • the second component can also comprise a peroxide- incompatible abrasive compound.
  • a peroxide-compatible abrasive compound can be incorporated into either or both of the first or second components.
  • the first component of a two component system of the present invention can comprise a peroxide compound and a calcium phosphate abrasive compound such as calcium pyrophosphate and the second component can comprise an alkaline compound.
  • the second component can also contain either or both of a peroxide-incompatible abrasive compound and a peroxide-compatible abrasive compound.
  • the first and second components can, independently, be in the form of a liquid or a semi-solid liquid such as a gel or paste.
  • the dual component system can be in the form of a kit which includes the first and second components along with instructions for combining the first and second components and/or instructions as to the method of use of the first and second components and the a mixture thereof. Such instructions as to the method of use can include the amount to be used, time period for applying the compositions, schedule for repeated application and the like.
  • equal amounts of the first component and the second component are combined in such a manner to effect mixing.
  • the time period for applying the compositions of the present invention to achieve tooth-whitening is sometimes referenced herein as "effective tooth-whitening period.” This represents the time period during which the compositions contact the tooth during a single application.
  • An "effective tooth-whitening period" can be about 10 minutes or less, about 15 minutes or less, about 20 minutes or less, about 25 minutes or less or about 30 minutes or less or more than about 30 minutes.
  • the tooth whitening composition can be applied in a single application or in repeated application.
  • compositions of the present invention can, in various embodiments, contain a thickening agent which imparts a high viscosity to the composition.
  • the compositions have a viscosity of from less than about 200 CPS up to about 10,000 or greater or from about 1000 cps up to about 9000 cps or from about 4000 to about 6000 cps.
  • the thickening agent can be a hydrophilic block copolymer of polyethylene oxide and polypropylene oxide such as a Pluronic® compound, for example Pluronic® F127 which is a trade name of BASF obtained therefrom (BASF Corporation, Mount Olive, New Jersey). Pluronic® F127 has a molecular weight of about 4000.
  • This substance can be present in the compositions at a concentration of about 5% by weight about 10% by weight, about 15% by weight, about 20% by weight, about 25% by weight, about 30% by weight or greater.
  • the Pluronic® F127 concentration in the first component containing the peroxide compound can be about 20% by weight
  • the concentration can be about 17% by weight and in the tooth-whitening mixture of the two, the concentration can be about 18.5% by weight.
  • Polyethylene oxide of high molecular weight can also be used in the compositions of the present invention as thickening agents.
  • Such polyetheylene oxide thickeners have a number average molecular weight, a viscosity average molecular weight, a weight average molecular weight or a Z-average molecular weight of about 50,000 to about 5,000,000.
  • One or more high molecular weight polyethylene oxide can be present in a concentration range of from about 0% to about 30% by weight, from about 10% by weight to about 25% by weight or from about 15% by weight to about 20% by weight.
  • One or more of glycerin, sorbitol and low molecular weight polyethylene glycol can also be included in the compositions as carrier materials which can also impart effects on viscosity.
  • the polyethylene glycol is a nonionic polymer of ethylene oxide.
  • the polyethylene glycol when present in the compositions of the present invention can have a number average, weight average, or Z average molecular weight of from about 200 to about 1000, from about 400 to about 800 or about 600.
  • the glycerin, sorbitol and polyethylene glycol can each independently be present in amounts of from about 0% to about 30% by weight, from about 5% by weight to about 25% by weight, from about 10% by weight to about 20% by weight, or from about 15% by weight to about 20% by weight.
  • compositions of the present invention can also contain added water in an amount of from about 5% by weight to about 40% by weight, from about 10% by weight to about 30% by weight or from about 5% by weight to about 20% by weight.
  • surfactants can also be included in the compositions of the present invention as solubilizing, dispersing and/or emulsifying agents.
  • compositions of the present invention can also contain flavoring substances at a concentration of from about 0.05% by weight to about 5% by weight.
  • Such flavoring substances include, for example, an essential oil, extract or flavoring aldehyde, ester or alcohol that imparts a flavor of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit, orange, apple, pear, peach, strawberry, cherry, apricot, watermelon, banana, coffee, cocoa, menthol, carvone, anethole or combinations thereof.
  • One or more sweetening agents can also be included in the compositions of the present invention.
  • Such sweetening agents can include sodium saccharin, sodium cyclamate, zylitol, aspartame and the like in a concentration of from about 0.01% by weight to about 1.0% by weight.
  • the compositions of the present invention can also be formulated to contain one or more desensitizing agents to reduce tissue sensitivity and irritation upon application of the tooth-whitening compositions.
  • desensitizing agents include, for example, potassium salts of weak acids, such as potassium citrate, potassium chloride, potassium tartrate, potassium bicarbonate, potassium oxalate, potassium nitrate as well as strontium salts and eugenol (4- allyl-2-methoxyphenol).
  • One or more of the sensitizers can be present in the compositions of the present invention at a concentration of from about 0.05% by weight to about 0.5% by weight or from about 0.1% by weight to about 0.25% by weight for eugenol and from about 1% by weight to about 10% by weight or from about 3% by weight to about 6% by weight for potassium salts of weak acids such as, for example potassium nitrate.
  • One or more redox color indicators that are oxidized by hydrogen peroxide can also be included in the second component of the dual-component system.
  • the color indicator can be a dye suitable for use in an tooth-bleaching composition such as, for food color additives certified under the Food Drug & Cosmetic Act for use in food and ingested drugs, including dyes such as FD&C Red No. 3 (sodium salt of tetraiodofluorescein), FD&C Yellow No. 5 (sodium salt of 4-p-sulfophenylazo-l-p-sulfophenyl-5-hydroxypyrazole-3 carboxylic acid), FD&C Yellow No. 6 (sodium salt of p-sulfophenylazo-B-naphtol-6- monosulfonate), FD&C Green No.
  • FD&C Red No. 3 sodium salt of tetraiodofluorescein
  • FD&C Yellow No. 5 sodium salt of 4-p-sulfophenylazo-l-p-sulfophenyl-5-hydroxypyrazole-3 carboxylic acid
  • the second component composition can contain one or more dyes at a concentration of from about 0.005% by weight to about 0.5% by weight or from about 0.025% by weight to about 0.15% by weight.
  • Agents that chelate metal ions can also be present in the compositions of the present invention.
  • Such chelating agents include sodium acid pyrophosphate, disodium calcium ethylene diamine tetraacetic acid, phosphoric acid, citric acid, sodium citrate, potassium citrate, sodium pyrophosphate, potassium pyrophosphate, disodium ethylenediamine tetraacetic acid and the like.
  • the chelating agents can be incorporated into the compositions of the present invention in an amount of from about 0.1% by weight to about 8% by weight or from about 0.5% by weight to about 3.0% by weight.
  • Fluoride compounds having anti-caries activity can also be incorporated in the compositions of the present invention. These substances release fluoride ions in an aqueous environment.
  • fluoride compounds include salts such as, for example, sodium fluoride, potassium fluoride, cuprous fluoride, stannous fluoride, stannous chlorofluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium monofluorophosphate, alumina mono- fluorophosphate and alumina difluorophosphate.
  • the fluoride compounds when present, can be at a concentration sufficient to release fluoride ion in an amount of from about 15 to about 1500 ppm.
  • Anti-forming agents such as simethicone can also be present in the compositions of the present invention at a concentration of from about 0% by weight to about 0.1% by weight.
  • Tooth whiteness can be visually observed or measured by any of various instruments measured.
  • One such instrument can be a colorimetry such as, for example, a Minolta portable Chroma-meter such as model CR-400 (Minolta Co ⁇ . Ramsey, New Jersey).
  • This colorimeter can be programmed to measure Hunter lab values of "L", "a” and “b” in which "L” values represent lightness and "a” and “b” values represent the chromaticity coordinates.
  • Lightness "L” values can represent dark to light color in which a value of 0 represents black and a value of 100 represents white.
  • Green to red can be expressed by the "a” value, the more positive value represented more red, and the more negative value represented more green color (-80 represents green and 100 represents red).
  • Blue to yellow can be expressed by the "b” value, a more positive value represented more yellow color in the sample (-80 represents blue and 70 represents yellow).
  • "L” values are used to measure tooth-whiteness.
  • EXAMPLE 1 This Example illustrates a two component tooth-whitening system in which the concentration of the peroxide compound in the tooth- whitening composition formed by combining the two components is about 3.5% by weight.
  • the composition of the first, peroxide component, and the second alkaline component are as shown in Table 1.
  • Table 1 Tooth-Whitening Composition having 3.5% H 2 O 2 .
  • a B Component Peroxide Component Alkaline Component Ingredients Weight % Weight % Deionized Water 14.3 31 Hydrogen peroxide 20 (35% solution) — Potassium Nitrate — 6 Glycerin 5 5 Polyethylene glycol 600 15 10 Pluronic F-127 20 17 Saccharin 0.2 — Sodium hydroxide — 0.5-0.75 FD+C Yellow #6 — 0.025 - 0.15 Eugenol 0.25 — Calcium pyrophosphate 25 30 Sodium lauryl sulfate — 0.4 Flavor 0.25 —
  • Components A and B were prepared in a Ross mixer (Charles Ross & Son Company, Hauppauge, NY) as follows.
  • Component A Water, saccharin and 30% of the total volume of 35% hydrogen peroxide were stirred in a beaker until the saccharin dissolves. PEG 600 and glycerin were added and the mixture was placed in the Ross mixer along with Pluronic F127 and stirred at high speed under vacuum until a clear gel formed (approximately 45 minutes). Calcium pyrophosphate was added and the mixture stirred at medium speed for another 10 minutes under vacuum. The remaining 70% of the peroxide volume was added and stirred 10 minutes at medium speed. Next, the flavor was added and the mixture was stirred 5 minutes at low speed. An extrudible paste having a pH of 6.0 was obtained.
  • Component B Water, sodium hydroxide potassium nitrate and FD+C Green #3 dye were mixed in a beaker until the potassium nitrate dissolved. PEG 600 and glycerin were added to the aqueous phase and the mixture was placed in the Ross mixing pot along with Pluronic F127. The mixture was stirred at high speed under vacuum until a clear gel formed (approximately 45 minutes). Calcium pyrophosphate, sodium lauryl sulfate, sodium bicarbonate and sodium hydroxide were added and the mixture stirred at medium speed for another 10 minutes under vacuum. An extrudable paste having a pH of 9.6 was obtained.
  • EXAMPLE 2 This example illustrates the in vitro whitening effect of the tooth-whitening composition of Example 1 containing peroxide compound at a concentration of 3.5% by weight and calcium pyrophosphate at a concentration of 27.5%.
  • Three compositions were tested. The composition of Example 1 was prepared by mixing component A with component B in approximately equal proportions. Comparative composition designated "C" was a simple pluronic gel prepared at approximately the same pH and peroxide concentration as the composition of Example 1, but having water in place of the calcium pyrophosphate.
  • Comparative composition designated "Cl” was a commercially available whitening composition comprised of a thickened Pluronic gel containing about 7% hydrogen peroxide at a pH of about 5.8 in addition to calcium pyrophosphate and dicalcium phosphate.
  • Extracted, naturally-stained human teeth were pumiced and initial color determined using a Minolta Chromameter CR-241.
  • Three teeth each were immersed for 15 minutes at 37 °C in each of the three tooth-whitening compositions. These 15 minute- treatments were repeated 8 times for a total contact time of 2 hours. Tooth shade was measured midway and at the end of the total treatment period.
  • the tooth-whitening effect of the composition of Example 1 was greater than that of comparative composition C at both measurement points.
  • the comparative composition C contained 3.5% by weight hydrogen peroxide as did the composition of Example 1, however, the composition of Example 1 also contained calcium pyrophosphate at a concentration 27.5%. This suggests that the calcium pyrophosphate contributed to the tooth-whitening effect of the composition of Example 1. Since the majority of the extrinsic staining was removed from the sample teeth with pumice, the improved whitening produced by calcium pyrophosphate is believed to result from removal of intrinsic tooth stain. Thus, the data above show that the calcium pyrophosphate provided a beneficial whitening benefit in addition to its effect on surface polishing and extrinsic stain removal.
  • Example 1 The whitening effect produced by the composition of Example 1 was greater than that produced by comparative composition, Cl, which contained hydrogen peroxide at a concentration of about 7% and a pH of about 9.
  • comparative composition, Cl which contained hydrogen peroxide at a concentration of about 7% and a pH of about 9.
  • EXAMPLE 3 This example illustrates the long-term in vitro effectiveness of the tooth- whitening composition of Example 1 containing peroxide compound at a concentration of 3.5% by weight and calcium pyrophosphate at a concentration of 27.5%.
  • Three compositions were tested. The composition of Example 1 was prepared by mixing component A with component B in approximately equal proportions.
  • Comparative composition designated "Cl” was a commercially available whitening composition comprised of a thickened Pluronic gel containing about 7% hydrogen peroxide at a pH of about 5.8 in addition to calcium pyrophosphate and dicalcium phosphate.
  • Comparative composition "C2" was a commercially available whitening composition comprising a thickened Pluronic gel which contained about 7.5% hydrogen peroxide at a pH of about 9 and no added abrasive compounds.
  • Five human extracted teeth each were repeatedly treated with comparative composition "Cl” for a periods of 30 minutes per treatment; or comparative composition "C2" for periods of 30 minutes per treatment. Another five human extracted teeth were treated with the composition of Example 1 for periods of 20 minutes per treatment.
  • EXAMPLE 4 This example illustrates the in vivo testing of the tooth-whitening composition of Example 1 containing peroxide compound at a concentration of 3.5% by weight and calcium pyrophosphate at a concentration of 27.5%.
  • the whitening efficacy of the composition of Example 1 was also compared to comparative composition Cl in a 2-week clinical study. One cell used comparative composition Cl 30 minutes twice daily and the other cell used the composition of Example 1 for 20 minutes once daily. Tooth shade was evaluated after 14 days using a Vita shade guide. The results are summarized in the Table 2.
  • Example 1 provides the same whitening effect as comparative example Cl, but at half the peroxide level and 1/3 the total wear time.
  • EXAMPLE 5 This Example illustrates a two component tooth-whitening system in which the concentration of the peroxide compound in the tooth-whitening composition formed by combining the two components is about 5% by weight.
  • the composition of the first, peroxide component, and the second alkaline component are as shown in Table 4. Table 4. Tooth-Whitening Composition having 5% H 2 O 2
  • a B Component Peroxide Component Alkaline Component Ingredients Weight % Weight % Deionized Water 24 30.2 Hydrogen peroxide 10 — Potassium Nitrate — 10 Polyox (PEG 2M) 5 — Glycerin 5 25 Polyethylene glycol 600 10 3 Xanthan — 0.7 Na carboxymethyl cellulose — 0.5 Pluronic F-127 20 2 Sodium saccharin — 0.2 Titanium dioxide — 1 Sodium hydroxide (50%) — 1 TiO 2 — 1 FD+C Green #3 — 0.025 Zeodent 115 (silica abrasive) — 17.5 Zeodent 165 (silica thickener) — 3 Sodium bicarbonate ⁇ 5 Calcium pyrophosphate 25 — Sodium lauryl sulfate — 0.4
  • EXAMPLE 6 This example illustrates the in vitro whitening effect of the tooth-whitening composition of Example 5 containing peroxide compound at a concentration of 5% by weight and calcium pyrophosphate at a concentration of 12.5%.
  • In Vitro assessment of stain removal by the tooth-whitening composition of Example 5 was determined by an in vitro study procedure using human extracted teeth as described above in Example 2. The teeth were polished with a prophy paste to remove any surface stain. The root portions of five teeth were placed in a row and immersed in an impression compound. To mimic in vivo use, a tray for the sample teeth was prepared by placing a piece of tray material in a tray former and heated until the material began to soften.
  • composition "CIA” the single component peroxide paste similar to component A alone but containing hydrogen peroxide at a concentration of 3.5% and designated composition "CIA" as described above was evaluated for tooth whitening efficacy following the procedure of the Example 3 above.
  • the ⁇ E values of the tray covered teeth were measured at 30 minute intervals for composition CIA.
  • a commercially available professional tooth whitening composition was also evaluated for tooth whitening efficacy with chromameter measurements being performed also at 30 minute intervals.
  • the commercial whitening composition, designated composition "C2" as described above was a thickened Pluronic gel which contained 7.5% peroxide at a of about pH 9.
  • the unexpected enhancement in whitening efficacy produced by the compositions of Examples 1 and 5 in comparison to the comparative composition C2 may be due to the presence in the composition of calcium pyrophosphate and silica abrasives which serve to aid in extrinsic stain removal and, boost the effective peroxide concentration delivered inside the tooth by the increased density and solid content of the compositions of Example 1 and 5 as compared to the comparative composition C2.
  • larger amounts of peroxide are believed to have been delivered by the compositions of Examples 1 and 5 to the teeth per unit weight of paste.
  • the peroxide ingredient in the compositions of Example 1 and 2 are believed to have been concentrated into the water soluble portion of the composition and it is believed that this concentrated portion may have diffused into the teeth to remove intrinsic stain.
  • EXAMPLE 7 This example illustrates the in vivo assessment of whitening efficacy of the composition of Example 5.
  • the composition of Example 5 was prepared by combining equal weight amounts of Components A and B. Whitening efficacy of the composition was also compared to that of comparative composition C2 in a two week human clinical study wherein one cell of 9 subjects used composition C2 thirty minutes twice daily according to the manufacturer's instruction. The other cell with 12 patients used the composition of Example 5 for fifteen minutes once daily. Tooth shade was evaluated after 0, 5, 7 and 14 days using a value- ordered Vita shade guide. The results are summarized in Table 6. Table 6. In vivo Whitening Efficacy of Composition Containing 5% H O 2 .
  • the patients involved in the study rated their tooth sensitivity and gingival irritation on a scale of zero (none) to 5, the higher the number, the greater the tooth sensitivity and gingival irritation experienced by the patient involved in the study.
  • Patient rated their perception of tooth sensitivity and gingival irritation using this scale before using the product (baseline) and after using the product for 7 days and 14 days.
  • the patient ratings of gum irritation and tooth sensitivity minus the baseline ratings are recorded in Table 7 below.

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Abstract

L'invention concerne une composition de dentifrice à deux composants contenant du peroxyde, ayant un effet blanchissant plus efficace et entraînant une irritation gingivale et une sensibilité dentaire minimales. La composition selon l'invention comprend un premier composant de dentifrice aqueux qui contient un composé peroxyde et un système abrasif compatible avec le composé peroxyde, ainsi qu'un deuxième composant de dentifrice aqueux qui contient un composé désensibilisateur et un abrasif incompatible avec le composé peroxyde, ces deux composants étant maintenus séparés. Selon l'invention, lesdits composants sont mélangés et combinés pour la première fois, puis appliqués sur la surface des dents. L'effet blanchissant est amélioré, tandis que la sensibilité dentaire et l'irritation gingivale restent minimales.
PCT/US2005/002332 2004-01-26 2005-01-25 Procedes et compositions de blanchiment dentaire presentant une concentration reduite en peroxyde WO2005072692A1 (fr)

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Application Number Priority Date Filing Date Title
EP05711997A EP1718368A1 (fr) 2004-01-26 2005-01-25 Procedes et compositions de blanchiment dentaire presentant une concentration reduite en peroxyde
CA002553672A CA2553672A1 (fr) 2004-01-26 2005-01-25 Procedes et compositions de blanchiment dentaire presentant une concentration reduite en peroxyde
BRPI0507098-8A BRPI0507098A (pt) 2004-01-26 2005-01-25 sistema de dentifrìcio de componente duplo, composição dentifrìcia, método para branquear um dente em um mamìfero, e, método para diminuir o tempo de branqueamento, aumentar a eficácia do branqueamento ou diminuir a irritação oral em um processo de branqueamento de dentes
AU2005209271A AU2005209271A1 (en) 2004-01-26 2005-01-25 Dental-bleaching compositions and methods with reduced peroxide concentration

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US60/539,421 2004-01-26

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WO2010132126A1 (fr) * 2009-05-14 2010-11-18 Nuvora, Inc. Composition de blanchiment des dents aromatisée sous la forme d'une matrice à libération prolongée
WO2011133793A3 (fr) * 2010-04-21 2013-09-19 Discus Dental, Llc Méthode permettant de nettoyer et de blanchir simultanément les dents
WO2014084851A1 (fr) * 2012-11-30 2014-06-05 Colgate-Palmolive Company Compositions de soin buccal à couleur stable
US8888489B2 (en) 2012-10-23 2014-11-18 Oraceutical Llc Method of simultaneously cleaning and whitening teeth
US9320580B2 (en) 2013-04-21 2016-04-26 Oraceutical Llc Hand-held tooth whitening instrument with applicator reservoir for whitening composition and methods of using same
US10912717B2 (en) 2010-04-21 2021-02-09 Oraceutical Llc Compositions and methods for whitening teeth

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JP2016503053A (ja) * 2012-12-21 2016-02-01 コルゲート・パーモリブ・カンパニーＣｏｌｇａｔｅ−Ｐａｌｍｏｌｉｖｅ Ｃｏｍｐａｎｙ 制御された分配ホワイトニング組成物
EP3003979B1 (fr) * 2013-05-24 2019-08-14 Solvay SA Particules non oxydantes
CN105792896B (zh) * 2013-12-02 2019-08-13 高露洁-棕榄公司 用于口腔护理组合物的两部分氧化体系
MX361008B (es) * 2014-05-15 2018-11-22 Procter & Gamble Composiciones para el cuidado bucal que contienen polietilenglicol para estabilidad fisica.
ES2686269T3 (es) * 2014-05-15 2018-10-17 The Procter & Gamble Company Composiciones para el cuidado bucal que contienen polietilenglicol para la estabilidad física
RU2019114453A (ru) 2016-10-26 2020-11-27 Дзе Проктер Энд Гэмбл Компани Источник электромагнитного излучения и многофазная композиция для ухода за полостью рта
EP3811922A1 (fr) * 2019-10-24 2021-04-28 Koninklijke Philips N.V. Kit, système et procédé de préparation et d'utilisation d'une composition contenant du péroxyde
EP3881677A1 (fr) * 2020-03-18 2021-09-22 Corticalis AS Composition multifonctionnelle de nettoyage et/ou de débridement
CN119112679B (zh) * 2024-11-13 2025-02-14 杭州纳美智康科技有限公司 美白牙膏及其制备方法、美白牙齿的方法

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US5849269A (en) * 1996-11-26 1998-12-15 The Procter & Gamble Company Oral compositions containing fluoride, pyrophosphate, peroxide, and nonionic and/or amphoteric surfactants
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WO2004028500A1 (fr) * 2002-09-27 2004-04-08 Colgate-Palmolive Company Dentifrice a deux composants pour le blanchiment des dents

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US6488913B2 (en) * 2000-09-20 2002-12-03 Scientific Pharmaceuticals, Inc Two-part composition for high efficacy teeth whitening comprising a mixture of peroxides and/or percarbonates of metals

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US5648064A (en) * 1995-07-07 1997-07-15 Gaffar; Abdul Oral compositions having accelerated tooth whitening effect
US5849269A (en) * 1996-11-26 1998-12-15 The Procter & Gamble Company Oral compositions containing fluoride, pyrophosphate, peroxide, and nonionic and/or amphoteric surfactants
WO1998031331A1 (fr) * 1997-01-15 1998-07-23 Unilever N.V. Procede pour rendre les dents plus blanches
US5928628A (en) * 1997-10-23 1999-07-27 Pellico; Michael A. Two-component dental bleaching system and method
WO2004028500A1 (fr) * 2002-09-27 2004-04-08 Colgate-Palmolive Company Dentifrice a deux composants pour le blanchiment des dents

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010132126A1 (fr) * 2009-05-14 2010-11-18 Nuvora, Inc. Composition de blanchiment des dents aromatisée sous la forme d'une matrice à libération prolongée
WO2011133793A3 (fr) * 2010-04-21 2013-09-19 Discus Dental, Llc Méthode permettant de nettoyer et de blanchir simultanément les dents
US9101438B2 (en) 2010-04-21 2015-08-11 Oraceutical Llc Method of simultaneously cleaning and whitening teeth
US10912717B2 (en) 2010-04-21 2021-02-09 Oraceutical Llc Compositions and methods for whitening teeth
US8888489B2 (en) 2012-10-23 2014-11-18 Oraceutical Llc Method of simultaneously cleaning and whitening teeth
US9662284B2 (en) 2012-10-23 2017-05-30 Oraceutical Llc Methods for whitening teeth
US9775790B2 (en) 2012-10-23 2017-10-03 Oraceutical Llc Method and compositions for whitening teeth
WO2014084851A1 (fr) * 2012-11-30 2014-06-05 Colgate-Palmolive Company Compositions de soin buccal à couleur stable
US9320580B2 (en) 2013-04-21 2016-04-26 Oraceutical Llc Hand-held tooth whitening instrument with applicator reservoir for whitening composition and methods of using same

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ZA200606072B (en) 2008-02-27
BRPI0507098A (pt) 2007-06-19
AR047457A1 (es) 2006-01-18
AU2005209271A1 (en) 2005-08-11
RU2391964C2 (ru) 2010-06-20
TW200534874A (en) 2005-11-01
EP1718368A1 (fr) 2006-11-08
RU2006130793A (ru) 2008-03-10
CN1933800A (zh) 2007-03-21

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