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WO2010045280A2 - Composition de blanchiment des dents activée par la lumière et procédés relatifs à celle-ci - Google Patents

Composition de blanchiment des dents activée par la lumière et procédés relatifs à celle-ci Download PDF

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Publication number
WO2010045280A2
WO2010045280A2 PCT/US2009/060580 US2009060580W WO2010045280A2 WO 2010045280 A2 WO2010045280 A2 WO 2010045280A2 US 2009060580 W US2009060580 W US 2009060580W WO 2010045280 A2 WO2010045280 A2 WO 2010045280A2
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Prior art keywords
film
dioxide
composition
chlorine
oxide
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Ceased
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PCT/US2009/060580
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WO2010045280A3 (fr
Inventor
Marcos Gomez
Barry Keven Speronello
S. Frank Castellana
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BASF Catalysts LLC
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BASF Catalysts LLC
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Publication of WO2010045280A2 publication Critical patent/WO2010045280A2/fr
Anticipated expiration legal-status Critical
Publication of WO2010045280A3 publication Critical patent/WO2010045280A3/fr
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    • 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
    • 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
    • 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
    • A61K8/20—Halogens; 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
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/28—Zirconium; 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
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/29—Titanium; 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
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
    • A61K8/8105—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • A61K8/8111—Homopolymers or copolymers of aliphatic olefines, e.g. polyethylene, polyisobutene; Compositions of derivatives of such polymers
    • 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
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • 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
    • A61K2800/81—Preparation or application process involves irradiation
    • 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

  • Extrinsic and intrinsic staining also contribute to tooth.
  • Extrinsic staining refers to surface stains, such as those caused by tea, coffee, red wine, and other foods rich in polyphones. Extrinsic staining primarily occurs as a result of charged surface interactions between the positively-charged food molecules and the negatively-charged tooth pellicle, the protein film on the tooth surface that is derived from salivary proteins. Extrinsic stains are removed through the use of surfactants and/or abrasives, which cause their physical removal from the tooth surface.
  • Intrinsic staining refers to stains that exist below enamel surface, or that penetrate below enamel surface. Intrinsic staining can happen when food molecules seep into enamel flaws and cracks, or, in some cases, between enamel rods. Intrinsic discoloration can also occur following a change to the structural composition or thickness of the dental hard tissues. Certain metabolic diseases and tooth trauma can also cause intrinsic staining. Tetracycline also causes intrinsic staining.
  • Intrinsic stain removal can be achieved by a variety of methods including use of peroxides or peroxide analogs, with or without chemical, light or heat activation, to bleach the stains. This method oxidizes organic compounds within the enamel and dentin, thereby changing colored materials to non-colored materials; it does not remove the stain itself. Acids and dehydration methods, which lead to opacification of enamel to obscure the subsurface stains, are also used to remove or mask intrinsic staining.
  • Tooth whitening products are available over-the-counter and as professional services in a dentist's office.
  • Over-the-counter products typically contain carbamide peroxide or hydrogen peroxide as the bleaching agent. These products have concentrations of up to 21% carbamide peroxide (equivalent to 7% hydrogen peroxide) or as much as 10% hydrogen peroxide. They also contain carbomers (for thickening and control) and acidifiers (for peroxide stabilization in aqueous solution), or alternatively have an anhydrous glycerin base.
  • In-office treatments almost always use hydrogen peroxide as the oxidizer, at concentrations of 15% or more, and typically in the 25 to 35% range.
  • Tooth whitening products both over-the counter and particularly professional treatments, have several unpleasant side effects, including tooth sensitivity, soft tissue irritation and tooth surface changes.
  • Transient tooth sensitivity is the most common side effect reported. Hydrogen peroxide and carbamide peroxide have not been found to induce pathological pulpal changes in testing, although 10% carbamide peroxide has been reported as causing mild, reversible histological changes. It is believed that the hypersensitivity associated with whitening is caused by dehydration, due to the acidified and thickened, substantially anhydrous, hydrophilic gels used in the peroxide formulations and that are held against the teeth. Dehydration results in a negative osmotic pressure and in odontoblastic processes being drawn into the dentinal tubules. Other factors that may contribute to dehydration include whitening lights used in in-office treatments. While sensitivity may be transient, it is a very undesirable side effect.
  • Oral mucosa irritation is the second most-common side effect reported.
  • Systems using higher concentrations of hydrogen peroxide or carbamide peroxide result in more gingival irritation than lower concentration formulations.
  • peroxide is regarded as safe at low concentrations, peroxide has the potential to induce cell changes at high concentrations over an extended period of time.
  • Tooth surface changes have been observed for hydrogen peroxide and carbamide peroxide in in-vitro testing. Although recent reports on this issue have conflicting results, this aspect of tooth whitening products currently available remains a point of concern. Tn addition, tooth whitening formulations are usually acidic; acids can decalcify and etch teeth, causing a temporary opacification of underlying discolorations. These side effects often result in the need for remineralization therapies in connection with tooth whitening treatment, particularly those using professional products.
  • Chlorine dioxide (CIO 2 ) has been suggested as an alternative to peroxide based bleaching agents for tooth whitening applications.
  • Chlorine dioxide (ClO 2 ) is well known as a disinfectant as well as a strong oxidizing agent.
  • the bactericidal, algaecidal, fungicidal, bleaching and deodorizing properties of chlorine dioxide are also well known.
  • the traditional method for preparing chlorine dioxide involves reacting sodium chlorite with gaseous chlorine (Cl 2 (g)) ; hypochlorous acid (HOCl), or hydrochloric acid (HCI).
  • the reactions are:
  • Chlorine dioxide may also be prepared from chlorate anion by either acidification or a combination of acidification and reduction. Examples of such reactions include:
  • US 6,582,682 discloses an oral care composition comprising "stabilized chlorine dioxide” that, upon exposure to the mildly acidic pH in the oral cavity, produces chlorine dioxide,
  • US 6,479,037 discloses preparing a chlorine dioxide composition for tooth whitening wherein the composition is prepared by combining a chlorine dioxide precursor (CDP) portion with an acidulant (ACD) portion.
  • the CDP portion is a solution of metal chlorite at a pH greater than 7.
  • the ACD is acidic, preferably having a pH of 3.0 to 4.5.
  • the CDP is applied to the tooth surface.
  • the ACD is then applied over the CDP to activate the metal chlorite and produce chlorine dioxide.
  • the pH at the contact interface is preferably less than 6 and, most preferably, in the range of about 3.0 to 4.5.
  • this method exposes the oral mucosa to possible contact with a strongly highly acidic reagent (ACD).
  • the invention provides a method of whitening a tooth surface comprising the steps of contacting a tooth surface with a film or moldable solid comprising a chlorine-dioxide- generating composition comprising an energy-activatable catalyst and a solid containing chlorite anions; and exposing the film or moldable solid to electromagnetic energy, wherein the composition generates and releases an efficacious amount of chlorine dioxide gas when exposed to electromagnetic energy, thereby whitening the contacted tooth surface,
  • the electromagnetic energy is selected from ultraviolet light and visible light other than incandescent light.
  • the solid containing chlorite anions is a salt.
  • the salt may be selected from the group consisting of an alkali metal chlorite, an alkaline-earth metal chlorite, a chlorite salt of a transition metal ion and combinations thereof.
  • the alkali metal chlorite is one of sodium chlorite, potassium chlorite and combinations thereof.
  • the chlorine-dioxide-generating composition may comprise between about 50 wt. % and about 99,99 wt. % of the energy-activatable catalyst and between about 0.01 wt. % and about 50 wt. % of a solid containing chlorite anions.
  • the composition further comprises at least one of a uv stabilizer, a uv blocker, a light filtering agent, and a photosensitizer.
  • the composition excludes a uv stabilizer.
  • the energy-activatable catalyst is selected from the group consisting of a metal oxide, a metal sulfide, and a metal phosphide.
  • the energy-activatable catalyst is a metal oxide selected from the group consisting of titanium dioxide (TiO 2 ), zinc oxide (ZnO), tungsten trioxide (W03), ruthenium dioxide (RuO 2 ), iridium dioxide (IrO 2 ), tin dioxide (SnO 2 ), strontium titanate (SrTiO 3 ), barium titanate (BaTiO 3 ), tantalum oxide (Ta 2 O 5 ), calcium titanate (CaTiO 3 ), iron (III) oxide (Fe 2 O 3 ), molybdenum trioxide (MoO 3 ), niobium pentoxide (NbOs), indium trioxide (In 2 O 3 ), cadmium oxide (CdO), hafnium oxide (HfO 2 ), titanium dioxide (TiO
  • the film or moldable solid further comprises a polymeric material, a wax or a combination thereof.
  • the film or moldable solid may comprise from about 0.1 to about 70 weight % of the chlorine-dioxide-generating composition and about 30 to about 99.9 weight % of the polymeric material, a wax or a combination thereof.
  • the film or moldable solid comprises at least one of polyethylene, polypropylene, ethyl vinyl acetate, a polyethylene wax and a microcrystalline wax.
  • the film or moldable solid comprising a chlorine-dioxide- generating composition releases substantially no oxy-chlorine anions.
  • the film or moldable solid is substantially non-cytotoxic and/or substantially non-irritating to soft oral tissues in preferred embodiments.
  • hard tooth tissue is not substantially damaged in the practice of the inventive method.
  • the film or moldable solid comprising a chlorine-dioxide- generating composition is in the form of a dental tray or a dental film.
  • the invention further comprises a dental device comprising a film or moldable solid comprising a polymeric material, a wax or a combination thereof; and a chlorine-dioxide- generating composition comprising an energy-activatable catalyst and a solid containing chlorite anions, wherein the composition generates and releases an efficacious amount of chlorine dioxide gas when exposed to electromagnetic energy
  • the dental device is a dental tray.
  • the dental device is a dental film.
  • the device is substantially non-irritating and/or substantially non-cytotoxic to soft oral tissues.
  • the method of the invention is practiced with a film or moldable solid comprising a composition containing an energy-activatable catalyst and anions that generate chlorine dioxide when the composition is exposed to electromagnetic energy, such as visible or ultraviolet light.
  • the anions are either oxidized by the activated catalyst or reacted with species generated during activation of the catalyst to generate the gas.
  • the generation of gas can be suspended by stopping exposure of the composition to electromagnetic energy, and resumed by again exposing the composition to electromagnetic energy.
  • the composition can be repeatedly activated and deactivated in this manner as needed for a desired use.
  • the film or moldable solid comprising the composition is substantially permeable to chlorine dioxide and preferably, is substantially non-permeable to oxy-chlorine anions.
  • there is minimal-to-no contact between oxy-chlorine anions and soft tissues of the mouth and the method is substantially non- cytotoxic.
  • the method is also substantially non-irritating to oral tissues.
  • Tt is understood that any and all whole or partial integers between any ranges set forth herein are included herein.
  • tooth whitening refers to a lightening of tooth shade relative to the tooth shade prior to treatment. Lightening is assessed on an isolated or an in situ tooth by standard, art-recognized methods of assessing tooth shade, which include qualitative, quantitative and semi-quantitative methods. For instance, lightening may be assessed by simple visual inspection, e.g., by comparing "before” and “after” photographs of the treated teeth.
  • a tooth may be deemed whitened when the tooth shade relative to the tooth shade prior to treatment is two or more shades lighter, as assessed by Vita classical shade guide (preferably, under controlled visible light conditions) or two or more levels as assessed using the Vita Bleachedguide 3D- MASTER Shade system, which utilizes a multiple color spectrophotometer and includes half lightness levels.
  • a difference of one shade is referred to herein as a "shade value unit" (SVU).
  • SVU shade value unit
  • a difference of two shades is a 2 SVU difference.
  • the Vita Classical Shade Guide is arranged in the following order (as recommended by the manufacturer) for value assessment:
  • “Bleaching agent” as used herein refers to the active ingredient, or combination of ingredients, in a composition that causes the lightening and/or removal of the chromagens that contribute to the dark shade of a tooth.
  • an "efficacious amount" of a bleaching agent is intended to mean any amount of a bleaching agent that will result in tooth whitening, as defined herein, using methods of assessment known to the skilled artisan, as discussed above of a tooth, with one or more treatments.
  • cytotoxic refers to the property of causing lethal damage to mammalian cell structure or function.
  • a composition is deemed “substantially non- cytotoxic” or “not substantially cytotoxic” if the composition meets the United States Pharmacopeia (USP) biological reactivity limits of the Agar Diffusion Test of USP ⁇ 87> "Biological Reactivity, in vitro,” (approved protocol current in 2007) when the active pharmaceutical ingredient (API) is present in an efficacious amount.
  • USP United States Pharmacopeia
  • irritating refers to the property of causing a local inflammatory response, such as reddening, swelling, itching, burning, or blistering, by immediate, prolonged, or repeated contact.
  • a composition is deemed “substantially non-irritating” or “not substantially irritating” if the composition is judged to be slightly or not irritating using any standard method for assessing oral mucosal irritation.
  • Non-limiting examples of such methods include: HET- CAM (hen's egg test-chorioallantoic membrane); slug mucosal irritation test; and in vitro tests using tissue-engineered oral mucosa.
  • hard tooth tissue refers to at least one of enamel and dentin.
  • hard tooth tissue damage refers to at least one of a reduction of microhardness of enamel, a reduction of microhardness of dentin, an increase in the surface roughness of enamel and an increase in the surface roughness of dentin.
  • a composition "does not substantially damage hard tooth tissue" if one or more of the following is met for a tooth after treatment relative to the tooth prior to treatment: 1) enamel microhardness is decreased by an amount less than about 15% and/or the reduction is not statistically significant at the 5% confidence level; 2) dentin microhardness is decreased by an amount less than about 15% and/or the reduction is not statistically significant at the 5% confidence level; 3) enamel surface roughness is increased by an amount no more than about 20% and/or the increase is not statistically significant at the 5% confidence level; and 4) dentin surface roughness is increased by an amount no more than about 8% and/or the increase is not statistically significant at the 5% confidence level.
  • oxy-chiorine anion refers to chlorite (ClO 2 " ) and/or chlorate (ClO 3 " ) anions
  • remineralization refers to the process of repair of acid damaged tooth structure by the recrystallization of mineral salts on or within the tooth architecture.
  • demineraiization refers to the process of mineral loss from teeth caused by acid, chelating agents or other accelerants of dissolution. Demineraiization can occur on tooth surfaces and/or below tooth surfaces, depending on the composition of the demineralizing agent, the contacting medium, the concentration and the pH.
  • soft oral tissue refers to all oral mucosal tissue, including but not limited to, buccal mucosa, gingival mucosa (gums), soft palate mucosa, tongue mucosa and mouth floor mucosa.
  • contacting a tooth surface with a film or moldable solid encompasses actual physical contact between the surface and the film or solid. It also includes proximity between the surface and film or solid, wherein the proximity is sufficient for the chlorine dioxide released by the film or moldable solid to contact the tooth surface for efficacious effect.
  • substantially permeable to chlorine dioxide means that an efficacious quantity of chlorine dioxide can permeate and be released from a material comprising a chlorine-dioxide-generating composition on the time scale of the intended use of the material.
  • not substantially permeable to oxy-chlorine anions means that on the time scale of intended use of a material, the amount of oxy-chlorine anion that permeates and is released from a material comprising a chlorine-dioxide-generating composition is not a cytotoxic amount.
  • the invention provides a method of whitening a tooth, the method comprising contacting a tooth surface with a film or moldable solid comprising a chlorine-dioxide- generating composition and exposing the film or moldable solid to electromagnetic energy, wherein the composition generates and releases an efficacious amount of chlorine dioxide gas when exposed to electromagnetic energy.
  • the film or moldable solid is substantially non-irritating to soft tissues and hard in the mouth. It is contemplated that the method of the invention will not substantially damage hard tooth tissue.
  • the film or moldable solid is, in preferred embodiments, substantially non-cytotoxic.
  • cytotoxicity of prior art chlorine dioxide-containing compositions results predominantly from the presence of oxy- chlorine anions, and not from the presence of chlorine, which can be a product of chlorine dioxide decomposition. Tooth whitening without cytotoxic effect on soft tissues of the mouth can therefore be obtained by minimizing or eliminating contact between oxy-chlorine anions and soft oral tissue.
  • the invention is practiced using a film or moidable solid that comprises a composition that generates chlorine dioxide when exposed to electromagnetic energy, such as light.
  • the composition is described in US Pat. No. 7,273,567, incorporated herein by reference in its entirety.
  • the composition comprises an energy-activatable catalyst and a source of chlorite anions capable of being oxidized by the activated catalyst or reacted with species generated during activation of the catalyst to generate chlorine dioxide gas.
  • the composition preferably comprises between about 50 wt. % and about 99.99 wt. % of an energy-activatable catalyst capable of being activated by electromagnetic energy, and between about 0.01 wt. % and about 50 wt.
  • % of a source of chlorite anions and more preferably, between about 80 wt. % and about 98 wt. % of the energy-activatabie catalyst and between about 2 wt. % and about 20 wt. % of the chlorite anion source, and most preferably, between about 86 wt. % and about 96 wt. % of the energy-activatable catalyst and between about 4 wt. % and about 14 wt. % of the chlorite anion source,
  • the energy-activatable catalyst is activated and the chlorite anions are oxidized or reacted to generate and release chlorine dioxide.
  • the composition generates a gas via one or more of the following mechanisms.
  • the energy-activatable catalyst absorbs a photon having energy in excess of the band gap.
  • An electron is promoted from the valence band to the conduction band, producing a valence band hole.
  • the valence band hole and electron diffuse to the surface of the energy-activatable catalyst where each can chemically react.
  • An anion is oxidized by the activated catalyst surface when an electron is transferred from the anion to a valence band hole, forming the gas. It is believed that chlorine dioxide is generated by such transfer of an electron from a chlorite anion to a valance band hole.
  • chlorine dioxide can also be formed via reaction of an anion with protic species generated during activation of the catalyst by abstraction of an electron from water, chemisorbed hydroxyl, or some other hydrated species. While the composition can be formulated to release several parts per million of gas per cubic centimeter per day for a period of at least one day, one week, one month or six months, the composition can be formulated so that chlorine dioxide is released during less than one day, and in some embodiments, in less than about 5 hours.
  • Chlorine dioxide gas is generated and released when the composition contains a source of chlorite anions.
  • a solid contains the chlorite anions.
  • Suitable solids include a salt of chlorite anions and a counterion; an inert material such as a sulfate, a zeolite or a clay impregnated with the anions; a polyelectrolyte such as polyethylene glycol, an ethylene oxide copolymer, or a surfactant ; or a solid electrolyte or ionomer such as nylon of NafionTM (DuPont),
  • Suitable chlorite salts that can be incorporated into the composition include alkali metal chlorites such as sodium chlorite or potassium chlorite, alkaline- earth metal chlorites such as calcium chlorite, or chlorite salts of a transition metal ion, a protonated primary, secondary or tertiary amine, or a quaternary amine such as ammonium chlorite
  • Preferred salts include sodium, potassium, calcium, lithium or ammonium salts of a chlorite.
  • Suitable chlorite sources such as sodium chlorite, are stable at processing temperatures in excess of about 90° C, when incorporated in the compositions useful in the present invention, allowing for processing at relatively high temperatures.
  • Commercially- available forms of chlorite can contain additional salts and additives such as tin compounds to catalyze conversion to a gas.
  • Electromagnetic energy sources include light, such as sunlight, fluorescent light, and ultraviolet light, for photo-activation of the composition. Ultraviolet light and visible light other than incandescent light, such as blue light, are preferred sources of electromagnetic energy in the method of the invention.
  • Additives such as UV blockers can also be included in the composition if it is desirable to limit the wavelength range transmitted to the energy-activatable catalyst. Photosensitizers can be added to shift the absorption wavelength of the composition, particularly to shift an ultraviolet absorption wavelength to a visible absorption wavelength to improve activation by room lighting. UV absorbers can be added to the composition to slow the gas generation and release rate.
  • any semiconductor activated by electromagnetic energy, or a particle or other material incorporating such a semiconductor can be used as the energy-activatable catalyst of the composition.
  • Such semiconductors are generally metallic, ceramic, inorganic, or polymeric materials prepared by various processes known in the art, such as sintering.
  • the semiconductors can also be surface treated or encapsulated with materials such as silica or alumina to improve durability, dispersibility or other characteristics of the semiconductor.
  • Catalysts for use in the invention are commercially available in a wide range of particle sizes from nanoparticles to granules.
  • Representative energy-activatable catalysts include metal oxides such as anatase, rutile or amorphous titanium dioxide (TiO 2 ), zinc oxide (ZnO), tungsten trioxide (Wo 3 ), ruthenium dioxide (RuO 2 ), iridium dioxide (IrO 2 ), tin dioxide (SnO 2 ), strontium titanate (SrTiO 3 ), barium titanate (BaTiO 3 ), tantalum oxide (Ta 2 O 5 ), calcium titanate (CaTiO 3 ), iron (III) oxide (Fe 2 O 3 ), molybdenum trioxide (MoO 3 ), niobium pentoxide (NbOs), indium trioxide (In 2 O 3 ), cadmium oxide (CdO), hafnium oxide (HfO 2 ), zirconium oxide (ZrO 2 ), manganese dioxide (MnO 2 ), copper oxide (Cu 2 O), vanadium pentoxid
  • Transition metal oxides such as titanium dioxide and zinc oxide are preferred because they are chemically stable, non-toxic, inexpensive, exhibit high photocatalytic activity, and are available as nanoparticles useful in preparing transparent formed or extruded plastic products. Also preferred are calcium titanate and zirconium oxide. In some preferred embodiments, the energy-activatable catalyst excludes heavy metals.
  • the rate of gas release from the composition used in the method of the invention, activation of the composition to initiate gas release, and the release rate profile can be altered in various ways, such as by changing the concentration of energy-activatable catalyst or anion source in the composition, adding a base, surfactant, diluent, or light filtering additive to the composition, adding materials such as silicates to complex active surface sites, introducing charge, lattice or surface defects in the catalyst (e.g., Ti 3+ impurities in titanium based catalysts), changing the method of processing the composition, modulating light wavelength and intensity, or changing the order of addition of ingredients in preparing the composition.
  • any conventional additive based upon the total weight of the composition can be included in the composition.
  • additives include colorants and dyes, fragrances, fillers, lubricants, stabilizers, accelerators, retarders, enhancers, blending facilitators, controlled release agents, antioxidants, UV blockers, mold release agents, plasticizers, biocides, flow agents, anti-caking agents, processing aids, and light filtering agents.
  • Additives for controlling gas release include bases, surfactants and light filtering agents.
  • a base is believed to stabilize anions during processing and participate in the electron transfer by producing hydroxyl radicals which aid in oxidation of the anions.
  • the amount of base within the composition can be adjusted to alter the time period of gas release and enhance the thermal stability of the composition. For example, the concentration of the base can be increased if a longer delay of gas release is desired. Up to about 50 wt. % of a base based upon the total weight of the composition can be included in a composition.
  • Suitable bases include, but are not limited to, an alkali metal hydroxide such as lithium, sodium or potassium hydroxide, an alkaline-earth metal hydroxide such as calcium or magnesium hydroxide, a hydroxide salt of a transition metal ion, a protonated primary, secondary or tertiary amine, or a quaternary amine such as ammonium hydroxide.
  • a surfactant is believed to create a mobile ion layer on a surface of the composition to speed charge transfer between the anions and valence band holes. Any surfactant that alters the gas release rate can be added to the composition.
  • Representative surfactants include Triton X-301 ® (an ethoxylated alkylphenol sulfate salt manufactured by Union Carbide) and Triton X- 100 ® (an alkyl aryl ethoxylate manufactured by Union Carbide).
  • Light filtering additives can control the transfer of incident light into the composition to decrease the gas release rate.
  • Suitable light filtering additives include silicates and clays. Any silicate that is soluble in water or a water solution of a water miscibie organic material can be used in preparing the compositions of the invention. Suitable silicates include sodium silicate, sodium metasilicate, sodium sesquisilicate, sodium orthos ⁇ icate, borosilicates and aluminosilicates. Commercially-available forms of such silicates suitable for use generally include sodium and potassium cations.
  • the ratio of silicon measured as SiO 2 to alkali metal cation measured as M 2 O in the silicate particles, wherein M is selected from the group consisting of sodium and potassium, is between about 2,0 and about 4.0, preferably between about 2.3 and about 3.5, most preferably between about 2.5 and about 3.2.
  • the chlorine-dioxide-gas-generating composition is generally prepared as a powder that is subsequently incorporated into a film or moldable solid for use in the invention.
  • the powder particles are preferably about 50 Angstroms to about 1 millimeter in size.
  • a powder can be made by preparing a suspension of the components in a solvent and then removing the solvent by, for instance, spray drying the suspension.
  • the suspension is preferably prepared by admixing an energy-activatable catalyst, a solvent, and a chlorite salt.
  • the salt is mixed with the solvent to form a solution and the energy-activatable catalyst is admixed with the solution to form the suspension.
  • the suspension is handled and stored under conditions where it is not exposed to electromagnetic energy of a wavelength that would activate the catalyst (e.g., in dark conditions for photoactive catalysts).
  • the energy-activatable catalyst and solvent can be admixed to form a slurry, and the salt can be added to the slurry to form the suspension, or both the energy-activatable catalyst and the salt can be mixed with a solvent before they are admixed to form the suspension.
  • ultrasonic mixing, high-shear mixing, or any conventional homogenizing method can be used.
  • the solvent used to form the suspension is any liquid in which the salt is soluble, such as water or a water solution of a water miscibie organic material such as an alcohol, ketone (e.g., acetone), polyacrylate (e.g., polymethylmethacrylate)), or amide (e.g., dimethylformamide).
  • a water miscibie organic material such as an alcohol, ketone (e.g., acetone), polyacrylate (e.g., polymethylmethacrylate)), or amide (e.g., dimethylformamide).
  • the suspension can be spray dried to form a powder by any method known in the art including, for example, any known atomization methods, such as nozzles or rotary discs.
  • the inlet temperature and outlet temperature are maintained at about 250 to about 350° C. and about 100 to about 150° C, respectively for an aqueous suspension, and will vary as known in the art for suspensions containing other solvents.
  • the spray drying process generally occurs rapidly (e.g., within up to about 60 seconds).
  • the powder may then be further dried by any conventional method.
  • Other solvent removal techniques can also be used to form the powder, including filtration, centrifugation, drying the suspension such that the salt is chemisorbed by the energy-activatable catalyst particles, or any other solid-liquid separation process. Gas release efficiencies of 50 to 95% are typical of the powder.
  • the powder and compositions comprising the powder are stored and handled under conditions where it is not exposed to electromagnetic energy of a wavelength that would activate the catalyst (e.g., in dark conditions for photoactive catalysts).
  • the morphology of the powder can be altered by changing the particle size, solids concentration or relative ratio of components, viscosity, surface tension or temperature of the feed solution, the feed rate, residence time, air flow rate, air temperature, flow direction in the dryer, or the type of nozzle or atomizer used in the spray drying process as is known in the art.
  • the powder can also be made by any conventional coating process, such as fluidization.
  • a fluidization method the salt solution is aerosolized by passing the material through small diameter nozzles into the chamber of the fluidized bed where it can impinge upon the fluidized energy-activatable catalyst core particles.
  • the powder Upon contact with the fluidized energy- activatable catalyst core particles, the powder is formed as the salt solution evaporates.
  • the powder can then be stored in a container that blocks electromagnetic energy of a wavelength capable of activating the energy-activatable catalyst.
  • the powder can also be ground or micronized to reduce its particle size and form a finer powder.
  • the powder can also be prepared using mechanical blending of salt particles and energy-activatable catalyst particles as described in Examples 1 and 3 of US Pat. No. 7,273,567, mechanical-fluidized blending and other known powder preparation methods.
  • the powder is then combined with a polymeric material, a wax, or a combination thereof that is permeable to chlorine dioxide but is not substantially permeable to oxy-chlorine anions.
  • the combination is formed into a dental film, or a moldable solid.
  • a dental film refers to a substantially planar object made of a pliable, conformable material that can be substantially fitted to the surface of teeth.
  • the moldabie solid may be used to prepare a dental tray. Such trays may be custom made or non-custom made.
  • One method of preparing a custom dental tray makes use of a "boil and bite" material, which is made out of a thermoformable plastic, such as ethyl vinyl acetate ( 11 EVA”) or polyethylene, comprising the powder.
  • a customized tray is created by heating the thermoformable plastic in boiling water causing it to melt at a biologically acceptable temperature, and then placing it directly over an individual's teeth where it cools and retains its new shape. To practice the method of the invention, the tray is then positioned in the patient's mouth and exposed to the appropriate electromagnetic energy to generate chlorine dioxide for the treatment episode.
  • Representative polymers include polyolefins such as polyethylene and polypropylene, polyethylene terephthalate, polyvinyl chloride, polyurethanes, metallocene polymers, polyesters, polyacrylic esters, acrylic, polystyrene, polycarbonates, polyamides, polyester amides, ethylene-vinyl acetate copolymers, ethylene-methacrylate copolymers, and polyacetals, Suitable waxes include microcrystalline wax, paraffin wax, and synthetic wax such as chlorinated wax, polyethylene wax, polyethylene glycols and polypropylene glycols.
  • Preferred polymers are polyolefins including, but not limited to, polyethylene and polypropylene.
  • the formed or molded products preferably include between about 0.1 and about 70 wt. % of the powder and between about 30 and about 99.9 wt. % of the polymeric material, and more preferably, between about 1 and about 50 wt. % of the powder and between about 50 and about 99 wt. % of the polymeric material, and most preferably, between about 2 and about 50 wt. % of the powder and between about 50 and about 98 wt. % of the polymeric material.
  • the formed or molded products can be made by any conventional polymer processing method.
  • a powder or powder pellets of the invention and the material can be mixed together in a mixer, such as a Henschel mixer, and fed to an extruder or molding apparatus operated at a temperature not exceeding about 200° C. to form a melt.
  • the melt can be cast-extruded as a film, formed into pellets using dry air cooling on a vibrating conveyer, or formed into a desired shape by conventional injection-molding, thermal-forming, or compression-molding methods.
  • the melt can be applied on a surface as a film by using well-known hot melt, dip coat, spray coat, curtain coat, dry wax, wet wax, and lamination processes.
  • the manufacture of cast and blown films is described in Examples 10 and 1 1 of US Pat. No. 7,273,567.
  • the composition of the invention is in nanoparticle form (e.g., 50 Angstrom diameter)
  • a transparent film may be formed.
  • additives can be added to the materials as needed.
  • Such additives include crosslinking agents, UV stabilizers, flame retardants, emulsifiers, compatibilizers, lubricants, antioxidants, colorants, and dyes.
  • a multilayered composite can be formed to generate a gas within an enclosure formed of the composite.
  • a composite includes a chloi ⁇ ne-di oxide-gas-generating layer and a barrier layer.
  • the gas-generating layer which is formulated as a film or moldable solid as discussed above, includes an energy-activatable catalyst capable of being activated by electromagnetic energy and anions capable of being oxidized or reacted to generate a gas.
  • the barrier layer is adjacent to a surface of the gas-generating layer.
  • the barrier layer is transparent to electromagnetic energy such that it transmits the energy to the gas generating layer. However the barrier layer is impermeable or only semipermeable to the gases generated and released by the gas-generating layer.
  • the gas-generating layer when exposed to electromagnetic energy, is capable of generating and releasing the gas after activation of the catalyst and oxidation or reaction of the anions,
  • the barrier layer is expected to minimize chlorine dioxide release from the barrier portion or side of the composite. The release of chlorine dioxide is therefore concentrated on the gas-generating portion or side of the composite.
  • the multilayered composite may be in the form of a dental film or a dental tray for use in the present invention.
  • the gas- generating layer of the composite is placed in contact or immediately proximal to a tooth surface to practice the method of the invention.
  • compositions of the invention can also be blended with moisture-activatable gas- releasing compositions, such as those described by Wellinghoff et al. in U.S. Pat. Nos. 5,360,6095,5,631,300; 5,639,295; 5,650,446; 5,668,185; 5,695,814; 5,705,092; 5,707,739; 5,888,528; 5,914,120; 5,922,776; 5,965,264; 5,980,826; 6,046,243 and 6,605,304, to provide a moisture and/or energy-activatable composition effective for the above uses as well as those known for moisture-activatable compositions.
  • moisture-activatable gas- releasing compositions such as those described by Wellinghoff et al. in U.S. Pat. Nos. 5,360,6095,5,631,300; 5,639,295; 5,650,446; 5,668,185; 5,695,814; 5,705,092; 5,707,739; 5,888,528
  • a composition for electromagnetic energy- controlled and moisture-controlled generation and release of at least one gas includes an energy- activatable catalyst capable of being activated by electromagnetic energy, and at least one chlorite anion source.
  • the anions are capable of reacting with a protic species generated during activation of the catalyst or oxidizing to generate chlorine dioxide.
  • the anions also can be capable of reacting with hydronium ions to generate the gas.
  • different anions can be present which are capable of reacting with hydronium ions to generate at least one gas other than that released by the first anion source (i.e., a second anion source).
  • the composition also includes an acid releasing agent as described in the U.S. patents ns identified above.
  • the acid releasing agent is either an acid, a substance that can be hydrolyzed to an acid (i.e., a substance that reacts with the water that diffuses into the composition to form an acid), or a mixture thereof,
  • the hydronium ions resulting from acid hydrolysis diffuse through the composition and react with anions to generate a gas.
  • the composition When exposed to electromagnetic energy and moisture, the composition is capable of generating and releasing the gas or gasses after activation of the catalyst and oxidation or reaction of the anions.
  • a composition is described in Example 13 of US Pat. No. 7,273,567.
  • the method of the invention is practiced by contacting a tooth surface with a film or inoldable solid comprising a chlorine-dioxide-generating composition and exposing the film or moldable solid to electromagnetic energy, wherein the composition generates and releases an efficacious amount of chlorine dioxide gas when exposed to electromagnetic energy.
  • the energy-activatable catalyst of the composition catalyzes the generation of chlorine dioxide during exposure to the electromagnetic energy.
  • chlorine dioxide is generated and released substantially only when the film or moldable solid is exposed to electromagnetic energy.
  • Chlorine dioxide generation continues during continual exposure, ending when exposure to electromagnetic energy is stopped or the reactants are substantially all consumed.
  • the electromagnetic energy is ultraviolet light or visible light other than incandescent light.
  • the film or moldable solid is contemplated to minimize or eliminate oxy-chlorine anion contact with soft oral tissue
  • the film or moldable solid in preferred embodiments, is expected to be substantially non-cytotoxic to soft oral tissue.
  • the film or moldable solid is also substantially non-irritating to soft and hard oral tissue.
  • the duration of contact with the tooth surface during which chlorine dioxide is generated and released needed to achieve a measurable degree of tooth whitening can be readily determined by the skilled artisan in view of the teachings herein.
  • the composition of the invention does not substantially damage hard tooth tissue.
  • duration of contact with chlorine dioxide release ranges from seconds to minutes, preferably at least about 60 seconds, more preferably at least about 1, 2, 3, 4 or 5 minutes, still more preferably about 6, 7, 8, 9 or 10 minutes, yet more preferably about 11 , 12, 13, 14 or 15 minutes, though contact can range up to 16, 17, 18 19 or 20 minutes, and further up to 21, 22 ⁇ 23, 24, 25, 26, 27, 28 ⁇ 29 or 30 minutes, and further up to 35, 40, 45, 50 ⁇ 55, or 60 minutes or longer in some circumstances.
  • duration of contact with chlorine dioxide release ranges between about 1 and about 60 minutes, more preferably, from about 5 minutes to about 30 minutes, and more preferably still, about 10 to about 20 minutes.
  • duration of contact with chlorine dioxide release for a treatment is about 15 minutes.
  • Treatment frequency is also readily determined by skilled artisan armed with the present disclosure.
  • Treatment may comprise one episode of tooth contact with chlorine dioxide or more than one episode.
  • the film or moldable solid may be exposed to continual electromagnetic energy during a treatment episode. Alternatively, exposure may be periodic during the treatment.
  • Treatment episodes may be contiguous, separated in time (e.g., a few hours to a few days, a few days to a few weeks, and also longer intervals including several months to a year or more) or both.
  • a dental film or dental tray of the invention is used for a single treatment episode. In other embodiments, the dental film or dental tray is used for two or more treatment episodes. In between uses, multi-use items are stored in the dark to minimize or eliminate chlorine dioxide generation.
  • the film or moldable solid comprising a chlorine-dioxide-generating composition may also be used in a method of polishing teeth.
  • the invention further provides a kit comprising a film or moldable solid comprising a chlorine-dioxide-generating composition, wherein the composition generates and releases an efficacious amount of chlorine dioxide gas when exposed to electromagnetic energy, and an instructional material, which describes using the composition in a method of whitening a tooth.
  • an "instructional material” includes a publication, a recording, a diagram, or any other medium of expression, which can be used to communicate the usefulness of the composition and/or compound of the invention in a kit.
  • the instructional material of the kit may, for example, be affixed to a container that contains the compound and/or composition of the invention or be shipped together with a container which contains the compound and/or composition.
  • the instructional material may be shipped separately from the container with the intention that the recipient uses the instructional material and the compound cooperatively. Delivery of the instructional material may be, for example, by physical delivery of the publication or other medium of expression communicating the usefulness of the kit, or may alternatively be achieved by electronic transmission, for example by means of a computer, such as by electronic mail, or download from a website.
  • the invention also provides a dental device comprising 1) a composition for electromagnetic energy-controlled generation and release of chlorine dioxide and 2) a polymeric material which is permeable to chlorine dioxide but is not substantially permeable to oxy- chlorine anions.
  • the dental device is a dental film. In another embodiment, the dental device is a dental tray.

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Abstract

L'invention porte sur un procédé de blanchiment des dents qui utilise une composition qui génère du dioxyde de chlore lorsqu'elle est exposée à de l'énergie électromagnétique. L'invention porte également sur des dispositifs utiles dans la mise en œuvre du procédé.
PCT/US2009/060580 2008-10-16 2009-10-14 Composition de blanchiment des dents activée par la lumière et procédés relatifs à celle-ci Ceased WO2010045280A2 (fr)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017154978A (ja) * 2016-02-29 2017-09-07 株式会社トクヤマデンタル 歯牙漂白用組成物、歯牙漂白用キット、及び歯牙漂白方法
US11071801B2 (en) 2015-08-18 2021-07-27 Wisconsin Alumni Research Foundation Release of ClO2 gas from medical device packaging film
CN115697282A (zh) * 2020-07-28 2023-02-03 米纳斯吉拉斯联合大学 包含改性的铌化合物的牙齿增白凝胶、方法和用途
US20240252702A1 (en) * 2022-02-22 2024-08-01 Phiex Technologies, Inc. Light-activated chlorine dioxide-releasing powder
US12084601B2 (en) 2017-12-28 2024-09-10 Amcor Flexibles North America, Inc. Packaging patches having disinfecting sealing layer

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2290233B (en) * 1994-05-21 1998-06-17 Medical Express Tooth-whitening compositions containing both chlorite and chlorate salts
EP0917455A1 (fr) * 1996-07-29 1999-05-26 Robert Eric Montgomery Compositions a base de dioxyde de chlore servant a blanchir la dentition
US7273567B1 (en) * 1999-11-24 2007-09-25 Microactive Corp. Energy-activated compositions for controlled sustained release of a gas

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11071801B2 (en) 2015-08-18 2021-07-27 Wisconsin Alumni Research Foundation Release of ClO2 gas from medical device packaging film
US11224671B2 (en) 2015-08-18 2022-01-18 Wisconsin Alumni Research Foundation Release of ClO2 gas from produce packaging film
US11590472B2 (en) 2015-08-18 2023-02-28 Wisconsin Alumni Research Foundation Methods and compositions for on-demand release of ClO2 gas from UV-activated chlorite ion
JP2017154978A (ja) * 2016-02-29 2017-09-07 株式会社トクヤマデンタル 歯牙漂白用組成物、歯牙漂白用キット、及び歯牙漂白方法
US12084601B2 (en) 2017-12-28 2024-09-10 Amcor Flexibles North America, Inc. Packaging patches having disinfecting sealing layer
CN115697282A (zh) * 2020-07-28 2023-02-03 米纳斯吉拉斯联合大学 包含改性的铌化合物的牙齿增白凝胶、方法和用途
US20240252702A1 (en) * 2022-02-22 2024-08-01 Phiex Technologies, Inc. Light-activated chlorine dioxide-releasing powder

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