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    • 专利摘要:
    Summary "surfactant systems for zinc containing compositions" are described oral health compositions comprising an orally acceptable carrier, a basic free or salt amino acid, precipitated calcium carbonate particles, a zinc ion source and a selected surfactant system. from at least one of a nonionic surfactant poloxamer and a betaine zwitterionic surfactant or a mixture thereof.
    公开号:BR112015012959B1
    申请号:R112015012959-5
    申请日:2012-12-06
    公开日:2018-12-11
    发明作者:Richard Scott Robinson；Wilbens Josias
    申请人:Colgate-Palmolive Company；
    IPC主号:
    专利说明:

    (54) Title: COMPOSITION FOR ORAL CARE (73) Holder: COLGATE-PALMOLIVE COMPANY. Address: 300 PARK AVENUE, NEWYORK, UNITED STATES OF AMERICA (US), 10022 (72) Inventor: RICHARD SCOTT ROBINSON; WILBENS JOSIAS.
    Validity Term: 20 (twenty) years from 12/06/2012, subject to legal conditions
    Issued on: 12/11/2018
    Digitally signed by:
    Liane Elizabeth Caldeira Lage
    Director of Patents, Computer Programs and Topographies of Integrated Circuits
    1/37
    COMPOSITION FOR ORAL CARE
    BACKGROUND [0001] There is a need in the art for oral care compositions, which, upon use, provide increased antibacterial efficacy, increased anti-plaque efficacy and / or anti-gingivitis efficacy, in combination with good foaming properties when applied to the oral cavity and / or the increased absorption of an antibacterial component by the dental surface. The modalities of the present invention are directed to these purposes.
    SUMMARY [0002] In some embodiments, the present invention provides a composition for oral care, which, after use, provides increased prevention or reduced sensitivity of the tooth and additionally can provide increased antibacterial efficacy, increased anti-plaque efficacy and / or anti-gingivitis efficacy, in combination with good foaming properties when applied to the oral cavity and / or increased absorption of an antibacterial component by the dental surface.
    [0003] In some embodiments, the present invention consequently provides an oral care composition comprising an orally acceptable carrier, a basic amino acid in free or salt form, precipitated calcium carbonate particles, a source of zinc ions and a system surfactant selected from at least one of a non-ionic block copolymer surfactant and a betaine zwitterionic surfactant or a mixture thereof. In some embodiments, the nonionic block copolymer surfactant comprises a poloxamer.
    2/37 [0004] Optionally, the nonionic surfactant poloxamer is present in an amount of 0.25 to 2% by weight, still optionally from 0.5 to 1.5% by weight, even more optionally about 1% in weight, based on the weight of the oral care composition.
    [0005] Optionally, the nonionic surfactant poloxamer has a polyoxypropylene molecular mass of 3000 to 5000 g / mol and a polyoxyethylene content of 60 to 80 mol%. Still optionally, the nonionic surfactant poloxamer comprises poloxamer 407.
    [0006] Optionally, the betaine zwitterionic surfactant is present in an amount of 0.25 to 2% by weight, still optionally from 0.5 to 1.5% by weight, even more optionally about 1% by weight, with based on the weight of the oral care composition.
    [0007] Optionally, the betaine zwitterionic surfactant comprises a C8-C16 amidopropyl betaine. Also optionally, the betaine zwitterionic surfactant comprises cocoamidopropyl betaine.
    [0008] Optionally, precipitated calcium carbonate particles are present in an amount of 10 to 50% by weight, still optionally from 25 to 40% by weight, based on the weight of the oral care composition.
    [0009] Optionally, precipitated calcium carbonate particles have an average particle size no larger than a dentin tubule of a mammalian tooth. Typically, precipitated calcium carbonate particles have an average particle size of 1 to 5 µm.
    [00010] Optionally, precipitated calcium carbonate particles comprise a mixture of particles
    3/37 [larger] primary particles having a particle size variation of 1 to 7 μm and secondary [smaller] particles having a particle size variation of 0.5 to 6 μm. Typically, the primary particles are present in an amount of 5 to 20% by weight based on the weight of the oral care composition and the secondary particles are present in an amount of 5 to 40% by weight based on the weight of the composition for oral care. oral care, more typically, the primary particles are present in an amount of 5 to 15% by weight based on the weight of the oral care composition and the secondary particles are present in an amount of 20 to 30% by weight based on the weight composition for oral care.
    [00011] Optionally, the basic amino acid in the free or salt form comprises arginine bicarbonate.
    [00012] Optionally, the basic amino acid in free or salt form is present in an amount of 5 to 15% by weight, still optionally from 7 to 12% by weight, based on the weight of the oral care composition.
    [00013] Optionally, the source of zinc ions comprises at least one of zinc citrate, zinc lactate, zinc gluconate or zinc oxide or any mixture of any two or more of these.
    [00014] Optionally, the source of zinc ions is present in an amount of 0.5 to 3% by weight, still optionally from 1 to 2% by weight, based on the weight of the oral care composition.
    [00015] Optionally, the source of zinc ions comprises a mixture of zinc oxide and zinc citrate. Optionally, zinc citrate is also
    4/37 present in an amount of 0.25 to 0.75% by weight based on the weight of the oral care composition and zinc oxide is present in an amount of 0.75 to 1.25% by weight based in the weight of the oral care composition.
    [00016] Optionally, the orally acceptable carrier comprises sorbitol, which is present in an amount of 12 to 25% by weight, still optionally from 15 to 20% by weight, based on the weight of the oral care composition.
    [00017] Optionally, the oral care composition does not comprise sodium lauryl sulfate. Still optionally, the oral care composition does not comprise any anionic surfactant.
    [00018] Optionally, the composition is formulated in a toothpaste in the form of a paste or gel.
    [00019] Optionally, the composition is formulated in a form adapted to be applied without dilution inside the oral cavity directly on the surface of a mammalian tooth and to be kept inside the cavity on the surface for a period of at least 1 hour to treat or prevent dental hypersensitivity.
    [00020] Optionally, the oral care composition increases the absorption of zinc ions by the surface of a mammalian tooth in a method comprising applying the oral care composition on the dental surface.
    [00021] Optionally, the oral care composition increases the foaming of the oral care composition in an oral cavity in a method comprising applying the composition to the surface of a mammalian tooth in the oral cavity.
    [00022] The invention further provides a method of reducing dental sensitivity comprising applying an oral care composition of the invention to the surface of a mammalian tooth.
    [00023] The invention further provides a method of occluding a dentin tubule within the scope of a mammalian tooth comprising applying to the dental surface a composition according to the invention.
    [00024] The invention further provides a method for increasing the absorption of zinc ions by the surface of a mammalian tooth comprising applying to the dental surface a composition according to the invention.
    [00025] The invention further provides the use, in an oral care composition comprising an orally acceptable carrier, a basic amino acid in the free or salt form and precipitated calcium carbonate particles, from the combination of a source of zinc ions and a surfactant system selected from at least one of a nonionic surfactant poloxamer and a betaine zwitterionic surfactant or a mixture of these, to increase the absorption of zinc ions by the surface of a mammalian tooth by applying the composition on the surface of a mammalian tooth.
    [00026] The invention further provides the use, in an oral care composition comprising an orally acceptable carrier, a basic amino acid in the free or salt form, precipitated calcium carbonate particles and a source of zinc ions, from a system surfactant selected from at least one of a non-ionic surfactant poloxamer and a zwitterionic surfactant of
    6/37 betaine or a mixture thereof, to increase the foaming of the oral care composition in an oral cavity by applying the composition to the surface of a mammalian tooth in the oral cavity.
    [00027] The compositions can contain additional therapeutic and non-therapeutic components, and can also be used in the practice of various methods, all of which are included within the scope of the invention. The composition and methods within the scope of the invention can be useful, for example, in reducing or eliminating a mammal's dental sensitivity, improving / maintaining systemic health and / or occluding dentin tubules.
    [00028] The present invention is, at least in part, based on the finding by the present inventors that a modified surfactant system in combination with a source of metal ions as an antibacterial component can provide increased foaming and / or absorption of metal ions on the dental surface of an oral care composition comprising a basic amino acid in free or salt form and precipitated calcium carbonate particles to treat or alleviate hypersensitivity.
    [00029] In some embodiments, the composition can be formulated into a toothpaste in the form of a paste or gel, in particular a toothpaste suitable for use when brushing teeth, causing foaming in the oral cavity.
    [00030] In other embodiments, the composition can be formulated for use as a leave-on oral care composition (without rinsing) that can be applied to the dental surface and can be left inside the oral cavity by a
    7/37 prolonged period of time without causing damage to the fluoride of the teeth or irritation by the surfactant system. In addition, the compositions can be formulated to have a viscosity and rheology such that they can be dispensed directly in an undiluted form on a dental surface using an applicator to provide relief against dental hypersensitivity, such as a dispenser that extruded an extrudate of the composition by a narrow cross section.
    DETAILED DESCRIPTION [00031] It should be understood that the detailed description and specific examples, when indicating modalities of the invention, are intended for illustrative purposes only and are not intended to limit the scope of the invention.
    [00032] As stated in this application, all compositional percentages are by weight of the total composition, unless otherwise specified.
    [00033] In some embodiments, the present invention provides an oral care composition comprising an orally acceptable carrier, a basic amino acid in free or salt form, precipitated calcium carbonate particles, a source of zinc ions and a surfactant system selected from at least one of a non-ionic block copolymer surfactant and a betaine zwitterionic surfactant or a mixture of these in some modalities, the non-ionic block copolymer surfactant comprises a poloxamer.
    [00034] In some embodiments, the present invention even provides a method of reducing dental sensitivity
    8/37 comprising applying an oral care composition of the invention to the surface of a mammalian tooth.
    [00035] In some embodiments, the present invention further provides a method of closing a dentin tubule within the surface of a mammalian tooth comprising applying a composition according to the invention to the dental surface.
    [00036] In some embodiments, the present invention further provides a method of increasing the absorption of zinc ions by the surface of a mammalian tooth comprising applying to the dental surface a composition according to the invention.
    [00037] In some embodiments, the present invention further provides the use, in an oral care composition comprising an orally acceptable carrier, a basic amino acid in free or salt form and precipitated calcium carbonate particles, from the combination of a source zinc ions and a surfactant system selected from at least one of a non-ionic poloxamer surfactant and a betaine zwitterionic surfactant or a mixture of these, to increase the absorption of zinc ions by the surface of a mammalian tooth through the application of composition on the surface of a mammalian tooth.
    [00038] In some embodiments, the present invention further provides the use, in an oral care composition comprising an orally acceptable carrier, of a basic amino acid in free or salt form, precipitated particles of calcium carbonate and an ion source zinc, of a surfactant system selected from at least one of a non-ionic surfactant poloxamer and
    9/37 a zwitterionic betaine surfactant or a mixture thereof, to increase the foaming of the oral care composition in an oral cavity by applying the composition to the surface of a mammalian tooth in the oral cavity.
    [00039] As stated above, the system for relieving dentin hypersensitivity includes a basic amino acid in the free or salt form and precipitated particles of calcium carbonate. Optionally, precipitated calcium carbonate particles are present in an amount of 10 to 50% by weight, or from 25 to 40% by weight, based on the weight of the oral care composition.
    [00040] Optionally, precipitated calcium carbonate particles have an average particle size no larger than a dentin tubule of a mammalian tooth. Typically, precipitated calcium carbonate particles have an average particle size of 1 to 5 µm.
    [00041] Optionally, the precipitated calcium carbonate particles comprise a mixture of [larger] primary particles which have a particle size variation of 1 to 7 pm and secondary particles having a particle size variation of 0.5 to 6 pm pm.
    [00042] Typically, the primary particles are present in an amount of 5 to 20% by weight based on the weight of the oral care composition and the secondary particles are present in an amount of 5 to 40% by weight based on the weight of the oral care. composition for oral care. More typically, the primary particles are present in an amount of 5 to 15% by weight based on the weight of the oral care composition and the secondary particles
    10/37 are present in an amount of 20 to 30% by weight based on the weight of the oral care composition.
    [00043] Optionally, the basic amino acid in the free or salt form comprises arginine. In some embodiments, the basic amino acid in the free or salt form comprises arginine bicarbonate.
    [00044] Optionally, the basic amino acid in free or salt form is present in an amount of 5 to 15% by weight, or from 7 to 12% by weight, based on the weight of the oral care composition.
    [00045] Optionally, the oral care composition further comprises particles of silica that have an average particle size no larger than a dentin tubule of a mammalian tooth. Such silica particles can be included to relieve dentin hypersensitivity. Typically, the silica particles have an average particle size of 1 to 5 pm. Optionally, the silica particles are present in an amount of 2 to 10% by weight, or 3 to 6% by weight, based on the total weight of the oral care composition.
    [00046] In some embodiments, the oral care composition comprises a source of zinc ions as an anti-plaque / anti-gingivitis component. Zinc ions have an antibacterial efficacy when used in the oral cavity, which in turn can act to reduce plaque and / or gingivitis.
    [00047] In some embodiments, the source of zinc ions comprises at least one among zinc citrate, zinc lactate, zinc gluconate or zinc oxide or any mixture of any two or more of these.
    11/37 [00048] The source of zinc ions can be present in an amount of 0.5 to 3% by weight, still optionally from 1 to 2% by weight, based on the weight of the oral care composition.
    [00049] In some embodiments, the source of zinc ions comprises a mixture of zinc oxide and zinc citrate. In these embodiments, zinc citrate can be present in an amount of 0.25 to 0.75% by weight based on the weight of the oral care composition and zinc oxide can be present in an amount of 0.75 to 1 , 25% by weight based on the weight of the oral care composition.
    [00050] The compositions can contain additional therapeutic and non-therapeutic components, and can also be used in the practice of various methods, all of which are included within the scope of the invention. The composition and methods within the scope of the invention can be useful, for example, in reducing or eliminating a mammal's dental sensitivity, improving / maintaining systemic health, and / or occluding dentin tubules.
    [00051] Additional antibacterial agents can be incorporated into the oral care compositions of the invention, in addition to the source of zinc ions. Common antibacterial agents used in oral care include triclosan, chlorhexidine, cetylpyridinium chloride and other quaternary amines. These agents, when present, are incorporated into the oral care composition in effective amounts that do not substantially adversely affect the desired properties and characteristics of the composition.
    [00052] Surfactants are used in the oral care composition of the invention to provide properties of
    12/37 foaming, flavor, aroma, texture and mouthfeel to the compositions, in particular making the compositions more cosmetically acceptable. In particular embodiments, the surfactants used in the composition of the invention are employed to provide such properties that are substantially cosmetically equivalent to dentifrice compositions that incorporate sodium lauryl sulfate. Surfactant components are detergent materials that impart detergent and foaming properties to the composition.
    [00053] In some embodiments, the oral care composition comprises a surfactant system selected from at least one of a nonionic surfactant poloxamer and a betaine zwitterionic surfactant or a mixture thereof. In preferred embodiments, the oral care composition does not comprise sodium lauryl sulfate, and more preferably, the oral care composition does not comprise any anionic surfactant.
    [00054] In some embodiments, the nonionic surfactant poloxamer is present in an amount of 0.25 to 2% by weight, still optionally from 0.5 to 1.5% by weight, still optionally about 1% by weight, based on the weight of the oral care composition.
    [00055] Optionally, the nonionic surfactant poloxamer has a polyoxypropylene molecular mass of 3000 to 5000 g / mol and a polyoxyethylene content of 60 to 80 mol%. Typically, the non-ionic poloxamer surfactant comprises poloxamer 407, which is commercially available as Pluronic F-127 (Pluronic is a trademark of BASF Corporation).
    13/37 [00056] In some embodiments, the betaine zwitterionic surfactant is present in an amount of 0.25 to 2% by weight, still optionally from 0.5 to 1.5% by weight, still optionally about 1% by weight, based on the weight of the oral care composition.
    [00057] Typically, the betaine zwitterionic surfactant comprises a C 8 -C 16 amidopropyl betaine. More typically, the betaine zwitterionic surfactant comprises cocoamidopropyl betaine.
    [00058] Other surfactants, which may be anionic, cationic, zwitterionic, amphoteric or non-ionic, and are known for use in oral care compositions, may optionally be present in the composition.
    [00059] In some embodiments, the oral compositions of the invention also include a polymeric adherent material to aid in the retention of calcium carbonate particles, and, if present, of silica particles, within the dentin tubules under salivary flow and during exposure to acidic foods and drinks.
    [00060] The polymeric adherent material can be any known or be developed in the art that adheres to the surface of a mammalian tooth and / or to the heterogeneous biofilm that can also be present on the surface of a tooth. Adhesion can occur by any means, such as ionic interaction, Van der Waals forces, hydrophobic and hydrophilic interactions, etc. The adherent material can be, for example, any homopolymers or copolymers (hereinafter referred to collectively as polymers) that adhere to the surface of a tooth. Such polymers can include cellulose polymers, for example, one or more
    14/37 hydroxyalkylcellulose polymers, such as hydroxypropylmethylcellulose (HPMC), hydroxyethylpropylcellulose (HEPC), hydroxybutylmethylcellulose (HBMC), carboxymethylcellulose (CMC).
    [00061] In some embodiments, the polymeric adherent material comprises at least one cellulose material, for example, sodium carboxymethylcellulose.
    [00062] Polymers may alternatively or additionally include poly (ethylene oxide) polymers (such as POLOX from Dow Chemical), linear PVP and cross-linked PVP, PEG / PPG copolymers (such as BASF Pluracare LI220), ethylene oxide block copolymers (EO ) - propylene oxide (PO) (as polymers sold under the brand name Pluronic available from BASF Corporation), ester gum, shellac, pressure sensitive silicone adhesives (such as BioPSA from Dow-Corning), methacrylates or mixtures thereof. In one embodiment, a copolymer comprises (PVM / MA). In one embodiment, a copolymer comprises poly (methylvinylether / maleic anhydride). In another embodiment, a copolymer comprises poly (methylvinylether / maleic acid). In another embodiment, a copolymer comprises poly (methyl vinyl ethyl ether / maleic acid) semesters. In another embodiment, a copolymer comprises mixed salts of poly (methylvinylether / maleic acid).
    [00063] Polymers of any molecular weight can be used, including, for example, molecular weights of 50,000 to 500,000, 500,000 to 2,500,000 or 2,500,000 to 10,000,000 (calculated by average number or average weight).
    [00064] In some embodiments, the oral care compositions of the invention may also contain a source of
    15/37 fluoride ions or fluoride-providing component, as an anti-caries agent in sufficient quantity to provide about 25 ppm to 5,000 ppm of fluorine ions and include inorganic fluoride salts, such as soluble alkali metal salts. For example, preferred fluoride sources are sodium fluoride, potassium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium monofluorophosphate as well as tin fluorides, such as stannous fluoride and stannous chloride. Sodium monofluorophosphate is preferred.
    [00065] However, in some embodiments with preference, the toothpaste does not comprise any fluoride compound or fluoride ion source. Such modalities are desired by some consumers who wish to avoid fluoride as an active component in the composition of their toothpaste. In addition, in leave-on compositions, no fluoride compound or fluoride ion source is typically present, to avoid too long exposure of teeth and gums to fluoride ions.
    [00066] In addition to fluoride compounds, may also be included anticalculus agents such as pyrophosphate salts including pyrophosphate metallic salts diálcali or tetra-alkali as Na 4 P 2 O 7, K 4 P 2 O 7, Na 2 K 2 P 2 0 7 , Na2H2P2O7 and K2H2P2O7 sodium tripolyphosphate, long chain polyphosphates, such as sodium hexametaphosphate and cyclic phosphates, such as sodium trimetaphosphate. These anti-tartar agents can be included in the oral care composition at a concentration of 1 to 5% by weight.
    [00067] In some embodiments, the oral care compositions of the invention comprise an orally carrier
    16/37 acceptable.
    As used in this application, an orally acceptable vehicle ”refers to a material or combination of materials that are safe for use in the compositions of the present invention, with a reasonable benefit / risk ratio.
    [00068] The terms vehicle "or aqueous vehicle", as used throughout this description, denote any safe and effective material for use in this application. Such materials include, for example, thickening agents, wetting agents, ionic active ingredients, buffering agents, anti-calculating agents, abrasive polishing materials, peroxide sources, alkali metal bicarbonate salts, titanium dioxide, coloring agents, flavoring systems, sweetening agents , antimicrobial agents, phytotherapeutic agents, desensitizing agents, bleaching agents and mixtures thereof.
    [00069]
    Orally acceptable vehicles used to prepare the oral care composition of the invention can include an aqueous phase containing at least one humectant.
    [00070] humectant concentration typically totals about 5 to about 75% by weight of the composition.
    Optionally, the orally acceptable carrier comprises at least one humectant which is present in an amount of 15 to 60% by weight based on the weight of the composition, still optionally from 20 to 35% by weight based on the weight of the composition.
    [00071] Optionally, the humectant comprises a mixture of humectants, just like any mixture of sorbitol, glycerin and / or xylitol.
    [00072] In some embodiments, the orally acceptable vehicle comprises sorbitol which is present in a
    17/37 amount from 12 to 25% by weight, still optionally from 15 to 20% by weight, based on the weight of the oral care composition. The reference in this application to sorbitol refers to the material typically commercially available as an aqueous solution of 70% by weight. In other words, when the orally acceptable carrier comprises 12 to 25% sorbitol by weight, this means that the active sorbitol concentration is 8.4 to 17.5% by weight, each amount being based on the weight of the composition for oral care.
    [00073] In other embodiments, the orally acceptable carrier comprises glycerin which is present in an amount of 15 to 35% by weight based on the weight of the oral care composition, still optionally from 20 to 30% by weight based on the weight of the composition for oral care.
    [00074] Water is typically present in the amount of at least about 10% by weight, and generally about 25 to 70% by weight of the dentifrice composition. The water used in the preparation of commercially suitable oral compositions should preferably be deionized and without organic impurities. These amounts of water include free water that is added plus that introduced with other materials, such as sorbitol.
    [00075] Optionally, the orally acceptable carrier further comprises at least one cellulose polymer selected from one or more hydroxypropylmethylcellulose (HPMC), hydroxyethylpropylcellulose (HEPC), hydroxybutylmethylcellulose (HBMC) and carboxymethylcellulose (CMC). Typically, a cellulose polymer is present in an amount of 0.5 to 2.5% by weight based on the weight of the
    18/37 oral care composition, more typically from 0.7 to 1.5% by weight based on the weight of the oral care composition.
    [00076] Commercially available polymers can be used in the present invention. It is understood that over time, the size, weight and / or the exact composition of a commercially available polymer can be modified. Based on the disclosure presented in this application, the skilled person will know how to determine whether such polymers are useful in the invention.
    [00077] In some embodiments, the oral care composition may, in particular, be a toothpaste composition that may be a toothpaste or gel and in particular is formulated for use in a toothbrush. When formulated as a dentifrice, the composition can comprise fluorine or fluoride compound to provide anti-carious efficacy.
    [00078] In other modalities, the composition is formulated as a “leave-on” composition that can be applied without dilution and left in the oral cavity for an extended period of time. Such a composition does not include any components or additives that would cause damage or irritation to the oral cavity. Preferably, the “leave-on” composition is formulated in a form adapted to be applied without dilution inside the oral cavity directly on the surface of a mammalian tooth and to be kept inside the cavity on the surface for a period of at least 1 hour to treat or prevent dental hypersensitivity.
    19/37 [00079] The composition according to the invention can also comprise one or more additional agents typically selected from an anti-plaque agent, a bleaching agent, an antibacterial agent, a cleaning agent, a flavoring agent, a sweetening agent, agents adhesion agents, foam modulators, abrasives, pH modifying agents, humectants, mouthfeel agents, dyes, abrasive, tartar control agent (anti-calculus), salivary stimulating agent, nutrient and combinations thereof.
    [00080]
    Preferably, the specific materials and compositions to be used in this invention are, therefore, pharmaceutically or cosmetically acceptable, clinically effective and / or clinically effective. As used in this application, such a pharmaceutically acceptable "or cosmetically acceptable", clinically effective ", and / or clinically effective component" is one that is suitable for use in humans and / or animals and is provided in an appropriate amount (a clinically effective) to provide the desired therapeutic, prophylactic, sensory, decorative or cosmetic benefit without undue adverse side effects (such as toxicity, irritation and allergic response) with a reasonable benefit / risk ratio.
    [00081] The oral care compositions described in this application can be formulated in any form of application that allows the contact of the amino acid, calcium carbonate particles and zinc ions with the dental surface. For example, the compositions can be formulated in a mouthwash, a paste, a gel, a
    20/37 lozenge (soluble or chewable), a spray, a gum and a film (entirely or partially soluble, or insoluble). The composition can contain any conventional excipients or vehicles, although these vary depending on the dosage form or the selected dosage means.
    [00082] Excipients or vehicles may include, for example, humectants, dyes, flavorings, glycerin, sorbitol, xylitol, water or other solvents, gum bases, thickening agents, surfactants, carrageenan (Irish moss), xanthan gum and carboxymethylcellulose. sodium, starch, polyvinyl pyrrolidone, hydroxyethylpropylcellulose, hydroxybutylmethylcellulose, hydroxypropylmethylcellulose, and hydroxyethylcellulose and amorphous silica.
    [00083] Suitable thickeners include natural polymers such as carrageenan, xanthan gum, polyglycol of various molecular weights sold under the trade name Poliox and polyvinylpyrrolidone. Compatible inorganic thickeners include amorphous silica compounds that function as thickeners and include colloidal silica compounds available under the trade name Cab-o-sil manufactured by Cabot Corporation and distributed by Lenape Chemical, Bound Brook, N.J .; Zeodent 165 from the J. M. Huber Chemicals Division, Havre de Grace, Md. 21078, Md. 21078; and Sylodent 15, available from Davison Chemical Division of W. R. Grace Corporation, Baltimore, Md. 21203. Other inorganic thickeners include natural and synthetic clays such as hectorite clays, lithium magnesium silicate (laponite) and magnesium aluminum silicate (Veegum).
    21/37 [00084] The thickening agent is preferably present in the oral care composition in amounts of 0.1 to 10% by weight, preferably 3 to 7% by weight based on the weight of the oral care composition.
    [00085] Thickeners particularly suitable for use in the oral care composition of the invention include natural and synthetic gums and colloids. Optionally, the orally acceptable carrier comprises at least one gum selected from xanthan and loadena gum. Still optionally, the orally acceptable carrier comprises from 0.1 to 0.3% by weight of xanthan gum based on the weight of the oral care composition.
    [00086] The oral care composition of the invention can also contain a flavoring agent. Flavoring agents that are used in the practice of the invention include essential oils as well as various flavoring aldehydes, esters, alcohols and similar materials. Examples of essential oils include mint, peppermint, gualtéria, sassafras, cloves, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit and orange oils. Chemicals such as menthol, carvone and anethole are also useful. Of these, the most commonly used are mint and mint oils.
    [00087] The flavoring agent can be incorporated into the oral care composition in a concentration of 0.1 to 5% by weight and typically 0.5 to 1.5% by weight.
    [00088] Sweeteners can also be present in oral care compositions. Artificial sweeteners include sodium saccharin, sucralose and potassium acesulfame. One or more sweetening agents can be
    22/37 incorporated into the oral care composition at a concentration of 0.05 to 2% by weight.
    [00089] Various other materials can be incorporated into the oral care compositions of this invention, including desensitizers, such as potassium nitrate; bleaching agents; preservatives; silicones; coloring agents and chlorophyll compounds. These additives, when present, are incorporated into the oral care composition in amounts that do not substantially adversely affect the desired properties and characteristics.
    [00090] The oral care composition of the invention can be prepared by any means known in the art. For example, methods of preparing toothpaste are well known, for example, as described in US-B-3966863; US-B-3980767; US-B-4328205; and US-B-4358437, the contents of which are incorporated into this application by reference. In general, any humectant (for example, glycerin, sorbitol, propylene glycol and / or polyethylene glycol) is dispersed in water in a conventional mixer under agitation. In this dispersion, thickeners are added, such as carboxylmethylcellulose (CMC), loadena, or xanthan gum;
    any anionic polycarboxylate; any salts, such as sodium fluoride anticaries agents; and any sweeteners.
    [00091] The resulting mixture is stirred until a homogeneous gel phase is formed. In the gel phase any pigments used, such as TiO2, and in addition any acid or base necessary to adjust the pH of the composition are added. These ingredients are mixed until a homogeneous phase is obtained.
    23/37 [00092] The mixture is then transferred to a high speed / vacuum mixer, in which the surfactant ingredients are added to the mixture. The calcium carbonate particles and any silica particles used are added later. Any water-insoluble agent, such as triclosan, is solubilized in flavoring oils to be included in the toothpaste, and this solution is added to the mixture, which is then mixed at high speed ranging from 5 to 30 minutes, under a vacuum of 20 to 50 mm of Hg. The resulting product is a homogeneous product in gel or paste, semi-solid, extrusable.
    [00093] The oral care composition according to the present invention can be administered or applied to a human or other animal. The composition is suitable for administration or application to the oral cavity of a human or animal individual.
    [00094] In one embodiment, the composition containing the amino acid and the calcium carbonate particle can be applied to the tooth using conventional brushing techniques (for example, using a toothbrush). In another embodiment, such a composition can be applied to the tooth using a method other than conventional brushing techniques. Other application methods, particularly for “leave-on” compositions, include manual application (for example, applying a composition to a tooth using one or more fingers, rubbing it over the dental surface, rubbing them in a circular motion, etc ...), or application using any known dental appliance or applicator, for example, which extrudes the composition onto the teeth. It will be understood, based on the revelation presented
    24/37 in this application, that any method of spreading a composition over a tooth, optionally using varying degrees of physical pressure, is encompassed by the invention.
    [00095] The desensitization of a tooth according to the invention can be measured by any technique presented in this application or any technique known to the skilled person.
    [00096] The application of the composition on the dental surface results in the introduction of the composition in one or more dentin tubules. The composition is applied to the teeth by any method presented in this application or known in the art.
    [00097] The invention also includes within its scope several related methods. For example, the invention includes within its scope methods of reducing and methods of occluding a dentin tubule from a mammalian tooth, methods of protecting dentin from acid-mediated degradation and methods of reducing dental sensitivity.
    [00098] Each of these methods includes the steps of applying any of the compositions described above on the dental surface. The application can be carried out by any method, as long as the adherent material and particles are placed in contact with the dental surface. The application can be carried out by brushing, flossing, prophylaxis, irrigation, scrubbing, rinsing (washing the oral cavity), foam / gel and application in tray, chewing, spraying, painting, etc., or applied by film or strip .
    [00099] Dental sensitivity can be reduced according to a method of the invention by applying a composition of the invention to a dental surface. An
    25/37 composition can be applied using a traditional method, as described in detail throughout this application, or by any device or applicator, if typically associated with dental use. In one embodiment, one or more human fingers are used to apply a dental composition that reduces sensitivity to one or more teeth. A finger can be used to spread the composition over the surface of a tooth or otherwise apply the composition to the surface of a tooth.
    [000100] The application can be at least once a day, although up to five times a day may be preferred and can be carried out over a period of time, for example, a week, up to a year, up to three years or for all life.
    [000101] Various modalities will now be described with reference to the following non-limiting examples.
    EXAMPLES
    Comparative Examples 1 and 2 [000102] Tooth compositions having the formula of Table 1 are prepared.
    [000103] Both compositions of Comparative Examples 1 and 2 include arginine bicarbonate and precipitated calcium carbonate which is known to be effective against dental hypersensitivity. However, the composition of Comparative Example 2 differed from that of Comparative Example 1 by adding 1% zinc oxide by weight (ZnO) as an effective anti-gingivitis and anti-plaque antibacterial asset.
    26/37 [000104] As shown in Table 1 (below), both compositions comprised an anionic surfactant, in particular sodium lauryl sulfate (SLS).
    TABLE 1
    Ingredient Ex. Comp. 1 Ex. Comp. 2 Sorbitol (70% by weight solutionaq.) 23 23 Sodium CMC 0.72 0.72 Sodium bicarbonate 0.5 0.5 N-silicate 0.8 0.8 Titanium dioxide 0.5 0.5 Precipitated calcium carbonate - Light 10 10 Calcium carbonate 25 25 Arginine bicarbonate (70% 13.86 13.86 Xanthan gum 0.135 0.135 Sodium saccharin 0.3 0.3 Sodium Monofluorophosphate 1.1 1.1 Flavoring 1.1 1.1 Sodium lauryl sulfate 1.5 1.5 Zinc oxide1 Water QS QS
    [000105] When used to brush teeth, it is important for the consumer that the toothpaste forms a stable foam in the oral cavity. To evaluate the foam properties of the dentifrice compositions of
    21/91
    Comparative Examples 1 and 2, the compositions were mixed with water and stirred to form a foam. A given amount of the composition was stirred with a given amount of water. The amount of foam formed in a tube, in an in vitro test, was quantified after 2 minutes. The results are shown in Table 2 (below).
    TABLE 2
    Foam volume (Comparative Units) Comparative Example 1 - SLS, arginine andcalcium carbonate 284 Comparative Example 2 - SLS, arginine and calcium carbonate, 1% by weight of ZnO 28 Comparative Example 3 - SLS and calcium carbonate, 1% by weight of ZnO, without arginine 283 Comparative Example 4 - SLS and calcium carbonate, 0.5% by weight of ZnO, 2% by weight of zinc citrate 37 Comparative Example 5 - arginine and calcium carbonate, 1% by weight of ZnO, polysorbate 20 0 Example 1 - arginine, calcium carbonate, 1% by weight of ZnO, 1% by weight of poloxamer 407 78 Example 2 - arginine, calcium carbonate, 1% by weight of ZnO, 2% by weight of poloxamer 407 161 Example 3 - arginine, carbonate 153
    28/37
    calcium, 1% by weight of ZnO, 3.4% by weight of cocoamidopropyl betaine (30% active)Example 4 - arginine, calcium carbonate, 1% by weight of ZnO, 0.5% by weight of zinc citrate, 1% by weight of poloxamer 407, 3.4% by weight of cocoamidopropyl betaine (30% active) 161
    [000106] It can be seen that the SLS-containing composition of Comparative Example 1 exhibited good foam properties, but that the addition of ZnO to the composition significantly deteriorated the foam properties.
    [000107] The invention, at least in part, was intended to overcome the foam-reducing effect by introducing a source of zinc ions into an oral care composition including a basic amino acid in the free or salt form and precipitated calcium carbonate particles .
    Comparative Examples 3 and 4 [000108] Tooth compositions having the formula of Table 3 are prepared.
    [000109] Both compositions of Comparative Example 3 and 4 also included precipitated calcium carbonate and SLS. However, the composition of Comparative Example 3 did not include arginine bicarbonate whereas the composition of Comparative Example 4 included the same amount of arginine bicarbonate as Comparative Example 1. Comparative examples 3 and 4 included, as sources of zinc ions , zinc oxide 0.5% by weight (ZnO) and zinc citrate 2.0% by weight.
    TABLE 3
    29/37
    Ingredient Ex.Comp.3 Ex.Comp.4 Sorbitol (70% by weight aq. Solution) 29.93 23 Sodium CMC 0.72 0.72 Sodium bicarbonate 0.5 0.5 N-silicate 0.8 0.8 Titanium dioxide 0.5 0.5 Precipitated calcium carbonate - Light 10 10 Precipitated calcium carbonate - High absorption 25 25 Arginine bicarbonate (70% by weightaq. solution) - 13.86 Xanthan gum 0.135 0.135 Sodium saccharin 0.3 0.3 Sodium Monofluorophosphate 1.1 1.1 Flavoring 1.1 1.1 Sodium lauryl sulfate 1.5 1.5 Zinc oxide 0.5 0.5 Zinc citrate trihydrate 2 2 Benzilic alcohol 0.3 - Water QS QS
    [000110] To evaluate the foam properties of the toothpaste compositions of Comparative Examples 3 and 4, the compositions were tested for the volume of foam in relation to Comparative Examples 1 and 2. The results are shown in Table 2 (above).
    [000111] It can be seen that when arginine is absent from the composition containing calcium carbonate, as in Comparative Example 3, the combination of SLS and the source of
    30/37 zinc ions does not significantly reduce the volume properties of foam compared to Comparative Example 1 which contained arginine, but not zinc ions.
    [000112] A comparison of Comparative Examples 3 and 4 demonstrates that when arginine is added to the composition containing SLS and calcium carbonate as in Comparative Example 3, which also contains the source of zinc ions, the foam volume properties are not significantly reduced. These comparative data show that there is some combined effect that results from the presence of arginine that affects the foam volume properties in the presence of zinc ions and SLS.
    Example 1 [000113] The oral care composition of Example 1 was modified when compared to Comparative Example 1 by the inclusion of a surfactant system that did not include an anionic surfactant or SLS, but instead included a nonionic surfactant, in particular 1 % by weight of poloxamer 407 (Pluronic F-127), in combination with the components arginine and calcium carbonate and ZnO.
    [000114] The composition is shown in Table 4.
    [000115] The oral care composition of Example 1 was also subjected to the same foam test in vitro and the results are shown in Table 2 (above).
    TABLE 4
    Ingredient Ex. 1 Ex. 2 Ex. 3 Ex. 4 Sorbitol (70% by weight solutionaq.) 23 23 23 23 Sodium CMC 0.72 0.72 0.72 0.72 Sodium bicarbonate 0.5 0.5 0.5 0.5
    31/37
    N-silicate 0.8 0.8 0.8 0.8 Titanium dioxide 0.5 0.5 0.5 0.5 Precipitated calcium carbonate - Light 10 10 10 10 Precipitated calcium carbonate - High absorption 25 25 25 25 Arginine bicarbonate (70%weight aq. solution) 13.86 13.86 13.86 13.86 Xanthan gum 0.135 0.135 0.135 0.135 Sodium saccharin 0.3 0.3 0.3 0.3 Sodium Monofluorophosphate 1.1 1.1 1.1 1.1 Flavoring 1.1 1.1 1.1 1.1 Poloxamer 407 1 2 - 1 Cocoamidopropyl betaine (30%weight aq. solution) - - 3.34 3.34 Zinc oxide 1 1 1 1 Tri-zinc citratehydrated - - - 0.5 Water QS QS QS QS
    [000116] Table 2 shows that employing a poloxamer surfactant compared to the SLS surfactant in Comparative Example 2 increases the quality of the foam.
    [000117] In addition, the foam volume is increased compared to Comparative Example 4 by modifying the SLS surfactant.
    Example 2 [000118] The oral care composition of Example 2 was modified when compared to Example 1 by including 2% by weight of poloxamer 407 (Pluronic F-127),
    32/37 in combination with the components arginine and calcium carbonate and ZnO. The composition is shown in Table 4.
    [000119] The oral care composition of Example 2 was also subjected to the same foam test in vitro and the results are shown in Table 2 (above). Table 2 shows that by increasing the content of poloxamer 407 the foam volume was increased, and the supply of 2% by weight of poloxamer 407 provided a foam volume not significantly less than for the composition of Comparative Example 1 that did not comprised zinc ions.
    [000120] In addition, the foam volume has been increased compared to Comparative Example 4 by modifying the SLS surfactant.
    Example 3 [000121] The oral care composition of Example 3 was modified when compared to Example 1 by including 3.4% by weight of cocoamidopropyl betaine (30% by weight of the active component) instead of poloxamer 407 (Pluronic F -127), in combination with the components arginine and calcium carbonate and ZnO. The composition is shown in Table 4.
    [000122] The oral care composition of Example 3 was also subjected to the same foam test in vitro and the results are shown in Table 2 (above). Table 2 shows that cocoamidopropyl betaine provided a similar volume of foam compared to the poloxamer 407 of Example 2.
    [000123] In addition, the foam volume was increased compared to Comparative Example 4 by modifying the SLS surfactant.
    33/37
    Example 4 [000124] The oral care composition of Example 3 was modified when compared to Example 3 by the inclusion of a combined surfactant system of not only 3.4% by weight of cocoamidopropyl betaine (30% by weight of the active component) but also 1% by weight of poloxamer 407 (Pluronic F-127), in combination with the components arginine and calcium carbonate. In addition, zinc ions were supplied not only by 1% by weight of ZnO but also by 0.5% by weight of zinc citrate. The composition is shown in Table 4.
    [000125] The oral care composition of Example 4 was also subjected to the same foam test in vitro and the results are shown in Table 2 (above). Table 2 shows that the combined surfactant system of cocoamidopropyl betaine and poloxamer 407 provided a similar volume of foam compared to Example 2 although there was a higher zinc content due to the addition of 0.5% by weight of zinc citrate to the content of zinc oxide of 1.0% by weight.
    [000126] In addition, the foam volume has been increased compared to Comparative Example 4 by modifying the SLS surfactant.
    [000127] The composition of Example 4 which included the combined surfactant system unexpectedly provided the best foam volume properties for a given zinc ion content when used in the oral care composition comprising calcium carbonate and arginine.
    Comparative Example 5
    34/37 [000128] The oral care composition of Comparative Example 5 was modified when compared to Example 1 by the use of a polysorbate 20 nonionic surfactant instead of the poloxamer surfactant. The non-ionic surfactant polysorbate 20 was present in an amount of 1% by weight, and in combination with the same components arginine and calcium carbonate. In addition, zinc ions were similarly supplied by 1% by weight of ZnO. The composition is shown in Table 5 (below).
    TABLE 5
    Ingredient Ex. Comp.5 Sorbitol (70% by weight aq. Solution) 23 Sodium CMC 0.72 Sodium bicarbonate 0.5 N-silicate 0.8 Titanium dioxide 0.5 Precipitated calcium carbonate - Light 10 Precipitated calcium carbonate - High absorption 25 Arginine bicarbonate (70% by weight solutionaq.) 13.86 Xanthan gum 0.135 Sodium saccharin 0.3 Sodium Monofluorophosphate 1.1 Flavoring 1.1 Polysorbate 20 1 Zinc oxide 1 Water QS
    [000129] The Example Oral Care Composition
    Comparative 5 was also subjected to the same foam test
    35/37 in vitro and the results are shown in Table 2 (above). Table 2 shows that the non-ionic surfactant polysorbate 20 provided significantly worse foam volume compared to Example 1. This shows that the non-ionic surfactant systems of the present invention provide the increased foam volume compared to other non-ionic surfactant systems.
    Example 5 [000130] The oral care composition of Example 5 included a surfactant system that did not include any anionic surfactants or SLS, but instead included a surfactant system according to the invention, in combination with the components arginine and calcium carbonate and a source of zinc ions.
    [000131] The composition is shown in Table 6 (below).
    TABLE 6
    Ingredient Ex. 5 Ex.Comp. 6 Ex.Comp. 7 Sorbitol (70% by weight solutionaq.) 23 23 23 Sodium CMC 0.72 0.72 0.8 Sodium bicarbonate 0.5 0.5 0.5 N-silicate 0.8 0.8 0.8 Titanium dioxide 0.5 0.5 0.5 Precipitated calcium carbonate- Light 10 10 10 Precipitated calcium carbonate- High absorption 25 25 25 Arginine bicarbonate (70% by weight aq. Solution) 13.86 13.86
    36/37
    Xanthan gum 0.135 0.135 0.135 Sodium saccharin 0.3 0.3 0.3 Sodium Monofluorophosphate 1.1 1.1 1.1 Flavoring 1.1 1.1 1.1 Polysorbate 20 0.50 - - Cocoamidopropyl betaine (30% by weight aq. Solution) 3.34 Sodium lauryl sulfate - 1.5 1.5 Zinc oxide 1 1 1 Water QS QS QS
    [000132] The oral care composition of Example 5 was subjected to an in vitro test to determine zinc adhesion on a saliva-covered hydroxyapatite disc. The results are shown in Table 7 (below).
    TABLE 7
    Zinc Mpg Absorption / Disc Example 5 304 Comparative Example 6 235 Comparative Example 7 28
    Comparative Examples 6 and 7 [000133] The oral care composition of Comparative Example 6 has been modified when compared to Example 5 by employing the anionic surfactant SLS instead of the surfactant system of the invention.
    [000134] The oral care composition of Comparative Example 7 has been modified when compared to Example 5 as it does not include arginine.
    37/37 [000135] The oral care compositions of Comparative Examples 6 and 7 were subjected to the same in vitro test to determine zinc adhesion on a saliva-covered hydroxyapatite disc. The results are also shown in Table 7.
    [000136] Table 7 shows that by using a surfactant system according to the invention, in comparison with the SLS surfactant in Comparative Example 6, the absorption of zinc was increased.
    [000137] In addition, Table 7 shows that when arginine is not present in the composition, as in Comparative Example 7, the absorption of zinc is minimal.
    [000138] Consequently, when used in a composition comprising arginine, zinc ions and calcium carbonate, the surfactant system used in the invention increased the absorption of zinc ions in comparison with the use of SLS and in comparison with a composition that it does not understand arginine.
    1/3
    权利要求:
    Claims (12)
    [1]
    1. Composition for oral care characterized by the fact that it comprises an orally acceptable carrier, a basic amino acid in free or salt form, calcium carbonate, a source of zinc ions and at least one surfactant selected from a copolymer surfactant in non-ionic block and a betaine zwitterionic surfactant or a mixture of these, in which the oral composition is free from any anionic surfactant.
    [2]
    2. Oral care composition according to claim 1, characterized by the fact that the non-ionic block copolymer surfactant is present in an amount of 0.25 to 2% by weight, or 0.5 to 1.5 %, or 1%, based on the weight of the oral care composition.
    [3]
    3. Oral care composition according to claim 1 or 2, characterized in that the nonionic block copolymer surfactant comprises a poloxamer, for example poloxamer 407.
    [4]
    4. Oral care composition according to claim 1, characterized by the fact that the betaine zwitterionic surfactant is present in an amount of 0.25 to 2% by weight, or 0.5 to 1.5%, or 1%, based on the weight of the oral care composition.
    [5]
    5. Oral care composition according to any one of claims 1 to 4, characterized in that the betaine zwitterionic surfactant comprises a Cb - C16 amidopropyl betaine, for example cocoamidopropyl betaine.
    [6]
    6. Composition for oral care, according to claim 1, characterized by the fact that carbonate
    Petition 870180124662, of 9/3/2018, p. 12/10
    2/3 of calcium is present in an amount of 10 to 50% by weight, or 25 to 40% by weight, based on the weight of the oral care composition.
    [7]
    7. Oral care composition according to any one of claims 1 to 6, characterized by the fact that calcium carbonate has an average particle size not larger than a dentin tubule of a mammalian tooth, for example 1 to 5 pm.
    Oral care composition according to claim 1, characterized by the fact that the basic amino acid in free or salt form comprises arginine bicarbonate.
    [8]
    9. Oral care composition according to any one of claims 1 to 8, characterized in that the basic amino acid in free or salt form is present in an amount of 5 to 15% by weight, or from 7 to 12 % by weight, based on the weight of the oral care composition.
    [9]
    10. Oral care composition according to claim 1, characterized by the fact that the source of zinc ions comprises at least one among zinc citrate, zinc lactate, zinc gluconate, or zinc oxide or any mixture of any two or more of these.
    [10]
    11. Oral care composition according to any one of claims 1 to 10, characterized in that the source of zinc ions is present in an amount of 0.5 to 3% by weight, or 1 to 2% by weight, based on the weight of the oral care composition.
    [11]
    12. Composition for oral care, according to claim 11, characterized by the fact that the source of
    Petition 870180124662, of 9/3/2018, p. 12/11
    3/3 zinc ions comprise a mixture of zinc citrate and zinc oxide, for example in which zinc citrate is present in an amount of 0.25 to 0.75% by weight based on the weight of the care composition oral, and zinc oxide is present in an amount of 0.75 to 1.25% by weight based on the weight of the oral care composition.
    [12]
    13. Oral care composition according to claim 1, characterized by the fact that the orally acceptable vehicle comprises sorbitol, which is present in an amount of 12 to 30% by weight, or 15 to 25% by weight,
    based on the weight of the composition for oral care.14. Composition for care oral, according with The claim 1, characterized by the fact that what The composition comprises fluoride stony and in what O
    stannous fluoride is present in an amount sufficient to provide 25 ppm to 5000 ppm of fluoride ions.
    Petition 870180124662, of 9/3/2018, p. 12/12
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    AU2012396297A1|2015-05-28|
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    CN104822360A|2015-08-05|
    IL238842A|2020-04-30|
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    法律状态:
    2018-06-05| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|
    2018-10-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2018-12-11| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/12/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    PCT/US2012/068108|WO2014088575A1|2012-12-06|2012-12-06|Surfactant systems for zinc containing compositions|
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