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WO2007066837A1 - Systemes de distribution d'un composant de blanchiment des dents faisant appel a la gelification in situ - Google Patents

Systemes de distribution d'un composant de blanchiment des dents faisant appel a la gelification in situ Download PDF

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Publication number
WO2007066837A1
WO2007066837A1 PCT/KR2005/004132 KR2005004132W WO2007066837A1 WO 2007066837 A1 WO2007066837 A1 WO 2007066837A1 KR 2005004132 W KR2005004132 W KR 2005004132W WO 2007066837 A1 WO2007066837 A1 WO 2007066837A1
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Prior art keywords
teeth
delivery system
agent
water
acid
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Ceased
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PCT/KR2005/004132
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English (en)
Inventor
Ji-Young Kim
Sug-Youn Chang
Sang-Nyun Kim
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LG H&H Co Ltd
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LG Household and Health Care Ltd
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Priority to PCT/KR2005/004132 priority Critical patent/WO2007066837A1/fr
Publication of WO2007066837A1 publication Critical patent/WO2007066837A1/fr
Anticipated expiration legal-status Critical
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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
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/733—Alginic acid; Salts thereof

Definitions

  • the present invention relates to a delivery system for tooth whitening component which is water-soluble before being applied to teeth but forms a water- insoluble film on the surface of teeth in oral cavity through in situ gelling.
  • the delivery system becomes water-insoluble after being applied to teeth to have superior adhesion maintenance to teeth and gum, which is thus suitable for such case that sufficient contact time is required to attain desired whitening effects within a short period of time.
  • an element such as a rubber dam
  • an element such as a rubber dam
  • hydrogen peroxide at a low concentration of 16% can be combined with the use of laser, heat activator or photo activator so as to exert synergistic effects.
  • the in- office bleaching product has disadvantages of severe irritation and earlier retention due to the use of high-concentration hydrogen peroxide.
  • these products are disadvantageous in that they are expensive and wearers need to regularly visit a dentist.
  • OTC over-the-counter
  • the strip for teeth whitening has poor adhesion to teeth, a wearer feels an unnatural sensation.
  • the strip is not closely fixed to teeth, a wearer feels that the strip is loose and cannot continuously wear the strip for 30 minutes or more.
  • the strip has poor adhesion to teeth when compared to other attachment-type products, sites between highly indented teeth and a highly irregular row of teeth, including snaggleteeth, cannot be sufficiently whitened.
  • USP 5,425,953 (1992) to Sintov et al. discloses a composition containing a water-soluble, low-viscosity cellulose polymer as a film- forming agent and a bleaching agent for the purpose of teeth whitening and other dental uses.
  • the composition is a liquid formulation to be spread on teeth. Since the composition has a low viscosity, it can be spread on sites between teeth or irregular teeth so that the drawbacks of tray products and strip products can be solved. However, since the water-soluble cellulose polymer may be diluted or dissolved within 5 minutes, the composition has a serious drawback in that a sufficient contact time between the whitening ingredient and teeth cannot be guaranteed.
  • USP 6,569,408, USP 6,589,512 and USP 6,692,727 all of which were issued to Yue et al., disclose methods for the delivery of effective ingredients, including teeth whitening ingredients, to the oral cavity using organosiloxanes. Since the organosiloxanes are highly hydrophobic, they are not readily dissolved in and removed from the moist oral cavity. However, the hydrophobicity of organosiloxanes impedes diffusion of hydrophilic drugs, particularly a strong oxidant as a teeth whitening agent, which makes it difficult to attain desired effects within a short period of time. Further, the use of a large amount of the organosiloxanes may give a messy feeling after being applied to teeth.
  • US Patent Publication No. 2003/0219390 discloses a tooth whitening liquid composition comprising a carbomer with a poly( ethylene oxide).
  • the liquid composition contains 20-30% of ethanol as a solvent.
  • the solvent is vaporized to allow the poly(ethylene oxide) as a film-forming agent to form a film.
  • the film is sticky due to the carbomer, and thus it can remain on the teeth for a desired time.
  • the desired film may not be adequately formed on the teeth surface when the drying time is insufficient due to various factors, e.g., the spreading thickness of the ethanol, the dry state of the teeth and the humidity of the oral cavity.
  • the poly(ethylene oxide) film is water-soluble, the film may be diluted or dissolved in saliva.
  • USP 6,312,666 to Oxman et al. mentions a delivery system for teeth whitening using a formulation whose temperature is increased in the oral cavity. Based on this characteristic of the delivery system,
  • Oxman et al. suggested a product capable of solving the problem associated with the use of conventional trays and strips, i.e. difficult application to sites between teeth and to an irregular row of teeth, in USP 6,620,405.
  • the patent describes a system which can be applied to teeth using a brush or by spraying because the system is a low-viscosity liquid during storage at room temperature and before being spread, but is converted to a gel having no mobility because the system becomes highly viscous due to the temperature of the oral cavity after being applied to teeth.
  • the gelling temperature of the poloxamer is increased and thus converts the gel to a sol, after which the sol is easily removed and thus desired results are not readily obtained.
  • the present invention has been made in view of the above problems, and it is an object of the present invention to provide a delivery system for a teeth whitening ingredient that is a low-viscosity liquid when being applied to teeth and is readily applicable to gaps between teeth and to irregular teeth to form a water-insoluble film in oral cavity, thereby exhibiting superior adhesion maintenance to the teeth.
  • a liquid delivery system for a teeth whitening ingredient which comprises a first agent containing a water-soluble calcium ion source, and a second agent containing a water-soluble alginate wherein at least one of the first agent and the second agent contains a material for improving adhesion to teeth and a teeth whitening ingredient.
  • a liquid delivery system for a teeth whitening ingredient which comprises a first agent containing a water-insoluble calcium ion source, and a second agent containing an acid capable of causing the water-insoluble calcium ion source of the first agent to generate water-soluble calcium ions wherein at least one of the first agent and the second agent contains a water-soluble alginate, a material for improving adhesion to teeth and a teeth whitening ingredient.
  • a liquid delivery system for a teeth whitening ingredient which comprises a first agent containing a water-soluble calcium ion source, a peroxide as the teeth whitening ingredient and silica, and a second agent containing a water-soluble alginate wherein at least one of the first agent and the second agent contains a material for improving adhesion to teeth.
  • a liquid delivery system for a teeth whitening ingredient which comprises a first agent containing a water-insoluble calcium ion source, a peroxide as the teeth whitening ingredient and silica, and a second agent containing an acid capable of causing the water-insoluble calcium ion source of the first agent to generate water-soluble calcium ions and a water-soluble alginate wherein at least one of the first agent and the second agent contains a material for improving adhesion to teeth.
  • the delivery system for a teeth whitening ingredient according to the present invention is a system for delivering effective ingredients to the oral cavity to form a water-insoluble gel or film through in situ gelling when being applied to teeth in the oral cavity.
  • the delivery system of the present invention uses in situ gelling of the alginate to form a water-insoluble film on the surface of teeth within a short time when the first agent joins the second agent. That is, the water- soluble polymer alginate joins calcium ions to form a water-insoluble gel or film.
  • the delivery system of the present invention is advantageously not affected by various conditions of the oral cavity, e.g., pH, temperature, water content, etc., and is safe because no organic solvent is used, hi addition, since the hydrophilic composition is highly spreadable when being applied to teeth, which are also hydrophilic, it offers convenience while being used and can avoid a messy feeling caused when a hydrophobic composition, such as silicone, is used. Furthermore, since the delivery system of the present invention contains a polymer having superior adhesion maintenance to teeth and mucous membranes of the gum in the oral cavity, it can remain at desired sites for a desired time due to its sufficient adhesion maintenance to the sites after a water-insoluble alginate film or gel is formed on the desired sites. Also, since the delivery system of the present invention forms a very thin film, no unnatural sensation is felt. Since the ingredients are edible, there is no need for the removal of the ingredients after use.
  • the delivery system of the present invention is simply applied to teeth once or twice daily using a suitable instrument, such as a brush, it offers convenience while being used.
  • the delivery system of the present invention overcomes the problems of conventional attachment-type products and tray products, e.g., need for removal after use, and difficult whitening of sites between teeth and non-uniform application to snaggleteeth due to poor flexibility or elasticity.
  • the delivery system of the present invention solves the problems associated with the use of conventional spreadable whitening agents, e.g., immediate dissolution of hydrophilic films formed on teeth due to the action of saliva, a messy feeling of lipophilic films, and difficult diffusion of whitening ingredients.
  • the delivery system of the present invention is hydrophilic before being applied to teeth, it is highly spreadable on the teeth, hi addition, since the delivery system of the present invention forms a water-insoluble film and has superior adhesion maintenance to teeth after being applied to the teeth, it can remain on the teeth in the oral cavity for a desired time, thus ensuring a sufficient contact time, which is an essential factor to attain whitening effects within a short period of time.
  • the delivery system of the present invention is a system suitable for delivering a teeth whitening ingredient to the moist oral cavity.
  • in situ gelling systems using environmental sensitive polymers have been introduced as systems for controlling the delivery of effective ingredients.
  • Most of such in situ gelling systems are effective in internal environments of the body whose temperature is always maintained at 37°C and at sites where humidity is maintained to some degree.
  • the application of in situ gelling systems is limited in some places, such as the oral cavity, where sudden temperature changes are frequently caused due to cold beverages and hot foods, and saliva is always secreted, particularly, saliva is excessively secreted by foreign materials entering the oral cavity.
  • ingredients that can be used in the compositions are very limited.
  • the polymer used in the present invention is a polysaccharide having a natural carboxylate group as a pendant.
  • the polymer is widely used for various purposes in the fields of foods, and is a safe ingredient commonly used in the fields of pharmaceuticals.
  • the delivery system of the present invention since the delivery system of the present invention uses water as a solvent, it is advantageous in terms of sensitivity.
  • Hydrogel formulations maintain their shapes by water absorption. Since hydrogel formulations are water insoluble but hydrophilic, they are advantageous over other polymer systems. However, since most hydrogel formulations have covalently crosslinked networks, which generally have a chemical toxicity, they are not suitable to use in the oral cavity.
  • the delivery system of the present invention uses a non-covalent crosslinking with a physical gel. Since the delivery system of the present invention uses divalent or trivalent cations, e.g., calcium ions, as crosslinkers, it is harmless to humans.
  • water-insoluble film refers to a thin film insoluble in water, and includes film-like gels having a high viscosity and no flowability.
  • liquid refers to a state that has a relatively low viscosity and is flowable.
  • in situ referred to herein has a dictionary meaning originating from the Latin language and the Greek language and refers to "in its proper position” in English.
  • in situ gelling refers to gelling occurring at a desired site (by inducing a reaction at a desired site).
  • Gels prepared through crosslinking of polysaccharides having a carboxylate group as a pendant have been used in the dental impression material and food preparation technologies.
  • water-insoluble alginate gels are mainly used.
  • a water-insoluble alginate gel is commonly prepared when a water-soluble alginate is converted to an insoluble alginate by a reaction with divalent or trivalent cations in an aqueous solution.
  • Calcium ions are cations that are most mainly used to produce a water- insoluble alginate gel.
  • Calcium chloride is a compound used to generate calcium ions.
  • any compound that easily generates calcium ions in water can be used in the present invention. Easy generation of calcium ions includes simple dissolution in water and generation of calcium ions via a reaction with an acid.
  • the reaction rate is most significantly affected by the concentration of the calcium ions.
  • the control over the concentration of calcium ions in a solution can be achieved by controlling the concentration of calcium ions in the composition.
  • the control over the concentration of calcium ions in a solution can be achieved by controlling the concentration of water-insoluble calcium ions or the concentration of the acid.
  • a gel retarder can be used. The reason for the use of the gel retarder is that the solubility of calcium poorly soluble or insoluble in water can be increased by raising the pH of the solution.
  • Gelation of the alginate may occur through three mechanisms, i.e. diffusion setting, internal setting, and setting by cooling.
  • the delivery system of the present invention is not particularly limited to one of the three mechanisms. Considering that the delivery system of the present invention is applied to teeth in the oral cavity, diffusion setting and internal setting are preferred over setting by cooling. In order to autonomously control the reaction rate so as to cause in situ gelling after being uniformly applied to desired sites, internal setting is preferred over diffusion setting.
  • Diffusion setting is the simplest mechanism among the three mechanisms, and is mainly used in encapsulation using an alginate.
  • diffusion setting calcium ions are diffused into an alginate solution to prepare a gel. Since the diffusion rate is low, diffusion setting is suitable only for the production of thin strips or for the surface coating. According to diffusion setting, the diffusion rate is increased with increasing concentration of calcium ions, which satisfies the object of the present invention to form a thin film on teeth and the gum in the oral cavity to a significant extent. Since the reaction rate is too high during diffusion setting, however, gelation may occur as soon as the first agent joins the second agent before being applied to desired sites of teeth.
  • the reaction rate can be controlled by controlling the concentration of calcium ions or the water-soluble alginate or by the addition of a gel retarder
  • diffusion setting is disadvantageous over internal setting in that the reaction speed cannot be easily controlled.
  • calcium chloride is generally used as the calcium ion source. Since calcium chloride produces an unpleasant smell, it may be unsuitable when used at a high concentration, hi this case, the use of calcium lactate is preferably considered.
  • Internal setting is also referred to as "bulk setting”. Internal setting normally takes place at room temperature, and has an advantage in that generation of calcium ions is controlled in a system.
  • Calcium ion sources that are insoluble in water under neutral or alkaline conditions and are capable of generating calcium ions under acidic conditions are suitable in internal setting.
  • suitable calcium ion sources include calcium sulfate, hydrated calcium sulfate, dicalcium phosphate, and calcium carbonate.
  • any calcium source can be used in internal setting that is insoluble in water under alkaline conditions and is capable of generating free calcium ions under acidic conditions or when combined with an acid.
  • the advantage of internal setting is that calcium ions are generated at a high rate. When it is intended to retard the rate, methods that can be employed in diffusion setting can be applied. Particularly, the rate can be retarded by controlling the kind and concentration of the acid used.
  • Setting by cooling is a mechanism wherein a gelling ingredient, an alginate, a calcium salt, sequestrant and the like are dissolved in hot water, and the solution is cooled, thereby achieving setting.
  • a gelling ingredient, an alginate, a calcium salt, sequestrant and the like are dissolved in hot water, and the solution is cooled, thereby achieving setting.
  • the dissolution may be problematic.
  • setting by cooling may cause an inconvenience in use without an external aid.
  • a water-insoluble film is formed when in situ gelling occurs in an alginate, but the alginate film exhibits no stickiness, i.e. no adhesion and adhesion maintenance to teeth, in view of the inherent characteristics of the alginate film.
  • the present inventors have conducted intensive studies to solve the above problems. As a result, the inventors have developed a delivery system for a teeth whitening ingredient that is harmless to humans, has a gelation time sufficient to offer convenience while being used, and can be readily attached to teeth.
  • a polymer is preferred that has superior adhesion and adhesion maintenance to teeth and is compatible with an alginate without impeding the mechanism of in situ gelling. More preferably, the gelling time is not extended by the addition of the polymer.
  • a highly water-soluble polymer is preferred because water is preferred as a main solvent in the delivery system of the present invention.
  • Most preferred is a polymer that has increased adhesion and/or adhesion maintenance to teeth and mucous membranes but has no adhesion to the parts opposite to the teeth and mucous membranes.
  • polystyrene resin examples include polyvinyl pyrrolidone (PVP), shellac, rosin, polyacrylic acid (PAA), carbopol, carbophil, polysaccharides, polymethyl vinyl ether/maleic acid copolymers (Gantrez), chitosan, hydroxypropyl cellulose (HPC), hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HEC), methyl cellulose (MC), polyox, polyethylene glycol (PEG), poly(N-isopropylacrylamide), poly(N- isopropylacrylamide-co-acrylic acid), poloxamer, pulluran, polyvinyl alcohol (PVA), guar gum, carrageenan, polyacrylate, polyacrylamide, polymethacrylate, polyethacrylate, poly(acrylamide), poly(methacrylate), poly(hydroxyalkylmethacrylate), poly(maleic anhydride), poly(maleate), poly(amide), poly(ethylene amine
  • polymers may be used alone or in any combination.
  • Polyvinyl pyrrolidone (PVP), polyvinyl alcohol (PVA) and hydroxypropylmethyl cellulose (HPMC) are preferred, and HPMC is most preferred.
  • PVP polyvinyl pyrrolidone
  • PVA polyvinyl alcohol
  • HPMC hydroxypropylmethyl cellulose
  • These polymers may be dissolved in water before use, and may be crosslinked to prepare hydrogels.
  • the hydrogels may be used alone or in combination with the polymers.
  • Hydrogels prepared by crosslinking polymers having superior adhesion to teeth absorb water, further enhancing the adhesion to teeth, and are water-insoluble so that their shape is maintained. Accordingly, the hydrogels have an advantage of high retention in the moist oral cavity.
  • the hydrogels can be applied in the form of micronized powders.
  • a thermally sensitive polymer such as poloxamer, poly(N-isopropylacrylamide) or poly(N-isopropylacrylamide-co- acrylic acid
  • poloxamer poly(N-isopropylacrylamide) or poly(N-isopropylacrylamide-co- acrylic acid)
  • the adhesion is increased and the rigidity is varied depending on changes in temperature. Accordingly, a delivery system having superior mechanical strength can be attained when the gelling temperature of these polymers is equal to the temperature of the oral cavity, which is higher than room temperature.
  • the first agent is an aqueous solution essentially containing a water-soluble calcium ion source and the second agent is an aqueous solution essentially containing a water-soluble alginate.
  • a polymer for improving the adhesion to teeth and a teeth whitening ingredient are included in one or both of the first and second agents.
  • the delivery system of the present invention can be applied to teeth in the form of a spray, mouthwash, paste, ointment, gel, or liquid.
  • the first and second agents can be separately packaged into different formulations.
  • the first and second agents can be mixed in a two-barrel container having one orifice before use, and then the mixture can be applied to desired sites. Even when the first and second agents are separately packaged, a mixture of the first and second agents can be prepared just before use and then it can be applied to desired sites. Alternatively, the first and second agents are sequentially applied to desired sites, or vice versa.
  • the first agent essentially contains a water- insoluble calcium ion source, unlike in the first agent used in diffusion setting, and the second agent essentially contains an acid capable of reacting with the water-insoluble calcium ion source of the first agent to generate water-soluble calcium ions.
  • a water-soluble alginate and a polymer for improving the adhesion to teeth are included as essential ingredients in one or both of the first and second agents.
  • a teeth whitening ingredient may be included as essential ingredients in one or both of the first and second agents.
  • the delivery system of the present invention can be applied to teeth in the form of a spray, mouthwash, paste, ointment, gel, or liquid.
  • the first and second agents can be separately packaged into different formulations.
  • the first and second agents can be mixed in a two-barrel container having one orifice before use, and then the mixture can be applied to desired sites. Even when the first and second agents are separately packaged, a mixture of the first and second agents can be prepared just before use and then it can be applied to desired sites. Alternatively, the first and second agents are sequentially applied to desired sites, or vice versa.
  • any grade product that is used in the oral cavity can be used in the present invention.
  • a grade having a high content of L-guluronic acid (G-block), which is a moiety capable of bonding with calcium ions to cause gelling, is more preferred in terms of superior in situ gelling and short gelling time within a desired range.
  • G-block L-guluronic acid
  • the reason for this is that two G- blocks of the alginate are arranged in parallel during formation of the water- insoluble alginate to form diamond-like holes whose area cooperatively binds with calcium ions.
  • an alginate having a high G-block content is preferred over the use of an alginate having a high M-block content in the alginate consisting of G-block and M-block.
  • the use of an alginate having a high G-block content facilitates desired gelling even at a lower polymer concentration and a low calcium concentration, promotes the formation of a gel, and improves the physical properties.
  • sodium alginate Manugel DMB (ISP) which is used in foods and has a high G-block content, has the above-mentioned advantages.
  • the selection of the alginate may be varied depending on the kind of desired formulations. This is because formulations have different characteristics, particularly viscosity.
  • a desired viscosity can be attained by partially controlling the concentration of the alginate, and by selecting an alginate having a desired viscosity grade (low, intermediate, high viscosity, etc.).
  • the concentration of the alginate may be slightly different according to the viscosity grades of the alginate.
  • the concentration of the alginate is preferably 15% or less, more preferably 10% or less, and most preferably 5% or less.
  • a superporous hydrogel or an effervescent, which is used for wound dressing, may be added to the delivery system of the present invention in order to increase the diffusion rate of the effective ingredients.
  • This addition cannot be applied to diffusion setting, but can be applied to internal setting. That is, in the case where internal setting is employed as an in situ gelling mechanism, when an acid contained essentially in one chamber joins another acid in the other chamber, an effervescent can be added to form bubbles (or foam). The bubbles thus formed broaden the surface area contacting with effective ingredients and make the surface porous, thus increasing the diffusion rate of the effective ingredients.
  • the effervescent may be alkali metal carbonate or alkali metal bicarbonate.
  • Suitable effervescents include, but are not limited to, sodium carbonate, sodium bicarbonate, calcium carbonate, potassium carbonate, and mixtures thereof.
  • the effervescent is not particularly restricted so long as it can be used in pharmaceuticals and foods acceptable in the oral cavity.
  • water-soluble calcium ion source examples include calcium chloride, calcium lactate, calcium citrate, calcium aspartate, calcium saccharate, calcium oxovalerate, calcium gluconate, calcium lactobionate, and calcium lactogluconate.
  • the water-soluble calcium ion source is not specially restricted so long as it can be used in the oral cavity and is water-soluble. Preferred are calcium chloride, calcium lactate, calcium lactogluconate, and mixtures thereof.
  • water-insoluble calcium ion source as an essential ingredient of the first agent in internal setting include, but are not limited to, calcium carbonate, calcium phosphate dibasic (CaHPO 4 ), barium carbonate, zinc carbonate, and mixtures thereof.
  • the water-insoluble calcium ion source is not particularly restricted so long as it is used in pharmaceuticals and foods acceptable in the oral cavity and is capable of joining an acid to generate water-soluble calcium ions.
  • Suitable acids are acetic acid, citric acid, tartaric acid, succinic acid, formic acid, glycolic acid, malonic acid, dichloroacetic acid, oxalic acid, lactic acid, malic acid, gluconic acid, adipic acid, fumaric acid, alginic acid, maleic acid, and mixtures thereof.
  • the teeth whitening ingredient used in the delivery system of the present invention is not particularly limited so long as it can be applied to teeth in the oral cavity to exert whitening effects.
  • a strong oxidant is effective as the teeth whitening ingredient.
  • the teeth whitening ingredient is not particularly restricted so long as it exerts teeth whitening effects and can be used in products acceptable in the oral cavity.
  • suitable teeth whitening ingredients include peroxides and metal chlorites.
  • peroxides there can be mentioned hydrogen peroxide, carbamide peroxide, calcium peroxide, perborates, percarbonates, peroxyacids, and persulfates. Sodium percarbonate is most preferred among percarbonates.
  • metal chlorites there can be mentioned calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite.
  • the viscosity of the first and second agents has a great influence on the uniformity of application.
  • a peroxide as the teeth whitening ingredient is contained in the first agent and an alginate is contained in the second agent
  • the use of an additional thickener for increasing the viscosity is required in the first agent but is not required in the second agent, hi terms of effective teeth whitening
  • the first agent has a low viscosity similar to water, only a portion of the first agent is gelled with the alginate of the second agent and a considerable portion of the first agent runs down. As a result, an amount of the peroxide lower than the intended level will be used for whitening. Since an organic polymeric material is commonly used as a thickener, it tends to be structurally modified by the peroxide during storage at high temperature. Accordingly, when the polymer used as a thickener has low compatibility with the peroxide, some of the peroxide and viscosity is lost. Even when the polymer is highly compatible with the peroxide, a loss in viscosity inevitably takes place.
  • the system according to one embodiment of the present invention essentially contains a considerable amount of water-soluble calcium ions for in situ gelling with the alginate.
  • calcium since calcium also has low compatibility with the peroxide, the decomposition of the peroxide is accelerated during storage at high temperature.
  • the present inventors have conducted intensive research through a series of experimental trial and error to solve the problems of deteriorated viscosity and instability that may be caused when a peroxide is used as the teeth whitening ingredient in the system of the present invention.
  • the present inventors have found that a system using an inorganic material is more suitable than that using an organic material.
  • the delivery system essentially contains an inorganic thickener. Even if a highly reactive peroxide is used as the teeth whitening agent of the delivery system, no or little peroxide and viscosity are lost during long-term storage at high temperature. As a consequence, since all the peroxide is completely used in the in situ gelling, uniform whitening effects can be attained immediately after preparation and even after long-term storage at high temperature.
  • suitable inorganic thickeners include fumed silica and precipitated silica of various grades. Fumed silica is more preferred. Representative commercially available products of fumed silica are Cab-O-Sil (Cabot) and Aerosil (Degussa). A representative commercially available product of precipitated silica is Zeodent (Huber). Since fumed silica is produced by the hydrolysis of a chlorosilane in a flame of hydrogen and oxygen at a high temperature of 1,000 0 C, it advantageously has a high purity. Further, fumed silica whose surface is not treated is hydrophilic and has an advantage of easy wetting. Surface-treated fumed silica is lipophilic and water-repellent.
  • fumed silica products may be used alone, but is used in a mixture thereof in order to obtain desired physical properties.
  • hydrophilic fumed silica include LM-130, LM-150, LM-150D, M-5, M-5P, M-7D, PTG, MS-55, MS-75D, H-5, HP-50, HS-5 and EH-5, which are produced by Cab-O-Sil, and Aerosol 90, Aerosil 130, Aerosil 150, Aerosil 200, Aerosil 300 and Aerosil 380, which are produced by Degussa.
  • lipophilic fumed silica examples include, but are not limited to, TS-720 (Cab-O-Sil), and Aerosil R202, Aerosil R805, Aerosil R812, Aerosil R812S, Aerosil R972 and Aerosil R974, which are produced by Degussa.
  • the content of the inorganic thickener may vary depending on the grade of the silica used and the desired viscosity.
  • the hydrophilic silica, the lipophilic silica or a mixture thereof can be used in an amount of 0.5% to 30%, preferably 2.5% to 25%, and more preferably 5% to 20%.
  • the fumed silica alone is used to increase the viscosity of the preferred system according to the present invention, the viscosity is maintained during storage at high temperature but a partial loss of the peroxide is observed. This phenomenon can be more clearly observed when the polymer is added to improve the adhesion and adhesion maintenance to teeth.
  • a chelating agent is added as a peroxide stabilizer or a gel retarder effective in the in situ gelling system using an alginate and calcium ions.
  • the chelating agent can be used, irrespective of diffusion setting and internal setting.
  • gel retarders or calcium sequestrants
  • examples of gel retarders (or calcium sequestrants) that are used in edible formulations acceptable on teeth in the oral cavity include sodium hexametaphosphate, tetrasodium pyrophosphate, and sodium citrate.
  • the gel retarder chelates calcium ions in the composition to lower the concentration of the calcium ions reacting with the alginate, thereby retarding the gelling rate.
  • the gel retarder also acts as a peroxide stabilizer in the system using the peroxide according to the present invention.
  • the peroxide is highly stable with time during storage at high temperature.
  • decomposition of the peroxide is more or less promoted during storage and whitening effects of the peroxide may be deteriorated in use after long-term storage.
  • a chelating agent as the gel retarder is added to chelate metal ions having low compatibility with the peroxide, thereby solving the above problems.
  • the peroxide is used as a main whitening agent, and a polyphosphate may be further used to improve the whitening effects along with the peroxide.
  • a polyphosphate may be further used to improve the whitening effects along with the peroxide.
  • preferred polyphosphates include tetrasodium pyrophosphate (TSPP), sodium acid pyrophosphate (SAPP), sodium tripolyphosphate (STP), sodium potassium pyrophosphate, tetrapotassium pyrophosphate (TKPP), acidic sodium metaphosphate, and acidic sodium polyphosphate.
  • TSPP tetrasodium pyrophosphate
  • SAP sodium acid pyrophosphate
  • STP sodium tripolyphosphate
  • TKPP tetrapotassium pyrophosphate
  • acidic sodium metaphosphate acidic sodium metaphosphate
  • acidic sodium polyphosphate acidic sodium polyphosphate.
  • these polyphosphates can be used alone or in combination with the strong oxidant.
  • the polyphosphates are good metal chelating agents and can effectively remove tooth stains formed by metals, such as iron, calcium and magnesium, contained in foods or working circumstances, it is known that the polyphosphates contribute to the improvement in whitening effects to some extent. Accordingly, since the combined use of the polyphosphate with the strong oxidant in the system of the present invention improves whitening effects and extends the contact time between teeth and the polyphosphate, it is expected to be effective in the inhibition of the formation of tooth stains and removal of tooth stains. It is preferred that the above-mentioned teeth whitening ingredients be highly compatible with not only the alginate but also the composition of the present invention.
  • the advantage that the delivery system of the present invention can remain for a desired time after being applied to teeth provides teeth whitening effects and may be effective in simultaneous or separate delivery of the teeth whitening ingredient and effective ingredients to the oral cavity.
  • effective ingredients include anticalculus agents, fluoride ion sources, antimicrobial agents, dentinal desensitizing agents, anesthetic agents, antifungal agents, anti-inflammatory agents, H-2 antagonists, anticaries agents, remineralization agents, vitamins, minerals, and the like.
  • fluoride ion sources include sodium fluoride, stannous fluoride, indium fluoride, amine fluoride, and sodium monofluorophosphate.
  • a preferred reminerlaization agent is hydroxyapatite, which is a main constituent component of teeth.
  • reminerlaization agents include agents capable of forming in situ hydroxyapatite via a reaction.
  • anticalculus agents include agents capable of chelating calcium ions, such as polyphosphates and pyrophosphates. These anticalculus agents are effective in teeth whitening. Since the ingredients for improving whitening effects are already mentioned above, the detailed explanations thereof are omitted.
  • antimicrobial agents include triclosan, chlorhexidine, alexidine, hexetidine, sanguinarine, benzalkonium chloride, salicylanilide, domiphen bromide, cetylpyridinium chloride (CPC), and tetradecylpyridinium chloride (TPC).
  • Essential oils can also be used.
  • anti-inflammatory agents include aspirin, ketorolac, flurbiprofen, piroxicam, and meclofenamic acid.
  • vitamins and minerals include thiamine, riboflavin, nicotinic acid, pantothenic acid, pyridoxine, biotin, folic acid, vitamin B 12 , lipoic acid, ascorbic acid, vitamin A, vitamin D, vitamin E, and vitamin K. Coenzymes can also be included.
  • the delivery system of the present invention uses no volatile solvent, it is not necessary for users to open their mouth for a longer time than is needed to sufficiently dry the delivery system. Accordingly, the delivery system of the present invention is more convenient in use than conventional products. Special care must be taken to maintain the applied state until gelling.
  • the time taken to gel is limited to 5 minutes or less, preferably 1 minute or less, and most preferably 30 seconds or less.
  • the gelling time may be varied depending on the usage of the delivery system. For example, since the first and second agents must be uniformly mixed in a two-barrel container having one orifice before being applied, the delivery system must be designed taking the mixing time into consideration.
  • the delivery system of the present invention can be applied in various formulations in accordance with various methods.
  • formulations include, for example: those having reduced viscosity, such as hairsprays; those that can be spread on desired sites by touching, such as aqueous poultices; those that can be applied using brushes, such as manicures; those that can be applied using toothbrushes, such as toothpastes, those that can be used by gargling, such as mouthwashes; and those that can be squeezed through a small hole, such as high- quality cosmetics.
  • These formulations can be directly applied to teeth by squeezing or can be squeezed on separate instruments, such as containers and brushes, before being applied to teeth.
  • first and second agents may be separately used in the delivery system of the present invention, hi this case, the application of the first and second agents can be performed in various methods. Specifically, the first agent can be applied to teeth using a toothbrush, and then the second agent can be brought into contact with the teeth using a mouthwash by gargling. Of cause, both first and second agents can be applied to teeth using a brush in accordance with the same method. Various combinations are possible. The first and second agents can be mixed in a two-barrel or two-chamber container having one orifice without separately using the agents.
  • the first agent is first applied to teeth using an appropriate instrument and then the second agent is applied thereto, or vice versa.
  • the formulation can be applied to teeth by spraying a spray, spreading a liquid having a suitable viscosity using an appropriate instrument (e.g., a brush), or spreading a paste (e.g. a toothpaste) using an appropriate instrument (e.g., a toothbrush).
  • the first agent combines with the second agent to form a film within a short time without being affected by various conditions of the oral cavity. Since the film thus formed is edible, it can be easily removed during daily life, e.g., eating foods, drinking beverages and brushing teeth without the need for the removal of the film.
  • the system of the present invention can be directly applied to teeth, instead of separate application of the first and second agents.
  • the first and second agents are mixed just before use and then the mixture is applied to teeth using an appropriate instrument.
  • the first and second agents are mixed in a two-barrel container having one orifice just before use, and then the mixture discharged through the orifice of the container is applied to teeth using an appropriate instrument.
  • the film formed on teeth has superior adhesion maintenance to teeth.
  • the film since the film is water-insoluble, it can be maintained at desired sites for a desired time although saliva is naturally secreted or excessively secreted by a foreign material suddenly entering the oral cavity.
  • the system of the present invention more effectively whitens teeth in the absence of food or beverage until the desired time of use after being applied.
  • the system of the present invention is still convenient while being used despite drinking a slight amount of water or beverage.
  • the delivery system of the present invention comprises no backing layer, it is safe and suitable for overnight use. Particularly, since a relatively small amount of saliva is secreted and movements are few in the oral cavity while sleeping, there is no danger that the delivery system of the present invention may be dissolved while sleeping, which ensures a sufficient contact time between the delivery system and teeth. Accordingly, the delivery system of the present invention attains satisfactory whitening effects within a short period of time. Since the delivery system of the present invention is not lipophilic, it does not give a messy feeling. Accordingly, the delivery system of the present invention gives a comfortable feeling while being used despite retention for a long time.
  • composition trimethylsiloxy silicate, dimethicone, silicone, sodium percarbonate, sodium bicarbonate, aluminum hydroxide, ethyl acetate, hydrophobic silica, MEK, and flavor [Comparative Example 2] "SIMPLY WHITE NIGHT" (Colgate)
  • Composition alcohol, water, urea peroxide, PEG 2M, glycerin, Carbopol, sodium phosphate, and phosphoric acid.
  • Example 3 was the same as that of Example 3, except that HPMC, an ingredient for improving the adhesion maintenance to teeth, was not used.
  • the composition of Comparative Example 4 was the same as that of Example 3, except that sodium alginate, an in situ gelling agent, was not added.
  • the composition of Comparative Example 5 was the same as that of Example 8, except that HPMC, an ingredient for improving the adhesion maintenance to teeth, was not used.
  • Comparative Example 6 was the same as that of Example 8, except that sodium alginate, an in situ gelling agent, was not added.
  • the composition of Comparative Example 7 was the same as that of Example 8, except that sodium alginate, a thickener, was added to the first agent instead of silica.
  • artificial teeth were prepared, and their in vitro characteristics were compared.
  • the artificial teeth were prepared by constituting 96% of the outermost exposed enamel layer of teeth and 60% of the dentin layer positioned under the enamel layer using hydroxyapatite.
  • the teeth were discolored using a solution containing coffee, tea, mucin, etc. Details of the procedure were as follows.
  • a hydroxyapatite powder was formed into tablets by means of an IR press, sintered at l,000°C, molded with an epoxy resin, and surface-etched using a strong acid to obtain tablet specimens.
  • the tablet specimens were dipped in a trypticase soybroth (TSB) solution containing tea, coffee, iron and mucin, followed by drying. The dipping and drying were repeated over one week to contaminate the specimens.
  • the specimens were mildly washed under running water with a toothbrush to remove water-soluble and loosely-bound contaminants. Finally, the specimens were dried at room temperature.
  • TTB trypticase soybroth
  • compositions prepared in the examples and comparative examples were applied to the respective discolored specimens.
  • the resulting specimens were allowed to stand at room temperature for one minute to ensure the time taken for the formation of films on teeth. This is because when the compositions are actually applied to teeth, 30 seconds to one minute are taken to form films on the teeth while keeping users' mouth open.
  • the specimens were dipped in water for one minutes, and taken out of the water. This is to determine whether or not the compositions can be maintained on teeth when a large amount of saliva is suddenly secreted in the oral cavity and users drink water.
  • the specimens were softly wiped with a tissue and were confirmed as to whether or not the compositions were sticky and remained on the specimens. This is to confirm whether the films or gels formed on teeth are so sticky to the tongue and other parts of the oral cavity that they give a messy feeling to users, and to confirm how much amount of the compositions remains despite various applied physical stimuli.
  • compositions prepared in the examples and comparative examples were applied to the HAP tablet specimens, allowed to stand in air at room temperature for one minute, and dipped in water for one minute. After the specimens were taken out of the water, they were wiped with a tissue. It was confirmed as to whether the compositions were sticky and the applied states remained unchanged. Three specimens were used for each test, and the obtained results are shown in Table 1.
  • Examples 1 to 10 are formulations prepared through in situ gelling of an alginate and showed teeth whitening effects and superior adhesion maintenance to teeth. Particularly, the compositions of Examples 6 to 10 are formulations prepared using a peroxide as a teeth whitening ingredient and silica as a thickener.
  • the composition of Comparative Example 1 is a product currently available under the trade name "Crest Night Effects" from P&G, U.S.A.
  • the composition of Comparative Example 2 is a product currently available under the trade name "Simply White Night” from Colgate.
  • the composition of Comparative Example 3 was the same as that of Example 3, except that HPMC, an ingredient for improving the adhesion maintenance to teeth, was not used.
  • the composition of Comparative Example 4 was the same as that of Example 3, except that sodium alginate was not added.
  • the composition of Comparative Example 5 was the same as that of Example 8, except that HPMC, an ingredient for improving the adhesion maintenance to teeth, was not used.
  • the composition of Comparative Example 6 was the same as that of Example 8, except that sodium alginate was not added.
  • Stickiness of the compositions to a hand is expressed as "sticky” or “non- sticky” in Table 1.
  • the amount of the compositions remaining on the specimens after dipping and the amount of the compositions remaining on the specimens after wiping the remaining water are expressed as percentages of the area of the compositions remaining on the discolored specimens.
  • compositions of the examples and comparative examples were applied to the discolored specimens, allowed to stand at room temperature for one minute, and dipped in water for one minute. After the specimens were taken out of the water, they were wiped three times with a tissue. Thereafter, the dry specimens were allowed to stand in a thermo-hygrostat at a temperature of 37°C and a humidity of 95% for 6 hours, and dried at room temperature. L values of the specimens were measured. Difference in the L values, ⁇ L, before and after the application was calculated for each specimen, and the results are shown in Table 2 below.
  • Example 8 and Comparative Examples 1 and 7 were evaluated immediately after preparation or purchase. The same test was conducted after storage at 40°C for four weeks. The results are shown in Table 3.
  • Example 5 11 wwaass highly hydrophobic, the whitening agent was not readily diffused, causing poor whitening effects. It appears that since the composition of Comparative Example 7 showed poor peroxide stability (see, Table 4), it exhibited poor whitening effects. In contrast, since the composition of Example 8 had superior adhesion maintenance to teeth and was formed into a water- insoluble film, it had superior initial whitening effects and superior stability of the peroxide contained in the composition with the passage of time during long-term storage at high temperature.
  • the delivery system for a teeth whitening ingredient according to the present invention is a hydrophilic composition that is applied in a liquid form to the surface of teeth, it can be applied to gaps between teeth or irregular teeth.
  • the delivery system of the present invention is formed into a water-insoluble film on the surface of teeth, it has superior adhesion to the teeth without being readily dissolved in saliva and moisture present in the oral cavity, thereby ensuring a sufficient contact time between the delivery system and the teeth so that the effective ingredients affect the desired sites. Therefore, the delivery system of the present invention can attain superior whitening effects of the desired level within a short period of time.
  • the delivery system of the present invention solves the disadvantages of conventional alginate systems, i.e. poor adhesion and adhesion maintenance to teeth, is convenient and easy to use, and can remain at desired sites for a desired time, it can achieve superior whitening effects of the desired level within a short period of time.
  • the delivery system of the present invention overcomes the problems of dental treatments using trays and OTC products using strips, i.e. removal or washing of the trays and strips after use, and solves the problems of difficult whitening of sites between teeth and an irregular row of teeth.
  • the delivery system of the present invention solves the drawbacks of spreadable liquid-type OTC products, i.e. rapid dissolution in the moist oral cavity.
  • the delivery system of the present invention is not lipophilic, it offers no messy feeling.

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Abstract

La présente invention se rapporte à un système liquide de distribution d'un ingrédient de blanchiment des dents. Le système liquide de distribution selon l'invention est hydrosoluble avant d'être appliqué sur les dents, mais forme, par gélification in situ, un film non hydrosoluble sur la surface des dents dans la cavité buccale. Etant donné qu'il est non hydrosoluble après application et présente une meilleure adhérence aux dents et à la gencive sur la durée, le système de distribution selon l'invention peut être utilisé lorsqu'il est nécessaire d'assurer un temps de contact suffisant pour obtenir des effets de blanchiment désirés en une courte période d'utilisation.
PCT/KR2005/004132 2005-12-06 2005-12-06 Systemes de distribution d'un composant de blanchiment des dents faisant appel a la gelification in situ Ceased WO2007066837A1 (fr)

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GB2499317B (en) * 2012-02-10 2014-01-08 Periproducts Ltd Multicomponent oral care composition
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US10744096B2 (en) 2013-03-15 2020-08-18 Allergan Pharmaceuticals International Limited Pharmaceutical soft gelatin capsule dosage form with modified guar gum
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EP3046532A4 (fr) * 2013-09-17 2017-02-15 Colgate-Palmolive Company Composition de soin buccal
CN105555248A (zh) * 2013-09-17 2016-05-04 高露洁-棕榄公司 口腔护理组合物
US20160228335A1 (en) * 2015-02-05 2016-08-11 University Of Maryland, Baltimore Rechargeable calcium phosphate-containing dental materials
US10813849B2 (en) * 2015-02-05 2020-10-27 University Of Maryland, Baltimore Rechargeable calcium phosphate-containing dental materials
WO2017024110A1 (fr) 2015-08-04 2017-02-09 Isp Investments Llc Polymères dérivés d'éthers d'alcool vinylique à fonction amino et leurs applications
US10064870B2 (en) 2015-11-03 2018-09-04 Zoetis Services Llc Sol-gel polymer composites and uses thereof
US10729698B2 (en) 2015-11-03 2020-08-04 Zoetis Services Llc Sol-gel polymer composites and uses thereof
TWI759273B (zh) * 2015-11-24 2022-04-01 南韓商Ｌｇ生活健康股份有限公司 牙齒或牙齒周邊部貼附用製劑
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CN108472251A (zh) * 2016-01-13 2018-08-31 株式会社 Lg 生活健康 口腔用制剂
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AU2017206470B2 (en) * 2016-01-13 2022-08-18 Lg Household & Health Care Ltd. Preparation for oral cavity
US10925830B2 (en) 2016-01-13 2021-02-23 Lg Household & Health Care Ltd. Preparation for oral cavity
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JP2021107451A (ja) * 2016-01-13 2021-07-29 エルジー ハウスホールド アンド ヘルスケア リミテッド 口腔用製剤
CN114306214A (zh) * 2016-01-13 2022-04-12 株式会社Lg生活健康 口腔用制剂
CN108472251B (zh) * 2016-01-13 2022-02-01 株式会社 Lg 生活健康 口腔用制剂
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US10201491B2 (en) 2016-03-29 2019-02-12 Safewhite, Inc. Polyelectrolyte dental adhesives for whitening teeth and teeth components
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US10500314B2 (en) * 2016-04-15 2019-12-10 Soochow University Flexible substrate/liquid electrolyte viscous composite material and preparation method therefor
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EP3881901A1 (fr) * 2020-03-18 2021-09-22 Corticalis AS Composition liquide améliorée pour le nettoyage, l'aseptisation et/ou la désinfection
CN115605269A (zh) * 2020-03-18 2023-01-13 科蒂科利斯公司（No） 用于清洁、消毒和/或杀菌的改良液体组合物
WO2023135503A1 (fr) * 2022-01-13 2023-07-20 Ids Research Societa' A Responsabilita' Limitata Composition de blanchiment des dents contenant des vitamines

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