WO2022004598A1 - Patch for teeth - Google Patents

Patch for teeth Download PDF

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Publication number
WO2022004598A1
WO2022004598A1 PCT/JP2021/024169 JP2021024169W WO2022004598A1 WO 2022004598 A1 WO2022004598 A1 WO 2022004598A1 JP 2021024169 W JP2021024169 W JP 2021024169W WO 2022004598 A1 WO2022004598 A1 WO 2022004598A1
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WO
WIPO (PCT)
Prior art keywords
patch
tooth
teeth
mouthpiece
water
Prior art date
Application number
PCT/JP2021/024169
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French (fr)
Japanese (ja)
Inventor
翔吾 小宮山
徹也 吉岡
Original Assignee
株式会社サンギ
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Publication date
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Publication of WO2022004598A1 publication Critical patent/WO2022004598A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/02Cosmetics or similar toiletry preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/24Phosphorous; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

  • the present invention relates to a patch for teeth and a method for producing the same.
  • the product for attaching a tooth described in Patent Document 1 uses a fibroin film or a sheet as a poorly water-soluble support, on which a layer of an oral care composition containing an oral care active ingredient is formed.
  • the strip described in Patent Document 2 is a film containing a phosphate whitening agent and a water-soluble or water-dispersible polymer system
  • the dental adhesive film described in Patent Document 3 is a water-soluble or swellable supporting substance and a support material thereof. It is a film made of an active compound incorporated therein.
  • the patch for adhering to a tooth or a peripheral portion of a tooth described in Patent Document 4 is composed of a drug layer that transmits a drug to the tooth and a support layer containing a water-soluble polymer and a water-insoluble polymer together.
  • the strip described in Patent Document 2 and the dental adhesive film described in Patent Document 3 are both film-shaped and thin, they are surely torn or torn when stretched to make contact with the gap between teeth. I could't get it in contact with my teeth.
  • these film-shaped tooth patches are applicable to the back teeth or the entire tooth because most of the products are within the range visible to others, that is, the size is such that the upper and lower sides can cover approximately 6 to 8 front teeth. Was difficult.
  • the tooth-attaching product described in Patent Document 1 and the patch described in Patent Document 4 are provided with a support, so that the product can be pressed against the tooth in order to push the pharmaceutical product into the gap between the teeth. Since it is not elastic, it is difficult to make contact with the gap between the teeth and along the surface of the tooth, and since it has a support that is insoluble in water, the support remains in the oral cavity after use, which causes discomfort and is also used. It was inconvenient to have to take out the support left behind.
  • the present invention solves the above-mentioned problems, and an object of the present invention is to provide a tooth patch that can suppress discomfort in the oral cavity, has a good usability, and is excellent in wearability.
  • the present inventors have started to study a tooth patch that has a good usability and is easy to adhere to teeth. Therefore, we proceeded with the development of a mouthpiece-shaped tooth patch that can be applied to the entire tooth in the oral cavity, and applied a thick mouthpiece-shaped water-soluble patch made of an aqueous gel to all upper and lower teeth. did. As a result, the feeling of close contact with the tooth surface including the gap between the teeth was improved to some extent, but the large volume of the pharmaceutical product caused discomfort due to a strong foreign body feeling, and the patch was applied to the mouth even for a few minutes. Was difficult to maintain.
  • a water-soluble gel was used as a base, and an oral care active ingredient was contained therein, and bubbles were formed in the water-soluble gel containing the oral care active ingredient to form a tooth patch. It was found that even if the thickness of the gel is increased, it is easy to come into contact with the teeth because of its elasticity, it is easy to dissolve and remove it, and even if the volume is the same, the specific gravity can be lightened, so that the feeling of foreign matter can be reduced. With such a tooth patch, even if it is molded into the shape of a mouthpiece, it does not feel a foreign substance and has a good usability, and can have excellent adhesion to teeth.
  • this tooth patch has self-sustaining property, it is possible to produce a tooth patch having various shapes as well as a mouthpiece shape, and even if it is in the form of a film, it has appropriate strength unlike the conventional one. It was possible to produce a patch for teeth having an excellent feeling of use while having the above. The present invention is thus completed.
  • a tooth patch containing a water-soluble gel as a base, an active ingredient for oral care, and containing air bubbles (2) The tooth patch according to (1) above, which has a specific gravity of 0.1 to 1.4. (3) The tooth patch according to (1) or (2) above, wherein the active ingredient for oral care contains calcium phosphate. (4) The tooth patch according to any one of (1) to (3) above, wherein the calcium phosphate is hydroxyapatite or tricalcium phosphate. (5) The tooth patch according to any one of (1) to (4) above, which is characterized by having a mouthpiece shape.
  • a method for producing a patch for teeth in which an active ingredient for oral care is added to an aqueous solution in which a water-soluble gel is dissolved, the mixture is stirred and foamed, and then cooled and solidified.
  • the present invention can provide a patch for teeth that can suppress discomfort in the oral cavity, has a good usability, and is excellent in wearability. Further, it is possible to provide a patch for teeth having excellent adhesion to teeth.
  • FIG. 1 is a diagram showing a state in which a mouthpiece-shaped tooth patch, which is an embodiment of the tooth patch of the present invention, is attached to a tooth.
  • FIG. 2 is a view of the mouthpiece-shaped tooth patch of FIG. 1 as viewed from above.
  • the tooth patch of the present invention is based on a water-soluble gel, contains an active ingredient for oral care, and contains air bubbles.
  • the patch for teeth of the present invention is applied to a tooth (including a peripheral portion or a peripheral tissue of the tooth) and is used for infiltrating the oral care active ingredient into the tooth.
  • the water-soluble gel in the present invention is not particularly limited as long as it is a water-soluble gel, regardless of its properties, type, origin, etc., but for example, gelatin, pectin, pullulan, carrageenan, tamarind, gum arabic, arabinogalactan, etc. Examples thereof include gelling agents such as curdlan, tragant gum, gellan gum, carrageenan gum, and locust bean gum.
  • Gels made from these gelling agents are preferable because they are materials that dissolve or disintegrate when contained in the mouth. These gelling agents may be used alone or in combination of two or more. Among these, gelatin is preferable because of its ease of manufacture, the tactile sensation of the patch, the hardness, and the shape retention.
  • the content of the gelling agent in the tooth patch of the present invention is preferably 0.05 to 15.0% by mass in terms of solid matter with respect to the entire tooth patch after molding (after solidification), and 0. 5 to 10.0% by mass is more preferable, and 1.0 to 6.0% by mass is further preferable.
  • the content of the gelling agent is within the above range, it has an appropriate viscosity that is easy to stir and easily contains air bubbles when aerated during the manufacturing process of the tooth patch, and it is not too hard and not too soft after aeration. Molding is possible easily. If it is used beyond this range, it may not gel, or the viscosity of the raw material after aeration may increase excessively and become too hard, which may make molding difficult. In addition, even if it can be molded, it has excessive elasticity and feels like rubber, and the texture is deteriorated. The amount of saliva in the mouth may not sufficiently dissolve the pharmaceutical product, and the feeling of use may be significantly reduced.
  • the water content of the tooth patch of the present invention is preferably 0 to 70.0% by mass, more preferably 0 to 60.0% by mass, based on the entire molded (solidified) tooth patch. It is more preferably 0 to 30.0% by mass.
  • the water content is closely related to the specific gravity of the tooth patch, and a lower value is preferable in order to suppress the feeling of foreign matter in the oral cavity. Further, from the viewpoint of stability, it is necessary to devise a method to prevent evaporation when the tooth patch has a large water content, and it is preferable that the tooth patch has a smaller water content and is almost dry without such a problem. If the water content exceeds this range, it may not solidify or become a viscous liquid, or even if solidified, it may be strong enough to be easily chewed by the teeth and may not be suitable for oral use.
  • the oral care active ingredient in the present invention is not particularly limited as long as it is generally used as an oral care active ingredient.
  • These oral care active ingredients may be used alone or in combination of two or more.
  • the remineralization accelerator include calcium phosphate such as hydroxyapatite and tricalcium phosphate.
  • the content of the oral care active ingredient contained in the tooth patch of the present invention is particularly limited as long as it can exhibit various effects such as operability at the time of manufacture, viscosity of the patch, elasticity and shape retention. However, it can be used within the range stipulated by laws such as the Pharmaceuticals and Medical Devices Act.
  • the content thereof can be preferably 0.05 to 35.0% by mass with respect to the entire tooth patch, and the content of sodium polyphosphate or the like can be preferably exemplified.
  • the content thereof is preferably 0.05 to 12.0% by mass based on the entire tooth patch.
  • the oral care active ingredient in the present invention the combined use of these is preferable.
  • the content of hydroxyapatite is in the range of 5.0 to 10.0% by mass
  • the content of sodium polyphosphate is in the range of 0.1 to 3.0% by mass. Is more preferable in combination with.
  • the tooth patch of the present invention may contain ingredients other than the active ingredient for oral care in the base of the water-soluble gel.
  • the other components are not particularly limited as long as they are components generally used in the oral cavity, and examples thereof include sweeteners and flavors.
  • the sweetener is not particularly limited, but sugar alcohols, which are non-cariogenic materials, are preferable, and examples thereof include maltitol, xylitol, erythritol, lactitol, mannitol, sorbitol, reduced maltose starch syrup, and reduced starch syrup. Can be done. These sweeteners may be used alone or in combination of two or more.
  • the quality may be food, food additive, pharmaceutical additive, or Japanese Pharmacopoeia, and the form may be powder, crystalline, granular, slurry, liquid, etc. It can be used regardless. Above all, it is preferable to use powdered maltitol having a sweetness close to that of sucrose and having a mild and mellow aftertaste.
  • the content of the other components is not particularly limited as long as it can exhibit various effects such as operability at the time of manufacturing, viscosity of the patch, elasticity and shape retention, and for example, in the case of sugar alcohols, it is not limited.
  • the content thereof is preferably 10.0 to 90.0% by mass, more preferably 20.0 to 60.0% by mass, and 30.0 to 50.0% by mass with respect to the entire tooth patch. % Is more preferable.
  • the tooth patch of the present invention is applied to a tooth (including a tooth peripheral part or a peripheral tissue) and is used for infiltrating an oral care active ingredient into the tooth. Since the patch for teeth of the present invention contains air bubbles, it maintains a certain formability at room temperature and can be applied to the back teeth. In addition, it has appropriate elasticity, dissolution time in the oral cavity, adhesion to teeth, and the like. In addition, the tooth patch of the present invention is excellent in wearability in the oral cavity because it can have an appropriate specific density by containing air bubbles.
  • the specific gravity of the tooth patch of the present invention is preferably 0.1 to 1.4, more preferably 0.2 to 1.0.
  • the specific gravity of the tooth patch in the present invention is the ratio of the mass of the tooth patch to the mass of pure water when the mass of the tooth patch of the same volume and the mass of pure water are compared.
  • pure water is mainly water from which most of impurities such as water-soluble chemical substances such as inorganic substances, organic substances and salts, fine particles such as iron rust and sand, and microorganisms such as bacteria, algae and fungi have been removed. Indicates that there is.
  • the purification method for removing these is not particularly specified, and RO water, distilled water, and ion-exchanged water (demineralized water) fall under this category, and are collectively referred to as pure water.
  • the amount of air bubbles in the tooth patch of the present invention is not particularly limited as long as the tooth patch has elasticity and solubility suitable for use in the oral cavity, but the specific gravity of the tooth patch is limited. It is preferably within the above range.
  • the tooth patch of the present invention contains air bubbles to reduce the specific gravity, so that the feeling of foreign matter can be suppressed as much as possible and can be held in the mouth for a long time even if the amount of the pharmaceutical product can cover the back teeth or the entire tooth. The wearability can be easily improved. Further, by adjusting the elasticity of the base material by controlling the specific gravity and the content of air bubbles, the adhesion and solubility between the base material and the teeth can be easily improved.
  • the active ingredient contained in the dental patch can be reliably and effectively permeated into the teeth. Furthermore, it tends to have appropriate hardness and smoothness at room temperature, and in addition, the inclusion of saliva in the mouth can increase the viscosity. Therefore, even if the patch is shaped like a mouthpiece that occupies a large volume in the mouth during use, it can be used while being in close contact with the entire tooth without any discomfort or foreign matter, so that the patch can be shaped like a mouthpiece. .. Further, even if it has a plate-like shape such as a film, it can be brought into close contact with the teeth without any discomfort or foreign matter.
  • the patch for teeth in the present invention refers to a patch for oral care that is attached to a tooth and permeates or supplies an active ingredient for oral care to the tooth, regardless of the classification of pharmaceuticals, quasi-drugs, foods, and the like.
  • the method for producing the tooth patch of the present invention is not particularly limited, and examples thereof include the following production methods.
  • a gelling agent and an active ingredient for oral care are added to water. Add other ingredients as needed. Bubbles are generated by performing an aeration operation such as stirring in the mixed solution after addition. After that, it is molded into a predetermined shape by pouring it into a mold or the like.
  • the gelling agent When the gelling agent is dissolved in water, it may be heated if necessary. If the amount of water in the mixed solution after the addition of each component becomes excessive, the water concentration may be adjusted to a predetermined value. The water concentration can be adjusted, for example, by heating the mixed solution to evaporate the water. Further, depending on the gelling agent used, a swelling operation is performed in advance.
  • a gelling agent and, if necessary, a component other than the gelling agent are added to water to perform a swelling operation.
  • a mixed solution containing other components not contained in the gelling agent solution is prepared.
  • a mixed liquid in which each component is mixed can be prepared.
  • all the raw materials including water may be dissolved and suspended in a predetermined amount in order for preparation.
  • a foaming agent may be added to facilitate the generation of air bubbles.
  • the foaming agent is not particularly limited as long as it can be used in the oral cavity, and examples thereof include a surfactant.
  • the surfactant examples include sodium lauryl sulfate, alkyl glycoside, coconut oil fatty acid amide propyl betaine, sodium N-lauroyl-L-glutamate and the like.
  • the aeration operation is preferably performed so that the specific gravity when the liquid after aeration is solidified is 0.1 to 1.4, and more preferably 0.2 to 1.0.
  • a tooth patch can be manufactured by molding with a mold having a shape applicable to the back teeth such as a mouthpiece and solidifying the mold.
  • a mouthpiece-shaped tooth patch which is an embodiment of the tooth patch of the present invention, will be described.
  • the shape of the mouthpiece in the present invention is not particularly limited as long as it is generally called a mouthpiece shape.
  • An embodiment of the mouthpiece shape in the present invention will be described with reference to FIGS. 1 and 2.
  • the mouthpiece M has a predetermined thickness t and has a substantially U-shape similar to that of a dental arch in a plan view.
  • the mouthpiece M has elasticity because it contains air bubbles. As shown in FIG. 1, the mouthpiece M is attached between the upper and lower teeth 5a and 6a in the oral cavity, and the mouthpiece M is deformed by clenching the upper and lower teeth 5a and 6a to deform the upper dentition 5 and the lower part.
  • the upper surface 10 and the lower surface 20 of the mouthpiece M have a width at least in contact with the upper dentition 5 or the lower dentition 6 of the wearer, and the central portion thereof is substantially U-shaped in a plan view and is vertically oriented. It has recesses 11 and 21 that are recessed. The recesses 11 and 21 are provided for positioning the upper dentition 5 and the lower dentition 6 and for facilitating the penetration of the teeth 5a and 6a into the mouthpiece M.
  • the recesses 11 and 21 formed on the upper surface 10 and the lower surface 20 are provided independently without penetrating each other. As a result, when the mouthpiece M is attached, the mouthpiece M can be interposed between the upper dentition 5 and the lower dentition 6, and the mouthpiece M wraps around the entire circumference of the teeth 5a and 6a and adheres to the mouthpiece M. It is held as if it were.
  • the recesses 11 and 21 may have any shape, but more preferably, they are formed in a mortar shape having tapered surfaces 12 whose both side portions gradually narrow toward the bottom.
  • the width H of the openings of the recesses 11 and 21 may be uniform, but more preferably, it is designed according to the width of each tooth 5 or 6 of a general adult dentition, for example, FIG. As shown in, it is formed so as to gradually spread from the central portion to both ends of the substrate. This is to facilitate the penetration of the teeth 5 and 6 into the recesses 11 and 21. Further, by forming both side surfaces of the recesses 11 and 21 in a tapered shape, each tooth 5a and 6a presses the tapered surface 12 when the mouthpiece M is attached, so that both side surfaces of the recesses 11 and 21 are inward. It becomes easy to tilt, and it is possible to easily wrap around the teeth 5a and 6a.
  • the oral care active ingredient contained in the base of the mouthpiece M permeates the teeth 5a and 6a.
  • the thickness t of the mouthpiece M is formed so as to gradually decrease from the central portion toward both ends, so that it becomes easier to insert the mouthpiece M into the oral cavity when the mouthpiece M is attached. There is.
  • the thickness t of the mouthpiece M can be appropriately set, but at least it is set to such an extent that the entire circumference of the teeth 5a and 6a can be covered by the deformation caused by the biting of the teeth 5a and 6a.
  • each tooth 5a of the upper and lower dentition 5 and the lower dentition 6 is attached.
  • 6a is held in the oral cavity for a predetermined time until it is dissolved while being wrapped in the mouthpiece M. Therefore, the oral care active ingredient contained in the mouthpiece M can be infiltrated into each of the teeth 5a and 6a for a predetermined time. Further, by providing the recesses 11 and 21 in the mouthpiece M, the teeth 5a and 6a can be easily penetrated into the mouthpiece M, and the mouthpiece M can be easily attached to the peripheral surfaces of the teeth 5a and 6a.
  • the mouthpiece M is, for example, molded by a known molding technique using molds of several sizes in advance, and by preparing molds of several sizes, it is possible to deal with a plurality of people having different tooth patterns. It is possible. Further, in this embodiment, the tooth and the patch for the peripheral portion of the tooth or the peripheral tissue are in the shape of a mouthpiece, but the shape may be a rectangular parallelepiped shape and may be deformed and used when the wearer is placed in the oral cavity. .. In this case, the recesses 11 and 21 are formed linearly along the longitudinal direction of the central portion.
  • the shape of the mouthpiece in the present invention is not limited to the above, and the shape of the tooth patch of the present invention is not limited to the shape of the mouthpiece.
  • Example 1 First, the following solutions 1 and 2 were prepared, and the prepared solutions 1 and 2 were used to prepare a patch for teeth.
  • (Preparation of solution 1) 4.2 g of gelatin was swelled for 20 minutes or more by adding 5 to 8 times the amount of purified water. This was completely dissolved while stirring with a hot stirrer at 60 to 70 ° C. Next, 30.0 g of powdered reduced maltose was added to the dissolved aqueous solution in small portions in a plurality of times and completely dissolved to obtain Solution 1.
  • Preparation of solution 2 To 10.0 g of purified water, 0.5 g of sodium polyphosphate was added and completely dissolved. To this, 5.0 g of hydroxyapatite was added and suspended.
  • Solution 2 was added little by little to solution 1 with stirring, and the two solutions were completely mixed and suspended. This was stirred while being heated with a hot stirrer at 70 to 80 ° C., and evaporated until the water content reached a predetermined concentration.
  • a surfactant N-lauroyl-L-sodium glutamate
  • the temperature of the hot stirrer was set to about 60 ° C., 0.3 g of fragrance was added, and the mixture was stirred with a household hand mixer for 5 seconds. This was poured into the mouthpiece-shaped molds shown in FIGS. 1 and 2 and cooled in a refrigerator at 4 ° C. for 30 minutes to harden to obtain a tooth patch.
  • Example 2 A tooth patch was prepared in the same manner as in Example 1 except that the stirring time with a hand mixer was set to 3 minutes.
  • Example 3 A tooth patch was prepared in the same manner as in Example 1 except that the amount of gelatin compounded was 1.2 g and the stirring time with a hand mixer was 7 minutes.
  • Example 4 Instead of cooling in a refrigerator at 4 ° C., a patch for teeth was prepared in the same manner as in Example 3 except that the product was frozen in a refrigerator at ⁇ 80 ° C. and then the water content was almost removed by a freeze-dryer.
  • Table 1 shows the content of each component in the tooth patch (after molding by cooling solidification) prepared in Examples 1 to 4.
  • the content of water (purified water) was measured by a moisture meter (Shimadzu Corporation, MOC-120H).
  • the dissolution time of 3 minutes or more and less than 5 minutes was defined as 4, 5 minutes or more and less than 10 minutes was defined as 3, 1 minute or more and less than 3 minutes or 10 minutes or more and less than 20 minutes was defined as 2, and the others were defined as 1.
  • the results of the evaluation are shown in Table 2.
  • the tooth patch of the present invention can be suitably used as a patch for applying the active ingredient for oral care to teeth. Further, it can be suitably used as a mouthpiece-shaped patch.
  • Mouthpiece t Mouthpiece thickness H Concave opening width 10 Upper surface of mouthpiece 11 Upper concave surface 12 Tapered surface 20 Lower surface of mouthpiece 21 Lower concave portion 5 Upper dentition 5a Upper dentition 6 Lower dentition 6a Lower tooth

Abstract

The present invention addresses the problem of providing a patch which is for teeth, with which an unpleasant feeling in an oral cavity can be suppressed, and which has a favorable feeling of use and excellent fitting properties. This patch for teeth contains a water-soluble gel as a base, an effective component for oral cavity care, and bubbles. This method for producing a patch for teeth includes adding an effective component for oral cavity care to an aqueous solution in which a water-soluble gel is dissolved, stirring and foaming the resultant, and then cooling and solidifying the resultant.

Description

歯牙用貼付剤Tooth patch
 本発明は、歯牙用貼付剤及びその製造方法に関する。 The present invention relates to a patch for teeth and a method for producing the same.
 従来から歯のホワイトニングや再石灰化などの口腔ケアを目的としたフィルム状の歯牙用貼付剤が知られている。このような歯牙用貼付剤は、使用者自身が簡易に使用可能であるとともに、口腔内において比較的長時間の滞留が可能であるという利点から様々な製品が開発されている。この種の歯牙用貼付剤としては、口腔ケアを目的とした各種有効成分や薬用成分をフィルム状の基剤に含有させた技術や、各種有効成分や薬用成分を含む層を支持体上に形成したものが種々提案されている(特許文献1~4参照)。 Conventionally, a film-shaped tooth patch for oral care such as tooth whitening and remineralization has been known. Various products have been developed for such tooth patches because they can be easily used by the user himself and can stay in the oral cavity for a relatively long time. As a patch for teeth of this type, a technology in which various active ingredients and medicinal ingredients for the purpose of oral care are contained in a film-shaped base, and a layer containing various active ingredients and medicinal ingredients are formed on a support. Various proposals have been made (see Patent Documents 1 to 4).
 特許文献1記載の歯牙貼付用製品は、難水溶性の支持体としてフィブロインフィルム又はシートを使用し、その上に口腔ケア有効成分を含有する口腔ケア用組成物の層を形成したものである。特許文献2記載のストリップは、リン酸塩ホワイトニング剤及び水溶性又は水分散性ポリマー系を含むフィルムであり、特許文献3記載の歯科用接着フィルムは、水溶性又は膨潤性の支持物質、及びその中に組み込まれている活性化合物からなるフィルムである。また、特許文献4記載の歯牙又は歯牙周辺部付着用パッチは、歯牙に薬物を伝達する薬物層と、水溶性高分子と水不溶性高分子とを一緒に含む支持層からなるものである。しかしながら、特許文献2記載のストリップ及び特許文献3記載の歯科用接着フィルムは、いずれもフィルム形状であり薄いため、歯と歯の隙間に接触させるために引き伸ばすとちぎれたり破れたりして、確実に歯に接触させることができなかった。また、これらフィルム状の歯牙用貼付剤は、ほとんどの製品が他者から見える範囲内、すなわち上下ともおおよそ前歯6~8歯をカバーできる程度の大きさであるため、奥歯又は歯全体への適用が困難であった。さらに、歯全体への適用を考えた場合、フィルムのような薄い形状では剤型の維持が困難であり、剤型維持のためには適度な厚みが必須となる。しかしながら、厚みを増した形状では、体積が大きくなるため口腔内に歯牙用貼付剤を適用した際に強い異物感を生じ、口腔内での装着を維持し続ける事が苦痛となる等装着性に関する問題が際立つ。また、市販されている歯牙用貼付剤は、一般的に乾燥したフィルム形状であるため、歯牙に貼付した際に密着性が悪く、基材と歯の間に隙間が生じる等の理由により口腔ケアを目的とした成分が歯牙全体に浸透しにくかった。一方、特許文献1記載の歯牙貼付用製品及び特許文献4記載のパッチは、支持体を備えることにより、歯と歯の隙間に製剤を押しこむために歯に押し付けることは可能であるが、支持体に弾力性がないため歯の隙間と歯の表面に沿って接触させることは難しく、さらに水に不溶の支持体を有するため、使用後に口腔内に支持体が残るので不快感が生じ、また使用後に残った支持体を取り出さなければならず不便であった。 The product for attaching a tooth described in Patent Document 1 uses a fibroin film or a sheet as a poorly water-soluble support, on which a layer of an oral care composition containing an oral care active ingredient is formed. The strip described in Patent Document 2 is a film containing a phosphate whitening agent and a water-soluble or water-dispersible polymer system, and the dental adhesive film described in Patent Document 3 is a water-soluble or swellable supporting substance and a support material thereof. It is a film made of an active compound incorporated therein. Further, the patch for adhering to a tooth or a peripheral portion of a tooth described in Patent Document 4 is composed of a drug layer that transmits a drug to the tooth and a support layer containing a water-soluble polymer and a water-insoluble polymer together. However, since the strip described in Patent Document 2 and the dental adhesive film described in Patent Document 3 are both film-shaped and thin, they are surely torn or torn when stretched to make contact with the gap between teeth. I couldn't get it in contact with my teeth. In addition, these film-shaped tooth patches are applicable to the back teeth or the entire tooth because most of the products are within the range visible to others, that is, the size is such that the upper and lower sides can cover approximately 6 to 8 front teeth. Was difficult. Further, when considering application to the entire tooth, it is difficult to maintain the dosage form with a thin shape such as a film, and an appropriate thickness is indispensable for maintaining the dosage form. However, in the shape with increased thickness, the volume becomes large, so when the tooth patch is applied to the oral cavity, a strong foreign body feeling is generated, and it becomes painful to continue to wear it in the oral cavity. The problem stands out. In addition, since commercially available tooth patches generally have a dry film shape, they have poor adhesion when applied to teeth, and oral care is provided because a gap is created between the base material and the teeth. It was difficult for the ingredients intended for this to penetrate the entire tooth. On the other hand, the tooth-attaching product described in Patent Document 1 and the patch described in Patent Document 4 are provided with a support, so that the product can be pressed against the tooth in order to push the pharmaceutical product into the gap between the teeth. Since it is not elastic, it is difficult to make contact with the gap between the teeth and along the surface of the tooth, and since it has a support that is insoluble in water, the support remains in the oral cavity after use, which causes discomfort and is also used. It was inconvenient to have to take out the support left behind.
特開2007-169181号公報Japanese Unexamined Patent Publication No. 2007-169181 特表2009-521396号公報Special Table 2009-521396 Gazette 特表2004-536032号公報Japanese Patent Publication No. 2004-536032 特表2018-532712号公報Special Table 2018-532712 Gazette
 本発明は、上記問題点を解決するものであり、口腔内における不快感を抑制できて使用感が良く装着性に優れた歯牙用貼付剤を提供することを課題とする。 The present invention solves the above-mentioned problems, and an object of the present invention is to provide a tooth patch that can suppress discomfort in the oral cavity, has a good usability, and is excellent in wearability.
 本発明者らは、使用感が良く、歯に密着させやすい歯牙用貼付剤の検討を開始した。そこで、口腔内の歯全体に適用することができるマウスピース形状の歯牙用貼付剤の開発を進め、水性ゲルで作製した厚みを持たせたマウスピース形状の水溶性貼付剤を上下全歯に適用した。その結果、歯間の隙間を含め歯面への密着感はある程度改善されたが、製剤の体積の多さのために強い異物感による不快感を生じ、数分間の時間でさえ口中に貼付剤を維持することは困難であった。そのため、さらに検討を進めたところ、水溶性ゲルを基剤として、これに口腔ケア有効成分を含有させ、口腔ケア有効成分を含有した水溶性ゲル中に気泡を形成することにより、歯牙用貼付剤の厚みを厚くしても、弾力性を有するため歯に接触させやすく、溶解、除去が容易であり、同体積量であっても比重が軽くできるため異物感が少なくできることを見いだした。このような歯牙用貼付剤であれば、マウスピース形状に成形しても異物感を感じずに使用感が良く、歯との密着性に優れることができる。また、この歯牙用貼付剤は自立性を有するため、マウスピース形状だけでなく種々の形状の歯牙用貼付剤を作製することが可能であり、フィルム状であっても従来とは異なり適切な強度を有しながら使用感に優れた歯牙用貼付剤を作製できるものであった。本発明はこうして完成されたものである。 The present inventors have started to study a tooth patch that has a good usability and is easy to adhere to teeth. Therefore, we proceeded with the development of a mouthpiece-shaped tooth patch that can be applied to the entire tooth in the oral cavity, and applied a thick mouthpiece-shaped water-soluble patch made of an aqueous gel to all upper and lower teeth. did. As a result, the feeling of close contact with the tooth surface including the gap between the teeth was improved to some extent, but the large volume of the pharmaceutical product caused discomfort due to a strong foreign body feeling, and the patch was applied to the mouth even for a few minutes. Was difficult to maintain. Therefore, as a result of further studies, a water-soluble gel was used as a base, and an oral care active ingredient was contained therein, and bubbles were formed in the water-soluble gel containing the oral care active ingredient to form a tooth patch. It was found that even if the thickness of the gel is increased, it is easy to come into contact with the teeth because of its elasticity, it is easy to dissolve and remove it, and even if the volume is the same, the specific gravity can be lightened, so that the feeling of foreign matter can be reduced. With such a tooth patch, even if it is molded into the shape of a mouthpiece, it does not feel a foreign substance and has a good usability, and can have excellent adhesion to teeth. Further, since this tooth patch has self-sustaining property, it is possible to produce a tooth patch having various shapes as well as a mouthpiece shape, and even if it is in the form of a film, it has appropriate strength unlike the conventional one. It was possible to produce a patch for teeth having an excellent feeling of use while having the above. The present invention is thus completed.
 すなわち、本発明は以下に示す事項により特定されるものである。
(1)水溶性ゲルを基剤とし、口腔ケア有効成分を含有し、気泡を含む歯牙用貼付剤。
(2)比重が、0.1~1.4であることを特徴とする上記(1)記載の歯牙用貼付剤。
(3)口腔ケア有効成分がリン酸カルシウムを含むことを特徴とする上記(1)又は(2)記載の歯牙用貼付剤。
(4)リン酸カルシウムがハイドロキシアパタイト又はリン酸三カルシウムであることを特徴とする上記(1)~(3)のいずれか記載の歯牙用貼付剤。
(5)マウスピース形状であることを特徴とする上記(1)~(4)のいずれか記載の歯牙用貼付剤。
(6)水溶性ゲルを溶解した水溶液に口腔ケア有効成分を加え撹拌して発泡させ、その後冷却して固化させる歯牙用貼付剤の製造方法。
(7)冷却は、冷蔵又は凍結乾燥であることを特徴とする上記(6)記載の歯牙用貼付剤の製造方法。
That is, the present invention is specified by the following matters.
(1) A tooth patch containing a water-soluble gel as a base, an active ingredient for oral care, and containing air bubbles.
(2) The tooth patch according to (1) above, which has a specific gravity of 0.1 to 1.4.
(3) The tooth patch according to (1) or (2) above, wherein the active ingredient for oral care contains calcium phosphate.
(4) The tooth patch according to any one of (1) to (3) above, wherein the calcium phosphate is hydroxyapatite or tricalcium phosphate.
(5) The tooth patch according to any one of (1) to (4) above, which is characterized by having a mouthpiece shape.
(6) A method for producing a patch for teeth, in which an active ingredient for oral care is added to an aqueous solution in which a water-soluble gel is dissolved, the mixture is stirred and foamed, and then cooled and solidified.
(7) The method for producing a tooth patch according to (6) above, wherein the cooling is refrigeration or freeze-drying.
 本発明は、口腔内における不快感を抑制できて使用感が良く装着性に優れた歯牙用貼付剤を提供することができる。また、歯牙に対する密着性に優れた歯牙用貼付剤を提供することができる。 The present invention can provide a patch for teeth that can suppress discomfort in the oral cavity, has a good usability, and is excellent in wearability. Further, it is possible to provide a patch for teeth having excellent adhesion to teeth.
図1は、本発明の歯牙用貼付剤の一実施形態であるマウスピース形状の歯牙用貼付剤を歯に装着する状態を示す図である。FIG. 1 is a diagram showing a state in which a mouthpiece-shaped tooth patch, which is an embodiment of the tooth patch of the present invention, is attached to a tooth. 図2は、図1のマウスピース形状の歯牙用貼付剤を上側から見た図である。FIG. 2 is a view of the mouthpiece-shaped tooth patch of FIG. 1 as viewed from above.
 本発明の歯牙用貼付剤は、水溶性ゲルを基剤とし、口腔ケア有効成分を含有し、気泡を含む。本発明の歯牙用貼付剤は、歯牙(歯牙周辺部または周辺組織を含む)に貼付され、歯牙に口腔ケア有効成分を浸透させるために用いられる。本発明における水溶性ゲルは、水溶性のゲルであれば特に制限されず、性状、種類、由来等を問わないが、例えば、ゼラチン、ペクチン、プルラン、カラギーナン、タマリンド、アラビアガム、アラビノガラクタン、カードラン、トラガントガム、ジェランガム、カラヤガム、ローカストビーンガム等のゲル化剤を挙げることができる。これらのゲル化剤によるゲルは、口中に含むことで溶解または崩壊する素材であるので好ましい。これらのゲル化剤は、1種で使用してもよく、2種以上組み合わせて使用してもよい。これらの中でも製造の容易さ、貼付剤の触感、硬さ、形状の保持性などからゼラチンが好ましい。 The tooth patch of the present invention is based on a water-soluble gel, contains an active ingredient for oral care, and contains air bubbles. The patch for teeth of the present invention is applied to a tooth (including a peripheral portion or a peripheral tissue of the tooth) and is used for infiltrating the oral care active ingredient into the tooth. The water-soluble gel in the present invention is not particularly limited as long as it is a water-soluble gel, regardless of its properties, type, origin, etc., but for example, gelatin, pectin, pullulan, carrageenan, tamarind, gum arabic, arabinogalactan, etc. Examples thereof include gelling agents such as curdlan, tragant gum, gellan gum, carrageenan gum, and locust bean gum. Gels made from these gelling agents are preferable because they are materials that dissolve or disintegrate when contained in the mouth. These gelling agents may be used alone or in combination of two or more. Among these, gelatin is preferable because of its ease of manufacture, the tactile sensation of the patch, the hardness, and the shape retention.
 本発明の歯牙用貼付剤におけるゲル化剤の含有量は、成形後(固化後)の歯牙用貼付剤全体に対して、固形物換算で0.05~15.0質量%が好ましく、0.5~10.0質量%がより好ましく、1.0~6.0質量%が更に好ましい。ゲル化剤の含有量が前記範囲にあると、歯牙用貼付剤の製造過程でエアレーションしたときに、撹拌し易く気泡を含みやすい適度な粘性を持ち、エアレーション後は固過ぎず柔らか過ぎないため比較的容易に成形が可能となる。この範囲を超えて使用する場合、ゲル化しないおそれ、又はエアレーション後の原料粘度が過度に増加し固くなり過ぎるため成形が困難となるおそれがある。また、成形できたとしても過度な弾力性を有してゴムのような触感で質感が悪くなる、口内の唾液量では製剤が十分に溶解しなくなる等の使用感が著しく低下するおそれがある。 The content of the gelling agent in the tooth patch of the present invention is preferably 0.05 to 15.0% by mass in terms of solid matter with respect to the entire tooth patch after molding (after solidification), and 0. 5 to 10.0% by mass is more preferable, and 1.0 to 6.0% by mass is further preferable. When the content of the gelling agent is within the above range, it has an appropriate viscosity that is easy to stir and easily contains air bubbles when aerated during the manufacturing process of the tooth patch, and it is not too hard and not too soft after aeration. Molding is possible easily. If it is used beyond this range, it may not gel, or the viscosity of the raw material after aeration may increase excessively and become too hard, which may make molding difficult. In addition, even if it can be molded, it has excessive elasticity and feels like rubber, and the texture is deteriorated. The amount of saliva in the mouth may not sufficiently dissolve the pharmaceutical product, and the feeling of use may be significantly reduced.
 本発明の歯牙用貼付剤における水分含有量は、成形後(固化後)の歯牙用貼付剤全体に対して、0~70.0質量%が好ましく、0~60.0質量%がより好ましく、0~30.0質量%が更に好ましい。水分の含有量は歯牙用貼付剤の比重と密接に関係しており、口腔内での異物感を抑えるためにはより低い値である方が好ましい。また安定性の観点から、歯牙用貼付剤の水分量が多いものでは蒸発しないようにする工夫が必要となり、水分量がより少なくほぼ乾燥状態であればそのような問題もなく好ましい。水分含有量がこの範囲を超えると、固化しないか粘性の強い液体になる、あるいは固化しても歯で簡単に噛み切れる強度のものに仕上がり口腔内の使用に適したものにならないおそれがある。 The water content of the tooth patch of the present invention is preferably 0 to 70.0% by mass, more preferably 0 to 60.0% by mass, based on the entire molded (solidified) tooth patch. It is more preferably 0 to 30.0% by mass. The water content is closely related to the specific gravity of the tooth patch, and a lower value is preferable in order to suppress the feeling of foreign matter in the oral cavity. Further, from the viewpoint of stability, it is necessary to devise a method to prevent evaporation when the tooth patch has a large water content, and it is preferable that the tooth patch has a smaller water content and is almost dry without such a problem. If the water content exceeds this range, it may not solidify or become a viscous liquid, or even if solidified, it may be strong enough to be easily chewed by the teeth and may not be suitable for oral use.
 本発明における口腔ケア有効成分は、口腔ケア有効成分として一般に使用されるものであれば特に制限されず、例えば、再石灰化促進剤、ステイン予防及び/又は除去剤、歯石予防及び/又は除去剤、ホワイトニング剤、う蝕予防及び/又は修復剤、知覚過敏予防及び/又は抑制剤、口臭予防、除去及び/又は隠蔽剤、歯肉炎予防及び/又は改善剤、歯周病予防及び/又は改善剤等を挙げることができる。これらの口腔ケア有効成分は、1種で使用してもよく、2種以上組み合わせて使用してもよい。再石灰化促進剤としては、ハイドロキシアパタイト、リン酸三カルシウム等のリン酸カルシウムを挙げることができる。 The oral care active ingredient in the present invention is not particularly limited as long as it is generally used as an oral care active ingredient. , Whitening agent, caries prevention and / or repair agent, hypersensitivity prevention and / or suppressant, halitosis prevention, removal and / or concealing agent, calculus prevention and / or ameliorating agent, periodontal disease prevention and / or ameliorating agent And so on. These oral care active ingredients may be used alone or in combination of two or more. Examples of the remineralization accelerator include calcium phosphate such as hydroxyapatite and tricalcium phosphate.
 本発明の歯牙用貼付剤に含まれる口腔ケア有効成分の含有量は、製造時の操作性、貼付剤の粘度、弾力性や保形性などの種々の効果が発現できる量であれば特に制限されず、医薬品医療機器等法などの法律に定められた範囲内で使用することができる。ハイドロキシアパタイト、リン酸三カルシウム等のリン酸カルシウム再石灰化促進剤の場合、その含有量は歯牙用貼付剤全体に対して0.05~35.0質量%を好適に例示でき、ポリリン酸ナトリウム等のホワイトニング剤の場合、その含有量は歯牙用貼付剤全体に対して0.05~12.0質量%を好適に例示できる。本発明における口腔ケア有効成分としては、これらの併用が好ましい。特にホワイトニングと再石灰化を目的とした貼付剤では、ハイドロキシアパタイトの含有量は5.0~10.0質量%、ポリリン酸ナトリウムの含有量は、0.1~3.0質量%の範囲での併用が更に好ましい。 The content of the oral care active ingredient contained in the tooth patch of the present invention is particularly limited as long as it can exhibit various effects such as operability at the time of manufacture, viscosity of the patch, elasticity and shape retention. However, it can be used within the range stipulated by laws such as the Pharmaceuticals and Medical Devices Act. In the case of calcium phosphate remineralization accelerators such as hydroxyapatite and tricalcium phosphate, the content thereof can be preferably 0.05 to 35.0% by mass with respect to the entire tooth patch, and the content of sodium polyphosphate or the like can be preferably exemplified. In the case of a whitening agent, the content thereof is preferably 0.05 to 12.0% by mass based on the entire tooth patch. As the oral care active ingredient in the present invention, the combined use of these is preferable. Especially for patches intended for whitening and remineralization, the content of hydroxyapatite is in the range of 5.0 to 10.0% by mass, and the content of sodium polyphosphate is in the range of 0.1 to 3.0% by mass. Is more preferable in combination with.
 本発明の歯牙用貼付剤は、水溶性ゲルの基剤中に、口腔ケア有効成分以外の他の成分を含んでもよい。他の成分としては、口腔内で一般に使用される成分であれば特に制限されず、例えば、甘味料、香料等を挙げることができる。甘味料としては特に制限されないが、非う蝕性の素材である糖アルコール類が好ましく、例えば、マルチトール、キシリトール、エリスリトール、ラクチトール、マンニトール、ソルビトール、還元麦芽糖水飴、還元澱粉糖化物等を挙げることができる。これらの甘味料は、1種で使用してもよく、2種以上組み合わせて使用してもよい。その品質は、いずれも食品、食品添加物、医薬品添加物、日本薬局方品として販売されているもので良く、その形態も粉末状、結晶状、顆粒状、スラリー状、液状など状態の如何を問わず使用することが可能である。中でもショ糖に近い甘味度であり、穏和で後味のないまろやかさのある粉末状のマルチトールの使用が好ましい。他の成分の含有量は、製造時の操作性、貼付剤の粘度、弾力性や保形性などの種々の効果が発現できる量であれば特に制限されず、例えば、糖アルコール類の場合、その含有量は、歯牙用貼付剤全体に対して固形物換算で10.0~90.0質量%が好ましく、20.0~60.0質量%がより好ましく、30.0~50.0質量%が更に好ましい。 The tooth patch of the present invention may contain ingredients other than the active ingredient for oral care in the base of the water-soluble gel. The other components are not particularly limited as long as they are components generally used in the oral cavity, and examples thereof include sweeteners and flavors. The sweetener is not particularly limited, but sugar alcohols, which are non-cariogenic materials, are preferable, and examples thereof include maltitol, xylitol, erythritol, lactitol, mannitol, sorbitol, reduced maltose starch syrup, and reduced starch syrup. Can be done. These sweeteners may be used alone or in combination of two or more. The quality may be food, food additive, pharmaceutical additive, or Japanese Pharmacopoeia, and the form may be powder, crystalline, granular, slurry, liquid, etc. It can be used regardless. Above all, it is preferable to use powdered maltitol having a sweetness close to that of sucrose and having a mild and mellow aftertaste. The content of the other components is not particularly limited as long as it can exhibit various effects such as operability at the time of manufacturing, viscosity of the patch, elasticity and shape retention, and for example, in the case of sugar alcohols, it is not limited. The content thereof is preferably 10.0 to 90.0% by mass, more preferably 20.0 to 60.0% by mass, and 30.0 to 50.0% by mass with respect to the entire tooth patch. % Is more preferable.
 本発明の歯牙用貼付剤は、歯牙(歯牙周辺部または周辺組織を含む)に貼付され、歯牙に口腔ケア有効成分を浸透させるために用いられる。本発明の歯牙用貼付剤は、気泡を含むため、常温で一定の成形性を保持し奥歯まで適用可能である。加えて、適度な弾力性、口腔内での溶解時間、歯牙への密着性等を有する。また、本発明の歯牙用貼付剤は、気泡を含むことにより適度な比重とすることができるため、口腔内での装着性に優れる。本発明の歯牙用貼付剤の比重は、0.1~1.4が好ましく、0.2~1.0がより好ましい。本発明における歯牙用貼付剤の比重とは、同体積の歯牙用貼付剤の質量と純水の質量とを比較したときの、純水の質量に対する歯牙用貼付剤の質量の比である。ここで、純水とは、主に無機物・有機物・塩類等の水溶性の化学物質、鉄さびや砂等の微粒子、バクテリア・藻類・真菌類等の微生物などの不純物のほとんどが除去された水であることを示す。これらを除去する精製方法は特に規定されず、RO水、蒸留水、イオン交換水(脱塩水)がこれに該当し、まとめて純水という。本発明の歯牙用貼付剤における気泡の量は、歯牙用貼付剤が口腔内で使用するのに適切な弾力性及び溶解性を有する程度であれば特に制限されないが、歯牙用貼付剤の比重が上記の範囲になる程度であることが好ましい。本発明の歯牙用貼付剤は、気泡を含ませ比重を減らすことで、奥歯又は歯全体をカバーできる製剤量であっても異物感を極力抑えられ口中に長く保持することが可能であるため、容易に装着性を改善することができる。また、比重や気泡の含有量をコントロールして基材の弾力性を調整することで、基材と歯の密着性や溶解性を容易に高めることができる。これにより、歯科用貼付剤に含有されている有効成分を確実かつ効果的に歯に浸透させることができる。さらに、常温で適度な硬さや滑らかさを有しやすく、加えて口中の唾液を含むことで粘稠性が増加するようにできる。そのため、貼付剤を、例えば使用時に口中に占める体積が大きいマウスピース形状にしても違和感や異物感なく、歯全体に密着させながら使用できるので、貼付剤をマウスピース形状とすることが可能となる。また、例えばフィルムのような板状の形状であっても違和感や異物感なく歯に密着させることができる。また、不溶性の基材を使用する必要がなく、水溶性ゲル、口腔ケア有効成分、甘味料、香料等の摂取しても害のない成分のみで構成されるため、使用後に吐き出す必要がなく、歯に貼付した後に溶解して歯に有効成分を浸透させ、他の成分は摂取される食品として使用することができる。本発明における歯牙用貼付剤とは、医薬品、医薬部外品、食品等の区分にかかわらず、歯牙に貼付して歯牙に口腔ケア有効成分を浸透させる又は供給するものをいう。 The tooth patch of the present invention is applied to a tooth (including a tooth peripheral part or a peripheral tissue) and is used for infiltrating an oral care active ingredient into the tooth. Since the patch for teeth of the present invention contains air bubbles, it maintains a certain formability at room temperature and can be applied to the back teeth. In addition, it has appropriate elasticity, dissolution time in the oral cavity, adhesion to teeth, and the like. In addition, the tooth patch of the present invention is excellent in wearability in the oral cavity because it can have an appropriate specific density by containing air bubbles. The specific gravity of the tooth patch of the present invention is preferably 0.1 to 1.4, more preferably 0.2 to 1.0. The specific gravity of the tooth patch in the present invention is the ratio of the mass of the tooth patch to the mass of pure water when the mass of the tooth patch of the same volume and the mass of pure water are compared. Here, pure water is mainly water from which most of impurities such as water-soluble chemical substances such as inorganic substances, organic substances and salts, fine particles such as iron rust and sand, and microorganisms such as bacteria, algae and fungi have been removed. Indicates that there is. The purification method for removing these is not particularly specified, and RO water, distilled water, and ion-exchanged water (demineralized water) fall under this category, and are collectively referred to as pure water. The amount of air bubbles in the tooth patch of the present invention is not particularly limited as long as the tooth patch has elasticity and solubility suitable for use in the oral cavity, but the specific gravity of the tooth patch is limited. It is preferably within the above range. The tooth patch of the present invention contains air bubbles to reduce the specific gravity, so that the feeling of foreign matter can be suppressed as much as possible and can be held in the mouth for a long time even if the amount of the pharmaceutical product can cover the back teeth or the entire tooth. The wearability can be easily improved. Further, by adjusting the elasticity of the base material by controlling the specific gravity and the content of air bubbles, the adhesion and solubility between the base material and the teeth can be easily improved. As a result, the active ingredient contained in the dental patch can be reliably and effectively permeated into the teeth. Furthermore, it tends to have appropriate hardness and smoothness at room temperature, and in addition, the inclusion of saliva in the mouth can increase the viscosity. Therefore, even if the patch is shaped like a mouthpiece that occupies a large volume in the mouth during use, it can be used while being in close contact with the entire tooth without any discomfort or foreign matter, so that the patch can be shaped like a mouthpiece. .. Further, even if it has a plate-like shape such as a film, it can be brought into close contact with the teeth without any discomfort or foreign matter. In addition, there is no need to use an insoluble base material, and since it is composed only of ingredients that are harmless to ingest, such as water-soluble gels, oral care active ingredients, sweeteners, and fragrances, there is no need to spit them out after use. After being applied to the teeth, it dissolves and allows the active ingredient to penetrate into the teeth, and the other ingredients can be used as ingested foods. The patch for teeth in the present invention refers to a patch for oral care that is attached to a tooth and permeates or supplies an active ingredient for oral care to the tooth, regardless of the classification of pharmaceuticals, quasi-drugs, foods, and the like.
 本発明の歯牙用貼付剤の製造方法は特に制限されないが、例えば以下の製造方法を挙げることができる。水に、ゲル化剤及び口腔ケア有効成分を添加する。必要に応じて他の成分を添加する。添加後の混合液に撹拌等のエアレーション操作を行うことにより気泡を発生させる。その後、鋳型等に流し込むことにより所定の形状に成形する。ゲル化剤を水に溶解させるときは、必要に応じて加熱してもよい。各成分添加後の混合液における水分量が過剰となった場合は、所定の水分濃度に調整してもよい。水分濃度の調整は、例えば、混合液を加温して水分を蒸発させる操作等で行うことができる。また、使用するゲル化剤によっては予め膨潤操作を行う。この場合は、ゲル化剤と、必要に応じてゲル化剤以外の成分を水に添加して膨潤操作を行う。これとは別に、ゲル化剤溶液に入っていない他の成分を混合した混合液を調製する。そして、これらを混合することにより各成分を混合した混合液を調製することができる。また、膨潤操作の必要のないゲル化剤においては、水を含む全ての原料を所定量ずつ順に溶解、懸濁して調製してもよい。気泡を発生しやすくするために、発泡剤を添加してもよい。発泡剤としては口腔内で使用できるものであれば特に制限されないが、例えば界面活性剤を挙げることができる。界面活性剤としては、ラウリル硫酸ナトリウム、アルキルグリコシド、ヤシ油脂肪酸アミドプロピルベタイン、N-ラウロイル-L-グルタミン酸ナトリウム等を挙げることができる。エアレーション操作は、エアレーション後の液を固化させたときの比重が0.1~1.4となるように行うことが好ましく、0.2~1.0となるように行うことがより好ましい。エアレーション操作を上記のように行うと、成形性に優れ、また気泡を含み比重の小さい歯牙用貼付剤を製造することができる。そのため、例えば、マウスピースのような奥歯まで適用可能な形状の鋳型で型取りし、固化させることで歯牙用貼付剤を製造することができる。 The method for producing the tooth patch of the present invention is not particularly limited, and examples thereof include the following production methods. A gelling agent and an active ingredient for oral care are added to water. Add other ingredients as needed. Bubbles are generated by performing an aeration operation such as stirring in the mixed solution after addition. After that, it is molded into a predetermined shape by pouring it into a mold or the like. When the gelling agent is dissolved in water, it may be heated if necessary. If the amount of water in the mixed solution after the addition of each component becomes excessive, the water concentration may be adjusted to a predetermined value. The water concentration can be adjusted, for example, by heating the mixed solution to evaporate the water. Further, depending on the gelling agent used, a swelling operation is performed in advance. In this case, a gelling agent and, if necessary, a component other than the gelling agent are added to water to perform a swelling operation. Separately, a mixed solution containing other components not contained in the gelling agent solution is prepared. Then, by mixing these, a mixed liquid in which each component is mixed can be prepared. Further, in the gelling agent that does not require a swelling operation, all the raw materials including water may be dissolved and suspended in a predetermined amount in order for preparation. A foaming agent may be added to facilitate the generation of air bubbles. The foaming agent is not particularly limited as long as it can be used in the oral cavity, and examples thereof include a surfactant. Examples of the surfactant include sodium lauryl sulfate, alkyl glycoside, coconut oil fatty acid amide propyl betaine, sodium N-lauroyl-L-glutamate and the like. The aeration operation is preferably performed so that the specific gravity when the liquid after aeration is solidified is 0.1 to 1.4, and more preferably 0.2 to 1.0. When the aeration operation is performed as described above, it is possible to produce a patch for teeth which is excellent in moldability and contains air bubbles and has a low specific density. Therefore, for example, a tooth patch can be manufactured by molding with a mold having a shape applicable to the back teeth such as a mouthpiece and solidifying the mold.
 本発明の歯牙用貼付剤の一実施形態であるマウスピース形状の歯牙用貼付剤について説明する。本発明におけるマウスピース形状は、一般的にマウスピース形状といわれるものであれば、その形状は特に制限されない。本発明におけるマウスピース形状の一実施形態を図1及び2により説明する。マウスピースMは、所定の厚みtを有し、平面視において歯列弓と同様な略U字形状をしている。マウスピースMは、気泡を含むことにより弾力性を有している。マウスピースMは、図1に示すように、口腔内の上下の歯牙5a、6aの間に装着され、上下の歯牙5a、6aを噛み締めることでマウスピースMを変形させ、上側歯列5と下側歯列6の歯牙5a、6aの周囲全体がマウスピースMによって包み込まれることで歯牙5a、6aに対してマウスピースMに含まれる口腔ケア有効成分を浸透させることが可能である。マウスピースMの上面10及び下面20は、少なくとも装着者の上側歯列5又は下側歯列6が接する幅を有し、その中央部には、平面視略U字状であって鉛直方向に窪んだ凹部11、21を有する。この凹部11、21は、上側歯列5と下側歯列6の位置決め用と、各歯牙5a、6aをマウスピースMの内部に侵入させやすくするために設けられる。また、上面10及び下面20に形成された互いの凹部11、21は、貫通せずに独立して設けられている。これにより、マウスピースMの装着時において、上側歯列5と下側歯列6との間にマウスピースMを介在させることができ、マウスピースMが歯牙5a、6aの周囲全体を包み込んで密着するようにして保持される。また、凹部11、21は、どのような形状であっても構わないが、より好ましくは、両側部が底部に向かって徐々に狭まるテーパ面12を有するすり鉢状に形成される。また、凹部11、21の開口の幅Hは、均等であっても構わないが、より好ましくは、例えば一般的な大人の歯列の各歯牙5、6の幅に応じて設計され、図2に示すように、基体の中央部から両端部に向かって徐々に広がるように形成される。これは、各歯牙5、6を凹部11、21内に侵入させやすくするためである。また、凹部11、21の両側面をテーパ状に形成することで、マウスピースMを装着した際に各歯牙5a、6aがテーパ面12を押圧するため、凹部11、21の両側面が内側に傾き易くなり、歯牙5a、6aの周囲を包み込みやすくすることが可能である。また、マウスピースMが歯牙5a、6aの周囲に密着して保持されることで、マウスピースMの基剤中に含まれる口腔ケア有効成分が各歯牙5a、6aに浸透される。また、マウスピースMの厚みtは、中央部から両端部に向かって徐々に薄くなるように形成されており、マウスピースMを装着する際において、口腔内にマウスピースMを挿入しやすくなっている。なお、マウスピースMの厚みtは、適宜設定可能であるが、少なくとも歯牙5a、6aの噛み締めによって生じる変形によって歯牙5a、6aの周囲全体を覆うことができる程度に設定される。 A mouthpiece-shaped tooth patch, which is an embodiment of the tooth patch of the present invention, will be described. The shape of the mouthpiece in the present invention is not particularly limited as long as it is generally called a mouthpiece shape. An embodiment of the mouthpiece shape in the present invention will be described with reference to FIGS. 1 and 2. The mouthpiece M has a predetermined thickness t and has a substantially U-shape similar to that of a dental arch in a plan view. The mouthpiece M has elasticity because it contains air bubbles. As shown in FIG. 1, the mouthpiece M is attached between the upper and lower teeth 5a and 6a in the oral cavity, and the mouthpiece M is deformed by clenching the upper and lower teeth 5a and 6a to deform the upper dentition 5 and the lower part. By wrapping the entire circumference of the teeth 5a and 6a of the side dentition 6 with the mouthpiece M, it is possible to allow the oral care active ingredient contained in the mouthpiece M to permeate the teeth 5a and 6a. The upper surface 10 and the lower surface 20 of the mouthpiece M have a width at least in contact with the upper dentition 5 or the lower dentition 6 of the wearer, and the central portion thereof is substantially U-shaped in a plan view and is vertically oriented. It has recesses 11 and 21 that are recessed. The recesses 11 and 21 are provided for positioning the upper dentition 5 and the lower dentition 6 and for facilitating the penetration of the teeth 5a and 6a into the mouthpiece M. Further, the recesses 11 and 21 formed on the upper surface 10 and the lower surface 20 are provided independently without penetrating each other. As a result, when the mouthpiece M is attached, the mouthpiece M can be interposed between the upper dentition 5 and the lower dentition 6, and the mouthpiece M wraps around the entire circumference of the teeth 5a and 6a and adheres to the mouthpiece M. It is held as if it were. Further, the recesses 11 and 21 may have any shape, but more preferably, they are formed in a mortar shape having tapered surfaces 12 whose both side portions gradually narrow toward the bottom. Further, the width H of the openings of the recesses 11 and 21 may be uniform, but more preferably, it is designed according to the width of each tooth 5 or 6 of a general adult dentition, for example, FIG. As shown in, it is formed so as to gradually spread from the central portion to both ends of the substrate. This is to facilitate the penetration of the teeth 5 and 6 into the recesses 11 and 21. Further, by forming both side surfaces of the recesses 11 and 21 in a tapered shape, each tooth 5a and 6a presses the tapered surface 12 when the mouthpiece M is attached, so that both side surfaces of the recesses 11 and 21 are inward. It becomes easy to tilt, and it is possible to easily wrap around the teeth 5a and 6a. Further, by holding the mouthpiece M in close contact with the periphery of the teeth 5a and 6a, the oral care active ingredient contained in the base of the mouthpiece M permeates the teeth 5a and 6a. Further, the thickness t of the mouthpiece M is formed so as to gradually decrease from the central portion toward both ends, so that it becomes easier to insert the mouthpiece M into the oral cavity when the mouthpiece M is attached. There is. The thickness t of the mouthpiece M can be appropriately set, but at least it is set to such an extent that the entire circumference of the teeth 5a and 6a can be covered by the deformation caused by the biting of the teeth 5a and 6a.
 このように構成された本実施形態のマウスピースMは、装着者が上下の歯牙5a、6aによってマウスピースMを噛み締めて装着した際に、上下歯列5と下側歯列6の各歯牙5a、6aの周囲がマウスピースMに包み込まれた状態で溶解されるまで所定の時間口腔内で保持される。したがって、マウスピースMに含まれる口腔ケア有効成分を所定の時間各歯牙5a、6aに浸透させることが可能である。また、マウスピースMに凹部11、21を設けることで歯牙5a、6aをマウスピースMの内部に侵入させやすくすることができるとともに、歯牙5a、6aの周面にマウスピースMを付きやすくすることができる。なお、マウスピースMは、例えば、予め数種類の大きさの鋳型を用いて、公知の成形技術により成形され、数種類の大きさの鋳型を揃えておくことで歯型形状の異なる複数の人々に対応可能である。また、本実施例では、歯牙および歯牙周辺部または周辺組織用貼付剤をマウスピース形状としているが、直方体形状として、装着者の口腔内に装着する際に変形して使用する形態としても構わない。この場合、凹部11、21は、中央部長手方向に沿って直線状に形成される。なお、本発明におけるマウスピース形状は上記に限定されるものでなく、本発明の歯牙用貼付剤の形状はマウスピース形状に限定されるものではない。 In the mouthpiece M of the present embodiment configured as described above, when the wearer clenches the mouthpiece M with the upper and lower teeth 5a and 6a and attaches the mouthpiece M, each tooth 5a of the upper and lower dentition 5 and the lower dentition 6 is attached. , 6a is held in the oral cavity for a predetermined time until it is dissolved while being wrapped in the mouthpiece M. Therefore, the oral care active ingredient contained in the mouthpiece M can be infiltrated into each of the teeth 5a and 6a for a predetermined time. Further, by providing the recesses 11 and 21 in the mouthpiece M, the teeth 5a and 6a can be easily penetrated into the mouthpiece M, and the mouthpiece M can be easily attached to the peripheral surfaces of the teeth 5a and 6a. Can be done. The mouthpiece M is, for example, molded by a known molding technique using molds of several sizes in advance, and by preparing molds of several sizes, it is possible to deal with a plurality of people having different tooth patterns. It is possible. Further, in this embodiment, the tooth and the patch for the peripheral portion of the tooth or the peripheral tissue are in the shape of a mouthpiece, but the shape may be a rectangular parallelepiped shape and may be deformed and used when the wearer is placed in the oral cavity. .. In this case, the recesses 11 and 21 are formed linearly along the longitudinal direction of the central portion. The shape of the mouthpiece in the present invention is not limited to the above, and the shape of the tooth patch of the present invention is not limited to the shape of the mouthpiece.
 以下、実施例を交えて本発明をより詳細に説明するが、本発明の形態の範囲はこれに限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to examples, but the scope of the present invention is not limited to this.
 [実施例1]
まず、次の溶液1及び2を調製し、調製した溶液1及び2を使用して歯牙用貼付剤を作製した。
(溶液1の調製)
ゼラチン4.2gを5~8倍量の精製水を加えて20分以上膨潤させた。これを60~70℃のホットスターラーで撹拌しながら完全に溶解させた。次に、溶解した水溶液に粉末還元麦芽糖30.0gを少量ずつ複数回に分けて加え、完全に溶解させて溶液1を得た。(溶液2の調製)
精製水10.0gにポリリン酸ナトリウム0.5gを加え、完全に溶解させた。これにハイドロキシアパタイト5.0gを加えて懸濁させた。さらに発泡剤として界面活性剤(N-ラウロイル-L-グルタミン酸ナトリウム)を0.5g、pH調整剤としてクエン酸三ナトリウムを0.9g加えてよく撹拌して溶液2を得た。
(歯牙用貼付剤の作製)
溶液1に溶液2を撹拌しながら少量ずつ加え、2液を完全に混合・懸濁させた。これを70~80℃のホットスターラーで加温しながら撹拌し、所定濃度の水分量となるまで蒸発させた。所定濃度の水分量となったらホットスターラーを60℃程度にし、0.3gの香料を加えて家庭用ハンドミキサーで5秒撹拌した。これを図1及び2のマウスピース形状の鋳型に流し込み、4℃の冷蔵庫にて30分冷やし固めることで歯牙用貼付剤を得た。
[Example 1]
First, the following solutions 1 and 2 were prepared, and the prepared solutions 1 and 2 were used to prepare a patch for teeth.
(Preparation of solution 1)
4.2 g of gelatin was swelled for 20 minutes or more by adding 5 to 8 times the amount of purified water. This was completely dissolved while stirring with a hot stirrer at 60 to 70 ° C. Next, 30.0 g of powdered reduced maltose was added to the dissolved aqueous solution in small portions in a plurality of times and completely dissolved to obtain Solution 1. (Preparation of solution 2)
To 10.0 g of purified water, 0.5 g of sodium polyphosphate was added and completely dissolved. To this, 5.0 g of hydroxyapatite was added and suspended. Further, 0.5 g of a surfactant (N-lauroyl-L-sodium glutamate) was added as a foaming agent, and 0.9 g of trisodium citrate was added as a pH adjuster, and the mixture was stirred well to obtain Solution 2.
(Preparation of patch for teeth)
Solution 2 was added little by little to solution 1 with stirring, and the two solutions were completely mixed and suspended. This was stirred while being heated with a hot stirrer at 70 to 80 ° C., and evaporated until the water content reached a predetermined concentration. When the water content reached a predetermined concentration, the temperature of the hot stirrer was set to about 60 ° C., 0.3 g of fragrance was added, and the mixture was stirred with a household hand mixer for 5 seconds. This was poured into the mouthpiece-shaped molds shown in FIGS. 1 and 2 and cooled in a refrigerator at 4 ° C. for 30 minutes to harden to obtain a tooth patch.
 [実施例2]
ハンドミキサーでの撹拌時間を3分とした以外は実施例1と同様に歯牙用貼付剤を作製した。
[Example 2]
A tooth patch was prepared in the same manner as in Example 1 except that the stirring time with a hand mixer was set to 3 minutes.
 [実施例3]
ゼラチンの配合量を1.2gとし、ハンドミキサーでの攪拌時間を7分とした以外は実施例1と同様に歯牙用貼付剤を作製した。
[Example 3]
A tooth patch was prepared in the same manner as in Example 1 except that the amount of gelatin compounded was 1.2 g and the stirring time with a hand mixer was 7 minutes.
 [実施例4]
4℃の冷蔵庫にて冷却する代わりに、-80℃の冷蔵庫で凍結し、その後、凍結乾燥機で水分をほぼ除去した以外は実施例3と同様に歯牙用貼付剤を作製した。
[Example 4]
Instead of cooling in a refrigerator at 4 ° C., a patch for teeth was prepared in the same manner as in Example 3 except that the product was frozen in a refrigerator at −80 ° C. and then the water content was almost removed by a freeze-dryer.
 実施例1~4で作製した歯牙用貼付剤(冷却固化による成形後)における各成分の含有量を表1に示す。水(精製水)の含有量は水分計(島津製作所、MOC-120H)により測定した。 Table 1 shows the content of each component in the tooth patch (after molding by cooling solidification) prepared in Examples 1 to 4. The content of water (purified water) was measured by a moisture meter (Shimadzu Corporation, MOC-120H).
Figure JPOXMLDOC01-appb-T000001
Figure JPOXMLDOC01-appb-T000001
 実施例1~4と同配合で、同様に固化させたサンプルを作成し、その質量を同体積の純水の質量と比較することにより比重を測定した。内寸が55mm×37mm×14mm(横×長さ×高さ)の容器に25℃の純水(蒸留水)を満たしたときの純水の質量は28.72g(基準値)であった。前記容器の内容積と同体積のサンプルの質量は、実施例1で41.04g、実施例2で23.25g、実施例3で11.45g、実施例4で6.31gであった。したがって、それぞれの比重(サンプルの質量/純水の質量)は、実施例1で1.4、実施例2で0.8、実施例3で0.4、実施例4で0.2と求められた。 Samples solidified in the same manner as in Examples 1 to 4 were prepared, and the specific gravity was measured by comparing the mass with the mass of pure water of the same volume. The mass of pure water when a container having an internal dimension of 55 mm × 37 mm × 14 mm (width × length × height) was filled with pure water (distilled water) at 25 ° C. was 28.72 g (reference value). The mass of the sample having the same volume as the internal volume of the container was 41.04 g in Example 1, 23.25 g in Example 2, 11.45 g in Example 3, and 6.31 g in Example 4. Therefore, the respective specific gravities (mass of sample / mass of pure water) were determined to be 1.4 in Example 1, 0.8 in Example 2, 0.4 in Example 3, and 0.2 in Example 4. Was done.
 実施例1~4で得られた歯牙用貼付剤の使用感及び製造の観点の評価として、弾力性、製剤の色合い、溶解時間、口腔内での異物感(装着性)、歯面への接着性、成形のし易さを検討した。評価の基準はスコアリング方式を採用し、とても良い[4]、良い[3]、少し悪い[2]、悪い[1]とした。なお、溶解時間の検討方法は、歯牙用貼付剤を20mm×20mm×10mm(縦×横×高さ)の大きさにカットし、35×φ8mmの撹拌子を用いて400rpmの回転速度、200mLの蒸留水中における完全溶解時間とした。溶解時間が3分以上5分未満を4、5分以上10分未満を3、1分以上3分未満又は10分以上20分未満を2、それ以外を1とした。評価の結果を、表2に示す。 As an evaluation from the viewpoint of usability and manufacturing of the tooth patch obtained in Examples 1 to 4, elasticity, color of the pharmaceutical product, dissolution time, foreign matter feeling in the oral cavity (wearability), adhesion to the tooth surface We examined the properties and ease of molding. The scoring method was adopted as the evaluation standard, and it was set as very good [4], good [3], a little bad [2], and bad [1]. The method for examining the dissolution time is to cut the tooth patch into a size of 20 mm × 20 mm × 10 mm (length × width × height), and use a stirrer of 35 × φ8 mm at a rotation speed of 400 rpm and 200 mL. The complete dissolution time in distilled water was used. The dissolution time of 3 minutes or more and less than 5 minutes was defined as 4, 5 minutes or more and less than 10 minutes was defined as 3, 1 minute or more and less than 3 minutes or 10 minutes or more and less than 20 minutes was defined as 2, and the others were defined as 1. The results of the evaluation are shown in Table 2.
Figure JPOXMLDOC01-appb-T000002
Figure JPOXMLDOC01-appb-T000002
 本発明の歯牙用貼付剤は、口腔ケア有効成分を歯牙に適用するための貼付剤として好適に使用できる。さらに、マウスピース形状の貼付剤として好適に使用できる。 The tooth patch of the present invention can be suitably used as a patch for applying the active ingredient for oral care to teeth. Further, it can be suitably used as a mouthpiece-shaped patch.
 M   マウスピース
 t   マウスピースの厚み
 H   凹部の開口の幅
 10  マウスピースの上面
 11  上側凹部
 12  テーパ面
 20  マウスピースの下面
 21  下側凹部
 5   上側歯列
 5a  上側歯牙
 6   下側歯列
 6a  下側歯牙
M Mouthpiece t Mouthpiece thickness H Concave opening width 10 Upper surface of mouthpiece 11 Upper concave surface 12 Tapered surface 20 Lower surface of mouthpiece 21 Lower concave portion 5 Upper dentition 5a Upper dentition 6 Lower dentition 6a Lower tooth

Claims (7)

  1.  水溶性ゲルを基剤とし、口腔ケア有効成分を含有し、気泡を含む歯牙用貼付剤。 A tooth patch that uses a water-soluble gel as a base, contains an active ingredient for oral care, and contains air bubbles.
  2.  比重が、0.1~1.4であることを特徴とする請求項1記載の歯牙用貼付剤。 The tooth patch according to claim 1, wherein the specific gravity is 0.1 to 1.4.
  3.  口腔ケア有効成分がリン酸カルシウムを含むことを特徴とする請求項1又は2記載の歯牙用貼付剤。 The tooth patch according to claim 1 or 2, wherein the active ingredient for oral care contains calcium phosphate.
  4.  リン酸カルシウムがハイドロキシアパタイト又はリン酸三カルシウムであることを特徴とする請求項1~3のいずれか記載の歯牙用貼付剤。 The tooth patch according to any one of claims 1 to 3, wherein the calcium phosphate is hydroxyapatite or tricalcium phosphate.
  5.  マウスピース形状であることを特徴とする請求項1~4のいずれか記載の歯牙用貼付剤。 The tooth patch according to any one of claims 1 to 4, which is characterized by having a mouthpiece shape.
  6.  水溶性ゲルを溶解した水溶液に口腔ケア有効成分を加え撹拌して発泡させ、その後冷却して固化させる歯牙用貼付剤の製造方法。 A method for manufacturing a tooth patch that is made by adding an oral care active ingredient to an aqueous solution in which a water-soluble gel is dissolved, stirring and foaming, and then cooling and solidifying.
  7.  冷却は、冷蔵又は凍結乾燥であることを特徴とする請求項6記載の歯牙用貼付剤の製造方法。 The method for producing a tooth patch according to claim 6, wherein the cooling is refrigeration or freeze-drying.
PCT/JP2021/024169 2020-06-29 2021-06-25 Patch for teeth WO2022004598A1 (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5583709A (en) * 1978-12-20 1980-06-24 Lion Corp Fluorine-containing preparation
JP2003040722A (en) * 2001-07-23 2003-02-13 Kuraray Co Ltd Coating composition for tooth after bleaching and method for coating
JP2004501958A (en) * 2000-07-04 2004-01-22 エルテーエス ローマン テラピー−ジステーメ アーゲー Rapidly degradable administrable dosage forms for release of active ingredients in the oral cavity or body cavity
WO2013108384A1 (en) * 2012-01-19 2013-07-25 株式会社ツキオカ Film-shaped dentifrices
JP2018002594A (en) * 2016-06-27 2018-01-11 ライオン株式会社 Tooth whitening composition and tooth whitening set
JP2018532712A (en) * 2015-09-09 2018-11-08 エルジー ハウスホールド アンド ヘルスケア リミテッド Tooth removal patches that can be removed by brushing

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5583709A (en) * 1978-12-20 1980-06-24 Lion Corp Fluorine-containing preparation
JP2004501958A (en) * 2000-07-04 2004-01-22 エルテーエス ローマン テラピー−ジステーメ アーゲー Rapidly degradable administrable dosage forms for release of active ingredients in the oral cavity or body cavity
JP2003040722A (en) * 2001-07-23 2003-02-13 Kuraray Co Ltd Coating composition for tooth after bleaching and method for coating
WO2013108384A1 (en) * 2012-01-19 2013-07-25 株式会社ツキオカ Film-shaped dentifrices
JP2018532712A (en) * 2015-09-09 2018-11-08 エルジー ハウスホールド アンド ヘルスケア リミテッド Tooth removal patches that can be removed by brushing
JP2018002594A (en) * 2016-06-27 2018-01-11 ライオン株式会社 Tooth whitening composition and tooth whitening set

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