Film for intraoral application

Abstract

The present invention aims to provide an intraoral adhesive film that combines adhesive properties and slow dissolution properties in a well-balanced manner. [Solution] The present invention provides an intraoral adhesive film containing (A) ιcarrageenan and (B) κcarrageenan. Preferably the film further contains (C) a water-soluble polymer such as tamarind gum, gum arabic, karaya gum, xanthan gum, gellan gum, tragacanth gum, guar gum, tara gum, locust bean gum, pullulan, gelatin, casein, pectin, agar, glucomannan, galactomannan, starch, carboxymethyl starch, dextrin, alginic acid, alginic acid ester, chitin, chitosan, carboxymethylcellulose, λcarrageenan, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, and ethylcellulose.

Description

[Technical Field]

[0001] This invention relates to a film for intraoral application. [Background technology]

[0002] Regarding film formulations to be applied to the oral cavity, for example, Patent Document 1 describes that when an edible film containing glycerin, crystalline cellulose, and sodium alginate was applied to the palate at bedtime, it took about 30 minutes for the film to completely dissolve, indicating good slow dissolution properties. Patent Document 2 describes that a gel containing ι-carrageenan can be used as a tongue position improvement support material. [Prior art documents] [Patent Documents]

[0003] [Patent Document 1] Japanese Patent Publication No. 2008-189568 [Patent Document 2] Japanese Patent Publication No. 2021-183081 [Overview of the Initiative] [Problems that the invention aims to solve]

[0004] However, conventional intraoral adhesive films have an insufficient duration of effectiveness, as the time it takes for the film to completely dissolve (retention time) after being applied to the oral cavity is only about 30 minutes. Furthermore, there are usability issues, such as reduced adhesion to the oral surface in the presence of saliva.

[0005] The present invention aims to provide an intraoral adhesive film that combines adhesive properties and slow dissolution properties in a well-balanced manner. [Means for solving the problem]

[0006] The present invention provides the following [1] to

[11] . [1] (A) Iotakarageenan, and (B) Kappa Carrageenan An intraoral adhesive film containing [a specific ingredient]. [2] The intraoral adhesive film according to [1], wherein the total amount of (A) and (B) is 20 to 60% by mass of the film composition. [3] An intraoral adhesive film according to [1] or [2], wherein the mass ratio of (A) and (B) ((A) / (B)) is 0.1 or greater. [4] (C) One or more water-soluble polymers selected from tamarind gum, gum arabic, karaya gum, xanthan gum, gellan gum, tragacanth gum, guar gum, tara gum, locust bean gum, pullulan, gelatin, casein, pectin, agar, glucomannan, galactomannan, starch, carboxymethyl starch, dextrin, alginic acid or its salts, alginic acid esters, chitin, chitosan, carboxymethylcellulose or its salts, lambda carrageenan, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, and ethylcellulose. An intraoral adhesive film according to any one of items [1] to [3], further containing the above. [5] (D) One or more selected from sugar alcohols and polyhydric alcohols An intraoral adhesive film according to any one of items [1] to [4], further containing the above. [6] The intraoral adhesive film according to [5], wherein the sugar alcohol is one or more selected from sorbitol, xylitol, maltitol, erythritol, lactitol, and reduced starch syrup. [7] The intraoral adhesive film according to [5], wherein the polyhydric alcohol is one or more selected from glycerin, propylene glycol, butylene glycol, and polyethylene glycol. [8] An intraoral adhesive film as described in [1] to [7], which is for application to the palate. [9] The intraoral adhesive film described in [8] for tongue training.

[10] An intraoral adhesive film as described in [8] for improving tongue position.

[11] An intraoral adhesive film as described in [1] to

[10] , which is a food, quasi-drug, cosmetic, or pharmaceutical.

Advantages of the Invention

[0007] According to the present invention, there is provided an intraoral adhesive film that has both good adhesiveness and good slow solubility in a balanced manner. The film of the present invention can be expected to be used for tongue training and tongue position improvement.

Brief Description of the Drawings

[0008] [Figure 1] FIG. 1 is a questionnaire sheet regarding the tongue position used in the examples.

Modes for Carrying Out the Invention

[0009] 〔1. Components of the Intraoral Adhesive Film〕 〔1.1 (A) and (B): Carrageenan〕 The film of the present invention contains carrageenan. Carrageenan is a polysaccharide composed of repeating units of D-galactose and is classified into the following three classes (Formula (1): κ-carrageenan, Formula (2): ι-carrageenan, Formula (3): λ-carrageenan) according to the number of sulfate groups. The film contains at least a combination of (A) ι-carrageenan and (B) κ-carrageenan.

Chemical formula

[0010] -(A) ι-carrageenan- ι-carrageenan (ι-carrageenan) has two sulfate groups per molecule. By blending ι-carrageenan, the flexibility of the film can be increased, which helps to improve the adhesiveness (adhesive force to the palate).

[0011] The content of ι-carrageenan is preferably 10% by mass or more, more preferably 11% by mass or more, and still more preferably 12% by mass or more. Thereby, the flexibility of the film can be further enhanced, and the adhesiveness can be fully exhibited. The upper limit is preferably 30% by mass or less, more preferably 25% by mass or less, and still more preferably 23% by mass or less. Thereby, the adhesiveness can be adjusted within an appropriate range. Therefore, it is preferably 10 to 30% by mass, more preferably 11 to 25% by mass, and still more preferably 12 to 23% by mass.

[0012] -(B) κ-carrageenan- κ-carrageenan has one sulfate group per molecule. By blending κ-carrageenan, the slow solubility can be enhanced (the strength of the film can be increased, and the time until complete dissolution can be extended).

[0013] The content of κ-carrageenan is preferably 5% by mass or more, 10% by mass or more, more preferably 12% by mass or more, and still more preferably 13% by mass or more. Thereby, the slow solubility can be improved. The upper limit is preferably 30% by mass or less, more preferably 25% by mass or less, and still more preferably 23% by mass or less. Thereby, the adhesive force to the palate and the dissolution rate (dissolution time) can be appropriately adjusted. Therefore, it is preferably 5 to 30% by mass, 10 to 30% by mass, more preferably 12 to 25% by mass, and still more preferably 13 to 23% by mass.

[0014] -A + B- The total content (A + B) of ι-carrageenan and κ-carrageenan in the film is preferably 20% by mass or more, more preferably 23% by mass or more, and still more preferably 25% by mass or more. The upper limit is preferably 60% by mass or less, more preferably 50% by mass or less, and still more preferably 46% by mass or less. Therefore, it is preferably 20 to 60% by mass, more preferably 23 to 50% by mass, and still more preferably 25 to 46% by mass.

[0015] -A / B (mass ratio)- The ratio (A / B) of iotacarrageenan content in the film to kappacarrageenan content is preferably 0.1 or higher, more preferably 0.5 or higher, even more preferably 1 or higher, particularly preferably 1.1 or higher, and most preferably 1.2 or higher. This improves the adhesiveness of the film. The upper limit is preferably 5 or lower, more preferably 3 or lower, 2.5 or lower, 2.3 or lower, even more preferably 2 or lower, and most preferably 1.8 or lower. This extends the time until complete dissolution and improves slow dissolution. Therefore, it is preferably 0.1 to 5 or lower, 0.5 to 5 or lower, more preferably 1 to 3 or lower, even more preferably 1 to 2.5 or lower, 1 to 2.3 or lower, 1 to 2 or lower, 1.1 to 2 or lower, and particularly preferably 1.2 to 1.8 or lower.

[0016] -Lambda Carrageenan- The film may contain lambda-carrageenan (λ-carrageenan) to the extent that it does not impair the effects of the present invention. Lambda-carrageenan has three sulfate groups per molecule.

[0017] [1.2 (C): Water-soluble polymer] The film of the present invention may further contain other (C) water-soluble polymers other than (A) and (B).

[0018] (C) The water-soluble polymer may be any water-soluble polymer other than kappa or iotacarrageenan, for example, (C1) gum-based polymer and (C2) polymer other than C1. Examples of (C1) include tamarind gum, gum arabic, karaya gum, xanthan gum, gellan gum, tragacanth gum, guar gum, tara gum, and locust bean gum, as well as two or more combinations selected from these. Tamarind gum is preferred as the (C1) component.

[0019] Examples of (C2) include proteins such as gelatin and casein (preferably gelatin); cellulose derivatives such as carboxymethylcellulose or its salts (e.g., sodium salt, calcium salt), hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, ethylcellulose, and salts thereof; polysaccharides other than cellulose such as pullulan, pectin, dextrin, starch, carboxymethyl starch, glucomannan, and galactomannan (preferably pullulan); alginic acid derivatives such as alginic acid or its salts (e.g., sodium salt, ammonium salt) and alginic acid esters (e.g., propylene glycol alginate); agar, chitin, and chitosan. It is preferable to contain at least gelatin, pectin, agar, glucomannan, galactomannan, starch, alginic acid or its salts, chitosan, carboxymethylcellulose or its salts, lambda carrageenan, and pullulan, as well as two or more combinations selected from these. (C2) The component is preferably a protein (e.g., gelatin) or a polysaccharide other than cellulose (e.g., pullulan), and from the viewpoint of improving adhesion, a polysaccharide other than cellulose (e.g., pullulan) is more preferred. (C) The water-soluble polymer may be a single component, but a combination of two or more components is preferred, and a combination of (C1) and (C2) (each of which may be one or two or more) is more preferred. (C1) can improve the effects of both adhesion and slow dissolution, and (C2) can improve adhesion. By combining both (C1) and (C2), adhesion and slow dissolution can be exhibited in a good balance.

[0020] The content of component (C) is preferably 10% by mass or more, more preferably 15% by mass or more, and particularly preferably 20% by mass or more. This allows for good adhesion. The upper limit is preferably 50% by mass or less, more preferably 47% by mass or less, and even more preferably 45% by mass or less. This allows for efficient adhesion. Therefore, it is preferably 10 to 50% by mass, more preferably 15 to 47% by mass, and even more preferably 20 to 45% by mass. When (C1) and (C2) are included, the mass ratio of (C1) / (C2) is preferably 0.1 to 9, more preferably 0.2 to 4, and even more preferably 0.4 to 3.

[0021] -A+B+C- When component (C) is included, the total content of components (A) to (C) (A+B+C) is preferably 30% by mass or more, more preferably 38% by mass or more, even more preferably 45% by mass or more, particularly preferably 50% by mass or more, and optimally 55% by mass or more. The upper limit is preferably 90% by mass or less, more preferably 85% by mass or less, and even more preferably 80% by mass or less. Therefore, it is preferably 30-90% by mass, more preferably 38-85% by mass, 45-85% by mass, even more preferably 50-85% by mass, and optimally 55-85% by mass. This allows for a good balance between slow dissolution and adhesive properties.

[0022] -(A+B) / C(mass ratio)- When component (C) is included, the ratio of the content of components (A) and (B) to the total content of component (C), (A+B) / C, is preferably 0.5 or more, more preferably 0.6 or more, even more preferably 0.7 or more, and particularly preferably 1.0 or more. The upper limit is preferably 5.0 or less, more preferably 2.0 or less, even more preferably 1.5 or less, and particularly preferably 1.3 or less. Preferably 0.5 to 5.0, more preferably 0.6 to 2.0, even more preferably 0.7 to 1.5, and particularly preferably 1.0 to 1.3. This allows for a good balance between slow dissolution and adhesive properties. -(A+B) / (A+B+C)- When component (C) is included, the ratio of components (A) and (B) to the total content of components (A), (B), and (C) (A+B) / (A+B+C) is preferably 0.2 or more, more preferably 0.3 or more, even more preferably 0.4 or more, and even more preferably 0.5 or more. The upper limit is preferably 0.8 or less, more preferably 0.7 or less, and even more preferably 0.6 or less. Therefore, it is preferably 0.2 to 0.8, more preferably 0.3 to 0.7, even more preferably 0.4 to 0.7, 0.5 to 0.7, and 0.4 to 0.6.

[0023] [1.3 (D): Sugar alcohols and / or polyhydric alcohols] The film of the present invention may further contain (D) sugar alcohols and polyhydric alcohols. This can impart flexibility to the film, reduce cracking and chipping, and potentially improve its adhesive properties. Examples of sugar alcohols include sorbitol, xylitol, maltitol, erythritol, lactitol, reduced starch syrup, and combinations of two or more selected from these, with sorbitol or a combination containing it being preferred. Examples of polyhydric alcohols include dihydric or trihydric polyhydric alcohols such as glycerin, propylene glycol, butylene glycol (e.g., 1,3-butylene glycol), and polyethylene glycol, with combinations of two or more selected from these, with glycerin or a combination containing it being preferred. Component (D) may be either a sugar alcohol or a polyhydric alcohol, or both. By including a sugar alcohol (preferably a combination of a sugar alcohol and a polyhydric alcohol), adhesion may be improved.

[0024] (D) The content of sugar alcohols and / or polyhydric alcohols is preferably 5% by mass or more, more preferably 7% by mass or more, and even more preferably 10% by mass or more. This can further improve the adhesiveness and allow sufficient adhesion to the palate to be achieved. The upper limit is preferably 30% by mass or less, more preferably 27% by mass or less, and even more preferably 25% by mass or less. This can further improve the adhesive strength of the film. Therefore, it is preferably 5 to 30% by mass, more preferably 7 to 27% by mass, and even more preferably 10 to 25% by mass.

[0025] [1.4 Optional components] The film may contain other components. Examples include surfactants, sweeteners, fragrances, bioactive ingredients, plasticizers, colorants, preservatives, and combinations of two or more of these.

[0026] - Surfactants - The inclusion of surfactants allows for the emulsification and uniform blending of components such as fragrances and physiologically active ingredients, which are often poorly soluble, as needed. Examples of surfactants include nonionic surfactants, anionic surfactants, and amphoteric surfactants, with nonionic surfactants being preferred. Examples of nonionic surfactants include glycerin fatty acid esters (e.g., monoglyceryl stearate, decaglyceryl laurate), sugar fatty acid esters (e.g., sucrose fatty acid ester, maltose fatty acid ester, lactose fatty acid ester), sorbitan fatty acid ester, polyglycerin fatty acid ester, polyoxyethylene sorbitan fatty acid ester (e.g., polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monostearate), polyoxyethylene fatty acid ester (e.g., polyoxyethylene hydrogenated castor oil), fatty acid ethanolamide (e.g., myristic acid mono or diethanolamide), polyoxyethylene higher alcohol ether, polyoxyethylene polyoxypropylene copolymer, and polyoxyethylene polyoxypropylene fatty acid ester, with glycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, polyglycerin fatty acid ester, and polyoxyethylene sorbitan fatty acid ester being preferred. The content of the nonionic surfactant is preferably 0.01 to 10% by mass, more preferably 0.1 to 7% by mass, and even more preferably 0.5 to 5% by mass.

[0027] -sweetener- Examples of sweeteners include aspartame, acesulfame potassium, enzyme-treated stevia, sucralose, saccharin, sodium saccharin, stevia, neotame, sucrose, fructose, glucose, starch syrup, lactose, reduced maltose syrup, powdered reduced maltose syrup, glucose-fructose liquid sugar, fructose-glucose liquid sugar, and honey. The sweetener content is preferably 0.01 to 10% by mass, more preferably 0.1 to 7% by mass.

[0028] -Fragrance- The flavorings are not particularly limited and can be any flavorings that can be used in food. Examples include fruit flavors such as strawberry, grape, peach, melon, mango, banana, lychee, apple, orange, lemon, pineapple, and mixed fruit flavors; vanilla; caramel; coffee; cinnamon; milk; tea; mint; herbal; or a mix of two or more flavors selected from these. The flavoring content is preferably 0.01 to 10% by mass, more preferably 0.1 to 7% by mass, and even more preferably 0.5 to 5% by mass.

[0029] - Bioactive ingredients - Examples of physiologically active ingredients include bad breath preventatives, antipyretic analgesics, multi-symptom cold medicines, hypnotics and sedatives, anti-drowsiness agents, pediatric sedatives, cough suppressants and expectorants, oral disinfectants and stomatitis remedies, toothache and periodontitis remedies, oral disinfectants, mouthwashes, anti-allergic agents, rhinitis remedies, nasal sprays, anti-vertigo drugs, gastrointestinal drugs, vitamins, antibacterial agents, antihistamines, anti-inflammatory agents, antiviral agents, antifungal biological agents, anesthetics, immunosuppressants, antimetabolites, anthelmintics, amoeba exterminators, analgesics, anti-arthritis agents, antipsychotics, antihypertensive agents, muscle relaxants, and their active ingredients. These ingredients may be derived from plants, animals, or microorganisms, or they may be chemically synthesized. Specifically, for example, acetaminophen, aspirin, ethyl aminobenzoate, aminoethylsulfonic acid, isopropylmethylphenol, liquid phenol, ethenzamide, decalinium chloride, benzalkonium chloride, benzethonium chloride, lysozyme chloride, chlorhexidine hydrochloride, naphazoline hydrochloride, phenylpropanolamine hydrochloride, phenylephrine hydrochloride, pseudoephedrine hydrochloride, meclizine hydrochloride, lidocaine hydrochloride, glycyrrhizinates (e.g., dipotassium glycyrrhizinate), glycyrrhetinic acid, stearyl glycyrrhetinate), glycyrrhetinic acid, stearyl glycyrrhetinate, cetylpyridinium chloride, diphenhydric acid Min, dl-methyl ephedrine hydrochloride, caffeine, anhydrous caffeine, guaifenesin, potassium guaiacolsulfonate, zinc citrate, glucuronolactone, zinc gluconate, calcium gluconate, chlorhexidine gluconate, sodium chondroitin sulfate, diphenhydramine salicylate, thymol, sodium copper chlorophyllin, scopolamine hydrobromide, sodium bicarbonate, tranexamic acid, nicotinic acid, nicotinamide, noscapine, peppermint oil, calcium pantothenate, vitamins (e.g., vitamin A, vitamin B1, vitamin B2 (e.g., riboflavin), vitamin B6 (e.g., pyridoxine hydrochloride), vitamin B 12Vitamin C (e.g., ascorbic acid, calcium ascorbate), vitamin D, vitamin E (e.g., tocopherol acetate), hinokitiol, bromovalerylurea, total belladonna alkaloids, povidone-iodine, chlorpheniramine maleate, dl-chlorpheniramine maleate, l-menthol, dl-menthol, belladonna extract, iodine, dihydrocodeine phosphate, fosexitin, N-formamidoylchenamycin, tetracycline, chloramphenicol, neomycin, carbenicillin, colistin, penicillin G, polymyxy Vancomycin, Sehazoline, Cephaloridine, Tibrolihamycin, Gramicidin, Bacitracin, Sulfonamide, Gentamycin, Kanamycin, Amikacin, Disomicin, Tobramycin, Nalidixic Acid, Norfloxacin, Fludaranine, Nitrofurazone, Pyrilamine, Chlorpheniramine, Tetrahydrazoline, Antazolin, Cortisone, Hydrocortisone, Cortisone Acetate, Betamethasone, Thymol, Dexamethasone, Dexamethasone Sodium Phosphate, Triclosan, Prednisone, Methylprednisolone, Med Lyson, Fluorometholone, Fluorocortone, Prednisolone, Prednisolone sodium phosphate, Triamcinolone, Indomethacin, Sulindac, Ecothiophate, Physostigmine salicylate, Diisopropyl fluorophosphate, Epinephrine, Dipivolyl epinephrine, Neostigmine, Ecothiopate iodide, Demepotassium bromide, Carbachol, Metacholine, Bethanechol, Atropine, Homatropine, Scopolamine, Ephedrine, Cocaine, Tropicamide, Phenylephrine, Cyclopentolate, Oxyphenonium, O Icatropin, timolol, glycerol, urea, ivermectin, pyrimethamine, trisulfapyrimidine, clindamycin, acyclovir, 5-iodo-2-deoxyuridine, adenosine arabinoside, trifluorothymidine, interferon, acetazoleamide, dichlorphenamide, amphotericin B, nistatin, flucytosine, natamycin, miconazole, etidocaine cocaine, benoxynate, dibucaine hydrochloride, diclonin hydrochloride, naepain, phenacaine hydrochloride, pipelocaine, propalacaine hydrochloride, tetracaine hydrochloride,Hexylcaine, bupivacaine, lidocaine, mepivacaine, rose bengal, adrenaline, hydroxyamphetamine, pilocarpine, chymotrypsin, EDTA, deferoxamine, methotrexate, cyclophosphamide, azathioprine, insulin, minerals, crocetin, collagen (e.g., hydrolyzed collagen, soluble collagen, etc.), ornithine, resveratrol, chlorogenic acid, caffeic acid, ubiquinone (e.g., coenzyme Q10), flavonoids (e.g., flavanone, flavone, flavonol, isoflavone, catechin, anthocyanin), enzymes (e.g., dextranase, mutanase, amylase, protease, lytec enzyme), fluorides (e.g., sodium fluoride, sodium monofluorophosphate, tin fluoride, etc.) Examples include fluoride, ε-aminocaproic acid, allantoin, tranexamic acid, allantoin chlorohydroxyaluminum, azulene, dihydrocholesterol, metal salts (e.g., zinc, copper salts, tin salts), condensed phosphates, ethane hydroxydiphosphonate, potassium nitrate, aluminum lactate, strontium chloride, hydroxyethylcellulose dimethyldiallylammonium chloride, sodium chloride, water-soluble copper compounds (e.g., copper chlorophyll, copper gluconate), zeolites and other tartar preventatives, amino acids (e.g., alanine, glycine, proline), plant extracts (e.g., thyme, scutellaria baicalensis extract, clove extract, witch hazel extract), caropeptides, polyvinylpyrrolidone, yeast products, other known functional ingredients, and combinations of two or more of these.

[0030] Examples of preservatives include benzoic acid, its sodium salt, and parabens.

[0031] Examples of coloring agents include Red No. 3, Red No. 104, Yellow No. 4, Blue No. 1, Green No. 3, titanium mica, red iron oxide, and titanium dioxide.

[0032] Examples of pH adjusting agents include phosphoric acid or its salts (such as sodium phosphate and sodium dihydrogen phosphate), citric acid or its salts (such as sodium citrate), malic acid or its salts, gluconic acid or its salts, maleic acid or its salts, succinic acid or its salts, glutamic acid or its salts, lactic acid, hydrochloric acid, acetic acid, nitric acid, sodium hydroxide, potassium hydroxide, sodium acetate, and sodium carbonate.

[0033] -moisture- The film may contain moisture. The moisture content is preferably 10% by mass or less. This ensures the film is sufficiently dry, stabilizing components (A) and (B) and suppressing adverse effects on physical properties. The lower limit of the moisture content is not particularly limited, but for example, it is 0% by mass or more, preferably 0.01% by mass or more.

[0034] [2. Shape and size of intraoral adhesive film] The film of the present invention has at least one surface (viewed from the thickness direction) on which a portion (preferably the entire surface) can be attached to the palate, and preferably both surfaces can be attached.

[0035] [2.1 Shape] There are no particular restrictions on the shape of the film surface (shape as viewed from the thickness direction), but examples include polygons such as squares, circles, and ellipses. Among these, polygons and ellipses are preferred, and squares and ellipses are more preferred. With a square or ellipse shape, while the film is attached, not only the anterior but also the posterior part of the tongue will naturally feel raised, allowing for more efficient tongue training and improvement of tongue position. The square can be either a square or a rectangle, but a rectangle is preferred. With a rectangle, the posterior part of the tongue will be raised more naturally, and it will also be easier to attach to the palate. In addition, various other design shapes (for example, stars, hearts, animals, plants, characters, etc.) can also be used.

[0036] [Size 2.2] The surface size of the film is 100mm. 2 The above is preferable, 120 mm2 The above is more preferable, 150 mm 2 or more, 200 mm 2 or more, 250 mm 2 or more, 300 mm 2 or more is even more preferable. It can be appropriately set according to the size of the palate of the subject, such as for children or adults. The upper limit is 600 mm 2 or less is preferable, 500 mm 2 or less is more preferable, 400 mm 2 or less is more preferable, 300 mm 2 or less is even more preferable. Since the oral surface, especially the palate, has an uneven shape, ensuring easy attachment and improving the adhesiveness (for example, suppressing peeling during the process) becomes easier by being within the above upper limit range.

[0037] <得 When the film surface is rectangular or elliptical, the ratio of the long side to the short side or the major axis to the minor axis is preferably 1:5 to 3:4, more preferably 1:4 to 3:4, and even more preferably 2:3 to 3:4. For example, the long side × short side or the major axis and the minor axis are 20 mm × 30 mm, more preferably 20 mm × 15 mm.

[0038] The thickness of the film is preferably 100 μm or more, more preferably 120 μm or more, and even more preferably 150 μm or more. Thereby, sustained solubility can be maintained and the time until complete dissolution can be extended. Also, the upper limit is preferably 300 μm or less, more preferably 250 μm or less, and even more preferably 200 μm or less. Thereby, while the time until complete dissolution is long, discomfort in the oral cavity, reduction in film flexibility, and peeling during the process can be suppressed, and adhesiveness and the feeling of fitting to the palate can be kept good. Therefore, it is 100 to 300 μm, preferably 120 to 250 μm, more preferably 150 to 200 μm. Thereby, a film capable of exhibiting balanced sustained solubility and adhesiveness can be obtained. The film may have a single-layer structure or a laminated structure of two or more films (multi-layer film). In the case of a laminate of two or more films, each film may be the same or may be made of different compositions and materials.

[0039] The packaging form of the film is not particularly limited. For example, each film may be individually packaged (e.g., in a pouch), or multiple films may be laminated and packaged with an anti-adhesion sheet sandwiched between them. Two or more individually packaged films or laminated films may be stored together in a packaging bag or container that can be opened and closed (e.g., with a zipper at the opening). The material of the packaging material is not particularly limited as long as it is moisture-resistant, for example, aluminum, and packaging materials composed of sheets containing an aluminum layer are preferably used. This allows physical properties such as adhesion and slow dissolution to be maintained until use. As the anti-adhesion sheet, a sheet material that does not adhere to the film and has good sliding properties is preferred, for example, release paper such as laminated paper, thin paper, or coated paper. A desiccant may be placed in the packaging bag or container along with two or more individually packaged films or laminated films.

[0040] [3. Physical properties of the film] The film of the present invention has a dissolution rate per unit thickness when applied to the oral cavity of, for example, 0.2 minutes / μm or more, preferably 0.3 minutes / μm or more, and can be applied for a long period of time while maintaining its thinness without compromising usability.

[0041] [4. Film manufacturing method] The method for manufacturing the film of the present invention is not particularly limited. For example, one method involves mixing film raw materials (each of the above-mentioned components) (mixing by stirring, heating, and melting as necessary), forming it into a film (for example, by thinly coating it on a substrate, drying, and then peeling it off), and adjusting the size as necessary (for example, by cutting or die-cutting).

[0042] [5. Uses of film] -How to use- The film of the present invention is used by being applied to the oral cavity. Upon application, the film dissolves and disappears within the oral cavity. The application site can be anywhere in the oral cavity, preferably the palate, particularly the area including the palate, and more preferably the area extending from near the incisive papilla of the palate toward the back (the area including the so-called spot). This facilitates its use for applications such as tongue training and tongue position improvement.

[0043] -Applications- The film of the present invention can be used for tongue training and / or tongue position improvement. Tongue training can strengthen the tongue muscles and / or improve tongue dexterity, and is expected to have effects such as improved pronunciation and articulation, improved swallowing ability, improved nutritional status, improved mouth breathing, increased saliva secretion (improved oral environment), brain activation, improved snoring, prevention of sleep apnea syndrome, and prevention of sarcopenia. Furthermore, by improving tongue position, it is expected to improve tongue habits (for example, bad tongue habits such as pushing the back of the teeth with the tongue or sticking the tongue out between the teeth). In more detail, for tongue position improvement applications (for tongue position learning and tongue position training), the tongue can be guided to the correct tongue position, and is expected to be particularly effective in improving tongue position in subjects with tongue position abnormalities such as tongue thrusting and low tongue position. Since tongue position abnormalities have been suggested to be related to malocclusion and speech abnormalities, it is expected that these symptoms will be alleviated, and further, it is expected that saliva secretion will be promoted, sagging and wrinkles of the face and neck will be prevented, and teeth grinding will be reduced. For tongue training and / or tongue position improvement purposes, by applying the film to the ideal tongue position (incisive papilla, spot) and licking it, it is possible to naturally acquire tongue dexterity and / or the correct tongue position in a non-invasive, delicious, and enjoyable way, and it is expected that these will become habitual.

[0044] The film of the present invention may be used in any of the following applications: food (e.g., functional foods), quasi-drugs, cosmetics (makeups), and pharmaceuticals. In the case of pharmaceuticals, target users include patients with tongue position abnormalities (tongue thrusting habits), low tongue position, sleep apnea syndrome, and dementia. In the case of food and quasi-drugs, target users are not limited, and include, for example, those who expect to prevent or alleviate tongue position abnormalities, improve swallowing ability, improve mouth breathing, improve saliva secretion, activate the brain, and improve pronunciation and articulation. The film is preferably used once a day, but may be used two or more times (e.g., three times a day, morning, noon, and evening). Film use is preferably continued from the viewpoint of effect development, more preferably daily or every other day (e.g., every other day, every two days, or every three days), and even more preferably daily. When used once a day, it is preferable to use it for three days or more (more preferably five days or more, seven days or more, fourteen days or more, or twenty-eight days or more).

[0045] The applications of the film of the present invention are not limited to tongue training and tongue position improvement, but can also be used in other pharmaceuticals, quasi-drugs, cosmetics, and food products where adhesiveness and slow dissolution are desired. This enhances the retention of each component incorporated into the film within the oral cavity. The components incorporated into the film include the aforementioned active ingredients, fragrances, sweeteners, and other optional components, and one or more can be appropriately selected depending on the application. In particular, by selecting active ingredients, the functionality of each active ingredient can be efficiently exerted. For example, by selecting a caries prevention agent (e.g., fluoride), it can be used as a film for preventing tooth decay. Furthermore, by selecting a bactericidal or antibacterial agent (e.g., cetylpyridinium chloride, benzalkonium chloride, benzethonium chloride, isopropylmethylphenol, zinc gluconate, zinc citrate, triclosan, thymol, hinokitiol, lysozyme chloride, etc.), it can be used as a film for preventing bad breath. Furthermore, by selecting a tartar preventative (e.g., ethane hydroxydiphosphonate), a desensitizing agent (e.g., potassium nitrate, aluminum lactate, strontium chloride), or another tartar preventative (e.g., zeolite), the film can be used with each respective function. Additionally, by selecting a saliva secretion promoter (e.g., lemon, pickled plum, plum vinegar, rooibos, polyglutamic acid, sodium polyglutamate, potassium polyglutamate, ammonium polyglutamate, citric acid or its salt, malic acid or its salt, tartaric acid or its salt, succinic acid or its salt, plant extracts, etc.), the film can be used to promote saliva secretion. Finally, by selecting a cosmetic ingredient (e.g., collagen, ceramide, vitamin A, vitamin C, vitamin E, vitamin P, hyaluronic acid, caffeine, potassium, ginkgo biloba extract, isoflavones, peptides, astaxanthin, cysteine, placenta, lycopene, zinc, etc.), the film can be used for cosmetic purposes. [Examples]

[0046] The present invention will be described in detail below with reference to examples. Note that the following examples are not intended to limit the present invention.

[0047] Examples 1-8 and Comparative Examples 1-4 A film formulation (edible film) was manufactured using the materials and formulations shown in Tables 3 and 4, following the procedure described below. <Manufacturing method for film formulations>

[0048] [Examples 1-8] Glycerin and sorbitol were dissolved in hot water, then pullulan (or gelatin), carrageenan, and tamarind gum were added and stirred until dissolved. This mixture was designated A. Glycerin fatty acid ester was mixed with a flavoring and dissolved in hot water, then a sweetener was added and stirred until dissolved. This mixture was designated B. Next, mixture A and mixture B were mixed to prepare mixture C.

[0049] The resulting mixture C was stretched thinly onto a plastic support so that it would result in a film thickness X (Table 1) after drying, and dried at 60°C to 90°C. After drying, the film was cut to the sizes shown in Table 3, peeled off the support, and obtained a film formulation.

[0050] [Comparative Example 1] A film formulation was obtained by following the same procedure as in Example 1, except that agar was used instead of carrageenan.

[0051] [Comparative Example 2] Glycerin was dissolved in pre-stirred hot water, hydroxypropyl methylcellulose (HPMC) was added, and after dispersion in hot water, the mixture was cooled and dissolved to prepare a solution. Pectin dissolved in hot water was also mixed into the above solution to obtain solution A. Solution A was used in place of mixed solution A in the manufacturing method of Example 1, and the rest of the procedure was carried out in the same manner (the timing of fragrance addition was the same as in the example sample) to obtain a film formulation.

[0052] [Comparative Examples 3 and 4] A film formulation was obtained by following the same procedure as in Example 6, except that instead of using two types of carrageenan, 35% by weight of ι-carrageenan only (Comparative Example 3) or 35% by weight of κ-carrageenan only (Comparative Example 4) was used.

[0053] <Test Example 1> Physical Properties of Film Formulations The following tests were conducted using each of the prepared film formulations.

[0054] Three evaluators were instructed to apply a sample film to their upper jaw (area A in Figure 1) without wiping away saliva, lick the film with their tongues, and measure the time from application to complete dissolution, which was defined as the intraoral application time.

[0055] Furthermore, the adhesive strength immediately after application and during application (adhesion strength immediately after application, adhesion strength during application) was evaluated according to the following criteria (Table 3).

[0056] [Table 1]

[0057] [Footnote to Table 1] "Fitting well" means that the entire surface of the film adheres tightly to the mouthpiece and no longer falls off.

[0058] [Table 2]

[0059] [Footnote to Table 2] The evaluation of adhesive strength was considered complete once the adhesive was peeled off.

[0060] [Table 3]

[0061] [Table 4]

[0062] Comparative Example 1 failed to form a film, Comparative Example 4 could not be applied to the palate, and the film formulations of Comparative Examples 2 and 3 had short intraoral application times of 13 minutes and 17 minutes, respectively, and fast dissolution rates per unit thickness of 0.08 min / μm and 0.1 min / μm, respectively. In contrast, the film formulations of Examples 1 to 8 all had intraoral application times of 20 minutes or more, dissolution rates per unit thickness of 0.2 min / μm or more, and adhesive strength immediately after application and during application exceeded 2, showing a good balance of adhesion and slow dissolution. In particular, Examples 1 to 5 and 7 to 8, where (A) / (B) was 0.6 to 1.7, had high slow dissolution with dissolution rates per unit thickness of 0.3 min / μm or more. Furthermore, Examples 1, 4 and 6 to 8, where (A) / (B) was 1.3 to 2.5, showed particularly good adhesion. Furthermore, Examples 1, 4, 7, and 8, where (A) / (B) was between 1.3 and 1.7, showed particularly good gradual dissolution and adhesive strength. Furthermore, a film formulation with the same composition and method as in Example 8, and a film thickness X of 155 μm after drying, was prepared and evaluated, and similarly good solubility and adhesive strength were obtained.

[0063] <Test Example 2> Effect of improving tongue position The effect of the film formulation of Example 1 (using grape-flavored fragrance) on improving tongue position was verified. The subjects were two individuals who answered in a questionnaire regarding tongue position (Figure 1) that the position of the tip of the tongue was outside the vicinity of the palatal spot (C / D / E). They were instructed to apply the film formulation (same size as in Example 1) to the vicinity of the palatal spot (Figure 1: area A) once a day at a time of their choosing, and other usage methods were left to their discretion. The results of the questionnaires regarding tongue position, collected weekly, and the results of the questionnaire regarding the film formulation, collected after 4 weeks (at the end of the study), are shown in Tables 5 and 6 below, respectively. The film formulation was applied daily throughout the study period.

[0064] [Table 5]

[0065] [Table 6]

[0066] These results show that changes in tongue position during rest (not while the patch is applied, but in a relaxed state) were observed starting one week after the start of the trial, and after two weeks, the tip of the tongue shifted to near the palatal spot, confirming an improvement in low tongue position. Although no specific instructions were given to the subjects regarding usage (for example, "actively lick the film formulation," "consciously raise your tongue," etc.), both subjects reported feeling that their tongues naturally rose while the patch was applied, and they were also aware of changes in tongue position during rest (when the patch was not applied).

Claims

1. (A) Iotakarageenan, and (B) Kappa Carrageenan An intraoral adhesive film containing [a specific ingredient].

2. The intraoral adhesive film according to claim 1, wherein the total amount of (A) and (B) is 20 to 60% by mass of the film composition.

3. The intraoral adhesive film according to claim 1 or 2, wherein the mass ratio of (A) and (B) ((A) / (B)) is 0.1 or greater.

4. (C) One or more water-soluble polymers selected from tamarind gum, gum arabic, karaya gum, xanthan gum, gellan gum, tragacanth gum, guar gum, tara gum, locust bean gum, pullulan, gelatin, casein, pectin, agar, glucomannan, galactomannan, starch, carboxymethyl starch, dextrin, alginic acid or its salts, alginic acid esters, chitin, chitosan, carboxymethylcellulose or its salts, lambda carrageenan, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, and ethylcellulose. The intraoral adhesive film according to claim 1 or 2, further containing the above.

5. (D) One or more selected from sugar alcohols and polyhydric alcohols The intraoral adhesive film according to claim 1 or 2, further containing the above.

6. The intraoral adhesive film according to claim 5, wherein the sugar alcohol is one or more selected from sorbitol, xylitol, maltitol, erythritol, lactitol, and reduced starch syrup.

7. The intraoral adhesive film according to claim 5, wherein the polyhydric alcohol is one or more selected from glycerin, propylene glycol, butylene glycol, and polyethylene glycol.

8. An intraoral film for application to the palate, as described in claim 1 or 2.

9. An intraoral adhesive film according to claim 8, for use in tongue training.

10. An intraoral adhesive film according to claim 8, for improving tongue position.

11. An intraoral adhesive film according to claim 1 or 2, which is a food product, a quasi-drug, a cosmetic, or a pharmaceutical product.

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