Cleaning agent for intraoral device in tablet form

Abstract

To provide a cleaning agent for an intraoral device in a tablet form that can suppress sticking during tablet formation and prevent a decrease in hardness of the formed tablet, while containing at least one selected from the group consisting of isopropyl methylphenol and its structural isomers, and menthol.SOLUTION: An cleaning agent for an intraoral device in a tablet form comprises (A) at least one selected from the group consisting of isopropyl methylphenol and its structural isomers, (B) menthol, and (C) a carbonate having a median particle diameter of 150 to 400 μm.SELECTED DRAWING: None

Description

Technical Field

[0001] The present disclosure relates to an oral appliance cleaning agent for tablets that can easily remove plaque from oral appliances, suppress sticking during tableting molding, and suppress a decrease in the hardness of tablets when formed into tablets.

Background Art

[0002] Oral appliances such as dentures are prone to adhesion of bacteria, biofilms, and other deposits. If left unwashed, they can not only cause bad breath but also contribute to the induction of oral diseases such as periodontal disease. Therefore, as part of oral care, it is essential to clean and keep oral appliances clean. Bacteria and dirt attached to oral appliances cannot be sufficiently removed by brushing, so cleaning with a cleaning agent is important.

[0003] The cleaning of oral appliances with a cleaning agent is generally performed by immersing the oral appliance in cleaning water prepared by adding the cleaning agent to water. Conventionally, oral appliance cleaning agents have been formulated with surfactants and foaming agents (carbonic acid compounds and acids), which are designed to exhibit chemical cleaning power due to the surfactant action and physical cleaning power due to the foaming action when added to water, thereby enhancing the cleaning effect. However, biofilms and the like attached to oral appliances cannot be sufficiently removed by the action of surfactants or foaming agents, so even when cleaned with an oral appliance cleaning agent, a large amount remains on the oral appliance, contributing to plaque.

[0004] Conventionally, in order to remove biofilms attached to oral appliances, oral appliance cleaning agents containing bleaching agents have been used.

[0005] In addition, it is also known that by incorporating enzymes such as protease, cellulase, β-1,3-glucanase, lipase, and mutanase into a denture cleanser, it is possible to impart an effect of removing biofilm adhering to the denture (see, for example, Patent Documents 1 to 4). Further, Patent Document 5 describes that a liquid composition for denture cleaning containing (A) polyoxyethylene alkyl ether having an average addition mole number of ethylene oxide of 10 to 20 and an alkyl group having 12 to 20 carbon atoms, (B) protease, and (C) a cationic bactericide exhibits excellent removal power and bactericidal power against denture biofilm.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Summary of the Invention

Problems to be Solved by the Invention

[0007] However, even in the case of a cleaning agent for oral appliances containing a bleaching agent or an enzyme, the effect of removing biofilm is not sufficient, and it has not been possible to sufficiently remove the sliminess of oral appliances caused by biofilm or the like. Thus, in a cleaning agent for oral appliances containing a bleaching agent or an enzyme, there is a limit to the effect of removing the sliminess of oral appliances. Further, from the viewpoint of expanding the variety of cleaning agents for oral appliances, the development of new formulation technologies for easily removing the sliminess of oral appliances has been demanded.

[0008] The inventor studied new formulation technologies for removing the sliminess of intraoral appliances and found that, unexpectedly, by combining at least one selected from the group consisting of isopropylmethylphenol and its structural isomers with menthol in an intraoral appliance cleaner, the sliminess of the intraoral appliance can be easily removed.

[0009] However, when at least one selected from the group consisting of isopropylmethylphenol and its structural isomers is combined with menthol in an intraoral appliance cleaner, in the tableting of the intraoral appliance cleaner, the binding force between the components in the tablet decreases, and sticking (a phenomenon in which a part of the raw material adheres to the pestle or mortar and a part of the tablet peels off) is likely to occur, or when the intraoral appliance cleaner is formed into a tablet, sufficient hardness cannot be obtained, and the tablet is likely to chip or crack with a slight impact, facing a new problem.

[0010] An object of the present disclosure is to provide an intraoral appliance cleaner for tablets that contains at least one selected from the group consisting of isopropylmethylphenol and its structural isomers and menthol, can suppress the occurrence of sticking during tableting, and can suppress a decrease in the hardness of the tablet when formed into a tablet.

Means for Solving the Problems

[0011] The inventor conducted intensive studies to solve the above problems and found that, unexpectedly, by further adding a carbonate having a median diameter of 150 to 400 μm to an intraoral appliance cleaner containing at least one selected from the group consisting of isopropylmethylphenol and its structural isomers and menthol, the occurrence of sticking during tableting can be suppressed, and a decrease in the hardness of the tablet when formed into a tablet can be suppressed. The present disclosure was completed by further studies based on such findings.

[0012] That is, the present disclosure provides an invention in the following aspects. Item 1. An oral appliance cleaner for tablets, comprising at least one selected from the group consisting of (A) isopropylmethylphenol and its structural isomers, (B) menthol, and (C) a carbonate having a median diameter of 150 to 400 μm. Item 2. The oral appliance cleaner for tablets according to Item 1, wherein the structural isomer is thymol. Item 3. The oral appliance cleaner for tablets according to Item 1 or 2, wherein the oral appliance cleaner is a denture cleaner. Item 4. A method for producing a tablet-shaped oral appliance cleaner, comprising subjecting a raw material mixture containing at least one selected from the group consisting of (A) isopropylmethylphenol and its structural isomers, (B) menthol, and (C) a carbonate having a median diameter of 150 to 400 μm to a tableting step. Item 5. Use of a composition containing at least one selected from the group consisting of (A) isopropylmethylphenol and its structural isomers, (B) menthol, and (C) a carbonate having a median diameter of 150 to 400 μm for cleaning oral appliances. Item 6. Use of a composition containing at least one selected from the group consisting of (A) isopropylmethylphenol and its structural isomers, (B) menthol, and (C) a carbonate having a median diameter of 150 to 400 μm as an oral appliance cleaner for tablets. Item 7. An oral appliance cleaning method, comprising immersing an oral appliance in water into which a tablet-shaped oral appliance cleaner containing at least one selected from the group consisting of (A) isopropylmethylphenol and its structural isomers, (B) menthol, and (C) a carbonate having a median diameter of 150 to 400 μm is put.

Advantages of the Invention

[0013] The oral appliance cleaner for tablets of the present disclosure contains, in combination, at least one selected from the group consisting of isopropylmethylphenol and its structural isomers and menthol, and can easily peel off and remove the slime of the oral appliance. Further, by cleaning the oral appliance using the tablet-shaped oral appliance cleaner obtained by tableting and molding using the oral appliance cleaner for tablets of the present disclosure, when the cleaned oral appliance is reinstalled by hand and after reinstallation in the oral cavity, the discomfort caused by the slime of the oral appliance can be reduced. Further, since the oral appliance cleaner for tablets of the present disclosure can easily remove the slime of the oral appliance, there is an advantage that the variations of the oral appliance cleaner having the effect of removing the slime of the oral appliance can be expanded. Further, the oral appliance cleaner for tablets of the present disclosure contains at least one selected from the group consisting of isopropylmethylphenol and its structural isomers and menthol, and further contains a carbonate having a median diameter of 150 to 400 μm, so sticking can be suppressed during tableting and molding. Thereby, since the manufacturing loss in the tableting and molding process can be suppressed, high manufacturing efficiency can be realized in industrial manufacturing. Furthermore, since the oral appliance cleaner for tablets of the present disclosure contains at least one selected from the group consisting of isopropylmethylphenol and its structural isomers and menthol, and further contains a carbonate having a median diameter of 150 to 400 μm, a decrease in the hardness of the tablet can be suppressed when molded into a tablet. Thereby, it is possible to effectively prevent the tablet from chipping or cracking due to a slight impact during transportation of the tablet or the like.

Mode for Carrying Out the Invention

[0014] In this specification, the notation X~Y regarding a numerical range indicates that it is X or more and Y or less.

[0015] In this specification, the "oral appliance" means a dental wearing appliance that needs to be detached and attached in the oral cavity, such as a complete denture (complete denture), a partial denture (partial denture), an orthodontic appliance, a retainer, and a mouthpiece.

[0016] 1. Oral appliance cleaner for tablets The oral appliance cleaner for tablets of the present disclosure (hereinafter, also simply referred to as "oral appliance cleaner") comprises at least one selected from the group consisting of (A) isopropylmethylphenol and its structural isomers (hereinafter, may be referred to as component (A)), (B) menthol (hereinafter, may be referred to as component (B)), and (C) a carbonate having a median diameter of 150 to 400 μm (hereinafter, may be referred to as component (C)). Hereinafter, the oral appliance cleaner of the present disclosure will be described in detail.

[0017] [(A) Isopropylmethylphenol and its structural isomers] The oral appliance cleaner of the present disclosure contains, as component (A), at least one selected from the group consisting of isopropylmethylphenol and its structural isomers. In the oral appliance cleaner of the present disclosure, component (A) is a component for easily removing (making it easy to remove) the slime of the oral appliance when combined and formulated with component (B). Further, by containing component (A) in the oral appliance cleaner, an antibacterial and bactericidal effect can be imparted to the oral appliance cleaner. In the present specification, "isopropylmethylphenol" means "4-isopropyl-3-methylphenol". The structural isomers of isopropylmethylphenol are not particularly limited as long as they are pharmaceutically acceptable. Examples include thymol and carvacrol. From the viewpoint of easily and effectively removing the slime of the oral appliance, thymol is preferred.

[0018] In the oral appliance cleaner of the present disclosure, the content of component (A) may be appropriately set within the range in which the desired slime removal effect can be obtained. For example, it is 0.001 to 10% by weight. From the viewpoint of easily and effectively removing the slime of the oral appliance, it is preferably 0.01 to 5% by weight, more preferably 0.03 to 1% by weight, and still more preferably 0.05 to 0.5% by weight.

[0019] [(B) Menthol] The oral appliance cleaner of the present disclosure contains menthol as component (B). In the oral appliance cleaner of the present disclosure, component (B) is a component for easily removing (making it easier to remove) the sliminess of the oral appliance when combined with component (A). Further, by including menthol in the oral appliance cleaner, a refreshing feeling can be given to the wearer's oral cavity when the cleaned oral appliance is worn, and the cleaning effect can be felt.

[0020] As the menthol, any of the d-form, l-form, and dl-form may be used, but from the viewpoint of easily and effectively removing the sliminess of the oral appliance, l-menthol is preferably used. Further, menthol can also be used in the form of essential oil. The essential oil containing menthol is not particularly limited, and examples thereof include spearmint oil, peppermint oil, perilla oil, and white perilla oil. The exemplified menthol and essential oils may be used alone or in combination of two or more.

[0021] In the oral appliance cleaner of the present disclosure, the content of component (B) (the content converted to the amount of menthol when using essential oil) may be appropriately set within a range where a desired sliminess removal effect can be obtained. For example, it is 0.001 to 10% by weight, and from the viewpoint of easily and effectively removing the sliminess of the oral appliance, preferably 0.01 to 5% by weight, more preferably 0.03 to 1% by weight, and even more preferably 0.05 to 0.5% by weight.

[0022] In the oral appliance cleaner of the present disclosure, the content ratio of component (B) to component (A) is not particularly limited. The content of component (B) is, for example, 10 to 1000 parts by weight per 100 parts by weight of component (A). From the viewpoint of easily and effectively removing the sliminess of the oral appliance, preferably 50 to 500 parts by weight, more preferably 70 to 300 parts by weight, and even more preferably 80 to 200 parts by weight.

[0023] [(C) Carbonate having a median diameter of 150 to 400 μm] The oral appliance cleaner of the present disclosure contains a carbonate having a median diameter of 150 to 400 μm as the component (C). The oral appliance cleaner containing the component (A) and the component (B) has drawbacks such as being prone to sticking during tableting or not obtaining sufficient hardness when formed into tablets. However, in the oral appliance cleaner of the present disclosure, by containing the component (C), the above-mentioned drawbacks are overcome, the occurrence of sticking during tableting can be suppressed, and the decrease in the hardness of the tablets can be suppressed when formed into tablets. Further, when the oral appliance cleaner of the present disclosure contains an acid described later, the component (C) serves as a component of a foaming agent and plays a role of reacting with the acid during the cleaning of the oral appliance to generate carbon dioxide gas.

[0024] The carbonate is not particularly limited, and examples thereof include alkali metal salts of carbonic acid such as sodium carbonate and potassium carbonate, alkaline earth metal salts of carbonic acid such as magnesium carbonate and calcium carbonate, and ammonium carbonate. Preferably, it is an alkali metal salt of carbonic acid, and more preferably sodium carbonate. The exemplified carbonates may be used alone or in combination of two or more.

[0025] The carbonate has a median diameter of 150 to 400 μm, and from the viewpoint of more effectively suppressing the occurrence of sticking during tableting and more effectively suppressing the decrease in the hardness of the tablets when formed into tablets, it is preferably 155 to 385 μm, more preferably 155 to 370 μm. In the present disclosure, the median diameter means the particle diameter (D50) at which the cumulative degree is 50% in the volume cumulative standard particle size distribution measured using a particle size distribution measuring device.

[0026] The D10 of the carbonate is not particularly limited, but from the viewpoint of more effectively suppressing the occurrence of sticking during tableting and more effectively suppressing the decrease in the hardness of the tablets when formed into tablets, it is preferably 45 to 120 μm, more preferably 50 to 115 μm. In the present disclosure, D10 means the particle diameter at which the cumulative degree is 10% in the volume cumulative standard particle size distribution measured using a particle size distribution measuring device.

[0027] The D25 of the carbonate is not particularly limited, but from the viewpoint of more effectively suppressing the occurrence of sticking during tableting and from the viewpoint of more effectively suppressing the decrease in tablet hardness when formed into tablets, it is preferably 85 to 230 μm, more preferably 90 to 225 μm. In the present disclosure, D25 means the particle diameter at which the cumulative degree is 25% in the volume cumulative standard particle size distribution measured using a particle size distribution measuring device.

[0028] The D75 of the carbonate is not particularly limited, but from the viewpoint of more effectively suppressing the occurrence of sticking during tableting and from the viewpoint of more effectively suppressing the decrease in tablet hardness when formed into tablets, it is preferably 275 to 530 μm, more preferably 280 to 525 μm. In the present disclosure, D75 means the particle diameter at which the cumulative degree is 75% in the volume cumulative standard particle size distribution measured using a particle size distribution measuring device.

[0029] The D90 of the carbonate is not particularly limited, but from the viewpoint of more effectively suppressing the occurrence of sticking during tableting and from the viewpoint of more effectively suppressing the decrease in tablet hardness when formed into tablets, it is preferably 490 to 670 μm, more preferably 495 to 665 μm. In the present disclosure, D90 means the particle diameter at which the cumulative degree is 90% in the volume cumulative standard particle size distribution measured using a particle size distribution measuring device.

[0030] The mode diameter of the carbonate is not particularly limited, but from the viewpoint of more effectively suppressing the occurrence of sticking during tableting and from the viewpoint of more effectively suppressing the decrease in tablet hardness when formed into tablets, it is preferably 120 to 500 μm, more preferably 130 to 490 μm. In the present disclosure, the mode diameter means the particle diameter at the peak in the volume cumulative standard particle size distribution measured using a particle size distribution measuring device.

[0031] The particle diameter of the carbonate can be adjusted by known methods, for example, classification treatment using a sieve or the like, and a method of mixing carbonates having different particle size distributions.

[0032] In the oral appliance cleaner of the present disclosure, the content of component (C) may be appropriately set within a range that can suppress the occurrence of sticking during tableting and can suppress the decrease in the hardness of the tablets when formed into tablets. For example, it is 1 to 50% by weight. From the viewpoint of more effectively suppressing the occurrence of sticking during tableting and more effectively suppressing the decrease in the hardness of the tablets when formed into tablets, it is preferably 5 to 40% by weight, more preferably 10 to 30% by weight, and even more preferably 15 to 25% by weight.

[0033] In the oral appliance cleaner of the present disclosure, the content ratio of component (C) to component (A) is not particularly limited. The content of component (C) per 1 part by weight of component (A) is, for example, 1 to 1000 parts by weight. From the viewpoint of more effectively suppressing the occurrence of sticking during tableting and more effectively suppressing the decrease in the hardness of the tablets when formed into tablets, it is preferably 10 to 800 parts by weight, more preferably 50 to 600 parts by weight, and even more preferably 100 to 500 parts by weight.

[0034] In the oral appliance cleaner of the present disclosure, the content ratio of component (C) to component (B) is not particularly limited. The content of component (C) per 1 part by weight of component (B) is, for example, 1 to 1000 parts by weight. From the viewpoint of more effectively suppressing the occurrence of sticking during tableting and more effectively suppressing the decrease in the hardness of the tablets when formed into tablets, it is preferably 10 to 800 parts by weight, more preferably 50 to 600 parts by weight, and even more preferably 100 to 500 parts by weight.

[0035] [Other components] The oral appliance cleaner of the present disclosure may contain other components as necessary, as long as it does not interfere with the effects of the present disclosure.

[0036] (Foaming agent) The oral appliance cleaner of the present disclosure preferably contains a foaming agent. When the oral appliance cleaner of the present disclosure contains a foaming agent, carbon dioxide bubbles can be generated in the cleaning water, and the stickiness of the oral appliance can be more easily and effectively removed by exerting the physical cleaning power due to the foaming action.

[0037] Regarding the type of the foaming agent, there is no particular limitation as long as it is non-toxic and physiologically acceptable, and those commonly used in oral appliance cleaners (i.e., those capable of generating carbon dioxide in water) can be widely used.

[0038] Examples of the foaming agent include, for example, a combination of a carbonic acid compound and an acid. The carbonic acid compound other than the carbonate is not particularly limited, and examples thereof include bicarbonates and double salts of bicarbonates and the carbonate. The carbonic acid compound may be used alone or in combination of two or more. The bicarbonate is not particularly limited, and examples thereof include alkali metal bicarbonates such as sodium bicarbonate and potassium bicarbonate, alkaline earth metal bicarbonates such as magnesium bicarbonate and calcium bicarbonate, and ammonium bicarbonate. Examples of the double salt of the bicarbonate and the carbonate include, but are not particularly limited to, sodium sesquicarbonate. The carbonic acid compound is preferably a bicarbonate. Also, the acid is not particularly limited, and examples thereof include organic acids such as citric acid, tartaric acid, fumaric acid, malic acid, maleic acid, gluconic acid, succinic acid, and salicylic acid; inorganic acids such as phosphoric acid and sulfamic acid. The acid may be used alone or in combination of two or more.

[0039] Regarding the ratio of the carbonic acid compound to the acid in the foaming agent, there is no particular limitation as long as the two can react in water to generate carbon dioxide. However, based on 100 parts by weight of the carbonic acid compound, the content of the acid is, for example, 10 to 200 parts by weight, preferably 15 to 150 parts by weight, and more preferably 20 to 100 parts by weight.

[0040] When the oral appliance cleaner of the present disclosure contains a foaming agent, the content of the foaming agent (total amount of carbonic acid compound (including the carbonate) and acid) is not particularly limited as long as sufficient carbon dioxide bubbles can be generated during the cleaning of the oral appliance. For example, it may be 10 to 75% by weight, preferably 20 to 70% by weight, more preferably 30 to 65% by weight.

[0041] (Bleaching agent) The oral appliance cleaner of the present disclosure preferably contains a bleaching agent. By including a bleaching agent, the cleaning power can be improved, and the slime on the oral appliance can be removed more effectively.

[0042] Regarding the type of bleaching agent used in the oral appliance cleaner of the present disclosure, there is no particular limitation as long as it is non-toxic and physiologically acceptable, and those commonly used in oral appliance cleaners can be widely used.

[0043] Examples of the bleaching agent include oxygen-based bleaching agents such as monopersulfate hydrogen salt, perborate, percarbonate, and persulfate.

[0044] Examples of the monopersulfate include alkali metal salts of monopersulfuric acid such as sodium monopersulfate and potassium monopersulfate (e.g., bis(peroxymonosulfuric acid)·bis(sulfuric acid)·pentapotassium), ammonium monopersulfate, and hydrates thereof. Examples of the perborate include alkali metal salts of perboric acid such as sodium perborate and potassium perborate, ammonium perborate, and hydrates thereof. Examples of the percarbonate include alkali metal salts of percarbonic acid such as sodium percarbonate and potassium percarbonate, ammonium percarbonate, and hydrates thereof. Examples of the persulfate include alkali metal salts of persulfuric acid such as sodium persulfate and potassium persulfate, ammonium persulfate, and hydrates thereof. The exemplified bleaching agents may be used alone or in combination of two or more. Among the exemplified bleaching agents, monopersulfate, perborate, and percarbonate are preferred, alkali metal salts of monopersulfuric acid, alkali metal salts of perboric acid, and alkali metal salts of percarbonic acid are more preferred, and potassium monopersulfate, sodium perborate, and sodium percarbonate are even more preferred.

[0045] In the oral appliance cleaner of the present disclosure, the content of the bleaching agent may be appropriately set within a range that can exhibit a desired bleaching effect. For example, it may be 1 to 40% by weight, preferably 5 to 35% by weight, more preferably 5 to 30% by weight.

[0046] (Bleaching activator) When the oral appliance cleaner of the present disclosure contains an oxygen-based bleaching agent, it may contain a bleaching activator. The bleaching activator is a component that reacts with HO2 - generated from the oxygen-based bleaching agent in water to generate a more highly bleaching organic peracid.

[0047] As the bleaching activator, known ones can be used without particular limitation. For example, tetraacetylethylenediamine; alkanoyloxybenzenesulfonic acid having an alkanoyl group with 1 to 18 carbon atoms, preferably 8 to 12 carbon atoms, or a salt thereof; alkanoyloxybenzoic acid having an alkanoyl group with 1 to 18 carbon atoms, preferably 8 to 12 carbon atoms, or a salt thereof, etc. can be mentioned. Examples of the salt include alkali metal salts, ammonium salts, etc. The exemplified bleaching activators may be used alone or in combination of two or more. Among the exemplified bleaching activators, tetraacetylethylenediamine is preferable from the viewpoint of excellent efficiency in generating organic peracids.

[0048] In the oral appliance cleaner of the present disclosure, the content of the bleaching activator may be appropriately adjusted according to the content of the oxygen-based bleaching agent. For example, 0.01 to 5% by weight, preferably 0.1 to 3% by weight, more preferably 0.5 to 2% by weight can be mentioned.

[0049] (Surfactant) The oral appliance cleaner of the present disclosure may contain a surfactant. The surfactant serves as a component that exhibits a chemical cleaning action.

[0050] The type of the surfactant incorporated in the oral appliance cleaner of the present disclosure is not particularly limited as long as it can be used as a component of the cleaner, and any of an anionic surfactant, a cationic surfactant, a nonionic surfactant, and an amphoteric surfactant may be used. Among these surfactants, preferably an anionic surfactant can be mentioned.

[0051] Examples of anionic surfactants include α-olefin sulfonates, alkyl sulfates, alkylbenzene sulfonates, alkylsulfonacetates, alkane sulfonates, and the like. Examples of the salt form of the anionic surfactant include alkali metal salts such as sodium and potassium, alkaline earth metal salts such as magnesium and calcium, ammonium salts, amine salts, and acid addition salts such as hydrochloride salts. Among the anionic surfactants, α-olefin sulfonates and alkyl sulfates are preferred, and sodium α-olefin sulfonate and sodium lauryl sulfate are more preferred.

[0052] In the oral appliance cleaner of the present disclosure, one surfactant may be blended alone, or two or more surfactants may be blended in combination.

[0053] In the oral appliance cleaner of the present disclosure, the content of the surfactant is not particularly limited as long as it can exhibit a foaming action during the cleaning of the oral appliance, and may be appropriately set according to the type of the surfactant used, the cleaning power to be provided, and the like. For example, the total amount of the surfactant is 0.1 to 10% by weight, preferably 0.5 to 7% by weight, and more preferably 1 to 5% by weight.

[0054] (Sugar alcohol) The oral appliance cleaner of the present disclosure may contain a sugar alcohol. The sugar alcohol is a component that serves as a binder.

[0055] The type of the sugar alcohol is not particularly limited. For example, sorbitol, mannitol, xylitol, erythritol, and the like can be mentioned. The exemplified sugar alcohols may be used alone or in combination of two or more. Among the exemplified sugar alcohols, sorbitol is preferred.

[0056] In the oral appliance cleaner of the present disclosure, the content of sugar alcohol is, for example, 1 to 30% by weight, preferably 3 to 20% by weight, more preferably 4 to 15% by weight, in terms of the total amount of sugar alcohol.

[0057] (Polyalkylene glycol) The oral appliance cleaner of the present disclosure may contain a polyalkylene glycol. The polyalkylene glycol is a component that serves as a binder.

[0058] Specific examples of the polyalkylene glycol include polyethylene glycol, polypropylene glycol, polybutylene glycol, and the like.

[0059] The polyalkylene glycol may be used alone or in combination of two or more. Among the exemplified polyalkylene glycols, polyethylene glycol is preferably used.

[0060] In the oral appliance cleaner of the present disclosure, the content of the polyalkylene glycol is, for example, 0.1 to 5% by weight, preferably 0.5 to 2% by weight, more preferably 0.5 to 1.5% by weight.

[0061] (Lubricant) The oral appliance cleaner of the present disclosure may contain a lubricant in order to facilitate the process of forming into tablets.

[0062] The type of the lubricant is not particularly limited. For example, magnesium stearate, calcium stearate, sodium stearyl fumarate, sucrose fatty acid ester, sodium lauryl sulfate, talc, light anhydrous silicic acid, hydrous silicon dioxide, and the like can be mentioned.

[0063] The lubricant may be used alone or in combination of two or more. Among the exemplified lubricants, magnesium stearate is preferably used.

[0064] In the oral appliance cleaner of the present disclosure, the content of the lubricant is, for example, 0.01 to 1% by weight, preferably 0.015 to 0.5% by weight, more preferably 0.02 to 0.3% by weight.

[0065] In addition, other additives that can be incorporated into the oral appliance cleaner of the present disclosure include, for example, a base material (such as sodium sulfate), a fragrance (other than menthol), a fragrance impregnating agent, an enzyme (such as protease), a pigment, magnesium oxide, a deodorant, an anti-tartar agent, an anti-rust agent, a chelating agent, a pH adjuster, a sweetener, a cooling agent (other than menthol), a foam stabilizer, a preservative, an antibacterial agent (other than isopropylmethylphenol and its structural isomers), a bactericidal agent (other than isopropylmethylphenol and its structural isomers), a preservative, a bulking agent, an excipient, a disintegrant, and a fluidizing agent, etc. The other components exemplified above may be blended singly or in any combination of two or more.

[0066] 2. Formulation form and manufacturing method of oral appliance cleaner The tablet-shaped oral appliance cleaner of the present disclosure is obtained by tableting and molding using the oral appliance cleaner for tablets of the present disclosure. The formulation into tablets can be carried out by a generally adopted tableting and molding method. For example, a raw material mixture obtained by mixing components (A) to (C) and other additives blended as necessary may be subjected to a tableting process. Since the oral appliance cleaner for tablets of the present disclosure contains component (C) together with components (A) and (B), sticking can be suppressed during tableting and molding, and manufacturing loss in the tableting and molding process can be suppressed, so high manufacturing efficiency can be realized in industrial production. In addition, since the oral appliance cleaner for tablets of the present disclosure contains component (C) together with components (A) and (B), a decrease in the hardness of the tablets can be suppressed when formed into tablets. Thereby, it is possible to effectively prevent the tablets from chipping or cracking due to slight impact during transportation of the tablets, etc. Also, prior to the tableting process, the mixture may be granulated into granules as necessary.

[0067] In addition, in the tablet-shaped oral appliance cleaner of the present disclosure, the weight per tablet is not particularly limited and may be appropriately set in consideration of ease of use. However, it is desirable to set the weight per tablet to the amount required for cleaning an oral appliance once. Specifically, the weight per tablet of the tablet-shaped oral appliance cleaner of the present disclosure is 1 to 4 g, preferably 2 to 3 g.

[0068] 3. Use of the oral appliance cleaner The tablet-shaped oral appliance cleaner of the present disclosure is used as a cleaner for various oral appliances, and is particularly preferably used as a denture cleaner.

[0069] 4. Method of using the oral appliance cleaner The tablet-shaped oral appliance cleaner of the present disclosure is put into water, heated if necessary, and an oral appliance to be cleaned (preferably a denture) is placed in the water, and the tablet-shaped oral appliance cleaner of the present disclosure is dissolved to clean the oral appliance. In addition, since the tablet-shaped oral appliance cleaner of the present disclosure contains component (A) and component (B), it is possible to easily remove the sliminess of the oral appliance by immersing the oral appliance in the cleaning solution. Thereby, when the oral appliance after cleaning is reinstalled by hand and after reinstallation, the discomfort caused by the sliminess of the oral appliance can be reduced.

[0070] The water used when cleaning an oral appliance using the tablet-shaped oral appliance cleaner of the present disclosure is not particularly limited, and examples thereof include tap water, purified water, distilled water, and physiological saline.

[0071] When cleaning an oral appliance using the tablet-shaped oral appliance cleaner of the present disclosure, the tablet-shaped oral appliance cleaner of the present disclosure may be added after immersing the oral appliance in water, or the oral appliance may be immersed after adding the tablet-shaped oral appliance cleaner of the present disclosure to water.

[0072] In addition, in the cleaning of the intraoral appliance, the ratio of the tablet-shaped intraoral appliance cleaner of the present disclosure to water is appropriately set according to the composition of the tablet-shaped intraoral appliance cleaner of the present disclosure, the degree of stickiness of the intraoral appliance to be cleaned, etc. For example, with respect to 100 parts by weight of water, the tablet-shaped intraoral appliance cleaner is usually about 1 to 10 parts by weight, preferably about 1 to 5 parts by weight. More specifically, in the cleaning of the intraoral appliance once, 100 to 200 mL of water is prepared, and 1 to 20 g, preferably 1 to 10 g, more preferably 1 to 5 g of the tablet-shaped intraoral appliance cleaner of the present disclosure is added thereto.

[0073] The temperature during the cleaning of the intraoral appliance may be about room temperature. Also, the time for immersing the intraoral appliance in the intraoral appliance cleaning solution is usually 5 minutes to 24 hours, preferably 10 minutes to 12 hours, more preferably 30 minutes to 8 hours.

[0074] In addition, during the cleaning of the intraoral appliance, it is not necessary to stir the water added with the intraoral appliance cleaner, etc., but it may be stirred as needed in order to more effectively remove the stickiness of the intraoral appliance. Also, in order to more effectively remove the stickiness of the intraoral appliance, the intraoral appliance may be scrubbed with a cleaning tool such as a brush.

Examples

[0075] Examples are shown below to more specifically explain the invention of the present disclosure, but the present disclosure is not limited thereto.

[0076] <Measurement of Median Diameter, D10, D25, D75, D90, and Mode Diameter of Carbonate> The particle sizes of the sodium carbonate and potassium carbonate used were measured using a particle size distribution measuring device (SALD-2100, a laser diffraction particle size distribution measuring device manufactured by Shimadzu Corporation), and the median diameter, D10, D25, D75, D90, and mode diameter were obtained from the resulting volume cumulative standard particle size distribution. The particle size of the sodium carbonate was adjusted by adjusting the mixing ratio of the following two types of sodium carbonate as necessary. Also, the particle size of the potassium carbonate was adjusted by adjusting the mixing ratio of the following two types of potassium carbonate as necessary. · Sodium carbonate with a median diameter of 430 μm, D10 of 240 μm, D25 of 315 μm, D75 of 570 μm, D90 of 700 μm, and mode diameter of 480 μm · Sodium carbonate with a median diameter of 110 μm, D10 of 40 μm, D25 of 70 μm, D75 of 160 μm, D90 of 210 μm, and mode diameter of 130 μm · Potassium carbonate with a median diameter of 430 μm, D10 of 240 μm, D25 of 315 μm, D75 of 570 μm, D90 of 700 μm, and mode diameter of 480 μm · Potassium carbonate with a median diameter of 110 μm, D10 of 40 μm, D25 of 70 μm, D75 of 160 μm, D90 of 210 μm, and mode diameter of 130 μm

[0077] Test Example 1 (Evaluation of sticking and tablet hardness) The compositions obtained by mixing the respective components shown in Tables 1 and 2 using a Lodige mixer (manufactured by Matsubo Corporation, model number: M20) were tableted and molded at a pressure of 5 t using a mold with a diameter of 20φ and a tableting device (manufactured by Kikusui Seisakusho Co., Ltd., rotary powder molding machine, model number: CLEC1518SS7JZ) to produce a tablet-shaped oral appliance cleaner weighing 2 g per tablet. A total of 3 sets of pestles were evenly installed on the turntable of the tableting device. After continuously tableting 100 tablets of the oral appliance cleaner, the pestles were observed, and the number of sets of pestles with sticking occurring on either the mortar or the pestle was counted. The results are shown in Tables 1 and 2. Further, each of the manufactured tablet-shaped oral appliance cleaners was set on a Schreiner hardness meter (manufactured by DR.SCHLEUNIGER PHARMATRON, tablet hardness meter 6D). The test speed of the breaking terminal was set to 0.5 mm / second, and the load when the load sensor (load cell) broke the tablet was recorded as the hardness (kgf). This operation was performed on 3 tablets, and the average value of the hardness (rounded to the second decimal place) was calculated. The results are shown in Tables 1 and 2. When the hardness of the tablet is less than 4.8 kgf, the frequency of chipping or cracking of the tablet due to impact during tablet transportation etc. becomes very high. Therefore, the hardness of the tablet is preferably 4.8 kgf or more, more preferably 5.0 kgf or more, and still more preferably 5.5 kgf or more.

[0078]

Table 1

[0079]

Table 2

[0080] As shown in Tables 1 and 2, in the oral appliance cleaner containing isopropylmethylphenol or thymol and l-menthol, when a carbonate having a median diameter of 155 or 370 μm was blended, the occurrence of sticking could be effectively suppressed and the decrease in the hardness of the tablet could be suppressed (Examples 1 to 10). On the other hand, in the oral appliance cleaner containing isopropylmethylphenol or thymol and l-menthol, when a carbonate having a median diameter of 110 or 140 μm was blended, the hardness of the tablet was sufficient, but the occurrence of sticking was observed (Comparative Examples 1 to 10). Also, when a carbonate having a median diameter of 430 μm was blended, the occurrence of sticking could be effectively suppressed, but the decrease in the hardness of the tablet could not be suppressed (Comparative Examples 11 to 16).

[0081] Test Example 2 (Numeri removal test) A composition obtained by mixing each component shown in Table 3 using a Redge mixer (manufactured by Matsubo Co., Ltd., model number: M20) was tabletted into a 2 g tablet-shaped oral appliance cleaner per tablet by pressing at 7 t using a mold with a diameter of 20φ and a tableting device (manufactured by Kikusui Seisakusho Co., Ltd., rotary powder molding machine, model number: CLEC1518SS7JZ).

[0082] For the tablet-shaped oral appliance cleaners produced in Experimental Examples 1 to 4 and Comparative Experimental Examples 1 to 9, a numeri removal test was conducted by the following method.

[0083] <Numeri Removal Test> (1) Preparation of a resin chip with attached biofilm 5 ml of TSB (Tryptic Soy Broth) medium was placed in a 15 mL tube, inoculated with Streptococcus mutans (NBRC13955), and cultured at 35°C for 1 to 2 days. Next, the obtained culture solution was suspended in the TSB medium to prepare a Streptococcus mutans suspension with an adjusted turbidity (OD) of 1.05 to 1.10 at 600 nm. Separately, Candida albicans (NBRC1595) was inoculated into a PDA medium (potato dextrose agar medium) and cultured at 35°C for 1 to 2 days. The cultured Candida albicans was collected, suspended in the TSB medium, and a Candida albicans suspension with an adjusted turbidity (OD) of 1.45 to 1.50 at 600 nm was prepared. The obtained Streptococcus mutans suspension and Candida albicans suspension were mixed at a volume ratio of 1:1 to prepare a bacterial suspension.

[0084] A resin chip (20 mm × 20 mm, single-sided abrasiveness with a thickness of 1.5 mm; made of polymethyl methacrylate resin) was immersed in 100 ml of a 200 ppm aqueous hypochlorous acid solution for 10 minutes and then thoroughly washed with water to be sterilized. The sterilized resin chips were placed one by one in each well of a 6-well plate, 4.95 ml of a TBS (Tris-Buffered Saline) solution containing 5 wt% sucrose was added to each well, and further 50 μl of the bacterial suspension was added, followed by culturing at 37°C for 24 hours to prepare a resin chip with attached biofilm.

[0085] After culturing, the culture solution in each well was removed, 6 ml of distilled water was added to each well, and after pipetting 10 times, the water in the well was removed. Washing was performed by repeating this operation 2 to 3 times until the turbidity of the distilled water added to each well disappeared, and a resin chip with biofilm attached was obtained.

[0086] (2) Washing of the resin chip 180 ml of purified water was put into a 300-ml cup and immersed in a constant temperature bath maintained at 40°C. Next, the resin chip with biofilm attached was immersed in each cup, and one tablet of each oral appliance cleaner prepared in Experimental Examples 1 to 4, Comparative Experimental Examples 1 to 9, and Reference Example 4 was put into each cup to prepare an oral appliance cleaning solution in each cup and allowed to stand. One hour after the addition of the oral appliance cleaner, each resin chip was taken out with tweezers and placed in each well of a 6-well plate filled with purified water. Then, the resin chip was slowly reciprocated 5 times in the well to remove the cleaner attached to the resin chip, and each washed resin chip was obtained.

[0087] (3) Evaluation of the removability of filminess of the washed resin chip Five evaluators washed their index fingers with ethanol. Then, the surface of the resin chip with biofilm attached before washing was gently rubbed with the index finger in a circular motion, and based on the following evaluation criteria, with "no filminess" being "1" and "not peeling off no matter how many times it is rubbed" being "9", the ease of peeling of the filminess was evaluated by a 9-level evaluation in 1-point increments. As a result, all the evaluations of the 5 people were 9. Next, the ease of peeling of the biofilm of the resin chip (reference sample) washed with the oral appliance cleaner prepared in Reference Example 4 was evaluated in the same manner as above, and the average value of the evaluations of the 5 people (average value of the reference sample) was determined. Thereafter, the ease of peeling of the biofilm of the resin chip (evaluation sample) washed with each oral appliance cleaner prepared in Experimental Examples 1 to 4 and Comparative Experimental Examples 1 to 9 was evaluated in the same manner as above, and the average value of the evaluations of the 5 people (average value of the evaluation sample) was determined. JPEG2025089779000003.jpg26153

[0088] Then, the score for improving the stain removability was obtained by the following formula. It can be said that the higher the value of the score for improving the stain removability, the easier it is to remove the stain. The results are shown in Table 3. Score for improving stain removability = Average value of the reference sample - Average value of the evaluation sample

[0089]

Table 3

[0090] From the results in Table 3, it was confirmed that the oral appliance cleaners prepared in Experimental Examples 1 to 4 containing both isopropylmethylphenol or thymol and l-menthol had higher values of the score for improving stain removability and could remove stains more easily than the oral appliance cleaners prepared in Comparative Experimental Examples 1 to 9 containing isopropylmethylphenol, thymol, or l-menthol alone.

[0091] Also, when the stain removability test was conducted using ethylene vinyl acetate chips or copolymerized polyester chips, which are mouthpiece and retainer materials, instead of the resin chips, which are denture materials, the same results as above were obtained. That is, it was confirmed that also in the case of mouthpiece and retainer materials, the oral appliance cleaners prepared in Experimental Examples 1 to 4 had higher values of the score for improving stain removability and could remove stains more easily than the oral appliance cleaners prepared in Comparative Experimental Examples 1 to 9.

[0092] Formulation Example Tablet-shaped oral appliance cleaners having the compositions shown in Tables 4 and 5 were produced in the same manner as in Test Example 1, and the sticking and the hardness of the tablets were evaluated. It was confirmed that any of the oral appliance cleaners for tablets could effectively suppress the occurrence of sticking and could effectively suppress the decrease in the hardness of the tablets.

[0093]

Table 4

[0094]

Table 5

Claims

1. An oral appliance cleaner for tablets, comprising: (A) at least one selected from the group consisting of isopropylmethylphenol and its structural isomers; (B) menthol; and (C) a carbonate having a median diameter of 150 to 400 μm.

2. The oral appliance cleaner for tablets according to claim 1, wherein the structural isomer is thymol.

3. The oral appliance cleaner for tablets according to claim 1 or 2, wherein the oral appliance cleaner is a denture cleaner.

4. A method for producing a tablet-shaped oral appliance cleaner, comprising subjecting a raw material mixture containing: (A) at least one selected from the group consisting of isopropylmethylphenol and its structural isomers; (B) menthol; and (C) a carbonate having a median diameter of 150 to 400 μm to a tableting step.

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