Intraoral device cleaning agent for effervescent tablets

A combination of isopropylmethylphenol or thymol, menthol, and a specific carbonate in effervescent tablets addresses the inefficacy of existing cleansers by enhancing slime removal and maintaining tablet integrity, reducing production issues and improving cleaning efficacy.

WO2025191864A1PCT designated stage Publication Date: 2025-09-18KOBAYASHI PHARMA CO LTD
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Patent Information

Application Number
PCT/JP2024/010347
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-03-15
Publication Date
2025-09-18

AI Technical Summary

Technical Problem

Existing oral instrument cleansers, including those with bleach or enzymes, are ineffective in removing slime from oral instruments and face issues such as sticking during tableting and decreased tablet hardness when formulated into tablets.

Method used

Incorporating a combination of isopropylmethylphenol or thymol, menthol, and a carbonate with a median diameter of 150 to 400 μm, along with bicarbonate and an acid, to create an effervescent tablet formulation that suppresses sticking and maintains tablet hardness.

Benefits of technology

The formulation effectively removes slime from oral instruments, reduces production losses due to sticking, and prevents tablet chipping or cracking, ensuring high production efficiency and effective cleaning.

✦ Generated by Eureka AI based on patent content.

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Abstract

The purpose of the present disclosure is to provide an intraoral device cleaning agent for effervescent tablets, said cleaning agent containing menthol and at least one chemical selected from the group consisting of isopropyl methylphenol and thymol, suppressing the occurrence of sticking during tableting, and suppressing a decrease in the hardness of tablets during a tablet molding process. An intraoral device cleaning agent for effervescent tablets according to the present disclosure is characterized by containing, (A) 0.01-0.1 wt%, in total, of at least one chemical selected from the group consisting of isopropyl methylphenol and thymol, (B) 0.01-0.1 wt% of menthol, (C) 5-30 wt% of a carbonate having a median diameter of 150-400 μm, and (D) 5-40 wt% of a hydrogen carbonate and 10-30 wt% of an acid as foaming agents.
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Description

Oral appliance cleaner for effervescent tablets

[0001] The present disclosure relates to an oral instrument cleaner for effervescent tablets that can easily remove slime from oral instruments, suppress the occurrence of sticking during tableting, and suppress a decrease in tablet hardness when formed into tablets.

[0002] Dentures and other oral appliances are prone to the accumulation of bacteria, biofilms, and other deposits, and if left uncleaned, this can not only cause bad breath but can also contribute to the development of oral diseases such as periodontal disease. Therefore, cleaning oral appliances and keeping them clean is essential as part of oral care. Because bacteria and dirt adhering to oral appliances cannot be sufficiently removed by brushing, cleaning with a detergent is important.

[0003] Cleaning of intraoral appliances with a detergent is generally performed by adding the detergent to water to prepare cleaning water, and then immersing the intraoral appliances in the water. Conventionally, intraoral appliance cleaners have been formulated with surfactants and foaming agents (carbonate compounds and acids), and are designed to enhance cleaning effectiveness by exerting chemical cleaning power through surface activation and physical cleaning power through foaming when added to water. However, biofilms and other substances adhering to intraoral appliances cannot be sufficiently removed by the action of surfactants and foaming agents, and therefore remain in large quantities on the intraoral appliances even after cleaning with an intraoral appliance cleaner, contributing to slime formation.

[0004] Conventionally, an intraoral appliance cleanser containing a bleaching agent has been used to remove biofilms adhering to intraoral appliances.

[0005] It is also known that the addition of enzymes such as protease, cellulase, β1,3-glucanase, lipase, and mutanase to a denture cleanser can impart an effect of removing biofilms attached to dentures (see, for example, Patent Documents 1 to 4). Patent Document 5 describes that a denture cleanser liquid composition containing (A) a polyoxyethylene alkyl ether having an average number of ethylene oxide added of 10 to 20 and an alkyl group having 12 to 20 carbon atoms, (B) a protease, and (C) a cationic disinfectant, exhibits excellent removal and disinfecting properties against denture biofilms.

[0006] Japanese Patent Laid-Open No. 63-101313 Japanese Patent Laid-Open No. 58-134014 Japanese Patent Laid-Open No. 57-142910 Japanese Patent Laid-Open No. 51-38415 Japanese Patent Laid-Open No. 2008-179615

[0007] However, even oral instrument cleansers containing bleach or enzymes are not effective in removing biofilms, and have not been able to fully remove slime from oral instruments caused by biofilms, etc. Thus, oral instrument cleansers containing bleach or enzymes have limitations in their effectiveness in removing slime from oral instruments. Furthermore, from the perspective of expanding the variety of oral instrument cleansers, there has been a demand for the development of new formulation technologies that can easily remove slime from oral instruments.

[0008] The present inventors have investigated new formulation technologies for removing slime from intraoral appliances and have unexpectedly found that slime from intraoral appliances can be easily removed by incorporating a combination of at least one member selected from the group consisting of isopropylmethylphenol and thymol in an intraoral appliance cleanser.

[0009] However, when the intraoral instrument cleanser is formulated with a combination of at least one selected from the group consisting of isopropylmethylphenol and thymol and menthol, new problems arise: the bonding strength between the components in the tablet is reduced during tableting of the intraoral instrument cleanser, making sticking (a phenomenon in which part of the raw materials adheres to the punch or die, causing part of the tablet to peel off) more likely to occur; and when the intraoral instrument cleanser is molded into a tablet, sufficient hardness is not obtained, making the tablet more likely to chip or crack with even a slight impact.

[0010] An object of the present disclosure is to provide an oral instrument cleanser for effervescent tablets that contains at least one selected from the group consisting of isopropylmethylphenol and thymol, and menthol, and yet can suppress the occurrence of sticking during tableting and can suppress a decrease in tablet hardness when formed into a tablet.

[0011] The present inventors have conducted extensive research to solve the above-mentioned problems and have unexpectedly found that by further blending a carbonate having a median diameter of 150 to 400 μm with an oral instrument cleanser containing at least one selected from the group consisting of isopropylmethylphenol and thymol and menthol, it is possible to suppress the occurrence of sticking during tableting and to suppress a decrease in tablet hardness when the tablets are formed. The present disclosure has been completed based on this finding and through further research.

[0012] That is, the present disclosure provides the following aspects of the invention. Item 1. An intraoral instrument cleanser for effervescent tablets, comprising (A) 0.01 to 0.1 wt % in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt % of menthol, (C) 5 to 30 wt % of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt % of a bicarbonate and 10 to 30 wt % of an acid as effervescent agents. Item 2. An intraoral instrument cleanser for effervescent tablets according to Item 1, wherein the intraoral instrument cleanser is a denture cleanser. Item 3. An intraoral instrument cleanser in tablet form, obtained from the intraoral instrument cleanser for effervescent tablets according to Item 1 or 2. Item 4. Item 4. A method for producing a tablet-shaped intraoral instrument cleanser, comprising subjecting a raw material mixture containing (A) 0.01 to 0.1 wt% in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt% of menthol, (C) 5 to 30 wt% of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt% of a bicarbonate as a foaming agent and 10 to 30 wt% of an acid to a tableting step. Item 5. Use of a composition containing (A) 0.01 to 0.1 wt% in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt% of menthol, (C) 5 to 30 wt% of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt% of a bicarbonate as a foaming agent and 10 to 30 wt% of an acid, for cleaning intraoral instruments. Use of a composition comprising (A) 0.01 to 0.1 wt% in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt% of menthol, (C) 5 to 30 wt% of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt% of a bicarbonate and 10 to 30 wt% of an acid as effervescent agents, as an intraoral instrument cleanser for effervescent tablets.Item 7. Use of a composition comprising (A) 0.01 to 0.1 wt % in total of at least one member selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt % of menthol, (C) 5 to 30 wt % of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt % of a bicarbonate as a foaming agent and 10 to 30 wt % of an acid, as a tablet-shaped intraoral instrument cleanser. Item 8. Item 9. A method for cleaning an intraoral instrument, comprising immersing an intraoral instrument in water containing a tablet-shaped intraoral instrument cleaner containing (A) 0.01 to 0.1 wt % in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt % of menthol, (C) 5 to 30 wt % of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt % of a bicarbonate as a foaming agent and 10 to 30 wt % of an acid. Item 10. Use of a composition comprising (A) 0.01 to 0.1 wt% in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt% of menthol, (C) 5 to 30 wt% of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt% of a bicarbonate as an effervescent agent and 10 to 30 wt% of an acid, for the production of an intraoral instrument cleanser for effervescent tablets. Item 11. Use of a composition comprising (A) 0.01 to 0.1 wt% in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt% of menthol, (C) 5 to 30 wt% of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt% of a bicarbonate as an effervescent agent and 10 to 30 wt% of an acid, for the production of an intraoral instrument cleanser in tablet form.

[0013] The oral instrument cleanser for effervescent tablets of the present disclosure contains at least one selected from the group consisting of isopropylmethylphenol and thymol in combination with menthol, thereby easily peeling and removing slime from oral instruments. Furthermore, cleaning oral instruments with the tablet-shaped oral instrument cleanser obtained by tableting with the oral instrument cleanser for effervescent tablets of the present disclosure can reduce discomfort caused by slime on the oral instruments when manually reinserting the cleaned oral instruments and after reinserting them into the oral cavity. Furthermore, the oral instrument cleanser for effervescent tablets of the present disclosure can easily remove slime from oral instruments, thereby advantageously expanding the variety of oral instrument cleansers that are effective in removing slime from oral instruments. Furthermore, the oral instrument cleanser for effervescent tablets of the present disclosure contains at least one selected from the group consisting of isopropylmethylphenol and thymol and menthol, and further contains a carbonate having a median diameter of 150 to 400 μm, thereby suppressing sticking during tableting. This reduces production losses in the tableting process, enabling high production efficiency in industrial production. Furthermore, the oral instrument cleanser for effervescent tablets of the present disclosure contains at least one selected from the group consisting of isopropylmethylphenol and thymol, and menthol, and also contains a carbonate having a median diameter of 150 to 400 μm, thereby preventing a decrease in tablet hardness when formed into tablets. This effectively prevents chipping or cracking of tablets due to slight impact during transportation, etc.

[0014] In this specification, the notation X to Y regarding a numerical range means that the range is from X to Y.

[0015] In this specification, the term "intraoral appliance" refers to a dental appliance that must be worn and removed in the oral cavity, such as a complete denture, a partial denture, an orthodontic appliance, a retainer, and a mouthpiece.

[0016] 1. Oral Instrument Cleanser for Effervescent Tablets The oral instrument cleanser for effervescent tablets of the present disclosure (hereinafter also referred to simply as "oral instrument cleanser") is characterized by comprising a total amount of 0.01 to 0.1 wt% of (A) at least one selected from the group consisting of isopropylmethylphenol and thymol (hereinafter sometimes referred to as component (A)), 0.01 to 0.1 wt% of (B) menthol (hereinafter sometimes referred to as component (B)), 5 to 30 wt% of (C) a carbonate having a median diameter of 150 to 400 μm (hereinafter sometimes referred to as component (C)), and 5 to 40 wt% of a bicarbonate and 10 to 30 wt% of an acid as (D) an effervescent agent (hereinafter sometimes referred to as component (D)). The oral instrument cleanser of the present disclosure is described in detail below.

[0017] [(A) Isopropylmethylphenol and its structural isomer] The intraoral instrument cleanser of the present disclosure contains, as component (A), at least one selected from the group consisting of isopropylmethylphenol and thymol. In the intraoral instrument cleanser of the present disclosure, component (A) is a component that, when combined with component (B), facilitates the removal of slime from intraoral instruments (making removal easier). Furthermore, by including component (A) in the intraoral instrument cleanser, it is possible to impart antibacterial and bactericidal effects to the intraoral instrument cleanser. As used herein, "isopropylmethylphenol" means "4-isopropyl-3-methylphenol".

[0018] In the cleanser for intraoral instruments of the present disclosure, the total content of component (A) is 0.01 to 0.1 wt %, preferably 0.05 to 0.1 wt %, from the viewpoint of easily removing slime from intraoral instruments.

[0019] [(B) Menthol] The intraoral instrument cleanser of the present disclosure contains menthol as component (B). In the intraoral instrument cleanser of the present disclosure, component (B) is a component that, when combined with component (A), facilitates (makes removal easier) the removal of slime from intraoral instruments. Furthermore, by including menthol in the intraoral instrument cleanser, a refreshing feeling can be imparted to the wearer's mouth when wearing the cleaned intraoral instrument, allowing the wearer to experience the cleaning effect.

[0020] As menthol, any of the d-, l-, and dl-isomers may be used, but l-menthol is preferred from the viewpoint of easily and effectively removing slime from intraoral appliances. Menthol can also be used in the form of essential oil. Essential oils containing menthol are not particularly limited, but examples include spearmint oil, peppermint oil, peppermint oil, and peppermint white oil. The above-exemplified menthols and essential oils may be used alone or in combination of two or more.

[0021] In the cleanser for intraoral instruments of the present disclosure, the content of component (B) (when an essential oil is used, the content converted into the amount of menthol) is 0.01 to 0.1% by weight, and preferably 0.05 to 0.1% by weight, from the viewpoint of easily removing slime from intraoral instruments.

[0022] In the cleanser for intraoral instruments of the present disclosure, the content ratio of component (B) to component (A) is not particularly limited, and the content of component (B) per 100 parts by weight of component (A) is, for example, 10 to 1000 parts by weight. From the viewpoint of easily and effectively removing slime from intraoral instruments, the content is 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 with a Median Diameter of 150 to 400 μm] The intraoral instrument cleanser of the present disclosure contains, as component (C), a carbonate with a median diameter of 150 to 400 μm. Oral instrument cleansers containing components (A) and (B) have drawbacks such as a tendency for sticking to occur during tableting and an insufficient hardness when formed into tablets. However, the intraoral instrument cleanser of the present disclosure overcomes these drawbacks by including component (C), thereby suppressing the occurrence of sticking during tableting and preventing a decrease in tablet hardness when formed into tablets. Furthermore, when the intraoral instrument cleanser of the present disclosure contains an acid, as described below, component (C) serves as a constituent of the effervescent agent, reacting with the acid to generate carbon dioxide gas during cleaning of intraoral instruments.

[0024] The carbonate is not particularly limited, and examples thereof include alkali metal carbonates such as sodium carbonate and potassium carbonate, alkaline earth metal carbonates such as magnesium carbonate and calcium carbonate, and ammonium carbonate, among which alkali metal carbonates are preferred, and sodium carbonate is more preferred. The carbonates exemplified above 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 a decrease in tablet hardness 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 a volume-accumulated particle size distribution measured using a particle size distribution measuring device.

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

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

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

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

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

[0031] The particle size of the carbonate can be adjusted by known methods, such as classification using a sieve or mixing carbonates with different particle size distributions.

[0032] In the cleanser for oral instruments of the present disclosure, the content of component (C) is 5 to 30% by weight, preferably 10 to 30% by weight, from the viewpoint of effectively suppressing the occurrence of sticking during tableting and from the viewpoint of effectively suppressing a decrease in tablet hardness when formed into tablets.

[0033] In the cleanser for intraoral instruments of the present disclosure, the content ratio of component (C) to component (A) is not particularly limited, and the content of component (C) per 1 part by weight of component (A) is, for example, 50 to 1000 parts by weight. From the viewpoint of more effectively suppressing the occurrence of sticking during tableting and more effectively suppressing a decrease in tablet hardness when formed into tablets, the content is preferably 100 to 800 parts by weight, more preferably 200 to 600 parts by weight, and even more preferably 200 to 400 parts by weight.

[0034] In the cleanser for intraoral instruments of the present disclosure, the content ratio of component (C) to component (B) is not particularly limited, and the content of component (C) per 1 part by weight of component (B) is, for example, 50 to 1000 parts by weight. From the viewpoint of more effectively suppressing the occurrence of sticking during tableting and more effectively suppressing a decrease in tablet hardness when formed into tablets, the content is preferably 100 to 800 parts by weight, more preferably 200 to 600 parts by weight, and even more preferably 200 to 400 parts by weight.

[0035] [Foaming Agent] The intraoral instrument cleanser of the present disclosure contains a foaming agent, which is a combination of bicarbonate and acid, as component (D). By containing the foaming agent, the intraoral instrument cleanser of the present disclosure can generate carbon dioxide bubbles in the rinse water, and the foaming action exerts physical cleansing power, making it possible to more easily and effectively remove slime from intraoral instruments.

[0036] The bicarbonate salt is not particularly limited, and examples thereof include alkali metal bicarbonate salts such as sodium bicarbonate and potassium bicarbonate, alkaline earth metal bicarbonate salts such as magnesium bicarbonate and calcium bicarbonate, and ammonium bicarbonate. The bicarbonate salts may be used alone or in combination of two or more. 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; and inorganic acids such as phosphoric acid and sulfamic acid. The acid may be used alone or in combination of two or more.

[0037] The hydrogen carbonate constituting the effervescent agent is preferably an alkali metal hydrogen carbonate, more preferably sodium hydrogen carbonate, and the acid constituting the effervescent agent is preferably an organic acid, more preferably citric acid or malic acid.

[0038] In the oral instrument cleanser of the present disclosure, the content of bicarbonate is 5 to 40% by weight, preferably 5 to 30% by weight.

[0039] In the oral instrument cleanser of the present disclosure, the acid content is 10 to 30 wt %, and preferably 15 to 30 wt %.

[0040] In the foaming agent, the ratio of the hydrogen carbonate to the acid is not particularly limited as long as the two can react in water to generate carbon dioxide. The content of the acid per 100 parts by weight of the hydrogen carbonate is, for example, 25 to 600 parts by weight, preferably 30 to 400 parts by weight, and more preferably 35 to 200 parts by weight.

[0041] [Other Components] In addition to the components described above, the intraoral instrument cleanser of the present disclosure may contain other components as needed, to the extent that the effects of the present disclosure are not impaired.

[0042] (Bleaching Agent) The intraoral instrument cleanser of the present disclosure preferably contains a bleaching agent. By including a bleaching agent, cleaning power can be improved and slime on the intraoral instruments can be removed more effectively.

[0043] The type of bleaching agent used in the intraoral instrument cleanser of the present disclosure is not particularly limited as long as it is non-toxic and physiologically acceptable, and a wide range of bleaching agents commonly used in intraoral instrument cleansers can be used.

[0044] Bleaching agents include, for example, oxygen bleaching agents such as monopersulfates, perborates, percarbonates, and persulfates.

[0045] Specific examples of monopersulfates include alkali metal salts of monopersulfate such as sodium monopersulfate and potassium monopersulfate (e.g., bis(peroxymonosulfate), bis(sulfate), pentapotassium), ammonium monopersulfate, and hydrates thereof. Specific examples of perborates include alkali metal salts of perboric acid such as sodium perborate and potassium perborate, ammonium perborate, and hydrates thereof. Specific examples of percarbonates include alkali metal salts of percarbonate such as sodium percarbonate and potassium percarbonate, ammonium percarbonate, and hydrates thereof. Specific examples of persulfates include alkali metal salts of persulfate such as sodium persulfate and potassium persulfate, ammonium persulfate, and hydrates thereof. The bleaching agents exemplified above may be used alone or in combination of two or more. Among the bleaching agents exemplified above, preferred are monopersulfate, perborate, and percarbonate, more preferred are alkali metal monopersulfate, alkali metal perborate, and alkali metal percarbonate, and even more preferred are potassium monopersulfate, sodium perborate, and sodium percarbonate.

[0046] In the intraoral instrument cleanser of the present disclosure, the content of the bleaching agent may be appropriately set within a range that can exert the desired bleaching effect, and may be, for example, 1 to 40% by weight, preferably 5 to 35% by weight, and more preferably 5 to 30% by weight.

[0047] (Bleach activator) When the intraoral instrument cleaner of the present disclosure contains an oxygen bleaching agent, it may also contain a bleach activator. The bleach activator is HO generated from the oxygen bleaching agent in water. -It reacts with the bleaching agent to generate organic peracids with a stronger bleaching effect.

[0048] The bleach activator may be any known bleach activator without any particular limitation, and examples thereof include tetraacetylethylenediamine; alkanoyloxybenzenesulfonic acids or salts thereof having an alkanoyl group containing 1 to 18 carbon atoms, preferably 8 to 12 carbon atoms; and alkanoyloxybenzoic acids or salts thereof having an alkanoyl group containing 1 to 18 carbon atoms, preferably 8 to 12 carbon atoms. Examples of the salts include alkali metal salts and ammonium salts. The bleach activators exemplified above may be used alone or in combination of two or more. Of the bleach activators exemplified above, tetraacetylethylenediamine is preferred from the viewpoint of excellent efficiency in generating organic peracids.

[0049] In the intraoral instrument cleanser of the present disclosure, the content of the bleaching activator may be adjusted appropriately depending on the content of the oxygen bleach, and may be, for example, 0.01 to 5 wt %, preferably 0.1 to 3 wt %, and more preferably 0.5 to 2 wt %.

[0050] (Surfactant) The intraoral instrument cleanser of the present disclosure may contain a surfactant. The surfactant serves as a component that exerts a chemical cleaning action, etc.

[0051] The type of surfactant to be incorporated into the intraoral instrument cleanser of the present disclosure is not particularly limited as long as it is usable as a component of a cleanser, and any of anionic surfactants, cationic surfactants, nonionic surfactants, and amphoteric surfactants may be used. Among these surfactants, anionic surfactants are preferred.

[0052] Examples of anionic surfactants include α-olefin sulfonates, alkyl sulfates, alkylbenzene sulfonates, alkyl sulfoacetates, and alkanesulfonates. Examples of salt forms of anionic surfactants 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 hydrochlorides. Among the anionic surfactants, preferred are α-olefin sulfonates and alkyl sulfates, and more preferred are sodium α-olefin sulfonate and sodium lauryl sulfate.

[0053] In the oral instrument cleanser of the present disclosure, one type of surfactant may be blended alone, or two or more types of surfactants may be blended in combination.

[0054] In the cleanser for intraoral instruments of the present disclosure, the content of surfactant is not particularly limited as long as it can exert a foaming effect when cleaning intraoral instruments, and may be set appropriately depending on the type of surfactant used, the cleaning power to be provided, etc., but examples include a total surfactant content of 0.1 to 10 wt %, preferably 0.5 to 7 wt %, and more preferably 1 to 5 wt %.

[0055] (Sugar Alcohol) The oral instrument cleanser of the present disclosure may contain a sugar alcohol. The sugar alcohol is a component that functions as a binder.

[0056] The type of sugar alcohol is not particularly limited, and examples thereof include sorbitol, mannitol, xylitol, erythritol, etc. The sugar alcohols exemplified above may be used alone or in combination of two or more. Among the sugar alcohols exemplified above, sorbitol is preferred.

[0057] In the oral instrument cleanser of the present disclosure, the sugar alcohol content is, for example, 1 to 30 wt %, preferably 3 to 20 wt %, and more preferably 4 to 15 wt %, in terms of the total amount of sugar alcohol.

[0058] (Polyalkylene Glycol) The oral instrument cleanser of the present disclosure may contain polyalkylene glycol, which is a component that functions as a binder.

[0059] Specific examples of polyalkylene glycols include polyethylene glycol, polypropylene glycol, and polybutylene glycol.

[0060] The polyalkylene glycol may be used alone or in combination of two or more. Among the polyalkylene glycols exemplified above, polyethylene glycol is preferred.

[0061] In the intraoral instrument cleanser of the present disclosure, the content of polyalkylene glycol is, for example, 0.1 to 5 wt %, preferably 0.5 to 2 wt %, and more preferably 0.5 to 1.5 wt %.

[0062] (Lubricant) The oral instrument cleanser of the present disclosure may contain a lubricant to facilitate the molding process into tablets.

[0063] The type of lubricant is not particularly limited, and examples thereof include magnesium stearate, calcium stearate, sodium stearyl fumarate, sucrose fatty acid esters, sodium lauryl sulfate, talc, light anhydrous silicic acid, and hydrous silicon dioxide.

[0064] The lubricant may be used alone or in combination of two or more. Among the lubricants exemplified above, magnesium stearate is preferred.

[0065] In the intraoral instrument cleanser of the present disclosure, the content of the lubricant is, for example, 0.01 to 1 wt %, preferably 0.015 to 0.5 wt %, and more preferably 0.02 to 0.3 wt %.

[0066] Furthermore, other additives that can be blended into the intraoral instrument cleanser of the present disclosure include, for example, base materials (sodium sulfate, etc.), flavorings (other than menthol), flavoring impregnating agents, enzymes (proteases, etc.), colorants, magnesium oxide, deodorants, anti-tartar agents, anti-rust agents, chelating agents, pH adjusters, sweeteners, cooling agents (other than menthol), foam stabilizers, preservatives, antibacterial agents (other than isopropylmethylphenol and thymol), bactericides (other than isopropylmethylphenol and thymol), antiseptics, bulking agents, excipients, disintegrants, and fluidizing agents. The other components exemplified above may be blended singly or in any combination of two or more.

[0067] 2. Formulation and Manufacturing Method of the Oral Instrument Cleanser The tablet-shaped oral instrument cleanser of the present disclosure is obtained by tableting the oral instrument cleanser for effervescent tablets of the present disclosure. Tablet formulation can be achieved using a commonly employed tableting method. For example, a raw material mixture containing components (A) to (D) and other additives, if necessary, can be subjected to a tableting process. The oral instrument cleanser for effervescent tablets of the present disclosure contains component (C) in addition to components (A) and (B), thereby suppressing sticking during tableting and reducing production losses in the tableting process, thereby achieving high production efficiency in industrial production. Furthermore, the oral instrument cleanser for effervescent tablets of the present disclosure contains component (C) in addition to components (A) and (B), thereby suppressing a decrease in tablet hardness when formed into tablets. This effectively prevents chipping or cracking of tablets due to slight impact during transportation, etc. Furthermore, prior to the tableting step, the mixture may be granulated into granules as required.

[0068] Furthermore, in the tablet-shaped intraoral instrument cleanser of the present disclosure, the weight of each tablet is not particularly limited and may be appropriately set based on ease of use, but it is desirable to set the weight of each tablet to the amount necessary for one intraoral instrument cleansing. Specifically, the weight of each tablet is 1 to 4 g, preferably 2 to 3 g.

[0069] 3. Uses of the Cleanser for Intraoral Instruments The tablet-shaped cleanser for intraoral instruments of the present disclosure is used as a cleaner for various intraoral instruments, and is particularly suitable for use as a denture cleaner.

[0070] 4. Method of Using the Intraoral Instrument Cleanser The tablet-form intraoral instrument cleanser of the present disclosure is added to water, heated if necessary, and the intraoral instrument (preferably a denture) to be cleaned is placed in the water. The tablet-form intraoral instrument cleanser of the present disclosure dissolves and foams, thereby cleaning the intraoral instrument. Furthermore, since the tablet-form intraoral instrument cleanser of the present disclosure contains component (A) and component (B), slime on the intraoral instrument can be easily removed by immersing the intraoral instrument in the cleaning solution. This reduces discomfort caused by slime on the intraoral instrument when and after manually reinserting the intraoral instrument after cleaning.

[0071] The water used when cleaning an oral appliance using the tablet-shaped oral appliance cleanser of the present disclosure is not particularly limited, but examples include tap water, purified water, distilled water, and physiological saline.

[0072] When cleaning an oral appliance using the tablet-type oral appliance cleaner of the present disclosure, the oral appliance may be immersed in water and then the tablet-type oral appliance cleaner of the present disclosure added, or the oral appliance may be immersed in water after adding the tablet-type oral appliance cleaner of the present disclosure.

[0073] Furthermore, in cleaning intraoral instruments, the ratio of the tablet-form intraoral instrument cleanser of the present disclosure to water is appropriately set depending on the composition of the tablet-form intraoral instrument cleanser of the present disclosure, the degree of slime of the intraoral instruments to be cleaned, etc., but for example, the tablet-form intraoral instrument cleanser may typically be about 1 to 10 parts by weight, preferably about 1 to 5 parts by weight, per 100 parts by weight of water. More specifically, in one cleaning of intraoral instruments, 100 to 200 mL of water may be prepared, to which 1 to 20 g, preferably 1 to 10 g, more preferably 1 to 5 g, of the tablet-form intraoral instrument cleanser of the present disclosure may be added.

[0074] The temperature during cleaning of intraoral instruments may be about room temperature. The time for immersing the intraoral instruments in the cleaning solution for intraoral instruments is usually about 5 minutes to 24 hours, preferably 10 minutes to 12 hours, and more preferably 30 minutes to 8 hours.

[0075] Furthermore, while cleaning the intraoral appliances, it is not necessary to agitate the water to which the intraoral appliance cleanser has been added, but the water may be stirred as needed to more effectively remove slime from the intraoral appliances. Furthermore, the intraoral appliances may be scrubbed with a cleaning tool such as a brush to more effectively remove slime from the intraoral appliances.

[0076] The invention of the present disclosure will be explained in more detail below by showing examples, but the present disclosure is not limited to these examples.

[0077] <Measurement of median diameter, D10, D25, D75, D90, and mode diameter of carbonate> The particle diameters of the sodium carbonate and potassium carbonate used were measured using a particle size distribution analyzer (SALD-2100 laser diffraction particle size distribution analyzer, manufactured by Shimadzu Corporation), and the median diameter, D10, D25, D75, D90, and mode diameter were obtained from the obtained volume-accumulation particle size distribution. The particle diameter of sodium carbonate was adjusted, if necessary, by adjusting the mixing ratio of the following two types of sodium carbonate. Furthermore, the particle diameter of potassium carbonate was adjusted, if necessary, by adjusting the mixing ratio of the following two types of potassium carbonate. - Sodium carbonate having a median diameter of 430 μm, D10 of 240 μm, D25 of 315 μm, D75 of 570 μm, D90 of 700 μm, and a mode diameter of 480 μm. - Sodium carbonate having a median diameter of 110 μm, D10 of 40 μm, D25 of 70 μm, D75 of 160 μm, D90 of 210 μm, and a mode diameter of 130 μm. - Potassium carbonate having a median diameter of 430 μm, D10 of 240 μm, D25 of 315 μm, D75 of 570 μm, D90 of 700 μm, and a mode diameter of 480 μm. Potassium carbonate with a median diameter of 110 μm, a D10 of 40 μm, a D25 of 70 μm, a D75 of 160 μm, a D90 of 210 μm, and a mode diameter of 130 μm

[0078] Test Example 1 (Evaluation of Sticking and Tablet Hardness) The components shown in Tables 1 and 2 were mixed using a Lödige mixer (Matsubo Co., Ltd., Model No. M20) to form a composition. The composition was compressed into tablets at a compression force of 5 t using a 20φ die and a tableting machine (Kikusui Seisakusho Co., Ltd., rotary powder molding machine, Model No. CLEC1518SS7JZ) to produce tablet-shaped oral instrument cleansers weighing 2 g per tablet. Three sets of mortars and pestles were evenly spaced on the turntable of the tableting machine. After continuously compressing 100 tablets of oral instrument cleansers, the mortars and pestles were observed, and the number of sets of mortars and pestles in which sticking occurred in either the mortar or the pestle was counted. The results are shown in Tables 1 and 2. Each tablet-shaped oral instrument cleanser produced was also placed in a Schleuniger hardness tester (Dr. Schleuniger Pharmatron, Tablet Hardness Tester 6D). The test speed of the breaking terminal was set to 0.5 mm / sec, and the load applied by the load sensor (load cell) when the tablet was broken was recorded as hardness (kgf). This procedure was performed on three tablets, and the average hardness (rounded to one decimal place) was calculated. The results are shown in Tables 1 and 2. If the tablet hardness is less than 4.8 kgf, the frequency of chipping or cracking of the tablet due to impact during transportation, etc. is very high. Therefore, the tablet hardness is preferably 4.8 kgf or more, more preferably 5.0 kgf or more, and even more preferably 5.5 kgf or more.

[0079]

[0080]

[0081] As shown in Tables 1 and 2, when a carbonate having a median diameter of 155 or 370 μm was added to an intraoral instrument cleanser containing isopropylmethylphenol or thymol and l-menthol, the occurrence of sticking was effectively suppressed and a decrease in tablet hardness was also suppressed (Examples 1 to 10). On the other hand, when a carbonate having a median diameter of 110 or 140 μm was added to an intraoral instrument cleanser containing isopropylmethylphenol or thymol and l-menthol, the tablet hardness was sufficient but sticking was observed (Comparative Examples 1 to 10). Furthermore, when a carbonate having a median diameter of 430 μm was added, the occurrence of sticking was effectively suppressed but a decrease in tablet hardness could not be suppressed (Comparative Examples 11 to 16).

[0082] Test Example 2 (Slime Removal Test) The components shown in Table 3 were mixed using a Lödige Mixer (Matsubo Corporation, model number: M20) to form a composition, which was then compressed into tablets at a compression force of 7 t using a 20φ diameter mold and a tableting machine (Kikusui Seisakusho Co., Ltd., rotary powder molding machine, model number: CLEC1518SS7JZ) to produce tablet-shaped oral instrument cleaners weighing 2 g per tablet.

[0083] The tablet-shaped intraoral instrument cleansers produced in Experimental Examples 1 to 4 and Comparative Experimental Examples 1 to 9 were subjected to a slime removal test by the following method.

[0084] <Slime Removal Test> (1) Preparation of Resin Chips with Biofilms 5 ml of TSB (Tryptic Soy Broth) medium was placed in a 15 mL tube, and Streptococcus mutans (NBRC13955) was inoculated and cultured at 35 ° C for 1-2 days. The resulting culture was then suspended in TSB medium to prepare a Streptococcus mutans suspension with an OD at 600 nm adjusted to 1.05-1.10. Separately, Candida albicans (NBRC1595) was inoculated into PDA medium (potato dextrose agar medium) and cultured at 35 ° C for 1-2 days. The Candida albicans cultured after cultivation was recovered and suspended in TSB medium to prepare a Candida albicans suspension with an OD at 600 nm adjusted to 1.45-1.50. The obtained Streptococcus mutans suspension and Candida albicans suspension were mixed in a volume ratio of 1:1 to prepare a bacterial suspension.

[0085] Resin chips (20 mm x 20 mm, 1.5 mm thick, single-sided polishable; made of polymethyl methacrylate resin) were sterilized by immersion in 100 ml of 200 ppm hypochlorous acid solution for 10 minutes and then thoroughly rinsing with water. One sterilized resin chip was placed in each well of a 6-well plate, and 4.95 ml of TBS (Tris-Buffered Saline) solution containing 5 wt% sucrose was added to each well. 50 μl of the bacterial suspension was then added. The chips were cultured at 37°C for 24 hours to produce resin chips with attached biofilms.

[0086] After incubation, the culture medium was removed from each well, 6 ml of distilled water was added to each well, and the wells were pipetted 10 times before the water was removed. This washing procedure was repeated 2-3 times until the distilled water added to each well became clear, yielding resin chips with attached biofilms.

[0087] (2) Washing of Resin Chips 180 ml of purified water was placed in a 300 ml cup and immersed in a thermostatic bath maintained at 40°C. Next, the resin chips with biofilms attached were immersed in each cup, and one tablet of each of the intraoral instrument cleaners prepared in Experimental Examples 1 to 4, Comparative Experimental Examples 1 to 9, and Reference Example 4 was added to each cup, and an intraoral instrument cleaning solution was prepared in each cup and allowed to stand. One hour after adding the intraoral instrument cleaner, each resin chip was removed with tweezers and placed in a respective well of a 6-well plate filled with purified water. The resin chip was then slowly moved back and forth five times in the well to remove the cleaner adhering to the resin chip, and each washed resin chip was obtained.

[0088] (3) Evaluation of Slime Removal Ability of Resin Chips After Cleaning Five evaluators washed their index fingers with ethanol. Then, they gently rubbed the surface of the resin chip with the biofilm attached before cleaning in a circular motion with their index fingers. Based on the evaluation criteria shown in the diagram below, the ease of slime removal was evaluated using a 9-point scale with increments of 1, with "1" representing "no slime" and "9" representing "does not come off no matter how many times it is rubbed." All five evaluators gave a score of 9. Next, the ease of biofilm removal on the resin chip (reference sample) cleaned with the intraoral instrument cleaner prepared in Reference Example 4 was evaluated in the same manner as above, and the average of the five evaluations (average of the reference sample) was calculated. Then, the ease of biofilm removal on the resin chip (evaluation sample) cleaned with each of the intraoral instrument cleaners 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 of the five evaluations (average of the evaluation sample) was calculated.

[0089] The slime removability improvement score was then calculated using the following formula. It can be said that the higher the slime removability improvement score, the easier the slime is to remove. The results are shown in Table 3. Slime removability improvement score = average value of reference samples - average value of evaluation samples

[0090]

[0091] The results in Table 3 confirm that the intraoral instrument cleansers prepared in Experimental Examples 1 to 4, which contain both isopropylmethylphenol or thymol and l-menthol, have higher slime removal improvement scores and can remove slime more easily than the intraoral instrument cleansers prepared in Comparative Experimental Examples 1 to 9, which contain isopropylmethylphenol, thymol, or l-menthol alone.

[0092] Furthermore, when the slime removal test was performed using ethylene vinyl acetate chips or copolymer polyester chips, which are materials for mouthpieces and retainers, instead of the resin chips, which are materials for dentures, the same results were obtained. That is, even for mouthpiece and retainer materials, the intraoral instrument cleansers prepared in Experimental Examples 1 to 4 had higher slime removal improvement scores than the intraoral instrument cleansers prepared in Comparative Experimental Examples 1 to 9, confirming that slime can be removed more easily.

[0093] Formulation Examples Tablet-shaped intraoral instrument cleaners having the compositions shown in Tables 4 and 5 were produced in the same manner as in Test Example 1, and evaluations of sticking and tablet hardness were carried out. It was confirmed that all tablet-shaped intraoral instrument cleaners were able to effectively prevent sticking and effectively prevent a decrease in tablet hardness.

[0094]

[0095]

Claims

1. A cleanser for intraoral instruments for effervescent tablets, comprising: (A) 0.01 to 0.1 wt% in total of at least one member selected from the group consisting of isopropylmethylphenol and thymol; (B) 0.01 to 0.1 wt% of menthol; (C) 5 to 30 wt% of a carbonate having a median diameter of 150 to 400 μm; and (D) 5 to 40 wt% of a bicarbonate and 10 to 30 wt% of an acid as effervescent agents.

2. An oral instrument cleanser for effervescent tablets according to claim 1, which is a denture cleanser.

3. A tablet-shaped cleanser for oral instruments obtained from the cleanser for oral instruments for effervescent tablets according to claim 1 or 2.

4. A method for producing a tablet-shaped oral instrument cleaner, comprising subjecting a raw material mixture containing (A) 0.01 to 0.1 wt% in total of at least one selected from the group consisting of isopropylmethylphenol and thymol, (B) 0.01 to 0.1 wt% of menthol, (C) 5 to 30 wt% of a carbonate having a median diameter of 150 to 400 μm, and (D) 5 to 40 wt% of a bicarbonate as a foaming agent and 10 to 30 wt% of an acid to a tableting process.

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