JP7536809B2 - Cleansing composition for intraoral appliances - Google Patents

Description

The present invention relates to a cleansing composition for intraoral instruments.

As the population ages rapidly in recent years, the number of people who are forced to wear oral appliances such as dentures is increasing at an accelerating rate. These oral appliances tend to retain denture plaque, food residue, and other dirt that accumulates while they are worn. As a result, even after the oral appliance is removed, it tends to become a breeding ground for denture plaque. As a result, if the oral appliance is re-worn as is, it may cause bad breath, dental caries, periodontal disease, etc., so careful daily care is essential.

In this context, various compositions have been developed to contribute to the practice of denture care. For example, Patent Document 1 discloses an antibacterial agent for dentures that contains 15 to 45% by mass of a fatty acid having 8 to 22 carbon atoms or a salt thereof, a specific fatty acid glyceride, a sulfosuccinic acid ester, and the like in specific amounts, and is effective in killing and disinfecting bacteria and fungi.
On the other hand, Patent Document 2 discloses a liquid composition for cleaning dentures which contains a surfactant, a sulfite, and a water-soluble polyphosphate in specific contents and mass ratios and has a specific pH value, and Patent Document 3 discloses a liquid composition for cleaning dentures which contains a surfactant, a sulfite, a specific polyphosphate, and a specific amount of a polyhydric alcohol, and which has a specific water content and a specific pH value.

JP 2011-195496 A JP 2010-168352 A JP 2011-126868 A

However, the technology described in Patent Document 1 above is limited to merely increasing antibacterial activity. Furthermore, the technologies described in Patent Documents 2 and 3 above only examine the stability of sulfite ion concentration over time and the stability of appearance during low-temperature storage.

On the other hand, the inventors have discovered that when a particular fatty acid or a salt thereof is stored at low temperatures, for example in a liquid form, it becomes cloudy and its structure becomes unstable at first, but after a while the structure stabilizes and returns to transparency, but there is a problem in that it takes time for this structure to be stabilized.
Therefore, the present invention relates to a cleansing agent composition for intraoral instruments that can effectively improve low-temperature storage stability.

The inventors conducted extensive research to solve the above problems and discovered a cleanser composition for intraoral appliances that has excellent low-temperature storage stability, in that it contains a specific chelating agent in a specific mass ratio relative to an extremely limited amount of a specific fatty acid or salt thereof, thereby making it possible to shorten the time until the fatty acid salt is stabilized at low temperatures. It was also found that the cleanser composition for intraoral appliances of the present invention can effectively remove denture plaque firmly attached to intraoral appliances such as dentures, and also has excellent foaming properties.

That is, the present invention relates to a composition comprising the following components (A) and (B):
The present invention provides a cleanser composition for intra-oral instruments, comprising: (A) a fatty acid or a salt thereof having from 10 to 20 carbon atoms, the amount of which is 0.1% by mass to 20% by mass in terms of fatty acid; and (B) a chelating agent having a molecular weight of from 80 to less than 600, wherein the mass ratio ((A)/(B)) of the content of component (A) to the content of component (B) is 0.05 or more and 20 or less.

The cleanser composition for intraoral instruments of the present invention can exhibit excellent low-temperature storage stability, which makes it possible to shorten the time until the fatty acid having 10 to 20 carbon atoms or its salt (A) is stabilized at low temperatures.

The present invention will be described in detail below.
In this specification, the term "oral appliance" refers to a dental appliance that needs to be attached and removed in the oral cavity, such as a complete denture, a partial denture, an orthodontic appliance, a retainer (hereinafter, these are also collectively referred to as "dentures, etc."), or a mouthpiece, a mouthguard, etc. Specifically, for example, a complete denture (total denture) is a denture to be attached to an edentulous jaw, and is composed of artificial teeth and a denture base. On the other hand, a partial denture (partial denture) is a denture to be attached to a jaw that has partially lost teeth, and is composed of artificial teeth, a denture base, and abutment devices such as clasps, rests, and attachments, and orthodontic appliances and retainers have a similar structure. The material of the denture base generally includes resins such as acrylic resin, and the material of the artificial teeth and abutment devices includes metals such as titanium and ceramics in addition to the above resins. The material of the mouthpiece and mouthguard generally includes resins such as ethylene vinyl acetate.
In addition, in this specification, "denture plaque" means an aggregate of bacteria attached to intraoral appliances and extracellular substances produced by the bacteria.

The cleanser composition for intraoral instruments of the present invention contains, as component (A), 0.1% by mass to 20% by mass of a fatty acid or a salt thereof having from 10 to 20 carbon atoms, calculated as the fatty acid. The cleanser composition for intraoral instruments of the present invention can effectively enhance the low-temperature stability of component (A). Furthermore, component (A) can disrupt the aggregated structure of denture plaque, effectively detaching the denture plaque from the intraoral instruments, and is therefore considered to exert an excellent denture plaque removal effect and maintain high cleansing performance.
Furthermore, since good foaming can be achieved, the agent can be effectively adhered to every corner of the intraoral appliance after it has been removed from the oral cavity.

The fatty acids constituting the fatty acid of component (A) and the fatty acid salt of component (A) have a carbon number of 10 to 20, preferably 12 to 20, more preferably 14 to 20, and even more preferably 16 to 20. Such fatty acids may have a saturated or unsaturated straight or branched chain, and from the viewpoint of the denture plaque removal effect, those having an unsaturated straight chain are more preferable.

Specific examples of the fatty acid of component (A) and the fatty acid salt of component (A) include capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, palmitoleic acid, oleic acid, linoleic acid, linolenic acid, vaccenic acid, gadoleic acid, eicosenoic acid, isostearic acid, and arachidic acid, as well as mixed fatty acids thereof, such as coconut oil fatty acid and palm oil fatty acid. Among them, from the viewpoint of fully exerting the denture plaque removing effect, one or more selected from lauric acid, myristic acid, palmitic acid, stearic acid, palmitoleic acid, oleic acid, linoleic acid, linolenic acid, vaccenic acid, gadoleic acid, and eicosenoic acid are preferred, one or more selected from palmitoleic acid, oleic acid, linoleic acid, linolenic acid, vaccenic acid, gadoleic acid, and eicosenoic acid are more preferred, and oleic acid is more preferred.
Examples of the salt of component (A) include one or more selected from inorganic salts selected from sodium salts, potassium salts, magnesium salts, and ammonium salts, organic amine salts such as monoethanolammonium salts, diethanolammonium salts, and triethanolammonium salts, and basic amino acid salts such as arginine salts. Among these, from the viewpoint of fully exerting the denture plaque removing effect, sodium salts or potassium salts are preferred, and potassium salts are particularly preferred.

The content of component (A) in the cleanser composition for intraoral instruments of the present invention is 0.1% by mass or more, preferably 0.2% by mass or more, more preferably 0.3% by mass or more, and even more preferably 0.5% by mass or more, in terms of fatty acid, from the viewpoint of effectively maintaining low-temperature stability while exhibiting good foaming and excellent denture plaque removal effect. The content of component (A) in the cleanser composition for intraoral instruments of the present invention is 20% by mass or less, preferably 15% by mass or less, more preferably 10% by mass or less, and even more preferably 5% by mass or less, in terms of fatty acid, from the viewpoint of effectively suppressing a decrease in low-temperature stability while ensuring the denture plaque removal effect of component (A) and from the viewpoint of preventing the appearance of an unpleasant flavor when the intraoral instrument is worn after application. The content of component (A) in the cleanser composition for intraoral instruments of the present invention is 0.1% by mass or more and 20% by mass or less, in terms of fatty acid, preferably 0.2 to 15% by mass, more preferably 0.3 to 10% by mass, and even more preferably 0.5 to 5% by mass.

The cleanser composition for intra-oral instruments of the present invention contains, as component (B), a chelating agent having a molecular weight of 80 or more and less than 600. This makes it possible to exhibit excellent foaming while satisfactorily ensuring low-temperature stability that is liable to be reduced by component (A).
The molecular weight of the component (B) means a value calculated from the chemical formula weight.

More specifically, component (B) is preferably one or more selected from phosphoric acid, phosphonic acid, aminocarboxylic acid, oxycarboxylic acid, and salts thereof. These salts also include hydrates (hydrated salts).
Specific examples of phosphoric acid or a salt thereof include pyrophosphoric acid or a salt thereof, tripolyphosphoric acid or a salt thereof, metaphosphoric acid or a salt thereof, and phytic acid or a salt thereof.
Specific examples of the phosphonic acid or a salt thereof include hydroxyethanediphosphonic acid or a salt thereof, aminotrimethylenephosphonic acid or a salt thereof, ethylenediaminetetramethylenephosphonic acid or a salt thereof, and phosphonobutanetricarboxylic acid or a salt thereof.
Specific examples of aminocarboxylic acids or salts thereof include edetic acid (EDTA) or salts thereof, nitrilotriacetic acid (NTA) or salts thereof, hydroxyethyliminodiacetic acid (HIDA) or salts thereof, tetrasodium 3-hydroxy-2,2'-iminodisuccinate (HIDS) or salts thereof, diethylenetriaminepentaacetic acid (DPTA) or salts thereof, hydroxyethylethylenediaminetriacetic acid (HEDTA) or salts thereof, dihydroxyethylglycine (DHEG) or salts thereof, L-glutamic acid diacetate (GLDA) or salts thereof, and methylglycine diacetate (MGDA) or salts thereof.
Specific examples of oxycarboxylic acids or salts thereof include citric acid or salts thereof, malic acid or salts thereof, tartaric acid or salts thereof, gluconic acid or salts thereof, oxalic acid or salts thereof, maleic acid or salts thereof, malonic acid or salts thereof, succinic acid or salts thereof, aspartic acid or salts thereof, and glutamic acid or salts thereof.
Among these, from the viewpoint of effectively achieving both excellent low-temperature stability and good foaming, one or more selected from phosphoric acid, phosphonic acid, and salts thereof are preferred, phosphonic acid or a salt thereof is more preferred, and hydroxyethanediphosphonic acid or a salt thereof is even more preferred.

From the viewpoint of effectively achieving both excellent low-temperature stability and good foaming, the content of component (B) in the cleansing composition for intraoral instruments of the present invention is preferably 0.1% by mass or more, more preferably 0.2% by mass or more, even more preferably 0.4% by mass or more, even more preferably 0.5% by mass or more, and even more preferably 1.5% by mass or more. From the viewpoint of maintaining an excellent denture plaque removal effect, the content of component (B) in the cleansing composition for intraoral instruments of the present invention is preferably 20% by mass or less, more preferably 15% by mass or less, even more preferably 12% by mass or less, even more preferably 8% by mass or less, and even more preferably 6% by mass or less. The content of component (B) in the cleansing composition for intraoral instruments of the present invention is preferably 0.1% by mass or more and 20% by mass or less, more preferably 0.2 to 15% by mass, even more preferably 0.4 to 12% by mass, even more preferably 0.5 to 8% by mass, and even more preferably 1.5 to 6% by mass.

The mass ratio of the content of component (A) to the content of component (B) ((A)/(B)) is, from the viewpoint of effectively achieving both excellent low-temperature stability and good foaming, 0.05 or more, preferably 0.1 or more, more preferably 0.15 or more, even more preferably 0.2 or more, even more preferably 0.25 or more, and is 20 or less, preferably 10 or less, more preferably 5 or less, even more preferably 4 or less, even more preferably 3 or less, even more preferably 2 or less, even more preferably 1 or less, and even more preferably 0.8 or less. The mass ratio ((A)/(B)) of the content of component (A) to the content of component (B) is 0.05 or more and 20 or less, preferably 0.1 or more and 10 or less, more preferably 0.15 or more and 5 or less, even more preferably 0.2 to 4, even more preferably 0.25 to 3, even more preferably 0.25 to 2, even more preferably 0.25 to 1, and even more preferably 0.25 to 0.8.

The cleanser composition for intraoral appliances of the present invention preferably further contains one or more surfactants (C) selected from anionic surfactants (c1), nonionic surfactants (c2), and amphoteric surfactants (c3) other than component (A) in order to provide excellent low-temperature stability and good foaming and to fully exert the denture plaque removal effect.

Specific examples of component (c1), which is an anionic surfactant other than component (A), include one or more selected from N-acylamino acids, N-acyltaurines, α-olefinsulfonic acids, and salts thereof.

The acyl group of the N-acylamino acid and N-acyltaurine is preferably derived from a fatty acid having a saturated or unsaturated straight or branched chain, and is preferably an acyl group having 6 to 22 carbon atoms, more preferably an acyl group having 10 to 20 carbon atoms, and even more preferably an acyl group having 12 to 18 carbon atoms.
Such acyl groups are preferably one or more selected from a capryloyl group, a lauroyl group, a myristoyl group, a palmitoyl group, a stearoyl group, and a cocoyl group, more preferably one or more selected from a lauroyl group, a myristoyl group, and a cocoyl group, even more preferably one or more selected from a lauroyl group and a cocoyl group, and still more preferably a cocoyl group.

The amino acid moiety constituting the N-acyl amino acid may be any of glutamic acid, aspartic acid, and glycine, and may be any of the D-form, L-form, or a mixture of the D-form and L-form, with the L-form being preferred. Specifically, such N-acyl amino acids are preferably one or more selected from N-lauroyl glutamic acid, N-myristoyl glutamic acid, N-cocoyl glutamic acid, N-lauroyl aspartic acid, N-myristoyl aspartic acid, and N-cocoyl aspartic acid, N-lauroyl glycine, N-myristoyl glycine, and N-cocoyl glycine, and more preferably one or two selected from N-cocoyl glutamic acid, N-lauroyl glutamic acid, and N-myristoyl glutamic acid.

As the N-acyltaurine, one or more selected from cocoyl methyl taurine, N-caproyl methyl taurine, N-lauroyl taurine, N-lauroyl methyl taurine, N-myristoyl methyl taurine, N-palmitoyl methyl taurine, N-stearoyl methyl taurine, and N-oleoyl methyl taurine are preferred, and one or two selected from N-lauroyl methyl taurine and N-myristoyl methyl taurine are more preferred.

The olefin group contained in the α-olefin sulfonic acid and its salts preferably has 8 to 18 carbon atoms, more preferably 14 to 16 carbon atoms, and even more preferably 14 carbon atoms.

These salts include alkali metal salts such as sodium and potassium; alkaline earth metal salts such as calcium and magnesium; other inorganic salts such as aluminum and zinc; ammonium salts; organic amine salts such as monoethanolamine, diethanolamine, and triethanolamine; and basic amino acid salts such as arginine salts, lysine salts, histidine salts, and ornithine salts. These may be used alone or in combination of two or more.

Specific examples of the nonionic surfactant of component (c2) include one or more selected from polyoxyethylene hydrogenated castor oil, fatty acid sorbitan esters, fatty acid polyoxyethylene sorbitan esters, sucrose fatty acid esters, and alkyl glycosides.
The average number of moles of ethyleneoxy groups added in the polyoxyethylene hydrogenated castor oil is preferably 20 to 100 moles, and more preferably 40 to 80 moles.

Specific examples of the amphoteric surfactant of component (c3) include one or more selected from acetate betaines such as lauryl dimethylamino acetate betaine; coconut oil fatty acid amido alkyl betaines such as coconut oil fatty acid amido propyl betaine; alkyl sulfobetaines such as lauryl sulfobetaine and lauryl hydroxysulfobetaine; imidazolinium betaines such as 2-alkyl-N-carboxymethyl-N-hydroxyethyl-N-imidazolium betaine; carboxybetaines; alkyl imidazoline betaine salts such as N-alkyl-1-hydroxyethyl imidazoline betaine sodium; and alkyl amine oxides such as lauryl dimethylamine oxide.
Among these, one or more selected from coconut oil fatty acid amido alkyl betaine, alkyl sulfobetaine, and alkylamine oxide are preferred, and coconut oil fatty acid amido alkyl propyl betaine and alkylamine oxide are more preferred.

Among these components (C), from the viewpoint of effectively increasing low-temperature storage stability while ensuring excellent foaming, component (c1) is preferred, and it is more preferred that the component (c1) is one or more selected from N-acyl amino acids, N-acyltaurines, and salts thereof.

The content of component (C) in the cleanser composition for intraoral instruments of the present invention is preferably 0.2% by mass or more, more preferably 0.3% by mass or more, and even more preferably 0.5% by mass or more, from the viewpoint of effectively increasing both low-temperature storage stability and foaming, and from the viewpoint of fully exerting the denture plaque removal effect. The content of component (C) in the cleanser composition for intraoral instruments of the present invention is preferably 10% by mass or less, more preferably 8% by mass or less, and even more preferably 5% by mass or less, from the viewpoint of increasing good solubility or dispersibility of each component. The content of component (C) in the cleanser composition for intraoral instruments of the present invention is preferably 0.2% by mass or more and 10% by mass or less, more preferably 0.3 to 8% by mass, and even more preferably 0.5 to 5% by mass.

The mass ratio of the content of component (C) to the content of component (A) ((C)/(A)) is preferably 0.2 or more, more preferably 0.3 or more, even more preferably 0.5 or more, and preferably 5 or less, more preferably 4 or less, even more preferably 3 or less, from the viewpoint of effectively achieving both good foaming and good denture plaque removal effect together with excellent low-temperature stability.

The cleanser composition for intraoral instruments of the present invention preferably further contains a solvent (D) from the viewpoint of further increasing the compatibility of components (A) and (B) and effectively achieving both excellent low-temperature stability and good foaming.

Specific examples of component (D) include one or more selected from monohydric or dihydric alcohols having from 2 to 6 carbon atoms, and alcohols having an aromatic group.
More specific examples of the monohydric or dihydric alcohol having 2 to 6 carbon atoms include glycerin, ethanol, propanol, butanol, isopropanol, propylene glycol, butylene glycol, dipropylene glycol, diethylene glycol monobutyl ether, and ethylene glycol.
More specific examples of alcohols having an aromatic group include phenoxyethanol, diethylene glycol monophenyl ether, triethylene glycol monophenyl ether, polyethylene glycol monophenyl ether, benzyloxyethanol, and diethylene glycol monobenzyl ether.
Among these, from the viewpoint of effectively achieving both low temperature stability and good foaming, one or more selected from glycerin, propylene glycol, phenoxyethanol, benzyl alcohol, dipropylene glycol, and diethylene glycol monobutyl ether are preferred, and it is more preferred to contain a combination of two or more of these.

The content of component (D) in the cleanser composition for intraoral instruments of the present invention is preferably 1% by mass or more, more preferably 2% by mass or more, and even more preferably 3% by mass or more, from the viewpoint of effectively increasing both low-temperature storage stability and foaming. The content of component (D) in the cleanser composition for intraoral instruments of the present invention is preferably 30% by mass or less, more preferably 25% by mass or less, and even more preferably 15% by mass or less, from the viewpoint of increasing good solubility or dispersibility of each component. The content of component (D) in the cleanser composition for intraoral instruments of the present invention is preferably 1% by mass or more and 30% by mass or less, more preferably 2 to 25% by mass, and even more preferably 3 to 15% by mass.

The mass ratio of the content of component (D) to the content of component (A) ((D)/(A)) is preferably 1 or more, more preferably 3 or more, even more preferably 5 or more, and preferably 30 or less, more preferably 25 or less, even more preferably 20 or less, from the viewpoint of further increasing the compatibility of component (A) and component (B) and effectively achieving both excellent low-temperature stability and good foaming.

The mass ratio ((D)/(B)) of the content of component (D) to the content of component (B) is preferably 0.5 or more, more preferably 1 or more, even more preferably 2 or more, preferably 30 or less, more preferably 25 or less, even more preferably 20 or less, even more preferably 10 or less, and even more preferably 6 or less, from the viewpoint of further increasing the compatibility of component (A) and component (B) and effectively achieving both excellent low-temperature stability and good foaming.

From the viewpoint of exerting an excellent denture plaque removing effect, the cleansing composition for intra-oral instruments of the present invention preferably further contains an anionic homopolymer or copolymer (E). The anionic homopolymer or copolymer is a homopolymer or copolymer containing a structural unit derived from an anionic monomer, and allows the excellent denture plaque removing effect of component (A) to be exerted more effectively.
Furthermore, component (E) may be a homopolymer consisting of structural units derived from only one type of anionic monomer, or may be a copolymer consisting of structural units derived from two or more types of anionic monomers, or may be a copolymer consisting of structural units derived from anionic monomers and structural units derived from monomers other than anionic monomers.

From the viewpoint of effectively improving the denture plaque removal effect, the mass average molecular weight of component (E) is preferably 2000 or more, more preferably 5000 or more, even more preferably 8000 or more, and even more preferably 10000 or more. From the viewpoint of ensuring good solubility or dispersibility of each component, the mass average molecular weight of component (E) is preferably 500000 or less, more preferably 350000 or less, even more preferably 200000 or less, and even more preferably 100000 or less. The mass average molecular weight of component (E) is preferably 2000 or more and 500000 or less, more preferably 5000 to 350000, even more preferably 8000 to 200000, and even more preferably 10000 to 100000.
The mass average molecular weight (Mw) of component (E) means a value determined by gel permeation chromatography (using chloroform solvent, a calibration curve established using linear polystyrene as a standard, and a refractive index detector).

From the viewpoint of greatly contributing to the exertion of the denture plaque removal effect, the anionic monomer-derived structural unit contained in component (E) is preferably a structural unit derived from an anionic monomer (e1) having a carboxyl group, a sulfo group, or a phosphate group. Specific examples of the monomer (e1) constituting component (E) include one or more selected from acrylic acid, methacrylic acid, itaconic acid, maleic acid, fumaric acid, sulfonic acid, styrenesulfonic acid, methacryloyloxyalkylsulfonic acid, methacrylamide alkylsulfonic acid, acryloyloxyalkylphosphate, and anhydrides thereof, monomers partially substituted with alkyl groups, etc., and sugar-derived monomers such as glycopyranose in which a carboxymethyl group is bonded to a portion of a hydroxyl group. Among them, a monomer not containing an aromatic ring or an alicyclic ring in the molecular structure is preferable, and one or more selected from acrylic acid, methacrylic acid, maleic acid, and sulfonic acid are more preferable.

From the viewpoint of effectively ensuring the exertion of an excellent denture plaque removal effect, the content of the structural units derived from anionic monomers in 100% by mass of all structural units of component (E) is preferably 15% by mass or more, more preferably 35% by mass or more, even more preferably 50% by mass or more, and preferably 100% by mass or less.

Specific examples of component (E) include one or more selected from acrylic acid homopolymer, methacrylic acid homopolymer, crosslinked acrylic acid homopolymer, acrylic acid/maleic acid copolymer, acrylic acid/methacrylic acid copolymer, acrylic acid/sulfonic acid copolymer, vinyl acetate/maleic acid copolymer, phosphinic acid/acrylic acid copolymer, carboxymethylcellulose, xanthan gum, gellan gum, alginic acid, carrageenan, pectin, and hyaluronic acid. Among these, from the viewpoint of exerting an excellent denture plaque removal effect, one or more selected from acrylic acid homopolymer, acrylic acid/maleic acid copolymer, acrylic acid/methacrylic acid copolymer, and acrylic acid/sulfonic acid copolymer are preferred, one or more selected from acrylic acid/maleic acid copolymer and acrylic acid/sulfonic acid copolymer are more preferred, and acrylic acid/maleic acid copolymer is even more preferred.

The mass ratio of the constituent units derived from acrylic acid monomers to the constituent units derived from maleic acid monomers constituting the acrylic acid/maleic acid copolymer (acrylic acid/maleic acid) is preferably 0.01 to 99, more preferably 0.05 to 50, even more preferably 0.1 to 10, and even more preferably 0.1 to 5.

The content of component (E) in the cleansing composition for intraoral instruments of the present invention is preferably 0.05% by mass or more, more preferably 0.07% by mass or more, even more preferably 0.2% by mass or more, and even more preferably 0.3% by mass or more, from the viewpoint of ensuring excellent denture plaque removal effect. Also, the content of component (E) in the cleansing composition for intraoral instruments of the present invention is preferably 8% by mass or less, more preferably 7% by mass or less, even more preferably 6% by mass or less, even more preferably 5% by mass or less, even more preferably 4% by mass or less, and even more preferably 2% by mass or less, from the viewpoint of ensuring good solubility or dispersibility of each component and ensuring excellent low-temperature storage stability. The content of component (E) in the cleansing composition for intra-oral instruments of the present invention is preferably 0.05% by mass or more and 8% by mass or less, more preferably 0.07 to 7% by mass, even more preferably 0.2 to 6% by mass, even more preferably 0.2 to 5% by mass, even more preferably 0.3 to 4% by mass, and even more preferably 0.3 to 2% by mass.

The mass ratio of the content of component (E) to the content of component (A) ((E)/(A)) is preferably 0.1 or more, more preferably 0.2 or more, even more preferably 0.3 or more, and is preferably 5 or less, more preferably 4 or less, even more preferably 2 or less, from the viewpoint of effectively achieving both excellent low-temperature stability, good foaming, and good denture plaque cleansing properties.

The cleanser composition for intraoral instruments of the present invention preferably further contains water (F) from the viewpoint of ensuring excellent denture plaque removal effect by exhibiting excellent low-temperature storage stability and good foaming while dispersing or dissolving the above-mentioned components well, and from the viewpoint of increasing the diffusibility of the cleanser composition for intraoral instruments after application to the intraoral instruments.

The content of component (F) in the cleanser composition for intra-oral devices of the present invention is preferably more than 50% by mass, more preferably 56% by mass or more, even more preferably 60% by mass or more, and preferably 99% by mass or less, more preferably 98.5% by mass or less, and even more preferably 98% by mass or less.
In the present invention, water means the total water contained in the cleanser composition for intra-oral instruments, including not only purified water directly blended in the cleanser composition for intra-oral instruments, but also the water contained in each of the blended components. In addition, water in the present invention includes water that is blended in advance in the cleanser composition for intra-oral instruments, but also includes the water used for dilution or dissolution when the cleanser composition is in a state where it is diluted with water or dissolved in water before use.
The water content can be measured by calculation from the amount of water blended and the amount of water in the blended components, but can also be measured, for example, with a Karl Fischer moisture meter.

The cleanser composition for intra-oral appliances of the present invention may contain, in addition to the above-mentioned components, pH adjusters such as carbonates, bicarbonates, hydroxides, organic acids such as citric acid, malic acid, lactic acid, tartaric acid, succinic acid, and salts thereof; surfactants other than the above-mentioned components; anti-inflammatory agents; preservatives; fragrances; pigments; dyes; bleaching agents; enzymes, etc., to the extent that the effects of the present invention are not impaired.

The pH of the cleanser composition for intraoral instruments of the present invention at 25°C is preferably 7 or more, more preferably 8 or more, even more preferably 8.5 or more, preferably 14 or less, more preferably 13 or less, even more preferably 12 or less, even more preferably 11.5 or less, and even more preferably 10 or less, from the viewpoint of ensuring excellent denture plaque removal effect while achieving both excellent low-temperature storage stability and good foaming.

The cleanser composition for intra-oral instruments of the present invention may be in the form of a liquid, foam, paste, gel, concentrated, powder, granule, or tablet, and may further be in the form of a liquid cleanser composition for intra-oral instruments of the present invention filled in a foam-discharging container, a spray container, or an aerosol container in which the cleanser composition for intra-oral instruments of the present invention is impregnated.
When the cleanser composition for intra-oral instruments of the present invention is applied in a concentrated, powdered, granular, or tablet form, the low-temperature stability of the cleanser composition for intra-oral instruments of the present invention means the low-temperature stability when diluted with water or the like or dissolved in water, and the foaming means the foaming produced when diluted with water or the like or dissolved in water.

In particular, from the viewpoint of fully enjoying the effects of the present invention, the cleanser composition for intraoral instruments of the present invention is preferably in a liquid form (liquid cleanser composition), and more preferably in a foam form in which the liquid cleanser composition for intraoral instruments of the present invention is filled into a foam-dispensing container, and it is preferable that the contents of the cleanser composition for intraoral instruments of the present invention are discharged in foam form from the foam-dispensing container at the time of use to clean the intraoral instruments.

Thus, the cleanser composition for intraoral appliances of the present invention, which has both excellent low-temperature stability and foaming properties, when discharged in foam form onto an intraoral appliance, allows the foam to adhere well to the intraoral appliance and allows the composition to reach every corner of the intraoral appliance, which has a complex shape, to effectively and effectively remove excellent denture plaque. As a result, by simply rinsing the intraoral appliance with water after application of the composition, it becomes possible to easily and effectively remove firmly attached denture plaque stains without the need for any additional physical force such as brushing.

The cleanser composition for intraoral instruments of the present invention is used by first immersing an intraoral instrument such as a denture in the cleanser composition for intraoral instruments, or by applying the cleanser composition to the intraoral instrument by foaming, coating, dropping, spraying, or the like, and then leaving the composition for a certain period of time. The leaving time is usually 20 to 30 minutes, and can also be shortened to 5 to 10 minutes.
Next, after leaving it for a while, the intraoral appliance is rinsed with water or the like to wash away the cleanser composition for intraoral appliances. In the case of the cleanser composition for intraoral appliances of the present invention, more preferably, it is sufficient to simply rinse it away, and there is no need to apply any additional physical force such as brushing.

When the cleanser composition for intra-oral appliances of the present invention is filled in liquid form into a foam-dispensing container, it is used by discharging it in foam form from the foam-dispensing container, covering an intra-oral appliance such as a denture with the foam, and then leaving it for a certain period of time.
The time for covering the intraoral appliance with the foam is preferably 1 minute or more, more preferably 2 minutes or more, and even more preferably 3 minutes or more, from the viewpoint of fully enjoying the excellent denture plaque removal effect. Also, the time for covering the intraoral appliance with the foam is preferably 30 minutes or less, more preferably 20 minutes or less, and even more preferably 10 minutes or less, from the viewpoint of fully exerting the effect of the foam. And the time for covering the intraoral appliance with the foam is preferably 1 minute or more and 30 minutes or less, more preferably 2 to 20 minutes, and even more preferably 3 to 10 minutes.

The amount of foam covering the intraoral appliance is, from the viewpoint of fully exerting a good foaming effect and fully enjoying an excellent denture plaque removal effect, preferably 0.05 g or ^more , more preferably 0.07 g or more, even more preferably 0.1 g or more, and preferably 3.5 g or less, more preferably 3.2 g or less, and even more preferably 3 g or less, per 1 cm2 of the surface area of the intraoral appliance.

After the intraoral appliance is covered with the foam, it is preferable to rinse the intraoral appliance with water to wash away the cleaner composition. When the liquid cleaner composition for intraoral appliances of the present invention is filled in a foam-dispensing container and applied in the form of a foam, an excellent denture plaque removal effect can be exhibited while washing away the covering foam simply by rinsing the intraoral appliance with water without requiring any particular physical additional force, and since the composition has excellent low-temperature stability, the effect can be maintained regardless of the storage environment, and the constant burden on users such as elderly people can be reduced and the frequency of use can be easily increased.
In addition, after the intraoral appliance is covered with the foam, it is preferable to rinse the intraoral appliance with water after the composition has been applied without applying any additional physical force, which makes it possible to clean the intraoral appliance simply and effectively.

The foam-discharging container filled with the cleansing agent composition for intra-oral instruments of the present invention is a container equipped with a foam-forming mechanism, and foam is formed by spraying or discharging from the container.
Specifically, a container equipped with a foam-forming mechanism is a container that can form foam by spraying or discharging the contents filled in the container from a spray or discharge port to the outside of the container via the foam-forming mechanism. Examples of containers equipped with such a foam-forming mechanism include trigger-type spray containers and pump-type dispenser containers.

A trigger-type spray container has a container body in which the contents are filled, and a trigger and a sprayer which are foam-forming mechanisms, and when the trigger is pulled during use, the contents are sprayed to the outside from the nozzle of the sprayer to form foam. Such a trigger-type spray container may be of either a direct pressure type or a pressure-accumulation type.
A pump-type dispenser container comprises a container body into which the contents are filled, a tube or nozzle, and a foam-forming mechanism such as a mesh inside these. When using the container, by pressing part of it, the contents are ejected from the outlet of the tube or nozzle to the outside, forming a foam.
When the cleansing composition for intraoral instruments of the present invention is used to clean intraoral instruments, it is preferable to use a trigger-type spray container among these containers, from the viewpoint of fully exerting the foam effect.

When using a trigger-type spray container, in order to fully utilize the foam effect, it is desirable to set the spray diameter at a spray distance of 20 cm to preferably 2 cm or more, more preferably 3 cm or more, preferably 10 cm or less, and more preferably 8 cm or less.
In addition, in a trigger-type spray container, the spray force of the cleaner composition contained therein is desirably set to preferably 1 g f or more, more preferably 3 g f or more, and preferably 10 g f or less, more preferably 8 g f or less at a spray distance of 20 cm, from the viewpoint of effectively forming foam.

In relation to the above-mentioned embodiment, the present invention further discloses the following cleansing agent composition for an intraoral instrument.
[1] The following components (A) and (B):
A cleansing agent composition for intra-oral instruments, comprising: (A) a fatty acid or a salt thereof having from 10 to 20 carbon atoms, the amount of which is 0.1% by mass to 20% by mass in terms of fatty acid; and (B) a chelating agent having a molecular weight of from 80 to less than 600, wherein the mass ratio ((A)/(B)) of the content of component (A) to the content of component (B) is 0.05 or more and 20 or less.
[2] A cleansing composition for intra-oral instruments as described in [1] above, wherein the number of carbon atoms of the fatty acid of component (A) and the fatty acid constituting the fatty acid salt of component (A) is preferably 12 or more and 20 or less, more preferably 14 or more and 20 or less, and even more preferably 16 or more and 20 or less, and the fatty acid of component (A) may have a saturated or unsaturated straight-chain or branched chain, and more preferably has an unsaturated straight-chain.
[3] A cleanser composition for intra-oral instruments according to the above [1] or [2], wherein the content of component (A) is preferably 0.2 mass% or more, more preferably 0.3 mass% or more, even more preferably 0.5 mass% or more, and preferably 15 mass% or less, more preferably 10 mass% or less, and even more preferably 5 mass% or less, in terms of fatty acids.
[4] The cleanser composition for intra-oral instruments according to any one of the above [1] to [3], wherein component (B) is one or more selected from phosphoric acid, phosphonic acid, aminocarboxylic acid, oxycarboxylic acid, and salts thereof, including hydrates (hydrated salts), preferably one or more selected from phosphoric acid, phosphonic acid, and salts thereof, more preferably phosphonic acid or a salt thereof, and even more preferably hydroxyethanediphosphonic acid or a salt thereof.
[5] The cleanser composition for intra-oral instruments according to any one of [1] to [4] above, wherein the content of component (B) is preferably 0.1 mass% or more, more preferably 0.2 mass% or more, even more preferably 0.4 mass% or more, still more preferably 0.5 mass% or more, still more preferably 1.5 mass% or more, preferably 20 mass% or less, more preferably 15 mass% or less, even more preferably 12 mass% or less, still more preferably 8 mass% or less, and still more preferably 6 mass% or less.

[6] The cleanser composition for intra-oral instruments according to any one of the above [1] to [5], wherein the mass ratio of the content of component (A) to the content of component (B) ((A)/(B)) is preferably 0.1 or more, more preferably 0.15 or more, even more preferably 0.2 or more, even more preferably 0.25 or more, preferably 10 or less, more preferably 5 or less, even more preferably 4 or less, still more preferably 3 or less, still more preferably 2 or less, still more preferably 1 or less, and still more preferably 0.8 or less.
[7] The cleanser composition for intraoral instruments according to any one of the above [1] to [6], further comprising one or more surfactants (C) selected from anionic surfactants (c1), nonionic surfactants (c2), and amphoteric surfactants (c3) other than component (A).
[8] The cleanser composition for intra-oral instruments of the above [7], wherein the content of component (C) is preferably 0.2 mass% or more, more preferably 0.3 mass% or more, even more preferably 0.5 mass% or more, and preferably 10 mass% or less, more preferably 8 mass% or less, and even more preferably 5 mass% or less.
[9] The cleanser composition for intra-oral instruments according to the above [7] or [8], wherein the mass ratio of the content of component (C) to the content of component (A) ((C)/(A)) is preferably 0.2 or more, more preferably 0.3 or more, even more preferably 0.5 or more, and is preferably 5 or less, more preferably 4 or less, even more preferably 3 or less.

[10] The cleanser composition for intra-oral instruments according to any one of the above [1] to [9], further comprising a solvent (D), the content of which is preferably 1 mass% or more, more preferably 2 mass% or more, even more preferably 3 mass% or more, preferably 30 mass% or less, more preferably 25 mass% or less, and even more preferably 15 mass% or less.
[11] The cleanser composition for intra-oral instruments according to the above [10], wherein the mass ratio of the content of component (D) to the content of component (A) ((D)/(A)) is preferably 1 or more, more preferably 3 or more, even more preferably 5 or more, and preferably 30 or less, more preferably 25 or less, even more preferably 20 or less.
[12] The cleanser composition for intra-oral instruments according to the above [10] or [11], wherein the mass ratio of the content of component (D) to the content of component (B) ((D)/(B)) is preferably 0.5 or more, more preferably 1 or more, even more preferably 2 or more, and preferably 30 or less, more preferably 25 or less, even more preferably 20 or less, still more preferably 10 or less, and even more preferably 6 or less.
[13] The cleansing composition for intraoral instruments according to any one of the above [1] to [12], further comprising an anionic homopolymer or copolymer (E).
[14] The cleanser composition for intra-oral instruments according to any one of the above [1] to [13], further comprising water (F), the content of which is preferably more than 50% by mass, more preferably 56% by mass or more, even more preferably 60% by mass or more, and preferably 99% by mass or less, more preferably 98.5% by mass or less, and even more preferably 98% by mass or less.

[15] The cleanser composition for intra-oral instruments according to any one of the above [1] to [14], which has a pH at 25°C of preferably 7 or more, more preferably 8 or more, even more preferably 8.5 or more, and preferably 14 or less, more preferably 13 or less, even more preferably 12 or less, still more preferably 11.5 or less, and even more preferably 10 or less.
[16] The detergent composition for intra-oral instruments according to any one of [1] to [15] above, may be in the form of a liquid, foam, paste, gel, concentrated, powder, granule, or tablet. It is preferably in the form of a liquid, and more preferably in the form of a foam in which the liquid detergent composition for intra-oral instruments of the present invention is filled in a foam-dispensing container.

The present invention will be described in detail below with reference to examples. Unless otherwise specified in the table, the content of each component is expressed as mass %.

[Examples 1 to 26, Comparative Examples 1 to 4]
Each cleanser composition for intraoral instruments was prepared by mixing the components shown in Tables 1 and 4. The obtained cleanser compositions for intraoral instruments were evaluated according to the following methods.
The results are shown in Tables 1 to 4.

Evaluation of low-temperature storage stability
Each of the obtained cleanser compositions for intraoral instruments was filled to the full capacity of an 80 ml transparent PET (polyethylene terephthalate) bottle and storage was initiated at -5°C. Every seven days, the contents of the cleanser composition for intraoral instruments were visually observed from the outside of the PET container and the number of days until each cleanser composition for intraoral instruments became uniformly transparent was counted.

Evaluation of foaming
Each of the obtained cleanser compositions for intra-oral instruments was filled into a foam-ejecting container (a trigger-type spray container set to a spray diameter of 5 cm at a spray distance of 20 cm and a spray force of 5 gf), and sprayed 10 times in foam form from the nozzle into a 200 ml measuring cylinder (manufactured by Nikko Hansen, material: PMMA, manufacturer's model number: 30-0106-55). The total volume of foam (ml) was measured and converted into the foam volume per gram of composition (ml/g), which was used as an index for evaluating foaming. The measurement temperature was 25°C.

<Evaluation of denture plaque removal effect>
1) Preparation of denture plaque model Agar plates (Anaero Columbia Agar with RSB, Nippon Becton Dickinson) were streaked with glycerol stocks of Streptococcus mutans JCM5705 and Candida albicans JCM1542. The plates were stored in a plastic case together with a _CO2 pack under anaerobic conditions and cultured at 37°C for 48 to 72 hours. A single colony was picked up from the cultured agar plate and placed in a cell culture flask containing 20 mL of liquid medium A (SCD medium Daigo (manufactured by Nippon Pharmaceutical Co., Ltd.) 3% by mass, Bacto Yeast Extract (manufactured by Becton Dickinson) 0.5% by mass) and stirred. The plates were stored in a plastic case together with a _CO2 pack under anaerobic conditions and cultured at 37°C for 24 hours. The culture solution was diluted with liquid medium A to OD = 0.5. This diluted solution was diluted with liquid medium B (SCD medium Daigo 3% by mass, Bacto Yeast Extract 0.5% by mass, D(+)-glucose (Fuji Film Wako Pure Chemical Industries, Ltd.) 1% by mass, sucrose (Fuji Film Wako Pure Chemical Industries, Ltd.) 2% by mass) to give S. mutans OD = 0.01 and C. albicans OD = 0.0001. A sterilized aqueous solution of calcium chloride (Fuji Film Wako Pure Chemical Industries, Ltd.) was further mixed with this diluted solution to give a final calcium ion concentration of 100 ppm to prepare a denture plaque model test solution.
Next, the saliva-treated denture substrate (manufactured by Kyoyu Co., Ltd., material: polymethyl methacrylate resin, 1 cm) was placed in a 24-hole plate, and 1 mL of the prepared denture plaque model test liquid was added to each well. The plate was then stored in a plastic case together with a _CO2 pack under anaerobic conditions and cultured at 37°C for 16 hours. For the saliva treatment, first, stimulated saliva collected from a healthy adult was centrifuged (3000 rpm, 25°C, 10 minutes), and the supernatant was filter-sterilized to prepare a saliva sample. Next, the denture substrate was placed in a 24-hole plate, and 1 mL of the prepared saliva sample was added to each well. The plate was then stored in a plastic case and left to stand at 37°C for 6 hours. The saliva sample in the plate was then sucked up using a vacuum pump.

2) Evaluation of denture plaque removal effect The denture plaque model test liquid in the plate was sucked up using a vacuum pump, 1 mL of ion-exchanged water was added, and the plate was shaken for 5 minutes. Next, the water was sucked up using a pump, and 1 mL of each of the above-obtained detergent compositions for intraoral appliances was prepared separately in a 24-well plate. Next, the denture base plate on which the denture plaque model was formed was immersed in the prepared solution and left to stand for 5 minutes.
Then, each composition was sucked up, 1 mL of ion-exchanged water was added, and the mixture was shaken for 5 minutes. This operation was repeated three times. The shaking was performed using a shaker (BioShake iQ (manufactured by Wakembie Tech Co., Ltd.)) at room temperature (25°C) and 550 rpm. Next, the water was sucked up, and 750 μL of 0.1% by mass crystal violet (CV) solution was added, followed by shaking for 15 minutes.

The CV staining solution was then sucked up using a pump, 1 mL of ion-exchanged water was added, and the mixture was shaken for 5 minutes, which was repeated twice. Next, the water was sucked up using a pump, 500 μL of ethanol was added, and the mixture was pipetted. The extract was then diluted 10-fold with ion-exchanged water, and the absorbance OD _{595 nm} was measured using a microplate recorder (TECAN, wavelength-variable absorbance microplate reader, Sunrise Rainbow Thermo).
In addition, the denture plaque removal rate (%) was calculated according to the following formula (1) using the absorbance OD _{595 nm} (initial value) obtained simply by washing with ion-exchanged water without using the above-obtained composition as the standard.
Denture plaque removal rate (%) =
100- {OD _{595 nm} when the above-obtained composition was used / Only washed with ion-exchanged water
OD _{595 nm} } × 100 ... (1)

A higher denture plaque removal rate indicates a higher denture plaque removal effect, so the denture plaque removal effect was evaluated based on this value and according to the following criteria.
AA: AA: Denture plaque removal rate is 80% or more. A: Denture plaque removal rate is 70% or more but less than 80%. B: Denture plaque removal rate is 60% or more but less than 70%. C: Denture plaque removal rate is 35% or more but less than 60%. D: Denture plaque removal rate is 20% or more but less than 35%. E: Denture plaque removal rate is less than 20%.

Formulation examples of the cleansing composition for intraoral instruments of the present invention are shown below.
*1 to *3 are the same as in Table 1, and *4 is AQUALIC GH-004, manufactured by Nippon Shokubai Co., Ltd.

[Formulation Example 1]

[Formulation Example 2]

[Formulation Example 3]

[Formulation Example 4]

Claims (7)

The following components (A) and (B):
(A) a fatty acid having 10 to 20 carbon atoms or a salt thereof, the amount of which is 0.1% by mass or more and 20% by mass or less in terms of fatty acid; (B) a chelating agent having a molecular weight of 80 to less than 600 ;
A cleansing agent composition for intra-oral instruments, in which the mass ratio ((A)/(B)) of the content of component (A) to the content of component (B) is 0.05 or more and 20 or less , and the pH at 25°C is 8.5 or more and 14 or less . The cleansing composition for intraoral instruments according to claim 1, wherein component (B) is one or more selected from phosphoric acid, phosphonic acid, aminocarboxylic acid, oxycarboxylic acid, and salts thereof. The cleansing composition for intraoral instruments according to claim 1 or 2, wherein the content of component (B) is 0.1% by mass or more and 20% by mass or less. The cleanser composition for intraoral instruments according to any one of claims 1 to 3 further contains one or more surfactants (C) selected from anionic surfactants (c1), nonionic surfactants (c2), and amphoteric surfactants (c3) other than component (A). Further, the composition contains one or more solvents (D) selected from monohydric or dihydric alcohols having from 2 to 6 carbon atoms and alcohols having an aromatic group,
5. The cleanser composition for intra-oral instruments according to any one of claims 1 to 4, wherein the mass ratio ((D)/(A)) of the content of component (D) to the content of component (A) is 1 or more and 20 or less, and the mass ratio ((D)/(B)) of the content of component (D) to the content of component (B) is 0.5 or more and 20 or less. The cleanser composition for intraoral instruments according to any one of claims 1 to 5 further contains more than 50% by mass and not more than 99% by mass of water (F). The cleansing composition for intraoral instruments according to any one of claims 1 to 6, which is in the form of a foam.