Denture stabilizer

Abstract

To provide a denture stabilizer that exhibits adequate retention duration and allows easy removal or cleaning.SOLUTION: A denture stabilizer comprises: (A) at least one water-soluble polymer selected from the group consisting of polyacrylic acid, polyacrylate, alginic acid, alginate, and alginic acid ester, and (B) at least one water-soluble adhesive polymer selected from the group consisting of a methoxyethylene-maleic anhydride copolymer salt and carboxymethylcellulose.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a denture adhesive that has both sufficient retention time and ease of removal and cleaning. [Background technology]

[0002] Denture adhesives are sometimes used when fitting dentures into the mouth. Denture adhesives are applied to the surface of the denture base, which is the base of the dentures, to increase adhesion and adhesion to the gums and upper jaw, preventing the dentures from slipping when eating or speaking.

[0003] There are various types of denture adhesives, including cream, powder, and cushion types. Among them, "Polygrip (registered trademark)," which is classified as a cream type, has the top market share among denture adhesives and is sold in large quantities not only at dental clinics but also at general drugstores. Denture adhesives absorb saliva in the mouth to provide adhesiveness, improving the retention and stability of dentures. The main adhesive components are water-swellable, water-soluble polymers such as sodium / calcium methoxyethylene maleic anhydride copolymer salt (PVMA salt) and carboxymethylcellulose (CMC). Cream-type denture adhesives, including Polygrip, also contain hydrophobic ointment bases such as liquid paraffin and white petrolatum. The denture adhesive is retained in the mouth by a balance between the water absorption and viscosity of the water-soluble polymer and the resistance to leaching provided by the hydrophobic ointment base.

[0004] Many denture wearers want their dentures to stay in place for a long time without slipping or falling out of their mouths. For this reason, many denture adhesives, especially those sold to the general public, are characterized by their ability to maintain strong retention over a long period of time.

[0005] However, dentures and denture adhesives are not retained in the mouth permanently and must be removed from the mouth periodically and properly cleaned. However, it is not easy to completely remove denture adhesive that has adhered to the mouth or dentures. Particularly in care settings, it is often the case that cooperation from denture wearers is not obtained or that it is difficult to devote the time and effort to the process, resulting in occasional cases where denture adhesive that has not been completely removed remains in the mouth or on the dentures.

[0006] Bacteria can grow on the surface of denture adhesive remaining in the mouth or on dentures, forming a biofilm that can lead to denture stomatitis. It has also been suggested that oral bacteria may be involved in diseases such as bacterial endocarditis, aspiration pneumonia, and respiratory tract infections. Many denture wearers are elderly and often in poor general health, making them more susceptible to these diseases. Therefore, there is a need for denture adhesives that can be easily removed or cleaned.

[0007] As mentioned above, conventional denture adhesives contain a water-soluble polymer, such as PVMA salt or CMC, and a hydrophobic ointment base. A high ratio of these water-soluble polymers results in a denture adhesive that is easy to remove but has a short retention time, while a high ratio of hydrophobic ointment base results in a denture adhesive that has a long retention time but is difficult to remove. No denture adhesive is known that combines the contradictory properties of "sufficient retention time" and "easy removal or cleaning." Summary of the Invention [Problem to be solved by the invention]

[0008] An object of the present invention is to provide a denture adhesive that has sufficient retention time and is easy to remove or clean. [Means for solving the problem]

[0009] The present inventors have conducted extensive research to solve the above problems and have found that a denture adhesive comprising (A) at least one water-soluble polymer selected from the group consisting of polyacrylic acid, polyacrylates, alginic acid, alginates, and alginate esters, and (B) at least one water-soluble adhesive polymer selected from the group consisting of methoxyethylene maleic anhydride copolymer salts and carboxymethylcellulose, has a sufficient retention time and can be easily removed or cleaned.

[0010] The present invention was completed based on the above findings, and provides the following denture adhesive. [1] A denture adhesive comprising (A) at least one water-soluble polymer selected from the group consisting of polyacrylic acid, polyacrylates, alginic acid, alginates, and alginate esters, and (B) at least one water-soluble adhesive polymer selected from the group consisting of methoxyethylene maleic anhydride copolymer salts and carboxymethylcellulose. [2] The denture adhesive according to [1], wherein the concentration of the water-soluble polymer (A) is 0.1 to 12 mass % relative to the total amount of the denture adhesive. [3] A denture adhesive according to [1] or [2], wherein the concentration of the water-soluble adhesive polymer (B) is 5 to 90% by mass relative to the total amount of the denture adhesive. [4] The denture adhesive according to any one of [1] to [3], further comprising (C) a hydrocarbon base. [5] The denture adhesive according to [4], wherein the concentration of the hydrocarbon base (C) is 10 to 90% by mass based on the total amount of the denture adhesive. [Effects of the Invention]

[0011] Many of the cream-type denture adhesives commonly used in the past contain a large amount of hydrophobic ointment base, making them highly hydrophobic and difficult to remove even with water rinsing. However, when a large amount of water-swellable, water-soluble polymer is added to facilitate removal, the retention time is shortened, making it difficult to achieve both "sufficient retention time" and "easy removal or cleaning." In contrast, the denture adhesive of the present invention contains at least one water-soluble polymer (A) selected from the group consisting of polyacrylic acid, polyacrylates, alginic acid, alginates, and alginate esters in addition to the water-swellable, water-soluble adhesive polymer (B) that has been used conventionally, thereby achieving both sufficient retention time and excellent removability and cleaning properties. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present invention will be described in detail below. The denture adhesive of the present invention comprises (A) at least one water-soluble polymer selected from the group consisting of polyacrylic acid, polyacrylates, alginic acid, alginates, and alginate esters, and (B) at least one water-soluble adhesive polymer selected from the group consisting of methoxyethylene maleic anhydride copolymer salts and carboxymethylcellulose.

[0013] (A) Water-soluble polymer The salts of polyacrylic acid and alginic acid may be any pharmaceutically acceptable salt, such as salts with inorganic bases (alkali metal salts such as sodium salts and potassium salts, alkaline earth metal salts such as calcium salts and magnesium salts, metal salts such as zinc salts and aluminum salts, ammonium salts, etc.), salts with organic bases (methylamine salts, triethylamine salts, triethanolamine salts, morpholine salts, piperazine salts, pyrrolidine salts, tripyridine salts, picoline salts, etc.). Among these, salts with inorganic bases are preferred, alkali metal salts are more preferred, and sodium salts are even more preferred. When the denture adhesive of the present invention contains a polyacrylate and / or an alginate, it may be a composition containing a polyacrylate and / or an alginate, or it may be a composition in which a polyacrylate and / or an alginate is separately blended with a polyacrylic acid and / or an alginate and an organic or inorganic base, resulting in a polyacrylate and / or an alginate in the composition.

[0014] Alginic acid and alginate salts with various viscosities are available, ranging from 20 to 1000 mPa·s. Among these, those with viscosities of 100 mPa·s or more, 300 mPa·s or more, 500 mPa·s or more, 600 mPa·s or more, or 700 mPa·s or more are preferred for the present invention. The viscosity can also be 900 mPa·s or less, or 800 mPa·s or less. There are also multiple polyacrylic acids and polyacrylates with various viscosities, which can range from 200 to 200,000 mPa·s. Among these, those with a viscosity of 3,000 mPa·s or more, 5,000 mPa·s or more, 7,000 mPa·s or more, or 9,000 mPa·s or more, and 17,000 mPa·s or less, 15,000 mPa·s or less, 13,000 mPa·s or less, or 11,000 mPa·s or less are suitable for the present invention.

[0015] The concentration of the (A) water-soluble polymer can be 0.1% by mass or more, 0.5% by mass or more, 1% by mass or more, 2% by mass or more, 3% by mass or more, or 4% by mass or more, and can be 12% by mass or less, 10% by mass or less, 9% by mass or less, 8% by mass or less, or 7% by mass or less, based on the total amount of the denture adhesive. This range ensures sufficient retention time and ease of removal or rinsing. When multiple (A) water-soluble polymers are included, this concentration refers to their combined concentration.

[0016] (B) Water-soluble adhesive polymer The salt of methoxyethylene maleic anhydride copolymer may be any pharmaceutically acceptable salt, and examples thereof include salts with inorganic bases (alkali metal salts such as sodium salt and potassium salt, alkaline earth metal salts such as calcium salt and magnesium salt, metal salts such as zinc salt and aluminum salt, ammonium salt, etc.) and salts with organic bases (methylamine salt, triethylamine salt, triethanolamine salt, morpholine salt, piperazine salt, pyrrolidine salt, tripyridine salt, picoline salt, etc.). Among these, salts with inorganic bases are preferred, alkali metal salts and alkaline earth metal salts are more preferred, sodium salt and calcium salt are even more preferred, and Na / Ca salt, which is a mixture of sodium salt and calcium salt, is particularly preferred. When the denture stabilizer of the present invention contains a methoxyethylene maleic anhydride copolymer salt, it may be a composition containing a methoxyethylene maleic anhydride copolymer salt, or a composition in which a methoxyethylene maleic anhydride copolymer and an organic or inorganic base are separately blended, resulting in a methoxyethylene maleic anhydride copolymer salt in the composition.

[0017] The molecular weight of the methoxyethylene maleic anhydride copolymer can be 200,000 or more, 400,000 or more, 600,000 or more, 800,000 or more, or 1,000,000 or more, and can be 2,400,000 or less, 2,200,000 or less, or 2,000,000 or less. Carboxymethyl cellulose having a variety of viscosities is available, and the range can be 7 to 15,000 mPa·s. Among these, carboxymethyl cellulose having a viscosity of 30 mPa·s or more, 50 mPa·s or more, or 100 mPa·s or more and 10,000 mPa·s or less, 5,000 mPa·s or less, or 1,000 mPa·s or less is suitable for the present invention.

[0018] In the present invention, the viscosity is a value measured using a Brookfield viscometer according to Method 2 of the Rotational Viscometer Method, Viscosity Measurement Method of the General Test Methods of the Japanese Pharmacopoeia, 18th Edition, in a 0.5 to 2.0% aqueous solution of each polymer compound at 20 to 25°C. In the present invention, the molecular weight of the polymer compound is a mass average molecular weight, and the method for measuring it includes size exclusion chromatography, a general test method in the 18th edition of the Japanese Pharmacopoeia.

[0019] The concentration of (B) water-soluble adhesive polymer can be 5% by weight or more, 10% by weight or more, 20% by weight or more, 30% by weight or more, or 40% by weight or more, and can be 90% by weight or less, 80% by weight or less, 70% by weight or less, 60% by weight or less, or 55% by weight or less, based on the total amount of denture adhesive. This range ensures sufficient retention time and ease of removal or rinsing. When multiple (B) water-soluble adhesive polymers are used, this concentration refers to the total concentration of all of them.

[0020] The content ratio of the (B) water-soluble adhesive polymer can be 4 parts by mass or more, 5 parts by mass or more, 6 parts by mass or more, 7 parts by mass or more, 8 parts by mass or more, 10 parts by mass or more, 15 parts by mass or more, or 20 parts by mass or more per part by mass of the (A) water-soluble polymer, and can be 80 parts by mass or less, 70 parts by mass or less, 60 parts by mass or less, 50 parts by mass or less, or 55 parts by mass or less. Within this range, the composition has a sufficient retention time and is easy to remove or wash off. When multiple (A) water-soluble polymers or multiple (B) water-soluble adhesive polymers are contained, this content ratio refers to the ratio of their total contents.

[0021] base The denture adhesive of the present invention may further comprise a base. Oily bases include petrolatum (white petrolatum, yellow petrolatum), gelling hydrocarbons (such as Plastibase), ozokerite, ceresin, microcrystalline wax, squalene, squalane, α-olefin oligomers, hydrocarbons such as paraffin, liquid paraffin, and light liquid paraffin; higher alcohols such as cetyl alcohol, cetostearyl alcohol, stearyl alcohol, and behenyl alcohol; shea butter, carnauba wax, cocoa butter, candelilla wax, avocado oil, olive oil, camellia oil, macadamia nut oil, evening primrose oil, jojoba oil, rapeseed oil, egg yolk oil, sesame oil, castor oil, safflower oil, and cotton. Examples of suitable oils include vegetable oils such as rice bran oil, soybean oil, tea seed oil, rice bran oil, rice germ oil, wheat germ oil, peanut oil, sunflower oil, almond oil, corn oil, coconut oil, orange oil, sage oil, palm oil, mink oil, meadowfoam oil, lavender oil, rosemary oil, and rosehip oil; animal oils such as lanolin, orange roughy oil, squalane, horse oil, whale wax, and beeswax; cellulose derivatives such as ethyl cellulose, hydroxypropyl cellulose, and hydroxypropyl methylcellulose; and synthetic polymers such as polyvinylpyrrolidone, carboxyvinyl polymer, and alkyl acrylate methacrylate copolymer. Examples of aqueous bases include water; lower alcohols such as ethanol and isopropanol; and polyhydric alcohols such as polyethylene glycol, propylene glycol, dipropylene glycol, 1,3-butylene glycol, glycerin, diglycerin, and isoprene glycol. One or more bases can be used. By combining components that are solid at room temperature with components that are liquid at room temperature and selecting the ratio, the denture adhesive's consistency can be adjusted to a paste-like consistency that is easy to use.

[0022] The denture adhesive of the present invention preferably contains a hydrocarbon base, and more preferably contains petrolatum (particularly white petrolatum) and / or paraffin (particularly liquid paraffin). Hydrocarbon bases are suitable because they are safe and almost tasteless and odorless. Because hydrocarbon bases are oily components, they prevent the denture adhesive from being dissolved by saliva and other moisture in the oral cavity, which could cause a loss of denture retention.

[0023] When a hydrocarbon base is included, its concentration can be 10% by weight or more, 20% by weight or more, 30% by weight or more, 40% by weight or more, or 45% by weight or more, and 90% by weight or less, 80% by weight or less, 70% by weight or less, 60% by weight or less, or 55% by weight or less, based on the total amount of the denture adhesive. This range ensures sufficient retention time and ease of removal or rinsing. When multiple hydrocarbon bases are included, this concentration refers to the total concentration of all of them.

[0024] When a hydrocarbon base agent is included, its content can be 4 parts by mass or more, 5 parts by mass or more, 6 parts by mass or more, 7 parts by mass or more, 8 parts by mass or more, 10 parts by mass or more, 15 parts by mass or more, or 20 parts by mass or more per part by mass of the (A) water-soluble polymer, and can be 80 parts by mass or less, 70 parts by mass or less, 60 parts by mass or less, 50 parts by mass or less, or 40 parts by mass or less. Within this range, the composition has a sufficient retention time and is easy to remove or wash off. When multiple (A) water-soluble polymers or multiple hydrocarbon base agents are included, this content ratio refers to the ratio of their total contents.

[0025] The denture adhesive of the present invention preferably does not contain an aqueous base, particularly does not contain water. If an aqueous base (particularly water) is contained, its content may be greater than 0% by mass, up to 0.001%, 0.01%, 0.1%, or 1% by mass, based on the total mass of the denture adhesive.

[0026] Optional ingredients In addition to the (A) water-soluble polymer, (B) water-soluble adhesive polymer, and base, the denture adhesive of the present invention may contain other ingredients within the range that does not impair the effects of the present invention. Such ingredients include additives such as preservatives, stabilizers, release enhancers, deodorants, cooling agents, fragrances, and colorants, as well as functional ingredients. One or more of these other ingredients may be used.

[0027] Examples of preservatives include glycerin fatty acid esters; parabens such as isobutyl parahydroxybenzoate, isopropyl parahydroxybenzoate, methyl parahydroxybenzoate, sodium methyl parahydroxybenzoate, ethyl parahydroxybenzoate, sodium ethyl parahydroxybenzoate, butyl parahydroxybenzoate, propyl parahydroxybenzoate, and sodium propyl parahydroxybenzoate; benzoic acids such as benzoic acid, sodium benzoate, and benzyl benzoate; and quaternary ammonium salts such as benzalkonium chloride, benzethonium chloride, methylbenzethonium chloride, cetylpyridinium chloride, tetraethylammonium bromide, and didecyldimethylammonium chloride.

[0028] The glycerin fatty acid ester may be any of monoglycerides, diglycerides, and triglycerides, but monoglycerides and diglycerides are preferred.Specific examples include acetate monoglyceride, citric acid monoglyceride, succinic acid monoglyceride, diacetyltartaric acid monoglyceride, and lactic acid monoglyceride. Commercially available glycerin fatty acid esters include SY Glystar manufactured by Sakamoto Pharmaceutical Co., Ltd., Monoglycerin MB manufactured by NOF Corporation, and Poem B-100, Poem HB, Poem J-0381V, Poem J-2081, Poem TR-FB, Poem W-10, and Poem W-60 manufactured by Riken Vitamin Co., Ltd.

[0029] Examples of stabilizers include titanium oxide, sodium chloride, potassium chloride, magnesium chloride, and aluminum lactate. Exfoliation enhancers include calcium carbonate, calcium phosphate, bentonite, silicon dioxide, and the like. Deodorizers include sodium copper chlorophyllin and polyphenols. Cooling agents include menthol, anethole, eugenol, camphor, geraniol, and the like. Examples of functional ingredients include anti-inflammatory agents such as glycyrrhetinic acid, glycyrrhetinic acid salts, glycyrrhizinic acid, and glycyrrhizinic acid salts; disinfectants such as isopropylmethylphenol, triclosan, cetylpyridinium chloride, dequalinium chloride, benzethonium chloride, benzalkonium chloride, chlorhexidines, and hinokitiol; antibiotics; vitamins such as ascorbic acid, ascorbic acid derivatives, and tocopherol acetate; and enzymes for decomposing dental plaque such as dextranase, amylase, protease, mutanase, bacteriolytic enzymes, and lysozyme.

[0030] Purpose The denture adhesive of the present invention is applied to the denture base surface or the gingival mucosa and is used to stably hold, maintain, or fix a denture to the gingival mucosa surface by its adhesive power. Products used in a similar manner include denture adhesive fillers and denture base lining materials, and the denture adhesive of the present invention can also be considered a denture adhesive filler or a short-term denture base lining material. [Example]

[0031] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0032] (1) Preparation of denture adhesive Denture adhesives having the compositions shown in Tables 1 and 2 were prepared by mixing the components. In each example and comparative example, sodium alginate, sodium polyacrylate, and CMC were used with viscosities of approximately 800 mPa·s, 10,000 mPa·s, and 150 mPa·s, respectively. PVMA with a mass-average molecular weight of approximately 1,000,000 was used. [Table 1] [Table 2]

[0033] (2) Evaluation of denture adhesive retention time The retention time of the prepared formulation in the human oral cavity was evaluated. 0.6 g of the formulation was applied to a splint made to fit the shape of the subject's palate and attached to the palate. After lunch three hours after wearing it, and after dinner 10 hours after wearing it, it was confirmed whether the splint attached to the subject's palate was retained by the formulation, and the retention time was evaluated according to the following criteria. 〇: Two meals (lunch and dinner) were retained. △: One meal (lunch) was retained. ×: Not even one meal (lunch) was retained.

[0034] The evaluation results are shown in Tables 1 and 2. The preparations of Examples 1 to 6 containing (A) sodium alginate or sodium polyacrylate, and (B) PVMA salt and CMC were able to hold a denture-like splint for one or more servings and were therefore suitable for practical use as denture stabilizers. In contrast, the preparations of Comparative Examples 2, 3, and 5, which did not contain (B) PVMA salt and CMC, were unable to hold even a single serving of splint. Note that the preparation of Comparative Example 5 contained a large amount of aqueous base other than component (A), and therefore the splint came off quickly.

[0035] (3) Evaluation of denture adhesive cleansing properties The cleaning properties of the prepared formulation were evaluated. 0.35 g of the formulation was applied to a 5 cm x 5 cm acrylic plate and immersed in water for 1 minute. The plate was then washed with running water at 3 L / min, and the time until the formulation on the surface of the acrylic plate was completely removed was measured.

[0036] The results are shown in Tables 1 and 2. The preparations of Examples 1 to 6 could be removed within 60 seconds, demonstrating good cleansing properties. In contrast, the preparation of Comparative Example 1, which did not contain (A) sodium alginate or sodium polyacrylate, and the preparation of Comparative Example 4, which contained sodium hyaluronate as the water-soluble polymer instead of (A) sodium alginate or sodium polyacrylate, required a long time for the preparation to be completely removed. Comparative Example 4 was prepared using sodium hyaluronate as the water-soluble polymer, but did not achieve both a good balance between retention time and cleansing ability. [Industrial Applicability]

[0037] The denture adhesive of the present invention is an unprecedented formulation that combines long retention time with easy cleaning, and will be particularly useful in the super-aging society of the future.

Claims

1. A denture adhesive comprising (A) at least one water-soluble polymer selected from the group consisting of polyacrylic acid, polyacrylates, alginic acid, alginates, and alginate esters, and (B) at least one water-soluble adhesive polymer selected from the group consisting of methoxyethylene maleic anhydride copolymer salts and carboxymethylcellulose.

2. 2. The denture adhesive according to claim 1, wherein the concentration of the water-soluble polymer (A) is 0.1 to 12% by mass based on the total amount of the denture adhesive.

3. 3. The denture adhesive according to claim 1, wherein the concentration of the water-soluble adhesive polymer (B) is 5 to 90% by mass relative to the total amount of the denture adhesive.

4. 3. The denture adhesive of claim 1, further comprising (C) a hydrocarbon base.

5. 5. The denture adhesive according to claim 4, wherein the concentration of (C) the hydrocarbon base is 10 to 90% by mass based on the total amount of the denture adhesive.

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