JP2000197645A - Powder aerosol type denture stabilizer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a denture stabilizer capable of rapidly exhibiting high tacky adhesive power after mounting by compounding a hydrophilic polymer compound with an essential component relating to tacky adhesion and forming a power aerosol type by specific component constitution, such as a spray agent. SOLUTION: The tacky adhesive component and the spray agent are incorporated into the power aerosol type denture stabilizer having the excellent tacky adhesive power and tacky adhesive stability in the oral cavity and the hydrophilic polymer compound is used as the tacky adhesive component on the occasion of preparation of the denture stabilizer described above. A copolymer of methyl vinyl ether of 20,000 to 100,000 in average molecular weight and maleic anhydride and/or the partial salt of this copolymer and carboxymethyl cellulose sodium of 50,000 to 400,000 in average molecular weight and <=1.0 in the degree of substitution of carboxymethyl group are used for the tacky adhesive component. More than 75% of the particles of the tacky adhesive component are preferably below 250 μm. Further, polyvinylpyrrolidone and hydroxyproyl cellulose may be compounded in addition to the tacky adhesive component.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a new form of powder aerosol-type denture stabilizer which is easy to use and has excellent adhesive strength and adhesive stability in the oral cavity.

[0002]

2. Description of the Related Art In general, compatibility of complete dentures and partial dentures is deteriorated in accordance with the years since preparation or due to physiological changes in the oral cavity. As a result, the gap between the denture and the mandibular ridge becomes large, causing rattling and a decrease in mastication ability. In such a case,
It is necessary for a specialist such as a dentist or the like to perform a treatment such as a bed change. Denture stabilizers can address such incompatibilities,
It is used as a temporary medical device until it is repaired and prepared by a dentist, or until it visits a dental clinic. In addition, there are times when even a complete denture that fits normally needs to be fixed more strongly when going out or eating. Also in such a case, a denture stabilizer is used temporarily.

[0003] Commercially available denture stabilizer compositions include cream (ointment, adhesive) types having a hydrophilic adhesive polymer such as sodium carboxymethyl cellulose and polyethylene glycol as a main adhesive component, and polyvinyl acetate. And a cushion (adhesion) type containing a plasticizer such as ethanol as a main component. In addition, there are powder type, sheet type, and the like having the same adhesive mechanism as the cream type but different dosage forms. Among them, the cream type completely fills the gap between the ridge and the denture with a hydrophilic polymer swelled by saliva, and stably holds the denture by their adhesive strength. These types of denture stabilizers disperse a hydrophilic polymer in a hydrophobic excipient and retain the denture by hydration with saliva.

The method of using the cream type is such that when a denture is wet or damp, it is difficult to attach a stabilizer, so that moisture is completely removed and an appropriate amount is slightly spread. On the other hand, in the case of the powder type, which stabilizes the denture by the same mechanism as the cream type, an appropriate amount is evenly applied to the surface in contact with the mucous membrane of the denture while the denture is moist, and after the denture is spread, the excess powder is dentured. It is said that it is lightly tapped and dropped, and is attached. As described above, the operation of applying the denture stabilizer to the denture is complicated, and no attempt has been made to improve or solve the complexity.

[0005] Not only is the operation of application complicated, but it is not easy to apply any of the above types of denture stabilizers to dentures uniformly and adequately with current application methods. It is. In the case of the cream type, generally, a method is used in which a denture stabilizer is glued at several places on the denture base, and the denture is spread over the entire denture base by attaching the denture to the mouth and holding it down. This means that sometimes the denture stabilizer is applied in excess of the appropriate amount, so when the denture is worn, the denture stabilizer protrudes from between the mouth and the denture and sticks in the mouth, making the user very uncomfortable. I can make it.

Conversely, if the amount of the first application is insufficient or the application position is inappropriate, even if the denture is pushed to spread the denture stabilizer, an area where the cover cannot be formed may occur. With the same denture stabilizer, one of the factors that determine the adhesion of dentures with denture stabilizers is that, except for the marginal closure force, the denture stabilizer covers the area between the denture and the oral mucosa. It is the size of the area where the interface is adhered. In some cases, the expected edge sealing power may not be sufficiently obtained. When the application amount is insufficient or the application position is inappropriate, the adhesive strength becomes insufficient, which greatly affects the usability.

In the case of the powder type, the denture stabilizer is applied after moistening the denture. However, since the hydrophobic denture surface repels water and the shape of the surface is very complicated, it is uniformly applied on the denture base. It is difficult to do. Therefore, it cannot be sufficiently applied to a necessary portion uniformly, and it is recognized that, as in the case of the cream type, it is insufficient to impart adhesive force or adhesion to the denture.

In the cushion type, after taking out the denture stabilizer from the tube, spreading it by hand, putting it on the mouth, removing the portion protruding from the denture with a finger, pressing it well, and then putting it back on the mouth again The mounting method is a commonly used coating method. Further, as a dosage form for applying a denture stabilizer to a denture, a powdered aerosol type denture stabilizer is not in the range of the technology disclosed so far.

[0009]

SUMMARY OF THE INVENTION An object of the present invention is to provide a denture stabilizer which can be applied simply and easily to a denture surface having a complicated surface shape without any excess or shortage. An object of the present invention is to provide a denture stabilizer which can reduce the inconvenience and discomfort of the user due to the fact that the denture can express the high adhesive force quickly and in a short time and stabilize the denture as compared with the conventional denture stabilizer.

[0010]

Means for Solving the Problems The inventors of the present invention have conducted intensive studies on the above-mentioned problems, and as a result, by using a powdered aerosol method, the denture stabilizer can be easily applied to complex and diverse denture surface shapes. To obtain the knowledge that can reach and apply
Furthermore, the present invention has found a denture stabilizer which expresses a high adhesive strength quickly after mounting by blending a hydrophilic polymer compound with a main component related to adhesion and forming a powder aerosol type by a specific component composition such as a propellant. Was completed. The denture stabilizer of the present invention is an aerosol type denture stabilizer which has excellent stability over time and can withstand long-term storage. Accordingly, the present invention relates to a powdered aerosol-type denture stabilizer containing an aerosol, especially a hydrophilic polymer compound.

The pressure-sensitive adhesive component used in the present invention is a hydrophilic polymer compound, which may be used as a normal denture stabilizer, for example, sodium carboxymethylcellulose,
Semi-synthetic polymers such as hydroxymethylcellulose, hydroxyethylcellulose and hydroxypropylmethylcellulose. Natural polymers such as gum arabic, gum tragacanth, locust bean gum, guar gum, agar, karaya gum, carrageenan, and sodium alginate. Polyvinyl alcohol, a copolymer of methyl vinyl ether and maleic anhydride, a partial alkali metal and / or alkaline earth metal salt of the copolymer, polyacrylic acid,
Examples include synthetic polymers such as sodium polyacrylate and polyethylene oxide containing partially neutralized products. Further, high molecular compounds composed of natural and artificial amino acids may be mentioned, and these may be used alone or in combination of two or more. The amount of these compounds is preferably 5 to 50% by weight based on the total amount of the composition.

Among them, a partial alkali metal and / or alkaline earth metal salt of a copolymer of methyl vinyl ether and maleic anhydride, sodium carboxymethylcellulose, or a combination thereof is preferable, and the average molecular weight is particularly preferably 20,000 to 100,000. And / or a partial salt of the copolymer of methyl vinyl ether and maleic anhydride having an average molecular weight of 50,000
Carboxymethylcellulose sodium having a substitution degree of 0 to 400,000 and a carboxymethyl group of 1.0 or less is preferred. 75% of the particles of the adhesive component used in the present invention
When the above is less than 250 μm, preferably less than 100 μm, and more preferably less than 30 μm, high adhesive strength is exhibited in a short time after mounting.

In the composition of the present invention, the dispersibility of the adhesive component can be improved by blending polyvinylpyrrolidone, hydridoxypropylcellulose or a surfactant which is soluble in ethanol in addition to the adhesive component. Can be used alone or in combination of two or more. Among them, polyvinylpyrrolidone and / or a nonionic surfactant having an HLB value of 6 or less are particularly preferable.
Among nonionic surfactants having a B value of 6 or less, sorbitan fatty acid ester compounds are preferred.

The sorbitan fatty acid esters include sorbitan monostearate, sorbitan sesquistearate, sorbitan tristearate, sorbitan monooleate, sorbitan sesquioleate, sorbitan trioleate, sorbitan monooleate, sorbitan sesquioleate, trio Sorbitan oleate, sorbitan monoisostearate and sorbitan sesquiisostearate are preferred, and sorbitan monooleate, sorbitan sesquioleate and sorbitan trioleate are particularly preferred.

The most preferred composition in the present invention is that the adhesive component is a partial alkali metal and / or alkaline earth metal salt of a copolymer of methyl vinyl ether and maleic anhydride having an average molecular weight of 20,000 to 100,000, It is composed of sodium carboxymethylcellulose having an average molecular weight of 50,000 to 400,000 and a degree of carboxymethyl group substitution of 1.0 or less, and has an average molecular weight of 70,000 to 2
Containing 000,000 polyvinylpyrrolidone, wherein at least 75% of the particles of these components are less than 250 μm, preferably less than 100 μm, more preferably less than 30 μm;
Develops high adhesive strength shortly after mounting. The amount of polyvinylpyrrolidone at that time was 0.1 to 10 with respect to the total amount.
The amount of the sorbitan fatty acid ester compound is 0.1 to 10% by weight based on the total weight.

The propellant used in the present invention includes liquefied petroleum gas, dimethyl ether, carbon dioxide, nitrogen and the like.
Liquefied petroleum gas is preferred. The amount of the propellant is 20 to 95% by weight based on the total amount. When a compressed gas such as carbon dioxide or nitrogen is used as the propellant, ethanol may be blended as a dispersion medium for the adhesive component.

In the present invention, in addition to the above components, known components used in denture stabilizers, for example, liquid paraffin,
An oily base such as a vegetable oil, a fragrance, a pigment, and the like can be appropriately blended. In this case, the compounding amount of the oil base is generally 0.1 to 10% by weight based on the total amount of the stabilizer.

[0018]

EXAMPLES Next, the present invention will be described in more detail by way of examples, but the present invention is not limited thereto.
Unless otherwise specified, [%] indicates [% by weight]. 1. Adhesive Strength Test The adhesive strength of the denture stabilizer according to the present invention was evaluated in comparison with the adhesive strength of a conventional denture stabilizer. Example 1 shown below was mixed and filled in a conventional manner to produce a denture stabilizer.
Comparative Examples 1 (cream type) and 2 (powder type)
A commercially available product having a white color or a color close thereto was selected and used as it was. A denture base that covers only the upper palate and has no artificial teeth (hereinafter referred to as the palate floor) is recruited by 5 subjects, and a small clasp that can be connected to metal fittings using a denture base material so that the color becomes red. It was attached to the central part and the oral side, and prepared for each subject. In the case of the comparative example, the denture stabilizer was applied to the palate floor according to the respective instructions, and in the case of the example, it was applied based on the separately prepared instruction manual. After pressing the palate floor against the palatal mucosa for 1 minute after wearing, immediately measure the adhesive strength,
After 1 hour, 3 hours, and 5 hours, the adhesion was measured. To measure the maximum adhesive force, the metal fitting with the thread was attached to the clasp of the denture, and the other end of the thread was attached to the jig of the measuring device and pulled at 100 mm / min through the pulley for guiding the thread. did.

Example 1 Ingredients Compounding amount (%) Sodium carboxymethyl cellulose 15.0 Methyl vinyl ether / maleic anhydride copolymer salt 5.0 Polyvinylpyrrolidone 2.0 Liquid paraffin 1.0 Sorbitan fatty acid ester 2 0.0 Ethanol 25.0 Liquefied petroleum gas 40.0 Total 100.0 The results are shown in Table 1.

[0020]

[Table 1]

As shown in Table 1, Example 1 shows a higher adhesive strength at wearing than the conventional denture stabilizer, and the tendency remains unchanged even after 1 hour, 3 hours, and 5 hours. It is recognized that high adhesive strength is maintained. The adhesive main components of Example 1 and Comparative Example 1 are different in blending amount and blending ratio, but are partially common, and the composition of the adhesive component, adhesive aid and spray formulation in the Examples are excessive or insufficient for the denture. It is considered that the high adhesion was exhibited by the application without the presence of the adhesive.

2. Application Test An application test was performed to evaluate the application of the spray-type denture stabilizer according to the present invention to dentures. The subjects who participated in the adhesion test applied the denture denture stabilizer to the palate floor using the palate bed using the same denture stabilizer according to the instruction manual. After putting on the palatal floor and pressing the palatal floor against the palatal mucosa with a finger for 1 minute, the palatal floor was immediately removed, and a photograph was taken from the mucosal surface direction. At the same time, the presence or absence of the denture stabilizer protruding into the oral cavity was also recorded orally. O on the photo
Cover with an HP sheet, trace the outline of the palate floor with a pen, draw out the outline of the area where the denture stabilizer is attached, paint the interior, and use an image processing device to apply the denture stabilizer to the area of the palate floor. The ratio of the applied area was represented by the application rate (%) according to Formula 1: application rate (%) = (application area / palate floor area) × 100. Table 2 shows the results.

[0023]

[Table 2]

Only in the case of Example 1, no protrusion of the denture stabilizer from the palate amount was observed. In both Comparative Example 1 (cream type) and Comparative Example 2 (powder type), the amount of the applied denture stabilizer was not significantly changed regardless of the presence or absence of protrusion, and the conventional denture stabilizer was uniform. It can be seen that it is not easy to apply without excess or shortage.
In the case of the powder type, there were reports from subjects that the denture stabilizer spilled out into the mouth as a powder after wearing the palate floor, and the denture stabilizer, which partially overlapped the powder as a spill, fell into the mouth. It is considered that As described above, it was observed that the denture stabilizer could be easily applied to the spray type without any excess or shortage. However, it was recognized that a sufficient amount could not be applied to any of the other types. The application function of the -type stabilizer was shown to be very good.

3. Practical Test Examples 2 to 9 were mixed and filled in a conventional manner as shown in Table 3 to produce denture stabilizers. In Comparative Examples 1 and 2, purchased commercial products were used as they were. Five denture wearers recruited for this test were evaluated for adhesiveness, property stability, ease of application, and protrusion by using the above-mentioned denture stabilizer by the following methods, and comprehensively evaluated. The evaluation method will be described.

(1) Adhesiveness A proper amount of denture stabilizer is applied to a maxillary complete denture made of methacrylic resin according to a conventional method, and the denture is placed in the oral cavity. Five hours later, the adhesiveness of the complete denture was sensory evaluated according to the following criteria. 3: good, 2: neither, 1: bad

(2) Initial adhesiveness A denture stabilizer was applied to the complete denture, and the adhesive strength after 5 minutes was sensory evaluated according to the following criteria. 3: good, 2: neither, 1: bad

(3) Ease of application An appropriate amount of denture stabilizer was applied to a maxillary complete denture made of methacrylic resin according to a conventional method, and the ease of application was organoleptically evaluated according to the following criteria. 3: Easy to apply, 2: Neither, 1: Difficult to apply

(4) Protrusion Apply an appropriate amount of denture stabilizer to the upper denture made of methacrylic resin according to a conventional method, and attach it to the oral cavity to determine whether the denture stabilizer protrudes from between the denture and the gum during use. The sensory evaluation was performed according to the following criteria. 3: No, 1: Yes

In each evaluation, the average value of five subjects was calculated, and the results are shown in Table 3 based on the following evaluation criteria. ：: Average score is 2.34 or more Δ: Average score is 1.68 or more and less than 2.34 ×: Average score is less than 1.68

(5) Comprehensive evaluation Comprehensive evaluation was performed by calculating the average value of each evaluation item for each of the examples and comparative examples, and based on the following evaluation criteria in the same manner as in the above evaluation.
It was shown to. A: Average score is 2.5 or more B: Average score is less than 2.5

[0032]

[Table 3]

Commercial product a is a cream type denture stabilizer,
Commercial product b is a powder type denture stabilizer.

【The invention's effect】

According to the present invention, a powder aerosol-type denture stabilizer excellent in operability and adhesion can be provided.

Claims (4)

[Claims] 1. A powder aerosol denture stabilizer comprising an adhesive component and a propellant. 2. The powder aerosol-type denture stabilizer according to claim 1, further comprising polyvinylpyrrolidone and / or a surfactant. 3. The adhesive component has an average molecular weight of 20,000.
A copolymer of methyl vinyl ether and maleic anhydride of 0 to 100,000 and / or a partial salt of the copolymer, and an average molecular weight of 50,000 to 400,000
3. A powder aerosol-type denture stabilizer according to any one of claims 1 and 2, wherein sodium carboxymethylcellulose having a degree of substitution of 0 and a carboxymethyl group of 1.0 or less is blended. 4. At least 75% of the adhesive component particles have a particle size of 250 μm.
4. A particle having a particle size of less than
The powder aerosol-type denture stabilizer according to any one of the above items.