JP2001212160A - Denture stabilizer composition - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a denture stabilizer composition which has excellent fixation force irrespective of the presence or absence of moisture on the surface of a denture base, and which does not remain on the mucous membrane when removing the denture base from the mucous membrane. provide. SOLUTION: The denture stabilizer composition is mainly composed of a hydrophobic rubber-like substance (A), a water-swellable substance (B) and a polyethylene wax (C), wherein the hydrophobic rubber-like substance (A)
Has adhesive strength to the denture base surface substantially free of moisture, and the water-swellable polymer substance (B) has adhesive strength to the denture base surface and mucous membrane substantially containing water. The denture stabilizer composition, wherein the polyethylene wax (C) has an action of accelerating the denture stabilizer composition from peeling off the mucous membrane when the denture base is removed from the mucous membrane.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a denture stabilizer composition having an excellent fixation force and capable of removing a denture base by removing the denture stabilizer composition from the mucous membrane (peelability).

[0002]

2. Description of the Related Art Denture stabilizers are used to temporarily fix incompatible denture bases caused by age-related absorption and deformation of the ridges to the palate mucosa, and to supplement functions such as occlusion, mastication, and conversation. Preparation. Currently marketed denture stabilizers are broadly classified into two types, "adhesive type" and "adhesive type", depending on the mechanism of fixing the denture base to the oral mucosal surface.

[0003] A denture stabilizer of the close contact type is one that removes air by filling in the gap between the denture base and the surface of the oral mucosa to vacuum-adsorb the denture base to the mucous membrane. In Japan, this type is the main type of denture stabilizer. It has become. This close-fitting type has a rubber-like cushion and has the advantage of reducing irritation or pain to the gums and mucous membranes of the denture base during chewing and occlusion, but the surface of the denture base using denture stabilizers is exposed to moisture such as saliva. When wet, sufficient fixing force cannot be obtained because the water works as a separating agent. Therefore, the instructions for use of most commercially available denture stabilizers indicate "wiping the surface of the denture base". Conversely, if the mucosal surface is not wet with water such as saliva, it will not be able to exhibit the adsorptive power of the denture stabilizer.

On the other hand, the adhesive type sticks the denture to the mucosal surface by absorbing saliva between the denture base and the surface of the oral mucosa and exerting adhesiveness using a water-soluble adhesive polymer as a main agent. Powder, paste, liquid,
It is provided in various dosage forms such as sheet form. Generally, the adhesive type has better fixing force than the close contact type.

[0005]

DISCLOSURE OF THE INVENTION The present invention provides a denture stabilizing method which has excellent fixation force irrespective of the presence or absence of moisture on the surface of a denture base, and has no denture stabilizer composition remaining on the mucous membrane when the denture base is removed from the mucous membrane. It is an object of the present invention to provide an agent composition.

[0006]

Means for Solving the Problems The present inventors have conducted intensive studies to solve the above-mentioned problems, and as a result, have completed the present invention. That is, according to the present invention, there is provided a denture stabilizer composition comprising a hydrophobic rubber-like substance (A), a water-swellable substance (B) and a polyethylene wax (C) as a main base. The substance (A) has an adhesive force to a denture base surface substantially free of moisture, and the water-swellable polymer substance (B) has a tackiness to a denture base surface and mucous membrane substantially containing water. A denture stabilizer composition having adhesiveness, wherein the polyethylene wax (C) has an action of promoting the denture stabilizer composition from the mucous membrane when the denture base is removed from the mucous membrane. Is done.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION The denture stabilizer composition of the present invention is substantially free of moisture when fixing a denture base (in a state where the moisture is so dry that no eyes can observe the moisture).
When used on denture base surface and oral mucosal surface,
The denture base is fixed by the adhesive force of its hydrophobic rubber-like substance, while it is substantially moist (in a state where it is clearly wet enough to observe the water with the eyes) on the denture base surface and the oral mucosal surface When the denture base is used, the water-swellable polymer substance swells due to the moisture on the surface of the denture base, covers the hydrophobic rubber-like substance, generates adhesive strength, and the denture base is fixed by the adhesive strength.

[0008] As the hydrophobic rubber-like substance (A), conventionally known various substances are used. Such substances include hydrocarbon-based rubber-like substances, for example, rubber-like substances such as polybutadiene, polyisoprene, ethylene-propylene copolymer, butyl rubber, polybutene, and polyisobutylene, which are crosslinked or non-crosslinked rubbers. Substances. Other rubbery substances include acrylic rubber and the like. Of these, polyisobutylene and polybutene are particularly preferred rubbery substances. In addition, polyisobutylene and polybutene are represented by the average molecular weight described in the official food additive standard, and in the case of polyisobutylene, those having an average molecular weight of 8700 to 200,000,
Preferably it is 8700 to 60000. The hydrophobic rubbery substance (A) may be one kind of polyisobutylene, or a combination of two or more kinds of polyisobutylene having different average molecular weights. In the case of polybutene, those having an average molecular weight of 500 to 8700, preferably 3000 to 5500 are good. One type may be used, or two or more types of polybutene having different average molecular weights may be used in combination.

Further, polyisobutylene and polybutene
Types may be combined. In this case, the polyisobutylene used has an average molecular weight of 8700 to 200,000, preferably 8700 to 60000, and the polybutene has an average molecular weight of 500 to 8700, preferably 500 to 3000.

The rubbery substance of the present invention does not include a silicon-based rubbery substance and a fluorine-containing hydrocarbon-based rubbery substance. These are rubbery substances that have strong peeling power, and when used as the main substrate, the expected adhesion and adhesion are not obtained, and on the contrary, they tend to come off due to their peeling action,
Sufficient fixability cannot be obtained, and it is not suitable as a denture stabilizer.
Further, a polyvinyl acetate rubbery substance is not included in the rubbery substance of the present invention. A composition comprising polyvinyl acetate and a water-swellable polymer cannot be fixed to a metal floor such as a Co-Cr alloy unless moisture is present substantially on the surface of a denture base, and cannot be fixed. Engineering plastics such as polysulfone and polycarbonate are not suitable as a material because of poor adhesion and insufficient fixing force.

The compounding amount of the hydrophobic rubbery substance used in the present invention is 1 to 70% (mass percentage, hereinafter the same) in the composition, preferably 5 to 40%. Most preferred is 5-10%. When it is less than 1%, the fixing power is insufficient when the denture base surface is substantially free of moisture, and when it is more than 70%, the fixing power is insufficient when there is substantially moisture.

The water-swellable polymer substance (B) used in the present invention
Various conventionally known materials are used. Such substances include, for example, natural polymer substances such as karaya gum, gum arabic, tragacanth gum, sodium alginate, sodium carboxymethylcellulose, metal salts of polyacrylic acid, polyethylene oxide, polyvinylpyrrolidone, and alkyl vinyl ether maleic anhydride. Synthetic or semi-synthetic polymers such as polymer salts and acids are included. These may be crosslinked or non-crosslinked. Particularly preferred are salts of carboxymethylcellulose, polyethylene oxide, alkyl vinyl ether maleic anhydride copolymer.

The compounding amount of the water-swellable polymer substance (B) is preferably 5 to 60%, particularly preferably 15 to 50% in the composition.
If it is less than 5%, the adhesive strength becomes insufficient due to the small amount of the water-swellable polymer substance when substantially water is present, and the fixing power becomes insufficient. On the other hand, if it exceeds 60%, the substantial amount of the rubber-like substance on the surface of the denture stabilizer involved in the adhesion becomes insufficient when substantially no water is present, so that the adhesive force of the hydrophobic rubber-like substance becomes insufficient. A sufficient fixing force cannot be obtained.

The amount of the polyethylene wax (C) is as follows:
0.5 to 40%, preferably 2 to 25%, particularly 5
-10% is preferred. If the content is 0.5% or less, the effect of the polyethylene wax cannot be exerted, and the denture stabilizer composition remains on the mucous membrane when the denture base is removed from the oral cavity. On the other hand, if the amount is more than 40%, it is too hard to exert a fixing force.

The average molecular weight of the polyethylene wax (C) is preferably from 500 to 10,000, and
If it is larger, it becomes hard and unsuitable in terms of softening point and viscosity.

The denture stabilizer composition of the present invention may contain, in addition to the above-mentioned components, commonly used auxiliary components such as higher alcohols, fatty acid alkyl esters, surfactants, water-insoluble powders, polyhydric alcohols, and natural alcohols. Wax, paraffins, polypropylene glycol and the like can be blended.

[0017] The higher alcohol may have 8 to 8 carbon atoms.
24, preferably 12-18, such as cetanol, cetostearyl alcohol, stearyl alcohol, behenyl alcohol, oleyl alcohol, hexyldecanol, isostearyl alcohol, octyldecanol, decyltetradecanol, decylalcohol, octyldodecanol, Lauryl alcohol, mythyl alcohol, cetyl alcohol, aralkyl alcohol and the like, preferably oleyl alcohol, stearyl alcohol and lauryl alcohol. The main purpose of blending the higher alcohol is as a softener for the hydrophobic rubber-like substance (A) or an accelerator for peeling from the denture base. Oleyl alcohol is most preferred in view of its effect and odor.

In the fatty acid alkyl ester, the fatty acid has a chain length of 5 to 20 carbon atoms, preferably 9 to 18 carbon atoms. When the chain length is 4 or less, irritation is felt on the mucous membrane, and when the chain length is 21 or more, bleeding is caused to contaminate the denture base. The alkyl moiety is a saturated or unsaturated alkyl group derived from a monohydric or polyhydric alcohol having a chain length of 1 to 20 carbon atoms, preferably a saturated or unsaturated alkyl group having 3 to 18 carbon atoms. It is. Specifically, isopropyl pentanoate, stearyl pentanoate, isoseti octoate, cetyl 2-ethylhexanoate, methyl isononanoate, isononyl isononate, isodecyl isononanoate, isotridecyl isononanoate, hexyldecyl dimethyloctanoate, hexyl laurate, Isocetyl myristate, isopropyl myristate, myristyl myristate, ethyl isostearate, hexyl isostearate, isopropyl isopalmitate, octyl isopalmitate, isocetyl stearate, ethyl stearate, eicosyl stearate, isopropyl palmitate, isopropyl palmitate, stearyl eicosanate, Cetyl octanoate, cetostearyl octanoate, glyceryl trioctanoate, hexyl laurate, octyl dode myristate Le, octyl palmitate, cetyl palmitate, butyl stearate, octyl stearate, stearyl stearate, neopentyl glycol dioctanoate, isopropyl isostearate, butyl isostearate, isocetyl isostearate,
Glyceryl triisostearate, ethyl oleate,
Glyceryl trioctanoate, triacetyl glycerin,
Diacetyl glycerin, ethylene glycol diacetate and the like.

The higher alcohol and the fatty acid alkyl ester can be used alone or in combination.
It is 45%, preferably 10 to 30%.

Examples of the surfactant include various conventionally known surfactants, for example, mono- to triglyceride of stearic acid, mono- to triglyceride of oleic acid, acetylated glyceryl monostearate such as sucrose fatty acid ester and acetyl glyceryl monostearate. And sorbitan monostearate. Preferred are glycerin fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, glycerin monostearate, and sucrose fatty acid ester. In the present invention, the lipophilic surfactant has an HLB of 10 or less, preferably an HLB.
Of 3 to 5 is preferred. The compounding amount is 0.1 to
5%, preferably 0.2-3%.

As other components used in the present invention, a water-insoluble powder other than the above-mentioned polyethylene wax may be added as a release agent and a hardness adjuster. Examples of the water-insoluble powder include calcium carbonate, calcium hydrogen phosphate, silica, zeolite, polypropylene powder, and cellulose powder. As polyhydric alcohol,
Divalent and trivalent ones are used, for example, ethylene glycol, propylene glycol, glycerin and the like.
Examples of natural wax include beeswax, wood wax, candelilla wax, microcrystalline wax, paraffin wax, carnauba wax, rice wax and the like. As the paraffins, liquid or solid at room temperature such as liquid paraffin is used, and its carbon number is 5
~ 25.

As long as the effects of the present invention are not significantly impaired, a silicone-based polymer, a fluorine-modified polymer or the like can be blended as a release agent. Furthermore, as long as the effect of the present invention is not impaired, a small amount of polyvinyl acetate can be blended for improving the cushioning properties of the denture stabilizer composition. The denture stabilizer composition of the present invention may contain, in addition to the above-mentioned components, if necessary, for example, a non-toxic oil and fat, an emulsifier, a wetting agent, a pH adjuster, a preservative, a dye or a pigment, a fragrance, etc. It can be processed into paste (cream), sheet and other dosage forms. In this case, the non-toxic oils and fats include hardened vegetable oils and the like.

The denture stabilizer composition of the present invention can be produced in the same manner as known denture stabilizers, and can be used in the same manner as conventional ones.

[0024]

The composition of the present invention has a fixability due to the adhesive force of the hydrophobic rubbery substance (A) as a component and a fixability due to the adhesive force due to the water swelling of the water-swellable polymer substance (B). In addition, regardless of the presence or absence of moisture on the surface of the denture and the presence or absence of moisture in the oral cavity, the adhesive exerts an adhesive force and can obtain a sufficient fixing force. Further, the adhesive strength is exhibited regardless of the type of denture base (acrylic floor, engineering plastic floor such as polysulfone / polycarbonate, metal floor such as Co-Cr alloy), and sufficient fixing force can be obtained. As another effect, the denture stabilizer composition of the present invention has appropriate hardness by using the hydrophobic rubber-like substance (A),
Because it can be applied regardless of the size of the gap between the denture base and the mucous membrane, one type covers the applicable range of the adhesive type, which is suitable for small gaps, and the adhesive type, which is suitable for large gaps. be able to. Further, the denture stabilizer composition of the present invention contains polyethylene wax (C), so that when the denture base is removed, the denture stabilizer composition remains on the denture base and does not remain on the mucous membrane. The resulting denture stabilizer composition has an improved usability with an improved residual feeling. As described above, according to the present invention, it is possible to provide a denture stabilizer composition having both the advantages of the conventional two types (adhesion / adhesion type).

[0025]

The present invention will be specifically described below with reference to examples. The present invention is not limited to the following examples.
The blending percentages in each case are all percentages by mass.

Example 1 (%) Polyisobutylene (average molecular weight: 40000) 30.0 Sodium carboxymethylcellulose 5.0 Polyethylene oxide (average molecular weight: 4,000,000) 3.0 Methoxyethylene maleic anhydride copolymer salt (I. SP Japan Co., Ltd .: Gantrez) 5.0 Oleyl alcohol (Shin Nippon Rika Co., Ltd .: Vegikol) 30.0 Polyethylene wax (Sanyo Chemical Co., Ltd .: Sunwax) 5.0 Polypropylene glycol (average molecular weight: 3000, Sanyo Chemical Co., Ltd.) 2.0: Liquid paraffin Total: 100.0

Example 2 (%) Polyisobutylene (average molecular weight: 60000) 25.0 Sodium carboxymethylcellulose 20.0 Oleyl alcohol. 35.0 Polyethylene wax (manufactured by Sanyo Chemical Co., Ltd .: Sunwax) 10.0 Liquid paraffin Total 100.0

Example 3 (%) Polyisobutylene (average molecular weight: 40000) 20.0 Sodium carboxymethylcellulose 10.0 Oleyl alcohol 45.0 Polyethylene wax (Sun wax manufactured by Sanyo Chemical Co., Ltd.) 15.0 Liquid paraffin Balance .0

Example 4 (%) Polyisobutylene (average molecular weight: 40000) 20.0 Sodium carboxymethylcellulose 6.0 Polyethylene oxide (average molecular weight: 4,000,000) 1.0 Methoxyethylene maleic anhydride copolymer salt (I. SP Japan Co., Ltd .: Gantrez) 5.0 Oleyl alcohol 35.0 Polyethylene wax (Sanyo Chemical Co., Ltd .: Sunwax) 20.0 Polypropylene glycol (average molecular weight: 3000) 1.0 Liquid paraffin balance Total 100.0

Comparative Example 1 (%) Vinyl acetate resin (degree of polymerization: 1500) 60.0 Polypropylene glycol (average molecular weight: 3000) 5.0 Beeswax 3.0 Light calcium carbonate 1.0 60% ethanol Balance 100.0

Comparative Example 2 (%) Carboxymethylcellulose 50.0 Liquid paraffin 20.0 White petrolatum Balance 100.0

Comparative Example 3 (%) Polyisobutylene (average molecular weight: 40000) 50.0 Sodium carboxymethylcellulose 8.0 Polyethylene oxide (average molecular weight: 4,000,000) 8.0 Methoxyethylene maleic anhydride copolymer salt (I. 8.0 Oleyl alcohol 20.0 Sorbitan fatty acid ester 2.0 Polypropylene glycol (average molecular weight: 3000) 2.0 Liquid paraffin Total 100.0

Next, the performances of the compositions obtained in the above Examples and Comparative Examples as denture stabilizer compositions were evaluated as follows. (Evaluation method) (1) Adhesiveness (adhesive strength) Thickness 6 having a hole of 22 mm in diameter and 0.5 mm in depth
A mm acrylic resin plate is prepared. The hole is filled with each denture stabilizer composition. 15mm diameter (1.8cm ² area) on plunger of rheometer (manufactured by Sun Kagaku),
Materials for denture bases of dental acrylic resin, dental engineering plastic (dental polycarbonate resin) and dental metal (Co-Cr alloy) with a thickness of 3 mm are # 20.
After polishing with water-resistant abrasive paper of No. 00, it is adhered with a double-sided tape.
Each plunger is pressed against the denture stabilizer composition under a load of 1 kgf for 30 seconds and then pulled immediately. The maximum tensile strength at that time was measured. Surface condition of each denture base material attached to plunger Drying: Dry the surface with a dryer. Wetting: Water was sprayed with a sprayer so as to be 0.02 g / 1.8 cm ² , and water was attached. Water content 0.02g /
1.8 cm ² corresponds to about 20 times the amount of water remaining after once wiping excess water on the surface of the denture base with commercially available tissue paper. Evaluation criteria (tensile strength) ◎: 0.7 kg or more ○: 0.5 to 0.6 kg △: 0.3 to 0.4 kg ×: 0.3 kg or less

[0034]

[Table 1]

(2) Residue in the oral cavity 1 g of each preparation is applied to a complete denture made of three kinds of materials (acryl, embra, metal), fixed in the oral cavity, and occlusal pressure is applied. If it does, wipe it off and maintain it. After 10 minutes, remove the denture from the oral cavity. At that time, it was confirmed whether the stabilizer composition remained on the denture (adhesion to the denture) or remained on the mucous membrane (adhesion to the mucous membrane). Evaluation criteria A: A lot of denture stabilizer compositions are attached. B: A little denture stabilizer composition is attached. C: A denture stabilizer composition is not attached.

[0036]

[Table 2]

The denture stabilizer composition according to the present invention is produced as follows. Polyisobutylene and liquid (oleyl alcohol, liquid paraffin, etc.) in a stainless steel kettle heated to 80 ° C
And stirred. After mixing thoroughly, add polyethylene wax,
The temperature is increased to 150 ° C. and stirring is further performed. After the polyethylene wax has dissolved, the temperature is reduced to 70 ° C. The water-swellable polymer substance, polypropylene glycol and sorbitan fatty acid ester are charged and stirring is continued. After the temperature is further lowered and reaches 50 ° C., decompression is started. When the room temperature (25 to 30 ° C.) is reached, the stirring and the pressure reduction are stopped. After returning to atmospheric pressure, the preparation was taken out as a sample.

Claims (1)

[Claims] 1. A denture stabilizer composition comprising a hydrophobic rubber-like substance (A), a water-swellable substance (B) and a polyethylene wax (C) as main bases, wherein the hydrophobic rubber-like substance (A) )
Has adhesive strength to the denture base surface substantially free of moisture, and the water-swellable polymer substance (B) has adhesive strength to the denture base surface and mucous membrane substantially containing water. The denture stabilizer composition, wherein the polyethylene wax (C) has an action of accelerating the denture stabilizer composition from peeling off the mucous membrane when the denture base is removed from the mucous membrane.