JP2002095681A - Composition of denture stabilizer - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a composition of a denture stabilizer which is fixative regardless of moisture on the surface of a denture base, is less tacky in the mouth while using, and has an excellent usability. SOLUTION: A composition of a denture stabilizer contains a hydrophobic rubber-like material A, a water swelling high polymer B, and an aliphatic ester C of viscosity less than 200 mPa. s. The hydrophobic rubber-like material A is adhesive to the surface of the denture base in which no moisture exists materially, and the water swelling high polymer B becomes adhesive to the surface of the denture base and mucous membranes in which moisture exists materially. The aliphatic ester C softens the hydrophobic rubber-like material A and makes it easy to remove the composition from the mouth and the denture.

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 which has excellent fixing power, has a low stickiness during use in the oral cavity, has an excellent use feeling, and is easily removed after use.

[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 burying it in the gap between the denture base and the surface of the oral mucosa and adsorbs the denture base to the mucous membrane under vacuum. In Japan, this type is the mainstream of denture stabilizer. It has become. This close contact 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 a denture stabilizer 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 stabilizer composition which is excellent in fixation force regardless of the presence or absence of moisture on the surface of a denture base, and which has less stickiness during use in the cavity and is excellent in use feeling. That is the subject.

[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, the hydrophobic rubbery substance (A) and the water-swellable polymer substance (B) have a viscosity of 200 mP.
A denture stabilizer composition containing an aliphatic ester (C) having an a · s (20 ° C.) or less, wherein the hydrophobic rubber-like substance (A) is applied to a denture base surface substantially free of moisture. The water-swellable polymer substance (B) has an adhesive force to the denture base surface and mucous membrane where water is substantially present, and the aliphatic ester (C) has A denture stabilizer composition is provided which softens the hydrophobic rubbery substance (A) and facilitates the removal of the composition from the cavity and from the denture.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION The denture stabilizer composition of the present invention is substantially free of moisture (in a state in which the moisture is so dry that no eyes can observe the moisture) on denture base surfaces and oral mucosal surfaces. Shows good adhesion due to the hydrophobic rubbery substance (A), while the surface of the denture base and the oral mucosa surface where water is substantially present (in a state where the water is clearly visible to the eye) Shows good adhesive strength due to the water-swellable substance (B).

[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 hydrophobic rubbery substance (A) used in the present invention does not include a silicon rubbery substance and a fluorine-containing hydrocarbon rubbery substance. These are rubbery substances with strong peeling power, and when used as a main base material, they do not have the expected adhesion and adhesion, but they tend to come off due to their peeling action and have sufficient fixation. Not suitable as denture stabilizer. Further, a polyvinyl acetate rubbery substance is not included in the hydrophobic rubbery substance (A) 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 / polycarbonate) are not suitable as a material for denture stabilizer because of poor adhesion and insufficient fixing force.

The compounding amount of the hydrophobic rubbery substance (A) used in the present invention is 1 to 70% (weight percentage, hereinafter the same) in the composition, preferably 5 to 40%, and particularly preferably. 5 to 10%. If it is less than 1%, the fixation force is insufficient when the denture base surface is substantially free of moisture, while 7
If it exceeds 0%, the fixing force is insufficient when water is present.

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 aliphatic ester (C) used in the present invention
Is an ester of an aliphatic carboxylic acid having 3 or more carbon atoms, preferably 5 or more carbon atoms, and an aliphatic alcohol having 2 or more carbon atoms, preferably 3 or more carbon atoms.
Esters having an mPa · s or less, preferably 50 mPa · s or less. The upper limit of the number of carbon atoms of the aliphatic carboxylic acid and the upper limit of the number of carbon atoms of the aliphatic alcohol are not particularly limited, and are determined so that the viscosity of the ester does not exceed 200 mPas. The upper limit of the number of carbon atoms is usually about 18, and the upper limit of the number of carbon atoms of the aliphatic alcohol is usually about 24. Note that two or more aliphatic esters may be combined. When the viscosity of the aliphatic ester used in the present invention exceeds 200 mPa · s (20 ° C.), the obtained denture stabilizer composition is not preferable because it becomes hard.

The aliphatic carboxylic acid component in the aliphatic ester (C) includes saturated and unsaturated carboxylic acids. Such include isononanoic acid, di-2
-Ethylhexanoic acid, capric acid, caprylic acid, myristic acid, palmitic acid, tri-2-ethylhexanoic acid, stearic acid, oleic acid, isostearic acid, isoperargonic acid, lauric acid, caprylic capric acid and the like. On the other hand, the aliphatic alcohol component includes a monohydric or polyhydric saturated or unsaturated alcohol. Such materials include isononyl alcohol, isotridecyl alcohol, neopentyl glycol, isopropyl alcohol, octyl alcohol, octyl dodecyl alcohol, glycerin, isostearyl alcohol, octyl dodecyl alcohol, 2-ethylhexyl alcohol, hexyl alcohol, Myristyl alcohol, cetyl alcohol, oleyl alcohol and the like are included.

Specific examples of the aliphatic ester (C) used in the present invention include: isononyl isononanoate (viscosity at 20 ° C .: 6 mPa · s), isotridecyl isononanoate (11 mPa · s), di-2-ethyl Neopentyl glycol hexanoate (12 mPa · s), neopentyl glycol dicaprate (19 mPa · s),
Isopropyl myristate (10 mPa · s), isopropyl palmitate (10 mPa · s), octyl palmitate (11 mPa · s), octyl dodecyl myristate (37 mPa · s), tri2-
Glyceryl ethylhexanoate (same as above: 40 mPa · s),
Glyceryl tricaprate, glyceryl tricaprylate, glyceryl tri (caprylate / caprate) (same as: 2
3 mPa · s) and the like. The aliphatic ester (C) used in the present invention softens the hydrophobic rubbery substance (A),
It facilitates removal of the composition from the oral cavity and from dentures. In addition, it suppresses stickiness during oral use of the composition, and improves the feeling of use of the composition.

The amount of the aliphatic ester (C) is 0.1%.
1 to 40%, preferably 1 to 20%, particularly preferably 5 to 15%. If it is less than 0.1%, the effect of the ester cannot be exerted, so that sufficient hydrophobic rubber-like substance cannot be softened. In addition, it deteriorates the feeling of use in the oral cavity or the removal / cleanability of the denture stabilizer composition from the oral cavity and the denture. When the amount is more than 40%, liquid separation occurs.

The denture stabilizer of the present invention may contain, in addition to the above-mentioned components, conventional components such as higher alcohols, insoluble powders, polyhydric alcohols, natural and synthetic waxes, paraffins and the like as auxiliary components. .

The above-mentioned higher alcohol has 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, myristyl alcohol, cetyl alcohol and the like.

As other components used in the present invention, a water-insoluble powder or the like may be added as a release agent and a hardness adjusting agent. Examples of the water-insoluble powder include calcium carbonate, calcium hydrogen phosphate, silica, zeolite, polypropylene powder, cellulose powder and the like. As the polyhydric alcohol, dihydric and trihydric alcohols 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. Examples of the synthetic wax include polyethylene wax, modified wax (hardened castor oil, paraffin wax, etc.). As the paraffin, liquid or solid at room temperature such as liquid paraffin is used, and its carbon number is 5 to 25.

As long as the effects of the present invention are not significantly impaired, a silicon-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, and the like. 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.

[0023]

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 that is suitable for small gaps and the adhesive type that is suitable for large lifting. can do. In addition, the denture stabilizer composition of the present invention contains an aliphatic ester (C) having a viscosity of 1 to 200 mPa · s to provide an excellent feeling in use in the oral cavity and the oral cavity of the denture stabilizer composition. A denture stabilizer composition having easy cleaning properties such as easy removal from dentures.

[0024]

The present invention will be specifically described below with reference to examples. The present invention is not limited to the following examples. The blending amount% in each example is% by weight.

Example 1 Polyisobutylene (average molecular weight: 40000) 25.0 (%) sodium carboxymethylcellulose 10.0 polyethylene oxide 1.0 methoxyethylene maleic anhydride copolymer salt 5.0 di-2-ethylhexanoic acid Neopentyl glycol 20.0 Polyethylene wax 15.0 Liquid paraffin remaining

Example 2 Polyisobutylene (average molecular weight: 40000) 20.0 (%) sodium carboxymethylcellulose 20.0 glyceryl tri (capryl / caprate) 10.0 polyethylene wax 20.0 liquid paraffin residue

Example 3 Polyisobutylene (average molecular weight: 40000) 30.0 (%) sodium carboxymethylcellulose 10.0 octyl palmitate 25.0 polyethylene wax 15.0 liquid paraffin residue

Example 4 Polyisobutylene (average molecular weight: 40000) 25.0 (%) sodium carboxymethylcellulose 5.0 methoxyethylene maleic anhydride copolymer salt 15.0 oleyl alcohol 2.0 isopropyl myristate 10.0 polyethylene Wax 15.0 Liquid paraffin remaining

Example 5 Polyisobutylene (average molecular weight: 40000) 20 (%) sodium carboxymethylcellulose 20 methoxyethylene maleic anhydride copolymer salt 30 tri (caprylic / capric acid) glyceryl 15 liquid paraffin residue

Comparative Example 1 Vinyl acetate resin (degree of polymerization: 1500) 60.0 (%) polypropylene glycol 5.0 beeswax 3.0 calcium carbonate 1.0 60% ethanol residue

Comparative Example 2 Sodium carboxymethylcellulose 50.0 (%) Liquid paraffin 20.0 White petrolatum residue

Next, the compositions obtained in the above Examples and Comparative Examples
For the following, its performance as a denture stabilizer composition
Was evaluated as follows. Table 1 shows the results. (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. In the hole, each denture
The composition is filled. Rheometer (made by Sun Science)
15mm diameter plunger (1.8cm area) ^Two), Thickness
3mm dental acrylic resin, dental engineering
Plastic (dental polycarbonate resin), dental
# 200 for metal denture base materials (Co-Cr alloy)
After polishing with a water-resistant abrasive paper of No. 0, adhere with a double-sided tape. each
The plunger is applied to the denture stabilizer composition with a load of 1 kgf for 3 times.
After pressing for 0 seconds, pull immediately. The maximum tensile strength at that time
It was measured. Surface condition of denture base material attached to plunger Drying: Dry the surface with a dryer. Wetting: 0.02 g / 1.8 cm of water with a sprayer^Twobecome
As described above to allow moisture to adhere. Water content 0.02g /
1.8cm^TwoIs a commercially available tissue paper on the surface of the denture base
Approximate amount of water remaining after wiping excess water
It corresponds to 20 times. 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 (2) Oral feeling of use (discomfort, discomfort, etc.) Attach and use a denture with a denture stabilizer. At that time,
Denture stabilizers "protrude", "dissolve", "taste", "ni
The discomfort and discomfort caused by “I” were evaluated. <Evaluation Criteria> ○: No discomfort (discomfort) △: Some discomfort (discomfort) ×: Strong discomfort (discomfort) (3) Ease of removal (removability / cleanability) Denture stabilizer for denture Attach and attach, and after use, remove the denture
Take out (remove). Denture stabilizer and denture remaining on oral mucosa
The ease of removing the denture stabilizer remaining in the sample was evaluated. ：: Can be easily removed. △: Slightly difficult to remove ×: Very difficult to remove

[0033]

[Table 1]

<Method for Producing the Composition> Preparation of the composition of the present invention (Example) Polyisobutylene and liquid components (oleyl alcohol, liquid paraffin, etc.) in a stainless steel kettle heated to 80 ° C
And stirred. When the polyethylene wax is blended, the temperature is further increased to 150 ° C. after the introduction, and the mixture is further stirred. After the polyethylene wax has dissolved, the temperature is reduced to 70 ° C. The water-swellable polymer substance is 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. 2. Composition Preparation of Comparative Example The production method was in accordance with the usual production method of a denture stabilizer composition.

Claims (1)

[Claims] 1. A denture stabilizer composition comprising a hydrophobic rubber-like substance (A), a water-swellable polymer substance (B) and an aliphatic ester (C) having a viscosity of 200 mPa · s (20 ° C.) or less. The hydrophobic rubber-like substance (A) has an adhesive force to a denture base surface substantially free of moisture, and the water-swellable polymer substance (B) is substantially free of water. Adhesive to existing denture base surfaces and mucous membranes, the aliphatic ester (C) softens the hydrophobic rubbery substance (A) and removes the composition from the cavity and from the denture A denture stabilizer composition characterized in that: