Fixing composition for jaw prosthesis

FIELD: medicine.

SUBSTANCE: invention refers to stomatology and concerns composition for dental prosthesis fixation. Fixing composition for jaw prosthesis contains adhesion activator, thickener, paraffin-like substance and fine-grained filler. Thickener is carbomer with dynamic viscosity specified by standard Ph. Eur. 4, from 2000 to 26000 mPa-s. Composition provides adherence within 50 to 100 N and continuous fine consistency.

EFFECT: production of composition for dental prosthesis fixation with improved adherence.

2 ex, 1 tbl, 3 cl

 

The invention relates to a fixing composition for the jaw (teeth) prosthetic devices with adhesion promoters, thickening agent, paraminophenol substance and finely dispersed filler.

Such fixing compositions are applied to fit the so-called "third teeth" to the mucosa of the soft palate and to the profile of the gums through thick and strong landing or at least to improve fit. For this to false teeth is applied to a fixing composition, and the jaw is inserted into the mouth. The surface of the fixing composition is moistened by saliva, adhesion promoters swells, thus a holding action. Defining properties for the fixing composition good actions are adhesive force and the duration of fixation. While the mechanisms that are responsible for holding the action is very complicated.

After aspiration of saliva and air tightly fitting prosthesis formed zone of reduced pressure, which, on the one hand, are created intentionally, and on the other hand, arise due to inaccuracies in the manufacturing process. Quickly swelling adhesion promoters fills these voids and reduces their adverse properties. Because of the thickness of the fixing composition it cannot otkazyvatsa as easy as saliva.

If the denture comes in movement is their perpendicular to its base, after achieving critical distance of the liquid film is broken. When the surviving valve area inside it occurs much more or less homogeneous area of low pressure. If the valve area is no longer available or it is broken, viscous adhesion promoters, in particular ointment able to replace it. So, here they assume the function of the strip.

The viscosity of the fixing composition plays an important role. If there is a change of position of the prosthesis relative to its base, this is prevented by the force caused by the viscosity of the fixing composition. They at least slow down the process. Due to the large thickness of the fixing composition capable of exerting forces of the big shift resistance. In addition, they prevent the rapid equalization of pressure through the distribution of saliva and provide an action valve area over a longer time. Fixing composition to prevent or reduce the so-called oscillatory movement of the prosthesis, thus improving its function and help to reduce tissue damage. The factors that lead to retention of the denture, always act in a comprehensive manner.

The basis of the invention has the task to provide another fixing composition in the form of rassasivayushee composition, which compared with the camping products on the market has comparable or better traction force and stability consistency.

Suddenly this problem was solved by means of the fixing composition for maxillary dentures, which as a thickener contains carbomer dynamic viscosity, determined by the standard Ph.Eur. 4, from 2000 up to 26,000 MPa·C. According to one preferred variant implementation of the dynamic viscosity of carbomer used according to the invention, is from 3,000 to 22,000 MPa·with, in particular also from 4000 to 18000 MPa·with, for example, from 4000 to 14000 MPa·C.

Carbomer according to the invention is present in the fixing composition for maxillary dentures in an amount of from 1 to 15 wt.%, preferably from 5 to 12 wt.%, based on the weight of the composition.

Unexpectedly, it was found that with Carbonara used according to the invention, is achieved very good values of traction and very good consistency of the composition. This consistency is maintained during long time storage. Good holding effect is unexpected because carbomer are not the adhesion promoters and, on the other hand, carbomer with a viscosity of 30,000 MPa·no longer can provide the desired properties.

Carbomer is a designation, according to the Association CTFA (Cosmetic, Toiletry and Fragance Association), carbopol® or polymers of acrylic acid with high molecular weight. Carbomer give after it is ralizatsii highly viscous gel-like substance. Carbomer according to the invention described in the European Pharmacopoeia Ph.Eur. 4. Ausgabe, Grundwerk 2002. Carbomer used according to the invention have a content of carboxyl groups from 56 to 68%, calculated on dry substance. For the fixing composition according to the invention for maxillary dentures are used only carbomer that are permitted for use on the mucous membrane.

In addition carbonero used according to the invention, razmazyvaya fixing composition for maxillary dentures contain adhesion promoters, paraminophenol substance and finely dispersed filler. The composition according to the invention may contain other additives, such as flavorings, colorings and preservatives. All these substances meet the requirements of the European Pharmacopoeia (Ph.Eur. 4).

Suitable adhesion promoters in the compositions according to the invention are carboxymethylcellulose (CMC)and their salts with alkali and alkaline earth metals. Particularly suitable sodium carboxymethylcellulose. Can be used one carboxymethylcellulose or a mixture of at least two carboxymetilcellulose or their salts. Various carboxymethyl cellulose or its salt can have different degrees of crosslinking and/or grain size. Such carboxymethylcellulose may have, for example, the degree of substitution of from about 0.65 to 1,40, p is edocfile from 0.75 to 0.90, or approximately from 1.0 to 1.35. Their degree of polymerization can range from 500 to 2000.

The adhesion promoters fixing composition according to the invention can be present in an amount of from 15 to 50 wt.%, preferably from 20 to 45 wt.%, based on the weight of the composition.

The composition according to the invention contains parafinoterapy component. Parafinoterapy component may be semi-liquid paraffin, according to the European Pharmacopoeia 2001, and/or white vaseline, according to the German Pharmacopoeia 2000. White petrolatum may be contained in the composition according to the invention in quantities of from 10 to 20 wt.%, preferably from 13 to 17 wt.%, based on the weight of the composition. Semi-liquid paraffin can be used in an amount of from 25 to 35 wt.%, preferably from 28 to 33 wt.%, based on the weight of the composition.

To establish the desired viscosity to the composition according to the invention can add highly dispersed silicic acid type Aerosil or siloed. These types usually have a specific surface according to BET of from 50 to 500 m2/, Particularly preferably the use of highly dispersed silicic acid with a specific surface area according to BET of 150 to 300 m2/, highly dispersed silicic acid may be contained in the composition in an amount of from 0.2 to 2 wt.%, preferably from 0.8 to 1.5 wt.%, based on the weight of the composition.

Fixing ointment for maxillary dentures? what about the invention can be obtained, for example, those that take the semi-liquid paraffin and then coloring, taste improver and preservative and heated with stirring to a temperature of about 45°C, the resulting mixture is stirred until then, until it forms milky colored solution. Then the container with the mixture can be added in molten form additional parafinovogo components, such as vaseline, and homogenized. Finally, the mixture can be added to the solids, and the resulting mixture is homogenized. The homogenization can be carried out, for example, a stirrer and a homogenizer in a vacuum at a temperature of about 45°C for about 60 minutes. After that, the product can be cooled with stirring to 25°C and carefully remove it from the air.

The composition according to the invention has the form of a homogeneous solid to slightly grainy paste and can provide traction force, measured by means of the control device, which is designed for quasi-static load from 50 to 100 N. Ideal device for testing the tensile, compression and bending, for example, according to DIN 50220/07 .93, DIN 51221/T1 T2/07.93 and DIN 51223/07 .93.

Further, the invention is illustrated in the following examples.

Example 1

The composition according to the invention has the following composition:

12.00 gcarbomer (viscosity 7500 MPa· C)
41,00 gsodium carboxymethylcellulose
31,73 gsemi-liquid paraffin
14,00white petrolatum
1.10 ghighly disperse silicon dioxide (Aerosil® 200)
0.10 gmenthol
0.04 gazorubine (E 122
0.03 gmethyl-4-hydroxybenzoate

To obtain this composition was weighed semi-liquid paraffin was injected into the container to mix. Then add the varnish azorubine, menthol and methyl-4-hydroxybenzoate and was heated to 45°C under stirring enabled homogenizer, stirred 20 minutes to form a milky-red solution. Then he slapped the jelly, melted on the heating tile, brought up to 55°C and was sucked into the container for the mixture. Was stirred for 20 minutes with the connected homogenizer.

Was given a solid mixture of carbomer, highly dispersed silicon dioxide and sodium carboxymethylcellulose and poured into the feeding funnel. Then the solid mixture when operating the agitator and the homogenizer was slowly sucked into a vacuum, so no inclusions were not formed. The vacuum was stirred with a mixer and homogenizer for 60 minutes at 45°C. the resulting mixture was cooled with stirring to 25°C and riches is entrusted to drain the air.

Example 2

For comparison, the compositions according to the invention with a known composition as compositions according to the invention were taken of the composition of example 1 and the composition containing carbomer 5 wt.% and sodium carboxymethylcellulose 48 wt.%.

In the composition of the comparison were present carbomer with a dynamic viscosity of 30,000 MPa·with contents of 10 and 5 wt.% with respectively 43 and 48 wt.% sodium carboxymethylcellulose. Another comparative sample contained as a thickener 30 wt.% Na/Ca salt of a copolymer metilfenidato ether and maleic anhydride (Gantrez®).

To test the adhesion forces with the help of the device Zwick 1120 to disk Plexiglas marked points, was uniformly applied on the marking plate 1.5 g fixing ointments, and between the ointment evenly distributed small drops of 0.5 g of distilled water. The test duration was 2.5 min at a load of 42,67 N. The measurements were carried out after preparation, and after two weeks and four weeks of storage at room temperature.

In addition, the tested species compositions after storage for some time (from the moment of preparation of up to four months after preparation) at different temperatures of storage. The results after two months storage at 20°C presented in the table. The percentages indicated in wt.% in the calculations of the e on the weight of the composition. Bond strength was determined directly after preparation.

No.RecipeAdhesive forceConsistency
112% carbomer / 43% CMC80,49 Nvery good
25% carbomer / 48% CMC75,63 Nvery good
312% carbomer (WASC. 30 PA·) / 43% CMCmeasurement impossibletoo hard
45% carbomer (WASC. 30 PA·C) / 48% CMC30,33 Ntoo hard
530% Gantrez® / 23% CMC71,53 Nthe separation of the phases after 2 months at 20°C

The samples according to the invention after storage for four months still have the desired consistency. This is also true for the four-month storage at 30°C or 40°C. In contrast, the sample 5 detects a small separation of the phases after two weeks of storage at 30°C.

1. Fixing composition for maxillary dentures with adhesion promoters, thickening agent, paraminophenol substance finely dispersed filler, characterized in that the thickener is ka is bomer dynamic viscosity, determined by Ph.Eur. 4, from 2000 up to 26,000 MPa·C contained in the fixing composition in an amount of from 1 to 15 wt.% in calculating the masses of the fixing composition, and the adhesion promoters selected from one or more carboxymetilcellulose and/or their salts.

2. Fixing composition for maxillary prosthesis according to claim 1, characterized in that the dynamic viscosity, determined according to Ph.Eur. 4, is from 3,000 to 22,000 MPa·C.

3. Fixing composition for maxillary prosthesis according to claim 1, characterized in that the dynamic viscosity, determined according to Ph.Eur. 4, ranges from 4000 to 18000 MPa·C.



 

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