Adhesive preparation for mandibular prostheses

Abstract

A vegetable-based adhesive preparation for mandibular prostheses. The preparation has improved adhesive properties, consistency and stability as a result of a filler containing: 35 to 45 wt. % vegetable oil; 25 to 50 wt % structure-forming stabilizer; 5 to 15 wt % bonding agent; and silicon oxide making up the remainder.

Claims

1. Adhesive preparation for mandibular prostheses, comprising: 35 wt. % to 50 wt. % vegetable oil; 25 wt. % to 50 wt. % structure-forming stabilizer, the structure-forming stabilizer comprising one or more of xanthan gum, hydroxypropylcellulose (HPC) and carboxymethylcellulose (CMC), especially as carboxymethylcellulose sodium salt; 5 wt. % to at most 9 wt. % polyacrylic acid as bonding agent; and a remainder, said remainder being 3 wt. % to 6 wt. % filler containing silicon oxide and having a density between 0.08 g/cm.sup.3 and 0.23 g/cm.sup.3, a particle size in a range of 1 to 40 mm, said adhesive preparation comprising an adhesive force between 40 N and 150 N.

2. Adhesive preparation in accordance with claim 1, wherein the vegetable oil is one or more of Saint John's wort oil, almond oil, olive oil, rapeseed oil, soybean oil, sunflower seed oil, grapeseed oil, and wheat germ oil.

3. Adhesive preparation in accordance with claim 1, wherein the filler contains silicon dioxide precipitated from a solution.

4. Adhesive preparation in accordance with claim 1, wherein a density of the filler, preferably at least of the silicon dioxide is between 0.19 g/cm.sup.3 and 0.21 g/cm.sup.3.

5. Adhesive preparation in accordance with claim 1, wherein an average pore size of the adhesive preparation is greater than 30 nm.

6. Adhesive preparation in accordance with claim 1, wherein the filler contains less than 0.1 wt. % styrene-isoprene copolymer in relation to the weight of the filler.

7. Adhesive preparation in accordance with claim 1, wherein the filler contains less than 0.1 wt. % aluminum stearate in relation to the weight of the filler.

8. Adhesive preparation in accordance with claim 1, wherein said adhesive preparation comprises between 70 N and 110 N.

9. Adhesive preparation in accordance with claim 1, wherein a vegetable oil percentage of 40 wt. % to 45 wt. % is provided.

10. Adhesive preparation in accordance with claim 1, wherein 40 wt. % to 50 wt. % structure-forming stabilizer is provided.

11. Adhesive preparation in accordance with claim 1, wherein 40 wt. % to 45 wt. % vegetable oil, 41 wt. % to 46 wt. % structure-forming stabilizer, and 4 wt. % to 6 wt. % filler containing silicon oxide are provided.

12. Adhesive preparation in accordance with claim 1, wherein the filler contains at least 0.001 wt. % styrene-isoprene copolymer in relation to the weight of the filler.

13. Adhesive preparation in accordance with claim 1, wherein the filler contains at least 0.01 wt. % styrene-isoprene copolymer in relation to the weight of the filler.

14. Adhesive preparation in accordance with claim 1, wherein the filler contains at least 0.001 wt. % aluminum stearate in relation to the weight of the filler.

15. Adhesive preparation in accordance with claim 1, wherein the filler contains at least 0.01 wt. % aluminum stearate in relation to the weight of the filler.

16. Adhesive preparation for mandibular prostheses, comprising: an adhesive preparation composition consisting essentially of 35 wt. % to 50 wt. % vegetable oil, 25 wt. % to 50 wt. % structure-forming stabilizer, 5 wt. % to at most 9 wt. % polyacrylic acid as bonding agent and a remainder, said remainder being 3 wt. % to 6 wt. % filler containing silicon oxide, the structure-forming stabilizer being one or more of xanthan gum, hydroxypropylcellulose (HPC), carboxymethylcellulose sodium salt and carboxymethylcellulose (CMC).

17. Adhesive preparation for mandibular prostheses, comprising: an adhesive preparation composition consisting of 35 wt. % to 50 wt. % vegetable oil, 25 wt. % to 50 wt. % structure-forming stabilizer, 5 wt. % to at most 9 wt. % polyacrylic acid as bonding agent and a remainder, said remainder being 3 wt. % to 6 wt. % filler containing silicon oxide, the structure-forming stabilizer being one or more of xanthan gum, hydroxypropylcellulose (HPC), carboxymethylcellulose sodium salt and carboxymethylcellulose (CMC).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In the drawings:

(2) FIG. 1 is a graphic view showing adhesive force values for various adhesive preparations.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(3) Referring to the drawings in particular, FIG. 1 shows adhesive force mean values from two measurements in Newtons (N) for a plurality of commercially available adhesive preparations, which are designated with A through P as well as two adhesive force preparations according to the present invention based on olive oil, on the one hand, and based on soybean oil, on the other hand, whose exact composition appears from Tables 1 through 3.

(4) The adhesive composition H is the composition known from practice, which is based on olive oil and does not contain earth-oil-based basic substances, such as paraffin or vaseline, which are given I through P with all other adhesive compositions A through G.

(5) It is shown that while the prior-art, olive-oil-based adhesive composition has a comparably extremely low adhesive force of less than 20 N with otherwise acceptable adhesive force values of over 40 N or 50 N, while the likewise vegetable-oil-based adhesive force compositions according to the present invention V-E-11-hcolive 11 and VE-E-11-hcsojall show optimal adhesive force values in the range of over 100 N, whereby, as stated, adhesive force values of over 50 N are still completely acceptable, which, however, are obtained up to now only by paraffin-based or vaseline-based adhesive force compositions.

(6) The filler of the tables is continuously silicon-oxide-based filler with 99% silicon oxide (silica) and low percentages of styrene-isoprene copolymer and aluminum stearate of less than 0.1 wt. % each. If no specific data are contained in each of the tables, the component designations and percentages indicated in the heading of the tables apply. Deviating components are themselves optionally indicated in the individual fields of the table, just as deviating percentages of the components indicated in the heading.

(7) The adhesive force and consistency measurements, which are the basis of the attached Tables 1 through 3 are carried out as follows, the latter analogous to DIN 10331/ISO 16305:

(8) The adhesive force measurements are carried out with the structure measuring apparatus A-XT plus from Stable Micro Systems Ltd., Godalming, Surrey, Great Britain. For the measurement, 0.75 g (0.01 g) of adhesive cream with a sample temperature of 25 C.1 C. was applied to an unengraved side of the sample holder in lumps. The forward and testing speeds are each 0.5 mm/sec, the return speed is 10.0 mm/sec. The pressing pressure was 1,000.0 g, and the trigger value was 5.0 g. Five hundred measurement points were determined per measurement.

(9) The consistency measurement was carried out such that 1.0 g of the test substance tempered to 20 C. is applied in lumps to a glass plate in the middle. The glass plate with the test substance was placed on the extensometer, tempered to 20 C., for 10 min. to 15 min., before another glass plate (diameter=11.5 cm) with a weight of 47.85 g was placed on. Then, the upper glass plate was weighted down with the test weight of the apparatus of 331.3 g (total weight 379.15 g). The diameter of the circle or ellipse formed was determined after 15 min.

(10) An extremely preferred formulation V-E-11-hcsoja-11 according to the present invention containing 42 wt. % soybean oil, 9 wt. % polyacrylic acid as bonding agent, as is represented by the designation Carbopol 971P NF from the Lubrizol Corporation, Wickliffe, Ohio, USA, 44 wt. % of carboxymethylcellulose sold, for example, by the Dow Deutschland Anlagengesellschaft mbH, Schwalbach under the designation WALOCEL as structure-forming stabilizer and 5 wt. % filler is shown in line 1 in Table 1. This adhesive preparation has an optimal-soft-consistency of 4.4 cm to 4.5 cm with an adhesive force of 92 N, as FIG. 1 shows.

(11) While the formulations 4 through 6 of Table 1 with consistencies between 3.5 cm and 3.8 cm have a likewise acceptable adhesive force of 63 N to 76 N, it is shown that the consistency of the adhesive preparation is too stiff or too firm (formulation 2 of Table 1) in the event of a sharper reduction of the vegetable oil percentage with simultaneous increasing of the carboxymethylcellulose percentage to markedly above 50%, and this may also not be compensated by reducing the filler (formulation 3 of Table 1).

(12) Table 2 shows that the structure-forming stabilizer carboxymethylcellulose (Walocel) may basically also be completelyor even partiallysubstituted by the structure-forming stabilizer xanthan gum, whereby the adhesive force decreases slightly compared to carboxymethylcellulose, but absolutely also lies markedly above the lower limit of 40 N. Therefore, the table shows also that bonding agents with a markedly higher viscosity than 29,000 mPa may be used and absolutely very good adhesive values with suitable consistency are obtained.

(13) Adhesive preparations according to the present invention have a body-compatible, particularly also mucous-membrane-compatible slightly acidic pH value of more than 5.

(14) Surprisingly, formulations 4 and 5 of Table 3 show that the use of a suitable bonding agentas used in the other compositionsa means suitable as a structure-forming stabilizer, such as Keldent, leads to a dramatic drop in the adhesive force, aside from the fact that the adhesive preparation is, moreover, also too stiff.

(15) TABLE-US-00001 TABLE 1 ADHESIVE CREAM TEST SERIES 2011 Carbopol Natural 971P Oil NF CMC Filler 30% 45% 5% 15% 30% 50% 3% 6% PHYSICAL PROPERTIES 1 FORMULATION 42% 9% 44% 5% Consistency = 4.4/4.5 cm V-E-11-hcsoja-11 Adhesive force = 92 N 2 V-E-11-hcsoja-12-a x 9% 56% 5% => too firm, pliability absent! 3 V-E-11-hcsoja-12 x 9% 58% x => too firm, pliability absent! 4 V-E-11-hcsoja-13 x 9% 40% x Consistency = 3.8/3.8 cm Adhesive force = 76 N 5 V-E-11-hcsoja-14 x x 44% x Consistency = 3.5/3.6 cm Adhesive force = 63 N 6 V-E-11-hcsoja-15 x x 34% x Consistency = 3.5/3.5 cm Adhesive force = 75 N

(16) TABLE-US-00002 TABLE 2 ADHESIVE CREAM TEST SERIES 2011 Natural Carbopol 974P Oil NF Structure Filler 30% 45% 5% 15% 25% 45% 3% 6% PHYSICAL PROPERTIES 1 FORMULATION 42% 9% 44% 5% Consistency = 4.4/4.5 cm V-E-11-hcsoja-11 Carbopol Walocel Adhesive force = 92 N 971P NF 60,000 2 V-E-11-hccarb974-2 45% 15% 35% 5% Consistency = 3.6/3.6 cm Walocel Adhesive force = 78 N 60,000 3 V-E-11-hccarb974-3 45% 12% 38% 5% Consistency = cm Keldent Adhesive force = 77 N 4 V-E-11-hccarb974-4 42% 9% 44% 5% Consistency = 3.6/3.6 cm Keldent Adhesive force = 69 N

(17) TABLE-US-00003 TABLE 3 ADHESIVE CREAM TEST SERIES 2011 99% Silica**** <0.1% styrene/isoprene Carbopol copolymer Natural 971P CMC (or) HEC (or) <0.1% aluminum Oil* NF** Xanthan Gum*** stearates 30% 45% 5% 15% 25% 45% 3% 6% PHYSICAL PROPERTIES 1 PATENT 42% 9% 44% 5% Consistency = 4.4/4.5 cm FORMULATION Walocel Adhesive force = 92 N V-E-11-hcsoja-11 60,000 2 V-E-11-hckel-1 42% 9% 44% 5% Consistency = 4.0/4.0 cm Keldent Adhesive force = 72 N 3 V-E-11-hckel-2 42% 9% 44% 5% Consistency = 2.9/3.0 cm Keltrol CG Adhesive force = 25 N 4 V-E-11-hckel-3 42% 53% 5% Adhesive force = 1.3 N Keldent => too firm, pliability absent! 5 V-E-11-hckel-4 42% 9% 44% 5% Adhesive force = 0.6 N Keldent Walocel => too firm, pliability absent! 60,000 6 V-E-11-hcnat-1 42% 9% 44% 5% Adhesive force = 39 N Natrosol HX => too firm, gritty, pliability absent!

(18) While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.