Pasty preparation for forming a semirigid dressing

Abstract

The invention relates to a pasty preparation for forming a semirigid dressing, said preparation having the following formulation: 30-70% by weight water, 1-10% by weight gelling agent, 10-40% by weight glycerol or polyvalent alcohols, in particular propylene glycol or sorbitol, 0-30% by weight oil, 0.5-5% by weight water-soluble salts, 0.5-2% by weight rheological fillers, and 1-5% adsorbent fillers.

Claims

1. A paste-like preparation for forming a semirigid dressing comprising the following formulation: 30-70% by weight of water, 1-10% by weight of gelling agent, 10-40% by weight of glycerol or polyhydric alcohols, 0-30% by weight of oil, 0.2-5% by weight of water-soluble salts, 0.2-2% by weight of rheological fillers, and 1-5% by weight of adsorbent fillers, wherein the preparation is a zinc-free preparation.

2. The preparation as claimed in claim 1, wherein the formulation further contains 0.05-0.5% by weight of metals and/or metal compounds that have an antimicrobial action.

3. The preparation, of claim 2, wherein metals or metal compounds that have an antimicrobial action are silver and/or copper.

4. The preparation as claimed in claim 1, wherein the gelling agent is a water-soluble polymer selected from the group consisting of gelatin, starch derivatives, cellulose derivatives, alginates, acacia, agar, and mixtures thereof.

5. The preparation of claim 1, wherein the oil is a paraffinic and/or olefinic oil.

6. The preparation of claim 1, wherein the rheological fillers are selected from the group consisting of aluminum oxide, magnesium oxide, silicon dioxide, and mixtures thereof.

7. The preparation claims of claim 1, wherein the adsorbent fillers are selected from the group consisting of activated carbon, cyclodextrin, finely dispersed silica, and mixtures thereof.

8. The preparation of claim 1, wherein the preparation has a viscosity of 30-6000 mPas at 60° C.

9. The preparation of claim 1, wherein the adsorbent fillers are dispersed in powder form in the paste-like preparation.

10. The preparation of claim 1, wherein it is yellowish, beige, gray or black in color.

11. A semirigid dressing set consisting of a strip-form textile carrier and a preparation of claim 1.

12. A method of treating states and conditions selected from the group consisting of venous thrombosis, swelling caused by injuries or impairment of venous function, chronic venous insufficiency, including venous leg ulcers and phlebedema, thrombophlebitis, phlebothrombosis, fractures of the fibula without deformity, distortions, luxations, tendovaginitis, further treatment after plaster casts, reduction of post-traumatic edema, for rapid decongestion and elimination of chronic edema, phlebitis of deep and superficial veins, post-thrombotic states, aftercare of bone fractures, and mixtures thereof, wherein the method comprises employing the paste-like preparation for forming a semirigid dressing of claim 1.

13. A semirigid dressing preparation comprising a strip-form textile carrier to which the preparation of claim 1 is applied.

14. The semirigid dressing preparation as claimed in claim 13, wherein the textile carrier is coated or impregnated or coatable or impregnatable with the preparation.

15. The semirigid dressing preparation of claim 13, wherein the textile carrier is selected from the group consisting of a woven fabric, knitted fabric, crocheted fabric or nonwoven fabric.

16. The semirigid dressing preparation or semirigid dressing set as claimed in claim 13, wherein the textile carrier is elastic.

17. The semirigid dressing preparation as claimed in claim 13, wherein the weight ratio of carrier to preparation is from 1:3 to 1:6.

18. A compression, support or relief bandage comprising the semirigid dressing preparation of claim 13.

19. A method for producing a semirigid dressing preparation of claim 13, wherein the preparation is applied to one or both sides of the strip-form textile carrier material.

20. A semirigid dressing obtained from a semirigid dressing preparation of claim 13, wherein the water at least partly evaporates from the preparation within 12-48 h as a result of which the bandage is less flexible than prior to evaporation.

Description

EXAMPLE 1

Zinc-Free Paste Bandage (Semirigid Dressing Preparation) with Activated Carbon as Adsorbent Filler (Dry Type)

(1) The paste-like preparation according to the invention is produced according to the following formulation:

(2) TABLE-US-00001 Comp. A 490 g of demineralized water (equivalent to 56.9%) Comp. B 37.5 g of carboxymethyl (equivalent to 4.4%) cellulose Comp. C 10.0 g of gelatin (equivalent to 1.1%) Comp. D 300 g of glycerol 85% (equivalent to 34.8%) Comp. E 6.7 g of calcium chloride (equivalent to 0.8%) dihydrate Comp. F 17.0 g of activated carbon (equivalent to 2.0%) Total amount 861.2 g (equivalent to 100%)

(3) A heatable vessel (volume 2000 ml) fitted with a stirrer unit is charged with the specified amount of demineralized water (comp. A) and heated to 40° C. Component B as a further gelling agent (Walocel CRT 30 GA, manufacturer Dow, Walsrode) in powder form is added slowly at medium stirrer speed (1000 rpm) and the mixture is stirred for 30 minutes until a clear solution has formed. Component C (Gelita pharma-grade gelatin Gold Extra 180 Bloom, manufacturer Gelita AG, Eberbach) in powder form is then added slowly and the mixture is again stirred for 30 minutes until a clear solution has formed. This is followed by the successive addition of component D (pharma-grade glycerol 85%, manufacturer Biesterfeld, Friedrichsthal) and E, as water-soluble salt, (calcium chloride dihydrate, manufacturer Merck, Darmstadt). The mixture is up to this point a light yellow-beige color. Finally, the activated carbon (Carbopal SC 11 PG, manufacturer Donaucarbon, Frankfurt) in powder form is added and stirred in until a homogeneous deep black paste has formed. This paste is cooled to 30° C. with constant stirring (speed 500 rpm) and used in this form for coating the carrier textile. The paste is optically homogeneous in appearance. No sedimentation is discernible within 3 days.

(4) The mass from example 1 is stable to storage for several weeks (4-8) without microbial colonization (surface covering of mold) being visible or noticeable through an odor of decomposition.

(5) To produce the semirigid dressing (paste dressing) according to the invention or a semirigid dressing preparation, the carrier fabric specified below is used, which is produced on a ribbon loom with a rapier weft insertion device:

(6) Longitudinally elastic gauze bandage according to DIN 61634 with firm selvages, type 564, width 10 cm:

(7) TABLE-US-00002 Material composition of the 71% viscose, 29% polyamide, fabric plain weave Warp thread 1/warp thread 2 17 tex viscose/78 dtex f 17 × 2 textured polyamide Thread count of warp thread 56/56 per 10 cm width 1/warp thread 2 Weft 17 dtex viscose Weft density 36 double weft per 10 cm stretched (DIN 61632) Weight per unit area stretched 32 g/m.sup.2 (DIN 61632) Elasticity in longitudinal direction (warp direction) Stretch/recovery according 140%/99% to DIN 61632 Air permeability DIN 53887 5000-7000 l/m.sup.2 sec

(8) Coating is carried out using a 2-roll foulard from Mathis, Oberhasli (CH), wherein one roll is driven and may be pressed against the other by means of compressed air. The paste is fed into the nip (gusset) of the two horizontally arranged rubber rollers (diameter 100 mm, width 300 mm, rubber Shore hardness 60°). The air pressure is then reduced such that there is a visible gap (0.5-1 mm) between the rollers. The elastic fabric strip is fed from above through the paste in the gusset into the nip until it is drawn through by the drive of the rollers. The textile strip coated with the paste then emerges below and is wound onto a cardboard tube serving as the roll core, keeping tension to a minimum and the edges as straight as possible. The contact pressure and gap are set such that the weight ratio of textile to paste is in the range from 1:3 to 1:6, depending on the desired paste content. On reaching the desired length, the coated strip is cut off and the end of the bandage is laid flush on the cylindrical reel. The gray-black paste dressing thus produced has the following characteristics:

(9) TABLE-US-00003 Color Gray-black Bandage width 10.0 cm Bandage diameter (on 30 mm core) 74 mm Bandage length unstretched (DIN 61632) 610 cm Bandage length stretched (DIN 61632) 1020 cm Stretch (DIN 61632) 67% Bandage weight (without core) 188 g Proportion by weight of textile 32 g Proportion by weight of preparation 156 g Weight ratio textile/preparation 1:4.9

(10) In analogous manner to the known zinc paste bandages, the semirigid dressing preparation according to example 1 is hermetically sealed inside a tubular bag packaging made from a three-layer barrier film that is impervious to air and water vapor (manufactured for example by Heyne & Penke, Dassel) and stored therein until use. Even after several weeks, the bandage remains usable and free of microbial colonization.

(11) For use, the tubular bag packaging is opened and the bandage is wound around the leg of the subject as a lower-leg compression bandage with 50% overlap and avoiding wrinkles. The layers stick to one another firmly, including in particular the bandage end on the substrate. The semirigid dressing preparation hardens to a semirigid dressing over the course of 12 to 24 hours, with the dressing feeling slightly rough and dry on the outside. The layers are stuck together even more firmly after drying and the gray-black color is a little lighter in appearance. The subject feels comfortable with the dressing and does not perceive any odors, even after wearing it for several days.

EXAMPLE 2

Zinc-Free Paste Bandage with Silicon Dioxide/Activated Carbon as Adsorbent Filler (Wet Type)

(12) The paste-like preparation according to the invention is produced according to the following formulation:

(13) TABLE-US-00004 Comp. A 490 g of demineralized water (equivalent to 56.7%) Comp. B 37.5 g of carboxymethyl (equivalent to 4.3%) cellulose Comp. C 10.0 g of gelatin (equivalent to 1.1%) Comp. D 150 g of glycerol 85% (equivalent to 17.4%) Comp. E 150 g of castor oil (equivalent to 17.4%) Comp. F 6.7 g of calcium chloride (equivalent to 0.8%) dihydrate Comp. G 2.5 g of silicon dioxide (equivalent to 0.3%) Comp. H 17.0 g of activated carbon (equivalent to 2.0%) Total amount 863.7 g (equivalent to 100%)

(14) Production is carried out in analogous manner to the procedure described in example 1, using the same chemicals in the sequence of components A to H. Used here as a new component E is castor oil (pharma-grade castor oil, manufacturer Kirsch Pharma, Salzgitter). Castor oil subsequently serves as a moisturizer and softener in the dressing, which is why this type of paste bandage (semirigid dressing) is referred to as “wet type”. In addition to activated carbon, silicon dioxide (Aerosil 200, manufacturer Degussa, Frankfurt) is added as a further filler with adsorption properties, as component G. Prior to mixing in component G, the mass is a milky gray-white. After adding the activated carbon (component H), a homogeneous deep black paste is formed, which is cooled to 30° C. with constant stirring at a speed of 550 rpm and is used in this form for coating the carrier textile. The paste is optically homogeneous in appearance; no sedimentation is discernible within 3 days.

(15) The mass from example 2 is likewise stable to storage for several weeks (4-8 weeks) without microbial colonization (surface covering of mold) being visible or noticeable through an odor of decomposition.

(16) Coating is carried out in analogous manner to the description in example 1. In this case, a gray-black paste bandage is again produced as a semirigid dressing preparation that has the following characteristics:

(17) TABLE-US-00005 Color Gray-black Bandage width 10.0 cm Bandage diameter (on 30 mm core) 7 3 mm Bandage length unstretched (DIN 61632) 615 cm Bandage length stretched (DIN 61632) 990 cm Stretch (DIN 61632) 61% Bandage weight (without core) 178 g Proportion by weight of textile 31.5 g Proportion by weight of preparation 146.5 g Weight ratio textile/preparation 1:4.6

(18) In analogous manner to example 1, the bandage is hermetically sealed inside a tubular bag packaging made of a suitable barrier film that is impervious to air and water vapor and stored therein until use. Even after several weeks, the bandage remains usable and free of microbial colonization.

(19) For use, the tubular bag packaging is opened and the bandage is wound around the leg of the subject as a lower-leg compression bandage with 50% overlap and avoiding wrinkles. In this case, the castor oil content means that the layers stick to one another less firmly, including in particular the end of the bandage/dressing. The dressing hardens into a semirigid dressing over the course of 12 to 24 hours and in this case, the bandage feels smooth, creamy, and wet on the outside. After drying, the layers are stuck to one another less firmly than in example 1, which is altogether desirable for the wet type. The gray-black color is in turn a little lighter in appearance. The subject feels comfortable with the dressing and does not perceive any odors, even after wearing it for several days.

EXAMPLE 3

Comparative Example: Zinc-Containing Paste Bandage without Adsorbent Filler (Dry Type)

(20) As a comparative example, a zinc-containing paste-like preparation without addition of fillers with adsorbent properties is produced according to the following formulation:

(21) TABLE-US-00006 Comp. A 490 g of demineralized water (equivalent to 49.3%) Comp. B 37.5 g of carboxymethyl (equivalent to 3.8%) cellulose Comp. C 10.0 g of gelatin (equivalent to 1.0%) Comp. D 300 g of glycerol 85% (equivalent to 30.2%) Comp. E 6.7 g of calcium chloride (equivalent to 0.7%) dihydrate Comp. F 150 g of zinc oxide (equivalent to 15.0%) Total amount 994.2 g (equivalent to 100%)

(22) Production is carried out in analogous manner to the procedure described in example 1, using the same chemicals in the sequence of components A to E. Zinc oxide (pharma-grade zinc oxide, manufacturer Briggemann KG, Heilbronn) is added as component F. This bright white paste is cooled to 30° C. with constant stirring (speed 500 rpm) and used in this form for coating the carrier textile. The paste is optically homogeneous in appearance; after 1 day slight sedimentation in the form of a zinc oxide sediment is discernible. A coating of mold develops after 1-2 weeks on the mass in the comparative example, which indicates microbial colonization. This is also evidenced by an intense putrid odor of decomposition.

(23) Coating the textile carrier to produce the finished paste bandage (semirigid dressing preparation) was therefore omitted.