DE2224700A1 - Dressing material and process for its manufacture - Google Patents

Description

concerning
Dressing material and process for its manufacture

The invention relates to dressing material, specifically to a dressing material which has the property of to stick to moist mucous membrane surfaces or to their moist skin surfaces. The dressing material is in the form of a Film, which is a water-soluble film-forming material contains, and that on a larger area with a water-insoluble metal salt of the film-forming material is provided.

The dressing material or the wound dressing can be with a Support material, for example a flat material made of plastic or a fabric or the like, be provided in order to to create a protective or reinforcing effect, or to stick the bandage to dry skin surfaces to enable. However, the actual dressing preferably consists of the film mentioned. In this form it is Dressing material particularly suitable for use in the oral cavity, where 3.B. serves to ulcers or to cover other wounds. However, the film can also be used on other moist mucous

209850/0819

• Flattened or curved skin surfaces are arranged, e.g. over open wounds in the skin that secrete fluids, or on normally damp wounds Surfaces of other cavities of the body where the properties of the film-forming material normally cause that the film adheres spontaneously to the surface in question.

The dressing material is placed in use so that the water-soluble material of the film is to be covered facing the moistened area “If this happens, it dissolves the water-soluble film-forming material slowly picks up. When the film contains a drug, as it usually does If so, this dissolving action causes the drug near the affected area of the body in a regulated manner is released slowly »the film is exposed to moisture on both sides, as is the case for example. When the dressing material is used in the oral cavity, the water-insoluble metal salt causes it the film-forming material on the outside of the film, that the rate at which the film dissolves decreases; this process helps to ensure that when the drug is released it will be absorbed by the patient's body "

It has already been suggested for "dressing materials to use various water-soluble film-forming organic substances; according to the invention the use of a Alginate or a carboxyalkyl cellulose, in particular from Carboxymethyl cellulose preferred The alkali metal salts of these two substances dissolve in water, being colloidal Solutions arise, and in both cases it proves expedient to use the sodium salt »The expression "Soluble in water" also refers to substances that form colloidal solutions »

The water-insoluble lethal salt of the film-forming Li material is preferably an EräalkaliiueLaIl-

20985 0/0819

salt, especially a calcium salt of alginate or carboxymethyl cellulose * You cannot use this in water; soluble Generate metal salt in a convenient way by adding a solution containing the metal in question, e.g. a Calcium chloride solution, applied to a surface of a sheet of the water-soluble film-forming material; on this is discussed in more detail below

In general, the film also contains a wetting agent or a plasticizer for the film forming agent Polymerizatmaterial ο True are the properties of the humectant or plasticizer for the invention not of decisive importance, but it is advisable to use a saturated aliphatic polyhydric alcohol, e.g. glycerine or sorbitol should be used.

If the film-forming material is an alginate, the weight fraction of the alginate is both its water-soluble as well as in its water-insoluble form for the film generally between 10% and 55% »preferably between 20% and 50% and in particular between 30% and 45%.

Carboxyalkyl cellulose is used as a film-forming material is used, the carboxyalkyl cellulose content of the film is both its water-soluble and its in The water-insoluble form is generally considerably less than the proportionate amount of the alginate.

The weight proportion of the humectant or plasticizer in the film can be between 10% and 70%, but a weight proportion of 20% to 40% is preferred »The weight ratio between the humidifier or plasticizer and the alginate is preferably not more than 1: 1, However, even under x 0.18: 1 «.uas weight ratio between the wetting or plasticizer and the carboxyalkyl cellulose can be significantly higher and B. 5 z _e ^ 1 or even up to 10: 1

9850/0819

"be.

In the film, the film-forming material is preferred in a length from 5% to 50% and in particular from 10% to 2 5% present in the form of the water-insoluble metal salt, while the est is present in a water-soluble form, at least in those cases where such films are in the oral cavity are used, too much of the insoluble material would result in an undesirable residue while the film would dissolve quickly if too little of the insoluble material was used there would be ο

Otherwise, the film generally consists primarily of water. However, a wide variety of other substances can also be present in the film. We can provide the film with pigments and / or dyes, so that the user can see which side of the film to the · relevant body surface are placed should · In addition, the "use can an opaque cover means, Zob. Of _TiO2 or ZnO, prove to be expedient "If the film is to be used in the oral cavity, it can also be provided with certain essences or flavorings" - the proportion of these substances and any other desired additives is not of critical importance, but it is usually only a minor one Amount not exceeding 5% of the weight of the entire film.

As mentioned, the film preferably contains one or more drugs that are slowly released while the film dissolves. You can use any drug that is externally applicable, and that is not reacts with other components of the film «The properties of the drug are irrelevant to the invention, Examples of types of drugs that can be used are the following are mentioned: locally acting foch pain anesthesia. e.g. lignocaine, antibacterial agents, e.g.

209850/08 19

Cetylpyridinium chloride, antibiotics, e.g. penicilin, growth stimulants, e.g. allantoin, disinfectants, antiseptics, analgesics and other substances. The amount of each drug contained in the film is determined according to the amount to be absorbed by the patient's body, as well as according to the area of the to be used Film Piece ο This amount is fairly easy to determine.

Further in accordance with the invention, a method of making dressing material is that described above Art has been created that includes measures to a sheet of the water-soluble film-forming material generate in order to apply a solution of a metal salt to a surface of this sheet material, so that on this Surface a water-insoluble metal salt of the film-forming material is formed, and that the flat material is to be dried, so that a filin-shaped product is obtained.

In one embodiment of a method according to. In accordance with the invention, a detent which has been freed of air and which contains the water-soluble film-forming material and further components of the aforementioned type is extruded through an opening of suitable shape, and the strand emerging from the opening is cut into slices, for example with the aid of a device resembling a microtome wherein the apparatus is arranged so that .the disks _o fall on a moving belt These discs then form the mentioned in the preceding paragraph flat material pieces, which are then treated in the manner described with, on the one metal salt solution and dried "

In another embodiment of a method according to the invention, a solution or paste is made from the film-forming material is applied to a flat surface in the form of separate drops, which are then rolled out flat in order to process them into the aforementioned pieces of flat material or sheets »These flattened drops

209850/081 9

are then in the manner described with cer jaetallsalzlösung treated and dried.

These two methods according to the invention offer the Advantage that the resulting Ulm is not tailored to needs, since it already receives the desired dimensions during its manufacture.

In a preferred method according to the invention, a solution of the water-soluble film-forming material is used processed into a sheet, part of the solvent is removed from this sheet before the sheet is mixed with the metal salt solution is treated »The following description applies in particular to this preferred method according to the invention *

When solving the water-soluble film formeiien i-iaterials is generally an aqueous one Solution, which may also contain a humectant, a plasticizer, a drug, a flavor, contains an essence, a dye or a pigment, if the finished product contains such substances should ο The concentration of this solution depends on the way in which it is to be processed into a sheet; the control of the concentration is important for practical operation, because a solution of high concentration can be so viscous that it can only be processed into leaves with difficulty; is the concentration If the solution is too low, however, excessive effort may be required for drying the leaves. If a device is used in which the .solution the effect of gravity is supplied, the solution can expediently have a Viass'er content of about 80 percent by weight habeno If, on the other hand, a device is used in which a pressure acts on the solution to be dispensed, the solution can generally have a higher concentration. Appropriate J> concentration values can be found for each particular Easily identify the case.

2098 507 08 1 9

The leaf-shaped product is partially dried, to transform the solution into a firm film »In the Preixis, the degree of dryness must be carefully regulated. Line excessive drying can cause the film to curl and possibly certain components be destroyed. If the drying process is insufficient, there is a risk that the calcium chloride solution or the solution another metal salt penetrates all parts of the film » However, the most appropriate drying conditions can easily be determined for each special case «

A metal salt solution, which is usually an aqueous solution of a chloride of,. Alkaline earth metal, particularly a calcium chloride solution, is applied to one side of the partially dried film. In many cases it is advantageous to ensure that this metal salt solution takes on a different color from the film so that the user can easily see which one is on the film has been made insoluble _o A brush or roller can be used to apply the metal salt solution «

as mentioned, it is preferred to make ten to 25 percent by weight of the film-forming material water-insoluble make «The kenge of the i'ietall salt applied to the film can be just enough to produce such an extent of this To achieve conversion; however, the length of the metal salt also exceed the sufficient kenge, and in this case part of this kenge must be replaced by the following Wash out can be removed again. According to the invention it is preferred to apply a ketallic salt solution, which is just enough to make the film-forming material water-insoluble in the desired iLur.

finally the treated film is further dried and cut into slices or other small pieces, (The size and shape of this little gap are not

BAD ÖFtlfctNAL 20985Ü / 0819

of crucial importance, but it has been shown that round disks with a diameter of 10 mm and with a weight of about 50 mg are particularly suitable for the treatment of ulcers in the L. and cavity. the Thickness of the I film. is usually between 0.07 and 0.5 mm, preferably, between 0.12 and 0.25 now, and it is e.g. about 0.2 mm "

The following example serves to further illustrate the invention.

Ingredients quantities

1o sodium alginate 100 g

2. Glycerin 85 g

3. "Öunset" yellow, 0.15% solution 0.015 g

4. Titanium dioxide, 2oo meshes / inch 0.5 6

5.ft contains 4.7 g

6. Eucalyptol 2.35 S 7 • Cetyl pyridinium chloride 0.47 S

8. Lignocaine Hydrochloride 2.35 S

9. i-ethyl alcohol 10 ml of 10o "water up to a weight of 1 kg

Ingredients 2, 3, 4, 10, 7 and 8 were introduced into a mixer with a Z-shaped idisch organ and mixed until the titanium dioxide was completely dispersed. Then ingredient 1 was added and the mixing process continued in vacuo for one hour. The dissolved in ingredient 9 ingredients 5 and 6 were also attached thereto, and this was mixed again iuaterial _o in a vacuum for 5 min Finally, the mixture was allowed to stand could escape all air bubbles "

Part of the gel recovered in this way was on a glass split in the shape of a sheet with a thickness of 2.5 mm spread »This product was stretched along a distance of 400 mm at a speed of 50 mm / min

20985Ü / 0819 ^8AD

passed through an infrared oven, with the glass plate in a distance of 3CO mm under the infrared heating device - ν ar, which had a power consumption of 2 kW.

The film produced in this way was with the aid of a roller; with an aqueous solution of 5 percent by weight calcium chloride, containing a red dye, coated, cooled with water and then immediately through the a second time Oven led.

The finished film had a thickness of about 0.2 mm and a moisture content of about 17%. The treatment with the calcium chloride solution sufficed to add about 20% of the sodium alginate to transform into calcium alginate. The film was cut into round bcheibai with a diameter of 10 mm, which were suitable for the treatment of ulcers in the oral cavity o

In this example, there was an excess length of calcium chloride is applied to the film, whereupon the coating was removed again by unwinding, yes In the industrial application of the process one would find such a relationship between the tightness and the concentration the calcium chloride solution so that rinsing was unnecessary

Claims

209850/0 819

Claims (1)

PATE HT Λ Ή SPR Ü 0 HE 1. Dressing material that adheres to moist mucous membranes or skin surfaces in the form of a film made of a water-soluble ! "transforming material, thereby identified draws that on the main part of the film area a water-insoluble metal salt of the forming material is available. 2. Bandage material according to claim 1, characterized in that g e k e η η that the film also contains a humectant and / or a plasticizer. 3. dressing material still claim 1 or 2, characterized in that the water-soluble film-forming Material is an alkali alginate. 4. Bandage material according to claim 3, characterized in that the water-insoluble Metallsala des film-forming material is an alkaline earth alginate. 5. bandage material according to claim 3 or 4, characterized g e indicates that the proportion of alginate Constitutes 20 to 50 percent by weight of the film. G ₀ dressing material according to one of claims 3 to 5, characterized in that the amount of the moistening or plasticizing agent makes up 20 to 40 percent by weight of the film, - provided that 2098 50/08 19th is that the weight ratio between the humidification or plasticizer and the alginate value 1: 1 does not exceed β 7 ο dressing material according to claim 1, characterized in that the water-soluble film-forming material is an alkali metal carboxyalkyl cellulose _o 8ο dressing material according to claim 7, characterized in that the water-insoluble metal salt of the film-forming material is an alkaline earth metal carboxyalkyl cellulose is" 9 ο dressing material according to claim 7 or 8, characterized characterized in that additionally a humidification or Plasticizer is present, and that the weight ratio between the moistening or Plasticizer and the carboxyalkyl cellulose does not exceed the value of 1β: 1 « 1Oo dressing material according to one of claims 1 to 9, characterized in that the weight of the of the water-insoluble icing salt of the film-forming material IC70 up to 25% of the total weight of the film-forming material matters. . . . 11. Dressing material according to one of claims 1 to 10, characterized in that the thickness of the iiilms 0.12 to 0.25 mrn is " 12. Dressing material according to one of claims: 1 to 11. thereby g e k e η η ζ ei Gh η e t,. that the l'ilm additional contains a drug. 15 ° "dressing material according to one of claims 1 to 12, thereby g e k e η η ζ e i c h η e t that the i'ilm to unite or contains several flavors, oils, and / or pigments. 2098.5C1- / 0..8.1.9 « 14. A method for producing a bandage material according to any one of claims 1 to 13, characterized in that there is a solution of the water-soluble Film-forming material processed into a flat material or sheet, part of the solvent from the sheet entj it, a solution of a on one flat side of the sheet Meta lalzes applies and the sheet with the formed water-insoluble metal salt of the film-forming material dries. 15. The method according to claim 14, characterized in that there is an aqueous solution of the film-forming Materials used that additionally contain a humectant, a plasticizer, a drug, a G-esclimackstoff, an essence, a dye or contains a pigment which it is desirable to have in the finished dressing material. 16. The method according to claim 14 or 15, characterized in that the metal salt solution is used an aqueous solution of calcium chloride is used. 209850/0819