NO129771B - - Google Patents

Description

Procedure for the production of ready-to-use

" ointment foil.

The present invention relates to a method of the kind stated in claim 1's preamble.

In dermatological treatment of skin surfaces as well as in wound treatment, ointments have been used for a long time. Ointments are generally applied to the skin area to be treated or,

as in the case of wound treatment, apply an ointment cloth, e.g. gas, which is placed over the place to be treated. To facilitate treatment, gas strips are treated with ointment, and are produced, for example, in the form of ointment compresses. Such methods are applicable only for anhydrous ointments, such as vaseline, anhydrous or almost anhydrous polyethylene glycol, while emulsion ointments, especially of the oil-in-water type, in the form of ready-to-use ointment gas, are subject to rapid drying out. The ointment plasters, which are no longer common today, were unwieldy

just in use. They contained sticky plastic wax and fat masses that had to be heated for application. The use of a powder is, although it is easily applied when ironing, not always appropriate, because the large inner surface absorbs a lot of moisture, which is not always desirable.

The method according to the invention is characterized by what is stated in the characterizing part of the claim. The ointment foil produced according to the method consists of a water-poor emulsion of the oil-in-water type, and is composed of: a) 20 - 60% of a fat phase of different composition, such as fatty alcohol, vaseline, wool grease or the like,

b) 2 - 12% of an emulsifier,

c) 3 - 20% of a film former,

d) 10 - 40% of a humectant, such as glycerol, sorbitol, sugar or similar, and e) 1 - 15% of a therapeutic and/or cosmetically active agent, as well as

1 - 15% water.

The foil can contain additives that improve the covering power of the ointment, for example titanium dioxide, zinc oxide and the like. Non-ionic, anion-active or cation-active compounds are primarily considered as emulsifiers. The film former consists of methyl or carboxymethyl cellulose, or another water-soluble and swellable cellulose derivative, alginate or the like.

The ointment foil is produced on the basis of an emulsion ointment of the oil-in-water type. The ointment is thereby brought into such a form that it can be used quickly, and so that one avoids touching the place to be treated, especially wounds. Furthermore, the unnecessary detour of coating a gas with ointment is avoided. This avoids the strong drying tendency that occurs when using powder, and makes use as an active ingredient carrier more universal. It has been shown by using the method for producing ready-to-use formed ointment foils that all these requirements can be met.

Attempts have been made to preserve oil-in-water emulsions by water extraction using dry evaporation or freeze-drying. After the addition of water, such concentrates can be returned to an oil-in-water emulsion by mechanical processing, such as stirring.

It has surprisingly been shown that a further extraction of water by means of heated surfaces, such as a heating roller, at the same time produces, with suitable oil-in-water emulsions, compact ointments in foil form which ideally satisfy all requirements. The ointment foil can be placed directly on the part to be treated, and foir itself after the applied body part. All application difficulties are avoided, and the application can be made much more hygienic than is possible with known ointment therapy. This is particularly interesting as a result of a rapid application for lesions on large surfaces, for burns and in connection with surgical interventions. Ointment foils produced in accordance with the present invention exhibit excellent stability and can be manufactured sterile in hygienic disposable packaging, which is an advantage not shown by known oil-in-water emulsions in normal tube packaging.

The starting materials used by the inventor

method are known oil-in-water emulsions, i.e. emulsions derived from a fat phase, e.g. mineral oil, ozokerite, vaseline, paraffin, fatty alcohols, vegetable oils, also in hydrated form, fatty acid esters and the like. Furthermore, they contain an emulsifier, for example sodium cetostearyl sulphate, ethoxylated fatty alcohols or complex emulsifiers, such as polyoxyethylene derivatives of sorbitol anhydrides, or also soap or other cationic compounds. The water phase of the emulsion contains a humectant, such as sorbitol, glycerol, sugar, polyethylene glycol or 1,2-propylene glycol. Such a starting emulsion can contain known active substances, for example disinfectant compounds such as p-chloro-m-cresol, oxyquinoline, antibiotics, sulfonamide, hexachlorophene, acridine dyes, p-hydroxybenzoic acid esters, but also disinfectants of the cationic type, such as e.g. benzalkonium chloride, cetylpyridinium chloride, etc. Further usable active substances are tanning substances, allantoin, urea, azulene, plant extracts, cortisone derivatives, vitamins, hormones, etc. Mainly all known active substances that can be used in diaper-in-water emulsions are also usable in ointment foils .

One or more film-forming compounds are added to these emulsions. Among those that are suitable are, for example, carboxyvinyl polymers, methylcellulose, carboxymethylcellulose and other water-soluble cellulose derivatives, vegetable slime formers, alginate, polyvinylpyrrolidone, copolymer of polyvinylpyrrolidone and vinyl acetate, agar agar, carrageenan or "Dextran", etc. The consistency of the emulsion is adjusted with water or water -alcohol mixture into a relatively easy-flowing paste. The obtained paste is spread by means of rolling or coating on a substrate, such as metal plate, glass or the like, and when the substrate is heated, the water phase evaporates to a residual moisture of 1 - 15%. Heated rollers are also particularly suitable for the drying process. In order to be able to remove the resulting film more easily, it is appropriate to coat the metal plate or the roller with a suitable synthetic material, e.g. polyethylene or polytetrafluoroethylene, enamel or glaze. The drying temperature is in the range 65 - 110°C. When using bulky active substances, vacuum can be advantageously used. The application of paste must be set so that after the drying process a film with the desired film thickness is obtained.

In another embodiment, an emulsion is prepared as previously indicated, as a thick paste, which is then converted to a dough consistency in a vacuum boiler using heat. The resulting mass is rolled out into thin foils which, according to the first embodiment, are pressed onto heated plates or rollers to thereby set the final water content at the desired level.

Appropriate film thickness is in the range 0.2 - 1.5 mm. A thus produced compact ointment in foil form is easy to apply and flexible. When this film is applied to the skin surface to be treated, it is in close surface contact with the substrate. Thereby, moisture can be extracted, especially in the case of oozing eczema or bleeding wounds. Indication of active substance at the surface contact point is thereby completely ensured. An ointment film produced according to this method can be used in its original form, but it can also be rolled on one side on a gas substrate. These ointment films are particularly suitable as an ointment substrate for adhesive plasters, possibly instead of the gas padding. By a mechanical connection between the ointment films and gas, burn wound dressings can be produced. Instead of gas, other tissues can also be used. The ointment foil produced according to the invention is a water-poor oil-in-water emulsion, but which nevertheless exhibits the properties of a real emulsion. It is dispersible in water and forms a flowable emulsion. Further absorption is prevented by the humectant used. Furthermore, the ointment foil can be sealed in a water-impermeable material until use.

Examples

1.) To produce a non-ionic emulsion, the fat phase was

consisting of 3 parts vaseline, 5 parts cetostearyl alcohol and 1 part fatty tall alcohol polyglycol ether with a hydroxyl number of 80-120

merged. The water phase, which consisted of 2 parts low-viscosity methyl cellulose, 1 part polyvinylpyrrolidone, 6 parts glycerol, 1 part panthenol, 1 part allantoin, 0.1 part benzalkonium chloride and 80 parts water, was heated to approx. 70°C. The water phase and the fat phase were then emulsified in a known manner. The finished emulsion was torn with 3 parts zinc oxide. The mass obtained was spread out to a thickness of approx. 2 mm on a Teflon-coated metal plate, after which the water was evaporated at 100°C to a residual moisture of approx. 3 - 4% in the film. The obtained film was taken down and was ready for use. 2. ) For the production of an anionic emulsion, the fat phase was consisting of 0.2 parts of paraffin oil, 3 parts of ozokerite, 3 parts of vaseline and 5 parts of cetyl stearyl alcohol (DAB^) (3rd addition), fused. The water phase consisting of 2.5 parts carboxymethylcellulose, 7 parts sorbitol, 0.1 part sodium p-chloro-m-creosolate and 90 parts water was heated to approx. 70°C. The water phase and the fat phase were emulsified in a known manner, and the finished emulsion was applied to a heated, slowly rotating roller in a layer of 2 mm thickness, and the water was evaporated to a residual moisture of approx. 5%. 3. ) For the preparation of a non-ionic emulsion, a fat fa see consisting of 6 parts vaseline, 10 parts cetyl stearyl alcohol, 1 part stearic acid and 2 parts polyoxyethylene sorbitol monooleate, melted. The water phase consisting of 4 parts methylcellulose, 10 parts glycerin, 1 part allantoin and 80 parts water heated to approx. 70°C. The water phase and the fat phase were emulsified in a known manner. In the finished emulsion, 0.5 parts of "Neomycin sulfate" and 0.05 parts of vitamin E acetate were incorporated. The emulsion was then spread on a plate in a 3 mm thick layer and then dried in vacuum at approx. 50°C. The residual moisture in the obtained film was 5%. 4. ) An anionic emulsion was prepared from a water phase be consisting of 3.3 parts petroleum jelly, 6.4 parts emulsifying cetyl stearyl alcohol (DAB^(3rd addition)), 0.5 parts polyethylene glycol-400 stearate, 0.1 part p-hydroxybenzoic acid butyl ester, 0.2 parts "Adeps lanae" which were merged. The water phase consisting of 2.2 parts carboxymethylcellulose, 1.2 parts polyvinylpyrrolidone, 5 parts "Polyethyleneglycol 4O0", 3 parts urea and 60 parts water was heated to approx. 70°C. The water phase and the fat phase were emulsified in a known manner, after which the obtained mass was evaporated in a vacuum boiler with stirring until a pasty consistency was obtained. This paste-like mass was rolled out thinly on a metal plate and then dried at 100°C until a residual moisture of approx. 5%. 5.) The emulsion according to example 1 was spread on a metal plate in an approx. 3 mm thick layer. For distribution on the metal plate, a layer of gas is incorporated into the mass. The water is then removed by evaporation at approx. 100°C to a residual moisture of approx. 3 - 4%.

Claims (5)

1. Procedure for the production of ointment foil in a ready-to-use form, especially for dermatological treatment of skin surfaces, characterized in that an oil-in-water emulsion containing: a) 20-60 parts by weight of a fatty phase such as fatty alcohol is produced in a manner known per se , vaseline, wool grease and the like, b) 2-12 " emulsifying agent, c) 3-20 " film-forming agent, d) 10-40 " humectant, such as glycerol, sorbitol, sugar, and the like, e) 1-15 " therapeutic and/or cosmetic active ingredient, after which the emulsion is spread on a substrate and heat-treated until the water content is 1 - 15%. 2. Method according to claim 1, characterized in that titanium dioxide, zinc oxide or the like is further added to the emulsion. 3. Method according to claims 1-2, characterized in that methyl, carboxymethyl cellulose or other water-soluble or swelling cellulose derivatives or an alginate are used as film formers. 4. Method according to claims 1-3, characterized in that the starting emulsion is distributed or coated on plates or drying rollers in suitable layer thicknesses, and that the layer thickness is chosen so that after a further removal of water, an ointment film is obtained with a layer thickness of 0.2 - 2 etc. 5. Method according to claims 1-4, characterized in that the water is removed by evaporation using heat, preferably at a temperature of 65 - HO°C at normal pressure and then at approx. 50°C under vacuum.