OROMUCOSAL FILM PREPARATION

Abstract

The Invention relates to an oromucosal film preparation. According to the invention, said oromucosal film preparation comprises an active-ingredient containing surface area (3) and an active-ingredient free surface area (4). Said surface area (4) which is free of active-ingredients can be used as an application aid for the safe and simple application of the film preparation.

Claims

1. An oromucosal film preparation, characterized in that it comprises an active-ingredient-containing plane region (3) and an active-ingredient-free plane region (4).

2. The film preparation as claimed in claim 1, characterized in that the active-ingredient-free plane region (4) occupies a proportion of 10 to 50%, preferably 10 to 40%, more preferably 20 to 30%, of the total area of the film preparation.

3. The film preparation as claimed in claim 1 or 2, characterized in that its total area is 1 to 10 cm.sup.2.

4. The film preparation as claimed in any of claims 1 to 3, characterized in that the active-ingredient-containing plane region (3) and the active-ingredient-free plane region (4) consist of two different films joined to one another.

5. The film preparation as claimed in claim 4, characterized in that the film formers of the two different films are identical.

6. The film preparation as claimed in claim 4, characterized in that the film formers of the two different films differ.

7. The film preparation as claimed in any of claims 1 to 6, characterized in that the film formers are selected from the group consisting of cellulose, cellulose derivatives, acrylic and methacrylic acid polymers, polyvinyl alcohols, polyvinyl acetate, polyvinylpyrrolidone and derivatives, polysaccharides and polymers based on starch.

8. The film preparation as claimed in any of claims 1 to 7, characterized in that the active-ingredient-containing plane region (3) and the active-ingredient-free plane region (4) are optically distinguishable.

9. A method for producing a film preparation as claimed in any of claims 1 to 7, characterized in that an active-ingredient-free film is joined to an active-ingredient-containing film.

10. The method as claimed in claim 8, characterized in that joining is effected thermally, by means of an adhesive or by means of moisture.

11. The method as claimed in claim 8, characterized in that the active-ingredient-free plane region (4) is joined to the active-ingredient-containing film by film formation in situ.

12. The method as claimed in claim 10, characterized in that the film formation in situ comprises extrusion and/or pressing.

Description

[0027] An exemplary embodiment of the invention will be described schematically on the basis of the drawing, showing:

[0028] FIG. 1: the production of an inventive film by solvent casting, in schematic form;

[0029] FIG. 2: a view of an inventive film;

[0030] FIG. 3: the oral administration of an inventive film.

[0031] Suitable example recipes for polymer solutions for producing a film according to the invention are as follows:

[0032] Base solution for the active-ingredient-containing film:

TABLE-US-00001 Hydroxypropylmethylcellulose (Pharmacoat ® 606) 15% Glycerol, anhydrous  3% Kollidon ® CL-M  5% Water 77%

[0033] Kollidon® CL-M (BASF) is a so-called disintegrant which allows a film to disintegrate in an aqueous environment owing to water uptake and swelling.

[0034] Base solution for the active-ingredient-free film:

TABLE-US-00002 Kollicoat ® IR Carmine 25% Glycerol, anhydrous  1% Water 74%

[0035] FIG. 1 shows schematically how an active-ingredient-free Polymer Solution 1 and an active-ingredient-containing Polymer Solution 2 are jointly cast (solvent casting). The two polymer solutions or layers can be drawn out in a planar manner either in parallel or in succession and adhere to one another. Thereafter, they are dried. The film preparation thus produced comprises an active-ingredient-containing region 3 and an active-ingredient-free region 4.

[0036] A preparation produced in this way can be cut into strips of suitable size, labeled altogether by 5, and packaged.

[0037] FIG. 3 shows schematically the use. The patient removes the film from the packaging at the active-ingredient-free region 4 and takes the active-ingredient-containing region 3 into the mouth. The hydrophilic polymer of the film begins to dissolve owing to contact with the saliva, and so the active-ingredient-free region 4 can be detached from the active-ingredient-containing region 3 and can be disposed of. Alternatively, it is likewise possible to take the entire film preparation including the active-ingredient-free region 4 into the mouth.