Oral thin film rolls with high levels of active ingredient loading

Abstract

The present invention relates to a method for producing a water-erodible, water-soluble or water-dispersible active ingredient dosage form, in which a film suitable for an oral film dosage form containing an active ingredient is produced first, and in a subsequent step, the surface of the film is activated to produce a sticky surface, and the activated film is then rolled up to form a rolled laminate.The present invention also relates to a rolled laminate produced by this method.The corresponding laminate is very stable, so that it can be dispensed and cut, and is suitable for administering active ingredients that must be given in larger amounts because their weight per unit area is much higher compared to conventional OTF products.

Description

[Technical Field]

[0001] The present invention relates to a method for producing a roll oral thin film laminate, and to the roll laminate produced by this method. [Background technology]

[0002] Oral thin films, also known as transmucosal delivery systems, are polymer-based thin films containing an active ingredient that, when applied to a mucous membrane, particularly the oral mucosa, deliver the active ingredient directly to the mucosa. These delivery systems have the advantage that the majority of the active ingredient is absorbed by the mucosa, thereby avoiding the first-pass effect that must be considered with traditional dosage forms of active ingredients in tablet form.

[0003] When trying to produce a film with high surface density, one difficulty encountered in the manufacture of oral thin film is actually encountered.In order to provide high surface density, on the one hand, it is necessary to produce the film that is provided for drying as a relatively thick film, which causes problems in the drying process.Alternatively, the film with high surface density can also be produced by applying multiple layers to each other layer by layer, with drying process in between, but this does not always result in the film product with satisfactory structural integrity.In addition, when constructing oral thin film layer by layer, multiple application and drying processes are required, so the manufacture of this film is relatively complicated.

[0004] When large amounts of active ingredient are administered by means of oral thin films, there is an additional problem in that only limited space is available at the application site, e.g., the roof of the mouth or in the cheek, and therefore these fundamental conditions limit the size of the film product.

[0005] Patent document 1 discloses an active ingredient-containing and / or excipient-containing product comprising at least two layers in rolled or folded form for controllable release of these substances with respect to time and / or dose, wherein the first layer, containing at least one active ingredient or excipient, is configured so that at least one of the parameters consisting of layer thickness, layer width, and active ingredient concentration is not constant within this layer. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] DE19946822A1 Summary of the Invention [Problem to be solved by the invention]

[0007] Against this background, there is a demand for dosage forms for active pharmaceutical ingredients and other substances that are administered in larger amounts. The dosage form must offer the advantages of application systems based on rapidly dissolving dosage forms such as oral thin films, and further, must deliver the maximum possible amount of active ingredient while maintaining a relatively small overall size. When manufacturing the dosage form, the known problems of oral thin films with high areal density must be avoided. [Means for solving the problem]

[0008] The present invention addresses this need. DETAILED DESCRIPTION OF THE INVENTION

[0009] It has been discovered that rolled laminates of films based on the same materials as conventional oral thin films can deliver high active ingredient contents in a limited volume and are formulated with a high total weight. Such rolled laminates can be easily placed in the cheek pouch or adjacent to or beneath the tongue, where they can release the active ingredient.

[0010] Accordingly, a first aspect of the present invention is a method for producing a water-erodible, water-soluble or water-dispersible active ingredient dosage form, comprising the steps of: (a) producing an active ingredient-containing film suitable as an oral film dosage form; (b) activating the surface of the film produced in (a) to produce a tacky surface; (c) winding the activated film from (b) to form a roll-up laminate; The present invention relates to a method, including:

[0011] Within the scope of this method, the sticky surface produced in (b) is suitably positioned in step (c) with the sticky side facing inwards so that no sticky residue remains on the outside of the final rolled laminate.

[0012] Films are typically produced in (a) by applying a free-flowing mass of the composition that will then form the film and drying the mass to form the film. A suitable apparatus for producing a corresponding film is shown schematically in FIG. 1. The free-flowing mass is applied to a substrate strip 2 via a suitable unit 1, forming a film 3 on the substrate strip. For example, by movement via a corresponding drive roll 5, the film is then guided into a dryer 4, where it is dried to form a solidified film. After drying, the film can be separated from the substrate strip 2.

[0013] In a preferred embodiment of the method according to the present invention, the surface is activated by etching in (b) to produce a sticky surface. For etching, a small amount of a suitable solvent, such as water or a pharmaceutically acceptable alcohol, such as ethanol, can be applied to the surface of the film in vapor form or liquid form, thereby swelling or dissolving the film to a limited extent in the area close to the surface. In this way, the film is swelled or dissolved to a limited extent, and then by winding the film, a composite is produced between the activated (first) surface and the unactivated (second) surface of the wound film. The advantage of swelling compared to etching lies in the fact that the film remains tightly adhered during this process. After winding, the small amount of water or pharmaceutically acceptable alcohol used to swell / etch the surface of the film can diffuse into the wound film and / or be removed from it by drying. Because no intermediate layer is produced with this type of activation, the wound laminate consists only of the film-forming material.

[0014] In a further preferred embodiment of the method according to the invention, the surface is activated in (b) by melting the surface, e.g. by heating and partially liquefying the surface by means of a suitable heating device, to produce a sticky surface.

[0015] In an alternative preferred embodiment, the surface is activated and a sticky surface is produced by applying a self-adhesive layer in (b), and the self-adhesive layer is formed from a water-erodible material, preferably a water-soluble or water-dispersible material. Water-soluble materials are preferred for the self-adhesive layer.

[0016] Such a self-adhesive layer can be produced, for example, by dissolving a water-soluble and / or water-dispersible material in water and / or a pharmaceutically acceptable solvent, preferably an alcohol such as ethanol, and spreading the resulting layer in a thin layer on a (dehesively finished) carrier film. This layer is then dried to a residual water or solvent content, imparting a certain adhesiveness to the layer. In this state, the layer is applied to the (first) surface of the film produced in step (a), at which point the carrier film can be removed. This allows the "self-adhesive layer" to have a very small layer thickness of 1 to 100 μm, particularly 2 to 20 μm, and particularly preferably 4 to 10 μm. Again, the residual water or solvent content in the rolled laminate can be dispersed by diffusion or reduced by drying.

[0017] This type of activation of the (first) surface of the film and finishing with a sticky surface is advantageous, especially when using a foam-like film in step (a). The risk of film swelling or etching is largely eliminated, and therefore the foam structure of the film is not disturbed. The (dried) material of the adhesive layer remains in the rolled laminate between the "activated" and "non-activated" surfaces of the film.

[0018] The application of the self-adhesive layer can be supported by lightly pressing the self-adhesive layer onto the active ingredient-containing layer, for example, with the aid of a rubber roller.When applying the self-adhesive layer, the pressing force must be set appropriately, so that the foam film containing active ingredient is not damaged by pressing.Those skilled in the art can determine the pressing force suitable here by known suitable tests.

[0019] A third type of activation of the (first) surface of the film consists in its melting: for this purpose, in particular when using foam-like films, energy (for example in the form of heat) is applied to this surface in such a way that this surface is softened and thus, after winding and subsequent cooling of the wound laminate, a permanent bond is formed between the thus activated (first) surface and the non-activated (second) surface.

[0020] The rolled laminate produced by the above method can be cut to suitable lengths if required and packaged by conventional means, for example, in a tubular bagging machine.

[0021] Regarding films suitable for oral film dosage forms, the present invention is not subject to any relevant limitations, provided that the film is, in principle, suitable for oral film dosage forms, i.e., the film dissolves relatively quickly upon contact with saliva and disintegrates to release the excipients or active ingredients contained therein. The components contained in the film must also be pharmaceutically acceptable. Pharmaceutically acceptable water-soluble polymers are particularly suitable film-forming materials. Particularly suitable water-soluble polymers include starch and starch derivatives, dextran, carboxymethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxypropylethylcellulose, sodium carboxymethylcellulose, cellulose derivatives such as ethyl or propylcellulose, polyacrylic acid, polyacrylate, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene oxide polymers, polyacrylamide, polyethylene glycol, gelatin, collagen, alginate, pectin, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar, agarose, carrageenan, and natural gum. Particularly preferred in the context of the present invention are water-soluble polymers selected from the group comprising polyvinyl alcohol, polyethylene glycol, polyethylene oxide, cellulose derivatives, pullulan, gelatin and agar. Most preferred in the context of the present invention is polyvinyl alcohol as the water-soluble polymer.

[0022] The proportion of film-forming polymer in a film suitable for oral film dosage forms is preferably 25 to 85 wt.%, preferably 50 to 85 wt.%, more preferably 60 to 80 wt.%. In some cases, the polymer content in the film may be in a lower range, for example, in the range of 25 to 50 wt.%, or preferably in the range of 38 to 40 wt.%, provided that the integrity of the film is not adversely affected.

[0023] The active ingredient is in principle any orally administrable active ingredient, preferably an active pharmaceutical ingredient. Active pharmaceutical ingredients suitable for oral use in the context of the present invention are, for example, antiallergics, antiarrhythmics, antibiotics, antidiabetics, antiepileptics, antihistamines, antitussives, cardiotonic drugs, diuretics, antihypertensives, expectorants, neuromuscular blocking agents, sex hormones, and hypertensives. Specific examples are acetaminophen, adrenaline, alprazolam, amlodipine, anastrozole, apomorphine, aripiprazole, atorvastatin, baclofen, benzocaine, benzocaine / menthol, benzydamine, buprenorphine, buprenorphine / naloxone, buprenorphine / naloxone / cetirizine, cetirizine, chlorpheniramine, clomipramine, dexamethasone, dextromethorphan, dextromethorphan / phenylephrine, diclofenac, diphenhydramine, diphenhydramine / phenylephrine, donepezil, dronabinol, epinephrine, escitalopram, famotidine, fentanyl, glimepiride, GLP-1 peptides, granisetron, insulin, insulin nanoparticles, insulin / GLP-1 nanoparticles, ketamine, ketoprofen, ketotifen, kadzil ... Fein, levocetirizine, loperamide, loratadine, meclizine, methylphenidate, midazolam, mirodenafil, montelukast, multimelate-001, naloxone, nicotine, nitroglycerin, olanzapine, olopatadine, ondansetron, oxybutynin, pectin, pectin / menthol, pectin / ascorbic acid, PediaSUNAT (artesunate and amodiaquine), pyrophosphate The active pharmaceutical ingredient may be xicam, phenylephrine, prednisolone, pseudoephedrine, risperidone, rivastigmine, rizatriptan, selegiline, sennaglycoside, sildenafil citrate, simethicone, sumatriptan, tadalafil, testosterone, triamcinolone acetonide, triptan, tropicamide, voglibose, zolmitriptan, zolpidem, or pharmaceutically acceptable salts of these compounds.The active pharmaceutical ingredient may also be in the form of a mixture of different active ingredients.As a non-active pharmaceutical ingredient, the dosage form according to the present invention may contain an active ingredient for oral hygiene, such as menthol.

[0024] The at least one active pharmaceutical ingredient is preferably contained in the film at a constant concentration, and in this regard has an active ingredient content uniformity ("content uniformity") of 85 to 115% of the target content, preferably 90 to 110% of the target content, and particularly preferably 95 to 105% of the target content, relative to the unit dose area of ​​the film (before winding).

[0025] The active ingredient content per dosage unit of the film roll produced by the process according to the invention is up to 500 mg, preferably up to 250 mg, particularly preferably up to 230 mg, more preferably up to 200 mg, and even more preferably up to 100 mg. The minimum active ingredient content per dosage unit is preferably 5 mg, more preferably 10 mg, and most preferably 12 mg. Depending on the application, the active ingredient content may also be in the higher ranges of the above-mentioned values, for example, above 50-100 mg or in the range of 30-50 mg.

[0026] The amount of active ingredient relative to the area of ​​the dosage form according to the invention before winding is suitably between 1 and 15 mg / cm. 2 , preferably 2.8 to 10 mg / cm 2 The range is.

[0027] The film according to the present invention, suitable as a film dosage form, can contain not only the above-mentioned film-forming polymer, but also other ingredients, in particular excipients selected from the group including colorants, aromatic substances, in particular flavors and / or odorants, sweeteners, flavoring agents, surfactants, enhancers, pH adjusters, preservatives and / or antioxidants. The addition of flavors, odorants and aromatic substances, either alone or in combination, is particularly advantageous. Suitable flavoring agents are, for example, ion exchange resins. The film suitable as a film dosage form preferably contains flavors, odorants and aromatic substances, either alone or in combination.

[0028] Additionally, films suitable for oral film dosage forms can contain pigments or UV absorbers that protect light-sensitive active ingredients incorporated into the film from UV light.

[0029] In addition to the above-mentioned auxiliary agents, the film suitable for oral film dosage form can also contain other components to optimize its flexibility and / or physical properties, such as plasticizers and / or humectants.Preferred plasticizers and / or humectants in the context of the present invention are selected from the group comprising, for example, glycerin, propylene glycol, polyethylene glycol and citric acid esters.Glycerin is particularly preferably used as a plasticizer.

[0030] Films suitable for use as film dosage forms can be embodied as more solid films (containing no gas) or as solidified foams. When films suitable for use as film dosage forms exist as solidified foams, they contain introduced gases such as air, nitrogen, or CO2, or other gases.

[0031] Suitable basic materials and methods for producing corresponding solidified foam formulations are described, for example, in EP 1296661 A2, EP 1959921 A2 or WO 2018 / 224591 A1.

[0032] When the film dosage form is embodied as a solidified foam, the voids of the foam may be present in the form of separated, preferably solidified, cells in the polymer matrix.

[0033] According to another embodiment, the voids are provided interconnected, preferably by forming a continuous channel system through the matrix.

[0034] When the film dosage form is embodied as a solidified foam, the voids of the foam suitably have a volume fraction of 5 to 98%, preferably 30 to 80%, relative to the total volume of the film (i.e., the self-adhesive layer provided is not taken into account in the volume fraction). In this way, the promotion of dissolution of the film dosage form is favorably influenced.

[0035] Another important parameter affecting the properties of the foam-based film dosage forms according to the present invention is the diameter of the voids or bubbles. The bubbles or voids are preferably generated with the aid of a foam whipping machine, which allows the diameter of the bubbles to be adjusted almost arbitrarily within a wide range. The diameter of the bubbles or voids is therefore in the range of 0.01 to 60 μm. The diameter is particularly preferably in the range of 10 to 50 μm.

[0036] The thickness of the film layer of a film suitable for an oral film dosage form is preferably in the range of about 0.01 to about 2 mm, and particularly preferably in the range of 0.02 to about 1 mm.

[0037] The present invention is also not subject to any relevant limitations regarding the material from which the self-adhesive layer is formed, provided that the self-adhesive layer is based on a pharmaceutically acceptable water-soluble or water-dispersible polymer. A suitable water-soluble or water-dispersible polymer is, for example, Plastoid E35H (softened Eudragit E100; lauric acid, adipic acid, and glycerin are added as modifiers). Further suitable water-soluble or water-dispersible polymers are, for example, shellac, vinylpyrrolidone / vinyl acetate copolymer, polyvinylcaprolactam / polyvinylacetate / polyethylene glycol copolymer, hydroxypropyl cellulose or hydroxypropylmethylcellulose, and / or polyvinylpyrrolidone. A very particularly preferred water-soluble polymer within the scope of the present invention is polyvinylpyrrolidone.

[0038] The aforementioned water-soluble polymer is suitably combined with a plasticizer.Examples of suitable plasticizers include, for example, glycerin, polyethylene glycol, particularly polyethylene glycol 200, sorbitol and / or tributyl citrate, among which glycerin, polyethylene glycol 200 and / or tributyl citrate are particularly preferred.A particularly preferred plasticizer is glycerin.

[0039] The adhesive is not subject to any relevant limitations regarding the ratio of water-soluble polymer to plasticizer, provided that the ratio is set so that the mixture is sufficiently tacky and usable. Examples of preferred mixture ratios are approximately 85-50 to approximately 15-50, preferably approximately 85-65 to approximately 15-35, even more preferably approximately 80-60 to approximately 20-40, even more preferably approximately 80-50 to approximately 20-50, even more preferably approximately 82-68 to approximately 18-32, and most preferably approximately 80-70 to approximately 20-30.

[0040] The preferred proportion of water-soluble or water-dispersible polymer in the self-adhesive layer is defined as a proportion of approximately 50 to 90, preferably approximately 60 to 85% in the film.

[0041] With this type of activation of the (first) surface of the film produced in step (a), an intermediate layer, even if only relatively extremely thin, remains between the activated (first) and non-activated (second) surfaces of the film in the roll-up laminate after winding, i.e. the layer thickness of the self-adhesive layer is preferably at least half, more preferably at least a quarter, even more preferably at least an eighth of the layer thickness of the film containing the active ingredient of the film dosage form.

[0042] The activated film can be wound up by a rotating brush, suitably at an angle of approximately 45°. Furthermore, a winding core can be attached to the laminate provided in a flat form, and the laminate can then be wound around this winding core. After completion, the winding core is removed, leaving a cavity in the center, which has a diameter of approximately 0.5 to 30 mm, preferably approximately 1 to 10 mm, and particularly preferably approximately 2 to 5 mm.

[0043] Alternatively, the winding core can remain in the system as part of the product, and this winding core is small or hollow, in this case provided in a ring shape, and contains an active ingredient or generally does not contain an active ingredient. In addition, the width of the winding core may exceed the maximum width of the laminate. The diameter of the winding core is suitably about 0.5 to 30 mm, preferably about 1 to 10 mm, and particularly preferably about 2 to 5 mm.

[0044] After winding in step (c), the rolled laminate can be divided into smaller individual portions. For this purpose, the method according to the invention suitably comprises a step of cutting the rolled laminate produced in step (c). Thus, portions of such a laminate roll are produced having a constant width, for example, 1 to 4 cm, in particular 1.5 to 2.5 cm.

[0045] The flexibility of the rolled laminates of the present invention in the production of different shapes and sizes is illustrated in Figure 2. In Figure 2A, a relatively long film is surface activated in a first step and then rolled up to obtain a relatively thick rolled laminate (d1). In Figure 2B, a shorter film is surface activated and then rolled up to obtain a thinner rolled laminate (d2). <d1)。

[0046] 2C and 2D illustrate the flexibility of a rolled laminate of adjustable length, allowing the desired amount of active ingredient to be tailored to the needs of an individual patient, for example, based on an active ingredient film having an active ingredient concentration predetermined by the manufacturer. The pre-rolled film laminate can be cut, for example, into quarters (C) or halves (D), resulting in film laminate pieces of different lengths (L2 = 2L1).

[0047] According to a second aspect, the present invention relates to a rolled laminate that can be produced or is produced by the method described above. The rolled laminate preferably has a weight of approximately 100 to 1000 mg, preferably approximately 200 to 800 mg.

[0048] Further preferred for the rolled laminate according to the invention is a residual solvent or residual water content of less than 10 wt.%, in particular less than 5 wt.%.

[0049] For the rolled laminate according to the present invention, it is essential that the laminate is substantially (i.e., more than 95 wt.%, preferably more than 98 wt.%), preferably completely, composed of water-soluble or water-dispersible components, so that when the laminate comes into contact with water, it dissolves or disintegrates relatively quickly, releasing the active ingredient incorporated therein. For this purpose, both the active ingredient-containing layer and any self-adhesive layer present suitably have a dissolution rate (determined for each film according to Conformity Test A for Disintegration Times of Capsules and Tablets, European Pharmacopoeia (2011), in which the layer is fixed directly to the shaft of a disintegration tester) of less than approximately 5 minutes, preferably less than approximately 120 seconds, more preferably less than approximately 50 seconds. If the rolled laminate according to the present invention contains an ion exchanger as a taste masking agent, this is understood to be a water-soluble or water-dispersible component in the context of the present invention.

[0050] The roll-up laminate according to the invention is particularly suitable for oral administration, including buccal, gingival or sublingual administration of the active ingredient, or palatal administration.

[0051] The rolled laminate can be modified in many ways. For example, it can be filled into a capsule and swallowed. Alternatively, the rolled laminate can be modified with a coating that is soluble in gastric juices, intended for dissolution in the stomach, or with a coating that is resistant to gastric juices, intended for dissolution in the intestines. Due to the rolled form, application in all body orifices (e.g., in the mouth, nasal passages, ear canal, anus, vagina) is possible without difficulty. In addition, the rolled material can be dispensed and cut as needed with a dispenser. Due to the roll form, the material can also be easily applied to the cheek pouch or under the tongue without any problems. Due to dissolution, very high areal densities of >100 mg / cm (e.g., with a diameter of 0.5 mm) can be achieved. Furthermore, relatively long pieces can be applied (<3 cm, i.e., >300 mg).

[0052] In the following, the present invention is illustrated in more detail on the basis of examples, which should not be considered in any way as limiting the scope of protection of the present application. [Example]

[0053] The foamed film was coated with an active ingredient layer (layer thickness: approximately 0.4 mm; surface density: 200 g / m) using the composition specified in the table below. 2 ) was manufactured for

[0054] [Table 1]

[0055] For production, additional raw materials were stirred into the PVA pre-solution, and the solids content was set to 34.5% with additional stirring using water. The resulting mixture was then homogenized for 2 hours, foamed using a foaming machine, and processed using a roll coater to form a foamed film. The residual solvent content of the dried film was approximately 3%.

[0056] An adhesive layer formed from PVP VA64 and glycerin was applied to this film by transferring it from a non-stick-finished carrier, and the laminate thus produced was rolled up with the adhesive layer on the inside and cut into small pieces. [Brief explanation of the drawings]

[0057] [Figure 1] FIG. 1 is a diagram illustrating an apparatus suitable for producing the corresponding film. [Figure 2] 2A and 2B are diagrams illustrating the flexibility of a rolled laminate for different shapes and sizes of manufactured products. FIG. 2A illustrates the flexibility of a relatively long film. FIG. 2B illustrates the flexibility of a shorter film. FIG. 2C illustrates the flexibility of a rolled laminate based on adjustable length, where a pre-wound film laminate is cut into four equal parts. FIG. 2D illustrates the flexibility of a rolled laminate based on adjustable length, where a pre-wound film laminate is cut into two equal parts.

Claims

1. 1. A method for producing a water-soluble or water-dispersible active ingredient dosage form, comprising: (a) producing a film suitable as an oral film dosage form, the film containing an active ingredient, wherein the oral film dosage form is present as a solidified foam; (b) activating the surface of the film produced in (a) to produce a tacky surface; (c) winding the film activated in (b) to form a roll-up laminate of said water-soluble or water-dispersible active ingredient dosage form; A method comprising:

2. 10. The method of claim 1, wherein the surface is activated by expanding, etching or melting the surface to create a tacky surface.

3. 2. The method of claim 1, wherein the surface is activated and a sticky surface is created by applying a self-adhesive layer, the self-adhesive layer being formed from a water-soluble or water-dispersible material.

4. A method according to any one of claims 1 to 3, characterized in that the film suitable as the oral film dosage form is based on a film-forming polymer selected from polyvinyl alcohol, polyethylene glycol, polyethylene oxide, cellulose derivatives, pullulan, gelatin, and agar.

5. 5. The method according to claim 4, wherein the film-forming polymer comprises 25 to 85 wt. % of the film.

6. A method according to any one of claims 1 to 5, characterized in that the film suitable as the oral film dosage form contains at least one excipient selected from flavorings or aromatic substances, colorants, plasticizers and sweeteners.

7. The active ingredients are acetaminophen, adrenaline, alprazolam, amlodipine, Nastrozole, apomorphine, aripiprazole, atorvastatin, baclofen, benzocaine, benzocaine / menthol, benzydamine, buprenorphine, buprenorphine / naloxone, buprenorphine / naloxone / cetirizine, cetirizine, chlorpheniramine, clomipramine, dexamethasone, dextromethorphan, dextromethorphan / phenylephrine, diclofenac, diphenhydramine, diphenhydramine / phenylephrine, donepezil, dronabinol, epinephrine, escitalopram, famotidine, fentanyl, glimepiride, GLP-1 peptide, granisetron, insulin, insulin nanoparticles, insulin / GLP-1 nanoparticles, ketamine, ketoprofen, ketotifen, caffeine, levocetirizine, loperamide, loratadine, meclizine, methylphenidate, 7. The method according to any one of claims 1 to 6, characterized in that the active pharmaceutical ingredient is selected from the group comprising midazolam, mirodenafil, montelukast, multimeric acid-001, naloxone, nicotine, nitroglycerin, olanzapine, olopatadine, ondansetron, oxybutynin, pectin, pectin / menthol, pectin / ascorbic acid, PediaSUNAT (artesunate and amodiaquine), piroxicam, phenylephrine, prednisolone, pseudoephedrine, risperidone, rivastigmine, rizatriptan, selegiline, sennaglycoside, sildenafil citrate, simethicone, sumatriptan, tadalafil, testosterone, triamcinolone acetonide, triptan, tropicamide, voglibose, zolmitriptan, zolpidem, or a pharmaceutically acceptable salt of these compounds.

8. 8. The method according to claim 3 or any one of claims 4 to 7 dependent thereon, characterized in that the self-adhesive layer is based on a water-soluble or water-dispersible polymer.

9. 9. The method according to claim 8, wherein the water-soluble or water-dispersible polymer accounts for 50 to 90 wt. % of the self-adhesive layer.

10. A method according to any one of claims 1 to 9, characterized in that the film suitable as the oral film dosage form contains a plasticizer and / or a humectant.

11. A roll-up laminate produced by the method according to any one of claims 1 to 10.

12. 12. The roll-type laminate according to claim 11, characterized in that it has a weight of 100 to 1000 mg.

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