Rolled oral thin films with high active ingredient load

Description

[0001] The present invention relates to a process for producing rolled oral thin film laminates, as well as rolled laminates produced by the process. State of the art

[0002] Oral thin films, also known as transmucosal delivery systems, are thin, polymer-based, drug-containing films that, when applied to a mucous membrane, particularly the oral mucosa, release the active ingredient directly into it. These delivery systems have the advantage that the active ingredient is largely absorbed through the mucosa, thus avoiding the "first-pass metabolism" that must be observed with conventional tablet delivery of an active ingredient.

[0003] In practice, films with high basis weights pose a challenge in the production of oral thin films. To achieve high basis weights, it is necessary to produce the film intended for drying as a comparatively thick film, which leads to problems during the drying process. Alternatively, films with high basis weights can also be produced by applying several layers on top of each other in layers with intermediate drying steps. However, this does not always result in a film product with satisfactory structural integrity. Furthermore, the layered construction of oral thin films requires multiple application and drying steps, which makes their production relatively complicated.

[0004] If larger amounts of active ingredient are to be administered using an oral thin film, there is also the problem that there is only limited space available at the application site, for example in the palate or cheek, so that the size of the film product is limited by these conditions.

[0005] WO 2018 / 224591 A1 discloses sheet-like dosage forms which dissolve or decompose in an aqueous environment for the release of active substances into a body orifice, comprising a polymer matrix in the form of a solidified foam having cavities.

[0006] DE 199 46 822 A1 discloses a preparation containing active ingredients and / or excipients for the time- and / or dose-controllable release of these substances, which comprises at least two layers in a rolled or folded form. The first of these layers, which contains the at least one active ingredient or excipient, is constructed such that at least one of the parameters of layer thickness, layer width, and active ingredient concentration in this layer is not constant.

[0007] Against this background, there is a need for dosage forms for pharmaceutical active ingredients and other substances that are administered in larger quantities. These dosage forms should realize the advantages of a delivery system based on a rapidly dissolving dosage form, such as an oral thin film, while also transporting the highest possible amount of active ingredient with relatively small external dimensions. The manufacturing of these dosage forms should avoid the known problems associated with high-weight oral thin films.

[0008] The present invention addresses this need. Description of the invention

[0009] It has been found that rolled laminates of films based on the same materials as conventional oral thin films can deliver a high drug concentration in a limited volume and can be formulated with a high total weight. Such rolled laminates can be easily placed in the buccal sac or next to or under the tongue, where they release the active ingredient.

[0010] Accordingly, a first aspect of the present invention relates to a process for producing a water-soluble or water-dispersible drug administration form comprising the steps (a) producing a film suitable as an oral film administration form containing an active ingredient, wherein the film administration is in the form of a solidified foam, (b) activating a surface of the film prepared in (a) to generate a sticky surface, and (c) rolling up the film activated in (b) to form a rolled laminate.

[0011] In the context of this process, it is expedient if the sticky surface generated in (b) is positioned in step (c) such that the sticky side is on the inside, so that no sticky residues remain on the outside in the finished rolled laminate.

[0012] The film in (a) is usually produced by applying a flowable mass of the composition, which subsequently forms the film, and drying the mass to form the film. A suitable device for producing such films is shown schematically in Fig. 1The flowable mass is conveyed through a suitable unit 1 onto a substrate tape 2 applied, whereby a film is formed on the substrate strip 3 Through movement, e.g. of corresponding drive rollers 5, The film is then placed in a dryer 4 and dried there to a solidified film. After drying, the film can be removed from the substrate tape 2 be separated.

[0013] In a preferred embodiment of the process according to the invention, the activation of the surface and the generation of a sticky surface in (b) are carried out by dissolving the surface. For dissolving, for example, a small amount of a suitable solvent, such as water or a pharmaceutically acceptable alcohol, e.g. ethanol, can act on the surface of the film in vapor form or be applied in liquid form, as a result of which the film swells or is dissolved to a limited extent in the area near the surface. With the film swollen or dissolved to a limited extent in this way, a bond can then be created between the activated (first) surface and the non-activated (second) surface of the rolled-up film by rolling it up. The advantage of swelling over dissolving is that the film remains coherent during this step. After rolling up, the small amount of water orThe pharmaceutically acceptable alcohol used to swell / dissolve the film's surface can be distributed through the rolled film by diffusion and / or removed from it by drying. Because no intermediate layer is formed with this type of activation, the rolled laminate consists exclusively of the material that forms the film.

[0014] In a further preferred embodiment of the process according to the invention, the activation of the surface and the generation of a sticky surface in (b) are carried out by melting the surface, for example by heating and partially liquefying the surface using a suitable heating device.

[0015] In an alternative preferred embodiment, the activation of the surface and the generation of a sticky surface in (b) are carried out by applying a self-adhesive layer, wherein the self-adhesive layer is formed from a water-soluble or water-dispersible material. A water-soluble material is preferred for the self-adhesive layer.

[0016] Such a self-adhesive layer is 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 it in a thin layer onto a (dehesive-treated) carrier film. This layer is dried to a residual water or solvent content that still imparts a certain tackiness to this layer. In this state, this layer is then applied to the (first) surface of the film produced in step (a), whereby the carrier film can be peeled off. This allows the "self-adhesive layer" to have a very thin layer thickness of 1 to 100 µm, in particular 2 to 20, and particularly preferably 4 to 10 µm. Here, too, the residual water or solvent content in the rolled-up laminate can be distributed by diffusion or reduced by drying.

[0017] This method of activating the (first) surface of the film and providing it with a sticky surface is particularly advantageous when using a foam film in step (a). The risk of swelling or dissolving of the film is largely eliminated, so the foam structure of the film is not compromised. 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 a self-adhesive layer can be assisted by gently pressing the self-adhesive layer onto the active ingredient-containing layer, for example, using a rubber roller. When applying self-adhesive layers, the pressure must be adjusted appropriately to ensure that, for example, a foam film containing an active ingredient is not damaged by the pressure. A specialist can determine a suitable pressure through appropriate testing.

[0019] A third way to activate the (first) surface of the film is by melting it. For this purpose, energy (e.g., in the form of heat) is applied to this surface, so that—when using a foam film—this surface softens. After rolling up and subsequent cooling of the rolled laminate, this leads to a firm bond between the thus activated (first) surface and the unactivated (second) surface.

[0020] Rolled laminates produced according to the process described above can then be cut to a suitable length if necessary and packaged in the usual way, e.g. by means of a flow-wrapping machine.

[0021] With regard to the film suitable for oral film administration, the present invention is not subject to any relevant restrictions, provided that the film is fundamentally suitable for oral film administration, i.e., it dissolves and disintegrates relatively quickly upon contact with saliva, thus releasing the excipient or active ingredient contained in the film. The ingredients contained in the film should also be pharmaceutically acceptable. Suitable film-forming materials include, among others, water-soluble polymers that are pharmaceutically acceptable.Particularly suitable water-soluble polymers include, for example, starch and starch derivatives, dextrans; cellulose derivatives such as carboxymethylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose, hydroxypropylethylcellulose, sodium carboxymethylcellulose, ethyl or propylcellulose; polyacrylic acid, polyacrylates, polyvinylpyrrolidones, polyvinyl alcohol, polyethylene oxide polymers, polyacrylamides, polyethylene glycol, gelatin, collagen, alginates, pectins, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar, agarose, carrageenan, and natural gums. 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 the film suitable for oral film administration is preferably 25 to 85 wt.%, preferably 50 to 85 wt.%, and more preferably 60 to 80 wt.%. In some cases, as long as this does not compromise the integrity of the film, the polymer content in the film may also be in the lower range, such as in the range of 25 to 50 wt.% or preferably in the range of 38 to 40 wt.%.

[0023] The active ingredient can, in principle, be any orally administrable active ingredient, with pharmaceutical active ingredients being preferred. Pharmaceutical active ingredients suitable for oral administration in the context of the present invention include, for example, antiallergic agents, antiarrhythmic agents, antibiotics, antidiabetic agents, antiepileptic agents, antihistamines, antitussives, cardiotronic agents, diuretics, antihypertensives, narcotics, neuromuscular blockers, sex hormones, and vasopressors. 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, Caffeine, Levocetirizine, Loperamide, Loratadine, Meclizine, Methylphenidate, Midazolam, Mirodenafil, Montelukast, Multimeric-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, Senna Glycosides, Sildenafil Citrate, Simethicone, Sumatriptan, Tadalafil, Testosterone, Triamcinolone Acetonide, Triptan, Tropicamide, Voglibose, Zolmitriptan, Zolpidem,or pharmaceutically acceptable salts of these compounds. The pharmaceutical active ingredient can also be present as a mixture of different active ingredients. The dosage form according to the invention can contain, for example, active ingredients for oral hygiene, such as menthol, as non-pharmaceutical active ingredients.

[0024] The at least one pharmaceutical active ingredient is preferably contained in the film at a constant concentration and thus has a 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, based on the area of ​​a unit dose of the film (before rolling up).

[0025] The active ingredient content per dosage unit of a rolled film produced by the process according to the invention is up to 500 mg, preferably up to 250 mg, particularly preferably up to 230 mg, further preferably up to 200 mg, and even more preferably up to 100 mg. On the other hand, the minimum active ingredient content per dosage unit can preferably be 5 mg, further preferably 10 mg, and most preferably 12 mg. Depending on the application, the amount of active ingredient can also be in the upper range of the above specifications, for example in the range of more than 50 to 100 mg or 30 to 50 mg.

[0026] The amount of active ingredient relative to the area of ​​the dosage form according to the invention before rolling up is advantageously in the range from 1 to 15 mg / cm 2 and preferably from 2.8 to 10 mg / cm 2 .

[0027] The film according to the invention suitable as a film administration form can contain, in addition to the aforementioned film-forming polymer, further ingredients, in particular excipients selected from the group comprising dyes, flavorings, in particular flavorings and / or odorants, sweeteners, taste-masking agents, surfactants, enhancers, pH regulators, preservatives, and / or antioxidants. The addition of flavorings, odorants, and aromas, individually or in combination, is particularly advantageous. A suitable taste-masking agent is, for example, an ion exchange resin. The film suitable as a film administration form preferably contains flavorings, odorants, and aromas, individually or in combination.

[0028] Furthermore, the film suitable as an oral film administration form can contain a pigment or a UV-absorbing agent that protects a light-sensitive active ingredient incorporated into the film from UV light. In addition to the excipients mentioned above, the film suitable as an oral film administration form can also contain additional components to optimize its flexibility and / or physical properties, such as a plasticizer and / or a humectant. Preferred plasticizers and / or humectants in the context of the present invention are, for example, selected from the group comprising glycerin, propylene glycol, polyethylene glycol, and citric acid esters. Glycerin is particularly preferred as a plasticizer.

[0029] The film suitable for use as a film-based delivery system is designed as a solidified foam. It can contain an incorporated gas, such as air, nitrogen, or CO2, or another gas.

[0030] Suitable base materials and processes for producing corresponding solidified foam formulations are described, for example, in EP 1 296 661 A2, EP 1 959 921 A2 or WO 2018 / 224591 A1.

[0031] The cavities of the foam can be isolated from each other in the polymer matrix, preferably in the form of solidified bubbles.

[0032] According to another embodiment, it is provided that the cavities are connected to one another, preferably by forming a coherent channel system penetrating the matrix.

[0033] The foam's cavities advantageously have a volume fraction of 5 to 98%, preferably 30 to 80%, based on the total volume of the film (i.e., any self-adhesive layers present are not taken into account for the volume fraction). This favorably influences the accelerated dissolution of the film-formed dosage form.

[0034] Another important parameter that influences the properties of the foam-based film-coated dosage form according to the invention is the diameter of the cavities or bubbles. The bubbles or cavities are preferably created using a foam-forming machine, with which the diameter of the bubbles can be adjusted almost arbitrarily within a wide range. Thus, the diameter of the bubbles or cavities can be in the range from 0.01 to 60 µm. The diameter is particularly preferably in the range from 10 to 50 µm. The thickness of the film layer of the film suitable as an oral film-coated dosage form is preferably in the range from about 0.01 to about 2 mm, and particularly preferably in the range from 0.02 to about 1 mm.

[0035] The present invention is also not subject to any relevant restrictions with regard to the material from which the self-adhesive layer is formed, with the proviso that the self-adhesive layer should be based on a pharmaceutically acceptable water-soluble or water-dispersible polymer. A suitable water-soluble or water-dispersible polymer is, for example, Plastoid E35H (plasticized Eudragit E100; lauric acid, adipic acid, and glycerin are added as modifiers). Other suitable water-soluble or water-dispersible polymers are, for example, shellac, a vinylpyrrolidone / vinyl acetate copolymer, a polyvinylcaprolactam / polyvinyl acetate / polyethylene glycol copolymer, hydroxypropylcellulose or hydroxypropylmethylcellulose, and / or polyvinylpyrrolidone. A particularly preferred water-soluble polymer within the scope of the present invention is polyvinylpyrrolidone.

[0036] The aforementioned water-soluble polymers are advantageously combined with a plasticizer. Suitable plasticizers include, for example, glycerin, polyethylene glycol, especially polyethylene glycol 200, sorbitol, and / or tributyl citrate, of which glycerin, polyethylene glycol 200, and / or tributyl citrate can be stated as particularly suitable. Glycerin is a particularly suitable plasticizer.

[0037] With regard to the ratio of water-soluble polymer to plasticizer, the adhesive is not subject to any relevant restrictions, as long as the ratio is adjusted so that the mixture is sufficiently tacky and processable. A favorable mixing ratio of water-soluble polymer to plasticizer can be specified as a ratio of about 85 to 50 to about 15 to 50, preferably from about 85 to 65 to about 15 to 35, even more preferably from about 80 to 60 to about 20 to 40, even more preferably from about 80 to 50 to about 20 to 50, even more preferably from about 82 to 68 to about 18 to 32, and most preferably from about 80 to 70 to about 20 to 30.

[0038] A suitable proportion of the water-soluble or water-dispersible polymer in the self-adhesive layer can be specified as a proportion of about 50 to 90 and preferably about 60 to 85% of the film.

[0039] With this type of activation of the (first) surface of the film produced in step (a), an intermediate layer - albeit a comparatively extremely thin one - remains between the activated (first) surface and the non-activated (second) surface of the film in the rolled-up laminate after rolling up, ie the visible thickness of the self-adhesive layer is preferably at least a factor of 2, more preferably at least a factor of 4 and even more preferably at least a factor of 8 lower than the layer thickness of the active ingredient-containing film of the film administration form.

[0040] The activated film can be conveniently rolled up using rotating brushes at an angle of approximately 45°. It is also possible to apply a winding core to the sheet-like laminate and then wind the laminate over this winding core. After completion, the winding core can be removed, creating a central recess. This can have a diameter of approximately 0.5 to 30 mm, preferably approximately 1 to 10 mm, and particularly preferably approximately 2 to 5 mm.

[0041] Alternatively, it is possible for the winding core to remain in the system as a component of the preparation. This winding core can be compact or hollow, in the form of a ring, containing an active ingredient or largely free of active ingredient. Furthermore, the width of the winding core can exceed the maximum width of the laminate. The diameter of the winding core is advantageously between about 0.5 and 30 mm, preferably between about 1 and 10 mm, and particularly preferably between about 2 and 5 mm.

[0042] The rolled laminate can be divided into smaller individual portions after rolling in step (c). For this purpose, the process according to the invention advantageously includes a step of dividing the rolled laminate produced in (c). This produces sections of such laminate rolls with a constant width, e.g., from 1 to 4 cm and in particular 1.5 to 2.5 cm.

[0043] The flexibility in producing different shapes and sizes of the rolled laminates according to the invention is Fig. 2 illustrated. In Fig. 2 A In a first step, a comparatively long film is activated on a surface and then rolled up, resulting in a comparatively thick rolled laminate (d1). Fig. 2 B a shorter film is activated on a surface and then rolled up, resulting in a thinner rolled laminate (d2 < d1).

[0044] In Fig. 2C and 2DThe flexibility is illustrated by the adjustable length of the rolled laminates, which allows, for example, the desired amount of active ingredient to be adapted to the individual patient's needs based on a drug film with a drug concentration predetermined by the manufacturer. A pre-rolled film laminate can, for example, be cut into 4 equal parts (C) or 2 equal parts (D), resulting in film laminate pieces of different lengths (L 2 = 2 L 1 ).

[0045] 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 about 100 to 1000 mg, and more preferably about 200 to 800 mg.

[0046] Furthermore, a residual solvent or residual water content of less than 10 wt.% and in particular less than 5 wt.% is preferred for the rolled laminate according to the invention.

[0047] It is essential for the rolled laminate according to the invention that it consists essentially (i.e., more than 95% by weight and preferably more than 98% by weight) and preferably entirely of water-soluble or water-dispersible components, so that the laminate dissolves or disintegrates relatively quickly upon contact with water and releases the active ingredient incorporated therein. For this purpose, both the active ingredient-containing layer and any self-adhesive layer present expediently have a dissolution rate (determined for the individual film according to adapted test A for the disintegration time of capsules and tablets, European Pharmacopoeia (2011), wherein the respective layer is attached directly to the shaft of the disintegration tester) of less than about 5 minutes, preferably less than about 120 seconds, and more preferably less than about 50 seconds.If the rolled laminate according to the invention contains an ion exchanger as a taste masking agent, this is considered a water-soluble or water-dispersible component in the context of this invention.

[0048] The rolled laminate according to the invention is particularly suitable for oral administration, including buccal, gingival or sublingual administration, of active ingredients or administration on the palate.

[0049] The rolled laminate can be modified in a variety of ways. For example, it can be filled into a capsule that can then be swallowed.

[0050] Alternatively, the rolled laminate can be modified with an enteric coating for dissolving in the stomach or with an enteric coating for dissolving in the intestine. The rolled form allows for easy application to all body orifices (for example, the mouth, nostrils, ear canals, anus, vagina). In addition, the rolled material can be dispensed and cut as needed in a dispenser. The roll form also allows the material to be easily applied in the cheek pouch or under the tongue without causing any discomfort. By dissolving, a very high basis weight of > 100 mg / cm (with a diameter of, for example, 0.5 mm) can be achieved. In addition, relatively long pieces can be applied (< 3 cm, i.e., more than 300 mg).

[0051] In the following, the present invention will be illustrated in more detail using an embodiment, which, however, should not be considered as limiting the scope of protection of the application in any way. Example 1

[0052] A foamed film with the composition given in the following table for the active ingredient layer (layer thickness: ~ 0.4 mm; basis weight 200 g / m 2< ) was produced. material function Percentage (% dry) Adhesive layer PVP VA64 polymer 80 Glycerin plasticizers 20 Active ingredient layer Polyvinyl alcohol 1< polymer 77,6 FD&C Red 40 dye 0,4 Saccharin Na sweetener 2,0 Sucralose sweetener 4,0 Glycerin Plasticizers / humectants 9,0 Cherry Flavor aroma 6,0 menthol aroma 1,0 1< = 35% in water

[0053] For production, the other ingredients were stirred into a PVA pre-solution and adjusted to a solids content of 34.5% with further stirring. The resulting mixture was then homogenized for 2 hours, foamed using a foaming machine, and processed into a foam film using a roll coater. The residual solvent content of the dried film was approximately 3%.

[0054] The adhesive layer made of PVP VA64 and glycerin was applied to this film by transfer from a release-treated carrier. The resulting laminate was rolled up with the adhesive layer inside and cut into portions.

Claims

1. A method for producing a water-soluble or water-dispersible active-ingredient-administering form comprising (a) producing a film, suitable as oral film-administering form, having a content of active ingredient, wherein the film-administering form is present as a solidified foam, (b) activating a surface of the film produced in (a) in order to generate a tacky surface, and (c) rolling up the film activated in (b) to form a rolled-up laminate.

2. The method according to claim 1, characterised in that the surface is activated and a tacky surface is generated by swelling, etching or melting of the surface.

3. The method according to claim 1, characterised in that the surface is activated and a tacky surface is generated by applying a self-adhering layer, wherein the self-adhering layer is formed from a water-erodible material and preferably a water-soluble or water-dispersible material.

4. The method according to at least one of claims 1 to 3, characterised in that the film suitable as an oral film-administering film is based on a film-forming polymer, selected from polyvinyl alcohol, polyethylene glycol, polyethylene oxide, cellulose derivatives, pullulan, gelatines, and agar, preferably on polyvinyl alcohol.

5. The method according to claim 4, characterised in that the film-forming polymer accounts for a proportion of from 25 to 85 and preferably from 60 to 80 wt.% in the film.

6. The method according to at least one of the preceding claims, characterised in that the film suitable as oral film-administering form contains at least one excipient selected from flavourings or aromatic substances, colouring agents, plasticisers and sweeteners.

7. The method according to at least one of the preceding claims, characterised in that the active ingredient is an active pharmaceutical ingredient selected from the group comprising 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, caffeine, levocetirizine, loperamide, loratadine, meclizine, methylphenidate, midazolam, mirodenafil, montelukast, multimeric-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, Senna glycosides, sildenafil citrate, simethicone, sumatriptan, tadalafil, testosterone, triamcinolone acetonide, triptan, tropicamide, voglibose, zolmitriptan, zolpidem, or pharmaceutically acceptable salts of these compounds.

8. The method according to claim 3 or a claim dependent thereon, characterised in that the self-adhering layer is based on a water-soluble or water-dispersible polymer, preferably on polyvinylpyrrolidone.

9. The method according to claim 8, characterised in that the water-soluble or water-dispersible polymer accounts for a proportion of from 50 to 90 and preferably from 60 to 85 wt.% in the self-adhering layer.

10. The method according to at least one of the preceding claims, characterised in that the film suitable as oral film-administering form or the self-adhering film contains a plasticiser and / or a humectant, preferably in the form of glycerol.

11. A rolled-up laminate, producible by a method according to any one of claims 1 to 10.

12. The rolled-up laminate according to claim 11, characterised in that it has a weight of from 100 to 1000 mg, and preferably from 200 to 800 mg.