Pharmaceutical dosage forms and method for production thereof

The method of 2D/3D printing active agent-free carrier structures with pharmaceutically active agents addresses the challenge of combining classical and additive production methods, resulting in diverse dosage forms with improved patient safety and compliance features.

JP2025122037APending Publication Date: 2025-08-20DIHESYS DIGITAL HEALTH SYST GMBH
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Patent Information

Application Number
JP2025081234
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2019-05-31
Filing Date
2025-05-14
Publication Date
2025-08-20

AI Technical Summary

Technical Problem

Existing methods for producing pharmaceutical dosage forms struggle to combine the advantages of classical production with those of additive processes.

Method used

A method involving 2D and/or 3D printing of an active agent-free carrier structure with pharmaceutically active agents applied in compartments, using techniques like FFF, FLM, binder jetting, and voxel printing, allowing for the creation of solid or semi-solid dosage forms with visible information structures.

Benefits of technology

Enables the production of diverse pharmaceutical dosage forms with enhanced patient safety and compliance features, such as QR codes and color-coded information, while integrating multiple active agents and additives.

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Abstract

To provide a method for producing pharmaceutical dosage forms which enables the combination of the advantages of classical production of solid or semi-solid dosage forms with those of the production of dosage forms by additive processes.SOLUTION: A method for producing a solid or semi-solid pharmaceutical dosage form comprising an active agent-free carrier structure and at least one pharmaceutical active agent provided to at least one region of the carrier structure, the method comprising the steps of: (i) supplying at least one active agent-free carrier structure into a printing device designed for 2D and / or 3D printing of at least one pharmaceutical active agent; and (ii) applying at least one pharmaceutical active agent by 2D and / or 3D printing on at least one region of the surface of the carrier structure in the printing device.SELECTED DRAWING: Figure 2
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Description

[Technical Field]

[0001] The present invention relates to a method for producing a solid or semi-solid dosage form of a pharmaceutically active agent, in which an active agent-free carrier structure is fed into a 2D or 3D printing device, respectively, and at least one pharmaceutically active agent (active pharmaceutical ingredient, pharmaceutic component) is applied to at least one compartment of the carrier structure by the printing device through a 2D or 3D printing process, respectively. The present invention also relates to semi-solid or solid dosage forms producible by the method of the present invention. [Background technology]

[0002] An additive 3D printing process for producing pharmaceutical dosage forms by fused filament fabrication (FFF) is known from WO 2016 / 038356 A1. In a similar process, other forms such as granules, pellets, powders or flakes are used instead of filaments as starting material, and are then printed in the form of filaments (Fused Layer Modeling, FLM). Summary of the Invention [Problem to be solved by the invention]

[0003] The technical problem of the present invention is to provide a method for the production of pharmaceutical dosage forms that allows combining the advantages of the classical production of solid or semi-solid dosage forms, respectively, with the advantages of producing dosage forms by additive processes. [Means for solving the problem]

[0004] The above technical problems are solved by the embodiments of the present invention disclosed in the claims, this specification and the accompanying drawings.

[0005] In particular, the present invention provides a method for producing a solid or semi-solid pharmaceutical dosage form comprising an active agent-free carrier structure and at least one pharmaceutically active agent provided in at least one compartment of said carrier structure, the method comprising the steps of: (i) providing a carrier structure that does not contain at least one active agent in a printing device designed for 2D and / or 3D printing of at least one pharmaceutically active agent; and (ii) applying at least one pharmaceutically active agent to at least one compartment of the surface of the carrier structure in the printing device by 2D and / or 3D printing; A method comprising: [Brief explanation of the drawings]

[0006] [Figure 1A] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 1B] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 1C] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 1D] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 2] 1 shows a photographic representation of the top surface of an exemplary dosage form of the present invention. [Figure 3A] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 3B] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 4A] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 4B] 1A-1D show schematic top views of different exemplary dosage forms of the present invention. [Figure 5] 1 shows a top view schematic of an exemplary dosage form of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0007] According to the present invention, the application of one or more pharmaceutically active agents to the active agent-free carrier is carried out by an additive manufacturing process, provided in the present invention as a two-dimensional (2D) or three-dimensional (3D) printing process, which may also combine 2D and 3D printing processes.

[0008] In one embodiment of this method, the active agent is present in a filament in a meltable filament carrier material or filament substrate material, whereby multiple active agents can be used, or are intended to be used, respectively, and these active agents can coexist in one filament or in different filaments. In this embodiment, such meltable active agent-containing filaments are printed in at least one section on a carrier structure that does not contain an active agent, in accordance with a per se known FFF (Filament-Fusion Fabrication) process, for example, as described in WO 2016 / 038356 A1. In another embodiment, each meltable carrier material or substrate containing one or more active agents is present in a different form, preferably as granules, pellets, powder, or flakes, and is printed in the form of a filament in at least one section on the carrier structure by per se known FLM (Fused Layer Modeling), typically by hot melt extrusion using a printing device designed for the FLM process.

[0009] In another embodiment, binder printing methods known per se, such as those described in EP 2968994 A1, can be used to print, preferably 3D print, one or more pharmaceutically active agents. In this embodiment, the active agent(s) are present in a powder containing, in addition to the active agent(s), pharmaceutically acceptable additives such as binders, antioxidants, flavorings, sweeteners, or similar substances compatible with binder jetting. After applying a layer of powder to the carrier structure, a binder liquid is applied to the powder layer by a printing device, preferably in a point-by-point or section-by-section manner to form an active agent arrangement on the carrier material that does not contain the active agent. Optionally, excess powder can be removed. The steps of applying a powder layer, applying a binder liquid at least pointwise or sectionwise, and optionally removing excess powder are repeated, optionally with powder containing one or more other pharmaceutically active agents, until a predetermined three-dimensional arrangement of one or more active agents is obtained on the active agent-free carrier structure. In a final step, any unbound powder present can be removed.

[0010] According to a further preferred embodiment of the present invention, an additional method for applying one or more active agents is provided, in which the three-dimensional formation of an active agent-containing structure on a carrier is preferably carried out by layer-by-layer application of a single volumetric increment (hereinafter also referred to as "voxel") of a liquid, at least a portion of which contains the active agent(s). The volumetric increment is preferably applied layer-by-layer so as to form at least a semi-solid, preferably solid, active agent-containing structure on the carrier structure, at least in sections, that does not contain the active agent. The liquid may be, for example, a molten material or at least a flowable material or a liquid. Here, the one or more active agent-containing volumetric increments contain the active agent(s) in the molten material or at least a flowable material, or dissolved, dispersed, or emulsified in the liquid.

[0011] The applied volume increments can be defined in an essentially free manner, for example, in the form of droplets, spheres, points, cylinders, cubes, rectangular prisms, or other shapes. Preferred voxel shapes are, for example, droplets and spherical voxels. The volume shapes (such as the above examples) and sizes of the volume increments can be combined essentially freely and independently of each other.

[0012] The bonding between the applied volume increments of a single layer can be achieved in various ways. In one embodiment, such bonding between voxels can occur by solidification after application on the carrier structure, for example, when using a meltable material, which can be achieved by different mechanisms, such as simple cooling and / or chemical solidification using known substances. In another embodiment, a suitable binder can be added to the voxel material, for example, a dispersion or solution, which hardens the voxels after application. The hardening of the binder can be induced by heat, which can be applied, for example, by a light source, preferably a suitable heat source in the printing device, such as a laser device. The hardening of the binder can also be induced chemically by corresponding starter molecules and / or light of a suitable wavelength, which can be preferably irradiated by a laser device. In a further embodiment, the liquid of the volume increment can contain one or more starter compounds, typically one or more monomers of a polymer, and after application of the voxels, polymerization is initiated by suitable means, such as light, heat, or other polymerization initiators, so that the voxels harden and bond to adjacent voxels.

[0013] In a further preferred embodiment, a two-dimensional arrangement of a substance or composition containing active agent(s) is applied, i.e., printed, onto a carrier structure. The 2D printing process can also be combined with the 3D printing process described above, for example, by first applying, preferably through one of the above processes, at least a section of a three-dimensional active agent-containing arrangement, which is then applied as a final two-dimensional arrangement with or without active agent(s). According to a preferred embodiment, particularly in a 2D printing process, a liquid containing active agent(s), preferably a solution, emulsion, or suspension containing active agent(s), is applied, i.e., printed, section by section. After application of a liquid such as an active agent-containing solution, emulsion, or suspension, a portion of the liquid, e.g., a solution, suspension, or emulsion, is typically absorbed by the carrier structure, while another portion remains on the surface of the carrier. The (remaining) liquid (such as a solution, suspension, or emulsion) then evaporates, leaving a solid, at least semi-solid, component on the carrier structure, which is loaded with active agent(s).

[0014] Suitable carriers or substrates are particularly preferred for the voxel printing method as well as the FLM / FFF process, and are carriers suitable for hot melt extrusion (HME), such as low-melting waxes and polymers, in which the pharmaceutically active agent(s) are present. In addition to the low-melting carrier, the HME mixture may contain additional processing agents and auxiliaries, such as binders, emollients, antioxidants, flavorings, and sweeteners. Suitable HME carriers and emollients are disclosed, for example, in Crowley et al. (2007) Drug Development and Industrial Pharmacy, 33, pages 909-926 (carriers: pages 917-919, especially Table 1; emollients: pages 917 and 920, especially Table 2), and are expressly incorporated herein by reference.

[0015] The above-mentioned additive processes, particularly the voxel printing process (or "voxel-jetting"), are typically and preferably performed with computer assistance. Thus, a calculated two-dimensional or three-dimensional image of the object to be printed, at least an image of the material arrangement containing the active agent(s), is created, for example, using a typical CAD program. A computer-generated representation of the dosage form or at least the active agent-containing arrangement can also be achieved by scanning an existing dosage form. In the preferred case of voxel printing, the computer-generated model image is then subdivided into desired, essentially freely selectable, volume increments (voxels), with the resolution of the actual dosage form increasing with smaller volume increments. The active agent and / or coloring substance, as well as any further optional required materials and their amounts (concentration in the volume increment), can be assigned to each volume increment that is ultimately printed. Printing devices suitable for voxel printing are described, for example, in US 2017 / 03,68755 A1 and US 6,070,107. In the case of the FFF or FLM process, each printed configuration or dosage form is computer-aidedly subdivided into corresponding filaments.

[0016] In a preferred embodiment of the present invention, multiple active agents, i.e., two or more active agents, are applied in step (ii), and the active agents can be printed together in one step or multiple separate steps. In this embodiment, the active agents can be applied to the same or different compartments of the carrier structure. In this embodiment, the active agents can be applied in compartments separated from each other or spatially one above the other.

[0017] In a particularly preferred embodiment, the method according to the present invention further comprises applying at least one coloring substance to at least one compartment of the carrier structure using 2D and / or 3D printing in such a way that the applied substance forms at least one information structure visible on the carrier structure. This allows the coloring substance(s) to be applied separately from the active agent(s). It is preferred to apply the coloring substance(s) together with the pharmaceutically active agent(s). In one embodiment, each substance can thus individually label one or more compartments to which the respective active agent(s) is applied. This embodiment can therefore provide information about the active agent(s) and their classification in the complete dosage form printed on a carrier that does not contain the active agent. As a further development of this embodiment of the present invention, the active agent-containing compartments can contain different amounts or concentrations of the active agent(s), reflected by the concentration of the respective coloring substance. It should be understood that different coloring substances can be mixed (e.g., in the filament for the FLM / FFF process, in the powder for the binder jetting method, or in the voxels of the preferred embodiment) so that the entire visible spectrum can be used by selecting the respective mixture(s).

[0018] According to the invention, the term "coloring substances" also includes luminescent, in particular fluorescent, substances.

[0019] Each information structure formed or generated by the coloring substance(s) can display various information, as several different information structures can be used with different coloring substances and / or different amounts of the same coloring substance, which can be combined in essentially any desired manner. According to the present invention, it is particularly intended that at least one information structure encodes information regarding the type or nature of the active agent applied on the carrier structure, and / or the amount(s) of the active agent(s) applied on the carrier structure, and / or the time or duration when the dosage form is intended to be taken, and / or the date when the dosage form is intended to be taken, and / or patient-related data (such as the patient's name, age, sex, medication, disease, etc.), and / or the entity responsible for paying for the dosage, and / or the attending physician, and / or the pharmaceutical company providing the dosage form, and / or the medical unit dispensing the dosage form.

[0020] The information structure can be selected from a wide range of applications. Thus, the material(s) can be printed in the form of a QR code, letters and / or numbers. Different patterns such as lines, grids, dots, two-dimensional patterns, etc. can also be printed, with the preferred embodiment of voxel printing being understood to generally offer the most diverse possibilities. Thus, the printed image of the code can include an active agent and, as described above, can simultaneously encode desired data relating to the patient, doctor, pharmacist, and / or qualified medical or pharmaceutical professional.

[0021] Those skilled in the art will understand that, depending on the particular additive manufacturing process selected, the optional coloring substance(s) may be present in the respective substrate composition along with the pharmaceutically active agent(s). Thus, in the case of the FLM / FFF process, the coloring substance(s) are present, for example, in the filament carrier or substrate material of the printed filament along with the active agent(s). The same applies to powders in the case of binder jetting processes. Also, according to the present invention, in the case of preferred voxel printing, the coloring substance(s) are present along with the active agent(s) in the molten substrate material or in a solution or dispersion intended for the selected volume increment.

[0022] Using the method of the present invention, a variety of solid or semi-solid dosage forms can be produced, such as tablets, e.g., oblong tablets, troches, implantable tablets, multi-use tablets, dispersible tablets, delayed release tablets, vaginal tablets, ocular tablets, coated tablets, matrix tablets, chewable tablets, film-coated tablets, modified release tablets, lacquer tablets, and enteric-coated tablets, capsules, plasters, suppositories, or thin films such as ODF (orally dissolving film or orally disintegrating film) products.

[0023] According to the present invention, the carrier structure can also be produced by an additive manufacturing process, which can use the FLM / FFF printing, binder jetting, and / or voxel printing methods outlined above. Thus, according to the present invention, the carrier structure can first be produced by such a process in a corresponding printing device, and then provided in such a way that the active agent-containing arrangement can be applied. Alternatively, the carrier structure can be produced by a conventional manufacturing process for pharmaceutical dosage forms, then provided in a suitable 2D or 3D printing device (particularly preferred is a printing device designed for voxel printing), and finally, the active agent-containing arrangement is produced on the carrier structure.

[0024] A further aspect of the present invention is a semi-solid or solid dosage form, preferably a dosage form as described above, producible by the process of the present invention.

[0025] Therefore, the present invention relates to a solid or semi-solid dosage form comprising a carrier structure without an active agent, in which at least one pharmaceutically active agent is applied to at least its compartments in a two-dimensional and / or three-dimensional arrangement. As mentioned above, multiple pharmaceutically active agents (i.e., two or more active agents) can also be applied to the same or different compartments of the carrier structure. As already outlined above about this method, the active agents can be applied in compartments separated from each other or spatially one on top of the other.

[0026] Preferably, the dosage form also has a coloring substance applied to at least one section of the carrier material so that the applied substance forms at least one visible information structure on the carrier structure. A preferred embodiment of this aspect has already been outlined in connection with the method according to the invention. In particular, the at least one information structure can encode information about the type or nature of the active agent applied to the carrier structure, and / or the amount(s) of the active agent(s) applied to the carrier structure, and / or the time or duration at which the dosage form is intended to be taken, and / or the date at which the dosage form is intended to be taken, and / or patient-related data (such as the patient's name, age, sex, medication, disease, etc.), and / or the party responsible for paying for the cost, and / or the patient's doctor, and / or the pharmaceutical company providing the dosage form, and / or the medical unit dispensing the dosage form. The patient-related data is preferably selected from the patient's name, age, sex, medication, and disease.

[0027] As already outlined above, the dosage form may contain a variety of information structures, preferably those described above for the method.

[0028] 1A-1D show top view schematics of different exemplary dosage forms of the present invention, in which active agent-containing configurations each containing patient-related data or information at the time of dosing or a similar time are printed onto a flat, active agent-free carrier structure: 1. Patient name or address; 2. Higher resolution print space extension for dynamic dosing; 3. Batch number or patient ID; 4. Personalized notes at the time of dosing.

[0029] 2 shows a photographic representation of the top surface of an exemplary dosage form of the present invention, in which an active agent-containing arrangement including a QR Code® is printed on a carrier that does not contain an active agent. Information structures printed in accordance with the present invention in the form of a QR Code® can enhance patient safety and further advantageously ensure connection to an electronic patient file.

[0030] 3A and 3B show top view schematics of different exemplary dosage forms of the present invention, in which graphic printed patterns are applied to ensure easy identification of medications and help improve compliance, especially for children and elderly patients.

[0031] Figures 4A and 4B show top-view schematic diagrams of different exemplary dosage forms of the present invention, in which active agent-containing configurations are applied to sub-areas. Figure 4A shows a dosage form with printed areas of different dosage amounts for subsequent adjustment. Figure 4B shows a dosage form with printed areas with two different active agent concentrations or active agents.

[0032] Figure 5 shows a top view schematic of a representative dosage form of the present invention, with an information structure showing a company logo applied. In a similar manner, a logo signature of a clinic, pharmaceutical company, manufacturer, or hospital can also be applied. Such dosage forms help to enhance patient identification with the unit using the respective signature.

[0033] The present invention relates in particular to the following aspects and preferred embodiments:

[0034] 1. A method is provided for producing a solid or semi-solid pharmaceutical dosage form comprising an active agent-free carrier structure and at least one pharmaceutically active agent provided in at least one compartment of said carrier structure, the method comprising the steps of: (i) providing a carrier structure that does not contain at least one active agent in a printing device designed for 2D and / or 3D printing of at least one pharmaceutically active agent; and (ii) applying at least one pharmaceutically active agent to at least one compartment of the surface of the carrier structure in the printing device by 2D and / or 3D printing; A method comprising:

[0035] 2. The method according to item 1, wherein in step (ii) multiple active agents are applied, said active agents being applied together in one step or in multiple separate partial steps.

[0036] 3. The method according to item 2, wherein the active agents are applied to the same or different compartments of the carrier structure.

[0037] 4. The method according to item 3, wherein the active agents are applied in compartments separated from each other or spatially one above the other.

[0038] 5. The method according to any one of items 1 to 4, further comprising applying at least one coloring substance by 2D and / or 3D printing to at least one compartment of the carrier structure such that the applied substance forms at least one information structure visible on the carrier structure.

[0039] 6. The method according to item 5, wherein the at least one coloring substance is applied together with the at least one pharmaceutically active agent.

[0040] 7. The method according to item 5 or 6, wherein the at least one information structure encodes information regarding the type or nature of the active agent applied on the carrier structure, and / or the amount(s) of the active agent(s) applied on the carrier structure, and / or the time or duration when the dosage form is intended to be taken, and / or the date when the dosage form is intended to be taken, and / or patient-related data, and / or the entity responsible for paying for the cost, and / or the attending physician, and / or the pharmaceutical company providing the dosage form, and / or the medical unit dispensing the dosage form.

[0041] 8. The method according to item 7, wherein the patient-related data is selected from the group consisting of the patient's name, age, sex, medication, and disease.

[0042] 9. The method according to any one of items 5 to 8, wherein the information structure is selected from the group consisting of a QR code, letters, and numbers.

[0043] 10. The method according to any one of items 1 to 9, wherein the carrier structure is present as a tablet, capsule, suppository, plaster or film.

[0044] 11. The method according to item 10, wherein the tablet is selected from the group consisting of oblong tablets, troches, implantable tablets, multi-use tablets, dispersible tablets, delayed release tablets, vaginal tablets, ophthalmic tablets, coated tablets, matrix tablets, chewable tablets, film-coated tablets, modified release tablets, lacquer tablets, and enteric-coated tablets.

[0045] 12. The method according to any one of items 1 to 11, wherein the method is a fused filament fabrication (FFF) method or a fused layer modeling (FLM) method.

[0046] 13. The method of claim 12, wherein the active agent(s) and the optional coloring substance(s) are present in one filament or different filaments comprising a filament carrier material in which the active agent(s) and the optional coloring substance(s) are embedded.

[0047] 14. The method according to any one of items 1 to 11, wherein the method is a binder jetting method.

[0048] 15. The method according to item 14, wherein the active agent(s) and the optional coloring substance(s) are present in one or more powdered carrier substances.

[0049] 16. The method according to any one of items 1 to 11, wherein in step (ii) a single volumetric increment of liquid is applied, at least a portion of the volumetric increment to which the liquid is applied contains the active agent(s) and the optional coloring substance(s), and wherein the volumetric increment solidifies after application.

[0050] 17. The method of claim 16, wherein the volume increments are applied layer by layer so that they at least partially contact each other.

[0051] 18. The method according to item 16 or 17, wherein the liquid is a molten material or a liquid.

[0052] 19. The method according to any one of items 1 to 11, wherein step (ii) comprises the following partial steps: applying a solution, suspension or emulsion containing one or more of said active agents to at least one section of said carrier material; and Allowing the solution, suspension or emulsion to evaporate so that the active agent(s) remain in at least one compartment of the carrier structure.

[0053] 20. The method of claim 19, wherein the support structure absorbs a portion of the solution, suspension, or emulsion during the evaporation step.

[0054] 21. A solid or semi-solid pharmaceutical dosage form containing at least one pharmaceutically active agent and prepared by the method according to any one of items 1 to 20.

[0055] 22. A solid or semi-solid dosage form comprising a carrier structure without an active agent, onto which at least a two-dimensional and / or three-dimensional arrangement comprising at least one pharmaceutically active agent is applied at least compartmentally.

[0056] 23. The dosage form according to item 22, wherein multiple active agents are coated on the carrier structure.

[0057] 24. The dosage form according to item 23, wherein the active agents are applied to the same or different compartments on the carrier structure.

[0058] 25. The dosage form according to item 24, wherein the active agents are applied in compartments separate from each other or spatially one above the other.

[0059] 26. The dosage form according to any one of items 23 to 25, wherein at least one coloring substance is further applied to at least one compartment of the carrier structure such that the applied substance forms at least one visible information structure on the carrier structure.

[0060] 27. The dosage form according to item 26, wherein the at least one information structure encodes information relating to the type or nature of the active agent applied on the carrier structure, and / or the amount(s) of the active agent(s) applied on the carrier structure, and / or the time or duration when the dosage form is intended to be taken, and / or the date when the dosage form is intended to be taken, and / or patient-related data, and / or the entity responsible for paying for the cost, and / or the attending physician, and / or the pharmaceutical company providing the dosage form, and / or the medical unit dispensing the dosage form.

[0061] 28. The dosage form according to item 27, wherein the patient-related data is selected from the group consisting of the patient's name, age, sex, medication, and disease.

[0062] 29. The dosage form according to any one of items 26 to 28, wherein the information structure is selected from the group consisting of a QR code, letters, and numbers.

[0063] 30. The dosage form according to any one of items 23 to 29, which is present as a tablet, capsule, suppository, plaster or film.

[0064] 31. The dosage form according to item 30, wherein the tablet is selected from the group consisting of oblong tablets, troches, implantable tablets, multi-use tablets, dispersible tablets, delayed release tablets, vaginal tablets, ophthalmic tablets, coated tablets, matrix tablets, chewable tablets, film-coated tablets, modified-release tablets, lacquer tablets, and enteric-coated tablets.

Claims

1. A method is provided for producing a solid or semi-solid pharmaceutical dosage form comprising an active agent-free carrier structure and at least one pharmaceutically active agent provided in at least one compartment of said carrier structure, the method comprising the steps of: (i) providing a carrier structure free of at least one active agent in a printing device designed for 2D and / or 3D printing of at least one pharmaceutically active agent; and (ii) applying at least one pharmaceutically active agent to at least one compartment of the surface of the carrier structure in said printing device by 2D and / or 3D printing; A method comprising:

2. 10. The method of claim 1, wherein in step (ii) multiple active agents are applied, and the active agents are applied together in one step or in multiple separate partial steps.

3. The method of claim 2 , wherein the active agents are applied to the same or different compartments of the carrier structure.

4. 4. The method of claim 3, wherein the active agents are applied in compartments separated from one another or spatially one above the other.

5. 5. The method according to claim 1, further comprising applying at least one coloring substance by 2D and / or 3D printing to at least one compartment of the carrier structure, such that the applied substance forms at least one information structure visible on the carrier structure.

6. The method of claim 5 , wherein the at least one coloring substance is applied together with the at least one pharmaceutically active agent.

7. 7. The method of claim 5 or 6, wherein said at least one information structure encodes information regarding the type or nature of the active agent applied on said carrier structure, and / or the amount(s) of said active agent(s) applied on said carrier structure, and / or the time or duration when said dosage form is intended to be taken, and / or the date when said dosage form is intended to be taken, and / or patient-related data, and / or the entity responsible for paying for the cost, and / or the attending physician, and / or the pharmaceutical company providing said dosage form, and / or the medical unit dispensing said dosage form.

8. 8. The method of claim 7, wherein the patient-related data is selected from the group consisting of a patient's name, age, sex, medication, and disease.

9. The method of any one of claims 5 to 8, wherein the information structure is selected from the group consisting of a QR code, letters, and numbers.

10. The method according to any one of claims 1 to 9, wherein the carrier structure is present as a tablet, capsule, suppository, plaster or film.

11. 11. The method of claim 10, wherein the tablet is selected from the group consisting of oblong tablets, lozenges, implantable tablets, multi-use tablets, dispersible tablets, delayed release tablets, vaginal tablets, ophthalmic tablets, coated tablets, matrix tablets, chewable tablets, film coated tablets, modified release tablets, lacquer tablets, and enteric coated tablets.

12. The method of any one of claims 1 to 11, wherein the method is a Fused Filament Fabrication (FFF) method or a Fused Layer Modeling (FLM) method.

13. 13. The method of claim 12, wherein the active agent(s) and the optional coloring substance(s) are present in one filament or different filaments comprising a filament carrier material in which the active agent(s) and the optional coloring substance(s) are embedded.

14. The method according to any one of claims 1 to 11, wherein the method is a binder jetting method.

15. 15. The method of claim 14, wherein the active agent(s) and the optional coloring material(s) are present in one or more powdered carrier materials.

16. 12. The method of any one of claims 1 to 11, wherein in step (ii) a single volumetric increment of liquid is applied, at least a portion of the volumetric increment to which the liquid is applied contains the active agent(s) and the optional coloring substance(s), and wherein the volumetric increment solidifies after application.

17. The method of claim 16 , wherein the volume increments are applied layer by layer such that they at least partially contact one another.

18. 18. The method of claim 16 or 17, wherein the liquid is a molten material or a liquid.

19. 12. The method according to any one of claims 1 to 11, wherein step (ii) comprises the following partial steps: applying a solution, suspension or emulsion containing one or more of said active agents to at least one compartment of said carrier material; and Allowing the solution, suspension or emulsion to evaporate so that the active agent(s) remain in at least one compartment of the carrier structure.

20. 20. The method of claim 19, wherein the support structure absorbs a portion of the solution, suspension, or emulsion during the evaporation step.

21. A solid or semi-solid pharmaceutical dosage form containing at least one pharmaceutically active agent and prepared by the method of any one of claims 1 to 20.

22. A solid or semi-solid dosage form comprising a carrier structure containing no active agent, to which at least a two-dimensional and / or three-dimensional arrangement containing at least one pharmaceutically active agent is applied at least compartmentally.

23. 23. The dosage form of claim 22, wherein multiple active agents are coated on the carrier structure.

24. 24. The dosage form of claim 23, wherein the active agents are applied to the same or different compartments on the carrier structure.

25. 25. The dosage form of claim 24, wherein the active agents are applied in compartments separate from one another or spatially one above the other.

26. 26. The dosage form of any one of claims 23 to 25, further comprising at least one coloring substance applied to at least one compartment of the carrier structure such that the applied substance forms at least one visible information structure on the carrier structure.

27. 27. The dosage form of claim 26, wherein the at least one information structure encodes information regarding the type or nature of the active agent applied to the carrier structure, and / or the amount(s) of the active agent(s) applied to the carrier structure, and / or the time or duration when the dosage form is intended to be taken, and / or the date when the dosage form is intended to be taken, and / or patient-related data, and / or the entity responsible for paying for the cost, and / or the attending physician, and / or the pharmaceutical company providing the dosage form, and / or the medical unit dispensing the dosage form.

28. 28. The dosage form of claim 27, wherein the patient-related data is selected from the group consisting of the patient's name, age, sex, medication, and disease.

29. 29. The dosage form of any one of claims 26 to 28, wherein the information structure is selected from the group consisting of a QR code, letters, and numbers.

30. 30. The dosage form according to any one of claims 23 to 29, which is present as a tablet, capsule, suppository, plaster or film.

31. 31. The dosage form of claim 30, wherein the tablet is selected from the group consisting of oblong tablets, lozenges, implantable tablets, multi-use tablets, dispersible tablets, delayed release tablets, vaginal tablets, ophthalmic tablets, coated tablets, matrix tablets, chewable tablets, film coated tablets, modified release tablets, lacquer tablets, and enteric coated tablets.

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