Pharmaceutical Dosage Forms and Method For Their Production

Abstract

The invention relates to a method for producing solid or semi-solid dosage forms of pharmaceutical active ingredients. According to the method, an active-ingredient-free carrier structure is arranged in a 2D or 3D printing device and at least one pharmaceutical active ingredient is applied to at least one portion of the carrier structure by way of a 2D or 3D printing method carried out by the printing device. The invention also relates to semi-solid or solid dosage forms that are producible by the method according to the invention.

Claims

1. A method for producing a solid or semisolid pharmaceutical dosage form containing an active agent-free carrier structure and at least one pharmaceutical agent which is provided on at least a region of the carrier structure, the method comprising: (i) providing at least one active agent-free carrier structure in 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.

2. The method of claim 1 wherein in step (ii) more than one active agent is applied, wherein the active agents are applied together in one step or in several separate partial steps.

3. The method of claim 2 wherein the active agents are applied onto the same at least one region or different regions of the carrier structure.

4. The method of claim 3 wherein the active agents are applied within a region separated from one another or spatially one above the other.

5. The method according to claim 1 wherein the method further comprises applying at least one colored substance by 2D and/or 3D printing onto at least one region 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 colored substance is applied together with the at least one pharmaceutical active agent.

7. The method of claim 5 wherein the at least one information structure encodes information on the kind or the nature of the active agents applied onto the carrier structure and/or on the amount(s) of the active agent(s) applied onto the carrier structure and/or on the intended time point or intended time period of taking of the dosage form and/or the intended date of taking of the dosage form and/or on patient-related data and/or on the cost center and/or on the attending physician and/or on the pharmaceutical company providing the dosage form and/or on the medical unit dispensing the dosage form.

8. The method of claim 7 wherein the patient-related data are selected from the group consisting of name, age, sex, medication, and diseases of the patient.

9. The method claim 5 wherein the information structure is selected from the group consisting of QR codes, characters, and numbers.

10. The method according to claim 1 wherein the carrier structure is present as a tablet, capsule, suppository, plaster or thin film.

11. The method of claim 10 wherein the tablet is selected from the group consisting of oblong shape tablets, lozenges, implantable tablets, multiapplication tablets, disperse tablets, retard tablets, vaginal tablets, eye tablets, coated tablets, matrix tablets, chewable tablets, film-coated tablets, modified-release tablets, lacquer tablets, and enteric coated tablets.

12. The method according to claim 1 wherein the method is a filament fused filament fabrication (FFF) method or a fusion layer modeling (FLM) method.

13. The method of claim 12 where the active agent(s) and the optional colored substance(s) are present in one filament or different filaments which comprise(s) a filament carrier substance into which the active agent(s) and the optional colored substance(s) is/are embedded.

14. The method according to claim 1 wherein the method is a binder jetting method.

15. The method of claim 14 wherein the active agent(s) and the optional colored substance(s) are present in one or more powder carrier substances.

16. The method according to claim 1 wherein in step (ii) single volume increments of a fluid are applied, wherein at least part of the applied volume increments of the fluid contains the active agent(s) and the optional color substance(s), and wherein the volume increments solidify after application.

17. The method of claim 16 wherein the volume increments are applied layer wise such that they contact each other at least partially.

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

19. The method according to claim 1 wherein step (ii) comprises the following partial steps: applying a solution, suspension or emulsion containing the agent or agents onto at least a region of the carrier substance; and evaporating the solution, suspension or emulsion such that the active agent(s) remain on the at least one region of the carrier structure.

20. The method of claim 19 wherein the carrier structure absorbs part of the solution, suspension or emulsion during the evaporation step.

21. A solid or semisolid pharmaceutical dosage form which contains at least one pharmaceutical active agent and is prepared by the method according to claim 1.

22. A solid or semisolid dosage form comprising an active agent-free carrier structure onto which at least a two- and/or three-dimensional arrangement containing at least one pharmaceutical active agent is applied at least region wise.

23. The dosage form of claim 22 wherein more than one active agent is applied onto the carrier structure.

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

25. The dosage form of claim 24 wherein the active agents are applied with a region separated from one another or spatially one above the other.

26. The dosage form according to claim 23 wherein at least one colored substance is further applied onto at least one region of the carrier structure such that the applied substance forms at least one information structure visible on the carrier structure.

27. The dosage form of claim 26 wherein the at least on information structure encodes information on the kind or the nature of the active agents applied onto the carrier structure and/or on the amount(s) of the active agent(s) applied onto the carrier structure and/or on the intended time point or intended time period of taking of the dosage form and/or the intended date of taking of the dosage form and/or on patient-related data and/or on the cost center and/or on the attending physician and/or on the pharmaceutical company providing the dosage form and/or on the medical unit dispensing the dosage form.

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

29. The dosage form according to claim 26 wherein the information structure is selected from the group consisting of QR codes, characters, and numbers.

30. The dosage form according to claim 23 being present as a tablet, capsule, suppository, plaster or thin film.

31. The dosage form of claim 30 wherein the tablet is selected from the group consisting of oblong shape tablets, lozenges, implantable tablets, multiapplication tablets, disperse tablets, retard tablets, vaginal tablets, eye tablets, coated tablets, matrix tablets, chewable tablets, film-coated tablets, modified-release tablets, lacquer tablets, and enteric coated tablets.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIGS. 1A to 1D show schematic representations of top views of different exemplary dosage forms of the invention, wherein active agent-containing arrangements comprising patient-related data or information, respectively, on the time point of taking, or similar were printed onto a flat active agent-free carrier structure. 1 Name or address of patient; 2 enlargement of printing space for higher resolution for dynamic dosing; 3 batch number or patient ID; 4 personalized note for time point of taking.

[0030] FIG. 2 shows a photographic representation of a top view of an exemplary dosage form of the invention, wherein an active agent-containing arrangement comprising a QR code was printed on an active agent-free carrier. An information structure printed according to the invention in the form of a QR code can increase patient safety and can further beneficially ensure a connection to the electronic patient file.

[0031] FIGS. 3A and 3B show schematic representations of top view of different exemplary dosage forms of the invention, wherein graphic printing patterns are applied, which serve particularly for children and geriatric patients in ensuring a simple identification of the drug and increasing compliance.

[0032] FIGS. 4A and 4B show schematic representations of top view of different exemplary dosage forms of the invention, wherein active agent-containing arrangements are applied on subareas. FIG. 4A shows a dosage form having printed areas of different dosages for subsequent adaptation. FIG. 4B shows a dosage form having printed areas with 2 different active agent concentrations or active agents.

[0033] FIG. 5 shows a schematic representation of a top view of an exemplary dosage form of the invention, wherein an information structure is applied showing a company's logo. In a similar manner, signs of clinics, pharmaceutical companies, manufacturers or clinic logos can also be applied. Such dosage forms preferably serve to increase the identification of the patient with the unit using the respective sign.

DETAILED DESCRIPTION OF THE INVENTION

[0034] The present invention relates particularly to the following aspects and preferred embodiments:

[0035] Point 1. A method for producing a solid or semisolid pharmaceutical dosage form containing an active agent-free carrier structure and at least one pharmaceutical agent which is provided on at least a region of the carrier structure, the method comprising: [0036] (i) providing at least one active agent-free carrier structure in a printing device designed for 2D and/or 3D printing of at least one pharmaceutical active agent; and [0037] (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.

[0038] Point 2. The method of point 1 wherein in step (ii) more than one active agent is applied, wherein the active agents are applied together in one step or in several separate partial steps.

[0039] Point 3. The method of point 2 wherein the active agents are applied onto to the same or different regions of the carrier structure.

[0040] Point 4. The method of point 3 wherein the active agents are applied within a region separated from one another or spatially one above the other.

[0041] Point 5. The method according to any one of the preceding points wherein the method further comprises applying at least one colored substance by 2D and/or 3D printing onto at least one region of the carrier structure such that the applied substance forms at least one information structure visible on the carrier structure.

[0042] Point 6. The method of point 5 wherein the at least one colored substance is applied together with the at least one pharmaceutical active agent.

[0043] Point 7. The method of point 5 or 6 wherein the at least one information structure encodes information on the kind or the nature of the active agents applied onto the carrier structure and/or on the amount(s) of the active agent(s) applied onto the carrier structure and/or on the intended time point or intended time period of taking of the dosage form and/or the intended date of taking of the dosage form and/or on patient-related data and/or on the cost center and/or on the attending physician and/or on the pharmaceutical company providing the dosage form and/or on the medical unit dispensing the dosage form.

[0044] Point 8. The method of claim point 7 wherein the patient-related data are selected from the group consisting of name, age, sex, medication, and diseases of the patient.

[0045] Point 9. The method according to any one of points 5 to 8 wherein the information structure is selected from the group consisting of QR codes, characters, and numbers.

[0046] Point 10. The method according to any one of preceding points wherein the carrier structure is present as a tablet, capsule, suppository, plaster or thin film.

[0047] Point 11. The method of point 10 wherein the tablet is selected from the group consisting of oblong shape tablets, lozenges, implantable tablets, multiapplication tablets, disperse tablets, retard tablets, vaginal tablets, eye tablets, coated tablets, matrix tablets, chewable tablets, film-coated tablets, modified-release tablets, lacquer tablets, and enteric coated tablets.

[0048] Point 12. The method according to any one of preceding points wherein the method is a filament fused filament fabrication (FFF) method or a fusion layer modeling (FLM) method.

[0049] Point 13. The method of point 12 wherein the active agent(s) and the optional colored substance(s) are present in one filament or different filaments which comprise(s) a filament carrier substance into which the active agent(s) and the optional colored substance(s) is/are embedded.

[0050] Point 14. The method according to any one of points 1 to 11 wherein the method is a binder jetting method.

[0051] Point 15. The method of point 14 wherein the active agent(s) and the optional colored substance(s) are present in one or more powder carrier substances.

[0052] Point 16. The method according to any one of points 1 to 11 wherein in step (ii) single volume increments of a fluid are applied, wherein at least part of the applied volume increments of the fluid contains the active agent(s) and the optional color substance(s), and wherein the volume increments solidify after application.

[0053] Point 17. The method of point 16 wherein the volume increments are applied layer wise such that they contact each other at least partially.

[0054] Point 18. The method of point 16 or 17 wherein the fluid is a molten material or a liquid.

[0055] Point 19. The method according to any one of points 1 to 11 wherein step (ii) comprises the following partial steps: [0056] applying a solution, suspension or emulsion containing the agent or agents onto at least a region of the carrier substance; and [0057] evaporating the solution, suspension or emulsion such that the active agent(s) remain on the at least one region of the carrier structure.

[0058] Point 20. The method of point 19 wherein the carrier structure absorbs part of the solution, suspension or emulsion during the evaporation step.

[0059] Point 21. A solid or semisolid pharmaceutical dosage form which contains at least one pharmaceutical active agent and is prepared by the method according to any one of the points.

[0060] Point 22. A solid or semisolid dosage form comprising an active agent-free carrier structure onto which at least a two- and/or three-dimensional arrangement containing at least one pharmaceutical active agent is applied at least region wise.

[0061] Point 23. The dosage form of point 22 wherein more than one active agent is applied onto the carrier structure.

[0062] Point 24. The dosage form of point 23 wherein the active agents are applied on the same or different regions on the carrier structure.

[0063] Point 25. The dosage form of point 24 wherein the active agents are applied with a region separated from one another or spatially one above the other.

[0064] Point 26. The dosage form according to any one of points 23 to 25 wherein at least one colored substance is further applied onto at least one region of the carrier structure such that the applied substance forms at least one information structure visible on the carrier structure.

[0065] Point 27. The dosage form of point 26 wherein the at least on information structure encodes information on the kind or the nature of the active agents applied onto the carrier structure and/or on the amount(s) of the active agent(s) applied onto the carrier structure and/or on the intended time point or intended time period of taking of the dosage form and/or the intended date of taking of the dosage form and/or on patient-related data and/or on the cost center and/or on the attending physician and/or on the pharmaceutical company providing the dosage form and/or on the medical unit dispensing the dosage form.

[0066] Point 28. The dosage form of point 27 wherein patient-related data is selected form the group consisting of name, age, sex, medication, and diseases of the patient.

[0067] Point 29. The dosage form according to any one of claims 26 to 28 wherein the information structure is selected from the group consisting of QR codes, characters, and numbers.

[0068] Point 30. The dosage form according to any one of claims 23 to 29 being present as a tablet, capsule, suppository, plaster or thin film.

[0069] Point 31. The dosage form of claim 30 wherein the tablet is selected from the group consisting of oblong shape tablets, lozenges, implantable tablets, multiapplication tablets, disperse tablets, retard tablets, vaginal tablets, eye tablets, coated tablets, matrix tablets, chewable tablets, film-coated tablets, modified-release tablets, lacquer tablets, and enteric coated tablets.