WO2025214546A1 - Device and method for producing a pharmaceutical product - Google Patents

Abstract

The invention relates to a device (10) and a method for producing a pharmaceutical product for direct dispensing to a patient. The device has a plurality of containers (24) for receiving in each case one pharmaceutical active ingredient, wherein the pharmaceutical active ingredients differ from one another; and at least one dosing device (25) for providing a specific amount of at least one of the pharmaceutical active ingredients from at least one of the containers (24); at least one processing device (28) for shaping the pharmaceutical product from the determined amount of the at least one pharmaceutical active ingredient provided by the at least one dosing device (24); a control unit connected to the dosing device (25) and the processing device (28) for controlling the production of the pharmaceutical product; a control panel (14) connected to the control unit for requesting a dispensing of the pharmaceutical product by the patient; and a dispensing unit (16) for dispensing the pharmaceutical product. By means of the device (10), personalised medicaments or pharmaceutical products can be produced at any time and dispensed directly to a patient.

Description

Device and method for producing a pharmaceutical product

The invention relates to a device for producing a pharmaceutical product. Furthermore, the following embodiments relate to a method for producing a pharmaceutical product.

Many medications and pharmaceutical products can be purchased in pharmacies or drugstores without a doctor's prescription. For prescription-only medications and pharmaceutical products, however, patients require a doctor's prescription. They can submit the prescription to a pharmacy and, if the pharmacy has it in stock, receive the medication there. Medications purchased from pharmacies usually contain standardized amounts of one or more active ingredients. The formulation may contain too many or too few active ingredients for people with different body sizes or different medical conditions. Furthermore, the availability of medications depends on the pharmacy's inventory and opening hours.

There is a constant need to adapt medicines and pharmaceutical products to the needs of patients and to improve the availability of these medicines and pharmaceutical products.

DE 10 2019 134 284 A1 describes a device and a method for 3D printing medications in the form of tablets, whereby liquid, pasty or powdery materials can be used.

DE 11 2022 001 694 T5 describes a medication management system designed to detect the actual intake of a medication.

US 2023 / 0414452 A1 discloses a system and a method for producing personalized doses containing pharmaceutically active substances. US 2017 / 0 360 714 A1 describes a method for delivering personalized medication to an individual using a 3D printer.

US 2014 / 0 134 320 A1 discloses a method and a system for producing personalized medicines by printing.

US 2003 / 0 010 791 A1 describes a method and a device for dispensing a personalized pharmaceutical mixture.

WO 2022 / 135 919 A1 describes a method for producing patient-optimized dosage forms of medications produced by 2D or 3D printing.

Based on this situation, the object of the present invention is to accelerate the production of personalized medicines or pharmaceutical products and to enable constant availability.

The present object is achieved by the device according to claim 1 and the method according to claim 10. Advantageous embodiments are specified in the subclaims.

The object is accordingly achieved by a device for producing a pharmaceutical product for direct dispensing to a patient, comprising: a plurality of containers for each containing a pharmaceutical active ingredient, wherein the pharmaceutical active ingredients differ from one another; at least one dosing device for providing a specific amount of at least one of the pharmaceutical active ingredients from at least one of the containers; at least one processing device for shaping the pharmaceutical product from the specific amount of the at least one pharmaceutical active ingredient provided by the at least one dosing device; a control unit connected to the dosing device and the processing device for controlling the production of the pharmaceutical product; a control panel connected to the control unit for requesting dispensing of the pharmaceutical product by the patient; a dispensing unit for dispensing the pharmaceutical product.

By providing a variety of different active ingredients, pharmaceutical products can be specifically manufactured in the composition intended for each patient, and the patient can be better treated by taking the personalized pharmaceutical products. For this purpose, the device has a dosing device for providing a specific amount of the at least one pharmaceutical active ingredient from at least one of the containers. The amount and/or combination of active ingredients provided by the dosing device can then be formed into the finished product by means of the processing device and dispensed to the patient via the dispensing unit. Using the control panel, the patient can request a composition predetermined by the doctor in accordance with a prescription. The control panel forwards the corresponding information about the desired composition to the control unit, which then controls the manufacturing process of the pharmaceutical product via the dosing device and the processing device.

The device described above allows personalized medications or pharmaceutical products to be produced independently of pharmacy or drugstore opening hours and dispensed directly to a patient without delay.

The following are listed here only as examples of different active ingredients, which may include prescription and non-prescription active ingredients or combinations of active ingredients. However, the combination of active ingredients and their quantities are limited to a specific prescription issued by a doctor for a patient: - Acetylsalicylic acid, which can be used as a pain reliever, fever reducer, anti-inflammatory, and blood thinner;

- Gabapentin, which can be used to treat epilepsy or as a painkiller; - Amitriptyline, which can be used as an antidepressant, for sleep disorders or as a painkiller;

- Diclofenac, which can be used as a painkiller, anti-inflammatory or anti-rheumatic;

- Ketamine, which can be used as a painkiller, anesthetic or antidepressant;

- Paracetamol, which can be used as a painkiller and fever reducer;

- Ibuprofen, which can be used as a painkiller;

- Caffeine, which can be used as an enhancer;

- Lysine, which can be used as an enhancer or to strengthen the immune system;

- Antihistamines, phytopharmaceuticals or melatonin, which can be used as sleeping aids.

Compare also the active ingredients and excipients mentioned in DE 10 2019 134 284 A1.

Advantageous aspects are explained below, and preferred modified embodiments are described further below. Explanations, particularly regarding advantages and definitions of features, are essentially descriptive and preferred, but not limiting, examples. If an explanation is limiting, this will be expressly stated.

The active ingredients can be in powder or liquid form. An active ingredient can, in particular, be a polymeric active ingredient that can be combined with other active ingredients to form a pharmaceutical product using 3D printing, pressing, sintering, and/or mold filling. The particle size diameter of a powder is preferably a maximum of 100 micrometers. In particular, the powder grains have a particle size in the range of 25 to 60 micrometers. The active ingredients are used, in particular, without an additional binder. This simplifies the manufacturing process and reduces production costs.

The dosing device can, when providing a specific amount of the at least one pharmaceutical active ingredient or a specific A composition of at least two different pharmaceutical active ingredients, the individual active ingredients are layered on top of each other. Layering active ingredients promotes even distribution of the active ingredients. Additional mixing is not necessary. However, a separate arrangement of different active ingredients, for example, separated by a layer impermeable to the active ingredients, has also proven effective - depending on the combination of active ingredients. This allows both liquid and powdered active ingredients to be combined in a single dosage form.

The finished pharmaceutical product can be in the form of a tablet or capsule. During the manufacturing process using the device, a composition of a plurality of active ingredients is formed into a tablet or capsule.

In a preferred embodiment of the above, the at least one dosing device is designed for selective powder deposition or hot-melt extrusion. When providing a specific amount of the at least one pharmaceutical active ingredient or a specific composition of at least two different pharmaceutical active ingredients, the dosing device can arrange the individual active ingredients in layers one above the other, particularly by means of selective powder deposition (SPD).

The dosing device can therefore be designed as a coater. The dosing device can alternatively or additionally have an extruder for carrying out hot-melt extrusion. It is particularly provided that an extruder is arranged in the device for each active ingredient provided. By means of hot-melt extrusion, each individual active ingredient provided can be formed into a filament and further processed. For the production of a pharmaceutical product with a specific composition comprising several active ingredients, the layer-by-layer application of the active ingredients in the form of filaments can be carried out by means of an additive manufacturing process, in particular by means of 3D printing. By producing the filaments by means of hot-melt extrusion, a better solubility and bioavailability of the Medications can be achieved. In particular, it is provided that the at least one dosing device is operatively connected to each of the containers and draws the at least one pharmaceutical active ingredient from a container to provide a specific amount of the active ingredient. The dosing device and each container are connected to one another via at least one pipe system.

In a preferred embodiment of the above, it is provided that the at least one processing device is designed as a mold-filling device and/or pressing device and/or sintering device and/or 3D printer. The pressing device and mold-filling device have, in particular, a pressure cylinder with a cylinder head for shaping the pharmaceutical product. By pressing, the active ingredient or the composition of a plurality of active ingredients can be pressed together in a predefined shape with a material bond. This can be done with or without the addition of heat. In the sintering device, the active ingredients can be melted and bonded together in a material bond. A filament made of one or a plurality of active ingredients, previously produced by the dosing device, can be shaped by means of 3D printing.

In a preferred embodiment of the above, the control panel includes at least one control unit for verifying the patient's identity. Verifying the patient's identity is extremely important for the manufacture and dispensing of prescription drugs or pharmaceutical products. A patient can identify themselves, in particular, using an identity card and/or a health card and/or a bank card. When using a bank card, the user's identity can be confirmed by entering a PIN during the parallel payment process. In particular, the control unit includes a card reader and/or a camera and/or an RFID scanner and/or the like. The camera can be used for identity verification and/or for monitoring the device.

In a preferred embodiment of the above, it is provided that the control panel has at least one input unit for operating the device and for the patient to request the pharmaceutical product. Using the input unit, the patient can request a pharmaceutical product prescribed by the doctor in a specific quantity or with a specific composition of active ingredients. In particular, it is provided that the input unit comprises at least one button and/or a touchscreen and/or a scanning device, in particular a QR scanner, and/or a card reader for reading medical prescriptions and/or health insurance cards. A control unit as described above can simultaneously function as an input unit. By reading medical prescriptions or health insurance cards, incorrect input by the patient is avoided and authorization to dispense and purchase the pharmaceutical product is ensured.

In a preferred embodiment of the above, the control panel includes a cash transaction unit for paying for the requested pharmaceutical products. In particular, the cash transaction unit is configured to determine the user's bank details using a card reader and/or RFID scanner. Preferably, the cash transaction unit is configured to accept and dispense banknotes and/or coins.

In a preferred embodiment of the above, the device comprises at least one transceiver for transmitting and receiving data. In particular, the transceiver is configured to transmit data wired and/or wirelessly to at least one server and/or to receive data from at least one server. Preferably, the transceiver is connected to the control unit for verifying the user's identity, the input unit, and/or the money transaction unit. By networking the individual components of the device, an electronic prescription can be obtained from the health insurance server, for example, via the health insurance card. Likewise, a comparison of personal data can be queried, and identity verification can be improved. Furthermore, the device can be connected to external devices in facilities such as doctor's offices, hospitals, or the like via the transceiver. via the external devices and the desired medications or pharmaceutical products can be requested.

In a preferred embodiment of the above, the device comprises an evaluation unit for comparing the patient's personal data with the doctor's prescription and for authorizing the production of the pharmaceutical product. By comparing the data determined by the input field, in particular personal data and medication data, using the evaluation unit, it can be ensured that only authorized persons can obtain prescription medication. The device only begins production of the pharmaceutical product once the patient's data has been verified.

In a preferred embodiment of the above, the device comprises a housing, which is preferably made of a high-strength material, in particular steel. The containers, the at least one dosing device, and the at least one processing device are arranged within the housing. The control panel and the dispensing unit are assigned to an outer surface of the housing. The housing protects the device against theft and vandalism.

The object is further achieved by a method for producing pharmaceutical products using a device according to the invention, which comprises the following steps:

Providing different pharmaceutical active ingredients in the multiple containers;

Requesting a pharmaceutical product with a specific active ingredient composition by a patient via the control panel; establishing the patient's identity and the patient's eligibility to obtain the pharmaceutical product via the control panel;

Providing a specific amount of the at least one pharmaceutical active ingredient from at least one of the containers by means of the dosing device; Shaping the pharmaceutical product from the provided amount of at least one pharmaceutical active ingredient by means of the processing device;

Dispensing of the finished pharmaceutical product by the dispensing unit to the patient.

Examples of possible combinations of active ingredients that can be produced include:

Paracetamol in combination with ibuprofen, diclofenac in combination with ibuprofen, ibuprofen in combination with lysine, etc.

A preferred technical solution is explained in more detail below with reference to the accompanying drawings using preferred embodiments. The term "figure" is abbreviated to "Fig." in the drawings.

In the drawings

Fig. 1 is a schematic external view of a first embodiment of an apparatus for producing pharmaceutical products;

Fig. 2 is a schematic view of the components installed in a device for producing pharmaceutical products according to Fig. 1.

The described embodiment can be modified and/or supplemented in many ways within the scope of the claims.

Fig. 1 shows a schematic external view of a first embodiment of a device 10 for producing a pharmaceutical product. The device has a housing 12 made of high-strength material, in particular steel. This allows the device 10 to be securely protected against theft and vandalism. A control panel 14 for operating the device 10 and for requesting the pharmaceutical product by a patient is arranged on an outer surface of the housing 12. The control panel 14 can be used to In addition, the patient's identity can be established and financial transactions can be carried out. The control panel 14 has a card reader 18 for reading health insurance cards, bank cards, and/or identification documents. A scanning device 22 can be used to scan medical prescriptions and order the production of pharmaceutical products with an active ingredient composition tailored to the patient. The finished product can then be removed by the patient as tablet(s) or capsule(s) via the dispensing unit 16. In addition, the device 10 has a camera 20 for comparing the user's biometric data with the scanned identification documents.

Fig. 2 shows a schematic view of the components installed in a device 10 for producing a pharmaceutical product according to Fig. 1. Within the housing 12 are a plurality of containers 24 for receiving and storing different active ingredients. A dosing device 25 is arranged adjacent to the containers 24. The dosing device 25 is connected to the containers 24 via a pipe system 38 for mass transfer and operates on the principle of selective powder deposition (SPD). In this process, the dosing device 25 has a plurality of cylindrical rollers 26 which are designed to be movable over a base 32. Each roller 26 has a specific active ingredient and applies it layer by layer as needed in a specific amount and at a specific location, in particular on a cylinder head 34 of the processing device 28. The active ingredient can then be pressed into a tablet form or into a capsule in the finished product 30 via a pressure cylinder 36 of the processing device 28 and dispensed to the user of the device 10. List of reference symbols

10 Device 12 Housing

14 Control panel

16 Output unit

18 card reader

20 Camera 22 Scanning device

24 containers

25 Dosing device/coater

26 roll

28 Processing device 30 Product

32 Underground

34 cylinder head

36 printing cylinders

38 Pipe system

Claims

Patent claims 1. A device for producing a pharmaceutical product for direct dispensing to a patient, comprising: a plurality of containers (24) each for holding a pharmaceutical active ingredient, wherein the pharmaceutical active ingredients differ from one another; at least one dosing device (25) for providing a specific amount of at least one pharmaceutical active ingredient from at least one of the containers (24); at least one processing device (28) for shaping the pharmaceutical product from the specific amount of the at least one pharmaceutical active ingredient provided by the at least one dosing device (24); a control unit connected to the dosing device (25) and the processing device (28) for controlling the production of the pharmaceutical product; a control panel (14) connected to the control unit for requesting dispensing of the pharmaceutical product by the patient; a dispensing unit (16) for dispensing the pharmaceutical product. 2. Device according to claim 1, wherein the at least one dosing device (25) is designed for selective powder deposition or hot melt extrusion, wherein the at least one dosing device (25) is operatively connected to the at least one container and draws the at least one pharmaceutical active ingredient from the at least one container (24) for the provision of a specific amount of the active ingredient. 3. Device according to claim 1 or 2, wherein the at least one processing device (28) is designed as a mold filling device, pressing device, sintering device and/or 3-D printer. 4. Device according to one of the preceding claims, wherein the control panel (14) has at least one control unit for verifying the identity of the patient, wherein the control unit comprises a card reader (18) and/or a camera (20) and/or a scanning device (22). 5. Device according to one of the preceding claims, wherein the control panel (14) has at least one input unit for operating the device (10) and for requesting the pharmaceutical product by the patient, wherein the input unit comprises at least one button and/or a touchscreen and/or a scanning device (22) and/or a card reader (18) for reading medical prescriptions and/or health insurance cards. 6. Device according to one of the preceding claims, wherein the control panel (14) comprises a money transaction unit for paying for the requested pharmaceutical product. 7. Device according to one of the preceding claims, wherein the device (10) has at least one transceiver for transmitting and receiving data. 8. Device according to one of the preceding claims, wherein the device (10) has an evaluation unit for comparing the patient's personal data with a medical prescription and for authorizing the manufacture of the pharmaceutical product. 9. Device according to one of the preceding claims, wherein the device (10) comprises a housing (12), wherein the containers (24), the at least one dosing device (25) and the at least one processing device (28) are arranged within the housing (12), and wherein the control panel (14) and the dispensing unit (16) are associated with an outer surface of the housing (12). 10. A method for producing pharmaceutical products using a device (10) according to any one of claims 1 to 9, comprising the following steps: providing different pharmaceutical active ingredients in the plurality of containers (24); Requesting a pharmaceutical product with a specific active ingredient composition by a patient via the control panel (14); Determining the patient's identity and the patient's authorization to obtain the pharmaceutical product via the control panel (14); Providing a specific amount of the at least one pharmaceutical active ingredient from at least one of the containers (24) by means of the dosing device (25); Shaping the pharmaceutical product from the provided amount of the at least one pharmaceutical active ingredient by means of the processing device (28); Dispensing the finished pharmaceutical product to the patient by the dispensing unit (16).