Systems and methods for producing pharmaceutical objects via 3D printing

Abstract

Systems and methods for producing pharmaceutical objects via 3D printing are disclosed. System for producing pharmaceutical subjects, such as tablets, granules and capsules, comprising a 3D printer (2) having: a mechanical system (3) movable in one or more directions; at least one print head (5) having a nozzle (37) movable by a mechanical system; a susceptor system (4) carrying a printing susceptor (6) that receives the prepared mixture (27) applied by the printhead. The system includes at least one carriage (35) holding a cartridge (28). Printing may be performed on formatted printing locations (49) on the base. The method includes providing at least one drug substance in at least one cartridge, placing the cartridge in a carriage, establishing a fluid connection between the cartridge and a printhead such that the drug substance can exit the printhead through a printhead nozzle, moving the printhead nozzle according to a 3D printing procedure, dispensing the drug substance to a printing base.

Description

[0001] This application is a divisional application of patent application No. 201880040373.8 filed on December 17, 2019, entitled "System and method for producing pharmaceutical objects by 3D printing". Technical Field

[0002] This invention relates to a system and method for producing pharmaceutical objects via 3D printing.

[0003] The present invention relates in particular to a technique for manufacturing 3D objects by applying, accumulating or forming layers for forming 3D printed articles, and in particular to a system specially modified for manufacturing a variety of tablets, granules, capsules, suppositories, implants and other pharmaceuticals. Background Technology

[0004] The system for producing tablets, granules, and capsules using 3D printing disclosed in this invention has not been disclosed in the prior art. To date, 3D printing has never been widely applied in any way to the pharmaceutical and manufacturing of pharmaceutical or non-pharmaceutical tablets, granules, or capsules.

[0005] In the prior art, only WO2017034951 is known, which discloses a 3D printing apparatus and system for producing pharmaceutical tablets. According to this invention, a powdered mixture is applied to a moving belt to form the first layer of the tablet before a binder fluid is sprayed, which integrates the mixture and prepares it to receive the next layer. This process is repeated many times to form a solid, but particularly porous, tablet that can be orally dispersed in water.

[0006] The main drawback of this particular invention is the method of tablet manufacturing, as it involves the continuous application of a mixture, a portion of which is not used in tablet preparation, resulting in raw material waste. Furthermore, a limiting factor is that the equipment can only produce porous tablets using powder blends, which prevent the manufacture of other types of products (such as capsules or compact granules), and it does not offer the possibility of printing objects using fluid raw materials, performing the printing process by continuously applying layers of material in repetitive steps until a porous tablet is formed.

[0007] Most drugs are administered via the digestive tract, aiming for absorption in the intestines or entry into the bloodstream through the oral or rectal mucosa. Drug intake offers several advantages: it is painless and easy; abundant digestive secretions promote drug dissolution; and the pH variations along the digestive tract provide a suitable environment for the absorption of almost all drugs. Furthermore, the high fluidity, large surface area, and rich blood supply of the digestive tract mucosa greatly facilitate absorption. The absorption rate can vary depending on the tablet formulation, such as the ease of disintegration, the solubility of the outer shell, and / or the size of the granules contained in the capsule. Finally, the relatively slow absorption via the digestive system allows for early intervention should any errors occur.

[0008] Despite the numerous advantages of manufacturing drugs administered via the digestive tract, the production of granules, tablets, capsules, and related pharmaceutical or non-pharmaceutical formulations has, to date, been a complex and particularly expensive process. The costs of new drug development, manufacturing units, specialized machinery and materials used in drug production, and increased labor costs have led to significant increases in drug prices.

[0009] Another drawback is the high cost of maintaining sufficient quantities of medicines in emergency situations. This is especially true in remote and sparsely populated areas where potential emergencies can lead to large stockpiles of medicines that often remain unused until they expire. Summary of the Invention

[0010] Therefore, the object of the present invention is to advantageously overcome the above-mentioned disadvantages and deficiencies of the prior art by providing a system for producing pharmaceutical objects such as tablets, granules and capsules by means of 3D printing.

[0011] Another object of the present invention is to provide a system for producing pharmaceutical objects such as tablets, granules and capsules by means of 3D printing, to produce individual prints according to the individual user's choice.

[0012] This problem is addressed by a system for producing pharmaceutical objects such as tablets, granules, and capsules via 3D printing, the system comprising a 3D printer having a mechanical system movable in one or more directions.

[0013] In the context of this invention, pharmaceutical objects include pills, tablets, granules and capsules, suppositories, implants and other pharmaceutical products that are administered or placed in the body of a mammal.

[0014] The system further includes at least one printhead having a nozzle that can be moved by a mechanical system. Preferably, the system includes one printhead.

[0015] The system further includes a base system for receiving the prepared mixture applied by the printhead.

[0016] The printhead performs the action of printing products by distributing repeating layers of material on top of the print base to form predefined shape objects.

[0017] A printhead includes at least one print nozzle. The nozzle is part of the printhead to allow material to flow across the printhead. They may or may not have valves to control the flow of the material according to the properties of various fluid substances, such as powders, granules, liquids, gels, creams, pastes, etc.

[0018] The system further includes at least one holder for holding at least one cartridge containing printable material. The cartridge can be removed and / or replaced.

[0019] Each cartridge may contain one or more active ingredients (APIs), including but not limited to: antibiotics, statins, stimulants, preservatives, antipyretics, chemotherapeutic agents, anti-inflammatory drugs, antifungal drugs, hormonal substances, diuretics, contraceptives, and psychotropic drugs (antidepressants, antipsychotics, etc.).

[0020] The cartridge may contain one or more of a variety of excipients, including but not limited to: adhesives, coatings, anti-adhesives, pigments, fragrances, resins, flow aids, lubricants, adsorbents, mediators, sweeteners, solvents, inert powders, biodegradable polymers, waxes, preservatives, disintegrants, etc.

[0021] The medicine container may contain one or more of a variety of substances used in Eastern medicine, including but not limited to herbal pharmacological substances.

[0022] The medicine container may contain one or more of a variety of substances used in homeopathy, including but not limited to tinctures.

[0023] The cartridge may contain one or more of a variety of substances used in bioengineering medicine, including but not limited to stem cells.

[0024] The cartridge may contain one or more of a variety of complex substances produced from any of the aforementioned groups of substances in any suitable mixing manner.

[0025] The cartridge may contain various substances that are still under development or research but have not yet been made public.

[0026] The advantage of this invention is that it provides a system for producing pharmaceutical objects such as tablets, capsules and granules by means of 3D printing, which can use a cartridge having a corresponding active substance and a corresponding plastic or binder substance to be used in 3D printing.

[0027] When the cartridge is empty or other substances are needed, it can be removed from the holder and a new cartridge can be inserted.

[0028] To make the invention useful, another advantage of the invention is that it provides a system for producing pharmaceutical objects (such as tablets, capsules, and granules) of different sizes and with optional additional functions, covering both simple and more complex 3D printing requirements.

[0029] In addition, the system may include multiple holders for cartridges, each cartridge containing different substances for printing more than one drug in a single continuous or simultaneous manner.

[0030] The holder can hold multiple cartridges containing a specific set of printable material for printing a certain type of drug object. When printing different types of drug objects, the entire set of cartridges can be replaced.

[0031] In an advantageous embodiment, the system has more than one printhead.

[0032] The mechanical system may include a robotic arm that terminates at a print head and can move in one, two, or three directions to accurately print the desired item in one pass through the print head.

[0033] A robotic arm is an example of a mechanical arm, typically programmable, that functions similarly to a human arm; the arm can be the sum of its mechanisms or part of a more complex robot. The links of such a robotic hand are connected by joints, allowing rotational motion (such as in articulated robots) or translational (linear) displacement. The links of a robotic hand can be viewed as forming a kinematic chain. The end of the kinematic chain of a robotic hand is called an end effector, and it is analogous to a human hand.

[0034] For the needs of this system, the following types of robotic arms can be used:

[0035] - Cartesian robot / gantry robot: used for picking and placing work, applying sealant, assembly operations, handling machine tools, and arc welding. It is a robot whose arm has three translational joints whose axes coincide with the Cartesian coordinator.

[0036] - Cylindrical robot: Used for assembly operations, processing at machine tools, spot welding, and processing at die-casting machines. It is a robot whose axes form a cylindrical coordinate system.

[0037] - Spherical robots / polar coordinate robots are used to handle machine tools, spot welding, die casting, dressing machines, gas welding, and electric arc welding. It is a robot whose axes form a polar coordinate system.

[0038] - SCARA robot: Used for pick-and-place operations, applying sealant, assembly operations, and handling machine tools. This robot features two parallel rotary joints to provide compliance in a planar plane.

[0039] - Articulated robots: used for assembly operations, die casting, finishing machines, gas welding, arc welding, and spraying. These are robots whose arms have at least three rotary joints.

[0040] - Parallel Robot: One application is as a mobile platform for handling cockpit flight simulators. It is a robot whose arms have both translational and rotational joints.

[0041] - Anthropomorphic robot: Its shape resembles a human hand, such as individual fingers and a thumb.

[0042] The mechanical system may include a support frame (also called a bridge), which is a common mechanical structure in 3D printers. The support frame consists of a structure that is vertical and parallel to the ground. The support frame carries the print head and allows it to move in the up / down direction and / or in the x-direction and / or in the y-direction, or to remain stationary, while the print base makes all necessary movements.

[0043] The system may include a feed line for establishing a fluid connection between the carriage and the printhead. Printing material can flow from a cartridge in the carriage to the printhead through the feed line. The printing line may be flexible, allowing the carriage to remain in a fixed position as the printhead is moved to the printing position via a mechanical system.

[0044] Alternatively, the carriage and printhead can be brought close to each other to establish a direct fluid connection between the cartridge in the carriage and the printhead.

[0045] Preferably, the system includes a case unit having at least one bracket, and preferably multiple brackets.

[0046] In particular, at least a portion of the box unit is movable, allowing the bracket to perform movements.

[0047] For example, by moving the cartridge unit, a cartridge held in one of multiple trays can be transported to a delivery position where a fluid connection can be established between the cartridge and the printhead. Following another movement of the cartridge unit, another cartridge can be moved to the delivery position, allowing multiple substances to be sequentially filled into the printhead.

[0048] The cartridge unit may include actuators, particularly servo motors, pneumatic actuators, hydraulic actuators, chain actuators, or magnetic actuators, to enable at least a portion of the cartridge unit to move, particularly to move one or more carriages.

[0049] Multiple trays can be arranged on a disc conveyor belt, so that all trays must be moved in order to move a single cartridge. Alternatively, multiple trays can be arranged in a row on a guide rail and can be moved to be carried to the conveying position.

[0050] In a preferred embodiment of the system, the system includes at least one movable push rod, preferably attached to the holder, for dispensing cartridges. Therefore, cartridges used in this system do not require mechanical means to dispense them. The movable push rod and the actuator for moving the push rod provide accurate and reproducible dosing based on the amount of substance measured according to the selected formulation.

[0051] The system may further include an opening device, preferably connected to a bracket, for opening the cartridge. For example, the bracket may include a needle for flushing into the cartridge, a cap remover, or a pin for opening a valve on the cartridge.

[0052] The system may further include a sealing device, preferably connected to a tray, for at least temporarily sealing the cartridge during periods when printing is not required.

[0053] The system may include a reading unit, preferably connected to a bracket, to identify markings on the cartridge. Therefore, the system can identify the type of substance contained in the cartridge, the date of use, the target quantity, or other data associated with the cartridge.

[0054] The reading unit can provide logistical support, such as statistical data or automatic order filling. The benefits of logistical support include reduced size, weight, and energy consumption.

[0055] In a preferred embodiment of the system, the system includes a bracket with a temperature control device. The bracket can provide heating and / or cooling for the cartridges.

[0056] In a preferred embodiment of the system, the system includes a printhead with temperature control devices. The printhead may be heatable and / or coolable.

[0057] Specifically, the printhead includes a printhead body with notches, heat sinks, or channels for guiding a tempering agent, such as a tempering fluid or tempering gas, like cooling air. Alternatively, the printhead may include a heat conductor that can be electrically heated.

[0058] If high temperatures are required, the printhead may be covered by a heat shield.

[0059] In a preferred embodiment, the printhead includes a printhead body that provides a volume for printing material. The printhead body may include an opening for receiving fluid material from a cartridge, which may in particular be connected to a feed line.

[0060] Advantageously, the printhead includes a stirring and / or discharging tool, particularly a worm gear, arranged in the printhead body.

[0061] The mixing and / or discharging tool can be movable, for example, it can rotate within the printhead body.

[0062] The mixing tool provides a way to mix multiple substances delivered from multiple cartridges into the printhead.

[0063] An ejection tool provides a means to expel a certain amount of material through the printhead during printing. The ejection tool can be a pushing tool that can move within the printhead body. The printhead may include tools suitable for mixing and pushing.

[0064] Preferably, the system includes an actuator for moving the stirring and / or pushing tool.

[0065] Alternatively, the printhead may include ejection tools, such as extrusion tools or folding tools, for reducing the size of the printhead body, such that material is expelled from the printhead nozzle as the volume of the printhead body is reduced.

[0066] Preferably, the system includes an actuator for moving the discharge tool.

[0067] The printhead may comprise a dual body: a) an outer cylindrical or other shaped rigid body, preferably made of recyclable material; and b) an inner container made of an elastic / flexible / compressible material. A stopper may be present at the top, and a cap may be present at the bottom, connecting the two bodies and housing a print nozzle that may be equipped with a valve.

[0068] Another advantage of the present invention is that it provides a system for producing pharmaceutical objects such as tablets, granules and capsules by means of 3D printing, the system having a pushing tool including a punch that pushes an appropriate amount of material out of the print head at a time to print the pharmaceutical.

[0069] In a preferred embodiment, the printhead includes tools suitable for mixing and agitation. For this purpose, the mixing tool may be at least partially foldable, and in particular, the mixing tool includes a foldable head.

[0070] Agitators with folded heads can be made of aramid (Kevlar), carbon fiber, or epoxy resin.

[0071] The folded head provides a vacuum effect at the printhead nozzle to prevent dripping.

[0072] Advantageously, the printhead includes a nozzle with a valve, such as a check valve, gate valve, ball valve, or needle valve.

[0073] The printhead may include spray nozzles and supply lines for compressed air, steam, water, solvents, pharmaceutical inks, digestible color inks, etc.

[0074] Steam can bind to very dry materials, allowing for very high production rates and highly porous final products. Steam can also accelerate pharmacokinetics.

[0075] The same operation can be accomplished using steam and adhesives, as well as combinations of pharmaceutical adhesives / solvents and water.

[0076] Compressed air can help dry items in production, or be used in the same way as steam, but with pills (etc.) made from substances affected by heat and / or water.

[0077] Colored inks can be used to mark different dosages.

[0078] In an advantageous embodiment of the invention, the system includes a thermal printhead equipped with a worm gear to stir the mixture prior to 3D printing.

[0079] Another advantage of the present invention is that it provides a foldable printhead that, in addition to stirring, also extracts air from the mixture, producing more compact tablets, granules, or capsules when needed.

[0080] Advantageously, the system includes an energy emitter linked to the printhead. The energy emitter can be mounted on a mechanical system and can move with the printhead, or it can be directly attached to the printhead. The energy emitter provides a quantity of material for drying or fixing after exiting the printhead nozzle.

[0081] Specifically, the energy emitter is a photopolymer headlamp, an infrared emitter, a laser, a microwave emitter, a liquid nitrogen spray nozzle, a compressed air nozzle, or a steam nozzle.

[0082] The printhead may include multiple nozzles. Therefore, multiple drug objects can be printed in parallel.

[0083] In an advantageous embodiment of the invention, the system includes a cleaning unit for cleaning the printhead and / or cartridge. The cleaning unit may include a washing tank and / or a washing port. The washing port may be connected to a cleaning fluid reservoir and / or a cleaning fluid filtration system.

[0084] After use, it is preferable to clean the printhead along with a stirring and / or pushing tool to prevent contamination when using a printhead with a different formulation the next time.

[0085] A cleaning unit can be a special location reserved in a 3D printing system. A cleaning unit may include an enclosed area with doors for housing the print head.

[0086] These doors or openings should ideally have all the necessary automation so that they can be controlled to open, close, lock, and be monitored, along with all other mechanisms within the area.

[0087] Doors or openings should preferably have the necessary sealing to isolate the enclosed area from the rest of the system without compromising critical system functions such as vacuum and climate control (which, when in use, is achieved by evaporating the liquid used and stored here or by using steam). The printhead is moved here via a mechanical system immediately after use.

[0088] The cleaning unit preferably includes a heated air supply for drying the printhead, nozzles for distributing steam, compressed air, water and / or solvent spray, vacuum suction for removing steam and excess liquid, brushes, needles for cleaning very narrow nozzles, valves, vent valves, a water tank containing solvent and / or water (in which the printhead can be immersed and cleaned), an ultrasonic transmitter and / or a dedicated cleaning laser transmitter.

[0089] The water tank may include a liquid circulation system, which may include a circulator, filters (such as activated carbon filters), microfilters and specialized chemical filters (such as HEPA H13 filters) and their necessary piping.

[0090] In a preferred embodiment of the invention, the system includes a temperature control system for regulating the temperature of the printing base. The printing base system may include air ducts or channels for guiding a tempering agent, such as tempering fluid or tempering gas (e.g., cooling air).

[0091] The temperature of the printing base can be adjusted within the range of -5°C to 40°C. Preferably, the printing base is heated to aid evaporation and promote the drying of the printed object.

[0092] Advantageously, the system includes a printing base comprising formatted printing positions, particularly convex recesses, for shaping the drug object. The substance can be printed on the formatted printing positions that can accommodate it, which affects the shape of the drug object. The bottom side of the object may, for example, have a convex shape instead of a flat plane.

[0093] The formatted printing positions allow for the formation of pharmaceutical objects, such as pills, which have the same form as most such objects (e.g., pills) made by conventional methods. They can have symmetrical lens shapes.

[0094] It can also be formed into more complex shapes to help with immediate visual recognition of the produced items, such as hearts, rhombuses, and teddy bears for pediatric use.

[0095] The bottom side can also have the shape of a gummy bear, Santa Claus, Easter Bunny, or any other typical food form, making it possible to print drug objects in the shape of such typical food forms.

[0096] The printing base can have a recess suitable for receiving pill blister packs. Typically, pill blister packs are made from suitable vacuum-formed plastic sheets. The drug object can be printed inside the positioned blister pack. Therefore, time is saved, and contact with anything outside the sterile environment of the 3D printer is avoided.

[0097] After printing is complete, the sealing device can apply a sealing film or membrane to airtightly seal the blister pack.

[0098] Further action could be to mark the sealed blister pack using a marking device such as a laser connected to the mechanical system.

[0099] The system may include a printing base comprising a heat conductor, specifically arranged on a side opposite to the side having formatted printing positions. Therefore, the printing base can be directly heated, for example, for drying printing material.

[0100] The system may include a temperature sensor for monitoring the temperature of the printing substrate. The temperature sensor may be a contact sensor or a non-contact sensor, such as an infrared or laser sensor.

[0101] The system may include a temperature control unit, which includes a temperature sensor, a thermostat, and / or a thermal switch.

[0102] The printing base can be made of metal and / or metal alloys, such as aluminum alloys, corrosion-resistant aluminum sheets formed from high-purity aluminum with a surface layer metallurgically bonded to a high-strength aluminum alloy core material, such as stainless steel varieties, like 310-310S, high-alloy austenitic stainless steel for high-temperature applications. High chromium and nickel content gives the steel excellent oxidation resistance and high strength at high temperatures, or makes type 316 excellent for food and surgical applications. The addition of molybdenum alloys prevents specific forms of corrosion because it increases resistance to chloride corrosion, etc.

[0103] The printing substrate can be made of plastics and / or composite materials. It can be made of tempered glass such as borosilicate glass or 7740 glass. The printing substrate can also include ceramics, such as glass-ceramics. Glass-ceramics combine the manufacturing advantages of glass with the unique properties of ceramics. They can withstand brazing temperatures up to 700°C while retaining characteristics such as zero porosity, high strength, toughness, low thermal expansion, high-temperature stability, machinability, high chemical durability, biocompatibility, and airtightness. In manufacturing, glass-ceramics offer the combined value of the strength of ceramics and the hermeticity of glass.

[0104] Preferably, the printing substrate has a coating, particularly a ceramic glaze coating. The printed pharmaceutical object may detach from the printing substrate and will not adhere to it.

[0105] Many types of coatings can be used, such as: ceramic glaze, waterproof layer or coating of vitreous material that has been fused with the ceramic body by firing, silica nanocoating, silver nanocoating with antibacterial and antifungal properties, and titanium dioxide (TiO2) nanoparticles with bactericidal and antifouling properties.

[0106] The base system may also include an object remover.

[0107] The object remover can be formed by a tilting mechanism that tilts the printing base so that the printed drug object slides down the printing base to a collection point, such as into a container.

[0108] An object remover can be formed by connecting a movable extractor pin or a gas nozzle to a formatted print position on the print base. Each printed object can be ejected from the print position by pressure from the extractor pin thrusting out of a hole in the print position or by pressure from a blown-out nozzle.

[0109] In a preferred embodiment of the invention, the base system includes a base retainer for receiving the print base. The print base can be removed and / or replaced.

[0110] Printers with different formatted print positions can be used in the same system. A printer with the object to be printed can be removed from the system and replaced with a new printer.

[0111] In another advantageous embodiment, the system for 3D printing includes a mechanical base system capable of moving the printing base in one or more directions.

[0112] For example, the printing base can be raised at the printing height and lowered after printing. The printing base can also be moved to complete the movement of the mechanical system used to move the print head, so that complete 3D printing can be achieved solely through one-dimensional or two-dimensional movement of the print head.

[0113] Advantageous systems for 3D printing tablets, granules, and capsules have a thermally controlled base with formatted printing positions that have air ducts for precise control of the temperature and humidity of the printed articles.

[0114] In a preferred embodiment of the invention, the system includes a chamber for establishing a controlled atmosphere, particularly a chamber with a door. The system is equipped with individual units such as ventilation filters, ventilation ducts, air filters, activated carbon filters, air conditioning systems, air drying systems, vacuum systems with vacuum pumps, and head cleaning reservoirs.

[0115] The advantage of this invention is that the proposed system can operate autonomously or in conjunction with a computer to accept orders for 3D printing granules, tablets and capsules.

[0116] The system is preferably controlled by a computer or a series of computers to function. The computer runs on an operating system such as Windows, Linux, or IO and provides all the software required to perform the task.

[0117] The computer preferably controls all operations and actions of the system. Each subsystem, device, and mechanism can be controlled and made to function by a controller. A controller is a comparison device that receives input signals from measured process variables, compares those values ​​with predetermined control point values, and determines the appropriate output signal quantity required by the final control element to provide corrective measures in control loops, PLCs, EPROMs, etc.

[0118] In many cases, the same cable that connects each device to the computer can be the power source for that device (e.g., USB). The computer may have all the necessary subsystems to interact with the user, such as a screen (touchscreen, capacitive screen, LCD, or others), input methods (touchscreen, keyboard, multifunction buttons, or others), sound and / or visual prompting systems, power on / off buttons, and any other means of interaction.

[0119] Computers can be equipped with the necessary software to perform their functions.

[0120] The computer preferably includes the ability to run automated diagnostics on each subsystem of the organization and notify users of any part of the system that requires maintenance or repair or that a failure is imminent. This reduces maintenance costs and increases system availability.

[0121] Preferably, the computer monitors the calibration of the moving mechanism as needed.

[0122] The computer preferably stores a database of the selection of any available mixtures and any methods suitable for producing any product, as well as the form of each product (pills, granules, tablets, suppositories, etc.).

[0123] The computer preferably stores a database of usage statistics and can notify users that cartridges containing specific substances or mixtures of substances are running out, or even directly order cartridges that need to be sorted online, thereby facilitating logistics operations.

[0124] The database required for the system's operation can be stored in the computer's memory and / or online (Internet data storage, remote servers, the cloud, etc.). It can be updated (as well as program updates) when new products become available, or it can be recovered from in case of a failure. For this purpose, the computer can be equipped with a modem (modem, router, etc.) that connects to the web via cable or wireless technology. Backups of computer programs, databases, etc., can be provided via flash drives, external hard drives, online data storage, etc.

[0125] The computer can interact with other devices (external computers, computer accessories such as mice, keyboards, webcams, portable hard drives, microphones, printers, scanners and speakers, tablet computers, smartphones, screens, etc.) via cables (USB, DVI, HDMI, etc.) or wirelessly.

[0126] In the case of small systems (desktop or portable), the computer can be located outside the system (standalone).

[0127] All electronic control subsystems—controllers, regulators, etc.—can communicate directly (via cable) or indirectly (via Bluetooth, WIFI, IR, or others) through an interface device (system to computer) that includes the necessary drivers and programs (or apps) installed on the computer used.

[0128] The module can provide power to all subsystems of the system. The module includes a power input (cable and / or wireless charger), a power converter (e.g., 220V / 12V), a battery or battery pack, a UPS (Uninterruptible Power Supply, also known as an uninterruptible power supply, UPS or battery / flywheel backup power supply, which is an electrical device that provides emergency power to the load in the event of a failure of the input power or main power supply), an auxiliary or emergency power system or a backup generator, and a power output (USB or other).

[0129] This problem is also addressed by a method for producing pharmaceutical objects such as tablets, granules, and capsules via 3D printing, particularly utilizing the system described above.

[0130] The method includes the following steps.

[0131] At least one drug substance is provided in at least one cartridge. The cartridge is placed in a holder. A fluid connection is established between the cartridge and the print head, allowing the drug substance to exit the print head through the print head nozzle. The print head nozzle is moved according to the 3D printing program, and the drug substance is dispensed onto the printing base.

[0132] The cartridge can be transferred to the print head and can move with the print head.

[0133] Preferably, a certain amount of at least one pharmaceutical substance is administered from the cartridge to the printhead, and the substance is stirred in the printhead, particularly a mixture of multiple pharmaceutical substances.

[0134] It can print drug fluids that are composed and mixed according to a specified formula.

[0135] Multiple cartridges, each containing a different drug substance, can be arranged in a cartridge. The cartridge can be moved relative to the printhead to a position where the selected cartridge is fluidly connected to the printhead. A specific amount of the corresponding drug substance can be administered into the printhead, thereby preparing a drug mixture according to a drug formulation.

[0136] In an advantageous embodiment, the system includes multiple printheads that move independently, each distributing material to a printing base. A first printhead may be filled with a shell or cap material, another printhead may be filled with a first content material, and yet another printhead may contain a second content material, enabling the printing of a pharmaceutical object within an internal structure.

[0137] The method according to the invention is advantageous in situations where individually designed pharmaceutical objects with similar compositions must be provided periodically, such as in hospitals, nursing homes, cruise ships, naval vessels, or refugee camps.

[0138] The storage of matrix materials is easier than the storage of each and all realizations of certain drugs.

[0139] This achieves packaging reduction that is both eco-friendly and cost-effective.

[0140] A print base with formatted print positions can be applied to the print base system before printing. Drug substances can then be dispensed onto the formatted print positions.

[0141] After printing, the print head may need to be cleaned.

[0142] Preferably, the method includes the step of providing at least one substance in at least one cartridge, the substance including at least one selected from fat, starch, flour, gelatin, sweetener, natural flavoring, artificial flavoring and coloring.

[0143] These food-grade ingredients ensure that the printed objects are easy to digest and delicious.

[0144] The capsule may also contain other food substances that can be used as excipients, such as emulsifiers, stabilizers, thickeners, binders, sweeteners, sugar coating additives, anti-caking agents, emulsifiers, acidifiers, acidity regulators, defoamers and foaming agents, antioxidants, fillers, food colorings, color retention agents, flavorings, taste enhancers, glazing agents, humectants, preservatives, stabilizers, sweeteners, etc.

[0145] Additional substances can be provided in separate cartridges, allowing composite materials containing pharmaceutical and food substances to be mixed in the printhead according to a predetermined formula.

[0146] In a preferred embodiment of the method, the pharmaceutical substance provided in at least one cartridge includes at least one of antipyretics, analgesics, antimalarial drugs, antibiotics, antiseptics, psychotropic drugs, mood stabilizers, hormone replacements, oral contraceptives, stimulants, sedatives, and statins.

[0147] Antipyretics, such as acetaminophen, reduce fever, fever, or heat. Analgesics or pain relievers, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), or opioids, relieve pain. Antimalarial drugs, such as chloroquine and hydroxychloroquine, treat malaria. Antibiotics inhibit bacterial growth. Antiseptics prevent bacteria from growing near burns, cuts, and wounds. Mood stabilizers include, for example, lithium and valproamide. Hormone substitutes include, for example, estrogen or progesterone. Oral contraceptives include, for example, diethylstilbestrol, biphasic pills, and triphasic pills. Stimulants include, for example, methylphenylacetate and amphetamine. Chlorpromazine is an example of an antiepileptic drug. Librium, diazepam, and alprazolam are examples of benzodiazepine sedatives and hypnotics. Statins include, for example, lovastatin, pravastatin, and simvastatin.

[0148] The system and method of this invention can be applied to the formulation of pediatric paracetamol preparations. Children aged 6 to 8 years should take 250 mg every 4 to 6 hours, children aged 8 to 10 years should take 375 mg, children aged 10 to 12 years should take 500 mg, and children aged 12 to 15 years should take 750 mg.

[0149] In one example, cocoa butter, cocoa powder, sugar, and milk or chocolate chunks, along with a certain amount of paracetamol, are suitable for producing the desired drug. For example, 250 mg of paracetamol is dispensed into the printhead, mixed, and combined. The printhead is heated to reach a temperature that melts the components.

[0150] The main reason for not using chocolate and other flavor-appealing substances to date is the fact that they can be mistaken for snacks and can lead to poisoning due to overconsumption.

[0151] By using a 3D printer capable of precise drug delivery to produce such drug objects, this danger is effectively eliminated, and because of this, the shapes of such tablets can be easily distinguished, and extremely small quantities of tablets can be produced.

[0152] On the other hand, substances found in chocolate can help people who don't usually like them accept medication.

[0153] The production of these tablets will serve as an example of functionality for a 3D printing system.

[0154] The first step is to give the system the input specifying the desired product, such as 250 mg paracetamol-chocolate tablets for pediatric use.

[0155] The system selects a cartridge containing the desired ingredient (substance) and fills the printhead at the filling position after its protective cap is removed sequentially. The cartridge nozzle is then cleaned by a cleaning device, and its cap is replaced. While the mixing mechanism begins to combine the drug and excipient, the printhead is heated to 30 to 35 degrees Celsius to help melt the excipient.

[0156] The printhead is positioned above the print base and begins the printing program according to commands from specialized software. The print base then cools the object as it is being printed to help it cure rapidly at a temperature of 20 degrees Celsius. Simultaneously, the system's airflow and temperature control devices help cool the tablet being constructed.

[0157] The process ends with the printing base delivering the produced product to be packaged, and the printhead and base are thoroughly cleaned and sterilized in preparation for the next task of the system. Other excipients that can be used to obtain the desired tablet flavor and texture include cocoa butter, cocoa powder, sugar, milk, white chocolate, caramel, strawberry, dark chocolate, and other flavors.

[0158] These and other objects, features and advantages of the invention will become apparent in the following detailed description. Attached Figure Description

[0159] The invention will become apparent to those skilled in the art from the accompanying drawings, which are illustrated in an exemplary, non-limiting manner.

[0160] Figure 1 A perspective view illustrating a basic embodiment of a 3D printing production system for tablets, granules, and capsules is shown.

[0161] Figure 2 A perspective view of a basic embodiment of a system for producing tablets, granules, and capsules by means of 3D printing is shown, with the system's doors open;

[0162] Figure 3A perspective view of an exemplary embodiment of the production system is shown, and when connected to a computer, the system's dual printheads are also shown.

[0163] Figure 4 A perspective view of another exemplary embodiment of a system for producing tablets, granules, and capsules by means of 3D printing is shown;

[0164] Figure 5 A rear perspective view of a system for producing tablets, granules, and capsules using 3D printing is shown, along with how the supply is executed;

[0165] Figure 6 An embodiment of a tablet, granule, and capsule production system using 3D printing is shown in cross-sectional view, along with its various components;

[0166] Figure 7 Another embodiment of a tablet, granule, and capsule production system via 3D printing is shown in perspective, with the system's doors open;

[0167] Figure 8 A perspective view of the exemplary embodiment of the system described above is shown in cross-section;

[0168] Figure 9 A cross-sectional front view of the system is shown, illustrating its various components;

[0169] Figure 10 A cross-sectional view is shown. Figure 7 The rear view of the system;

[0170] Figure 11 This is a sectional view of the rear view of the aforementioned system, showing its further details from different angles;

[0171] Figure 12 Another embodiment is shown Figure 7 The rear view of the system;

[0172] Figure 13 An exemplary embodiment of a 3D printing system machine equipped with dual printheads and a movable mechanical base is shown;

[0173] Figure 14 An alternative embodiment of the 3D printer for the illustrated system is shown, which is capable of continuously feeding the mixture for printing;

[0174] Figure 15 Another alternative embodiment of the 3D printer is shown, in which the arm of the 3D printer can move in one or more directions, and the print head and base can move in one or more directions;

[0175] Figure 16An alternative embodiment of the 3D printer for the illustrated system is also shown;

[0176] Figure 17 A robotic arm that can be used for 3D printing of tablets, granules and capsules using the system of the present invention is shown;

[0177] Figure 18 An alternative frame that can be used as a 3D printer in the system of the present invention is shown;

[0178] Figure 19 A partial longitudinal cross-sectional view of the 3D-printed cartridge of the present invention for granules, tablets and capsules is shown;

[0179] Figure 20 A longitudinal cross-sectional view of a cartridge containing a mixture suitable for each case is shown, while

[0180] Figure 21 Alternative embodiments of cartridges with different tip types are shown;

[0181] Figure 22 The slender cartridge holder that can be used in this system is shown, as well as the punch for propelling the mixture;

[0182] Figure 23 A variation of the rotatable cartridge holder is shown;

[0183] Figure 24 An alternative embodiment of a system for producing tablets, granules and capsules by means of 3D printing is shown in cross-sectional view, in which the arrangement of the cartridge and the print head can be seen;

[0184] Figure 25 A thermal printhead with a support base and accessory bracket is shown, as well as

[0185] Figure 26 The back of the thermal head and its corresponding cooling fan are shown;

[0186] Figure 27 A thermal head is shown, which has a feeding device and a photopolymer headlamp on a head bracket;

[0187] Figure 28 (a) and (b) show the thermal head and its corresponding cross-section, in which there are obvious notches that cause heat loss;

[0188] Figure 29 (a) and (b) show thermal printing bases with formatted printing positions or simple types of items for printing;

[0189] Figure 30 A cross-sectional view of a base with an air duct for air circulation is shown;

[0190] Figure 31 A foldable worm gear that can be used in the production system of the present invention is shown;

[0191] Figure 32 A perspective view of a worm gear having an active material inlet and an air outlet is shown.

[0192] Figure 33 It shows Figure 32 A cross-sectional view of the base of the foldable worm gear;

[0193] Figure 34 The foldable worm gear is shown when fully folded.

[0194] Figure 35 This is a cross-sectional view of a multi-print head with a worm gear in a 3D printing production system for tablets, granules, and capsules that can be used in this invention;

[0195] Figure 36 A print base with formatted print positions is shown;

[0196] Figure 37 An example of a base system is shown;

[0197] Figure 38 Another example of a base system is shown;

[0198] Figure 39 A printing base with a pull-out pin in (a) a passive position and (b) a withdrawn position is shown;

[0199] Figure 40 Examples of compressible cartridges are shown in (a) the first position, (b) the second position, and (c) the third position;

[0200] Figure 41 A cartridge holder arranged in a cartridge unit is shown. Detailed Implementation

[0201] Referring now to the accompanying drawings, we will describe exemplary embodiments of a system for producing tablets, granules, and capsules by means of 3D printing, so that its operation is easy to understand.

[0202] The basic structure of the system is as follows Figure 1As shown, it includes a display 1 with buttons or touch controls, from which the user can input necessary data and monitor displayed instructions during system operation. It also includes a 3D printer 2 with a mechanical system 3 comprising a robotic arm movable in one or more directions, a base system 4 fixed or mechanically movable in one or more directions, and a print head 5 that dispenses a mixture according to instructions received from software to 3D print tablets, granules, and capsules on a print base 6. The 3D printer 2 is located within a chamber 7, which is closed by a door 8. Figure 2 This creates a controlled environment during printing.

[0203] The system of the present invention for producing tablets, granules and capsules by means of 3D printing is further equipped with a power cable 9 ( Figure 3 It can be connected to computer 10. This connection can be wired or wireless. However, the system itself can have a built-in computing unit on the base 11, so that its operation does not require a connection to an external computer 10.

[0204] In an alternative embodiment of the invention, the system for producing tablets, granules, and capsules by means of 3D printing can be... Figure 4 In a similar form, it includes a display 1 and a power cable 9. Figure 5 ) and printing chamber 7, in which 3D printer 2 is located.

[0205] However, it further includes one or more ventilation ducts 12, which facilitate proper air circulation within the printing chamber 7. The system is also equipped with an air filter 13. Figure 6 The air filter, used for cleaning the circulating air, is removable for cleaning or replacement as needed. The computer unit 14 and supply unit 15 of the entire system can operate completely autonomously.

[0206] In another alternative embodiment of the invention, the system for producing tablets, granules and capsules by means of 3D printing may have additional functional elements, enabling it to be used in more complex applications.

[0207] The system has a display 1 ( Figure 7 ) and gate 8, and also has a voltage regulator 15 ( Figure 10 ) and uninterruptible power supply 16 ( Figure 9 The power supply unit allows for uninterrupted operation of the system.

[0208] To control and maintain appropriate atmospheric conditions in the printing chamber 7 and throughout the system, an air conditioning and air drying system 17 is provided, while ventilation ducts 12 allow ambient air to enter as needed. The air conditioning and air drying system 17 is connected to the printing chamber 7 by means of one or more air supply and return ducts 18, and is generally connected to the interior of the system, so as to help create appropriate conditions during actuation.

[0209] The system also features an activated carbon filter 19 ( Figure 8 The vacuum pump 20 and the negative pressure container 21 are used to absorb carbon dioxide and other harmful substances from the circulating air, while the vacuum pump 20 and the negative pressure container 21 help to generate a vacuum or appropriate pressure conditions as required.

[0210] The system may have a cleaning unit 67, which includes a washing tank 22, and a washing tank port 23 ( Figure 12 The printhead 5 is washed and cleaned in this process. In this case, it has a reservoir 24 for the cleaning fluid for the printhead 5 and a filtration system 25 for the head cleaning fluid to ensure that there is no debris after cleaning the printhead 5.

[0211] The cleaning solution can be selected from the following examples.

[0212] - Organic acids, surfactant compounds, and corrosion inhibitors, which can be used with precious metals, stainless steel, non-ferrous metals, chromium-plated metals, glass, plastics, semi-precious stones, quartz, and ceramics to remove polishing pastes, oxide films, and annealing colors, such as glycolic acid.

[0213] - Acids, solubilizers, and wetting agents used to remove oxide films from non-ferrous metals without corroding metal surfaces and / or to remove lime deposits, such as phosphoric acid.

[0214] - Alkali, complexing agents, chelating agents, solubilizers, surfactants, surfactants used to remove synthetic resins, mixtures of amorphous resins, polishing agents and abrasives, such as KOH-based or NaOH-based detergent residues, especially with bactericidal and antiviral activity.

[0215] - Neutral pH detergents with a pH of 6-9 are used to clean aluminum and other soft metals, such as NpH sterile or neutral detergents.

[0216] The cleaning solution should preferably be free of phosphates and chlorine.

[0217] After 3D printing, the printhead preferably uses pre-filtered, dry air, which is heated shortly before entering the cleaning unit. The air can be filtered again with a suitable filter, such as a HEPA H13 filter required in Europe. The detergent can be used with ultrasonic or spray technology or as a foam detergent.

[0218] The system will have a corresponding computing unit 14 ( Figure 11 ), used to process and execute commands, as previously reported.

[0219] As mentioned above, each system has a 3D printer 2 ( Figure 13 The 3D printer 2 has a mechanical system 3 that terminates at one or more print heads 5 for printing on a base system 4. The base system 4 can be fixed or moved in one or more directions according to its axis of freedom 26. Similarly, in an alternative embodiment of the invention, the mechanical system 3 can move in one direction, for example, upward and downward. Figure 15 ), moving in two directions, such as up and down, and left and right ( Figure 16 ), or even have different shapes ( Figure 17 ( ), which offers greater freedom.

[0220] For example, Figure 18 The 3D printer 2 has a base system 4 and a mechanical system 3, the base system 4 having a base 6 that moves in two dimensions, and the mechanical system 3 being similarly movable in two dimensions. 3D printing of tablets, granules, and capsules requires one or more mixtures of active substances and substances with plastic (adhesive) properties, depending on the final product to be produced.

[0221] Figure 19 The mixture 27 may be solely an active substance, solely a plastic or adhesive, or a combination thereof, and may be in liquid form within a cartridge 28, which is fed into the printhead 5 or via a container 29. Figure 14 The feed is constantly supplied to the container, which is connected to the printhead 5 via a feed line 30 (e.g., a dispensing pipe).

[0222] The number of containers 29 connected to the printhead 5 may be greater than one. Further, or alternatively, the cartridge 28 may be permanently attached to the head 5 and replaced individually after it is emptied. In another alternative embodiment, the mixture 27 may also be in the form of filaments.

[0223] Because the viscosity of the mixture used varies depending on the finished product, the cartridge 28 has different cross-sectional ends. Therefore, it can have a wider cross-section at the end 31. Figure 20 ), or has a narrower cross-section ( Figure 21 To seal the bottom side of cartridge 28, a cap 32 may be used, without excluding the use of any other suitable closure. The upper side of cartridge 28 has a downwardly movable cap 33, which is constructed from... Figure 22The punch 34 is pushed to provide the mixture 27 to the print head 5. The cap 33 may be equipped with suitable devices, such as a radio frequency identification system, to enable the punch 34 to determine its exact position and the associated cartridge information 28.

[0224] A cartridge may have a valve at its nozzle to prevent overflow, drying, etc. A valve is a device that regulates, directs, or controls the flow of fluids (gases, liquids, fluidized solids, or slurries) by opening, closing, or partially blocking various channels. Valves are technically accessories, but are usually discussed as a separate category. In an open valve, fluid flows from high pressure to low pressure.

[0225] The simplest and oldest valve is simply a freely hinged valve disc that descends to prevent fluid (gas or liquid) from flowing in one direction, but is pushed away by the flow in the opposite direction. This is called a check valve because it can prevent or “stop” flow in one direction. Modern control valves can regulate downstream pressure or flow and operate on complex automated systems. These valves can be spring-loaded, elastic (made of silicon or other materials with similar elasticity), with orifices or cutouts (straight, cross-shaped, etc.) to allow material to be expelled from the cartridge when pressure is applied to the shaft at the plug. In this case, the protective cap of the cartridge nozzle can be fitted with a small needle. Alternatively, in the case of a cutout on the valve that is adapted to its shape (e.g., cross-shaped), at least one vane can be used.

[0226] The valve can be of different types. For example, if the material contained in the cartridge is dry (solid) (such as powder, granules, etc.), it can be a dosing device that controls the flow rate, or an on / off valve (gate valve, ball valve, needle valve, etc.) used with liquids. The valve can be pressure-inserted into the cartridge nozzle or glued in place. In the case of solid materials, the valve mechanism can be formed in the lower part of the cartridge itself.

[0227] Each system may be equipped with more than one cartridge 28 having the same or different mixtures 27 and the same or different ends 31.

[0228] The cartridge 28 is arranged in a bracket 35, which may be elongated or even rotatable. Figure 23 The carriage 35, mechanically driven by a servo motor or other suitable device, guides the appropriate cartridge 28 to the loading position, allowing the punch 34 to push an appropriate amount of mixture 27 onto the print head to initiate the process. The carriage 35 may be located within the 3D printer 2. Figure 24 ), and guide it above the base system 4 to begin the process, or it can be securely positioned at the location where the arm 36 receives the cartridge 28 at one time ( Figure 17 The size of the bracket 35 and the number of cartridges 28 it can hold are limited only by the available space in the system.

[0229] The size or shape of the cartridge can vary depending on the two manufacturing methods. They can be larger, for example, mass-produced in a factory; medium-sized, for use in pharmacies and hospitals; or smaller, for use on a desktop or mobile device.

[0230] The cartridge as described is preferably made of a material that will not interact with or contaminate the included substances in any way (e.g., oxidation of metals in contact with aqueous or alcoholic solvents).

[0231] Such materials include a wide variety of metals, such as stainless steel and aluminum alloys, and in any case, techniques for forming a film-like coating can be used to isolate the contained material from any metal that might damage it; therefore, theoretically, any metal can be used. Examples of such techniques include electroplating, spraying or dipping, ceramic coating, or even internal extrusion of suitable plastic films.

[0232] Such materials include a wide variety of plastics, and in this case, care must be taken to avoid pollution caused by reactions (such as alcohol solvents and some types of polyethylene plastics) or the release of volatile gases and / or oils contained in the plastic itself (such as certain polyethylene, polyurethane and polyester materials).

[0233] In any case, a wide variety of plastic materials can be used, such as epoxy resin, certain nylons, polyethylene, and even more composite materials (e.g., nylon with glass microspheres made by injection molding or epoxy resin combined with ceramic microspheres).

[0234] For plastics, the aforementioned techniques can be used to further enhance protection against the contained substances, or unsuitable materials can be used by forming an inner layer of protective material suitable for the task (e.g., double extrusion of PET or PETG and ABS. Such techniques are commonly used in plastic, disposable, water and soda bottles). Harder or non-extrudable plastics can be temporarily conductive and thus plated, or a protective layer can be simply formed by spraying or dipping with a suitable material. Glass and ceramics can be used in any case.

[0235] Preferably, the cartridge incorporates various identification methods (RIFD or other chips, barcodes or others) within its body, which are provided to the reading unit 66 on the tray or storage container (see...). Figure 41 This information provides an interface that allows the system to identify the ingredients, enabling the selection of the correct volume, or to identify the shelf life of each product, the remaining volume in each cartridge, and the frequency of use. This information can be used as statistical data to optimize production and to automate the supply chain by ordering replacements and renewals in a timely manner when needed.

[0236] Printhead 5 is a device designed to apply the necessary amount of mixture 27 to produce the corresponding granules, tablets, or capsules. Printhead 5 is provided with nozzle 37 ( Figure 26 The nozzle 37 supplies the mixture 27; and the printhead body 38 is formed, for example, as a cylinder, having an envelope 39. The printhead 5 further has a support 40 ( Figure 28 (a) is held in place by it in the head support 41 ( Figure 24 (or arm 36)

[0237] To improve temperature control of mixture 27, the printhead can be a thermal printhead ( Figure 25 For this purpose, it has a heating element 42 with a notch 43, which causes heat loss, and a cooling fan 44 may also be provided at its rear. Figure 26 This further improved temperature control.

[0238] In another alternative embodiment, the print head 5 may be provided with an energy emitter 45, which in this example is a photopolymer headlamp (…). Figure 27 ), which is supported on arm 46 for the mixture 27 that requires its presence.

[0239] In another alternative embodiment, the printhead 5 may have a liquid nitrogen spray nozzle for directly cooling the printed item.

[0240] In an alternative embodiment of the invention, the print head 5 may be provided with a stirring and / or discharging tool 47, which in this example is a worm gear. Figure 22 The worm gear rotates continuously or intermittently by means of a servo motor, agitating the mixture within the printhead 5. In this way, the mixture 27 will maintain the necessary viscosity, depending on the application to be used.

[0241] In another alternative embodiment of the invention, the worm 47 may have a foldable head 48. Figure 31 In addition to stirring the mixture 27, it also compresses it appropriately by removing air. For this purpose, it has a hole 51 at the top of the head 48. Figure 32 Solvents, active pharmaceutical substances, or mixtures are typically introduced through this orifice; and air is expelled through orifice 50 by compression. When not in use, stopper 52 can be used. Figure 33 The hole is sealed. The foldable head 48 can be made of stainless steel, thermoplastic materials, and composite materials, such as para-aramid synthetic fibers or shape memory metals. Figure 34 ).

[0242] In another alternative embodiment of the printhead (5), it may have a worm 47, with or without a foldable head 48, with or without a heating element 42, and with more than one nozzle 37. Figure 35This allows 3D printing to proceed at a faster speed.

[0243] 3D printing of tablets, granules, and capsules as described above on base 6 of base system 4 ( Figure 29 (b)) Execute on.

[0244] The printing base 6 can also be temperature controlled, and it can also have... Figure 29 (a) and Figure 36 The formatted print position 49 shown is used to form tablets, granules, or capsules by applying mixture 27.

[0245] After 3D printing is complete, the item is removed from base 6, and then the base is repositioned onto base system 4 for later processing. Base 6 may further include air ducts 50. Figure 30 It allows natural or forced air to flow on the base 6 in order to reduce the evaporation of moisture in the produced items.

[0246] Figure 37 An example of a heatable pedestal system 4 is shown. The printing pedestal system 4 includes a temperature control system 68 and a fan 55, the temperature control system 68 having an air duct 53 and a channel 54 for guiding the tempering agent.

[0247] The print base 6 is removably held by the print base holder 57 and can be pushed in and pulled out.

[0248] Figure 38 Another example of base system 4 is shown, in which fan 55 is arranged laterally from printed base 6.

[0249] Figure 39 A base system 4 including a pull-out pin 56 is shown. Figure 39 In (a), the pull-out pin 56 is in the passive position, closing the hole 58 in the formatted print position 49. The pull-out pin 56 is arranged on a plate 59, which can move vertically. When the plate moves upward, the pull-out pin 56 is in the pulled-out position. Figure 39 (b) The pull pin 56 extends beyond the hole 58 and can print the printout from the formatted print position 49 (not explicitly shown).

[0250] Figure 40 Examples of compressible cartridge 28 are shown in (a) the first position, (b) the second position, and (c) the third position.

[0251] The cartridge 28 may include a dual body: an outer cylindrical rigid body 60 and an inner container 61 made of compressible material. A stopper 62 is present at the top, which can be pressed down to expel the printing material (not shown) from the lower end 31 of the cartridge 28.

[0252] When cartridge 28 is arranged on a mechanical system and a printing nozzle (not shown) is mounted on its lower end 31, cartridge 28 can be used as a printhead.

[0253] Figure 41 A cartridge holder 35 is shown arranged in a cartridge unit 63. Each holder 35 can receive a cartridge 28. The cartridge unit 63 includes a rotary actuator 64 and a belt 65 for moving the cartridge 28. Each holder 35 includes a reading unit 66 for reading the markings on the cartridge 28.

[0254] When it is necessary to fill the printhead with material using cartridge 28 (not shown), the upper cap 69 is removed by upper cap remover 70. For clarity, a holder 35 positioned near upper cap remover 70 is shown without a cartridge. Similarly, the lower cap 71 is also removed by lower cap remover 72. The cartridge is then moved to dispensing location 73, where holder 35 is tilted together with cartridge 28. The cartridge contacts push rod actuator 74, which forces a certain amount of material from cartridge 28 into the printhead.

[0255] After dispensing, the cartridge 28 can be cleaned in the wash cup 75, which can be lifted by the wash cup actuator 76.

[0256] It should be noted here that the invention has been described with reference to exemplary, but not limited, embodiments. Any changes or modifications to the shapes, sizes, forms, materials, and components used in manufacturing and assembly (unless they are new inventive steps and do not contribute to the technical development of known steps) should be considered within the scope and purpose of the invention.

[0257] Aspects of the present invention

[0258] I. A system for producing tablets, granules and capsules via 3D printing, comprising a display (1), a base (11) having a built-in computer unit (14), a power cable (9), and a 3D printer (2) within a chamber (7) having a door (8), a system having a robotic arm (3) movable in one or more directions, a base system (4) having a carrier base (6) movable in one or more directions, and a print head (5) on the robotic arm system (3) having a nozzle (37) and a head cylinder (38) with an envelope (39), characterized in that the print head (5) applies a prepared mixture (27) to the base (6) for 3D printing of tablets, granules and capsules.

[0259] II. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the system has a ventilation duct (12) and an air filter (13) for circulating and purifying air within a chamber (7).

[0260] III. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the system has a power supply unit (15) with a voltage regulator and an uninterruptible power supply (16).

[0261] IV. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the system has an air conditioning and air drying system (17) connected to the printing chamber (7) via an air supply and return duct (18).

[0262] V. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the system has an activated carbon filter (19) for absorbing carbon dioxide.

[0263] VI. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the system has a vacuum pump (20) for generating a vacuum and a negative pressure container (21).

[0264] VII. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the system has a washing tank (22), a washing port (23) connected to a cleaning fluid reservoir (24), and a cleaning fluid filtration system (25) for cleaning the printhead (5).

[0265] VIII. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the mixture (27) is fed to the print head (5) via a cartridge (28).

[0266] IX. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that a cartridge (28) is arranged on a holder (35).

[0267] X. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that a mixture (27) is fed from a container (29) to a print head (5) via a dispensing tube (30).

[0268] XI. A system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that the mixture (27) is in the form of filaments.

[0269] XII. A cartridge for use in a system for producing tablets, granules and capsules via 3D printing according to aspect I, containing a printing mixture (27), and the end (31) of the cartridge having a cap (32) and a removable cover (33) on its upper side.

[0270] XIII. A printhead for use in a system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that it has a heating element (42) with a notch (43) and a cooling fan (44) for controlling the temperature of a mixture (27).

[0271] XIV. A printhead for use in a system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that it has a photopolymer headlamp (45) on an arm (46).

[0272] XV. A printhead for use in a system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that it has a liquid nitrogen spray nozzle.

[0273] XVI. A printhead for use in a system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that it carries a worm gear (47) actuated by a servo motor for stirring a mixture (27).

[0274] XVII. A printhead for use in a system for producing tablets, granules and capsules via 3D printing according to aspects I and XV, characterized in that the worm (47) has a foldable head (48) for compressing a mixture (27) and has holes (49, 50) for entering the solvent and venting air, respectively.

[0275] XVIII. A printhead for use in a system for producing tablets, granules and capsules via 3D printing according to aspect I, characterized in that it has more than one nozzle (37).

[0276] XIX. A printing base for a 3D printing system according to aspect I, characterized in that it has a formatted printing position (49) for forming tablets, granules and capsules.

[0277] XX. A printing base for a 3D printing system according to aspect I, characterized in that it has an air duct (50) for physical or forced airflow on the base (6).

Claims

1. A system for producing pharmaceutical objects via 3D printing, comprising a 3D printer (2) having: a mechanical system (3) movable in one or more directions; at least one print head (5) having a nozzle (37) movable via the mechanical system (3); and a base system (4) supporting a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein, The printing base includes one or more formatted printing positions (49) for shaping the drug object, wherein the formatted printing positions (49) are adapted to receive blister packs such that the drug object can be printed directly inside the blister packs, and wherein the system includes a sealing device for applying a sealing film or membrane to hermetically seal the blister packs after printing is completed.

2. The system according to claim 1, wherein, The formatted printing position (49) is a convex recess.

3. The system according to claim 1, wherein, The formatted print position (49) has a shape that helps to immediately visually identify the drug object, such as a heart, a rhombus, a teddy bear, etc.

4. The system according to any one of the preceding claims, comprising a marking device for marking the sealed blister after sealing is completed.

5. The system according to any one of the preceding claims includes a heat conductor arranged on a side opposite to the side having the formatted printing position for heating the printing base (6).

6. The system according to claim 5, comprising a temperature sensor for monitoring the temperature of the printing base (6).

7. The system according to any one of the preceding claims, wherein, The printing base (6) is made of metal and / or metal alloy, corrosion-resistant aluminum plate formed of high-purity aluminum with surface layer metallurgically bonded to high-strength aluminum alloy core material, high-alloy austenitic stainless steel for high-temperature applications, plastic and / or composite material, tempered glass or glass ceramic.

8. The system according to any one of the preceding claims, wherein, The printing base (6) has a coating.

9. The system according to claim 8, wherein, The coating is a ceramic glaze coating, a water-impermeable layer coating of a vitreous substance fused with the ceramic body, a silica nano-coating, or a silver nano-coating.

10. The system according to any one of the preceding claims, comprising an object remover for removing a printed object from the printing base.

11. The system according to claim 10, wherein, The object remover is formed by a movable extraction pin or gas nozzle that can be connected to the formatted printing position (49) of the printing base (6).

12. The system according to any one of the preceding claims, wherein, The base system (4) includes a base retainer (57) for receiving the printing base (6) for removal and / or replacement of the printing base.

13. The system according to any one of the preceding claims, wherein, The system includes at least one holder (35) for holding a cartridge (38) containing a printable substance, wherein the substance is a gel and / or paste.

14. A method for producing a pharmaceutical object via 3D printing, comprising the following steps: (i) A system is provided comprising a 3D printer (2) having: a mechanical system (3) capable of moving in one or more directions; at least one print head (5) having a nozzle (37) capable of moving via the mechanical system (3); And a base system (4) for carrying a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein the printing base includes one or more formatted printing positions (49) for shaping the drug object. (ii) 3D print the drug object within the formatted printing position (49) of the printing base (6), The formatted print position (6) is adapted to receive a blister pack, and the following steps are performed after step (i): inserting the blister pack into the formatted print position (49) of the print base (6), and then 3D printing the drug object within the blister pack. The step of 3D printing the drug object within the blister pack is performed after the printing is completed, in which a sealing film or membrane is applied to airtightly seal the blister pack.

15. The method according to claim 14, wherein, The following steps are performed after the step of applying the sealing film or membrane: After sealing is completed, the sealed blister is marked.

16. The method according to claim 14 or 15, wherein, The materials used in 3D printing are gels and / or pastes.

17. A system for producing pharmaceutical objects via 3D printing, comprising a 3D printer (2) having: a mechanical system (3) movable in one or more directions; at least one print head (5) having a nozzle (37) movable via the mechanical system (3); and a base system (4) supporting a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein, The system includes at least one holder (35) for holding at least one cartridge (28), the at least one cartridge (28) containing at least one printable pharmaceutical substance filled in the print head, wherein the pharmaceutical substance is a powder, granules, liquid, gel, cream or paste, and wherein... - The at least one cartridge (28) contains more than one of a variety of pharmaceutical substances. - Alternatively, the at least one cartridge (28) contains one of a variety of pharmaceutical substances, and at least one other cartridge contains a different pharmaceutical substance, such that the various pharmaceutical substances are filled into the printhead (5) according to a specified formula and mixed by a mixing tool to obtain the prepared mixture (27).

18. The system according to claim 17, wherein, The nozzle (37) includes a valve to control the flow of the substance according to the properties of the substance.

19. The system according to claim 17, wherein, The valve is a check valve or an on / off valve.

20. The system according to any one of claims 17-19, wherein, A fluid connection is established between the cartridge (28) and the print head (5) via a feed line, or a direct fluid connection is established between the cartridge (28) and the print head (5).

21. The system according to any one of claims 17-19, wherein, Depending on the viscosity of the substance, the cartridge (28) has different cross-sectional ends.

22. The system according to claim 21, wherein, The cartridge (28) has a wider or narrower cross-section at the end (31).

23. The system according to any one of claims 17-22, wherein, The printing base (6) includes one or more formatted printing positions (49) for shaping the drug object.

24. The system according to claim 23, wherein, The formatted printing position (49) is a convex recess.

25. The system according to claim 23, wherein, The formatted print position (49) is adapted to receive a blister pack, so that the drug object can be printed directly inside the blister pack.

26. The system of claim 25, further comprising a sealing device for applying a sealing film or membrane after printing to hermetically seal the blister pack.

27. The system of claim 26, further comprising a marking device for marking the sealed blister after sealing is completed.

28. The system according to any one of claims 17-27, wherein, The system includes a reading unit (66) connected to the bracket (35) for identifying the identification mark on the cartridge (28).

29. A method for producing a pharmaceutical object via 3D printing, comprising the following steps: (i) A system is provided comprising a 3D printer (2) having: a mechanical system (3) capable of moving in one or more directions; at least one print head (5) having a nozzle (37) capable of moving via the mechanical system (3); and a base system (4) for carrying a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein the system includes at least one bracket (35) for holding at least one cartridge (28). (ii) The cartridge (28) is filled with at least one printable pharmaceutical substance, wherein the substance is a powder, granules, liquid, gel, cream, or paste. (iii) Filling the printhead (5) with the at least one pharmaceutical substance from the cartridge (28), and (iv) 3D printing the drug object, In step (ii) - Fill at least one of the multiple drug substances (28) - Alternatively, at least one cartridge (28) may be filled with one of a variety of pharmaceutical substances, and at least one other cartridge may be filled with a different pharmaceutical substance. Multiple drug substances are filled into the printhead (5) according to a specified formula and mixed by a mixing tool to obtain the prepared mixture (27).

30. The method according to claim 29, wherein, The printing base (6) includes one or more formatted printing positions (49) adapted to receive blister packs, such that the drug object in step (iii) can be printed directly inside the blister packs.

31. The method according to claim 30, wherein, The system also includes a sealing device for applying a sealing film or membrane to further hermetically seal the blister after step (iii).

32. The method according to claim 31, wherein, The system also includes a marking device for marking the sealed blister, such that a further marking step of the sealed blister is performed after the step of hermetically sealing the blister.

33. A system for producing pharmaceutical objects via 3D printing, comprising a 3D printer (2) having: a mechanical system (3) movable in one or more directions; at least one print head (5) having a nozzle (37) movable via the mechanical system (3); and a base system (4) supporting a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein, The system includes at least one bracket (35) for holding a cartridge (28), wherein the printhead (5) is temperature controlled, and the printhead (5) includes a printhead body (38) having a notch, a heat sink, or a channel for guiding a temperature-regulating agent, wherein the printhead (5) includes a printhead body (38, 42) having an opening for receiving fluid material from the cartridge, the cartridge being connectable to a feed line (3), wherein the printhead (5) includes a stirring and / or discharging tool (47) disposed in the printhead body (38, 42), wherein the stirring and / or discharging tool (47) is at least partially foldable.

34. The system according to claim 33, wherein, The system includes a feed line (30) for establishing a fluid connection between the carriage (35) and the printhead (5).

35. The system according to claim 33 or 34, wherein, The system includes a case unit (63) having at least one bracket (35), the case unit (63) being movable such that the bracket (35) can perform movement.

36. The system according to claim 35, wherein, The box unit (63) includes an actuator (64), which is a servo motor, a pneumatic actuator, a hydraulic actuator, a chain actuator, or a magnetic actuator.

37. The system according to claim 33 or 34, wherein, The system includes at least one movable push rod attached to the bracket (35) for discharging a cartridge (28).

38. The system according to claim 33 or 34, wherein, The system includes an opening device and / or a closing device, the opening device being connected to the bracket (35) for opening the cartridge (28), and the closing device being connected to the bracket (35) for closing the cartridge (28).

39. The system according to claim 33 or 34, wherein, The system includes a reading unit (66) connected to the bracket (35) for identifying identification marks on the cartridge (28).

40. The system according to claim 33 or 34, wherein, The system includes an energy emitter (45) which is linked to the printhead (5).

41. The system according to claim 33 or 34, wherein, The printhead (5) includes multiple nozzles (37).

42. The system according to claim 33 or 34, wherein, The system includes a cleaning unit (67) for cleaning the printhead and / or cartridge, the cleaning unit (67) including a washing tank (22) and / or washing port (23) capable of connecting to a cleaning fluid reservoir (24) and / or a cleaning fluid filtration system (25).

43. The system according to claim 33 or 34, wherein, The system includes a temperature control system (68) for adjusting the temperature of the printing base (6).

44. The system according to claim 43, wherein, The base system (4) includes an air duct (53) and / or channel (55) for guiding the thermostat.

45. The system according to claim 33 or 34, wherein, The system includes a printing base (6) which includes formatted printing positions (49) for shaping the drug object.

46. ​​The system according to claim 33 or 34, wherein, The system includes a printing base (6) which includes a heat conductor arranged on a side opposite to the side having a formatted printing position (49).

47. The system according to claim 33 or 34, wherein, The system includes a printing base (6) with a coating.

48. The system according to claim 33 or 34, wherein, The base system includes an object remover, which includes a movable pull-out pin (56) or gas nozzle capable of connecting to a formatted print position (49) of the print base (6).

49. The system according to claim 33 or 34, wherein, The base system (4) includes a base retainer (57) for receiving the printing base (6).

50. The system according to claim 33 or 34, wherein, The system includes a chamber (7) for establishing a controlled atmosphere having at least one of the following: - A vacuum system with a vacuum pump (20), - Air conditioning system, - Air filter (13). - Ventilation duct (12). - Air drying system (17), and - Activated carbon filter (19).

51. The system according to claim 33, wherein, The drug targets are tablets, granules, and capsules.

52. The system according to claim 38, wherein, The opening device is a needle or cap remover.

53. The system according to claim 33, wherein, The stirring and / or discharging tool (47) is a worm gear.

54. The system according to claim 33, wherein, The stirring tool (47) includes a foldable head (48).

55. The system according to claim 40, wherein, The energy emitter (45) is a photopolymer headlamp or an infrared emitter or a liquid nitrogen spray nozzle or a compressed air nozzle or a steam nozzle.

56. The system according to claim 45, wherein, The printing position (49) is a convex recess.

57. The system according to claim 47, wherein, The coating is a ceramic glaze coating.

58. The system according to claim 50, wherein, The chamber (7) has a door (8).

59. A method for producing a pharmaceutical object via 3D printing using a system according to any one of the preceding claims, comprising the steps of: - To provide at least one pharmaceutical substance in at least one cartridge. - Place the cartridge in the holder. - Establish a fluid connection between the cartridge and the printhead, allowing the drug substance to exit the printhead through the nozzle. - The print head nozzle is moved according to the 3D printing program to dispense the drug substance onto the printing base.

60. The method according to claim 59, wherein, The cartridge is transferred to the print head and moves together with the print head.

61. The method according to claim 59, wherein, A certain amount of at least one drug substance is administered from the cartridge to the printhead, and the substance is stirred in the printhead to mix multiple drug substances.

62. The method according to claim 61, wherein, Multiple cartridges are arranged in a cartridge, each containing a different drug substance, and the cartridge is moved relative to the printhead to a position where the selected cartridges are in fluid communication with the printhead, and a certain amount of the corresponding drug substance is administered into the printhead, thereby preparing a drug mixture according to a drug formulation.

63. The method according to any one of claims 59-61, wherein, A print base (6) with a formatted print position is applied to the print base system (4).

64. The method according to any one of claims 59-62, wherein, Clean the print head (5) after printing.

65. The method according to any one of claims 59-62, comprising the step of providing at least one substance in at least one cartridge, said substance comprising at least one selected from fat, starch, flour, gelatin, sweetener, natural flavoring, artificial flavoring and coloring.

66. The method according to any one of claims 59-62, wherein, The drug substance includes at least one of the following: antipyretics, analgesics, antimalarial drugs, antibiotics, preservatives, mood stabilizers, hormone substitutes, oral contraceptives, stimulants, sedatives, and statins.

67. The method according to claim 59, wherein, The drug targets are tablets, granules, and capsules.

68. A system for producing pharmaceutical objects via 3D printing, comprising a 3D printer (2) having: a mechanical system (3) movable in one or more directions; at least one print head (5) having a nozzle (37) movable via the mechanical system (3); and a base system (4) supporting a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein, The system includes at least one bracket (35) for holding at least one cartridge (28) containing at least one printable pharmaceutical substance filled in the print head, wherein the pharmaceutical substance is a powder, granules, liquid, gel, cream or paste, and wherein the system has at least one valve to control the flow of the pharmaceutical substance according to the characteristics of the pharmaceutical substance.

69. The system according to claim 68, wherein, The valve is provided at the nozzle (37) as a check valve, gate valve, ball valve or needle valve.

70. The system according to claim 68 or 69, wherein, The cartridge (28) has a nozzle with a valve.

71. The system according to claim 70, wherein, The valve is a check valve or an on / off valve.

72. The system according to claim 70 or 71, wherein, The valve is pressure-inserted into the cartridge nozzle (3) or glued to the cartridge nozzle (3).

73. The system according to any one of claims 70-72, wherein, The valve forms the lower part of the cartridge (28).

74. The system according to any one of claims 68-73, wherein, A fluid connection is established between the cartridge (28) and the print head (5) via a feed line, or a direct fluid connection is established between the cartridge (28) and the print head (5).

75. A method for producing a pharmaceutical object via 3D printing, comprising the following steps: (i) A system is provided comprising a 3D printer (2) having: a mechanical system (3) capable of moving in one or more directions; at least one print head (5) having a nozzle (37) capable of moving via the mechanical system (3); and a base system (4) for carrying a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein the system includes at least one bracket (35) for holding at least one cartridge (28). (ii) The cartridge (28) is filled with at least one printable pharmaceutical substance, wherein the substance is a powder, granules, liquid, gel, cream, or paste. (iii) Filling the printhead (5) with at least one pharmaceutical substance from the cartridge (28), and (iv) 3D printing the drug object, The flow of the drug substance is controlled by a valve based on the characteristics of the at least one printable drug substance.

76. The method according to claim 75, wherein, The valve is provided at the nozzle (37) as a check valve, gate valve, ball valve or needle valve.

77. The method according to claim 75 or 76, wherein, The cartridge (28) has a nozzle with a valve.

78. The method according to claim 75, wherein, A fluid connection is established between the cartridge (28) and the print head (5) via a feed line, or a direct fluid connection is established between the cartridge (28) and the print head (5).

79. A system for producing pharmaceutical objects via 3D printing, comprising a 3D printer (2) having: a mechanical system (3) movable in one or more directions; at least one print head (5) having a nozzle (37) movable via the mechanical system (3); and a base system (4) supporting a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein, The system includes at least one bracket (35) for holding at least one cartridge (28) containing at least one printable pharmaceutical substance filled in the print head, and wherein the system includes opening and / or closing devices.

80. The system according to claim 79, wherein, The opening device is connected to the bracket (35).

81. The system according to claim 79, wherein, The enclosure is connected to the bracket (35).

82. The system according to claim 79 or 81, wherein, The sealing device includes means for applying the cap (69) to the cartridge (28).

83. The system according to claim 80, wherein, The bracket (35) includes a needle or blade for injecting into the cartridge (28).

84. The system according to claims 80 and 82, wherein, The bracket (35) includes a cap (69) remover (70).

85. The system according to claim 80, wherein, The bracket (35) includes a pin for opening the valve of the cartridge (28).

86. The system according to claim 79 or 81, wherein, The sealing device includes means for applying a cap (32) to seal the bottom side of the cartridge (28).

87. A system for producing pharmaceutical objects via 3D printing, comprising a 3D printer (2) having: a mechanical system (3) movable in one or more directions; at least one print head (5) having a nozzle (37) movable via the mechanical system (3); and a base system (4) supporting a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein, The system includes at least one bracket (35) for holding at least one cartridge (28), the at least one cartridge (28) containing at least one printable pharmaceutical substance filled in the print head, and wherein the system includes a cleaning unit (67) for cleaning the print head (5) and / or the cartridge (28).

88. The system according to claim 87, wherein, The cleaning unit (67) also includes a washing tank (22).

89. The system according to claim 88, wherein, The cleaning unit (67) also includes a washing tank port (23) for connecting to a reservoir (24) for cleaning fluid.

90. The system according to claim 89, wherein, The cleaning unit (67) also includes a cleaning fluid filtration system (25).

91. The system according to claim 89 or 90, wherein, The cleaning solution is selected from organic acids, surfactant compounds, corrosion inhibitors, acids, solubilizers, wetting agents, alkalis, complexing agents, chelating agents, solubilizers, surface-active compounds, surfactants, and neutral pH cleaning agents.

92. The system according to any one of claims 87-91, wherein, The cleaning unit (67) also includes a washing cup (75) for cleaning the cartridge (28).

93. A method for producing a pharmaceutical object via 3D printing, comprising the following steps: (i) A system is provided comprising a 3D printer (2) having: a mechanical system (3) capable of moving in one or more directions; at least one print head (5) having a nozzle (37) capable of moving via the mechanical system (3); and a base system (4) for carrying a printing base (6) for receiving a prepared mixture (27) applied by the print head (5), wherein the system includes at least one bracket (35) for holding at least one cartridge (28), and wherein the system includes a cleaning unit (67) for cleaning the print head (5) and / or the cartridge (28). (ii) The cartridge (28) is filled with at least one printable pharmaceutical substance. (iii) The print head (5) is filled with the at least one pharmaceutical substance from the cartridge (28). (iv) 3D printing the drug object, (v) Clean the printhead (5) and / or cartridge (28) with the cleaning unit (67).

94. The method according to claim 93, wherein, The printhead is cleaned in the washing tank (22) with cleaning fluid from the reservoir (24) supplied through the tank port (23).

95. The method according to claim 94, wherein, The cleaning fluid is filtered using a cleaning fluid filtration system (25).

96. The method according to claim 94 or 95, wherein, The cleaning solution is selected from organic acids, surfactant compounds, corrosion inhibitors, acids, solubilizers, wetting agents, alkalis, complexing agents, chelating agents, solubilizers, surface-active compounds, surfactants, and neutral pH cleaning agents.

97. The method according to any one of claims 93-96, wherein, Clean the cartridge (28) with a washing cup (75).

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