Method for the automated production of individualized tablets and tablet press for the automated production of individualized tablets

Abstract

The present invention relates to a method and tablet press (1) for automatically producing a specifiable number of individual tablets (101, 102, 103) having a specifiable amount of a first active substance (14). The tablet press (1) includes a compression chamber (2), a first material container (10) that can be filled with the first active substance (14), a first introduction device (12), a control system (6), and an input device (30). The compression chamber (2) includes an extendable upper punch (40), an extendable lower punch (50), at least one die (60, 61, 62), and a weighing device (16) disposed below the at least one die (60, 61, 62) so that the mass of material filled into a central opening (60a, 61a, 62a) in the die (60, 61, 62) can be measured. The input device (30) is configured to transmit the target number (35) and target mass (36) of individualized tablets (101, 102, 103) to be produced to the control system (6). The control system (6) reads the measurement data from the weighing device (16) and causes an amount of first active substance (14) corresponding to the target mass (36) to be filled into the central openings (60a, 61a, 62a) and compressed into tablets (101, 102, 103) by the upper punch (40) and the lower punch (50), repeating this process until the target number (35) of tablets (101, 102, 103) have been produced.

Description

[Technical Field]

[0001] The present invention relates to a method for automatically producing a specified number of individualized tablets having a specified amount of a first active substance by a tablet press.

[0002] The present invention also relates to a tablet press for automatically producing a specified number of individualized tablets having a specified amount of a first active substance. [Background technology]

[0003] Tablets play an essential role in today's medical and non-medical fields, from administering medicines to providing nutritional supplements.

[0004] Tablets are typically made using a die with a central opening into which the active substance is filled, and then a lower punch and an upper punch press the active substance into the central opening to form a tablet.

[0005] To meet the high demand for tablets, tablets are often produced in standardized sizes containing a defined amount of active substance. For this purpose, for example, rotary presses are used, consisting of up to 100 dies and punches driven synchronously by a rotating plate. Such presses can produce up to 1.6 million tablets per hour.

[0006] However, especially in medical applications, the amount of active substance to be administered depends on the individual patient, their absorption capacity of the active substance, and their current health condition, especially children and the elderly, who may require specially tailored dosages.

[0007] Since common medical preparations of active substances usually only have a few standard dosages, doctors and pharmacists often have to choose a dosage that is too high because a dosage that is too low will not produce the desired therapeutic effect. However, a dosage that is too high puts unnecessary strain on the patient's organs and can lead to damage in the long term. In addition, breaking tablets into smaller pieces with a knife would be a burden on the patient and is not practical.

[0008] Additionally, tablets are often sold in a fixed number of tablets per tablet package, which can lead to wasted pharmaceutical ingredients and the disposal of excess tablets that patients do not need. Summary of the Invention [Problem to be solved by the invention]

[0009] The object of the present invention is to simplify the administration and intake of active substances administered to patients in individualized tablets.

[0010] This object is achieved in particular by the following method steps for the automatic production of a specifiable number of individualized tablets with a specifiable amount of a first active substance using a compact tablet press: inputting into an input device a target number indicating the number of tablets to be produced and a target mass indicating the amount of first active substance per tablet; transmitting a target number and a target mass from an input device to a control system of the tablet press, the control system controlling the first introducing device, the weighing device, the upper extendable punch, and the lower extendable punch; a step of filling a quantity of a first active substance corresponding to a target mass from a first material container into a central opening of the die by a first introducing device, wherein during filling, a pressing surface of a lower punch closes the central opening, and an amount of the first active substance filled into the central opening is measured by a measuring device in which the lower punch and the die are disposed during filling; compressing the first active material by extending a pressing surface of the upper punch into the central opening; and releasing the compressed tablet from the die by extending the pressing surface of the lower punch into the central opening; The tablet press has only one lower punch, The steps of adding the amount of a first active substance, compressing the first active substance, and releasing the compressed tablets are repeated until the number of compressed tablets corresponds to a target number.

[0011] In particular, a tablet container is placed in a receiving chamber of a tablet press prior to the method, and after release of the compressed tablet, the tablet is transported to the tablet container by a transport device controlled by the control system.

[0012] This method provides the patient with a specifiable target number of personalized tablets having a specifiable target mass of a first active substance. The target mass is determined, for example, by a physician or pharmacist, taking into account the health status and physical characteristics of the patient (e.g., weight, etc.). Because the active substance contained in the tablet exactly corresponds to the target mass, there is no need to split the tablet. In this way, excessively high dosages are advantageously avoided, and the tablet is easier for the patient to take.

[0013] By arranging the lower punch and die on the metering device, the material of the first active substance filled into the central opening can be accurately and reliably metered during filling.

[0014] The target number is determined, for example, by a physician or pharmacist, preferably taking into account how quickly the patient's health condition changes and how frequently dosage adjustments are required. The target number is preferably selected to produce enough tablets to treat the patient until the next diagnosis, without producing excess tablets. Tablet waste due to providing standardized tablet packages containing more tablets than necessary is advantageously avoided.

[0015] The tablet press is advantageously compact. This is particularly achieved by the tablet press being composed of only a single upper punch and / or a single lower punch. The tablet press may be installed, for example, in a doctor's office, a pharmacy, or a patient's home. Preferably, the tablets are produced immediately in the doctor's office, pharmacy, or patient's home after determining the target mass and target number. In this way, a decentralized method for producing personalized tablets outside of a clinical trial site is provided. Because patients require a relatively small number of personalized tablets, their production does not require a high production rate. Instead, multiple tablet presses according to the present invention in multiple doctor's offices, pharmacies, or patient's homes are advantageously provided to meet patients' needs for personalized tablets.

[0016] The first material container is releasably fixed to the first inlet of the tablet press, particularly the opening of the compression chamber. This allows the first material container to be replaced quickly and advantageously, for example, when tablets with different active substances are produced. The first inlet device is particularly a component of the first material container and is formed integrally therewith. The first active substance can be either a single active substance or a mixture of different active substances.

[0017] The upper punch and / or the lower punch can be extended vertically. In particular, the outer periphery of the pressing surface of the upper punch and / or the pressing surface of the lower punch corresponds to the inner periphery of the central opening of the die. In particular, the pressing surface of the lower punch closes the central opening from below, in that the pressing surface of the lower punch is pressed into the central opening from below. This forms a trough, the wall of which is formed by the central opening and the bottom of which is formed by the pressing surface of the lower punch. In particular, to press the first active substance, the pressing surface of the upper punch extends vertically upward into the central opening while pressing. To release the pressed tablet, the pressing surface of the upper punch is returned upward, and the pressing surface of the lower punch is extended upward, in particular until it is flush with the upper edge of the die.

[0018] The input device comprises an input means for inputting the target mass and target number, in particular a touch panel. In particular, the input device is also capable of displaying the input target number and / or the input target mass and / or additional information, in particular patient information and / or information about the first active substance, on a data display device. The input device further comprises an input means by which tablet production is initiated. In particular, the input device constitutes a security access system. For example, the input device is protected by an access code or comprises a fingerprint authentication device. According to one embodiment, the input device is a fixed component of the tablet press. According to another embodiment, the input device is an external unit that transmits the target number and target mass to the control system. According to another embodiment, the input device is an interface of the tablet press by means of which the target number and target mass are transmitted from the external unit to the control system.

[0019] In particular, the target number and target mass are coded into an identifier, in particular a barcode, which is in particular printed on a prescription issued to the patient. Preferably, the identifier is read by an imaging device, in particular a camera, of the input device and transmitted to the control system, which determines the target number and target mass from the identifier.

[0020] According to one embodiment, the compression chamber is removably fixed to the tablet press, in particular the compression chamber, together with the lower punch and the die disposed therein, is designed as an exchangeable compression chamber insert.

[0021] The control system is particularly a computer, and is configured to read the target mass and target number inputted into the input device and operate the first introduction device, the weighing device, the upper punch, the lower punch, and the conveying device.

[0022] The conveying device particularly comprises a pressing device, by which the produced tablets are pressed down by the pressing surface of the lower punch. The conveying device particularly further comprises a channel that opens upward into a tablet container arranged in the receiving chamber. The tablets pressed down by the pressing surface of the lower punch fall through the channel into the tablet container. Immediately after the pressed tablets are conveyed, the next tablets are produced until the target number is reached.

[0023] According to one embodiment, the control system calculates the fill volume and thus the target circumference taking into account the target mass of the first active substance and, if necessary, the bulk density, and selects a target die from at least two dies arranged in the tablet press having different inner circumferences, and activates a first positioning device so that the inner circumference of the central opening of the target die corresponds to the target circumference and the target die is positioned above the lower punch, in particular the first positioning device being a rail device on which the at least two dies arranged in the tablet press are arranged, in particular fixed.

[0024] Advantageously, in this way, the size of the pressed tablet can be changed.For this purpose, the control system automatically determines the filling amount and therefore the appropriate target circumference using the target mass and, if necessary, the bulk density of the first active substance, and selects the appropriate target die and places it above the lower punch.Therefore, manual die replacement is not necessary.In this way, due to the variation in tablet size, it is possible to produce individual tablets with significantly different amounts of active substance.

[0025] In particular, at least three dies having central openings with different inner peripheries are fixed to a first positioning device.

[0026] More preferably, the outer periphery of the pressing surface of the upper punch for pressing the first active substance is adapted to the inner periphery of the die, and multiple upper punch shafts extending vertically and telescopically from the upper punches arranged inside each other are extended downward so that the outer periphery of the outer extended upper punch shaft corresponds to the inner periphery of the die.

[0027] By aligning the outer periphery of the pressing surface of the upper punch with the inner periphery of the die, it is advantageous to eliminate the need to replace the upper punch when using a die with a different inner periphery. The outer periphery of the pressing surface of the upper punch is accommodated by extending the upper punch shaft. The pressing surface of the upper punch corresponds to the entire pressing surface of the extended upper punch shaft. In particular, the pressing surface of the upper punch shaft is formed so that the pressing surface of the upper punch is always continuous.

[0028] In particular, for each die arranged on the first positioning device, the upper punch constitutes a related upper punch shaft, the cross-sectional shape of which corresponds to the cross-sectional shape of the central opening of one of the dies. In particular, the upper punch shaft corresponding to the central opening and all upper punch shafts arranged further inward are always extended to press the first active substance. In particular, the upper punch shafts are essentially arranged substantially without gaps inside each other. In this way, the pressing surface of the upper punch is always free of grooves, and tablets with smooth surfaces can be produced.

[0029] Preferably, the outer periphery of the pressing surface of the lower punch is adapted to the inner periphery of the die before the amount of first active substance is filled, and a plurality of vertically telescopically extending lower punch shafts arranged inside each other extend upward, and the outer periphery of the outwardly extending lower punch shafts corresponds to the inner periphery of the die.

[0030] Furthermore, by fitting the outer periphery of the pressing surface of the lower punch to the inner periphery of the die, it is advantageously unnecessary to replace the lower punch when using a die with a different inner periphery. In particular, after fitting the pressing surface of the lower punch to the inner periphery of the die, the pressing surface of the lower punch is extended below the central opening to close the central opening from below.

[0031] The lower punch shaft is preferably constructed as a mirror image of the upper punch shaft so that the advantages and properties described with respect to the upper punch shaft also apply to the lower punch shaft.

[0032] According to one embodiment, the lower punch and the die are integral, and in particular, the lower punch and the die are relatively movable in the up-down direction. In particular, the lower punch and the die are connected by a spring. After the lower punch is extended, the spring force pulls the lower punch back to its starting position.

[0033] The mass of the first active substance filled into the central opening is preferably adjusted by placing the die and the lower punch on the metering device, in particular by means of at least one lifting device, before filling. Unfilled state obtained by the metering device measurement Value , weighing device is measured by , the total mass acting during filling, consisting of the mass of the die, the mass of the lower punch, and the mass of the first active material filled into the central opening It is calculated by subtracting The die and the lower punch are in particular lifted by at least one lifting device after filling and before compression of the first active substance.

[0034] After the die and lower punch are positioned and before filling, the total mass is measured to obtain a measurement value for the unfilled state. This measurement value is subtracted from the total mass being filled to calculate the mass of the first active material filled into the central opening. Filling ends when the mass of the first active material filled into the central opening matches the target mass. To control the filling process, the total mass measurement data recorded by the weighing device is sent to a control system. From the total mass measurement data, the control system calculates the current mass of the first active material filled into the central opening. When the target mass is reached, the control device controls the introduction device of the first material container to end filling. In particular, the control device couples the weighing device to the first introduction device using an algorithm.

[0035] After lifting, the die and the lower punch no longer rest on the metering device, so that the metering device is not damaged during compression. The lifting and lowering are particularly performed by at least one lifting device. The lifting device is particularly configured to move the die and the lower punch vertically. In particular, the lower punch and / or at least one die rest on a platform that can be moved vertically by the at least one lifting device. After the lower punch and die are placed on the metering device, the platform is particularly moved downward until the lower punch and die rest only on the metering device and no longer on the platform during filling.

[0036] Preferably, the pressure acting on the lower punch and / or the upper punch is measured in at least one lifting device, in particular by means of a pressure measuring device.

[0037] In this way, the applied pressure can be measured during the compression process. The pressure measuring device is in particular a force transducer in the sense of a pressure load cell. By this means, it is advantageously possible to monitor the pressure during tablet production, to control the tablet hardness and / or breakage resistance and to prevent damage to the punch and / or die.

[0038] Preferably, before the first active substance is filled, the first introduction device is positioned vertically above the central opening by a second positioning device, in particular a horizontally movable rail device, and after the amount of first active substance is filled and before the first active substance is compressed, the upper punch is positioned vertically above the central opening by the second positioning device, and the first introduction device is positioned, in particular fixed, in a manner that allows it to be moved vertically on the second positioning device.

[0039] The second positioning device advantageously simplifies the filling of the first active substance. By positioning the first introducing device above the central opening, the first active substance can be filled directly from above without loss. After the first active substance is filled, the first introducing device is moved sideways so that the upper punch is positioned above the central opening.

[0040] In particular, the first introducing device is moved horizontally by the second positioning device while filling the first active substance. In particular, the first introducing device is repeatedly moved horizontally from left to right within the die by the second positioning device during filling. This is particularly advantageous when filling large and / or oval dies to ensure even distribution of the active substance.

[0041] In particular, the second feed device is moved horizontally by the second positioning position. In this way, it is possible to produce tablets with two adjacent layers. To this end, the first feed device is moved over the first corner of the die, and the second feed device is moved over the second corner of the die. The first corner is filled with the first active substance by the first feed device, and the second corner is filled with the second active substance by the second feed device. Then, a bilayer tablet with adjacent layers is compressed.

[0042] The rail device provides a reliable and compact positioning device that allows the first introducing device and upper die to move horizontally. If the first introducing device is also movable vertically, the first introducing device can be positioned above the central opening and then lowered sufficiently so that the lower edge of the first positioning device is positioned below the upper edge of at least one die. In other words, the first introducing device is lowered into the central opening. In this way, spillage of the active material is prevented during filling, ensuring that the entire amount of active material enters the central opening.

[0043] This object is further achieved by a method for producing a specifiable number of individualized bilayer tablets having a specifiable amount of a first active substance and a specifiable amount of a second active substance, the method comprising carrying out the steps of the method described above with the following additional steps: inputting a second layer target mass into the input device and transmitting the second layer target mass to a control system, the second layer target mass indicating an amount of a second active per bilayer tablet; positioning a second introducing device of a second material container above the central opening by a second positioning device; filling the central opening with a quantity of a second active material corresponding to a second layer target mass by a second introduction device; positioning the upper punch above the central opening with a second positioning device; and and compressing the second active material by extending the pressing surface of the upper punch into the central opening; A method wherein all additional steps, except for inputting the second layer target mass and transmitting the second layer target mass, are performed after compression of the first active substance and before release of the compressed tablet.

[0044] Prior to carrying out this method, the second material container filled with the second active substance is fixed to the tablet press so that it can be moved horizontally by the second positioning device. In particular, the first material container and / or the second material container are equipped with an RFID chip. This allows the tablet press to clearly identify the material container regardless of its location. The target mass measurement for the second layer is performed in the same manner as the target mass measurement. Before filling the second active substance, the die and lower punch are placed on the weighing device, and the total mass is measured. In particular, the compression of the first active substance is performed at a lower pressure than the compression of the second active substance. In this way, a cavity for the second active substance is formed by the compression of the first active substance, preventing the two tablet halves from coming apart after compression of the second active substance.

[0045] This method advantageously allows for the production of personalized bilayer tablets tailored to the patient's needs. After the first layer is formed by filling and compressing the first active substance, a second positioning device is used to position a second introducing device above the central opening, and the central opening is filled with the target mass of the second layer of the second active substance. The second active substance is then compressed by an upper punch to form a second layer on top of the first layer. The produced bilayer tablet is then removed from the die in the manner described above and transferred to a tablet container.

[0046] This object is also achieved by providing a tablet press for the automatic production of a specifiable number of individualized tablets having a specifiable amount of a first active substance, the tablet press comprising: a compression chamber; a first material container capable of being filled with the first active substance; a first introduction device; a control system; and an input device, wherein the compression chamber comprises an extendable upper punch, an extendable lower punch, at least one die, and a metering device arranged below the at least one die; The tablet press has only one lower punch, A tablet press machine configured such that the mass of material filled into the central opening of the die can be measured by placing the die and lower punch on a measuring device, the input device is configured to send a target number and target mass of individualized tablets to be produced to a control system, the control system reads the measurement data from the measuring device and drives the first introducing device, upper punch and lower punch so that an amount of a first active substance corresponding to the target mass is filled into the central opening of the die and compressed by the upper punch and lower punch to form a tablet, and this process is repeated until the target number of tablets is produced.

[0047] This tablet press embodies the same advantages, features, and characteristics as the previously described method for automatically producing a specifiable number of individualized tablets having a specifiable amount of a first active substance by a tablet press.

[0048] The tablet press according to the invention preferably represents a decentralized device for producing individualized tablets, which are produced on-site, i.e., directly in a doctor's office, a pharmacy, or a pharmaceutical manufacturing facility, by a specialist physician or pharmacist, or by the patient after appropriate training. Individualized tablets avoid incorrect or excessive dosing and facilitate patient administration, as there is no need to split the tablets.

[0049] The upper punch and / or the lower punch can be extended, particularly in the vertical direction. According to one embodiment, the lower punch is arranged at a fixed position within the compression chamber. Therefore, according to this embodiment, the position of the lower punch within the compression chamber does not change in the horizontal direction, and the lower punch only extends and moves up and down in the vertical direction. This makes it easy to measure the pressing force acting on the lower punch.

[0050] The compressed tablet is released by extending the lower punch within the central opening. The tablet press particularly includes a receiving chamber for receiving the tablet container. The first introducing device is particularly formed as part of the first material container or separately therefrom. The input device particularly comprises an input means for inputting a target number indicating the number of individual tablets to be produced.

[0051] According to one embodiment, the tablet press comprises at least two dies whose central openings have different inner circumferences, and the control system is configured to calculate the fill volume, and thus the target circumference, taking into account the target mass and, if necessary, the bulk density of the first active substance, select a target die from the at least two dies, and activate a first positioning device so that the inner circumference of the central opening of the target die corresponds to the target circumference and the target die is positioned above the lower punch, in particular the first positioning device is a rail device arranged between the upper punch and the lower punch and on which the at least two dies are arranged, in particular fixed.

[0052] Preferably, the upper punch has at least two upper punch shafts arranged inside each other and extending telescopically in the vertical direction, and by the individual extension of the upper punch shafts, the outer periphery of the pressing surface of the upper punch can be adapted to the inner periphery of the central opening of at least one die.

[0053] Also preferably, the lower punch has at least two lower punch shafts arranged inside each other and extending telescopically in the vertical direction, and the individual extension of the lower punch shafts allows the outer periphery of the pressing surface of the lower punch to fit the inner periphery of the central opening of at least one die.

[0054] Preferably, the compression chamber comprises a first push-pull device capable of inserting at least one upper locking pin into a horizontal hole provided in the side wall of the upper punch shaft to fix a definable number of upper punch shafts in the vertical direction, and in particular, the compression chamber comprises a second push-pull device capable of inserting at least one lower locking pin into a horizontal hole provided in the side wall of the lower punch shaft to fix a definable number of lower punch shafts in the vertical direction.

[0055] The lock pin allows only the desired punch shaft to extend when the upper and lower punches are extended.

[0056] The upper punch is extended, in particular, by an upper piston that presses the upper punch from above. The lower punch is extended, in particular, by a lower piston that presses the lower punch from below. In particular, the upper piston is connected only to the innermost upper punch shaft, and the lower piston is connected only to the innermost lower punch shaft. When additional upper punch shafts and / or lower punch shafts are extended, these additional upper punch shafts and / or lower punch shafts are connected to the inner upper punch shafts and / or lower punch shafts using connecting pins. The connecting pins are driven, in particular, by a rod-shaped pushing / pulling device. This pushing / pulling device is guided, in particular, in a groove running vertically inside the punch carrier, and can move synchronously with the up and down movement of the extended upper punch shaft and / or lower punch shaft.

[0057] Preferably, the tablet press comprises at least one lifting device configured to raise and lower the at least one die and the lower punch, in particular vertically.

[0058] In particular, the die and the lower punch are positioned on the metering device by at least one lifting device before filling with the first active substance or the second active substance, and are lifted after filling with the first active substance or the second active substance.

[0059] Also preferably, a second positioning device is provided that allows the upper punch and the first introduction device, and in particular the second introduction device for the second material container, to be alternately positioned vertically above the central opening of the die arranged above the lower punch.

[0060] Preferably, the second positioning device is a rail device on which the first introduction device and the upper punch are arranged, in particular fixed, and capable of being moved horizontally, and the first introduction device is arranged, in particular fixed, on the rail device so as to be movable also vertically.

[0061] According to a preferred embodiment, the compression chamber is dust-tight, in particular the receiving chamber can be closed dust-tight.

[0062] Advantageously, this makes it possible to avoid contamination of the chamber and / or the tablet containers arranged therein and / or the area outside the tablet press.

[0063] In particular, the lower punch and the die are integrally formed, and in particular, the lower punch and the die are coupled to each other in the vertical direction by a spring.

[0064] Preferably, the lower punch has a recess on its lower surface formed to match the shape of the protrusion on the upper surface of the weighing device.

[0065] This ensures that the lower punch and die rest securely on the scale during filling and that the mass of active material filled is accurately measured.

[0066] Further features of the invention will become apparent from the description of embodiments according to the invention, in conjunction with the claims and the accompanying drawings, which may embody individual features or combinations of several features. [Brief explanation of the drawings]

[0067] The present invention is described below, without limiting the general idea of ​​the invention, on the basis of exemplary embodiments with reference to the drawings, whereby explicit reference is made to the drawings for the disclosure of all details according to the invention not described in more detail in the text.

[0068] [Figure 1] FIG. 1 is a simplified schematic diagram of a tablet press for automatically producing a specifiable number of individualized tablets containing a specifiable amount of a first active substance. [Figure 2] FIG. 2 is a simplified schematic diagram showing an input device of the tablet press machine of FIG. 1. [Figure 3] FIG. 1 is a simplified schematic cross-sectional view of the compression chamber and material container of a tablet press with an active substance added. [Figure 4] FIG. 1 is a simplified cross-sectional schematic view of the compression chamber and material container of a tablet press during compression of an active substance. [Figure 4b] FIG. 2 is a cross-sectional view showing a simplified schematic diagram of a lower punch and die connected by a spring, and a weighing device. [Figure 4c] 4b is a simplified schematic cross-sectional view of the lower punch of the die and the metering device during filling; FIG. [Figure 5] FIG. 2 is a plan view showing a schematic simplified view of the first positioning device. [Figure 6] FIG. 10 is a plan view showing a schematic simplified view of the second positioning device. [Figure 7a] 1 is a simplified schematic diagram showing an upper punch having extendable upper punch shafts disposed inside each other; FIG. [Figure 7b] 1 is a simplified schematic diagram showing an upper punch having extendable upper punch shafts disposed inside each other; FIG. [Figure 7c] 1 is a simplified schematic diagram showing a lower punch having extendable lower punch shafts disposed inwardly of one another; FIG. [Figure 7d] 1 is a simplified schematic diagram showing a lower punch having extendable lower punch shafts disposed inwardly of one another; FIG. [Figure 8a]FIG. 1 is a simplified cross-sectional view showing an upper punch, a lower punch, and multiple dies in a compression process for tablets with different amounts of active substance. [Figure 8b] FIG. 1 is a simplified cross-sectional view showing an upper punch, a lower punch, and multiple dies in a compression process for tablets with different amounts of active substance. [Figure 8c] FIG. 1 is a simplified cross-sectional view showing an upper punch, a lower punch, and multiple dies in a compression process for tablets with different amounts of active substance. [Figure 9a] FIG. 1 is a simplified plan view showing a schematic diagram of an upper punch in a compression process for tablets with different amounts of active substance. [Figure 9b] FIG. 1 is a simplified plan view showing a schematic diagram of an upper punch in a compression process for tablets with different amounts of active substance. [Figure 9c] FIG. 1 is a simplified plan view showing a schematic diagram of an upper punch in a compression process for tablets with different amounts of active substance.

[0069] In the drawings, identical or similar elements and / or parts are provided with the same reference numerals in each case so that they do not have to be explained again. DETAILED DESCRIPTION OF THE INVENTION

[0070] FIG. 1 shows a simplified, exemplary embodiment of a tablet press 1 according to the present invention. The tablet press 1 includes a compression chamber 2, a first material container 10 filled with a first active substance 14, a storage chamber 3 in which a tablet container 100 can be placed, a transport device 4 for transporting the produced tablets from the compression chamber 2 to the tablet container 100, a control system 6 for controlling the tablet press 1, and an input device 30 for operating the tablet press 1. In the embodiment of the tablet press 1 shown in FIG. 1, the first material container 10 is disposed in a housing of the tablet press 1 and removably secured thereto. For example, the first material container 10 can be removed from the housing via a flap (not shown) for replacement or refilling. In particular, the input device 30 constitutes a security access system. For example, the input device 30 can be secured by an access code or can be a fingerprint authentication device.

[0071] According to one embodiment, the compression chamber 2 is designed as an exchangeable compression chamber insert. For this purpose, the compression chamber 2 is removably fixed to the tablet press 1. For replacement, the compression chamber insert can be removed from the tablet press and replaced with another compression chamber insert.

[0072] The control system 6 is, for example, a computer configured to control the tablet press 1 such that a target number of individualized tablets having a target mass of the first active substance 14 are automatically produced. According to a preferred embodiment, the chamber 3 can be closed to prevent dust from escaping the tablet press 1 and to prevent contaminants from entering the tablet press 1 during tablet production.

[0073] FIG. 2 is a simplified schematic detail view of the input device 30, which is a touch panel of the tablet press 1 in the illustrated embodiment. The input device 30 comprises a data display 31, e.g., an area of ​​a screen, on which information about the first active substance 14 and / or the patient is displayed. The input device 30 further comprises a number of input means 32, 33, 34, e.g., additional areas of a screen. The input means 32, 33, 34 allow the input of a target number 35, a target mass 36, and, if necessary, a second layer target mass 37. The input values ​​are displayed for confirmation. Furthermore, further input means (not shown) are provided, by which the production of tablets can be initiated. According to another embodiment, the input device 30 is an external unit or an interface for communication with an external unit. In this case, the target number 35, the target mass 36, and, if applicable, the second layer target mass 37 are input to the external unit and transmitted to the control system 6.

[0074] 3 shows a simplified schematic cross-sectional view of one embodiment of a tablet press 1 with a compression chamber 2 and a first material container 10. The first material container 10 is provided with a first introduction device 12 for filling a first active substance 14 into the central opening of the die 60. According to another embodiment, the first material container 10 is connected to the first introduction device 12. The first introduction device 12 is, for example, a closable funnel.

[0075] The lower punch 50 is disposed within the compression chamber 2 so as to extend from below into the die 60. The lower punch 50 is extendable in the vertical direction. Before the first active material 14 is filled into the die 60, the lower punch 50 is extended from below into the die 60 so as to form a trough for accommodating the first active material 14. Alternatively, the lower punch 50 is permanently disposed within the die 60. In either case, the lower punch 50 can be moved in the vertical direction 120 at the central opening of the die.

[0076] The die 60 and / or lower punch 50 are positioned on a platform 70. According to one embodiment, the platform 70 is a first positioning device. An additional die (not shown in FIG. 3) is secured to the first positioning device and can be moved into position above the lower punch 50 by rotating the first positioning device. According to another embodiment, only one die 60 and one lower punch 50 are secured to the platform 70.

[0077] The platform 70, and therefore also the die 60 and the lower punch 50, can be raised and lowered in the vertical direction 120 by a lifting device 130 consisting of a first spindle 131 and a second spindle 132. Furthermore, the pressing force acting on the lower punch 50 during the compression process can be determined by a pressing force measuring device (not shown) provided in the lifting device 130 and / or by the power consumption of the lifting device 130. A weighing device 16 is arranged below the die 60 and the lower punch 50.

[0078] The tablet press 1 also includes an upper punch 40 that is surrounded and supported by an upper punch carrier 41. The upper punch 40 can be extended in the vertical direction by an upper piston 96.

[0079] The first introducing device 12 and the upper punch 40 are fixed to a second positioning device 80, which in the illustrated embodiment is a rail device.

[0080] To fill the die 60 with the first active material 14, the control system 6 drives the second positioning device 80 to position the first introduction device 12 above the lower punch 50 and die 60, as shown in FIG. 3 . Naturally, this occurs only if the first introduction device 12 is not already positioned above the lower punch 50. Furthermore, the die 60 and lower punch 50 are positioned above the weighing device 16, which measures the total weight of the die 60, lower punch 50, and the first active material 14 filled into the die. To prevent spillage of the first active material 14 during filling, the first introduction device 12 is lowered so that its lower edge is below the upper edge of the die 60. The first introduction device 12 then fills the central opening of the die 60 with the first active material 14 until the target mass 36 is reached. This is monitored by the weighing device 16.

[0081] After the die 60 is filled, the first active substance 14 is pressed into it. This is shown in FIG. 4. To this end, the die 60 and the lower punch 50 are lifted from the metering device 16 by the lifting device 130, the introducing device 12 is moved vertically upward, and the control system 6 controls the second positioning device 80 so that the upper punch 40 is positioned above the lower punch 50 and the die 60. The upper punch 40 is then extended from above into the central opening of the die 60 by the upper piston 96. In this way, the first active substance 14 is pressed between the pressing surfaces of the lower punch 50 and the upper punch 40 to form a tablet.

[0082] After pressing the tablet, both the upper punch 40 and the lower punch 50 move upward to release the tablet from the die 60. The tablet is then pressed down from the lower punch 50 by, for example, a pressing device (not shown) of the conveying device 4, and falls through a channel of the conveying device 4 into the tablet container 100.

[0083] This method is repeated until the target number of 35 tablets has been produced. The chamber 3 is then opened and the tablet container 100 is removed. The tablet container 100 is now filled with the target number 35 individualized tablets having the target mass 36 of the first active substance 14.

[0084] FIG. 4b is a simplified cross-sectional view of an exemplary embodiment of the weighing device 16, die 60, and lower punch 50. In the illustrated embodiment, only one die 60 is included, which forms a unit with the lower punch 50 and is connected to each other by a spring 65. In FIG. 4b, the spring 65 is compressed, causing the lower punch 50 to extend to the upper edge of the central opening 60a of the die. This is recommended, for example, when ejecting compressed tablets. The unit consisting of the lower punch 50 and die 60 is placed on a platform 70 that can be moved in the vertical direction 120 by a lifting device 130. The weighing device 16 is located below the die 60 and lower punch 50. The weighing device 16 has a convex portion 17 on its upper surface that is shaped to fit the concave portion 51 on the lower surface of the lower punch 50. The concave portion 51 of the lower punch 50 is adjacent to the concave portion 71 of the platform 70, and together they form a cavity, shown by the dashed line in FIG. 4b. The recess 71 allows the weighing device 16 to move within the platform 70 so as to contact the lower punch.

[0085] FIG. 4c shows the system of FIG. 4b being filled with active material. The die 60 and lower punch 50 are pulled apart in the vertical direction 120 under the force of spring 65, which creates a trough in the central opening 60a of the die 60 through which the active material is filled. The lower punch 50 rests on the metering device 16 so that the protrusion 17 conforms to the recess 51. The platform 70 is lowered until the lower punch 50 is positioned solely on the metering device 16 and not on the platform 70. In this way, the metering device 16 measures the total mass of the lower punch 50, the die 60, and the active material loaded into the trough during filling. The active material is loaded as usual by the introduction device 12, not shown in FIGS. 4b and 4c.

[0086] FIG. 5 is a simplified top view of a platform 70, designed as a first positioning device of a possible embodiment of the tablet press 1. In the illustrated embodiment, the first positioning device is designed as a rail device. Three dies 60, 61, and 62 are fixed to the first positioning device. The dies 60, 61, and 62 have central openings 60a, 61a, and 62a, respectively, with different circular inner peripheries 60b, 61b, and 62b. The central openings 60a, 61a, and 62a penetrate the platform 70 so that the punches 40 and 50 are not blocked by the platform 70. The position of one of the dies 60, 61, and 62 above the lower punch 50 can be set by moving the first positioning device in the horizontal direction 110. In this way, the target circumference of the tablets to be produced can be set so that the tablet press 1 can produce tablets with a wide range of target masses 36 of the first active substance 14.

[0087] Alternatively, the shape of the tablet can be adjusted by providing the central openings 60a, 61a, 62a with an oval shape instead of a circular shape.

[0088] 6 is a schematic, simplified plan view of the second positioning device 80. In the illustrated embodiment, this is designed as a rail device. The upper punch 40, the first material container 10, and in the illustrated embodiment, the second material container 20, are fixed to the rail device and can be moved in a horizontal direction 110 by the rail device to be alternately positioned above the lower punch 50.

[0089] The second material container 20 is filled with the second active substance 24 for producing a bilayer tablet. For example, after the first active substance 14 is pressed by the second positioning device 80, the second feed device of the second material container 20 is positioned above the lower punch 50, and the second active substance 24 is loaded into the central opening 60a of the die 60 positioned above it. The upper punch 40 is then moved above the lower punch 50 to compress the bilayer tablet. To produce a bilayer tablet with adjacent layers, the first active substance 14 is loaded into a first corner of the die 60 by the first feed device 12, and the second active substance 24 is loaded into a second corner of the die 60 by the second feed device, and the tablet is then compressed.

[0090] 7a and 7b illustrate one embodiment of a telescopically extendable upper punch 40. The upper punch 40 is comprised of three telescopically extendable upper punch shafts 44, 45, and 46 arranged inwardly of one another. In FIG. 7a, all three upper punch shafts 44, 45, and 46 are elongated together so that the outer periphery 43 of the pressing surface 42 of the upper punch 40 corresponds to the outer periphery of the outermost upper punch shaft 46. In FIG. 7b, only the innermost upper punch shaft 44 is elongated so that the outer periphery 43 of the pressing surface 42 of the upper punch 40 corresponds to the outer periphery of the innermost upper punch shaft 44. The outer peripheries of the upper punch shafts 44, 45, and 46 have shapes complementary to the inner peripheries 60b, 61b, and 62b of the dies 60, 61, and 62, respectively.

[0091] 7c and 7d show an embodiment of a telescopically extendable lower punch 50 formed as a mirror image of the upper punch 40. As with the upper punch 40, the outer periphery 53 of the pressing surface 52 of the lower punch 50 can be varied by individually extending the lower punch shafts 54, 55, and 56.

[0092] FIG. 8a shows a simplified cross-sectional view of the telescopically extending upper punch 40, the telescopically extending lower punch 50, and the die 60 during the compression of a large tablet 101. In this case, a die 60 having a large central opening 60a is used. All of the upper punch shafts 44, 45, and 46 and the lower punch shafts 54, 55, and 56 are used to compress the tablet 101. In the illustrated embodiment, one or more horizontal holes 47 are provided in the upper punch shafts 44, 45, and 46, into which the upper locking pin 48 can be inserted by one or more first, schematically shown, pushing / pulling devices 49. Similarly, in the illustrated embodiment, one or more horizontal holes 57 are provided in the lower punch shafts 54, 55, and 56, into which the lower locking pin 58 can be inserted by one or more second, schematically shown, pushing / pulling devices 59. As the largest die 60 is used, the locking pins 48, 58 are retracted so that they do not engage the horizontal holes 47, 57. The direction of pressure of the upper piston 96 is indicated by the arrow.

[0093] 8b is a simplified schematic cross-sectional view of a medium-sized tablet 102 during production. For this purpose, a die 61 having a medium-sized central opening 61a is used. Locking pins 48, 58 are partially inserted into holes 47, 57 so that the outermost punch shafts 46, 56 are fixed vertically and only the middle and inner punch shafts 44, 45, 54, 55 extend. In this way, the outer peripheries 43, 53 of the pressing surfaces 42, 52 fit into the inner periphery 61b of the die 61.

[0094] 8c is a simplified cross-sectional view of the small tablet 103 during production. For this purpose, a die 62 with the smallest central opening 62a is used. Locking pins 48, 58 are fully inserted into holes 47, 57 to vertically fix the outermost and middle punch shafts 45, 46, 55, 56, leaving only the inner punch shafts 44, 45, 54, 55 extended. In this way, the outer peripheries 43, 53 of the pressing surfaces 42, 52 fit into the inner periphery 62b of the die 62.

[0095] 8a, and additionally shows the upper punch carrier 41 as the outermost ring. A horizontal hole 91 is provided perpendicular to the hole 47. A connecting pin 92 is guided in the hole 91 and is inserted into and retracted from the hole 91 by a third pushing / pulling device 90.

[0096] In the embodiment shown in Figures 8a, 8b, 8c, 9a, 9b, and 9c, the upper piston 96 directly drives the inner upper punch shaft 44, while the lower piston (not shown) directly drives the inner lower punch shaft 54. The upper punch shafts 44, 45, and 46 are connected to one another by connecting pins 92 as needed so that they move up and down synchronously. This is also done for the lower punch 50. In Figure 9a, the connecting pin 92 connects all three upper punch shafts 44, 45, and 46 to one another so that they all extend vertically together. A vertical groove is provided in the upper punch carrier 41 to prevent the third pushing / pulling device 90 from getting stuck inside the upper punch carrier 41.

[0097] Fig. 9b is a schematic plan view of Fig. 8b. The connecting pin 92 connects only the inner upper punch shaft 44 and the intermediate upper punch shaft 45, and the outer upper punch shaft 46 is fixed in the vertical direction.

[0098] Fig. 9c is a simplified plan view of Fig. 8c. The connecting pin 92 is inserted so that only the inner upper punch shaft 44 extends, and the intermediate upper punch shaft 45 and the outer upper punch shaft 46 are fixed in the vertical direction.

[0099] In the context of the present invention, features marked "particularly" or "preferably" are understood to be optional features.

[0100] All of the shown features, including those that can be inferred solely from the drawings, and each individual feature disclosed in combination with other features, are considered essential to the invention, either alone or in combination. Embodiments according to the invention can be realized by each individual feature or by a combination of several features. [Explanation of symbols]

[0101] 1 tablet press machine 2 compression chambers 3 Containment Room 4. Conveyor equipment 6. Control System 10 First material container 12 First introduction device 14 First active substance 16 Weighing device 17 Convex part 20 Second material container 24 Second active substance 30 Input Devices 31 Data display section 32, 33, 34 Input means 35 Target Number 36 Target mass 37 Second layer target mass 40 Upper Punch 41 Upper punch carrier 42 Pressing surface 43 Outer circumference 44, 45, 46 Upper punch axis 47 horizontal hole 48 Upper lock pin 49 First Push-Pull Device 50 Lower Punch 51 Recess 52 Pressing surface 53 Outer circumference 54, 55, 56 Lower punch shaft 57 horizontal hole 58 Lower lock pin 59 Second push-pull device 60, 61, 62 Dies 60a, 61a, 62a central opening 60b, 61b, 62b inner circumference 65 spring 70 Platform 71 Recess 80 Second positioning device 90 Third Push-Pull Device 91 horizontal hole 92 connecting pin 94 Pressure measuring device 96 Upper piston 100 pill containers 101, 102, 103 tablets 110 Horizontal 120 vertical direction 130 Lifting equipment 131 First Spindle 132 Second Spindle

Claims

1. 1. A method for automatically producing a specifiable number of individualized tablets (101, 102, 103) having a specifiable amount of a first active substance (14) by means of a tablet press (1), comprising: inputting a target number (35) indicating the number of tablets (101, 102, 103) to be produced and a target mass (36) indicating the amount of the first active substance (14) per tablet (101, 102, 103) into an input device (30); transmitting the target number (35) and the target mass (36) from the input device (30) to a control system (6) of the tablet press (1), wherein the control system (6) controls a first introducing device (12), a weighing device (16), an upper extendable punch (40), and a lower extendable punch (50); a step of filling the amount of the first active substance (14) corresponding to the target mass (36) from the first material container (10) into the central openings (60a, 61a, 62a) of the dies (60, 61, 62) by the first introducing device (12), wherein during filling, the pressing surface (52) of the lower punch (50) closes the central openings (60a, 61a, 62a) on one side, and the amount of the first active substance (14) filled into the central openings (60a, 61a, 62a) is measured by the metering device (16) on which the lower punch (50) and the dies (60, 61, 62) are disposed during filling; compressing the first active substance (14) by extending the pressing surface (42) of the upper punch (40) into the central opening (60a, 61a, 62a); and releasing the compressed tablet (101, 102, 103) from the die (60, 61, 62) by extending the pressing surface (52) of the lower punch (50) into the central opening (60a, 61a, 62a); The tablet press (1) is provided with only one lower punch (50), The steps of filling the amount of the first active substance (14), compressing the first active substance (14) and releasing the compressed tablets are repeated until the number of compressed tablets (101, 102, 103) corresponds to the target number (35).

2. 2. The method according to claim 1, wherein an outer periphery (43) of the pressing surface (42) of the upper punch (40) for compressing the first active substance (14) is adapted to an inner periphery (60b, 61b, 62b) of the die (60, 61, 62), and a plurality of upper punch shafts (44, 45, 46) extending vertically and telescopically of the upper punch (40) arranged inside each other are extended downward, and the outer periphery (43) of the outer extended upper punch shaft (44, 45, 46) corresponds to the inner periphery (60b, 61b, 62b) of the die (60, 61, 62).

3. 3. The method according to claim 1 or 2, wherein an outer periphery (53) of the pressing surface (52) of the lower punch (50) is adapted to an inner periphery (60b, 61b, 62b) of the die (60, 61, 62) before the amount of the first active substance (14) is filled, and a plurality of vertically telescopically extending lower punch shafts (54, 55, 56) of the lower punch (50) arranged inside each other are extended upward, and the outer periphery (53) of the outer extended lower punch shaft (54, 55, 56) corresponds to the inner periphery (60b, 61b, 62b) of the die (60, 61, 62).

4. 4. The method according to claim 1, wherein the mass of the first active substance (14) filled into the central opening (60a, 61a, 62a) is calculated by subtracting an unfilled measurement taken by the metering device (16) by placing the die (60, 61, 62) and the lower punch (50) on the metering device (16) before filling from a total mass measured by the metering device (16) acting during filling, the total mass consisting of the mass of the die (60, 61, 62), the mass of the lower punch (50), and the mass of the first active substance (14) filled into the central opening (60a, 61a, 62a), and wherein the die (60, 61, 62) and the lower punch (50) are lifted after filling and before compressing the first active substance (14).

5. 5. The method according to claim 1, wherein the pressure acting on the lower punch (50) and / or the upper punch (40) is measured in at least one lifting device (130) that lifts the die (60, 61, 62) and the lower punch (50).

6. 6. The method according to claim 1, wherein the first introducing device (12) is positioned vertically above the central opening (60a, 61a, 62a) by a second positioning device (80) before the amount of the first active substance (14) is filled, and the upper punch (40) is positioned vertically above the central opening (60a, 61a, 62a) by the second positioning device (80) after the amount of the first active substance (14) is filled and before the first active substance (14) is compressed, and the first introducing device (12) is positioned on the second positioning device (80) so as to be movable also in the vertical direction.

7. 1. A method for producing a specifiable number of individualized bilayer tablets having a specifiable amount of a first active substance (14) and a specifiable amount of a second active substance (24), comprising: The method of claim 6 further comprises the following additional steps: inputting a second layer target mass (37) into the input device (30) and transmitting the second layer target mass (37) to the control system (6), the second layer target mass (37) indicating the amount of the second active substance (24) per bilayer tablet; positioning a second introducing device of a second material container (20) above the central opening (60a, 61a, 62a) by the second positioning device (80); filling the central openings (60a, 61a, 62a) with an amount of second active material (24) corresponding to the second layer target mass (37) by the second introducing device; positioning the upper punch (40) above the central openings (60a, 61a, 62a) by the second positioning device (80); and, and compressing the second active substance (24) by extending the pressing surface (42) of the upper punch (40) into the central opening (60a, 61a, 62a), The method, wherein all additional steps except for inputting the second layer target mass (37) and transmitting the second layer target mass (37) are performed after compression of the first active substance (14) and before release of the compressed tablet (101, 102, 103).

8. A tablet press (1) for the automatic production of a specifiable number of individualized tablets (101, 102, 103) having a specifiable amount of a first active substance (14), comprising: The apparatus comprises a compression chamber (2), a first material container (10) capable of being filled with the first active substance (14), a first introduction device (12), a control system (6) and an input device (30), the compression chamber (2) comprises an extendable upper punch (40), an extendable lower punch (50), at least one die (60, 61, 62) and a metering device (16) arranged below the at least one die (60, 61, 62); The tablet press (1) is provided with only one lower punch (50), By disposing the dies (60, 61, 62) and the lower punch (50) on the measuring device (16), the mass of the material filled in the central openings (60a, 61a, 62a) of the dies (60, 61, 62) can be measured; the input device (30) is configured to transmit to a control system (6) a target number (35) and a target mass (36) of the individualized tablets (101, 102, 103) to be produced; The control system (6) reads measurement data from the weighing device (16), and drives the first introducing device (12), the upper punch (40), and the lower punch (50) so that an amount of the first active substance (14) corresponding to the target mass is filled into the central opening (60a, 61a, 62a) of the die (60, 61, 62) and compressed by the upper punch (40) and the lower punch (50) to form the tablets (101, 102, 103), and repeats this process until the target number (35) of the tablets (101, 102, 103) are produced.

9. 9. The tablet press (1) according to claim 8, wherein the upper punch (40) comprises at least two upper punch shafts (44, 45, 46) arranged inside each other and extending telescopically in the vertical direction, whereby the outer periphery (43) of the pressing surface (42) of the upper punch (40) can be adapted to the inner periphery (60b, 61b, 62b) of the central opening (60a, 61a, 62a) of the at least one die (60, 61, 62) by the individual extension of the upper punch shafts (44, 45, 46).

10. 10. The tablet press (1) according to claim 9, wherein the lower punch (50) comprises at least two lower punch shafts (54, 55, 56) arranged inside each other and extending telescopically in the vertical direction, whereby the outer periphery (53) of the pressing surface (52) of the lower punch (50) can be adapted to the inner periphery (60b, 61b, 62b) of the central opening (60a, 61a, 62a) of the at least one die (60, 61, 62) by individual extension of the lower punch shafts (54, 55, 56).

11. 11. The tablet press (1) according to claim 9 or claim 10, wherein the compression chamber (2) comprises a first pushing / pulling device (49) in which at least one upper locking pin (48) can be inserted into a horizontal hole (47) provided in the side wall of the upper punch shaft (44, 45, 46) in order to fix a definable number of the upper punch shafts (44, 45, 46) in the vertical direction.

12. 12. The tablet press (1) according to any one of claims 8 to 11, comprising at least one lifting device (130) configured to raise and lower the at least one die (60, 61, 62) and the lower punch (50).

13. 13. The tablet press (1) according to any one of claims 8 to 12, further comprising a second positioning device (80) that can alternately position the upper punch (40) and the first introducing device (12) vertically above the central opening (60a, 61a, 62a) of the die (60, 61, 62) arranged above the lower punch (50).

14. 14. The tablet press (1) according to claim 13, wherein the second positioning device (80) is a rail device on which the first introducing device (12) and the upper punch (40) are arranged and which can be moved in a horizontal direction (110).

15. 15. A tablet press (1) according to any one of claims 8 to 14, wherein the lower punch (50) has a recess (51) on its lower surface formed to match the shape of a protrusion (17) on the upper surface of the weighing device (16).

Images