EP1693182B1 - Procédé et dispositif pour le pressage d'essai de comprimés multi-couches ou de comprimés enrobés - Google Patents

Procédé et dispositif pour le pressage d'essai de comprimés multi-couches ou de comprimés enrobés Download PDF

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Publication number
EP1693182B1
EP1693182B1 EP20060002217 EP06002217A EP1693182B1 EP 1693182 B1 EP1693182 B1 EP 1693182B1 EP 20060002217 EP20060002217 EP 20060002217 EP 06002217 A EP06002217 A EP 06002217A EP 1693182 B1 EP1693182 B1 EP 1693182B1
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EP
European Patent Office
Prior art keywords
filling
rotor
punches
layer
cam
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
EP20060002217
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German (de)
English (en)
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EP1693182A3 (fr
EP1693182A2 (fr
Inventor
Ingo Schmidt
Ulrich Gathmann
Bernd Malner
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Fette GmbH
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Fette GmbH
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Filing date
Publication date
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Publication of EP1693182A3 publication Critical patent/EP1693182A3/fr
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Publication of EP1693182B1 publication Critical patent/EP1693182B1/fr
Expired - Fee Related legal-status Critical Current
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B30PRESSES
    • B30BPRESSES IN GENERAL
    • B30B11/00Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/005Control arrangements
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B30PRESSES
    • B30BPRESSES IN GENERAL
    • B30B11/00Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/08Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
    • B30B11/085Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable for multi-layer articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B30PRESSES
    • B30BPRESSES IN GENERAL
    • B30B11/00Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/34Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses for coating articles, e.g. tablets

Definitions

  • the invention relates to a method for the test squeezing of at least two layers of tablets according to claim 1 in the experimental squeeze of coated tablets according to claim 2 and an apparatus for performing the method according to claim 6.
  • Rotary tablet presses are known to have a rotary drive driven rotor having a die plate, top and bottom punches guided in respective guides and having a cam system. Furthermore, at least one pressing station is provided, which usually has an upper and lower pressure roller, with the aid of which upper and lower punches are pressed into the matrix in when you pass the pressing station. Usually, two pairs of pressure rollers are provided for pre-pressing and final pressing of the material. Finally, a filling device is provided, by means of which the material to be pressed is filled into the die holes. The rotor is continuously rotated, with the filling device constantly filling material in the associated die bores and the associated lower punch ejects the finished pressed tablet from the die bore, from where it is guided by means of a scraper in a channel.
  • multilayer tablets with such rotary tablet presses.
  • the multilayer tablets are produced in one revolution of the rotor, wherein one filling device per layer and a pressure roller assembly (pressing station) is provided. If z. B. produces a three-layer tablet, three filling devices are provided at 180 ° distance and three pressing stations with at least one pressure roller pair between the filling devices.
  • coated tablets It is also known to produce so-called coated tablets with the aid of a rotary press. Under coated tablets is usually understood a two-layer tablet in which a core is disposed between the layers. After filling and pressing the first layer, a core of another material is placed on the first layer and then a second layer is filled. In the production of such coated tablets can be proceeded in various ways. It is conceivable to refill the first layer and to carry out a compression only when the second layer is filled. Alternatively, the first layer can be pressed before the core is inserted. Subsequently, the compression of both layers with core. Finally, it is also possible to press the core after insertion a degree in the first layer. This can also be done with the upper punch in the pressing station. The processes described can take place during one revolution of the rotor.
  • the rotor is rotated and accelerated so that it has the desired production speed in the printing station. After one revolution, the rotor is stopped in the filling position. During the rotation of the rotor signals or waveforms of the measuring points are recorded and placed in a computer for display and evaluation.
  • EP-A-0 572 816 describes a method for pressing two-layer tablets in a double rotary press, in which the tablets pressed layer by layer and the two-layer compacts are then ejected in a removal station and removed.
  • the compacts produced in the test sections after the compression of the first layer are removed in an intermediate sampling station and fed to a test station, wherein the first layers are precompressed more strongly before sampling in the intermediate sampling station than during normal production.
  • the further compressed second layers are fed to a bad channel or also the test station at the latest after removal of the single-layer compacts in the removal station.
  • the document EP-A 0 572 816 also discloses a device according to the preamble of claim 6.
  • the invention has for its object to provide a method for the test-molding of multi-layer or coated tablets, on the one hand under Production conditions is feasible and on the other hand manages with little press material.
  • the rotor is provided with a pair of punches and with the aid of the operating computer and control computer, the rotor can be moved to a defined filling position in which the pair of punches is in this position.
  • the lower punch is in a first fill position while the ejector cam is in an inactive position.
  • the template is filled with the material for the first layer.
  • the pressure rollers have taken a first printing position in the pressing station.
  • the adjustment of the control cams and the pressure rollers is done with the aid of suitable adjusting drives, such as a hydraulic or pneumatic or electromechanical drive.
  • the rotor is rotated by one turn until the pair of dies has reached the filling position again. This is done a pressing of the first layer of the multilayer tablet. Since the ejection cam has been in an inactive position, the first layer is not expelled, but remains in the die bore. After reaching the filling position again, the filling curve is brought into a position in which a metered filling of the second layer of the multilayer tablet can take place.
  • the pressure rollers are brought into a second printing position. Further, the ejector curve is brought into an ejector position when only a two-layer tablet is to be produced. During the second revolution of the rotor, therefore, the second layer is pressed and ejected the two-layer tablet through the Auswerferkurve and the associated lower punch. For the production of a multilayer tablet with n layers therefore n rotations of the rotor d. H. One revolution per shift required with each individual adjustment of the cams and the pressure rollers.
  • the signals of the individual measuring points, z. B. for the pressing force recorded and fed to a control computer for display and evaluation.
  • the measured signals serve z. B. for determining the compression characteristic of the press material.
  • the process for producing a coated tablet is similar to the method according to claim 1.
  • the core is inserted. This can be pressed in a further revolution of the rotor with the help of the upper punch a little in the lower layer.
  • the filling of the press material and the core can be done by hand.
  • a filling device for example, a filling device rotatable about a vertical axis, which has a chamber for receiving a layer material per layer of the multilayer tablets.
  • a rotary drive Upon rotation of the filling device by means of z. B. a rotary drive, in each case a filling outlet of a chamber is aligned with the die bore in the filling position.
  • the inventive method has a number of advantages. Press tests could be carried out with a rotor fitted with only one pair of punches, with or without dummy dies. The changeover times to other press materials or other stamp types is very short. In the press trials, a low dust formation, since only small amounts of material are used.
  • All process-relevant settings can be adjusted and tested in the press trials: speed of the rotor, pressing force in the press station, thickness, hardness and weight of the tablets, etc.
  • the data determined in the press trial and various settings can be transferred directly to a production rotary press, such as z. As the speed, the pressing force, thickness, hardness, weight of the tablets, etc.
  • the measurement data for each pressing process are available directly and can be displayed in the operating computer, evaluated and stored with all process-related data.
  • Fig. 1 is a rotor 10 of a rotary tablet press indicated with a die plate 12 having a plurality of die holes 14 on a pitch circle.
  • the rotor 10 is driven by a suitable rotary drive, which in turn is controlled by an operating computer and control computer (not shown).
  • the rotor 10 are two pressing stations 16, 18 associated with upper and lower pressure roller, in each case only an upper pressure roller 20 and 22 can be seen. With the help of the pairs of pressure rollers, upper and lower punches are pressed into the die bores 14 when they pass over or under the pressure rollers in order to press the material located in the die bore.
  • the rotor is associated with only one pair of punches, namely upper and lower punches, which in turn are associated with only one die bore 14.
  • the stamp pair is in Fig. 1 not shown.
  • the rotor 10 is associated with a filling device 24. It is rotatable about a vertical axis, as indicated by the arrow 26. The rotation can be done by means of a suitable, not shown here rotary drive.
  • the filling device 24 has three filling chambers 28 arranged at 180 ° intervals on, the filling output can be aligned depending on the rotational position to a die bore 14. In the manufacture of a three-layer tablet, each filling chamber 28 is filled with a material for a layer of the three-layer tablet.
  • Fig. 2 is the above-mentioned press-stamp pair shown seven times.
  • the upper punch is denoted by 30 and the lower punch by 32. It also recognizes the die 34 with the die bore 14, which are associated with the punches 30, 32.
  • the seven positions shown correspond to three revolutions of the rotor 10. In position 1, the pair of punches 30, 32 are in the filling position, and the rotor 10 is at a standstill.
  • a first amount of material 36 is filled into the die bore 14. The amount is therefore determined by the position of the lower punch 32, which is brought with a filling curve 38 in the desired position.
  • filling curve 38 and pressure rollers 18, 19 are set in the desired manner in order to specify the required pressing parameters.
  • the adjustment is made by means of suitable adjustment drives, which are not shown here. However, it is understood that, depending on the number of desired over-rotation very well an adjustment before the next revolution of the rotor and the next pressing process takes place.
  • the Auswerferkurve 44 also has an adjustment (not shown), which the Auswerferkurve 44 during the first two revolutions to Fig. 2 adjusted to an inactive position to avoid ejection of the previously pressed layers.
  • the control of the individual adjusting drives and the rotary drive for the rotor 10 and the filling device 24 is carried out by an operating computer and control computer such that, after appropriate programming or before setting, these processes take place automatically.
  • a suitable measuring device which is not shown here, registers various process parameters, such. B. rotational speed of the rotor 10, pressing force on the pressure rollers 18, 19, etc., which can then be processed in the operating computer in a suitable manner to z. For example, change the settings at the next trial press.

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  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (7)

  1. Procédé pour le pressage d'essai dans des conditions de production de comprimés constitués de n couches dans une presse à comprimés rotative qui présente un rotor (10) pouvant être entraîné à rotation avec des alésages de matrice (14), des guides d'estampe, au moins une station de pressage (16, 18) et un système de cames de commande, dans lequel le système de cames de commande présente entre autres une came de remplissage (38) et une came d'éjection (44) pour une estampe inférieure (32), et dans lequel les rouleaux presseurs (20, 22) de la station de pressage (16, 18) et les cames de commande sont réglables en hauteur par des entraînements de réglage appropriés, comprenant les étapes suivantes :
    - le rotor (10) pourvu d'une estampe supérieure et d'une estampe inférieure (30, 32), c'est-à-dire d'une paire d'estampes, est amené avec la paire d'estampes dans une position de remplissage définie dans laquelle l'alésage de matrice (14) associé à la paire d'estampes est rempli du matériau de la première couche du comprimé, dans lequel la came de remplissage (38) est amenée dans une première position, la came d'éjection (44) dans une position inférieure et les rouleaux presseurs dans une première position de pressage par des entraînements de réglage associés ;
    - le rotor (10) est ensuite tourné d'une rotation entière et la paire d'estampes arrêtée dans la position de remplissage ;
    - la came de remplissage (38) est déplacée dans une deuxième position de remplissage et les rouleaux presseurs dans une deuxième position de pressage ;
    - l'alésage de matrice (14) contenant la première couche est ensuite rempli du matériau de la deuxième couche ; et
    - le rotor (10) est tourné d'une autre rotation entière et la paire d'estampes est de nouveau arrêtée dans la position de remplissage, etc.
    - lors de la nième rotation du rotor (10), la came d'éjection (44) est déplacée dans la position d'éjection et l'estampe inférieure (32) éjecte le comprimé multicouches.
  2. Procédé pour le pressage d'essai de comprimés (comprimés enrobés) dans des conditions de production qui sont composés de deux couches et d'un noyau disposé entre les couches dans une presse à comprimés rotative qui présente un rotor (10) pouvant être entraîné à rotation avec des alésages de matrice (14), des guides d'estampe, au moins une station de pressage (16, 18) et un système de cames de commande, dans lequel le système de cames de commande présente entre autres une came de remplissage (38) et une came d'éjection (44) pour une estampe inférieure (32), et dans lequel les rouleaux presseurs de la station de pressage (16, 18) et les cames de commande sont réglables en hauteur par des entraînements de réglage appropriés, comprenant les étapes suivantes :
    - le rotor (10) pourvu d'une estampe supérieure et d'une estampe inférieure (30, 32), c'est-à-dire d'une paire d'estampes, est amené avec la paire d'estampes dans une position de remplissage définie dans laquelle l'alésage de matrice (14) associé à la paire d'estampes est rempli du matériau de la première couche du comprimé, dans lequel la came de remplissage (38) est amenée dans une première position, la came d'éjection (44) dans une position inférieure et les rouleaux presseurs dans une première position de pressage par des entraînements de réglage associés ;
    - le rotor (10) est ensuite tourné d'une rotation entière et la paire d'estampes arrêtée dans la position de remplissage ;
    - un noyau est placé sur la première couche dans l'alésage de matrice (14) dans la position de remplissage ;
    - une seconde couche est versée dans l'alésage de matrice (14) après la mise en place du noyau ou après une rotation du rotor (10) lorsque la position de remplissage est de nouveau atteinte ;
    - la seconde couche est pressée dans une seconde position de pressage des rouleaux presseurs (20, 22) lors d'une rotation entière du rotor (10) et la paire d'estampes est de nouveau arrêtée dans la position de remplissage ;
    - lors de la dernière rotation du rotor (10), la came d'éjection (44) est déplacée dans la position d'éjection et l'estampe inférieure (32) éjecte le comprimé enrobé.
  3. Procédé selon la revendication 1 ou 2, caractérisé en ce que les valeurs de force de compression sont enregistrées pendant chaque rotation du rotor (10) et acheminées en ligne à un poste de travail pour la presse à comprimés rotative.
  4. Procédé selon l'une quelconque des revendications 1 à 3, caractérisé en ce que l'entraînement pour le rotor (10) est conçu de sorte qu'il a une vitesse de production dans ces zones de la station à rouleaux presseurs.
  5. Procédé selon la revendication 2, caractérisé en ce que le noyau est pressé au moyen des rouleaux presseurs dans la première couche lors de la rotation du rotor (10) avec une première couche et le noyau sur la première couche.
  6. Dispositif pour le pressage d'essai de comprimés constitués au moins de deux couches dans une presse à comprimés rotative, comprenant un rotor (10) pouvant être entraîné à rotation avec des alésages de matrice (14), des guides d'estampe pour une estampe supérieure et une estampe inférieure (30, 32), une station de pressage (16, 18) présentant des rouleaux presseurs (20, 22) et un système de cames de commande, dans lequel le système de cames de commande présente entre autres une came de remplissage (38) et une came d'éjection (44) pour l'estampe inférieure (32), et dans lequel les rouleaux presseurs (20, 22) et les cames de commande sont réglables en hauteur par un entraînement de réglage approprié chacun, et dans lequel un poste de travail est prévu pour la commande des parties individuelles de la presse rotative, caractérisé en ce que le rotor (10) contient uniquement une estampe supérieure et une estampe inférieure (30, 32), c'est-à-dire une paire d'estampes, le poste de travail est programmable de sorte que la paire d'estampes de la presse (30, 32) peut être amenée automatiquement dans une position de remplissage définie dans laquelle l'estampe inférieure (32) peut être amenée par le biais de sa came de remplissage (38) dans une position de remplissage souhaitée, la came d'éjection (44) peut être amenée par son entraînement de réglage dans une position inactive, qu'un dispositif de remplissage (24) pivotant autour d'un axe vertical est en outre prévu, lequel présente une chambre (28) pour la réception d'un matériau de couche par couche des comprimés multicouches et une sortie de remplissage d'une chambre (28) peut à chaque fois être orientée avec un alésage de matrice (14) dans la position de remplissage lors de la rotation du dispositif de remplissage (24).
  7. Dispositif selon la revendication 6, caractérisé en ce qu'un entraînement rotatif est prévu pour le dispositif de remplissage (24), lequel peut être commandé par le poste de travail et le poste de commande.
EP20060002217 2005-02-19 2006-02-03 Procédé et dispositif pour le pressage d'essai de comprimés multi-couches ou de comprimés enrobés Expired - Fee Related EP1693182B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE200510007790 DE102005007790B4 (de) 2005-02-19 2005-02-19 Verfahren und Vorrichtung zur Versuchspressung von Mehrschichttabletten oder Manteltabletten

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EP1693182A2 EP1693182A2 (fr) 2006-08-23
EP1693182A3 EP1693182A3 (fr) 2008-07-30
EP1693182B1 true EP1693182B1 (fr) 2013-12-11

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US20120195992A1 (en) 2012-08-02
EP1693182A3 (fr) 2008-07-30
DE102005007790B4 (de) 2007-06-28
US20060186568A1 (en) 2006-08-24
EP1693182A2 (fr) 2006-08-23
DE102005007790A1 (de) 2006-08-24
US8119045B2 (en) 2012-02-21
US8382465B2 (en) 2013-02-26

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