EP1693182A2 - 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
EP1693182A2
EP1693182A2 EP20060002217 EP06002217A EP1693182A2 EP 1693182 A2 EP1693182 A2 EP 1693182A2 EP 20060002217 EP20060002217 EP 20060002217 EP 06002217 A EP06002217 A EP 06002217A EP 1693182 A2 EP1693182 A2 EP 1693182A2
Authority
EP
European Patent Office
Prior art keywords
rotor
filling
layer
pressing
pair
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.)
Granted
Application number
EP20060002217
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German (de)
English (en)
Other versions
EP1693182A3 (fr
EP1693182B1 (fr
Inventor
Ingo Schmidt
Ulrich Gathmann
Bernd Malner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fette GmbH
Original Assignee
Fette GmbH
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Filing date
Publication date
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Publication of EP1693182A2 publication Critical patent/EP1693182A2/fr
Publication of EP1693182A3 publication Critical patent/EP1693182A3/fr
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Publication of EP1693182B1 publication Critical patent/EP1693182B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • 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 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 into 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.
  • the invention is therefore based on the object of specifying a method for the test extrusion of multilayer or coated tablets which on the one hand can be carried out under production conditions and on the other hand manages with a low press material expenditure.
  • the rotor is provided with only one 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.
  • a rotor 10 of a rotary tablet press is 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 pair of dies is not shown in Fig. 1.
  • 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 the above-mentioned press-stamp pair is 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 in Fig. 2 correspond to three revolutions of the rotor 10.
  • position 1 the pair of punches 30, 32 are in the filling position, and the rotor 10 is at a standstill.
  • a first quantity 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.
  • the pressing process takes place in which the press-punches 30, 32 pass between the upper pressure roller 18 and the lower pressure roller 19 (in FIG. 2, for the sake of simplicity, the pressure roller pair of the pressing station 16 in FIG. 1 omitted.)
  • position 2 the first layer of a three-layer tablet is thus pressed.
  • the rotor 10 is stopped again in the filling position of the press-punches 30, 32 and it is filled with the material 38 for the second layer.
  • the second layer is pressed, and in position 5, the filling is carried out with a third layer of material 40, which is also pressed in position 6 to form a multilayer tablet, which is designated in position 7 at 42 and the lower punch 32 is ejected from the die bore.
  • an ejector 44 is provided.
  • 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 adjusts the Auswerferkurve 44 during the first two revolutions of FIG. 2 in 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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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (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 Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP20060002217 2005-02-19 2006-02-03 Procédé et dispositif pour le pressage d'essai de comprimés multi-couches ou de comprimés enrobés Expired - Lifetime 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

Publications (3)

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

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Family Applications (1)

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EP20060002217 Expired - Lifetime EP1693182B1 (fr) 2005-02-19 2006-02-03 Procédé et dispositif pour le pressage d'essai de comprimés multi-couches ou de comprimés enrobés

Country Status (3)

Country Link
US (2) US8119045B2 (fr)
EP (1) EP1693182B1 (fr)
DE (1) DE102005007790B4 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006136611A1 (fr) 2005-06-23 2006-12-28 Korsch Ag Machine de formation de pastilles a plateau tournant, et procede pour realiser une pastille multicouche
DE102011101286A1 (de) * 2011-05-10 2012-11-15 Fette Compacting Gmbh Rundläuferpresse und Verfahren zum Betreiben einer Rundläuferpresse
EP2977195A1 (fr) * 2014-07-21 2016-01-27 M & R Automation GmbH dispositif et procédé de fabrication de comprimés multi-couches
CN110150707A (zh) * 2017-12-28 2019-08-23 浙江东来天然生物制品有限公司 条状食品成型设备

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Publication number Priority date Publication date Assignee Title
DE102005007790B4 (de) 2005-02-19 2007-06-28 Fette Gmbh Verfahren und Vorrichtung zur Versuchspressung von Mehrschichttabletten oder Manteltabletten
SI1889198T1 (sl) 2005-04-28 2015-02-27 Proteus Digital Health, Inc. Farma-informacijski sistem
US8802183B2 (en) 2005-04-28 2014-08-12 Proteus Digital Health, Inc. Communication system with enhanced partial power source and method of manufacturing same
WO2008016183A1 (fr) * 2006-08-04 2008-02-07 Brother Kogyo Kabushiki Kaisha Appareil de formation d'image
KR101677698B1 (ko) 2009-04-28 2016-11-21 프로테우스 디지털 헬스, 인코포레이티드 고신뢰성 섭취가능 이벤트 마커들 및 이를 사용하는 방법
UA109424C2 (uk) * 2009-12-02 2015-08-25 Фармацевтичний продукт, фармацевтична таблетка з електронним маркером і спосіб виготовлення фармацевтичної таблетки
JP6463599B2 (ja) 2010-04-07 2019-02-06 プロテウス デジタル ヘルス, インコーポレイテッド 小型の摂取可能なデバイス
JP2014504902A (ja) 2010-11-22 2014-02-27 プロテウス デジタル ヘルス, インコーポレイテッド 医薬品を有する摂取可能なデバイス
WO2015112603A1 (fr) 2014-01-21 2015-07-30 Proteus Digital Health, Inc. Produit ingérable pouvant être mâché et système de communication associé
US9756874B2 (en) 2011-07-11 2017-09-12 Proteus Digital Health, Inc. Masticable ingestible product and communication system therefor
WO2014120669A1 (fr) 2013-01-29 2014-08-07 Proteus Digital Health, Inc. Films polymères hautement dilatables et compositions les contenant
WO2014144738A1 (fr) 2013-03-15 2014-09-18 Proteus Digital Health, Inc. Appareil, système et procédé de détection de métal
US9796576B2 (en) 2013-08-30 2017-10-24 Proteus Digital Health, Inc. Container with electronically controlled interlock
US10084880B2 (en) 2013-11-04 2018-09-25 Proteus Digital Health, Inc. Social media networking based on physiologic information
US11051543B2 (en) 2015-07-21 2021-07-06 Otsuka Pharmaceutical Co. Ltd. Alginate on adhesive bilayer laminate film
WO2018018034A1 (fr) 2016-07-22 2018-01-25 Proteus Digital Health, Inc. Capture et détection électromagnétique de marqueurs d'événement ingérables
IL265827B2 (en) 2016-10-26 2023-03-01 Proteus Digital Health Inc Methods for producing capsules with ingestible event markers
CN108572602B (zh) * 2018-07-23 2024-03-15 上海海得控制系统股份有限公司 一种压片机的控制装置
NL2021552B1 (en) * 2018-09-03 2020-04-30 Besi Netherlands Bv Method and device for selective separating electronic components from a frame with electronic components
DE102023125660B3 (de) * 2023-09-21 2025-02-13 Fette Compacting Gmbh Verfahren zur Versuchspressung von Presslingen in einer Rundläuferpresse
DE102023135488A1 (de) * 2023-12-18 2025-06-18 Fette Compacting Gmbh Vorrichtung und Verfahren zum Entstauben von Tabletten oder Kapseln

Citations (1)

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Publication number Priority date Publication date Assignee Title
EP0572816A1 (fr) 1992-06-02 1993-12-08 Wilhelm Fette GmbH Procédé et dispositif de compactage de comprimés à deux couches sur une presse à table tournante avec deux postes

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DE2742572B1 (de) * 1977-09-22 1979-03-29 Fette Wilhelm Gmbh Verfahren zum Herstellen von Tabletten und Tablettenpresse
DE3520203A1 (de) * 1985-06-05 1986-12-11 Wilhelm Fette Gmbh, 2053 Schwarzenbek Rundlaeufer-tablettiermaschine und verfahren zur steuerung ihrer druckrollen
US4880373A (en) * 1988-04-28 1989-11-14 The Upjohn Company Tablet press
DE3939956A1 (de) * 1989-12-02 1991-06-06 Fette Wilhelm Gmbh Verfahren und einrichtung zum ueberwachen der presskraefte einer tablettiermaschine
US5223192A (en) * 1989-12-02 1993-06-29 Firma Wilhelm Fette Gmbh Method of and arrangement for monitoring pressing forces in a pelletizing machine
US5322655A (en) * 1993-02-19 1994-06-21 Thomas Engineering, Inc. Method for monitoring and controlling the weights of each layer of a multilayer tablet
DE19844390B4 (de) * 1998-09-28 2005-09-22 Wilhelm Fette Gmbh Verfahren zur Herstellung von Tabletten in einer Rundläufertablettiermaschine
DE19964225C2 (de) * 1999-12-17 2002-01-24 Henkel Kgaa Preßverfahren für mehrphasige Formkörper
DE10161572B4 (de) * 2001-12-14 2004-03-25 Wilhelm Fette Gmbh Tablettenpressvorrichtung
DE10202820C1 (de) * 2002-01-25 2003-03-13 Fette Wilhelm Gmbh Satz von Presstempeln und/oder Matrizen für eine Tablettiermaschine
DE10207764B4 (de) * 2002-02-23 2005-11-17 Wilhelm Fette Gmbh Verfahren zur Kontrolle der Montage von Einzelkomponenten und/oder Baugruppen einer Tablettiermaschine
DE10319024B3 (de) * 2003-04-28 2004-08-12 Fette Gmbh Verfahren zur Versuchspressung von Tabletten
DE102005007790B4 (de) 2005-02-19 2007-06-28 Fette Gmbh Verfahren und Vorrichtung zur Versuchspressung von Mehrschichttabletten oder Manteltabletten

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
EP0572816A1 (fr) 1992-06-02 1993-12-08 Wilhelm Fette GmbH Procédé et dispositif de compactage de comprimés à deux couches sur une presse à table tournante avec deux postes

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006136611A1 (fr) 2005-06-23 2006-12-28 Korsch Ag Machine de formation de pastilles a plateau tournant, et procede pour realiser une pastille multicouche
DE102011101286A1 (de) * 2011-05-10 2012-11-15 Fette Compacting Gmbh Rundläuferpresse und Verfahren zum Betreiben einer Rundläuferpresse
DE102011101286B4 (de) * 2011-05-10 2013-10-17 Fette Compacting Gmbh Rundläuferpresse und Verfahren zum Betreiben einer Rundläuferpresse
EP2977195A1 (fr) * 2014-07-21 2016-01-27 M & R Automation GmbH dispositif et procédé de fabrication de comprimés multi-couches
WO2016012427A1 (fr) * 2014-07-21 2016-01-28 M & R Automation Gmbh Dispositif et procédé de fabrication de comprimés à plusieurs couches
CN110150707A (zh) * 2017-12-28 2019-08-23 浙江东来天然生物制品有限公司 条状食品成型设备

Also Published As

Publication number Publication date
US8119045B2 (en) 2012-02-21
US20060186568A1 (en) 2006-08-24
US20120195992A1 (en) 2012-08-02
US8382465B2 (en) 2013-02-26
DE102005007790B4 (de) 2007-06-28
EP1693182A3 (fr) 2008-07-30
EP1693182B1 (fr) 2013-12-11
DE102005007790A1 (de) 2006-08-24

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