EP1844924A2 - Procédé de régulation de la quantité d'agents actifs de tablettes pendant la production d'une presse rotative pour comprimés - Google Patents

Procédé de régulation de la quantité d'agents actifs de tablettes pendant la production d'une presse rotative pour comprimés Download PDF

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Publication number
EP1844924A2
EP1844924A2 EP07005438A EP07005438A EP1844924A2 EP 1844924 A2 EP1844924 A2 EP 1844924A2 EP 07005438 A EP07005438 A EP 07005438A EP 07005438 A EP07005438 A EP 07005438A EP 1844924 A2 EP1844924 A2 EP 1844924A2
Authority
EP
European Patent Office
Prior art keywords
amount
active ingredient
tablets
measured
pressure roller
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
EP07005438A
Other languages
German (de)
English (en)
Other versions
EP1844924A3 (fr
EP1844924B1 (fr
Inventor
Ingo Schmidt
Ines Andersen
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
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Fette GmbH filed Critical Fette GmbH
Publication of EP1844924A2 publication Critical patent/EP1844924A2/fr
Publication of EP1844924A3 publication Critical patent/EP1844924A3/fr
Application granted granted Critical
Publication of EP1844924B1 publication Critical patent/EP1844924B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02—Presses 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
    • B30B11/08—Presses 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/005—Control arrangements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/30—Feeding material to presses
    • B30B15/302—Feeding material in particulate or plastic state to moulding presses

Definitions

  • the invention relates to a method for controlling the amount of active ingredient of tablets during production in a rotary tablet press according to claim 1.
  • Rotary tablet presses are well known; a rotor with optionally segmented die plate contains holes on a pitch circle, which are associated with lower and upper punch, which are controlled by means of curve elements in position.
  • a printing station which has at least one upper and one lower pressure roller, the stamping material which is filled into the die bore is pressed into a tablet by means of the stamps (if a tablet is mentioned above and below, this need not necessarily be a pharmaceutical tablet, but instead may be a compact of any molding material containing certain active ingredients or ingredients which have an effect on application).
  • the tablets produced must meet certain quality requirements, such as weight, hardness, height, etc.
  • the filling of the die bores or the bores of segments takes place via a suitable filling system, e.g. a Greschuh, wherein the amount of the pressing material in the die holes on the position of the lower punch depends. It is therefore known to provide a metering curve in a station in the region of the filling station, which predetermines the position of the lower punches and thus the amount that can be received in the die bore. If this is to be changed, an adjustment of the metering curve takes place via a suitable adjusting device.
  • a suitable filling system e.g. a Greschuh
  • the stamps are pressed in the printing station with a predetermined force against the pressing material. This force is measured. It is also known to maintain the pressing force at a predetermined value by comparing the measured pressing force values with a desired value. If the measured pressing force value (usually maximum value) deviates from the desired value, the metering curve is adjusted in order to increase or decrease the amount introduced. In this way, the tablet is produced with a constant weight of mostly constant height (ridge height).
  • the control of the pressing force via a suitable control loop, the control and operating computer of Includes tablet press. It is generally known to operate such tablet presses with a control and operating computer.
  • An essential quality criterion in the production of tablets is their amount of active ingredient and / or the amount of additives. This is especially true for pharmaceutical tablets. It must be ensured that the tablets have a constant amount of active ingredient. Also in this case, it is known to take samples and measure the drug content.
  • HPLC High Performance Liquid Chromatography
  • NIRS Near Infrared Spectroscopy
  • LIF Laser Induced Fluorescence Spectroscopy
  • the invention has for its object to provide a method for the production of tablets by means of a rotary tablet press, with which it is possible to keep the amount of active ingredient tablets either absolute or relative to the tablet weight within predetermined limits during production automatically constant.
  • the amount of active ingredient is measured and compared with a setpoint value. In the event of a deviation from the nominal value, more or less active substance per die bore is added via the filling material, for example by adjusting the metering curve.
  • the change in the filling quantity results in a change in the pressing force, because during tablet production the pressing forces on the lower or upper pressure roller are measured, and the control and operating computer compares the pressing force measured values with a predetermined pressing force setpoint in a manner known per se ,
  • the then measured pressing force then deviates from its nominal value. This deviation adjusts the capacity until the Preßkraftabweichung of the setpoint is again about zero.
  • the lower or upper pressure roller is adjusted, with too small an amount of active an adjustment of the pressure rollers away from each other and too high an amount of drug causes an adjustment of the pressure rollers towards each other, and only a pressure roller needs to be adjusted.
  • Variations in the proportion of active ingredient within the amount of powder to be compressed can be caused by upstream mixing processes, the filling process in smaller containers or by segregation, the latter, for example, by vibrations directly in the tablet press. Since there is a direct relationship between the weight of a tablet and the amount of active ingredient, it is thus possible to bring about a change in the Preßmaterialdostechnik in the die holes of the rotor, a change in the absolute amount of active ingredient of the tablets The consequence may be an increase in weight of the tablets to the deficiency or to compensate for the excess amount of active ingredient.
  • the amount of active ingredient can be determined approximately with an online measuring device, for example according to the NIRS or the LIF method.
  • the sample tablets are automatically fed to the active substance testing device.
  • the active ingredient is measured, digitized and transmitted as a current actual value via any computer interface to the control and operating computer of the machine.
  • the latter can automatically carry out a necessary correction of the metered quantity of the pressing material, for example by changing the position of a pressure roller in the printing station and thus setting a different pressing force / actual value.
  • the deviation between the setpoint and actual value of the pressing forces is compensated by a corresponding correction of the height-adjustable metering curve.
  • the active ingredient measuring device also determines the weight of the tablets, and the control and operating computer compares the ratio of active ingredient amount to weight with a predetermined ratio setpoint for active ingredient content and weight.
  • the weight and thus the amount of active ingredient of the tablet can be adjusted relative to the weight on the scheme described.
  • the measurement of the amount of active ingredient within the tablet press e.g. with the already mentioned methods.
  • the single figure shows schematically a part of a rotary press for the production of tablets with a regulation on the active ingredient content of the tablets.
  • a developed rotor 10 of a rotary tablet press is shown schematically. It contains a die plate 12 with die holes 14 each of which a lower punch 16 and an upper punch 18 is assigned. The ram are guided by individual guide cam elements 20 and 22 respectively. They will not be described in detail with the exception of a Medkurvenelements 24 and a Dosierkurvenelements 26.
  • the rotor 10 also includes punch guides 28 and 30.
  • the rotor is assigned a filling station 32, the press material 34 successively fills into individual die holes 14. Such devices are well known and will not be described in detail.
  • the filling cam 24 for the lower punches 16 ensures that during filling the lower punches have a predetermined position.
  • the Dosierkurvenelement 26 leads to a minimal lifting of the lower punch after the filling process, whereby the final amount to be absorbed by the Matrizenbohritch 14, is specified.
  • 32 two printing stations 38 and 40 are arranged behind the filling station, each with an upper pressure roller 42 and 44 and a lower pressure roller 46 and 48. 38 is thus the pre-press station and 40 the main printing station. With the help of the printing stations 38, 40, the pressing material 34 is pressed in the die holes 14 into a tablet.
  • the upper punches 18 are returned, and the tablets 50 with the aid of Lower punch 16 and the Auswerferkurve 22 ejected. Subsequently, a stripping from the top of the die plate 12, which is not shown.
  • Indicated at 52 is that one or some of the produced tablets 50 are diverted to an active ingredient and / or weight tester 54.
  • the digitized values for the amount of active ingredient of the tablets and their weight from the device are given to a control and operating computer 56, which otherwise also controls or regulates the operation of the tablet presses.
  • the pressure rollers 42, 44 and 46 are shown stationary in the figure. Normally, the pressure rollers are height adjustable.
  • the pressure roller 48 is also mounted vertically adjustable in a guide 58 and can be adjusted by means of a Druckrollenverstellvorraum 60 relative to the upper pressure roller 44, for example, to change the web height of a tablet and / or to vary the pressing force.
  • the lower pressure roller 48 is also assigned a pressing force measuring device 62, the values of which are given digitized to the control and operating computer 56.
  • the Dosierkurvenelement 26 is also adjustable by means of a DosierkurvenVerstellvorraum 64 in height. As a result, the amount of pressed material to be filled into the die bores 14 is variable.
  • the value for the measured amount of active substance is compared with a desired value. If the measured value deviates from the desired value, a signal is applied to the pressure roller adjustment device 60, which adjusts the pressure roller, via the function line 66 in accordance with the control deviation. The pressing force measuring device thereby measures a changed pressing force. This measurement is given via the function line 68 to the control and operating computer 56. The control and operating computer compares the measured pressing force value with a pressing force setpoint. In the event of a deviation, a control signal is applied to the dosing curve adjusting device 64 in accordance with the control deviation, whereby the quantity filled into the die bores 14 is changed.
  • the pressure roller 48 is moved downwards via the adjusting device 58. This reduces the actual pressing force.
  • the control deviation of the pressing forces which is detected in the operating computer 56, leads to an adjustment of the metering curve 26, whereby the actual pressing force again approaches the target pressing force. If the amount of active substance is too large, the procedure is reversed, ie an adjustment of the pressure roller 48 takes place upwards. The resulting pressing force difference leads to a reduction of the filled material, so that in turn actual and target pressing force approach each other.
  • the amount of active substance can be absolutely measured and regulated. However, it is also possible to measure and regulate the ratio to the weight and thus the proportion of active ingredient.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
EP07005438.2A 2006-04-12 2007-03-16 Procédé de régulation de la quantité d'agents actifs de tablettes pendant la production d'une presse rotative pour comprimés Not-in-force EP1844924B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102006017196A DE102006017196B4 (de) 2006-04-12 2006-04-12 Verfahren zur Regelung der Wirkstoffmenge von Tabletten während der Produktion in einer Rundläufertablettenpresse

Publications (3)

Publication Number Publication Date
EP1844924A2 true EP1844924A2 (fr) 2007-10-17
EP1844924A3 EP1844924A3 (fr) 2008-09-03
EP1844924B1 EP1844924B1 (fr) 2014-07-02

Family

ID=38134103

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07005438.2A Not-in-force EP1844924B1 (fr) 2006-04-12 2007-03-16 Procédé de régulation de la quantité d'agents actifs de tablettes pendant la production d'une presse rotative pour comprimés

Country Status (3)

Country Link
US (1) US7471992B2 (fr)
EP (1) EP1844924B1 (fr)
DE (1) DE102006017196B4 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102294837A (zh) * 2011-08-04 2011-12-28 安徽中人科技有限责任公司 一种制备小直径颗粒状植入剂的压药机
EP2168761A3 (fr) * 2008-09-25 2012-12-12 Fette GmbH Procédé de surveillance de la qualité de matériaux de compression en poudre et une presse rotative destinée à l'exécution du procédé
EP2236274A3 (fr) * 2009-04-04 2012-12-19 Fette GmbH Station de pressage dans une presse rotative
CN103085310A (zh) * 2011-11-07 2013-05-08 四川汇利实业有限公司 带有进料槽的高效压片机
CN104015395A (zh) * 2014-06-03 2014-09-03 唐伟 一种用于粉末转化为片状、环状和其他异形成品的设备
EP3900923A1 (fr) * 2020-04-22 2021-10-27 4K Global Holding UG (haftungsbeschränkt) Procédé de fabrication automatisée de comprimés individualisés et presse à comprimés destinée à la fabrication automatisée de comprimés individualisés
CN114929464A (zh) * 2020-01-08 2022-08-19 I·M·A·工业机械自动装置股份公司 压片机
CN117281737A (zh) * 2023-11-22 2023-12-26 山西旺龙药业集团有限公司 一种生产诺氟沙星胶囊剂的灌装装置及其方法

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US7799273B2 (en) 2004-05-06 2010-09-21 Smp Logic Systems Llc Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes
US7444197B2 (en) 2004-05-06 2008-10-28 Smp Logic Systems Llc Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes
US8802183B2 (en) 2005-04-28 2014-08-12 Proteus Digital Health, Inc. Communication system with enhanced partial power source and method of manufacturing same
CA2789262C (fr) 2005-04-28 2016-10-04 Proteus Digital Health, Inc. Systeme pharma-informatique
WO2010129288A2 (fr) 2009-04-28 2010-11-11 Proteus Biomedical, Inc. Marqueurs d'évènement comestibles à haute fiabilité et leurs procédés d'utilisation
EP2427166B1 (fr) 2009-05-07 2013-10-16 Gea Pharma Systems Limited Module de production de comprimés et procédé de production continue de comprimés
UA109424C2 (uk) * 2009-12-02 2015-08-25 Фармацевтичний продукт, фармацевтична таблетка з електронним маркером і спосіб виготовлення фармацевтичної таблетки
DE102010005780B4 (de) 2010-01-27 2013-07-11 Fette Compacting Gmbh Rundläufer-Tablettenpresse und Verfahren zum Pressen von Tabletten in einer Rundläufer-Tablettenpresse
CN102905672B (zh) 2010-04-07 2016-08-17 普罗秋斯数字健康公司 微型可吞服装置
EP2642983A4 (fr) 2010-11-22 2014-03-12 Proteus Digital Health Inc Dispositif ingérable avec produit pharmaceutique
DE102011050290B4 (de) * 2011-05-11 2013-11-07 Ima Kilian Gmbh & Co.Kg Rundläufer-Tablettenpresse mit Tablettenablauf, Tablettenablauf hierfür, Wiegeeinrichtung hierfür und Verfahren zum Herstellen von Tabletten auf einer Tablettenpresse
US9756874B2 (en) 2011-07-11 2017-09-12 Proteus Digital Health, Inc. Masticable ingestible product and communication system therefor
WO2015112603A1 (fr) 2014-01-21 2015-07-30 Proteus Digital Health, Inc. Produit ingérable pouvant être mâché et système de communication associé
WO2014120669A1 (fr) 2013-01-29 2014-08-07 Proteus Digital Health, Inc. Films polymères hautement dilatables et compositions les contenant
US10175376B2 (en) 2013-03-15 2019-01-08 Proteus Digital Health, Inc. Metal detector apparatus, system, and method
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
EP2965897B1 (fr) 2014-07-10 2018-10-03 I.M.A. INDUSTRIA MACCHINE AUTOMATICHE S.p.A. Machine à presser des comprimés et procédé de production et de pesage de comprimés
US11051543B2 (en) 2015-07-21 2021-07-06 Otsuka Pharmaceutical Co. Ltd. Alginate on adhesive bilayer laminate film
CN109843149B (zh) 2016-07-22 2020-07-07 普罗秋斯数字健康公司 可摄入事件标记的电磁感测和检测
US10820831B2 (en) 2016-10-26 2020-11-03 Proteus Digital Health, Inc. Methods for manufacturing capsules with ingestible event markers
IT201900019649A1 (it) * 2019-10-23 2021-04-23 Ima Spa Macchina comprimitrice e metodo di compressione.

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EP1568480A2 (fr) 2004-02-20 2005-08-31 Fette GmbH Méthode et dispositif pour le contrôle de qualité dans la fabrication de comprimés

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EP1568480A2 (fr) 2004-02-20 2005-08-31 Fette GmbH Méthode et dispositif pour le contrôle de qualité dans la fabrication de comprimés

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2168761A3 (fr) * 2008-09-25 2012-12-12 Fette GmbH Procédé de surveillance de la qualité de matériaux de compression en poudre et une presse rotative destinée à l'exécution du procédé
US8568630B2 (en) 2008-09-25 2013-10-29 Fette Gmbh Rotary press for quality surveillance of powdered pressed material
EP2236274A3 (fr) * 2009-04-04 2012-12-19 Fette GmbH Station de pressage dans une presse rotative
US8453565B2 (en) 2009-04-04 2013-06-04 Fette Gmbh Pressing station in a rotary press
CN102294837A (zh) * 2011-08-04 2011-12-28 安徽中人科技有限责任公司 一种制备小直径颗粒状植入剂的压药机
CN103085310A (zh) * 2011-11-07 2013-05-08 四川汇利实业有限公司 带有进料槽的高效压片机
CN104015395A (zh) * 2014-06-03 2014-09-03 唐伟 一种用于粉末转化为片状、环状和其他异形成品的设备
CN104015395B (zh) * 2014-06-03 2015-09-30 唐伟 一种用于粉末转化为片状、环状和其他异形成品的设备
CN114929464A (zh) * 2020-01-08 2022-08-19 I·M·A·工业机械自动装置股份公司 压片机
US12172401B2 (en) 2020-01-08 2024-12-24 I.M.A. Industria Macchine Automatiche S.P.A. Tablet press machine
EP3900923A1 (fr) * 2020-04-22 2021-10-27 4K Global Holding UG (haftungsbeschränkt) Procédé de fabrication automatisée de comprimés individualisés et presse à comprimés destinée à la fabrication automatisée de comprimés individualisés
WO2021213709A1 (fr) * 2020-04-22 2021-10-28 Ingo Krause Procédé de production automatisée de comprimés individualisés et presse à comprimés pour la production automatisée de comprimés individualisés
CN117281737A (zh) * 2023-11-22 2023-12-26 山西旺龙药业集团有限公司 一种生产诺氟沙星胶囊剂的灌装装置及其方法
CN117281737B (zh) * 2023-11-22 2024-02-02 山西旺龙药业集团有限公司 一种生产诺氟沙星胶囊剂的灌装装置及其方法

Also Published As

Publication number Publication date
DE102006017196B4 (de) 2008-09-11
US20070241127A1 (en) 2007-10-18
EP1844924A3 (fr) 2008-09-03
DE102006017196A1 (de) 2007-10-25
US7471992B2 (en) 2008-12-30
EP1844924B1 (fr) 2014-07-02

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