EP2483658A1 - Procédé et dispositif pour effectuer un test de dureté sur des comprimés - Google Patents

Procédé et dispositif pour effectuer un test de dureté sur des comprimés

Info

Publication number
EP2483658A1
EP2483658A1 EP09783483A EP09783483A EP2483658A1 EP 2483658 A1 EP2483658 A1 EP 2483658A1 EP 09783483 A EP09783483 A EP 09783483A EP 09783483 A EP09783483 A EP 09783483A EP 2483658 A1 EP2483658 A1 EP 2483658A1
Authority
EP
European Patent Office
Prior art keywords
line sensor
support
parallel light
solid substance
substance sample
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.)
Withdrawn
Application number
EP09783483A
Other languages
German (de)
English (en)
Inventor
Christian G. Müller
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.)
Erweka GmbH
Original Assignee
Erweka 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 Erweka GmbH filed Critical Erweka GmbH
Publication of EP2483658A1 publication Critical patent/EP2483658A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
    • G01N3/40—Investigating hardness or rebound hardness
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/88—Investigating the presence of flaws or contamination
    • G01N21/95—Investigating the presence of flaws or contamination characterised by the material or shape of the object to be examined
    • G01N21/9508—Capsules; Tablets
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/0077—Testing material properties on individual granules or tablets
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2203/00—Investigating strength properties of solid materials by application of mechanical stress
    • G01N2203/0058—Kind of property studied
    • G01N2203/0076—Hardness, compressibility or resistance to crushing
    • G01N2203/0085—Compressibility

Definitions

  • the present invention relates to a method and apparatus for performing a hardness test on solid substance samples such as tablets. It is in particular the necessary for carrying out the hardness test alignment of the solid substance sample on a support.
  • Devices for testing the physical properties of objects, for example, of shaped substance samples, such as tablets, for quality control and characterization are known in a great variety of designs. In the vast majority of cases an always constant orientation of the object in relation to the test or measuring device is indispensable because of the reproducibility of the test result. In the pharmaceutical industry, such devices are used, for example, in the quality control of solid drug forms. The determination of dimensioning, hardness and other parameters is of great importance for the quality assurance due to the strict quality requirements in the pharmaceutical sector.
  • a load cell which consists essentially of a break jaws and a stop.
  • the tablet is moved onto a test bench between the jaw and the stop, whereby it is important for a reproducible measurement that the force be applied along a defined tablet axis. Therefore, not only the position but also the orientation of the tablet during the fracture test is important.
  • the orientation of the tablet longitudinal axis is aimed at at right angles to the pressure surfaces of the breaking jaws and stop, ie the surfaces which come into contact with the tablet, for the fracture test.
  • the tablet te preferably positioned at the stop, or the stopper is moved up to the tablet before the test. If the tablet is correctly positioned and aligned, the break jaw is moved against the stop, thereby measuring the force required to break.
  • the patent EP 0 983 495 B1 likewise discloses a device for carrying out hardness tests, in which, in a first step, the tablet is transported onto the test table and then the spatial position of the tablet is determined, for example, by means of a camera. Subsequently, the jaws and stop are moved relative to the (unchanged in its position on the test table) specimen that the direction of movement of the jaw with the preferred axis of the tablet matches. Under preferential axis is to be understood that axis along which the hardness test is to be performed. The stop is then placed in the immediate vicinity of the specimen, before finally driven the break jaw against the stop and measured the force used to break.
  • This is in particular a method, preferably an automatic method, for determining the hardness of solid substance samples, wherein
  • a solid substance sample is conveyed onto a support between a breaking jaw and a stop, and
  • the hardness of the solid substance sample is determined by the break jaw moved towards the stop and the necessary force is measured, the method is characterized in that additionally at least sending out parallel light in the direction of the solid substance sample from one or more light emitters,
  • the parallel light and / or the absence of the parallel light is detected by one or more line sensors,
  • the orientation of the solid substance sample is determined on the basis of the parallel light detected by at least one line sensor and / or on the basis of the absence of the parallel light detected by at least one line sensor,
  • the break jaw and the stopper and / or the support are rotated about an axis which passes through the support and is arranged perpendicular to this until the breaking jaw and the stop against the solid substance sample have reached the position intended for measurement, before finally the Hardness of the solid substance sample is determined.
  • the light sensor part of a line sensor i. the line-shaped arrangements of light sensors (hereinafter: "sensor line”) is preferably less than 100 ⁇ m, and in particular less than 10 ⁇ m or less than 5 ⁇ m wide
  • the line sensor measures with its sensor line preferably no gray levels, but performs only a light / dark rating Compared to a camera that provides analog data, this means a huge reduction in the amount of data and thus a substantial acceleration of the measurement process If no focusing takes place, ie, in contrast to the camera, no test images have to be produced and evaluated and no readjustment is necessary, the amount of data is further reduced.
  • both the break jaw and the stopper and the support are rotated about an axis which passes through the support and is arranged perpendicular to this.
  • the rotation of the support has the advantage that it is easier to accomplish apparatus.
  • the solid substance sample can change its position due to the low friction and the inertia during the movement. It may therefore be advantageous to first rotate the overlay to approximate the position of the break jaw and abutment of the position intended for measurement (in relation to the solid substance sample). Subsequently, the break jaw and the stopper can be rotated to bring them to the position intended for measurement. It is preferred if the angle of rotation of the support is greater than the angle of rotation of the break jaw and the stop.
  • the hardness of the solid substance sample is determined by the break jaw moved towards the stop and the necessary force is measured.
  • the term "force” is preferably used to describe the force itself or Guided sizes are understood. However, it may also be preferred if the term “force” is understood to mean other quantities which allow a conclusion to be drawn about the hardness of the solid substance sample; in particular, these quantities are proportional to the force.
  • the orientation of the solid substance sample is determined, as mentioned above, on the basis of the light detected by the line sensor and / or on the basis of the absence of the parallel light detected by the line sensor. It is not an object of the present invention to set out in detail which type of evaluation is used for this purpose.
  • the person skilled in the art knows how to determine the orientation of the substance sample from data produced by a line sensor. For example, he will use a computer to do this.
  • the person skilled in the art is also able to determine correction data from data on the position of the break jaw and the stop and / or the overlay as well as from the data mentioned for the orientation of the solid substance sample.
  • a control of the device can then take place in order to bring the breaking jaw and the stop against the substance sample in the position provided for the measurement.
  • the stop can be fixed. However, it is preferred if the stop - as well as the break jaws - is mobile, so that it can be approached before the endurance test of the solid substance sample.
  • the object (method / device) according to the invention is particularly preferred if it has one or more of the following features / method steps:
  • the dimensions of the solid substance sample are determined on the basis of the light detected by a line sensor.
  • a line sensor Of particular interest is the height and / or length and / or width of the solid substance sample.
  • the inventive method if it is characterized in that at least one line sensor is moved perpendicular to the support and / or that the support is moved vertically, wherein the line sensor is preferably aligned horizontally.
  • the line sensor passes through the horizontal plane in which the highest point of the substance sample lies, and the height of the solid substance sample is determined on the basis of the parallel light detected by the line sensor and / or on the basis of the absence of parallel light detected by the line sensor.
  • the line sensor and / or the support is moved over a distance which corresponds at least to the height of the solid substance sample.
  • At least one line sensor and / or the support is rotated about an axis which passes through the support and is arranged perpendicular to this and that the length and / or width and / or height and or orientation of the solid substance sample is determined on the basis of the parallel light detected by the line sensor and / or on the basis of the absence of parallel light detected by the line sensor. It is advantageous if during the rotation per 0.1 -1 degrees, preferably per 0.3-0.7 degrees, a detection of parallel light or a measurement by the line sensor takes place.
  • the above method is of particular importance when the line sensor is oriented horizontally and, during rotation, is located in a horizontal plane located between the overlay and the highest point of the compound sample, it being preferred that the line sensor be rotated during the scan Rotation is arranged in a horizontal plane, which is located in the middle between the support and the highest point of the substance sample. It can also be advantageous if the line sensor is arranged during the rotation in a horizontal plane, which forms a sectional area of maximum area with the substance sample. Methods as described are preferred when the line sensor is horizontally aligned and there is at least one other line sensor that is vertically aligned.
  • At least the height of the solid substance sample can be determined on the basis of the parallel light detected by the vertically arranged line sensor and / or on the basis of the absence of the parallel light detected by the vertically arranged line sensor.
  • the inventive method when first the height of the solid substance sample is determined and then the line sensor (either by movement of the line sensor itself or by movement of the support) is moved to that height in which the interface between the solid substance sample and a horizontal plane is maximum. For most tablets or comparable pharmaceutical substance samples, this is half the height, i. the position between the point of contact with the overlay and the highest point of the compound sample. Half the height is therefore also preferred in the context of the present invention. Subsequently, the length and width and / or the orientation of the solid substance sample can be determined as described above.
  • the solid substance sample is positioned by means of a positioning unit (eg slide) on the support and / or transported on the support. It may be preferred if the positioning unit strips off the support and / or the break jaw and the stop after the measurement.
  • the positioning unit is preferably movable horizontally and vertically.
  • the positioning unit is designed as a ring. This cleans the two jaws after the measurement by a horizontal movement over the support and thereby removes the remainder of the tablet from the support (see exemplary embodiment). The tablet can also be weighed on the pad. It may therefore be preferred if the support is designed as a balance for this purpose.
  • the invention also includes an apparatus for determining the hardness of solid substance samples, which has at least the following features:
  • breaking jaw and the stop and / or the support are rotatable about an axis which runs through the support and is arranged perpendicular to the latter
  • the article (method / device) according to the invention is particularly preferred if it has one or more of the following features:
  • the light emitters are preferably punctiform light sources such as laser diodes.
  • Said light emitter and / or the line sensor is preferably arranged laterally of the support and preferably aligned horizontally.
  • the light emitter is preferably located opposite the line sensor, and it is preferred that the light emitter and the line sensor be on opposite sides of the overlay.
  • the light emitter and the line sensor are mounted so that the parallel light of the light emitter can pass directly to the line sensor.
  • the light emitted by the light emitter light is deflected by optical elements, before it is detected by the line sensor.
  • each sensor line has at least 50%, in particular at least 80%, of its length a distance from the optional additional sensor lines. This distance is preferably greater than the width of the sensor line or it is at least 0.1 mm or at least 0.2 mm or at least 0.5 mm or at least 1 mm.
  • the device can be characterized in that at least one line sensor is movable perpendicular to the support and / or that the support is vertically movable, wherein the line sensor is preferably aligned horizontally.
  • the line sensor and / or the support is preferably movable vertically over a distance which corresponds at least to the height of the solid substance sample.
  • the device can be characterized in that at least one line sensor and / or at least one light emitter and / or the support is rotatable about an axis which extends through the support and is arranged perpendicular to this.
  • break jaws, stop, light emitter and line sensors are arranged so that they are movable together.
  • At least one light emitter and / or at least one line sensor can be movable.
  • at least one side of the support arranged light emitter and / or line sensor is designed to be vertically movable and if at least one side of the support arranged light emitter and / or line sensor is rotatable about an axis which extends through the support and arranged perpendicular to this is. This makes it possible first to determine the height of the solid substance sample (see method above) before the light emitter or the light sensor is moved to half the height of the substance sample and then the substance sample is orbited to determine the orientation and the length or Width of the same to determine.
  • the present invention may be an above-mentioned device even if the line sensor is oriented horizontally, preferably at least one further line sensor is vertically aligned. It is preferred if the device has a positioning unit for positioning the solid substance sample on the support and / or for transporting the solid substance sample onto the support, wherein the positioning unit is preferably arranged and configured such that it supports the support and / or the break jaw and can strip off the stopper and / or so that it can remove the solid substance sample or parts thereof from the pad.
  • the device may have a balance.
  • the support may be a weighing plate.
  • the device has at least one evaluation electronics (for example a computer or a microcontroller) or at least one interface for connection to an evaluation electronics.
  • evaluation electronics for example a computer or a microcontroller
  • the evaluation electronics can determine correction data. By means of this correction data, it is then possible for the evaluation electronics to control the rotation of the breaking jaw and of the abutment and / or the rotation of the support, so that the breaking jaw and the abutment with respect to the solid substance sample reach the position intended for the measurement.
  • the position of the break jaw and the stop provided for the measurement depends on the axis along which the force is to be applied to the solid substance sample. This in turn depends on the shape of the substance sample. This is usually the longitudinal axis of the substance sample. The jaw and stop must be aligned parallel to the axis of the substance sample before the measurement.
  • the solid substance sample is preferably a compressed substance sample and / or a pharmaceutical substance sample and / or a drug formulation and / or a tablet or a capsule or a suppository or a dragee.
  • the solid substance sample may, for example, also be a detergent tablet or a fertilizer tablet.
  • FIGS. 1 to 7 show a device according to the invention in various stages of carrying out a hardness test on a solid substance sample (here: tablet).
  • the illustrated process of hardness testing also includes the prior determination of the orientation of the tablet and its measurement.
  • Figs. 1, 4, 5, and 7 are shown in plan view, while Figs. 2, 3 and 6 represent the side view of a device according to the invention.
  • 1, 2, 3, 4, 5, 6 and 7 show the performance of a hardness test on a solid substance sample (here: tablet) with prior determination of the orientation and measurement of tablet dimensions.
  • the measuring station (see Fig.1, top view) with break jaws (1), stop (2), support (3), light emitter (4) and line sensor (5) is placed in the test device below the pan (not shown), so that After weighing, the tablets can fall into the measuring station.
  • the positioning unit (7) is moved down. The weighing pan is opened and the tablet (6) falls into the positioning unit (7). As shown in Figure 2 (side view), the positioning unit (7) then moves to the upper position.
  • the measuring unit with the line sensor (5) and the light emitter (4) is moved upward to detect the highest point of the tablet (6) and thus also to measure the thickness (ie height) of the tablet (6). Then the measuring unit moves to the middle (half height) of the tablet (6) ( Figure 3, side view). 4 shows how the complete unit with break jaws (1), stop (2), light emitter (4) and line sensor (5) 360 ° around the support (3) is rotated. During this rotation, the width and the length of the tablet (6) are measured and the position / orientation of the tablet (6) on the support (3) is detected. As shown in Fig. 5, the break jaw (1) and the stopper (2) are positioned in the longitudinal direction of the tablet (6).
  • FIGS. 6 and 7 respectively show, in side view and top view, how the broken tablet (6) is removed from the support by means of the positioning unit (7), thus making the device ready for a new measurement. This also means that the positioning unit (7) is shut down. This then pushes the tablet fragments into a waste container (not shown) and simultaneously strips the break jaw (1), the stop (2) and the support (3), or cleans them.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Length Measuring Devices By Optical Means (AREA)

Abstract

L'invention concerne un procédé pour déterminer la dureté d'échantillons de substance solide et un dispositif pour sa mise en oeuvre. Un échantillon de substance solide (6) est transporté sur un support (3) entre une mâchoire de fracture (1) et une butée (2) dans le cadre du procédé. Le procédé est caractérisé en ce que de la lumière parallèle est envoyée par un émetteur de lumière (4) en direction de l'échantillon de substance solide (6) et la lumière parallèle et/ou l'absence de lumière parallèle est détectée par un capteur de lignes (5). Ensuite, l'orientation de l'échantillon de substance solide (6) est déterminée sur la base de la lumière parallèle détectée par le capteur de lignes (5) et/ou sur la base de l'absence de lumière parallèle détectée par le capteur de lignes. Puis la mâchoire de fracture (1) et la butée (2) et/ou le support (3) sont amenés à tourner autour d'un axe qui s'étend à travers le support (3) et est disposé perpendiculairement à celui-ci jusqu'à ce que la mâchoire de fracture (1) et la butée (2) aient atteint la position prévue pour la mesure par rapport à l'échantillon de substance solide (6). Enfin, la dureté de l'échantillon de substance solide (6) est déterminée, en ce sens que la mâchoire de fracture (1) est mue en direction de la butée (2) et la force nécessaire pour ce faire est mesurée.
EP09783483A 2009-09-28 2009-09-28 Procédé et dispositif pour effectuer un test de dureté sur des comprimés Withdrawn EP2483658A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2009/062524 WO2011035818A1 (fr) 2009-09-28 2009-09-28 Procédé et dispositif pour effectuer un test de dureté sur des comprimés

Publications (1)

Publication Number Publication Date
EP2483658A1 true EP2483658A1 (fr) 2012-08-08

Family

ID=42167558

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09783483A Withdrawn EP2483658A1 (fr) 2009-09-28 2009-09-28 Procédé et dispositif pour effectuer un test de dureté sur des comprimés

Country Status (2)

Country Link
EP (1) EP2483658A1 (fr)
WO (1) WO2011035818A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2771640B1 (fr) 2011-10-25 2021-01-20 Sotax Ag Dispositif d'essai de tablette
EP2587261A1 (fr) 2011-10-25 2013-05-01 Pharmatron AG Station de test de comprimés
DE102013015582B3 (de) * 2013-09-20 2014-10-16 Thilo Kraemer Prüfgerät zum Durchführen einer Härtemessung an Prüflingen
DE102013113126B3 (de) 2013-11-27 2014-12-31 Erweka Gmbh Verfahren und Vorrichtung zur Prüfung von Tabletten
DE102015109377B4 (de) 2015-06-12 2018-11-08 Thilo Kraemer Prüfvorrichtung für Tabletten
DE202015009582U1 (de) 2015-09-01 2018-05-29 Erweka Gmbh Vorrichtung zur Prüfung von Tabletten
EP3524976A1 (fr) 2018-02-08 2019-08-14 Erweka GmbH Dispositif et procédé d'étalonnage de la vitesse et de la résistance à la rupture d'un appareil d'essai de comprimés

Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2009115311A1 (fr) * 2008-03-19 2009-09-24 Thomas Kollewe Procédé et dispositif de détermination de la position et de l'orientation d'un échantillon

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DE9116289U1 (fr) * 1991-07-23 1992-08-06 Advanced Nuclear Fuels Gmbh, 4450 Lingen, De
DE4312550C1 (de) * 1993-04-17 1994-09-15 Hpf Hans P Friedrich Elektroni Vorrichtung zur Bewertung von sich fortbewegenden Objekten
ES2171034T3 (es) * 1997-05-23 2002-08-16 Norbert Kramer Procedimiento y dispositivo para la realizacion de una prueba de dureza en muestras de prueba, especialmente en comprimidos o pildoras.
ITBO20020433A1 (it) * 2002-07-04 2004-01-05 Ima Spa Metodo per il controllo optoelettronico di articoli farmaceutici
DE202008010270U1 (de) * 2008-07-31 2008-10-09 Pharma Test Apparatebau Gmbh Vorrichtung zur Durchführung des Härtetests von Prüflingen

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WO2009115311A1 (fr) * 2008-03-19 2009-09-24 Thomas Kollewe Procédé et dispositif de détermination de la position et de l'orientation d'un échantillon

Non-Patent Citations (1)

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Title
See also references of WO2011035818A1

Also Published As

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