EP1216680B1 - Procédé d'estampage rotatif et coin de remplissage pour fabrication de capsules, notamment de capsules molles - Google Patents

Procédé d'estampage rotatif et coin de remplissage pour fabrication de capsules, notamment de capsules molles Download PDF

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Publication number
EP1216680B1
EP1216680B1 EP00811211A EP00811211A EP1216680B1 EP 1216680 B1 EP1216680 B1 EP 1216680B1 EP 00811211 A EP00811211 A EP 00811211A EP 00811211 A EP00811211 A EP 00811211A EP 1216680 B1 EP1216680 B1 EP 1216680B1
Authority
EP
European Patent Office
Prior art keywords
wedge
filling
capsules
filling wedge
cooling
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 - Lifetime
Application number
EP00811211A
Other languages
German (de)
English (en)
Other versions
EP1216680A1 (fr
Inventor
Leo Stolz
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.)
Swiss Caps Rechte und Lizenzen AG
Original Assignee
Swiss Caps Rechte und Lizenzen AG
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
Priority to AT00811211T priority Critical patent/ATE320237T1/de
Application filed by Swiss Caps Rechte und Lizenzen AG filed Critical Swiss Caps Rechte und Lizenzen AG
Priority to DE50012405T priority patent/DE50012405D1/de
Priority to EP00811211A priority patent/EP1216680B1/fr
Priority to ES00811211T priority patent/ES2257998T3/es
Priority to PCT/CH2001/000711 priority patent/WO2002049572A1/fr
Priority to JP2002550916A priority patent/JP2004520104A/ja
Priority to US10/432,507 priority patent/US6935090B2/en
Priority to AU1810402A priority patent/AU1810402A/xx
Publication of EP1216680A1 publication Critical patent/EP1216680A1/fr
Application granted granted Critical
Publication of EP1216680B1 publication Critical patent/EP1216680B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B9/00—Enclosing successive articles, or quantities of material, e.g. liquids or semiliquids, in flat, folded, or tubular webs of flexible sheet material; Subdividing filled flexible tubes to form packages
    • B65B9/02—Enclosing successive articles, or quantities of material between opposed webs
    • B65B9/023—Packaging fluent material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use

Definitions

  • This invention relates to a rotary die process for making capsules, in particular soft capsules, according to the preamble of claim 1.
  • This rotating mold roll process has been known and used for many years and today represents one of the most widespread encapsulation processes for the preparation of pharmaceutical, dietetic and technical capsules.
  • Conventional rotary-die methods are described, for example, in "The Capsule",ticianliche Verlagsgesellschaft MBH, Stuttgart, 1983.
  • a prerequisite for the formation of the capsules between the two forming rollers is to achieve a sufficiently high temperature for the welding of the two bands of material to form a seamless capsule.
  • the wedge temperature is about 43 ° C +/- 5 ° C. It is already known to arrange a heater within the filling wedge to maintain the desired sealing temperature.
  • the heating device may be heating cartridges inserted into the filling wedge or tubes for passing a liquid heating medium, as e.g. in EP-A-227 060 is described.
  • US Pat. No. 4,662,155 discloses a rotary die process for gelatine capsules and a corresponding filling wedge, in which the contents can be protected from the potentially harmful influence of air by means of an inert gas.
  • the filling wedge to the supply channel approximately parallel to the wedge surface extending channels.
  • This object is achieved according to the invention with a method having the features in claim 1. It has surprisingly been found that despite the narrow spatial conditions in the filling wedge with a reduction of heat transfer high temperature differences between the product and material strips can be maintained.
  • the heat transfer can be reduced by the cooling medium, which is passed through the cooling channel between the feed channel in the filling wedge and the wedge surface. It may be a liquid or a gaseous cooling medium. It would of course also conceivable that the cooling channel extends concentrically around each supply channel to ensure the highest possible heat dissipation.
  • the cooling medium can circulate in a cooling circuit and be cooled down again after flowing through the cooling channel in a heat exchanger.
  • a constantly renewing Cooling medium such as tap water or ambient air to be passed through the cooling circuit.
  • the heating of the wedge surface facing portion of the filling wedge can be done with different heaters. If the heating with a liquid heating means, even a coupling with the cooling circuit would be conceivable by the heated coolant is completely or partially supplied to the heating circuit before cooling takes place at the heat exchanger.
  • the region of the filling wedge facing the feed channel is kept at an operating temperature of less than 50 ° C. and, in addition, if the temperature difference between the region facing the feed channel and the region facing the wedge surface the filling wedge is at least 10 ° C.
  • the invention also relates to a filling wedge for a machine for producing capsules, in particular of soft capsules, having the features in claim 8.
  • a filling wedge for a machine for producing capsules, in particular of soft capsules, having the features in claim 8.
  • the thermal separation at the filling wedge can be achieved by the at least one heat-insulating cavity which extends over the width of the filling wedge.
  • the cavity may be formed as a cooling channel, which is connected to a coolant source.
  • the cavity may be part of a cooling circuit, wherein the heat dissipated is discharged again and again to a heat exchanger.
  • a liquid or a gaseous coolant can be passed.
  • Conceivable coolants would be eg oil, water, glycols or nitrogen.
  • the heat-insulating cavity could be evacuated to reduce the thermal conductivity, but also before use or it could be filled with special gases to improve the insulating effect.
  • the heating device is moved as far away as possible from the supply channels and as close as possible to the wedge surface.
  • This is particularly advantageous possible, with a flat, electrical resistance heating, which extends directly in or below the wedge surface.
  • the principle of such a heater corresponds approximately to that of the rear window heating in cars.
  • the heating wires or heating tracks can be laid directly under the sliding layer of the wedge surface.
  • FIG. 1 shows a rotary die machine 16 used for the processing of two thermoplastic material endless belts 2, 2 '.
  • the material strips are extruded at the extruders 17, 17 'of slot dies and each with a pair of rollers 18, 18' withdrawn and rolled to the correct thickness.
  • the encapsulation process known per se is shown in more detail in FIG.
  • the two oppositely rotating forming rolls 3, 3 ' connect the material strips 2, 2' brought to melting temperature to seamless capsules 1, these being simultaneously separated from the remaining material strip or net 22.
  • the filling wedge 4 with the supply channel 5 is arranged in the gusset of the two forming rollers and extends into the self-closing capsules.
  • the filling material 6 in the filling material tank 19 is supplied via a metering pump 21, wherein the amount can be adjusted at a metering valve 20.
  • the filling material is a powdery substance
  • a special feeding mechanism is used, as described, for example, in JP-A-10-211257.
  • the filling wedge 4 according to FIG. 3 has concave wedge surfaces 12, 12 'adapted to the outer shell of the forming rolls. These surfaces are preferably provided with a Teflon coating.
  • a plurality of supply channels 5 extend to the tip of the filling wedge. Between these feed channels and the wedge surfaces, a planar cooling channel 8, 8 'is arranged on both sides. Holes are arranged close to the wedge surfaces, which extend over the entire width of the filling wedge and which can be filled with heating cartridges 13. Also in the region of the wedge surfaces temperature sensors 15 are arranged.
  • the supply channels 5 are additionally separated from the heating cartridges 13 by step-like cavities 7, 7 '.
  • a cover plate 23 is screwed onto the filling wedge. This simultaneously forms the upper end of the cooling channels 8, 8 'and the cavities 7, 7', but contains holes which expose the supply channels 5.
  • the cooling channels 8, 8 ' can be flowed through by a liquid coolant.
  • the cavities 7, 7 ' form a natural barrier to the transfer of heat, whereby it would of course be conceivable to carry off heat also via the cavities, for example by blowing in ambient air with a ventilator.
  • the heat transfer reducing means it is obviously possible to maintain a relatively high temperature difference between the wedge surfaces 12, 12 'and the supply channels 5 and thus also to process temperature-sensitive filling goods.
  • the temperature difference between medium (25 ° C) and wedge surface (80 ° C) can thus be> 50 ° C.
  • the filling wedge according to FIG. 4 has a similar structure as in the exemplary embodiment according to FIG. 3.
  • the heating of the wedge surfaces 12, 12 'does not take place via heating cartridges, but via a planar resistance heater 14, which is arranged directly on the wedge surface. It may be meandering arranged heating tracks, which can be applied in a suitable manner.
  • the heating source is further away from the supply channels 5 and the heat of the heater is delivered directly where it is needed, namely on the wedge surfaces 12, 12 '.
  • the cross-sectional shape of the filling wedge can be designed differently and it is particularly possible to form the cavity 7 substantially larger. In the illustrated embodiment, no additional cooling channel is provided and the cooling takes place exclusively on the cavity 7.
  • the temperature sensor 15 is also laid directly in the wedge tip.
  • FIG. 5 shows schematically the interaction of the filling wedge 4 with the means for heating or cooling.
  • Thedeholraum 7 is integrated into a cooling circuit 9, which is supplied from a coolant source 11 with coolant 10.
  • the circulation takes place via a coolant pump 24.
  • a heat exchanger 25 is provided for the re-cooling of the heated coolant.
  • the coolant pump 24 can be controlled via the temperature sensors 15 arranged in the filling wedge.
  • the electrical resistance heaters 14 on the wedge surfaces are connected to a circuit 26 connected via a transformer 27 is supplied with electrical energy.
  • the power supply can also be controlled or controlled via the temperature sensors 15.
  • the closure plate 31 is designed as a slide which can be raised and lowered on the vertical guides 29 in the direction of arrow a.
  • individual injection pipes 30 are arranged, via which the supply of the filling material takes place.
  • Each injection tube is provided at its end with a conical sealing seat which cooperates with a corresponding seat 32 on the inside of the filling wedge. From there, a relatively short supply channel 5 leads to both sides of the wedge surfaces 12, 12 '. By a slight bias of the injection pipes 30 a tight connection is ensured at the conical valve seat.
  • the cavity 7 surrounding the injection pipes 30 can be charged with a gaseous cooling medium.
  • a gaseous cooling medium Located below the wedge surfaces 12, 12 'eroded cavities 28 are arranged, which can accommodate a flexible resistance heating element. Of course, additional holes could be arranged for a liquid coolant in the filling wedge.
  • FIGS. 8 and 9 show a possibility of how liquid coolant can be guided via a laterally arranged connection plate 33 to the narrow, chess-like cooling channels 8, 8 '.
  • the connection plate 33 is screwed laterally to the filling wedge 4 via suitable fastening means.
  • a system of cooling holes 34 connects to the laterally exposed cooling channels 8, 8 '.
  • the cooling channels are sealed by the cover plate, not shown here. At both end faces of the filling wedge such distribution plates can be arranged.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Medicinal Preparation (AREA)
  • Moulds For Moulding Plastics Or The Like (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (16)

  1. Procédé à outil rotatif pour fabriquer des capsules (1), en particulier des capsules molles, selon lequel au moins deux bandes de matière (2, 2') sont réunies grâce à des rouleaux profilés (3, 3') qui tournent en sens inverse, et sont transformées en capsules, un produit de remplissage (6) étant amené entre les bandes de matière qui se ferment pour former les capsules, par l'intermédiaire d'un coin de remplissage (4) disposé dans la zone d'alimentation des rouleaux profilés, à travers au moins un conduit d'amenée (5),
    caractérisé en ce qu'entre le conduit d'amenée (5) et au moins une surface de coin (12, 12') tournée vers une bande de matière, le transfert de chaleur est réduit grâce à des moyens actifs de telle sorte qu'un agent réfrigérant (10) est amené par au moins un conduit de refroidissement (8) entre le conduit d'amenée (5) et ladite surface de coin, le conduit de refroidissement s'étendant sur la surface de la largeur du coin de remplissage.
  2. Procédé selon la revendication 1, caractérisé en ce que l'agent réfrigérant (10) circule dans un circuit de refroidissement (9) et est à nouveau refroidi dans un échangeur de chaleur (25) après avoir traversé le conduit de refroidissement (8).
  3. Procédé selon la revendication 1 ou 2, caractérisé en ce que la zone du coin de remplissage (4) tournée vers la surface de coin (12, 12') est chauffée à l'aide d'un dispositif de chauffage (13, 14).
  4. Procédé selon l'une des revendications 1 à 3, caractérisé en ce que la zone du coin de remplissage (4) tournée vers le conduit d'amenée (5) est maintenue à une température de fonctionnement inférieure à 50°C.
  5. Procédé selon l'une des revendications 1 à 4, caractérisé en ce qu'à l'aide de l'agent réfrigérant, une différence de température d'au moins 10°C est maintenue entre la zone tournée vers le conduit d'amenée et la zone du coin de remplissage tournée vers la surface de coin.
  6. Procédé selon l'une des revendications 1 à 5, caractérisé en ce que les bandes de matière (2, 2') se composent d'une masse contenant de l'amidon et en ce qu'elles sont formées par extrusion avant d'arriver entre les rouleaux profilés (3, 3').
  7. Procédé selon la revendication 6, caractérisé en ce que la température de fusion pour la liaison des deux bandes de matière entre les rouleaux profilés est d'au moins 50°C.
  8. Coin de remplissage (4) pour une machine (16) pour fabriquer des capsules, en particulier des capsules molles selon le procédé à outil rotatif, avec deux surfaces de coin (12, 12') de préférence concaves et au moins un conduit d'amenée (5) qui s'étend entre les surfaces de coin, pour l'éjection du produit de remplissage (6),
    caractérisé en ce qu'il est prévu entre le conduit d'amenée (5) et au moins une surface de coin (12, 12') au moins une cavité calorifuge (7, 8) qui réduit le transfert de chaleur, la cavité s'étendant sur la surface de la largeur du coin de remplissage.
  9. Coin de remplissage selon la revendication 8, caractérisé en ce que la cavité est constituée par un conduit de refroidissement (8) qui est apte à être raccordé à une source d'agent réfrigérant (11).
  10. Coin de remplissage selon la revendication 9, caractérisé en ce que la cavité (8) fait partie d'un circuit de refroidissement (9) qui est apte à être raccordé à au moins un échangeur de chaleur (25).
  11. Coin de remplissage selon l'une des revendications 8 à 10, caractérisé en ce qu'il est prévu en plus de la cavité (8) apte à être raccordée à une source d'agent réfrigérant au moins une autre cavité (7).
  12. Coin de remplissage selon l'une des revendications 8 à 11, caractérisé en ce qu'il est prévu entre la cavité qui réduit le transfert de chaleur et la surface de coin (12, 12') un dispositif de chauffage (13, 14).
  13. Coin de remplissage selon la revendication 12, caractérisé en ce que le dispositif de chauffage est constitué par au moins une cartouche chauffante (13) disposée dans un perçage.
  14. Coin de remplissage selon la revendication 13, caractérisé en ce que le dispositif de chauffage est constitué par au moins un chauffage à résistance électrique plan qui s'étend directement dans ou sous la surface de coin (12, 12').
  15. Coin de remplissage selon l'une des revendications 12 à 14, caractérisé en ce qu'il est prévu sur le coin de remplissage au moins un capteur de température (15) par l'intermédiaire duquel la puissance de chauffage du dispositif de chauffage et/ou la puissance de refroidissement d'un dispositif de refroidissement sont réglables.
  16. Machine (16) pour fabriquer des capsules, en particulier des capsules molles selon le procédé à outil rotatif, avec au moins un coin de remplissage (4) selon l'une des revendications 8 à 15 et au moins deux rouleaux profilés aptes à tourner en sens inverse et destinés à réunir au moins deux bandes de matière (2, 2') et à les transformer en capsules.
EP00811211A 2000-12-20 2000-12-20 Procédé d'estampage rotatif et coin de remplissage pour fabrication de capsules, notamment de capsules molles Expired - Lifetime EP1216680B1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
DE50012405T DE50012405D1 (de) 2000-12-20 2000-12-20 Rotary-Die-Verfahren und Füllkeil zum Herstellen von Kapseln, insbesondere Weichkapseln
EP00811211A EP1216680B1 (fr) 2000-12-20 2000-12-20 Procédé d'estampage rotatif et coin de remplissage pour fabrication de capsules, notamment de capsules molles
ES00811211T ES2257998T3 (es) 2000-12-20 2000-12-20 Procedimiento de troquelado rotatorio y cuña de llenado para fabricar capsulas, en especial capsulas blandas.
AT00811211T ATE320237T1 (de) 2000-12-20 2000-12-20 Rotary-die-verfahren und füllkeil zum herstellen von kapseln, insbesondere weichkapseln
PCT/CH2001/000711 WO2002049572A1 (fr) 2000-12-20 2001-12-13 Procede a matrice rotative et cale de remplissage destinee a la production de capsules, notamment de capsules souples
JP2002550916A JP2004520104A (ja) 2000-12-20 2001-12-13 カプセル、特にソフトカプセルを製造するためのロータリー式ダイ法及び充填用ウェッジ
US10/432,507 US6935090B2 (en) 2000-12-20 2001-12-13 Rotary-die-method and fill wedge for producing capsules, in particular soft capsules
AU1810402A AU1810402A (en) 2000-12-20 2001-12-13 Rotary-die-method and fill wedge for producing capsules, in particular soft capsules

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP00811211A EP1216680B1 (fr) 2000-12-20 2000-12-20 Procédé d'estampage rotatif et coin de remplissage pour fabrication de capsules, notamment de capsules molles

Publications (2)

Publication Number Publication Date
EP1216680A1 EP1216680A1 (fr) 2002-06-26
EP1216680B1 true EP1216680B1 (fr) 2006-03-15

Family

ID=8175086

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00811211A Expired - Lifetime EP1216680B1 (fr) 2000-12-20 2000-12-20 Procédé d'estampage rotatif et coin de remplissage pour fabrication de capsules, notamment de capsules molles

Country Status (8)

Country Link
US (1) US6935090B2 (fr)
EP (1) EP1216680B1 (fr)
JP (1) JP2004520104A (fr)
AT (1) ATE320237T1 (fr)
AU (1) AU1810402A (fr)
DE (1) DE50012405D1 (fr)
ES (1) ES2257998T3 (fr)
WO (1) WO2002049572A1 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6949256B2 (en) 2002-01-18 2005-09-27 Banner Pharmacaps, Inc. Non-gelatin capsule shell formulation
US7887838B2 (en) 2002-01-18 2011-02-15 Banner Pharmacaps, Inc. Non-gelatin film and method and apparatus for producing same
JP2005170863A (ja) * 2003-12-12 2005-06-30 Nippon Starch Chemical Co Ltd デンプン組成物を用いた軟カプセル剤、その製造方法およびその製造用自動機
CA2737880A1 (fr) * 2008-09-26 2010-04-01 Sankyo Co., Ltd. Procede de fabrication d'une capsule molle et appareil pour ce faire
US8727754B2 (en) 2009-03-26 2014-05-20 Swiss Caps Rechte Und Lizenzen Ag Method and device for producing soft capsules
CA2817959A1 (fr) * 2010-07-19 2012-01-26 Procaps Sa Appareil et procede ameliores pour la fabrication de capsules a enveloppe molle
CN107530358B (zh) 2015-04-23 2021-08-06 巴斯夫欧洲公司 含有甾醇和增溶剂的凝胶胶囊
AU2017382322B2 (en) 2016-12-23 2023-04-06 R.P. Scherer Technologies, Llc Multiple-fill/chamber softgel die
CA3069207C (fr) * 2019-05-01 2022-10-18 Paul Lukas Procedes et systemes de marquage laser de capsules pharmaceutiques pendant la fabrication
WO2022129002A1 (fr) 2020-12-15 2022-06-23 Dsm Ip Assets B.V. Dispersion grossière comprenant de la statine et de l'huile de vitamine e
BR112023018888A2 (pt) * 2021-03-17 2023-12-05 Procaps Sa Placa distribuidora e segmento de cunha de enchimento, máquina para fabricar cápsulas, processo de moldagem em matriz rotativa, e, cápsula gelatinosa livre de bolhas de ar

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Publication number Priority date Publication date Assignee Title
US3269088A (en) * 1963-09-09 1966-08-30 Scherer Corp R P Apparatus for making fluid filled capsules
US4662155A (en) * 1983-10-06 1987-05-05 Chasman Sydney A Method and apparatus for forming capsules
US6482516B1 (en) * 1993-07-20 2002-11-19 Banner Pharmacaps, Inc. Enrobed tablet
WO2000028976A1 (fr) * 1998-11-16 2000-05-25 A.B. Technologies, L.L.C. Capsules souples a alveoles multiples et procede de fabrication associe
YU33001A (sh) * 1998-11-17 2004-05-12 F. Hoffmann-La Roche Ag. Postupak za proizvodnju kapsula punjenih tečnim supstancama
US6340473B1 (en) * 1999-07-07 2002-01-22 R.P. Scherer Technologies, Inc. Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same

Also Published As

Publication number Publication date
US20040060258A1 (en) 2004-04-01
US6935090B2 (en) 2005-08-30
EP1216680A1 (fr) 2002-06-26
AU1810402A (en) 2002-07-01
DE50012405D1 (de) 2006-05-11
JP2004520104A (ja) 2004-07-08
ATE320237T1 (de) 2006-04-15
WO2002049572A1 (fr) 2002-06-27
ES2257998T3 (es) 2006-08-16

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