EP1249219B1 - Verfahren und Vorrichtung zum Herstellen von Formkörpern aus einem biopolymeren Material - Google Patents

Verfahren und Vorrichtung zum Herstellen von Formkörpern aus einem biopolymeren Material Download PDF

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Publication number
EP1249219B1
EP1249219B1 EP00128701A EP00128701A EP1249219B1 EP 1249219 B1 EP1249219 B1 EP 1249219B1 EP 00128701 A EP00128701 A EP 00128701A EP 00128701 A EP00128701 A EP 00128701A EP 1249219 B1 EP1249219 B1 EP 1249219B1
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EP
European Patent Office
Prior art keywords
strip
heat treatment
material strip
tool
shaped bodies
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
EP00128701A
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German (de)
English (en)
French (fr)
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EP1249219A1 (de
Inventor
Alois Peter
Rico Ménard
Valentin Lutz
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
Application filed by Swiss Caps Rechte und Lizenzen AG filed Critical Swiss Caps Rechte und Lizenzen AG
Priority to AT00128701T priority Critical patent/ATE446075T1/de
Priority to DE50015770T priority patent/DE50015770D1/de
Priority to EP00128701A priority patent/EP1249219B1/de
Priority to ES00128701T priority patent/ES2334973T3/es
Priority to PCT/EP2001/014837 priority patent/WO2002053088A1/de
Priority to US10/451,936 priority patent/US20040071808A1/en
Publication of EP1249219A1 publication Critical patent/EP1249219A1/de
Application granted granted Critical
Publication of EP1249219B1 publication Critical patent/EP1249219B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • 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

  • the invention relates to a method and an apparatus for producing shaped articles, in particular capsules, from a biopolymer material, in particular based on starch, according to the preamble of the independent claims 1 and 8.
  • Shaped bodies, in particular capsules, are today produced in continuous, automatable processes from endless material strips.
  • the production of the shaped body shell and the filling of the same happens, in particular in one-piece capsules, in a single step.
  • moldings are made, from which the capsule shells are assembled during and after filling by welding the outer edges of the moldings.
  • the molding is done either by means of diverging and merging forms, e.g. in the Norton, Banner and Schering processes or by means of rotating forming rolls, as e.g. in the rotary-die process and in the accordogel process ("The Capsule” Fahrig / Hofer, Stuttgart, 1983, Lachmann / Liebermann / Kanig, "The Theory and Practice of Industrial Pharmacy", Third Edition, Philadelphia 1986).
  • the filling takes place with the aid of metering pumps, which deliver a defined amount of active substance during the punching and welding of the molded parts to form a one-piece capsule shell.
  • Welding i.
  • the seams
  • the production process for moldings made of endless material straps makes a number of demands.
  • One of the main requirements is the ability to use endless material belts To form a sufficient strength, which have a sufficient elongation at break and elasticity.
  • Gelatin bands in particular for soft gelatine capsules, can be prepared from a homogeneous mass of gelatin and water which is readily flowable at 40 ° C. to 80 ° C., which usually also contains additives such as glycerol and sorbitol. This is done at atmospheric pressure, where the mass of so-called spreaders is gravity poured or extruded through a slot on a cooled drum. The mass should solidify at about 15 ° C to 25 ° C (gel state). At lower extrusion temperatures, the water content must be increased to lower the melting point and viscosity, or extrusion under pressure must be performed. At extrusion temperatures above 100 ° C there is a risk that the mixture foams on exiting from the so-called spreader.
  • EP 0 397 819 a process for producing thermoplastically processable starch, wherein the crystalline fraction in the starch is less than 5%.
  • the process consists of mixing native starch with at least 10% by weight of an aggregate having a solubility parameter of at least 30.7 (MPa) 1/2 .
  • the mixture is transferred under heat in a temperature range between 120 ° C and 220 ° C in a melt, wherein an internal pressure of about 30 to 300 bar can be assumed.
  • the water content of the starch is already reduced to less than 5% in the melt.
  • the starch film which after the in EP 397 819
  • the disclosed method does not show the weldability or seam strength, which would meet the quality requirements of one-piece molded body shells, in particular capsule shells.
  • a method and an apparatus for producing Formed bodies are made of endless belts based on biopolymers, which allow the production of reproducible moldings, especially when the base mass of the belts is extruded under pressure and / or at high temperatures.
  • the material band between the extrusion die and the die is subjected to at least one heat treatment to reduce stresses at a treatment station.
  • the temperature for the heat treatment must be selected so that the desired relaxation of the material bands results and the belt can be controlled without further stress build-up. This temperature depends on the process and the material.
  • the desired relaxation in the context of the invention is achieved when the strip after the heat treatment no longer anisotropic but has isotropic mechanical properties, so that the mechanical properties of the strip in the longitudinal direction and in the transverse direction to a good approximation are identical.
  • a definition for the term pair "anisotropic / isotropic" can be found in Römpp Chemie Lexikon, ed.: J. Falbe, M. Regitz, 9th edition, 1992, Georg Thieme Verlag, Stuttgart.
  • the tapes treated according to the invention thus also have a uniform elongation at break and a uniform elastic modulus E over the entire material strip.
  • an elongation at break of at least 100% and a modulus of elasticity of less than or equal to 2 MPa in the temperature range from 40 ° C. to 80 ° C. are particularly advantageous.
  • the measurement of the elongation at break and the modulus of elasticity E can be carried out according to DIN standard 53455 or DIN EN ISO 527-1 to ISO 527-3.
  • the elongation at break is measured according to this DIN standard at the corresponding encapsulation temperature.
  • At least one material strip is extruded and then subjected to heat at a treatment arrangement.
  • a treatment arrangement it is also possible to extrude a plurality of material strips and then to subject them to a heat treatment.
  • molded body is to be understood as meaning any type of molded article which is suitable for receiving a filling material and sealingly enclosing it in the interior.
  • This includes not only capsules but also other forms such. B. balls, pillows and figures.
  • B. balls, pillows and figures To date, there are numerous developments and deviations from the basic principle of the capsule.
  • Biopolymers materials in the context of the invention are all materials that can be extruded by suitable methods to endless material bands. According to the invention, this also includes physically and / or chemically modified biopolymers. Examples of biopolymers according to the invention are cellulose, in particular partially hydroxypropylated cellulose, alginates, carrageenan, galactomannans, glucomannans, casein and starch. Likewise, mixtures of different biopolymer materials within the meaning of the invention are conceivable.
  • starch should be understood to mean native starches as well as physically and / or chemically modified starches.
  • all starches irrespective of the plant from which they are obtained, are suitable.
  • it is starch whose amylopectin content is more than 50% based on the total weight of the anhydrous starch.
  • Potato starch is particularly suitable.
  • the process according to the invention can be an integral part of a known process for the production of moldings from endless bands of material, such as e.g. the Norton, Banner and Schering process or the methods by means of rotating forming rolls, e.g. realized in the Rotary-Die process and in the Accogel process ("The capsule” Fahrig / Hofer, editors, Stuttgart, 1983, Lachmann / Liebermann / Kanig, "The Theory and Practice of Industrial Pharmacy", Third Edition, Philadelphia 1986).
  • At least two material strips are processed according to the Rotary-Die principle into moldings, wherein each of the material strips is subjected to at least one heat treatment between extrusion and processing into moldings at a treatment station.
  • the Rotary Die process with rotating forming rolls has been known and used for many years and today represents one of the most widespread encapsulation processes for the production of pharmaceutical, dietetic and technical shaped bodies.
  • the endless material bands are applied to both sides with heat.
  • the heat treatment can be effected by radiation, in particular by IR radiation.
  • IR radiation in particular by IR radiation.
  • the use of ultrasound, microwave and other suitable radiation sources for heating is conceivable.
  • the material bands are passed to a radiator or through a preheated cavity of a treatment arrangement, in particular passed through a heating tunnel.
  • the material strips are passed through a heatable bath, in particular an oil bath.
  • a heatable bath in particular an oil bath.
  • the bath temperature is preferably maintained in a range between 40 ° C and 80 ° C.
  • the tension of the material strips is kept constant with a compensating means, in particular with the aid of at least one dancer roller.
  • Overlengths can z. B. by unequal or fluctuating rotational speeds of responsible for the movement of the endless material belts means of transportation, especially roles, arise.
  • Another object of the present invention is an apparatus for producing moldings, in particular capsules, from a biopolymer material, in particular based on starch, with at least one extrusion tool for extruding an endless material strip and at least one molding tool for processing the material strip under the influence of a filling material to moldings wherein between the extrusion die and the mold at least one treatment station for applying the material strip is arranged with heat.
  • the treatment arrangement has at least one radiation source, in particular an infrared radiation source. Also conceivable are combinations of different radiation sources.
  • the treatment station has at least one heating element, wherein the material strips are acted upon by convection heat.
  • the device according to the invention comprises a heatable bath, in particular an oil bath.
  • a heatable bath in particular an oil bath.
  • an oil is used, which is harmless from a pharmaceutical and toxicological point of view in the subsequent application of the moldings.
  • oils are known and listed in the relevant legislation.
  • the oil bath can be mixed with other additives that the properties of the material bands, such. B. affect elasticity or elongation at break positive.
  • a heatable oil bath is particularly suitable for relaxing material strips, in particular based on starch.
  • the device has at least one stripping device for stripping off liquid from the surface of the material strips between the oil bath and the molding tool.
  • the stripping device can be designed such that the film thickness of the film remaining on the surface of the material strips can be predetermined.
  • the device has at least one compensating means, in particular a dancer roller, for maintaining a uniform longitudinal tension of the material bands.
  • a compensating means in particular a dancer roller, for maintaining a uniform longitudinal tension of the material bands.
  • Unlength of the bands z. B. arise by non-synchronous means of transport, can be compensated. In particular, so can the tension so be kept as low as possible, particularly advantageous below 0.5 Mpa.
  • the mold of the apparatus is a rotary die apparatus having two forming rolls and a filling wedge.
  • the device has at least one adjustable positioning arrangement on which the extrusion tool and the molding tool can be adjusted relative to one another.
  • a rigid but adjustable arrangement of extrusion and molding tool is achieved relative to each other.
  • the positioning could z. B. have a displaceable on a rail machine frame for the extrusion tool.
  • FIG. 1 shows a schematic representation of an inventive device for producing moldings from endless material bands in the rotary die process.
  • the rotary die machine shown is used in a known manner for the processing of two endless material bands 15, 15 '.
  • the material strips are extruded on each of an extrusion die 1, 1 'on the extruder 13 of slot dies 10 and withdrawn, each with a pair of rollers 7a, 7b and rolled to a constant thickness.
  • the extruders 13 are continuously supplied with biopolymeric material 12, in particular with starch-based material.
  • the extruded material strips 15 are fed to a mold 2 in a known manner. Shown is a substantially horizontal supply of material strips to the mold. Of course it is also conceivable the material bands in any to supply another angle to the mold. A vertical feed is particularly advantageous because it allows the load on the strip to be minimized by gravity.
  • the molding tool consists of two molding rolls 4a, 4b, wherein in the surfaces of the molding rolls 4a, 4b, the recesses required for the deformation of the molded body 11, in particular to capsules, are arranged.
  • a filling wedge 5 is arranged, through which by means of a feed pump 6 from a Golfguttank 8 filling material 9 between the material belts 15, 15 'is introduced, wherein the material bands are deformed on the forming rollers 4a, 4b to capsules 11.
  • a feed pump 6 from a Greintank 8 filling material 9 between the material belts 15, 15 'is introduced, wherein the material bands are deformed on the forming rollers 4a, 4b to capsules 11.
  • liquid, pasty or, in certain cases, also powdery filling material 9 is also conceivable is the encapsulation of pellets, tablets and much more.
  • the material strips 15 between the extrusion die 1 and the die 2 are subjected to heat at a treatment arrangement 3a, 3b.
  • the heat treatment in the embodiment shown by radiation z.
  • different guide and / or drive rollers 20 can be attached at corresponding locations.
  • FIG. 2 shows a schematic representation of an inventive device for producing moldings from endless material bands 15, 15 'in the Norton process.
  • a material strip 15, 15 ' are extruded from an extrusion die 1 and stripped with a pair of rollers 7 and rolled to the correct thickness.
  • the material strip 15 ' is guided in the region between the extrusion die 1 and the die 2 by a treatment station 3 for applying heat.
  • the heat is generated by the radiator 24 in a heating tunnel 26.
  • the material strip 15 ' can be guided via corresponding guide and / or drive rollers 20 to the mold 2.
  • the dancer roller 21 is accordingly movable on an axis perpendicular to the direction of movement of the material strip 15 by a distance D required for maintaining the longitudinal tension of the material strip 15.
  • the dancer roller could also be used to measure the actual tension on a sensor 29.
  • the sensor could therefore also be used for feed control or for emergency shutdown with inadmissible tension. It is particularly favorable if the tensile stress is kept below 0.5 MPa.
  • the material band 15 in the Norton process in a known manner into shaped bodies 11, in particular capsules shaped.
  • the capsules are formed between a preforming unit 17 and a capsule forming unit 16.
  • the capsules are preformed in a hose-like manner and filled via filling channels 18, which are supplied via a filling material feed 14.
  • the final encapsulation takes place.
  • the capsule is preformed lengthwise in the upper mold part, the preforming unit 17. It remains open at the top to allow the addition of the filling material 9.
  • FIG. 3 shows a schematic representation of an alternative embodiment of an inventive device.
  • the material strip 15 extruded from an extrusion die 1 is supplied to an oil bath 27 via drive rollers 19, which are driven by a motor M.
  • the oil bath 27 can be heated via a heating unit 28.
  • the desired relaxation of the material strip 15 is achieved by the release of conserved stresses.
  • the material band 15 is lubricated by the oil bath 27.
  • a dancer roller 21 is mounted in the region of the oil bath 27.
  • the dancer roller 21 is otherwise the same design as in the embodiment according to FIG. 2 ,
  • the material strip 15 is supplied on leaving the oil bath 27 of a stripping device 22. Excess oil can be removed from the surface of the material strip 15 on this stripping device 22.
  • the stripping device 22 can be designed so that the film thickness of the oil film remaining on the surface of the material strips 15 can be set to a predeterminable value.
  • the relaxed material band as already shown via guide rollers 20 is fed to a mold 2.
  • this is the molding tool 2 of a device operated in the rotary-die method. This method has a particularly favorable effect from that additional heat was introduced in the embodiment shown by the oil bath on the starch ribbon 15. As a result, the segment temperature in the region of the filling wedge 5 can be kept low.
  • FIG. 4 shows a diagram of the elongation at break of starch bands 15 before and after treatment with the inventive method.
  • the elongation at break can be measured according to DIN standard 53455. Shown is in FIG. 4 the elongation at break in percent as a function of the temperature. Both the values for the elongation at break in the longitudinal direction and in the transverse direction of the starch strips 15 were determined.
  • the elongations at break of at least 100% required for the forming process of the material strip 15 to form a shaped body 11 are achieved over the entire temperature range, both in the longitudinal direction and in the transverse direction. This is particularly important because a minimum elongation at break of 100% is necessary to encapsulate with existing Rotary-Die processes.
  • FIG. 4 Clear that the elongation at break in the longitudinal and transverse directions before treatment with the inventive method are different.
  • the starch band has anisotropic mechanical properties, which are due in particular to the resulting during the extrusion of the tapes conserved voltages.
  • the processing of anisotropic ribbons can lead to bulky shaped bodies, in particular capsules, which increasingly also get caught in the forming rollers and hinder the production process.
  • the starch ribbon 15 is relaxed after heat treatment and has isotropic properties.
  • the measured breaking elongation of the material strips 15 is identical in the longitudinal direction and in the transverse direction to a good approximation. In the further processing of such material strips uniform moldings 11 are formed, which do not get caught in the forming rollers.
  • FIG. 5 shows a diagram of the elastic modulus of thickness bands 15 before and after treatment with the inventive method.
  • the measurement of the modulus of elasticity E can be carried out according to DIN EN ISO 527-1 to ISO 527-3.
  • the modulus of elasticity in particular in the range of 40 ° C. to 80 ° C., which is important for the processing of the material bands 15 into shaped bodies 11, is significantly reduced to 2 MPa and less. This is particularly important because a modulus of elasticity of at most 2 MPa is necessary to perform encapsulation with existing Rotary-Die methods.
  • the maximum pressure resp. the residence time of the material bands in Medkeil Symposium be chosen so that the material band can be "inflated" to a capsule.
  • the filling wedge floats freely on the forming rollers and ensures the seal. The pressure can therefore not be increased arbitrarily, otherwise the filling material runs out between the material band and filling wedge.
  • a deep modulus of elasticity of the material bands 15 plays a crucial role.
  • the method according to the invention thus proves to be particularly advantageous with regard to the reduction of the modulus of elasticity achieved thereby.
  • the material properties of the material strips are optimized for subsequent processing into shaped bodies.

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  • 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)
  • Extrusion Moulding Of Plastics Or The Like (AREA)
  • Materials For Medical Uses (AREA)
EP00128701A 2000-12-29 2000-12-29 Verfahren und Vorrichtung zum Herstellen von Formkörpern aus einem biopolymeren Material Expired - Lifetime EP1249219B1 (de)

Priority Applications (6)

Application Number Priority Date Filing Date Title
AT00128701T ATE446075T1 (de) 2000-12-29 2000-12-29 Verfahren und vorrichtung zum herstellen von formkörpern aus einem biopolymeren material
DE50015770T DE50015770D1 (de) 2000-12-29 2000-12-29 Verfahren und Vorrichtung zum Herstellen von Formkörpern aus einem biopolymeren Material
EP00128701A EP1249219B1 (de) 2000-12-29 2000-12-29 Verfahren und Vorrichtung zum Herstellen von Formkörpern aus einem biopolymeren Material
ES00128701T ES2334973T3 (es) 2000-12-29 2000-12-29 Procedimiento y dispositivo para la obtencion de cuerpos moldeados a partir de un material biopolimero.
PCT/EP2001/014837 WO2002053088A1 (de) 2000-12-29 2001-12-15 Verfahren und vorrichtung zum herstellen von formkörpern, insbesondere kapseln, aus einem stärke enthaltenden biopolymeren material
US10/451,936 US20040071808A1 (en) 2000-12-29 2001-12-15 Method and device for producing shaped bodies, especially capsules, from a biopolymer material containing starch

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP00128701A EP1249219B1 (de) 2000-12-29 2000-12-29 Verfahren und Vorrichtung zum Herstellen von Formkörpern aus einem biopolymeren Material

Publications (2)

Publication Number Publication Date
EP1249219A1 EP1249219A1 (de) 2002-10-16
EP1249219B1 true EP1249219B1 (de) 2009-10-21

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ID=8170865

Family Applications (1)

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EP00128701A Expired - Lifetime EP1249219B1 (de) 2000-12-29 2000-12-29 Verfahren und Vorrichtung zum Herstellen von Formkörpern aus einem biopolymeren Material

Country Status (6)

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US (1) US20040071808A1 (es)
EP (1) EP1249219B1 (es)
AT (1) ATE446075T1 (es)
DE (1) DE50015770D1 (es)
ES (1) ES2334973T3 (es)
WO (1) WO2002053088A1 (es)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7887838B2 (en) * 2002-01-18 2011-02-15 Banner Pharmacaps, Inc. Non-gelatin film and method and apparatus for producing same
US6949256B2 (en) * 2002-01-18 2005-09-27 Banner Pharmacaps, Inc. Non-gelatin capsule shell formulation
ATE376415T1 (de) * 2003-01-08 2007-11-15 Swiss Caps Rechte & Lizenzen Formkörper bestehend aus gelatinfreiem material und gefüllt mit einer flüssigen füllmasse
US20050196437A1 (en) * 2004-03-02 2005-09-08 Bednarz Christina A. Hard capsules
US7494667B2 (en) 2004-03-02 2009-02-24 Brunob Ii B.V. Blends of different acyl gellan gums and starch
PT103380B (pt) * 2005-11-09 2007-09-13 Univ Do Minho Linha de extrusão laboratorial para a produção de filme tubular convencional e biorientado, com comutação simples entre as duas técnicas
EP2108677A1 (de) 2008-04-10 2009-10-14 Swiss Caps Rechte und Lizenzen AG Thermoplastische Stärkemassen
EP2595610A4 (en) * 2010-07-19 2015-10-28 Procaps S A IMPROVED DEVICE AND METHOD FOR PRODUCING SOFT GEL CAPSULES
CN105456037B (zh) * 2015-08-14 2022-05-17 新昌县恒泰隆机械设备有限公司 一种匀油机构及胶囊生产线
AU2017371180B2 (en) * 2016-12-08 2023-05-11 R.P. Scherer Technologies, Llc A method to relieve stress in capsule shells to reduce propensity to break

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US2643416A (en) * 1949-03-05 1953-06-30 Norton Co Apparatus for casting ribbons of gelatin and the like
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EP1112740A1 (de) * 1999-12-30 2001-07-04 Greither, Peter Verwendung eines Polyglycerine enthaltenden wasserlöslichen Mittels
DE50004562D1 (de) * 2000-05-03 2004-01-08 Swiss Caps Rechte & Lizenzen Verfahren und Vorrichtung zum Herstellen eines flexiblen Bandes aus wenigstens zwei verchiedenen, bei Wärmezufuhr fliessfähigen Massen
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US6949256B2 (en) * 2002-01-18 2005-09-27 Banner Pharmacaps, Inc. Non-gelatin capsule shell formulation

Also Published As

Publication number Publication date
EP1249219A1 (de) 2002-10-16
DE50015770D1 (de) 2009-12-03
ATE446075T1 (de) 2009-11-15
ES2334973T3 (es) 2010-03-18
US20040071808A1 (en) 2004-04-15
WO2002053088A1 (de) 2002-07-11

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