WO2008148176A1 - Film hautement hydrofuge multicouches utilisé dans la production d'emballages thermoformés pour produits pharmaceutiques ou médicaux et procédé de fabrication d'un tel film - Google Patents

Film hautement hydrofuge multicouches utilisé dans la production d'emballages thermoformés pour produits pharmaceutiques ou médicaux et procédé de fabrication d'un tel film Download PDF

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Publication number
WO2008148176A1
WO2008148176A1 PCT/BE2007/000057 BE2007000057W WO2008148176A1 WO 2008148176 A1 WO2008148176 A1 WO 2008148176A1 BE 2007000057 W BE2007000057 W BE 2007000057W WO 2008148176 A1 WO2008148176 A1 WO 2008148176A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
high moisture
moisture barrier
barrier film
layer high
Prior art date
Application number
PCT/BE2007/000057
Other languages
English (en)
Inventor
Michiel Willem Adriaan Van Den Berg
Johan Willy Declerck
Original Assignee
Tekni-Plex Europe, Naamloze Vennootschap
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 Tekni-Plex Europe, Naamloze Vennootschap filed Critical Tekni-Plex Europe, Naamloze Vennootschap
Priority to PCT/BE2007/000057 priority Critical patent/WO2008148176A1/fr
Publication of WO2008148176A1 publication Critical patent/WO2008148176A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C—APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C1/00—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating
    • B05C1/04—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating for applying liquid or other fluent material to work of indefinite length
    • B05C1/08—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating for applying liquid or other fluent material to work of indefinite length using a roller or other rotating member which contacts the work along a generating line
    • B05C1/0826—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating for applying liquid or other fluent material to work of indefinite length using a roller or other rotating member which contacts the work along a generating line the work being a web or sheets
    • B05C1/0834—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating for applying liquid or other fluent material to work of indefinite length using a roller or other rotating member which contacts the work along a generating line the work being a web or sheets the coating roller co-operating with other rollers, e.g. dosing, transfer rollers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin

Definitions

  • Multi-layer high moisture barrier film for use in the production of pharmaceutical or medical thermoformed blister packs and a method for manufacturing such a film.
  • the present invention concerns a multi-layer high moisture barrier film or sheet designed for thermoforming pharmaceutical or medical blister packs.
  • Multi-layer high moisture barrier films are used in many industrial applications, but one particularly important application is their use for thermoforming pharmaceutical or medical blister packs.
  • These blister packs are characterised in that they are combined of a thermoformed thermoplastic single-layer or multi-layer high moisture barrier film with a lidding foil .
  • the blister pack is further characterised by combining one or, in most cases, several product cavities which may be separated by perforations to facilitate carrying one single unit dosage.
  • These dosages usually come in the form of capsules, lozenges or tablets of a product meant for oral intake.
  • Liquids and creams are also possible, however, as are other possibilities of administration such as topical, ocular, auricular or anal.
  • the product is pushed out of a cavitythrough the lidding foil.
  • a pharmaceutical blister pack is therefore also called a "push-through package” or blister strip.
  • thermoformed plastic of the package carrying the dosages is characterised in that it provides sufficient rigidity and thickness around the cavity in which the tablet is placed to prevent physical damage in transport on the one hand, but on the other hand the plastic is sufficiently collapsible or deformable to allow the patients or consumers to press the tablet through the lidding foil .
  • This lidding foil is typically composed of aluminium which offers good barrier and push-through properties.
  • Peel-open blisters or so-called "child resistant” peel/push variants are also common.
  • the barrier polymers are usually attached on a thermoformable rigid carrier layer such as Polyvinylchloride (hereafter PVC) , Polyethylene Terephthalate (PET) or Cyclic Olefin Copolymers (COC) .
  • PVC Polyvinylchloride
  • PET Polyethylene Terephthalate
  • COC Cyclic Olefin Copolymers
  • the thickness of the rigid carrier sheet is typically chosen in the range of 100 to 350 microns .
  • Table 1 below provides an incomplete overview of the most common multi-layer high barrier sheet materials used to manufacture pharmaceutical and medical blister packs .
  • dry bond lamination can be used to manufacture a multi-layer high moisture barrier sheet.
  • the adhesive is prepared for production in suspension form, whereby the adhesive solids are dissolved in a liquid phase.
  • the adhesive which may have several components, is then coated on one of the sheet substrates and subsequently passed through an oven to evaporate the liquid phase.
  • the coating of the adhesive is typically done via a gravure coating roll, equipped with a metering doctor blade.
  • the adhesive is dry and tacky, the substrate sheet carrying the dried adhesive and the second film are passed together through a set of heated nip rollers, exercising pressure.
  • the combination of heat and pressure will activate the adhesive, known as cross-linking, to form a permanent bond between the layers of the film.
  • the adhesive solids are suspended in an organic solvent.
  • organic solvent suspended adhesives are easier to dry, but a disadvantage of them is that they raise environmental and operator safety concerns.
  • Another known technique is wet bond lamination, whereby the adhesive is prepared for production in suspension form and the adhesive solids are dissolved in a liquid phase.
  • the adhesive which may have several components, is coated on one of the -sheet substrates by means of a gravure coating roll, equipped with a metering doctor blade. Subsequently, both films are attached by passing them through the nip rollers, whereby the adhesive is still wet.
  • the laminated film is dried in an oven whereby the liquid part of the adhesive is evaporated through one of the sheets . In this case one of the sheets needs to be highly permeable for the liquid such as paper, and therefore this technique is not suitable for multi-layer high moisture barrier films.
  • the adhesive is prepared by mixing two components into a paste, whereby the viscosity can be adjusted with temperature.
  • the adhesive is then applied to one of the sheet substrates by means of a series of transfer rollers.
  • the adhesive coating weight can thereby be controlled by adjusting transfer roller speeds and temperature/viscosity.
  • Polyurethane chemistry is typically used for these types of adhesives, whereby completion of the cross-linking may take one or more days, depending on the ambient temperature.
  • thermoformable rigid barrier films require an adhesive layer with greater thickness (2 to 3 g/m 2 ) so that solventless lamination at present is not a conventional technique for barrier films .
  • the invention relates to a multi-layer high moisture barrier film for use in the production of pharmaceutical or medical thermoformed blister packs characterised in that the film is manufactured by solventless lamination in five or more layers which from the inner layer to the outer layer are an inner layer, a layer of adhesive, a core layer, another layer of said adhesive and an outer layer respectively, whereby said inner, core and outer layers consist of one or more polymers .
  • a multi-layer high moisture barrier film according to the invention can be produced more cheaply because solventless lamination is a more energy efficient technique than dry bond lamination since no oven is required to evaporate the liquid phase of a dry bond lamination adhesive, less upfront capital investment is required for the lamination technique and since less floor space is required for the lamination machine installation.
  • a multi-layer high moisture barrier film according to the invention exhibits higher chemical resistance to aggressive products than conventional barrier films .
  • Significant advantages of a multi-layer high moisture barrier film according to the invention is that it is safer in production than solvent-based barrier films because no organic solvents are evaporated in the environment with a solventless lamination technique, thus raising no environmental and operator safety concerns .
  • An advantage over water-based dry bond lamination barrier films is that a multi-layer high moisture barrier film by solventless lamination exhibits higher bond strength.
  • the multi-layer high moisture barrier film involves a Polychlorotrifluoroethylene
  • PCTFE polyurethane
  • PU Polyurethane
  • An advantage of this embodiment is that the multi-layer high moisture barrier film does not curl preferentially to one side when heated.
  • multi-layer barrier films whereby the inner layer and the outer layer are both made of PVC, Polypropylene (PP) , PE, COC, Polyethylene Terephthalate Glycol (PETG) , Amorphous Polyethylene Terephthalate (APET) , Polystyrene (PS) , a blend of Linear Low Density Polyethylene (LLDPE) with COC or an acrylonitrile-methyl acrylate copolymer grafted onto a nitrile rubber, which is commercially known as Barex®, and whereby the core layer is made ofPCTFE.
  • PVC Polypropylene
  • PE PE
  • COC Polyethylene Terephthalate Glycol
  • APET Amorphous Polyethylene Terephthalate
  • PS Polystyrene
  • LLDPE Linear Low Density Polyethylene
  • Barex® acrylonitrile-methyl acrylate copolymer grafted onto a nitrile rubber
  • An advantage of a high moisture barrier film or sheet structure according to this embodiment, made with solventless adhesives is that they can be sterilized by autoclave, preferably by steam sterilization at 121°C for 30 minutes, because the polymers used in this multi-layer structure are able to maintain dimensional stability at autoclave conditions, which is not the case for a high moisture barrier film manufactured by dry bond lamination.
  • the present invention also relates to a method for manufacturing a multi-layer high moisture barrier film by solventless lamination.
  • figure 1 shows a schematic of the multi-layer high moisture barrier film structure in accordance with the present invention
  • figure 2 shows a schematic of the solventless lamination machine configuration for making a multi-layer high moisture barrier film according to the invention
  • figure 3 shows the multi-layer high moisture barrier film as re-wound on the master reel .
  • the multi-layer high moisture barrier film 1 for use in the production of pharmaceutical or medical thermoformed blister packs is represented in figure 1 and consists of five or more layers which, from the inner layer to the outer layer, are an inner layer 2, a layer of adhesive 3, a core layer 4, another layer of said adhesive 3 and an outer layer 5 respectively, whereby said inner layer 2 , core layer 4 and outer layer 5 consist of one or more polymers.
  • the multi-layer high moisture barrier film 1 involves a PCTFE core layer 4, two layers of PU adhesive layers 3 of equal thickness on each side of the PCTFE core layer 4; and two layers of PVC of equal thickness attached to the other side of the PU adhesive layers forming the inner and outer layer 2, 5 of the high moisture barrier film 1 such that the material is symmetrical in a five layer composition: PVC / adhesive / PCTFE / adhesive / PVC.
  • this embodiment offers the advantage that the multi-layer high moisture barrier film does not curl preferentially to one side when heated.
  • the inner layer 2 and the outer layer 5 are both PP, PE, COC, PETG, APET, PS, a blend of LLDPE with COC or an acrylonitrile-methyl acrylate copolymer grafted onto a nitrile rubber, which is commercially known as Barex®, and whereby the core layer 4 is PCTFE.
  • the inner layer 2 is composed of a combination of PE, Ethylene Vinyl Alcohol Co-Polymer Resin (EVOH) and PE
  • the core layer 4 is a co-extrusion film of APET, PETG and APET (PETGAG) and the outer layer 5 is PCTFE .
  • the multi-layer high moisture barrier film 1 according to the invention is manufactured by a solventless lamination technique involving two separate laminating steps, for which an example of a machine configuration is shown in figure 2.
  • the adhesive 3 is prepared by mixing two components into a paste, whereby the viscosity can be adjusted with temperature.
  • the adhesive 3 is applied to one of the sheet substrates, say, the inner layer 2, that has been unwound from reels 7 and passed through a corona treater 8 which modifies the serface tension by electric discharge in order to increase the bond strength.
  • the adhesive coating weight can be controlled by adjusting the temperature (which directly influences the viscosity) and speeds of the transfer rollers 6. These parameters are established for each type of inner layer 2.
  • the inner layer 2 After the inner layer 2 has been coated with the adhesive 3, it is brought together with the core layer 4 by passing them through nip rollers 9. The higher temperature of the nip rollers 9 will accelerate the cross-linking of the adhesive layer 3 to the inner layer 2 and the core layer 4 and this laminated film 10 is rewound onto the master reel 11.
  • the laminating step is repeated in order to bond the laminated film 10 by means of a second layer of adhesive 3 with the outer layer 5 in order to obtain the multi-layer high moisture barrier film 1.
  • laminating steps can be changed or that there is only one laminating step by for example providing two consecutive sets of transfer rollers 6 and/or nip rollers 9.
  • the concentric pressure 12 in radial direction on the multi-layer high moisture barrier film 1 needs to be sufficiently high. This will be the case if the film 1 would be thin and flexible, but in the present case of a multi-layer high moisture barrier film 1, the multi-layer high moisture barrier film 1 will be thicker, typically 100 to 350 microns, and thus the adhesive coating weight will be higher, typically 2 to 3 g/m 2 , making the multi-layer high moisture barrier film 1 more sensitive to the formation of gas bubbles . This is also due to the increased rigidity of the multi-layer high moisture barrier film 1 which results in less concentric pressure 12 on the underlying film layers of the master reel 11. The minimum amount of concentric pressure 12 on the film that is required to prevent the formation of gas bubbles is obtained, however, by rewinding the master reel 11 with sufficient reel tension 13, as shown in figure 4.
  • the required amount of reel tension 13 is empirically obtained and depends on the type of polymers used in the multi-layer high moisture barrier film 1.
  • the concentric pressure 12 is increased by increasing the amount of reel tension 13.
  • the smallest pressure 14 occurs at the circumference of the master reel 11 and the largest concentric pressure 15 occurs near the core
  • the core 16 of the master reel 11 must be chosen sufficiently strong in order to prevent the core 16 to collapse under the largest concentric pressure 15.
  • the core 16 can be made of cardboard treated with polymers, but is preferably made of steel or plastic.
  • a cheap lead-in film 17 made of PVC, PE, PET or waste film is attached at the multi-layer high moisture barrier film 1 and re-wound at the end of the master reel 11.
  • the outer lead-in film 17 made of PVC, PE, PET or waste film is attached at the multi-layer high moisture barrier film 1 and re-wound at the end of the master reel 11.
  • 17 preferably consists of a minimum of 2% of the total length of the films 1, 17 rewound on the master reel 11.
  • the blister packs made from the multi-layer high moisture or oxygen barrier film 1 are passed through an autoclave whereby they are sterilized, preferably by steam sterilization at 121°C for 30 minutes, provided said multilayer high moisture barrier film 1 is composed of known autoclavable polymers such as PP, COC, a blend of COC with LLDPE and PCTFE .
  • multi-layer high moisture barrier film 1 and method for manufacturing such a film 1 specifically relates to a multi-layer high moisture barrier film for use in the production of pharmaceutical or medical thermoformed blister packs, but it is not excluded that such a multi-layer high moisture barrier film manufactured by solventless lamination can be used for other applications .

Abstract

L'objet de la présente invention concerne un film hautement hydrofuge multicouches utilisé dans la production d'emballages thermoformés pour produits pharmaceutiques ou médicaux, ce film (1) ayant pour caractéristique le fait d'être fabriqué par contre collage sans solvant en au moins cinq couches qui sont respectivement et de l'intérieur vers l'extérieur : une couche interne (2), une couche adhésive (3), une couche centrale (4), une autre couche adhésive (3) et une couche externe (5), les couches interne, centrale et externe (2, 4, 5) étant réalisées en un ou plusieurs polymères.
PCT/BE2007/000057 2007-06-08 2007-06-08 Film hautement hydrofuge multicouches utilisé dans la production d'emballages thermoformés pour produits pharmaceutiques ou médicaux et procédé de fabrication d'un tel film WO2008148176A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/BE2007/000057 WO2008148176A1 (fr) 2007-06-08 2007-06-08 Film hautement hydrofuge multicouches utilisé dans la production d'emballages thermoformés pour produits pharmaceutiques ou médicaux et procédé de fabrication d'un tel film

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/BE2007/000057 WO2008148176A1 (fr) 2007-06-08 2007-06-08 Film hautement hydrofuge multicouches utilisé dans la production d'emballages thermoformés pour produits pharmaceutiques ou médicaux et procédé de fabrication d'un tel film

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WO2008148176A1 true WO2008148176A1 (fr) 2008-12-11

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US8057896B2 (en) 2005-01-06 2011-11-15 Selig Sealing Products, Inc. Pull-tab sealing member with improved heat distribution for a container
US8201385B2 (en) 2007-08-24 2012-06-19 Selig Sealing Products, Inc. Multi-purpose covering and method of hygienically covering a container top
US8308003B2 (en) 2007-06-22 2012-11-13 Selig Sealing Products, Inc. Seal for a container
US8522990B2 (en) 2007-03-23 2013-09-03 Selig Sealing Products, Inc. Container seal with removal tab and holographic security ring seal
CN103320042A (zh) * 2013-07-15 2013-09-25 张家港康得新光电材料有限公司 一种pet基材橡胶型压敏胶带的制备方法以及胶带
US8703265B2 (en) 2007-03-23 2014-04-22 Selig Sealing Products, Inc. Container seal with removal tab and piercable holographic security seal
US8715825B2 (en) 2005-01-06 2014-05-06 Selig Sealing Products, Inc. Two-piece pull-tab sealing member with improved heat distribution for a container
US8746484B2 (en) 2011-06-24 2014-06-10 Selig Sealing Products, Inc. Sealing member with removable portion for exposing and forming a dispensing feature
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US9028963B2 (en) 2012-09-05 2015-05-12 Selig Sealing Products, Inc. Tamper evident tabbed sealing member having a foamed polymer layer
US9193513B2 (en) 2012-09-05 2015-11-24 Selig Sealing Products, Inc. Tabbed inner seal
US9221579B2 (en) 2013-03-15 2015-12-29 Selig Sealing Products, Inc. Inner seal with a sub tab layer
EP2998099A1 (fr) * 2014-09-22 2016-03-23 Klocke Verpackungs-Service GmbH Procédé de fabrication et de remplissage d'un conditionnement d'application pour un produit pharmaceutique liquide
EP2998098A1 (fr) * 2014-09-22 2016-03-23 Klocke Verpackungs-Service GmbH Procédé de fabrication et de remplissage d'un conditionnement d'application pour un produit pharmaceutique liquide
US9440768B2 (en) 2013-03-15 2016-09-13 Selig Sealing Products, Inc. Inner seal with an overlapping partial tab layer
US9533805B2 (en) 2005-04-15 2017-01-03 Selig Sealing Products, Inc. Seal stock laminate
US9624008B2 (en) 2007-03-23 2017-04-18 Selig Sealing Products, Inc. Container seal with removal tab and security ring seal
US9834339B2 (en) 2011-03-28 2017-12-05 Selig Sealing Products, Inc. Laminate structure to stabilize a dimensionally unstable layer
US10179667B2 (en) 2016-02-29 2019-01-15 Klocke Verpackungs-Service Gmbh Method for the production and filling of an application package for a liquid pharmaceutical product
US10259626B2 (en) 2012-03-08 2019-04-16 Selig Sealing Products, Inc. Container sealing member with protected security component and removal tab
US10532836B2 (en) 2016-02-29 2020-01-14 Klocke Verpackungs-Service Gmbh Method for the productions and filling of an application package for a liquid pharmaceutical product
US10556732B2 (en) 2015-03-03 2020-02-11 Selig Sealing Products, Inc. Tabbed seal concepts
US10604315B2 (en) 2014-02-05 2020-03-31 Selig Sealing Products, Inc. Dual aluminum tamper indicating tabbed sealing member
EP3597422A4 (fr) * 2017-03-17 2020-12-16 Fujimori Kogyo Co., Ltd. Stratifié, récipient à coque et emballage à déchirement par pression
US10899506B2 (en) 2016-10-28 2021-01-26 Selig Sealing Products, Inc. Single aluminum tamper indicating tabbed sealing member
US10934069B2 (en) 2016-10-28 2021-03-02 Selig Sealing Products, Inc. Sealing member for use with fat containing compositions
US11254481B2 (en) 2018-09-11 2022-02-22 Selig Sealing Products, Inc. Enhancements for tabbed seal
CN114574119A (zh) * 2022-03-24 2022-06-03 江苏日邦节能科技有限公司 一种三层共挤芯层微发泡pp膜胶带的制作方法
US11708198B2 (en) 2018-07-09 2023-07-25 Selig Sealing Products, Inc. Grip enhancements for tabbed seal
US11858241B2 (en) 2018-05-29 2024-01-02 Klöckner Pentaplast Gmbh Transparent polymer film with discolouration compensation
US11866242B2 (en) 2016-10-31 2024-01-09 Selig Sealing Products, Inc. Tabbed inner seal
US11891479B2 (en) 2020-11-18 2024-02-06 Klöckner Pentaplast Of America, Inc. Thermoformed packaging and methods of forming the same

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US8715825B2 (en) 2005-01-06 2014-05-06 Selig Sealing Products, Inc. Two-piece pull-tab sealing member with improved heat distribution for a container
US9815589B2 (en) 2005-01-06 2017-11-14 Selig Sealing Products, Inc. Tabbed sealing member with improved heat distribution for a container
US8057896B2 (en) 2005-01-06 2011-11-15 Selig Sealing Products, Inc. Pull-tab sealing member with improved heat distribution for a container
US9102438B2 (en) 2005-01-06 2015-08-11 Selig Sealing Products, Inc. Tabbed sealing member with improved heat distribution for a container
US9533805B2 (en) 2005-04-15 2017-01-03 Selig Sealing Products, Inc. Seal stock laminate
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