EP2331430B1 - Unite d'emballage - Google Patents

Unite d'emballage Download PDF

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Publication number
EP2331430B1
EP2331430B1 EP09782876A EP09782876A EP2331430B1 EP 2331430 B1 EP2331430 B1 EP 2331430B1 EP 09782876 A EP09782876 A EP 09782876A EP 09782876 A EP09782876 A EP 09782876A EP 2331430 B1 EP2331430 B1 EP 2331430B1
Authority
EP
European Patent Office
Prior art keywords
unit
blister
packaging
support
packaging unit
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.)
Active
Application number
EP09782876A
Other languages
German (de)
English (en)
Other versions
EP2331430A1 (fr
Inventor
Petra Busch
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.)
Boehringer Ingelheim International GmbH
Original Assignee
Boehringer Ingelheim International 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 Boehringer Ingelheim International GmbH filed Critical Boehringer Ingelheim International GmbH
Priority to EP09782876A priority Critical patent/EP2331430B1/fr
Publication of EP2331430A1 publication Critical patent/EP2331430A1/fr
Application granted granted Critical
Publication of EP2331430B1 publication Critical patent/EP2331430B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/04—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
    • B65D83/0445—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments
    • B65D83/0463—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments formed in a band or a blisterweb, inserted in a dispensing device or container
    • 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
    • B65D2215/00—Child-proof means
    • B65D2215/02—Child-proof means requiring the combination of simultaneous actions

Definitions

  • the invention relates to a packaging unit, comprising a blister unit with a filling material, in particular a pharmaceutically active substance formulation, receiving cavities forming receiving chambers, and a receiving unit carrying the blister unit and releasably connected thereto, having a size corresponding to the blister unit (See, for example US 4,706,815 or US 2006/0006091 ) Furthermore, the invention relates to a method for producing such a packaging unit.
  • blister packs are frequently used which serve to protect the respective contents, namely the pharmaceutical active ingredient formulation, from environmental influences from the outside and to prevent an associated influencing of the pharmaceutical quality of the respective active substance formulation.
  • Blister packs have at least one blister unit which is formed from a base or carrier film in which the filling material, ie the respective pharmaceutical active ingredient formulation, receiving cavities, and a cover film which covers the top of the respective bottom or carrier film and in particular the cavities closed Closing receiving chambers exists.
  • the cover film and the base or carrier film can be constructed from one or more layers of different or the same materials.
  • the cover film is bonded to the base or carrier film, for example by gluing, welding or sealing, in particular by means of a hot glue or sealing wax process.
  • cover film and / or the bottom or carrier film are formed as metal and / or plastic and / or paper foil.
  • Typical metal foils are, for example, aluminum foils or aluminum composite foils.
  • a blister unit consists of a cover foil made of aluminum, which closes a deep-drawn bottom or carrier foil made of aluminum.
  • This deep-drawn bottom or carrier film may also comprise an aluminum foil to prevent the entry of water into the cavity for receiving the pharmaceutical product.
  • the aluminum foil of the base or carrier foil, but also the cover foil can be covered on one or both sides with further plastic and / or paper foils.
  • the materials of cover film and base or carrier film may also be present in several layers.
  • plastic films typically include polyvinyl chloride (PVC), cycloolefin copolymer, polychlorotrifluoroethylene (PCFE), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), polyester (UP), Polyacrylate, polyamide (PA) or a multilayer plastic composite film of one or more of these substances, for example consisting of a combination of polychlorotrifluoroethylene (PCTFE) with polyvinyl chloride (PVC) or polyvinyl chloride (PVC) with polyvinylidene chloride (PVdC).
  • PCTFE polychlorotrifluoroethylene
  • PVdC polyvinylidene chloride
  • wallet packaging is a combination of blister pack and carton.
  • a wallet can be unfolded like a purse and closed again. It consists of one or more blister units in the form of blister cards, which are provided with a secondary packaging, e.g. B. from folding carton, are firmly connected.
  • the blister cards can be glued, sealed or riveted to the secondary packaging, for example. Also, they can be fixed with labels on the secondary packaging.
  • a wallet can be divided into a different number of cardboard layers (panels). The wallet may contain information in the form of a booklet or attached to it.
  • the blister units or blister cards used must continue to be part of packaging units comply with the respective regulatory requirements. Blister cards that are used in Europe or the US differ in terms of child safety and senior friendliness.
  • blister cards are used whose structure is described in the BfArm list referring to DIN 55559.
  • the blister cards or blister units are produced on a blister machine from an opaque PVC mold, carrier or bottom foil and an aluminum cover foil.
  • the blister cards can be divided by longitudinal and transverse perforation into individual, each having a cavity sections.
  • the cover sheet is opened above the cavity. In the case of tablets, this is done in particular by pushing the tablet through the cover foil of the blister. Due to the combination of materials and the specific cross perforation described in the BfArm list, the blister cards are considered to be child resistant.
  • blister cards could be used which are type-tested according to DIN 14375 and are therefore considered childproof.
  • blister cards which consist of a transparent PVC molding, carrier or bottom film and a so-called peel-push cover film, which consists of several layers, for example aluminum / PET paper (from inside to outside) is.
  • These blister cards or blister units are also cross-perforated by longitudinal and transverse perforations and contain non-sealed areas at defined locations.
  • To remove the Tablets or the pharmaceutical drug formulation is usually first a cavity isolated to get to a grip tab (not sealed area), with the paper / PET layer is peeled off.
  • a transverse perforation is necessary so that the aluminum layer remains intact on the blister cavity during stripping. In particular, this perforation may be mounted at right angles to the direction of tear.
  • the tablet or pharmaceutical drug formulation is forced through the aluminum layer. Due to the material combination and the design of the cross perforation as well as the unsealed areas, these blister cards or blister units are considered child-safe and / or senior-friendly according to CFR 16 Part 1700.
  • the invention is therefore based on the object to provide a releasable attachment of a blister unit to a receiving unit in a packaging unit of the type mentioned.
  • the packaging unit can be used both for European blisters and for those for the American market, wherein the receiving unit can be designed the same for both applications.
  • an already child-proof packaging unit is created by the attachment and arrangement of the blister unit on the receiving unit, since for the removal of the pharmaceutical active ingredient formulation, in particular in tablet form from the blister unit this only in the form of a receiving tray receiving unit must be removed, before then a targeted Removal of the respective pharmaceutical Drug formulation in tablet or capsule form by pushing through the receiving chamber occlusive cover or closure foil can be done.
  • the blister unit clampingly detecting closure or fastening mechanism of the fastener must be solved.
  • the blister unit can not be removed due to the blister unit encompassing raised edge of the receiving unit, in particular of children.
  • the parental control therefore already exists in that it is necessary for the removal of the blister unit to recognize that first of all the closure or fastening mechanism has to be released with one hand in order to be able to remove the blister unit from the encompassing raised edge of the receiving unit so far, that the blister unit can be grasped by hand and removed completely from the receiving unit.
  • This specific procedure, which is necessary for the removal of the blister from the receiving unit is still sufficiently senior-friendly.
  • the blister unit has two spaced-apart, in particular circular, holes forming a locking opening and the receiving unit has two fastening elements.
  • the receiving unit has two fastening elements.
  • all fastening elements are arranged detectable simultaneously with fingers of one hand and formed depressible.
  • the fastening elements which can be depressurized by applying a compressive force by hand, represent a particularly expedient realization of a clamping holder.
  • the fastening element or the respective fastening elements expediently forms a flexible, in particular elastically movable, clamping holder.
  • the fastening element or the fastening elements is preferably releasable by pressurization from its locking position clampingly detecting the blister unit.
  • a particularly expedient embodiment can be realized with the aid of a collar section formed on the fastening element penetrating the respective locking opening, which engages behind the edge of the respective associated locking opening and grips it by clamping. Therefore, the fastening element or the fastening elements each have at least one after penetration of the respectively associated Arresting opening whose edge engaging behind collar portion.
  • a structurally proven and easy-to-implement way to form and design the fasteners is that the fastener or the fasteners each have two protruding from the bottom surface of the receiving unit, depressible elastic clamping tongues.
  • Such a fixture, the clamping detection of the blister unit by applying a compressive force and depression of the fastener or fasteners is solvable, is known to be used, for example, in the attachment of CD / DVD discs in injection molded plastic folding jaws. It is therefore advantageous to produce the receiving unit by means of an injection molding of plastic.
  • the blister unit comprises a carrier film and a cover film, wherein it is advantageous according to a further embodiment to produce the blister unit, in particular the carrier film, by means of a thermoforming or thermoforming process.
  • the blister unit and the receiving unit are part of a wallet. All information on the pharmaceutical drug formulation is then directly available through the Wallet.
  • the Recording unit with a folding to a wallet blank, in particular a Faltkartonzuonce connected can be made, for example, by applying the receiving unit of the packaging unit to a side surface of the folding carton blank and fastening it there, for example by gluing.
  • the invention provides that two spaced-apart holes are punched into the blister unit and these are each plugged onto a fastening element projecting from the bottom surface of the receiving unit.
  • the connection of the receiving unit in the form of a receiving tray with the blister unit makes it difficult for children to recognize the opening mechanism necessarily to be actuated to remove the blister unit.
  • Adults solve the attachment or locking the blister unit from the receiving tray by depending on the number of fasteners with one or two fingers of one hand, for example with the thumb and the middle finger, the fastener or the two fasteners depress and with the other hand the Remove blister unit.
  • the distance between the two fasteners is selected so large that they can not be detected and depressed by a child's hand simultaneously. To remove the blister card therefore a second hand is needed.
  • the blister unit 1 according to Fig. 1 consists of a rectangular blister card 2 with two spaced apart symmetrically arranged on the longitudinal axis of the blister card 2 Arret ists- or locking holes 3 in the form of circular punched out of the blister card 2 holes 3a.
  • the perspective view shows the existing of a carrier film or bottom sheet 4 side of the blister unit 1. From this page are formed by a thermoforming or thermoforming cavities 5 forth, forming the receiving chambers 6. In each of the receiving chambers 6 is a pharmaceutical drug formulation in the form of a tablet or capsule contained as a filling. On the side facing away from the molded cavities 5 side of the blister unit 1, the receiving chambers are closed by means of a carrier film.
  • the injection-molded plastic receiving unit 7 according to FIG Fig. 2 has a circumferential raised edge 8, which encloses a rectangular area corresponding to the rectangular area and thus the size of the blister unit 1.
  • On the bottom surface 9 are spaced from each other and corresponding to the locking holes 3 of the blister unit 1 formed fasteners 10a, 10b, forth.
  • 11b of the fastening elements 10a, 10b clampingly adjoin the inside edge of the respective associated locking opening 3 and hold the blister unit 1 in a clamping manner in the receiving shell 12 formed by the raised edge 8
  • the fastening elements 10a, 10b are designed to be depressible by pressure forces which can be applied by the fingers of one hand and are thus flexible and elastic.
  • the respective peripheral section 11a, 11b can be removed from the respectively associated, correspondingly formed inner edge of the locking openings 3 and the friction forces forming Loosen clamping bracket.
  • the fastening elements 10a, 10b form, in cooperation with the hole-shaped punched-out locking openings 3, a releasable clamping holder by means of which the blister unit 1 can be detachably fastened to the receiving unit 1 supporting it in the receiving tray 12 and removed again.
  • Fig. 3 shows the packaging unit 13 in its composed of blister unit 1 and receiving unit 7 locking position in which the fasteners 10a, 10b penetrate the hole-shaped punched locking holes 3, so that the blister unit 1 rests on the bottom surface 12 of the receiving unit 7 and is held near the bottom surface 9 ,
  • the peripheral portions 11a, 11b clampingly engage the inner edges of the respective locking opening 3 and hold the blister unit 1 in the illustrated locking position.
  • the raised edge 8 surrounds the blister unit 1, so that it is not possible to reach with the finger of one hand to the cover sheet side of the blister unit 1 facing the bottom surface 12.
  • the user can place the blister unit 1 again on the receiving unit 7 such that the fasteners 10a, 10b are brought into coincidence with the holes 3a in overlap, so that by pressure application with the fingers of one hand, the blister unit 1 in the direction of the bottom surface 12 of Recording unit 7 can be depressed and thereby the fasteners 10a, 10b penetrate again into the locking holes 3 and the peripheral portions 11a, 11b create a clamping against the inner edge wall of the respective associated locking opening 3.
  • the fastening elements 10a, 10b and the corresponding locking openings 3 are arranged at such a distance from one another that the fastening elements 10a, 10b are detectable and depressable simultaneously with the fingers of one hand.
  • a blister web is produced in the thermoforming or thermoprocessing process and, after filling the cavities with the desired pharmaceutical active substance formulation, provided with a cover foil and punched out in the form of the card-shaped blister unit 1.
  • the hole-shaped locking holes 3 are introduced simultaneously or subsequently by punching blister card material.
  • the blister unit 1 provided with the locking openings 3 is then inserted into the receiving tray 12, wherein the fastening elements 10a, 10b are brought into a congruent superimposition with the hole-shaped locking openings 3 and moved by their mutual Aufration Blister unit 1 and receiving unit 7 in their mutual locking position. In this sense, the blister unit 1 is attached to the receiving unit 7.
  • the blister unit 1 has two locking openings 3 and the receiving unit 7 has two fastening elements 10a, 10b. However, it is already sufficient if the blister unit 1 has at least one locking opening 3 and the receiving unit 7 has at least one fastening element 10a or 10b.
  • the user presses the two fastening elements 10a, 10b of the packaging unit 13 Fig. 3 low, so that the clamping brackets formed by the peripheral portions 11a, 11b can be solved with the inner edge regions of the locking holes 3 and the blister unit 1 can be removed.
  • the locking openings 3 are then again brought into congruent superimposition with the fastening elements 10a, 10b and the blister unit 1 is pressed onto the fastening elements 10a, 10b.
  • the blister unit 1 does not rest on the bottom surface 9 of the receiving unit 7, but near it on the receiving surfaces 14a, 14b.
  • the peripheral raised edge 8 prevents the cover sheet side of the blister unit 1 in the in Fig. 3 shown locking position of the blister unit 1 can be detected on the receiving unit 7 by hand.
  • fastening elements 10a, 10b are pressed down once, without the blister unit 1 being removed, then the fastening elements 10a, 10b again move into their locking position which arrests the locking device when the pressure is relieved back. This also makes a contribution to the child safety of the packaging unit 13.
  • the packaging unit 13 may be part of a so-called wallet, for example, by the receiving unit 7 is attached to a foldable blank, in particular Falt Actuallyzusacrificing, whose individual foldable surfaces or pages are foldable in succession or superimposition.
  • a wallet may also be accompanied by a booklet which contains the required information about the pharmaceutical active ingredient formulation packed in the blister unit 1.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Wrappers (AREA)

Claims (13)

  1. Unité d'emballage, comportant des cavités (5) réalisant des chambres de réception (6) recevant une unité thermoformée (1) avec un produit de remplissage, en particulier une formulation de substances actives pharmaceutique, et une unité de réception (7) portant l'unité thermoformée (1) et reliée de manière amovible à celle-ci, dont la taille correspond à l'unité thermoformée (1), l'unité thermoformée (1) présentant au moins une ouverture d'arrêt (3) et l'unité de réception (7) réalisant une coque de réception (12) entourant l'unité thermoformée (1) avec un bord relevé (8), de la surface de fond (9) de laquelle dépasse au moins un élément de fixation (10a, 10b) maintenant l'unité thermoformée (1) de manière amovible par serrage dans la coque de réception (12) et s'engageant dans l'ouverture d'arrêt (3), caractérisée en ce que l'élément de fixation (10a, 10b) est réalisé de manière à pouvoir être saisi et enfoncé avec le doigt et peut être détaché par sollicitation de pression de la position d'arrêt saisissant l'unité thermoformée (1) par serrage.
  2. Unité d'emballage selon la revendication 1, caractérisée en ce que l'unité thermoformée (1) présente deux trous (3a) espacés, en particulier circulaires, réalisant des ouvertures d'arrêt (3) et l'unité de réception (7) présente deux éléments de fixation (10a, 10b).
  3. Unité d'emballage selon l'une quelconque des revendications 1 à 2, caractérisée en ce que l'élément de fixation ou les éléments de fixation respectifs (10a, 10b) réalisent un support de serrage flexible, en particulier mobile élastiquement.
  4. Unité d'emballage selon l'une quelconque des revendications 1 à 3, caractérisée en ce que l'élément de fixation ou les éléments de fixation (10a, 10b) présentent chacun respectivement au moins une section de collet venant en prise derrière son bord après pénétration de l'ouverture d'arrêt (3) associée respectivement.
  5. Unité d'emballage selon l'une quelconque des revendications 1 à 4, caractérisée en ce que l'élément de fixation ou les éléments de fixation (10a, 10b) présentent respectivement au moins deux languettes de serrage élastiques enfonçables dépassant de la surface de fond (9) de l'unité de réception (7).
  6. Unité d'emballage selon l'une quelconque des revendications 1 à 5, caractérisée en ce que l'unité thermoformée (1) comporte un film support (4) et un film de recouvrement.
  7. Unité d'emballage selon la revendication 6, caractérisée en ce que l'unité thermoformée (1) est maintenue avec le film de recouvrement tournée vers la surface de fond (9) de l'unité de réception (7) dans la coque de réception (12).
  8. Unité d'emballage selon l'une quelconque des revendications 1 à 7, caractérisée en ce que l'unité thermoformée (1), en particulier le film support (4) est fabriqué à l'aide d'un processus d'emboutissage profond ou de thermoformage.
  9. Unité d'emballage selon l'une quelconque des revendications 1 à 8, caractérisée en ce que l'unité de réception (7) est fabriquée à l'aide d'un procédé de moulage par injection en plastique.
  10. Unité d'emballage selon l'une quelconque des revendications 1 à 9, caractérisée en ce que l'unité thermoformée et l'unité de réception (7) sont des constituants d'une pochette.
  11. Unité d'emballage selon l'une quelconque des revendications 1 à 10, caractérisée en ce que l'unité de réception (7) est reliée à une pièce découpée pliable en une pochette, en particulier une pièce découpée en carton pliable.
  12. Procédé de fabrication d'une unité d'emballage selon l'une quelconque des revendications 1 à 11, caractérisé en ce qu'une carte thermoformée est fabriquée et l'unité de carte thermoformée (1) est équipée d'au moins une ouverture d'arrêt (3) après le remplissage en produit de remplissage par estampage au moins d'un trou (3a) et est enfichée avec celle-ci sur un élément de fixation (10a, 10b) correspondant, réalisant un support de serrage d'une unité de réception (7) en forme de coque en plastique.
  13. Procédé selon la revendication 12, caractérisé en ce que deux trous espacés (3a) sont estampés dans l'unité thermoformée (1) et ceux-ci sont enfichés respectivement sur un élément de fixation (10a, 10b) dépassant de la surface de fond (9) de l'unité de réception (7).
EP09782876A 2008-09-12 2009-09-10 Unite d'emballage Active EP2331430B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09782876A EP2331430B1 (fr) 2008-09-12 2009-09-10 Unite d'emballage

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08164235 2008-09-12
EP09782876A EP2331430B1 (fr) 2008-09-12 2009-09-10 Unite d'emballage
PCT/EP2009/061760 WO2010029128A1 (fr) 2008-09-12 2009-09-10 Unité d’emballage

Publications (2)

Publication Number Publication Date
EP2331430A1 EP2331430A1 (fr) 2011-06-15
EP2331430B1 true EP2331430B1 (fr) 2013-03-13

Family

ID=41395900

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09782876A Active EP2331430B1 (fr) 2008-09-12 2009-09-10 Unite d'emballage

Country Status (5)

Country Link
US (1) US8991605B2 (fr)
EP (1) EP2331430B1 (fr)
JP (1) JP5583671B2 (fr)
CA (1) CA2736906C (fr)
WO (1) WO2010029128A1 (fr)

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US10737863B2 (en) 2015-10-19 2020-08-11 Abbvie Inc. Medication packaging and dispensing system
USD779340S1 (en) * 2015-11-20 2017-02-21 Hongfujin Precision Electronics (Zhengzhou) Co., Ltd. Package case

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Also Published As

Publication number Publication date
CA2736906C (fr) 2018-01-30
WO2010029128A1 (fr) 2010-03-18
JP2012501923A (ja) 2012-01-26
US8991605B2 (en) 2015-03-31
US20110259781A1 (en) 2011-10-27
JP5583671B2 (ja) 2014-09-03
EP2331430A1 (fr) 2011-06-15
CA2736906A1 (fr) 2010-03-18

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