EP1554191B1 - Starre kunststoffschutzhülle für eine blisterpackung - Google Patents

Starre kunststoffschutzhülle für eine blisterpackung Download PDF

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Publication number
EP1554191B1
EP1554191B1 EP03773732A EP03773732A EP1554191B1 EP 1554191 B1 EP1554191 B1 EP 1554191B1 EP 03773732 A EP03773732 A EP 03773732A EP 03773732 A EP03773732 A EP 03773732A EP 1554191 B1 EP1554191 B1 EP 1554191B1
Authority
EP
European Patent Office
Prior art keywords
case
blister
upper panel
blister pack
hinge
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
EP03773732A
Other languages
English (en)
French (fr)
Other versions
EP1554191A1 (de
Inventor
Hervé GATTEFOSSE
Patrick Sivera
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.)
Sanofi Aventis France
Original Assignee
Sanofi Aventis France
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 Sanofi Aventis France filed Critical Sanofi Aventis France
Publication of EP1554191A1 publication Critical patent/EP1554191A1/de
Application granted granted Critical
Publication of EP1554191B1 publication Critical patent/EP1554191B1/de
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
    • 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, 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, 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, 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
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers

Definitions

  • the invention relates to a protective case for a blister containing medicaments.
  • the invention more particularly relates to a protective case for a blister, containing medicaments for clinical trials, of the type comprising a semi-rigid horizontal upper plate comprising blister-shaped cells delimiting open housing downwards which are sealed with lids and each containing a medicament capable of being expelled by the flat underside of the blister by tearing the blister operculum.
  • a drug is clinically tested before being marketed.
  • the effectiveness of the drug is tested by administering the active ingredient to a first group of patients and by administering a placebo to a second control group of patients.
  • the case consists of a folded flexible cardboard sheet comprising a central panel flanked by two lateral flaps that can be folded down on the central flap.
  • the blister is trapped between the central panel and a first lateral flap.
  • the central panel and the first flap are each perforated with holes matching the location of the cells.
  • the perforated flap is then folded down and then sealed on the central panel, for example by gluing.
  • the holes of the central panel allow the ejection of the drug by pressing on the cell and tearing of the lid, the drug then being recovered under the underside of the case.
  • the second lateral flap forms a cover for protecting the cells of the blister.
  • the drug information leaflet is located on one or both sides of the lid.
  • packaging the blister in such a case requires a first operation of positioning the blister in the pre-glued case, then a gluing operation of the perforated flap on the central flap which can take up to 7 seconds.
  • US-A-3,587,517 describes for example a case which has a rigid bottom on which a rigid flap is rotatably mounted around a lateral hinge.
  • a drug blister is intended to be clamped flat between the bottom and the flap.
  • the bottom and the flap have holes matching the location of the cells of the blister.
  • the case also has a rigid cover which is rotatably mounted relative to the bottom between a folded position above the flap so as to protect the cells from shocks, and an open position in which the cells are accessible.
  • US-A-4998623, US-A-5323907, US-A-6082544 and US-A3587517 are considered to represent the state of the art.
  • this case is not suitable for use in clinical trials.
  • the case is reusable because the flap has reversible closure means relative to the bottom. It is thus possible to replace the original blister a similar blister but containing substances of different nature without the appearance of the holster suggests such a substitution.
  • it is essential that the case is tamperproof once the blister is trapped between the bottom and the flap.
  • the invention proposes a case of the type described above, characterized in that the fastening means are fastening means that can not be dismounted by elastic interlocking.
  • a longitudinal, vertical and transverse orientation indicated by the trihedron L, V, T of FIG. 1 will be used in the remainder of the description and in the claims, in a non-limiting manner.
  • FIG. 1 a protective case 10 of a blister 12 of drugs.
  • the case 10 is here empty and is in an unfolded state of origin in which it is ready to receive the drug blister 12.
  • the blister 12 comprises a semi-rigid horizontal top plate 14 which comprises cells 16, in the form of blisters defining open housing downwards which are closed by lids 17 shown in Figure 7.
  • Each housing can to shelter a drug 19 that can be expelled by the flat lower face 18 of the blister 12 by deformation of the cell 16 and by tearing of the lid 17 as illustrated by the central cell 16 in FIG. 7.
  • the drugs 19 are packaged for example in the form of tablets, capsules, suppositories likely to be protected by a blister.
  • the case 10 comprises in particular a central bottom 20 which is mainly formed by a horizontal plate generally rectangular whose small front sides 22 and rear 24 are oriented transversely and whose long lateral sides 26 and 28 are oriented longitudinally according to Figure 1.
  • the bottom 20 is in particular intended to support the flat lower face 18 of the blister 12 which is placed along the arrow F of FIG.
  • the bottom plate 20 has a side edge 30 which extends vertically upwardly from the two long sides 26 and 28 as well as from the rear small side 24.
  • a rectangular and flat flap 32 is mounted articulated around a transverse hinge front 34, on the small front side 22 of the bottom 20, between an unfolded position and a folded position.
  • the flap 32 In the folded position, as shown in FIGS. 2 and 7, the flap 32 generally covers the bottom 20 in order to trap the blister 12 between the lower face 36 of the flap 32 and the upper face 38 of the bottom 20. The flap 32 is then surrounded by the edge 30 of the bottom 20.
  • the flap 32 and the bottom 20 respectively comprise holes 40 and 42 which are made in concordance with the locations of the cells 16 of the blister 12 when the flap 32 is in the folded position.
  • the cells 16 and the holes 40 and 42 are here made in the form of four longitudinal rows of nine units.
  • the holes 40 of the flap 32 give access to the cells 16 to the user who can thus select a drug 19 and eject it by pressing vertically on the cell 16 chosen, the drug 19 being then ejected to through the cover 17 and the associated hole 42 of the bottom 20 as illustrated by the arrow F 'of FIG. 7.
  • the case 10 comprises non-removable or tamper-proof means for fastening the flap 32 in the folded position on the bottom 20.
  • the flap 32 is more precisely fixed by vertical elastic engagement of a series of pairs of elements each comprising a male element 44 and a female element 46.
  • the fastening means are shown in more detail in FIGS. 4 and 5.
  • the male element 44 consists of a lug 48 which extends vertically upwards from the upper face 38 of the bottom 20.
  • the free end of the lug 48 has a head 50 in the form of a half-sphere whose horizontal flat is oriented downwards.
  • the lug 48 is intended to cooperate with the associated female element 46 which is carried by the flap 32.
  • the female element 46 is a well 54 with a pierced bottom which extends vertically from the surface upper portion 56 of the flap 32.
  • the well 54 has a lower opening 52 intended to receive the hemispherical head 50 of the lug 48.
  • the well 54 also has vertical slots which divide the well 54 into two symmetrical halves in order to facilitate its elastic deformation and consequently the engagement of the male element 44.
  • the well 54 has a frustoconical shape whose lower base is located at the opening 52 and which is intended to increase the resistance to disengagement by clamping effect.
  • the engagement apertures 52 of the shutter 32 are encircled by a skirt 58 for protecting the pairs of fixing elements 44, 46 which extends vertically from the upper surface 56 of the shutter 32 and that prevents any attempt to disassemble by spacing the two halves of each well 54.
  • the pairs of elements 44, 46 for fixing elastic interlocking are here six in number.
  • the lugs 48 carried by the bottom 20 are distributed on the periphery of the bottom 20 at the rate of two lateral lugs 48L on each large lateral side 26 and 28 of the bottom 20 and two front lugs 48F on the small rear side 24.
  • the lugs 48 determine precisely the horizontal position of the blister 12 with respect to the ejection holes 42 during the introduction of the latter in the bottom 20 and before folding the flap 32.
  • the small front side 22 of the blister 12 is adjacent to the hinge before 34.
  • the lugs 48 and the front hinge 34 thus advantageously form positioning stops for the blister 12 relative to the bottom 20.
  • the case 10 also comprises a cover 60 which is particularly visible in FIGS. 2 and 6.
  • the cover 60 is a plate of dimensions roughly similar to those of the bottom 20.
  • the cover 60 is hingedly mounted on the upper edge of the edge 30 of the small rear side 24, around a rear transverse hinge 62, between an open position and a closed position.
  • the lid 60 discovers the upper portion of the blister 12 so as to allow access to the drugs 19 to a user.
  • the lid can be opened at 180 ° while completely freeing access to the blister.
  • the cover 60 In the closed position, as shown in FIG. 6, the cover 60 is generally horizontal and its lower cuff 64 is pressed on the upper edge of the edge 30 of the bottom 20.
  • the cover 60 has at its free end, that is to say say the opposite side to the rear hinge 62, a flange 66 which extends perpendicularly from its cuff 64 so as to close the small front side 22 of the case 10 which has no vertical edge 30.
  • the cover 60 encloses and protects the upper face 14 of the blister 12, and in particular the cells 16. In the closed position, only the obverse 68 of the cover 60 is visible.
  • the obverse 68 of the cover 60 may in particular serve as a support for an information notice 70 on the drugs 19 contained in the case 10.
  • the notice 70 is for example glued on the obverse 68 or on the reverse side 64.
  • the record can also be printed or inscribed on the cover in recess or in relief.
  • the flap 32 has two tabs 72 which protrude beyond the front hinge 34. In the folded position of the flap 32, these two tabs 72 extend horizontally from the small front side 22 of the case 10.
  • the tabs 72 are intended to hook the lid 60 in the closed position by elastic interlocking with grooves (not shown) carried by the flange 66 of the lid 60.
  • the middle of the flange 66 of the cover 60 draws a boss 74 forming a grip to allow the user to disengage the cover 60 from the grip of the tabs 72 to open the case 10 by lifting.
  • the case 10 is here made entirely of rigid plastic material.
  • the case 10 is thus resistant to shocks, and its mechanical properties are not altered when exposed to a humid atmosphere.
  • the case 10 is made integrally by molding in one piece.
  • the front hinges 34 and rear 62 are then each made of a plastic film integrally formed with the bottom 20.
  • the case 10 is advantageously made of a polypropylene-type material so that the closures and repeated openings of the lid 60 do not cause fatigue failure of the rear hinge 62 during use of the case 10.
  • the lugs 48 are also made integral with the bottom 20, and the female elements are made integrally with the flap 32. The manufacture of this case 10 does not require any assembly operation since it consists of a single piece.
  • the flap 32 is folded over the blister 12 against the bottom 20.
  • the blister 12 is then automatically positioned horizontally because the fold formed at the front hinge 34 by the flap 32 and the bottom 20 pushes the blister 12 which is laterally guided in position by the lateral lugs 48L, and stopped in abutment against the front lugs 48F.
  • the wells 54 of the flap 32 are then brought vertically in contact with the lugs 48 which penetrate through the lower opening 52.
  • the rounded head 50 of the lug 48 elastically separates the two halves of the well 54.
  • the well 54 is recalled elastically in its original form against the lug 48, under the head 50.
  • the pairs of fasteners 44 and 46 are then in the nested position and the flap 32 thus traps the blister 12 against the bottom 20 in a way that can not be dismantled.
  • the user grasps the case 10 closed by supporting the underside of the bottom 20 in the palm of his hand and squeezing the two large lateral sides 26 and 28 between his fingers. Then he opens with the other hand the cover 60 of the case 10 by lifting the boss 74. Finally, he presses the finger the cell 16 containing the desired drug 19 to eject it through the hole 42 of the bottom 20, in the palm of the hand that supports the case 10.
  • the flap 32 being surrounded very closely by the edge 30 of the bottom 20, it is difficult to support to insert a lever in the gap between the flap 32 and the bottom 20 to lift the flap 32.
  • the only solution to reach the blister 12 is to cut the heads 50 of each lug 48, leaving indelible traces. That is to say that in case of rape, the case 10 carries traces impossible to camouflage.
  • the flap 32 and the bottom 20 are two separate parts.

Landscapes

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

Claims (12)

  1. Schutzhülle (10) für eine Blisterverpackung (12), welche Medikamente (19) enthält, die für klinische Versuche bestimmt sind, der Art, welche eine halb-starre waagerechte obere Platte (14) aufweist, welche Zellen (16) in Form von Blasen aufweist, die nach unten offene Sitze abgrenzen, welche von Deckeln (17) verschlossen sind und welche jeweils ein Medikament (19) enthalten, das geeignet ist, durch die flache Unterseite (18) der Blisterverpackung (12) durch Zerreißen des Deckels (17) der Blisterverpackung (12) ausgetrieben zu werden, und der Art, bei welcher die Hülle (10) aufweist:
    - einen perforierten waagerechten Boden (20), auf welchem die Unterseite (18) der Blisterverpackung (12) lagert; und
    - eine perforierte obere Platte (32), welche die Oberseite (14) der Blisterverpackung (12) bedeckt;
    - und der Art, bei welcher die Blisterverpackung (12) zwischen dem Boden (20) und der oberen Platte (32), welche jeweils Löcher (40, 42) in Übereinstimmung mit der Anordnung der Zellen (16) aufweist, festgesetzt ist, wobei die Hülle Befestigungsmittel (44, 46) der oberen Platte (32) bezogen auf den Boden (20) aufweist, wobei der Boden (20) und die obere Platte (32) der Hülle (10) aus einem starren Kunststoff hergestellt sind,
    dadurch gekennzeichnet, dass die Befestigungsmittel (44, 46) durch elastische Einpassung unzerlegbare Befestigungsmittel sind.
  2. Hülle (10) gemäß dem vorausgegangenen Anspruch, dadurch gekennzeichnet, dass diese wenigstens einen Vorsprung (48) aufweist, welcher einen Anschlag zur waagerechten Positionierung der Blisterverpackung (12) bezogen auf die Auswurflöcher (42) des Bodens (20) der Hülle (10) bildet.
  3. Hülle (10) gemäß dem vorausgegangenen Anspruch, dadurch gekennzeichnet, dass der Vorsprung (48) ein männliches Element (44) der Befestigungsmittel durch elastische Einpassung bildet, wobei das zugehörige weibliche Element (46) von der oberen Platte (32) getragen wird.
  4. Hülle (10) gemäß einem der vorausgegangenen Ansprüche, dadurch gekennzeichnet, dass das männliche Element (44) und das weibliche Element (46) jeweils mit dem Boden (20) und der oberen Platte (32) aus dem gleichen Material hergestellt werden.
  5. Hülle (10) gemäß einem der vorausgegangenen Ansprüche, dadurch gekennzeichnet, dass der Boden (20) einen Rand (30) aufweist, der sich senkrecht nach oben erstreckt und der die obere Platte (32) umgibt.
  6. Hülle (10) gemäß einem der vorausgegangenen Ansprüche, dadurch gekennzeichnet, dass die obere Platte eine Klappe (32) ist, die gelenkig um eine transversale Achse mittels einem ersten Scharnier (34) auf einer Seite (22) des Bodens (20) befestigt ist, welche keinen senkrechten Rand (30) aufweist.
  7. Hülle (10) gemäß dem vorausgegangenen Anspruch, dadurch gekennzeichnet, dass das erste Scharnier (34) aus einem Kunststofffilm gebildet ist, der mit dem Boden (20) und mit der oberen Platte (32) aus dem gleichen Material hergestellt ist.
  8. Hülle (10) gemäß einem der Ansprüche 6 oder 7, dadurch gekennzeichnet, dass das erste Scharnier (34) einen Anschlag für die Positionierung der Blisterverpackung (12) bezogen auf die Löcher (42) des Bodens (20) bildet.
  9. Hülle (10) gemäß einem der Ansprüche 5 bis 8, dadurch gekennzeichnet, dass sie eine obere Abdeckung (60) zum Schutz der Zellen (16) aufweist, die aus starrem Kunststoff hergestellt ist und die bezogen auf den Boden um ein zweites Scharnier (62) zwischen einer geschlossenen Position, in welcher sie die Zellen (16) der Blisterverpackung (12) durch Zusammenwirken der Form mit dem Boden (20) umgibt, und einer geöffneten Position, in welcher die Zellen (16) für einen Benutzer zugänglich sind, schwenkbar ist.
  10. Hülle (10) gemäß dem vorausgegangenen Anspruch, dadurch gekennzeichnet, dass das zweite Scharnier (62) ein Kunststofffilm ist, der mit dem Boden (20) und der Abdeckung (60) aus einem Material hergestellt ist.
  11. Hülle (10) gemäß einem der Ansprüche 9 oder 10, dadurch gekennzeichnet, dass die Abdeckung (60) durch Mittel aufgrund des Zusammenwirkens von komplementären Formen (72) zwischen der Abdeckung (60) und der oberen Platte (32) und/oder dem Boden (20) in geschlossener Position gehalten wird.
  12. Hülle (10) gemäß einem der vorausgegangenen Ansprüche, dadurch gekennzeichnet, dass die elastische Einpassung durch elastische Verformung des weiblichen Elements (46) hergestellt wird.
EP03773732A 2002-10-14 2003-10-07 Starre kunststoffschutzhülle für eine blisterpackung Expired - Lifetime EP1554191B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0212719A FR2845668B1 (fr) 2002-10-14 2002-10-14 Etui de protection d'un blister realise en matiere plastique rigide
FR0212719 2002-10-14
PCT/EP2003/050699 WO2004035414A1 (fr) 2002-10-14 2003-10-07 Etui de protection d’un blister realise en matiere plastique rigide

Publications (2)

Publication Number Publication Date
EP1554191A1 EP1554191A1 (de) 2005-07-20
EP1554191B1 true EP1554191B1 (de) 2006-06-07

Family

ID=32039684

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03773732A Expired - Lifetime EP1554191B1 (de) 2002-10-14 2003-10-07 Starre kunststoffschutzhülle für eine blisterpackung

Country Status (10)

Country Link
US (1) US7419056B2 (de)
EP (1) EP1554191B1 (de)
JP (1) JP4727991B2 (de)
AR (1) AR041576A1 (de)
AT (1) ATE328810T1 (de)
AU (1) AU2003282116A1 (de)
DE (1) DE60305957T2 (de)
FR (1) FR2845668B1 (de)
TW (1) TW200406189A (de)
WO (1) WO2004035414A1 (de)

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USD694644S1 (en) 2012-03-28 2013-12-03 Aventisub Ii Inc. Clamshell package having blisters
US8919559B2 (en) 2012-03-28 2014-12-30 Aventisub Ii Inc. Package with break-away clamshell
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USD697813S1 (en) 2012-03-28 2014-01-21 Aventisub Ii Inc. Clamshell having blisters received therein
USD687313S1 (en) 2012-03-28 2013-08-06 Aventisub Ii Inc. A-shaped blister card
US9108784B2 (en) * 2012-06-29 2015-08-18 R.J. Reynolds Tobacco Company Dispensing container, packaged product assembly, and related method
USD731783S1 (en) * 2014-04-16 2015-06-16 Abbvie Inc. Template for a prescription medicine container
US9406245B2 (en) 2014-09-03 2016-08-02 Michael Barbera Patient medicine identity display
ES2626779T3 (es) * 2014-09-08 2017-07-26 Edwin Kohl Instalación y procedimiento para el reenvasado de diferentes medicamentos desde sus blísteres originales respectivos a blísteres de llenado
US20160338517A1 (en) * 2014-10-28 2016-11-24 Chad Raynell Snowden Tray insert with retained food service items
US9414993B2 (en) * 2014-12-09 2016-08-16 Michael Flynn Sealable pill organizer and dispenser
EP3316995B1 (de) 2015-06-30 2022-04-13 EMD Millipore Corporation Abdichtungsgehäuse für filterkassette
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Also Published As

Publication number Publication date
JP4727991B2 (ja) 2011-07-20
US7419056B2 (en) 2008-09-02
US20060118452A1 (en) 2006-06-08
JP2006502775A (ja) 2006-01-26
AR041576A1 (es) 2005-05-18
WO2004035414A1 (fr) 2004-04-29
FR2845668B1 (fr) 2005-08-05
EP1554191A1 (de) 2005-07-20
AU2003282116A1 (en) 2004-05-04
DE60305957D1 (de) 2006-07-20
DE60305957T2 (de) 2007-06-14
ATE328810T1 (de) 2006-06-15
FR2845668A1 (fr) 2004-04-16
TW200406189A (en) 2004-05-01

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