EP1554191B1 - Rigid plastic protective case for a blister pack - Google Patents

Description

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.

• un fond horizontal perforé sur lequel repose la face inférieure du blister ; et
• une plaque supérieure perforée qui recouvre la face supérieure du blister ;

et du type dans lequel le blister est emprisonné entre le fond et la plaque supérieure qui comportent chacun des trous en concordance avec l'emplacement des alvéoles, l'étui comportant des moyens de fixation de la plaque supérieure par rapport au fond, le fond et la plaque supérieure de l'étui étant réalisés en matière plastique rigide.The case is of the type which comprises:

• a perforated horizontal bottom on which rests the lower face of the blister; and
• a perforated upper plate which covers the upper face of the blister;

and of the type in which the blister is trapped between the bottom and the top plate which each have holes in accordance with the location of the cells, the case comprising means for fixing the upper plate relative to the bottom, the bottom and the upper plate of the case being made of rigid plastic material.

A drug is clinically tested before being marketed. For example, 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.

It is known to deliver the blistered medicine in a wallet-shaped case, also called "wallet", which is integrated an information leaflet concerning the drug it contains. The blister is trapped in the case, or "wallet" so that the drug is always accompanied by the corresponding record.

In double-blind clinical studies, the cases must be indistinguishable from each other regardless of their content: placebo or active ingredients.

According to a known example, 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.

Such a case allows in particular to use the contents of the blister without ever separating it from the record. The permutation of drugs or a placebo is thus prevented.

In addition, an attempt to violate the case usually results in visible degradation.

However, such a cardboard case is flexible and it deforms with use. The cardboard is more likely to deform if exposed to a humid atmosphere.

In addition, it is conceivable that during a rape of the holster, the degradations are camouflaged by gluing again the perforated side flap on the central panel.

Finally, 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.

However, 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. For the result of clinical trials is reliable, it is essential that the case is tamperproof once the blister is trapped between the bottom and the flap.

In order to improve the conditioning times and to solve the other problems mentioned above, 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.

• l'étui comporte au moins un ergot formant butée de positionnement horizontal du blister par rapport aux trous d'éjection du fond de l'étui ;
• l'ergot constitue un élément mâle des moyens de fixation par emboîtement élastique, l'élément femelle associé étant porté par la plaque supérieure ;
• l'élément mâle et l'élément femelle sont réalisés venus de matière avec le fond et avec la plaque supérieure, respectivement ;
• le fond comporte un bord qui s'étend verticalement vers le haut et qui entoure la plaque supérieure ;
• la plaque supérieure est un volet qui est monté articulé autour d'un axe transversal au moyen d'une première charnière sur un côté du fond qui est dénué de bord vertical ;
• la première charnière est formée par un film de plastique qui est réalisé venu de matière avec le fond et avec la plaque supérieure ;
• la première charnière forme butée de positionnement du blister par rapport aux trous du fond ;
• l'étui comporte un couvercle supérieur de protection des alvéoles qui est réalisé en matière plastique rigide et qui est monté pivotant par rapport au fond autour d'une seconde charnière entre une position fermée dans laquelle il enveloppe les alvéoles du blister par coopération de forme avec le fond, et une position ouverte dans laquelle les alvéoles sont accessibles à un utilisateur ;
• la seconde charnière est un film de plastique qui est réalisé venu de matière avec le fond et le couvercle ;
• le couvercle est maintenu en position fermée par des moyens par coopération de formes complémentaires entre le couvercle et la plaque supérieure et/ou le fond ;
• l'emboîtement élastique est réalisé par déformation élastique de l'élément femelle.

According to other features of the invention:

• the case comprises at least one lug forming a stop for horizontal positioning of the blister with respect to the ejection holes in the bottom of the case;
• the lug constitutes a male element of the fastening means by elastic interlocking, the associated female element being carried by the upper plate;
• the male element and the female element are made integrally with the bottom and the top plate, respectively;
• the bottom has an edge that extends vertically upward and surrounds the top plate;
• the upper plate is a flap which is mounted hinged about a transverse axis by means of a first hinge on one side of the bottom which is devoid of vertical edge;
• the first hinge is formed by a plastic film which is made integral with the bottom and the top plate;
• the first hinge forms the positioning stop of the blister with respect to the bottom holes;
• the case comprises an upper cover for protection of the cells which is made of rigid plastics material and which is pivotally mounted relative to the bottom around a second hinge between a closed position in which it envelopes the cells of the blister by form cooperation with the bottom, and an open position in which the cells are accessible to a user;
• the second hinge is a plastic film which is made integrally with the bottom and the lid;
• the lid is held in the closed position by means of cooperation of complementary shapes between the lid and the upper plate and / or the bottom;
• the elastic engagement is achieved by elastic deformation of the female element.

• la figure 1 est une vue en perspective éclatée d'un étui de protection réalisé selon les enseignements de l'invention, l'étui étant ouvert et déplié, prêt à recevoir un blister de médicaments ;
• la figure 2 représente l'étui de la figure 1 avec son couvercle en position ouverte qui montre le blister de médicament emprisonné dans l'étui ;
• la figure 3 est une vue de dessus qui illustre le fond de l'étui sur lequel blister de médicament est positionné ;
• la figure 4 est une vue en perspective et en section partielle selon le plan de coupe 4-4 de la figure 2 qui représente en détail les moyens de fixation par emboîtement élastique du volet intermédiaire sur le fond de l'étui, avant l'emboîtement ;
• la figure 5 est une vue qui représente les moyens de fixation de la figure 4, après l'emboîtement ;
• la figure 6 représente l'étui de la figure 1 avec son couvercle qui est en position fermée et qui comporte une notice d'information ;
• la figure 7 est une vue à grande échelle et en section longitudinale selon le plan de coupe 7-7 de la figure 6.

Other features and advantages of the invention will appear during the reading of the detailed description which follows for the understanding of which reference will be made to the appended drawings in which:

• Figure 1 is an exploded perspective view of a protective case made according to the teachings of the invention, the case being opened and unfolded, ready to receive a drug blister;
• Figure 2 shows the case of Figure 1 with its cover in the open position showing the drug blister trapped in the case;
• Figure 3 is a top view illustrating the bottom of the case on which drug blister is positioned;
• FIG. 4 is a view in perspective and in partial section along the sectional plane 4-4 of FIG. 2, which shows in detail the fastening means by elastic interlocking of the intermediate flap on the bottom of the case, before the interlocking ;
• Figure 5 is a view which shows the fixing means of Figure 4, after the interlocking;
• FIG. 6 represents the case of FIG. 1 with its cover which is in the closed position and which comprises an information notice;
• FIG. 7 is a view on a large scale and in longitudinal section along the sectional plane 7-7 of FIG. 6.

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.

There is shown in Figure 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.

In known manner, 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, of dimensions substantially complementary to those of the bottom 20, 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.

In the unfolded position, as represented in FIG. 1, the flap 32 completely discovers the bottom 20 of the case 10.

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.

As shown in FIG. 2, 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. According to this embodiment, 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.

Thus, when the lug 48 is fitted into the female element 46, as shown in FIG. 5, the upper end of the well 54 abuts with the lower flat surface of the lug 48 in order to prevent any vertical movement of the lug 48. flap 32 with respect to the bottom 20. The flap 32 is thus secured to the bottom 20, and the blister 12 is trapped in the case 10.

In addition, 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.

As can be seen in FIG. 1, 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.

As shown in Figure 3, 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.

In the open position, as illustrated in Figure 2, 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.

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.

Thus, 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 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.

According to this embodiment, 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.

During the operation of packaging the blister 12 in the case 10, an operator places the blister 12, cells 16 upwards, on the bottom 20 between the lugs 48 as illustrated by the arrow F of FIG. case 10 being unfolded, with its three parts 20, 32 and 60 horizontal such as at the outlet of the mold.

Then, 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. Then, 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.

With this case 10, it is not necessary to exactly position the blister 12 in the case 10, since the exact positioning is obtained when the flap 32 is folded and fixed. This method of attachment is advantageously fast and does not use any external means.

When using the case 10, 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.

Such a case 10 makes it difficult to attempt rape to remove the blister 12.

Indeed, 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.

It is also difficult to attempt to spread the slats 54 which border the nesting orifice 52 of the flap 32 in order to release the head 50 of the corresponding lug 48 because the periphery of the orifice 52 is protected by the skirt 58 In addition, this operation should be performed simultaneously on the six fastening means simultaneously because of the rigidity of the flap 32.

Thus, 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.

In a variant not shown of the invention, the flap 32 and the bottom 20 are two separate parts.

Claims (12)

1. A protective case (10) for a blister pack (12) containing medicines (19) intended for clinical trials, of the type comprising a semi-rigid horizontal upper panel (14) comprising blister-shaped cells (16) delimiting housings open at the bottom and which are obturated by covers (17) and each of which contains a medicine (19) able to be expelled by the flat lower face (18) of the blister pack (12) by tearing the cover (17) of the blister (12), and of the type wherein the case (10) comprises:

   - a perforated horizontal bottom (20) upon which the lower face (18) of the blister pack (12) lays; and

   - a perforated upper panel (32) which covers the upper face (14) of the blister pack (12);

   and of the type in which the blister pack (12) is trapped between the bottom (20) and the upper panel (32) each of which comprise holes (40, 42) coinciding with the location of the cells (16), the case comprising means (44, 46) of fixing the upper panel (32) with respect to the bottom (20), the bottom (20) and the upper panel (32) of the case (10) being made of rigid plastic,
   characterized in that the fixing means (44, 46) are elastic interlocking means that cannot be dismantled.
2. The case (10) as claimed in the preceding claim, characterized in that it comprises at least one pin (48) forming a stop for the horizontal positioning of the blister pack (12) with respect to the ejection holes (42) in the bottom (20) of the case (10).
3. The case (10) as claimed in the preceding claim, characterized in that the pin (48) constitutes a male element (44) of the elastic interlocking fixing means, the associated female element (46) being carried by the upper panel (32).
4. The case (10) as claimed in one of the preceding claims, characterized in that the male element (44) and the female element (46) are formed in one piece with the bottom (20) and with the top panel (32) respectively.
5. The case (10) as claimed in one of the preceding claims, characterized in that the bottom (20) comprises a rim (30) that extends vertically upwards and which surrounds the upper panel (32).
6. The case (10) as claimed in one of the preceding claims, characterized in that the upper panel is a flap (32) that is mounted such that it articulates about a transverse axis by means of a first hinge (34) on one side (22) of the bottom (20) which has no vertical rim (30).
7. The case (10) as claimed in the preceding claim, characterized in that the first hinge (34) is formed by a plastic film which is formed in one piece with the bottom (20) and with the upper panel (32).
8. The case (10) as claimed in one of claims 6 or 7, characterized in that the first hinge (34) forms a stop for positioning the blister pack (12) with respect to the holes (42) in the bottom (20).
9. The case (10) as claimed in one of claims 5 to 8, characterized in that it comprises an upper lid (60) for protecting the cells (16) which is made of rigid plastic and which is mounted such that it pivots with respect to the bottom about a second hinge (62) between a closed position in which it envelopes the cells (16) of the blister pack (12) by cooperation of its shape with that of the bottom (20), and an open position in which the cells (16) are accessible to a user.
10. The case (10) as claimed in the preceding claim, characterized in that the second hinge (62) is a plastic film which is formed in one piece with the bottom (20) and the lid (60).
11. The case (10) as claimed in one of claims 9 or 10, characterized in that the lid (60) is held in the closed position by means working by cooperation of complementary shapes (72) between the lid (60) and the upper panel (32) and/or the bottom (20).
12. The case (10) as claimed in one of the preceding claims, characterized in that the elastic interlocking is produced by elastic deformation of the female element (46).

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