EP1398277A1 - Secure blister pack for pharmaceutical use, card and corresponding method of production - Google Patents

Abstract

A blister pack (11), for packaging pharmaceuticals, has at least one main film (1121) closed by a protective cap. A blister pack (11), for packaging pharmaceuticals, has at least one main film (1121) closed by a protective cap. The cap is covered by a protective film (113) which can be opened and closed. The protective film swings at one end as a hinge (115) against the main film. The free end of the protective film has a closure (114) welded to the main film to separate the blister. In the closed position, the closure is attached to the blister, and is separated from it when opened for access. The pack has a number of blisters, separated by dividing lines (12), matching the number of doses required for the pharmaceutical.

Description

The invention relates to the field of product packaging pharmaceuticals. More specifically, the invention relates to a secure blister especially with regard to use not controlled by a child.

• le dosage du comprimé ;
• la qualité de l'emballage ;
• le remplissage des alvéoles des blisters ;
• l'operculage ;
• le codage et la traçabilité ;
• le nombre de plaquettes dans un emballage ;
• la présence de la notice ;
• ...

In the pharmaceutical field, consumer safety is a major concern for drug companies. These implement verification procedures aimed in particular at checking:

• dosage of the tablet;
• the quality of the packaging;
• filling the blister cells;
• sealing;
• coding and traceability;
• the number of blisters in a package;
• the presence of the notice;
• ...

However, the means implemented by product manufacturers do not prevent incidents related to taking product. In particular, children can easily access the medicine without that this one is not intended for them, then to absorb it, with consequences more or less serious depending on the composition of the drug in question.

Indeed, drugs are most often packaged in wafers formed from a thermoformed film to present cells containing a tablet, a capsule or others, the alveolus being closed by a cover in aluminum.

This cover, conventionally with a thickness of the order of 25 microns, has main function of retaining the tablet or capsule in the blister while protecting it from outside agents.

Clearly, lids of this type are therefore designed to be very fragile, in order to tear easily by the simple push exerted on the tablet or capsule to the outside of the socket.

Also, the packaging of drugs is generally very simple to open, it is easy for a child left temporarily without supervision of release the contents of a packaging of drugs left within reach.

Such a threat is of course very present in the minds of parents or any other person responsible for one or more children, the drugs are therefore most often stored in places hardly accessible for children to avoid any incident.

Faced with this remaining risk, however, several solutions have been proposed in the prior art.

We know in particular a packaging of medicines described by the document published under number EP-1 057 749, according to which the blister is presented in parallelepiped form and has an upper face having a sealed cell and a lower face having an orifice, connected by pairs of pleats on two facing edges, the other two edges being provided tear strips. When the packaging is kept closed by both strips, the cell is offset from the orifice and does not allow extraction of the drug. On the other hand, after having separated the tear-off bands, the set of lateral folds allows the alveolus of the upper face to correspond with the hole on the underside, which allows the medication to be taken.

Such packaging is relatively complicated to manufacture and requires specific equipment, which makes it expensive.

The operation consisting in depositing a sealing film between the two faces interconnected by two sides facing each other, requires tools particular.

In addition, handling the blister is complex, certainly giving it the secure character sought, but at the expense of practicality of use. This disadvantage is accompanied by the fact that such a blister does not appear obvious to use at first sight for the user, who may be perplexed to the point of must consult the instructions for use to achieve its ends.

We also know a blister described by the document published under DE number - 2 919 713 and according to which a first part of the blister having an alveolus is extended by a part, alveolate or not, intended to be folded then glued, using an adhesive, against the first part. According to this document, the cells are not sealed with an aluminum film and can be accessed to the medicine by tearing off the folded part of the first dimpled part.

Such a solution has several drawbacks.

First, during manufacture, the pull-out resistance of the adhesive is difficult to obtain precisely: this resistance depends on the adhesive itself, but also the thickness of the deposit, the pressing, the drying ... We can therefore achieve a random result, ranging from a low resistance to tearing off (the two parts then being too easily detachable, the safety objective not being reached) to a strong resistance to lifting which can lead to sometimes insurmountable difficulties in achieving the drug release.

Second, the cells are not sealed (the application of a operculum being made delicate due to the presence of the adhesive over the entire surface of the parts to be bonded), the drug is no longer retained when the user proceeds to separate the two parts glued together. The operation tearing off the glued parts can be associated with a more or less shaking consequent of the blister, this shaking being likely to cause the flight or the drug falling out of its socket, without the user having the possibility of retaining him, his two hands being mobilized by the opening of the blister.

Such packaging therefore proves difficult to manufacture reliably. and regular, and impractical to use.

The invention particularly aims to overcome the drawbacks of prior art.

More specifically, the invention aims to provide a packaging of medicines in the form of tablets, capsules or similar, which is secure in particular with regard to use by children without supervision or control.

At the same time, the invention aims to provide such a packaging that is easier to manufacture than art solutions prior.

The invention also aims to provide such packaging convenient to use when taking the medication it contains.

The invention also aims to provide such packaging which either inexpensive to make.

• dans ladite position de sécurité, lorsque ladite portion de fermeture est attachée audit blister,
• dans ladite position d'accès audit opercule, lorsque ladite portion de fermeture est séparée dudit blister,

ledit blister comprenant un nombre d'alvéoles correspondant à une prise unitaire du produit pharmaceutique que ledit blister contient.These objectives and others which will appear subsequently are achieved thanks to the invention which relates to a blister for pharmaceutical use, of the type comprising at least one main film having at least one cell closed by a cover covered by at least a movable protective film between a safety position and a position for access to said cover of said blister, characterized in that said protective film forms a cover capable of pivoting around a portion of its periphery forming a hinge relative to said main film , another portion of the periphery of said so-called closing protective film being welded to said main film and being separable from said blister, so that the protective film is:

• in said safety position, when said closure portion is attached to said blister,
• in said access position to said cover, when said closure portion is separated from said blister,

said blister comprising a number of cells corresponding to a unit intake of the pharmaceutical product that said blister contains.

In this way, we obtain a blister reliably secured and which turns out practical use.

In fact, it is reliably secure since it requires three successive steps to access its content: it is first necessary to separate the closing portion of the blister, to rotate, like a hood, the film protection, then push the drug out of its socket causing the tear in the lid.

We therefore considerably increase the number of manipulations by compared to most of the previous solutions, in particular those described by the document DE - 2 919 713, in which the medicament can be released in one single step.

In addition, the closing portion is provided to require an effort that the average child cannot produce, preventing them from accessing drug.

• sa conception et son fonctionnement apparaissent d'emblée à l'utilisateur;
• il suffit de séparer la portion de fermeture pour retrouver rapidement une apparence de blister classique et connue, son principe d'utilisation devenant alors habituel.

It is also practical to use in the sense that:

• its design and operation immediately appear to the user;
• it suffices to separate the closure portion to quickly find a classic and known blister appearance, its principle of use then becoming usual.

Furthermore, such a blister is intended for single use. Indeed, the closure portion is separated at the time of use irreversible. At the same time, the tablet (s) in an open blister are a priori all consumed, the number of cells being provided to correspond to one intake unit defined by dosage.

Thus, the blister according to the invention cannot be closed, it becomes easy check whether the blisters still stored in the packaging have been opened or not.

According to an advantageous solution, said protective film has also at least one cell closed by a cover.

Of course, given the vocation of the blister according to the invention to have a single use, such a configuration will be adopted insofar as the dosage indicates taking the tablets (or capsules, or other ...) in pairs.

This case can notably occur when for the same dosage of a drug molecule, it becomes preferable, even mandatory, to manufacture two smaller tablets, rather than one with dimensions such that it becomes difficult for the consumer to swallow.

According to a preferred solution, said protective film and said main film form a one-piece assembly, said hinge portion being constituted by at least one fold. In this case, said cells are advantageously closed with the same sealing film.

This way you get a simple design blister that can be produced in large series and at low cost with conventional tools and controlled.

Advantageously, said closure portion is delimited by a pre-cut.

Thus, the pullout resistance of the closure portion can be obtained so as to be greater than the force generally produced by a child.

On the other hand, such a precut may allow tearing, easily and quickly, by an older person.

Preferably, the blister essentially has the form of a parallelogram, said hinge portion and said closure portion extending on opposite edges of said blister.

Such a blister thus has a shape perfectly suited to a presentation in a plate in which the blisters are arranged next to each other others.

Advantageously, said main film and said protective film are made of a heat-sealable material. In this case, said closure portion is preferably devoid of said sealing film.

The invention also relates to a plate comprising at least two blisters as described above.

Preferably, said blisters of such a plate are separated by at least one pre-cut line.

The blisters are thus easily separable from the wafer, without risk of damage a neighboring blister and, more particularly, without damaging the means provided for securing the blisters.

• pliage d'un film thermoformé comprenant au moins une alvéole operculée de façon à recouvrir ledit opercule par ledit film de protection ;
• soudage dudit film principal avec ledit film de protection, la soudure ne s'étendant pas à la zone de pliage ;
• réalisation d'une prédécoupe le long de ladite soudure.

The invention also relates to a method for manufacturing a blister as described above and / or a wafer as described above, characterized in that it comprises the steps of:

• folding a thermoformed film comprising at least one sealed cover so as to cover said cover with said protective film;
• welding said main film with said protective film, the weld not extending to the folding zone;
• making a precut along said weld.

Such a method proves to be relatively simple to implement and allows therefore mass production of blisters with a very good rate of conformity and at a cost price fully compatible with the requirements of the market.

Preferably, said welding step is carried out by heat sealing.

Advantageously, the folding line is produced during a step of precut or thermoforming.

According to another advantageous characteristic, the method comprises at least one precut step applied so as to form at least one line separation between said blisters.

• la figure 1 est une vue d'une plaquette formée de plusieurs blisters selon l'invention ;
• les figures 2 à 4 sont des vues des étapes successives d'extraction d'un comprimé contenu dans un blister d'une plaquette selon l'invention ;
• les figures 5, 6a, 6b, 7 et 8 sont des vues des étapes successives illustrant un procédé de fabrication d'une plaquette selon l'invention.

Other characteristics and advantages of the invention will appear more clearly on reading the following description of a preferred embodiment of the invention, given by way of illustrative and nonlimiting example, and of the appended drawings among which:

• Figure 1 is a view of a plate formed of several blisters according to the invention;
• Figures 2 to 4 are views of the successive stages of extraction of a tablet contained in a blister from a wafer according to the invention;
• Figures 5, 6a, 6b, 7 and 8 are views of successive steps illustrating a method of manufacturing a wafer according to the invention.

Figure 1 shows a wafer 1 comprising four blisters 11 of essentially rectangular in shape, separated from each other by lines of pre-cut 12 allowing their separation from the wafer as it will be explained in more detail later.

• un film principal 112 présentant une alvéole 1121 contenant un comprimé, une gélule ou toute autre forme d'un produit médicamenteux ou pharmaceutique généralement non liquide ou non pulvérulent ;
• un film de protection 113 recouvrant la face plane du film principal 112.

According to this embodiment, the blisters include:

• a main film 112 having a cell 1121 containing a tablet, a capsule or any other form of a medicinal or pharmaceutical product generally non-liquid or non-pulverulent;
• a protective film 113 covering the flat face of the main film 112.

Note that the cell 1121 is closed by a sealing film, masked and made inaccessible by the presence of the protective film 113 in the configuration of the blister 11 illustrated in FIG. 1.

Note also that the films 112 and 113 are made of a material heat sealable, in this case PVC.

According to the invention, the blister 11 has a closure strip 114, separable from the rest of the blister, and formed by welding the main films 112 and protection 113, which are also joined by a hinge portion 115

As illustrated, the separation of the closure strip 114 from the rest of the blister is facilitated by the presence of a precut 116.

According to the present embodiment of the invention, the films 112 and 113 are made in one piece, in the same material, the hinge 115 being formed by a folding between the two films.

It is understood that, in the configuration illustrated in FIG. 1, the film 113 forms a cover capable of pivoting relative to the main film 112, the pivoting of the film 113 not being possible as long as the two films are held together by the presence of the weld between them at the level of the closure strip 114.

The extraction of the content of a blister according to the invention will now be explained using figures 2 to 4.

First, a blister 11 is separated from the rest of the wafer 1 (Figure 2), the operation being carried out by simple uprooting using the line of precut 12 which separates two blisters.

The separation of the closure strip 114 is then carried out (FIG. 3) using the precut line 116.

At this stage, the films 112 and 113 are no longer integral with one another on their edge opposite the hinge folding 115. They can therefore be deployed in relation to each other so as to occupy a position such that the one illustrated in figure 4.

The contents of cell 1121 can then be extracted from the blister by proceeding in a conventional manner, that is to say by exerting a push on the alveolus likely to tear the lid (become accessible) which closes the cell and make take the content out through the opening thus produced.

The manufacturing process according to the invention, applied to a wafer formed of several blisters will now be described with reference to FIGS. 5 to 8.

Beforehand, it is noted that the present embodiment of the process aims making a blister with two cells, each of films 112 and 113 being provided with a cell, respectively 1121 and 1131.

These cells 1121 and 1131 are closed by the same sealing film deposited in a single operation.

It will be understood that the process which will be described later can be implemented similarly for the production of a blister in which only the main film presents a cell.

FIG. 5 illustrates the initial step according to which films 112 and 113 extend essentially flat (with the exception of the alveoli) in the extension of each other, the cells they present having previously been obtained by thermoforming.

Of course, the alveoli were filled with a tablet or a capsule.

As illustrated in Figure 5, the blister sockets have been closed by a sealing film which extends over almost the entire surface of the blister between the borders 117. Indeed, an area corresponding to the closure strip 114 carried out thereafter, is kept devoid of the sealing film of each side of the plate.

In this essentially flat configuration of the blister, precut lines 12 separating the blisters from each other.

A pre-cut line corresponds to the hinge fold 115, is also produced (such a fold can also be obtained by thermoforming according to another possible embodiment).

This type of precut is achieved by equipment and modes well known to those skilled in the art.

Films 112 and 113 are then folded over each other so as to be present as illustrated in FIG. 6a (the volume of the cells extending well heard on both sides of the blister as it appears clearly on the figure 6b).

We then proceed to a heat sealing step of the area without of the sealing film, thus forming the closure strip 114.

A new precut line 116, along the closure strip 114, is then carried out.

One or more plates thus obtained are finally introduced, with their instructions, in a packaging in a conventional manner per se.

Claims (14)

Blister (11) for pharmaceutical use, of the type comprising at least one main film (112) having at least one cell (1121) closed by a cover covered by at least one protective film (113) movable between a safety position and a position of access to said cover of said blister, characterized in that said protective film (113) forms a cover capable of pivoting around a portion of its periphery forming a hinge (115) relative to said main film (112), another portion of the periphery of said protective film (113) called closure film (114) being welded to said main film (112) and being separable from said blister (11), so that the protective film (113) is: in said safety position, when said closure portion (114) is attached to said blister (11), in said access position to said cover, when said closure portion (114) is separated from said blister (11), said blister (11) comprising a number of cells (1121), (1131) corresponding to a unit intake of the pharmaceutical product that said blister (11) contains. Blister (11) according to claim 1, characterized in that said protective film (113) also has at least one cell (1131) closed by a cover. Security blister (11) according to either of Claims 1 and 2, characterized in that the said protective film (113) and the said main film (112) form a one-piece assembly, the said hinge portion (115) being constituted by at least one fold. Blister (11) according to Claims 2 and 3, characterized in that the said cells (1121), (1131) are closed by the same sealing film. Blister (11) according to any one of claims 1 to 4, characterized in that said closure portion (114) is delimited by a precut (116). Blister (11) according to any one of Claims 1 to 5, characterized in that it essentially has the shape of a parallelogram, said hinge portion (115) and said closure portion (114) extending over opposite edges of said blister. Blister (11) according to any one of claims 1 to 6, characterized in that said main film (112) and said protective film (113) are made of a heat-sealable material. Blister (11) according to claim 7, characterized in that said closure portion (114) is devoid of said sealing film. Plate (1) characterized in that it comprises at least two blisters (11) according to any one of claims 1 to 8. Plate according to claim 9, characterized in that said blisters are separated by at least one pre-cut line (12). Method for manufacturing a blister (11) according to any one of Claims 1 to 8 and / or a wafer (1) according to any one of Claims 9 and 10, characterized in that it comprises the steps from: folding a thermoformed film comprising at least one cell (1121), (1131) sealed so as to cover said cover with said protective film (113); welding said main film (112) with said protective film (113), the weld not extending to the folding region (115); making a precut (116) along said weld. A method according to claim 11, characterized in that said welding step is carried out by heat sealing. Manufacturing method according to one of claims 11 and 12, characterized in that the folding line (115) is produced during a precut or thermoforming step. Method of manufacturing according to any one of Claims 11 to 13, of a wafer (1) according to any of Claims 9 and 10, characterized in that it comprises at least one precut step applied so as to form at least one separation line (12) between said blisters.

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