FR2844504A1 - SECURE BLISTER FOR PHARMACEUTICAL USE, PLATE AND MANUFACTURING METHOD THEREOF - Google Patents

Abstract

The subject of the invention is a blister pack (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 movable protective film (113). between a safety position and a position of access to said cover of said blister pack, characterized in that said protective film (113) forms a cover capable of pivoting around a portion of its periphery forming a hinge (115) with respect to said film main (112), another portion of the periphery of said protective film (113) called closure (114) being welded to said main film (112) and being separable from said blister (11), so that the protective film ( 113) either: - in said safety position, when said closing portion (114) is attached to said blister (11), - in said access position to said cover, when said closing portion (114) is separated from said blister ( 11), said blister (11) comprising a number of cells (1121), (1131) corresponding to a unit dose of the pharmaceutical product that said blister (11) contains.

Description

Secure blister for pharmaceutical use, plate and method of

corresponding manufacturing.

  The invention relates to the field of packaging of pharmaceutical products. More specifically, the invention relates to a secure blister, in particular with regard to use that is not controlled by a child. In the pharmaceutical field, consumer safety is a major concern for drug companies. These implement verification procedures aimed in particular at controlling: the dosage of the tablet; - the quality of the packaging; - filling the blister cells; - sealing; - coding and traceability; - the number of plates in a package; 1 5 - the presence of the notice; However, the means implemented by the manufacturers of pharmaceutical products do not make it possible to avoid incidents related to taking the product. In particular, children can easily access the drug without it being intended for them, and then absorb it, with more or less consequences.

  less serious depending on the composition of the drug in question.

  Indeed, drugs are most often packaged in

  platelets formed of a thermoformed film to present cells containing a tablet, a capsule or the like, the cell being closed by an aluminum seal.

  The main function of this seal, conventionally with a thickness of about 25 microns, is to hold the tablet or capsule in the blister.

  protecting it from outside agents.

  Clearly, the covers 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, since the medicine packaging is generally very simple to open, it is easy for a child left temporarily unattended.

  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 of any other person having one or more children under their responsibility, the medicaments therefore being most often stored in places which are difficult for children to access in order to avoid any incident.

  Faced with this remaining risk, however, several solutions have been

proposed in the prior art.

  Known in particular is a packaging for medicaments described by the document published under the number EP-1 057 749, according to which the blister is in the form of a parallelepiped 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 with tearable bands. When the package is kept closed by the two bands, the cell is offset from the orifice and does not allow the 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 be matched

  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.

  Indeed, the operation of depositing a sealing film between the two faces connected together by two sides facing each other, requires special tools. In addition, handling the blister is complex, certainly giving it the desired security, but to the detriment of practicality of use. This drawback is accompanied by the fact that such a blister pack does not appear obvious to use at first sight for the user, who may remain perplexed to the point of

  must consult the instructions for use to achieve its ends.

  There is also known a blister described by the document published under the number DE-2 919 713 and according to which a first part of the blister having a cell 5 is extended by a part, which is alveolate or not, intended to be folded and then glued to the 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.

  Firstly, during manufacture, the peel resistance of the adhesive is difficult to obtain precisely: this resistance depends on the adhesive itself, but also on the thickness of the deposit, of the pressing, of the drying ... We can therefore arrive at a random result, ranging from a low resistance to tearing off (the two parts then being too easily detachable, the safety objective not being achieved) to a high resistance to uprooting which can lead to sometimes insurmountable difficulties in achieving the

drug release.

  Secondly, since the alveoli are not sealed (the application of a seal being made delicate due to the presence of the adhesive over the entire surface of the parts to be bonded), the medicament is no longer retained when the user proceeds to separate the two parts glued together. However, the operation of tearing off the glued parts can be associated with a more or less substantial shaking of the blister, this shaking being capable of causing the medication to take off or fall out of its socket, without the user having the 25 possibility of retaining it, both hands being mobilized by the opening of the blister. Such packaging therefore proves difficult to manufacture reliably.

  and regular, and impractical to use.

  The object of the invention is in particular to overcome the drawbacks of the prior art.

  More specifically, the object of the invention is to propose a packaging of medicaments in the form of tablets, capsules or the like, 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 packaging which is simpler to manufacture than the solutions of the prior art. The invention also aims to provide such packaging

  which is convenient to use when taking the drug it contains.

  The invention also aims to provide such packaging which

either inexpensive to achieve.

  These objectives and others which will appear subsequently are achieved by virtue of 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 at least one 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 20 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 closing portion is attached to said blister, - in said position of access to said cover, when said closure portion is separated from said blister , said blister comprising a number of cells corresponding to a unit outlet

  of the pharmaceutical product that said blister contains.

  In this way, a blister is obtained which is reliably secured and which is practical for use.

  Indeed, it is securely reliably insofar as it requires three successive steps to access its content: it is first of all necessary to separate the closing portion of the blister, to rotate, like a cover, the film of protection, then push the drug out of its socket causing the tear in the seal. The number of manipulations is therefore considerably increased compared to most of the prior solutions, in particular those described by document DE 2 919 713, in which the medicament can be released in one

single step.

  In addition, the closing portion is designed to require an effort that the average child cannot produce, preventing them from accessing the medication. It is moreover practical to use in the sense that: its design and its operation are immediately apparent to the user; - just separate the closure portion to quickly find a classic and known blister appearance, its principle of use

then becoming habitual.

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

unit defined by dosage.

  Thus, since the blister according to the invention cannot be closed, it becomes easy to 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 obligatory, to manufacture two tablets of reduced dimensions, rather than one having

  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.

  In this way, a simple design blister is obtained which can be produced in large series and at a lower cost with conventional and controlled tools. Advantageously, said closure portion is delimited by a precut. Thus, the resistance to tearing of the closure portion can be obtained so as to be greater than the force that can generally produce a child. On the other hand, such a precut may allow tearing,

  easily and quickly, by an older person.

  Preferably, the blister has the shape essentially of a parallelogram, said portion forming a hinge and said closing portion.

  extending on opposite edges of said blister.

  Such a blister thus has a shape perfectly suited to a presentation in blister 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 30 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 damaging a neighboring blister and, more particularly, without damaging the

  means provided for securing the blisters.

  The invention also relates to a method of 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 at least one cell sealed 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;

  - Performing a precut along said weld.

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

  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 the 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 shape, separated from each other by precut lines 12 allowing their separation from the wafer as will be explained in more detail below.

  According to the present embodiment, the blisters comprise: a main film 112 presenting a cell 1121 containing a tablet, a gelatin capsule or any other form of a generally non-liquid or non-pulverulent drug or pharmaceutical product;

  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 25 of protection 113, which are also joined together by a portion forming a hinge 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 produced in one piece, in the same material, the hinge 115 being

  formed by a folding between the two films.

  We understand that, in the configuration illustrated in Figure 1, the film 5 l 13 forms a cover capable of pivoting relative to the main film 1 12, the pivoting of the film 113 is not achievable as long as the two films are held integral due to the presence of the weld between them at the level of the

closure strip 114.

  The extraction of the contents of a blister according to the invention will now be explained with the aid of FIGS. 2 to 4.

  Initially, a blister 11 is separated from the rest of the wafer 1 (FIG. 2), the operation being carried out by simple uprooting with the help of the line

  of precut 12 which separates two blisters.

  The separation of the closure strip 114 is then carried out (FIG. 3) 15 with the help of the precut line 11 16.

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

the one illustrated in figure 4.

  The contents of the 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 cell so as to tear the seal (become accessible) which closes the cell. and to do

  take the content out through the opening thus produced.

  The manufacturing method according to the invention, applied to a wafer 25 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 method aims at producing a blister having 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 method which will be described subsequently can be implemented in a similar manner for the production of a blister in which only the main film has a cell. FIG. 5 illustrates the initial step according to which the films 112 and 113 extend essentially flat (with the exception of the cells) in the extension of one another, the cells which they present having previously

been obtained by thermoforming.

  Of course, the alveoli were filled with a tablet or a capsule. As illustrated in FIG. 5, the blister cells have been closed by a sealing film which extends over almost the entire surface of the blister between the edges 117. In fact, an area corresponding to the closure strip 114 15 made subsequently, 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 precut 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.

  The films 112 and 113 are then folded over one another so as to be presented as illustrated in FIG. 6a (the volume of the cells of course extending on either side of the blister as it appears clearly in Figure 6b). We then proceed to a heat sealing step of the area without

  of the sealing film, thus forming the closure strip 114.

  il 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 (12)

  1- 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 position of security and an access position to said lid 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 10 (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) 15 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) com taking a corresponding number of cells (1121), (1131)   to a unit intake of the pharmaceutical product that said blister (1 1) contains.   2 - Blister (11) according to claim 1, characterized in that said protective film (13) also has at least one cell (1131) closed by a cover.   3 - Blister (11) security according to any one of claims 1 and 2, characterized in that said protective film (113) and said main film (112) 25 form a one-piece assembly, said portion forming a hinge (115) being consisting of at least one fold.   4 - Blister (11) according to claims 2 and 3, characterized in that 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).   6 - 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   on opposite edges of said blister.   7 - Blister (11) according to any one of claims 1 to 6, characterized in that said main film (112) and said protective film (113) are produced made of a heat-sealable material.   8 - Blister (11) according to claim 7, characterized in that said closure portion 10 (114) is devoid of said sealing film.   9 - 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 precut line (12).   11- Method of manufacturing a blister (11) according to any one of   claims 1 to 8 and / or a plate (1) according to any one of   Claims 9 and 10, characterized in that it comprises the steps of:   - folding a thermoformed film comprising at least one cell (1121), (1131) sealed so as to cover said cover with said protective film (113); - welding of said main film (112) with said protective film (113), the welding not extending to the folding zone (15);   - Making a precut (116) along said weld.   12 - Method according to claim 11, characterized in that said welding step is carried out by heat sealing.   13 - Manufacturing method according to one of claims 11 and 12, characterized in that the folding line (115) is performed during a precut step or thermoforming.   14 - Manufacturing process according to any one of claims 11 to 13, 30 of a wafer (1) according to any one 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.