US20130081968A1

US20130081968A1 - Film container of a blister that cannot be extruded

Info

Publication number: US20130081968A1
Application number: US13/516,784
Authority: US
Inventors: Stephan Kurtze; Stefan Lustenberger
Original assignee: Boehringer Ingelheim International GmbH
Current assignee: Boehringer Ingelheim International GmbH
Priority date: 2009-12-22
Filing date: 2010-12-21
Publication date: 2013-04-04
Also published as: WO2011076789A1; JP2013514949A; EP2516291A1

Abstract

The invention relates to a film container of a blister that cannot be extruded, comprising a base film and a cover film for implementing a receiving chamber (4) for a filling material, in particular an active pharmaceutical ingredient formulation, wherein the receiving chamber (4) is connected to an opening area (6) for removing the filling material. The opening area (6) of the receiving chamber (4) is protected by means of at least one film section (7, 8) that can be separated at least in sections from the film container (1).

Description

The invention relates to a film container of a blister that cannot be pressed through, having a base film and a cover film, to form a receiving chamber for a filling material, particularly a pharmaceutical active substance formulation, the receiving chamber being connected to an opening area for removing the filling material.
Film containers, so-called blisters, are used, among other things, for protecting pharmaceutical active substance formulations from external environmental effects, which in some circumstances may affect the pharmaceutical quality of the active substance formulation, and generally consist of a cover film and a base film, with cavities for the filling provided in the base film. The cover film and the base film may be made up of one or more layers of the same or different materials. The cover film is attached to the base film in sealed manner for example by adhesive bonding, welding or sealing. The cover film and/or the base film are generally in the form of a metal and/or plastic and/or paper film. These materials may be present in a plurality of layers. Typical metal films include for example aluminium films and composite aluminium films which are made from aluminium and a plastic, for example. The material used for the plastic films may be polyvinylchloride (PVC), cyclo-olefin-copolymer (COC), polychlorotrifluoroethylene (PCFE), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), polyester (UP), polyacrylate, polyamide (PA) or another plastic or a multi-layer composite plastic film, consisting for example of a combination of polychlorotrifluoroethylene (PCTFE), which is known particularly by the brand name Aclar®, registered as a trade mark by Honeywell International, Inc., with polyvinylchloride (PVC) or polyvinyl chloride (PVC) with polyvinylidene chloride (PVdC). Often a film container or blister consists of an aluminium cover film which seals the base film to accommodate the pharmaceutical product or active substance. This thermoformed base film may also comprise an aluminium foil to prevent water from entering the cavity for holding the pharmaceutical product. In order to create another diffusion barrier or increase the mechanical stability of the blister, the aluminium foil of the base film or the cover film may optionally be covered on one or both sides with additional plastic and/or paper films.
In some states regulations on childproof packaging of medical products are being considered or are already in existence, to make it difficult for children to get hold of medicaments.
The problem of the invention is to provide a film container of the kind mentioned hereinbefore which is highly childproof.
According to the invention the problem is solved by the fact that the opening area of the receiving chamber is protected by at least one film section that can be detached from the film container at least in sections.
As a result of this measure, it is necessary first of all to detach a foil section from the foil container at least far enough to allow access to the opening area, which enables the filling, particularly a tablet or capsule, to be removed from the receiving chamber. This first detachment of the foil section constitutes a difficulty in removing the filling from the receiving chamber which cannot easily be overcome particularly by small children, who are particularly at risk of damage to their health by taking a drug not meant for them, for example, as the method of opening the receiving chamber is unusual and hence more difficult for a child. An adult, on the other hand, will readily be able to grasp and implement the processes for opening the receiving chamber. The foil section does not have to be completely detachable in every case, but will always be capable of being torn away sufficiently to expose the opening area or the opening aid, to allow subsequent access to the opening area of the individual film container and enable the corresponding receiving chamber to be opened in order to remove the contents. Obviously, the individual components of the film container, i.e. its base film and cover film, are sufficiently stable in construction to ensure that they cannot simply be torn open.
To make unauthorised opening of the receiving chamber even more difficult, two film sections that can be at least partly detached from the film container one after another are advantageously provided for protecting the opening area.
According to a further feature, the first film section is arranged in the peripheral edge area of the preferably angular film container and the second film section opens into the first film section. It is therefore visually easy to see that the first film section has to be removed first to give access to the perforation of the second film section so that the latter can be detached from the film packaging.
To ensure that the first film section can be detached relatively easily from the film container, the first film section is preferably triangular in shape and forms a corner of the film container, the first film section being connected to the film container via a perforation which extends up to at least one outer edge of the film container. Within the scope of the invention the term “perforation” denotes both an actual punching through of a material or of a plurality of layers or plies of a material of the blister, and a thinning of the material, a bending line, fold line, embossed marking or the like. Perforations of this kind may be produced by machine during the manufacture of the film pack to enable individual film containers or parts thereof to be torn off or separated.
The corner that forms the first film section can be bent, for example, before being torn off, to make separation easier. The separation is carried out starting from the outer edge of the film container at which the perforation starts. By means of the perforation ending at the outer edge, the separation of the film section can be carried out relatively easily in a kind of peeling action.
To ensure the desired sequence of the tearing off of the two film sections, the second film section is advantageously connected to the film container via a perforation which starts at the perforation of the first film section and extends approximately to an outer edge of the film container, past the opening area. Therefore the end of the perforation associated with the second film section is only accessible after the first film section has been torn off and the second film section can be separated from the film container by a kind of peeling action to expose the opening area. Obviously, it is not absolutely essential to tear the first or second film section away from the film container completely. The first film section only has to be detached to the point where the perforation of the second film section is exposed and the second film section has to be removed until the opening area is reached.
Expediently, a blister card comprises a plurality of film containers that can be separated as segments. The film containers usually have a rectangular base surface and are combined to form a rectangular blister card. By means of perforations in the shape of a cross between the individual film containers, the latter can easily be separated from the other film containers of the blister card. Naturally, when the base area is substantially triangular, the film containers may also form a closed circle or a polygon.
To provide a further safety measure to avoid unauthorised removal of a product contained in the film container, particularly by a child, it is advantageously necessary to remove the film container from the blister card in order to separate the first film section. In one embodiment the removable first film sections point into the centre of the blister card and the film containers are preferably of rectangular configuration. Therefore, the film containers first have to be separated in order to gain access to the first film section, which has to be removed before the second film section can be torn off, so as to reach the opening area which has to be opened in another step in order to remove the filling contained in the receiving chamber of the film container.
Expediently, the opening region is embodied as a gripping tab for removing the cover film or it comprises a notch or a cut as a weakened area of the base film and/or the cover film. Accordingly, the opening area consists of tear-off or peel/push openings known from the prior art.
For ease of operation when providing a relatively large contact surface, the gripping tab advantageously extends with its longitudinal side parallel to the perforation of the second film section. Once the second film section has been separated from the film container, the entire length of the perforation is available as a free edge for the gripping tab, which is easy for the fingers to grip.
In the tear-off variant of the opening region, the notch or the cut starts perpendicularly and centrally from the perforation of the second film section and extends in the direction of the receiving chamber. After the second film section has been torn off, the film container can be torn open along the notch.
In the film container according to the invention, the base film consists of plastics, aluminium or a combination of these materials. The shape, size and number of the respective cavities of the receiving chambers in the base film is adapted to the filling material that is to be placed therein, such as for example a tablet or the like. Naturally, a single blister card may comprise a plurality of film containers having the corresponding number of receiving chambers. The base film is made, for example, on the side facing the filling material, from a layer of polyvinylchloride (PVC) that is approximately 60 thick, followed by a roughly 45 μm thick aluminium film, which is in turn attached to a roughly 25 μm thick film of an oriented polyamide (oPA).
Advantageously, the cover film is a composite aluminium film, which consists, for example, on the side facing the filling, of an aluminium film roughly 20 μm thick and attached thereto a film, roughly 23 μm thick, of a polyethylene terephthalate (PET). Clearly, the base film and the cover film may also be identical or made from other materials.
It will be understood that the features mentioned above and about to be explained hereinafter may be used not only in the particular combination specified but also in other combinations. The scope of the invention is defined only by the claims.

The invention is hereinafter explained in more detail by means of a number of embodiments by way of example, with reference to the associated drawings, wherein:

FIG. 1 shows a plan view of a blister card with film containers according to the invention,

FIG. 2 is an enlarged view of the film container according to detail II in FIG. 1,

FIG. 3 is an enlarged view of the film container according to detail II in FIG. 1, in a first alternative embodiment,

FIG. 4 is an enlarged view of the film container according to detail II in FIG. 1, in a second alternative embodiment, and

FIG. 5 is an enlarged view of the film container according to detail II in FIG. 1, in a third alternative embodiment.

The blister card 2 comprising a plurality of film containers 1 embodied as blisters comprises a base film with cavities 3 and a cover film, which is attached to the base film in suitable manner, preferably using a heat-seal lacquer, to form closed receiving chambers 4 in the region of the cavities 3, each for at least one filling, particularly a pharmaceutical active substance formulation. The receiving chambers 4 are elongated and round in this case, but could obviously be of any appropriate shape. The individual film containers 1 can be separated according to FIG. 1 along intersecting perforations 5, i.e. can be removed from the blister card 2, and have a substantially rectangular base, according to FIGS. 2 to 4. To make it more difficult to remove the filling from the receiving chamber 4 of a film container 1, particularly for children, an opening area 6 associated with the receiving chamber 4 is protected by two film sections 7, 8 which can be separated from the film container 1 at least in sections one after the other, the first film section 7 which is to be separated first facing towards the centre of the blister card 2, so that in order to remove the first film section 7 the film container 1 first has to be removed from the blister card 2.
The first film section 7 is arranged in the edge region of the film container 1 and is of triangular configuration. By means of a perforation 10 extending from one outer edge 9 of the film container 1 to another outer edge 9, the first film section 7 that forms one corner of the film container 1 is connected to the film container 1, while the outer edges 9 between which the perforation 10 of the first film section 7 extends are determined by the perforations 5 of the blister card 2 and are formed after the separation of the film container 1.
Starting from the perforation 10 of the first film section 7 is a perforation 11 of the second film section 8, which is arranged so that it is only accessible after the first film section 7 has been at least partly removed. The perforation 11 of the second film section 8 in particular does not extend as far as one of the outer edges 9 of the film container 1, in order to prevent the second film section 8 from being detached before the first film section 7 has been torn away. After the at least partial removal of the second film section 8 the opening area 6 is accessible.
According to FIGS. 2 and 3 the opening area 6 comprises a cut 12 as a weakening of the base film and cover film, running substantially perpendicularly and centrally away from the perforation 11 of the second film section 8 and extending in the direction of the receiving chamber 4.
In an alternative embodiment according to FIG. 4, the opening area 6 is embodied as a gripping tab 13 for pulling the cover film away from the base film, the longitudinal side 14 of which runs parallel to the perforation 11 of the second film section 8.
To enable filling to be removed from the receiving chamber 4 of a film container 1, first of all the film container 1 has to be separated from the blister card 2 along the intersecting perforations 5. Then the first film section 7 is detached from the film container 1 along the perforation 10 associated therewith to a point where the perforation 11 associated with the second film section 8 is accessible. The second film section 8 is then pulled off by a kind of peeling action at least until the opening area 6 associated with the receiving chamber 4 is exposed. If the opening area 6 is formed by a gripping tab 13, the second film section 8 should if possible be detached as far as an outer edge, and preferably completely. Finally, the film container 1 is opened, either by tearing along the cut 12 or by separating the cover and base films by means of the tear tab 13, and the filling can be removed from the receiving chamber 4. In all, it is possible to open this film container 1 in four steps that are to be carried out one after the other; these steps are unusual and thus make it more difficult for a child to gain access to the contents of the receiving chamber 4.
In an alternative embodiment according to FIG. 5, the film container 1 is round and the perforation 10 of the first film section 7 runs in a peripheral edge region of the film container 1. As already described, the perforation 11 of the second film section 8 becomes accessible after the first film section 7 has been removed and the opening area 6 embodied here as a cut 12 can be reached after the second film section 8 has been torn away. The round film container 1 can therefore be opened in three steps to be performed successively, which are also unusual and make it more difficult for a child to gain access to the contents of the receiving chamber 4.

Claims

1. A film container or blister that cannot be pressed through and so is child-proof, having a base film and a cover film, to form a receiving chamber (4) for a filling material, the receiving chamber (4) being connected to an opening area (6) for the removal of the filling material, characterised in that the opening area (6) of the receiving chamber (4) is protected by at least one film section (7, 8) that can be detached from the film container (1) at least in sections.

2. The film container according to claim 1, characterised in that two film sections (7, 8) that can be detached from the film container (1) at least in sections are provided for protecting the opening area (6).

3. The film container according to claim 2, characterised in that the first film section (7) is arranged in the peripheral edge region of the film container (1) and the second film section (8) opens into the first film section (7).

4. The film container according to claim 2, in that the first film section (7) is triangular in construction and forms a corner of the film container (1), the first film section (7) being connected to the film container (1) by a perforation (10) which extends up to at least one outer edge (9) of the film container (1).

5. The film container according to claim 2, characterised in that the second film section (8) is connected to the film container (1) by a perforation (11) that starts from the perforation (10) of the first film section (7) and extends at least approximately to an outer edge (9) of the film container (1) past the opening region (6).

6. The film container according to claim 2, characterised in that a blister card (2) comprises a plurality of film containers (1) that can be separated into segments.

7. The film container according to claim 6, characterised in that in order to remove the first film section (7) the film container (1) has to be detached from the blister card (2).

8. The film container according to claim 6, characterised in that the detachable first film sections (7) face into the centre of the blister card (2) and the film containers (1) are of rectangular construction.

9. The film container according to claim 1, characterised in that the opening area (6) is embodied as a gripping tab (13) for pulling off the cover film or comprises a notch or a cut (12) as a weakening of the base film and/or of the cover film.

10. The film container according to claim 9, characterised in that the gripping tab (13) extends with its longitudinal side (14) parallel to the perforation (11) of the second film section (8).

11. The film container according to claim 9, characterised in that the notch or the cut (12) starts perpendicularly and centrally from the perforation (11) of the second film section (8) and extends in the direction of the receiving chamber (4).

12. The film container according to claim 1 wherein the filling material is a formulation comprising a pharmaceutically active substance.

13. The film container according to claim 1 which is angular.