Patent Application
20130199958
The present invention relates to a wafer pocket for accommodating a wafer, which means for accommodating a film patch having at least one active substance contained therein, for example for accommodating a medication wafer, in particular a wafer which contains active substances for the purpose of contraception or hormone replacement therapy, or else a wafer which contains other active substances, for example including non-medical ones, e.g. nicotine. In addition, flavorings or fragrances can also be contained in the wafer.
Typically, such primary packs of the type according to the invention contain a first and a second enveloping film, which are connected by at least one connecting region, such that a wafer accommodating compartment which is suitable for accommodating a wafer and which is sealed off toward the outside is formed between the first enveloping film and the second enveloping film.
A wafer pocket of this type is disclosed, for example, in DE 10 2004 047 447 A1. The pack described there, for example for wafer-like or film-like medicaments, has a carrier layer and a covering layer detachably connected thereto. In this pack, the carrier layer is not connected to the covering layer in a delimited surface region, so that, as a result, a compartment enclosed on all sides is produced and the surface region is completely enclosed by an edge region, in which the carrier layer is detachably connected to the covering layer. The compartment is used to accommodate the wafer-like or film-like medicament. In order to be to remove the medicament, the covering layer is detached or pulled off manually from the carrier layer in order to open the compartment.
However, it has transpired that, in this case, the manual detachment of covering film from the lower film is not readily possible if, on the side of the two layers respectively enclosing the compartment, the covering film and the lower film consist of a material which does not permit the seal to be released by peeling the covering film off the lower film, since the two layers form, as a result of the sealing, a connection that is not easily separated.
A further embodiment of a pack, in this case for foodstuffs, is described in WO 03/103950 A1. The pack specified there comprises two films connected to one another, which form an accommodating compartment enclosed on all sides, so that a foodstuff, for example, can be preserved securely closed therein. In order to reach the foodstuff, the pack can be torn open. For this purpose, a scribing structure produced by means of a focused laser beam, along which the films can be torn open, is introduced into one of the films, at least on the outer side.
Another embodiment, likewise for accommodating a foodstuff, is specified in U.S. Pat. No. 6,719,678 B1. The bag disclosed there comprises two film laminates, which are connected to one another at the edges by means of hot sealing. Furthermore, in addition to a scribing structure produced by means of a focused laser beam in a burst-resistant layer, a mechanical closure is provided on the respective inner side of the film laminate, with which the bag can be closed again via the scribing structure after being torn open.
The known bags are not suitable to accommodate a medication wafer and, to this extent, to ensure that the inner film layer is inert with respect to exchange of substances between product and film and, at the same time, to permit simple, problem-free removal of the medication wafer. The bags specified in WO 03/103950 A1 and U.S. Pat. No. 6,719,678 B1 for accommodating foodstuffs are not suitable for the preservation of medication wafers. Even if the wafer pocket were capable of being torn open for the removal of a medication wafer in accordance with the design specified in these documents, the removal of the wafer would be difficult because of its low thickness if it were dimensioned appropriately with a small accommodating compartment for the wafer, since the wafer could not be removed from the accommodating compartment manually without problems.
From this starting point, the present invention is based on the object of finding a primary pack which is used for the secure preservation of film-like objects, for example wafers, in which there are one or more active substances for use as medications or else one or more active substances which are not used as medications and which, in addition, possibly also contain flavorings or fragrances and from which the wafer or the other film-like object can be removed conveniently. In addition, the primary pack should also have a pleasing appearance, which means in particular appeal to the user by means of attractive and informative printing.
This object is achieved by the wafer pocket as claimed in claim 1. Preferred embodiments of the invention are specified in the subclaims.
To the extent that the term “wafer” is used in this description and in the claims, this is to be understood to mean a flat, flexible object or film patch which contains at least one active substance. Typically, such wafers are used for the administration of the active substance or the active substances to a human or animal body, in that a wafer contains this or these active substance(s) and, for the purpose of administration, is brought into contact with a point of the body of the individual at which the active substance or substances is/are administered. For example, a wafer can be a medication, in particular a contraceptive or a hormone replacement therapy agent or else another medication, or the wafer can also contain another active substance, for example one or more active substances of a nicotine plaster. In addition, the wafer can also contain another substance, such as a flavoring or fragrance. In another embodiment of the invention, the wafer can also contain only a flavoring, for example a sweetener and a flavoring aroma. Typically, the wafer is composed of a wafer matrix which dissolves during the administration or which discharges the active substance/s.
The wafer pocket according to the invention is formed by a first and a second enveloping film connected to one another via at least one connecting region, such that a wafer accommodating compartment which is suitable for accommodating a wafer and which is sealed off toward the outside is formed between the first enveloping film and the second enveloping film. In the connecting region, the first and the second enveloping film can be connected to one another in a force-fitting, form-fitting or materially connecting manner, for example by means of welding, cold or hot sealing or else by adhesive bonding. The connecting region closes off the wafer accommodating compartment from the outside, so that the quality of the wafer located in the wafer accommodating compartment is not impaired by external influences. Thus, secure, even relatively long, preservation is ensured. The enveloping films are typically laminates comprising a plurality of layers, each of which has different properties and fulfils different objectives. In principle, both enveloping films or else only one of the two enveloping films can also consist of only a single layer. The connecting region preferably encloses the wafer on all sides.
Furthermore, at least one of the enveloping films, possibly also both enveloping films, are weakened within a weakening region situated in the region of the wafer accommodating compartment, such that the wafer accommodating compartment can be opened by tearing open the wafer pocket along a tearing line that passes the weakening region. As a result, the wafer pocket can easily be torn open in one direction in order to remove the wafer.
In a manner according to the invention, the weakening region is spaced apart from each edge of the wafer pocket. In addition, the tearing line also runs partly outside the weakening region. These measures ensure that the weakening region does not impair the outer side of the wafer pocket. For example, a scribing structure could not readily be printed such that this would always be easily visible following the printing. If the weakening region were to extend between two edges of the wafer pocket, over the entire width of the latter, the external configuration of the wafer pocket would be considerably impaired as a result. Only by restricting the extent of the weakening region to a relatively small region which is therefore spaced apart from the edges of the wafer pocket is it possible to achieve a largely free design of the outer sides of the wafer pocket, so that, firstly, the esthetic impression is not impaired and, secondly, the application of the necessary information is not restricted by the weakening region.
It is preferred for at least one enveloping film of the wafer pocket, possibly also both enveloping films, to be weakened along a deflection line extending in the region of the wafer accommodating pocket or in the region of a deflection area, such that the wafer accommodating compartment can be opened by tearing the wafer pocket open along at least two edges of the wafer accommodating compartment. This not only includes the variant in which the wafer pocket is torn open parallel to, for example, at least two edges of the accommodating pocket, but also the variant in which the tearing line does not extend parallel to the edges. The deflection line or the deflection area preferably causes a deflection of an otherwise randomly extending tearing line as the wafer pocket is torn open.
In a particularly preferred embodiment of the invention, the wafer pocket according to the invention contains a wafer.
In a preferred embodiment of the invention, the weakening region is made in the form of a weakening line or in the form of a weakening area. For example, the weakening line can be formed as a trench-like structure which is introduced into the uppermost layer of an enveloping film. This trench-like structure is elongated and can have a width of several 100 μm. This structure is preferably at least 500 μm and particularly preferably at least 1 mm wide. Most preferably, the structure is at least 1.5 mm wide. The structure can in particular be up to 10 mm wide, for example. It is preferred if it is at most 5 mm wide and quite particularly preferred if it is at most 2.5 mm wide. The values indicated for the width are based on the surface of the enveloping film. If the structure does not have a rectangular cross section but, for example, a trapezoidal or triangular cross section, the width of the structures at the base thereof is lower than the values indicated. Alternatively, the weakening region can be a weakening area, for example an area-like depression—formed by removal—in at least one of the enveloping films. The area can be formed, for example, in the shape of a circle. Other area shapes are likewise conceivable, for example an ellipsoidal or triangular shape or another area shape. It is preferred for the area to have a boundary running around on at least one side, on which boundary the tearing line is deflected in another direction. The weakening line differs from the weakening area by its elongated shape, which has a side ratio (length to width) of at least 5, in particular at least 10.
In a further preferred embodiment of the invention, the first enveloping film and/or the second enveloping film is/are biaxially oriented. This achieves the situation where the enveloping films form a straight tearing line when torn, starting from the tearing point. Films formed in this way form preferred tearing lines in two mutually orthogonal directions, so that substantially straight tearing lines can be produced.
In a further preferred embodiment of the invention, the first and/or the second enveloping film is/are oriented in a direction at right angles to at least one edge of the wafer pocket. As a result, the wafer pocket can be torn open rectilinearly in a direction at right angles to the edge or to the edges of the wafer pocket.
In a further preferred embodiment of the invention, there is on at least one edge of the wafer pocket a respective edge weakening, from which the first enveloping film and the second enveloping film can be torn open. Thus, the wafer pocket can be torn specifically at a point on the edge of the pocket.
In a further preferred embodiment of the invention, the edge weakening is respectively formed by a notch or a cut on at least one edge of the wafer pocket. Via this notch or this cut, the enveloping films can be torn conveniently. The result is the starting point for the tearing line. The direction of the tearing line typically results as a preferred direction from the manufacturing conditions, starting from the notch or the cut. In principle, a single such notch or a single such cut on one edge of the wafer pocket is sufficient to open the wafer pocket. However, in order to leave the user the choice as to the edge from which he or she wishes to tear the wafer pocket open, such notches or cuts can be provided on both (adjacent) edges of the wafer pocket.
In a further preferred embodiment of the invention, the edge weakening is located within the connecting region, so that the accommodating compartment for the wafer has no connection to the outside and the wafer is thus sealed off hermetically in the accommodating compartment.
The wafer pocket tears open along a tearing line during opening. The deflection line or the deflection area influences the direction of the tearing line, which changes direction along the deflection line or within the deflection area, in particular along a boundary line of the deflection area. This is because, in this region, the material of the enveloping films which have the deflection line or deflection area is weakened or virtually completely removed. The deflection line forms a track which changes direction as it is torn open. In a corresponding way, the deflection area also produces a track at one of its boundaries, along which the tearing line changes direction. As a result, the accommodating compartment can be opened on at least two (adjacent) sides. This makes it possible for the user to open the wafer pocket widely in order to reach the wafer and to remove the latter easily.
If, on the other hand, the wafer pocket were to be opened only on one side, as is provided in U.S. Pat. No. 6,719,678 B1, for example, the opening of the accommodating pocket would only be very narrow, so that it would barely be possible to grip the wafer with the fingers. In this case, the removal of the wafer would be extremely difficult. Only by means of opening the accommodating compartment on at least two sides can the wafer be gripped easily, since at least the enveloping film which has been torn along the film weakening applied thereto along the deflection line or within the deflection area is then set back with respect to the wafer contained in the wafer pocket, and at least one edge of the wafer can be exposed or at least easily bent back, so that the wafer can be gripped easily.
According to one embodiment of the invention, it is possible for said deflection line or deflection area to be located in only one of the two enveloping films, so that only this enveloping film tears as the direction of the tearing line changes. The other enveloping film in this case is able to tear without changing direction, since there is no such deflection line, in which the material is weakened, in this enveloping film. The wafer accommodating compartment is thus opened only on the side on which the enveloping film has been weakened along the deflection line or within the deflection area and is torn off “diagonally”. In this case, the wafer can nevertheless be removed very easily, since it is partly exposed on the side on which the enveloping film weakened along the deflection line or within the deflection area has been torn off the wafer pocket, or because the wafer accommodating compartment can easily be turned back, so that the wafer can be gripped conveniently.
Of course, the wafer can also be removed conveniently from the wafer pocket if deflection lines, in the course of which the enveloping films are weakened, or deflection areas, along the boundaries of which the enveloping films tear easily, are located in both enveloping films, according to another embodiment of the invention. In this case, it is advantageous if the deflection lines or deflection areas of both enveloping films are located congruently above one another in the wafer pocket, so that the enveloping films tear open on mutually congruent tearing lines. However, adhesively bonding the two enveloping films to one another, for example by means of an excessively high input of heat, is to be avoided. In this case, for the ability to remove the wafer easily, it would also be sufficient if the deflection lines or deflection areas of the two enveloping films do not run exactly congruently with one another but only substantially congruently with one another, for example at a distance of a few millimeters, for example 2-5 mm, the two deflection lines not necessarily having to run parallel to one another or the deflection areas not necessarily having to be located immediately over one another, so that the boundary lines of the deflection areas causing the respective direction change of the tearing lines do not run parallel to one another. It would be advantageous in any case if the deflection lines or deflection areas are applied in such a way that, following the tearing, at least one film can be gripped with the fingers or projects or the wafer can be gripped at least by means of simply turning back the enveloping films.
In a preferred embodiment of the invention, the deflection line or the deflection area connects a first preferably straight tearing line section and a second preferably straight tearing line section to each other, it being possible for this connection preferably to be curved. The deflection line or the deflection area according to this embodiment can cause a direction change of the first tearing line section through about 90°, for example, or else a direction change through less than 90° or more than 90°. It is preferred for the tearing line to be rotated through 90° with respect to the original tearing direction as it is torn, so that the first tearing line section and the second tearing line section result. Said two tearing line sections according to this embodiment run substantially or else exactly at right angles to one another, if they each form a straight line and merge into one another along the preferably curved deflection line or along a preferably curved boundary line of the deflection area, along which the enveloping film or the two enveloping films tear. In the case in which the tearing line is deflected by the deflection area, the latter preferably has an outer boundary line, on which the tearing line is deflected from the first tearing line section to the second tearing line section. This is because, within the deflection area, the enveloping film provided with this deflection area is weakened, so that, as the film is torn, the tearing line propagates in one direction until it meets the outer boundary line. The tearing line is then deflected in the direction in which the boundary line runs. Of course, when the tearing line already meets the outer boundary line tangentially when encountering the deflection area, said tearing line also runs further along this boundary line.
In a particularly preferred embodiment, the deflection line has ends located in the region of the cavity, first and second tangents to the respective ends of the deflection lines running at right angles to one another and the first tearing line section running along the first tangent and the second tearing line section running along the second tangent. As a result, the first preferably straight tearing line formed during the tearing runs into the preferably curved course of the deflection line without any further direction change and, from there, without any further direction change, merges into the second tearing line running at right angles to the first tearing line and once more preferably running straight.
In a further preferred embodiment of the invention, at least one of the two tearing lines is defined by an edge weakening, for example a notch or cut on an edge of the wafer pocket.
The weakening of the material of the enveloping film or the enveloping films, formed in the course of the deflection line or in the region of the deflection area, is made in the form of one or more scribing structures in the enveloping material or in the enveloping materials, in that a preferably focused laser beam is aimed at the first and/or second enveloping film (notching by means of a laser beam). As a result of this action of the laser beam on the enveloping film, the material of the uppermost layer or of the uppermost layers of the enveloping film is evaporated or otherwise removed, for example as a result of decomposition, so that thinning of the uppermost material layer along the deflection line or in the region of the deflection area occurs. To this end, sufficient interaction between the laser beam and the upper material of the enveloping film is necessary. A method of this type is explained in more detail, for example, in WO 03/103950 A1.
It is advantageous if only one component of the enveloping film is at least partly removed, for example an outer layer of the enveloping film. It is likewise possible for the weakening of only a single enveloping film to be produced along a deflection line or in a region of a deflection area or for the weakening of both enveloping films to be produced along deflection lines or in regions of deflection areas.
In a further preferred embodiment of the invention, the wafer pocket is separably connected to one or more tear-off sections on one side. The tear-off section or sections can be separated from the wafer pocket. Via the tear-off section or sections, the wafer pockets can be accommodated in stacked form in a secondary pack, by the tear-off section or sections being held firmly in the secondary pack. The fact that the tear-off section or sections can be separated from the respective wafer pocket, for example by being torn off, means that the wafer pockets can be released singly from the secondary pack. The ability to separate the respective wafer pocket from the corresponding tear-off section can be implemented, for example, via at least one perforation in each case.
In a further preferred embodiment of the invention, the tear-off sections can be shaped such that they can be accommodated in a retaining module in a secondary pack. For example, the retaining module can partly enclose the tear-off sections, such that the tear-off sections are connected to the wafer pockets only via respective connecting regions, for example having the perforation. Alternatively, cut-outs aligned with one another in order to accommodate a retaining element passing through the cut-outs can be located within the tear-off sections. By using each of these embodiments, the wafer pockets are retained in the secondary pack.
It is particularly preferred for the first and the second enveloping film each to be formed from a layer composite made of layers connected to one another, in order to achieve an optimum structure of the layer composite with regard to the compatibility of the respective film with the wafer, the ability to handle the wafer pocket, for example during opening, the outer configuration, for example for outer printing, and further requirements specific to medication.
In a particularly preferred embodiment of the invention, the first and the second enveloping film on the sides coming into contact with the wafer are covered with a material which is inert with respect to the active substance or substances of the wafer, which means that the active substances do not penetrate or migrate into this material. This material is preferably Barex®, an acrylonitrile-methacrylate copolymer, which is located for example in the form of a layer on the inner side. The inert layers of the enveloping films thus face the cavity for the wafer. Therefore, chemical inertness of the first and the second enveloping film with respect to the active substance of the wafer is virtually achieved.
Furthermore, the first and the second enveloping film can each have a printable polymer layer on the outwardly facing sides, in order to be able to provide the wafer pocket with an imprint. The printable polymer layers of the first and second enveloping film can in particular consist of polyethylene terephthalate.
The inert inner layers and the printable polymer layers of the first and the second enveloping film can advantageously be connected to one another via a respective aluminum film. These aluminum films act as moisture barriers.
The figures explained below serve to illustrate the invention further.
Identical designations designate identical elements in the figures.
The wafer pocket 1 shown in
The wafer pocket 1 comprises two enveloping films 9, 11 (
In the upper enveloping film 9 and in the lower enveloping film 11, notches 10 are formed along a deflection line 5 by laser removal (
Along the notches 10, the material of the upper enveloping film 9 and the lower enveloping film 11 is weakened such that, as the wafer pocket 1 is opened, the enveloping films tear along the notches 10. In order to open the wafer pocket 1, the enveloping films 9, 11 are firstly torn, starting from a cut 6, so that the result is a first tearing line section 7 running straight. This first tearing line section 7 then meets the deflection line 5, so that the direction of the tearing line is pivoted through 90° (to the left). In the further course of the opening of the wafer pocket 1, the tearing line further follows the further course specified by 8 (second tearing line section). As a result, the wafer accommodating chamber 3 is opened at two edges, so that the wafer 4 can be gripped conveniently with the fingers and taken out.
The wafer pocket 1 is torn off the tear-off section 20 as necessary. The tear-off section 20 then remains in the secondary pack, while the wafer pocket 1 can be torn open in order to remove the wafer 4.
In a second embodiment of the invention, the deflection line 5 runs in a curve, starting almost from the edges of the wafer pocket 1 (
In a third embodiment of the invention, there is a deflection area 12 on both enveloping films 9, 11 (the latter not shown in
| Number | Date | Country | Kind |
|---|---|---|---|
| 102010028361.4 | Apr 2010 | DE | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP2011/056788 | 4/28/2011 | WO | 00 | 4/15/2013 |
