SK4652000A3 - Child-proof pack for pressure-sensitive products which also have a comparatively large surface, such as transdermal therapy systems (tts) - Google Patents

Abstract

The invention relates to a child-safe pack (10) for pressure-sensitive therapeutic products which also have a comparatively large surface (1), such as transdermal therapy systems (TTS). Said pack is configured as a blister-peel pack with a comparatively dimensionally stable, transparent or translucent support film (2) and a peelable, comparatively highly flexible and extremely tear-resistant cover film (3), at least one area (4) for accommodating the product (1) being formed. The pack can be sealed with a sealing medium on adherends around a peripheral edge (5). The invention is characterised in that an aid to breaking the pack open (6) is provided in the form of a weakened section (9) in the film (2). Said weakened section is located along a join line (x-x) in the pack (10) and is weakened by indentation, perforation or embrittlement. The section can be broken open by bending to expose a breaking edge (20) which is used to hold and peel away the cover film (3) over the support film (2). The inventive pack is also characterised in that the stiffness of the sealed-together films (2,3) in relation to the weakened section (9) is measured in such a way that the strength required to bend the aid to breaking the pack open (6) is too great for a child's fingers but is appropriate for an adult.

Description

Technical field

The invention relates to child-resistant packaging of relatively large and pressure-sensitive products such as transdermal therapeutic systems (TTS), etc.

BACKGROUND OF THE INVENTION

In order to fulfill the important property of being child-resistant, strips of highly tear-resistant packaging material, such as for example, in packaging bags, are required to produce a package of this kind. In addition, these strips of packaging material must be permeable to the active substance used, as well as the evaporation products thereof, whether they must also have vapor barrier and atmospheric moisture properties. Furthermore, to maintain the necessary barrier function, a solid, undamaged running and airtightly sealed weld seam must form an impermeable, sealed edge of the package. In addition, specially adapted welding media and / or welding media are used to achieve the desired peeling property on the impermeable weld seams. welding media combinations such as TE-layer, peeling varnishes, etc. Packages for solid medicines are already provided in the retail network. These are packages that can be opened without a tool, sealed in child-proof materials, such as tapes, wafers and bubble strips, which are packaging for products no longer sensitive to pressure, such as tablets, pills, capsules, etc. , and which are pushed out and removed by a corresponding force through the aluminum foil to be removed from the package. The force for it ^{- the} need is dimensioned so that the child's hands cannot expend it.

Currently, a number of states are considering, or are already in place, binding regulations for the introduction of child-resistant packages in a number of medical products. This applies in particular to medicines which, in the case of unauthorized use or admission, pose a high risk, especially in children, due to the toxic effects of their constituents. On the other hand, medicaments which are flexible and pressure-sensitive due to their particular mode of application cannot be extruded through the package as described above. However, many patients find it disadvantageous and difficult to remove a therapeutic product from a child-resistant package requiring an auxiliary use of a tool such as e.g. scissors or knife.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a tool-free, child-resistant and non-child-resistant package of relatively large and pressure-sensitive products such as transdermal therapeutic systems (TTS), etc., in which no pressure is applied.

The object of the invention is achieved in a child-proof package of the type mentioned in the preamble of the first claim by means of the features set out in its characterizing part.

The advantages which are achieved according to the invention are, in particular, that from now on a simple, child-resistant, non-tool-opening package is now planned, which does not exert any pressure on the product and which is best suited for packaging in this form large-area and pressure-sensitive therapeutic products such as transdermal therapeutic systems, the stiffness of the sealed films being dimensioned at the point of weakening such that the necessary finger strength to bend the break-off device cannot be developed by children, but is appropriate for adults.

The treatment provides that, after breaking the carrier film, the broken piece of film forms a tab to assist the peeling of the cover film from the edge of the carrier film, which greatly facilitates the release and removal of the product.

Advantageous modifications of the child-resistant package are made according to the respective dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further details, features and advantages of the invention will become apparent from the following explanation of an exemplary embodiment schematically shown in the drawings.

Fig. 1 is a cross-sectional view of a child-resistant package with a breakage aid in the carrier film;

Fig. 2 is a top view of the child-resistant package of FIG. 1;

Fig. 3 shows the child-resistant package in section, after breaking off the break-off aid in peeling the cover film from the product on the broken auxiliary tab, also in section;

Fig. 4 shows a cross-sectional view of a child-resistant package with a product recess and an associated recess for gripping on the carrier film as well as an adhesive adhesive product;

Fig. 5 shows a cross-sectional view of a further embodiment of a package with an adhesive adhesive product on a carrier film and on an auxiliary tab disposed thereon.

DETAILED DESCRIPTION OF THE INVENTION

In FIG. 1, the child-resistant package 10 for relatively large and pressure-sensitive therapeutic products 1, such as transdermal therapeutic systems (TTS), etc., is designed according to the invention as a blister peel-off package with a relatively shape-stable, transparent or translucent carrier film 2; It is possible to weld it on the adhesive surfaces of the surrounding edge 5 and to weld it in the area of the edge 5 by means of a breaking device 6 in the form of thinning of the film 2 along the xx line. packaging 10, for example by scoring, perforating or embrittling, etc. It can be broken by bending the weakened film 2 and thereby releasing the broken edge 20, on which the cover film 3 is graspable and retractable via the carrier film 2 (FIG. 3).

In this embodiment, the child-resistant package 10 according to the invention is achieved by stiffness with respect to each other at the edge 5 of the sealed foils 2, X relative to the weakening 9 at the breaking device 6 along the connecting line x-x. is designed so that the necessary force of the fingers to bend the breaker 6 cannot be developed by children, but is appropriate for adults.

To illustrate the location and implementation of the individual elements of the child-resistant package 10, this is shown in FIG. 2 in a top view. The figure shows the position of the product I, for example a circular TTS, in the center of the package 10 inside the storage space 4 formed of the cover sheet X, together with the sealing medium sealing areas 5 where the sealing medium of the carrier and covering foils are sealed outside the weak dotted line. 2, X.

Fig. 3 shows a package 10 according to the invention after breaking off the breaking device 6 in the carrier film 2, with an auxiliary clip 14 having a broken edge 20 which can be bent back and which can be loosened by peeling off the cover film X. the possibility of opening the package 10 without exposing the product 1 therein to pressure.

In FIG. 4 shows an embodiment for packaging 10 in which at least one recess X for receiving the therapeutic product L is formed in the carrier film 2. In order for the product 1 to be easily gripped after opening the package, an additional recess 11 may be formed at the edge of the recess 8. This is then particularly useful when the product 1 is adhered to the backing sheet 2 by an adhesive layer 19, as shown in the example of FIG. 4. In order for the product X with its adhesive layer 19 to be easily released from the carrier film 2 after breaking the carrier film 2 on the breakable aid 16, this is provided by an additional weakening 16 '. The weakening 16 'in the carrier film 2 may be formed predominantly as a desired fracture site and preferably close to the grip recess 11.

In FIG. 5 shows another embodiment for the package 10. in which the adhesive-like product 1 is applied to a flat, relatively rigid carrier film 2 and covered with a particularly flexible cover film 3 and wrapped approximately on its shape and also welded at the edges. In this case, an expedient provision can be made in which a protruding stiffening aid 17 is provided on the edge of the adhesive patch 1 to facilitate the removal of the adhesive patch L

Claims (5)

PATENT CLAIMS 1 Child-resistant packaging for relatively large and pressure sensitive therapeutic products (1), such as transdermal therapeutic systems (TTS), designed as a blister peel-off package with a relatively shape-stable, transparent or translucent carrier film (2) and a peelable, relatively a highly flexible and tear-resistant covering film (3), forming at least one product storage space (4), sealable by welding medium on adhesive surfaces around the surrounding edge (5), characterized in that: - comprises on its underside a breakage aid in the form of a weakened line (6), for example by scoring, perforating or embrittling the shape-stable carrier film (2) along the line (x-x), - the weakened line (6) is separable by bending back and tearing off the film (2) to release the broken edge (20), whereby a bendable auxiliary tab (14) with a broken edge (20) is recovered on the cover film (3), and - strength respectively. the stiffness of the mutually welded films (2, 3) is dimensioned so that the necessary finger force to bend back and tear the carrier film (2) on the breakage device (6) until it breaks in the weakened line (xx) cannot be developed by the child's hands, for adults is appropriate. Child-resistant package according to claim 1, characterized in that after the carrier film (2) has been broken, the broken film piece (14) is formed as an auxiliary clip for peeling off the cover film (3 J) from the edge (5) of the carrier film - (1) · Child-resistant package according to claim 1 or 2, characterized in that the product (1) is applied to a flat, relatively stiff carrier foil (2) and covered with a particularly flexible covering foil (3) and sealed according to its shape. Child-resistant package according to one or more of Claims 1 to 3, characterized in that the covering film (3) is designed as a substrate for releasing the adhesive-adhesive product (1), wherein a protruding device (17) protruding from the edge of the product (1). The grip is designed to facilitate product removal (1). Child-resistant package according to one or more of Claims 1 to 4, characterized in that a protruding stiffening device (17) for facilitating the release of the patch is provided from the edge of the adhesive-adhesive patch (1).