HK1162011B - Single-dose packagings and method for producing thereof as well as usage thereof - Google Patents

Description

Single dose package, method of manufacture and use thereof

Technical Field

The invention relates to a highly inert (hochinert) single-dose package for film-like or film-like administration and Transdermal Therapeutic Systems (TTS), which can be opened easily, but is still childproof.

The invention also comprises a method for manufacturing a single-dose package according to the invention, which method is characterized by a saving in material usage.

Background

Medicament packaging is subject to multiple tasks. On the one hand, packaging by a single dose should ensure, for example: only a certain dose is always administered at one time point, while multiple doses are avoided.

On the other hand, the packaging should also protect the medicament from environmental influences, such as light and humidity, which often lead to decomposition of the active ingredient and thus to the unavailability of the medicament. It is in containers containing a plurality of dosage units that the following problems arise: the quality of the dose is negatively impaired by the repeated opening of the container to take a dose, wherein the greater this impairment, the more sensitive the mode of administration is to mechanical or physicochemical loads. In particular, the shape of the film-like medicament is particularly demanding for packaging, since the film is sensitive to physicochemical influences (e.g. light, moisture, oxygen) due to its large surface area, and to mechanical loads in terms of its structure.

In addition, the package should also protect children from taking their medication unintentionally or from easily administering their medication to themselves.

A particular problem in the design of such safe medicament packages is that on the one hand the package is of greatest safety against unintentional self-administration, and in particular for children who are curiously motivated to open the package, often coloured medicaments which are aromatic in order to mask the unpleasant taste and/or odour of the active substance are mixed with sugar or other sweeteners and administered, or the contained transdermal therapeutic system preparation is used for playing.

On the other hand, the packaging should be easy to open in such a way that adults and especially the elderly, as well as persons with motor impairment, can open the packaging without problems and ensure good compliance when taking the medicament.

As is evident from the fact nature of the above-mentioned problems, solutions to these tasks seem to be of no other choice, since children often need great patience, creativity and intuition when starting to open the package, while older users often abandon the necessary careful reading of operating instructions or explanatory illustrations and the unnecessary use of knives or scissors to open the package, or in the worst case, when such aids are not at hand, abandon the use of medication due to the difficulty of opening the package, thus reducing patient compliance.

A further problem with the single-dose packaging of film-like or film-like administration forms and transdermal therapeutic systems is that the ratio of the area of the single dose to the active substance content is considerably greater than with other administration forms, such as tablets or suppositories, and cannot be reduced by folding or bending.

Thus, the size of the film sheet determines the size of the package. Furthermore, due to the sensitivity of the membrane already discussed, it is required to use expensive high barrier films which are able to withstand mechanical loads and at most allow small amounts of gas and moisture to penetrate in order to ensure the necessary protection for the mode of administration.

This results in the following disadvantages: not only the upper side of a large-area administration form, but also its lower side must be covered with a film, which involves high material expenditure and also leads to high packaging costs due to the expensive film, which significantly increases the cost of a single dose and may lead to an extremely unfavorable ratio of packaging costs to product costs. It should also be mentioned here that, in particular, child-resistant packaging requires additional material expenditure in the safety design.

The following suggestions are known from the prior art for a package that is easy to open, but that protects a child.

DE102004047445a1 discloses a non-reclosable package for products which are hazardous to health, comprising two packaging material elements which are arranged one above the other, a first planar section, and a second planar section which is located outside or adjacent to the first planar section, the two packaging material elements being detachably connected at one or more edges of the first planar section, wherein at least one fully enclosed cavity for accommodating a package is formed between the two packaging material elements, which are also detachably connected at one or more edges of the second planar section. At least one of the two packaging material elements is provided with at least one structure which extends in the second plane section and which enables tearing of the packaging material element.

In the publication US2006/0023976a1, a pull-open pouch for one or more doses of a medicament is described, in which two webs of packaging material are joined to a seal at the edges and in the region of the sealed edges an upper surface structure is provided which enables tearing, which is bifurcated by a signature. The edges of the bag must be folded along the signature to enable tearing and opening at the upper surface structure.

DE102006041921a1 describes a child-resistant packaging for film webs containing active substances, which packaging comprises a carrier layer and a cover layer detachably connected thereto and, in a paired arrangement, has two opposite planar regions separated from one another by a spacer, in which regions the cover layer is not connected to the carrier layer, so that two separate, fully enclosed spaces are formed for the paired accommodation of the film webs. The inner side of the spacer has a further planar area in which the carrier layer is not connected to the cover layer, thus forming a completely enclosed cavity. There is at least one perforation line inside the spacer. The disadvantage of this solution is that only child-resistant packaging for pairs of films (film-like administration) is provided. When the child protection is broken to remove one dosage form, the other dosage form can still be packaged chemically sealed, but no child protection measures are therefore available. In this connection, such a package according to DE102006041921a1 is only used if the interval between the administration of the first agent and the administration of the second agent is not too great.

In the film packages known from DE102004047445a1, US2006/0023976a1 and DE102006041921a1, the task of providing child protection and at the same time protecting the package from chemical damage is achieved by using a bag which can be pulled apart and which is produced by heat-pressure sealing and comprises two films, each of which contains a thin aluminum layer. Such film packs have a laterally disposed cut which does not itself cut the side of the bag. The bag must therefore be folded over an angle of more than 90 deg. in the centre of the cut in order to create a tear notch at the side of the bag edge. This exposes an opening aid for gripping, by means of which the two films of the bag can be pulled apart from one another.

The solutions described above are all based on peelable films in common, i.e. the product-contacting laminate of the film construction must be peelable and can be removed relatively easily from the thin layer lying thereon. These layers are in practice always polyethylene-based release layers or similar compositions which have a relatively weak seal seam strength (and thus can be peeled off).

In addition, such films have the following disadvantages: for the transfer of active substances, they are often not inert, which has the consequence that, over the storage time, the active substance migrates into the packaging and is thus lost from the pharmaceutical product. Depending on the application, the strength of the sealing seam is in many cases also reduced by the fact that the sealing polymer is weakened by the embedding of other, non-weldable auxiliary materials. As a side effect, the auxiliary material also reduces the tightness of the sealing seam to gases such as water vapour and oxygen, which impairs the storage stability of the packaging, and can be problematic due to the absorption of water by hygroscopic products, which can also lead to an increasing decomposition of products sensitive to oxygen, for example.

Furthermore, the material consumption for producing such a package is increased by the fact that, in order to open the package, it is necessary to have an unsealed section which serves as a "peel-off grip aid, wherein the minimum size of this grip aid is defined by the anatomical conditions.

Packaging of film-like or film-like medicaments/administration forms therefore poses particular requirements, since films and membranes react sensitively to physicochemical (e.g. light, moisture, oxygen) and mechanical loads.

Even if the single film-like or film-like administration is satisfactory for protecting the individually packaged products, it has the disadvantage that it is very expensive in practice, since it requires a large amount of material and the corresponding packaging can only be produced relatively slowly.

Disclosure of Invention

The aim of the invention is to provide a childproof single-dose package for film-like or film-like administration and for Transdermal Therapeutic Systems (TTS) on the basis of a sealed film, which ensures a minimum film consumption per single dose, is inert with respect to the package, can be easily opened and still has a maximum tightness of the sealing seam.

Furthermore, it is an object of the present invention to provide a method for manufacturing a single reagent pack according to the present invention.

To this end, the invention provides a single-dose package for transdermal therapeutic systems or film administration in the form of a tear-off sealed-edge pouch with a non-peelable, completely circumferential and continuous sealing surface or seam, comprising two packaging material elements arranged one above the other, which form the upper and lower sides of a pouch containing a product, wherein at least one of the packaging material elements is a metal layer and at least one of the packaging material elements is a film laminate having an at least three-layer structure; and the outer layer of the at least three-layer film laminate has a minimum tensile strength of 30N, wherein this outer layer has at least one linear weakness which does not contact the edge of the package, which is in superimposed alignment on the upper and lower sides, and which has a reduced tensile strength for enabling opening of the package.

The invention accordingly also provides a method for producing a single-dose package as described above, comprising the steps of preparing a first web of packaging material having an at least three-layer structure; preparing a second web of wrapping material; positioning a wrapper on one of the two webs of wrapping material; placing and connecting the two webs of wrapping material one above the other to form each an element of wrapping material in such a way that for each wrapper a fully closed compartment is formed for accommodating the wrapper, and at one or more edges of said compartment the two elements of wrapping material are inseparably connected to each other; applying at least one line of weakness by removing an uppermost tear-resistant film layer of a packaging material element configured as a multilayer film laminate, wherein the line of weakness extends not only through the sealing face but also through the unsealed product containing area; along a line extending transversely to the web direction of the packaging material web in the region of the sealing surface, successive packaging units are separated by cutting or perforation.

The single-dose package according to the invention is a tearable sealed-edge pouch with a completely circumferential and continuous, i.e. uninterrupted, non-peelable sealing surface, wherein the upper side and the lower side of the sealed-edge pouch are formed by two packaging material elements which are arranged one above the other and form a receptacle for a package.

Since the peeling ability of the closure seam is no longer required according to the invention, a highly inert closure material can be used, which in turn has a favorable effect on the durability of the package.

Preferably, the sealing surfaces constitute the outer boundaries of the package, so that when it is possible to open the pouch by "peeling off", there is also no possibility of gripping at all, that is to say opening the pouch by detaching the sealing seams from each other or from the adjoining laminate layers. In this way opening of the bag by a weakened sealing seam, which is virtually impossible to peel, is prevented.

At least one of the layers of the packaging material element is a metal layer to ensure the high tightness required for single dose packaging.

Furthermore, at least one of the packaging material elements is a film laminate having a structure of at least three layers, the outermost layer of which, i.e. the layer remote from the product, has a minimum tensile strength of 30N, so that it is not possible to open the package by simply tearing it without auxiliary tools.

Since the first at least three layers of packaging material have a high tensile strength, it is possible to use a more advantageous film laminate having a lower tensile strength as the second packaging material element, in order to save costs.

In a preferred embodiment, the first and second packaging material elements have the same structure.

In order to ensure that the package cannot be opened manually without additional aids (since there is an outer tear-resistant laminate layer and a non-peelable sealing seam), the outermost layer of the at least three-layer film laminate (which is of decisive relationship for the tensile strength of the multilayer laminate) has a line-shaped weakening (line of weakness) with a reduced tensile strength, wherein, when using the same, tear-resistant packaging material element, lines of weakness that overlap one another are applied directly on both sides of the single-dose package.

Preferably, the line of weakness is created by removing or significantly reducing the thickness of the outer, remote layer of the film laminate from the wrapper, thereby reducing the tensile strength.

In one embodiment, the reduction or removal of the outermost, tear-resistant layer of the film laminate is achieved by laser ablation or laser scoring (scoring by a laser), wherein this step may be conveniently incorporated into the production process. However, other methods are also conceivable, for example targeted mechanical cutting/etching or chemical etching or dissolving of the outer layer to produce the line of weakness.

An alternative embodiment provides that: the line of weakness is a broken (discontinuous) line, i.e. the layer which resists tearing is not removed continuously, but rather remains small connecting ribs of the tear-resistant material which do not hinder tearing and continuous tearing.

This way of providing the weakening lines only at the outermost layer of the laminate has the advantage that the metal layer with high gas tightness is not damaged and thus provides maximum protection of the package from moisture and oxygen.

In a preferred embodiment, the beginning of the line of weakness does not touch (i.e. is not joined to) the periphery of the package, and therefore, in order to openly expose the beginning of the line of weakness along which the package can be torn and which predefines the tear path, the package must first be bent.

This two-step procedure can be carried out without problems for adults but is not obvious for children, in particular because only the uppermost layer of the film laminate is weakened, but not the entire film, as is known from the prior art, by easily recognizable incisions, which also attract the interest of children.

A particularly preferred embodiment therefore provides for: the outermost, tear-resistant layer is removed only at the level of the marked fold region extending perpendicularly to the line of weakness, while the layer thickness is only reduced to such an extent in the direction in which the remaining line of weakness extends: that is, continued tearing may be achieved, but tearing may no longer be resumed.

In a further embodiment, the tensile strength of the packaging material element is so high that continued tearing can only be achieved in the region of the line of weakness. In this way, the tear seam is prevented from propagating into the packaging region where the mechanically sensitive product is located.

In a preferred embodiment, the line of weakness extends not only across the sealed face but also across the unsealed product containing area, wherein preferably the line of weakness extends parallel to the edges of the package and the line of weakness, when extending across the unsealed product containing area, is spaced from the sealed face by less than 5mm, preferably less than 3mm, particularly preferably less than 2mm, most preferably less than 1 mm.

It is furthermore preferred that the line of weakness extends at least 50%, further preferred at least 65%, even more preferred at least 80%, and particularly preferred at least 90% over the length of the side of the package where it is located, wherein the maximum extension is limited to 95% because the line of weakness does not contact (i.e. does not intersect) the edge of the package according to the present invention.

Another embodiment provides that: the package has two linear weaknesses, preferably extending at right angles to each other and meeting at a point at a corner of the package.

Furthermore, in a preferred embodiment, the product receiving area has a bulge which extends into the sealing surface, wherein the line of weakness passes through the product receiving area in the region of the bulge, and wherein the bulge does not extend over the entire length of the side of the receiving area, but preferably occupies 95% to 50%, more preferably 85% to 55%, even more preferably 75% to 60%, and particularly preferably 66% of the length of the side of the receiving area.

In one embodiment, the bulge extends on both sides of the single-dose package, so that the package can be opened at a corner by means of two lines of weakness and the package can be removed more easily. Furthermore, the arch provides the necessary space for opening the package by separation at the tear line given by the weakening, without damaging the product. The additional space is considered as a safety zone that prevents the product from being accidentally gripped and damaged during tearing, while additionally ensuring that the product does not slide inside the package, since the sealed edges of the product are tightly restrained in position within the remaining containment zone.

According to another embodiment, the single-dose package has a position limiting mechanism that limits the product within the product containing area, preferably made by heat and pressure sealing. The position limiting means can be designed as narrow connecting ribs between the upper film layer and the lower film layer.

To mark the line of weakness and to make it easier to open the package, the line of weakness and/or the line of bending can be marked, for example by marking with a colour, or other conventional means of marking.

The sealed-edge pouch of the present invention comprises two packaging material elements arranged one above the other, namely a first packaging material element and a second packaging material element.

The packaging material used to make the sealed-edge pouches may preferably be a packaging material with a slight permeability to gases and moisture.

In order to assume the different functions which the packaging material is to fulfil, packaging materials having a structure of at least three layers are particularly suitable.

In this packaging material, individual layers or laminae of the packaging material are joined to form a composite structure, preferably in the form of a laminate, which individual layers of the packaging material assume one or more functions.

According to the invention, the outermost layer of the packaging material element is characterized by a high tensile strength, which layer cannot be destroyed manually without additional tools. However, the tear produced at the predetermined weak point can be further enlarged and tear propagation can be achieved, so that further tearing can be carried out manually without the need for auxiliary tools. Preferably, the layer is a polyethylene terephthalate layer having a layer thickness of 12-25 μm; other materials and layer thicknesses common to those skilled in the art may also be used.

Furthermore, the outer layer is preferably printable/printed, so that for example product markings and tear aids can be added.

In a particular embodiment, the outer layer of the packaging material element can be an oriented material, i.e. a uniaxially stretched material, the tensile strength of which is further increased in one direction, so that, for example, a further tearing without weakening the outer layer is not possible.

The second layer or the middle layer in the three-layer structure is made of a metal foil, preferably aluminum, with a thickness of 9 to 25 μm. This metal layer is used to achieve the tightness of the package against moisture and air.

The inner layer is a sealable plastic layer, wherein the sealing seam produced by this layer cannot be reopened.

The laminate is preferably joined by heat and pressure sealing, but may be joined by other suitable sealing methods, such as cold sealing, ultrasonic sealing, laser sealing, or equivalent film welding methods known to those skilled in the art, as long as a non-detachable sealing seam is obtained.

The sealing seam or sealing area preferably has a width of 0.1mm to 10cm, particularly preferably a width of 1mm to 2cm, and very particularly preferably a width of 2mm to 8mm, and this sealing seam or sealing area preferably extends over the entire length and width of the packaging material element. The width of the sealing seam may also be somewhat greater where specifically stated. In order to additionally increase the difficulty of opening the package, at least one of the sealing seams is constructed wider than the remaining sealing seams.

Among the materials known to the person skilled in the art, the selection of plastics such as polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polypropylene (PP), Polyethylene (PE),(BP chemical; copolymer of acrylonitrile and butadiene)Aclar^TM(Honeywell; high barrier film composed of polychlorotrifluoroethylene [ PCTFE ]), and(Ticona; cycloolefin copolymer films), in which the layer thickness is typically 20 to 100 μm and in which high-density plastics which are inert with respect to the active substance in the packaged administration form and/or absorb it only insignificantly are particularly suitable.

Is a plastic ionomer having high toughness, which contains metal ions in the molecular chain and thus has a crosslinked structure. .

It is preferable thatThe film isIs a copolymer which consists essentially of chlorinated trifluoroethylene.

Is an amorphous transparent interpolymer based on cyclic and linear olefins, which is free of ionic inclusions. It is preferable thatThe film is made from ethylene and norbornene.

The preferred Barex film is produced by graft copolymerization of 73-77 parts by weight of acrylonitrile and 23-27 parts by weight of methacrylate with the introduction of 8-10 parts by weight of a butadiene-acrylonitrile copolymer with a butadiene content of about 70% by weight.

Particularly preferred high barrier film laminates for use as packaging material elements are made ofLayer (20-40 μm), aluminum film (9-25 μm) and PET layer (10-30 μm).

The thickness of the multilayer film laminate is preferably in the range of 35 to 300 μm, particularly preferably in the range of 50 to 200 μm.

The tensile strength of the packaging material is at least 30N, preferably at least 40N, and particularly preferably 50N. Preferably, the tensile strength of the packaging material, measured on two mutually connected packaging material elements constituting the package, is below 2000N, particularly preferably below 200N and very particularly preferably below 100N.

If different film laminates are used as the first and second packaging material elements, the minimum easy tear of the second film laminate is less than the minimum easy tear of the first film laminate, which is preferably > 30N, particularly preferably > 50N.

The continuous tensile strength of the packaging material must not be too low, since this no longer ensures sufficient protection of the package and the following risks may arise: inadvertently opening the package and/or damaging the package. This can be seen by simple experimentation. The continuous tensile strength of the packaging material, measured on two mutually connected packaging material elements constituting the package, is less than 20N, preferably less than 5N, particularly preferably less than 1N.

The tensile strength and continuous tensile strength of the packaging material can be determined by means of known tensile testers, using simultaneously a sample holder for a tear test (model 00740) (e.g. available from FRANK test equipment ltd of D-69488 bikan).

The tear strength is several times the continuous tear resistance in order to enable or facilitate continued tearing of the packaging material. Preferably, the ratio of tear strength to continuous tear strength is in the range of 20: 1 to 500: 1, particularly preferably in the range of 50: 1 to 250: 1, with respect to the tensile strength and continuous tear strength of two packaging material elements connected to one another.

The tensile strength in the region of the line of weakness, measured on the two interconnected packaging material elements forming the package, is less than 20N, preferably less than 5N, particularly preferably less than 1N.

Drawings

The single-dose package according to the invention will be further explained below with reference to the drawings. Here, the drawings are only for illustrating the present invention, and the present invention is not limited to the illustrated case.

Fig. 1 shows a preferred embodiment of a single-dose package according to the invention in a top view, with an arch of the product-receiving region and position-limiting mechanisms on both sides of the package and two perpendicularly extending lines of weakness through the arch region.

Figure 2 shows a single-dose package as in figure 1, but with only a line of weakness along one side of the package;

fig. 3 shows a sequence of bending and tearing operations for opening the single-dose package in fig. 1.

Detailed Description

The packaging (1) according to the invention can be a sealed-edge bag comprising two packaging material elements arranged one above the other, wherein one packaging material element forms a cover layer and the other packaging material element forms a lower layer, between which the product (5), preferably a transdermal therapeutic system or a film-like or film-like administration, is arranged. The two packaging material elements are sealed to each other in such a way that the product (5) is surrounded by a circumferential and coherent non-peelable sealing edge (3). Thereby creating a fully enclosed product containment area (4) containing product (5) therein.

The sealed-edge pouch (1) has a front edge (8), a rear edge (9) and two preferably parallel-running side edges (10, 10').

The sealed-edge pouch also has lines of weakness (20, 21) of reduced tensile strength along which the wrapper component can be torn.

In addition, the sealed-edge pouch in fig. 1 also has an arch at the front edge and the side edges 10', through which the tear line defined by the line of weakness extends, so that the product (5) is not damaged. The position restricting mechanism (35, 35') prevents movement of the product.

The child-resistant measures of the package are achieved by: the line of weakness used to tear open the package is only exposed after child resistance has been overcome. This safety measure is formed in such a way that the line of weakness does not extend to the edge and the originally tear-resistant material of the packaging material element can only be torn after the initial end of the line of weakness is exposed by bending the package along an optionally provided bending line, allowing the product to be removed. Manual tearing of the package is not possible in other areas due to the tensile strength of the packaging material.

Since the uppermost layer of the laminate is removed or reduced only in a small area relative to the plane of the package in order to achieve weakening, the stability and the tightness of the package are only minimally impaired.

According to the invention, the line of weakness used to tear the wrapper should not contact the edge of the package, so that the structure exposes the beginning of the area of weakness for tearing only when the package is folded along a line extending through the structure, for example along line a-a' (fig. 3).

The line of weakness, which makes it possible to tear the packaging material element, may be present in one of the two packaging material elements, for example when the second packaging material element has a lower tensile strength, or in both packaging material elements, wherein the last-mentioned embodiment is preferred. In this case, the weakening lines for tearing the packaging material are arranged in superposed alignment in the two packaging material elements.

By combining the packaging material according to the invention with a child-resistant design, the package can be designed such that it can only be opened in a defined sequence by at least two steps:

(i) folding or bending the package along a line thereby exposing the weakened structure for tearing;

(ii) the package is torn again at the weakened structure at the edge and the tear continues along this structure.

This operation is very difficult for children, especially young children, especially since the lines of weakness cannot be easily identified, since there is only a small removal of material without a notch. It is problem-free for adults and may not require the assistance of tools. In a particularly preferred embodiment, the single-dose package achieves child protection according to DIN EN14375 and/or according to ASTM D3475-03 a.

The invention also relates to a method for producing a single-dose package for transdermal therapeutic systems or for administration in the form of a film. This method is distinguished by a particular saving in material compared with known methods.

Since there is no peelable seal and the package is torn directly along the weakening line, no additional surface for opening out a gripping aid or the like is required for a child-resistant package, as is known from DE102004047445a 1. The individual packages are placed directly against each other and the additional material loss beyond the package is determined only by the size of the sealing surfaces and, in some embodiments, by the bulges and position limiting means. There is also no scrap resulting from complex shapes. Thus, the manufacture of the single-dose package of the invention can be achieved without loss of packaging material.

The method for manufacturing said single-dose package comprises the steps of:

-preparing a first web of packaging material having at least a three-layer structure;

-preparing a second web of packaging material;

-positioning a package on one of two webs of packaging material;

-placing and connecting the two webs of packaging material one above the other in such a way that for each package a fully closed compartment is formed for accommodating the package, at one or more edges of which two packaging material elements are inseparably connected to each other;

-adding at least one line of weakness by removing the uppermost tear-resistant film layer of the multi-layer film laminate, wherein the line of weakness extends not only through the sealed face but also through the unsealed product containing area, but does not touch the edges of the package.

Along a line extending transversely to the web direction of the web of packaging material in the region of the sealing surface, successive packaging units are separated from each other by cutting or perforation.

The order of the method steps described above is not mandatory; for example, the line of weakness for tearing the wrapper may be added in a later step.

Preferably, the non-detachable connection between the packaging material elements is realized by means of heat-pressure sealing in a temperature range between 50 ℃ and 200 ℃, in particular in a temperature range between 50 ℃ and 90 ℃. The non-detachable connection between the two webs of packaging material can also be achieved by other heat or cold sealing methods, such as ultrasonic sealing, laser sealing or the like.

The packages can be manufactured in batches, for example on rotary sealing machines, from a continuous strip efficiently.

In a preferred embodiment the line of weakness is created during manufacture by laser ablation or laser scoring, wherein, in the case of a tear resistant film laminate, the lines of weakness are applied in direct register, overlapping registration, of the first and second packaging material elements.

Another embodiment provides that: within the product containing region, some position limiting mechanism is preferably provided by heat and pressure sealing.

Claims (21)

1. Single-dose packaging for transdermal therapeutic systems or film-like administration forms of a tearable sealed-edge pouch with a non-peelable, completely circumferential and continuous sealing surface or sealing seam, comprising two packaging material elements arranged one above the other, which form the upper and lower side of a product-containing pouch, wherein at least one of the layers of the packaging material elements is a metal layer and at least one of the packaging material elements is a film laminate having an at least three-layer structure; and the outer layer of the at least three-layer film laminate has a minimum tensile strength of 30N, wherein this outer layer has at least one linear weakness which does not contact the edge of the package, which linear weakness is in superposed alignment on the upper and lower sides, and which linear weakness has a reduced tensile strength for enabling opening of the package.

2. A single-dose package according to claim 1, wherein, in the region of the line-shaped weakness, an outer layer of the film laminate remote from the package is removed or its thickness is significantly reduced.

3. A single-dose package according to claim 1 or 2, wherein the line-shaped weakness is made by laser ablation of an outer layer of a film laminate of said packaging material element.

4. Single-dose package according to claim 1 or 2, wherein the linear weakness extends not only through the sealing face but also through the unsealed product containing area.

5. The single-dose package according to claim 1 or 2, wherein the package has two linear weaknesses.

6. Single dose package according to claim 5, wherein the two linear weaknesses extend at right angles to each other and meet at a point.

7. Single-dose package according to claim 1 or 2, wherein the linear weakness is a discontinuous line.

8. Single dose package according to claim 1 or 2, wherein the linear weakness extends through the product containing area at a distance of less than 5mm from the sealing face.

9. A single dose package according to claim 8 wherein the linear weakness extends through the product containing region at a distance of less than 3mm from the sealing face.

10. A single dose package according to claim 8 wherein the linear weakness extends through the product containing region at a distance of less than 2mm from the sealing face.

11. A single dose package according to claim 8 wherein the linear weakness extends through the product containing region at a distance of less than 1mm from the sealing face.

12. Single-dose package according to claim 1 or 2, wherein the linear weakness is visually marked.

13. The single-dose package according to claim 1 or 2, wherein the two packaging material elements have the same structure.

14. Single-dose package according to claim 1 or 2, wherein the product containing area has an arch extending into the sealing face, wherein a linear weakness passes through the containing area in the region of the arch.

15. Single-dose package according to claim 14, wherein the bulge does not extend over the entire length of the side of the containment region.

16. Method for manufacturing a single-dose package according to any one of claims 1 to 15, comprising the steps of,

-preparing a first web of packaging material having at least a three-layer structure;

-preparing a second web of packaging material;

-positioning a package on one of the two webs of packaging material;

-forming a packaging material element by placing and connecting the two webs of packaging material one above the other in such a way that for each package a fully closed compartment is formed for accommodating the package, and at one or more edges of said compartment the two packaging material elements are inseparably connected to each other;

-adding at least one line of weakness by removing the uppermost tear-resistant film layer of the packaging material element configured as a multilayer film laminate, wherein the line of weakness extends not only through the sealing face but also through the unsealed product containing area;

the successive packaging units are separated by cutting or perforating along a line extending transversely to the web direction of the web of packaging material in the region of the sealing surface.

17. The method of claim 16, wherein the line of weakness is created by laser ablation or laser scoring.

18. A method according to claim 16 or 17, wherein the first and second film laminate sheets as elements of said packaging material are constructed of at least three layers and are provided with lines of weakness directly opposite each other.

19. A method according to claim 16 or 17, wherein the webs of packaging material are connected to each other by means of sealing surfaces or seams.

20. A method according to claim 19, wherein the webs of packaging material are connected to each other by means of a sealing surface or a sealing seam using a lacquer.

21. Use of a single-dose package according to any one of claims 1 to 15 for transdermal therapeutic systems or film-like administration forms of the package.