Dosage packaging, manufacturing apparatus, and manufacturing method

Abstract

The present invention proposes a dosage packaging (1A, 1) for a pharmaceutical product (2), as well as an apparatus and a method for producing and filling such dosage packaging (1A, 1). A predetermined breaking zone (10, 9) for opening the dosage packaging (1A, 1) by breaking the breaking zone (10, 9) is generated by thermoforming. To this end, the apparatus comprises a forming tool (102A, 102) having a forming device for forming the predetermined breaking zone (10, 9). Alternatively or additionally, the predetermined breaking zone (10, 9) can form a cross-sectional reduction or nozzle (19) of the dosage channel (7A, 7) of the dosage packaging (1A, 1).

Description

[Technical Field]

[0001] The present invention relates to dosage packaging, preferably for liquid pharmaceutical products, as well as methods of manufacturing and filling dosage packaging and apparatus for manufacturing dosage packaging. [Background technology]

[0002] The dosage packaging is produced in particular by thermoforming, a process in which a plastic sheet, in particular a film or foil, is heated to a flexible forming temperature and then formed into a specific shape in a mold. Furthermore, the plastic sheet is preferably trimmed after forming in the mold.

[0003] Dosage packaging is in particular packaging for liquid pharmaceutical products that contains or stores the product and is also useful for administering the product to a patient, in particular a pipette, or a packaging that can be used as or transformed into a pipette.

[0004] The medicinal product is preferably a liquid and / or product that is to be applied onto the skin and / or fur of a patient, preferably a domestic animal such as a cat or dog.

[0005] EP 2 998 098 A1 and EP 2 998 099 A1 relate to methods for producing and filling dosage packaging for liquid pharmaceutical products. The packaging is produced by a thermoforming process in which a deep-drawn film is heated to plasticize it in at least a partial region, the plasticized region is deep-drawn into a forming tool to form a chamber for the product and a cannula-shaped dosage channel opening into the chamber, the product is introduced into the chamber, and the filled deep-drawn film is covered with a cover film to close the chamber and the dosage channel. In the end regions, the dosage channel is provided with cracks or grooves that form predetermined tear zones at which the tip of the additional channel can be torn to open the dosage packaging. The predetermined tear zones are produced before the deep-drawn film is heated. The deep-drawn film is a laminated composite film having one layer of polypropylene (PP) and one layer of acrylonitrile-methyl acrylate copolymer (AMAB), and the cracks or grooves are produced by cutting through the PP layer.

[0006] The methods disclosed in EP 2 998 098 A1 and EP 2 998 099 A1 have several drawbacks.

[0007] First, the creation of the grooves requires an extra step in addition to the thermoforming step in which the chamber and dispensing channel are formed.

[0008] Furthermore, the method of creating a predetermined break zone by cutting through the PP layer does not work well when the film has a different composition than described and / or the system setup for cutting is more complicated.

[0009] EP 2 432 701 B1 is a document relating to a non-resealable thermoformed packaging for liquid or pasty substances. The packaging includes a rigid shell forming a storage space for the substance, a tear zone, and a grip zone. The packaging can be opened by tearing the upper portion of the grip zone within the tear zone. The grip zone contains a leakage path for the substance that closes automatically when the user does not apply pressure to prevent the substance from being released after opening the packaging. The tear zone can be weakened by a break line created using a pre-cutting tool such as a blade, a laser system, or a high-pressure water jet.

[0010] US 2015 / 151891 A1 is a document relating to a packaging for containing a fluid product having a unitary body including a break-away cap. The packaging includes a first laminate sheet and a second laminate sheet that are thermoformed together to form the unitary body. Initially, the unitary body includes a break-away cap that seals a nozzle portion for dispensing the fluid product. A user can separate the break-away cap from the unitary body by tearing or cutting at a pre-weakened area. The pre-weakened area is a perforation or dividing line formed in the unitary body.

[0011] EP 1 263 389 B1 is a document relating to a container for a liquid or pasty substance. The container has two separate half-doses arranged in two respective partial containers. The top of the container presents two different pre-cut lines, one of which connects the necks of both partial containers and the other of which connects the neck of a single partial container. The container can be opened along either of these pre-cut lines, selectively allowing the opening of one or both partial containers and thus the administration of a full or half dose of the product. The container can be produced by thermoforming the container while leaving the channel open for filling, filling the product through the open channel, and then welding the filling channel closed.

[0012] US 5,215,221 A is a document relating to a unit dose dispenser for powdered medicines. The dispenser has a gas chamber and a product reservoir adjacent to each other and separated by a rupturable seal. The dispenser chamber is formed from a heated thermoplastic sheet. If a tear tip is desired, the sheet is pre-divided before thermoforming. The product reservoir is then filled with the powdered product, after which the backsheet is heat-fused to the thermoformed blister at the tear site between the gas chamber and the product reservoir. To use the dispenser, its tip is removed along the partially divided tear line. Next, pressure is applied to the gas chamber by squeezing the dispenser, rupturing the seal and releasing a gas jet into the product reservoir, fluidizing and dispensing the powdered product.

[0013] Further packaging and methods disclosed in prior art documents suffer from similar drawbacks, in particular where the break zone is formed by perforating, splitting or cutting, which requires an extra step in manufacturing and / or is not suitable for or more complicated to set up with certain plastic materials. [Prior art documents] [Patent documents]

[0014] [Patent Document 1] EP 2 998 098 A1 [Patent Document 2] EP 2 998 099 A1 [Patent Document 3] EP 2 432 701 B1 [Patent Document 4] US 2015 / 151891 A1 [Patent Document 5] EP 1 263 389 B1 [Patent Document 6] US 5,215,221 A Summary of the Invention [Problem to be solved by the invention]

[0015] In other words, the problem aimed at by the present invention is to provide a solution that makes the production of dosage packaging faster, more efficient and / or easier and / or that allows for reliable opening of dosage packaging, preferably largely independent of packaging material. [Means for solving the problem]

[0016] The above object is achieved by a method according to claim 1, a device according to claim 15 or a dosage packaging according to claim 25. Advantageous further developments are the subject of the dependent claims.

[0017] That is, the present invention relates, inter alia, to methods of manufacturing and filling dosage packaging, to apparatus for manufacturing dosage packaging, and to dosage packaging. The methods described herein are preferably carried out using the apparatus described herein, and the dosage packaging described herein is preferably manufactured using the methods described herein.

[0018] According to a first aspect, the present invention relates to a method for manufacturing and filling dosage packaging for preferably liquid pharmaceutical products, the method being preferably a thermoforming method.

[0019] According to this method, a preferably multi-layer plastic sheet is at least partially heated to a thermoforming temperature, which is in particular a temperature at which the plastic sheet or heated areas thereof become plasticized and / or which makes it possible to form the plastic sheet or heated areas thereof into a desired shape using a forming tool.

[0020] A plastic sheet is then stretched over and / or into the forming tool to form the bottom part of the dosage packaging, in particular a bottom part having a cavity for receiving the pharmaceutical product and a surrounding rim, which is preferably at least essentially flat.

[0021] In a next step, the cavity is filled with the pharmaceutical product, after which the cavity is covered with a cover which is fixed to the rim so that the cavity is completely closed.

[0022] According to the invention, in particular exclusively or essentially, a predetermined break zone is created in the bottom part using a molding tool and / or during the step of forming the bottom part, which has the advantage that no extra step is required to form the predetermined break zone, the break zone can be formed to have any desired shape, and the break zone can be specifically tailored or adapted to different plastic materials.

[0023] In particular, the predetermined breaking zone is generated without cutting and / or without a cutting step before or after the step of forming the bottom part and / or without using a cutting tool. "Cutting-free" preferably means that no cutting is performed to form the predetermined breaking zone. That is, the proposed method advantageously provides a simpler manufacturing method that can be used for different plastic materials.

[0024] Also in the sense of the present invention, perforating, dividing or similar operations are preferably to be understood as one or more "cutting". That is to say, the term "cut-free" may also preferably include or be replaced or supplemented with expressions such as "perforation-free" etc. Likewise, a cutting stage / tool ​​may also be a perforation stage / tool ​​etc.

[0025] The cavity preferably comprises a chamber and a dispensing channel in fluid communication with and / or opening into the chamber. The dispensing channel is preferably elongated and / or straight and / or has a smaller diameter and / or volume than the chamber, so that the dispensing packaging can be used and / or transformed into a pipette that allows the pharmaceutical product to be applied directly from the packaging to the patient.

[0026] The predetermined break zone is preferably configured to allow the dosage packaging to be opened by breaking the packaging along the break zone, for example, the dosage packaging can be folded or bent along the predetermined break zone such that the packaging material is severed, thereby opening the packaging.

[0027] The predetermined break zone is preferably formed as or includes a groove on the outer or inner surface of the dosage packaging, which is simple to manufacture and allows for easy and reliable opening of the dosage packaging and / or breaking of the predetermined break zone.

[0028] Preferably, the predetermined rupture zone comprises a protrusion opposite a groove. Thus, the predetermined rupture zone is preferably formed as or comprises a groove on the outer surface and a protrusion on the (opposite) inner surface, or vice versa.

[0029] Particularly preferably, the predetermined breaking zone is formed as a bend, kink or crease in the (wall of) the bottom part, in particular the grooves and protrusions are formed by bends / kinks / creases.

[0030] Forming the predetermined breaking zone as a bend / kink / fold and / or having a protrusion in addition to a groove preferably allows for easy manufacturing of the predetermined breaking zone and / or secure opening of the dosage packaging.

[0031] Preferably, the predetermined breaking zone is a region that preferably has at least essentially the same thickness as the region of the base part surrounding the breaking zone. In other words, the wall thickness of the base part is preferably at least essentially constant between the predetermined breaking zone and the region surrounding it. This has the advantage that the integrity and / or barrier properties of the plastic material can be maintained. In particular, the material is significantly less susceptible to crushing within the predetermined breaking zone than outside it.

[0032] However, if desired, for example depending on the plastic material, the predetermined breaking zone can be a thinner area than the area of ​​the bottom part surrounding the breaking zone, which can be advantageous to facilitate breaking, for example when using less brittle plastic materials.

[0033] It is preferred that the forming tool have a positive mold and a negative mold and / or that a positive mold and a negative mold are used to form the bottom part, which allows for very precise control of the shape of the bottom part and / or results in small manufacturing tolerances.

[0034] The predetermined rupture zone may be formed only in the region of the cavity, in particular in the region of its dosing channel. In other words, in this case, the predetermined rupture zone does not extend over and / or is not formed in the region of the rim. Alternatively, the predetermined rupture zone is formed or extends over both the cavity / dosing channel and the rim.

[0035] Preferably, different dosage packagings are formed with predetermined breaking zones having different shapes, and the forming device for forming the predetermined breaking zones is exchanged and / or adjusted to form the different dosage packagings. This allows different dosage packagings to be produced in a very wide variety of ways.

[0036] According to yet another aspect, which may also be realized independently, the present invention relates to an apparatus for producing dosage packaging, preferably for a liquid pharmaceutical product, the apparatus preferably being configured to carry out the methods described herein and / or to produce the dosage packaging described herein.

[0037] The apparatus preferably has a heating device for at least partially heating the multi-layer plastic sheet to a thermoforming temperature and a forming tool for forming the bottom part of the dosage packaging by stretching the plastic sheet over and / or into the forming tool.

[0038] The molding tool preferably has a forming device for forming a predetermined break zone in the bottom part. The forming device preferably forms a ridge and / or a recess on the mold surface of the molding tool. This allows the predetermined break zone to be formed as a groove and / or a bend / kink. It is possible to achieve a predetermined break zone that has a thickness that is at least essentially the same as or smaller than the surrounding material.

[0039] The forming device is preferably an adjustable and / or replaceable component of the forming tool, which allows for easy control and / or adaptation of the desired shape of the predetermined breaking zone, which allows for easy and / or efficient production of different dosage packagings, in particular dosage packagings with different predetermined breaking zones.

[0040] The forming tool preferably comprises a positive mould and a negative mould, which allows for precise control of the shape of the bottom part being formed and / or results in very small manufacturing tolerances.

[0041] Preferably, the negative mold and the positive mold have surfaces of complementary or corresponding shape, preferably at least in the area where the predetermined breaking zone is formed, in this way preferably a bend / kink can be produced in the wall of the bottom part as a predetermined breaking zone, in particular this wall having at least essentially the same thickness within the predetermined breaking zone as outside it.

[0042] Particularly preferably, the negative mold has ridges and the positive mold has complementary / corresponding recesses, or vice versa, to form the predetermined breaking zones.

[0043] Alternatively, the positive and negative molds can have surfaces of different or dissimilar shapes, such that the apparatus is configured to produce a predetermined fracture zone that is thinner than the areas surrounding the predetermined fracture zone. For example, the positive mold can be flat in the corresponding area while the negative mold includes ridges, or vice versa.

[0044] The forming tool, in particular the negative and / or positive mold, preferably comprises vents or holes for air to escape during thermoforming. Particularly preferably, the forming tool, in particular the negative and / or positive mold, comprises one or more vents in / also in the forming devices, in particular the ridges and / or recesses.

[0045] According to yet another aspect, which may also be realized independently, the present invention relates to dosage packaging, preferably for a liquid pharmaceutical product, preferably manufactured using the method and / or apparatus described herein.

[0046] The dosage packaging has a base part with a cavity for receiving the pharmaceutical product and a preferably flat rim surrounding it, and further has a cover that covers and completely closes the cavity.

[0047] The cavity preferably comprises a chamber for the pharmaceutical product and / or a dosing channel for administering / dispensing the pharmaceutical product, the dosing channel preferably being in fluid communication with the chamber.

[0048] Preferably, the administration channel is elongated and / or straight and / or has a smaller diameter, cross section and / or volume than the chamber.

[0049] The dosage packaging, in particular the bottom part, has a predetermined breaking zone intended to open the dosage packaging by breaking this predetermined breaking zone.

[0050] The predetermined rupture zone is preferably created solely or (at least) essentially by thermoforming. This reduces the number of steps required to produce the dosage packaging, thus making production faster and / or more efficient. In particular, less tooling is required to produce the dosage packaging.

[0051] In particular, the predetermined fracture zone is created without cutting and / or without the use of a cutting tool.

[0052] Alternatively or additionally, the predetermined rupture zone extends only across the cavity, in particular the dosing channel thereof, which preferably enhances the stability of the dosage packaging and / or reduces the risk of accidental opening of the dosage packaging.

[0053] Alternatively or additionally, in the region of and / or by the predetermined rupture zone, the dosing channel narrows and / or the (flow) cross section of the channel is reduced and / or a nozzle is formed. Advantageously, when the pharmaceutical product is dispensed from the dosage packaging, the pharmaceutical product can be accelerated by the narrowing channel, the cross section reduction and / or the nozzle as it exits the dosage packaging.

[0054] Furthermore, the reduced width channel, cross-section reduction, and / or nozzle preferably prevent overflow of the pharmaceutical product, despite the influence of gravity, unless an additional force is applied by the user, for example by pressing on the dosage packaging or chamber, which is advantageous in preventing accidental removal or spillage of the pharmaceutical product.

[0055] Alternatively or additionally, the predetermined breaking zone is formed as a bend, kink or fold in the base part (its wall) and / or the thickness of the (wall of the) base part is at least essentially constant in the area including the predetermined breaking zone and in the area surrounding it, which preferably enhances the stability of the dosage packaging and / or reduces the risk of accidental opening of the dosage packaging.

[0056] The predetermined breaking zone is preferably a weakened portion of the material of the dosage packaging or of the bottom part, in particular allowing the user to easily open the dosage packaging by breaking or bending / folding along the predetermined breaking zone.

[0057] Preferably, the predetermined breaking zone comprises or is formed by a groove on the outer or inner surface of the dosage packaging or the bottom part. Thus, the predetermined breaking zone is implemented in a simple manner.

[0058] The predetermined breaking zone may comprise a protrusion on an inner or outer surface of the dosage packaging or base part, in particular on the inner surface opposite the outer surface comprising the groove or on the outer surface opposite the inner surface comprising the groove.

[0059] Preferably, the protrusions (if provided on the inner surface) allow for the realization of reduced width channels, cross-section reductions and / or nozzles in a simple manner.

[0060] The protrusion preferably enhances the stability of the dosage packaging and / or reduces the risk of accidental opening of the dosage packaging. In particular, the wall thickness of the bottom part within the predetermined breaking zone may be constant and / or the same within the area surrounding the predetermined breaking zone.

[0061] The groove and / or protrusion can extend only across the cavity, in particular the dosing channel, or across both the cavity and the rim, ie at least essentially across the entire width of the dosing packaging or bottom part, in particular perpendicular to the dosing channel.

[0062] Preferably, the longitudinal extension of the groove and the protrusion may differ from each other.

[0063] In particular, the groove can extend across the cavity and the rim, whereas the protrusion only extends across the cavity. Advantageously, the rim can be kept free of protrusions and / or flat, which helps to attach the cover to the bottom part, especially the rim. However, at the same time, the groove can extend across the rim to form a predetermined break zone that can be more easily broken.

[0064] The dosage packaging, in particular the bottom part, may include deformations, such as marks or inscriptions, from the vent holes of the molding tool. In particular, at least one of such deformations may (also) be located in the predetermined breaking zone. This may contribute to improved breaking behavior.

[0065] Some of the above and below aspects, characteristic method variants and method steps of the present invention can be combined with one another in various combinations and / or in any order, but can also be carried out independently of one another.

[0066] Further aspects, features, advantages, and characteristics of the present invention will become apparent from the following description of preferred embodiments which refers to the claims and the drawings. [Brief explanation of the drawings]

[0067] [Figure 1] 1 is a schematic perspective view of dosage packaging according to the present invention; FIG. [Figure 2] 1 is a schematic perspective view of an opened dosage packaging according to the present invention; FIG. [Figure 3] FIG. 1 is a schematic cross-sectional view through dosage packaging packaged within secondary packaging. [Figure 4] 1 is a schematic diagram of an apparatus for producing dosage packaging according to the present invention. [Figure 5] 1 is a schematic cross-sectional view through the material of the bottom part of the dosage packaging. [Figure 6] FIG. 1 is a schematic cross-sectional view through the material of the cover of the dosage packaging. [Figure 7] 1 is a schematic cross-sectional view through a preferred material for the bottom part of the dosage packaging. [Figure 8] 1 is a schematic cross-sectional view through a preferred material for the cover of the dosage packaging. [Figure 9] 1 is a schematic plan view of administration packaging according to a first embodiment; FIG. [Figure 10] 10 is a schematic cross-sectional view of the dosage packaging taken along line XX in FIG. 9. [Figure 11] FIG. 10 is an enlarged detail view of a predetermined breaking zone according to the first embodiment. [Figure 12] FIG. 10 is an enlarged detail view of a predetermined fracture zone according to a second embodiment. [Figure 13] FIG. 10 is a schematic plan view of administration packaging according to a third embodiment. [Figure 14] 14 is a schematic cross-sectional view of the dosage packaging taken along line XIV-XIV of FIG. 13. [Figure 15] FIG. 10 shows an enlarged detail of the predetermined rupture zone according to the third embodiment in the region of the administration channel. [Figure 16] FIG. 10 shows an enlarged detail of the predetermined breaking zone according to the third embodiment in the region of the rim. [Figure 17]FIG. 10 shows an enlarged detail of the predetermined rupture zone according to the fourth embodiment in the region of the administration channel. [Figure 18] FIG. 10 shows an enlarged detail of the predetermined breaking zone according to the fourth embodiment in the region of the rim. [Figure 19] 5 is a schematic cross-section through a forming tool of the device according to FIG. 4. [Figure 20] 20 is a schematic cross-sectional detail of the forming tool of FIG. 19 in the region of a forming device of the forming tool for forming a predetermined breaking zone. [Figure 21] 10 is a schematic cross-sectional view through a forming tool of an apparatus according to another embodiment; [Figure 22] 22 is a schematic cross-sectional detail of the forming tool of FIG. 21 in the region of a forming device of the forming tool for forming a predetermined breaking zone. [Figure 23] FIG. 10 is a schematic plan view of administration packaging according to a fifth embodiment. [Figure 24] 24 is a schematic cross-sectional view of the administration packaging taken along line XXIV-XXIV of FIG. 23. [Figure 25] FIG. 10 is an enlarged detail view of a predetermined breaking zone according to a fifth embodiment. [Figure 26] 1 is a schematic perspective view of an embodiment of a mold of a forming tool; [Figure 27] FIG. 10 is a schematic perspective view of another embodiment of a mold of a forming tool. DETAILED DESCRIPTION OF THE INVENTION

[0068] In these figures, the same reference symbols are used for the same components and parts even when repeated descriptions are omitted.

[0069] Figures 1 to 3 illustrate dosage packaging 1 according to the invention. Figure 1 is a schematic perspective view of dosage packaging 1 in a closed or delivery state. Figure 2 shows dosage packaging 1 in a schematic perspective view in an open state and / or when transformed into a pipette. Figure 3 is a schematic cross-sectional view through dosage packaging 1 further showing secondary packaging 11 into which dosage packaging 1 is preferably or optionally delivered / sold.

[0070] As shown in FIG. 3, the dosage packaging 1 is preferably configured to receive and / or enclose or contain a pharmaceutical product 2 .

[0071] Pharmaceutical product 2 is preferably a liquid. Pharmaceutical product 2 is preferably a product for the treatment and / or prevention of fleas, ticks and / or lice, especially in dogs and / or cats. Preferably, pharmaceutical product 2 helps to control mange, especially in dogs.

[0072] The dosage packaging 1 comprises or consists of a base part 3 and a cover 4 .

[0073] The bottom part 3 comprises a cavity 5 for receiving the pharmaceutical product 2. The cavity 5 preferably comprises different sections, in particular a chamber 6 and a dosing channel 7.

[0074] The bottom part 3 has a rim 8 which surrounds, in particular completely surrounds, the cavity 5. The rim 8 is preferably at least essentially flat.

[0075] The cover 4 covers, closes and / or seals, preferably in a fluid-tight, especially liquid-tight and / or air-tight manner, the base part 3 or the cavity 5, in particular the chamber 6 and the dosing channel 7. Preferably, the dosage packaging 1, the base part 3 or the cavity 5 is closed with the cover 4 in such a way that it is storage stable and / or the product 2 cannot leak out of the sealed dosage packaging 1, the base part 3 or the cavity 5.

[0076] The cover 4 is preferably fixed or joined, in particular (heat) sealed, to the bottom part 3, in particular to the rim 8 or part thereof.

[0077] Preferably, the cover 4 is fixed or joined to the base part 3 or to the rim 8 by heat sealing and / or using a (thermal) ring seal that extends in particular along the entire circumference of the rim 8 and / or along the entire circumference of the edge 3A between the cavity 5 and the rim 8. However, in principle, other fixing means are also possible, for example it is also possible to adhesively join the cover 4 to the base part 3.

[0078] That is, preferably, the cover 4 is joined or sealed to the bottom part 3 at least in the area of ​​the edge 3 A between the cavity 5 and the rim 8 to close / seal the cavity 5 .

[0079] Particularly preferably, the cover 4 is fixed, bonded or sealed over the entire rim 8. However, the bond between the bottom part 3 and the cover 4 may be less strong outside the area of ​​the edge 3A and / or may weaken from this edge 3A towards the outside of the rim 8.

[0080] The bottom part 3, in particular the cavity 5 and the rim 8, are preferably produced by thermoforming or deep-drawing a plastic sheet. In particular, the cavity 5 is produced by deep-drawing or thermoforming respective areas of the plastic sheet into and / or onto a forming tool, while leaving the areas that will become the rim 8 after thermoforming / deep-drawing undeformed during the thermoforming / deep-drawing. This will be explained in more detail below.

[0081] The chamber 6 and the administration channel 7 are preferably in fluid communication with each other. In particular, the administration channel 7 opens into the chamber 6.

[0082] As shown in Figure 1, the chamber 6 preferably has an essentially triangular shape, but this shape is not required and the chamber 6 can have any desired shape.

[0083] The dosing channel 7 is preferably elongated and / or straight. Preferably, the dosing channel 7 has a smaller diameter and / or volume than the chamber 6. Preferably, the dosing channel 7 extends along the longitudinal axis A of the dosing packaging 1. The axis A is preferably the axis of symmetry of the dosing packaging 1.

[0084] The length of the administration channel 7 is preferably greater than 2 cm or 3 cm and / or less than 5 cm or 4 cm.

[0085] The length or longitudinal extension of the dosage packaging 1 or of the bottom part 3, in particular along the axis A, is preferably greater than 6 cm and / or less than 10 cm, particularly preferably about 8.5 cm.

[0086] In particular, the width of the dosing channel 7 or the rim 8 perpendicular to the axis A and / or adjacent to the dosing channel 7 or on one side thereof is preferably greater than 2 cm and / or less than 6 cm, particularly preferably about 4 cm.

[0087] The dosage packaging 1 can be opened so that the pharmaceutical product 2 enclosed in the dosage packaging 1 or cavity 5 can be pulled or pushed out of the dosage packaging 1 and / or administered to a patient (not shown). The patient is preferably a human or an animal, particularly a domestic animal such as a cat or dog. Preferably, the dosage packaging 1 is configured to administer the pharmaceutical product 2 directly to the skin and / or fur of the patient.

[0088] As shown in Figure 2, the dosage packaging 1 is in particular transformable into a pipette. In particular, the dosage packaging 1 is transformed into a pipette by opening it.

[0089] The dosage packaging 1, in particular the bottom part 3, comprises a predetermined breaking zone 9. The dosage packaging 1 is preferably openable at and / or by breaking the dosage packaging 1, in particular the bottom part 3, along the predetermined breaking zone 9.

[0090] In particular, the dosage packaging 1 can be opened by folding and / or bending along a predetermined breaking zone 9 .

[0091] The predetermined breaking zone 9 is preferably produced by thermoforming or deep-drawing, in particular at the same time as or in the same stage and / or using the same forming tool as the thermoforming or deep-drawing of the bottom part 3, as will be explained in more detail below with reference to Figures 4 and 19 to 22.

[0092] The predetermined breaking zone 9 preferably crosses the cavity 5 , in particular the dosing channel 7 , and / or is located in the region of the cavity 5 , in particular the dosing channel 7 .

[0093] The breaking zone 9 can be provided only in the region of the cavity 5 or of the dosing channel 7. In other words, the rim 8 can be at least essentially devoid of breaking zones 9, as will be explained in more detail below with reference to Figures 9 to 11. Alternatively, the breaking zone 9 can extend at least essentially along the entire (width) of the dosing packaging 1 and / or can be provided in the region of the cavity 5, in particular the dosing channel 7 and the rim 8, as shown for example in Figures 1 and 13 and will also be explained in more detail below.

[0094] The predetermined breaking zone 9 preferably extends transversely, in particular perpendicularly, to the axis A and / or to the administration channel 7 .

[0095] The predetermined breaking zone 9 is preferably located near the axial end of the channel 7 and / or the dosage packaging 1. Preferably, the distance from the predetermined breaking zone 9 to the axial end 7A of the dosage channel 7 is at most 15 mm or less, preferably at most 10 mm or less. The distance between the predetermined breaking zone 9 and the axial end 1A of the dosage packaging 1 is preferably at most 25 mm or less, in particular at most 20 mm or less.

[0096] Preferably, the distance between the predetermined breaking zone 9 and the axial end 7A of the administration channel 7 is greater than 15% or 20% and / or less than 40% or 30%, particularly preferably about 25%, of the total length of the administration channel 7.

[0097] Preferably, the distance between the predetermined breaking zone 9 and the axial end 1A of the dosage packaging 1 is greater than 10% or 15% and / or less than 40% or 30%, particularly preferably about 20%, of the total length or longitudinal extension of the dosage packaging 1 along the axis A.

[0098] The predetermined breaking zone 9 preferably defines a tip 10 of the dosage packaging 1 and / or the bottom part 3. The tip 10 is in particular a part or section of the dosage packaging 1 or the bottom part 3 that is opposite the chamber 6 with respect to the predetermined breaking zone 9.

[0099] The tip 10 can preferably be folded or bent apart, in particular by folding or bending the dosage packaging 1 along a predetermined breaking zone 9. In particular, this breaks the dosage packaging 1 or at least the bottom part 3 so that the dosage packaging 1 can be opened and / or the pharmaceutical product 2 can be removed, dispensed or pushed out through the dosing channel 7. This breaking is particularly shown in Figure 2.

[0100] As shown in FIG. 2, the cavity 5, in particular the open end 7B of the dosing channel 7, is preferably provided by breaking the dosing packaging 1, in particular along a predetermined breaking zone 9 and / or by bending / folding the tip 10.

[0101] By opening the dosing packaging 1 as described above, the dosing packaging 1 is preferably transformed into a pipette and / or can preferably be used to administer the pharmaceutical product 2 to a patient. In particular, the pharmaceutical product 2 can be administered by or from the dosing packaging 1 by depressing the chamber 6 such that it is pushed through the dosing channel 7 and exits / flows out of the dosing channel 7 at the open end 7B of the dosing channel 7 at the predetermined rupture zone 9.

[0102] Preferably, the chamber 6 has to be pressed / depressed in order to withdraw the pharmaceutical product 2. In other words, the dosing channel 7 and / or the open end 7B are preferably configured or dimensioned such that the product 2 cannot leak out based on gravity (only) and / or such that when the dosage packaging 1 is held with the open end 7B facing downwards, the product 2 does not flow out without applying a further force, in particular by pressing down on the chamber 6. In this way, accidental withdrawal of the pharmaceutical product 2 is prevented.

[0103] Particularly preferably, the flow cross section of the cavity 5, in particular of the dosing channel 7, is narrowed or reduced in the region of the open end 7B and / or the predetermined break zone 9. Preferably, therefore, a narrowing channel, cross section reduction or nozzle is formed in the region of the open end 7B and / or the predetermined break zone 9, as will be explained in more detail below with reference to Figures 9 to 11.

[0104] In the example shown in Figure 2, the cover 4 preferably remains intact or is not broken. In particular, the tip 10 preferably remains joined to the dosage packaging 1 by the cover 4 after folding or bending it or after opening the dosage packaging 1. However, solutions are also possible in this case in which the cover 4 also breaks completely or at least partially and / or the tip 10 is completely removed from the dosage packaging 1.

[0105] The dosage packaging 1 is preferably packaged in secondary packaging 11, particularly after its manufacture, for its delivery and / or storage, and / or prior to use for administering the enclosed pharmaceutical product 2 to a patient. The secondary packaging 11 is shown in FIG. 3.

[0106] The secondary packaging 11 is preferably blister packaging.

[0107] The secondary packaging 11 preferably comprises a base portion 12 and a cover or lid 13. The base portion 12 preferably has or forms a cavity or receptacle 14 for receiving the dosage packaging 1. The lid 13 preferably closes, in particular completely closes, the receptacle 14. The lid 13 is preferably fixed, in particular glued, to the base portion 12. Preferably, the lid 13 can be peeled away from the base portion 12 to remove the dosage packaging 1 from the secondary packaging 11 or receptacle 14.

[0108] Figure 4 shows in a very schematic view an apparatus 100 for producing dosage packaging 1. In the following, the apparatus 100 and a method for producing dosage packaging 1 will be described with reference to Figure 4.

[0109] The methods described herein are preferably performed using apparatus 100. Apparatus 100 is also preferably configured to perform the methods described herein.

[0110] The apparatus 100 preferably includes a heating device 101 and a forming tool 102 .

[0111] To produce the dosage packaging 1, preferably a plastic sheet 200 is guided through the apparatus 100 and the dosage packaging 1 is formed by thermoforming, in particular deep drawing, from this plastic sheet 200. The thermoforming is carried out in particular in a heating device 101 and / or a forming tool 102.

[0112] Preferably, the plastic sheet 200 is supplied in a rolled-up state and / or on or forming a roll, as shown schematically in Figure 4. Preferably, in particular in the unwinding or feeding stage, the plastic sheet 200 is unwound / unrolled and guided into the apparatus 100 and / or heating device 101. However, the plastic sheet 200 can also be fed to the apparatus 100 and / or heating device 101 in any other desired form or manner.

[0113] The plastic sheet 200 can be guided through the apparatus 100 continuously or in stages as desired.

[0114] After unwinding / feeding the plastic sheet 200 and / or during the heating stage, the plastic sheet 200 is preferably at least partially heated using a heating device 101 .

[0115] The heating device 101 is preferably configured to at least partially heat the plastic sheet 200. In particular, the heating device 101 is configured to heat a partial area of ​​the plastic sheet 200, from which partial area the bottom part 3 of the dosage packaging 1 is then preferably formed, in particular in the forming tool 102.

[0116] The heating device 101 is preferably configured to heat the plastic sheet 200 from both sides. Preferably, the heating device 101 includes at least one heating plate 101A, 101B, in particular two heating plates 101A, 101B, hereinafter referred to as the upper heating plate 101A and the lower heating plate 101B. The upper and lower heating plates 101A, 101B are configured to heat different sides of the plastic sheet 200.

[0117] Preferably, the heating device 101, in particular the heating plates 101A, 101B, heats the plastic sheet 200 to a plasticizing or thermoforming temperature.

[0118] The plasticizing or thermoforming temperature is preferably the temperature at which the plastic sheet 200 becomes plastic and / or can be thermoformed, in particular the temperature at which the plastic sheet 200 becomes soft and / or plastically deformable. The plastic material, here plastic sheet 200, is preferably capable of being deformed when it reaches the plasticizing or thermoforming temperature and retains the new shape after cooling or dropping to a temperature below the plasticizing or thermoforming temperature.

[0119] Preferably, the heating device 101 heats the plastic sheet 200 to a temperature of 180°C and / or the thermoforming temperature is at least 150°C and / or at most 200°C.

[0120] The two heating plates 101A, 101B can be operated at the same temperature or at different temperatures, preferably, when the plastic sheet 200 is multi-layered, in particular having layers made of different materials and / or with different plasticization / thermoforming temperatures, the two heating plates 101A, 101B are operated at different temperatures, in particular corresponding to the respective plasticization / thermoforming temperatures of the layers of the plastic sheet 200 facing each heating plate 101A, 101B.

[0121] After the heating step and / or in the (thermo)forming step, the (heated) plastic sheet 200 is preferably formed, in particular thermoformed, using a forming tool 102 .

[0122] The forming tool 102 is preferably configured to form the shape of the bottom part 3 from the plastic sheet 200. In particular, the forming tool 102 is configured to stretch the plastic sheet 200 or each of its heated partial areas. In particular, the heated areas of the plastic sheet 200 are stretched within or into the forming tool 102.

[0123] The forming tool 102 includes at least one mold 102 A, 102 B. Preferably, the forming tool 102 includes two molds 102 A, 102 B, hereinafter referred to as a negative mold 102 A and a positive mold 102 B.

[0124] Preferably, the plastic sheet 200 is stretched into the negative mold 102A and / or over the positive mold 102B.

[0125] The forming or stretching is preferably carried out by pressing the plastic sheet 200 onto the forming tool 102 or mold 102A and / or 102B, preferably by generating an overpressure or by blowing a gas, in particular air, onto the plastic sheet 200 and / or by generating a negative pressure in the forming tool 102 or mold 102A and / or 102B. Additionally or alternatively, the plastic sheet 200 can be pressed onto the forming tool 102 or mold 102A and / or 102B using a press. Particularly preferably, when two molds 102A, 102B are provided, one of the molds 102A, 102B acts as a press. It is also possible to provide a press, in particular in addition to a gas, only in partial areas, for example in areas requiring more precise forming, such as the dosing channel 7.

[0126] The predetermined fracture zone 9 is preferably created in the forming tool 102 and / or during the forming stage, and / or the apparatus 100, and in particular the forming tool 102, is configured for this purpose, as will be explained in more detail below.

[0127] Preferably, the predetermined breaking zone 9 is exclusively generated / manufactured in a (thermo)forming step and / or by means of a forming tool 102. In particular, the proposed method does not include a step of (partially) cutting the plastic sheet 200 in order to generate the predetermined breaking zone 9 and / or the proposed device 100 does not have or need a cutting tool for this purpose.

[0128] However, it is also possible that the predetermined fracture zone 9 is only essentially or mainly generated / manufactured during the (thermo)forming step and / or with the forming tool 102. It is to be understood that preferably the main or basic steps for generating / forming the predetermined fracture zone 9 are carried out during (thermo)forming and / or with the forming tool 102.

[0129] In contrast, in the prior art, the predetermined breaking zone is created only after the (thermo)forming step, for example by either perforating the otherwise finished packaging along certain lines or by cutting the plastic sheet before the (thermo)forming step.

[0130] In the prior art, particularly in EP 2 998 098 A1 and EP 2 998 099 A1, cutting the plastic sheet is a primary, fundamental, or forming step that occurs before the thermoforming step. While the cut portion of the plastic sheet may be further deformed when deep-drawn, such deformation does not create the predetermined fracture zone, since the predetermined fracture zone is already created by cutting the sheet. Moreover, such deformation is never a primary or primary step that creates the predetermined fracture zone. This is already evident in the prior art, where it is completely inconceivable that the predetermined fracture zone would be formed without cutting.

[0131] That is to say, the predetermined breaking zone 9 of the present invention is preferably produced without cutting and / or without a cutting step before or after the step of forming the bottom part and / or without using a cutting tool.

[0132] In the sense of the present invention, perforating, cutting or similar actions are also preferably to be understood as one or more "cutting". The term "without cutting" can therefore preferably also include or be replaced or supplemented by expressions such as "without perforating". Similarly, cutting stages / tools can be perforating stages / tools etc.

[0133] The forming tool 102 is preferably configured to form several bottom parts 3 simultaneously or in one step, in the example shown in Figure 4 it is configured to form 12 bottom parts 3 simultaneously, but other solutions are also possible, for example where only one bottom part 3 is formed in one forming step.

[0134] Preferably, the forming tool 102 and / or molds 102A, 102B are interchangeable to produce dosage packaging 1, in particular bottom part 3, of different shapes, e.g. to accommodate chambers 6 or pharmaceutical products 2 of different volumes.

[0135] After the forming step and / or during the filling step, the base part 3, in particular the one or more cavities 5, formed in the plastic sheet 200 are filled with the pharmaceutical product 2, in particular using a filling device 103 shown in dashed lines in Figure 4.

[0136] The filling step is preferably carried out after the plastic sheet 200 or its heated / thermoforming area has hardened and / or cooled or cooled below its plasticizing / thermoforming temperature.

[0137] After the filling step and / or in the covering / closing step, a cover sheet 300 is applied, in particular fixed or joined, to the plastic sheet 200. The closing / covering is preferably performed in a covering device 104, in particular a sealing device.

[0138] Preferably, the base part 3 or one or more cavities 5 formed in the plastic sheet 200 are covered or closed with a cover sheet 300, thereby forming the respective cover 4.

[0139] Preferably, the cover sheet 300 is supplied in a rolled-up state and / or is on or forms a roll, as shown diagrammatically in Figure 4. Preferably, the cover sheet 300 is unwound / unrolled and guided into the apparatus 100 and / or the covering device 104, in particular together with the plastic sheet 200. However, it is also possible to position the (rolled) cover sheet 300 completely inside the covering device 104.

[0140] The covering device 104 is preferably configured to join or seal, in particular heat seal, the covering sheet 300 to the plastic sheet 200 or onto the bottom part 3 in a particularly fluid-tight, in particular liquid-tight and / or airtight manner. However, other solutions are also possible, for example the covering device 104 can be configured to adhesively join the covering sheet 300 to the plastic sheet 200.

[0141] Preferably, the cover sheet 300 of the cover 3 is joined or sealed to the plastic sheet 200 of the bottom part 3 by sealing, preferably heat sealing, its sealing layer 305 to the sealing layer 205 of the plastic sheet 200. The sealing layers 205 and 305 are discussed in more detail below in connection with the discussion of Figures 5 to 8.

[0142] To secure the cover sheet 300 to the plastic sheet 200, the cover device 104 is preferably brought into contact with the cover sheet 300 so that the cover sheet 300 is pressed against the plastic sheet 200 at least in the area of ​​the bottom part 3 or its edge 3A. The cover device 104 is preferably heated at least in this area so that the cover sheet 300 is heat-sealed to the plastic sheet 300 at least in this contact area.

[0143] The joining / sealing is preferably carried out at least in the region of the edge 3A of the bottom part 3, or the cover device 104 is configured for it. For this purpose, the cover device 104 preferably has at least essentially the form of the edge 3A and / or comprises (for each bottom part 3) an annular sealing tool (not shown) which can be heated.

[0144] Particularly preferably, the joining / sealing is carried out in addition to the area of ​​the edge 3A, but also in the area surrounding it and / or in the area where the rim 8 will later be formed.

[0145] In principle, it is possible for the cover device 104 not to come into contact with this additional area and to use only the radiant heat of the device when heat-sealing the cover sheet 300 to the plastic sheet 200. This would result in a lower bond strength compared to the area where the cover device 102 contacts the cover sheet 300. However, solutions are also possible where the contact in this area is established with a similar and / or constant bond strength.

[0146] After the covering / closing and / or in the separation step, the dosage packaging 1 formed by the plastic sheet 200 and the cover sheet 300 is separated from the sheets and / or from each other.

[0147] For this purpose, the apparatus 100 preferably includes a separation device (not shown) downstream of the cover device 104. However, it is also possible to integrate the separation device into the cover device 104 and / or to configure the cover device 104 to separate the dosage packaging 1.

[0148] Preferably, the dosage packaging 1 is trimmed, punched or cut out.

[0149] The separation, in particular the punching / cutting, is preferably carried out along a line having a (certain) distance to the edge 3A and / or so as to form a rim 8. The line along which the dosage packaging 1 is separated, in particular the cutting or punching, is illustrated schematically in Figure 4 by a dashed line.

[0150] The dosage packaging 1 is preferably composed of a base part 3 and a cover 4, each of which includes specific functional layers, in particular a specific layer structure. Preferred embodiments of the plastic sheet 200 of the base part 3 and the cover sheet 300 of the cover 4, or the plastic sheet 200 and cover sheet 300 used to produce the base part 3 and the cover 4, are shown in Figures 5 to 8.

[0151] In the following description, when a plastic film or layer comprises or consists of a particular polymer, this means that the film or layer, respectively, comprises or consists of this polymer as the polymeric material of the film or layer, respectively, but further compositions, such as fillers and additives, may also be present in the film or layer, respectively.

[0152] As mentioned above, the plastic sheet 200 of the bottom part 3 is preferably a multi-layer film. The plastic sheet 200 of the bottom part 3 preferably comprises at least five layers: outer thermoformable layer 201, a cyclic olefin copolymer (COC) layer 202; inner thermoformable layer 203, a barrier layer 204, and Sealing layer 205, Includes.

[0153] A cyclic olefin copolymer layer 202 is disposed between the outer thermoformable layer 201 and the inner thermoformable layer 203 , and a barrier layer 204 is disposed between the sealing layer 205 and the inner thermoformable layer 203 .

[0154] Preferably, the plastic sheet 200 comprises at least five layers as described above in the layer sequence as described above, i.e. the plastic sheet 200 of the bottom part 3 comprises at least five layers in the following layer sequence: an outer thermoformable layer 201 followed by: a cyclic olefin copolymer (COC) layer 202, followed by an inner thermoformable layer 203, followed by: a barrier layer 204, followed by Sealing layer 205, Includes.

[0155] It is particularly preferred that the aforementioned layer is directly followed by another layer, i.e., the aforementioned preferred embodiments of the present invention envisage that the aforementioned layers are formed consecutively or in sequence and / or are not separated from another layer by an intermediate layer.

[0156] The outer thermoformable layer 201 typically forms the exterior surface of the dosage packaging 1 of the present invention.

[0157] Preferably, the plastic sheet 200 of the bottom part 3 further includes an intermediate layer 206, as shown in Figure 5. The intermediate layer 206 can be omitted from the plastic sheet 200, but it enhances the compatibility of the plastic sheet 200, particularly the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 is typically disposed between the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 typically comprises or is made of the same material as the sealing layer 205, and typically also has the same thickness. The sealing layer 205 is preferably a heat-seal layer for joining / sealing the bottom part 3 and the cover 4 together.

[0158] A preferred plastic sheet 200 of the bottom part 3 has the following layer structure: (a) outer thermoformable layer 201; (b) cyclic olefin copolymer layer 202; (c) inner thermoformable layer 203; (d) middle layer 206; (e) a barrier layer 204, and (f) sealing layer 205; Comprises or consists of.

[0159] The plastic sheet 200 of the bottom part 3 typically has a thickness in the range of 230 μm to 750 μm, in particular 300 μm to 650 μm, preferably 400 μm to 600 μm, more preferably 450 μm to 500 μm, particularly preferably 480 μm to 520 μm, and determines the shape of the dosage packaging 1 after deep drawing.

[0160] Cyclic olefin copolymer layer 202 is the main layer of plastic sheet 200. It comprises or consists of, and preferably consists of, cyclic olefin copolymer (COC).

[0161] Cyclic olefin copolymers (COC) are amorphous polymers obtained by copolymerization of cyclic monomers such as 8,9,10-trinorborn-2-ene (norbornene) or 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene (tetracyclododecene) with ethene. Particularly preferred for use in the present invention are copolymers of ethene and norbornene.

[0162] The cyclic olefin copolymer layer 202 typically provides rigidity and structural integrity to the bottom part 3 of the dosage packaging 1, particularly after deep-draw forming. Furthermore, the cyclic olefin copolymer layer 202 is brittle and will break under moderate pressure, making the cyclic olefin copolymer layer 202 suitable for fabricating disposable dosage packaging having a break zone 9 for opening the dosage packaging 1. Furthermore, COC has good moisture barrier properties, especially when used in large layer thicknesses. Furthermore, COC has good chemical resistance and barrier properties with respect to polar solvents and is resistant to acids and bases. A further advantage of COC is that it is available in high purity, thus eliminating the risk of impurities being extracted by solvents or active ingredients trapped within the package.

[0163] The cyclic olefin copolymer layer 202 preferably has a thickness in the range of 200 μm to 600 μm, in particular 250 μm to 500 μm, preferably 300 μm to 450 μm, more preferably 350 μm to 400 μm, and especially preferably 360 μm to 390 μm.

[0164] The inner thermoformable layer 203 and the outer thermoformable layer 201 enhance the thermoformability of the plastic sheet 200, making it more flexible, and therefore enhances the machinability of the plastic film 200 and provides protection for the fragile COC layer 202.

[0165] The outer thermoformable layer 201 and the inner thermoformable layer 203 preferably have a thickness in the range of 10 μm to 40 μm, in particular 12 μm to 35 μm, preferably 15 μm to 30 μm, more preferably 18 μm to 27 μm, and particularly preferably 20 μm to 25 μm.

[0166] Best results are obtained when the thickness of the cyclic olefin copolymer layer 202 to the thickness of the outer thermoformable layer 201 and / or the thickness of the inner thermoformable layer 203 is in the range of 5:1 to 30:1, particularly 7:1 to 25:1, preferably 10:1 to 22:1, more preferably 13:1 to 20:1, and especially preferably 15:1 to 18:1.

[0167] Furthermore, the outer thermoformable layer 201 and the inner thermoformable layer 203 comprise or consist of, in particular consist of, the same polymer. The polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is typically selected from the group consisting of polystyrene (PS), polyvinyl chloride (PVC), amorphous polyethylene terephthalate (APET), ethylene butyl acrylate (EBA), ethylene vinyl acetate (EVA), polypropylene (PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), and mixtures thereof.

[0168] According to the invention, it is preferred if the polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), or mixtures thereof. According to the invention, it is particularly preferred if the polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is polypropylene (PP).

[0169] The barrier layer 204 preferably comprises or consists of, and preferably consists of, a polymer selected from the group consisting of ethylene vinyl alcohol (EVOH), ethylene vinyl alcohol (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

[0170] According to the present invention, it is preferred if the polymer of the barrier layer 204 is selected from the group consisting of ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof. Best results are obtained if the polymer of the barrier layer 204 is ethylene vinyl alcohol (EVOH). The barrier layer 204 prevents substances from the surrounding environment from penetrating the packaging 1 and altering the pharmaceutical product 2, on the one hand, and prevents any undesired interactions between the pharmaceutical product 2 and the packaging 1, on the other hand. In particular, a barrier layer comprising or consisting of EVOH exhibits excellent barrier properties against chemicals and oxygen.

[0171] The barrier layer 204 has a thickness in the range of 2 μm to 20 μm, in particular 5 μm to 15 μm, preferably 7 μm to 12 μm.

[0172] The sealing layer 205 and / or the intermediate layer 206 preferably comprise or consist of, and preferably consist of, a polymer selected from the group consisting of polypropylene (PP), copolymers of propylene (CoPP), terpolymers of polypropylene (ter-PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very low density polyethylene (VLDPE), ionomer acid copolymers, ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol (EVA), or mixtures thereof.

[0173] According to a preferred embodiment of the present invention, the polymer of the sealing layer 205 and / or the intermediate layer 206 is selected from the group consisting of polypropylene (PP), copolymer of propylene (CoPP), terpolymer of polypropylene (ter-PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very low density polyethylene (VLDPE), or mixtures thereof.

[0174] It is preferred if the polymer of the sealing layer 205 and / or the intermediate layer 206 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very low density polyethylene (VLDPE), or mixtures thereof. Best results are obtained if the polymer of the sealing layer 205 and / or the intermediate layer 206 is polyethylene (PE).

[0175] The sealing layer 205 and / or the intermediate layer 206 have a thickness in the range of 10 μm to 50 μm, in particular 15 μm to 40 μm, preferably 17 μm to 35 μm, more preferably 20 μm to 30 μm, and particularly preferably 22 μm to 27 μm. As mentioned above, the sealing layer 205 and the intermediate layer 206 comprise or consist of the same polymer and have the same thickness.

[0176] A highly preferred plastic sheet 200 according to the present invention therefore has the following layer structure in the following layer sequence: (a) an outer thermoformable layer 201 comprising or consisting of PP, followed by: (b) a cyclic olefin copolymer layer 202 comprising or consisting of COC, followed by (c) an inner thermoformable layer 203 comprising or consisting of PP, followed by: (d) an optional intermediate layer 206 comprising or consisting of PE, followed by: (e) a barrier layer 204 comprising or consisting of EVOH, followed by: (f) a sealing layer 205 comprising or consisting of PE; Comprises or consists of.

[0177] It is particularly preferred that the aforementioned layer is directly followed by another layer, i.e., the aforementioned preferred embodiment of the present invention envisages that the aforementioned layers are formed consecutively or sequentially and / or are not separated from another layer by any further intermediate layer other than intermediate layer 206.

[0178] It is understood that the layers of the plastic sheet 200 of the bottom part 3 can be directly or indirectly bonded to one another. Direct bonding means that the layers are directly joined to one another, for example by coextrusion, a tie layer, or an adhesive layer. Indirect bonding means that a further layer, in particular a plastic sheet or metal foil, is placed between the respective layers.

[0179] As shown in FIG. 6, the cover sheet 300 of the cover 4 preferably comprises the following layers: protective layer 301, a first barrier layer 302; middle layer 303, a second barrier layer 304, and Sealing layer 305, comprising or consisting of The first barrier layer 302 is disposed between the protective layer 301 and the intermediate layer 303 , and the second barrier layer 304 is disposed between the intermediate layer 303 and the sealing layer 305 .

[0180] The cover sheet 300 typically has a thickness in the range of 50 μm to 200 μm, particularly 70 μm to 180 μm, preferably 80 μm to 150 μm, more preferably 90 μm to 140 μm, and particularly preferably 95 μm to 130 μm.

[0181] The protective layer 301 preferably comprises or consists of, and preferably consists of, a polymer selected from the group consisting of polyethylene terephthalate (PET), polyamide (PA), polyvinylidene difluoride (PVDF), and mixtures thereof. Preferably, the polymer of the protective layer 301 is polyethylene terephthalate (PET). The protective layer not only provides protection against mechanical damage, but also allows printing to be performed on the protective layer 301, especially when the protective layer comprises or consists of PET.

[0182] The protective layer preferably has a thickness in the range of from 5 μm to 25 μm, in particular from 7 μm to 20 μm, preferably from 10 μm to 14 μm.

[0183] The first barrier layer 302 is typically a metal foil, particularly an aluminum foil. Metal foils, particularly aluminum foils, offer excellent oxygen barrier properties. The first barrier layer typically has a thickness in the range of 5 μm to 25 μm, particularly 7 μm to 20 μm, and preferably 10 μm to 40 μm.

[0184] The intermediate layer 303 and the sealing layer 305 preferably comprise or consist of the same polymer. Typically, the intermediate layer 303 and / or the sealing layer 305 comprise or consist of, and preferably consist of, a polymer selected from the group consisting of polypropylene (PP), copolymers of propylene (CoPP), terpolymers of polypropylene (ter-PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very low density polyethylene (VLDPE), ionomer acid copolymers, ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol (EVA), or mixtures thereof.

[0185] In this regard, it is preferred if the polymer of the intermediate layer 303 and / or the sealing layer 305 is selected from the group consisting of polypropylene (PP), copolymers of propylene (CoPP), terpolymers of polypropylene (ter-PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very low density polyethylene (VLDPE), or mixtures thereof.

[0186] According to the invention, it is particularly preferred if the polymer of the intermediate layer 303 and / or the sealing layer 305 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very low density polyethylene (VLDPE), or mixtures thereof. It is particularly preferred if the polymer of the intermediate layer 303 and / or the sealing layer 305 is polyethylene (PE).

[0187] Furthermore, according to the invention, it is preferred if the intermediate layer 303 and the sealing layer 305 have the same thickness. Typically, the intermediate layer 303 and / or the sealing layer 305 have a thickness in the range of 10 μm to 50 μm, in particular 15 μm to 40 μm, preferably 17 μm to 35 μm, more preferably 20 μm to 30 μm, and particularly preferably 22 μm to 27 μm.

[0188] The second barrier layer 304 preferably comprises or consists of, and preferably consists of, a polymer selected from the group consisting of ethylene vinyl alcohol (EVOH), ethylene vinyl alcohol (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof. It is particularly preferred if the polymer of the second barrier layer 304 is selected from the group consisting of ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof. In accordance with a preferred embodiment of the present invention, the polymer of second barrier layer 304 is ethylene vinyl alcohol (EVOH).

[0189] Good results are obtained if the second barrier layer 304 has a thickness in the range of 2 μm to 20 μm, in particular 5 μm to 15 μm, preferably 7 μm to 12 μm.

[0190] According to a preferred embodiment, the cover sheet 300 has the following layer structure: protective layer 301, a first barrier layer 302; middle layer 303, a second barrier layer 304, and Sealing layer 305, It has.

[0191] In particular, the cover sheet 300 has the following layer structure in the following layer sequence: (i) a protective layer 301, followed by: (ii) a first barrier layer 302, followed by: (iii) a middle layer 303, followed by (iv) a second barrier layer 304, followed by: (v) sealing layer 305; can be envisioned to include or consist of

[0192] It is particularly preferred that the aforementioned layer is directly followed by another layer, i.e., the aforementioned preferred embodiments of the present invention envisage that the aforementioned layer is formed consecutively or in sequence and / or is not separated from another layer.

[0193] It is contemplated that the layers of the cover sheet 300 can be directly or indirectly bonded to one another. Direct bonding means that the layers are directly joined to one another, for example, by coextrusion, an adhesive layer, or a tie layer. Indirect bonding means that there is an additional layer, particularly a plastic sheet or metal foil, between the respective layers.

[0194] A highly preferred embodiment of the invention is that the plastic sheet 200 of the bottom part 3 has the following layer structure with the following layer sequence: (a) an outer thermoformable layer 201, in particular comprising or consisting of PP, followed by (b) a cyclic olefin copolymer layer 202, particularly comprising or consisting of COC, followed by (c) an inner thermoformable layer 203, in particular comprising or consisting of PP, followed by (d) an optional intermediate layer 206, which may include or consist of, among other things, PE, followed by: (e) a barrier layer 204, particularly comprising or consisting of EVOH, followed by: (f) a sealing layer 205, which comprises or consists in particular of PE; comprising or consisting of The cover sheet 300 has the following layer structure: (i) a protective layer 301, followed by: (ii) a first barrier layer 302, followed by: (iii) a middle layer 303, followed by (iv) a second barrier layer 304, followed by: (v) sealing layer 305; including or consisting of.

[0195] It is particularly preferred that the aforementioned layer is directly followed by another layer, i.e., the aforementioned preferred embodiment of the present invention envisages that the aforementioned layers are formed consecutively or in sequence and / or are not separated from another layer by any further intermediate layer other than intermediate layer 206.

[0196] According to the present invention, it is preferred to dispose a tie or adhesive layer between each layer of the cover sheet 300. The adhesive of the adhesive layer is preferably a polyurethane-based adhesive, in particular a water-based or solvent-based polyurethane adhesive. The tie layer is generally composed of an adhesive resin.

[0197] Additionally, it is preferred if both the plastic 200 and the cover sheet 300 include tie and adhesive layers between each functional layer.

[0198] According to a preferred embodiment shown in FIG. 7, the plastic sheet 200 has the following layer structure: (a) an outer thermoformable layer 201, preferably comprising or consisting of, in particular consisting of, PP; (b) bonding layer 207a, (c) a cyclic olefin copolymer layer 202 comprising or consisting of, in particular consisting of, COC; (d) bonding layer 207b, (e) an inner thermoformable layer 203, preferably comprising or consisting of, in particular consisting of, PP; (f) adhesive layer 208, (g) an intermediate layer 206, preferably comprising or consisting of, and especially consisting of, PE; (h) bonding layer 207c, (i) a barrier layer 204, preferably comprising or consisting of, and especially consisting of, EVOH; (j) bonding layer 207d, and (k) a sealing layer 205, preferably comprising or consisting of, in particular consisting of, PE; Comprises or consists of.

[0199] FIG. 8 shows a preferred layer structure of the cover sheet 300: (i) a protective layer 301, preferably comprising or consisting of PET; (ii) adhesive layer 308a; (iii) a first barrier layer 302, preferably comprising or consisting of, in particular consisting of, aluminum foil; (iv) adhesive layer 308b; (v) an intermediate layer 303, preferably comprising or consisting of, in particular consisting of, PE; (vi) a bonding layer 307a; (vii) a second barrier layer 304 preferably comprising or consisting of, and especially consisting of, EVOH; (viii) a bonding layer 307b; and (ix) a sealing layer 305, preferably comprising or consisting of, in particular consisting of, PE; is displayed.

[0200] Preferably, the cover sheet 300 is joined or sealed to the plastic sheet 200 by sealing layers 205 and 305. Preferably, the cover sheet 300 and the plastic sheet are joined or sealed by heat sealing.

[0201] In the following, different embodiments of the dosage packaging 1 according to the invention are explained in more detail. The different embodiments preferably differ (only) by the design of the predetermined breaking zone 9. In other words, the different embodiments of the dosage packaging 1 are preferably identical apart from the predetermined breaking zone 9.

[0202] Preferably, aspects, features and explanations described with respect to one embodiment also apply to other embodiments unless expressly stated otherwise, even if such explanations are not repeated.

[0203] Furthermore, the aspects, features and explanations described above with respect to the dosage packaging 1, particularly with reference to Figures 1 to 3, with respect to the apparatus 100 for manufacturing the dosage packaging 1, particularly with reference to Figure 4, and with respect to the preferred multi-layer structure, particularly with reference to Figures 5 to 8, preferably apply in addition to or correspondingly to the embodiments described below, even if such explanations are not repeated.

[0204] The embodiments of dosage packaging 1 described below preferably include aspects and features of dosage packaging 1 generally described with reference to FIGS. 1 to 3.

[0205] The embodiments of dosage packaging 1 described below are preferably produced or producible by the method and / or apparatus 100 described with reference to FIG.

[0206] The embodiments of dosage packaging 1 described below are preferably produced from the plastic sheet 200 and / or cover sheet 300 described with reference to Figures 5 to 8, and / or their bottom part 3 and / or cover 4 preferably have a multi-layer structure as described with reference to Figures 5 to 8.

[0207] However, the following embodiments do not necessarily have the aspects or features described above. For example, they may have different multi-layer structures than those in Figures 5 to 8.

[0208] A first embodiment of dosage packaging 1 is shown in FIGS.

[0209] 9 illustrates a schematic plan view of the dosage packaging 1 from the bottom side, i.e. towards the bottom part 3. In this view, the cover 4 is not visible as it is behind the bottom part 3.

[0210] Figure 10 illustrates a schematic cross-sectional view of the dosage packaging 1 along line XX in Figure 9. Figure 11 illustrates an enlarged detail of Figure 10 in the region of the fracture zone 9, labeled XI in Figure 10.

[0211] As indicated by the hatching, the rim 8 shown in Figure 11 is located behind the cross-sectional plane. The cover 4 preferably extends along the upper surface of the rim 8 over the cavity 5 or dosing channel 7, thereby sealing the cavity 5 or dosing channel 7 from above (in the orientation shown in these figures).

[0212] In a first embodiment, the predetermined breaking zone 9 extends only across the cavity 5, in particular across the dosing channel 7 thereof, as shown in particular in Figure 9. Preferably, in the first embodiment, the predetermined breaking zone 9 is not provided on the rim 8 and / or the rim 8 does not comprise a predetermined breaking zone 9. This preferably enhances the stability of the dosage packaging 1 and / or reduces the risk of accidental opening of the dosage packaging 1.

[0213] In this sense, the term "predetermined breaking zone" preferably refers to an area of ​​the dosage packaging 1, in particular the bottom part 3, that is specially prepared or created to ensure breaking / opening of the dosage packaging 1. In particular, the predetermined breaking zone 9 is therefore preferably a material weakening, and throughout this application the term "predetermined breaking zone" can be replaced with "material weakening".

[0214] Preferably, even when the predetermined breaking zone 9 is provided only in the region of the cavity 5 or the dosing channel 7, the rim 8 will nevertheless likewise break when the dosage packaging 1 is opened, in particular when the tip 10 is bent / folded, preferably in a defined manner, along the predetermined breaking zone 9. In other words, when bending / folding the tip 10, the material preferably breaks in the predetermined breaking zone 9, and this break propagates in a specifically defined manner into the rim 8, resulting in the breakage of the entire tip 10 of the base part 3.

[0215] In particular, the predetermined breaking zone 9 is provided only on the bottom part 3 and / or the cover 4 does not comprise the predetermined breaking zone 9 .

[0216] 11, the predetermined breaking zone 9 is preferably or comprises a depression, notch or groove 15. Preferably, the predetermined breaking zone 9 is or comprises a groove 15 on the outer surface 16 of the dosage packaging 1, in particular the base part 3.

[0217] The outer surface 16 of the dosage packaging 1 or of the base part 3 is in particular the surface of the base part 3 opposite the cavity 5 or hollow space adapted to receive the pharmaceutical product 2. Particularly preferably, the outer surface 16 is formed by an outer thermoformable layer 201.

[0218] Preferably, the grooves 15 have an at least essentially triangular shape in cross section and / or are at least essentially wedge-shaped, although other shapes are also possible.

[0219] The groove 15 preferably has and / or is defined by an angle W and a depth D.

[0220] The angle W is preferably the smaller angle between the main extension plane of the outer surface 16 and the main extension plane of the chamfered or inclined surface of the groove 15, in particular at the predetermined breaking zone 9 or edge of the groove 15, i.e., the edge where the outer surface 16 bends inward and / or begins to become a groove / recess.

[0221] If the groove 15 or its cross section is at least essentially triangular or wedge-shaped, the angle W is preferably the angle between one of the sides and the base of the (isosceles) triangular cross section.

[0222] However, the groove 15 can preferably be characterized by any other suitable angle that can be determined from the angle W, for example the angle at which the outer surface 16 actually bends inward or towards the cavity 5 or the administration channel 7 (which can be calculated as 180°-W) or, particularly in the case of a triangular or wedge shape, the opening angle of the groove 15 (i.e., the angle contained between the two inclined surfaces of the groove 15), which can be calculated as 180°-2W.

[0223] The depth D is preferably the distance measured from the main extension plane of the outer surface 16 to the lowest region of the groove 15, in particular perpendicular to this main plane.

[0224] If the groove 15 or its cross section is at least essentially triangular or wedge-shaped, the depth D is preferably the height or height difference (relative to the base) of the triangular cross section.

[0225] The angle W is preferably at least 20 degrees or at least 25 degrees, in particular at least 30 degrees, and / or at most 60 degrees or at most 55 degrees, in particular at most 50 degrees. Particularly preferred values ​​for the angle W are 30 degrees, 40 degrees, or 50 degrees.

[0226] The opening angle or groove angle is preferably at least 60 degrees or at least 70 degrees, in particular at least 75 degrees or at least 80 degrees, and / or at most 140 degrees or at most 130 degrees, in particular at most 125 degrees or at most 120 degrees. Particularly preferred values ​​are 80 degrees, 100 degrees or 120 degrees.

[0227] The depth D is preferably at least 0.05 mm, in particular at least 0.1 mm, and / or at most 0.5 mm, in particular at most 0.4 mm. Particularly preferred values ​​for the depth D are 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm.

[0228] The depth D is preferably at least 5% or 10%, in particular at least 15% or 20%, and / or at most 70% or 60%, in particular at most 50% or 40%, of the (wall) thickness T of the bottom part 3 .

[0229] Preferably, the groove 15 has, in its lowest region or valley, a (very) small radius of curvature, preferably smaller than 15% or 10%, in particular smaller than 5% or 2% of the depth D. Preferably, the radius of curvature is smaller than 50 μm or 20 μm, in particular smaller than 10 μm or 5 μm.

[0230] Preferably, within the predetermined breaking zone 9 , a protrusion 17 is formed on the inner surface 18 of the dosage packaging 1 , in particular the bottom part 3 .

[0231] The inner surface 18 of the dosage packaging 1 or of the bottom part 3 is in particular the surface of the bottom part 3 facing the cavity 5 or hollow space configured to receive the pharmaceutical product 2 and / or opposite the inner surface 16. Particularly preferably, the inner surface 18 is formed by a sealing layer 205.

[0232] Thus, the outer surface 16 and the inner surface 18 are preferably two opposing surfaces of the wall forming the base part 3. Particularly preferably, the inner surface 18 is at least the surface in contact with the pharmaceutical product 2 when the pharmaceutical product 2 is dispensed and / or the surface of the innermost layer or sealing layer 205. Particularly preferably, the outer surface 16 is the surface in contact with the ambient environment and / or the surface of the outermost layer or outer thermoformable layer 201.

[0233] The protrusion 17 is preferably located on the opposite side of the groove 15 .

[0234] Preferably, the protrusions 17 are formed correspondingly to the grooves 15, in particular extending in the same direction as the grooves 15, having the same length and / or width as the grooves 15 and / or having the same shape and / or angle as the grooves 15.

[0235] Preferably, the predetermined breaking zone 9 is a region that has the same thickness T as the region of the bottom part 3 surrounding the predetermined breaking zone 9. In other words, the (wall) thickness T of the bottom part 3 is preferably at least essentially constant in the region including the predetermined breaking zone 9 and in the region surrounding the predetermined breaking zone 9.

[0236] Preferably, therefore, the (wall) thickness T of the bottom part 3 in the area of ​​the groove 15 and / or protrusion 17 is at least essentially the same as in the area surrounding / adjacent to the groove 15 and / or protrusion 17.

[0237] The thickness T is preferably the distance between the outer surface 16 and the inner surface 18. Within the predetermined breaking zone 9, the thickness T is preferably the distance between the (face of) the groove 15 and the (face of) the protrusion 17.

[0238] The at least essentially constant thickness T is preferably obtained by forming the protrusions 17 in response to the depth D of the grooves 15, in particular by the protrusions 17 having the same or at least approximately the same height as the depth D of the grooves 15. In other words, the protrusions 17 are preferably at least essentially as high as the depth of the grooves 15 and / or the outer surface 16 is at least essentially as recessed as the protrusions of the inner surface 18 (at the predetermined breaking zones 9).

[0239] Preferably, the thickness T of the bottom part 3 both in the predetermined breaking zone 9 and in the area surrounding it is preferably at least 230 μm, in particular at least 300 or 400 μm, more preferably 450 or 480 μm, and / or at most 750 μm, in particular 650 or 600 μm, more preferably 500 μm or 520 μm.

[0240] In the first embodiment, the predetermined breaking zone 9 is preferably formed as a bend, kink or fold in (the wall of) the bottom part 3 .

[0241] In particular in a cross section perpendicular to the longitudinal extension of the predetermined breaking zone 9, the (walls of) the bottom part 3 in the predetermined breaking zone 9 or in its area is preferably at least essentially V-shaped.

[0242] Preferably, a reduced width flow channel, cross-section reduction or nozzle 19 is formed at / in the predetermined breaking zone 9 or in particular in the cavity 5 or in the dispensing channel 7 .

[0243] The channel height and / or flow cross section of the dosing channel 7 is preferably defined or bounded by the inner surface 18 and the cover 4, in particular the surface of the cover 4 facing the dosing channel 7 or formed by the sealing layer 305.

[0244] The height and / or width of the administration channel 7 away from the predetermined rupture zone 9, cross-section reduction or nozzle 19 is preferably greater than 0.5 mm, in particular greater than 1 mm and / or less than 4 mm or 3 mm.

[0245] The height and / or width of the administration channel 7 is preferably reduced at / within or by the predetermined breaking zone 9 by at least 0.05 mm or more and / or by a maximum of 0.5 mm or less, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm.

[0246] Preferably, the dosing channel 7 is narrowed or its (flow) cross section is reduced by a protrusion 17 or a nozzle 19 is formed. In particular, the protrusion 17 protrudes into the dosing channel 7 and / or towards the cover 4, thereby narrowing the channel and / or reducing its (flow) cross section.

[0247] When the dosage packaging 1 is opened, particularly by folding / bending along a predetermined breaking zone 9 or groove 15, a reduced width flow channel, cross-section reduction, or nozzle 19 is preferably formed or positioned at the open end 7B, particularly where the pharmaceutical product 2 flows out of the dosage packaging 1.

[0248] As mentioned above, the dosing channel 7 and / or the open end 7B are preferably configured or dimensioned such that the product 2 cannot leak out based on gravity (only). This configuration or dimensioning is particularly preferably achieved at least in part by a reduced width flow channel, reduced cross section or nozzle 19.

[0249] Preferably, the administration channel 7 or the open end 7B is narrowed, particularly by the protrusion 17, so that even when it is facing downwards, the pharmaceutical product 2 does not flow out / exit through the administration channel 7 or the open end 7B unless additional force is applied, for example by pressing on the chamber 6.

[0250] Thus, the pharmaceutical product 2 is preferably dispensed from the opened dosage packaging 1 only by pressing the chamber 6 .

[0251] Preferably, when dispensing the pharmaceutical product 2 and / or pressing the chamber 6, the pharmaceutical product 2 is accelerated, particularly preferably by a reduced width flow path, reduced cross section or nozzle 19, as it leaves the dosage packaging 1, particularly at the open end 7B.

[0252] Preferably, the reduced width flow channel, cross-section reducer or nozzle 19 (further) prevents the pharmaceutical product 2 from flowing, in particular from the chamber 6, past the reduced width flow channel, cross-section reducer or nozzle 19 and / or into the tip 10, the part of the dosing channel 7 defined by the tip 10 and / or towards the axial end 7A, in particular before the dosage packaging 1 is opened. Thus, preferably, the pharmaceutical product 2 is prevented from accumulating at the axial end 7A or within the tip 10. In this way, preferably, the pharmaceutical product 2 is not wasted or leaked out when the dosage packaging 1 is opened or the tip 10 is discarded.

[0253] FIG. 12 illustrates an enlarged detail in the region of the breaking zone 9 of a second embodiment of dosage packaging 1 in a view corresponding to the enlarged detail of the first embodiment shown in FIG.

[0254] Preferably, the only difference between the first and second embodiments is that the dosage packaging 1, the bottom part 3 or the predetermined breaking zone 9 does not include a protrusion 17 and / or does not include a reduced width flow channel, a reduced cross-section portion or a nozzle 19.

[0255] The dosing channel 7 of the second embodiment preferably has a constant distance between the inner surface 18 and the cover 4 and / or a constant (flow) cross section, especially also within the predetermined rupture zone 9 .

[0256] Along the axis A and / or along the section shown in FIG. 12, the inner surface 18 is preferably at least essentially flat, in particular within the predetermined breaking zone 9 (also).

[0257] Preferably, within the predetermined breaking zone 9, the thickness T of the (wall of) the bottom part 3 is reduced or decreased compared to the area surrounding the predetermined breaking zone 9. Particularly preferably, the thickness T is reduced by the depth D of the groove 15.

[0258] The ratio of the thickness at the predetermined fracture zone 9 (at its narrowest area) to the thickness in the area surrounding the predetermined fracture zone 9 is preferably at least 0.1 or 0.2 and / or at most 0.9 or 0.8.

[0259] Embodiments are also possible in which the dosage packaging 1, in particular the bottom part 3 or the predetermined breaking zone 9, has a protrusion 17 or a reduced width flow channel, cross-sectional reduction or nozzle 19, but nevertheless has a non-constant thickness T, for example a thickness T that is reduced in the area of ​​the protrusion 17 or the predetermined breaking zone 9 compared to the area surrounding the protrusion 17 or the predetermined breaking zone 9.

[0260] It is also contemplated that the thickness T may be reduced in some regions and increased in others compared to the average thickness T. For example, it is contemplated that the thickness T may be reduced at the tip of the protrusion 17 and increased at the base / skirt of the protrusion 17.

[0261] Preferably, the predetermined breaking zone 9 or material weakening of the bottom part 3 is formed by a bend / kink, by material reduction / thickness reduction or a combination thereof.

[0262] Below, third and fourth embodiments of the dosing packaging 1 are described which differ from the first and second embodiments, preferably in that the predetermined breaking zone 9 or its groove 15 extends across the rim 8 or is formed in both the dosing channel 7 and the rim 8.

[0263] Figures 13 to 15 illustrate a third embodiment of the dosage packaging 1 in views corresponding to Figures 9 to 11, respectively. In particular, Figure 13 shows a schematic plan view from the bottom side of the dosage packaging 1, Figure 14 shows a schematic cross-section of the dosage packaging 1 along XIV-XIV in Figure 13, and Figure 15 illustrates an enlarged detail of the part labelled XV in Figure 13. The cross-sections shown in Figures 14 and 15 are along the axis A, i.e. along or in the region of the dosage channel 7.

[0264] Figure 16 shows a schematic cross section of a dosage packaging 1 according to a third embodiment in the region of the rim 8 in an enlarged view similar to Figure 15. In the first and second embodiments, the rim 8 does not include a predetermined breaking zone 9 or groove 15, so a similar view has been omitted.

[0265] Figure 17 shows an enlarged detail of the fourth embodiment of the dosage packaging 1 in the region of the breaking zone 9 in a corresponding view with the enlarged detail of the other embodiments shown in Figures 11, 12 and 15. Figure 18 shows an enlarged detail of the fourth embodiment of the dosage packaging 1 in the region of the breaking zone 9 at the location of the rim 8 in a corresponding view with Figure 16.

[0266] In both the third and the fourth embodiment, the predetermined breaking zone 9 or groove 15 preferably extends across the cavity 5, in particular the dosing channel 7 and the rim 8. In other words, the predetermined breaking zone 9 or groove 15 preferably extends across the entire width of the dosing packaging 1, i.e. across the entire extension of the dosing packaging 1, in a direction transverse or perpendicular to (the longitudinal extension of) the dosing channel 7 or the axis A.

[0267] Preferably, the area of ​​the predetermined rupture zone 9 has, at the location of the rim 8, the same or similar characteristics as the location of the cavity 5 or dispensing channel 7 within the area of ​​the predetermined rupture zone 9.

[0268] The above explanations regarding the predetermined breaking zone 9, groove 15, angle W, depth D, etc. preferably also apply to the predetermined breaking zone 9 of the third and fourth embodiments, particularly preferably both in the region of the cavity 5 and in the region of the rim 8.

[0269] Preferably, the groove 15 has the same or similar characteristics in the region of the rim 8 as in the region of the cavity 5 or of the dosing channel 7, eg the same angle W, the same depth D, etc.

[0270] However, solutions are also possible in which the predetermined breaking zone 9 and / or the groove 15 differ from the rim 8. For example, it is conceivable that the groove 15 could have a smaller depth D in the rim 8 than in the cavity 5 or the dosing channel 7.

[0271] Preferably, the main or only difference between the third embodiment of FIGS. 13 to 16 and the fourth embodiment of FIGS. 17 and 18 is whether or not the protrusion 17 is formed on the rim 8 .

[0272] Preferably, the rim 8 in the third embodiment does not include a protrusion 17, as can be seen in particular in Figure 16, and / or the rim 8 in the fourth embodiment includes a protrusion 17, as can be seen in particular in Figure 18.

[0273] In the fourth embodiment, the protrusion 17 preferably extends across the entire width of the dosage packaging 1, i.e. across the entire extension of the dosage packaging 1, in a direction perpendicular to (the longitudinal extension of) the dosage channel 7 or the axis A. In particular, therefore, the edge 3A and / or the rim 8 also comprise the protrusion 17.

[0274] Preferably, the protrusions 17 have the same or similar properties in the area of ​​the rim 8 as in the area of ​​the cavity 5 or of the administration channel 7. However, solutions in which the protrusions 17 are different in the rim 8 are also possible.

[0275] Preferably, the cover 4 conforms or adapts to the surface of the rim 8. In other words, in the fourth embodiment, in the region of the predetermined breaking zone 9 or protrusion 17, the cover 4 (also) has a bulge or protrusion on its outside and a groove on its inside, as can be seen in Figures 17 and 18. In the third embodiment and / or when the rim 8 is flat or does not include a protrusion 17, the cover 4 is preferably at least essentially flat, especially also in the region of the predetermined breaking zone 9, as can be seen in Figures 15 and 16.

[0276] In the third embodiment, the thickness T is preferably reduced at the location of the rim 8 within the region of the predetermined rupture zone 9 compared to the region surrounding the predetermined rupture zone 9 and / or compared to the location of the administration channel 7 in the region of the administration channel 7.

[0277] In the fourth embodiment, the thickness T is preferably at least essentially constant over the entire length of the predetermined breaking zone 9 .

[0278] Preferably, the dosage packaging 1 according to the third embodiment comprises a reduced width flow channel, reduced cross section or nozzle 19 .

[0279] Preferably, the dosing packaging 1 according to the fourth embodiment has an at least essentially constant flow cross-section and / or does not comprise any reduced width channels, cross-section reducers or nozzles 19. This is achieved in particular by shaping the cover 4 in response to non-flat surfaces or protrusions 17 in the region of the predetermined breaking zone 9. However, solutions are also possible in which the cover 4 is non-flat only at the rim 8 and is still flat where it covers the cavity 5 or dosing channel 7, and in particular still flat in the region formed by the edge 3A.

[0280] Any combination of the different embodiments is possible, for example the predetermined breaking zone 9 of the third embodiment can also be formed without the protrusion 17 as in the second embodiment.

[0281] In the following, the forming tool 102 will be described in more detail with reference to Figures 19 to 22 and / or how the predetermined breaking zone 9 is generated in the proposed method, in particular during the thermoforming step and / or in the proposed apparatus 100, in particular the forming tool 102.

[0282] Figure 19 shows a schematic cross-sectional view of the forming tool 102 and the (thermoformed) plastic sheet 200 or bottom part 3. Figure 20 illustrates an enlarged detailed view of the cross-section of the forming tool 102 and the (thermoformed) plastic sheet 200 or bottom part 3 in the region of the forming device 102C. Figures 21 and 22 illustrate a forming tool 102 according to yet another embodiment in views corresponding to Figures 19 and 20, respectively.

[0283] The following description preferably applies to both embodiments unless otherwise specified.

[0284] 19 and 21 illustrate molds 102A, 102B separated from each other and from plastic sheet 200 / bottom part 3, and / or molds 102A, 102B immediately after thermoforming with plastic sheet 200 / bottom part 3 removed from molds 102A, 102B.

[0285] 20 and 22 illustrate the molds 102A, 102B lying against and / or thermoforming the plastic sheet 200 / bottom part 3. FIG.

[0286] The negative mold 102A preferably has a (concave) cavity and / or a concave form or (concave) surface 102D. The surface 102D of the negative mold 102A is preferably globally concave, but can be locally flat or even convex.

[0287] Particularly preferably, the negative mould 102A has a plurality of (concave) cavities for forming a plurality of bottom parts 3 (simultaneously / in one forming step) as described above with reference to FIG.

[0288] The positive mold 102B preferably has a (convex) ridge and / or convex form or (convex) surface 102E. The surface 102E of the positive mold 102B is preferably globally convex, but can be locally flat or even concave.

[0289] Particularly preferably, the positive mould 102B has a plurality of (convex) ridges for forming a plurality of bottom parts 3 (simultaneously / in one forming step) as described above with reference to FIG.

[0290] As explained above with respect to the apparatus 100 shown in FIG. 4 and the corresponding manufacturing method, it is possible for the forming tool 102 to include only the negative mold 102A or only the positive mold 102B, or for only one of the two molds 102A, 102B to be used during (thermo)forming. In this case, the plastic sheet 200 is preferably pressed against the negative mold 102A or the positive mold 102B, in particular pneumatically and / or by means of gas blown onto the plastic sheet 200, thereby adapting to the shape of the respective mold. Alternatively or additionally, negative pressure can be generated, for example, by sucking air or another gas out of the respective mold. Alternatively or additionally, a press or other mechanical force means can be used.

[0291] Particularly preferably, both a negative mold 102A and a positive mold 102B are prepared or used during or for the purpose of forming the bottom part 3. In this case, the positive mold 102B is preferably pressed against the negative mold 102A and / or vice versa, and / or the plastic sheet 200 is crushed or formed between the negative mold 102A and the positive mold 102B. Therefore, preferably, a mechanical force is applied to the plastic sheet 200 using the molds 102A, 102B. In this sense, one of the molds 102A, 102B can act as a press for the other mold 102A, 102B.

[0292] Preferably, even when both molds 102A, 102B are prepared / used, further blowing gas and / or generating negative pressure is used.

[0293] One of the molds 102A, 102B or one of the faces 102D, 102E may be only partially formed or provided in areas of the bottom part to be formed that require more precise forming. For example, the positive mold 102B or its (convex) face 102E may only be provided in the area where the dosing channels 7 are to be formed, or even only where the predetermined breaking zones 9 are to be formed. In such cases, preferably, in other areas the plastic sheet 200 is pressed against the respective mold 102A only by gas and / or negative pressure.

[0294] The molding tools 102, in particular the negative mold 102A and / or the positive mold 102B, are preferably configured to (thermo)form predetermined breaking zones 9, grooves 15 and / or protrusions 17, in particular during the (thermo)forming part of the production method.

[0295] The molding tool 102, in particular the negative mold 102A and / or the positive mold 102B, preferably comprises a forming or generating device 102C for (thermo)forming the predetermined breaking zones 9, grooves 15 and / or protrusions 17.

[0296] The forming devices 102C are preferably shaped to correspond to the (desired) predetermined breaking zones 9, specifically as protrusions or ridges 102F in the negative mold 102A and / or grooves or recesses 102G in the positive mold 102B.

[0297] It is also possible to provide protrusions or ridges 102F in the positive mold 102B and / or grooves or recesses 102G in the negative mold 102A to create / form predetermined fracture zones 9 according to a fifth embodiment described below with reference to Figures 23 to 25.

[0298] The forming device 102C preferably has a shape, scale, and / or dimensions that correspond to or are the same as the (desired) predetermined fracture zone 9, for example, in terms of angle W and / or depth D.

[0299] In particular, the forming device 102C is preferably elongated and / or wedge-shaped, similar to the predetermined fracture zone 9. In the case of a surface protrusion, its height preferably corresponds to or is the same as the (desired) depth D of the predetermined fracture zone 9. In the case of a surface depression, its depth preferably corresponds to or is the same as the (desired) depth D of the predetermined fracture zone 9.

[0300] Forming device 102C or ridge 102F preferably has sharp edges or ridges.

[0301] Preferably, the radius of curvature at the edge / ridge of the forming device 102C / ridge 102F is less than 15% or 10%, in particular less than 5% or 2% of the height of the forming device 102C / ridge 102F.

[0302] Preferably, the radius of curvature at the edge / ridge of the forming device 102C / ridge 102F is less than 50 μm or 20 μm, in particular less than 10 μm or 5 μm.

[0303] Preferably, the grooves 15 have the same or corresponding radii of curvature at their valleys and / or the protrusions 17 have the same or corresponding radii of curvature at their crests.

[0304] The forming device 102C can be embodied / formed / provided only in the negative mold 102A (e.g., as shown in Figures 19 and 20), only in the positive mold 102B (not shown), or both in the negative mold 102A and in the positive mold 102B (e.g., as shown in Figures 21 and 22).

[0305] In the case of the negative mold 102A, the forming device 102C is preferably configured as a protrusion or ridge 102F within the negative mold 102A and / or formed by it and / or within a (concave) cavity possessed by the (generally concave) surface 102D.

[0306] In the case of the positive mold 102B, the forming device 102C is preferably configured as a groove or recess 102G in and / or formed by the positive mold 102B and / or in a (convex) ridge having a (generally convex) surface 102E.

[0307] Preferably, the plastic sheet 200 conforms to the shape of the negative mold 102A and / or the positive mold 102B when pressed against the respective molds 102A, 102B. In particular, the plastic sheet 200 lies flat against the negative mold 102A or face 102D and / or the positive mold 102B or face 102E.

[0308] Particularly preferably, the plastic sheet 200 (as well) conforms to or lies flat against the forming device 102C, ridges 102F and / or recesses 102G, in particular when pressed against them, thereby forming predetermined breaking zones 9, grooves 15 and / or protrusions 17.

[0309] Depending on the desired configuration of the predetermined breaking zone 9, the forming device 102C is shaped accordingly.

[0310] The forming device 102C may be provided only in the area of ​​the molding tool 102, in particular one or both molds 102A, 102B, where the dispensing channel 7 is or is to be formed. Alternatively, the forming device 102C may be provided in the area where the rim 8 is to be formed.

[0311] When forming the bottom part 3, particularly during the forming stage, the predetermined breaking zones 9 are or will be formed only where the forming device 102C is provided.

[0312] When the forming device 102C is provided only in the area where the dosing channel 7 is to be formed or to be formed, the predetermined breaking zone 9 is accordingly formed or to be formed only in the area of ​​the dosing channel 7. Thus, preferably, the dosing packaging 1 or the bottom part 3 according to the first embodiment shown in Figures 9 to 11 and / or the second embodiment shown in Figure 12 and / or any other embodiment in which the predetermined breaking zone 9 is provided only at the location of the dosing channel 7 can be formed / produced in this way.

[0313] When the forming device 102C is also provided in the area where the rim 8 is or is to be formed, the predetermined breaking zone 9 is or is to be formed accordingly also in the area of ​​the rim 8. Thus, preferably, also the dosage packaging 1 or the bottom part 3 according to the third embodiment shown in Figures 13 to 16 and / or the fourth embodiment shown in Figures 17 and 18 and / or any other embodiment in which the predetermined breaking zone 9 is also provided at the location of the rim 8, for example the embodiment shown in Figures 1 to 3, can be formed / produced in this way.

[0314] Preferably, when both molds 102A, 102B are provided, or in the areas where both molds 102A, 102B are provided, molds 102A and 102B or their surfaces 102D and 102E at least essentially correspond to each other. In particular, surfaces 102D and 102E are at least essentially identical or have at least essentially the same shape, except for having opposite curvatures. However, in certain areas, in particular where predetermined fracture zones 9 are or are to be formed, molds 102A and 102B or their surfaces 102D and 102E can be shaped differently.

[0315] Preferably, in the embodiment shown in Figures 19 and 20, the negative mold 102A includes the forming device 102C. In particular, protrusions or ridges 102F are provided on the negative mold 102A or face 102D, particularly in the areas where the dosing channels 7 or the predetermined breaking zones 9 are or are to be formed, whereas no corresponding grooves or recesses are provided on the positive mold 102B.

[0316] As can be seen most clearly in Figure 20, the above results in a predetermined breaking zone 9 which preferably does not have a protrusion 17 and / or has a reduced thickness T. In particular, in this way it is possible to form dosage packaging 1 according to the second embodiment shown in Figure 12 and / or any other embodiment without a protrusion 17.

[0317] Alternatively, as exemplarily shown in Figures 21 and 22, a forming device 102C can be embodied / provided on both molds 102A, 102B. In particular, one mold 102A, 102B can include a protrusion or ridge 102F and the other mold 102B, 102A can include a corresponding groove or recess 102G, which protrusion or ridge 102F and groove or recess 102G in particular have the same, similar or corresponding angle W and / or height / depth D. In this way, it is possible to form / produce preferably dosage packaging 1 having a groove 15 and a corresponding protrusion 17, for example dosage packaging 1 according to the first embodiment shown in Figures 9 to 11 or the third or fourth embodiment shown in Figures 13 to 18, depending on whether the forming device 102C is provided only in the area of ​​the dosing channel 7 to be formed or also in the area of ​​the rim 8 to be formed.

[0318] The portions of the forming device 102C on the different molds 102A, 102B may correspond to each other in certain areas, but may differ in other areas.

[0319] For example, the forming device 102C or surface 102D may include a protrusion or ridge 102F extending along both the area where the dosing channel 7 is or is to be formed and the area where the rim 8 is or is to be formed, while the forming device 102C or surface 102E includes a groove or recess 102G only in the area where the dosing channel 7 is or is to be formed, but not in the area where the rim 8 is or is to be formed. In this way, the dosing packaging 1 according to the third embodiment shown in Figures 13 to 16 can preferably be formed / produced.

[0320] The forming device 102C may be integrally formed with the forming tool 102, in particular within the negative mold 102A and / or the positive mold 102B or their respective faces 102D, 102E.

[0321] 19 and 20, forming device 102C is preferably an integrally formed protrusion or ridge 102F of mold 102A or surface 102D. Depending on the desired shape of the predetermined fracture zone 9, the other mold 102B or surface 102E may additionally or alternatively include an integrally formed groove or recess 102G, for example, as shown in FIGS.

[0322] Preferably, the device 100 can be adapted to generate predetermined fracture zones 9 of different shapes.

[0323] As mentioned above, the forming tools 102, particularly the molds 102A, 102B, are preferably interchangeable, and the apparatus 100 can be made adaptable to produce differently shaped predetermined fracture zones 9 by replacing the forming tools 102, particularly one or both molds 102A, 102B, with forming tools 102 having different forming devices 102C.

[0324] Particularly preferably, the forming device 102C is displaceable, adjustable and / or exchangeable, in particular within the forming tool 102 or the respective mould 102A, 102B and / or without exchanging the entire forming tool 102 or the respective mould 102A, 102B. In particular, the apparatus 100 can preferably be adapted to produce predetermined fracture zones 9 of different shapes without exchanging the entire forming tool 102 or the respective mould 102A, 102B.

[0325] Preferably, the forming device 102C forms a displaceable, adjustable, and / or replaceable component of the forming tool 102.

[0326] For example, the forming device 102C can be designed as one or more inserts for the forming tool 102 or mold 102A, 102B, which are illustrated schematically in dashed lines in Figures 20 and 22.

[0327] The forming device 102C or insert may preferably be secured to the forming tool 102 or mold 102A, 102B in a press-fit and / or form-fit manner. For example, the forming device 102C or insert may be threaded into a corresponding threaded hole in the forming tool 102 or mold 102A, 102B.

[0328] The forming device 102C or insert can preferably be exchanged for a different forming device 102C or insert in order to produce or adapt the apparatus 100 or forming tool 102 to different types of dosage packaging 1 or predetermined breaking zones 9. Preferably, in this way, adaptation is possible without changing the (entire) forming tool 102 or mold 102A, 102B.

[0329] Alternatively or additionally, the forming device 102C may be adjustable or displaceable. Preferably, the forming device 102C is adjustable or displaceable orthogonally and / or parallel to the surfaces 102D, 102E.

[0330] In particular, the height / depth D and / or angle W of the forming device 102C, in particular the ridges 102F and / or recesses 102G, and further the height / depth D and / or angle W of the predetermined fracture zones 9 created thereby, may be adjustable. For example, it may be adjustable how deeply the forming device 102C is inserted or screwed into the shaping tool 102 or mold 102A, 102B.

[0331] Preferably, the forming device 102C is adjustable or displaceable to determine / change the position of the predetermined breaking zone 9 within the administration channel 7, for example to move this position closer to or away from the axial end 7A.

[0332] Figure 20 shows in enlarged detail an example of generating a predetermined fracture zone 9 having a reduced thickness T and / or according to the second embodiment shown in Figure 12, and / or using a negative mold 102A and a positive mold 102B having non-corresponding surfaces 102D, 102E, in particular using a forming device 102C provided / formed only within the negative mold 102A or on surface 102D.

[0333] The plastic sheet 200 is preferably crushed or compressed between the mold 102A and the mold 102B, particularly in the area of ​​the forming device 102C, and / or between the forming device 102C or the ridge 102F formed thereby and the face 102E of the other mold 102B on the (directly) opposite side of the forming device 102C.

[0334] Due to the crushing / compression and / or differently shaped surfaces 102D, 102E and / or forming device 102C, the thickness T of plastic sheet 200 is preferably reduced in the area of ​​forming device 102C. Preferably, in this way, a predetermined breaking zone 9 is created.

[0335] The forming devices 102C or ridges 102F preferably penetrate the plastic sheet 200.

[0336] Preferably, only the (outermost) layers of the plastic sheet 200, in particular the outer thermoformable layer 201, and more preferably also the cyclic olefin copolymer layer 202 and optionally also the inner thermoformable layer 203, are affected, penetrated and / or crushed / compressed by the forming device 102C or during thermoforming.

[0337] Preferably, the innermost layers, in particular at least the barrier layer 204 and the sealing layer 205, remain intact or are at least essentially unaffected, pierced or crushed / compressed by the forming device 102C or in the forming step. Thus, preferably, the sealing and barrier qualities of the plastic sheet 200 or bottom part 3 are not compromised by or at the predetermined breaking zone 9.

[0338] The height of the forming device 102C or the protuberance 102F is preferably less than the thickness of the plastic sheet 200, and particularly preferably less than the thickness of the cyclic olefin copolymer layer 202, or less than the combined thickness of the outer thermoformable layer 201 and the cyclic olefin copolymer layer 202, and optionally less than the combined thickness of the outer thermoformable layer 201 and the inner thermoformable layer 203.

[0339] Particularly preferably, the height of the forming device 102C or the ridge 102F corresponds to the (desired) depth D of the groove 15 to be produced.

[0340] The height of the forming device 102C or the ridge 102F is preferably at least 0.05 mm or more and / or at most 0.5 mm or less, with particularly preferred values ​​being 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm.

[0341] In yet another embodiment (such as that shown in Figures 21 and 22), as described above, the molds 102A, 102B may have corresponding surfaces 102D, 102E in the areas where the predetermined fracture zones 9 are or should be formed. In this case, the forming device 102C preferably consists of a protrusion or ridge 102F on one mold and a corresponding groove or recess 102G on the other mold.

[0342] In this case, the plastic sheet 200, in particular all of its layers, are pushed, bent or twisted inwards during (thermo)forming, in particular, for example, by the ridges 102F of the mold 102A into the recesses 102G of the mold 102B or vice versa, as shown in Figure 22. In this way, predetermined breaking zones 9 are formed, preferably with grooves 15 and corresponding protrusions 17.

[0343] In this embodiment, the plastic sheet 200 is preferably at least essentially uncrushed / compressed, and in particular at least essentially uncrushed / compressed on any of the outer layers as well.

[0344] Preferably, all layers of the plastic sheet 200 are affected by being bent / twisted inwards. However, the integrity of the inner layers, in particular at least the barrier layer 204 and the sealing layer 205, is preferably maintained. Thus, again, the sealing and barrier qualities of the plastic sheet 200 or the bottom part 3 are preferably not compromised by the predetermined breaking zone 9.

[0345] It is possible to have corresponding surfaces 102D, 102E only in certain areas and / or to bend / twist the plastic sheet 200 inward only in certain areas or crush / compress in other areas. For example, the plastic sheet 200 can be bent / twisted in areas where the dosing channel 7 is or is to be formed and crushed / compressed in areas where the rim 8 is or is to be formed, so as to be able to form the dosing packaging 1 or bottom part 3 according to the third embodiment shown in Figures 13 to 16.

[0346] In the following, a fifth embodiment of the dosage packaging 1 is described.

[0347] Figures 23 to 25 illustrate a fifth embodiment of dosage packaging 1 in views corresponding to Figures 9 to 11, respectively. In particular, Figure 23 shows a schematic plan view from the bottom side of dosage packaging 1, Figure 24 shows a schematic cross-section of dosage packaging 1 along line XXIV-XXIV in Figure 23, and Figure 25 illustrates an enlarged detail of the portion labeled XXV in Figure 24. The cross-sections shown in Figures 24 and 25 are along axis A, i.e. along or in the region of dosage channel 7.

[0348] In the fifth embodiment, the grooves 15 are provided on the inner surface 18 and / or the protrusions 17 are provided on the outer surface 16 and / or the bends / kinks point towards the outside of the bottom part 3 .

[0349] Compared to conventional embodiments, the positions of the grooves 15 and the protrusions 17 are preferably swapped and / or the predetermined breaking zones 9 are preferably bent / twisted in the opposite direction.

[0350] In contrast to the first embodiment of Figures 9 to 11, the dosing channel 7 is not reduced in width based on the predetermined rupture zone 9 of the fifth embodiment. Instead, a widening flow passage, in this case an expansion or diffuser 20, is preferably formed at / in or by the predetermined rupture zone 9, or in particular in the cavity 5 or dosing channel 7.

[0351] The height and / or width of the administration channel 7 is preferably enlarged at / within or by the predetermined rupture zone 9 by at least 0.05 mm or more and / or by a maximum of 0.5 mm or less, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm.

[0352] Preferably, the dosing channel 7 is widened or its (flow) cross section is enlarged by grooves 15 or a diffuser 20 is formed. In particular, the grooves 15 are formed on the inner surface 18, i.e. the surface 18 is recessed in the region of the predetermined rupture zone 9, whereby the channel is widened and / or its (flow) cross section is enlarged.

[0353] When the dosage packaging 1 is opened, particularly by folding / bending along a predetermined breaking zone 9 or groove 15, a widening channel, in the case of an expansion portion, or diffuser 20 is preferably formed or positioned at the open end 7B, particularly at the location where the pharmaceutical product 2 flows out of the dosage packaging 1.

[0354] The widening of the channel at the open end 7B allows for easier outflow of the pharmaceutical product 2, which may be advantageous for more viscous fluids, for example.

[0355] The preferred shapes, dimensions and / or other features of the predetermined breaking zones 9, in particular the grooves 15 and / or protrusions 17, described above with respect to the other embodiments also preferably apply correspondingly or correspondingly to the fifth embodiment.

[0356] It is clear that in some of the descriptions and definitions of the previous embodiments, the term "external surface 16" needs to be replaced by "internal surface 18" and vice versa to apply to the fifth embodiment. For example, in the fifth embodiment, the depth D is preferably the distance from the main extension plane of the internal surface 18 to the lowest region of the groove 15, measured in particular perpendicular to this main plane, and / or the angle W is preferably the smaller angle between the main extension plane of the internal surface 18 and the main extension plane of the chamfered or beveled surface of the groove 15, in particular at the predetermined breaking zone 9 or edge of the groove 15, i.e., the edge where the internal surface 18 bends outward and / or starts to become a groove / recess.

[0357] Particularly preferably, the remarks and preferred values ​​regarding the grooves 15 and / or protrusions 17, in particular regarding the thickness T, depth D and / or angle W, also preferably apply correspondingly or correspondingly to the fifth embodiment. Figure 25 exemplarily shows an angle W of approximately 40° (opening angle of approximately 100°).

[0358] In the fifth embodiment, the predetermined breaking zone 9, in particular the groove 15 and / or the protrusion 17, preferably extends only over the cavity 5, in particular the dosing channel 7, as in the first embodiment.

[0359] Particularly preferably, the predetermined breaking zone 9 extends across the cavity 5 or administration channel 7 or over its entire width, in particular transversely or perpendicularly to the axis A / channel 7 .

[0360] However, it is also possible that the predetermined breaking zone 9 extends only partially across the cavity 5 or dosing channel 7 or its width. For example, the predetermined breaking zone 9 can be (already) absent in the region close to the edge 3A and / or where the cavity 5 or dosing channel 7 transitions into the rim 8.

[0361] The above explanations and features regarding the total or partial extension of the predetermined breaking zone 9 preferably also apply to the above-mentioned embodiments, for example the first embodiment in which the predetermined breaking zone 9 does not extend across the rim 8.

[0362] 23 to 25 show a predetermined breaking zone 9 that extends only over the cavity 5 / dosing channel 7, it is also possible for the predetermined breaking zone 9 to extend beyond the cavity 5 / dosing channel 7, in particular also over the entire width of the rim 8 and / or the dosing packaging 1 or bottom part 3. As explained with respect to the previous embodiments, in this case both the groove 15 and the protrusion 17 can extend beyond the cavity 5 / dosing channel 7 (as in the fourth embodiment), or only one of the groove 15 or the protrusion 17 extends beyond the cavity 5 / dosing channel 7 (as in the third embodiment).

[0363] Furthermore, although the fifth embodiment according to Figures 23 to 25 shows a predetermined breaking zone 9 embodied as a bend / twist and / or having both a groove 15 and a protrusion 17, it is also possible to provide only a groove 15 on the inner surface 18 and no protrusion, in particular as in the second embodiment.

[0364] Consequently, any combination of the different embodiments is possible, in particular the fifth embodiment can be combined with any of the previous embodiments.

[0365] The forming tool 102, in particular the forming device 102C, is preferably configured / shaped according to the fifth embodiment, i.e. for the purpose of forming a bottom part 3 having a groove 15 on the inner surface 18 and / or a protrusion 17 on the outer surface 16, in particular a predetermined breaking zone 9.

[0366] In particular, the negative mold 102A includes recesses 102G and / or the positive mold 102B includes ridges 102F. Figure 27 exemplarily shows the negative mold 102A with corresponding recesses 102G.

[0367] 21 and 22, the positions of the ridges 102F and recesses 102G are preferably swapped to form / create the predetermined fracture zones 9 of the fifth embodiment. Otherwise, the above descriptions and features preferably apply accordingly or correspondingly, even if not repeated.

[0368] Similarly, it is also possible to provide only the positive mold 102B with ridges 102F and the negative mold 102A with no ridges or recesses, particularly complementary to the forming device 102C shown in Figures 19 and 20, in order to form predetermined breaking zones 9 with grooves 15 on the inner surface 18 and with reduced wall thickness and / or without protrusions 17. Otherwise, the above descriptions and features preferably apply accordingly or correspondingly, without being repeated.

[0369] If the forming device 102C is designed as an insert and / or interchangeable component in the respective molds 102A, 102B, it is possible to interchange these inserts, i.e., to provide an insert from the negative mold 102A in the positive mold 102B and vice versa, thereby adapting the forming device 102 to generate the predetermined fracture zone 9 of the fifth embodiment.

[0370] Figures 26 and 27 show, in schematic perspective views, exemplary preferred embodiments of the negative mold 102A of the molding tool 102. In this case, Figure 26 shows the negative mold 102A having ridges 102F to form the predetermined break zones 9, and Figure 27 shows the negative mold 102A having recesses 102G to form the predetermined break zones 9.

[0371] The above descriptions and features, particularly with respect to Figures 19 to 22, preferably apply correspondingly or correspondingly to the mold of Figures 26 and 27 without being repeated. Similarly, the following descriptions also preferably apply to the mold described above with respect to Figures 19 to 22.

[0372] Preferably, the negative mould 102A of FIG. 26 can be used to produce the dosage packaging 1 or the bottom part 3 according to the first embodiment and / or having the grooves 15 on the outer surface 16.

[0373] Preferably, the negative mould 102A of FIG. 27 can be used to produce dosage packaging 1 or bottom part 3 according to the fifth embodiment and / or having grooves 15 on the inner surface 18.

[0374] In order to produce a dosing packaging 1 or a bottom part 3 which also has a predetermined breaking zone 9 in the rim 8, the forming device 102C, in particular the ridge 102F or the recess 102G, preferably extends beyond the area for forming the cavity 5, in particular the dosing channel 7, and / or beyond the concave surface 102D. The following comments and features also preferably apply to such a mould 102A.

[0375] 26 and 27, the (negative) mold 102A preferably includes a plurality of (air) vents or holes 102H. The (also) corresponding positive mold 102B preferably includes a plurality of (air) vents or holes (not shown).

[0376] The vent holes 102H are preferably distributed over the entire faces 102D, 102E of the molds 102A, 102B, in particular evenly and / or along and / or mirror-symmetrically with respect to the axis A.

[0377] In plan or cross-sectional view, the vent 102H is preferably at least essentially circular, elliptical, or oval.

[0378] Preferably, the vent 102H extends through the molds 102A, 102B.

[0379] The vent holes 102H are preferably provided to allow air to escape from the moulds 102A, 102B when the bottom part 3 is thermoformed, in particular deep drawn.

[0380] In particular, when the plastic sheet 200 is forced into and / or pressed onto the molds 102A, 102B by negative and / or positive pressure, air between the plastic sheet 200 and the respective molds 102A, 102B escapes to the surrounding environment through the vent holes 102H. In this manner, the plastic sheet 200 can preferably lie flat against the molds 102A, 102B without any obstruction due to air trapped between it and the molds 102A, 102B.

[0381] Particularly preferably, as shown in Figures 26 and 27, one or more ventilation holes 102H, particularly preferably (exactly) three ventilation holes 102H, are positioned, arranged or formed in / at the forming device 102C, in particular in the ridges 102F and / or recesses 102G (as well).

[0382] Preferably, the ventilation holes 102H in / on the forming device 102C ensure that the plastic sheet 200 lies (snugly) against the forming device 102C and / or that the predetermined breaking zones 9 are created / formed in the desired shape.

[0383] The vent holes 102H, or at least the vent holes 102H in / on the forming device 102C, preferably have a diameter of at least 0.2 mm or 0.3 mm, in particular at least 0.4 mm or 0.5 mm, and / or at most 1.0 mm or 0.9 mm, in particular at most 0.8 mm or 0.7 mm. Particularly preferred diameters are 0.5 mm, 0.6 mm, or 0.7 mm.

[0384] In particular, the ratio of the diameter of one vent hole 102H positioned in the forming device 102C to the width of the dispensing channel 7 therein is preferably greater than 1:7 and / or less than 1:3. Particularly preferably, this ratio is about 1:6, 1:5 or 1:4.

[0385] Preferably, the diameter of the vent hole 102H located in the forming device 102C is greater than or approximately the same as the height of the forming device 102H.

[0386] The diameter of the vent hole 102H positioned in the forming device 102C is preferably smaller than the extension of the forming device 102C in the direction of the axis A or in the longitudinal extension of the administration channel 7.

[0387] Preferably, all of the vent holes 102H in the molds 102A and / or 102B have the same shape and / or size. However, it is also possible to provide vent holes 102H with different diameters. For example, the vent holes 102H on / in the forming device 102C may be smaller or larger than the vent holes 102H formed on the outside of the forming device 102C.

[0388] The location of the vent hole 102H may be visible on the finished dosage packaging 1 or on the bottom part 3. In particular, the bottom part 3 may have a deformation 21, such as a mark, bulge, bump, or inscription, at a corresponding location along the axis A. This is particularly true for the preferred plastic sheet 200 described with reference to Figures 5 and 7.

[0389] Particularly preferably, the dosage packaging 1 or the bottom part 3 has one or more deformations 21, such as marks, bulges, bumps or impressions, from or generated by the ventilation holes 102H (also) in the predetermined breaking zone 9. By way of example, Figure 25 shows deformations 21 in the predetermined breaking zone 9 in dashed lines.

[0390] The deformations 21 preferably have a diameter and / or shape that is similar (in plan view) to the diameter and / or shape of the respective vent hole 102H.

[0391] In particular, one or more deformations 21 in the predetermined fracture zone 9 can enhance the fracture behavior, in particular the frangibility.

[0392] Individual aspects, features, and method steps may be performed independently of one another, or may be performed in any desired combination or order.

[0393] List of Reference Numbers 1. Dosage Packaging 1A 1 shaft end 2. Pharmaceutical products 3 Bottom parts 3A Edge 4 Cover 5 Cavity 6 Chambers 7 Dosing Channels 7A 7 shaft end 7B Open end 8 rims 9 Predefined Break Zone 10 Tip 11 Second Package 12 Base part 13 Lid 14 Receptacle 15 groove 16 Exterior 17 Protrusion 18 Inner 19 Nozzle / Cross-Section Reducer 20 Diffuser / cross-sectional expansion section 21 Transformation 100 devices 101 Heating Device 101A Upper Heating Plate 101B Lower heating plate 102 molding tools 102A Negative mold 102B Positive Mold 102C Forming Device 102D (concave) surface 102E (convex) surface 102F Elevation 102G recess 102H Ventilation hole 103 Filling Device 104 Cover Device 200 plastic sheets 201 Outer thermoformable layer 202 Cyclic olefin copolymer layer 203 Inner thermoformable layer 204 Barrier Layer 205 Sealing layer 206 Middle Class 207 Connecting layer 208 Adhesive layer 300 cover sheets 301 Protective layer 302 First Barrier Layer 303 Middle Class 304 Second Barrier Layer 305 Sealing layer 306 Connecting layer 307 Adhesive layer A axis D Depth T Thickness W angle

Claims

1. - at least partially heating the preferably multi-layer plastic sheet (200), in particular to the thermoforming temperature; - forming a bottom part (3) of the dosage packaging (1) by stretching said plastic sheet (200) onto and / or into a forming tool (102), said bottom part (3) having a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) surrounding said cavity (5); - filling said cavity (5) with a pharmaceutical product (2); - covering said cavity (5) with a cover (4) and fastening said cover (4) to said rim (8) so that said cavity (5) is completely closed; 1. A method for producing and filling dosage packaging (1) for a preferably liquid pharmaceutical product (2), comprising: a predetermined breaking zone (9) is created in and / or during the step of forming the bottom part (3) using the forming tool (102); A method characterized by:

2. 2. The method according to claim 1, wherein the predetermined breaking zone (9) is generated in the bottom part (3) only or essentially with the forming tool (102) and / or only or essentially during the step of forming the bottom part (3).

3. 3. A method according to claim 1 or 2, characterized in that the predetermined breaking zone (9) is created without cutting and / or without using a cutting tool.

4. 4. The method according to claim 1, wherein the cavity (5) comprises a chamber (6) and a dosing channel (7) in fluid communication with the chamber (6), preferably the dosing channel (7) being elongated and / or straight and / or having a smaller diameter and / or volume than the chamber (6).

5. 5. The method according to any one of claims 1 to 4, characterized in that the predetermined breaking zone (9) is or comprises a groove (15) on the outer surface (16) of the dosage packaging (1).

6. 5. The method according to any one of claims 1 to 4, characterized in that the predetermined breaking zone (9) is or comprises a groove (15) on an inner surface (18) of the dosage packaging (1).

7. 7. A method according to claim 5 or 6, characterized in that the predetermined breaking zone (9) comprises a protrusion (17) opposite the groove (15).

8. 8. A method according to any one of claims 1 to 7, characterized in that the predetermined breaking zone (9) is an area that is thinner than the area of ​​the bottom part (3) surrounding the breaking zone (9).

9. 8. The method according to claim 1, wherein the predetermined breaking zone (9) is a region that preferably has at least essentially the same thickness as the region of the bottom part (3) surrounding the breaking zone (9).

10. 10. Method according to any one of the preceding claims, characterized in that the predetermined breaking zone (9) is formed as a kink in the wall of the bottom part (3).

11. 11. The method according to any one of claims 1 to 10, characterized in that a forming tool (102) having a negative mould (102A) and a positive mould (102B) is used to form the bottom part (3).

12. 12. The method according to any one of claims 1 to 11, characterized in that the predetermined rupture zone (9) is formed only in the region of the cavity (5), in particular in the dosing channel (7) of the cavity (5).

13. 13. The method according to any one of claims 1 to 12, characterized in that different dosage packagings (1) are formed having predetermined breaking zones (9) with different shapes, and a forming device (102C) for forming the predetermined breaking zones (9) is exchanged and / or adjusted to form the different dosage packagings (1).

14. The method is performed using an apparatus (100) according to any one of claims 15 to 24, and / or The dosage packaging (1) according to any one of claims 25 to 33 is manufactured, 14. The method according to any one of claims 1 to 13.

15. the apparatus (100) preferably has a heating device (101) for at least partially heating the multi-layer plastic sheet (200) to a thermoforming temperature, the device comprises a forming tool (102) for forming a bottom part (3) of a dosage packaging (1) by stretching said plastic sheet (200) onto and / or into said forming tool (102), said bottom part (3) having a cavity (5) for receiving a pharmaceutical product (2) and a rim (8) surrounding said cavity (5), An apparatus (100) for producing dosage packaging (1) for a preferably liquid pharmaceutical product (2), comprising: The forming tool (102) has a forming device (102C) for forming a predetermined breaking zone (9) in the bottom part (3), 1. An apparatus (100) comprising:

16. 16. Apparatus (100) according to claim 15, configured to generate the predetermined breaking zone (9) in the bottom part (3) solely or essentially with the forming tool (102).

17. 17. The device (100) according to claim 15 or 16, characterized in that it is configured to create the predetermined breaking zone (9) in the bottom part (3) without cutting and / or without using a cutting tool.

18. 18. The apparatus (100) of any one of claims 15 to 17, characterized in that the forming device (102C) forms protuberances (102F) and / or depressions (102G) on the surfaces (102D, 102E) of the molds (102A, 102B) of the forming tool (102).

19. 19. Apparatus (100) according to any one of claims 15 to 18, characterized in that the forming device (102C) is an adjustable and / or replaceable component of the forming tool (102).

20. 20. The apparatus (100) of any one of claims 15 to 19, wherein the forming tool (102) comprises a negative mold (102A) and a positive mold (102B).

21. 21. The apparatus (100) according to claim 20, characterized in that the negative mold (102A) and the positive mold (102B) have differently shaped surfaces (102D, 102E) in particular such that the apparatus (100) is configured to generate a predetermined breaking zone (9) that is thinner than the area of ​​the bottom part (3) surrounding the predetermined breaking zone (9).

22. 21. The apparatus (100) according to claim 20, wherein the negative mold (102A) and the positive mold (102B) have complementarily shaped surfaces (102D, 102E) such that the apparatus (100) is configured to generate a kink in the wall of the bottom part (3) as a predetermined breaking zone (9).

23. 23. The apparatus (100) of any one of claims 15 to 22, wherein one or more vent holes (102H) of the forming tool (102) are arranged in or formed in the forming device (102C).

24. An apparatus (100) according to any one of claims 15 to 23, characterized in that it is configured to carry out a method according to any one of claims 1 to 14 and / or to produce a dosage packaging (1) according to any one of claims 25 to 33.

25. The dosage packaging (1) has a base part (3) with a cavity (5) for receiving the pharmaceutical product (2) and preferably with a rim (8) surrounding said cavity (5), The dosage packaging (1) has a cover (4) that covers and completely closes said cavity (5), the dosage packaging (1), in particular said bottom part (3), has a predetermined breaking zone (9) for opening the dosage packaging (1) by breaking said breaking zone (9); Dosage packaging (1) for a preferably liquid pharmaceutical product (2), comprising: said predetermined breaking zone (9) is produced by thermoforming; and / or a cross-sectional reduction or nozzle (19) of the dosing channel (7) of said cavity (5) is formed in said predetermined breaking zone (9), and / or the predetermined breaking zone (9) extends only over the cavity (5), in particular over the dosing channel (7) of the cavity (5), and / or the predetermined breaking zone (9) is formed as a kink in the wall of the bottom part (3), and / or the wall thickness (T) of the bottom part (3) is at least essentially constant in the area including and surrounding the predetermined breaking zone (9); 1. A dosage packaging (1) comprising:

26. Dosage packaging (1) according to claim 25, characterized in that the predetermined breaking zone (9) is produced solely or essentially by thermoforming.

27. Dosage packaging (1) according to claim 25 or 26, characterized in that the predetermined breaking zone (9) is created without cutting and / or without the use of a cutting tool.

28. 28. Dosage packaging (1) according to any one of claims 25 to 27, characterized in that the predetermined breaking zone (9) has a protrusion (17) on the outer surface (16) of the dosage packaging (1), in particular the bottom part (3), and a groove (15) on the inner surface (18) of the bottom part (3).

29. 28. Dosage packaging (1) according to any one of claims 25 to 27, characterized in that the predetermined breaking zone (9) has a groove (15) on the outer surface (16) of the dosage packaging (1), in particular the bottom part (3), and a protrusion (17) on the inner surface (18) of the bottom part (3).

30. said groove (15) extending across said cavity (5), in particular across said dosing channel (7) and said rim (8); the protrusion (17) extends over the cavity (5) alone or over the cavity (5) and the rim (8); 30. Dosage packaging (1) according to claim 28 or claim 29.

31. 31. The dosage packaging (1) according to any one of claims 25 to 30, characterized in that the cavity (5) comprises a chamber (6) and a dosage channel (7) in fluid communication with the chamber (6), preferably the dosage channel (7) being elongated and / or straight and / or having a smaller diameter and / or volume than the chamber (6).

32. 32. The dosage packaging (1) according to any one of claims 25 to 31, characterized in that the bottom part (9) comprises deformations (21) from the ventilation holes (102H) of the forming tool (102), in particular one or more deformations (21) at the predetermined breaking zone (9).

33. Dosage packaging (1) according to any one of claims 25 to 32, characterized in that it is manufactured using a method according to any one of claims 1 to 14 and / or a device (100) according to any one of claims 15 to 24.

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