Application package, production device and production method

Abstract

The invention relates to an administration package (1A, 1) for a pharmaceutical product (2) and to a device and to a method for producing and filling such an administration package (1A, 1). A predetermined breaking zone (10, 9) is produced by thermoforming for opening the application package (1A, 1) by breaking the breaking zone (10, 9). For this purpose, the device comprises a moulding tool (102A, 102) having a moulding device for forming the predetermined fracture zone (10, 9). Alternatively or in addition, the predetermined breaking zone (10, 9) may form a reduced cross-section or nozzle (19) of the application channel (7A, 7) of the application package (1A, 1).

Description

Technical Field

[0001] The invention relates to an administration package for preferably liquid pharmaceutical products and to a method for producing and filling an administration package and to an apparatus for producing an administration package.

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

[0003] The administration package is in particular a package for a liquid pharmaceutical product, which contains the product or stores the product therein and can also be used to administer the product to a patient. The package is in particular a pipette or can be used as or transformed into a pipette.

[0004] The pharmaceutical preparation is preferably a liquid and / or a preparation to be applied to the skin and / or fur of a patient, preferably a domestic animal such as a cat or dog. Background Art

[0005] EP 2 998 098 A1 and EP 2 998 099 A1 relate to a method for producing and filling an application package for a liquid pharmaceutical product. The package is produced by a thermoforming process, wherein a deep-drawn film is heated in order to plasticize the film at least in a subregion, the plasticized region is deep-drawn into a molding tool to form a cavity for the product and a sleeve-like application channel leading to the cavity, the product is introduced into the cavity, and the filled deep-drawn film is covered with a covering film in order to close the cavity and the application channel. In an end region, the application channel has a slit or groove forming a predetermined breaking zone, at which the tip of the application channel can be broken in order to open the application package. The predetermined breaking zone is produced before the deep-drawn film is heated. The deep-drawn film is a laminated composite film having a layer of polypropylene (PP) and a layer of acrylonitrile-methacrylate copolymer (AMAB), and the slit or groove is 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 disadvantages.

[0007] Firstly, besides the thermoforming step for forming the cavities and the application channels, the creation of the recesses also requires an additional step.

[0008] Furthermore, the method of producing a predetermined breaking zone by cutting through the PP layer does not work when the film has a composition different from that described and / or the set-up of a system for cutting is more complex.

[0009] EP 2 432 701 B1 relates to a non-resealable thermoformed package for liquid or pasty substances. The package comprises a rigid shell forming a storage space for containing the substance, a breaking area and a clamping area. The package can be opened by tearing off an upper part of the clamping area in the breaking area. The clamping area contains an escape path for the substance, which escape path closes naturally when the user does not apply pressure, so that the substance is prevented from being discharged after opening the package. The breaking area can be weakened by a breaking line made using a pre-cutting tool (such as a blade, a laser system or a high-pressure water jet).

[0010] US2015 / 151891 A1 is about a package for containing a fluid product, the package having a monolithic body including a breakaway cap. The package comprises a first laminated sheet and a second laminated sheet that are thermoformed together to form the monolithic body. Initially, the monolithic body comprises a breakaway cap that seals a nozzle portion for dispensing the fluid product. A user can separate the breakaway cap from the monolithic body by tearing or cutting at a pre-weakened area. The pre-weakened area is a perforation or score line formed into the monolithic body.

[0011] EP 1 263 389 B1 relates to a container for liquid or pasty substances. The container has two separate half-doses placed in two respective half-containers. The top of the container presents two different pre-cut lines, one relating to the necks of the two half-containers and one relating to the neck of the only half-container. The container can be opened along either of the pre-cut lines, thereby allowing selective opening of one or both half-containers and thus administration of a whole dose or half-dose of the product. The container can be produced by thermoforming to leave a channel open for filling, through which the product is filled and then the filling channel is welded and closed.

[0012] US 5,215,221 A relates to a disposable unit dose dispenser for powdered medicaments. The dispenser has a gas chamber and a product reservoir adjacent to each other and separated by a rupturable seal. The chamber of the dispenser is formed by a heated thermoplastic sheet. If a break tip is required, the sheet is pre-graded before thermoforming. Next, the product reservoir is filled with the powdered product and a backing plate is then heat-sealed to the thermoformed blister and at the rupture site between the gas chamber and the product reservoir. To use the dispenser, its tip is removed along a break line that is part of the score line. Next, pressure is applied to the gas chamber by squeezing the dispenser to cause the seal to rupture and a gas jet to be discharged into the product reservoir to fluidize the powdered product and dispense the powdered product.

[0013] The packaging and methods disclosed in the further prior art documents have similar disadvantages. In particular, the breaking area is formed by perforation, scoring or cutting, which requires an additional step in the manufacture and / or is not suitable for certain plastic materials or is more complicated to arrange for certain plastic materials. Summary of the invention

[0014] An object of the present invention is therefore to provide a solution in which the production of an application package is made faster, more efficient and / or simpler and / or which allows the application package to be opened reliably, preferably almost independently of the packaging material.

[0015] The above problems are solved by a method according to claim 1, an apparatus according to claim 15 or an application package according to claim 25. Advantageous further developments are the object of the subsidiary claims.

[0016] Therefore, in particular, the present invention relates to a method for producing and filling an application package, an apparatus for producing an application package and an application package. The method described herein is preferably carried out with an apparatus described herein, and the application package described herein is preferably produced with the method described herein.

[0017] According to a first aspect, the invention relates to a method for producing and filling an administration package for a preferably liquid pharmaceutical product. The method is preferably a thermoforming method.

[0018] According to the method, a plastic sheet, preferably a plurality of layers, is at least partially heated to a thermoforming temperature. In particular, the thermoforming temperature is a temperature at which the plastic sheet or its heated region is plasticized and / or at which it becomes possible to form the plastic sheet or its heated region into a desired shape with a molding tool.

[0019] Next, the plastic sheet is stretched onto and / or into a molding tool so as to form a bottom portion of the administration package. Specifically, a bottom portion having a cavity for receiving the pharmaceutical product and a rim surrounding the cavity is formed. The rim is preferably at least substantially flat.

[0020] In a next step, the cavity is filled with the pharmaceutical product and thereafter covered with a cover and the cover is fixed to the rim so that the cavity is completely closed.

[0021] According to the invention, a predetermined breaking zone is produced in the bottom part (in particular only or substantially) using a moulding tool and / or during the step of forming the bottom part. This has the advantages that no additional steps for forming the predetermined breaking zone are required, the breaking zone can be formed to have any desired shape and the breaking zone can be tailored or adapted specifically to different plastic materials.

[0022] In particular, the predetermined breaking zone is produced before or after the step of forming the bottom portion and / or without cutting and / or without using a cutting tool without using a cutting step. "Without cutting" preferably means that no cutting is performed to form the predetermined breaking zone. Thus, the proposed method advantageously provides a simpler manufacturing method that can be used with different plastic materials.

[0023] In the sense of the present invention, a perforation, scoring or similar operation is preferably also understood as "cut or cuts". Therefore, the term "no cutting" preferably also includes expressions such as "no perforation" or similar or can be replaced or supplemented by expressions such as "no perforation" or similar. Similarly, a cutting step / tool ​​can also be a perforation step / tool, etc.

[0024] The cavity preferably comprises a chamber and an application channel that is in fluid communication with the chamber and / or leads to the chamber. The application channel is preferably elongated and / or straight and / or has a diameter and / or volume that is smaller than the chamber. Therefore, the application package can be used as and / or converted into a pipette so that the pharmaceutical product can be directly applied to a patient from the package.

[0025] The predetermined breaking zone is preferably configured to be able to open the application package by breaking the package along the breaking zone.For example, the application package can be folded or bent along the predetermined breaking zone so that the packaging material is cut and the package is thus opened.

[0026] The predetermined breaking zone is preferably formed as or comprises a groove on an outer surface or an inner surface of the application package. This is easy to produce and can simply and reliably open the application package and / or break the predetermined breaking zone.

[0027] Preferably, the predetermined breaking zone comprises a protrusion opposite the groove.Thus, the predetermined breaking zone preferably forms or comprises a groove on an outer surface and a protrusion on the (opposite) inner surface, or vice versa.

[0028] Particularly preferably, the predetermined breaking zone is formed as or comprises a bend or a kink or a fold in (the wall of) the bottom portion. In particular, the groove and the protrusion are formed by the bend / kink / fold.

[0029] Forming the predetermined breaking zone as a bend / knot / fold and / or also having a projection in addition to a groove preferably allows simple production of the predetermined breaking zone and / or reliable opening of the application package.

[0030] Preferably, the predetermined breaking zone is a region which preferably at least substantially has the same thickness as a region of the bottom portion surrounding the breaking zone. In other words, the wall thickness of the bottom portion is preferably at least substantially constant at the predetermined breaking zone and the region surrounding it. This has the advantage that the integrity of the plastic material and / or the sealing and barrier qualities can be maintained. In particular, the material is not squeezed significantly more in the predetermined breaking zone than outside the predetermined breaking zone.

[0031] However, if desired, for example depending on the plastic material, the predetermined breaking zone may also be a region thinner than a region of the bottom portion surrounding the breaking zone. This may be advantageous for easy breaking, for example, when using a less brittle plastic material.

[0032] Preferably, the moulding tool has a male mould and a female mould and / or a male mould and a female mould are used to form the bottom part. This allows very precise control of the shape of the bottom part and / or results in small manufacturing tolerances.

[0033] A predetermined breaking zone can be formed only in the region of the cavity, in particular in the region of an application channel of the cavity. In other words, the predetermined breaking zone then does not extend over the region of the rim and / or is not formed in the region of the rim. Alternatively, the predetermined breaking zone is formed on both the cavity / application channel and the rim or extends over both.

[0034] Preferably, different application packages are formed with predetermined breaking zones with different shapes, wherein a forming device for forming the predetermined breaking zones is replaced and / or adjusted for forming the different application packages. This allows the production of different application packages in a very efficient manner.

[0035] According to a further aspect which can also be realized independently, the invention relates to an apparatus for producing an administration package for a preferably liquid pharmaceutical product. The apparatus is preferably configured for carrying out the method described herein and / or for producing the administration package described herein.

[0036] The apparatus has a heating device for at least partially heating a preferably multilayer plastic sheet to a thermoforming temperature and a molding tool for forming a bottom portion of the application package by stretching the plastic sheet onto and / or into the molding tool.

[0037] The molding tool preferably has a forming device for forming a predetermined breaking zone in the bottom part. The forming device preferably forms a projection and / or a recess on a surface of a mold of the molding tool. By this, the predetermined breaking zone can be formed as a groove and / or a bend / knot. A predetermined breaking zone can be achieved which has a thickness at least substantially the same as or lower than the material surrounding the predetermined breaking zone.

[0038] The forming device is preferably an adjustable and / or replaceable component of the molding tool. By means of this, the desired shape of the predetermined breaking zone can be easily controlled and / or adapted. This allows easy and / or efficient production of different application packages, in particular application packages with different predetermined breaking zones.

[0039] The molding tool preferably has a male mold and a female mold. This allows the shape of the bottom portion to be formed to be precisely controlled and / or results in very small manufacturing tolerances.

[0040] Preferably, the female and male molds have surfaces of complementary or corresponding shape, preferably at least in the area where the predetermined breaking zone is to be formed. In this way, preferably a bend / kink can be produced in the wall of the bottom part as the predetermined breaking zone, in particular with respect to the wall having in the predetermined breaking zone at least substantially the same thickness as its exterior.

[0041] Particularly preferably, the female tool has a projection and the male tool has a complementary / corresponding recess for forming the predetermined breaking zone, or vice versa.

[0042] Alternatively, the male and female molds may have surfaces of different or non-corresponding shapes, in particular so that the apparatus is configured to produce a predetermined fracture zone that is thinner than the area surrounding the predetermined fracture zone. For example, the female mold may include a convex portion, while the male mold is flat in the corresponding area, or vice versa.

[0043] The molding tool, in particular the female and / or male mold, preferably comprises ventilation holes or vents for letting air escape during thermoforming. Particularly preferably, the molding tool, in particular the female and / or male mold, (also) comprises one or more ventilation holes, in particular protrusions and / or recesses, in / at the molding device.

[0044] According to a further aspect, which can also be realized independently, the invention relates to an administration package for a preferably liquid pharmaceutical product. The administration package is preferably produced with a method as described herein and / or with an apparatus as described herein.

[0045] This application package has a bottom portion, and this bottom portion has a cavity for receiving a pharmaceutical product and a preferably flat edge around this cavity.In addition, the application package has a cover that covers and completely closes a cavity.

[0046] The cavity preferably comprises a chamber for the drug product and / or an application channel for applying / dispensing the drug product. The application channel is preferably in fluid communication with the chamber.

[0047] Preferably, the application channel is elongated and / or straight and / or has a small diameter, cross-section and / or volume like a chamber.

[0048] The application package, in particular the bottom portion, has a predetermined breaking zone for opening the application package by breaking the predetermined breaking zone.

[0049] The predetermined breaking zone is preferably produced, in particular, only or (at least) substantially by thermoforming. This reduces the number of steps required to produce the application package and thus makes the production faster and / or more efficient. In particular, fewer tools are required to produce the application package.

[0050] In particular, the predetermined fracture zone is produced without cutting and / or without using a cutting tool.

[0051] As an alternative or in addition, the predetermined breaking zone extends only above the cavity, in particular the application channel of the cavity. This preferably enhances the stability of the application package and / or reduces the risk of accidental opening of the application package.

[0052] As an alternative or in addition, in the region of the predetermined breaking zone and / or by means of the predetermined breaking zone, the application channel is narrowed and / or the (flow) cross section of the channel is reduced and / or a nozzle is formed. Advantageously, when dispensing the pharmaceutical product from the application package, the pharmaceutical product can be accelerated by means of the narrowed channel, the cross section reduction and / or the nozzle when exiting the application package.

[0053] Furthermore, even under the influence of gravity, if no additional force is applied (e.g. by a user pressing on the administration package or chamber), the narrowed passage, cross-sectional reduction and / or nozzle preferably prevents the drug product from flowing therethrough. This is advantageous in preventing accidental removal or spillage of the drug product.

[0054] As an alternative or in addition, the predetermined breaking zone is formed as a bend or kink or fold in (the wall of) the bottom part, and / or the thickness of (the wall of) the bottom part is at least substantially constant in the area including and surrounding the predetermined breaking zone. This preferably increases the stability of the application package and / or reduces the risk of accidental opening of the application package.

[0055] The predetermined breaking area is preferably a weakening of the material of the application package or the bottom part. In particular, a user can easily open the application package by breaking or bending / folding the application package along the predetermined breaking area.

[0056] Preferably, the predetermined breaking zone has or is formed by a groove on an outer surface or an inner surface of the application package or the bottom portion. In this way, the predetermined breaking zone is realized in a simple manner.

[0057] The predetermined breaking zone may comprise an inner or outer surface of the application package or the bottom part, in particular a protrusion on the inner surface opposite to the outer surface comprising the recess or on the outer surface opposite to the inner surface comprising the recess.

[0058] Preferably, by means of projections (if provided on the inner surface), narrowing of the channel, cross-section reduction and / or nozzle can be realized in a simple manner.

[0059] The projection preferably enhances the stability of the application package and / or reduces the risk of accidental opening of the application package.In particular, the wall thickness of the bottom portion in the predetermined breaking zone may be constant and / or similar or identical as in the area surrounding the predetermined breaking zone.

[0060] The recess and / or projection can extend only over the cavity, in particular the application channel, or over both the cavity and the rim, ie at least substantially over the entire width of the application package or the bottom part, in particular perpendicularly to the application channel.

[0061] Preferably, the longitudinal extensions of the groove and the projection may differ from each other.

[0062] In particular, the groove may extend over the cavity and the rim, while the projection extends only over the cavity. Advantageously, the rim can be kept free of projections and / or can be kept flat. This facilitates application of the cover to the bottom part (particularly the rim). However, at the same time, the groove may also extend over the rim to form a more easily breakable predetermined breaking zone.

[0063] The application package (particularly the bottom part) can include deformations (such as markings or imprints) from the ventilation holes of a molding tool. In particular, at least one of these deformations can (also) be positioned at the predetermined breaking zone. This can contribute to an improved breaking behavior.

[0064] Several of the above-mentioned and subsequent aspects, characteristic method variants and method steps of the present invention can be combined with one another in various combinations and / or in any sequence, but can also be implemented independently of one another. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] With reference to the drawings, further aspects, features, advantages and characteristics of the present invention will be apparent from the following description of the invention claims and preferred embodiments.

[0066] Figure 1 A schematic perspective view of an application package according to the present invention;

[0067] Figure 2 An opened administration package according to the invention in a schematic perspective view;

[0068] Figure 3 A schematic cross section of an application package through packaging in a secondary packaging;

[0069] Figure 4 A schematic diagram of an apparatus for producing an application package according to the present invention;

[0070] Figure 5 A schematic cross section through the material of a bottom portion of the application package;

[0071] Figure 6 A schematic cross section through the material of a cover applied to the package;

[0072] Figure 7 A schematic cross section of a preferred material through a bottom portion of an applied package;

[0073] Figure 8 A schematic cross section of a preferred material through a cover for application packaging;

[0074] Fig. 9 A schematic plan view of an application package according to a first embodiment;

[0075] Fig.10 Along Fig. 9 A schematic cross section of the application package along line XX;

[0076] Fig.11 An enlarged detail of one of the predetermined breaking zones according to the first embodiment;

[0077] Fig.12 An enlarged detail of one of the predetermined breaking zones according to a second embodiment;

[0078] Fig.13 A schematic plan view of an application package according to a third embodiment;

[0079] Fig.14 Along Fig.13 A schematic cross section of the application package along line XIV-XIV;

[0080] Fig.15 An enlarged detail of a predetermined breaking zone in the region of an application channel according to a third embodiment;

[0081] Fig.16 An enlarged detail of a predetermined breaking zone in the region of an edge according to a third embodiment;

[0082] Fig.17 An enlarged detail of a predetermined breaking zone in the region of an application channel according to a fourth embodiment;

[0083] Fig.18 An enlarged detail of a predetermined breaking zone in the region of an edge according to a fourth embodiment;

[0084] Fig.19 By following Figure 4 A schematic cross-section of a molding tool of an apparatus;

[0085] Fig. 20 In the region of a forming device of a molding tool for forming a predetermined breaking zone Fig.19 A schematic cross-sectional detail of a molding tool;

[0086] Fig.21 A schematic cross section through a molding tool of an apparatus according to another embodiment;

[0087] Fig. 22 In the region of a forming device of a molding tool for forming a predetermined breaking zone Fig.21 A schematic cross-sectional detail of a molding tool;

[0088] Fig.23 A schematic plan view of an application package according to a fifth embodiment;

[0089] Fig.24 Along Fig.23 A schematic cross-section of the application package along line XXIV-XXIV;

[0090] Fig.25 An enlarged detail of one of the predetermined breaking zones according to the fifth embodiment;

[0091] Fig.26 A schematic perspective view of an embodiment of a mold of a molding tool; and

[0092] Fig. 27 A schematic perspective view of another embodiment of a mold of a molding tool.

[0093] In the drawings, the same reference numerals are used for the same components and parts even if duplicate description is omitted. DETAILED DESCRIPTION

[0094] Figures 1 to 3 An application package 1 according to the invention is shown. Figure 1 It is a schematic perspective view of a closed administration package 1 or in its transport state. Figure 2 In a schematic perspective view, the administration package 1 is shown in the open state and / or during conversion into a pipette. Figure 3 is a schematic section through the application package 1 , also showing a secondary package 11 in which the application package 1 is preferably or optionally transported / sold.

[0095] The administration package 1 is preferably configured to receive a pharmaceutical product 2 and / or to contain or include a pharmaceutical product 2, such as Figure 3 As shown in .

[0096] The pharmaceutical preparation 2 is preferably a liquid. The pharmaceutical preparation 2 is preferably a preparation for treating and / or preventing fleas, ticks and / or chewing lice (particularly in dogs and / or cats). Preferably, the pharmaceutical preparation 2 helps control scabies (particularly in dogs).

[0097] The application package 1 comprises or consists of a base part 3 and a cover 4 .

[0098] 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 an application channel 7.

[0099] The bottom portion 3 has a rim 8 surrounding, in particular completely surrounding, the cavity 5. The rim 8 is preferably at least substantially flat.

[0100] The cover 4 preferably covers, closes and / or seals the bottom part 3 or the cavity 5 (in particular the chamber 6 and the application channel 7) in a fluid-tight, in particular liquid-tight and / or air-tight manner. Preferably, the application package 1, the bottom part 3 or the cavity 5 is closed by means of the cover 4 so that it is storage-stable and / or so that the product 2 cannot escape from the closed application package 1, the bottom part 3 or the cavity 5.

[0101] The cover 4 is preferably fixed or joined, in particular (heat) sealed, to the bottom part 3, in particular the rim 8 or a part of the rim 8.

[0102] Preferably, the cover 4 is fixed or joined to the bottom part 3 or the rim 8 by heat sealing and / or by means of a (thermo) annular seal which in particular extends along the entire circumference of the rim 8 and / or of the edge 3A between the cavity 5 and the rim 8. In principle, however, other fixing methods are also possible, for example adhesively joining the cover 4 to the bottom part 3.

[0103] Therefore, preferably, the cover 4 is joined or sealed to the bottom part 3 at least in the region of the edge 3A between the cavity 5 and the rim 8 , so as to close / seal the cavity 5 .

[0104] Particularly preferably, the cover 4 is fixed, bonded or sealed to the entire rim 8. However, the bond between the bottom portion 3 and the cover 4 may be less secure outside the region of the rim 3A and / or may decrease from the rim 3A towards the outside of the rim 8.

[0105] The bottom part 3, in particular the cavity 5 and the rim 8, is preferably produced by thermoforming or deep drawing a plastic sheet. In particular, the cavity 5 is produced by deep drawing or thermoforming a respective region of the plastic sheet into and / or onto a molding tool, while after the thermoforming / deep drawing the region of the rim 8 is not deformed during the thermoforming / deep drawing step. This will be explained in more detail later.

[0106] The chamber 6 and the application channel 7 are preferably in fluid communication with each other. In particular, the application channel 7 opens into the chamber 6.

[0107] like Figure 1 , the chamber 6 preferably has a substantially triangular shape. However, this is not mandatory and the chamber 6 may have any desired shape.

[0108] The application channel 7 is preferably elongated and / or straight. Preferably, the application channel 7 has a smaller diameter and / or volume than the chamber 6. Preferably, the application channel 7 extends along a longitudinal axis A of the application package 1. The axis A is preferably a symmetry axis of the application package 1.

[0109] The length of the application channel 7 is preferably greater than 2 cm or 3 cm and / or less than 5 cm or 4 cm.

[0110] The length or longitudinal extension of the application package 1 or of the base part 3 , in particular along the axis A, is preferably greater than 6 cm and / or less than 10 cm, particularly preferably approximately 8.5 cm.

[0111] The width of the rim 8 (in particular perpendicular to the application channel 7 or the axis A and / or adjacent to or on a side of the application channel 7 ) is preferably greater than 2 cm and / or less than 6 cm, particularly preferably about 4 cm.

[0112] The application package 1 can be opened so that the pharmaceutical product 2 contained in the application package 1 or the cavity 5 can be taken out or pushed out of the application package 1 and / or applied to a patient (not shown). The patient is preferably a human or an animal, in particular a domestic animal (such as a cat or a dog). Preferably, the application package 1 is configured for applying the pharmaceutical product 2 directly to the skin and / or fur of a patient.

[0113] Specifically, the administration package 1 can be transformed into a pipette, such as Figure 2 In particular, by opening the application package 1 , the application package 1 is transformed into a pipette.

[0114] The application package 1 , in particular the bottom portion 3 , comprises a predetermined breaking zone 9 . The application package 1 is preferably openable at the predetermined breaking zone 9 and / or by breaking the application package 1 , in particular the bottom portion 3 , along the predetermined breaking zone 9 .

[0115] In particular, the application package 1 can be opened by folding and / or bending along the predetermined breaking zone 9 .

[0116] The predetermined breaking zone 9 is preferably produced by hot forming or deep drawing, in particular at the same time or in the same step as the hot forming or deep drawing of the bottom part 3 and / or using the same molding tool. Figure 4 and Figures 19 to 22Explain this in more detail.

[0117] The predetermined breaking zone 9 preferably passes through the cavity 5 (in particular the application channel 7 ) and / or is arranged in the region of the cavity 5 (in particular the application channel 7 ).

[0118] The break zone 9 may be provided only in the region of the cavity 5 or the application channel 7. In other words, the edge 8 may be at least substantially free of the break zone 9. Figures 9 to 11 This is explained in more detail. Alternatively, the breaking zone 9 can extend at least substantially along (the width of) the entire application package 1 and / or can be provided in the region of the cavity 5 (in particular the application channel 7 and the edge 8), such as for example in Figure 1 and Fig.13 and will be explained in more detail later.

[0119] The predetermined breaking zone 9 preferably extends transversely, in particular perpendicularly, to the axis A and / or the application channel 7 .

[0120] The predetermined breaking zone 9 is preferably arranged close to an axial end of the channel 7 and / or the application package 1. Preferably, the distance between the predetermined breaking zone 9 and the axial end 7A of the application 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 an axial end 1A of the application package 1 is preferably at most 25 mm or less, in particular at most 20 mm or less.

[0121] Preferably, the distance between the predetermined breaking zone 9 and the axial end 7A of the application channel 7 is greater than 15% or 20% and / or less than 40% or 30% of the total length of the application channel 7, particularly preferably about 20%.

[0122] Preferably, the distance between the predetermined breaking zone 9 and the axial end 1A of the application package 1 is greater than 10% or 15% of the total length or longitudinal extension of the application package 1 along the axis A and / or less than 40% or 30% of the total length or longitudinal extension of the application package 1 along the axis A, particularly preferably about 20%.

[0123] The predetermined breaking zone 9 preferably defines a tip 10 of the application package 1 and / or the bottom part 3. In particular, the tip 10 is a part or section of the application package 1 or the bottom part 3 which is opposite the chamber 6 with respect to the predetermined breaking zone 9.

[0124] The tip 10 can preferably be folded or bent, in particular by folding or bending the application package 1 along the predetermined breaking zone 9. In particular, this causes the application package 1 or at least the bottom portion 3 to break, so that the application package 1 can be opened and / or the pharmaceutical product 2 can be removed, dispensed or pushed out through the application channel 7. In particular, in Figure 2 This is shown in .

[0125] Preferably, an open end 7B of the cavity 5, in particular of the application channel 7, is produced by breaking the application package 1, in particular along the predetermined breaking zone 9 and / or by bending / folding the tip 10, such as Figure 2 As shown in .

[0126] By opening the administration package 1 as described, the administration package 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 administration package 1 by pressing on the chamber 6, so that the pharmaceutical product 2 is forced through the administration channel 7 and leaves / exits the administration channel 7 at its open end 7B at the predetermined breaking zone 9.

[0127] Preferably, it is necessary to press / push on the chamber 6 to remove the pharmaceutical product 2. In other words, the application channel 7 and / or the open end 7B are preferably configured or dimensioned such that no product 2 can escape due to (only) gravity and / or such that no product 2 flows out when the application package 1 is held, wherein the open end 7B points downwards without exerting further force, in particular without pushing on the chamber 6. In this way, accidental removal of the pharmaceutical product 2 is prevented.

[0128] Particularly preferably, the flow cross section of the chamber 5, in particular the application channel 7, is narrowed or reduced at the open end 7B and / or in the region of the predetermined break zone 9. Thus, preferably, a narrowed flow channel or a cross-sectional reduction or nozzle is formed at the open end 7B and / or in the region of the predetermined break zone 9. Reference will be made later to Figures 9 to 11 Explain this in more detail.

[0129] exist Figure 2 In the example shown in , the cover 4 preferably remains intact or unbroken. In particular, after folding or bending the application package 1 or opening the application package 1, the tip 10 is preferably still connected to the application package 1 via the cover 4. However, other solutions are also possible here, in which the cover 4 is also completely or at least partially broken and / or in which the tip 10 is completely removed from the application package 1.

[0130] The application package 1 is preferably packaged in a secondary package 11 , in particular after production of the application package 1 , for transport and / or storage and / or before use of the application package 1 for applying the contained pharmaceutical product 2 to a patient. Figure 3 Secondary packaging 11 is shown in FIG.

[0131] The secondary packaging 11 is preferably a blister pack.

[0132] The secondary package 11 preferably comprises a base part 12 and a cover or lid 13. The base part 12 preferably has or forms a cavity or receptacle 14 for receiving the application package 1. The lid 13 preferably closes (especially completely closes) the receptacle 14. The lid 13 is preferably fixed (especially glued) to the base part 12. Preferably, the lid 13 can be peeled off from the base part 12 so that the application package 1 can be removed from the secondary package 11 or the receptacle 14.

[0133] Figure 4 In a very schematic illustration, a device 100 for producing an application package 1 is shown. Figure 4 A device 100 and a method for producing an application package 1 are described.

[0134] The method as described herein is preferably performed with the apparatus 100. Then, the apparatus 100 is preferably configured for performing the method described herein.

[0135] The apparatus 100 preferably comprises a heating device 101 and a molding tool 102 .

[0136] To produce the application package 1, a plastic sheet 200 is preferably guided through the apparatus 100 and the application package 1 is formed from the plastic sheet 200 by thermoforming, in particular deep drawing. In particular, the thermoforming is carried out in the heating device 101 and / or the molding tool 102.

[0137] Preferably, the plastic sheet 200 is provided rolled up and / or on a roll or in the form of a roll, such as Figure 4 Preferably, in particular in an unfolding or feeding step, the plastic sheet 200 is loosened / unfolded and guided into the apparatus 100 and / or the heating device 101. However, the plastic sheet 200 can also be fed into the apparatus 100 and / or the heating device 101 in any other desired form or manner.

[0138] The plastic sheet 200 may be guided through the apparatus 100 continuously or stepwise, as desired.

[0139] After unwinding / feeding the plastic sheet 200 and / or in a heating step, the plastic sheet 200 is preferably at least partially heated by means of a heating device 101 .

[0140] The heating device 101 is preferably configured for at least partially heating the plastic sheet 200. In particular, the heating device 101 is configured for heating sub-regions of the plastic sheet 200, from which the bottom portion 3 of the application package 1 is then preferably formed, in particular in the molding tool 102.

[0141] The heating device 101 is preferably configured to heat the plastic sheet 200 from both sides. Preferably, the heating device 101 comprises at least one heating plate 101A, 101B, in particular two heating plates 101A, 101B, which are hereinafter referred to as an upper heating plate 101A and a lower heating plate 101B. The upper and lower heating plates 101A, 101B are configured to heat different sides of the plastic sheet 200.

[0142] Preferably, the heating device 101, in particular, the heating plate(s) 101A, 101B heats the plastic sheet 200 to a plasticizing temperature or a thermoforming temperature.

[0143] The plasticizing or thermoforming temperature is preferably a temperature at which the plastic sheet 200 is plasticized and / or thermoformable, in particular a temperature at which the plastic sheet 200 softens and / or becomes plastically deformable. A plastic material (here, the plastic sheet 200) can preferably be deformed when it has reached the plasticizing or thermoforming temperature and retain the new form after cooling or dropping below the plasticizing or thermoforming temperature.

[0144] Preferably, the heating device 101 heats the plastic sheet 200 to a temperature of 180°C and / or the plasticizing or thermoforming temperature is at least 150°C and / or at most 200°C.

[0145] The two heating plates 101A, 101B can be operated at the same temperature or at different temperatures. Preferably, if the plastic sheet 200 is multi-layered, in particular with layers of different materials and / or with different plasticizing / thermoforming temperatures, the two heating plates 101A, 101B are operated at different temperatures, in particular corresponding to the respective plasticizing / thermoforming temperatures of the layers of the plastic sheet 200 facing the respective heating plates 101A, 101B.

[0146] After heating and / or in a (thermo)forming step, the (heated) plastic sheet 200 is preferably formed (in particular thermoformed) by means of the moulding tool 102 .

[0147] The molding tool 102 is preferably configured for forming the shape of the bottom portion 3 from the plastic sheet 200. In particular, the molding tool 102 is configured for respectively stretching the plastic sheet 200 or a heated sub-region of the plastic sheet 200. In particular, the heated region of the plastic sheet 200 is stretched in or into the molding tool 102.

[0148] The molding tool 102 comprises at least one mold 102A, 102B. Preferably, the molding tool 102 comprises two molds 102A, 102B, hereinafter referred to as a female mold 102A and a male mold 102B.

[0149] Preferably, the plastic sheet 200 is stretched into the female mold 102A and / or onto the male mold 102B.

[0150] The forming or stretching is preferably performed by forcing the plastic sheet 200 against the molding tool 102 or the mold 102A and / or 102B, preferably by generating an overpressure or blowing a gas (especially air) against the plastic sheet 200, and / or by generating a negative pressure in the molding tool 102 or the mold 102A and / or 102B. In addition or alternatively, the plastic sheet 200 can be forced against the molding tool 102 or the mold 102A and / or 102B by means of a stamp. Particularly preferably, if two molds 102A, 102B are provided, one of the molds 102A, 102B acts as a stamp. In particular, in addition to a gas, a stamp can also be provided only in sub-areas, for example, in areas that require more precise forming, such as the application channel 7.

[0151] The predetermined breaking zone 9 is preferably produced in the molding tool 102 and / or during the molding step, and / or the apparatus 100, in particular the molding tool 102, is configured for this purpose. This will be explained in more detail later.

[0152] Preferably, the predetermined breaking zone 9 is created / produced only in the (thermo)forming step and / or with the aid of the molding tool 102. In particular, the proposed method does not comprise a step in which the plastic sheet 200 is (partially) cut in order to produce a predetermined breaking zone 9, and / or the proposed device 100 does not have or require a cutting tool for this purpose.

[0153] However, the predetermined breaking zone 9 can also be produced / produced only substantially or mainly in a (thermo)forming step and / or with the aid of the molding tool 102. Preferably, this is to be understood as meaning that the main or necessary steps for producing / forming the predetermined breaking zone 9 are performed during (thermo)forming and / or using the molding tool 102.

[0154] In contrast, in the prior art a predetermined breaking zone is only produced after the (thermo)forming step (e.g. by perforating an otherwise finished package along a specific line) or by cutting a plastic sheet before the (thermo)forming step.

[0155] In the prior art, in particular in EP 2 998 098 A1 and EP 2 998 099 A1, the cutting of the plastic sheet is a main or necessary or generating step that is carried out before the thermoforming step. When the plastic sheet is deep-drawn, the cutting of the plastic sheet can further deform the sheet, however, this deformation does not produce a predetermined breaking zone, because the production of the predetermined breaking zone occurs previously by cutting the sheet. Moreover, this deformation is of course not a necessary or main step for producing the predetermined breaking zone. This is evident from the fact that in the prior art, without cutting, the predetermined breaking zone would not be formed at all.

[0156] Therefore, 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 portion and / or without using a cutting tool.

[0157] In the concept of the present invention, a perforation, scoring or similar operation is preferably also understood as "cutting (cut) or "cuts"". Therefore, the term "no cutting" preferably also includes expressions such as "no perforation" or similar or can be replaced or supplemented by expressions such as "no perforation" or similar. Similarly, a cutting step / tool ​​can also be a perforation step / tool, etc.

[0158] The molding tool 102 is preferably configured to form a plurality of bottom portions 3 simultaneously (simultaneously / at the same time) or in one step, Figure 4 In the illustrated example shown in , twelve bottom portions 3 are formed simultaneously. However, other solutions, for example, in which only one bottom portion 3 is formed in one forming step, are also possible.

[0159] Preferably, the molding tool 102 and / or the mold(s) 102A, 102B are exchangeable in order to produce differently shaped administration packages 1 (in particular the bottom part 3 ), for example to accommodate different volumes of the chamber 6 or of the pharmaceutical product 2 .

[0160] After forming and / or in a filling step, the bottom portion(s) 3 (in particular one or more cavities 5) formed in the plastic sheet 200 is filled with the pharmaceutical product 2, in particular by means of a filling device 103, which is arranged at Figure 4 It is schematically indicated by a dotted line.

[0161] Filling is preferably performed after the plastic sheet 200 or the heated / thermoformed region thereof has hardened and / or cooled or dropped below the plasticizing / thermoforming temperature.

[0162] After filling and / or in a covering / closing step, a cover sheet 300 is applied, in particular fixed or joined, to the plastic sheet 200. Closing / covering is preferably performed in a covering device 104, in particular a sealing device.

[0163] Preferably, the bottom portion(s) 3 or one or more cavities 5 formed in the plastic sheet 200 are covered or closed by means of the cover sheet 300, thereby forming respective cover(s) 4.

[0164] Preferably, the cover sheet 300 is provided rolled up and / or provided on a roll or in the form of a roll, such as Figure 4Preferably, the cover sheet 300 is unwound / unrolled and introduced into the apparatus 100 and / or the covering device 104 (in particular together with the plastic sheet 200). However, the (wound) cover sheet 300 can also be completely positioned in the covering device 104.

[0165] The covering device 104 is preferably configured to join or seal (particularly heat seal) the cover sheet 300 to the plastic sheet 200 or (several) bottom parts 3 in a fluid-tight, particularly liquid-tight and / or air-tight manner. However, other solutions are also possible, for example, the covering device 104 can be configured to adhesively join the cover sheet 300 to the plastic sheet 200.

[0166] Preferably, the cover sheet 300 of the cover 3 is joined or sealed to the plastic sheet 200 of the bottom portion 3 by sealing, preferably heat sealing, the sealing layers 205 and 305 of the cover sheet 300 and the plastic sheet 200. Figures 5 to 8 The sealing layers 205 and 305 are explained in detail with reference to the explanation of FIG.

[0167] To fix the cover sheet 300 to the plastic sheet 200, the covering 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 region of the bottom portion(s) 3 or its / their edge(s) 3A. The covering device 104 is preferably heated at least in the contact region so that the cover sheet 300 is heat-sealed to the plastic sheet 300 at least in this region.

[0168] The joining / sealing is preferably carried out at least in the region of the edge(s) 3A of the bottom part(s) 3, or the covering device 104 is configured for this purpose. For this purpose, the covering device 104 preferably comprises (for each bottom part 3) an annular sealing tool (not shown) which at least substantially has the form of the edge 3A and / or can be heated.

[0169] Particularly preferably, the joining / sealing is performed in addition to the region of the edge(s) 3A also in the region surrounding the edge(s) 3A and / or in the region which will later form the rim(s) 8 .

[0170] In principle, the cover device 104 may not contact this additional area, but only use its radiant heat when heat sealing the cover sheet 300 to the plastic sheet 200. This would result in a reduced bond strength compared to the area where the cover device 102 contacts the cover sheet 300. However, solutions are also possible where a contact is also established in this area and / or with a constant bond strength.

[0171] After covering / closing and / or in a separation step, the application package(s) 1 formed by the plastic sheet 200 and the cover sheet 300 are separated from these sheets and / or from each other.

[0172] For this purpose, the apparatus 100 can comprise a separating device (not shown), preferably downstream of the covering device 104. However, a separating device can also be integrated into the covering device 104 and / or the covering device 104 can also be configured for separating the application package(s) 1 .

[0173] Preferably, the application package(s) 1 are trimmed, punched or cut.

[0174] The separation (in particular the punching / cutting) is preferably carried out along a line which has a (constant) distance to the edge(s) 3A and / or such that the edge(s) 8 are formed. The line along which the application package 1 is separated (in particular cut or punched) is formed by Figure 4 The dotted line in the figure indicates schematically.

[0175] The application package 1 preferably consists of a base part 3 comprising a special functional layer, in particular a special layer structure, and a cover 4 . Figures 5 to 8 2 shows a plastic sheet 200 of the bottom portion 3 and a cover sheet 300 of the cover 4, or a preferred embodiment for producing the plastic sheet 200 and the cover sheet 300 of the bottom portion 3 and the cover 4.

[0176] If in the following description a plastic film or a layer comprises a specific polymer or consists of a specific polymer, this means that the film or layer comprises or consists of this polymer as the polymer material of the film or layer, respectively. However, further components (e.g. fillers and additives) may also be present in the film or layer, respectively.

[0177] As described above, the plastic sheet 200 of the bottom portion 3 is preferably a multilayer film. The plastic sheet 200 of the bottom portion 3 preferably includes at least five layers:

[0178] an outer thermoformable layer 201,

[0179] a cyclic olefin copolymer (COC) layer 202,

[0180] an inner thermoformable layer 203,

[0181] A barrier layer 204 and

[0182] A sealing layer 205 is provided.

[0183] The cyclic olefin copolymer layer 202 is disposed between the outer thermoformable layer 201 and the inner thermoformable layer 203 and the barrier layer 204 is disposed between the sealant layer 205 and the inner thermoformable layer 203 .

[0184] Preferably, the plastic sheet 200 includes the above-mentioned at least five layers in the layer sequence as described above, that is, the plastic sheet 200 of the bottom portion 3 includes at least five layers in the following layer sequence:

[0185] The outer thermoformable layer 201, followed by

[0186] Cyclic olefin copolymer (COC) layer 202, followed by

[0187] The inner thermoformable layer 203, followed by

[0188] The barrier layer 204 is followed by

[0189] Sealing layer 205.

[0190] Particularly preferably, it is envisaged that the abovementioned layers follow one another, ie according to the above preferred embodiments of the invention the abovementioned layers are formed continuously or sequentially and / or are not separated from one another by intermediate layers.

[0191] The outer thermoformable layer 201 usually forms one outer surface of the application package 1 according to the invention.

[0192] Preferably, the plastic sheet 200 of the bottom portion 3 further comprises Figure 5 204. The intermediate layer 206 is shown in FIG. The intermediate layer 206 can be omitted in the plastic sheet 200, but further enhances the compatibility of the plastic sheet 200, especially the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 is usually arranged between the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 usually includes the same material as the sealing layer 205 or is composed of the same material as the sealing layer 205, and usually also has the same thickness. The sealing layer 205 is preferably a heat sealing layer for joining / sealing the bottom portion 3 and the cover 4.

[0193] One of the bottom parts 3 is preferably a plastic sheet 200 comprising or consisting of the following layer structure:

[0194] (a) an outer thermoformable layer 201,

[0195] (b) a cyclic olefin copolymer layer 202,

[0196] (c) an inner thermoformable layer 203,

[0197] (d) an intermediate layer 206,

[0198] (e) a barrier layer 204, and

[0199] (f) A sealing layer 205.

[0200] The plastic sheet 200 of the bottom portion 3 typically has a thickness in the range of 230 to 750 μm, in particular 300 to 650 μm, preferably 400 to 600 μm, more preferably 450 to 500 μm, particularly preferably 480 to 520 μm and determines the form of the application package 1 after deep drawing.

[0201] The cyclic olefin copolymer layer 202 is a main layer of the plastic sheet 200. It includes or consists of a cyclic olefin copolymer (COC), preferably consists of a cyclic olefin copolymer (COC).

[0202] Cyclic olefin copolymers (COC) are amorphous polymers obtained by copolymerization of cyclic monomers such as 8,9,10-triazacyclopentene (norbornene) or 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethylnaphthalene (tetracyclododecene) with ethylene. Particularly preferably, copolymers of ethylene and norbornene are used with the present invention.

[0203] The cyclic olefin copolymer layer 202 generally provides rigidity and structural integrity to the bottom portion 3 of the application package 1, especially after deep drawing. In addition, the cyclic olefin copolymer layer 202 is brittle and breaks under increased pressure, which makes it suitable for manufacturing disposable application packages with a breaking zone 9 for opening the application package 1. In addition, COC has good moisture barrier properties, especially when used with a high layer thickness. In addition, COC has good chemical resistance and barrier properties to polar solvents and is resistant to acids and bases. A further advantage of COC is that it can have a high purity, so that the solvent or active ingredient contained in a package cannot extract impurities.

[0204] The cycloolefin 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, particularly preferably 360 μm to 390 μm.

[0205] The inner thermoformable layer 203 and the outer thermoformable layer 201 enhance the thermoformable properties of the plastic sheet 200 and provide more flexibility to the plastic sheet 200 , thereby enhancing the machinability of the plastic film 200 and providing protection to the brittle COC layer 202 .

[0206] The outer thermoformable layer 201 and the inner thermoformable layer 203 preferably have a thickness in the range from 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, particularly preferably 22 μm to 25 μm.

[0207] Best results are obtained if the thickness of the cycloolefin copolymer layer 202 and the thickness of the outer thermoformable layer 201 and / or the thickness of the inner thermoformable layer 203 are in the range of from 5:1 to 30:1, in particular 7:1 to 25:1, preferably 10:1 to 22:1, more preferably 13:1 to 20:1, particularly preferably 15:1 to 18:1.

[0208] Furthermore, the outer thermoformable layer 201 and the inner thermoformable layer 203 comprise or consist of the same polymer, 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 acrylate (EBA), ethylene vinyl alcohol (EVA), polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE) and mixtures thereof.

[0209] According to the present 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 a mixture thereof. According to the present invention, it is particularly preferred if the polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is polypropylene (PP).

[0210] The barrier layer 204 preferably includes or 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 methacrylate (EMA), ethylene acrylate (EBA), ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN) or a mixture thereof.

[0211] According to the 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 environment from penetrating the package 1 and deteriorating the pharmaceutical product 2 on the one hand, and prevents any undesirable interaction between the pharmaceutical product 2 and the package 1 on the other hand. The barrier layer (especially comprising EVOH or consisting of EVOH) exhibits excellent barrier properties to chemicals and oxygen.

[0212] The barrier layer 204 has a thickness in the range from 2 μm to 20 μm, particularly 5 μm to 15 μm, preferably 7 μm to 12 μm.

[0213] The sealing layer 205 and / or the intermediate layer 206 preferably include or consist of a polymer selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene linear low density polyethylene (mLLDPE), very low density polyethylene (VLDPE), ionomers of acid copolymers, ethylene acrylic acid copolymers (EAA), ethylene methacrylic acid copolymers (EMAA), ethyl methacrylate (EMA), ethylene vinyl alcohol (EVA) or mixtures thereof.

[0214] 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), propylene copolymer (CoPP), polypropylene terpolymer (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 a mixture thereof.

[0215] 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 a mixture thereof. The best results are obtained if the polymer of the sealing layer 205 and / or the intermediate layer 206 is polyethylene (PE).

[0216] The sealing layer 205 and / or the intermediate layer 206 have a thickness in the range of from 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, particularly preferably 22 μm to 27 μm. As described above, preferably, the sealing layer 205 and the intermediate layer 206 include or consist of the same polymer and have the same thickness.

[0217] Therefore, according to one of the present inventions it is very preferred that the plastic sheet 200 comprises or consists of the following layer structure with the following layer sequence:

[0218] (a) an outer thermoformable layer 201 comprising or consisting of PP, followed by

[0219] (b) a cyclic olefin copolymer layer 202 comprising COC or consisting of COC, followed by

[0220] (c) an inner thermoformable layer 203 comprising or consisting of PP, followed by

[0221] (d) optionally, an intermediate layer 206 comprising PE or consisting of PE, followed by

[0222] (e) a barrier layer 204 comprising EVOH or consisting of EVOH, followed by

[0223] (f) A sealing layer 205 including or consisting of PE.

[0224] Particularly preferably, it is envisaged that the above-mentioned layers follow one another, ie according to the above preferred embodiments of the invention, the above-mentioned layers are formed continuously or sequentially and / or are not separated from one another by any further intermediate layers other than the optional intermediate layer 206 .

[0225] The layers of the plastic sheet 200 of the bottom part 3 can be directly or indirectly bonded to one another. A direct bond means that the layers are directly bonded to one another, for example, by coextrusion or by a tie layer or an adhesive layer. An indirect bond means that further layers, in particular plastic sheets or metal foils, are arranged between the respective layers.

[0226] like Figure 6 As shown in FIG. 4 , the cover sheet 300 of the cover 4 preferably includes or consists of the following layers:

[0227] a protective layer 301,

[0228] a first barrier layer 302,

[0229] a middle layer 303,

[0230] a second barrier layer 304, and

[0231] a sealing layer 305,

[0232] The first barrier layer 302 is disposed between the protection 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 .

[0233] The cover sheet 300 generally has a thickness in the range from 50 μm to 200 μm, in particular 70 μm to 180 μm, preferably 80 μm to 150 μm, more preferably 90 μm to 140 μm, particularly preferably 95 μm to 130 μm.

[0234] The protective layer 301 preferably comprises or consists of a polymer selected from the group consisting of, preferably consists of: polyethylene terephthalate (PET), polyamide (PA), polyvinylidene fluoride (PVDF) and mixtures thereof. Preferably, the polymer of the protective layer 301 is polyethylene terephthalate (PET). The protective layer not only provides protection from mechanical damage, but also allows printing on the protective layer 301, especially when the protective layer comprises or consists of PET.

[0235] The protective layer preferably has a thickness in the range from 5 μm to 25 μm, in particular 7 μm to 20 μm, preferably 10 μm to 14 μm.

[0236] The first barrier layer 302 is usually a metal foil, especially an aluminum foil. Metal foil (especially aluminum foil) provides excellent oxygen barrier properties. The first barrier layer usually has a thickness in the range of from 5 μm to 25 μm, especially 7 μm to 20 μm, preferably 10 μm to 40 μm.

[0237] The intermediate layer 303 and the sealing layer 305 preferably include or consist of the same polymer. Typically, the intermediate layer 303 and / or the sealing layer 305 include or consist of a polymer selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), metallocene linear low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), ionomers of acid copolymers, ethylene acrylic acid copolymers (EAA), ethylene methacrylic acid copolymers (EMAA), ethyl methacrylate (EMA), ethylene-vinyl alcohol (EVA) or mixtures thereof.

[0238] 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), propylene copolymer (CoPP), polypropylene terpolymer (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 a mixture thereof.

[0239] According to the present 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 a mixture thereof. It is particularly preferred if the polymer of the intermediate layer 303 and / or the sealing layer 305 is polyethylene (PE).

[0240] Furthermore, according to the invention, it is preferred if the intermediate layer 303 and the sealing layer 305 have the same layer thickness. Typically, the layer thickness of the intermediate layer 303 and / or the sealing layer 305 has 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, particularly preferably 22 μm to 27 μm.

[0241] The second barrier layer 304 preferably includes or 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 methacrylate (EMA), ethylene acrylate (EBA), ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or a mixture 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 a mixture thereof. According to a preferred embodiment of the present invention, the polymer of the second barrier layer 304 is ethylene vinyl alcohol (EVOH).

[0242] Good results are obtained if the second barrier layer 304 has a thickness in the range from 2 μm to 20 μm, in particular 5 μm to 15 μm, preferably 7 μm to 12 μm.

[0243] According to a preferred embodiment, the cover sheet 300 has the following layer structure:

[0244] a protective layer 301,

[0245] a first barrier layer 302,

[0246] a middle layer 303,

[0247] a second barrier layer 304, and

[0248] A sealing layer 305 is provided.

[0249] Specifically, it is conceivable that the cover sheet 300 comprises or consists of the following layer structure with the following layer sequence:

[0250] (i) Protective layer 301, followed by

[0251] (ii) a first barrier layer 302, followed by

[0252] (iii) Intermediate layer 303, followed by

[0253] (iv) a second barrier layer 304, followed by

[0254] (v) A sealing layer 305.

[0255] Particularly preferably, it is envisaged that the abovementioned layers follow one another, ie according to the above preferred embodiments of the invention the abovementioned layers are formed continuously or sequentially and / or are not separated from one another.

[0256] The layers of the cover sheet 300 can be directly or indirectly bonded to one another. A direct bond means that the layers are directly bonded to one another, for example, by coextrusion or by an adhesive layer or a tie layer. An indirect bond means that there are further layers (especially plastic sheets or metal foils) arranged between the respective layers.

[0257] A very preferred embodiment of the invention comprises that the plastic sheet 200 of the bottom part 3 comprises or consists of the following layer structure with the following layer sequence:

[0258] (a) an outer thermoformable layer 201, in particular comprising or consisting of PP, followed by

[0259] (b) a cyclic olefin copolymer layer 202, in particular comprising or consisting of COC, followed by

[0260] (c) an inner thermoformable layer 203, in particular comprising or consisting of PP, followed by

[0261] (d) optionally, an intermediate layer 206, in particular comprising or consisting of PE, followed by

[0262] (e) a barrier layer 204, in particular comprising EVOH or consisting of EVOH, followed by

[0263] (f) a sealing layer 205, in particular comprising PE or consisting of PE,

[0264] And the cover sheet 300 comprises the following layer structure or consists of the following layer structure:

[0265] (i) Protective layer 301, followed by

[0266] (ii) a first barrier layer 302, followed by

[0267] (iii) Intermediate layer 303, followed by

[0268] (iv) a second barrier layer 304, followed by

[0269] (v) A sealing layer 305.

[0270] Particularly preferably, it is envisaged that the above-mentioned layers follow one another, ie according to the above preferred embodiments of the invention, the above-mentioned layers are formed continuously or sequentially and / or are not separated from one another by any further intermediate layers other than the optional intermediate layer 206 .

[0271] According to the invention, it is preferred if a tie layer or adhesive layer is arranged between the layers 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 usually consists of an adhesive resin.

[0272] Furthermore, it is preferred if both the plastic 200 and the cover sheet 300 include linking layers and adhesive layers between the functional layers.

[0273] According to Figure 7 In one preferred embodiment shown in FIG. 1 , the plastic sheet 200 comprises or consists of the following layer structure:

[0274] (a) an outer thermoformable layer 201 preferably comprising or consisting of PP, in particular consisting of PP,

[0275] (b) a bonding layer 207a,

[0276] (c) a cyclic olefin copolymer layer 202 comprising or consisting of COC, in particular consisting of COC,

[0277] (d) a bonding layer 207b,

[0278] (e) an inner thermoformable layer 203 preferably comprising or consisting of PP, in particular consisting of PP,

[0279] (f) an adhesive layer 208,

[0280] (g) an intermediate layer 206 preferably comprising PE or consisting of PE, in particular consisting of PE,

[0281] (h) a bonding layer 207c,

[0282] (i) a barrier layer 204 preferably comprising or consisting of EVOH, in particular consisting of EVOH,

[0283] (j) a bonding layer 207d, and

[0284] (k) A sealing layer 205 preferably comprises PE or consists of PE, in particular consists of PE.

[0285] Figure 8 One preferred layer structure of the display cover sheet 300 is:

[0286] (i) a protective layer 301 preferably comprising PET or consisting of PET,

[0287] (ii) adhesive layer 308a,

[0288] (iii) a first barrier layer 302 preferably comprising or consisting of aluminum foil, in particular consisting of aluminum foil,

[0289] (iv) an adhesive layer 308b,

[0290] (v) an intermediate layer 303 preferably comprising PE or consisting of PE, in particular consisting of PE,

[0291] (vi) a bonding layer 307a,

[0292] (vii) a second barrier layer 304 preferably comprising EVOH or consisting of EVOH, in particular consisting of EVOH,

[0293] (viii) a bonding layer 307b,

[0294] (ix) The sealing layer 305 preferably comprises PE or consists of PE, in particular consists of PE.

[0295] Preferably, the cover sheet 300 is joined or sealed to the plastic sheet 200 by means of the sealing layers 205 and 305. Preferably, the cover sheet 300 and the plastic sheet are joined or sealed by heat sealing.

[0296] In the following, different embodiments of the application package 1 according to the invention are described in more detail. The different embodiments preferably differ (only) by the design of the predetermined breaking zone 9. In other words, apart from the predetermined breaking zone 9, the different embodiments of the application package 1 are preferably identical.

[0297] Preferably, unless explicitly stated otherwise, aspects, features, and explanations described for one embodiment are also applicable to other embodiments even if not repeated.

[0298] In addition, regarding the application package 1 (especially reference Figures 1 to 3 ), method and apparatus 100 for producing the same (particularly with reference to Figure 4 ) and preferably multilayer structures (especially reference Figures 5 to 8 )'s previously described aspects, features and explanations are preferably additionally or correspondingly applicable to the embodiments described below (even if there is no repetition).

[0299] The embodiments of the administration package 1 described below preferably have the general reference Figures 1 to 3 The aspects and features of the described application package 1.

[0300] The embodiment of the administration package 1 described below is preferably obtained by referring to Figure 4 A method and / or apparatus 100 described herein may be produced or may be used as described in reference Figure 4 A method and / or apparatus 100 is described for producing a product.

[0301] The embodiment of the administration package 1 described below is preferably as described in reference Figures 5 to 8 The plastic sheet 200 and / or the cover sheet 300 described above are produced, and / or the bottom portion 3 and / or the cover 4 thereof preferably have a Figures 5 to 8 A multi-layer structure is described.

[0302] However, the following embodiments do not necessarily have the aspects or features previously described. For example, they may have Figures 5 to 8 The multi-layer structure is different from a multi-layer structure.

[0303] Figures 9 to 11 A first embodiment of an administration package 1 is shown in FIG.

[0304] Fig. 9 A schematic plan view is shown from the bottom side of the application package 1 , ie facing the bottom part 3 . The cover 4 is not visible in this view, since it is behind the bottom part 3 .

[0305] Fig.10 Show along Fig. 9 A schematic cross section of the application package 1 along the line XX. Fig.11In the area showing the fracture zone 9 Fig.10 One of the details is enlarged, and the detail is Fig.10 Indicated by the mark XI.

[0306] As indicated by the shadows, Fig.11 The rim 8 shown in the figure is located behind the cross-sectional plane. The cover 4 preferably extends along the upper surface of the rim 8 and over the cavity 5 or application channel 7, thereby closing the cavity 5 or application 7 from above (in the orientation shown in the figure).

[0307] In a first embodiment, the predetermined breaking zone 9 extends only above the chamber 5, in particular the application channel 7 of the chamber 5, in particular as Fig. 9 Preferably, in the first embodiment, no predetermined breaking zone 9 is provided at the edge 8 and / or the edge 8 does not comprise a predetermined breaking zone 9. This preferably enhances the stability of the application package 1 and / or reduces the risk of accidental opening of the application package 1.

[0308] In this sense, the term "predetermined breaking zone" preferably means a region of the application package 1, in particular the bottom part 3, which is specially prepared or manufactured to ensure the breaking / opening of the application package 1. Therefore, in particular, the predetermined breaking zone 9 is preferably a material weakening and throughout the present application, the term "predetermined breaking zone" can be replaced by "material weakening".

[0309] Preferably, also when the predetermined breaking zone 9 is provided only in the region of the cavity 5 or the application channel 7, the rim 8 nevertheless also breaks when the application package 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 at the predetermined breaking zone 9 and the break propagates, in particular in a defined manner, into the rim 8, causing the entire tip 10 of the base portion 3 to break.

[0310] In particular, the predetermined breaking zone 9 is provided only on the bottom portion 3 and / or the cover 4 does not comprise the predetermined breaking zone 9 .

[0311] The predetermined breaking zone 9 is or preferably has a notch or a notch or a groove 15, in particular as in Fig.11 Preferably, the predetermined breaking zone 9 is or has a groove 15 on an outer surface 16 of the application package 1 (in particular the bottom part 3).

[0312] The outer surface 16 of the application package 1 or the bottom part 3 is in particular the surface of the bottom part 3 opposite the cavity 5 or hollow space configured for receiving the pharmaceutical product 2. Particularly preferably, the outer surface 16 is formed by the outer thermoformable layer 201.

[0313] Preferably, the groove 15 has an at least substantially triangular shape and / or at least substantially wedge-shaped in a cross section. However, other shapes are also possible.

[0314] The groove 15 preferably has an angle W and a depth D and / or is defined by an angle W and a depth D.

[0315] The angle W is preferably a smaller angle between the main extension plane of the outer surface 16 and the main extension plane of the inclined or inclined surface of the groove 15, especially at the edge of the predetermined breaking zone 9 or the groove 15 (i.e., the edge where the outer surface 16 bends inward and / or begins to form a groove / recess).

[0316] If the recess 15 or its cross section is at least substantially triangular or wedge-shaped, the angle W is preferably the angle between one of the legs and the base of the (isosceles) triangular cross section.

[0317] However, the groove 15 may also be characterized by any other suitable angle (which can be calculated as 180° minus W) which can preferably be determined from the angle W (for example, the angle at which the outer surface 16 actually bends inwardly or toward the cavity 5 or the application channel 7) or, in particular, in the case of a triangle or a wedge, by 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° minus 2 times W.

[0318] The depth D is preferably the distance from a main extension plane of the outer surface 16 to the lowermost area of ​​the recess 15 , in particular measured perpendicularly to the main plane.

[0319] If the recess 15 or its cross section is at least substantially triangular or wedge-shaped, the depth D is preferably the height (or altitude) of the (isosceles) triangular cross section (relative to the base).

[0320] 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.

[0321] The opening angle or the 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.

[0322] 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.

[0323] 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 thickness T of (the wall of) the bottom portion 3 .

[0324] Preferably, the groove 15 has a (very) small radius of curvature at its lowermost area or valley, preferably less than 15% or 10%, in particular less than 5% or 2%, of the depth D. Preferably, the radius of curvature is less than 50 μm or 20 μm, in particular less than 10 μm or 5 μm.

[0325] Preferably, a projection 17 is formed on an inner surface 18 of the application package 1 , in particular the bottom portion 3 , in the predetermined breaking zone 9 .

[0326] The inner surface 18 of the application package 1 or the bottom part 3 is particularly the surface of the bottom part 3 facing the cavity 5 or hollow space configured to receive the pharmaceutical product 2 and / or opposite to the inner surface 16. Particularly preferably, the inner surface 18 is formed by the sealing layer 205.

[0327] Thus, the outer surface 16 and the inner surface 18 are preferably two opposite surfaces forming the wall of the bottom portion 3. Particularly preferably, the inner surface 18 is the surface in contact with the pharmaceutical product 2 at least when the pharmaceutical product 2 is dispensed and / or the surface of the innermost or sealing layer 205. Particularly preferably, the outer surface 16 is the surface in contact with the environment and / or the surface of the outermost or outer thermoformable layer 201.

[0328] The protrusion 17 is preferably arranged opposite to the groove 15 .

[0329] Preferably, the protrusion 17 is formed to correspond to the groove 15 , in particular, extends in the same direction as the groove 15 , has the same length and / or width as the groove 15 , and / or has the same shape and / or angle as the groove 15 .

[0330] Preferably, the predetermined breaking zone 9 is a region having the same thickness T as a region of the bottom portion 3 surrounding the predetermined breaking zone 9. In other words, the thickness T of (the wall of) the bottom portion 3 is preferably at least substantially constant in the region including and surrounding the predetermined breaking zone 9.

[0331] Therefore, preferably, the thickness T of (the wall of) the bottom portion 3 in the region of the groove 15 and / or the projection 17 is at least substantially the same as in the region surrounding / adjacent to the groove 15 and / or the projection 17 .

[0332] The thickness T is preferably the distance between the outer surface 16 and the inner surface 18. In the predetermined breaking zone 9, the thickness T is preferably the distance between (the surface of) the groove 15 and the protrusion 17.

[0333] The at least substantially constant thickness T is preferably achieved by forming the projection 17 accordingly, in particular by having the projection 17 have the same or at least nearly the same height as the depth D of the recess 15. In other words, the projection 17 is preferably at least substantially as high as the depth of the recess 15, and / or the outer surface 16 is at least substantially as much concave as the inner surface 18 is convex (at the predetermined breaking zone 9).

[0334] The thickness T of the bottom portion 3, preferably both in the predetermined breaking zone 9 and in the area surrounding it, is preferably at least 230 μm, in particular at least 300 μm or 400 μm, more preferably 450 μm or 480 μm, and / or at most 750 μm, in particular 650 μm or 600 μm, more preferably 500 μm or 520 μm.

[0335] In the first embodiment, the predetermined breaking zone 9 is preferably formed as a bend or a kink or a fold in (the wall of) the bottom portion 3 .

[0336] In a cross section (in particular perpendicular to its longitudinal extension), the predetermined breaking zone 9 or (the wall of) the bottom part 3 in the region of the predetermined breaking zone 9 is preferably at least substantially V-shaped.

[0337] Preferably, a narrowed flow channel or a cross-sectional reduction or a nozzle 19 is formed at / in or by means of the predetermined breaking zone 9 , in particular in the chamber 5 or the application channel 7 .

[0338] The channel height and / or the flow cross section of the application channel 7 is preferably defined or delimited by the inner surface 18 and the cover 4 , in particular the surface of the cover 4 facing the application channel 7 or formed by the sealing layer 305 .

[0339] The height and / or width of the application channel 7 remote from the predetermined breaking zone 9 or the cross-sectional reduction or the nozzle 19 is preferably greater than 0.5 mm, in particular greater than 1 mm and / or less than 4 mm or 3 mm.

[0340] The height and / or width of the application channel 7 is preferably reduced by at least 0.05 mm or more and / or at most 0.5 mm or less, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm at / in or by the predetermined breaking zone 9 .

[0341] Preferably, the application channel 7 is narrowed or its (flow) cross section is reduced or the nozzle 19 is formed by means of a projection 17. In particular, the projection 17 projects into the application channel 7 and / or towards the cover 4, thereby narrowing the channel and / or reducing the (flow) cross section.

[0342] When the application package 1 is opened (particularly by folding / bending along the predetermined breaking zone 9 or groove 15), a narrowed flow channel or a cross-sectional reduction or nozzle 19 is preferably formed or positioned at the open end 7B, in particular where the drug product 2 exits the application package 1.

[0343] As already explained above, the application channel 7 and / or the open end 7B is preferably configured or dimensioned such that no product 2 can escape due to (only) gravity. This is particularly preferably achieved at least partially by means of a narrowing flow channel or cross-section reduction or nozzle 19.

[0344] Preferably, the application channel 7 or the open end 7B is narrowed, in particular by means of the protrusion 17, so that even if the open end 7B points downward, the drug product 2 is not discharged / leaves through the application channel 7 or the open end 7B without applying an additional force (for example, by pressing on the chamber 6).

[0345] The pharmaceutical product 2 is therefore preferably dispensed from the opened administration package 1 simply by pressing on the chamber 6 .

[0346] Preferably, when dispensing the pharmaceutical product 2 and / or pressing against the chamber 6 , the pharmaceutical product 2 is accelerated when leaving the application package 1 , in particular at the open end 7B, particularly preferably by means of a narrowing flow channel or cross-section reduction or nozzle 19 .

[0347] Preferably, the narrowed flow channel or the reduced cross-section or the nozzle 9 (also) prevents the drug product 2 from flowing, in particular from the chamber 6, through the narrowed flow channel or the reduced cross-section or the nozzle 19 and / or into the tip 10 or the portion of the application channel 7 comprised by the tip 10 and / or towards the axial end 7A, in particular before opening the application package 1. Thus, preferably, the drug product 2 is prevented from accumulating at the axial end 7A or in the tip 10. In this way, preferably, no drug product 2 is wasted or spilled when opening the application package 1 or disposing of the tip 10.

[0348] Fig.12 Corresponding to Fig.11 An enlarged detail of the first embodiment shown in FIG. 1 illustrates an enlarged detail of a second embodiment of the application package 1 shown in the region of the breaking zone 9 .

[0349] Preferably, the only difference between the first and the second embodiment is that the application package 1 or the bottom part 3 or the predetermined breaking zone 9 comprises no projection 17 and / or no narrowing flow channel or cross-section reduction or nozzle 19 .

[0350] The application 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, in particular also in the predetermined breaking zone 9 .

[0351] Along axis A and / or along Fig.12 In the cross section shown in , the inner surface 18 is preferably at least substantially flat, in particular (also) in the predetermined breaking zone 9.

[0352] Preferably, in the predetermined breaking zone 9, the thickness T of (the wall of) the bottom portion 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.

[0353] The ratio of the thickness at (the narrowest area of) the predetermined breaking zone 9 to the thickness in the area surrounding the predetermined breaking zone 9 is preferably at least 0.1 or 0.2 and / or at most 0.9 or 0.8.

[0354] Embodiments are also possible in which the application package 1 (in particular the bottom part 3 or the predetermined breaking zone 9) has a projection 17 or a narrowed flow channel or a cross-sectional reduction or a nozzle 19, but nevertheless has a non-constant thickness T compared to the area surrounding the projection 17 or the predetermined breaking zone 9, for example a reduced thickness T in the area of ​​the projection 17 or the predetermined breaking zone 9.

[0355] It is also conceivable that the thickness T decreases in some areas and increases in another area compared to the average thickness T. For example, the thickness T may decrease at the tip of the protrusion 17 and increase at the root / base of the protrusion 17 .

[0356] Preferably, the predetermined breaking zone 9 or a material weakening of the bottom portion 3 is formed by a bend / kink, by a material reduction / thickness reduction or by a combination thereof.

[0357] In the following, a third and a fourth embodiment of the application package 1 are described which preferably differ from the first and the second embodiment in that the predetermined breaking zone 9 or its groove 15 extends over the rim 8 or is formed at both the application channel 7 and the rim 8 .

[0358] Figures 13 to 15 Corresponding to Figures 9 to 11 The view of FIG. 1 shows a third embodiment of the application package 1. Specifically, Fig.13 A schematic plan view showing the bottom side of the application package 1, Fig.14 Show along Fig.13 A schematic cross section of the application package 1 along the line XIV-XIV in FIG. 1 , and Fig.15 Display marked as XV Fig.13 One zooms in on the details. Fig.14 and Fig.15 The section shown in FIG. 1 is along the axis A, ie along the application channel 7 or in the region of the application channel 7 .

[0359] Fig.16 Similar to Fig.15 An enlarged view shows a schematic cross section of the application package 1 according to the third embodiment in the region 1 of the rim 8. Since in these embodiments the rim 8 does not comprise a predetermined breaking zone 9 or a groove 15, similar figures for the first and second embodiments have been omitted.

[0360] Fig.17 Corresponding to Fig.11 , Fig.12 and Fig.15 One of the enlarged details of further embodiments shown in FIG. 1 shows an enlarged detail of a fourth embodiment of the application package 1 in the region of the breaking zone 9 . Fig.18 Corresponding to Fig.16 One illustration shows an enlarged detail of a fourth embodiment of the application package 1 in the region of the breaking zone 9 at the edge 8 .

[0361] In both the third and fourth embodiments, the predetermined breaking zone 9 or the groove 15 preferably extends over the cavity 5, in particular the application channel 7 and the rim 8. In other words, the predetermined breaking zone 9 or the groove 15 preferably extends over the entire width of the application package 1, i.e. over the entire extension of the application package 1 in a direction transversely or perpendicular to (the longitudinal extension of) the application channel 7 or the axis A.

[0362] Preferably, the area of ​​the predetermined breaking zone 9 at the edge 8 has the same or similar characteristics as the area of ​​the predetermined breaking zone 9 at the cavity 5 or the application channel 7 .

[0363] The above explanations regarding the predetermined breaking zone 9 , the groove 15 , the angle W, the depth D etc. preferably also apply to the predetermined breaking zone 9 of the third and fourth embodiments (particularly preferably in the region of both the cavity 5 and the rim 8 ).

[0364] Preferably, the groove 15 has the same or similar properties in the region of the rim 8 as in the region of the cavity 5 or of the application channel 7 , for example the same angle W, the same depth D or similar.

[0365] However, solutions are also possible in which the predetermined breaking zone 9 and / or the recess 15 are different at the edge 8. For example, the recess 15 can have a smaller depth D at the edge 8 than at the cavity 5 or application channel 7.

[0366] Preferably, according to Figures 13 to 16 The third implementation method and the Fig.17 and Fig.18 The main or only difference between the fourth embodiment and the present invention is whether the protrusion 17 is formed on the edge 8.

[0367] Preferably, the edge 8 in the third embodiment does not include a protrusion 17, such as Fig.16 As can be seen in the figure, and / or the edge 8 in the fourth embodiment includes a protrusion 17, such as in particular Fig.18 Visible in.

[0368] In the fourth embodiment, the projection 17 preferably extends over the entire width of the application package 1, i.e. over the entire extension of the application package 1 in a direction perpendicular to (the longitudinal extension of) the application channel 7 or the axis A. Thus, in particular, the edge 3A and / or the rim 8 also comprises the projection 17.

[0369] Preferably, the projection 17 has the same or similar properties in the region of the rim 8 as in the region of the cavity 5 or the application channel 7. However, solutions in which the projection 17 is different at the rim 8 are also possible.

[0370] Preferably, the cover 4 follows 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 projection 17, the cover 4 (also) has a protrusion or projection on its outer side and a groove on its inner side, such as Fig.17 and Fig.18 In the third embodiment and / or when the edge 8 is flat or does not include a projection 17, the cover 4 is preferably at least substantially flat, in particular also in the region of the predetermined breaking zone 9, such as in Fig.15 and Fig.16 Visible in.

[0371] In the third embodiment, the thickness T is preferably reduced in the region of the predetermined breaking zone 9 at the edge 8 compared to the surrounding region and / or the region of the predetermined breaking zone 9 at the application channel 7 .

[0372] In the fourth embodiment, the thickness T is preferably at least substantially constant over the entire length of the predetermined breaking zone 9 .

[0373] Preferably, the application package 1 according to the third embodiment comprises a narrowed flow channel or a cross-section reduction or a nozzle 19 .

[0374] Preferably, the application package 1 according to the fourth embodiment has an at least substantially constant flow cross section and / or does not comprise a narrowing flow channel or a cross-section reduction or nozzle 19. This is achieved in particular by shaping the cover 4 accordingly, in particular with a non-planar surface in the region of the predetermined breaking zone 9 or the projection 17. However, solutions are also possible in which the cover 4 is non-planar only at the edge 8, but is still planar where it covers the cavity 5 or the application channel 7, in particular in the region framed by the edge 3A.

[0375] Any combination of different embodiments is possible. For example, the predetermined breaking zone 9 of the third embodiment can also be formed without a protrusion 17 as in the second embodiment.

[0376] In the following and with reference to Figures 19 to 22 , the molding tool 102 and / or how the predetermined breaking zone 9 is produced in the proposed method, in particular during the thermoforming step, and / or in the proposed device 100, in particular the molding tool 102, is explained in more detail.

[0377] Fig.19 The moulding tool 102 with a (thermoformed) plastic sheet 200 or bottom portion 3 is shown in a schematic cross section. Fig. 20 An enlarged detail of a cross section of the molding tool 102 in the region of a molding device 102C with a (thermoformed) plastic sheet 200 or the bottom portion 3 is shown. Fig.21 and Fig. 22 Corresponding to Fig.19 and Fig. 20 The illustration of shows a molding tool 102 according to a further embodiment.

[0378] Unless otherwise stated, the following description preferably applies to both embodiments.

[0379] exist Fig.19 and Fig.21 , the molds 102A, 102B are shown spaced apart from each other and from the plastic sheet 200 / bottom portion 3 and / or (only) spaced apart when the plastic sheet 200 / bottom portion 3 is released from the molds 102A, 102B after thermoforming.

[0380] exist Fig. 20 and Fig. 22 , the molds 102A, 102B are shown against the plastic sheet 200 / bottom portion 3 and / or during thermoforming.

[0381] The female mold 102A preferably has a (concave) cavity and / or a concave form or (concave) surface 102D. The surface 102D of the female mold 102A is preferably generally concave, but can be flat or even convex in places.

[0382] Particularly preferably, the female mold 102A has a plurality of (concave) cavities for forming a plurality of bottom parts 3 (simultaneously / in one molding step), as already described above with reference to Figure 4 To explain.

[0383] The male mold 102B preferably has a (convex) projection and / or a convex form or (convex) surface 102E. The surface 102E of the male mold 102B is preferably generally convex, but can be flat or even concave in places.

[0384] Particularly preferably, the male mold 102B has a plurality of (convex) convex portions for forming a plurality of bottom portions 3 (simultaneously / in one molding step), as already described above with reference to Figure 4 To explain.

[0385] As mentioned above about Figure 4 1 and the corresponding production method illustrated in , the molding tool 102 may comprise only the female mold 102A or only the male mold 102B, or only one of the two molds 102A, 102B is used during (thermo)forming. In this case, the plastic sheet 200 is preferably forced against the female mold 102A or the male mold 102B, in particular pneumatically and / or by means of a gas blown onto the plastic sheet 200, so as to adapt to the shape of the respective mold. Alternatively or additionally, a negative pressure may be generated, for example, by sucking air or another gas from the respective mold. Alternatively or additionally, a stamp or other mechanical force means may be used.

[0386] Particularly preferably, both the female mold 102A and the male mold 102B are provided or used during the formation of the bottom portion(s) 3, or are provided or used to form the bottom portion(s) 3. In this case, preferably, the male mold 102B is pressed against the female mold 102A and / or vice versa and / or the plastic sheet 200 is pressed or formed between the female mold 102A and the male mold 102B. Thus, preferably, a mechanical force is applied to the plastic sheet 200 by means of the molds 102A, 102B. In this sense, one of the molds 102A, 102B can act as an impression of the other mold 102B, 102A.

[0387] Preferably, even when two molds 102A, 102B are provided / used, blowing a gas and / or generating a negative pressure are additionally used.

[0388] One of the molds 102A, 102B or the surfaces 102D, 102E may also be formed or provided only partially, in particular only in the region of the bottom portion to be formed which needs to be formed more accurately. For example, the male mold 102B or its (convex) surface 102E may be provided only in the region where the application channel 7 is formed, or even only in the region where the predetermined breaking zone 9 is formed. In this case, preferably, the plastic sheet 200 is forced against the respective mold 102A in other regions only by means of gas and / or negative pressure.

[0389] The molding tool 102, in particular the female mold 102A and / or the male mold 102B, is preferably configured for (thermo)forming the predetermined breaking zone 9, the recess 15 and / or the projection 17, in particular during a (thermo)forming step of the production method.

[0390] The molding tool 102 , in particular the female mold 102A and / or the male mold 102B, preferably comprises one of the molding means or generating means 102C for (thermo)molding the predetermined breaking zone 9 , the groove 15 and / or the projection 17 .

[0391] The forming means 102C is preferably shaped to correspond to the (desired) predetermined breaking zone 9, in particular to a projection or convexity 102F in the female mold 102A and / or a groove or recess 102G in the male mold 102B.

[0392] According to the reference later Figure 23 to Figure 25 A fifth embodiment of the invention may also provide a protrusion or convexity 102F in the male mold 102B and / or a groove or recess 102G in the female mold 102A for producing / forming a predetermined fracture zone 9. The molding device 102C preferably has a shape, size and / or dimensions corresponding to or identical to the (desired) predetermined fracture zone 9, for example, with respect to the angle W and / or the depth D.

[0393] In particular, the shaping means 102C is elongated and / or wedge-shaped, preferably like the predetermined breaking zone 9. In the case of a surface protrusion, its height preferably corresponds to or is identical to the (desired) depth D of the predetermined breaking zone 9. In the case of a surface indentation, its depth preferably corresponds to or is identical to the (desired) depth D of the predetermined breaking zone 9.

[0394] The shaping device 102C or the protrusion 102F preferably has a sharp edge or a sharp ridge.

[0395] Preferably, the radius of curvature at the edge / ridge of the forming device 102C / protrusion 102F is smaller than 15% or 10%, in particular smaller than 5% or 2%, of the height of the forming device 102 / protrusion 102F.

[0396] Preferably, the radius of curvature at the edge / ridge of the molding device 102C / protrusion 102F is smaller than 50 μm or 20 μm, in particular smaller than 10 μm or 5 μm.

[0397] Preferably, the grooves 15 have the same or a corresponding radius of curvature at their valleys, and / or the protrusions 17 have the same or a corresponding radius of curvature at their ridges.

[0398] The molding device 102C may be embodied / formed / provided only in the female mold 102A (e.g., as Fig.19 and Fig. 20 ), only in the male mold 102B (not shown), or in both the female mold 102A and the male mold 102B (e.g., as shown in Fig.21 and Fig. 22 ).

[0399] In the case of a female mold 102A, the molding device 102C is preferably configured as a protrusion or projection 102F in the female mold 102A and / or in the (concave) cavity formed by the female mold 102A and / or the (overall concave) surface 102D.

[0400] In the case of the male mold 102B, the forming means 102C is preferably configured as a recess or indentation 102G in the male mold 102B and / or in the (convex) cavity formed by the male mold 102B and / or the (integrally convex) surface 102E.

[0401] Preferably, when the plastic sheet 200 is forced against the female mold 102A and / or the male mold 102B, it conforms to the shape of the respective molds 102A, 102B. Specifically, the plastic sheet 200 lies flat against the female mold 102A or surface 102D and / or the male mold 102B or surface 102E.

[0402] Particularly preferably, the plastic sheet 200 (also) adapts or lies flat on the forming device 102C, the protrusion 102F and / or the recess 102G (especially when forced against the forming device 102C, the protrusion 102F and / or the recess 102G), thereby forming a predetermined breaking zone 9, a groove 15 and / or a protrusion 17.

[0403] Depending on the desired form of the predetermined breaking zone 9, the forming device 102C is shaped accordingly.

[0404] The shaping device 102C can be provided only in the region of the molding tool 102, in particular one or both molds 102, 102B, in which the application channel 7 is formed or is to be formed. Alternatively, the shaping device 102C can also be provided in the region in which the rim 8 is formed.

[0405] When forming the bottom portion 3, in particular in the shaping step, the predetermined breaking zone 9 is or will be formed only where the shaping means 102C are provided.

[0406] When the forming device 102C is provided only in the region where the application channel 7 is formed or is to be formed, the predetermined breaking zone 9 is or will be formed only in the region of the application channel 7 accordingly. Figures 9 to 11 The first embodiment shown in and / or according to Fig.12 One of the application packages 1 or the bottom part 3 of the second embodiment shown in and / or any other embodiment in which the predetermined breaking zone 9 is provided only at the application channel 7 can be formed / produced in this way.

[0407] When the forming device 102C is also provided in the region where the edge 8 is formed or to be formed, the predetermined breaking zone 9 is or will be formed accordingly in the region of the edge 8. Figures 13 to 16 The third embodiment shown in and / or according to Fig.17 and Fig.18 The fourth embodiment shown in FIG. 1 and / or any other embodiment in which the predetermined breaking zone 9 is also provided at the edge 8 (e.g. also at Figures 1 to 3 One of the application packages 1 or the bottom part 3 (the embodiment shown in FIG. 4 ) can be formed / produced in this way.

[0408] Preferably, when two molds 102A, 102B are provided or in the area where two molds 102A, 102B are provided, the molds 102A, 102B or their surfaces 102D, 102E at least substantially correspond to each other. In particular, the surfaces 102D, 102E are at least substantially identical or have at least substantially the same shape, except for having opposite curvatures. However, in particular areas where the predetermined breaking zone 9 is formed or is to be formed, the molds 102A, 102B or their surfaces 102D, 102E may be shaped differently.

[0409] Preferably, Fig.19 and Fig. 20 In the embodiment shown in , only the female mold 102A comprises the shaping means 102C. In particular, when a projection or convexity 102F is provided on the female mold 102A or the surface 102D, in particular in the area where the application channel 7 or the predetermined breaking zone 9 is formed or to be formed, no corresponding groove or notch is provided on the male mold 102B.

[0410] like Fig. 20 As can best be seen in FIG. 1 , this preferably results in a predetermined breaking zone 9 without a protrusion 17 and / or with a reduced thickness T. In particular, in this way, a predetermined breaking zone 9 can be formed according to Fig.12 An application package 1 without a protrusion 17 of the second embodiment shown in and / or any other embodiment.

[0411] Alternatively, the molding device 102C may be embodied / provided on the two molds 102A, 102B, such as Fig.21 and Fig. 22 In particular, one mold 102A, 102B may include a projection or convexity 102F and the other mold 102B, 102A may include a corresponding recess or notch 102G, in particular with the same or similar or corresponding angle W and / or height / depth D. In this way, depending on whether the forming device 102C is provided only in the area of ​​the application channel 7 to be formed or also in the area of ​​the edge 8 to be formed, it is preferably possible to form / produce an application package 1 with a recess 15 and a corresponding projection 17, for example according to Figures 9 to 11 The first embodiment shown in Figures 13 to 18 The administration package 1 of the third or fourth embodiment shown in FIG.

[0412] It is also possible that the parts of the molding device 102C on different molds 102A, 102B correspond to each other only in certain areas, but are different in other areas.

[0413] For example, the forming device 102C or the surface 102D may include a protrusion or convexity 102F, which extends along both the area where the application channel 7 is formed or to be formed and the area where the edge 8 is formed or to be formed, while the forming device 102C or the surface 102E includes a groove or notch 102G only in the area where the application channel 7 is formed or to be formed, but does not include a groove or notch 102G in the area where the edge 8 is formed or to be formed. In this way, preferably, it is possible to form / produce according to Figures 13 to 16 An application package 1 of the third embodiment is shown in FIG.

[0414] The shaping device 102C may be formed integrally with the molding tool 102, in particular the female mold 102A and / or the male mold 102B or their respective surfaces 102D, 102E.

[0415] exist Fig.19 and Fig. 20 In the example shown in FIG. 1 , the shaping means 102C is preferably a protrusion or convex portion 102F formed integrally with the mold 102A or the surface 102D. Depending on the desired shape of the predetermined breaking zone 9, the other mold 102B or the surface 102E may additionally or alternatively include an integrally formed groove or recess 102G, for example, Fig.21 and Fig. 22 As shown in .

[0416] Preferably, the apparatus 100 can be adapted for producing predetermined breaking zones 9 of different shapes.

[0417] As explained above, the molding tool 102 (particularly the molds 102A, 102B) is preferably replaceable. The apparatus 100 can be adapted to produce predetermined breaking zones 9 of different shapes by replacing the molding tool 102 (particularly one or both molds 102A, 102B) with a molding tool 102 having a different forming device 102C.

[0418] Particularly preferably, the shaping device 102C is displaceable, adjustable and / or replaceable, in particular within the molding tool 102 or the respective mold 102A, 102B and / or without replacing the entire molding tool 102 or the respective mold 102A, 102B. In particular, the apparatus 100 can preferably be adapted to produce predetermined breaking zones 9 of different shapes without replacing the entire molding tool 102 or the respective mold 102A, 102B.

[0419] Preferably, the molding device 102C forms a displaceable, adjustable and / or replaceable component of the molding tool 102 .

[0420] For example, the molding device 102C may be designed as one or more inserts for the molding tool 102 or the mold 102A, 102B. Fig. 20 and Fig. 22 Indicated very schematically by means of dotted lines.

[0421] The molding device 102C or insert can be preferably fixed to the molding tool 102 or the mold 102A, 102B in a force fit and / or form fit manner. For example, the molding device 102C or insert can be screwed into a corresponding screw hole of the molding tool 102 or the mold 102A, 102B.

[0422] To produce a different type of application package 1 or predetermined breaking zone 9, or to adapt the device 100 or the molding tool 102 thereto, the molding device 102C or the insert can preferably be exchanged for a different molding device 102C or the insert. Preferably, in this way, an adaptation is possible without replacing the (entire) molding tool 102 or the mold 102A, 102B.

[0423] Alternatively or in addition, the shaping device 102C may be adjustable or displaceable. Preferably, the shaping device 102C is adjustable or displaceable orthogonally and / or parallel to the surfaces 102D, 102E.

[0424] In particular, the height / depth D and / or angle W of the molding device 102C (particularly the protrusion 102F and / or the recess 102G) and the resulting predetermined fracture zone 9 may be adjustable. For example, the degree to which the molding device 102C is inserted or screwed into the molding tool 102 or the mold 102A, 102B may be adjustable.

[0425] Preferably, the shaping device 102C is adjustable or displaceable to determine / change the position of the predetermined breaking zone 9 within the application channel 7, for example, to move it further to the axial end 7A or further away from the axial end 7A.

[0426] Fig. 20 An enlarged detail is shown for producing a material having a reduced thickness T and / or according to Fig.12 The second embodiment shown in and / or having a female mold 102A and a male mold 102B with non-corresponding surfaces 102D, 102E, in particular an example of a predetermined breaking zone 9 of a molding device 102C provided / formed only in the female mold 102A or on the surface 102D.

[0427] The plastic sheet 200 is preferably squeezed or compressed between the molds 102A, 102B, in particular in the region of the molding means 102C and / or between the molding means 102C or the projection 102F formed thereby and the surface 102E of the other mold 102B (directly) opposite the molding means 102C.

[0428] Due to the squeezing / compression and / or differently shaped surfaces 102D, 102E and / or the forming device 102C, the thickness T of the plastic sheet 200 is preferably reduced in the region of the forming device 102C. In this way, preferably, a predetermined breaking zone 9 is produced.

[0429] The forming device 102C or the protrusion 102F preferably penetrates the plastic sheet 200 .

[0430] Preferably, only the (mostly) outer layers of the plastic sheet 200, in particular the outer thermoformable layer 201, preferably also the cyclic olefin copolymer layer 202, and optionally also the inner thermoformable layer 203 are affected, penetrated and / or squeezed / compressed by the forming device 102C or during thermoforming.

[0431] Preferably, the innermost layers (in particular at least the barrier layer 204 and the sealing layer 205) remain intact or at least substantially not affected, penetrated or squeezed / compressed by the forming device 102C or during the forming step. Thus, preferably, the sealing and barrier quality of the plastic sheet 200 or the bottom portion 3 is not impaired by or at the predetermined breaking zone 9.

[0432] The height of the forming device 102C or the protrusion 102F is preferably less than the thickness of the plastic sheet 200, and is particularly preferably less than the thickness of the cyclic olefin copolymer layer 202 or less than the sum of the outer thermoformable layer 201 and the cyclic olefin copolymer layer 202, and optionally the inner thermoformable layer 203.

[0433] Particularly preferably, the height of the shaping means 102C or of the projection 102F corresponds to the (desired) depth D of the recess 15 to be produced.

[0434] The height of the molding device 102C or the protrusion 102F is preferably at least 0.05 mm or more and / or at most 0.5 mm or less. Particularly preferred values ​​are 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm.

[0435] In a further embodiment (e.g., Fig.21 and Fig. 22In the embodiment shown in FIG. 1 , as explained above, the molds 102A, 102B may have corresponding surfaces 102D, 102E in the region where the predetermined fracture zone 9 is formed or should be formed. In this case, preferably, the molding device 102C comprises a protrusion or convex portion 102F on one mold and a corresponding groove or notch 102G on the other mold.

[0436] Then, the plastic sheet 200 (in particular all its layers) is pushed inwards or bent or kinked during (thermo)forming, in particular from the protrusion 102F of the mold 102A into the recess 102G of the mold 102B, or vice versa, for example, as Fig. 22 In this way, preferably, a predetermined breaking zone 9 with a groove 15 and a corresponding protrusion 17 is formed.

[0437] In this embodiment, the plastic sheet 200 is preferably at least substantially not squeezed / compressed, in particular at least substantially also none of the outer layers are squeezed / compressed.

[0438] Preferably, all layers of the plastic sheet 200 are affected, since all layers bend / kink inwardly. However, the integrity of the inner layers, in particular at least the barrier layer 204 and the sealing layer 205, is preferably maintained. Therefore, also in this case, the sealing and barrier quality of the plastic sheet 200 or the bottom part 3 is preferably not impaired by or at the predetermined breaking area 9.

[0439] The corresponding surfaces 102D, 102E may be present only in certain areas and / or the plastic sheet 200 may be bent / kinked inwardly only in certain areas or squeezed / compressed in other areas. For example, the plastic sheet 200 may be bent / kinked in an area where the application channel 7 is formed or to be formed and squeezed / compressed in an area where the edge 8 is formed or to be formed, so that a plastic sheet 200 according to the invention can be formed. Figures 13 to 16 One of the third embodiments shown in FIG. 1 is an application package 1 or a bottom part 3 .

[0440] Hereinafter, a fifth embodiment of the administration package 1 is described.

[0441] Figure 23 to Figure 25 Corresponding to Figures 9 to 11 The fifth embodiment of the application package 1 is shown in FIG. Fig.23 A schematic plan view is shown from the bottom side of the application package 1, Fig.24 Show along Fig.23 A schematic cross section of the application package 1 along the line XXIV-XXIV in FIG. 1 , and Fig.25 Display marked XXV Fig.24 One zooms in on the details. Fig.24 and Fig.25The section shown in FIG. 1 is along the axis A, for example along the application channel 7 or in the region of the application channel 7 .

[0442] 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 are towards the outside of the bottom portion 3 .

[0443] Compared to the previous embodiment, the positions of the groove 15 and the protrusion 17 are preferably interchanged and / or the predetermined breaking zone 9 is preferably bent / kinked in opposite directions.

[0444] and Figures 9 to 11 Compared to the first embodiment, the predetermined breaking zone 9 of the fifth embodiment does not narrow the application channel 7. Instead, preferably, a widened flow channel or cross-sectional enlargement or diffuser 20 is formed at / in or by the predetermined breaking zone 9, in particular in the cavity 5 or the application channel 7.

[0445] The height and / or width of the application channel 7 is preferably enlarged at / in or by the predetermined breaking zone 9 by at least 0.05 mm or more and / or at most 0.5 mm or less, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm.

[0446] Preferably, the application channel 7 is widened or its (flow) cross section is enlarged or the diffuser 20 is formed by means of a groove 15. In particular, the groove 15 is formed on the inner surface 18, i.e. the surface 18 is recessed in the region of the predetermined breaking zone 9, thereby widening the channel and / or enlarging the (flow) cross section.

[0447] When the application package 1 is opened (particularly by folding / bending along the predetermined breaking zone 9 or groove 15), a widened flow channel or cross-sectional enlargement or diffuser 20 is preferably formed or positioned at the open end 7B, particularly where the drug product 2 exits the application package 1.

[0448] The widening of the passageway at the open end 7B allows easier discharge of the drug product 2. This may be advantageous, for example, for a more viscous fluid.

[0449] The preferred shapes, sizes and / or other features of the predetermined breaking zone 9 (especially the groove 15 and / or the protrusion 17 ) described above for other embodiments are preferably also correspondingly applicable to the fifth embodiment.

[0450] Obviously, in some of the explanations and definitions of the previous embodiments, the term "external surface 16" needs to be replaced by "inner 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 inner surface 18 to the lowest area of ​​the groove 15, in particular the distance measured perpendicular to the main plane, and / or the angle W is preferably the smaller angle between the main extension plane of the inner surface 18 and the main extension plane of the inclined or slanted surface of the groove 15, in particular at the edge of the predetermined breaking zone 9 or groove 15 (i.e. the edge where the inner surface 18 bends outwards and / or begins to form a groove / recess).

[0451] Particularly preferably, the explanations and preferred values ​​for the recess 15 and / or the projection 17 (in particular with regard to the thickness T, the depth D and / or the angle W) preferably also apply accordingly or correspondingly to the fifth embodiment. Fig.25 An angle W of about 40° (an opening angle of about 100°) is exemplarily shown.

[0452] In the fifth embodiment, similarly to the first embodiment, the predetermined breaking zone 9 (in particular the groove 15 and / or the projection 17 ) preferably extends only over the cavity 5 (in particular the application channel 7 ).

[0453] Particularly preferably, the predetermined breaking zone 9 extends, in particular transversely or perpendicularly to the axis A / channel 7 , over the entire cavity 5 or application channel 7 or its width.

[0454] However, the predetermined breaking zone 9 may also extend only partially over the cavity 5 or application channel 7 or its width. For example, the area near the edge 3A and / or where the cavity 5 or application channel 7 transitions into the rim 8 may be (already) free of a predetermined breaking zone 9.

[0455] The above explanations and features concerning the entire or partial extension of the predetermined breaking zone 9 preferably also apply to the previous embodiments (eg the first embodiment) in which the predetermined breaking zone 9 does not extend over the edge 8 .

[0456] Although according to Figure 23 to Figure 25 The illustrative example of the fifth embodiment of the invention shows a predetermined breaking zone 9 extending only over the cavity 5 / application channel 7, but the predetermined breaking zone 9 may also extend beyond the cavity 5 / application channel 7, in particular also over the entire width of the rim 8 and / or the application package 1 or the bottom part 3. As already explained with respect to the previous embodiments, in this case both the groove 15 and the projection 17 may extend beyond the cavity 5 / application channel 7 (as in the fourth embodiment), or only one of the groove 15 or the projection 17 may extend beyond the cavity 5 / application channel 7 (as in the third embodiment).

[0457] In addition, although according to Figure 23 to Figure 25The illustrative example of the fifth embodiment shows the predetermined breaking zone 9 embodied as a bend / kink and / or having both a recess 15 and a projection 17, but it is also possible to provide only a recess 15 on the inner surface 18 without a projection, in particular similar to the second embodiment.

[0458] Therefore, any combination of different embodiments is possible. In particular, the fifth embodiment can be combined with any of the previous embodiments.

[0459] The molding tool 102 (in particular the molding device 102C) is preferably constructed / shaped accordingly to form the bottom part 3 (in particular the predetermined breaking zone 9) according to the fifth embodiment, that is, having a groove 15 on the inner surface 18 and / or a protrusion 17 on the outer surface 16.

[0460] Specifically, the female mold 102A includes a recess 102G and / or the male mold 102B includes a protrusion 102F. Fig. 27 A female mold 102A having a corresponding recess 102G is illustratively shown.

[0461] Compared to Fig.21 and Fig. 22 The positions of the previously described molding tool 102 or molding device 102C, the protrusion 102F and the recess 102G shown in FIG. 1 are preferably interchanged for forming / producing the predetermined breaking zone 9 of the fifth embodiment. Otherwise, even without repetition, the above explanations and features are preferably applicable accordingly or correspondingly.

[0462] Likewise, only a projection 102F may be provided on the male mold 102B and no projection or recess may be provided on the female mold 102A, particularly with Fig.19 and Fig. 20 102C is complementary to the forming device 102C shown in , to form a predetermined breaking zone 9 with a groove 15 on the inner surface 18 and with a reduced wall thickness and / or without a protrusion 17. Otherwise, even without repetition, the above explanations and features preferably apply accordingly or correspondingly.

[0463] If the molding device 102C is designed as an insert and / or replaceable component in the respective molds 102A, 102B, the molding device 102 can also be adapted for producing the predetermined fracture zone 9 of the fifth embodiment by interchanging such inserts, i.e., providing an insert of the female mold 102A in the male mold 102B, and vice versa.

[0464] Fig.26 and Fig. 27 An exemplary preferred embodiment of the female mold 102A of the molding tool 102 is shown in a schematic perspective view. Here, Fig.26 A female mold 102A having a convex portion 102F for forming the predetermined breaking zone 9 is shown, and Fig. 27 A negative mold 102A having a notch 102G for forming the predetermined breaking zone 9 is shown.

[0465] Even without duplication, especially if combined Figures 19 to 22 The above explanations and features described preferably also apply accordingly or correspondingly to Fig.26 and Fig. 27 Likewise, the following explanation preferably also applies to the previously combined Figures 19 to 22 The mold described.

[0466] Preferably, Fig.26 The negative mold 102A can be used to produce an application package 1 or a base part 3 according to the first embodiment and / or having a recess 15 on the outer surface 16.

[0467] Preferably, Fig. 27 The negative mold 102A can be used to produce an application package 1 or a bottom part 3 according to the fifth embodiment and / or having a recess 15 on the inner surface 18.

[0468] To produce an application package 1 or a bottom part 3 also having a predetermined breaking zone 9 at the edge 8, the forming means 102C (in particular the projection 102F or the recess 102G) preferably extend beyond the area for forming the cavity 5 (in particular the application channel 7) and / or beyond the concave surface 102D. The following explanations and features preferably also apply to these molds 102A.

[0469] like Fig.26 and Fig. 27 As shown in , the (female) mold 102A preferably includes a plurality of (air) vents or vent holes 102H. Preferably, the corresponding male mold 102B (also) includes a plurality of (air) vents or vent holes (not shown).

[0470] The ventilation holes 102H are preferably distributed over the entire surface 102D, 102E of the mold 102A, 102B, in particular evenly and / or along the axis A and / or mirror-symmetrically to the axis A.

[0471] In a plan view or in cross-section, the vent 102H is preferably at least substantially circular or elliptical or oval.

[0472] Preferably, the vent holes 102H extend through the entire mold 102A, 102B.

[0473] The ventilation holes 102H are preferably provided so that air can escape from the moulds 102A, 102B when the bottom part 3 is thermoformed, in particular deep drawn.

[0474] Specifically, when the plastic sheet 200 is pressed into and / or onto the molds 102A, 102B by negative pressure and / or positive pressure, the air between the plastic sheet 200 and the respective molds 102A, 102B escapes to the environment through the vent holes 102H. In this way, preferably, the plastic sheet 200 can be laid flat on the mold(s) 102A, 102B without any damage from the air trapped between the plastic sheet 200 and the mold(s) 102A, 102B.

[0475] Particularly preferably, as in Fig.26 and Fig. 27 As indicated therein, one or more ventilation holes 102H, particularly preferably (exactly) three ventilation holes 102H, are (also) positioned or configured or formed in / at the molding device 102C (particularly the protrusion 102F and / or the recess 102G).

[0476] Preferably, by means of ventilation holes 102H in / at the forming device 102C, it is ensured that the plastic sheet 200 is (snugly) abutted against the forming device 102C and / or the predetermined breaking zone 9 is produced / formed in the desired shape.

[0477] The ventilation holes 102H or at least (several) ventilation holes 102H in / at 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.

[0478] The ratio of the diameter of one ventilation hole 102H located in the application channel 7 to the width of the application channel 7 (particularly in / at the molding device 102C) is preferably greater than 1:7 and / or less than 1:3. Particularly preferably, the ratio is about 1:6, 1:5 or 1:4.

[0479] Preferably, the diameter of the ventilation hole(s) 102H located at the forming device 102C is greater than or approximately the same as the height of the forming device 102H.

[0480] The diameter of the ventilation hole(s) 102H located at the shaping device 102C is preferably smaller than the extent of the shaping device 102C in the direction of the axis A or the longitudinal extension of the application channel 7 .

[0481] Preferably, all vent holes 102H of the mold 102A and / or 102B have the same shape and / or size. However, vent holes 102H having different diameters may also be provided. For example, the vent hole(s) 102H at / in the molding device 102C may be smaller or larger than the vent hole 102H formed outside the molding device 102C.

[0482] The position of the ventilation hole 102H can be seen on the finished application package 1 or on the bottom part 3. In particular, the bottom part 3 can have a deformation 21 (such as a mark, a protrusion, a ridge or an imprint) at a corresponding position, for example, along the axis A. This is useful for example in combination with Figure 5 and Figure 7 This is particularly true of the preferred plastic sheet 200 described.

[0483] Particularly preferably, the application package 1 or the bottom part 3 has one or more deformations 21 (such as marks, protrusions, bumps or imprints) coming from or resulting from the ventilation holes 102H at the predetermined breaking zone 9. By way of example, Fig.25 A deformation 21 at the predetermined breaking zone 9 is shown by means of a dashed line.

[0484] The deformation 21 preferably has a diameter and / or shape (in a plan view) similar to the diameter and / or shape of the respective vent hole 102H.

[0485] In particular, by means of one or more deformations 21 at the predetermined breaking zone 9, the breaking behavior, in particular the brittleness, can be enhanced.

[0486] Individual aspects, features and method steps may be implemented independently of each other, but may also be implemented in any desired combination or order.

[0487] Reference Mark List

[0488] 1: Application packaging

[0489] 1A: Axial end of the packaging application

[0490] 2: Pharmaceutical products

[0491] 3: Bottom part

[0492] 3A: Edge

[0493] 4: Cover

[0494] 5: Cavity

[0495] 6: Chamber

[0496] 7: Application channel

[0497] 7A: Axial end of application channel

[0498] 7B: Open end

[0499] 8: Edge

[0500] 9: Predetermined fracture zone

[0501] 10: Cutting Edge

[0502] 11: Secondary packaging

[0503] 12: Base part

[0504] 13: Lid

[0505] 14: Container

[0506] 15: Groove

[0507] 16: Outer surface

[0508] 17: Protrusion

[0509] 18: Inner surface

[0510] 19: Nozzle / cross section reduction

[0511] 20: Diffuser / cross section expansion

[0512] 21: Transformation

[0513] 100: Equipment

[0514] 101: Heating device

[0515] 101A: Upper heating plate

[0516] 101B: Lower heating plate

[0517] 102: Molding tools

[0518] 102A: Female mold

[0519] 102B: Male mold

[0520] 102C: Molding device

[0521] 102D: (concave) surface

[0522] 102E: (convex) surface

[0523] 102F:convex part

[0524] 102G: Notch

[0525] 102H: Ventilation hole

[0526] 103: Filling device

[0527] 104: Covering device

[0528] 200: Plastic sheet (thin plate, thin sheet)

[0529] 201: Outer thermoformable layer

[0530] 202: Cyclic olefin copolymer layer

[0531] 203: Inner thermoformable layer

[0532] 204: Barrier layer

[0533] 205: Sealing layer

[0534] 206: Middle layer

[0535] 207a to 207d: bonding layer

[0536] 208: Adhesive layer

[0537] 300: Cover sheet

[0538] 301: Protective layer

[0539] 302: First barrier layer

[0540] 303: Middle layer

[0541] 304: Second barrier layer

[0542] 305: Sealing layer

[0543] 306: Connection layer

[0544] 307: Adhesive layer

[0545] A: Axis

[0546] D: Depth

[0547] T:Thickness

[0548] W: angle

Claims

1. A method for producing and filling an administration package (1) for a preferably liquid pharmaceutical product (2), the method comprising the following steps: - at least partially heating the preferably multilayer plastic sheet (200), in particular to thermoforming temperature, - forming a bottom part (3) of the application package (1) by stretching the plastic sheet (200) onto and / or into a molding tool (102), the bottom part (3) having a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) surrounding the cavity (5), - filling the cavity (5) with the pharmaceutical product (2), - covering the cavity (5) with a cover (4) and fixing the cover (4) to the rim (8) so that the cavity (5) is completely closed, Features A predetermined breaking zone (9) is produced in the bottom part (3) using the molding tool (102) and / or during the step of forming the bottom part (3).

2. The method according to claim 1, wherein: The predetermined breaking zone (9) is produced in the bottom part (3) exclusively or substantially using the molding tool (102) and / or exclusively or substantially during the step of forming the bottom part (3).

3. The method according to claim 1 or 2, wherein: The predetermined breaking zone (9) is produced without cutting and / or without using a cutting tool.

4. The method according to one of the preceding claims, wherein: The chamber (5) comprises a chamber (6) and an application channel (7) in fluid communication with the chamber (6), preferably wherein: The application channel (7) is elongated and / or straight and / or has a smaller diameter and / or volume than the chamber (6).

5. The method according to one of the preceding claims, wherein: The predetermined breaking zone (9) is or comprises a groove (15) on the outer surface (16) of the administration package (1).

6. The method according to claim 1, wherein: The predetermined breaking zone (9) is or comprises a groove (15) on the inner surface (18) of the administration package (1).

7. The method according to claim 5 or 6, wherein: The predetermined breaking zone (9) comprises a protrusion (17) opposite to the groove (15).

8. The method according to one of the preceding claims, wherein: The predetermined breaking region (9) is a region thinner than a region of the bottom portion (3) surrounding the breaking region (9).

9. The method according to claim 1, wherein: The predetermined breaking zone (9) is a region which preferably at least substantially has the same thickness as the region of the bottom portion (3) surrounding the breaking zone (9).

10. The method according to one of the preceding claims, wherein: The predetermined breaking zone (9) is formed as a kink in the wall of the bottom portion (3).

11. The method according to one of the preceding claims, wherein: A moulding tool (102) having a female mould (102A) and a male mould (102B) is used for forming the bottom part (3).

12. The method according to one of the preceding claims, wherein: The predetermined breaking zone (9) is formed only in the region of the chamber (5), in particular the application channel (7) of the chamber (5).

13. The method according to one of the preceding claims, wherein: Different application packages (1) are formed with predetermined breaking zones (9) having different shapes, wherein a forming device (102C) for forming the predetermined breaking zones (9) is replaced and / or adjusted to form the different application packages (1).

14. The method according to one of the preceding claims, wherein: The method is performed with a device (100) according to one of claims 15 to 24 and / or produces an application package (1) according to one of claims 25 to 33.

15. A device (100) for producing an administration package (1) for a preferably liquid pharmaceutical product (2), in, The device (100) comprises a heating device (101) for at least partially heating a preferably multi-layered plastic sheet (200) to a thermoforming temperature. The device comprises a molding tool (102) for forming a bottom portion (3) of the application package (1) by stretching the plastic sheet (200) onto and / or into the molding tool (102), wherein the bottom portion (3) comprises a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) surrounding the cavity (5), Features The molding tool (102) has molding means (102C) for forming a predetermined breaking zone (9) in the bottom portion (3).

16. The device (100) according to claim 15, wherein The device (100) is configured to produce the predetermined breaking zone (9) in the bottom part (3) only or essentially by means of the molding tool (102).

17. The device (100) according to claim 15 or 16, wherein: The device (100) is configured to produce the predetermined breaking zone (9) in the bottom portion (3) without cutting and / or without using a cutting tool.

18. The device (100) according to one of claims 15 to 17, wherein: The molding device (102C) forms protrusions (102F) and / or recesses (102G) on surfaces (102D, 102E) of the molds (102A, 102B) of the molding tool (102).

19. The device (100) according to one of claims 15 to 18, wherein: The molding device (102C) is an adjustable and / or replaceable component of the molding tool (102).

20. The device (100) according to one of claims 15 to 19, wherein: The molding tool (102) has a female mold (102A) and a male mold (102B).

21. The device (100) according to claim 20, wherein The female mold (102A) and the male mold (102B) have surfaces (102D, 102E) of different shapes, in particular so that the device (100) is configured to produce a predetermined breaking zone (9) which is thinner than the area of ​​the bottom part (3) surrounding the predetermined breaking zone (9).

22. The device (100) according to claim 20, wherein The female mold (102A) and the male mold (102B) have surfaces (102D, 102E) of complementary shape, so that the device (100) is configured to produce a kink in the wall of the bottom portion (3) as a predetermined breaking zone (9).

23. The device (100) according to one of claims 15 to 22, wherein: One or more vent holes (102H) of the molding tool (102) are arranged at the molding device (102C) or formed in the molding device (102C).

24. The device (100) according to one of claims 15 to 23, wherein: The device (100) is configured for carrying out the method according to one of claims 1 to 14 and / or for producing an administration package (1) according to one of claims 25 to 33.

25. An administration package (1) for a preferably liquid pharmaceutical product (2), in, The administration package (1) has a bottom part (3) having a cavity (5) for receiving the pharmaceutical product (2) and a rim (8) preferably surrounding the cavity (5), The application package (1) has a cover (4) covering and completely closing the cavity (5). The application package (1), in particular the bottom portion (3), has a predetermined breaking area (9) for opening the application package (1) by breaking the predetermined breaking area (9). Features The predetermined breaking zone (9) is produced by thermoforming, and / or The cross-section of the application channel (7) of the chamber (5) is reduced or the nozzle (19) is formed in the predetermined breaking zone (9), and / or The predetermined breaking zone (9) extends only above the chamber (5), in particular the application channel (7) of the chamber (5), and / or The predetermined breaking zone (9) is formed as a kink in the wall of the bottom portion (3) and / or the thickness (T) of the wall of the bottom portion (3) is at least substantially constant in a region including and surrounding the predetermined breaking zone (9).

26. The administration package (1) according to claim 25, wherein The predetermined breaking zone (9) is produced exclusively or substantially by means of thermoforming.

27. The administration package (1) according to claim 25 or 26, wherein The predetermined breaking zone (9) is produced without cutting and / or without using a cutting tool.

28. The application package (1) according to one of claims 25 to 27, wherein The predetermined breaking zone (9) has a protrusion (17) on the outer surface (16) of the application package (1), in particular the bottom part (3), and a groove (15) on the inner surface (18) of the bottom part (3).

29. The application package (1) according to one of claims 25 to 27, wherein The predetermined breaking zone (9) has a groove (15) on the outer surface (16) of the application package (1), in particular the bottom part (3), and a protrusion (17) on the inner surface (18) of the bottom part (3).

30. The administration package (1) according to claim 28 or 29, wherein The groove (15) extends over the cavity (5), in particular the application channel (7), and the rim (8), and the projection (17) extends only over the cavity (5) or over the cavity (5) and the rim (8).

31. The application package (1) according to one of claims 25 to 30, wherein The chamber (5) comprises a chamber (6) and an application channel (7) in fluid communication with the chamber (6), preferably wherein: The application channel (7) is elongated and / or straight and / or has a smaller diameter and / or volume than the chamber (6).

32. The application package (1) according to one of claims 25 to 31, wherein The bottom portion (9) comprises deformations (21) from the vent hole (102H) of the molding tool (102), in particular one or more deformations (21) at the predetermined breaking zone (9).

33. The application package (1) according to one of claims 25 to 32, wherein The application package ( 1 ) is produced with a method according to one of claims 1 to 14 and / or with a device ( 100 ) according to one of claims 15 to 24.

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