Administration packaging, production apparatus and production method

Abstract

This invention provides an application package for a pharmaceutical product, and an apparatus and method for producing and filling the application package. A predetermined fracture zone is created by thermoforming to open the application package by breaking the fracture zone. For this purpose, the apparatus includes a molding tool having a molding device for forming the predetermined fracture zone. Alternatively or further, the predetermined fracture zone may form a reduced cross-section or nozzle of an application channel of the application package. Alternatively or further, the predetermined fracture zone may extend only above the application channel and not above an edge of the application package. Alternatively or further, the predetermined fracture zone may be formed as a knot.

Description

Application, packaging, production equipment and production methods This invention relates to an application package for a preferred liquid pharmaceutical product, a method for producing and filling an application package, and an apparatus for producing an application package. Packaging is applied, particularly through thermoforming. Thermoforming is a method in which a plastic sheet (especially a film or foil) is heated to a bendable temperature and then formed into a specific shape in a mold. Furthermore, it is preferable to trim the plastic sheet after forming in the mold. The application packaging is particularly suitable for packaging a liquid pharmaceutical product that contains or stores the product and can also be used to administer the product to a patient. The packaging is particularly suitable for a pipette or can be used as or converted into a pipette. The pharmaceutical product is preferably a liquid and / or a product to be applied to the skin and / or fur of a patient (preferably a pet, such as a cat or dog). EP 2 998 098 A1 and EP 2 998 099 A1 relate to methods for producing and filling an application package for a liquid pharmaceutical product. The package is produced by a thermoforming process in which a deep-drawn film is heated to plasticize at least in a sub-region, the plasticized region is deep-drawn into a molding tool to form a chamber for the product and a tubular application channel leading to the chamber, the product is introduced into the chamber, and a cover film is used to cover the filled deep-drawn film to seal the chamber and the application channel. In an end region, the application channel has a crack or groove forming a predetermined fracture zone, at which the tip of the application channel can break to open the application package. The predetermined fracture zone is created before heating the deep-drawn film. 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 crack or groove is created by cutting through the PP layer. The methods disclosed in EP 2 998 098 A1 and EP 2 998 099 A1 have several drawbacks. First, in addition to the thermoforming steps that form the chamber and application channel, the creation of the groove also requires an additional step. Furthermore, when the membrane has a composition different from the one described and / or the setup of the system used for cutting is more complex, the method of creating a predetermined fracture zone by cutting through the PP layer does not work. EP 2 432 701 B1 relates to a non-resealable thermoformed package for liquids or pastes. The package includes a rigid shell forming a storage space for containing the substance, a fracture zone, and a clamping zone. The package can be opened by tearing off the upper portion of the clamping zone in the fracture zone. The clamping zone includes an escape path for the substance that closes naturally without pressure applied by the user, thus preventing the substance from leaking out after opening the package. The fracture zone can be weakened by creating a fracture line using a pre-cutting tool (such as a blade, laser system, or high-pressure water jet). US 2015 / 151891 A1 relates to a package for containing a fluid product, the package having a monolithic body including a detachable cap. The package includes a first laminate and a second laminate thermoformed together to form the monolithic body. Initially, the monolithic body includes a detachable cap that seals a nozzle portion for dispensing the fluid product. A user can separate the detachable cap from the monolithic body by tearing or cutting at a pre-weakened area. The pre-weakened area is formed into a perforation or score line in the monolithic body. EP 1 263 389 B1 relates to a container for a liquid or paste-like substance. The container has two separate half-doses disposed in two separate half-containers. The top of the container has two distinct pre-cut lines, one extending to the neck of both half-containers and the other to the neck of a single 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 the full dose or half dose of the product. The container can be manufactured by thermoforming to leave an open channel for filling, through which the product is filled and then welded to close the filling channel. US 5,215,221 A relates to a disposable unit-dose dispenser for a powdered drug. The dispenser has a gas chamber and a product reservoir adjacent to each other and separated by a ruptureable seal. The chamber of the dispenser is formed from 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 subsequently heat-sealed to the thermoformed blister at a break point between the gas chamber and the product reservoir. To use the dispenser, its tip is removed along one of the scoring lines. Pressure is then applied to the gas chamber by squeezing the dispenser to cause the seal to rupture and a gas jet to escape into the product reservoir, thereby fluidizing and dispensing the powdered product. Furthermore, the packaging and methods disclosed in previous technical documents have similar drawbacks. Specifically, the fracture zone is formed by perforation, scoring, or cutting, which requires an additional step in manufacturing and / or is unsuitable for certain plastic materials or requires more complex setup for certain plastic materials. Therefore, one of the objectives of this invention is to provide a solution in which the manufacture of an application package is faster, more efficient and / or simpler, and / or allows for reliable opening of the application package, preferably almost independently of the packaging material. The above problems are solved by methods such as those in technical solution 1, equipment such as those in technical solution 15, or application packaging such as those in technical solution 25. Further advantageous developments are the subject of the subsidiary technical solutions. Therefore, specifically, 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 performed using one of the apparatuses described herein, and the application package described herein is preferably produced using the method described herein. According to a first embodiment, the present invention relates to a method for producing and filling an application package for a preferred liquid pharmaceutical product. The method is preferably a thermoforming method. According to this method, at least a portion of one of the preferred multilayer plastic sheets is heated to a thermoforming temperature. Specifically, this thermoforming temperature is one at which the plastic sheet or its heated area becomes plasticized and / or the plastic sheet or its heated area is formed into a desired shape using a molding tool. Next, a plastic sheet is stretched onto and / or into a molding tool to form a bottom portion of the application package. Specifically, a bottom portion is formed having a cavity for receiving a pharmaceutical product and an edge surrounding the cavity. The edge is preferably at least substantially flat. In the next step, the cavity is filled with the drug product and then covered with a cap, which is then secured to the edge to completely seal the cavity. According to the present invention, a predetermined fracture zone is generated in the bottom portion (particularly by means of only or substantially) using a molding tool and / or during the step of forming the bottom portion. This has the advantages that no additional step is required to form the predetermined fracture zone, the fracture zone can be formed to have any desired shape, and the fracture zone can be specifically customized or adapted for different plastic materials. Specifically, a predetermined fracture zone is created before or after the step of forming the bottom portion and / or without the use of a cutting tool, without cutting, and / or without a cutting step. "Without cutting" preferably means without cutting to form the predetermined fracture zone. Therefore, the proposed method advantageously provides a simpler manufacturing method that can be used with various plastic materials. In the context of this invention, a perforation, scoring, or similar operation is preferably 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. The cavity preferably includes a chamber and an administration channel in fluid communication with and / or leading to the chamber. The administration channel is preferably elongated and / or straight and / or has a diameter and / or volume smaller than that of the chamber. Therefore, the administration package can be used as and / or transformed into a pipette, allowing the drug product to be administered directly from the package to a patient. The predetermined fracture zone is preferably configured to allow the application package to be opened by causing the package to fracture along the fracture zone. For example, the application package can be folded or bent along the predetermined fracture zone, thereby cutting the packaging material and thus opening the package. The predetermined fracture zone is preferably formed as or includes a groove on one of the outer or inner surfaces of the application package. This facilitates production and allows for simple and reliable opening of the application package and / or breaking of the predetermined fracture zone. Preferably, the predetermined fracture zone includes a protrusion opposite to the groove. Therefore, the predetermined fracture zone is preferably shaped to include a groove on an outer surface and a protrusion on an (opposite) inner surface, or vice versa. Particularly preferably, the predetermined fracture zone is formed as or includes one of the bends, knots, or creases in the bottom portion (wall). Specifically, the grooves and protrusions are formed by the bends / knots / creases. Forming the predetermined breakage area as a bend / knot / crease and / or having a protrusion in addition to a groove better allows for simple fabrication of the predetermined breakage area and / or reliable opening of the application packaging. Preferably, the predetermined fracture zone is a region having at least substantially the same thickness as a region surrounding the bottom portion of the fracture zone. In other words, the wall thickness of the bottom portion is preferably at least substantially constant in the predetermined fracture zone and the region surrounding it. This has the advantage of maintaining the integrity and / or sealing and barrier quality of the plastic material. Specifically, the material is not subjected to significantly more compression in the predetermined fracture zone than outside the predetermined fracture zone. However, depending on the needs, such as the plastic material, the predetermined fracture zone can also be a thinner area than one of the regions surrounding the bottom of the fracture zone. This can facilitate easier fracture, for example, when using a less brittle plastic material. Preferably, the molding tool has a male mold and a female mold and / or a male mold and a female mold for forming the bottom portion. This allows for very precise control over the shape of the bottom portion and / or results in small manufacturing tolerances. A predetermined fracture zone may be formed only in the region of the cavity, particularly in the region of one application channel of the cavity. In other words, the predetermined fracture zone then does not extend over the region of the edge and / or is not formed in the region of the edge. Alternatively, the predetermined fracture zone may be formed on or extend over both the cavity / application channel and the edge. Preferably, different application packages are formed having predetermined fracture zones of different shapes, wherein one of the forming devices used to form the predetermined fracture zones is replaced and / or adjusted to form different application packages. This allows for the production of different application packages in a highly efficient manner. According to a further embodiment that can also be implemented independently, the present invention relates to an apparatus for producing an application package for a preferred liquid pharmaceutical product. The apparatus is preferably configured to perform the methods described herein and / or to produce the application packages described herein. The equipment includes: a heating device for heating at least a portion of a preferred 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. The molding tool preferably includes a forming device for forming a predetermined fracture zone in the bottom portion. The forming device preferably forms a protrusion and / or a recess on a surface of a die within the molding tool. Thereby, the predetermined fracture zone can be formed as a groove and / or a bend / knot. A predetermined fracture zone can be achieved having a thickness at least substantially equal to or less than that of the material surrounding the predetermined fracture zone. The molding apparatus is preferably one of the molding tools with adjustable and / or replaceable components. This allows for easy control and / or adjustment of the desired shape of the predetermined fracture zone. This enables easy and / or efficient production of various application packages, especially application packages with different predetermined fracture zones. The molding tool preferably has a male mold and a female mold. This allows for precise control over the shape of the formed bottom portion and / or results in very small manufacturing tolerances. Preferably, the female and male molds have surfaces with complementary or corresponding shapes, preferably at least in the area where the predetermined fracture zone should be formed. In this way, preferably, a bend / knot can be formed in the wall of the bottom portion as the predetermined fracture zone, particularly with regard to a wall in the predetermined fracture zone having at least substantially the same thickness as its exterior. Preferably, the female mold has a protrusion and the male mold has a complementary / corresponding recess for forming a predetermined fracture zone, or vice versa. Alternatively, the male and female molds may have surfaces with different or non-corresponding shapes, particularly such that the device 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 protrusion, while the male mold is flat in the corresponding area, or vice versa. The molding tool (particularly the female mold and / or male mold) preferably includes vents or openings for air to escape during thermoforming. More preferably, the molding tool (particularly the female mold and / or male mold) also includes one or more vents, particularly protrusions and / or recesses, in / at the molding apparatus. According to a further embodiment that can also be implemented independently, the present invention relates to an application package for a preferred liquid pharmaceutical product. This application package is preferably manufactured using one of the methods and / or apparatuses described herein. The application package has a base portion having a cavity for receiving the drug product and a preferably flat edge surrounding the cavity. Furthermore, the application package has a cover that covers and completely seals the cavity. The cavity preferably includes a chamber for a pharmaceutical product and / or an administration channel for administering / dispensing the pharmaceutical product. The administration channel is preferably in fluid communication with the chamber. Preferably, the channel is elongated and / or straight and / or has a small diameter, cross-section and / or volume, like a chamber. The application package (particularly the bottom portion) has a predetermined fracture zone for opening the application package by breaking the predetermined fracture zone. The predetermined fracture zone is preferably created, particularly by thermoforming, either alone or (at least) substantially. This reduces the number of steps required to produce the application packaging and thus makes production faster and / or more efficient. Specifically, producing the application packaging requires fewer tools. Specifically, a predetermined fracture zone is created without cutting and / or without using a cutting tool. As an alternative or additional method, the predetermined fracture zone extends only above the cavity (particularly the application channel of the cavity). This better enhances the stability of the application package and / or reduces the risk of accidental opening of the application package. As an alternative or additional method, the application channel is narrowed and / or its (flow) cross-section is reduced within and / or by means of a predetermined fracture zone, and / or a nozzle is formed. Advantageously, when dispensing a drug product from the application package, the drug product can be accelerated upon discharge from the application package by means of the narrowed channel, reduced cross-section, and / or nozzle. Furthermore, even under the influence of gravity, without the application of additional force (e.g., pressure from a user onto the application package or chamber), the narrowed channel, reduced cross-section, and / or nozzle better prevent the flow of the drug product. This helps prevent accidental removal or spillage of the drug product. As an alternative or additional example, the predetermined fracture zone is formed as a bend, knot, or crease in the bottom portion (wall), and / or the thickness of the bottom portion (wall) is at least substantially constant in the area including and surrounding the predetermined fracture zone. This preferably enhances the stability of the application packaging and / or reduces the risk of accidental opening of the application packaging. The predetermined break zone is preferably a weakening of the material of the packaging or bottom portion. Specifically, a user can easily open the application packaging by breaking or bending / folding it along the predetermined break zone. Preferably, the predetermined fracture zone has a groove on one of the outer or inner surfaces of the application packaging or bottom portion, or is formed by such a groove. In this way, the predetermined fracture zone is achieved in a simple manner. The predetermined fracture zone may include one of the inner or outer surfaces of the application packaging or bottom portion, particularly one of the protrusions on the inner surface opposite to the outer surface including the groove or on the outer surface opposite to the inner surface including the groove. Preferably, the narrowing of the channel, the reduction of the cross-section and / or the nozzle can be achieved in a simple way by means of the protrusion (if provided on the inner surface). The protrusions better enhance the stability of the application packaging and / or reduce the risk of accidental opening of the application packaging. Specifically, the wall thickness of the bottom portion in the predetermined fracture zone can be constant and / or similar or the same as that in the area surrounding the predetermined fracture zone. The groove and / or protrusion may extend only above the cavity (especially the application channel), or above both the cavity and the edge, that is, at least substantially above the entire width of the application package or bottom portion, especially perpendicular to the application channel. Preferably, the longitudinal extensions of the grooves and protrusions can be different from each other. Specifically, the groove may extend above the cavity and the rim, while the protrusion extends only above the cavity. Advantageously, the rim can be kept without a protrusion and / or can be kept flat. This facilitates the application of the cover to the bottom portion (especially the rim). However, at the same time, the groove may also extend above the rim to form a predetermined fracture zone that is more prone to breakage. The application of packaging (particularly the bottom portion) may include deformations (such as markings or imprints) from vents in a molding tool. Specifically, at least one of these deformations may also be positioned at a predetermined fracture zone. This can help to improve fracture behavior. The above and subsequent states, feature method variations and method steps of the present invention can be combined in various ways and / or combined with each other in any sequence, but can also be implemented independently of each other. Figures 1 to 3 illustrate an application package 1 according to the present invention. Figure 1 is a schematic perspective view of the application package 1 in a closed state or in its delivery state. Figure 2 shows the application package 1 in an open state and / or when converted into a pipette in a schematic perspective view. Figure 3 is a schematic cross-section through the application package 1, also showing a secondary package 11 in which the application package 1 is preferably or as needed delivered / sold. The application package 1 is preferably configured to receive and / or contain or include a pharmaceutical product 2, as shown in Figure 3. Drug product 2 is preferably a liquid. Drug product 2 is preferably a product used for the treatment and / or prevention of fleas, ticks and / or chewing lice (especially in dogs and / or cats). Preferably, drug product 2 helps control scabies (especially in dogs). The application packaging 1 includes a bottom portion 3 and a cover 4, or is composed of a bottom portion 3 and a cover 4. The bottom portion 3 includes a cavity 5 for receiving the drug product 2. The cavity 5 preferably includes different sections, particularly a chamber 6 and an administration channel 7. The bottom portion 3 has a rim 8 surrounding (particularly completely surrounding) the cavity 5. The rim 8 is preferably at least substantially flat. The cover 4 preferably covers, closes, and / or seals the bottom portion 3 or cavity 5 (especially the chamber 6 and the application channel 7) in a fluid-tight, particularly liquid-tight and / or airtight manner. Preferably, the application package 1, the bottom portion 3, or the cavity 5 is sealed by the cover 4 to ensure storage stability and / or to prevent the product 2 from escaping from the sealed application package 1, the bottom portion 3, or the cavity 5. The cover 4 is preferably secured or engaged, especially (thermally) sealed to the bottom portion 3 (especially the edge 8 or a portion of the edge 8). Preferably, the cover 4 is secured or joined to the bottom portion 3 or the edge 8 by heat sealing and / or by means of a (heat) annular seal, which specifically extends along the entire circumference of the edge 8 and / or the edge 3A between the cavity 5 and the edge 8. However, in principle, other methods of securing are also possible, such as adhesively joining the cover 4 to the bottom portion 3. Therefore, preferably, the cover 4 is engaged or sealed to the bottom portion 3 at least in the area of ​​the edge 3A between the cavity 5 and the edge 8, so as to close / seal the cavity 5. Particularly preferably, the cover 4 is secured, joined, or sealed to the entire edge 8. However, the engagement between the bottom portion 3 and the cover 4 may be less secure outside the area of ​​the edge 3A, and / or may decrease from the edge 3A toward the outer side of the edge 8. The bottom portion 3 (particularly the cavity 5 and the edge 8) is preferably produced by thermoforming or deep drawing a plastic sheet. Specifically, the cavity 5 is created by deep drawing or thermoforming a respective area of ​​the plastic sheet into and / or onto a molding tool, resulting in the edge 8 remaining undeformed after thermoforming / deep drawing. This will be explained in more detail later. The chamber 6 and the application channel 7 are preferably in fluid communication with each other. Specifically, the application channel 7 leads to the chamber 6. As shown in Figure 1, chamber 6 preferably has a generally triangular shape. However, this is not mandatory and chamber 6 can have any desired shape. The application channel 7 is preferably elongated and / or straight. Preferably, the application channel 7 has a diameter and / or volume smaller than that of the chamber 6. Preferably, the application channel 7 extends along a longitudinal axis A of the application package 1. Axis A is preferably an axis of symmetry of the application package 1. 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. The application of the packaging 1 or the bottom portion 3, particularly along the length or longitudinal extension of axis A, is preferably greater than 6 cm and / or less than 10 cm, particularly preferably about 8.5 cm. The width of the edge 8 (particularly the side perpendicular to the application channel 7 or axis A and / or adjacent to or on one side of the application channel 7) is preferably greater than 2 cm and / or less than 6 cm, particularly preferably about 4 cm. The application package 1 can be opened to allow the drug product 2 contained in the application package 1 or cavity 5 to be removed or pushed out and / or applied to a patient (not shown). The patient is preferably a human or animal, particularly a domestic animal (such as a cat or dog). Preferably, the application package 1 is configured to apply the drug product 2 directly to the skin and / or fur of one of the patients. Specifically, application package 1 can be transformed into a pipette, as shown in Figure 2. Specifically, by opening application package 1, application package 1 is transformed into a pipette. The application package 1 (particularly the bottom portion 3) includes a predetermined fracture zone 9. The application package 1 is preferably opened at the predetermined fracture zone 9 and / or by breaking the application package 1 (particularly the bottom portion 3) along the predetermined fracture zone 9. Specifically, the application package 1 can be opened by folding and / or bending along the predetermined fracture zone 9. The predetermined fracture zone 9 is preferably produced by thermoforming or deep drawing, especially during or in the same step as the thermoforming or deep drawing bottom portion 3 and / or using the same molding tools. This will be explained in more detail later with reference to Figures 4 and 19 to 22. The predetermined fracture zone 9 preferably passes through the cavity 5 (especially the application channel 7) and / or is disposed in the region of the cavity 5 (especially the application channel 7). The fracture zone 9 may be provided only in the area of ​​the cavity 5 or the application channel 7. In other words, the edge 8 may be at least substantially free of the fracture zone 9. This will be explained in more detail later with reference to Figures 9 through 11. Alternatively, the fracture zone 9 may extend at least substantially along the entire width of the application package 1 and / or may be provided in the area of ​​the cavity 5 (particularly the application channel 7 and the edge 8), as shown, for example, in Figures 1 and 13 and also explained in more detail later. The predetermined fracture zone 9 is preferably transverse, particularly perpendicular to axis A and / or extends through the application channel 7. The predetermined fracture zone 9 is preferably located close to one of the axial ends of the channel 7 and / or the application package 1. Preferably, the distance from the predetermined fracture zone 9 to the axial end 7A of the application channel 7 is at most 15 mm or less, and more preferably at most 10 mm or less. The distance between the predetermined fracture zone 9 and one of the axial ends 1A of the application package 1 is preferably at most 25 mm or less, and particularly at most 20 mm or less. Preferably, the distance between the predetermined fracture zone 9 and the axial end 7A of the application channel 7 is greater than 15% or 20% of the total length of the application channel 7 and / or less than 40% or 30% of the total length of the application channel 7, particularly preferably about 20%. Preferably, the distance between the predetermined fracture 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 axis A and / or less than 40% or 30% of the total length or longitudinal extension of the application package 1 along axis A, particularly preferably about 20%. The predetermined fracture zone 9 preferably defines the tip 10 of one of the application package 1 and / or the bottom portion 3. Specifically, the tip 10 is a portion or section of the application package 1 or the bottom portion 3 opposite to the predetermined fracture zone 9 and the chamber 6. The tip 10 can be preferably folded or bent, particularly by folding or bending the application package 1 along a predetermined fracture zone 9. Specifically, this causes the application package 1 or at least the bottom portion 3 to fracture, allowing the application package 1 to be opened and / or the pharmaceutical product 2 to be removed, dispensed, or ejected through the application channel 7. Specifically, this is illustrated in Figure 2. Preferably, by causing the application package 1 to break, particularly along the predetermined fracture zone 9 and / or by bending / folding the tip 10, an open end 7B of the cavity 5 (particularly the application channel 7) is created, as shown in FIG2. By opening the application package 1 as described, the application package 1 preferably transforms into a pipette and / or can be preferably used to administer drug product 2 to a patient. Specifically, drug product 2 can be administered by pressing on the chamber 6, either through or from the application package 1, causing drug product 2 to be forced through the application channel 7 and exit / withdraw from the application channel 7 at a predetermined break zone 9 at its open end 7B. Preferably, it is necessary to press / push against chamber 6 to remove the drug product 2. In other words, the application channel 7 and / or the open end 7B are preferably configured or sized such that no product 2 can escape due to gravity (only) and / or that no product 2 flows out while the application package 1 is held, wherein the open end 7B points downward without the application of further force, particularly without pushing against chamber 6. In this way, accidental removal of the drug product 2 is prevented. Particularly preferably, the flow cross-section of cavity 5 (especially application channel 7) narrows or decreases at the open end 7B and / or in the region of the predetermined break zone 9. Therefore, preferably, a narrowed flow channel or reduced cross-section or nozzle is formed at the open end 7B and / or in the region of the predetermined break zone 9. This will be explained in more detail later with reference to Figures 9 through 11. In the example shown in Figure 2, the cap 4 preferably remains intact or unbroken. Specifically, after folding or bending the application package 1 or opening the application package 1, the tip 10 is still preferably connected to the application package 1 via the cap 4. However, other solutions are also possible here, in which the cap 4 is also completely or at least partially broken, and / or in which the tip 10 is completely removed from the application package 1. The application package 1 is preferably packaged in a secondary package 11, particularly after the production of the application package 1, for delivery and / or storage, and / or before the application package 1 is used to apply the contained pharmaceutical product 2 to a patient. The secondary package 11 is shown in Figure 3. Secondary packaging 11 is better than blister packaging. The secondary packaging 11 preferably includes a base portion 12 and a cover or lid 13. The base portion 12 preferably has or forms a cavity or reservoir 14 for receiving the application package 1. The lid 13 preferably closes (in particular, completely closes) the reservoir 14. The lid 13 is preferably secured (in particular, glued) to the base portion 12. Preferably, the lid 13 is detachable from the base portion 12 to remove the application package 1 from the secondary packaging 11 or the reservoir 14. Figure 4 illustrates, in a very schematic way, an apparatus 100 for producing application packaging 1. Hereinafter, the apparatus 100 and a method for producing application packaging 1 are described with reference to Figure 4. The method described herein is preferably performed using device 100. Device 100 is then preferably configured to perform the method described herein. The apparatus 100 preferably includes a heating device 101 and a molding tool 102. For the production of application packaging 1, a plastic sheet 200 is preferably guided through equipment 100 and formed from the plastic sheet 200 into application packaging 1 by thermoforming (especially deep drawing). Specifically, thermoforming is performed in a heating device 101 and / or a molding tool 102. Preferably, the plastic sheet 200 is rolled up and / or fed onto or formed on a roller, as schematically indicated in FIG4. Preferably, particularly in an unfolding or feeding step, the plastic sheet 200 is unrolled / unrolled and guided into the device 100 and / or heating device 101. However, the plastic sheet 200 may also be fed into the device 100 and / or heating device 101 in any other desired form or manner. As needed, the plastic sheet 200 can be continuously or gradually guided through the device 100. After the plastic sheet 200 is unfolded / fed and / or during a heating step, the plastic sheet 200 is preferably at least partially heated by means of the heating device 101. The heating device 101 is preferably configured to at least partially heat the plastic sheet 200. Specifically, the heating device 101 is configured to heat sub-regions of the plastic sheet 200, which then preferably form the bottom portion 3 of the application package 1 (particularly in the molding tool 102). The heating device 101 is preferably configured to heat the plastic sheet 200 from both sides. Preferably, the heating device 101 includes at least one heating plate 101A, 101B, and more particularly 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. Preferably, the heating device 101, in particular (a number of) heating plates 101A, 101B, heats the plastic sheet 200 to a plasticizing temperature or thermoforming temperature. The preferred plasticizing or thermoforming temperature is the temperature at which the plastic sheet 200 is plasticized and / or thermoformable, particularly the temperature at which the plastic sheet 200 softens and / or becomes malleable. A plastic material (here, the plastic sheet 200) is preferably deformable when it has reached the plasticizing or thermoforming temperature and retains its new form after cooling or dropping below the plasticizing or thermoforming temperature. 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. The two heating plates 101A and 101B can operate at the same temperature or at different temperatures. Preferably, if the plastic sheet 200 is multilayered, especially with layers of different materials and / or with different plasticizing / thermoforming temperatures, the two heating plates 101A and 101B operate at different temperatures, specifically corresponding to the respective plasticizing / thermoforming temperatures of the layers of the plastic sheet 200 facing the respective heating plates 101A and 101B. After heating and / or in a (thermo) forming step, the (heated) plastic sheet 200 is preferably formed (especially thermoforming) by means of a molding tool 102. The molding tool 102 is preferably configured to form the shape of the bottom portion 3 from the plastic sheet 200. Specifically, the molding tool 102 is configured to stretch the plastic sheet 200 or a heated sub-region of the plastic sheet 200, respectively. Specifically, the heated sub-region of the plastic sheet 200 is stretched into or drawn into the molding tool 102. The molding tool 102 includes at least one mold 102A, 102B. Preferably, the molding tool 102 includes two molds 102A, 102B, referred to below as a female mold 102A and a male mold 102B. Preferably, the plastic sheet 200 is stretched into the female mold 102A and / or onto the male mold 102B. Forming or stretching is preferably performed by forcing the plastic sheet 200 against the molding tool 102 or molds 102A and / or 102B, preferably by generating an overpressure or blowing a gas (especially air) onto the plastic sheet 200, and / or by generating a negative pressure in the molding tool 102 or molds 102A and / or 102B. Alternatively or additionally, the plastic sheet 200 can be forced against the molding tool 102 or molds 102A and / or 102B by means of a stamp. Particularly preferably, if two molds 102A and 102B are provided, one of the molds 102A and 102B serves as a stamp. In particular, besides a gas, a stamp may also be provided only in a sub-region, for example, in an area requiring more precise forming (such as application channel 7). The predetermined fracture zone 9 is preferably generated in the molding tool 102 and / or during the molding step, and / or the equipment 100 (especially the molding tool 102) is configured for this purpose. This will be explained in more detail later. Preferably, the predetermined fracture zone 9 is generated / produced only during the (thermo)forming step and / or by means of the molding tool 102. Specifically, the proposed method does not include a step in which the plastic sheet 200 is (partially) cut to generate a predetermined fracture zone 9, and / or the proposed equipment 100 does not have or require a cutting tool for this purpose. However, the predetermined fracture zone 9 may also be generated / produced primarily or entirely during the (thermo)forming step and / or by means of the molding tool 102. Preferably, this should be understood as performing the main or necessary steps for generating / forming the predetermined fracture zone 9 during (thermo)forming and / or using the molding tool 102. In contrast, in the prior art, a predetermined fracture zone is generated only after the (thermo)forming step (e.g., by perforating a package that is otherwise completed along a specific line), or by cutting a plastic sheet before the (thermo)forming step. In the prior art, particularly in EP 2 998 098 A1 and EP 2 998 099 A1, the cutting of the plastic sheet is a primary, necessary, or generating step performed before the thermoforming step. When the plastic sheet is deeply drawn, the cutting of the plastic sheet can further deform it; however, this deformation does not produce a predetermined fracture zone because the predetermined fracture zone is generated prior to the cutting of the sheet. Furthermore, this deformation is certainly not a necessary or primary step for generating the predetermined fracture zone. This is evident from the fact that in the prior art, without cutting, the predetermined fracture zone would not be formed at all. Therefore, the predetermined fracture zone 9 of the present invention is preferably generated without cutting and / or without a cutting step and / or without the use of a cutting tool before or after the step of forming the bottom portion. In the spirit of this invention, a piercing, scoring, or similar operation is also preferably understood as "cutting (or cuts)". Therefore, the term "no cutting" preferably also includes expressions such as "no piercing" or similar, or can be replaced or supplemented by expressions such as "no piercing" or similar. Similarly, a cutting step / tool ​​can also be a piercing step / tool, etc. The molding tool 102 is preferably configured to form a plurality of bottom portions 3 simultaneously or in a single step; in the example shown in Figure 4, twelve bottom portions 3 are formed simultaneously. However, other solutions (e.g., where only one bottom portion 3 is formed in a single forming step) are also possible. Preferably, the molding tool 102 and / or (a number of) molds 102A, 102B can be interchanged to produce application packages 1 (especially the bottom portion 3) of different shapes, for example to accommodate different volumes of chamber 6 or pharmaceutical product 2. After formation and / or in a filling step, in particular by means of a filling device 103, the pharmaceutical product 2 is used to fill the bottom portion 3 (in particular one or more cavities 5) formed in the plastic sheet 200, which is schematically indicated by dashed lines in FIG4. The filling is preferably performed after the plastic sheet 200 or its heated / thermoformed area has hardened and / or cooled or dropped below the plasticizing / thermoforming temperature. After filling and / or in a covering / closing step, a cover sheet 300 is applied (particularly secured or joined) to the plastic sheet 200. Closing / covering is preferably performed in a covering device 104 (particularly a sealing device). Preferably, by means of a cover sheet 300 covering or enclosing (a few) bottom portions 3 or one or more cavities 5 formed in the plastic sheet 200, (a few) respective covers 4 are formed. Preferably, the cover sheet 300 is rolled up and / or provided on or formed on a roller, as schematically indicated in FIG4. Preferably, the cover sheet 300 is unwound / unrolled and guided into the device 100 and / or the covering device 104 (particularly together with the plastic sheet 200). However, the (wound) cover sheet 300 may also be completely positioned within the covering device 104. The cover device 104 is preferably configured to join or seal (especially heat-seal) the cover sheet 300 to the plastic sheet 200 or (some) bottom portions 3 in a fluid-tight, particularly liquid-tight and / or airtight manner. However, other solutions are also possible; for example, the cover device 104 may be configured to adhesively join the cover sheet 300 to the plastic sheet 200. Preferably, the cover sheet 300 of the cover 4 is joined or sealed to the plastic sheet 200 of the bottom portion 3 by sealing, preferably by heat sealing, the cover sheet 300 and the plastic sheet 200 sealing layers 205 and 305. The sealing layers 205 and 305 are explained in detail below with reference to Figures 5 to 8. To secure the cover sheet 300 to the plastic sheet 200, the covering device 104 is preferably in contact with the cover sheet 300 such that the cover sheet 300 is pressed against the plastic sheet 200 at least in the area of ​​the bottom portion 3 or / and the area of ​​its edges 3A. The covering device 104 is preferably heated at least in the contact area such that the cover sheet 300 is heat-sealed to the plastic sheet 200 at least in that area. The engagement / sealing is preferably performed at least in the area of ​​at least one of the edges 3A of the bottom portion 3, or as a configuration for the covering device 104. For this purpose, the covering device 104 preferably includes (for each bottom portion 3) an annular sealing tool (not shown) that has at least substantially the form of an edge 3A and / or is heatable. Particularly preferably, in addition to the area of ​​(a few) edges 3A, the joining / sealing is also performed in the area surrounding (a few) edges 3A and / or in the area where (a few) edges 8 are later formed. In principle, when the cover sheet 300 is heat-sealed to the plastic sheet 200, the covering device 104 may not contact this additional area, but only utilize its radiant heat. This would result in a reduced bond strength compared to the area where the covering device 104 contacts the cover sheet 300. However, a solution is also possible if one contact is established in this area and / or a constant bond strength is achieved. After covering / closing and / or in a separation step, the application package 1 formed by the plastic sheet 200 and the cover sheet 300 is separated from the sheets and / or from each other. For this purpose, the device 100 may include a separation device (not shown) preferably downstream of the covering device 104. However, a separation device may also be integrated into the covering device 104 and / or the covering device 104 may also be configured to separate (a number of) application packages 1. Preferably, the (several) application packages 1 are trimmed, punched or cut. Separation (especially punching / cutting) is preferably carried out along a line having a (constant) distance to (some) edges 3A, and / or forming (some) edges 8. The line along which separation (especially cutting or punching) is carried out on the application package 1 is schematically indicated by the dashed line in Figure 4. The application packaging 1 preferably consists of a bottom portion 3 including a specific functional layer (especially a specific layer structure) and a cover 4. Figures 5 to 8 show 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. In the following description, if a plastic film or layer comprises or is composed of a specific polymer, it means that the film or layer comprises or is composed of that polymer as a polymeric material, respectively. However, further components (e.g., fillers and additives) may also be present in the film or layer. 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: an outer thermoformable layer 201, a cyclic olefin copolymer (COC) layer 202, an inner thermoformable layer 203, a barrier layer 204 and a sealing layer 205. 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 sealing layer 205 and the inner thermoformable layer 203. Preferably, the plastic sheet 200 comprises at least five layers in the layer sequence described above, that is, the plastic sheet 200 of the bottom portion 3 comprises at least five layers in the following layer sequence: an outer thermoformable layer 201, followed by a cyclic olefin copolymer (COC) layer 202, followed by an inner thermoformable layer 203, followed by a barrier layer 204, followed by a sealing layer 205. Particularly preferred is the assumption that the layers are formed one after another, that is, according to the preferred embodiments of the present invention, the layers are formed continuously or sequentially and / or are not separated from each other by intermediate layers. The outer thermoformable layer 201 typically forms the outer surface of one of the application packages 1 of the present invention. Preferably, the plastic sheet 200 of the bottom portion 3 further includes an intermediate layer 206 as shown in FIG. 5. The intermediate layer 206 may be omitted from the plastic sheet 200, but further enhances the compatibility of the plastic sheet 200, particularly the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 is typically disposed between the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 typically comprises or is composed of the same material as the sealing layer 205, and typically also has the same thickness. The sealing layer 205 is preferably a heat-sealing layer used for joining / sealing the bottom portion 3 and the cover 4. The preferred plastic sheet 200 of the bottom portion 3 includes or is composed of the following layer structures: (a) an outer thermoformable layer 201, (b) a cyclic olefin copolymer layer 202, (c) an inner thermoformable layer 203, (d) an intermediate layer 206, (e) a barrier layer 204, and (f) a sealing layer 205. The plastic sheet 200 of the bottom portion 3 typically has a thickness in the range of 230 µm to 750 µm, particularly 300 µm to 650 µm, more preferably 400 µm to 600 µm, more preferably 450 µm to 500 µm, and especially preferably 480 µm to 520 µm, and is determined to be in the form of the application packaging 1 after deep drawing. The cyclic olefin copolymer layer 202 is the main layer of the plastic sheet 200. It comprises or is composed of cyclic olefin copolymers (COC), preferably cyclic olefin copolymers (COC). Cyclic olefin copolymers (COCs) are amorphous polymers obtained by copolymerizing 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 preferred is the use of copolymers of ethylene and norbornene in conjunction with this invention. The cyclic olefin copolymer layer 202 typically provides rigidity and structural integrity to the bottom portion 3 of the application package 1, especially after deep drawing. Furthermore, the cyclic olefin copolymer layer 202 is brittle and fractures under increased pressure, making it suitable for manufacturing single-use packages with a fracture zone 9 for opening the application package 1. In addition, COC has good moisture-proof properties, especially when used with a high layer thickness. Furthermore, COC exhibits good chemical resistance and barrier properties to polar solvents, and is resistant to acids and alkalis. A further advantage of COC is that it can have high purity, preventing the extraction of impurities by solvents or active ingredients contained in a package. The cyclic olefin copolymer layer 202 preferably has a thickness in the range of 200 µm to 600 µm, particularly 250 µm to 500 µm, more preferably 300 µm to 450 µm, more preferably 350 µm to 400 µm, and especially preferably 360 µm to 390 µm. The inner thermoformable layer 203 and the outer thermoformable layer 201 enhance the thermoformability 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 for the brittle COC layer 202. The outer thermoformable layer 201 and the inner thermoformable layer 203 preferably have a thickness in the range of 10 µm to 40 µm, particularly 12 µm to 35 µm, more preferably 15 µm to 30 µm, more preferably 18 µm to 27 µm, and particularly preferably 22 µm to 25 µm. The best results are obtained if the thickness of the cyclic olefin copolymer layer 202, the thickness of the outer thermoformable layer 201, and / or the thickness of the inner thermoformable layer 203 are in the range of 5:1 to 30:1, particularly 7:1 to 25:1, more preferably 10:1 to 22:1, even more preferably 13:1 to 20:1, and especially preferably 15:1 to 18:1. Furthermore, the outer thermoformable layer 201 and the inner thermoformable layer 203 comprise the same polymer or are composed of the same polymer, particularly the same polymer. The polymers of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 are generally 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. According to the present invention, it is preferred that the polymers of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 are selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), or mixtures thereof. According to the present invention, it is particularly preferred that the polymers of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 are polypropylene (PP). The barrier layer 204 preferably comprises, or is composed of, a polymer selected from the group consisting of, or preferably consists of, the following polymers: 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-methyl methacrylate copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof. According to the present invention, it is preferable that the polymer system of the barrier layer 204 is selected from the group consisting of ethylene-vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof. Optimal results are obtained when the polymer system of the barrier layer 204 is ethylene-vinyl alcohol (EVOH). The barrier layer 204 prevents substances from the environment from penetrating the packaging 1 and deteriorating the pharmaceutical product 2, and also prevents any undesired interactions between the pharmaceutical product 2 and the packaging 1. The barrier layer (especially comprising or composed of EVOH) exhibits excellent barrier properties against chemicals and oxygen. The barrier layer 204 has a thickness ranging from 2 µm to 20 µm, particularly 5 µm to 15 µm, and preferably 7 µm to 12 µm. The sealing layer 205 and / or the intermediate layer 206 preferably comprise or are composed of a polymer selected from the group consisting of, more preferably, 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 acrylate copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methacrylate (EMA), ethylene-vinyl alcohol (EVA), or mixtures thereof. According to a preferred embodiment of the present invention, the polymer system 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 mixtures thereof. It is preferable that the polymer system of the sealing layer 205 and / or the intermediate layer 206 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), metallocene linear low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. Optimal results are obtained if the polymer system of the sealing layer 205 and / or the intermediate layer 206 is polyethylene (PE). The sealing layer 205 and / or the intermediate layer 206 have a thickness ranging from 10 µm to 50 µm, particularly 15 µm to 40 µm, more preferably 17 µm to 35 µm, more preferably 20 µm to 30 µm, and particularly preferably 22 µm to 27 µm. As described above, preferably, the sealing layer 205 and the intermediate layer 206 comprise or are composed of the same polymer and have the same thickness. Therefore, according to one preferred embodiment of the present invention, the plastic sheet 200 comprises or is composed of the following layer structure having the following layer sequence: (a) an outer thermoformable layer 201 comprising or composed of PP, followed by (b) a cyclic olefin copolymer layer 202 comprising or composed of COC, followed by (c) an inner thermoformable layer 203 comprising or composed of PP, followed by (d) an intermediate layer 206 comprising or composed of PE, if desired, followed by (e) a barrier layer 204 comprising or composed of EVOH, followed by (f) a sealing layer 205 comprising or composed of PE. Particularly preferred is the assumption that the layers are formed one after another, that is, according to the preferred embodiment of the invention described above, the layers are formed continuously or sequentially and / or are not separated from each other by any further intermediate layer other than the selected intermediate layer 206. The layers of the plastic sheet 200 in the bottom part 3 can be directly or indirectly bonded to each other. Direct bonding means that the layers are directly joined together, for example, by co-extrusion or by a connecting layer or an adhesive layer. Indirect bonding means that further layers (especially plastic sheets or metal foils) are disposed between the respective layers. As shown in Figure 6, the cover sheet 300 of the cover 4 preferably includes or is composed of the following layers: a protective layer 301, a first barrier layer 302, an intermediate layer 303, a second barrier layer 304, and a sealing layer 305, wherein the first barrier layer 302 is disposed between the protective layer 301 and the intermediate layer 303 and wherein the second barrier layer 304 is disposed between the intermediate layer 303 and the sealing layer 305. The cover sheet 300 typically has a thickness ranging from 50 µm to 200 µm, particularly 70 µm to 180 µm, more preferably 80 µm to 150 µm, more preferably 90 µm to 140 µm, and especially preferably 95 µm to 130 µm. The protective layer 301 preferably comprises or is composed of a polymer selected from the group consisting of, most preferably, 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 against mechanical damage but also allows printing on the protective layer 301, particularly when the protective layer comprises or is composed of PET. The protective layer preferably has a thickness ranging from 5 µm to 25 µm, particularly 7 µm to 20 µm, and more preferably 10 µm to 14 µm. The first barrier layer 302 is typically a metal foil, particularly an aluminum foil. The metal foil (especially the aluminum foil) provides excellent oxygen barrier properties. The first barrier layer typically has a thickness ranging from 5 µm to 25 µm, particularly 7 µm to 20 µm, and preferably 10 µm to 40 µm. The intermediate layer 303 and the sealing layer 305 preferably comprise or are composed of the same polymer. Typically, the intermediate layer 303 and / or the sealing layer 305 comprise or are composed of a polymer selected from the group consisting of, preferably, 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 copolymer (EAA), ethylene-methacrylic acid copolymer (EMAA), ethyl methacrylate (EMA), ethylene-vinyl alcohol (EVA), or mixtures thereof. In this regard, it is preferable that the polymer system 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 mixtures thereof. According to the present invention, it is particularly preferred that the polymer system of the intermediate layer 303 and / or the sealing layer 305 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), metallocene linear low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. It is particularly preferred that the polymer system of the intermediate layer 303 and / or the sealing layer 305 is polyethylene (PE). Furthermore, according to the present invention, it is preferable that 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, particularly 15 µm to 40 µm, preferably 17 µm to 35 µm, more preferably 20 µm to 30 µm, and particularly preferably 22 µm to 27 µm. The second barrier layer 304 preferably comprises, or is composed of, a polymer selected from the group consisting of, or preferably comprises, the following polymers: 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-methyl methacrylate copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof. It is particularly preferred that the polymer of the second barrier layer 304 is selected from the group consisting of ethylene-vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), or mixtures thereof. According to a preferred embodiment of the present invention, the second barrier layer 304 is a polymer-based ethylene-vinyl alcohol (EVOH). Good results are obtained if the second barrier layer 304 has a thickness in the range of 2 µm to 20 µm, particularly 5 µm to 15 µm, preferably 7 µm to 12 µm. According to a preferred embodiment, the cover sheet 300 has the following layer structure: a protective layer 301, a first barrier layer 302, an intermediate layer 303, a second barrier layer 304, and a sealing layer 305. To be clear, it is conceivable that the cover sheet 300 includes or is composed of the following layer structure having the following layer sequence: (i) a protective layer 301, followed by (ii) a first barrier layer 302, followed by (iii) an intermediate layer 303, followed by (iv) a second barrier layer 304, followed by (v) a sealing layer 305. Particularly preferred is the assumption that the layers are formed one after another, that is, according to the preferred embodiments of the present invention, the layers are formed continuously or sequentially and / or are not separated from each other. The layers of the cover sheet 300 can be adhered to each other directly or indirectly. Direct adhesion means that the layers are directly bonded to each other, for example, by co-extrusion or by an adhesive layer or a connecting layer. Indirect adhesion means that there are further layers (especially plastic sheets or metal foils) disposed between the respective layers. One preferred embodiment of the present invention includes a plastic sheet 200 of the bottom portion 3 comprising or composed of the following layer structures having the following layer sequence: (a) an outer thermoformable layer 201 comprising or composed of PP, followed by (b) a cyclic olefin copolymer layer 202 comprising or composed of COC, followed by (c) an inner thermoformable layer 203 comprising or composed of PP, followed by (d) an intermediate layer 206 comprising or composed of PE, if desired, followed by (e) a barrier layer 204 comprising or composed of EVOH, followed by (f) a sealing layer 205 comprising or composed of PE, and a cover sheet 300 comprising or composed of the following layer structures: (i) a protective layer 301, followed by (ii) a first barrier layer 302, followed by (iii) an intermediate layer 303, followed by (iv) The second barrier layer 304 is followed by (v) a sealing layer 305. Particularly preferred is the assumption that the layers are formed one after another, that is, according to the preferred embodiment of the invention described above, the layers are formed continuously or sequentially and / or are not separated from each other by any further intermediate layer other than the selected intermediate layer 206. According to the present invention, it is preferable that a connecting layer or adhesive layer is disposed between the layers of the cover sheet 300. The adhesive of the adhesive layer is preferably a polyurethane-based adhesive, particularly a water-based or solvent-based polyurethane adhesive. The connecting layer is typically composed of an adhesive resin. Furthermore, it is preferable if both the plastic 200 and the cover sheet 300 are included as a connecting layer and an adhesive layer between the functional layers. According to a preferred embodiment shown in Figure 7, the plastic sheet 200 comprises or is composed of the following layer structures: (a) an outer thermoformable layer 201 preferably comprising or composed of PP, particularly PP; (b) a connecting layer 207a; (c) a cyclic olefin copolymer layer 202 comprising or composed of COC, particularly COC; (d) a connecting layer 207b; (e) an inner thermoformable layer 203 preferably comprising or composed of PP, particularly PP; (f) an adhesive layer 208; (g) an intermediate layer 206 preferably comprising or composed of PE, particularly PE; (h) a connecting layer 207c; (i) a barrier layer 204 preferably comprising or composed of EVOH, particularly EVOH; (j) a connecting layer 207d; and (k) a connecting layer. Preferably, it comprises or is composed of PE, particularly one of the sealing layers 205 composed of PE. Figure 8 shows a preferred layer structure of the cover sheet 300: (i) a protective layer 301 preferably comprising PET or composed of PET, (ii) an adhesive layer 308a, (iii) a first barrier layer 302 preferably comprising aluminum foil or composed of aluminum foil, particularly composed of aluminum foil, (iv) an adhesive layer 308b, (v) an intermediate layer 303 preferably comprising PE or composed of PE, particularly composed of PE, (vi) a connecting layer 307a, (vii) a second barrier layer 304 preferably comprising EVOH or composed of EVOH, particularly composed of EVOH, (viii) a connecting layer 307b, and (ix) a sealing layer 305 preferably comprising PE or composed of PE, particularly composed of PE. Preferably, the cover sheet 300 is joined or sealed to the plastic sheet 200 by sealing layers 205 and 305. Preferably, the cover sheet 300 and the plastic sheet are joined or sealed by heat sealing. Hereinafter, different embodiments of the application packaging 1 according to the present invention are described in more detail. These different embodiments are preferably different (only) by means of the design of the predetermined fracture zone 9. In other words, apart from the predetermined fracture zone 9, the different embodiments of the application packaging 1 are preferably the same. Preferably, unless otherwise expressly stated, the manner, features and interpretations described with respect to one embodiment are applicable to other embodiments, even if not repeated. Furthermore, the previously described forms, features, and explanations of the application packaging 1 (particularly referring to Figures 1 to 3), the method and apparatus 100 for producing it (particularly referring to Figure 4), and the preferred multilayer structure (particularly referring to Figures 5 to 8) are preferably additionally or correspondingly applicable to the embodiments described below (even without repetition). The embodiments of application packaging 1 described below preferably have the appearance and features of application packaging 1 as generally described with reference to Figures 1 to 3. The application packaging 1 described below is preferably produced by one of the methods and / or apparatus 100 as described with reference to FIG4, or can be produced by one of the methods and / or apparatus 100 as described with reference to FIG4. The embodiment of the application packaging 1 described below is preferably produced from a plastic sheet 200 and / or a cover sheet 300 as described with reference to Figures 5 to 8, and / or the bottom portion 3 and / or the cover 4 thereof preferably have a multi-layer structure as described with reference to Figures 5 to 8. However, the following embodiments need not have the appearance or features previously described. For example, they may have a multilayer structure that is different from the multilayer structure in Figures 5 to 8. Figures 9 to 11 show a first embodiment of the application packaging 1. Figure 9 shows a schematic plan view from the bottom side of the application packaging 1 (i.e., facing the bottom portion 3). The cover 4 is not visible in this view because it is behind the bottom portion 3. Figure 10 shows a schematic cross-section of the applied package 1 along line XX in Figure 9. Figure 11 shows a magnified detail of one of the areas of Figure 10 in the fracture zone 9, indicated by the mark XI in Figure 10. As indicated by the shading, the edge 8 shown in Figure 11 is located behind the cross-sectional plane. The cover 4 preferably extends along the upper surface of the edge 8 and above the cavity 5 or application channel 7, thereby closing the cavity 5 or application channel 7 from above (in the orientation shown in the figure). In the first embodiment, the predetermined fracture zone 9 extends only above the cavity 5, particularly the application channel 7 of the cavity 5, as shown in FIG9. Preferably, in the first embodiment, the predetermined fracture zone 9 is not provided at the edge 8 and / or the edge 8 does not include the predetermined fracture 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. In this sense, the term "predetermined fracture zone" preferably means an area of ​​the application package 1, particularly the bottom portion 3, which is specifically prepared or manufactured to ensure the breakage / opening of the application package 1. Therefore, specifically, the predetermined fracture zone 9 is preferably a material weakening and is consistent throughout this application, and the term "predetermined fracture zone" can be replaced by "material weakening". Preferably, even when the predetermined fracture zone 9 is provided only in the area of ​​the cavity 5 or the application channel 7, the edge 8 also fractures when the application package 1 is opened, particularly when the tip 10 is preferably bent / folded along the predetermined fracture zone 9 in a defined manner. In other words, when the tip 10 is bent / folded, the material preferably fractures at the predetermined fracture zone 9 and the fracture propagates, particularly in a defined manner, to the edge 8, thereby causing the entire tip 10 of the bottom portion 3 to fracture. Specifically, the predetermined fracture zone 9 is provided only on the bottom portion 3 and / or the cover 4 does not include the predetermined fracture zone 9. The predetermined fracture zone 9 preferably has a dent, notch, or groove 15, particularly as shown in Figure 11. Preferably, the predetermined fracture zone 9 may have a groove 15 on one of the outer surfaces 16 of the application package 1 (particularly the bottom portion 3). The outer surface 16 of the packaging 1 or the bottom portion 3, particularly the surface of the bottom portion 3 opposite to the cavity 5 or hollow space configured to receive the pharmaceutical product 2, is applied. More preferably, the outer surface 16 is formed of an outer thermoformable layer 201. Preferably, the groove 15 has a shape that is at least substantially triangular and / or at least substantially wedge-shaped in a cross section. However, other shapes are also possible. The groove 15 preferably has an angle W and a depth D and / or is defined by an angle W and a depth D. The angle W is preferably between the main extending plane of the outer surface 16 and the main extending plane of the inclined or tilted surface of the groove 15, especially at the edge of the predetermined fracture zone 9 or the groove 15 (i.e., the edge where the outer surface 16 bends inward and / or begins to form a groove / notch). If the groove 15 or its cross section is at least substantially triangular or wedge-shaped, then the angle W is preferably the angle between one of the legs and the base of the (isosceles) triangular cross section. However, the groove 15 can also be characterized by any other suitable angle (which can be calculated as 180° minus W) that is better determined by the angle W (e.g., the angle by which the outer surface 16 is actually bent inward or towards the cavity 5 or the application channel 7), or specifically, in the case of a triangle or wedge, by the opening angle of the groove 15 (i.e., the angle between the two inclined surfaces of the groove 15) that can be calculated as 180° minus 2 times W. The depth D is preferably the distance between the main extension plane of the outer surface 16 and the lowest region of the groove 15, especially the distance measured perpendicular to the main plane. If the groove 15 or its cross section is at least substantially triangular or wedge-shaped, then the depth D is preferably the height / altitude of the (isosceles) triangular cross section (relative to the base). The angle W is preferably at least 20 degrees or at least 25 degrees, especially at least 30 degrees and / or at most 60 degrees or at most 55 degrees, especially at most 50 degrees. Particularly preferred values ​​for the angle W are 30 degrees, 40 degrees or 50 degrees. The opening angle or groove angle is preferably at least 60 degrees or at least 70 degrees, especially at least 75 degrees or at least 80 degrees and / or at most 140 degrees or at most 130 degrees, especially at most 125 degrees or at most 120 degrees. Particularly preferred values ​​are 80 degrees, 100 degrees or 120 degrees. The depth D is preferably at least 0.05 mm, particularly at least 0.1 mm and / or at most 0.5 mm, particularly at most 0.4 mm. Particularly preferred values ​​for depth D are 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm. The depth D is preferably at least 5% or 10%, particularly at least 15% or 20%, and / or at most 70% or 60%, particularly at most 50% or 40%, of the thickness T of the bottom portion 3 (wall). Preferably, the groove 15 has a (very) small radius of curvature at its lowest region or valley, preferably less than 15% or 10% of the depth D, particularly less than 5% or 2%. Preferably, the radius of curvature is less than 50 µm or 20 µm, particularly less than 10 µm or 5 µm. Preferably, a protrusion 17 is formed on one of the inner surfaces 18 of the application package 1 (particularly the bottom portion 3), in the predetermined fracture zone 9. The inner surface 18 of the application packaging 1 or the bottom portion 3, particularly the surface facing the bottom portion 3, is configured to receive the cavity 5 or hollow space of the drug product 2 and / or the surface opposite to the inner surface 16. More preferably, the inner surface 18 is formed of a sealing layer 205. Therefore, the outer surface 16 and the inner surface 18 are preferably two opposing surfaces forming the wall of the bottom portion 3. More preferably, the inner surface 18 is the surface that comes into contact with the drug product 2 at least during application and / or the surface of the innermost or sealing layer 205. More preferably, the outer surface 16 is the surface that comes into contact with the environment and / or the surface of the outermost or outer thermoformable layer 201. The protrusion 17 is preferably configured opposite to the groove 15. Preferably, the protrusion 17 is formed to correspond to the groove 15, particularly extending in the same direction as the groove 15, having the same length and / or width as the groove 15, and / or having the same shape and / or angle as the groove 15. Preferably, the predetermined fracture zone 9 is a region having the same thickness T as a region surrounding the bottom portion 3 of the predetermined fracture zone 9. In other words, the thickness T of the bottom portion 3 (the wall) is preferably at least substantially constant in the region including and surrounding the predetermined fracture zone 9. Therefore, preferably, the thickness T of the bottom portion 3 (the wall) in the region of the groove 15 and / or the protrusion 17 is at least substantially the same as in the region surrounding / adjacent to the groove 15 and / or the protrusion 17. The thickness T is preferably the distance between the outer surface 16 and the inner surface 18. In the predetermined fracture zone 9, the thickness T is preferably the distance between the groove 15 (the surface) and the protrusion 17. The thickness T, which is at least substantially constant, is preferably achieved by correspondingly forming a protrusion 17, particularly by a protrusion 17 having the same or at least nearly the same height as the depth D of the groove 15. In other words, the protrusion 17 is preferably at least substantially the same height as the depth of the groove 15, and / or the outer surface 16 is at least substantially as much recessed as the inner surface 18 (at the predetermined fracture zone 9). The thickness T of the bottom portion 3 in both the predetermined fracture zone 9 and the area surrounding it is preferably at least 230 µm, particularly at least 300 µm or 400 µm, more preferably 450 µm or 480 µm, and / or at most 750 µm, particularly 650 µm or 600 µm, more preferably 500 µm or 520 µm. In the first embodiment, the predetermined fracture zone 9 is preferably formed as one of the bends, knots, or creases in the bottom portion 3 (wall). In a cross section (particularly perpendicular to its longitudinal extension), the predetermined fracture zone 9 or the bottom portion 3 (wall) of the region of the predetermined fracture zone 9 is preferably at least substantially V-shaped. Preferably, a narrowed flow channel or a reduced cross-section or nozzle 19 is formed at or through the predetermined fracture zone 9, particularly in the cavity 5 or the application channel 7. The channel height and / or flow cross section of the application channel 7 are preferably defined or demarcated by the inner surface 18 and the cover 4, particularly the surface facing the application channel 7 or by the cover 4 formed by the sealing layer 305. The application channel 7 is located away from the predetermined fracture zone 9 or the cross-section is reduced or the height and / or width of the nozzle 19 is preferably greater than 0.5 mm, especially greater than 1 mm and / or less than 4 mm or 3 mm. The height and / or width of the application channel 7 are preferably reduced by at least 0.05 mm or more and / or at most 0.5 mm or less at or through the predetermined fracture zone 9, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm. Preferably, the application channel 7 is narrowed or its (flow) cross-section is reduced, or the nozzle 19 is formed by means of the protrusion 17. Specifically, the protrusion 17 protrudes into the application channel 7 and / or toward the cover 4, thereby narrowing the channel and / or reducing the (flow) cross-section. When the application package 1 is opened (particularly by folding / bending along the predetermined fracture zone 9 or groove 15), a narrowed flow channel or a reduced cross-section or nozzle 19 is preferably formed or positioned at the open end 7B, particularly where the drug product 2 is discharged from the application package 1. As explained above, the application channel 7 and / or open end 7B are preferably configured or sized such that no product 2 escapes due to gravity (only). This is particularly preferably achieved at least in part by means of a narrowed flow channel or a reduced cross-section or nozzle 19. Preferably, the application channel 7 or the open end 7B is narrowed, particularly by means of the protrusion 17, so that even if the open end 7B is pointing downward, the drug product 2 will not be discharged / exited through the application channel 7 or the open end 7B without the application of an additional force (e.g., by pressing on the chamber 6). Therefore, the drug product 2 is preferably dispensed by the self-opening application package 1 simply by pressing it onto the chamber 6. Preferably, when the drug product 2 is applied and / or pressed onto the chamber 6, the drug product 2 is accelerated, particularly at the open end 7B, especially by means of a narrowed flow channel or a reduced cross-section or when the nozzle 19 leaves the application package 1. Preferably, the narrowed flow channel or reduced cross-section or nozzle 9 also prevents the drug product 2, particularly from the chamber 6, from flowing through the narrowed flow channel or reduced cross-section or nozzle 19 and / or into the tip 10 or a portion of the application channel 7 included by the tip 10 and / or toward the axial end 7A, particularly before opening the application package 1. Therefore, preferably, this prevents the drug product 2 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 the application package 1 is opened or the tip 10 is disposed of. Figure 12 illustrates a second embodiment of the application package 1 in the region of the fracture zone 9, with an enlarged detail corresponding to the first embodiment shown in Figure 11. Preferably, the only difference between the first and second embodiments is that the application package 1 or the bottom portion 3 or the predetermined fracture zone 9 does not include the protrusion 17 and / or does not include the narrowed flow channel or the reduced cross-section or the nozzle 19. The application channel 7 of the second embodiment preferably has a constant distance between the inner surface 18 and the cover 4 and / or, in particular, a constant (flow) cross section in the predetermined fracture zone 9. Along axis A and / or along the section shown in Figure 12, the inner surface 18 is preferably at least substantially flat, especially in the predetermined fracture zone 9. Preferably, in the predetermined fracture zone 9, the thickness T of the bottom portion 3 (wall) is reduced or decreased compared to the area surrounding the predetermined fracture zone 9. Particularly preferably, the thickness T reduces the depth D of the groove 15. The ratio of the thickness at the predetermined fracture zone 9 (the narrowest region) to the thickness in the region surrounding the predetermined fracture zone 9 is preferably at least 0.1 or 0.2 and / or at most 0.9 or 0.8. The following embodiments are also possible: wherein the application package 1 (especially the bottom portion 3 or the predetermined fracture zone 9) has a protrusion 17 or a narrowed flow channel or a reduced cross section or nozzle 19, but nevertheless, it still has a non-constant thickness T relative to the area surrounding the protrusion 17 or the predetermined fracture zone 9, for example, a reduced thickness T in the area of ​​the protrusion 17 or the predetermined fracture zone 9. It is also conceivable that, compared to the average thickness T, the thickness T decreases in some regions and increases in others. For example, the thickness T may decrease at the tip of the protrusion 17 and increase at the root / base of the protrusion 17. Preferably, the material weakening of the predetermined fracture zone 9 or the bottom portion 3 is formed by a bend / knot, by a reduction in material / thickness, or by a combination thereof. In the following description, a third and fourth embodiment of the application packaging 1 is described, which differs from the first and second embodiments in that a predetermined fracture zone 9 or a groove 15 thereof extends above the edge 8 or is formed at both the application channel 7 and the edge 8. Figures 13 through 15 show a third embodiment of the application package 1 in views corresponding to Figures 9 through 11. Specifically, Figure 13 shows a schematic plan view from the bottom side of the application package 1, Figure 14 shows a schematic cross-section of the application package 1 along line XIV-XIV in Figure 13, and Figure 15 shows an enlarged detail of Figure 13 marked XV. The cross-sections shown in Figures 14 and 15 are along axis A, that is, along the application channel 7 or in the region of the application channel 7. Figure 16 shows a schematic cross-section of the application package 1 in region 1 of the edge 8 according to the third embodiment, in an enlarged view similar to that of Figure 15. Since the edge 8 does not include the predetermined break region 9 or groove 15 in these embodiments, similar figures of the first and second embodiments have been omitted. Figure 17 illustrates a magnified detail of a fourth embodiment of the application package 1 in the area of ​​the fracture zone 9, corresponding to one of the other embodiments shown in Figures 11, 12, and 15. Figure 18 illustrates a magnified detail of a fourth embodiment of the application package 1 in the area of ​​the fracture zone 9 at the edge 8, corresponding to one of Figure 16. In both the third and fourth embodiments, the predetermined fracture zone 9 or groove 15 preferably extends above the cavity 5 (particularly the application channel 7 and the edge 8). In other words, the predetermined fracture zone 9 or groove 15 preferably extends over the entire width of the application package 1, that is, over the entire extension of the application package 1 in either the transverse or perpendicular direction to the application channel 7 (the longitudinal extension) or axis A. Preferably, the region of the predetermined fracture zone 9 at the edge 8 has the same or similar characteristics as the region of the predetermined fracture zone 9 at the cavity 5 or the application channel 7. The above explanations regarding the predetermined fracture zone 9, groove 15, angle W, depth D, etc., are preferably also applicable to the predetermined fracture zone 9 of the third and fourth embodiments (particularly preferably in the area of ​​both cavity 5 and edge 8). Preferably, the groove 15 in the region of the edge 8 has the same or similar properties as in the region of the cavity 5 or the application channel 7, for example, the same angle W, the same depth D or the like. However, it is also possible to have different solutions for the predetermined fracture zone 9 and / or groove 15 at the edge 8. For example, the groove 15 may have a smaller depth D at the edge 8 than it does at the cavity 5 or application channel 7. Preferably, the main or only difference between the third embodiment according to Figures 13 to 16 and the fourth embodiment according to Figures 17 and 18 is whether the protrusion 17 is formed on the edge 8. Preferably, the edge 8 in the third embodiment does not include the protrusion 17, as can be seen in particular FIG. 16, and / or the edge 8 in the fourth embodiment includes the protrusion 17, as can be seen in particular FIG. 18. In the fourth embodiment, the protrusion 17 preferably extends over the entire width of the application package 1, that is, over the entire extension of the application package 1 in a direction perpendicular to either the application channel 7 or the longitudinal extension of axis A. Therefore, specifically, the edge 3A and / or the rim 8 also include the protrusion 17. Preferably, the protrusion 17 has the same or similar properties in the region of the edge 8 as it does in the region of the cavity 5 or the application channel 7. However, different solutions for the protrusion 17 at the edge 8 are also possible. Preferably, the cover 4 follows or adapts to the surface of the edge 8. In other words, in the fourth embodiment, in the region of the predetermined break zone 9 or protrusion 17, the cover 4 also has a protrusion or projection on its outer side and a groove on its inner side, as can be seen in Figures 17 and 18. In the third embodiment and / or when the edge 8 is flat or does not include the protrusion 17, the cover 4 is preferably at least substantially flat, especially in the region of the predetermined break zone 9, as can be seen in Figures 15 and 16. In the third embodiment, the thickness T is preferably reduced in the region of the predetermined fracture zone 9 at the edge 8, compared to the surrounding region and / or region of the predetermined fracture zone 9 at the application channel 7. In the fourth embodiment, the thickness T is preferably at least substantially constant over the entire length of the predetermined fracture zone 9. Preferably, the application package 1 according to the third embodiment includes a narrowed flow channel or a reduced cross-section or a nozzle 19. Preferably, the application package 1 according to the fourth embodiment has a flow cross-section that is at least substantially constant and / or does not include a narrowed flow channel or a reduced cross-section or nozzle 19. This is achieved in particular by shaping the cover 4 accordingly, especially in the region of the predetermined break zone 9 or the protrusion 17, to have a non-flat surface. However, the following solution is also possible: wherein the cover 4 is non-flat only at the edge 8, but remains flat at its covering cavity 5 or application channel 7, especially in the region framed by the edge 3A. Any combination of different embodiments is possible. For example, the predetermined fracture zone 9 of the third embodiment can also be formed without a protrusion 17, as in the second embodiment. The molding tool 102 and / or how the proposed method, particularly during the thermoforming step, and / or in the proposed equipment 100 (particularly the molding tool 102) are explained in more detail below and with reference to Figures 19 to 22. Figure 19 shows a schematic cross-section of a molding tool 102 having a (thermoformed) plastic sheet 200 or a bottom portion 3. Figure 20 shows an enlarged detail of a cross-section of the molding tool 102 in a region of a molding apparatus 102C having a (thermoformed) plastic sheet 200 or a bottom portion 3. Figures 21 and 22 illustrate the molding tool 102 according to a further embodiment, respectively, with illustrations corresponding to Figures 19 and 20. Unless otherwise stated, the following description is preferably applicable to both embodiments. In Figures 19 and 21, molds 102A and 102B are shown to be 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 molds 102A and 102B after thermoforming. In Figures 20 and 22, molds 102A and 102B are shown resting against plastic sheet 200 / bottom portion 3 and / or during thermoforming. The female mold 102A preferably has a cavity and / or a concave form or surface 102D. The surface 102D of the female mold 102A is preferably concave overall, but may be locally flat or even convex. Particularly preferred is that the female mold 102A has a plurality of (concave) cavities for forming a plurality of bottom portions 3 (simultaneously / in one molding step), as explained above with reference to Figure 4. The male mold 102B preferably has a (convex) protrusion and / or a convex form or (convex) surface 102E. The surface 102E of the male mold 102B is preferably generally convex, but may be locally flat or even concave. Particularly preferably, the male mold 102B has a plurality of (convex) protrusions for forming a plurality of bottom portions 3 (simultaneously / in one molding step), as explained above with reference to Figure 4. As explained above regarding the equipment 100 shown in Figure 4 and the corresponding production method, the molding tool 102 may include only a female mold 102A or only a male mold 102B, or only one of the two molds 102A and 102B may be used during (thermo)forming. In this case, the plastic sheet 200 is preferably, particularly pneumatically and / or by means of a gas blown onto the plastic sheet 200, forced against the female mold 102A or the male mold 102B, thereby conforming to the shape of the respective mold. Alternatively or additionally, a negative pressure may be generated, for example, by suctioning air or another gas from the respective mold. Alternatively or additionally, an impression mold or other mechanical force component may be used. Particularly preferably, both the female mold 102A and the male mold 102B are provided or used during the formation of (a number of) bottom portions 3, or are provided or used to form (a number of) bottom portions 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 extruded or formed between the female mold 102A and the male mold 102B. Therefore, preferably, a mechanical force is applied to the plastic sheet 200 by means of the molds 102A and 102B. In this sense, one of the molds 102A and 102B can act as an impression of the other mold 102B and 102A. Preferably, even when two molds 102A and 102B are provided / used, an additional gas is blown and / or a negative pressure is generated. One of the molds 102A, 102B or surfaces 102D, 102E may also be formed or provided only partially, particularly only in the area of ​​the bottom portion to be formed where more precise forming is required. For example, the male mold 102B or its (convex) surface 102E may be provided only in the area forming the application channel 7, or even only in the area forming the predetermined fracture zone 9. In this case, preferably, the plastic sheet 200 is forced against its respective mold 102A only in other areas by means of gas and / or negative pressure. The molding tool 102 (particularly the female mold 102A and / or the male mold 102B) is preferably configured to (thermally)form the predetermined fracture zone 9, the groove 15 and / or the protrusion 17, particularly during the (thermally)forming step of the production method. The molding tool 102 (particularly the female mold 102A and / or the male mold 102B) preferably includes a molding device or generating device 102C for (thermally) forming one of the predetermined fracture zone 9, the groove 15 and / or the protrusion 17. The molding device 102C is preferably shaped to correspond to the (desired) predetermined fracture zone 9, in particular to a protrusion or convex portion 102F in the female mold 102A and / or a groove or recess 102G in the male mold 102B. According to one of the fifth embodiments, which will be explained later with reference to Figures 23 to 25, a protrusion or convex portion 102F may also be provided in the male mold 102B and / or a groove or recess 102G may be provided in the female mold 102A to generate / form a predetermined fracture zone 9. The molding apparatus 102C preferably has a shape, measurement, and / or size corresponding to or the same as the (desired) predetermined fracture zone 9, for example, with respect to angle W and / or depth D. Specifically, the forming device 102C is elongated and / or wedge-shaped, preferably as the predetermined fracture zone 9. In the case of a surface protrusion, its height preferably corresponds to or is the same as the (desired) depth D of the predetermined fracture zone 9. In the case of a surface recess, its depth preferably corresponds to or is the same as the (desired) depth D of the predetermined fracture zone 9. The forming device 102C or the protrusion 102F preferably has a sharp edge or a sharp ridge. Preferably, the radius of curvature at the edge / ridge of the molding device 102C / protrusion 102F is less than 15% or 10% of the height of the molding device 102 / protrusion 102F, and particularly less than 5% or 2%. Preferably, the radius of curvature at the edge / ridge of the forming device 102C / protrusion 102F is less than 50 µm or 20 µm, and particularly less than 10 µm or 5 µm. Preferably, the groove 15 has the same or a corresponding radius of curvature at its valley, and / or the protrusion 17 has the same or a corresponding radius of curvature at its ridge. The molding apparatus 102C may be embodied / formed / provided only in the female mold 102A (e.g., as shown in Figures 19 and 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 Figures 21 and 22). In the case of female mold 102A, molding device 102C is preferably configured as a protrusion or convex part 102F in female mold 102A and / or in a (concave) cavity formed by female mold 102A and / or (integral concave) surface 102D. In the case of male mold 102B, molding device 102C is preferably configured as a groove or notch 102G in male mold 102B and / or in the (convex) cavity formed by male mold 102B and / or (integral convex) surface 102E. Preferably, when the plastic sheet 200 is forced to abut against the female mold 102A and / or the male mold 102B, it adapts to the shape of the respective molds 102A and 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. Particularly preferably, the plastic sheet 200 is adapted or laid flat on the molding device 102C, the protrusion 102F and / or the recess 102G (especially when forced against the molding device 102C, the protrusion 102F and / or the recess 102G), thereby forming a predetermined fracture zone 9, a groove 15 and / or a protrusion 17. Depending on the desired form of the predetermined fracture zone 9, the forming device 102C is shaped accordingly. The forming device 102C may be provided only in the area of ​​the molding tool 102 (particularly one or two molds 102, 102B) in which the application channel 7 is formed or to be formed. Alternatively, the forming device 102C may also be provided in the area of ​​the forming edge 8. When the bottom portion 3 is formed, especially during the molding step, the predetermined fracture zone 9 is formed only or will be formed only at the location where the molding device 102C is provided. When the forming device 102C is provided only in the area where the application channel 7 is formed or to be formed, the predetermined fracture zone 9 is correspondingly or will be formed only in the area of ​​the application channel 7. Therefore, preferably, the application package 1 or bottom portion 3 according to the first embodiment shown in Figures 9 to 11 and / or according to the second embodiment shown in Figure 12 and / or any other embodiment in which the predetermined fracture zone 9 is provided only at the application channel 7 can be formed / produced in this manner. When the molding apparatus 102C is also provided in the area where the edge portion 8 is formed or to be formed, the predetermined fracture zone 9 is also formed accordingly or will be formed accordingly in the area of ​​the edge portion 8. Therefore, preferably, the application package 1 or bottom portion 3 can be formed / produced in this manner according to the third embodiment shown in Figures 13 to 16 and / or according to the fourth embodiment shown in Figures 17 and 18 and / or any other embodiment in which the predetermined fracture zone 9 is also provided at the edge portion 8 (e.g., the embodiment also shown in Figures 1 to 3). Preferably, when two molds 102A and 102B are provided, or in the area where the two molds 102A and 102B are provided, the surfaces 102D and 102E of the molds 102A and 102B or the like correspond to each other at least substantially. Specifically, apart from having opposite curvatures, the surfaces 102D and 102E are at least substantially the same or have at least substantially the same shape. However, in specific areas where the predetermined fracture zone 9 is formed or to be formed, the surfaces 102D and 102E of the molds 102A and 102B or the like may be shaped differently. Preferably, in the embodiments shown in Figures 19 and 20, only the female mold 102A includes the forming device 102C. Specifically, when a protrusion or convex portion 102F is provided on the female mold 102A or surface 102D, particularly in the area where the application channel 7 or the predetermined fracture zone 9 is formed or to be formed, no corresponding groove or notch is provided on the male mold 102B. As best seen in Figure 20, this preferably results in a predetermined fracture zone 9 without a protrusion 17 and / or with a reduced thickness T. Specifically, in this manner, an application package 1 without a protrusion 17 can be formed according to the second embodiment and / or any other embodiment shown in Figure 12. Alternatively, the forming device 102C may be embodied / provided on two molds 102A, 102B, as illustratively shown in Figures 21 and 22. Specifically, one mold 102A, 102B may include a protrusion or convexity 102F and the other mold 102B, 102A may include a corresponding groove or notch 102G, particularly having 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 preferable to form / produce an application package 1 having a groove 15 and a corresponding protrusion 17, for example, an application package 1 according to the first embodiment shown in Figures 9 to 11 or according to the third or fourth embodiment shown in Figures 13 to 18. It is also possible that the parts of the molding device 102C on different molds 102A and 102B correspond to each other only in specific areas, but are different in other areas. For example, the forming device 102C or surface 102D may include a protrusion or convexity 102F extending along both the region where the application channel 7 is formed or to be formed and the region where the edge 8 is formed or to be formed. The forming device 102C or surface 102E may include a groove or notch 102G only in the region where the application channel 7 is formed or to be formed, but not in the region where the edge 8 is formed or to be formed. In this manner, preferably, an application package 1 according to one of the third embodiments shown in Figures 13 to 16 can be formed / produced. The molding apparatus 102C can be integrally formed with the molding tool 102, particularly the female mold 102A and / or the male mold 102B or their respective surfaces 102D, 102E. In the examples shown in Figures 19 and 20, the molding device 102C is preferably an integrally formed protrusion or convex portion 102F of the mold 102A or surface 102D. Depending on the desired shape of the predetermined fracture zone 9, another mold 102B or surface 102E may additionally or alternatively include an integrally formed groove or recess 102G, for example, as shown in Figures 21 and 22. Preferably, the equipment 100 can be adapted to produce predetermined fracture zones 9 of different shapes. As previously explained, the molding tool 102 (especially molds 102A, 102B) is preferably replaceable. The equipment 100 is suitable for producing predetermined fracture zones 9 of different shapes by replacing the molding tool 102 (especially one or two molds 102A, 102B) with one of the molding tools 102 having a different forming device 102C. Particularly preferably, the molding apparatus 102C is movable, adjustable, and / or replaceable, particularly within the molding tool 102 or the respective molds 102A, 102B and / or without replacing the entire molding tool 102 or the respective molds 102A, 102B. Specifically, the equipment 100 is preferably suited for producing predetermined fracture zones 9 of different shapes without replacing the entire molding tool 102 or the respective molds 102A, 102B. Preferably, the molding device 102C forms a movable, adjustable and / or replaceable component of one of the molding tools 102. For example, the molding device 102C may be designed to insert one or more of the molding tool 102 or molds 102A, 102B. This is indicated schematically by dashed lines in Figures 20 and 22. The molding device 102C or insert can preferably be 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 in one of the molding tool 102 or the mold 102A, 102B. To produce a different type of application packaging 1 or a predetermined fracture zone 9, or to adapt the equipment 100 or molding tool 102, the molding device 102C or insert can preferably be replaced with a different molding device 102C or insert. Preferably, in this way, an adaptation system is possible without replacing the (entire) molding tool 102 or molds 102A, 102B. Alternatively or additionally, the molding device 102C may be adjustable or displaceable. Preferably, the molding device 102C may be adjusted or displaced orthogonally and / or parallel to surfaces 102D, 102E. Specifically, the height / depth D and / or angle W of the forming device 102C (particularly the protrusion 102F and / or the recess 102G) and the subsequently produced predetermined fracture zone 9 can be adjusted. For example, the degree to which the forming device 102C is inserted into or screwed into the molding tool 102 or the mold 102A, 102B can be adjusted. Preferably, the molding device 102C is adjustable or repositionable to determine / change the position of the predetermined fracture 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. Figure 20 shows an example in magnified detail of a mold 102A and a male mold 102B having a reduced thickness T and / or according to the second embodiment shown in Figure 12 and / or having non-corresponding surfaces 102D, 102E, particularly having a predetermined fracture zone 9 provided only in / formed in the molding apparatus 102C on the surface 102D of the female mold 102A. The plastic sheet 200 is preferably extruded or compressed between molds 102A and 102B, particularly in the area of ​​molding device 102C and / or between the molding device 102C or protrusion 102F formed therefrom and the surface 102E of another mold 102B that is (directly) opposite to the molding device 102C. Due to extrusion / compression and / or the different shapes of the surfaces 102D, 102E and / or the molding apparatus 102C, the thickness T of the plastic sheet 200 is preferably reduced in the region of the molding apparatus 102C. In this way, a predetermined fracture zone 9 is preferably created. The molding device 102C or the protrusion 102F preferably penetrates the plastic sheet 200. Preferably, only the outermost layer of the plastic sheet 200, particularly the outer thermoformable layer 201, and preferably also the cyclic olefin copolymer layer 202, and if necessary, the inner thermoformable layer 203, is affected, penetrated, and / or squeezed / compressed by the molding apparatus 102C or during thermoforming. Preferably, the innermost layer (particularly at least the barrier layer 204 and the sealing layer 205) remains intact or at least substantially unaffected, penetrated, or squeezed / compressed by the molding device 102C or during the molding process. Therefore, preferably, the sealing and barrier quality of the plastic sheet 200 or the bottom portion 3 is not compromised by the predetermined fracture zone 9 or is not compromised at the predetermined fracture zone 9. The height of the molding device 102C or the protrusion 102F is preferably less than the thickness of the plastic sheet 200, particularly preferably less than the thickness of the cyclic olefin copolymer layer 202 or less than the sum of the outer thermoformable layer 201, the cyclic olefin copolymer layer 202, and the inner thermoformable layer 203 as needed. Preferably, the height of the forming device 102C or the protrusion 102F corresponds to the (desired) depth D of the groove 15 to be formed. The height of the forming 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. In a further embodiment (e.g., the embodiment shown in Figures 21 and 22), as explained above, molds 102A and 102B may have corresponding surfaces 102D and 102E in the region where the predetermined fracture zone 9 is formed or to be formed. In this case, preferably, the molding device 102C includes a protrusion or convex portion 102F on one mold and a corresponding groove or recess 102G on the other mold. Next, the plastic sheet 200 (in particular all its layers) is pushed inward, bent, or knotted during (thermo) forming, particularly by being pushed from the protrusion 102F of mold 102A into the recess 102G of mold 102B, or vice versa, for example, as shown in FIG22. In this way, preferably, a predetermined fracture zone 9 with a groove 15 and a corresponding protrusion 17 is formed. In this embodiment, the plastic sheet 200 is preferably not squeezed / compressed at least substantially, and in particular, at least substantially no outer layer is squeezed / compressed. Preferably, all layers of the plastic sheet 200 are affected because all layers bend / knot inward. However, the integrity of the inner layers (particularly at least the barrier layer 204 and the sealing layer 205) is preferably maintained. Therefore, in this case, the sealing and barrier quality of the plastic sheet 200 or the bottom portion 3 is preferably not damaged by the predetermined fracture zone 9 or is not damaged at the predetermined fracture zone 9. The plastic sheet 200 may have corresponding surfaces 102D, 102E only in specific areas and / or be bent / knotted inward only in specific areas or squeezed / compressed in other areas. For example, the plastic sheet 200 may be bent / knotted in the area where the application channel 7 is formed or to be formed and squeezed / compressed in the area where the edge 8 is formed or to be formed, so that an application package 1 or bottom portion 3 according to one of the third embodiments shown in Figures 13 to 16 can be formed. The fifth embodiment of the application packaging 1 is described below. Figures 23 through 25 show the fifth embodiment of the application package 1 in views corresponding to Figures 9 through 11. Specifically, Figure 23 shows a schematic plan view from the bottom side of the application package 1, Figure 24 shows a schematic cross-section of the application package 1 along line XXIV-XXIV in Figure 23, and Figure 25 shows an enlarged detail of Figure 24 marked XXV. The cross-sections shown in Figures 24 and 25 are along axis A, for example, along application channel 7 or in the region of application channel 7. In the fifth embodiment, the groove 15 is provided on the inner surface 18 and / or the protrusion 17 is provided on the outer surface 16 and / or the bend / knot is directed toward the outside of the bottom portion 3. Compared to the previous embodiment, the positions of the groove 15 and the protrusion 17 are preferably interchanged and / or the predetermined fracture zone 9 is preferably bent / knotted in opposite directions. Compared to the first embodiment shown in Figures 9 to 11, the predetermined fracture zone 9 in the fifth embodiment does not narrow the application channel 7. Instead, preferably, a widened flow channel or cross-sectional enlarger or diffuser 20 is formed at or through the predetermined fracture zone 9, particularly in the cavity 5 or the application channel 7. The height and / or width of the application channel 7 are preferably increased by at least 0.05 mm or more and / or at most 0.5 mm or less at or through the predetermined fracture zone 9, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm. 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. Specifically, the groove 15 is formed on the inner surface 18, that is, the surface 18 is recessed in the region of the predetermined fracture zone 9, thereby widening the channel and / or enlarging the (flow) cross-section. When the application package 1 is opened (particularly by folding / bending along the predetermined fracture zone 9 or groove 15), a widened flow channel or cross-sectional enlarger or diffuser 20 is preferably formed or positioned at the open end 7B, particularly where the drug product 2 is discharged from the application package 1. The channel is widened at the open end 7B to allow for easier discharge of drug product 2. This can be advantageous, for example, for a more viscous fluid. The preferred shape, size and / or other features of the predetermined fracture zone 9 (in particular the groove 15 and / or the protrusion 17) described above with respect to other embodiments are also preferably applicable to the fifth embodiment. Obviously, in some interpretations and definitions of the previous embodiments, the term "outer 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 extending plane of the inner surface 18 to the lowest region of the groove 15, particularly the distance measured perpendicular to the main plane, and / or the angle W is preferably the smaller angle between the main extending plane of the inner surface 18 and the main extending plane of the inclined or sloping surface of the groove 15, particularly at the predetermined break zone 9 or the edge of the groove 15 (i.e., the edge where the inner surface 18 bends outward and / or begins to form a groove / notch). Particularly preferably, the explanation and preferred values ​​of the groove 15 and / or the protrusion 17 (especially for the thickness T, depth D and / or angle W) are also preferably applicable to the fifth embodiment. Figure 25 illustratively shows an angle W of about 40° (an opening angle of about 100°). In the fifth embodiment, similar to the first embodiment, the predetermined fracture zone 9 (in particular the groove 15 and / or the protrusion 17) preferably extends only above the cavity 5 (in particular the application channel 7). Particularly preferably, the predetermined fracture zone 9 extends transversely or perpendicularly to axis A / channel 7 over the entire cavity 5 or the application channel 7 or its width. However, the predetermined fracture zone 9 may also extend only partially above 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 edge 8 may (already) lack the predetermined fracture zone 9. The above description and features regarding the entire or part of the extension of the predetermined fracture zone 9 are preferably also applicable to previous embodiments (e.g., the first embodiment) in which the predetermined fracture zone 9 does not extend above the edge portion 8. Although the illustrative example of the fifth embodiment according to Figures 23 to 25 shows a predetermined fracture zone 9 extending only above the cavity 5 / application channel 7, the predetermined fracture zone 9 may also extend beyond the cavity 5 / application channel 7, particularly extending over the entire width of the edge 8 and / or the application package 1 or the bottom portion 3. As explained with respect to the previous embodiments, in this case, both the groove 15 and the protrusion 17 may extend beyond the cavity 5 / application channel 7 (as in the fourth embodiment), or only one of the groove 15 or the protrusion 17 may extend beyond the cavity 5 / application channel 7 (as in the third embodiment). Furthermore, although the illustrative example of the fifth embodiment according to Figures 23 to 25 shows a predetermined fracture zone 9 embodied as a bend / knot and / or having both a groove 15 and a protrusion 17, it is also possible to provide only the groove 15 on the inner surface 18 without the protrusion, particularly similar to the second embodiment. Therefore, any combination of different embodiments is possible. Specifically, the fifth embodiment can be combined with any of the previous embodiments. The molding tool 102 (in particular the molding device 102C) is preferably constructed / shaped accordingly to form the bottom portion 3 (in particular the predetermined fracture 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. Specifically, the female mold 102A includes a notch 102G and / or the male mold 102B includes a protrusion 102F. Figure 27 illustratively shows a female mold 102A having a corresponding notch 102G. Compared to the molding tool 102 or forming apparatus 102C previously described as shown in Figures 21 and 22, the positions of the protrusion 102F and the notch 102G are preferably interchanged to form / produce the predetermined fracture zone 9 of the fifth embodiment. Otherwise, even without repetition, the above description and features are preferably applied accordingly. Similarly, a protrusion 102F may be provided only for the male mold 102B, while no protrusion or recess may be provided for the female mold 102A, particularly complementing the molding apparatus 102C shown in Figures 19 and 20, to form a predetermined fracture zone 9 having a groove 15 on the inner surface 18 and having a reduced wall thickness and / or not having a protrusion 17. Otherwise, even without repetition, the above description and features preferably also apply accordingly. If the molding device 102C is designed as an insert and / or replaceable component in each of the molds 102A and 102B, the molding device 102 can also be adapted to produce the predetermined fracture zone 9 of the fifth embodiment by interchanging these inserts, that is, providing the insert of the female mold 102A in the male mold 102B, and vice versa. Figures 26 and 27 show, in schematic perspective views, an exemplary preferred embodiment of the female mold 102A of the molding tool 102. Here, Figure 26 shows a female mold 102A with a protrusion 102F for forming a predetermined fracture zone 9, and Figure 27 shows a female mold 102A with a notch 102G for forming a predetermined fracture zone 9. Even without repetition, the above explanations and features, particularly as described in conjunction with Figures 19 to 22, are preferably also applicable to the molds of Figures 26 and 27. Similarly, the following explanations are preferably also applicable to the molds previously described in conjunction with Figures 19 to 22. Preferably, the female mold 102A of FIG26 can be used to produce an application package 1 or a bottom portion 3 having one of the grooves 15 on the outer surface 16 according to the first embodiment. Preferably, the female mold 102A of FIG27 can be used to produce an application package 1 or a bottom portion 3 having a groove 15 on the inner surface 18 according to the fifth embodiment. For the production of an application package 1 or a bottom portion 3 that also has a predetermined fracture zone 9 at the edge 8, the forming device 102C (particularly the protrusion 102F or the recess 102G) preferably extends beyond the area for forming the cavity 5 (particularly the application channel 7) and / or beyond the concave surface 102D. The following description and features are also preferably applicable to such molds 102A. As shown in Figures 26 and 27, 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). Vent holes 102H are preferably distributed above the entire surface 102D and 102E of molds 102A and 102B, especially uniformly and / or along axis A and / or mirror-symmetrically with axis A. In a plan view or cross section, the vent 102H is preferably at least substantially circular, elliptical, or oval. Preferably, the vent 102H extends through the entire mold 102A and 102B. Vent holes 102H are preferably provided so that air can escape from molds 102A and 102B when the bottom part 3 is thermoformed (especially deep drawn). Specifically, when the plastic sheet 200 is pressed into and / or onto the molds 102A and 102B by negative and / or positive pressure, the air between the plastic sheet 200 and the respective molds 102A and 102B escapes into the environment through the vent 102H. Preferably, in this manner, the plastic sheet 200 can be laid flat on the molds 102A and 102B without being damaged by the air trapped between the plastic sheet 200 and the molds 102A and 102B. Particularly preferably, as indicated in Figures 26 and 27, one or more vents 102H, especially more preferably (specifically) three vents 102H, are also positioned or configured or formed in / at the forming device 102C (particularly the protrusion 102F and / or the recess 102G). Preferably, the vent 102H in the molding device 102C ensures that the plastic sheet 200 (closely attached to the ground) is pressed against the molding device 102C and / or the predetermined fracture zone 9 to be generated / formed in the desired shape. The vent 102H or at least several vent 102H in / at the forming apparatus 102C preferably has a diameter of at least 0.2 mm or 0.3 mm, particularly at least 0.4 mm or 0.5 mm, and / or at most 1.0 mm or 0.9 mm, particularly at most 0.8 mm or 0.7 mm. Particularly preferred diameters are 0.5 mm, 0.6 mm or 0.7 mm. The ratio of the diameter of one of the vents 102H located in the application channel 7 to the width of the application channel 7 (particularly in / at the molding apparatus 102C) is preferably greater than 1:7 and / or less than 1:3. Particularly preferred is a ratio of about 1:6, 1:5 or 1:4. Preferably, the diameter of the (several) vent holes 102H located at the molding device 102C is greater than or approximately the same as the height of the molding device 102C. The diameter of the (several) vent holes 102H located at the molding device 102C is preferably smaller than the range of the molding device 102C in the direction of longitudinal extension of the shaft A or the application channel 7. Preferably, all vent holes 102H of molds 102A and / or 102B have the same shape and / or size. However, vent holes 102H with different diameters may also be provided. For example, some vent holes 102H at / in the molding device 102C may be smaller or larger than vent holes 102H formed outside the molding device 102C. The location of the vent 102H can be seen on the finished application package 1 or the bottom portion 3. Specifically, the bottom portion 3 may have a deformation 21 (such as a mark, protrusion, ridge, or imprint) at a corresponding location along axis A, for example. This is especially true for the preferred plastic sheet 200 as described in conjunction with Figures 5 and 7. Particularly preferably, the application packaging 1 or the bottom portion 3 has one or more vents 102H from the predetermined fracture zone 9 or one or more deformations 21 (such as markings, protrusions, ridges or imprints) produced by the vents 102H from the predetermined fracture zone 9. By way of example, Figure 25 shows one of the deformations 21 at the predetermined fracture zone 9 by means of dashed lines. Modification 21 preferably has (in a plan view) a diameter and / or shape similar to the diameter and / or shape of the respective vent 102H. Specifically, fracture behavior (especially brittleness) can be enhanced by deforming one or more of the nine predetermined fracture zones. Individual states, features, and method steps can be implemented independently of each other, but they can also be implemented in any desired combination or sequence. 1: Application Packaging 1A: Axial End of Application Packaging 2: Drug Product 3: Bottom Part 3A: Edge 4: Cover 5: Cavity 6: Chamber 7: Application Channel 7A: Axial End of Application Channel 7B: Open End 8: Edge 9: Pre-determined Break Zone 10: Tip 11: Secondary Packaging 12: Base Part 13: Cap 14: Container 15: Groove 16: Outer Surface 17: Protrusion 18: Inner Surface 19: Nozzle / Reduced Cross-section 20: Diffuser / Enlarged Cross-section 21: Deformation 100: Equipment 101: Heating Device 101A: Upper Heating Plate 101B: Lower Heating Plate 102: Molding Tool 102A: Female Mold 102B: Male Mold 102C: Molding Device 102D: (Concave) Surface 102E: (Convex) Surface 102F: Convex Part 102G: Notch 102H: Vent Hole 103: Filling Device 104: Covering Device 200: Plastic Sheet 201: Outer Thermoformable Layer 202: Cycloolefin Copolymer Layer 203: Inner Thermoformable Layer 204: Barrier Layer 205: Sealing Layer 206: Intermediate Layer 207a to 207d: Connecting Layer 208: Adhesive Layer 300: Cover Sheet 301: Protective Layer 302: First Barrier Layer 303: Intermediate Layer 304: Second Barrier Layer 305: Sealing Layer 307a: Connecting Layer 307b: Connecting Layer 308a: Adhesive Layer 308b: Adhesive Layer A: Axis D: Depth T: Thickness W: Angle Referring to the accompanying drawings, further features, advantages, and characteristics of the present invention will become clear from the following description of the claims and preferred embodiments. Figure 1: Schematic perspective view of an application package according to one embodiment of the present invention; Figure 2: An open application package according to one schematic perspective view of the present invention; Figure 3: Schematic cross-section of an application package passing through a secondary package; Figure 4: Schematic diagram of an apparatus for producing an application package according to the present invention; Figure 5: Schematic cross-section of the material of the bottom portion of the application package; Figure 6: Schematic cross-section of the material of the cover of the application package; Figure 7: Schematic cross-section of a preferred material of the bottom portion of the application package; Figure 8: Schematic cross-section of a preferred material of the cover of the application package; Figure 9: Schematic plan view of an application package according to a first embodiment; Figure 10: Schematic cross-section of an application package along line XX of Figure 9; Figure 11: Enlarged detail of a predetermined fracture zone according to the first embodiment; Figure 12: Enlarged detail of a predetermined fracture zone according to a second embodiment; Figure 13: Schematic plan view of an application package according to a third embodiment; Figure 14: Schematic cross-section of an application package along line XIV-XIV of Figure 13; Figure 15: Figure 16 shows an enlarged detail of a predetermined fracture zone in an application channel region according to a third embodiment; Figure 17 shows an enlarged detail of a predetermined fracture zone in an edge region according to a third embodiment; Figure 18 shows an enlarged detail of a predetermined fracture zone in an edge region according to a fourth embodiment; Figure 19 shows a schematic cross-section of a molding tool according to the apparatus of Figure 4; Figure 20 shows a schematic cross-sectional detail of the molding tool of Figure 19 in the region of a molding apparatus for forming a predetermined fracture zone; Figure 21 shows a schematic cross-section of a molding tool according to another embodiment; Figure 22 shows a schematic cross-sectional detail of the molding tool of Figure 21 in the region of a molding apparatus for forming a predetermined fracture zone; Figure 23 shows a schematic plan view of an application package according to a fifth embodiment; Figure 24 shows a schematic cross-section of an application package along line XXIV-XXIV of Figure 23; Figure 25 shows an enlarged detail of a predetermined fracture zone according to a fifth embodiment; Figure 26 shows a schematic plan view of an application package according to a fifth embodiment. Figure 27 shows a schematic perspective view of one embodiment of a molding tool or mold; and Figure 28 shows a schematic perspective view of another embodiment of a molding tool or mold. In the figures, even when repeated descriptions are omitted, the same component symbols are used for the same components and parts. 1: Application Packaging 1A: Axial end of the application packaging 3: Bottom part 4: Cover 5: cavity 6: Chamber 7: Application Channel 7A: Axial end of the application channel 8: Edge section 9: Pre-determined fracture zone 10: Tip A: Axis

Claims

1. A method for producing and filling an application package (1) for a pharmaceutical product (2), the method comprising the steps of: heating at least partially a plastic sheet (200); forming a bottom portion (3) of the application package (1) by stretching the plastic sheet (200) onto and / or into a molding tool (102), the bottom portion (3) having a cavity (5) for receiving the pharmaceutical product (2) and an edge (8) surrounding the cavity (5); filling the cavity (5) with the pharmaceutical product (2); covering the cavity (5) with a cover (4) and securing the cover (4) to the edge (8) such that the cavity (5) is completely closed; characterized in that a predetermined fracture zone (9) is generated in the bottom portion (3) using the molding tool (102) and / or during the step of forming the bottom portion (3), wherein the predetermined fracture zone (9) is generated without cutting and / or without using a cutting tool.

2. The method of claim 1, wherein the predetermined fracture zone (9) is generated in the bottom portion (3) only or substantially using the molding tool (102) and / or only or substantially during the step of forming the bottom portion (3).

3. The method of claim 1 or 2, wherein the cavity (5) includes a chamber (6) and an application channel (7) in fluid communication with the chamber (6).

4. The method of claim 1 or 2, wherein the predetermined fracture area (9) is or includes a groove (15) on one of the outer surfaces (16) of the application package (1).

5. The method of claim 1 or 2, wherein the predetermined fracture area (9) is or includes a groove (15) on one of the inner surfaces (18) of the application package (1).

6. The method of claim 4, wherein the predetermined fracture zone (9) includes a protrusion (17) opposite to the groove (15).

7. The method of claim 5, wherein the predetermined fracture zone (9) includes a protrusion (17) opposite to the groove (15).

8. The method of claim 1 or 2, wherein the predetermined fracture zone (9) is a region that is thinner than a region of the bottom portion (3) surrounding the fracture zone (9).

9. The method of claim 1 or 2, wherein the predetermined fracture zone (9) is a region having at least substantially the same thickness as a region surrounding the bottom portion (3) of the fracture zone (9).

10. The method of claim 1 or 2, wherein the predetermined fracture zone (9) is formed as a knot in the wall of the bottom portion (3).

11. The method of claim 1 or 2, wherein a molding tool (102) having a female mold (102A) and a male mold (102B) is used to form the bottom portion (3).

12. The method of claim 1 or 2, wherein the predetermined fracture zone (9) is formed only in one region of the cavity (5) or in one application channel (7) of the cavity (5).

13. The method of claim 1 or 2, wherein different application packages (1) are formed having predetermined fracture zones (9) of different shapes, wherein a molding device (102C) for forming the predetermined fracture zones (9) is replaced and / or adjusted for forming the different application packages (1).

14. An apparatus (100) for producing an application package (1) for a pharmaceutical product (2), wherein the apparatus (100) has a heating device (101) for heating at least partially a plastic sheet (200) to a thermoforming temperature, wherein the apparatus has 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), the bottom portion (3) having a cavity (5) for receiving the pharmaceutical product (2) and an edge (8) surrounding the cavity (5). The molding tool (102) is characterized by having a molding device (102C) for forming a predetermined fracture zone (9) in the bottom portion (3), wherein the device (100) is configured to generate the predetermined fracture zone (9) in the bottom portion (3) without cutting and / or without using a cutting tool.

15. The device (100) of claim 14, wherein the device (100) is configured to generate the predetermined fracture zone (9) in the bottom portion (3) by means of the molding tool (102) alone or substantially by means of the molding tool (102).

16. The apparatus (100) of claim 14 or 15, wherein the molding device (102C) forms a protrusion (102F) and / or a recess (102G) on one surface (102D, 102E) of one of the molds of the molding tool (102).

17. The device (100) of claim 14 or 15, wherein the molding device (102C) is an adjustable and / or replaceable component of the molding tool (102).

18. The apparatus (100) of claim 14 or 15, wherein the molding tool (102) has a female mold (102A) and a male mold (102B).

19. The apparatus (100) of claim 18, wherein the female mold (102A) and the male mold (102B) have surfaces (102D, 102E) of different shapes, such that the apparatus (100) is configured to produce a predetermined fracture zone (9) that is thinner than a region of the bottom portion (3) surrounding the predetermined fracture zone (9).

20. The device (100) of claim 18, wherein the female mold (102A) and the male mold (102B) have surfaces (102D, 102E) of complementary shapes, such that the device (100) is configured to generate a knot in the wall of the bottom portion (3) as a predetermined fracture zone (9).

21. The apparatus (100) of claim 14 or 15, wherein one or more vents (102H) of the molding tool (102) are disposed at or formed in the molding apparatus (102C).

22. An application package (1) for a pharmaceutical product (2), wherein the application package (1) has a bottom portion (3) having a cavity (5) for receiving the pharmaceutical product (2), wherein the application package (1) has a cover (4) covering and completely closing the cavity (5), wherein the application package (1) has a predetermined fracture zone (9) for opening the application package (1) by breaking the predetermined fracture zone (9). The predetermined fracture zone (9) is characterized by being generated by thermoforming, wherein the predetermined fracture zone (9) is generated without cutting and / or without using a cutting tool, and / or the cross-section of one of the application channels (7) of the cavity (5) is reduced or a nozzle (19) is formed in the predetermined fracture zone (9), and / or the predetermined fracture zone (9) extends only above the cavity (5) or above one of the application channels (7) of the cavity (5), and / or the predetermined fracture zone (9) is formed by a knot 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 fracture zone (9).

23. The application packaging (1) of claim 22, wherein the predetermined fracture zone (9) is generated solely or substantially by thermoforming.

24. The application packaging (1) of claim 22 or 23, wherein the predetermined fracture zone (9) has a protrusion (17) on an outer surface (16) of the bottom portion (3) and a groove (15) on an inner surface (18) of the bottom portion (3).

25. The application packaging (1) of claim 22, wherein the predetermined fracture zone (9) has a groove (15) on an outer surface (16) of the bottom portion (3) and a protrusion (17) on an inner surface (18) of the bottom portion (3).

26. The application package (1) of claim 24, wherein the groove (15) extends over the cavity (5) and a rim (8) surrounding the cavity (5), and the protrusion (17) extends only over the cavity (5) or over the cavity (5) and the rim (8).

27. The application package (1) of claim 25, wherein the groove (15) extends over the cavity (5) and a rim (8) surrounding the cavity (5), and the protrusion (17) extends only over the cavity (5) or over the cavity (5) and the rim (8).

28. The application package (1) of claim 22 or 23, wherein the cavity (5) includes a chamber (6) and an application channel (7) in fluid communication with the chamber (6).

29. The application package (1) of claim 22 or 23, wherein the bottom portion (3) includes a deformation (21) of a vent (102H) from a molding tool (102).

30. The application package (1) of claim 22 or 23, wherein the application package (1) is produced by one of the methods of claim 1 to 13 and / or one of the equipment (100) of claim 14 to 21.

31. A method for producing and filling an application package for a pharmaceutical product (2), the method comprising the steps described in any one of claims 1 to 13, characterized in that: the method is performed using an apparatus (100) described in any one of claims 14 to 21; and / or the method produces an application package (1) described in any one of claims 22 to 30.

32. An apparatus (100) for producing an application package (1) for a pharmaceutical product (2), the apparatus (100) comprising the features described in any one of claims 14 to 21, characterized in that: the apparatus (100) is configured to perform the method described in any one of claims 1 to 13; and / or the apparatus (100) is configured to produce an application package (1) as described in any one of claims 22 to 30.

Images