Application package and method for the production thereof

Abstract

The present invention relates to an application package and a method for its production. The application package comprises a base part and a cover obtained from a multilayer film.

Description

Technical Field

[0001] This invention relates to an application package for a preferred liquid pharmaceutical product, a method for producing and filling the application package, and the use of a plastic sheet for producing the application package.

[0002] 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.

[0003] Application packaging, particularly for liquid pharmaceutical products, that contains or stores the product and can also be used to administer the product to a patient. Packaging, in particular, for pipettes or can be used as or converted into pipettes.

[0004] 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 domestic animal, such as a cat or dog). Background Technology

[0005] EP 2 998 098 A1 and EP 2 998 099 A1 relate to a method for producing and filling an application package for a liquid pharmaceutical article. The package is produced by a thermoforming process in which a deep-drawing film is heated to plasticize at least in a sub-region, the plasticized region is deep-drawn into a molding tool to form a cavity for the article and a tubular application channel leading to the cavity, the article is introduced into the cavity, and a cover film is used to cover the filled deep-drawing film to seal the cavity 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-drawing film. The deep-drawing 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.

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

[0007] First, to avoid any unintended interactions between the solvent or active ingredient of the pharmaceutical product and the packaging, only specific combinations of plastic films may be used for capping films and deep-drawn films. The same applies to fracture zones: only specific material combinations may be used to ensure reproducible, complete fracture at the fracture zone and a ready-to-use pipette. Unfortunately, brands mentioned in EP 2 998 098 A1 or EP 2 998 099A1 respectively... The specific acrylonitrile-methacrylate copolymer (AMAB) for distribution is no longer available.

[0008] In addition to the thermoforming steps that form the chamber and application channel, the creation of the groove also requires an additional step.

[0009] Finally, 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.

[0010] Therefore, there is a need for a new combination of materials that enables this single-use packaging to be used in one of the liquid pharmaceutical products.

[0011] U.S. Patent Application US2012 / 0265159 A1 describes an apparatus for storing and dispensing a drug, and more specifically, an apparatus for dispensing a parasite-killing drug onto the skin of an animal. A particular interest lies in the configuration of the packaging apparatus, which is designed to include a wall or a second layer coupled to a substrate or a first layer, wherein the substrate and the wall define a drug reservoir. At least a portion of the wall or the second layer is configured to deform upon actuation of the wall to reduce the volume of one of the drug reservoirs, thereby facilitating dispensing of a drug from the apparatus.

[0012] Given the materials that may be included in the first or second layer of the device, it is specified that only the first and / or second layer, and any other layers, walls, and structures contained within any pharmaceutical container described, may be made of any suitable material. These materials may be selected to minimize interaction with the pharmaceutical agent and may be made of a substantially inert and / or flexible polymer, or a polymer having a specific stiffness. However, the materials are irrelevant to one of the possible opening mechanisms of the described device, and explicitly, the design of a predetermined fracture zone is not intended for one or all possible uses.

[0013] German utility model DE 201 16 341U1 describes a polyolefin multilayer film. This type of film is particularly suitable for applications involving perishable foods such as fresh meat or sausages. Therefore, the multilayer plastic film comprises at least two plastic layers, wherein at least one layer comprises a mixture of at least one semi-crystalline polyolefin and at least one amorphous polyolefin of greater than 5% by weight, and at least one further layer comprises a material having an oxygen barrier effect. The film is intended to be characterized by a uniform wall layer distribution after thermoforming, good thermoforming properties with low shrinkage after thermoforming, good puncture resistance under static and / or dynamic loads, good barrier properties against water vapor and oxygen, and consistent mechanical properties unrelated to hygroscopicity.

[0014] However, this document does not address or provide a basis for the potential suitability of multilayer films for medical applications, where multilayer films meet specific application requirements that cannot be equated with the material requirements for food packaging. Furthermore, the film is described as exceptionally puncture-resistant, even under mechanical strain. This material property appears unsuitable for application packaging intended to be opened by detaching or opening a specific portion of the packaging.

[0015] International application WO 2018 / 132113 A1 describes blister packaging for solid pharmaceutical products (i.e., tablets). These are formed of a multilayer structure comprising, in the following order: a first passive moisture barrier; a second passive moisture barrier; a first active moisture barrier comprising a first hygroscopic composition and a cyclic olefin copolymer; and a third passive moisture barrier, wherein the first, second, and third passive moisture barriers and the first active moisture barrier are continuous, discontinuous, or a combination thereof.

[0016] The text mentions that effective post-treatment is achieved by appropriately modifying the active moisture barrier using an elastomer and by surrounding it with a passive moisture barrier having a modulus equivalent to or lower than that of the active moisture barrier. In this regard, appropriate modification means either reducing the material's hardness or increasing its flexibility and elasticity. Therefore, it can be inferred that the described material is unsuitable for use in application packaging intended to be opened by detaching or opening a specific part of the packaging; on the contrary, it lacks hardness or fracturing ability, which constitutes a concern of WO 2018 / 132113 A1.

[0017] Therefore, prior art lacks suitable alternatives that can be used as substitutes for one of the materials described in EP 2 998 099 A1 or EP 2 998 099 A1, respectively. In this regard, it is explicitly stated that the controlled fracture properties of the polymeric material remain essentially unaffected.

[0018] Furthermore, there is a need for an efficient method for producing an application package that allows a predetermined fracture zone to be reproducibly formed within the application package. Summary of the Invention

[0019] Therefore, one object of the present invention is to provide a new combination of materials that protects the active ingredient of a liquid pharmaceutical product from environmental influences and does not exhibit any undesired chemical interactions with the solvent or active ingredient of the liquid pharmaceutical product, and further prevents the liquid pharmaceutical product or its components from leaking out of the packaging.

[0020] Furthermore, one object of the present invention is to provide a material combination that allows for precise opening of a distinct fracture zone of the packaging in a predetermined manner.

[0021] Finally, one object of the present invention is to provide a reinforced method for producing an application package.

[0022] To achieve the above objectives, the present invention proposes an application packaging as described in technical solution 1; furthermore, advantageous embodiments are the target objects of their respective subsidiary technical solutions.

[0023] Furthermore, in order to achieve the above objectives, the present invention proposes a method as described in technical solution 17; a further advantageous embodiment is the target object of the appended technical solution.

[0024] Furthermore, in order to achieve the above objectives, the present invention proposes an application as described in technical solution 21; a further advantageous embodiment is the target object of the appended technical solution.

[0025] It goes without saying that, in order to avoid unnecessary repetition, only one aspect of the invention will be described below, and correspondingly, other aspects of the invention will be described in terms of their special features, characteristics, implementation methods and advantages or similarities, without explicit mention.

[0026] Furthermore, this applies to all values ​​or parameters or similar parameters mentioned below that can, in principle, be determined or measured by standardized or explicitly stated determination methods or by determination methods familiar to those skilled in the art.

[0027] Furthermore, it goes without saying that all percentages related to weight or quantity are chosen by those skilled in the art to make the total result in 100%.

[0028] With these conditions attached, the invention will be described in more detail below.

[0029] Therefore, according to one of the first embodiments of the present invention, the object of the present invention is for use in the administration packaging of a preferred liquid pharmaceutical product.

[0030] The application package has a bottom portion having a cavity for receiving the drug product and a rim surrounding the cavity.

[0031] The application packaging has a cover that completely seals the cavity.

[0032] The application package (particularly the bottom portion) has a predetermined fracture zone for opening the application package by breaking the predetermined fracture zone.

[0033] The bottom portion is formed of a plastic sheet in the form of a multi-layered film, and the cover is a cover sheet in the form of a multi-layered film.

[0034] in

[0035] The bottom plastic sheet comprises at least five layers:

[0036] One outer thermoformable layer,

[0037] Monocyclic olefin copolymer (COC) layer,

[0038] One internal thermoformable layer

[0039] A barrier layer, preferably a barrier layer that blocks oxygen and / or chemicals.

[0040] A sealing layer, preferably a heat-sealing layer,

[0041] The cyclic olefin copolymer layer is disposed between the outer thermoformable layer and the inner thermoformable layer, and the barrier layer is disposed between the sealing layer and the inner thermoformable layer.

[0042] As the applicant has surprisingly discovered, this particular module allows for deep-drawn packaging suitable for single-use, breakable packaging for the administration of liquid pharmaceutical products. Specifically, the material composition allows for the secure encapsulation of the liquid pharmaceutical product within a package without any unwanted interactions between the package and the components of the liquid pharmaceutical product (particularly the active ingredient or solvent). Furthermore, substances from the environment (particularly oxygen and / or water vapor) cannot penetrate the package and degrade the liquid pharmaceutical product. This layered composition allows for the replacement of Barex films used to date, and the layer structure of the present invention has a thickness similar to that of known multilayer Barex films.

[0043] Compared to Barex-containing multilayer films used in the prior art, thermoformable deep-drawing films based on cyclic olefin copolymers (COCs) exhibit remarkably comparable or even enhanced chemical and mechanical properties. The cyclic olefin copolymer (COC) layer is the main layer of the multilayer plastic sheet forming the bottom portion of the packaging of this invention. The cyclic olefin copolymer (COC) layer comprises or is composed of COC, preferably composed of 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 with this invention.

[0044] COC is rigid, thus providing structural integrity and rigidity for the packaging used in this invention, but it is also brittle and therefore can be manufactured into packaging with a predetermined fracture zone for opening. Furthermore, COC has good moisture-proof properties, especially when used with a high-layer thickness. In addition, COC has good chemical resistance and barrier properties against polar solvents, and is resistant to acids and alkalis.

[0045] One further advantage of COC is that it can have high purity, so that the solvent or active ingredient contained in a package cannot extract impurities.

[0046] As described above, the COC layer is positioned between two thermoformable layers.

[0047] According to the present invention, the external thermoformable layer comprises or is composed of a polymer selected from the group consisting of, preferably, polystyrene (PS), polyvinyl chloride (PVC), amorphous polyethylene terephthalate (APET), ethylene butyl acrylate (EBA), ethylene vinyl acetate (EVA), polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), and mixtures thereof.

[0048] The outer thermoformable layer is typically the outer surface of the packaging, particularly the outer surface of the bottom portion of the packaging. Compared to the COC layer, the outer thermoformable layer is generally less rigid and less brittle. It protects the COC layer from damage and provides superior workability and enhanced thermoforming properties for multilayer films.

[0049] According to a preferred embodiment of the present invention, the polymer of the outer thermoformable layer is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), or mixtures thereof.

[0050] Optimal results are obtained when the outer thermoformable layer is made of polypropylene (PP). Polypropylene has good compatibility with COC. Furthermore, polypropylene is far less rigid and brittle than COC, and therefore, an outer thermoformable PP layer improves the thermoforming properties of the COC layer and protects the brittle COC layer from damage during handling, storage, or application. In addition, the PP layer enhances the handleability of multilayer films (especially COC layers). Specifically, a PP layer provides enhanced flexibility to the bottom portion of the COC layer and the plastic sheet used in the packaging of this invention.

[0051] The inner thermoformable layer typically comprises or is composed of a polymer selected from the group consisting of, preferably, polystyrene (PS), polyvinyl chloride (PVC), amorphous polyethylene terephthalate (APET), ethylene butyl acrylate (EBA), ethylene vinyl acetate (EVA), polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), and mixtures thereof.

[0052] According to the present invention, it is preferred that the polymer of the inner thermoformable layer is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), or mixtures thereof. Particularly good results are obtained when the polymer is polypropylene (PP).

[0053] According to the present invention, if a plastic film or layer comprises or is composed of a specific polymer, it means that the film or layer respectively comprises or is composed of the polymer that serves as the polymeric material of the film or layer. However, further components (e.g., fillers and additives) may also be present in the film or layer.

[0054] According to the present invention, it is preferred if the outer thermoformable layer and the inner thermoformable layer comprise (a plurality of) the same polymer, or are composed of (a plurality of) the same polymer, preferably composed of (a plurality of) the same polymer.

[0055] Preferably, the outer thermoformable layer and the inner thermoformable layer comprise the same material (i.e., polymer) or are composed of the same material (i.e., polymer). In this regard, it is particularly preferred if the outer thermoformable layer and the inner thermoformable layer comprise polypropylene (PP) or are composed of polypropylene (PP), preferably composed of polypropylene (PP). If the COC layer is disposed between two PP layers, the resulting multilayer film has particularly good processability. Specifically, on the one hand, the rigidity of the COC is reduced by PP, but on the other hand, the brittleness of the COC still allows for the creation of predetermined distinct fracture zones in the packaging.

[0056] Regarding the barrier layer, according to the present invention, it is preferred if the barrier layer comprises, or is composed of, a polymer selected from the group consisting of, or is composed of, the following polymers, preferably: ethylene-vinyl alcohol (EVOH), ethylene vinyl acetate (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methacrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

[0057] According to the present invention, it is preferred if the barrier layer comprises or is composed of a polymer selected from the group consisting of, preferably, ethylene-vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof.

[0058] According to one particularly preferred embodiment of the invention, the polymer of the barrier layer comprises or is composed of ethylene-vinyl alcohol (EVOH), preferably ethylene-vinyl alcohol (EVOH). Specifically, ethylene-vinyl alcohol provides good barrier properties against oxygen and against solvents and other chemicals or ingredients in pharmaceutical products.

[0059] Regarding the sealing layer, according to the present invention, it is preferred if the sealing layer comprises or is 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 acrylate copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methacrylate (EMA), ethylene-vinyl alcohol (EVOH), or mixtures thereof.

[0060] According to a preferred embodiment of the present invention, the polymer of the sealing layer 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. Particularly favorable results are obtained when the polymer 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.

[0061] According to the present invention, it is particularly preferred that the sealing layer comprises or is composed of polyethylene (PE), preferably polyethylene (PE). Polyethylene is one of the commonly used materials for sealing layers, possessing good water vapor barrier properties and being compatible with many barrier materials (especially EVOH).

[0062] As described above, the COC layer provides structural integrity to the application packaging. Therefore, the COC layer is typically the thickest layer of the multilayer plastic sheet forming the bottom portion of the application packaging of this invention.

[0063] According to the present invention, it is preferred if the cyclic olefin copolymer (COC) layer has a thickness of at least 200 μm, particularly 250 μm, preferably 300 μm, more preferably 350 μm, and especially preferably 360 μm.

[0064] Similarly, it is preferred if the cyclic olefin copolymer layer has a thickness of at most 600 μm, particularly 500 μm, preferably 450 μm, more preferably 400 μm, and especially preferably 390 μm.

[0065] Furthermore, good results are obtained if the cyclic olefin copolymer layer has a thickness in the range of 200 μm to 600 μm, particularly 250 μm to 500 μm, preferably 300 μm to 450 μm, more preferably 350 μm to 400 μm, and especially preferably 360 μm to 390 μm.

[0066] The COC layer with the above-mentioned thickness exhibits good water vapor barrier properties and can provide structural integrity and rigidity to the application packaging.

[0067] Regarding the outer thermoformable layer and the inner thermoformable layer, it is preferred if the outer thermoformable layer and / or the inner thermoformable layer have a thickness of at least 10 μm, particularly 12 μm, preferably 15 μm, more preferably 18 μm, and especially preferably 20 μm.

[0068] Similarly, according to the invention, it is preferred if the outer thermoformable layer and / or the inner thermoformable layer have a thickness of at most 40 μm, particularly 35 μm, preferably 30 μm, more preferably 27 μm, and especially preferably 25 μm.

[0069] According to one preferred embodiment of the invention, the outer thermoformable layer and / or the inner thermoformable layer have a thickness in the range of 10 μm to 40 μm, particularly 12 μm to 35 μm, preferably 15 μm to 30 μm, more preferably 18 μm to 27 μm, and especially preferably 20 μm to 25 μm.

[0070] According to the present invention, it is particularly preferred that both the outer thermoformable layer and the inner thermoformable layer have a thickness within one of the aforementioned ranges. Therefore, these relatively thin thermoformable layers can provide enhanced flexibility to the COC layer and enhance the processability of the multilayer plastic sheet used in the bottom portion according to the present invention.

[0071] According to the present invention, it is preferred if the thickness of the cyclic olefin copolymer layer and the thickness of the outer thermoformable layer and / or the thickness of the inner thermoformable layer are in the range of 5:1 to 30:1, particularly 7:1 to 25:1, preferably 10:1 to 22:1, more preferably 13:1 to 20:1, and especially preferably 15:1 to 18:1.

[0072] Regarding the barrier layer, according to the present invention, it is preferred if the barrier layer has a thickness of at least 2 μm, particularly 5 μm, and preferably 7 μm.

[0073] Furthermore, it is also preferred if the barrier layer has a thickness of up to 20 μm, particularly 15 μm, and preferably 12 μm.

[0074] According to the present invention, it is preferred if the barrier layer has a thickness in the range of 2 μm to 20 μm, particularly 5 μm to 15 μm, and preferably 7 μm to 12 μm.

[0075] Therefore, according to the present invention, a relatively thin barrier layer is preferably used.

[0076] According to one preferred embodiment of the invention, the sealing layer has a thickness of at least 10 μm, particularly 15 μm, preferably 17 μm, more preferably 20 μm, and especially preferably 22 μm.

[0077] In addition, the sealing layer typically has a thickness of up to 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and especially preferably 27 μm.

[0078] According to the present invention, particularly good results are obtained if the sealing layer has a thickness of 10 μm to 50 μm, especially 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.

[0079] According to a preferred embodiment of the present invention, the plastic sheet at the bottom of the application packaging includes an intermediate layer.

[0080] If the plastic sheet at the bottom of the packaging includes an intermediate layer, this intermediate layer is preferably disposed between the inner thermoformable layer and the barrier layer. An intermediate layer between the barrier layer and the inner thermoformable layer enhances the compatibility between the barrier layer and the inner thermoformable layer.

[0081] If the plastic sheet of the main body includes an intermediate layer, the intermediate layer typically comprises, or is composed of, a polymer selected from the group consisting of, or preferably consists of, the following polymers: 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 (EVOH), or mixtures thereof.

[0082] According to the present invention, a polymer selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), metallocene linear low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof is particularly preferred.

[0083] More preferably, the polymer is selected from the group consisting particularly 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.

[0084] Particularly good results are obtained if the intermediate layer includes or is composed of polyethylene (PE), especially polyethylene (PE).

[0085] According to the present invention, it is preferred if the intermediate layer of the plastic sheet at the bottom portion comprises the same polymer as the sealing layer, or is composed of the same polymer as the sealing layer, preferably composed of the same polymer as the sealing layer.

[0086] Regarding the thickness of the intermediate layer, it is preferred if the intermediate layer has a thickness of at least 10 μm, particularly 15 μm, preferably 17 μm, more preferably 20 μm, and especially preferably 22 μm.

[0087] Similarly, it is preferred if the intermediate layer has a thickness of at most 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and especially preferably 27 μm.

[0088] According to the present invention, particularly good results are obtained if the intermediate layer has a thickness of 10 μm to 50 μm, especially 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.

[0089] According to the present invention, it is preferred that the intermediate layer has the same thickness as the sealing layer.

[0090] According to a preferred embodiment of the present invention, the plastic sheet at the bottom portion comprises or is composed of the following layer structures, preferably comprising the following layer structures:

[0091] (a) An external thermoformable layer

[0092] (b) Cyclic olefin copolymer (COC) layer,

[0093] (c) An inner thermoformable layer

[0094] (d) An intermediate layer,

[0095] (e) a barrier layer, preferably an oxygen and / or chemical barrier layer, and

[0096] (f) A sealing layer, preferably a heat-sealing layer.

[0097] Particularly preferably, the layers are envisioned to be one after another, that is, according to the preferred embodiments of the invention described above, the layers are formed continuously or sequentially and / or are not separated from each other by any further intermediate layers other than the selected intermediate layer (d).

[0098] In this regard, particularly good results are obtained if the outer thermoformable layer and the inner thermoformable layer comprise or are composed of polyolefins (especially polypropylene (PP)), particularly polyolefins (especially polypropylene (PP)). Furthermore, it is preferred if the intermediate layer and the sealing layer comprise or are composed of polyolefins (especially polyethylene (PE)), preferably polyolefins (especially polyethylene (PE)). Additionally, it is preferred if the barrier layer comprises or is composed of ethylene-vinyl alcohol (EVOH).

[0099] The monolayers can be bonded to each other directly or indirectly. A direct bond means that the layers are in direct contact with each other (e.g., by co-extrusion), or that the layers are directly bonded together using a connecting layer or an adhesive layer. An indirect bond means that a further plastic film or metal foil is disposed between the monolayers.

[0100] Preferably, the layers are directly bonded to each other, as already stated.

[0101] Regarding this particular implementation, all the advantages, special features and characteristics described above in conjunction with other implementations also apply.

[0102] According to a preferred embodiment of the present invention, the plastic sheet at the bottom portion comprises or is composed of the following layer structures:

[0103] (a) In particular, an outer thermoformable layer comprising or composed of polypropylene, preferably of polypropylene.

[0104] (b) Cyclic olefin copolymer (COC) layer,

[0105] (c) In particular, it includes or is composed of polypropylene, preferably one of the following: an inner thermoformable layer.

[0106] (d) In particular, it includes or is composed of polyethylene (PE), preferably an intermediate layer composed of polyethylene (PE).

[0107] (e) In particular, a barrier layer comprising or composed of ethylene-vinyl alcohol (EVOH), preferably ethylene-vinyl alcohol (EVOH), and

[0108] (f) In particular, a sealing layer comprising or composed of polyethylene (PE), preferably composed of polyethylene (PE).

[0109] Regarding this particular implementation, all the advantages, special features and characteristics described above in conjunction with other implementations also apply.

[0110] The plastic sheet at the bottom of the packaging typically has a thickness of at least 230 μm, particularly 300 μm, preferably 400 μm, more preferably 450 μm, and especially preferably 480 μm.

[0111] Furthermore, according to the present invention, it is preferred if the plastic sheet of the bottom portion has a thickness of at most 750 μm, particularly 650 μm, preferably 600 μm, more preferably 550 μm, and especially preferably 520 μm.

[0112] Similarly, it is preferred if the plastic sheet at the bottom portion has a thickness in the range of 230 μm to 750 μm, particularly 300 μm to 650 μm, preferably 400 μm to 600 μm, more preferably 450 μm to 550 μm, and especially preferably 480 μm to 520 μm.

[0113] The plastic sheet with the aforementioned thickness at the bottom portion provides structural integrity to the packaging and has a thickness within the range of Barex films used in the prior art.

[0114] According to a specific and preferred embodiment of the present invention, the plastic sheet at the bottom portion further includes a bonding layer and / or an adhesive layer.

[0115] The bonding and adhesive layers typically have a very thin layer thickness of 2 μm to 20 μm, preferably 5 μm to 15 μm, which is used to bond multiple layers of plastic sheets together. According to the invention, if an adhesive layer is used, the adhesive is typically a solvent-based or water-based polyurethane adhesive. The bonding layer typically consists of an adhesive resin.

[0116] According to a preferred embodiment of the present invention, the plastic sheet at the bottom portion includes a connecting layer or an adhesive layer between the polymer layers.

[0117] As described above, the application packaging according to the present invention includes a cover consisting of a cover sheet. Typically, the cover sheet is a multilayer film comprising and consisting of the following layers:

[0118] A protective layer

[0119] a first barrier layer,

[0120] One intermediate layer,

[0121] A second barrier layer, and

[0122] A sealing layer, preferably a heat-sealing layer,

[0123] The first barrier layer is disposed between the protective layer and the intermediate layer, and the second barrier layer is disposed between the intermediate layer and the sealing layer.

[0124] The layers of the cover sheet may be in direct or indirect contact with each other. Direct contact means that the layers of the cover sheet are directly bonded to each other, for example, by co-extrusion or by an adhesive layer or a bonding layer. Indirect contact means that a further polymer layer or metal foil is disposed between at least two individual layers of the cover sheet.

[0125] In this context, if the aforementioned layers follow one another immediately, that is, according to a preferred embodiment of the present invention, the aforementioned layers are formed continuously or sequentially and / or are not separated from each other by any further intermediate layers other than the aforementioned intermediate layers.

[0126] The multilayer plastic sheet forming the bottom portion of the application packaging of the present invention is a relatively thick plastic sheet that provides one aspect of the form and structural integrity of the application packaging, while the cover sheet is a relatively thin multilayer film.

[0127] Typically, the cover sheet has a thickness of at least 50 μm, particularly 70 μm, preferably 80 μm, more preferably 90 μm, and especially preferably 95 μm.

[0128] Similarly, the cover sheet has a thickness of up to 200 μm, particularly 180 μm, preferably 150 μm, more preferably 140 μm, and especially preferably 130 μm.

[0129] According to a third embodiment of the invention, the cover sheet has a thickness ranging from 50 μm to 200 μm, particularly 70 μm to 180 μm, preferably 80 μm to 150 μm, more preferably 90 μm to 140 μm, and especially preferably 95 μm to 130 μm.

[0130] Regarding the protective layer of the cover sheet, good results are obtained if the protective layer comprises or is composed of a polymer selected from the group consisting of, preferably, polyethylene terephthalate (PET), polyamide (PA), polyvinylidene fluoride (PVDF), and mixtures thereof.

[0131] The protective layer provides protection for the application packaging and the liquid pharmaceutical composition or article contained therein from physical damage. Furthermore, the protective layer is preferably also a printable layer. According to the invention, optimal results are obtained if the protective layer comprises or is composed of polyethylene terephthalate (PET), preferably polyethylene terephthalate (PET).

[0132] The protective layer typically has a thickness of at least 5 μm, particularly 7 μm, and preferably 10 μm. Furthermore, the protective layer may have a thickness of up to 25 μm, particularly 20 μm, and preferably 15 μm.

[0133] Good results are obtained if the protective layer has a thickness in the range of 5 μm to 25 μm, particularly 7 μm to 20 μm, and preferably 10 μm to 14 μm.

[0134] As described above, the cover sheet includes a first barrier layer. In this regard, it is preferred that the first barrier layer comprises or is composed of a metal foil, preferably a metal foil. Particularly good results are obtained if the first barrier layer comprises or is composed of aluminum foil. Preferably, the first barrier layer is aluminum foil. Metal foil (especially aluminum foil) provides excellent oxygen and water vapor barrier properties and thus protects the liquid pharmaceutical composition or article from degradation, respectively.

[0135] The thickness of the first barrier layer can vary within a wide range. However, good results are obtained if the first barrier layer has a thickness of at least 5 μm, particularly 7 μm, and preferably 10 μm.

[0136] Similarly, it is preferred if the first barrier layer has a thickness of at most 25 μm, particularly 20 μm, and preferably 15 μm.

[0137] According to a preferred embodiment of the present invention, the first barrier layer has a thickness ranging from 5 μm to 25 μm, particularly 7 μm to 20 μm, and preferably 10 μm to 14 μm.

[0138] The intermediate layer of the cover sheet primarily enhances the compatibility between the first barrier layer and the further layers of the cover sheet (especially the second barrier layer). The material of the intermediate layer can be selected from any suitable material, provided it is compatible with any adjacent layer. However, good results are obtained if the intermediate layer comprises or is composed of a polymer selected from or composed of 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 (EVOH), or mixtures thereof.

[0139] In this regard, it is preferred that the polymer 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 even more preferred that the polymer of the interlayer 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.

[0140] Optimal results are obtained when the polymer is polyethylene (PE). Furthermore, it is preferable that the intermediate layer comprises or is composed of the same polymer as the sealing layer, preferably the same polymer as the sealing layer.

[0141] Typically, the intermediate layer has a thickness of at least 10 μm, particularly 15 μm, preferably 17 μm, more preferably 20 μm, and especially preferably 22 μm.

[0142] Similarly, good results are obtained if the intermediate layer has a thickness of at most 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and especially preferably 27 μm.

[0143] Furthermore, according to a preferred embodiment of the invention, the intermediate layer has a thickness ranging from 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 especially preferably 22 μm to 27 μm.

[0144] Regarding the second barrier layer, the second barrier layer is primarily a barrier layer for chemicals and should respectively prevent any unintended interactions between the liquid pharmaceutical composition or article and the packaging. Therefore, the second barrier layer of the cover sheet typically comprises, or is composed of, the same materials as, or are composed of the barrier layer of the multilayer plastic sheet of the bottom portion of the application packaging of the present invention, preferably the same materials.

[0145] The second barrier layer typically comprises or is composed of a polymer selected from the group consisting of, preferably, ethylene-vinyl alcohol (EVOH), ethylene vinyl acetate (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methacrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

[0146] Preferably, the second barrier layer comprises or is composed of a polymer selected from the group consisting of, most preferably, ethylene-vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof.

[0147] However, the best results are obtained if the second barrier layer comprises or is composed of ethylene-vinyl alcohol (EVOH), preferably ethylene-vinyl alcohol (EVOH).

[0148] Regarding the thickness of the second barrier layer, this thickness is typically comparable to that of the barrier layer of the multilayer plastic sheet at the bottom. Generally, the second barrier layer has a thickness of at least 2 μm, particularly 5 μm, and preferably 7 μm.

[0149] In addition, the second barrier layer typically has a thickness of up to 20 μm, particularly 15 μm, and preferably 12 μm.

[0150] According to one preferred embodiment of the invention, the second barrier layer has a range of 2 μm to 20 μm, particularly 5 μm to 15 μm, and preferably 7 μm to 12 μm.

[0151] As described above, the cover sheet includes a sealing layer. It is advantageous if the sealing layer comprises or is 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 (EVOH), or mixtures thereof.

[0152] Preferably, the polymer of the sealing layer 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. Particularly favorable results are obtained when the polymer is selected, particularly, 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. Most preferably, the sealing layer comprises or is composed of polyethylene (PE), and preferably is composed of polyethylene (PE).

[0153] According to a preferred embodiment of the present invention, the sealing layer of the multilayer plastic sheet at the bottom and the sealing layer of the cover sheet each comprise the same polymer or material, or are composed of the same polymer or material respectively. Using the same or highly similar materials results in good compatibility of the sealing layers and therefore excellent sealing performance.

[0154] The thickness of the sealing layer can vary within a wide range. However, it has proven advantageous if the sealing layer has a thickness of at least 10 μm, particularly 15 μm, preferably 17 μm, more preferably 20 μm, and especially preferably 22 μm.

[0155] Similarly, it has proven advantageous if the sealing layer has a thickness of at most 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and especially preferably 27 μm.

[0156] According to the present invention, good results are obtained if the sealing layer 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 especially preferably 22 μm to 27 μm.

[0157] According to a preferred embodiment, the cover sheet comprises or is composed of the following layer structures:

[0158] (i) In particular, a protective layer comprising or composed of PET, preferably composed of PET,

[0159] (ii) In particular, a first barrier layer comprising or composed of aluminum foil, preferably composed of aluminum foil.

[0160] (iii) In particular, it includes or is composed of polyethylene (PE), preferably an intermediate layer composed of polyethylene (PE).

[0161] (iv) In particular, a second barrier layer comprising or composed of EVOH, preferably composed of EVOH, and

[0162] (v) In particular, a sealing layer comprising or composed of polyethylene (PE), preferably composed of polyethylene (PE).

[0163] Regarding this particular implementation, all the features, advantages, and special characteristics described above in conjunction with other implementations also apply.

[0164] Furthermore, the cover sheet may further include a bonding layer and / or an adhesive layer. As depicted in the multilayer plastic sheet for bonding the bottom portion, the bonding layer and / or adhesive layer are used to bond the aforementioned layers of the cover sheet together and enhance the compatibility of these layers. The adhesive is typically a solvent-based or water-based polyurethane adhesive.

[0165] According to a preferred embodiment of the present invention, the cover sheet includes a connecting layer or an adhesive layer between the polymer layers or between the polymer layers and the metal foil.

[0166] Typically, the cover and bottom portion are at least partially joined by a sealing layer of the plastic sheet of the bottom portion and the cover sheet of the cover. Preferably, the cover and bottom portion are joined above the entire surface of the edge. The cover and bottom portion (particularly the plastic sheet of the bottom portion and the sealing layer of the cover sheet of the cover) are preferably joined by heat sealing.

[0167] According to a preferred embodiment of the present invention, the application packaging includes a bottom portion and a cover, wherein the plastic sheet of the bottom portion comprises at least five layers or is composed of at least five layers:

[0168] One outer thermoformable layer,

[0169] Monocyclic olefin copolymer layer,

[0170] One internal thermoformable layer

[0171] A barrier layer,

[0172] A sealing layer,

[0173] The cyclic olefin copolymer layer is disposed between the outer thermoformable layer and the inner thermoformable layer, and the barrier layer is disposed between the sealing layer and the inner thermoformable layer.

[0174] The cover sheet includes or is composed of the following layers:

[0175] A protective layer

[0176] a first barrier layer,

[0177] One intermediate layer,

[0178] A second barrier layer, and

[0179] A sealing layer, preferably a heat-sealing layer,

[0180] The first barrier layer is disposed between the protective layer and the intermediate layer, and the second barrier layer is disposed between the intermediate layer and the sealing layer.

[0181] The membrane assembly of the present invention has excellent machinability, particularly with respect to the shaping, sealing, cutting and stabilization of the membrane and the opening of the manufactured packaging.

[0182] With regard to this particular implementation, all the special features, characteristics and advantages mentioned above in conjunction with other implementations also apply.

[0183] According to a particular preferred embodiment of the present invention, the plastic sheet at the bottom portion comprises or is composed of the following layer structures:

[0184] (a) Preferably, the outer thermoformable layer comprises or is composed of polypropylene, particularly polypropylene.

[0185] (b) Cyclic olefin copolymer (COC) layer,

[0186] (c) Preferably, it comprises or is composed of polypropylene (PP), and more preferably, is composed of one of the following: an inner thermoformable layer.

[0187] (d) Preferably, it comprises or is composed of polyethylene (PE), and more preferably, it is composed of one of the following intermediate layers: polyethylene (PE).

[0188] (e) Preferably, it comprises or is composed of ethylene-vinyl alcohol (EVOH), and more preferably, it is a barrier layer composed of ethylene-vinyl alcohol (EVOH).

[0189] (f) Preferably, the sealing layer comprises or is composed of polyethylene (PE), particularly polyethylene (PE), and

[0190] The cover sheet includes or is composed of the following layers:

[0191] (i) Preferably, a protective layer comprises or is composed of polyethylene terephthalate (PET), particularly polyethylene terephthalate (PET).

[0192] (ii) Preferably, the first barrier layer comprises or is composed of aluminum foil, particularly aluminum foil.

[0193] (iii) An intermediate layer comprising or composed of polyethylene (PE), preferably polyethylene (PE).

[0194] (iv) Preferably, it comprises or is composed of ethylene-vinyl alcohol (EVOH), particularly a second barrier layer composed of ethylene-vinyl alcohol (EVOH), and

[0195] (v) Preferably, the sealing layer comprises or is composed of polyethylene (PE), particularly one of polyethylene (PE).

[0196] In this regard, all the advantages, features and particularities of this particular embodiment of the invention, in conjunction with other embodiments, also apply.

[0197] Regarding the predetermined fracture zone, the predetermined fracture zone of the application packaging is preferably created by thermoforming. 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.

[0198] 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 pharmaceutical product to be administered directly from the package to a patient.

[0199] The predetermined fracture zone is preferably configured to allow the application package to be opened by causing the package to break along the fracture zone. For example, the application package may be folded or bent along the predetermined fracture zone, thereby cutting the packaging material and thus opening the package.

[0200] The predetermined fracture zone is preferably formed as or includes a groove on one of the outer 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.

[0201] The predetermined fracture zone is preferably a region thinner than a region surrounding the bottom portion of the fracture zone. However, the predetermined fracture zone may also be a region having the same thickness as a region surrounding the bottom portion of the fracture zone.

[0202] A predetermined fracture zone is preferably formed only in the region of the cavity, particularly in the region of one of the application channels of the cavity. In other words, the predetermined fracture zone preferably does not extend above the region of the edge and / or is not formed in the region of the edge.

[0203] According to a second aspect of the present invention, a further object of the invention is a method for producing and filling an application package for a preferred liquid pharmaceutical article. The method is preferably a thermoforming method. The method described herein is preferably performed using one of the apparatuses described herein, and the application package previously described herein is produced using the method described herein.

[0204] According to the method, a plastic sheet, preferably multilayered, is at least partially heated to a thermoforming temperature. Specifically, this thermoforming temperature is one of the temperatures at which the plastic sheet or its heated areas are plasticized and / or whereby the plastic sheet or its heated areas are formed into a desired shape using a molding tool.

[0205] Next, the 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 article and an edge surrounding the cavity. The edge is preferably at least substantially flat.

[0206] In the next step, the cavity is filled with the pharmaceutical article and then covered with a cap, which is secured to the rim to completely seal the cavity. Preferably, the cavity is sealed by a sealing layer of a plastic sheet of the bottom portion and a sealing layer of the cap sheet of the cap. Preferably, the cap and the bottom portion are sealed over the entire surface of the rim.

[0207] According to the present invention, a predetermined fracture zone is generated in the bottom portion 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.

[0208] Preferably, the molding tool has a male mold and a female mold and / or a male mold and a female mold system 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.

[0209] A predetermined fracture zone is preferably formed only in the region of the cavity, particularly in the region of one of the application channels of the cavity. In other words, the predetermined fracture zone preferably does not extend above the region of the edge and / or is not formed in the region of the edge.

[0210] 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 very efficient manner.

[0211] For further details regarding the method of the present invention, please refer to the above description concerning the application packaging of the present invention, which is also applicable to the method of the present invention.

[0212] The application packaging of the present invention for a preferred liquid pharmaceutical product is preferably manufactured using a specific device. This device is preferably configured to perform the methods described herein and / or to produce the application packaging described herein.

[0213] 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.

[0214] The molding tool preferably has a forming device for forming a predetermined fracture zone in the bottom portion. This 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.

[0215] The molding apparatus is preferably an adjustable and / or replaceable component of the molding tooling. 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 different application packages, particularly application packages with different predetermined fracture zones.

[0216] 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.

[0217] Preferably, the female and male molds have complementary or corresponding shaping surfaces, 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.

[0218] Particularly 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.

[0219] Alternatively, the male and female molds may have different or non-corresponding surfaces for shaping, particularly such that the device is configured to create 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.

[0220] According to a third aspect of the present invention, a further object of the present invention is the use of plastic sheets for the production of application packaging for preferably liquid pharmaceutical products.

[0221] The plastic sheet used consists of at least five layers:

[0222] One outer thermoformable layer,

[0223] Monocyclic olefin copolymer (COC) layer,

[0224] One internal thermoformable layer

[0225] A barrier layer, preferably a barrier layer that blocks oxygen and / or chemicals.

[0226] A sealing layer, preferably a heat-sealing layer,

[0227] The cyclic olefin copolymer layer is disposed between the outer thermoformable layer and the inner thermoformable layer, and the barrier layer is disposed between the sealing layer and the inner thermoformable layer.

[0228] Plastic sheets are preferably used in one of the methods and / or apparatuses described herein.

[0229] The plastic sheet is preferably used in the production of an application package as described herein. Further details regarding the use of the invention are given by reference to the above description of the application package of the invention, and in particular to the description of the plastic sheet from which the application package is produced, which preferably also applies to this inventive use. Specifically, the plastic sheet for this inventive use may have any of the features described herein in connection with the application package of the invention and its production.

[0230] The above and subsequent states and features of the present invention can be combined with each other in various ways, but can also be implemented independently of each other. Attached Figure Description

[0231] Referring to the accompanying drawings, the further aspects, features, advantages, and characteristics of the present invention will become clear from the following description of the claims and preferred embodiments. Drawings shown:

[0232] Figure 1 A schematic perspective view of one application package according to one of the present invention;

[0233] Figure 2 According to the invention, an open application package is shown in one schematic perspective view;

[0234] Figure 3 A schematic cross-section of one application package that penetrates through the primary or secondary packaging;

[0235] Figure 4 A schematic diagram of an apparatus for producing an application package according to the present invention;

[0236] Figure 5 A schematic cross-section of the material applied to the bottom part of the packaging;

[0237] Figure 6 A schematic cross-section of one of the materials used to cover the packaging;

[0238] Figure 7 A schematic cross-section of one of the preferred materials used in the bottom portion of the packaging is shown.

[0239] Figure 8 A schematic cross-section is shown by applying one of the preferred materials of the packaging cover;

[0240] Figure 9 A schematic plan view of an application package according to one of the first embodiments;

[0241] Figure 10 Along Figure 9 A schematic cross-section of the application packaging of line XX;

[0242] Figure 11 Enlarged details of one of the predetermined fracture zones according to the first embodiment;

[0243] Figure 12 Enlarged details of one of the predetermined fracture zones according to a second embodiment;

[0244] Figure 13 A schematic plan view of an application package according to one of the third embodiments;

[0245] Figure 14 Along Figure 13 A schematic cross-section of the application packaging of line XIV-XIV;

[0246] Figure 15 Enlarged detail of a predetermined break zone in an area of ​​an application channel according to the third embodiment;

[0247] Figure 16 Enlarged detail of a predetermined fracture zone in the region of one edge according to the third embodiment;

[0248] Figure 17Enlarged detail of a predetermined break zone in an area of ​​an application channel according to a fourth embodiment;

[0249] Figure 18 Enlarged detail of a predetermined fracture zone in the region of one edge according to the fourth embodiment;

[0250] Figure 19 By according to Figure 4 A schematic cross-section of one of the molding tools used in the equipment;

[0251] Figure 20 In the region of a molding device, one of the molding tools used to form a predetermined fracture zone. Figure 19 A schematic cross-sectional detail of the molding tool;

[0252] Figure 21 A schematic cross-section of a molding tool according to one embodiment of the apparatus;

[0253] Figure 22 In the region of a molding device, one of the molding tools used to form a predetermined fracture zone. Figure 21 A schematic cross-sectional detail of the molding tool;

[0254] Figure 23 A schematic plan view of an application package according to one of the fifth embodiments;

[0255] Figure 24 Along Figure 23 A schematic cross-section of the application packaging of line XXIV-XXIV;

[0256] Figure 25 Enlarged details of one of the predetermined fracture zones according to the fifth embodiment;

[0257] Figure 26 A schematic perspective view of one of the molding tools, one of the molds, and one of the implementation methods; and

[0258] Figure 27 A schematic perspective view of one embodiment of a mold, one of the molding tools.

[0259] In the diagram, even if repeated descriptions are omitted, the same component symbols are used for the same components and parts. Detailed Implementation

[0260] Figures 1 to 3 The application packaging 1 according to one of the present invention is shown. Figure 1 A schematic perspective view of a closed application package 1 or in its transport state. Figure 2 An application package 1 is shown in a schematic perspective view in its open state and / or when it is converted into a pipette. Figure 3The schematic cross-section of the application packaging 1 is shown, as well as the secondary packaging 11 of the application packaging 1, which is preferably or as needed for delivery / sale.

[0261] Application packaging 1 is preferably configured to receive a pharmaceutical article 2 and / or contain or include the pharmaceutical article 2, such as Figure 3 As shown in the image.

[0262] Pharmaceutical product 2 is preferably a liquid. Pharmaceutical product 2 is preferably a product for treating and / or preventing fleas, ticks, and / or chewing lice (especially in dogs and / or cats). Preferably, pharmaceutical product 2 helps control scabies (especially in dogs).

[0263] 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.

[0264] The bottom portion 3 includes a cavity 5 for receiving the pharmaceutical article 2. The cavity 5 preferably includes different sections, particularly a chamber 6 and an administration channel 7.

[0265] The bottom portion 3 has an edge 8 surrounding (particularly completely surrounding) one of the cavities 5. The edge 8 is preferably at least substantially flat.

[0266] 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 means of the cover 4 to ensure its storage stability and / or to prevent the article 2 from escaping from the sealed application package 1, the bottom portion 3, or the cavity 5.

[0267] The cover 4 is preferably fixed or joined, in particular (thermally) sealed to the bottom portion 3 (in particular the edge 8 or a portion of the edge 8).

[0268] Preferably, the cover 4 is secured or joined to the bottom portion 3 or the edge portion 8 by means of a heat seal and / or a (heat) annular seal that extends in particular along the entire circumference of the edge portion 8 and / or the edge 3A between the cavity 5 and the edge portion 8.

[0269] 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.

[0270] 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 outside of the edge 8.

[0271] 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.

[0272] 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.

[0273] like Figure 1 As shown, chamber 6 preferably has a generally triangular shape. However, this is not mandatory and chamber 6 can have any desired shape.

[0274] 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 one of the longitudinal axes A of the application package 1. Axis A is preferably one of the axes of symmetry of the application package 1.

[0275] The length of the application channel 7 is preferably greater than 2cm or 3cm and / or less than 5cm or 4cm.

[0276] 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, and particularly preferably about 8.5 cm.

[0277] The width of the edge 8 (particularly perpendicular to the application channel 7 or axis A and / or adjacent to one side of the application channel 7 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.

[0278] The application package 1 can be opened so that the pharmaceutical product 2 contained in the application package 1 or cavity 5 can be removed or pushed out from the application package 1 and / or applied to a patient (not shown). The patient is preferably a human or animal, especially a domestic animal (such as a cat or dog). Preferably, the application package 1 is configured to apply the pharmaceutical product 2 directly to the skin and / or fur of one of the patients.

[0279] Specifically, application packaging 1 can be transformed into a pipette, such as Figure 2 As shown in the diagram. Specifically, by opening application package 1, application package 1 is transformed into a pipette.

[0280] The application package 1 (particularly the bottom portion 3) includes a predetermined fracture zone 9. The application package 1 is preferably openable 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.

[0281] Specifically, the application package 1 can be opened by folding and / or bending along the predetermined fracture zone 9.

[0282] The predetermined fracture zone 9 is preferably produced by thermoforming or deep drawing, particularly simultaneously with or in the same step as the thermoforming or deep drawing bottom portion 3 and / or using the same molding tool. More on this later... Figure 4 and Figures 19 to 22 This will be explained in more detail.

[0283] 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).

[0284] The fracture zone 9 may be provided only in the region of cavity 5 or application channel 7. In other words, the edge 8 may be at least substantially free of the fracture zone 9. (See later for reference.) Figures 9 to 11 This will be explained in more detail. 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), such as, for example, in Figure 1 and Figure 13 This is shown in the document and will be explained in more detail later.

[0285] The predetermined fracture zone 9 is preferably transverse, particularly perpendicular to axis A and / or extends through the application channel 7.

[0286] The predetermined fracture zone 9 is preferably located near the axial end of one of the channels 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 the axial end 1A of the application package 1 is preferably at most 25 mm or less, and particularly at most 20 mm or less.

[0287] 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%.

[0288] 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%.

[0289] 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 chamber 6 relative to the predetermined fracture zone 9.

[0290] The tip 10 may preferably be 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 article 2 to be removed, dispensed, or ejected through the application channel 7. Specifically, in Figure 2 This is shown in the image.

[0291] Preferably, by breaking the application package 1, particularly along the predetermined fracture zone 9, and / or by bending / folding the tip 10, an open end 7B of one of the cavities 5 (particularly the application channel 7) is created, such as... Figure 2 As shown in the image.

[0292] By opening the application package 1 as described, the application package 1 is preferably transformed into a pipette and / or can preferably be used to administer a drug product 2 to a patient. Specifically, the drug product 2 can be administered by pressing on the chamber 6, either through or from the application package 1, such that the drug product 2 is forced through the application channel 7 and exits / withdraws from the application channel 7 at a predetermined break zone 9 at its open end 7B.

[0293] Preferably, it is necessary to press / push against the chamber 6 to remove the drug article 2. In other words, the application channel 7 and / or the open end 7B are preferably configured or sized such that the article 2 can escape due to gravity (only) and / or that the article 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 the chamber 6. In this way, accidental removal of the drug article 2 is prevented.

[0294] 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 a reduced cross-section or nozzle is formed at the open end 7B and / or in the region of the predetermined break zone 9. Reference will be made later. Figures 9 to 11 This will be explained in more detail.

[0295] exist Figure 2 In the example shown, 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 preferably still 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.

[0296] 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. Figure 3 The image shows 11 pieces of secondary packaging.

[0297] The preferred secondary packaging is blister packaging.

[0298] 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 peelable from the base portion 12 to remove the application package 1 from the secondary packaging 11 or the reservoir 14.

[0299] Figure 4 A highly illustrative diagram illustrates one of the devices 100 used for producing application packaging 1. In the following text, reference is made to... Figure 4 Describes an apparatus 100 and a method for producing an application packaging 1.

[0300] The method described herein is preferably performed using device 100. Device 100 is then preferably configured to perform the method described herein.

[0301] The device 100 preferably includes a heating device 101 and a molding tool 102.

[0302] 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.

[0303] Preferably, the plastic sheet 200 is rolled up and / or supplied on or formed on a roller, such as Figure 4 The diagram illustrates this. Preferably, particularly in a unfolding or feeding step, the plastic sheet 200 is loosened / unfolded 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.

[0304] As needed, the plastic sheet 200 can be continuously or gradually guided through the device 100.

[0305] 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 a heating device 101.

[0306] 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).

[0307] 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.

[0308] Preferably, the heating device 101, in particular several heating plates 101A, 101B, heats the plastic sheet 200 to a plasticizing temperature or thermoforming temperature.

[0309] The plasticizing or thermoforming temperature is preferably 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) can preferably deform when it has reached the plasticizing or thermoforming temperature and retain the new form after cooling or dropping below the plasticizing or thermoforming temperature.

[0310] 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.

[0311] 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, particularly with different material layers and / or different plasticizing / thermoforming temperatures, the two heating plates 101A and 101B operate at different temperatures, particularly corresponding to the respective plasticizing / thermoforming temperatures of the layers of the plastic sheet 200 facing the respective heating plates 101A and 101B.

[0312] After heating and / or in a (thermo) forming step, the (heated) plastic sheet 200 is preferably formed (especially thermoformed) by means of a molding tool 102.

[0313] 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. Specifically, the heated sub-region of the plastic sheet 200 is stretched into or drawn into the molding tool 102.

[0314] 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.

[0315] Preferably, the plastic sheet 200 is stretched into the female mold 102A and / or onto the male mold 102B.

[0316] 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 acts as a stamp. In particular, in addition to a gas, a stamp may also be provided only in a sub-region, for example, in an area where more precise forming is required (such as in application channel 7).

[0317] 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.

[0318] 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.

[0319] 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.

[0320] 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 finished along a specific line), or by cutting a plastic sheet before the (thermo)forming step.

[0321] 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 deep-drawn, the cutting can further deform it; however, this deformation does not create a predetermined fracture zone because it was previously created by cutting the sheet. Furthermore, this deformation is certainly not a necessary or primary step for creating 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.

[0322] Therefore, the predetermined fracture zone 9 of the present invention is preferably generated before or after the step of forming the bottom portion and / or in the absence of cutting and / or cutting steps without the use of a cutting tool.

[0323] In the context of this invention, a piercing, scoring, or similar operation is 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.

[0324] The molding tool 102 is preferably configured to form a plurality of base portions 3 simultaneously or in one step. Figure 4 In the example shown, twelve base portions 3 are formed simultaneously. However, other solutions (e.g., where only one base portion 3 is formed in one forming step) are also possible.

[0325] Preferably, the molding tool 102 and / or (a number of) molds 102A, 102B are interchangeable to produce application packages 1 (especially the bottom portion 3) with different shapes, for example to accommodate different volumes of the chamber 6 or the pharmaceutical article 2.

[0326] After formation and / or in a filling step, particularly by means of a filling device 103, the pharmaceutical article 2 is used to fill the bottom portions 3 (particularly one or more cavities 5) formed in the plastic sheet 200. Figure 4 The dotted lines are used to indicate the meaning.

[0327] The filling is preferably performed after the plastic sheet 200 or its heated / thermoformed areas have hardened and / or cooled or dropped below the plasticizing / thermoforming temperature.

[0328] 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).

[0329] Preferably, several bottom portions 3 or one or more cavities 5 formed in the plastic sheet 200 are covered or enclosed by cover sheet 300, thereby forming several respective covers 4.

[0330] Preferably, the cover sheet 300 is rolled up and / or provided on a roller or formed into a roller, such as Figure 4 The diagram illustrates this. Preferably, the cover sheet 300 is loosened / unfolded 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 fully positioned within the covering device 104.

[0331] The covering 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.

[0332] 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 sealing layers 205 and 305 of the plastic sheet 200. The following is in conjunction with... Figures 5 to 8 The explanation will elaborate on sealing layers 205 and 305.

[0333] To secure the cover sheet 300 to the plastic sheet 200, the covering device 104 is preferably brought into 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.

[0334] The joining / 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 of 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.

[0335] Particularly preferably, in addition to the area of ​​the edges 3A, the joining / sealing is also performed in the area surrounding the edges 3A and / or in the area where the edges 8 are later formed.

[0336] In principle, when the cover sheet 300 is heat-sealed to the plastic sheet 200, the cover 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 cover 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.

[0337] After covering / closing and / or in a separation step, the application package 1 formed of plastic sheet 200 and cover sheet 300 is separated from and / or separated from each other.

[0338] 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 for separating (a number of) application packages 1.

[0339] Preferably, the (several) application packages 1 are trimmed, punched, or cut.

[0340] Separation (especially punching / cutting) is preferably carried out along a line having a (constant) distance to (several) edges 3A, and / or such that (several) edges 8 are formed. The line along which separation (especially cutting or punching) is performed on the application package 1 is achieved by... Figure 4 The dotted line in the middle indicates the meaning.

[0341] The application packaging 1 preferably consists of a bottom portion 3 including one of the specific functional layers (especially a specific layer structure) and a cover 4. Figures 5 to 8 The image shows the plastic sheet 200 of the bottom portion 3 and the cover sheet 300 of the cover 4, or a preferred embodiment for producing the plastic sheet 200 of the bottom portion 3 and the cover sheet 300 of the cover 4.

[0342] As described above, the plastic sheet 200 of the bottom portion 3 is a multilayer film. The plastic sheet 200 of the bottom portion 3 includes at least five layers:

[0343] One external thermoformable layer 201,

[0344] Monocyclic olefin copolymer (COC) layer 202,

[0345] One inner thermoformable layer 203,

[0346] Barrier layer 204 and

[0347] A sealing layer 205.

[0348] 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.

[0349] 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:

[0350] The outer thermoformable layer 201, followed by

[0351] Cyclic olefin copolymer (COC) layer 202, followed by

[0352] The inner thermoformable layer 203, followed by

[0353] Barrier layer 204, followed by

[0354] Sealing layer 205.

[0355] Particularly preferably, the layers are envisioned to be one after another, that is, according to the preferred embodiments described above, the layers are formed continuously or sequentially and / or are not separated from each other by intermediate layers.

[0356] The outer thermoformable layer 201 typically forms the outer surface of one of the application packages 1 of the present invention.

[0357] Preferably, the plastic sheet 200 of the bottom portion 3 further includes, as shown in the figure below. Figure 5 An intermediate layer 206 is shown. The intermediate layer 206 may be omitted from the plastic sheet 200, but it 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.

[0358] One of the bottom portions 3 is preferably a plastic sheet 200 comprising or composed of the following layer structures:

[0359] (a) An external thermoformable layer 201,

[0360] (b) Monocyclic olefin copolymer layer 202,

[0361] (c) An inner thermoformable layer 203

[0362] (d) Intermediate layer 206,

[0363] (e) A barrier layer 204, and

[0364] (f) A sealing layer 205.

[0365] The plastic sheet 200 of the bottom portion 3 typically has a thickness in the range of 230μm to 750μm, particularly 300μm to 650μm, preferably 400μm to 600μm, more preferably 450μm to 500μm, and especially preferably 480μm to 520μm, and is determined to be in the form of the application packaging 1 after deep drawing.

[0366] The cyclic olefin copolymer layer 202 is the main layer of the plastic sheet 200. It includes or is composed of cyclic olefin copolymers (COC), preferably composed of cyclic olefin copolymers (COC).

[0367] 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 disposable application packages with a fracture zone 9 for opening the application package 1. The cyclic olefin copolymer layer 202 preferably has a thickness ranging from 200 μm to 600 μm, particularly 250 μm to 500 μm, preferably 300 μm to 450 μm, more preferably 350 μm to 400 μm, and especially preferably 360 μm to 390 μm.

[0368] 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.

[0369] 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, preferably 15 μm to 30 μm, more preferably 18 μm to 27 μm, and especially preferably 22 μm to 25 μm.

[0370] The best results are obtained when 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, especially 7:1 to 25:1, preferably 10:1 to 22:1, more preferably 13:1 to 20:1, and particularly preferably 15:1 to 18:1.

[0371] Furthermore, the outer thermoformable layer 201 and the inner thermoformable layer 203 comprise 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 butyl acrylate (EBA), ethylene vinyl acetate (EVA), polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), and mixtures thereof.

[0372] According to the present invention, it is preferred that the polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), or mixtures thereof. According to the present invention, it is particularly preferred that the polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is polypropylene (PP).

[0373] 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 acetate (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methacrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

[0374] According to the present invention, it is preferred 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.

[0375] The barrier layer 204 has a thickness ranging from 2 μm to 20 μm, particularly from 5 μm to 15 μm, and preferably from 7 μm to 12 μm.

[0376] The sealing layer 205 and / or the intermediate layer 206 preferably comprise or consist 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 acrylate copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methacrylate (EMA), ethylene-vinyl alcohol (EVOH), or mixtures thereof.

[0377] 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.

[0378] It is preferred 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).

[0379] 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, preferably 17 μm to 35 μm, more preferably 20 μm to 30 μm, and especially 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.

[0380] Therefore, according to one of the most preferred plastic sheets 200 of the present invention, the sheet comprises or is composed of a layer structure having the following layer sequence:

[0381] (a) Includes an outer thermoformable layer 201 consisting of PP or one of PP components, followed by...

[0382] (b) comprising a cyclic olefin copolymer layer 202 consisting of COC or one of COC, followed by...

[0383] (c) Includes a thermoformable inner layer 203 of PP or one of PP components, followed by...

[0384] (d) As needed, include an intermediate layer 206 consisting of PE or PE, followed by...

[0385] (e) A barrier layer 204 comprising EVOH or composed of EVOH, followed by...

[0386] (f) A sealing layer 205 comprising or composed of PE.

[0387] Particularly preferably, the layers are envisioned to be one after another, that is, according to the preferred embodiments described above, the layers are formed continuously or sequentially and / or are not separated from each other by any further intermediate layers other than the selected intermediate layer 206.

[0388] The layers of the plastic sheet 200 in the bottom portion 3 can be directly or indirectly adhered to each other. Direct adhesion means that the layers are directly bonded to each other, for example, by co-extrusion or by a connecting layer or an adhesive layer. Indirect adhesion means that further layers (especially plastic sheets or metal foils) are disposed between the respective layers.

[0389] like Figure 6 As shown, the cover sheet 300 of the cover 4 includes or is composed of the following layers:

[0390] One protective layer 301,

[0391] a first barrier layer 302,

[0392] One intermediate layer 303,

[0393] A second barrier layer 304, and

[0394] A sealing layer 305,

[0395] The first barrier layer 302 is disposed between the protective layer 301 and the intermediate layer 303, and the second barrier layer 304 is disposed between the intermediate layer 303 and the sealing layer 305.

[0396] The cover sheet 300 typically has a thickness ranging from 50 μm to 200 μm, particularly 70 μm to 180 μm, preferably 80 μm to 150 μm, more preferably 90 μm to 140 μm, and especially preferably 95 μm to 130 μm.

[0397] 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.

[0398] The protective layer preferably has a thickness ranging from 5 μm to 25 μm, particularly 7 μm to 20 μm, and preferably 10 μm to 14 μm.

[0399] The first barrier layer 302 is typically a metal foil, particularly an aluminum foil. The metal foil (especially 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.

[0400] 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 (EVOH), or mixtures thereof.

[0401] In this regard, it is preferred if 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.

[0402] 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).

[0403] Furthermore, according to the present invention, it is preferred 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 especially preferably 22 μm to 27 μm.

[0404] 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 acetate (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methacrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof. It is particularly preferred if the polymer of the second barrier layer 304 is selected from the group consisting of ethylene-vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), 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).

[0405] 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.

[0406] According to a preferred embodiment, the cover sheet 300 has the following layer structure:

[0407] One protective layer 301,

[0408] a first barrier layer 302,

[0409] One intermediate layer 303,

[0410] A second barrier layer 304, and

[0411] A sealing layer 305.

[0412] To be clear, it can be envisioned that the cover sheet 300 includes or is composed of a layer structure having the following layer sequence:

[0413] (i) Protective layer 301, followed by

[0414] (ii) First barrier layer 302, followed by

[0415] (iii) Intermediate layer 303, followed by

[0416] (iv) Second barrier layer 304, followed by

[0417] (v) A sealing layer 305.

[0418] Particularly preferably, the layers are envisioned to be one after another, that is, according to the preferred embodiments described above, the layers are formed continuously or sequentially and / or are not separated from each other.

[0419] 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.

[0420] One preferred embodiment of the present invention includes a plastic sheet 200 of the bottom portion 3 comprising or consisting of a layer structure having the following layer sequence:

[0421] (a) In particular, it includes an outer thermoformable layer 201 consisting of PP or one of PP components, followed by...

[0422] (b) In particular, it includes a cyclic olefin copolymer layer 202 consisting of COC or one of COC, followed by...

[0423] (c) In particular, it includes a thermoformable layer 203 of PP or one of the components of PP, followed by...

[0424] (d) As needed, particularly including an intermediate layer 206 composed of or including PE, followed by...

[0425] (e) In particular, a barrier layer 204 comprising or composed of EVOH, followed by

[0426] (f) In particular, sealing layer 205 includes or is composed of PE,

[0427] Furthermore, the cover sheet 300 includes or is composed of the following layer structures:

[0428] (i) Protective layer 301, followed by

[0429] (ii) First barrier layer 302, followed by

[0430] (iii) Intermediate layer 303, followed by

[0431] (iv) Second barrier layer 304, followed by

[0432] (v) A sealing layer 305.

[0433] Particularly preferably, the layers are envisioned to be one after another, that is, according to the preferred embodiments described above, the layers are formed continuously or sequentially and / or are not separated from each other by any further intermediate layers other than the selected intermediate layer 206.

[0434] According to the present invention, it is preferred 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.

[0435] Furthermore, it is preferable if both the plastic 200 and the cover sheet 300 are included as a linking layer and an adhesive layer between the functional layers.

[0436] According to Figure 7 According to the preferred embodiment of the present invention shown in the figure, the plastic sheet 200 includes or is composed of the following layer structures:

[0437] (a) Preferably, the outer thermoformable layer 201 comprises or is composed of PP, particularly one of the components of PP.

[0438] (b) A connecting layer 207a,

[0439] (c) A cyclic olefin copolymer layer 202 comprising or composed of COC, particularly COC.

[0440] (d) Connecting layer 207b,

[0441] (e) Preferably, it comprises or is composed of PP, particularly one of the thermoformable inner layers 203 composed of PP.

[0442] (f) One adhesive layer 208,

[0443] (g) Preferably, the intermediate layer 206 comprises or is composed of PE, particularly one of the intermediate layers composed of PE.

[0444] (h) Connecting layer 207c,

[0445] (i) Preferably, the barrier layer 204 comprises or is composed of EVOH, particularly EVOH.

[0446] (j) A connecting layer 207d, and

[0447] (k) Preferably, the sealing layer 205 comprises or is composed of PE, particularly one of the sealing layers composed of PE.

[0448] Figure 8 One of the preferred layer structures of the display cover sheet 300:

[0449] (i) Preferably, it includes a protective layer 301 composed of PET or PET.

[0450] (ii) Adhesive layer 308a

[0451] (iii) Preferably, it comprises or is composed of aluminum foil, particularly a first barrier layer 302 composed of aluminum foil.

[0452] (iv) Adhesive layer 308b,

[0453] (v) Preferably, it comprises or is composed of PE, particularly an intermediate layer 303 composed of PE.

[0454] (vi) Connecting layer 307a,

[0455] (vii) Preferably, the second barrier layer 304 comprises or is composed of EVOH, particularly EVOH.

[0456] (viii) Connecting layer 307b,

[0457] (ix) Preferably, it comprises or is composed of PE, particularly a sealing layer 305 composed of PE.

[0458] According to the present invention, 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.

[0459] The following describes in more detail different embodiments of the application packaging 1 according to the present invention. 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.

[0460] Preferably, unless otherwise explicitly stated, the manner, features and explanations described for one embodiment are applicable to other embodiments, even if not repeated.

[0461] In addition, regarding the application of packaging 1 (especially reference 1) Figures 1 to 3 ), methods and equipment for producing it 100 (especially reference) Figure 4 ) and preferred multi-layer structures (especially reference) Figures 5 to 8 The previously described forms, features and explanations are preferably also applicable, or correspondingly applicable, to the embodiments described below (even without repetition).

[0462] The embodiment of the application packaging 1 described below preferably has a general reference. Figures 1 to 3 The state and characteristics of the application packaging 1 described.

[0463] The application packaging 1 described below is preferably implemented by means of, as referenced Figure 4 One of the methods and / or apparatuses described herein produces or can be produced by means of, as referenced Figure 4 One of the methods and / or equipment described herein is used for production.

[0464] The implementation method of application packaging 1 described below is based on reference to Figures 5 to 8 The plastic sheet 200 and / or cover sheet 300 described are produced, and / or the bottom portion 3 and / or cover 4 of the latter have as referenced. Figures 5 to 8 One of the described multi-layered structures.

[0465] Figures 9 to 11 The first embodiment of the application packaging 1 is shown in the figure.

[0466] Figure 9 A schematic plan view is shown 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.

[0467] Figure 10 Display along Figure 9 A schematic cross-section of the application packaging 1 of the line XX in the middle. Figure 11 Displaying the fracture zone 9 Figure 10 One is to zoom in on the details, which are then used... Figure 10 The XI mark indicates this.

[0468] For example, using shadow lines as indicators Figure 11 The edge 8 shown in the figure 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).

[0469] In the first embodiment, the predetermined fracture region 9 extends only above the cavity 5, particularly above the application channel 7 of the cavity 5, especially as... Figure 9As shown in the illustration. Preferably, in the first embodiment, a predetermined breakage zone 9 is not provided at the edge 8 and / or the edge 8 does not include the predetermined breakage 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.

[0470] In this sense, the term "predetermined fracture zone" preferably refers to 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 throughout this application, the term "predetermined fracture zone" can be replaced by "material weakening".

[0471] 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.

[0472] 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.

[0473] The predetermined fracture zone 9 preferably has a dent, notch, or groove 15, especially as in Figure 11 As shown in the figure. Preferably, the predetermined fracture zone 9 is a groove 15 on one of the outer surfaces 16 of the application package 1 (particularly the bottom portion 3).

[0474] The outer surface 16 of the application package 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 article 2. Particularly preferably, the outer surface 16 is formed of an outer thermoformable layer 201.

[0475] 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.

[0476] The groove 15 preferably has an angle W and a depth D and / or is defined by an angle W and a depth D.

[0477] 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).

[0478] 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.

[0479] However, the groove 15 can also be characterized by any other suitable angle (which can be calculated as 180° minus W) preferably 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) which can be calculated as 180° minus 2 times W.

[0480] Depth D is preferably the distance from the main extending plane of the outer surface 16 to the lowest region of the groove 15, particularly the distance measured perpendicular to the main plane.

[0481] 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).

[0482] 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.

[0483] 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.

[0484] 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.

[0485] 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).

[0486] 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.

[0487] 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.

[0488] The inner surface 18 of the application package 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 pharmaceutical article 2 and / or the surface opposite to the inner surface 16. Particularly preferably, the inner surface 18 is formed of a sealing layer 205.

[0489] Therefore, the outer surface 16 and the inner surface 18 are preferably two opposing surfaces forming the wall of the bottom portion 3. Particularly preferably, the inner surface 18 is the surface that comes into contact with the pharmaceutical article 2 at least during administration and / or the surface of the sealing layer 205. Particularly preferably, the outer surface 16 is the surface that comes into contact with the environment and / or the surface of the outer thermoformable layer 201.

[0490] The protrusion 17 is preferably arranged opposite to the groove 15.

[0491] 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.

[0492] 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.

[0493] Therefore, preferably, the thickness T of the bottom portion 3 (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.

[0494] 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 of which) and the protrusion 17.

[0495] 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 as high 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).

[0496] The thickness T of the bottom portion 3, preferably 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.

[0497] 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).

[0498] 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.

[0499] 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.

[0500] 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 layer 305.

[0501] 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.

[0502] 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.

[0503] Preferably, the application channel 7 is narrowed or its (flow) cross-section is reduced, or the nozzle 19 is formed by means of a 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.

[0504] When the application package 1 is opened (particularly by folding / bending along the predetermined fracture zone 9 or groove 15), preferably at the open end 7B, particularly where the pharmaceutical product 2 is discharged from the application package 1, a narrowed flow channel or a reduced cross-section or nozzle 19 is formed or positioned.

[0505] As explained above, the application channel 7 and / or open end 7B are preferably configured or sized such that the non-article 2 can be attributed to gravity (only) for escape. This is particularly preferably achieved at least in part by means of a narrowed flow channel or a reduced cross-section or nozzle 19.

[0506] Preferably, the application channel 7 or the open end 7B is narrowed, particularly by means of the protrusion 17, such that even if the open end 7B points downward, the drug article 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).

[0507] Therefore, the pharmaceutical product 2 is preferably dispensed by an administration package 1 that opens by pressing on the chamber 6.

[0508] 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 preferably by means of a narrowed flow channel or a reduced cross-section or when the nozzle 19 leaves the application package 1.

[0509] Preferably, the narrowed flow channel or reduced cross-section or nozzle 19 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, accumulation of the drug product 2 at the axial end 7A or in the tip 10 is prevented. 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.

[0510] Figure 12 To correspond to Figure 11 The illustration shows a magnified detail of one of the first embodiments of the application packaging 1 in the area of ​​the fracture zone 9, and a magnified detail of one of the second embodiments.

[0511] 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.

[0512] 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.

[0513] Along axis A and / or along Figure 12 The cross-section shown in the figure has an inner surface 18 that is preferably at least substantially flat, especially in the predetermined fracture zone 9.

[0514] 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.

[0515] 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.

[0516] The following implementation is 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 despite this, 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.

[0517] It is also conceivable that the thickness T decreases in some areas and increases in others compared to the average thickness T. For example, the thickness T may decrease at the tip of the protrusion 17 and increase at the foot / base of the protrusion 17.

[0518] 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.

[0519] In the following description, a third and fourth embodiment of the application package 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.

[0520] Figures 13 to 15 Each corresponding to Figures 9 to 11 The view shows a third embodiment of the application of packaging 1. Specifically, Figure 13 A schematic plan view of the bottom side of the self-application packaging 1 is shown. Figure 14 Display along Figure 13 A schematic cross-section of the application packaging 1 of line XIV-XIV in the middle, and Figure 15 Display marked as XV Figure 13 One of the ways to zoom in on details. Figure 14 and Figure 15 The cross section shown is along axis A, that is, along application channel 7 or in the area of ​​application channel 7.

[0521] Figure 16 With similar Figure 15 One enlarged view shows a schematic cross-section of the application package 1 in region 1 of the edge 8 according to the third embodiment. 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.

[0522] Figure 17 To correspond to Figure 11 , Figure 12 and Figure 15 The illustration shows a magnified detail of one of the other embodiments shown in the diagram, illustrating a fourth embodiment of the application packaging 1 in the area of ​​the fracture zone 9. Figure 18 To correspond to Figure 16 One of the illustrations shows a magnified detail of the area of ​​the fracture zone 9 at the edge 8 in the fourth embodiment of the application packaging 1.

[0523] 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 one of the directions of transverse or perpendicular to the longitudinal extension of the application channel 7 or axis A.

[0524] 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.

[0525] 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 in the third and fourth embodiments (particularly preferably in the area of ​​both cavity 5 and edge 8).

[0526] Preferably, the groove 15 has the same or similar properties in the region of the edge 8 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.

[0527] 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.

[0528] Preferably, according to Figures 13 to 16 The third implementation method and its basis Figure 17 and Figure 18 The main or only difference between the fourth embodiment is whether the protrusion 17 is formed on the edge 8.

[0529] Preferably, in the third embodiment, the edge 8 does not include the protrusion 17, such as in particular Figure 16 As can be seen, and / or in the fourth embodiment, the edge 8 includes a protrusion 17, such as in particular Figure 18 As can be seen in the text.

[0530] 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.

[0531] 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, solutions in which the protrusion 17 differs at the edge 8 are also possible.

[0532] 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 fracture 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, such as Figure 17 and Figure 18 As can be seen 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 area of ​​the predetermined fracture zone 9, such as in Figure 15 and Figure 16 As can be seen in the text.

[0533] 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 area and / or area of ​​the predetermined fracture zone 9 at the application channel 7.

[0534] In the fourth embodiment, the thickness T is preferably at least substantially constant over the entire length of the predetermined fracture zone 9.

[0535] Preferably, the application package 1 according to the third embodiment includes a narrowed flow channel or a reduced cross-section or a nozzle 19.

[0536] 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 area of ​​the predetermined break zone 9 or 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 area framed by the edge 3A.

[0537] Any combination of different implementation methods is possible. For example, the predetermined fracture zone 9 in the third implementation method can also be formed without any protrusion 17, as in the second implementation method.

[0538] In the following text and reference Figures 19 to 22The 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 used to produce the predetermined fracture zone 9.

[0539] Figure 19 A schematic cross-section is shown of a molding tool 102 having a (thermoformed) plastic sheet 200 or a bottom portion 3. Figure 20 An enlarged detail of a cross section of the molding tool 102 in the area of ​​a molding device 102C having a (thermoformed) plastic sheet 200 or a bottom portion 3. Figure 21 and Figure 22 Each corresponding to Figure 19 and Figure 20 The illustration shows the molding tool 102 according to a further embodiment.

[0540] Unless otherwise stated, the following description is preferably applicable to both embodiments.

[0541] exist Figure 19 and Figure 21 In the figure, molds 102A and 102B are shown to be spaced apart from each other and spaced apart 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.

[0542] exist Figure 20 and Figure 22 In the diagram, molds 102A and 102B are shown resting against plastic sheet 200 / bottom portion 3 and / or during thermoforming.

[0543] The female mold 102A preferably has a cavity and / or a concave shape or surface 102D. The surface 102D of the female mold 102A is preferably generally concave, but may be locally flat or even convex.

[0544] Particularly preferably, the female mold 102A has a plurality of (concave) cavities for forming a plurality of bottom portions 3 (simultaneously / in one molding step), as referenced above. Figure 4 To explain.

[0545] The male mold 102B preferably has a convex portion and / or a convex form or surface 102E. The surface 102E of the male mold 102B is preferably generally convex, but may be locally flat or even concave.

[0546] Particularly preferably, the male mold 102B has a plurality of protrusions for forming a plurality of bottom portions 3 (simultaneously / in one molding step), as referenced above. Figure 4 To explain.

[0547] As mentioned above... Figure 4 As illustrated by the equipment 100 and corresponding production method shown, 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 forced against the female mold 102A or the male mold 102B, particularly pneumatically and / or by means of a gas blown onto the plastic sheet 200, 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.

[0548] 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.

[0549] Preferably, even when two molds 102A and 102B are provided / used, a gas is also blown and / or a negative pressure is generated.

[0550] 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 only in other areas by means of gas and / or negative pressure.

[0551] 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.

[0552] 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.

[0553] The molding device 102C is preferably shaped to correspond to the (desired) predetermined fracture zone 9, in particular to be shaped to be one of the protrusions or convexities 102F in the female mold 102A and / or one of the grooves or recesses 102G in the male mold 102B.

[0554] According to what will be referred to later Figures 23 to 25 In one of the fifth embodiments, a protrusion or convex portion 102F may 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.

[0555] The forming apparatus 102C preferably has a shape, measure 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.

[0556] Specifically, the forming device 102C is elongated and / or wedge-shaped, preferably as in 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.

[0557] The forming device 102C or the protrusion 102F preferably has a sharp edge or a sharp ridge.

[0558] 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%.

[0559] 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.

[0560] 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.

[0561] The molding device 102C may only be embodied / formed / provided in the female mold 102A (e.g., as Figure 19 and Figure 20 (as shown in the image), only in male mold 102B (not shown), or in both female mold 102A and male mold 102B (e.g., as shown in the image). Figure 21 and Figure 22 (As shown in the image).

[0562] 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.

[0563] 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 a (convex) cavity formed by male mold 102B and / or (integral convex) surface 102E.

[0564] Preferably, when the plastic sheet 200 is forced 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.

[0565] 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) to form a predetermined fracture zone 9, a groove 15 and / or a protrusion 17.

[0566] Depending on the desired form of the predetermined fracture zone 9, the forming device 102C is shaped accordingly.

[0567] The forming device 102C may be provided only in the area of ​​the molding tool 102 (particularly one or two molds 102A, 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.

[0568] 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.

[0569] When the molding 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, according to Figures 9 to 11 The first embodiment shown in the figure and / or according to Figure 12 The second embodiment shown in the figure 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.

[0570] When the forming device 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, according to Figures 13 to 16 The third embodiment shown in the figure and / or according to Figure 17 and Figure 18 The fourth embodiment shown in the diagram and / or any other embodiment in which the predetermined fracture zone 9 is also provided at the edge 8 (e.g., also in...) Figures 1 to 3One of the embodiments shown in the figure can be formed / produced by applying packaging 1 or bottom part 3 in this manner.

[0571] Preferably, when two molds 102A and 102B are provided, or in the region where the two molds 102A and 102B are provided, the surfaces 102D and 102E of the molds 102A and 102B or their equivalents correspond to each other at least substantially. Specifically, the surfaces 102D and 102E are at least substantially the same or have at least substantially the same shape, except that they have opposite curvatures. However, in specific regions where the predetermined fracture zone 9 is formed or to be formed, the surfaces 102D and 102E of the molds 102A and 102B or their equivalents may be shaped differently.

[0572] Preferably, in Figure 19 and Figure 20 In the embodiment shown, 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.

[0573] like Figure 20 As is best seen, this preferably results in a predetermined fracture zone 9 without a protrusion 17 and / or with a reduced thickness T. Specifically, in this manner, a fracture zone can be formed according to... Figure 12 The second embodiment and / or any other embodiment shown in the illustration does not have a protrusion 17 when applying the packaging 1.

[0574] Alternatively, the molding device 102C may be embodied in / provided on two molds 102A, 102B, such as Figure 21 and Figure 22 The following is an illustrative illustration. Specifically, one mold 102A, 102B may include a protrusion or convexity 102F and another 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 preferably possible to form / produce an application package 1 having a groove 15 and a corresponding protrusion 17, for example, according to Figures 9 to 11 The first embodiment shown in the figure or according to Figures 13 to 18 Application packaging 1 of the third or fourth embodiment shown in the figure.

[0575] 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.

[0576] For example, the molding 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 molding device 102C or surface 102E includes 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, it is possible to form / produce according to... Figures 13 to 16 One of the third embodiments shown in the figure is the application of packaging 1.

[0577] The molding device 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.

[0578] exist Figure 19 and Figure 20 In the example shown, 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 Figure 21 and Figure 22 As shown in the image.

[0579] Preferably, the equipment 100 can be adapted to produce predetermined fracture zones 9 of different plastic shapes.

[0580] As previously explained, the molding tool 102 (especially molds 102A, 102B) is preferably replaceable. The equipment 100 can be adapted to produce 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 molding device 102C.

[0581] 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 apparatus 100 is preferably adapted to produce predetermined fracture zones 9 of different shapes without replacing the entire molding tool 102 or the respective molds 102A, 102B.

[0582] Preferably, the molding device 102C forms a movable, adjustable, and / or replaceable component of one of the molding tools 102.

[0583] For example, the molding device 102C may be designed for inserting one or more of the molding tool 102 or molds 102A, 102B. Figure 20 and Figure 22 The dotted lines in the middle are used to indicate this very schematically.

[0584] The molding device 102C or insert can preferably be fixed to the molding tool 102 or the mold 102A, 102B by a force-fit and / or form-fit method. 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.

[0585] 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.

[0586] 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.

[0587] 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.

[0588] Preferably, the molding device 102C is adjustable or movable 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.

[0589] Figure 20 A magnified detail shows the process used to produce materials with reduced thickness T and / or according to... Figure 12 The second embodiment shown in the figure and / or an example of a female mold 102A and a male mold 102B having non-corresponding surfaces 102D and 102E, particularly having a predetermined fracture zone 9 provided only in / formed in the female mold 102A or on the surface 102D.

[0590] 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.

[0591] Due to the extrusion / compression and / or different shaping 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, preferably, a predetermined fracture zone 9 is created.

[0592] The forming device 102C or the protrusion 102F preferably penetrates the plastic sheet 200.

[0593] Preferably, only the outermost layer of the plastic sheet 200, particularly the outer thermoformable layer 201, 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.

[0594] Preferably, the innermost layer (particularly at least the barrier layer 204 and the sealing layer 205) remains intact or at least substantially unaffected, pierced, 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 or at the predetermined fracture zone 9.

[0595] 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.

[0596] Particularly 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.

[0597] 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.

[0598] In a further embodiment (e.g., Figure 21 and Figure 22 In the embodiment shown 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.

[0599] Next, the plastic sheet 200 (especially all its layers) is pushed inward, bent, or knotted during (thermo) forming, particularly by the protrusion 102F of mold 102A into the recess 102G of mold 102B, or vice versa, for example, as Figure 22 As shown in the figure. In this manner, preferably, a predetermined fracture zone 9 with a groove 15 and a corresponding protrusion 17 is formed.

[0600] 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.

[0601] Preferably, all layers of the plastic sheet 200 are affected because all layers bend / knot inward. However, it is preferable to maintain the integrity of the inner layers (particularly at least the barrier layer 204 and the sealing layer 205). Therefore, in this case, the sealing and barrier quality of the plastic sheet 200 or the bottom portion 3 is preferably not damaged by or at the predetermined fracture zone 9.

[0602] The plastic sheet 200 may have corresponding surfaces 102D, 102E only in specific areas and / or bend / knot inward only in specific areas, or be extruded / 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 extruded / compressed in the area where the edge 8 is formed or to be formed, so that it can be formed according to Figures 13 to 16 One of the third embodiments shown in the image is the application of packaging 1 or bottom portion 3.

[0603] The fifth embodiment of the application packaging 1 is described below.

[0604] Figures 23 to 25 Each corresponding to Figures 9 to 11 The view shows the fifth embodiment of the application of packaging 1. Specifically, Figure 23 A schematic plan view is shown on the bottom side of the self-application packaging 1. Figure 24 Display along Figure 23 A schematic cross-section of the application packaging 1 of the middle line XXIV-XXIV, and Figure 25 Displaying items marked as XXV Figure 24 One of the ways to zoom in on details. Figure 24 and Figure 25 The cross section shown is along axis A, for example, along application channel 7 or in the region of application channel 7.

[0605] 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.

[0606] 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.

[0607] and Figures 9 to 11Compared to the first embodiment, 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.

[0608] 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 in the predetermined fracture zone or by means of the predetermined fracture zone 9, and particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm or 0.4 mm.

[0609] 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.

[0610] 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 pharmaceutical article 2 is discharged from the application package 1.

[0611] The channel is widened at the open end 7B to allow for easier discharge of the drug product 2. This can be advantageous, for example, for a more viscous fluid.

[0612] 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.

[0613] Obviously, in some of the explanations 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).

[0614] Particularly preferably, the description and preferred values ​​of the groove 15 and / or the protrusion 17 (especially for thickness T, depth D and / or angle W) are also preferably applicable to the fifth embodiment. Figure 25 An example is shown at an angle of approximately 40 degrees W (approximately 100 degrees of opening angle).

[0615] 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).

[0616] Particularly preferably, the predetermined fracture zone 9 extends transversely or perpendicularly to the axis A / channel 7 over the entire cavity 5 or the application channel 7 or its width.

[0617] 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.

[0618] The above description and features regarding the entire or partial 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.

[0619] Although according to Figures 23 to 25 An illustrative example of the fifth embodiment shows a predetermined fracture zone 9 extending only above the cavity 5 / application channel 7, but 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).

[0620] Furthermore, although according to Figures 23 to 25 An illustrative example of the fifth embodiment is shown as a bend / knot and / or a predetermined fracture zone 9 having both a groove 15 and a protrusion 17, but it is also possible to provide only the groove 15 on the inner surface 18 without the protrusion, particularly similar to the second embodiment.

[0621] Therefore, any combination of different implementation methods is possible. Specifically, the fifth implementation method can be combined with any of the previous implementation methods.

[0622] 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.

[0623] Specifically, the female mold 102A includes a notch 102G and / or the male mold 102B includes a protrusion 102F. Figure 27An example is shown of a female mold 102A having a corresponding notch 102G.

[0624] Compared to Figure 21 and Figure 22 The positions of the molding tool 102 or forming apparatus 102C, the protrusion 102F, and the recess 102G shown in the previous description 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.

[0625] Similarly, a protrusion 102F may be provided only for the male mold 102B, and no protrusion or recess may be provided for the female mold 102A, especially with Figure 19 and Figure 20 The forming apparatus 102C shown in the figure complements the formation of 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.

[0626] 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.

[0627] Figure 26 and Figure 27 An exemplary preferred embodiment of the female mold 102A of the molding tool 102 is shown in a schematic perspective view. Here, Figure 26 A female mold 102A with a protrusion 102F is shown for forming a predetermined fracture zone 9. Figure 27 A female mold 102A with a notch 102G is shown for forming a predetermined fracture zone 9.

[0628] Even without repetition, especially as in combination Figures 19 to 22 The above description and preferred features are also applicable accordingly. Figure 26 and Figure 27 The mold. Similarly, the following explanation preferably also applies to the previously combined Figures 19 to 22 The mold described.

[0629] Preferably, Figure 26 The female mold 102A can be used to produce an application package 1 or a bottom portion 3 having a groove 15 on the outer surface 16 according to the first embodiment.

[0630] Preferably, Figure 27The female mold 102A 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.

[0631] For the production of an application package 1 or bottom portion 3 that also has a predetermined fracture zone 9 at the edge 8, the forming device 102C (in particular the protrusion 102F or the recess 102G) preferably extends beyond the area for forming the cavity 5 (in particular the application channel 7) and / or beyond the concave surface 102D. The following explanations and features also preferably apply to such molds 102A.

[0632] like Figure 26 and Figure 27 As shown, 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).

[0633] Ventilation holes 102H are preferably distributed above the entire surface 102D and 102E of molds 102A and 102B, particularly evenly and / or along axis A and / or mirror-symmetrically with axis A.

[0634] In a plan view or cross-section, the vent 102H is preferably at least substantially circular, elliptical, or oval.

[0635] Preferably, the vent 102H extends through the entire mold 102A and 102B.

[0636] Vent hole 102H is preferably provided so that air can escape from mold 102A, 102B when the bottom part 3 is thermoformed (especially deep drawn).

[0637] 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. In this manner, preferably, 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.

[0638] Particularly preferred, such as in Figure 26 and Figure 27 As indicated, one or more vent holes 102H, particularly preferably three vent holes 102H, are positioned or configured or formed in / at the forming device 102C (especially the protrusion 102F and / or the recess 102G).

[0639] Preferably, the plastic sheet 200 (closely attached to the ground) is ensured to be generated / formed in the desired shape by means of the vent 102H in / at the molding device 102C and / or the predetermined fracture zone 9.

[0640] The vent 102H or at least (a number of) 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. A diameter of 0.5 mm, 0.6 mm, or 0.7 mm is particularly preferred.

[0641] 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 preferably, the ratio is about 1:6, 1:5 or 1:4.

[0642] 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.

[0643] 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 axis A or the application channel 7.

[0644] Preferably, all vents 102H in molds 102A and / or 102B have the same shape and / or size. However, vents 102H with different diameters may also be provided. For example, some vents 102H in / at the molding device 102C may be smaller or larger than vents 102H formed outside the molding device 102C.

[0645] 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 for example, if combined... Figure 5 and Figure 7 This is especially true for the preferred plastic sheet 200 described.

[0646] 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 The deformation of one of the nine predetermined fracture zones is shown by the dotted lines.

[0647] 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.

[0648] Specifically, fracture behavior (especially brittleness) can be enhanced by deforming one or more of the nine predetermined fracture zones.

[0649] One further aspect of the present invention relates to the use of a plastic sheet 200 for producing an application package 1 for a preferably liquid pharmaceutical product 2.

[0650] The application package 1 has a bottom portion 3, which has a cavity 5 for receiving the drug product 2 and a periphery 8 surrounding the cavity 5.

[0651] The application packaging 1 has a cover 4 that covers and completely seals the cavity 5.

[0652] The bottom portion 3 is preferably formed from a multi-layered plastic sheet 200 by thermoforming or deep drawing.

[0653] Its features

[0654] The plastic sheet 200 of the bottom part 3 includes at least five layers:

[0655] One external thermoformable layer 201,

[0656] Monocyclic olefin copolymer (COC) layer 202,

[0657] One inner thermoformable layer 203,

[0658] A barrier layer 204, preferably a layer that blocks oxygen and / or chemicals.

[0659] A sealing layer 205, preferably a heat-sealing layer,

[0660] 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.

[0661] 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.

[0662] Reference tag list

[0663] 1: Application Packaging

[0664] 1A: Axial end of the application packaging

[0665] 2: Pharmaceutical products

[0666] 3: Bottom part

[0667] 3A: Edge

[0668] 4: Cover

[0669] 5: cavity

[0670] 6: Chamber

[0671] 7: Application Channel

[0672] 7A: Axial end of the application channel

[0673] 7B: Open end

[0674] 8: Edge section

[0675] 9: Pre-determined fracture zone

[0676] 10: Tip

[0677] 11: Secondary packaging

[0678] 12: Base portion

[0679] 13: Lid

[0680] 14: Container

[0681] 15: Groove

[0682] 16: Outer surface

[0683] 17: Protrusion

[0684] 18: Inner surface

[0685] 19: Nozzle / Cross-section Reduction

[0686] 20: Diffuser / Cross-section Enlargement

[0687] 21: Deformation

[0688] 100: Equipment

[0689] 101: Heating device

[0690] 101A: Upper heating plate

[0691] 101B: Lower heating plate

[0692] 102: Molding Tools

[0693] 102A: Female mold

[0694] 102B: Positive mold

[0695] 102C: Molding device

[0696] 102D: (Concave) surface

[0697] 102E: (convex) surface

[0698] 102F:convex part

[0699] 102G: Notch

[0700] 102H: Vent

[0701] 103: Filling device

[0702] 104: Covering device

[0703] 200: Plastic sheets (thin plates, thin films)

[0704] 201: External thermoformable layer

[0705] 202: Cyclic olefin copolymer layer

[0706] 203: Inner thermoformable layer

[0707] 204: Barrier layer

[0708] 205: Sealing layer

[0709] 206: Intermediate Layer

[0710] 207a to 207d: Connecting Layers

[0711] 208: Adhesive layer

[0712] 300: Cover sheet

[0713] 301: Protective layer

[0714] 302: First barrier layer

[0715] 303: Intermediate Layer

[0716] 304: Second barrier layer

[0717] 305: Sealing layer

[0718] 307a, 307b: Connecting Layers

[0719] 308a, 308b: Adhesive layer

[0720] A: Axis

[0721] D: Depth

[0722] T: Thickness

[0723] W: angle

Claims

1. An application package (1) for a pharmaceutical product (2), comprising: The bottom portion (3) has a cavity (5) for receiving the pharmaceutical article (2) and a rim (8) surrounding the cavity (5). A cover (4) that covers and completely seals the cavity (5). A predetermined fracture zone (9) is provided for opening the application package (1) by breaking the fracture zone (9). The bottom portion (3) is formed of a plastic sheet (200) in the form of a multilayer film, and The cover (4) is a cover sheet (300) in the form of a multi-layer film. The plastic sheet (200) of the bottom portion (3) comprises at least 5 layers: External thermoformable layer (201), Cyclic olefin copolymer (COC) layer (202), wherein the cyclic olefin copolymer (COC) is obtained by copolymerization of cyclic monomers of 8,9,10-triazacyclopentene (norbornene) or 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethylnaphthalene (tetracyclododecene) with ethylene. Internal thermoformable layer (203), Barrier layer (204), and Sealing layer (205), and 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).

2. The application packaging (1) according to claim 1, wherein, The external thermoformable layer (201) comprises or is composed of polymers selected from the group consisting of: polystyrene (PS), polyvinyl chloride (PVC), amorphous polyethylene terephthalate (APET), ethylene butyl acrylate (EBA), ethylene vinyl acetate (EVA), polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), and mixtures thereof.

3. The application packaging (1) according to claim 1, wherein, The outer thermoformable layer (201) and the inner thermoformable layer (203) are made of the same polymer.

4. The application packaging (1) according to claim 1, wherein, The barrier layer (204) comprises polymers selected from the group consisting of: ethylene-vinyl alcohol (EVOH), ethylene vinyl acetate (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methacrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

5. The application packaging (1) according to claim 1, wherein, The sealing layer (205) comprises polymers selected from the group consisting of: polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), metallocene linear low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), ionomers of acid copolymers, ethylene-acrylic acid copolymer (EAA), ethylene-methacrylic acid copolymer (EMAA), ethyl methacrylate (EMA), ethylene-vinyl alcohol (EVOH), or mixtures thereof.

6. The application packaging (1) according to claim 1, wherein, The cyclic olefin copolymer layer (202) has a thickness ranging from 200 to 600 µm.

7. The application packaging (1) according to claim 1, wherein, The thickness of the cyclic olefin copolymer layer (202) relative to the thickness of the outer thermoformable layer (201) and / or the thickness of the inner thermoformable layer (203) is in the range of 5:1 to 30:

1.

8. The application packaging (1) according to claim 1, wherein, The plastic sheet (200) of the bottom portion (3) includes an intermediate layer (206).

9. The application packaging (1) according to claim 1, wherein, The plastic sheet (200) of the bottom portion (3) comprises at least 5 layers having the following layer sequence: The outer thermoformable layer (201) is followed by... The cyclic olefin copolymer (COC) layer (202) is followed by... The inner thermoformable layer (203) is followed by Optionally, the intermediate layer (206) is followed by... The barrier layer (204) is followed by The sealing layer (205).

10. The application packaging (1) according to claim 9, wherein, The external thermoformable layer (201) comprises polymers selected from the group consisting of: polystyrene (PS), polyvinyl chloride (PVC), amorphous polyethylene terephthalate (APET), ethylene butyl acrylate (EBA), ethylene vinyl acetate (EVA), polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), and mixtures thereof.

11. The application packaging (1) according to claim 9, wherein, The plastic sheet (200) comprises the following layer structure having the following layer sequence: (a) Includes an outer thermoformable layer (201) of PP, followed by... (b) A cyclic olefin copolymer layer (202) including COC, followed by... (c) Including an inner thermoformable layer (203) of PP, followed by (d) Optionally, the intermediate layer (206) including the PE, followed by... (e) A barrier layer (204) including EVOH, followed by (f) Includes a sealing layer (205) of PE.

12. The application packaging (1) according to claim 1, wherein, The cover sheet (300) comprises the following layers: Protective layer (301), The first barrier layer (302), Intermediate layer (303), second barrier layer (304) and Sealing layer (305), The first barrier layer (302) is disposed between the protective layer (301) and the intermediate layer (303), and the second barrier layer (304) is disposed between the intermediate layer (303) and the sealing layer (305).

13. The application packaging (1) according to claim 1, wherein, The cover sheet (300) includes the following layer structure having the following layer sequence: (i) The protective layer (301) is followed by (ii) The first barrier layer (302) is followed by (iii) The intermediate layer (303) is followed by (iv) The second barrier layer (304) is then for (v) Sealing layer (305).

14. The application packaging (1) according to claim 1, wherein, The cover (4) and the bottom portion (3) are at least partially joined by the sealing layers (205, 305) of the plastic sheet (200) of the bottom portion (3) and the cover sheet (300) of the cover (4).

15. The application packaging (1) according to claim 1, wherein, The plastic sheet (200) of the bottom portion (3) includes the following layer structure: (a) External thermoformable layer (201), (b) Cycloolefin copolymer layer (202), (c) Internal thermoformable layer (203), (d) Intermediate layer (206), (e) barrier layer (204), and (f) Sealing layer (205), and The cover sheet (300) includes the following layer structure: (i) Protective layer (301), (ii) First barrier layer (302), (iii) Intermediate layer (303), (iv) Second barrier layer (304) and (v) Sealing layer (305).

16. The application packaging (1) according to claim 1, wherein, The plastic sheet (200) of the bottom portion (3) includes the following layer structure having the following layer sequence: (a) External thermoformable layer (201), followed by (b) Cycloolefin copolymer layer (202), followed by (c) Inner thermoformable layer (203), followed by (d) Optionally, the intermediate layer (206) is followed by... (e) Barrier layer (204), followed by (f) Sealing layer (205), and The cover sheet (300) includes the following layer structure: (i) The protective layer (301) is followed by (ii) The first barrier layer (302) is followed by (iii) The intermediate layer (303) is followed by (iv) The second barrier layer (304) is then for (v) Sealing layer (305).

17. A method for producing and filling an application package (1) for a pharmaceutical article (2), in, The application package (1) has a bottom portion (3) having a cavity (5) for receiving the pharmaceutical article (2) and an edge (8) surrounding the cavity (5). The application package (1) has a cover (4) that covers and completely seals the cavity (5). The application package (1) has a predetermined fracture zone (9) for opening the application package (1) by breaking the fracture zone (9). The bottom portion (3) is formed of a plastic sheet (200) in the form of a multilayer film, and the cover (4) is a cover sheet (300) in the form of a multilayer film. The plastic sheet (200) of the bottom portion (3) comprises at least the following 5 layers: External thermoformable layer (201), Cyclic olefin copolymer (COC) layer (202), wherein the cyclic olefin copolymer (COC) is obtained by copolymerization of cyclic monomers of 8,9,10-triazacyclopentene (norbornene) or 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethylnaphthalene (tetracyclododecene) with ethylene. Internal thermoformable layer (203), Barrier layer(204), 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). The method includes the following steps: The multi-layered plastic sheet (200) is at least partially heated. The bottom portion (3) of the application package (1) is formed 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 article (2) and an edge (8) surrounding the cavity (5). Using the molding tool (102) and / or during the step of forming the bottom portion (3), a predetermined fracture zone (9) is created in the bottom portion (3). The cavity (5) is filled with the drug product (2), and The cavity (5) is covered with a cover (4) and the cover (4) is fixed to the edge (8) so that the cavity (5) is completely closed.

18. The method according to claim 17, wherein, The cavity (5) includes a chamber (6) and an application channel (7) in fluid communication with the chamber (6).

19. The method of claim 17, wherein, The predetermined fracture zone (9) is formed only in the region of the cavity (5).

20. An application package (1) for a pharmaceutical article (2), comprising: The bottom portion (3) has a cavity (5) for receiving the pharmaceutical article (2) and a rim (8) surrounding the cavity (5). A cover (4) that covers and completely seals the cavity (5). The bottom portion (3) is formed of a plastic sheet (200) in the form of a multilayer film. The plastic sheet (200) of the bottom portion (3) comprises at least the following 5 layers: External thermoformable layer (201), Cyclic olefin copolymer (COC) layer (202), wherein the cyclic olefin copolymer (COC) is obtained by copolymerization of cyclic monomers of 8,9,10-triazacyclopentene (norbornene) or 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethylnaphthalene (tetracyclododecene) with ethylene. Internal thermoformable layer (203), Barrier layer(204), 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).

Images