Dosage packaging and method of manufacturing the same

Abstract

DOSAGE PACKAGING AND METHOD OF MANUFACTURING SAME FIELD OF THE INVENTION The dosage packaging comprises a base part and a cover obtained from a multilayer film.

Description

Technical Field

[0001] The present invention relates to an administration packaging for preferably liquid pharmaceutical products, and methods for manufacturing and filling the administration packaging, and the use of a plastic sheet for manufacturing the administration packaging.

Background Art

[0002] Administration packaging is manufactured particularly by thermoforming. Thermoforming is a method in which a plastic sheet, particularly a film or foil, is heated to a flexible forming temperature and then formed into a specific shape within a mold. Further, the plastic sheet is preferably trimmed after being formed within the mold.

[0003] The administration packaging is particularly a packaging for liquid pharmaceutical products useful for confining the product or in which the product is stored and also for administering the product to a patient. The packaging is particularly a pipette or is used as a pipette or can be deformed into a pipette.

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

[0005] EP 2 998 098 A1 and EP 2 998 099 A1 relate to a method for manufacturing and filling dosing packaging for liquid pharmaceutical products. The packaging is manufactured by a thermoforming process in which a deep-drawn film is heated to plasticize in at least a partial region, the plasticized region is deep-drawn into a molding tool to form a chamber for the product and a cannula-shaped dosing channel opening into the chamber, the product is introduced into the chamber, and the filled deep-drawn film is covered with a cover film to close the chamber and the dosing channel. In the end region, the dosing channel is provided with a crack or groove that forms a predetermined break zone where the tip of the additional channel can be broken to open the dosing packaging. The predetermined break zone is generated before the deep-drawn film is heated. The deep-drawn film is a laminated composite film having one layer of polypropylene (PP) and one layer of acrylonitrile-methyl acrylate copolymer (AMAB), and the crack or groove is generated 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] Firstly, to avoid any undesirable interactions between the solvent or active ingredient of the pharmaceutical product and the packaging, only specific combinations of plastic films are usable for both the cover film and the deep-drawn film. The same applies to the break zone: that is, only specific material combinations are usable to ensure that a reproducible, clear break is obtained in the break zone and a useful pipette ready for immediate application. Unfortunately, certain acrylonitrile methyl acrylate copolymers (AMAB) mentioned in EP 2 998 098 A1 or EP 2 998 099 A1, respectively, and distributed under the brand name Barex®, are no longer available.

[0008] Furthermore, the creation of grooves requires an additional step beyond the thermoforming stage in which the chamber and administration channel are formed.

[0009] Finally, the method of generating a predetermined break zone by cutting through the PP layer does not work well when the film has a different composition than described and / or when the setup of the cutting system is more complex.

[0010] In other words, there is a need for new material combinations that enable the use of such disposable dosing packaging for liquid pharmaceutical products.

[0011] U.S. Patent Application U.S. 2012 / 0265159 A1 describes a device for storing and dispensing a drug, more specifically, a device that can be used to dispense an antiparasitic drug onto the skin of an animal. The focus is on the configuration of the packaging device, which is designed to include a substrate or a wall or a second layer bonded to a first layer, the substrate and the wall defining a drug reservoir. At least a portion of the wall or the second layer is configured to deform to reduce the volume of the drug reservoir when the wall is actuated, in order to facilitate dispensing the drug from the device.

[0012] With respect to materials that may potentially be included in the first or second layer of the device, it is merely stated that the first and / or second layer, as well as any other layers, walls, and structures contained within any of the described drug containers, can be composed of any suitable material. Such materials may be selected to minimize interaction with the drug and may consist of substantially inert and / or flexible polymers, or polymers having a certain degree of hardness. The materials, however, are not relevant to the potential opening mechanism of the described device, and specifically, not to the potential use or all possible use in relation to designing predetermined break zones.

[0013] German utility model DE 201 16 341 U1 describes a polyolefin multilayer film. The film is particularly suitable for applications involving fresh foods such as fresh meat or sausages. The multilayer plastic film thus comprises at least two plastic layers, at least one layer comprising a mixture of at least one semicrystalline polyolefin and at least one amorphous polyolefin in more than 5% by weight, and at least one further layer comprising a material having an oxygen barrier effect. The film is expected to be characterized by good thermoformability with a uniform wall thickness distribution after thermoforming, 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 regardless of moisture absorption.

[0014] This document, however, does not relate to or provide evidence for the potential suitability of multilayer films for medical applications, which involve specific application requirements that cannot be equivalent to those for food packaging. Furthermore, the film is described as particularly puncture-resistant even under mechanical strain. This material property appears unsuitable for dosing packaging intended to be opened by tearing or opening certain components of the packaging.

[0015] International application WO 2018 / 132113 A1 describes blister packaging for solid pharmaceuticals, i.e., tablets. These are formed by a multilayer structure comprising, in the following order: a first inert moisture barrier layer, a second inert moisture barrier layer, a first active moisture barrier layer comprising a first moisture-absorbing composition and a cyclic olefin copolymer, and a third inert moisture barrier layer, wherein the first, second, and third inert moisture barrier layers and the first active moisture barrier layer are in contact, non-contact, or a combination thereof.

[0016] It has been noted that effective post-treatment is possible by appropriate modification of the active moisture barrier layer using an elastomer, by surrounding the active moisture barrier layer with an inert moisture barrier layer having an elastic modulus equal to or lower than that of the active moisture barrier layer. Appropriate modifications in this regard are reducing the stiffness of the material or increasing its flexibility and elasticity, respectively. Thus, it can be concluded that the described material is unsuitable for use in dosing packaging intended to be opened by breaking or opening certain parts of the packaging, for the opposite being true, namely non-rigidity or non-breakability, which constitutes the focus of WO 2018 / 132113 A1.

[0017] Therefore, the prior art lacks suitable substitutes that could be used as replacements for the materials described in EP 2 998 099 A1 or EP 2 998 099 A1, respectively. In this regard, specifically, the aspects of controlled fracture of polymer materials remain largely unexplored.

[0018] Furthermore, there is a need for an efficient method for manufacturing dosing packages that allows for the reproducible formation of predetermined rupture zones within the dosing package. [Prior art documents] [Patent Documents]

[0019] [Patent Document 1] EP 2 998 098 A1 [Patent Document 2] EP 2 998 099 A1 [Patent Document 3] US 2012 / 0265159 A1 [Patent Document 4] DE 201 16 341 U1 [Patent Document 5] WO 2018 / 132113 A1 [Overview of the Initiative]

Problems to be Solved by the Invention

[0020] Therefore, an object of the present invention is to protect the active ingredient of a liquid pharmaceutical product from the influence of the surrounding environment, not to show any undesirable chemical interaction with the solvent or the active ingredient of the liquid pharmaceutical product, and further prevent the liquid pharmaceutical product or its composition from leaking from the packaging. Provide a new material combination.

[0021] Furthermore, an object of the present invention is to provide a material combination that enables obtaining a clear break zone in the packaging that allows the packaging to be accurately opened in a predetermined manner.

[0022] Finally, an object of the present invention is to provide an improved method for manufacturing a dosing packaging.

Means for Solving the Problems

[0023] To solve the above object, the present invention proposes the dosing packaging according to claim 1, and further, advantageous embodiments are the subject matters of the respective dependent claims.

[0024] Furthermore, to solve the above object, the present invention proposes the method according to claim 17, and still other advantageous embodiments are the subject matters of its dependent claims.

[0025] ]>Furthermore, to solve the above object, the present invention proposes the use according to claim 21, and still other advantageous embodiments are the subject matters of its dependent claims.

[0026] Of course, specific features, characteristics, embodiments, or advantages, etc. related only to one aspect of the present invention listed below to avoid unnecessary repetition are correspondingly applicable to other aspects of the present invention without the need for explicit mention.

[0027] Furthermore, it applies that all values ​​or parameters mentioned below can, in principle, be determined or measured by standardized or explicitly mentioned determination methods or by determination methods known to those skilled in the art.

[0028] Furthermore, it goes without saying that all weight or quantity-related percentages are selected by those skilled in the art so that they add up to 100%.

[0029] Now that these conditions have been met, the present invention will be described in more detail below.

[0030] In other words, the subject matter of the present invention according to a first aspect of the present invention is preferably a dosage package for liquid pharmaceutical products, The administration packaging has a bottom component having a cavity for receiving the pharmaceutical product and a rim surrounding it. The administration packaging has a cover that completely seals the cavity. The administration packaging, particularly the bottom component, has a predetermined break zone for opening the administration packaging by breaking the break zone. The bottom component is formed from a plastic sheet in the form of a multilayer film, and the cover is a cover sheet in the form of a multilayer film. The plastic sheet of the base component consists of at least five layers: outer thermoformable layer, Cyclic olefin copolymer (COC) layer, inner thermoformable layer, Barrier layer, preferably a barrier layer against oxygen and / or chemical substances, It includes a sealing layer, preferably a heat-seal layer. The cyclic olefin copolymer layer is positioned between the outer thermoformable layer and the inner thermoformable layer, and the barrier layer is positioned between the sealing layer and the inner thermoformable layer.

[0031] As the applicant unexpectedly discovered, the particular film combination described above makes it possible to obtain a deep-drawn packaging for disposable use as a breakable packaging for the administration of liquid pharmaceutical products. This material combination, in particular, makes it possible to safely encapsulate the liquid pharmaceutical product within the packaging without any undesirable interactions between the packaging and the components of the liquid pharmaceutical product, especially the active ingredient or the solvent. Furthermore, substances from the surrounding environment, especially oxygen and / or water vapor, cannot penetrate the packaging and degrade the liquid pharmaceutical product. The combination of layers described above makes it possible to replace Barex films that have been used to date, and the layer structure of the present invention has a thickness similar to that of known multilayer Barex films.

[0032] Thermoformed deep-drawn films based on cyclic olefin copolymers (COCs) surprisingly exhibit comparable or even enhanced chemical and mechanical properties compared to Barex, including multilayer films used in the prior art. The cyclic olefin copolymer (COC) layer is the main layer of the multilayer plastic sheet forming the bottom component of the dosing packaging of the present invention. The cyclic olefin copolymer (COC) layer contains 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-trinorborn-2-ene (norbornene) or 1,2,3,4,4a,5,8,8a-octahydro-1,4:5,8-dimethanonaphthalene (tetracyclododecene) with ethene. Particularly preferred for use in the present invention is the copolymer of ethene and norbornene.

[0033] COC is rigid and can therefore provide integrity and rigidity to the dosing packaging of the present invention, but it is also brittle and can therefore be manufactured in packaging that has a predetermined break zone for opening the packaging. Furthermore, COC has good moisture barrier properties, especially when used in large layer thicknesses. In addition, COC has good chemical resistance and barrier properties with respect to polar solvents and is resistant to acids and bases.

[0034] Another advantage of COC is that it is available in high purity, and therefore there is no risk of impurities being extracted by solvents or active ingredients trapped in the packaging.

[0035] As described above, the COC layer is placed between the two thermoformable layers.

[0036] According to the present invention, the outer thermoformable layer comprises or is composed of a polymer 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), chain-type low-density polyethylene (LLDPE), and mixtures thereof, and is preferably composed of such polymer.

[0037] The outer thermoformable layer is typically the outer surface of the dosing packaging, especially its bottom component. The outer thermoformable layer is usually neither harder nor more brittle than the COC layer. This layer protects the COC layer from breakage and provides the multilayer film with better processability and enhanced thermoformability.

[0038] In preferred embodiments 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), chain-type low-density polyethylene (LLDPE), or mixtures thereof.

[0039] Best results are obtained when the polymer of the outer thermoformable layer is polypropylene (PP). Polypropylene has good compatibility with COC. Furthermore, polypropylene is considerably less rigid and brittle than COC, and therefore, an outer thermoformable layer composed of PP enhances the thermoformability of the COC layer and protects the brittle COC layer from breakage during manufacturing, storage, or application. Moreover, the processability of the multilayer film, especially the COC layer, is enhanced by the PP layer. In particular, the PP layer provides enhanced flexibility to the COC layer and plastic sheet of the bottom component of the dosing packaging of the present invention.

[0040] The inner thermoformable layer comprises, or is preferably composed of, a polymer 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), chain-type low-density polyethylene (LLDPE), and mixtures thereof.

[0041] In the present invention, it is particularly preferable that the polymer of the inner thermoformable layer is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), or a mixture thereof. Particularly good results are obtained when the polymer is polypropylene (PP).

[0042] In this invention, when a plastic film or layer contains or is composed of a specific polymer, it means that the film or layer contains or is composed of the polymer as the polymer material of each film or layer. However, other components, such as fillers and additives, may also be present in each film or layer.

[0043] In the present invention, it is preferable that the outer thermoformable layer and the inner thermoformable layer contain or are composed of the same polymer.

[0044] Preferably, the outer thermoformable layer and the inner thermoformable layer contain or are composed of the same material, i.e., a polymer. In this regard, it is particularly preferable that the outer thermoformable layer and the inner thermoformable layer contain or are composed of polypropylene (PP). When the COC layer is placed between two PP layers, the processability of the resulting multilayer film is particularly good. In particular, the rigidity of the COC is reduced by the PP, while the fragility of the COC remains unchanged, allowing for the creation of a predetermined break zone that is clearly distinct from the rest of the packaging.

[0045] With respect to the barrier layer, the present invention preferably provides, or is composed of, a polymer 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 methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

[0046] In the present invention, it is preferable that the barrier layer comprises or is composed of a polymer selected from the group consisting of ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof.

[0047] In a particularly preferred embodiment of the present invention, the polymer of the barrier layer comprises or is composed of ethylene vinyl alcohol (EVOH), preferably composed of ethylene vinyl alcohol. In particular, ethylene vinyl alcohol provides good barrier properties that prevent oxygen and further prevent solvents and other chemicals or components of pharmaceutical products.

[0048] Regarding the sealing layer, the present invention provides a sealing layer made of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), ultra-low-density polyethylene (VLDPE), acid copolymer ionomer, ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol ( EVOH ), or a polymer selected from the group consisting of mixtures thereof, preferably comprising such polymer.

[0049] In preferred embodiments 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), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. Particularly good results are obtained when the polymer is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof.

[0050] In the present invention, it is particularly preferable that the sealing layer contains or is composed of polyethylene (PE). Polyethylene is a common material for sealing layers, has good water vapor barrier properties, and is compatible with many barrier materials, especially EVOH.

[0051] As already mentioned above, the COC layer provides structural integrity to the administration packaging. Therefore, the COC layer is typically the thickest layer forming the bottom component of the administration packaging of the present invention within the multilayer plastic sheet.

[0052] In the present invention, it is preferable that 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 most preferably 360 μm.

[0053] Similarly, it is preferable that the cyclic olefin copolymer layer has a thickness of up to 600 μm, particularly 500 μm, preferably 450 μm, more preferably 400 μm, and most preferably 390 μm.

[0054] Furthermore, good results are obtained when 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.

[0055] The COC layer having the aforementioned thickness exhibits good water vapor barrier properties and can provide structural integrity and rigidity to the administration packaging.

[0056] With respect to the outer thermoformable layer and the inner thermoformable layer, it is preferable that 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.

[0057] Similarly, according to the present invention, it is preferable that the outer thermoformable layer and / or inner thermoformable layer have a thickness of up to 40 μm, particularly 35 μm, preferably 30 μm, more preferably 27 μm, and most preferably 25 μm.

[0058] In preferred embodiments of the disclosure of the present invention, the outer thermoformable layer and / or 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 most preferably 20 μm to 25 μm.

[0059] In the present invention, it is particularly preferable that both the outer thermoformable layer and the inner thermoformable layer have thicknesses within the range described above. Thus, these relatively thin thermoformable layers can provide enhanced flexibility to the COC layer and improve the processability of the multilayer plastic sheet of the bottom component used in the present invention.

[0060] In the present invention, it is preferable that the ratio of the thickness of the cyclic olefin copolymer layer to the thickness of the outer thermoformable layer and / or the thickness of the inner thermoformable layer is in the range of 5:1 to 30:1, particularly 7:1 to 25:1, preferably 10:1 to 22:1, more preferably 13:1 to 20:1, and especially preferably 15:1 to 18:1.

[0061] With respect to the barrier layer according to the present invention, it is preferable that the barrier layer has a thickness of at least 2 μm, particularly 5 μm, and preferably 7 μm.

[0062] Furthermore, it is also preferable that the barrier layer has a thickness of up to 20 μm, particularly 15 μm, and preferably 12 μm.

[0063] In the present invention, it is preferable that 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.

[0064] In other words, according to the present invention, a relatively thin barrier layer is preferably used.

[0065] In a preferred embodiment of the present invention, the sealing layer has a thickness of at least 10 μm, particularly 15 μm, preferably 17 μm, more preferably 20 μm, and most preferably 22 μm.

[0066] Furthermore, the sealing layer typically has a thickness of up to 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and most preferably 27 μm.

[0067] The present invention yields particularly good results when 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 most preferably 22 μm to 27 μm.

[0068] In a preferred embodiment of the present invention, the plastic sheet of the bottom component of the administration packaging includes an intermediate layer.

[0069] When the plastic sheet of the bottom component of the dosing packaging includes an intermediate layer, the intermediate layer is preferably placed between the inner thermoformable layer and the barrier layer. The intermediate layer between the barrier layer and the inner thermoformable layer enhances the fit between the barrier layer and the inner thermoformable layer.

[0070] When the plastic sheet of the main component includes an intermediate layer, the intermediate layer is typically made of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), acid copolymer ionomer, ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol ( EVOH It comprises or is composed of a polymer selected from the group consisting of ), or mixtures thereof, preferably composed of such polymer.

[0071] In the present invention, it is particularly preferable 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), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof.

[0072] More preferably, the polymer is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof.

[0073] Particularly good results are obtained when the intermediate layer contains or is composed of polyethylene (PE).

[0074] According to the present invention, the intermediate layer of the plastic sheet of the bottom component contains or is composed of the same polymer as the sealing layer, and preferably is composed of the same polymer.

[0075] Regarding the thickness of the intermediate layer, it is preferable that 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.

[0076] Similarly, it is preferable that the intermediate layer has a thickness of up to 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and especially preferably 27 μm.

[0077] The present invention yields particularly good results when 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 most preferably 22 μm to 27 μm.

[0078] In the present invention, it is preferable that the intermediate layer has the same thickness as the sealing layer.

[0079] In a preferred embodiment of the present invention, the plastic sheet of the bottom component includes or is composed of the following layered structure, preferably: (a) an outer thermoformable layer; (b) Cyclic olefin copolymer layer (COC), (c) an inner thermoformable layer; (d) middle class; (e) Barrier layer, preferably an oxygen and / or chemical barrier layer, and (f) A sealing layer, preferably a heat-seal layer.

[0080] Particularly preferably, another layer is directly following the above-mentioned layer, that is, in the preferred embodiments of the present invention, the above-mentioned layers are assumed to be formed consecutively or sequentially and / or not separated from other layers by any further intermediate layer other than intermediate layer (d).

[0081] In this regard, particularly good results are obtained when the outer and inner thermoformable layers contain or are composed of polyolefin, especially polypropylene (PP). Furthermore, it is preferable that the intermediate layer and sealing layer contain or are composed of polyolefin, especially polyethylene (PE). Furthermore, it is preferable that the barrier layer contains or is composed of ethylene vinyl alcohol (EVOH).

[0082] Individual layers can be joined to each other directly or indirectly. Direct joining means, for example, that the layers are in direct contact with each other by co-extrusion, or that a bonding or adhesive layer is used to directly join the layers to each other. Indirect joining means that another plastic film or metal foil is placed between the individual layers.

[0083] Preferably, as described above, the layers are directly joined to each other.

[0084] With respect to this particular embodiment, all the advantages, special features, and characteristics described above with respect to other embodiments also apply.

[0085] In a preferred embodiment of the present invention, the plastic sheet of the bottom component includes or comprises the following layered structure: (a) an outer thermoformable layer which contains or is composed of polypropylene, preferably composed of polypropylene, (b) Cyclic olefin copolymer (COC) layer, (c) In particular, an inner thermoformable layer comprising or composed of polypropylene, preferably composed of polypropylene, (d) an intermediate layer that particularly contains or is composed of polyethylene (PE), preferably composed of polyethylene, (e) A barrier layer comprising or composed of ethylene vinyl alcohol (EVOH), and preferably composed of ethylene vinyl alcohol (EVOH), (f) A sealing layer that contains or is composed of polyethylene, preferably composed of polyethylene.

[0086] With respect to this embodiment, all the advantages, special features, and characteristics described above with respect to other embodiments also apply.

[0087] The plastic sheet of the bottom component of the administration 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.

[0088] Furthermore, according to the present invention, it is preferable that the plastic sheet of the bottom component has a thickness of up to 750 μm, particularly 650 μm, preferably 600 μm, more preferably 550 μm, and especially preferably 520 μm.

[0089] Similarly, according to the present invention, it is preferable that the plastic sheet of the bottom component 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 most preferably 480 μm to 520 μm.

[0090] The plastic sheet of the bottom component having the aforementioned thickness provides structural integrity to the package and has a layer thickness within the range of Barex films used in the prior art.

[0091] In certain and preferred embodiments of the present invention, the plastic sheet of the bottom component further comprises a binding layer and / or an adhesive layer.

[0092] The bonding layer and adhesive layer are very thin layers typically having a thickness of 2 μm to 20 μm, preferably 5 μm to 15 μm, and are used to bond layers of multilayer plastic sheets. In the present invention, when an adhesive layer is used, the adhesive is typically a solvent- or water-containing polyurethane adhesive. The bonding layer is typically composed of an adhesive resin.

[0093] In a preferred embodiment of the present invention, the plastic sheet of the bottom component includes a binding layer or adhesive layer between each polymer layer.

[0094] As described above, the administration packaging according to the present invention includes a cover made of a cover sheet. Typically, the cover sheet is a multilayer film comprising the following layers: protective layer, The first barrier layer, Middle class, The second barrier layer, and A sealing layer, preferably a heat-seal layer, Here, the first barrier layer is placed between the protective layer and the intermediate layer, and the second barrier layer is placed between the intermediate layer and the sealing layer.

[0095] The layers of the cover sheet can be in direct or indirect contact with one another. Direct contact means that the layers of the cover sheet are directly joined to one another, for example, by co-extrusion, an adhesive layer, or a bonding layer. Indirect contact means that another polymer layer or metal foil is placed between at least two individual layers of the cover sheet.

[0096] In this regard, it is particularly preferable that another layer directly follows the aforementioned layer, that is, in a preferred embodiment of the present invention, the aforementioned layer is formed consecutively or sequentially and / or is not separated from another layer by any further intermediate layer other than the aforementioned intermediate layer.

[0097] The multilayer plastic sheet forming the bottom component of the administration packaging of the present invention is a relatively thick plastic sheet that provides the form and structural integrity of the administration packaging, while the cover sheet is a relatively thin multilayer film.

[0098] 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.

[0099] 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.

[0100] According to a third embodiment of the present invention, the cover sheet typically has a thickness in the range of 50 μm to 200 μm, particularly 70 μm to 180 μm, preferably 80 μm to 150 μm, more preferably 90 μm to 140 μm, and most preferably 95 μm to 130 μm.

[0101] Regarding the protective layer of the cover sheet, good results are obtained when the protective layer contains or is composed of a polymer selected from the group consisting of polyethylene terephthalate (PET), polyamide (PA), polyvinylidene difluoride (PVDF), and mixtures thereof, preferably when it is composed of such a polymer.

[0102] The protective layer provides protection against physical damage to the administration packaging and the liquid pharmaceutical composition or pharmaceutical product contained therein. Furthermore, the protective layer is preferably a printable layer. The present invention yields best results when the protective layer contains or is composed of polyethylene terephthalate (PET), preferably PET.

[0103] 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 maximum thickness of 25 μm, particularly 20 μm, and preferably 15 μm.

[0104] Good results are obtained when 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.

[0105] As described above, the cover sheet includes a first barrier layer. In this regard, it is preferable that the first barrier layer includes or is composed of a metal foil. Particularly good results are obtained when the first barrier layer includes or is composed of aluminum foil. Preferably, the first barrier layer is aluminum foil. Metal foil, especially aluminum foil, provides excellent barrier properties against oxygen and water vapor, and thus protects each liquid pharmaceutical composition or pharmaceutical product from degradation.

[0106] The thickness of the first barrier layer can vary over a wide range. However, good results are obtained when the first barrier layer has a thickness of at least 5 μm, particularly 7 μm, and preferably 10 μm.

[0107] Similarly, it is preferable that the barrier layer has a thickness of up to 25 μm, particularly 20 μm, and preferably 15 μm.

[0108] In a preferred embodiment of the present invention, the first barrier layer preferably 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.

[0109] The intermediate layer of the cover sheet primarily enhances the fit between the first barrier layer and other layers of the cover sheet, particularly the second barrier layer. The material of the intermediate layer can be selected from any suitable material, as long as it is compatible with any of the adjacent layers. However, the intermediate layer may be made of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), acid copolymer ionomers, ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol ( EVOH ), or a polymer selected from the group consisting of mixtures thereof, preferably a polymer, is included or composed of such polymers.

[0110] In this regard, it is preferable 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), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. It is even more preferable that the polymer of the intermediate layer is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof.

[0111] The best results are obtained when the polymer is polyethylene (PE). It is even more preferable that the intermediate layer contains or is composed of the same polymer as the sealing layer.

[0112] 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.

[0113] Similarly, good results are obtained when the intermediate layer has a thickness of up to 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and especially preferably 27 μm.

[0114] Furthermore, in a preferred embodiment of the present invention, the intermediate 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 most preferably 22 μm to 27 μm.

[0115] With respect to the second barrier layer, the second barrier layer is primarily a chemical barrier layer that must prevent any undesirable interactions between each liquid pharmaceutical composition or pharmaceutical product and the packaging. Accordingly, the second barrier layer of the cover sheet typically comprises or is composed of the same multiple or one material as the barrier layer of the multilayer plastic sheet of the bottom component of the administration packaging of the present invention, and preferably is composed of the same material.

[0116] The second barrier layer typically comprises, and preferably comprises, a polymer 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 methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

[0117] Preferably, the second barrier layer comprises or is composed of a polymer selected from the group consisting of ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof.

[0118] However, the best results are obtained when the second barrier layer contains or is composed of ethylene vinyl alcohol (EVOH), preferably EVOH.

[0119] Regarding the thickness of the second barrier layer, the thickness is usually equivalent to that of the barrier layer of the multilayer plastic sheet of the bottom component. Generally, the second barrier layer has a thickness of at least 2 μm, particularly 5 μm, and preferably 7 μm.

[0120] Furthermore, the second barrier layer typically has a thickness of up to 20 μm, particularly 15 μm, and preferably 12 μm.

[0121] In a preferred embodiment of the present invention, the second barrier layer has a thickness of 2 μm to 20 μm, particularly 5 μm to 15 μm, and preferably 7 μm to 12 μm.

[0122] As described above, the cover sheet includes a sealing layer. The sealing layer is made of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), acid copolymer ionomer, ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol ( EVOH It has been demonstrated that it is advantageous to include, or to be composed of, a polymer selected from the group consisting of, or mixtures thereof, or preferably a polymer.

[0123] 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), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. Particularly good results are obtained when the polymer is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. Most preferably, the sealing layer contains or is composed of polyethylene (PE), and preferably is composed of polyethylene.

[0124] In a preferred embodiment of the present invention, the sealing layer of the multilayer plastic sheet of the bottom component and the sealing layer of the cover sheet contain or are composed of the same polymer or material. The use of the same or very similar material results in good fit of the sealing layers, and therefore, excellent sealing.

[0125] The thickness of the sealing layer can vary over a wide range. However, it has been shown to be advantageous when the sealing layer has a thickness of at least 10 μm, particularly 15 μm, preferably 17 μm, more preferably 20 μm, and most preferably 22 μm.

[0126] Similarly, it has been demonstrated that it is advantageous when the sealing layer has a thickness of up to 50 μm, particularly 40 μm, preferably 35 μm, more preferably 30 μm, and especially preferably 27 μm.

[0127] The present invention yields good results when 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.

[0128] In a preferred embodiment, the cover sheet includes or comprises the following layer structure: (i) A protective layer that includes or is composed of PET, preferably composed of PET, (ii) A first barrier layer comprising, and preferably comprising, aluminum foil, (iii) an intermediate layer that contains or is composed of polyethylene (PE), preferably composed of polyethylene, (iv) A second barrier layer comprising, and preferably comprising, EVOH in particular, and (v) A sealing layer that contains or is composed of polyethylene (PE), preferably composed of polyethylene (PE).

[0129] With respect to this particular embodiment, all the features, advantages, and special characteristics described above with respect to other embodiments also apply.

[0130] Furthermore, the cover sheet may further include a bonding layer and / or adhesive layer. As described above with respect to the multilayer plastic sheet of the bottom component, the bonding layer and / or adhesive layer is used to bond the aforementioned layers of the cover sheet and to enhance the fit of the layers. The adhesive is typically a solvent or water-containing polyurethane adhesive.

[0131] In a preferred embodiment of the present invention, the cover sheet includes a binding layer or adhesive layer between each polymer layer or between the polymer layer and the metal foil.

[0132] Typically, the cover and the bottom component are joined at least partially by the sealing layer of the plastic sheet of the bottom component and the sealing layer of the cover sheet of the cover. Preferably, the cover and the bottom component are joined across the entire rim. The cover and the bottom component, particularly the sealing layer of the plastic sheet of the bottom component and the sealing layer of the cover sheet of the cover, are preferably joined by heat sealing.

[0133] In a preferred embodiment of the present invention, the administration packaging includes a bottom component and a cover, wherein the plastic sheet of the bottom component has at least five layers: outer thermoformable layer, Cyclic olefin copolymer layer, inner thermoformable layer, Barrier layer, sealing layer, Includes or consists of The cyclic olefin copolymer layer is positioned between the outer thermoformable layer and the inner thermoformable layer, and the barrier layer is positioned between the sealing layer and the inner thermoformable layer. The cover sheet consists of the following layers: protective layer, The first barrier layer, Middle class, The second barrier layer, and A sealing layer, preferably a heat-seal layer, Includes or consists of The first barrier layer is placed between the protective layer and the intermediate layer, and the second barrier layer is placed between the intermediate layer and the sealing layer.

[0134] The film combination of the present invention has excellent machinability, particularly with respect to the molding, sealing, cutting, and stabilization of the film, and with respect to the opening of the manufactured packaging.

[0135] All the special features, characteristics, and advantages described with respect to other embodiments also apply to this particular embodiment.

[0136] In a particularly preferred embodiment of the present invention, the plastic sheet of the bottom component has the following layered structure: (a) Preferably an outer thermoformable layer comprising or composed of polypropylene, in particular composed of polypropylene, (b) Cyclic olefin copolymer layer (COC), (c) Preferably an inner thermoformable layer comprising or composed of polypropylene (PP), (d) Preferably an intermediate layer comprising or composed of polyethylene (PE), (e) Preferably a barrier layer comprising or composed of ethylene vinyl alcohol (EVOH), and (f) Preferably a sealing layer containing or composed of polyethylene (PE), in particular a sealing layer composed of polyethylene, Includes or consists of The cover sheet has the following layer structure: (i) Preferably a protective layer comprising or composed of polyethylene terephthalate (PET), in particular a protective layer composed of the same (ii) Preferably a first barrier layer comprising or composed of aluminum foil, in particular composed of aluminum foil, (iii) an intermediate layer containing or composed of polyethylene (PE), preferably composed of polyethylene, (iv) A second barrier layer preferably comprising or composed of ethylene vinyl alcohol (EVOH), and (v) Preferably a first barrier layer comprising or composed of polyethylene (PE), in particular composed of polyethylene It includes or consists of.

[0137] In this regard, all the advantages, features, and special characteristics discussed with respect to other embodiments of the present invention also apply to this particular embodiment.

[0138] With respect to the predetermined break zone of the dosing package, this area is preferably produced by thermoforming. This reduces the number of steps required to manufacture the dosing package, and therefore production becomes faster and / or more efficient. In particular, fewer tools are required for the production of the dosing package.

[0139] The cavity preferably comprises a chamber and a dosing channel that is in fluid communication with it and / or opens into the chamber. The dosing channel is preferably elongated and / or linear and / or has a smaller diameter and / or volume than the chamber. This allows the dosing packaging to be used as a pipette and / or deformed into a pipette so that the pharmaceutical product can be directly applied from the packaging to the patient.

[0140] The predetermined break zone is preferably configured to allow opening of the administration packaging by breaking the packaging along the break zone. For example, the administration packaging can be folded or bent along the predetermined break zone so that the packaging material is divided and as a result the packaging is opened.

[0141] The predetermined break zone is preferably formed as a groove on the outer surface of the dosing package or includes it. This predetermined break zone is easy to generate and allows for easy and reliable opening of the dosing package and / or breaking of the predetermined break zone.

[0142] The predetermined fracture zone is preferably a region thinner than the region of the bottom component surrounding the fracture zone. However, it is also possible for the predetermined fracture zone to be a region with the same thickness as the region of the bottom component surrounding the fracture zone.

[0143] The predetermined rupture zone is preferably formed only within the cavity region, particularly within the region of the administration channel. In other words, the predetermined rupture zone preferably does not extend across the rim region and / or is not formed within this region.

[0144] A further subject matter of the present invention according to a second aspect of the present invention is a method for manufacturing and filling dosing packages, preferably for liquid pharmaceutical products. The method is preferably a thermoforming method. The method described herein is preferably carried out using the apparatus described herein, and the dosing packages described herein are manufactured using the method described herein.

[0145] In this method, a multilayer plastic sheet is heated at least partially to a thermoforming temperature. The thermoforming temperature is, in particular, the temperature at which the plastic sheet or its heated region becomes plasticized and / or the temperature at which it becomes possible to form the plastic sheet or its heated region into a desired shape using a molding tool.

[0146] Next, a plastic sheet is stretched over and / or into a molding tool so that a bottom component of the administration packaging is formed. In particular, a bottom component is formed having a cavity for receiving the pharmaceutical product and a rim surrounding it. The rim is preferably at least basically flat.

[0147] In the next step, the cavity is filled with the pharmaceutical product, after which the cavity is covered with a cover, which is secured to the rim so that the cavity is completely closed. The cavity is closed, preferably by heat sealing, which seals the sealing layer of the plastic sheet of the bottom component with the sealing layer of the cover sheet of the cover. Preferably, the cover and bottom component are sealed across the entire surface of the rim.

[0148] The present invention generates a predetermined fracture zone within the bottom part during the process of forming the bottom part using a molding tool and / or during the process of forming the bottom part. This has the advantage that it does not require an extra step to form the predetermined fracture zone, the fracture zone can be formed to have any desired shape, and the fracture zone can be adjusted or adapted to be specific to different plastic materials.

[0149] It is preferable that the molding tool has a positive mold and a negative mold, and / or that the positive mold and negative mold are used to form the bottom part. This allows for very precise control of the shape of the bottom part and / or leads to small manufacturing tolerances.

[0150] The predetermined rupture zone is preferably formed only within the cavity region, particularly within the region of the administration channel. In other words, the predetermined rupture zone preferably does not extend across the rim region and / or is not formed within this region.

[0151] Preferably, different dosing packages are formed having predetermined break zones with different shapes, and the forming device for forming the predetermined break zones is interchangeable and / or modified to form different dosing packages. This allows for the production of different dosing packages in a highly efficient manner.

[0152] For further details regarding the method of the present invention, please refer to the above description of the administration packaging of the present invention, which also applies to the method of the present invention.

[0153] The dosing packaging of the present invention, preferably for liquid pharmaceutical products, is preferably manufactured using a specific apparatus. The apparatus is preferably configured to carry out the method described herein and / or to manufacture the dosing packaging described herein.

[0154] The apparatus preferably comprises a heating device for at least partially heating a multilayer plastic sheet to a thermoforming temperature, and a molding tool for forming the bottom component of a dosing package by stretching the plastic sheet onto and / or within the molding tool.

[0155] The molding tool preferably includes a forming device for forming a predetermined fracture zone within the bottom part. The forming device preferably forms ridges and / or depressions on the mold surface of the molding tool. This allows the predetermined fracture zone to be formed as a groove and / or bend / twist. A predetermined fracture zone can be achieved that has a thickness that is at least essentially the same as or less than the surrounding material.

[0156] The forming device is preferably an adjustable and / or interchangeable component of a forming tool. This allows for easy control and / or adaptation of the desired shape of a predetermined fracture zone. This enables the easy and / or efficient production of different dosing packages, particularly dosing packages having different predetermined fracture zones.

[0157] The molding tool preferably has a positive mold and a negative mold. This allows for precise control of the shape of the bottom part being formed and / or results in very small manufacturing tolerances.

[0158] Preferably, the negative mold and the positive mold have complementary or corresponding shaped surfaces, preferably within the region where a predetermined fracture zone is formed. In this way, preferably, a bend / twist can be generated as a predetermined fracture zone within the wall of the bottom part, and in particular, this wall has at least essentially the same thickness as the outside within the predetermined fracture zone.

[0159] Particularly preferably, the negative mold may have a ridge and the positive mold may have a complementary / corresponding depression, or vice versa, in order to form a predetermined fracture zone.

[0160] Alternatively, the positive and negative molds may have surfaces of different or inconsistent shapes, in particular, so that the apparatus is configured to produce a predetermined fracture zone that is thinner than the region surrounding the predetermined fracture zone. For example, the positive mold may be flat in a corresponding region while the negative mold may have a ridge, or vice versa.

[0161] A third aspect of the present invention, which concerns yet another subject of the present invention, is the use of plastic sheets for manufacturing administration packaging, preferably for liquid pharmaceutical products.

[0162] The plastic sheets used consist of at least five layers: outer thermoformable layer, Cyclic olefin copolymer (COC) layer, inner thermoformable layer, Barrier layer, preferably a barrier layer against oxygen and / or chemical substances, A sealing layer, preferably a heat-seal layer, Includes, The cyclic olefin copolymer layer is positioned between the outer thermoformable layer and the inner thermoformable layer, and the barrier layer is positioned between the sealing layer and the inner thermoformable layer.

[0163] The plastic sheet is preferably used in the method and / or apparatus described herein.

[0164] The plastic sheet is preferably used to manufacture the dosage packaging described herein. For further details of the use of the present invention, refer preferably to the above description relating to the dosage packaging of the present invention, which is also applicable to the use of the present invention, in particular to the description relating to the plastic sheet from which the dosage packaging is manufactured. In particular, the plastic sheet used in the present invention may have any of the features described herein relating to the dosage packaging of the present invention and its manufacture.

[0165] Some of the above and below aspects and features of the present invention can be combined with each other in various combinations, but they can also be implemented independently of each other.

[0166] Further aspects, features, advantages, and characteristics of the present invention will become apparent from the following description of preferred embodiments with reference to the claims and drawings. [Brief explanation of the drawing]

[0167] [Figure 1] This is a schematic perspective view of the administration packaging according to the present invention. [Figure 2] This is a schematic perspective view of an opened administration package according to the present invention. [Figure 3] This is a schematic cross-sectional view through the administration packaging packaged within the secondary packaging. [Figure 4] This is a schematic diagram of an apparatus for manufacturing a dosage package according to the present invention. [Figure 5] This is a schematic cross-sectional view through the material of the bottom component of the administration packaging. [Figure 6] This is a schematic cross-sectional view through the material of the cover of the administration packaging. [Figure 7] This is a schematic cross-sectional view through the preferred material of the bottom component of the administration packaging. [Figure 8] This is a schematic cross-sectional view through the preferred material of the dose packaging cover. [Figure 9] This is a schematic plan view of the administration packaging according to the first embodiment. [Figure 10] Figure 9 is a schematic cross-sectional view of the administration packaging along line XX. [Figure 11] This is an enlarged detail view of a predetermined fracture zone according to the first embodiment. [Figure 12] This is an enlarged detail view of a predetermined fracture zone according to the second embodiment. [Figure 13] This is a schematic plan view of the administration packaging according to the third embodiment. [Figure 14]Figure 13 is a schematic cross-sectional view of the administration packaging along line XIV-XIV. [Figure 15] This is a magnified detail view of a predetermined fracture zone according to the third embodiment in the region of the administration channel. [Figure 16] This is a magnified detail view of a predetermined fracture zone according to the third embodiment in the rim region. [Figure 17] This is a magnified detail view of a predetermined fracture zone according to the fourth embodiment in the region of the administration channel. [Figure 18] This is a detailed enlarged view of a predetermined fracture zone according to the fourth embodiment in the rim region. [Figure 19] This is a schematic cross-sectional view of the apparatus shown in Figure 4, passing through the molding tool. [Figure 20] Figure 19 is a schematic cross-sectional detail view of the molding tool in the region of the molding device for forming a predetermined fracture zone. [Figure 21] This is a schematic cross-sectional view through the molding tool of the apparatus according to another embodiment. [Figure 22] Figure 21 is a schematic cross-sectional detail view of the molding tool in the region of the molding device for forming a predetermined fracture zone. [Figure 23] This is a schematic plan view of the administration packaging according to the fifth embodiment. [Figure 24] Figure 23 is a schematic cross-sectional view of the administration packaging along line XXIV-XXIV. [Figure 25] This is an enlarged detail view of a predetermined fracture zone according to the fifth embodiment. [Figure 26] This is a schematic perspective view of an embodiment of a molding tool mold. [Figure 27] This is a schematic perspective view of another embodiment of the molding tool mold. [Modes for carrying out the invention]

[0168] In these diagrams, the same reference symbols are used for the same components and parts, even when repeated explanations are omitted.

[0169] Figures 1 to 3 illustrate the administration packaging 1 according to the present invention. Figure 1 is a schematic perspective view of the administration packaging 1 in a closed or delivery state. Figure 2 is a schematic perspective view of the administration packaging 1 in an open state and / or when transformed into a pipette. Figure 3 is a schematic cross-sectional view through the administration packaging 1, further showing a secondary packaging 11 in which the administration packaging 1 is preferably or optionally delivered / sold.

[0170] As shown in Figure 3, the administration packaging 1 is preferably configured to receive and / or contain the pharmaceutical product 2.

[0171] Pharmaceutical product 2 is preferably a liquid. Pharmaceutical product 2 is preferably a product for the treatment and / or prevention of fleas, ticks and / or lice, especially in dogs and / or cats. Preferably, pharmaceutical product 2 helps to suppress scabies, especially in dogs.

[0172] The administration packaging 1 includes or consists of a bottom component 3 and a cover 4.

[0173] The bottom component 3 includes a cavity 5 for receiving the pharmaceutical product 2. The cavity 5 preferably includes different sections, in particular a chamber 6 and an administration channel 7.

[0174] The bottom component 3 has a rim 8 that surrounds, and in particular completely surrounds, the cavity 5. The rim 8 is preferably at least basically flat.

[0175] The cover 4 covers, closes, and / or seals the bottom component 3 or cavity 5, particularly the chamber 6 and the dosing channel 7, preferably in a fluid-sealing manner, particularly in a liquid-tight and / or airtight manner. Preferably, the dosing packaging 1, bottom component 3, or cavity 5 is closed with the cover 4 to have storage stability and / or to prevent the product 2 from leaking out of the sealed dosing packaging 1, bottom component 3, or cavity 5.

[0176] The cover 4 is preferably fixed or joined, particularly (heat) sealed, to the bottom component 3, especially the rim 8 or a part thereof.

[0177] Preferably, the cover 4 is fixed or joined to the bottom component 3 or rim 8 by a heat seal and / or a (thermal) ring seal that extends particularly along the entire circumference of the rim 8 and / or along the entire circumference of the edge 3A between the cavity 5 and the rim 8.

[0178] In other words, preferably, the cover 4 is joined or sealed to the bottom part 3 in at least the area of ​​the edge 3A between the cavity 5 and the rim 8 in order to close / seal the cavity 5.

[0179] Particularly preferably, the cover 4 is fixed, joined, or sealed to the entire rim 8. However, the bond between the bottom part 3 and the cover 4 may not be very strong outside the area of ​​the edge 3A and / or may weaken from this edge 3A outward toward the rim 8.

[0180] The bottom component 3, particularly the cavity 5 and rim 8, is preferably produced by thermoforming or deep drawing a plastic sheet. In particular, the cavity 5 is produced by deep drawing or thermoforming each region of the plastic sheet in and / or on a molding tool, while leaving the region that will become the rim 8 after thermoforming / deep drawing undeformed during thermoforming / deep drawing. This will be explained in more detail later.

[0181] The chamber 6 and the administration channel 7 are preferably in fluid communication with each other. In particular, the administration channel 7 opens into the chamber 6.

[0182] As shown in Figure 1, the chamber 6 preferably has a basic triangular shape. However, this shape is not mandatory, and the chamber 6 can have any desired shape.

[0183] The administration channel 7 is preferably elongated and / or linear. Preferably, the administration channel 7 has a smaller diameter and / or volume than the chamber 6. Preferably, the administration channel 7 extends along the longitudinal axis A of the administration packaging 1. Axis A is preferably the axis of symmetry of the administration packaging 1.

[0184] The length of the administration channel 7 is preferably longer than 2 cm or 3 cm and / or shorter than 5 cm or 4 cm.

[0185] In particular, the length or longitudinal extension of the administration packaging 1 or bottom component 3 along axis A is preferably longer than 6 cm and / or shorter than 10 cm, and especially preferably about 8.5 cm.

[0186] In particular, the width of the rim 8 perpendicular to the administration channel 7 or axis A and / or adjacent to or touching one side of the administration channel 7 is preferably longer than 2 cm and / or shorter than 6 cm, and especially preferably about 4 cm.

[0187] The administration packaging 1 can be opened to allow the pharmaceutical product 2, which is enclosed in the administration packaging 1 or cavity 5, to be pulled out or pushed out of the administration packaging 1 and / or administered to a patient (not shown). The patient is preferably a human or an animal, particularly a livestock such as a cat or a dog. Preferably, the administration packaging 1 is configured to administer the pharmaceutical product 2 directly to the patient's skin and / or fur.

[0188] As shown in Figure 2, the administration packaging 1 is specifically deformable into a pipette. In particular, the administration packaging 1 is transformed into a pipette by opening it.

[0189] The dosing packaging 1, particularly the bottom component 3, includes a predetermined break zone 9. The dosing packaging 1 is preferably openable at the predetermined break zone 9 and / or by breaking the dosing packaging 1, particularly the bottom component 3, along the predetermined break zone 9.

[0190] In particular, the administration packaging 1 can be opened by folding and / or bending along a predetermined break zone 9.

[0191] The predetermined fracture zone 9 is preferably created by thermoforming or deep drawing the bottom part 3 at the same time as, or at the same stage as and / or using the same forming tool. This will be described in more detail later with reference to Figures 4 and 19 to 22.

[0192] The predetermined rupture zone 9 is preferably located across the cavity 5, particularly the administration channel 7, and / or within the region of the cavity 5, particularly the administration channel 7.

[0193] The rupture zone 9 can be located only within the cavity 5 or the administration channel 7. In other words, the rupture zone 9 can be at least essentially absent from the rim 8. This will be discussed in more detail later with reference to Figures 9 through 11. Alternatively, the rupture zone 9 can extend at least essentially along the entire width of the administration packaging 1 and / or be located within the cavity 5, particularly the administration channel 7 and the rim 8, as shown, for example, in Figures 1 and 13, and will also be discussed in more detail later.

[0194] The predetermined rupture zone 9 preferably extends transversely, and particularly perpendicularly, to the axis A and / or the administration channel 7.

[0195] The predetermined rupture zone 9 is preferably located near the axial end of the channel 7 and / or the administration packaging 1. Preferably, the distance from the predetermined rupture zone 9 to the axial end 7A of the administration channel 7 is at most 15 mm or less, preferably at most 10 mm or less. The distance between the predetermined rupture zone 9 and the axial end 1A of the administration packaging 1 is preferably at most 25 mm or less, particularly at most 20 mm or less.

[0196] Preferably, the distance between the predetermined rupture zone 9 and the axial end 7A of the administration channel 7 is longer than 15% or 20% and / or shorter than 40% or 30%, particularly preferably about 25%, of the total length of the administration channel 7.

[0197] Preferably, the distance between the predetermined rupture zone 9 and the axial end 1A of the dosing packaging 1 is longer than 10% or 15% and / or shorter than 40% or 30%, particularly preferably about 20%, of the total length or longitudinal extension of the dosing packaging 1 along axis A.

[0198] The predetermined rupture zone 9 preferably defines the tip 10 of the dosing packaging 1 and / or bottom component 3. The tip 10 is, in particular, the portion or section of the dosing packaging 1 or bottom component 3 that is opposite the chamber 6 with respect to the predetermined rupture zone 9.

[0199] The tip 10 can preferably be folded back or bent, particularly by folding or bending the administration packaging 1 along a predetermined break zone 9. In particular, this breaks the administration packaging 1 or at least the bottom component 3 so that the administration packaging 1 can be opened and / or the pharmaceutical product 2 can be drawn out, dispensed, or pushed out through the administration channel 7. This break is particularly shown in Figure 2.

[0200] As shown in Figure 2, preferably, the administration packaging 1 is broken along a particularly predetermined break zone 9 and / or the tip 10 is bent / folded to provide a cavity 5, in particular the open end 7B of the administration channel 7.

[0201] As described above, by opening the administration packaging 1, the administration packaging 1 can preferably be transformed into a pipette and / or preferably used to administer the pharmaceutical product 2 to a patient. In particular, the pharmaceutical product 2 can be administered by or from the administration packaging 1 by pressing the chamber 6 so that it is pushed through the administration channel 7 and exits / flows out of the administration channel 7 at the open end 7B of the administration channel 7 in a predetermined break zone 9.

[0202] Preferably, the chamber 6 must be pressed / pushed in order to extract the pharmaceutical product 2. In other words, the administration channel 7 and / or opening end 7B are preferably configured or sized so that the product 2 cannot leak out based on gravity (alone) and / or so that an additional force is applied when the administration packaging 1 is held with the opening end 7B facing downward, in particular by pressing the chamber 6, so that the product 2 does not leak out. In this way, accidental extraction of the pharmaceutical product 2 is prevented.

[0203] Particularly preferably, the flow cross-section of the cavity 5, and especially the administration channel 7, is narrowed or reduced within the region of the opening end 7B and / or a predetermined fracture zone 9. Therefore, preferably, a narrowed flow path, a cross-sectional reduction section, or a nozzle is formed within the region of the opening end 7B and / or the predetermined fracture zone 9. This will be described in more detail later with reference to Figures 9 to 11.

[0204] In the example shown in Figure 2, the cover 4 preferably remains intact or unbroken. In particular, the tip 10 preferably remains attached to the dosing packaging 1 by the cover 4 after it has been folded or bent or after the dosing packaging 1 has been opened. However, in this case, solutions are also possible in which the cover 4 is completely or at least partially broken, and / or the tip 10 is completely removed from the dosing packaging 1.

[0205] The administration packaging 1 is preferably packaged in secondary packaging 11, particularly after its manufacture, for delivery and / or storage, and / or before use for application to a patient the enclosed pharmaceutical product 2. The secondary packaging 11 is shown in Figure 3.

[0206] The secondary packaging 11 is preferably blister packaging.

[0207] 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 receptacle 14 for receiving the administration packaging 1. The lid 13 preferably closes, and especially completely closes, the receptacle 14. The lid 13 is preferably fixed, and especially bonded, to the base portion 12. Preferably, the lid 13 can be peeled off from the base portion 12 to remove the administration packaging 1 from the secondary packaging 11 or the receptacle 14.

[0208] Figure 4 shows a very schematic diagram of the apparatus 100 for manufacturing the administration packaging 1. The apparatus 100 and method for manufacturing the administration packaging 1 will be described below with reference to Figure 4.

[0209] The method described herein is preferably carried out using apparatus 100. Apparatus 100 is also preferably configured to carry out the method described herein.

[0210] The apparatus 100 preferably includes a heating device 101 and a molding tool 102.

[0211] To manufacture the dosing package 1, preferably a plastic sheet 200 is guided through the apparatus 100, and the dosing package 1 is formed from this plastic sheet 200 by thermoforming, particularly by deep drawing. Thermoforming is performed in particular within a heating device 101 and / or a molding tool 102.

[0212] As schematically shown in Figure 4, preferably the plastic sheet 200 is supplied in a rolled state and / or on or formed on a roll. Preferably, particularly during the unwinding or feeding stage, the plastic sheet 200 is fed / unwound and guided into the apparatus 100 and / or heating device 101. However, the plastic sheet 200 can be fed into the apparatus 100 and / or heating device 101 in any other preferred form or manner.

[0213] The plastic sheet 200 can be guided through the device 100 continuously or in stages as needed.

[0214] After the plastic sheet 200 has been unwound / fed and / or during the heating stage, the plastic sheet 200 is preferably at least partially heated using the heating device 101.

[0215] The heating device 101 is preferably configured to heat at least partially the plastic sheet 200. In particular, the heating device 101 is configured to heat a portion of the plastic sheet 200, from which the bottom component 3 of the dosing package 1 is preferably formed, particularly within the molding tool 102.

[0216] 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, more particularly two heating plates 101A, 101B, which will hereafter be referred to as the upper heating plate 101A and the lower heating plate 101B. The upper and lower heating plates 101A and 101B are configured to heat different sides of the plastic sheet 200.

[0217] Preferably, the heating device 101, particularly the heating plates 101A and 101B, heats the plastic sheet 200 to its plasticization temperature or thermoforming temperature.

[0218] The plasticizing temperature or thermoforming temperature is preferably the temperature at which the plastic sheet 200 becomes plasticized and / or thermoformable, in particular the temperature at which the plastic sheet 200 softens and / or becomes plastically deformable. The plastic material, in this specification, the plastic sheet 200 is preferably deformable when it reaches the plasticizing temperature or thermoforming temperature and retains its new shape after cooling or after the temperature drops below the plasticizing temperature or thermoforming temperature.

[0219] Preferably, the heating device 101 heats the plastic sheet 200 to a temperature of 180°C, and / or the thermoforming temperature is at least 150°C and / or at most 200°C.

[0220] The two heating plates 101A and 101B can be operated at the same temperature or at different temperatures. Preferably, if the plastic sheet 200 is multilayered and has multiple layers composed of different materials and / or having different plasticizing / thermoforming temperatures, the two heating plates 101A and 101B are operated at different temperatures, in particular, corresponding to the respective plasticizing / thermoforming temperatures of the layers of the plastic sheet 200 facing each heating plate 101A and 101B.

[0221] After the heating stage and / or the (thermal)forming stage, the (heated) plastic sheet 200 is formed, preferably using a molding tool 102, and more particularly by thermoforming.

[0222] The molding tool 102 is preferably configured to form the shape of the bottom part 3 from the plastic sheet 200. In particular, the molding tool 102 is configured to stretch the plastic sheet 200 or its heated portion. Specifically, the heated portion of the plastic sheet 200 is stretched within or into the molding tool 102.

[0223] The molding tool 102 includes at least one mold 102A, 102B. Preferably, the molding tool 102 includes two molds 102A, 102B, which will hereafter be referred to as the negative mold 102A and the positive mold 102B.

[0224] Preferably, the plastic sheet 200 is stretched into and / or on the negative mold 102A.

[0225] Forming or stretching is preferably carried out by pressing the plastic sheet 200 onto the molding tool 102 or molds 102A and / or 102B, preferably by generating overpressure, or by blowing gas, particularly air, onto the plastic sheet 200, and / or by generating negative pressure within the molding tool 102 or molds 102A and / or 102B. In addition to or instead of this, the plastic sheet 200 can be pressed onto the molding tool 102 or molds 102A and / or 102B using a press. Particularly preferably, when two molds 102A and 102B are provided, one of the molds 102A and 102B acts as the press. The press may also be provided only in a partial area, for example, in an area such as the dosing channel 7 where more precise forming is required, in addition to gas.

[0226] The predetermined fracture zone 9 is preferably generated within the molding tool 102 and / or during the forming stage, and / or the apparatus 100, in particular the molding tool 102, is configured for this purpose. This will be described in more detail later.

[0227] Preferably, the predetermined fracture zone 9 is generated / manufactured to a limited extent during the (thermal)forming stage and / or using the molding tool 102. In particular, the proposed method does not include a step of (partially) cutting the plastic sheet 200 to generate the predetermined fracture zone 9, and / or the proposed apparatus 100 does not have or require a cutting tool for this purpose.

[0228] However, predetermined fracture zones 9 can also be generated / manufactured simply, basically or primarily, during the (thermal)forming stage and / or using the molding tool 102. Preferably, it is understood that the main or basic stage for generating / forming predetermined fracture zones 9 is carried out during (thermal)forming and / or using the molding tool 102.

[0229] In contrast, in conventional technology, predetermined fracture zones are created only after the (thermal)forming stage, for example, by forming perforations along a certain line in the otherwise finished packaging, or by cutting the plastic sheet before the (thermal)forming stage.

[0230] In the prior art, particularly in EP 2 998 098 A1 and EP 2 998 099 A1, cutting the plastic sheet is a primary, basic, or generation stage that occurs before the thermoforming stage. Although the cut portion of the plastic sheet may be further deformed when deep-drawn, such deformation does not create the predetermined fracture zone because the generation stage of the predetermined fracture zone has already occurred by cutting the sheet. Furthermore, such deformation is by no means a basic or primary stage that generates the predetermined fracture zone. This is already evident from the fact that in the prior art, it is not at all conceivable that a predetermined fracture zone would be formed without cutting.

[0231] In other words, the predetermined fracture zone 9 of the present invention is preferably generated without cutting and / or without a cutting step before or after the step of forming the bottom part and / or without using a cutting tool.

[0232] In the sense of the present invention, perforation, cutting, or similar operations are preferably understood as one or more “cuts.” Accordingly, the term “without cutting” may preferably include, be replaced by, or complement expressions such as “without perforation.” Similarly, a cutting stage / tool ​​may be a perforation stage / tool, etc.

[0233] The molding tool 102 is preferably configured to form multiple bottom parts 3 simultaneously or in a single step, and in the example shown in Figure 4, it is configured to form 12 bottom parts 3 simultaneously. However, other solutions are also possible, for example, in which only one bottom part 3 is formed in a single molding step.

[0234] Preferably, the molding tool 102 and / or molds 102A, 102B can be interchanged to produce different shapes of dosing packaging 1, particularly bottom parts 3, for example, to adapt to chambers 6 or pharmaceutical products 2 of different volumes.

[0235] After the forming stage and / or during the filling stage, the bottom component 3 formed within the plastic sheet 200, particularly one or more cavities 5, is filled with the pharmaceutical product 2, in particular, using a filling device 103 shown by dashed lines in Figure 4.

[0236] The filling step is preferably performed after the plastic sheet 200 or its heated / thermoforming region has cooled down to a temperature below the curing and / or plasticizing / thermoforming temperature.

[0237] After the filling stage and / or during the covering / closing stage, the cover sheet 300 is added to the plastic sheet 200, and in particular, fixed or bonded. Closing / covering is preferably performed within a cover device 104, in particular a sealing device.

[0238] Preferably, the bottom component 3 or one or more cavities 5 formed within the plastic sheet 200 are covered or closed with a cover sheet 300, thereby forming their respective covers 4.

[0239] As schematically shown in Figure 4, preferably the cover sheet 300 is supplied and / or on a roll or formed thereon. Preferably, the cover sheet 300 is unwound and guided into the apparatus 100 and / or cover device 104, in particular together with the plastic sheet 200. However, it is also possible to position the (wound) cover sheet 300 entirely within the cover device 104.

[0240] The cover device 104 is preferably configured to join or seal the cover sheet 300 to the plastic sheet 200 or to the bottom component 3 in a particularly fluid-sealing manner, particularly a liquid-tight manner and / or an airtight manner, particularly a heat seal.

[0241] Preferably, the cover sheet 300 of the cover 3 is joined or sealed to the plastic sheet 200 of the bottom part 3 by sealing its sealing layer 305 with the sealing layer 205 of the plastic sheet 200, preferably by heat sealing. The sealing layers 205 and 305 will be described in detail below in relation to the description of Figures 5 to 8.

[0242] To secure the cover sheet 300 to the plastic sheet 200, the cover device 104 is preferably brought into contact with the cover sheet 300 so that the cover sheet 300 is pressed against the plastic sheet 200 in an area of ​​at least the bottom part 3 or its edge 3A. The cover device 104 is preferably heated in at least this area so that the cover sheet 300 is heat-sealed to the plastic sheet 300 in at least this contact area.

[0243] The joining / sealing is preferably performed within the area of ​​at least the edge 3A of the bottom part 3, or the cover device 104 is configured for this purpose. For this purpose, the cover device 104 preferably includes an annular sealing tool (not shown) that has at least essentially the form of an edge 3A and / or can be heated (with respect to each bottom part 3).

[0244] Particularly preferably, the joining / sealing is performed not only in the region of the edge 3A, but also in the surrounding region and / or the region where the rim 8 is later formed.

[0245] In principle, when heat-sealing the cover sheet 300 to the plastic sheet 200, the cover device 104 does not come into contact with this additional area, and only the radiant heat of the device is used. This results in a lower bonding strength compared to the area where the cover device 102 comes into contact with the cover sheet 300. However, solutions are also possible in which contact in this area is established similarly and / or with a certain bonding strength.

[0246] After covering / closing and / or during the separation phase, the administration packaging 1 formed by the plastic sheet 200 and the cover sheet 300 is separated from the sheets and / or from each other.

[0247] For this purpose, the device 100 can preferably include a separation device (not shown) downstream of the cover device 104. However, it is also possible to incorporate the separation device into the cover device 104 and / or configure the cover device 104 to separate the administration packaging 1.

[0248] Preferably, the administration packaging 1 is trimmed, punched out, or cut out.

[0249] Separation, especially punching out / cutting out, is preferably carried out along a line having a (constant) distance up to the edge 3A and / or such that the rim 8 is formed. The line along which the administration packaging 1 is separated, especially when cutting out or punching out, is schematically illustrated by a dashed line in FIG. 4.

[0250] The administration packaging 1 is preferably composed of a bottom part 3 and a cover 4 including specific functional layers, especially a specific layer structure. Preferred embodiments of the plastic sheet 200 of the bottom part 3 and the cover sheet 300 of the cover 4, or the plastic sheet 200 and the cover sheet 300 used to produce the bottom part 3 and the cover 4, are shown in FIGS. 5 to 8.

[0251] As described above, the plastic sheet 200 of the bottom part 3 is a multilayer film. The plastic sheet 200 of the bottom part 3 includes at least five layers: an outer thermoformable layer 201, a cyclic olefin copolymer (COC) layer 202, an inner thermoformable layer 203, a barrier layer 204, and a sealing layer 205, and includes.

[0252] The cyclic olefin copolymer layer 202 is positioned between the outer thermoformable layer 201 and the inner thermoformable layer 203, and the barrier layer 204 is positioned between the sealing layer 205 and the inner thermoformable layer 203.

[0253] Preferably, the plastic sheet 200 includes at least five layers in the layer sequence described above, i.e., the plastic sheet 200 of the bottom part 3 has at least five layers in the following layer sequence: Outer thermoformable layer 201, followed by, A cyclic olefin copolymer (COC) layer 202, followed by, The inner thermoformable layer 203, followed by, Barrier layer 204, followed by, Sealing layer 205, Includes.

[0254] Particularly preferably, another layer is directly following the above-mentioned layer; that is, in the preferred embodiments of the present invention described above, it is assumed that the above-mentioned layer is not separated from another layer by a continuous or sequentially formed and / or intermediate layer.

[0255] The outer thermoformable layer 201 typically forms the outer surface of the administration packaging 1 of the present invention.

[0256] Preferably, the plastic sheet 200 of the bottom part 3 further includes an intermediate layer 206, as shown in Figure 5. The intermediate layer 206 can be excluded from within the plastic sheet 200, but enhances the fit of the plastic sheet 200, particularly the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 is typically located between the inner thermoformable layer 203 and the barrier layer 204. The intermediate layer 206 typically contains or is composed of the same material as the sealing layer 205, and usually also has the same thickness. The sealing layer 205 is preferably a heat seal layer for joining / sealing the bottom part 3 and the cover 4.

[0257] The preferred plastic sheet 200 of the bottom component 3 has the following layer structure: (a) outer thermoformable layer 201; (b) Cyclic olefin copolymer layer 202, (c) inner thermoformable layer 203; (d) middle layer 206; (e) barrier layer 204, and (f) sealing layer 205; It includes or consists of.

[0258] The plastic sheet 200 of the bottom part 3 typically 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 500 μm, and especially preferably 480 μm to 520 μm, which determines the form of the dosing package 1 after deep drawing.

[0259] The cyclic olefin copolymer layer 202 is the main layer of the plastic sheet 200. It contains or is composed of a cyclic olefin copolymer (COC), and is preferably composed of a cyclic olefin copolymer (COC).

[0260] The cyclic olefin copolymer layer 202 typically provides rigidity and structural integrity to the bottom component 3 of the dosing package 1, especially after deep drawing. Furthermore, the cyclic olefin copolymer layer 202 is brittle and ruptures under strong pressure, and this brittleness makes the cyclic olefin copolymer layer 202 suitable for the production of disposable dosing packages having a rupture zone 9 for opening the dosing package 1. The cyclic olefin copolymer layer 202 preferably has a thickness in the range of 200 μm to 600 μm, particularly 250 μm to 500 μm, preferably 300 μm to 450 μm, more preferably 350 μm to 400 μm, and most preferably 360 μm to 390 μm.

[0261] The inner thermoformable layer 203 and the outer thermoformable layer 201 enhance the thermoformability of the plastic sheet 200, giving it greater flexibility, and thus enhancing the machinability of the plastic film 200 and providing protection for the fragile COC layer 202.

[0262] 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 particularly preferably 20 μm to 25 μm.

[0263] The best results are obtained when the thickness of the cyclic olefin copolymer layer 202 relative to the thickness of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is in the range of 5:1 to 30:1, particularly 7:1 to 25:1, preferably 10:1 to 22:1, more preferably 13:1 to 20:1, and particularly preferably 15:1 to 18:1.

[0264] Furthermore, the outer thermoformable layer 201 and the inner thermoformable layer 203 contain or are composed of the same polymer, particularly are composed of it. The polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is usually 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.

[0265] According to the present invention, it is preferable 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 preferable that the polymer of the outer thermoformable layer 201 and / or the inner thermoformable layer 203 is polypropylene (PP).

[0266] The barrier layer 204 is preferably ethylene vinyl alcohol (EVOH), ethylene vinyl acetateThe material comprises, and preferably comprises, a polymer selected from the group consisting of (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

[0267] In the present invention, it is preferable that the polymer of the barrier layer 204 is selected from the group consisting of ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof. The best results are obtained when the polymer of the barrier layer 204 is ethylene vinyl alcohol (EVOH). The barrier layer 204 prevents substances from the surrounding environment from penetrating the packaging 1 and altering the pharmaceutical product 2, and prevents any undesirable interactions between the pharmaceutical product 2 and the packaging 1. In particular, barrier layers containing or composed of EVOH exhibit excellent barrier properties against chemical substances and oxygen.

[0268] The barrier layer 204 has a thickness in the range of 2 μm to 20 μm, particularly 5 μm to 15 μm, preferably 7 μm to 12 μm.

[0269] The sealing layer 205 and / or the intermediate layer 206 is preferably polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), acid copolymer ionomer, ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol ( EVOH It comprises or is composed of a polymer selected from the group consisting of ), or mixtures thereof, preferably composed of such polymer.

[0270] In preferred embodiments of the present invention, the polymer of the sealing layer 205 and / or the intermediate layer 206 is selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof.

[0271] It is preferable that the polymer of the sealing layer 205 and / or the intermediate layer 206 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. The best results are obtained when the polymer of the sealing layer 205 and / or the intermediate layer 206 is polyethylene (PE).

[0272] The sealing layer 205 and / or the intermediate layer 206 have 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. As described above, the sealing layer 205 and the intermediate layer 206 contain or are composed of the same polymer and have the same thickness.

[0273] A highly preferred plastic sheet 200 according to the present invention has the following layer structure with the following layer sequence: (a) An outer thermoformable layer 201 containing or composed of PP, followed thereafter (b) A cyclic olefin copolymer layer 202 containing or composed of COC, thereafter, (c) An inner thermoformable layer 203 containing or composed of PP, thereafter, (d) an optional intermediate layer 206 including or composed of PE, thereafter (e) A barrier layer 204 containing or composed of EVOH, thereafter, (f) Sealing layer 205 containing or composed of PE, It includes or consists of.

[0274] Particularly preferably, another layer is directly following the above-mentioned layer, that is, in the preferred embodiments of the present invention, the above-mentioned layers are formed consecutively or sequentially and / or are not separated from other layers by any further intermediate layer other than intermediate layer 206.

[0275] The layers of plastic sheet 200 of the bottom component 3 can be bonded to each other directly or indirectly. Direct bonding means that the layers are directly joined to each other by, for example, co-extrusion, a bonding layer, or an adhesive layer. Indirect bonding means that yet another layer, in particular a plastic sheet or metal foil, is placed between each of the layers.

[0276] As shown in Figure 6, the cover sheet 300 of cover 4 consists of the following layers: protective layer 301, The first barrier layer 302, Middle class 303, The second barrier layer 304, and Sealing layer 305, Includes or consists of The first barrier layer 302 is positioned between the protective layer 301 and the intermediate layer 303, and the second barrier layer 304 is positioned between the intermediate layer 303 and the sealing layer 305.

[0277] The cover sheet 300 typically has a thickness in the range of 50 μm to 200 μm, particularly 70 μm to 180 μm, preferably 80 μm to 150 μm, more preferably 90 μm to 140 μm, and most preferably 95 μm to 130 μm.

[0278] The protective layer 301 preferably comprises or is composed of a polymer selected from the group consisting of polyethylene terephthalate (PET), polyamide (PA), polyvinylidene difluoride (PVDF), and mixtures thereof. Preferably, the polymer of the protective layer 301 is polyethylene terephthalate (PET). The protective layer not only provides protection against mechanical damage but also allows printing on the protective layer 301, especially when the protective layer contains or is composed of PET.

[0279] The protective layer preferably 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.

[0280] The first barrier layer 302 is typically a metal foil, particularly an aluminum foil. Metal foils, especially aluminum foils, provide excellent oxygen barrier properties. The first barrier layer typically has a thickness in the range of 5 μm to 25 μm, particularly 7 μm to 20 μm, and preferably 10 μm to 40 μm.

[0281] The intermediate layer 303 and the sealing layer 305 preferably contain or consist of the same polymer. Typically, the intermediate layer 303 and / or the sealing layer 305 contain polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain low-density polyethylene (LLDPE), metallocene chain low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), acid copolymer ionomers, ethylene acrylic acid copolymer (EAA), ethylene methacrylate copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol ( EVOH It comprises or is composed of a polymer selected from the group consisting of ), or mixtures thereof, preferably composed of such polymer.

[0282] In this regard, it is preferable that the polymer of the intermediate layer 303 and / or the sealing layer 305 is selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof.

[0283] In the present invention, it is particularly preferable that the polymer of the intermediate layer 303 and / or the sealing layer 305 is selected from the group consisting of polypropylene (PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), or mixtures thereof. It is particularly preferable that the polymer of the intermediate layer 303 and / or the sealing layer 305 is polyethylene (PE).

[0284] Furthermore, according to the present invention, it is preferable that the intermediate layer 303 and the sealing layer 305 have the same thickness. Typically, the thickness of the intermediate layer 303 and / or the sealing layer 305 is 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 most preferably 22 μm to 27 μm.

[0285] The second barrier layer 304 is preferably ethylene vinyl alcohol (EVOH), ethylene vinyl acetate The polymer of the second barrier layer 304 comprises, and preferably comprises, a polymer selected from the group consisting of (EVA), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), polyethylene naphthalate (PEN), ethyl methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof. It is particularly preferred that the polymer of the second barrier layer 304 is selected from the group consisting of ethylene vinyl alcohol (EVOH), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), and mixtures thereof. In a preferred embodiment of the present invention, the polymer of the second barrier layer 304 is ethylene vinyl alcohol (EVOH).

[0286] Good results are obtained when the second barrier layer 304 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.

[0287] In a preferred embodiment, the cover sheet 300 has the following layer structure: protective layer 301, The first barrier layer 302, Middle class 303, The second barrier layer 304, and Sealing layer 305, It holds.

[0288] In particular, the cover sheet 300 has the following layer structure in the following layer sequence: (i) Protective layer 301, followed by, (ii) The first barrier layer 302, followed by, (iii) Intermediate layer 303, followed by, (iv) The second barrier layer 304, followed by, (v) sealing layer 305; It can be assumed that it includes or consists of

[0289] Particularly preferably, another layer follows the above-mentioned layer directly; that is, in the preferred embodiments of the present invention described above, it is assumed that the above-mentioned layers are formed consecutively or sequentially and / or not separated from another layer.

[0290] The layers of the cover sheet 300 can be bonded to each other directly or indirectly. Direct bonding means that the layers are directly joined to each other, for example, by co-extrusion, an adhesive layer, or a bonding layer. Indirect bonding means that there is another layer, in particular a plastic sheet or metal foil, between each layer.

[0291] A very preferred embodiment of the present invention is that the plastic sheet 200 of the bottom component 3 has the following layer structure in the following layer sequence: (a) an outer thermoformable layer 201, which in particular contains or is composed of PP, followed thereafter (b) A cyclic olefin copolymer layer 202, in particular containing or composed of COC, thereafter (c) In particular an inner thermoformable layer 203 containing or composed of PP, thereafter (d) an optional intermediate layer 206, in particular containing or composed of PE, thereafter (e) A barrier layer 204 containing or composed of EVOH, thereafter (f) In particular, a sealing layer 205 containing or composed of PE, Includes or consists of The cover sheet 300 has the following layer structure: (i) Protective layer 301, followed by, (ii) The first barrier layer 302, followed by, (iii) Intermediate layer 303, followed by, (iv) The second barrier layer 304, followed by, (v) sealing layer 305; This includes including or being composed of.

[0292] Particularly preferably, another layer is directly following the above-mentioned layer, that is, in the above-mentioned preferred embodiments of the present invention, it is assumed that the above-mentioned layer is formed sequentially or in sequence and / or is not separated from another layer by any further intermediate layer other than the intermediate layer 206.

[0293] In the present invention, it is preferable to arrange a bonding layer or adhesive layer between each layer of the cover sheet 300. The adhesive of the adhesive layer is preferably a polyurethane-based adhesive, particularly an aqueous or solvent-based polyurethane adhesive. The bonding layer is generally composed of an adhesive resin.

[0294] Furthermore, it is preferable that both the plastic 200 and the cover sheet 300 include a bonding layer and an adhesive layer between each functional layer.

[0295] According to a preferred embodiment of the present invention shown in Figure 7, the plastic sheet 200 has the following layer structure: (a) Preferably an outer thermoformable layer 201 comprising or composed of PP, (b) The binding layer 207a and (c) A cyclic olefin copolymer layer 202 comprising or composed of COC, in particular, (d) The binding layer 207b, (e) Preferably an inner thermoformable layer 203 comprising or composed of PP, (f) Adhesive layer 208 and, (g) Preferably an intermediate layer 206 comprising or composed of PE, in particular composed of PE, (h) Bonding layer 207c, (i) Preferably a barrier layer 204 comprising or composed of EVOH, and in particular composed of EVOH, (j) binding layer 207d, (k) Preferably a sealing layer 205 comprising or composed of PE, in particular composed of PE, It includes or consists of.

[0296] Figure 8 shows a preferred layer structure of the cover sheet 300: (i) Preferably a protective layer 301 containing or composed of PET, (ii) Adhesive layer 308a and (iii) Preferably a first barrier layer 302 comprising or composed of aluminum foil, in particular composed of aluminum foil, (iv) Adhesive layer 308b and (v) Preferably an intermediate layer 303 comprising or composed of PE, in particular composed of PE, (vi) The binding layer 307a and (vii) Preferably a second barrier layer 304 comprising or composed of EVOH, in particular a second barrier layer composed of EVOH, (viii) binding layer 307b and, (ix) Preferably a sealing layer 305 comprising or composed of PE, in particular composed of PE, It is displaying.

[0297] 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.

[0298] The following describes in more detail different embodiments of the administration packaging 1 according to the present invention. The different embodiments preferably differ (only) in the design of a predetermined break zone 9. In other words, the different embodiments of the administration packaging 1 are preferably identical except for the predetermined break zone 9.

[0299] Preferably, the aspects, features, and descriptions described in relation to one embodiment apply to other embodiments as well, unless otherwise specified, even if such description is not repeated.

[0300] Furthermore, the embodiments, features, and descriptions described above with respect to the administration packaging 1 with particular reference to Figures 1 to 3, with respect to the apparatus 100 for manufacturing the administration packaging 1 with particular reference to Figure 4, and with respect to the preferred multilayer structure with particular reference to Figures 5 to 8, preferably apply in addition to or in proportion to the embodiments described below, even if such descriptions are not repeated.

[0301] The embodiments of the administration packaging 1 described below preferably have the characteristics and features of the administration packaging 1 as generally described with reference to Figures 1 to 3.

[0302] The embodiments of the administration packaging 1 described below are preferably manufactured or can be manufactured by the method and / or apparatus 100 described with reference to Figure 4.

[0303] The embodiments of the administration packaging 1 described below are manufactured from a plastic sheet 200 and / or a cover sheet 300 as described with reference to Figures 5 to 8, and / or the bottom component 3 and / or cover 4 of these embodiments have a multilayer structure as described with reference to Figures 5 to 8.

[0304] A first embodiment of the administration packaging 1 is shown in Figures 9 to 11.

[0305] Figure 9 illustrates a schematic plan view of the dosing packaging 1 from the bottom side, i.e., facing the bottom component 3. In this figure, the cover 4 is not visible because it is behind the bottom component 3.

[0306] Figure 10 illustrates a schematic cross-sectional view of the administration packaging 1 along line XX in Figure 9. Figure 11 illustrates a magnified detail view of Figure 10 within the area of ​​the fracture zone 9 indicated by label XI in Figure 10.

[0307] As shown in the hatching, the rim 8 shown in Figure 11 is located behind the cross-sectional plane. The cover 4 preferably extends along the top surface of the rim 8 across the cavity 5 or dosing channel 7, thereby sealing the cavity 5 or dosing channel 7 from above (in the orientation shown in these figures).

[0308] In the first embodiment, the predetermined break zone 9 extends only through the cavity 5, and in particular through its administration channel 7, as shown in Figure 9. Preferably, in the first embodiment, the predetermined break zone 9 is not provided on the rim 8, and / or the rim 8 does not include the predetermined break zone 9. This preferably enhances the stability of the administration packaging 1 and / or reduces the risk of accidental opening of the administration packaging 1.

[0309] In this sense, the term “predetermined break zone” preferably means an area of ​​the dosing packaging 1, in particular an area of ​​the bottom component 3 that is specially prepared or produced to ensure the breakage / opening of the dosing packaging 1. Thus, in particular the predetermined break zone 9 is preferably a material weakening, and throughout this application the term “predetermined break zone” may be replaced with “material weakening.”

[0310] Preferably, even when the predetermined break zone 9 is located only within the cavity 5 or the area of ​​the dosing channel 7, the rim 8 will also break regardless when the dosing packaging 1 is opened, particularly when the tip 10 is bent / folded along the predetermined break zone 9, preferably in a predetermined manner. In other words, when the tip 10 is bent / folded, the material preferably breaks at the predetermined break zone 9, and this break propagates within the rim 8 in a particularly predetermined manner, resulting in the break of the entire tip 10 of the bottom part 3.

[0311] In particular, the predetermined fracture zone 9 is provided only on the bottom component 3, and / or the cover 4 does not include the predetermined fracture zone 9.

[0312] In particular, as shown in Figure 11, the predetermined break zone 9 is preferably a recess, notch, or groove 15, or has one. Preferably, the predetermined break zone 9 is a groove 15 on the outer surface 16 of the dosing packaging 1, particularly the bottom part 3.

[0313] The outer surface 16 of the administration packaging 1 or bottom component 3 is, in particular, the surface of the bottom component 3 opposite the cavity 5 or hollow space configured to receive the pharmaceutical product 2. Particularly preferably, the outer surface 16 is formed by an outer thermoformable layer 201.

[0314] Preferably, the groove 15 has at least a basically triangular shape in cross-section and / or at least a basically wedge shape. However, other shapes are also possible.

[0315] The groove 15 preferably has an angle W and a depth D and / or is determined by them.

[0316] The angle W is preferably a smaller angle between the main extension plane of the outer surface 16 and the main extension plane of the chamfered or inclined surface of the groove 15, particularly at the edge of a predetermined fracture zone 9 or groove 15, i.e., at the edge where the outer surface 16 begins to curve inward and / or become a groove / recess.

[0317] When the groove 15 or its cross-section is at least fundamentally triangular or wedge-shaped, the angle W is preferably the angle between one side and the base of the (isosceles) triangular cross-section.

[0318] However, the groove 15 can preferably be characterized by any other suitable angle that can be determined from angle W, for example, the angle at which the outer surface 16 actually bends inward or toward the cavity 5 or administration channel 7 (which can be calculated as 180°-W), or the opening angle of the groove 15 (i.e., the angle contained between the two inclined surfaces of the groove 15), which can be calculated as 180°-2W, especially in the case of a triangular or wedge shape.

[0319] The depth D is preferably the distance from the main extension plane of the outer surface 16 to the lowest area of ​​the groove 15, measured particularly perpendicular to this main plane.

[0320] When the groove 15 or its cross-section is at least fundamentally triangular or wedge-shaped, the depth D is preferably the height or height difference (relative to the base) of the triangular cross-section.

[0321] The angle W is preferably at least 20 degrees or at least 25 degrees, particularly at least 30 degrees, and / or at most 60 degrees or at most 55 degrees, particularly at most 50 degrees. Particularly preferred values ​​for the angle W are 30 degrees, 40 degrees, or 50 degrees.

[0322] The opening angle or groove angle is preferably at least 60 degrees or at least 70 degrees, particularly at least 75 degrees or at least 80 degrees, and / or at most 140 degrees or at most 130 degrees, particularly at most 125 degrees or at most 120 degrees. Particularly preferred values ​​are 80 degrees, 100 degrees, or 120 degrees.

[0323] 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 the depth D are 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm.

[0324] 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 component 3 (wall).

[0325] Preferably, the groove 15 has a (very) small radius of curvature in its lowest region or valley, which is preferably less than 15% or 10% of the depth D, and particularly less than 5% or 2%. Preferably, the radius of curvature is less than 50 μm or 20 μm, and particularly less than 10 μm or 5 μm.

[0326] Preferably, a protrusion 17 is formed on the inner surface 18 of the administration packaging 1, particularly the bottom component 3, within a predetermined break zone 9.

[0327] The inner surface 18 of the administration packaging 1 or bottom component 3 is, in particular, the surface of the bottom component 3 facing the cavity 5 or hollow space configured to receive the pharmaceutical product 2 and / or the surface opposite the inner surface 16. Particularly preferably, the inner surface 18 is formed by a sealing layer 205.

[0328] Therefore, the outer surface 16 and the inner surface 18 are preferably two opposing surfaces of the wall forming the bottom component 3. Particularly preferably, the inner surface 18 is at least the surface that comes into contact with the pharmaceutical product 2 when dispensing the pharmaceutical product 2 and / or the surface of the sealing layer 205. Particularly preferably, the outer surface 16 is the surface that comes into contact with the surrounding environment and / or the surface of the outer thermoformable layer 201.

[0329] The protrusion 17 is preferably located on the opposite side of the groove 15.

[0330] Preferably, the projection 17 is formed in proportion to the groove 15, and in particular extends in the same direction as the groove 15, has the same length and / or width as the groove 15, and / or has the same shape and / or angle as the groove 15.

[0331] Preferably, the predetermined fracture zone 9 is a region having the same thickness T as the region of the bottom component 3 surrounding the predetermined fracture zone 9. In other words, the thickness T of the bottom component 3 (wall) is preferably at least basically constant within the region containing the predetermined fracture zone 9 and within the region surrounding the predetermined fracture zone 9.

[0332] Therefore, preferably, the thickness T (of the wall) of the bottom part 3 within the area of ​​the groove 15 and / or projection 17 is at least essentially the same as that within the area surrounding / adjacent to the groove 15 and / or projection 17.

[0333] The thickness T is preferably the distance between the outer surface 16 and the inner surface 18. Within a predetermined fracture zone 9, the thickness T is preferably the distance between the groove 15 (surface) and the projection 17 (surface).

[0334] A minimum and fundamentally constant thickness T is preferably obtained by forming the projection 17 in response to the depth D of the groove 15, particularly by having the projection 17 be the same as or at least substantially the same height as the depth D of the groove 15. In other words, the projection 17 is preferably at least as high as the depth of the groove 15, and / or the outer surface 16 is recessed at least as much as the ridge of the inner surface 18 (in a predetermined fracture zone 9).

[0335] Preferably, the thickness T of the bottom component 3 in both the predetermined fracture zone 9 and the surrounding region is preferably at least 230 μm, particularly at least 300 or 400 μm, more preferably 450 or 480 μm, and / or up to 750 μm, particularly 650 or 600 μm, more preferably 500 μm or 520 μm.

[0336] In the first embodiment, the predetermined fracture zone 9 is preferably formed as a bend, twist, or fold within the bottom part 3 (wall).

[0337] In particular, within a cross-section perpendicular to the longitudinal extension of the predetermined fracture zone 9, the predetermined fracture zone 9 or the bottom component 3 (wall) within that region is preferably at least basically V-shaped.

[0338] Preferably, a width reduction channel, cross-sectional reduction section, or nozzle 19 is formed in / within a predetermined fracture zone 9, or particularly within the cavity 5 or administration channel 7.

[0339] The channel height and / or flow cross-section of the administration channel 7 are preferably determined by the inner surface 18 and the cover 4, particularly the surface of the cover 4 facing the administration channel 7 or formed by the layer 305.

[0340] The height and / or width of the predetermined fracture zone 9, cross-sectional reduction section, or the dosing channel 7 at a location away from the nozzle 19 is preferably greater than 0.5 mm, particularly greater than 1 mm, and / or less than 4 mm or 3 mm.

[0341] The height and / or width of the administration channel 7 is preferably reduced by at least 0.05 mm or more in / within or by a predetermined rupture zone 9, and / or by a maximum of 0.5 mm or less, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm.

[0342] Preferably, the administration channel 7 is narrowed by a projection 17, or its (flow) cross-section is reduced, or a nozzle 19 is formed. In particular, the projection 17 protrudes into and / or toward the cover 4, thereby narrowing the channel and / or reducing its (flow) cross-section.

[0343] In particular, when the administration packaging 1 is opened by folding / bending along a predetermined break zone 9 or groove 15, the width reduction channel, cross-sectional reduction section, or nozzle 19 is preferably formed or positioned at the opening end 7B, especially where the pharmaceutical product 2 flows out of the administration packaging 1.

[0344] As described above, the administration channel 7 and / or opening end 7B are preferably configured or dimensional so that the product 2 cannot leak out based on gravity (alone). This configuration or dimensional configuration is particularly preferably achieved at least partially by a narrowed channel, a cross-sectional reduction section, or a nozzle 19.

[0345] Preferably, the administration channel 7 or opening end 7B is narrowed, in particular by the projection 17, so that even if it is facing downward, the pharmaceutical product 2 does not flow out through the administration channel 7 or opening end 7B unless additional force is applied, for example, by pressing the chamber 6.

[0346] Therefore, the pharmaceutical product 2 is preferably dispensed from the administration packaging 1, which is opened only by pressing the chamber 6.

[0347] Preferably, when dispensing the pharmaceutical product 2 and / or pressing the chamber 6, the pharmaceutical product 2 is accelerated, particularly preferably by a narrowed channel, a cross-sectional reduction section, or a nozzle 19, as it exits the administration packaging 1, especially at the open end 7B.

[0348] Preferably, the narrowing channel, cross-sectional reduction section, or nozzle 19 further prevents the pharmaceutical product 2 from flowing, particularly from the chamber 6, through the narrowing channel, cross-sectional reduction section, or nozzle 19, and / or into the tip 10, the portion of the administration channel 7 formed by the tip 10, and / or toward the shaft end 7A, especially before the administration packaging 1 is opened. Thus, preferably, the pharmaceutical product 2 is prevented from accumulating at the shaft end 7A or in the tip 10. In this way, preferably, the pharmaceutical product 2 is not wasted or leaked when the administration packaging 1 is opened or the tip 10 is discarded.

[0349] Figure 12 illustrates an enlarged detail view of the area within the rupture zone 9 of the second embodiment of the administration packaging 1, corresponding to the enlarged detail view of the first embodiment shown in Figure 11.

[0350] Preferably, the only difference between the first and second embodiments is that the dosing packaging 1, bottom component 3, or predetermined break zone 9 does not include a protrusion 17 and / or a width reduction channel, cross-sectional reduction section, or nozzle 19.

[0351] The administration channel 7 of the second embodiment preferably has a certain distance between the inner surface 18 and the cover 4 and / or a certain (flow) cross-section, particularly within a predetermined fracture zone 9.

[0352] Along axis A and / or along the section shown in Figure 12, the inner surface 18 is (likewise) preferably at least basically flat, particularly within the predetermined fracture zone 9.

[0353] Preferably, within a predetermined fracture zone 9, the thickness T of the bottom component 3 (wall) is reduced or lessened compared to the area surrounding the predetermined fracture zone 9. Particularly preferably, the thickness T is reduced by the depth D of the groove 15.

[0354] The ratio of the thickness in the predetermined fracture zone 9 (its 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.

[0355] The administration packaging 1, particularly the bottom component 3 or a predetermined fracture zone 9, has a protrusion 17 or a reduced width channel, a cross-sectional reduction portion, or a nozzle 19, but nevertheless, embodiments are also possible in which it has a non-constant thickness T, for example, a thickness T within the region of the protrusion 17 or predetermined fracture zone 9 that is reduced compared to the region surrounding the protrusion 17 or predetermined fracture zone 9.

[0356] It is also possible that the thickness T may decrease in one region and increase in another region compared to the average thickness T. For example, it is possible that the thickness T may decrease at the tip of the protrusion 17 and increase at the base of the protrusion 17.

[0357] Preferably, material weakening of a predetermined fracture zone 9 or bottom component 3 is formed by bending / twisting, material reduction / thickness reduction, or a combination thereof.

[0358] Below, we describe third and fourth embodiments of the dosing packaging 1, which, preferably, differ from the first and second embodiments in that a predetermined break zone 9 or groove 15 extends across the rim 8 or is formed in both the dosing channel 7 and the rim 8.

[0359] Figures 13 to 15 illustrate a third embodiment of the administration packaging 1, corresponding to Figures 9 to 11, respectively. In particular, Figure 13 shows a schematic plan view of the administration packaging 1 from the bottom, Figure 14 shows a schematic cross-sectional view of the administration packaging 1 along XIV-XIV in Figure 13, and Figure 15 illustrates an enlarged detail view of the portion labeled XV in Figure 13. The cross-sections shown in Figures 14 and 15 are along axis A, i.e., along or within the administration channel 7.

[0360] Figure 16 shows a schematic cross-section of the dosing packaging 1 according to the third embodiment within the region of the rim 8, in an enlarged view similar to that of Figure 15. In the first and second embodiments, the rim 8 does not include a predetermined break zone 9 or groove 15, so similar figures have been omitted.

[0361] Figure 17 shows an enlarged detail view of the fourth embodiment of the dosing packaging 1 within the fracture zone 9 region, corresponding to the enlarged detail views of the other embodiments shown in Figures 11, 12, and 15. Figure 18 shows an enlarged detail view of the fourth embodiment of the dosing packaging 1 at the location of the rim 8 within the fracture zone 9 region, corresponding to Figure 16.

[0362] In both the third and fourth embodiments, the predetermined fracture zone 9 or groove 15 preferably extends across the cavity 5, particularly the dosing channel 7 and the rim 8. In other words, the predetermined fracture zone 9 or groove 15 preferably extends across the entire width of the dosing packaging 1, i.e., across the entire length of the dosing packaging 1, in a direction transverse or perpendicular to the dosing channel 7 (or its longitudinal extension) or axis A.

[0363] Preferably, the predetermined fracture zone 9 region has the same or similar characteristics as the location of the cavity 5 or administration channel 7 within the predetermined fracture zone 9 region at the location of the rim 8.

[0364] The above description of the predetermined fracture zone 9, groove 15, angle W, depth D, etc., preferably also applies to the predetermined fracture zone 9 of the third and fourth embodiments, particularly preferably both within the cavity 5 region and within the rim 8 region.

[0365] Preferably, the groove 15 has the same or similar characteristics within the region of the rim 8 as within the region of the cavity 5 or the administration channel 7, for example, the same angle W, the same depth D, etc.

[0366] However, solutions are also possible in which the predetermined fracture zone 9 and / or groove 15 differ from those in the rim 8. For example, the groove 15 may have a smaller depth D than that in the rim 8, such as in the cavity 5 or administration channel 7.

[0367] Preferably, the main or sole difference between the third embodiment shown in Figures 13 to 16 and the fourth embodiment shown in Figures 17 and 18 is whether or not the projection 17 is formed on the rim 8.

[0368] Preferably, the rim 8 in the third embodiment does not include the projection 17, as can be seen particularly in Figure 16, and / or the rim 8 in the fourth embodiment includes the projection 17, as can be seen particularly in Figure 18.

[0369] In the fourth embodiment, the projection 17 preferably extends across the entire width of the dosing packaging 1, i.e., across the entire length of the dosing packaging 1, in a direction perpendicular to the dosing channel 7 (or its longitudinal extension) or axis A. Thus, in particular, the edge 3A and / or rim 8 also include the projection 17.

[0370] Preferably, the projection 17 has the same or similar characteristics within the region of the rim 8 as within the region of the cavity 5 or the administration channel 7. However, different solutions are also possible for the projection 17 in the rim 8.

[0371] Preferably, the cover 4 conforms to or adapts to the surface of the rim 8. In other words, in the fourth embodiment, as can be seen in Figures 17 and 18, within the area of ​​a predetermined break zone 9 or projection 17, the cover 4 (likewise) has an bulge or projection on its outside and a groove on its inside. In the third embodiment and / or when the rim 8 is flat or does not include a projection 17, as can be seen in Figures 15 and 16, the cover 4 is preferably at least basically flat, especially within the area of ​​a predetermined break zone 9.

[0372] In the third embodiment, the thickness T is preferably reduced at the location of the rim 8 within the region of the predetermined fracture zone 9, in comparison with the region surrounding the predetermined fracture zone 9 and / or at the location of the dosing channel 7 within the region of the dosing channel 7.

[0373] In the fourth embodiment, the thickness T is preferably at least essentially constant over the entire length of the predetermined fracture zone 9.

[0374] Preferably, the administration packaging 1 according to the third embodiment includes a width reduction channel, a cross-sectional reduction section, or a nozzle 19.

[0375] Preferably, the dosing packaging 1 according to the fourth embodiment has at least a basically constant flow cross-section and / or does not include a reduced width channel, cross-sectional reduction section, or nozzle 19. This is achieved, in particular, by molding the cover 4 in response to non-planar or protruding portions 17 within the region of a predetermined break zone 9. However, a solution is also possible in which the cover 4 is non-planar only at the rim 8 and still flat where it covers the cavity 5 or dosing channel 7, and in particular still flat within the region formed by the edge 3A.

[0376] Any combination of the different embodiments is possible. For example, the predetermined fracture zone 9 in the third embodiment can also be formed without the protruding portion 17, just as in the second embodiment.

[0377] The molding tool 102 is described in more detail below with reference to Figures 19 to 22, and / or how the predetermined fracture zone 9 is generated in the proposed method, particularly during the thermoforming stage, and / or within the proposed apparatus 100, especially the molding tool 102.

[0378] Figure 19 shows a schematic cross-sectional view of the molding tool 102 and the (thermoformed) plastic sheet 200 or bottom component 3. Figure 20 illustrates an enlarged detail view of the cross-section of the molding tool 102 and the (thermoformed) plastic sheet 200 or bottom component 3 within the region of the molding device 102C. Figures 21 and 22 illustrate the molding tool 102 according to yet another embodiment, corresponding to Figures 19 and 20, respectively.

[0379] The following description preferably applies to both embodiments unless otherwise specified.

[0380] Figures 19 and 21 illustrate molds 102A and 102B separated from each other and further separated from the plastic sheet 200 / bottom part 3, and / or molds 102A and 102B after thermoforming (directly) with the plastic sheet 200 / bottom part 3 removed from molds 102A and 102B.

[0381] Figures 20 and 22 illustrate molds 102A and 102B lying on and / or being thermoformed on a plastic sheet 200 / bottom part 3.

[0382] The negative mold 102A preferably has a (concave) cavity and / or a concave form or (concave) surface 102D. The surface 102D of the negative mold 102A is preferably generally concave, but can be locally flat or even convex.

[0383] Particularly preferably, the negative mold 102A has multiple (concave) cavities for forming multiple bottom parts 3 (simultaneously / in a single forming step), as described above with reference to Figure 4.

[0384] The positive mold 102B preferably has (convex) ridges and / or convex shapes or (convex) surfaces 102E. The surface 102E of the positive mold 102B is preferably convex overall, but can be locally flat or even concave.

[0385] Particularly preferably, the positive mold 102B has a plurality of (convex) ridges for forming a plurality of bottom parts 3 (simultaneously / in a single forming step) as described above with reference to Figure 4.

[0386] As described above with respect to the apparatus 100 and the corresponding production method shown in Figure 4, the molding tool 102 may include only the negative mold 102A or only the positive mold 102B, or use only one of the two molds 102A, 102B during (thermal)forming. In this case, the plastic sheet 200 is preferably pressed against the negative mold 102A or the positive mold 102B, particularly using a gas that is pneumatically and / or blown onto the plastic sheet 200, thereby conforming to the shape of each mold. Alternatively or in addition to this, negative pressure can be generated, for example, by drawing air or another gas from each mold. Alternatively or in addition to this, a press or other mechanical means can be used.

[0387] Particularly preferably, both the negative mold 102A and the positive mold 102B are prepared or used during or for the purpose of forming the bottom part 3. In this case, preferably, the positive mold 102B is pressed against the negative mold 102A and / or the reverse is done, and / or the plastic sheet 200 is crushed or formed between the negative mold 102A and the positive mold 102B. Thus preferably, mechanical force is applied to the plastic sheet 200 using the molds 102A and 102B. In this sense, one of the molds 102A and 102B can act as a mold for the other mold 102A and 102B.

[0388] Preferably, even when both molds 102A and 102B are being prepared / used, gas injection and / or negative pressure generation are also used.

[0389] One of the molds 102A, 102B or one of the surfaces 102D, 102E is partially formed or provided only in areas of the bottom part to be formed, particularly where more precise formation is required. For example, the positive mold 102B or its (convex) surface 102E may be provided only in areas where the dosing channel 7 is formed, or even only where a predetermined fracture zone 9 is formed. In such cases, preferably, in other areas, the plastic sheet 200 is pressed against each mold only by gas and / or negative pressure.

[0390] The molding tool 102, in particular the negative mold 102A and / or positive mold 102B, is preferably configured to (thermally) form predetermined fracture zones 9, grooves 15 and / or protrusions 17, especially during (thermal) forming of the production method.

[0391] The molding tool 102, in particular the negative mold 102A and / or positive mold 102B, preferably includes a forming device or generating device 102C for (thermally) forming predetermined fracture zones 9, grooves 15, and / or protrusions 17.

[0392] The forming device 102C is preferably formed as a projection or bulge 102F in the negative mold 102A and / or a groove or recess 102G in the positive mold 102B, in particular, to correspond to a (desired) predetermined fracture zone 9.

[0393] It is also possible to provide a protrusion or ridge 102F within the positive mold 102B and / or a groove or recess 102G within the negative mold 102A in order to generate / form a predetermined fracture zone 9 according to the fifth embodiment described below with reference to Figures 23 to 25.

[0394] The forming device 102C preferably corresponds to, or has the same shape, scale, and / or dimensions as, a predetermined fracture zone 9 (preferred) with respect to an angle W and / or depth D.

[0395] In particular, the forming device 102C is preferably elongated and / or wedge-shaped, similar to the predetermined fracture zone 9. In the case of a surface bulge, its height is preferably corresponding to or equal to the (desired) depth D of the predetermined fracture zone 9. In the case of a surface depression, its depth is preferably corresponding to or equal to the (desired) depth D of the predetermined fracture zone 9.

[0396] The forming device 102C or the raised portion 102F preferably has an acute-angled edge or an acute-angled ridge.

[0397] Preferably, the radius of curvature at the edge / ridge of the forming device 102C / ridge 102F is less than 15% or 10% of the height of the forming device 102 / ridge 102F, and particularly less than 5% or 2%.

[0398] Preferably, the radius of curvature at the edge / ridge of the forming device 102C / ridge 102F is less than 50 μm or 20 μm, and particularly less than 10 μm or 5 μm.

[0399] Preferably, the groove 15 has the same or corresponding radius of curvature in its valley, and / or the projection 17 has the same or corresponding radius of curvature in its ridge.

[0400] The forming device 102C can be embodied / formed / provided only within the negative mold 102A (for example, as shown in Figures 19 and 20), only within the positive mold 102B (not shown), or both within the negative mold 102A and the positive mold 102B (for example, as shown in Figures 21 and 22).

[0401] In the case of a negative mold 102A, the forming device 102C is preferably configured as a projection or bulge 102F in the negative mold 102A and / or formed thereby and / or in the (concave) cavity of the (overall concave) surface 102D.

[0402] In the case of a positive mold 102B, the forming device 102C is preferably configured as a groove or depression 102G in the (convex) ridges of the (overall convex) surface 102E that is in and / or formed by the positive mold 102B.

[0403] Preferably, the plastic sheet 200 conforms to the shape of the respective molds 102A and 102B when pressed against the negative mold 102A and / or positive mold 102B. In particular, the plastic sheet 200 lies flat against the negative mold 102A or surface 102D and / or positive mold 102B or surface 102E.

[0404] Particularly preferably, the plastic sheet 200 (as well as the plastic sheet) conforms to or lies flat against the forming device 102C, the ridge 102F and / or the depression 102G when pressed against them, thereby forming predetermined fracture zones 9, grooves 15 and / or protrusions 17.

[0405] Depending on the desired shape of the predetermined fracture zone 9, the forming device 102C is formed accordingly.

[0406] The forming device 102C may be provided only in the region of the forming tool 102, particularly in one or both of the molds 102A and 102B, where the dosing channel 7 is formed or is to be formed. Alternatively, the forming device 102C may be provided in the region where the rim 8 is formed.

[0407] When forming the bottom component 3, particularly during the forming stage, predetermined fracture zones 9 are formed or made only in the locations where the forming device 102C is provided.

[0408] When the forming device 102C is provided only within the region where the administration channel 7 is formed or is to be formed, the predetermined fracture zone 9 is formed or is to be formed only within the region of the administration channel 7. Therefore, preferably, the administration packaging 1 or bottom component 3 according to the first embodiment shown in Figures 9 to 11, and / or the second embodiment shown in Figure 12, and / or any other embodiment in which the predetermined fracture zone 9 is provided only in the location of the administration channel 7, can be formed / manufactured in this manner.

[0409] When the forming device 102C is applied to the region where the rim 8 is formed or is to be formed, the predetermined fracture zone 9 is also formed or is to be formed in the region of the rim 8. Therefore, preferably, the third embodiment shown in Figures 13 to 16, and / or the fourth embodiment shown in Figures 17 and 18, and / or any other embodiment in which the predetermined fracture zone 9 is also provided in the location of the rim 8, such as the dosing packaging 1 or bottom component 3 according to the embodiment shown in Figures 1 to 3, can be formed / manufactured in this manner.

[0410] Preferably, when both molds 102A and 102B are provided, or within a region where both molds 102A and 102B are provided, the molds 102A and 102B or their surfaces 102D and 102E correspond to each other at least fundamentally. In particular, surfaces 102D and 102E are at least fundamentally identical or at least have the same shape, except that they have opposite curvatures. However, within a certain region, particularly where a predetermined fracture zone 9 is formed or is to be formed, the molds 102A and 102B or their surfaces 102D and 102E can be molded differently.

[0411] Preferably, in the embodiments shown in Figures 19 and 20, the negative mold 102A includes a forming device 102C. In particular, the protrusions or ridges 102F are provided on the negative mold 102A or surface 102D, especially within the region where the dosing channel 7 or predetermined fracture zone 9 is formed or is to be formed, whereas no corresponding grooves or depressions are provided on the positive mold 102B.

[0412] As is most clearly visible in Figure 20, the above results preferably yield a predetermined fracture zone 9 having no protrusion 17 and / or a reduced thickness T. In particular, this can be used to form the dosing packaging 1 according to the second embodiment shown in Figure 12 and / or any other embodiment without the protrusion 17.

[0413] Alternatively, as illustrated in Figures 21 and 22, the forming device 102C can be embodied / provided on both molds 102A and 102B. In particular, one mold 102A or 102B may include a projection or ridge 102F, and the other mold 102B or 102A may include a corresponding groove or recess 102G, and these projections or ridges 102F and grooves or recesses 102G have the same, similar, or corresponding angles W and / or height / depth D. In this way, preferably a dosing package 1 having a groove 15 and a corresponding projection 17, for example, a dosing package 1 according to the first embodiment shown in Figures 9 to 11 or the third or fourth embodiment shown in Figures 13 to 18, can be formed / manufactured depending on whether the forming device 102C is provided only within the area of ​​the dosing channel 7 to be formed or also within the area of ​​the rim 8 to be formed.

[0414] The parts of the forming device 102C on different molds 102A and 102B may correspond to each other within certain regions, but may be different in other regions.

[0415] For example, the forming device 102C or surface 102D may include a projection or ridge 102F extending along both the region where the administration channel 7 is formed or is to be formed and the region where the rim 8 is formed or is to be formed, while the forming device 102C or surface 102E may include a groove or recess 102G only within the region where the administration channel 7 is formed or is to be formed, and not within the region where the rim 8 is formed or is to be formed. In this way, preferably, the administration packaging 1 according to the third embodiment shown in Figures 13 to 16 can be formed / manufactured.

[0416] The forming device 102C can be integrally formed with the forming tool 102, particularly within the negative mold 102A and / or the positive mold 102B or their respective surfaces 102D, 102E.

[0417] In the examples shown in Figures 19 and 20, the forming device 102C is preferably an integrally formed projection or ridge 102F of the mold 102A or surface 102D. Depending on the desired shape of the predetermined fracture zone 9, the other mold 102B or surface 102E may, for example, include an integrally formed groove or recess 102G, as shown in Figures 21 and 22.

[0418] Preferably, the apparatus 100 can be adapted to generate predetermined fracture zones 9 of different shapes.

[0419] As described above, the molding tool 102, in particular the molds 102A and 102B, are preferably interchangeable. The apparatus 100 can be adapted to generate predetermined fracture zones 9 of different shapes by replacing the molding tool 102, in particular one or both of the molds 102A and 102B, with a molding tool 102 having a different forming device 102C.

[0420] Particularly preferably, the forming device 102C is displaceable, adjustable, and / or interchangeable, especially within the forming tool 102 or each mold 102A, 102B and / or without replacing the entire forming tool 102 or each mold 102A, 102B. In particular, the device 100 can preferably be adapted to generate predetermined fracture zones 9 of different shapes without replacing the entire forming tool 102 or each mold 102A, 102B.

[0421] Preferably, the forming device 102C forms displaceable, adjustable, and / or interchangeable components of the forming tool 102.

[0422] For example, the forming device 102C can be designed as one or more inserts for the forming tool 102 or molds 102A and 102B. These inserts are schematically illustrated with dashed lines in Figures 20 and 22.

[0423] The forming device 102C or insert can preferably be fixed to the forming tool 102 or molds 102A, 102B by pressure fitting and / or shape fitting. For example, the forming device 102C or insert can be screwed into the corresponding screw holes of the forming tool 102 or molds 102A, 102B.

[0424] To generate various types of dosing packaging 1 or predetermined break zones 9, or to adapt the apparatus 100 or molding tool 102 to them, the forming device 102C or insert can preferably be replaced with a different forming device 102C or insert. Preferably, in this way, adaptation is possible without replacing the (entire) molding tool 102 or molds 102A, 102B.

[0425] Alternatively, or in addition to the above, the forming device 102C may be adjustable or displaceable. Preferably, the forming device 102C is adjustable or displaceable orthogonal and / or parallel to the surfaces 102D and 102E.

[0426] In particular, the height / depth D and / or angle W of the forming device 102C, especially the ridge 102F and / or depression 102G, and furthermore, the height / depth D and / or angle W of the predetermined fracture zone 9 generated thereby can be made adjustable. For example, the depth to which the forming device 102C is inserted or screwed into the forming tool 102 or molds 102A, 102B can be made adjustable.

[0427] Preferably, the forming device 102C is adjustable or displaceable to determine / change the position of a predetermined fracture zone 9 within the dosing channel 7, for example, by moving this position closer to or further away from the shaft end 7A.

[0428] Figure 20 shows an enlarged detail example of production using a negative mold 102A and a positive mold 102B having a reduced thickness T and / or a predetermined fracture zone 9 according to the second embodiment shown in Figure 12 and / or corresponding surfaces 102D, 102E, particularly using a forming device 102C provided / formed only within the negative mold 102A or on surface 102D.

[0429] The plastic sheet 200 is preferably crushed or compressed between mold 102A and mold 102B, particularly within the area of ​​the forming device 102C, and / or between the forming device 102C or the ridge 102F formed thereby and the other surface 102E of mold 102B on the (positive) opposite side of the forming device 102C.

[0430] Due to crushing / compression and / or different shaped surfaces 102D, 102E and / or forming device 102C, the thickness T of the plastic sheet 200 is preferably reduced within the area of ​​forming device 102C. Preferably in this way, a predetermined fracture zone 9 is generated.

[0431] The forming device 102C or the ridge 102F preferably penetrates the plastic sheet 200.

[0432] Preferably, only the outermost layer of the plastic sheet 200, particularly the outer thermoformable layer 201, more preferably the cyclic olefin copolymer layer 202, and even more optionally the inner thermoformable layer 203, are affected, penetrated, and / or crushed / compressed by or during thermoforming by the forming device 102C.

[0433] Preferably, the innermost layers, particularly at least the barrier layer 204 and the sealing layer 205, remain intact or are at least essentially unaffected, penetrated, or crushed / compressed based on or during the forming device 102C. Therefore, preferably, the sealing and barrier quality of the plastic sheet 200 or bottom component 3 is not impaired by or in the predetermined fracture zone 9.

[0434] The height of the forming device 102C or the ridge 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 combined thickness of the outer thermoformable layer 201 and the cyclic olefin copolymer layer 202, and optionally more preferably less than the combined thickness of that and the inner thermoformable layer 203.

[0435] Particularly preferably, the height of the forming device 102C or the ridge 102F corresponds to the (desired) depth D of the groove 15 that is produced.

[0436] The height of the forming device 102C or the ridge 102F is preferably at least 0.05 mm or longer 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.

[0437] In yet another embodiment (for example, as shown in Figures 21 and 22), as described above, the molds 102A and 102B may have corresponding surfaces 102D and 102E within the region where a predetermined fracture zone 9 is formed or is to be formed. In this case, preferably, the forming device 102C is composed of a projection or bulge 102F on one mold and a corresponding groove or recess 102G on the other mold.

[0438] In this case, the plastic sheet 200, and in particular all of its layers, are pressed inward, bent, or twisted during (thermal)forming, in particular, for example, as shown in Figure 22, by the ridge 102F of mold 102A into the recess 102G of mold 102B or vice versa. In this way, a predetermined fracture zone 9 having a groove 15 and a corresponding projection 17 is formed, preferably.

[0439] In this embodiment, the plastic sheet 200 is preferably not crushed / compressed at least essentially, and in particular, none of the outer layers are likewise not crushed / compressed.

[0440] Preferably, all layers of the plastic sheet 200 are affected by inward bending / twisting. However, the integrity of the inner layers, particularly at least the barrier layer 204 and the sealing layer 205, is preferably maintained. Thus, again, the sealing and barrier quality of the plastic sheet 200 or the bottom component 3 is preferably not impaired by the predetermined break zone 9.

[0441] The corresponding surfaces 102D and 102E are located only within certain regions, and / or the plastic sheet 200 can be bent / twisted inward only within certain regions or crushed / compressed in other regions. For example, the plastic sheet 200 can be bent / twisted within the region where the dosing channel 7 is formed or is to be formed, and crushed / compressed within the region where the rim 8 is formed or is to be formed, so that the dosing packaging 1 or bottom component 3 according to the third embodiment shown in Figures 13 to 16 can be formed.

[0442] The following describes a fifth embodiment of the administration packaging 1.

[0443] Figures 23 to 25 illustrate a fifth embodiment of the administration packaging 1, corresponding to Figures 9 to 11, respectively. In particular, Figure 23 shows a schematic plan view of the administration packaging 1 from the bottom, Figure 24 shows a schematic cross-sectional view of the administration packaging 1 along line XXIV-XXIV in Figure 23, and Figure 25 illustrates an enlarged detail view of the portion labeled XXV in Figure 24. The cross-sections shown in Figures 24 and 25 are along axis A, i.e., along or within the administration channel 7.

[0444] In the fifth embodiment, the groove 15 is provided on the inner surface 18 and / or the projection 17 is provided on the outer surface 16 and / or the bent / twisted portion faces outward from the bottom part 3.

[0445] Compared to conventional embodiments, the positions of the groove 15 and the protrusion 17 are preferably swapped, and / or the predetermined fracture zone 9 is preferably bent / twisted in opposite directions.

[0446] In contrast to the first embodiment shown in Figures 9 to 11, the dosing channel 7 is not narrowed based on the predetermined break zone 9 of the fifth embodiment. Instead, preferably, a widening channel, in the case of an expansion section, or diffuser 20 is formed in / inside or by the predetermined break zone 9, or particularly within the cavity 5 or dosing channel 7.

[0447] The height and / or width of the administration channel 7 is preferably expanded by at least 0.05 mm or longer and / or at most 0.5 mm or less, particularly preferably by 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm, in / within or by a predetermined rupture zone 9.

[0448] Preferably, the administration channel 7 is widened by a groove 15, or its (flow) cross-section is enlarged, or a diffuser 20 is formed. In particular, the groove 15 is formed on the inner surface 18, i.e., the surface 18 indents within the region of a predetermined fracture zone 9, thereby widening the channel and / or enlarging its (flow) cross-section.

[0449] When the administration packaging 1 is opened, particularly by folding / bending along a predetermined break zone 9 or groove 15, a widening channel, in the case of an enlargement section, or diffuser 20 is preferably formed or positioned at the opening end 7B, particularly where the pharmaceutical product 2 flows out of the administration packaging 1.

[0450] Widening the channel at the open end 7B allows for easier outflow of the pharmaceutical product 2. This is considered advantageous, for example, for more viscous fluids.

[0451] The predetermined fracture zones 9, particularly the grooves 15 and / or protrusions 17, and their preferred shapes, dimensions, and / or other features described above in relation to other embodiments are also preferably applied in accordance with or in correspondence to the fifth embodiment.

[0452] Some of the descriptions and definitions of the conventional embodiments will require the substitution of the term “outer surface 16” with “inner surface 18” and vice versa for application to the fifth embodiment. For example, in the fifth embodiment, the depth D is preferably the distance measured perpendicular to the main extension plane of the inner surface 18 from the main extension plane to the lowest area of ​​the groove 15, and / or the angle W is preferably the smaller angle between the main extension plane of the inner surface 18 and the main extension plane of the chamfered or inclined surface of the groove 15, particularly at a predetermined fracture zone 9 or the edge of the groove 15, i.e., the edge where the inner surface 18 begins to curve outward and / or become a groove / recess.

[0453] Particularly preferred, with respect to the groove 15 and / or projection 17, the description and preferred values, especially regarding the thickness T, depth D, and / or angle W, are also preferably applied in accordance with or in correspondence to the fifth embodiment. Figure 25 illustrates an angle W of about 40° (opening angle of about 100°).

[0454] In the fifth embodiment, the predetermined fracture zone 9, particularly the groove 15 and / or projection 17, preferably extends only over the cavity 5, particularly the dosing channel 7, as in the first embodiment.

[0455] Particularly preferably, the predetermined rupture zone 9 extends across the cavity 5 or the administration channel 7 or its entire width, particularly transversely or perpendicularly to the axis A / channel 7.

[0456] However, the predetermined rupture zone 9 may extend only partially over the cavity 5 or the administration channel 7 or its width. For example, the predetermined rupture zone 9 may be (already) absent in the region near the edge 3A and / or where the cavity 5 or administration channel 7 transitions to the rim 8.

[0457] The above description and features relating to the overall or partial extension of the predetermined fracture zone 9 preferably also apply to the embodiments described above, for example, the first embodiment in which the predetermined fracture zone 9 does not extend across the rim 8.

[0458] The embodiment of the fifth embodiment shown in Figures 23 to 25 shows a predetermined break zone 9 that extends only across the cavity 5 / dosage channel 7, but the predetermined break zone 9 can also extend beyond the cavity 5 / dosage channel 7, in particular across the entire width of the rim 8 and / or the dosage packaging 1 or bottom component 3. As described with respect to the embodiments above, in this case both the groove 15 and the projection 17 can extend beyond the cavity 5 / dosage channel 7 (as in the fourth embodiment), or only one of the groove 15 or the projection 17 can extend beyond the cavity 5 / dosage channel 7 (as in the third embodiment).

[0459] Furthermore, the embodiment of the fifth embodiment shown in Figures 23 to 25 shows a predetermined fracture zone 9 that is realized as a bent portion / torsion portion and / or has both a groove 15 and a protrusion 17. In particular, as with the second embodiment, it is also possible to provide only a groove 15 on the inner surface 18 and not provide a protrusion.

[0460] Consequently, any combination of the different embodiments is possible. In particular, the fifth embodiment can be combined with any of the conventional embodiments.

[0461] The molding tool 102, in particular the forming device 102C, is preferably configured / molded according to the fifth embodiment, i.e., to form a bottom part 3 having grooves 15 on an inner surface 18 and / or protrusions 17 on an outer surface 16, in particular for the purpose of forming a predetermined fracture zone 9.

[0462] In particular, the negative mold 102A includes a recess 102G and / or the positive mold 102B includes a ridge 102F. Figure 27 illustrates a negative mold 102A having the corresponding recess 102G.

[0463] Compared to the molding tool 102 or forming device 102C shown in Figures 21 and 22, the positions of the ridge 102F and the depression 102G are preferably interchangeable to form / generate the predetermined fracture zone 9 of the fifth embodiment. In other words, without repetition, the above description and features are preferably applied in a corresponding or analogous manner.

[0464] Similarly, to form a predetermined fracture zone 9 having a groove 15 on the inner surface 18 and having a reduced wall thickness and / or without a protrusion 17, it is also possible to provide a ridge 102F only on the positive mold 102B and no ridge or depression on the negative mold 102A, particularly in conjunction with the forming device 102C shown in Figures 19 and 20. In other respects, without needing to be repeated, the above description and features are preferably applied in a corresponding or indirect manner.

[0465] If the forming device 102C is designed as an insert and / or interchangeable component within the respective molds 102A and 102B, these inserts can be swapped, meaning that the forming device 102 can be adapted to generate the predetermined fracture zone 9 of the fifth embodiment by placing the insert of the negative mold 102A in the positive mold 102B and vice versa.

[0466] Figures 26 and 27 show schematic perspective views of exemplary preferred embodiments of the negative mold 102A of the molding tool 102. In this case, Figure 26 shows the negative mold 102A having a ridge 102F to form a predetermined fracture zone 9, and Figure 27 shows the negative mold 102A having a recess 102G to form a predetermined fracture zone 9.

[0467] In particular, the above descriptions and features with respect to Figures 19 to 22 preferably apply in accordance with or to the molds of Figures 26 and 27 without needing to be repeated. Similarly, the following descriptions also preferably apply to the molds described above with respect to Figures 19 to 22.

[0468] Preferably, the negative mold 102A in Figure 26 can be used to produce a dosing package 1 or bottom part 3 having grooves 15 on its outer surface 16 according to the first embodiment and / or.

[0469] Preferably, the negative mold 102A of Figure 27 can be used to produce a dosing package 1 or bottom part 3 having grooves 15 on the inner surface 18 according to the fifth embodiment and / or.

[0470] To produce a dosing packaging 1 or bottom component 3 having a predetermined break zone 9 on the rim 8, the forming device 102C, in particular the ridge 102F or recess 102G, preferably extends beyond the area for forming the cavity 5, in particular the dosing channel 7, and / or beyond the concave surface 102D. The following description and features also preferably apply to such a mold 102A.

[0471] As shown in Figures 26 and 27, the (negative) mold 102A preferably includes a plurality of (air) vents or holes 102H. Preferably, the (likewise) corresponding positive mold 102B also includes a plurality of (air) vents or holes (not shown).

[0472] The ventilation holes 102H are preferably distributed particularly evenly and / or along axis A and / or mirror-symmetrically with respect to axis A across the entire surfaces 102D and 102E of the molds 102A and 102B.

[0473] In plan or cross-sectional views, the ventilation holes 102H are preferably at least basically circular, elliptical, or oblong.

[0474] Preferably, the ventilation holes 102H extend through the molds 102A and 102B.

[0475] The ventilation holes 102H are preferably provided so that air can leak out of the molds 102A and 102B when the bottom part 3 is thermoformed, particularly when deep drawing is performed.

[0476] In particular, when the plastic sheet 200 is pushed into and / or pressed 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 leaks out into the surrounding environment through the vents 102H. In this way, preferably, the plastic sheet 200 can lie flat against the molds 102A and 102B without any obstruction by air trapped between it and the molds 102A and 102B.

[0477] Particularly preferably, as shown in Figures 26 and 27, one or more vents 102H, particularly preferably (exactly) three vents 102H, are positioned, arranged, or formed within / thereby in the forming device 102C, particularly the ridges 102F and / or depressions 102G.

[0478] Preferably, the ventilation holes 102H within / located in the forming device 102C ensure that the plastic sheet 200 lies (tightly) against the forming device 102C and / or that a predetermined break zone 9 is generated / formed in the desired shape.

[0479] The ventilation holes 102H, or at least the ventilation holes 102H located within / in the forming device 102C, preferably have a diameter of at least 0.2 mm or 0.3 mm, particularly at least 0.4 mm or 0.5 mm, and / or up to 1.0 mm or 0.9 mm, particularly up to 0.8 mm or 0.7 mm. Particularly preferred diameters are 0.5 mm, 0.6 mm, or 0.7 mm.

[0480] In particular, the ratio of the diameter of one vent 102H located within the forming device 102C to the width of the administration channel 7 located therein is preferably greater than 1:7 and / or less than 1:3. Particularly preferably, this ratio is about 1:6, 1:5, or 1:4.

[0481] Preferably, the diameter of the ventilation hole 102H located in the forming device 102C is greater than or approximately equal to the height of the forming device 102H.

[0482] The diameter of the vent hole 102H located in the forming device 102C is preferably smaller than the extension of the forming device 102C in the direction of axis A or the longitudinal extension direction of the administration channel 7.

[0483] Preferably, all vents 102H in molds 102A and / or 102B have the same shape and / or dimensions. However, it is also possible to provide vents 102H with different diameters. For example, vents 102H located in / inside forming device 102C may be smaller or larger than vents 102H formed on the outside of forming device 102C.

[0484] The location of the ventilation holes 102H may be visible on the finished dosing packaging 1 or bottom component 3. In particular, the bottom component 3 may have deformations 21 such as marks, bulges, bumps, or inscriptions at corresponding locations along axis A. This is particularly applicable to the preferred plastic sheet 200 described with reference to Figures 5 and 7.

[0485] Particularly preferably, the dosing packaging 1 or bottom component 3 has one or more deformations 21, such as marks, bulges, bumps, or inscriptions, from or generated by vents 102H in a predetermined break zone 9. As an example, Figure 25 shows the deformations 21 in a predetermined break zone 9 with dashed lines.

[0486] The deformation 21 preferably has a diameter and / or shape similar to the diameter and / or shape of each ventilation hole 102H (in the plan view).

[0487] In particular, the fracture behavior, especially the fragility, can be enhanced by one or more deformations 21 located in a predetermined fracture zone 9.

[0488] Another aspect of the present invention preferably relates to the use of a plastic sheet 200 for manufacturing a dosage package 1 for a liquid pharmaceutical product 2. The administration packaging 1 has a bottom part 3 having a cavity 5 for receiving the pharmaceutical product 2, and a rim 8 surrounding the cavity 5. The administration packaging 1 has a cover 4 that covers the cavity 5 and closes completely. The bottom part 3 is formed from a plastic sheet 200 in the form of a multilayer film, preferably by thermoforming or deep drawing. This use The plastic sheet 200 of the bottom part 3 consists of at least 5 layers: Outer thermoformable layer 201, A cyclic olefin copolymer (COC) layer 202, The inner thermoformable layer 203, The barrier layer 204 preferably includes a layer that is resistant to oxygen and / or chemical substances, A sealing layer 205, preferably a heat seal layer, Includes, A cyclic olefin copolymer layer 202 is positioned between the outer thermoformable layer 201 and the inner thermoformable layer 203, and a barrier layer 204 is positioned between the sealing layer 205 and the inner thermoformable layer 203. It is characterized by the following:

[0489] Each aspect, feature, and step of the method can be implemented independently of the others, but can also be implemented in any preferred combination or sequence.

[0490] List of reference numbers 1. Dosage packaging 1A 1 shaft end 2. Pharmaceutical products 3 Bottom parts 3A Edge 4 Covers 5 Cavity 6 Chambers 7. Administration Channels 7A 7 shaft end 7B Open end 8 rims 9. Predetermined fracture zone 10 Tip 11 Secondary Package 12 Base part 13 Lid 14 Receptacles 15 groove 16 Exterior 17 Protrusion 18. Inner self 19 Nozzle / Cross-section reduction section 20 Diffuser / Cross-sectional enlargement section 21 Transformation 100 devices 101 Heating devices 101A Upper heating plate 101B Lower heating plate 102 Molding Tools 102A Negative mold 102B Standard Mold 102C Forming Device 102D (concave) surface 102E (convex) surface 102F Elevation 102G recess 102H Ventilation holes 103 Filling device 104 Cover Devices 200 plastic sheets 201 Outer thermoformable layer 202 Cyclic olefin copolymer layer 203 Inner thermoformable layer 204 Barrier layer 205 Sealing layer 206 Middle Class 207 Connecting layer 208 Adhesive layer 300 Cover Sheets 301 Protective layer 302 The first barrier layer 303 Middle Class 304 The second barrier layer 305 Sealing layer 306 Connecting layer 307 Adhesive layer A axis D Depth T Thickness W angle

Claims

1. A dosage packaging for pharmaceutical products, A bottom component having a cavity for receiving the pharmaceutical product and a rim surrounding the cavity, A cover that covers the cavity and completely closes the cavity, It has a predetermined break zone for opening the administration packaging by breaking the break zone, The bottom component is formed from a plastic sheet in the form of a multilayer film, and the cover is a cover sheet in the form of a multilayer film. The plastic sheet of the bottom component consists of at least five layers: An outer thermoformable layer comprising or composed of a polymer 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), chain-type low-density polyethylene (LLDPE), and mixtures thereof, A cyclic olefin copolymer (COC) layer, Inner thermoformable layer, barrier layer, A sealing layer comprising a polymer selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), acid copolymer ionomer, ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol (EVOH), or mixtures thereof, Includes, 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. A dosage packaging characterized by the following:

2. The dosage packaging according to claim 1, wherein the outer thermoformable layer and the inner thermoformable layer are made from the same polymer.

3. The administration packaging (1) according to claim 1 or 2, wherein the barrier layer comprises a polymer 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 methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), poly(methyl methacrylate) (PMMA), ethylene / methyl methacrylate (EMMA), ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), polyacrylonitrile (PAN), or mixtures thereof.

4. The administration packaging according to claim 1 or claim 2, wherein the cyclic olefin copolymer layer has a thickness in the range of 200 to 600 μm.

5. The dosage packaging according to claim 1 or claim 2, wherein the thickness of the cyclic olefin copolymer layer is in the range of 5:1 to 30:1 compared to the thickness of the outer thermoformable layer and / or the thickness of the inner thermoformable layer.

6. The dosage packaging according to claim 1 or claim 2, wherein the plastic sheet of the bottom component includes an intermediate layer.

7. The plastic sheet of the bottom component has at least five layers having the following layer sequence: The aforementioned outer thermoformable layer, and thereafter, The cyclic olefin copolymer (COC) layer and the following, The aforementioned inner thermoformable layer, and thereafter, The aforementioned barrier layer and the following, The aforementioned sealing layer, The administration packaging according to claim 1 or claim 2, comprising:

8. The plastic sheet of the bottom component has six layers having the following layer sequence: The aforementioned outer thermoformable layer, and thereafter, The cyclic olefin copolymer (COC) layer and the following, The aforementioned inner thermoformable layer, and thereafter, The middle class, and the class that follows, The aforementioned barrier layer and the following, The aforementioned sealing layer, The administration packaging according to claim 1 or claim 2, comprising:

9. The dosage packaging according to claim 7, wherein the outer thermoformable layer comprises a polymer 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), chain-like low-density polyethylene (LLDPE), and mixtures thereof.

10. The aforementioned plastic sheet has a layered structure having the following layer sequence: (a) An outer thermoformable layer containing PP, and thereafter, (b) A cyclic olefin copolymer layer containing COC, and thereafter, (c) An inner thermoformable layer containing PP, and thereafter, (d) A barrier layer containing EVOH, followed thereafter (e) A sealing layer containing PE, The administration packaging according to claim 7, including the above.

11. The plastic sheet has a layered structure having the following layer sequence: (a) An outer thermoformable layer containing PP, and thereafter, (b) A cyclic olefin copolymer layer containing COC, and thereafter, (c) An inner thermoformable layer containing PP, and thereafter, (d) An intermediate layer containing PE, followed thereafter (e) A barrier layer containing EVOH, followed thereafter (f) A sealing layer containing PE, The administration packaging according to claim 8, including the above.

12. The aforementioned cover sheet consists of the following layers: protective layer, The first barrier layer, Middle class, The second barrier layer, and sealing layer, Includes, The first barrier layer is positioned between the protective layer and the intermediate layer, and the second barrier layer is positioned between the intermediate layer and the sealing layer. The administration packaging according to claim 1 or claim 2.

13. The cover sheet has the following layer structure having the following layer sequence: (i) A protective layer and the following (ii) The first barrier layer and the following, (iii) The middle class and the class that follows, (iv) The second barrier layer and the following, (v) Sealing layer and The administration packaging according to claim 1 or claim 2, comprising:

14. The cover and the bottom component are at least partially joined by the sealing layer of the plastic sheet of the bottom component and the sealing layer of the cover sheet of the cover. The administration packaging according to claim 1 or claim 2.

15. The plastic sheet of the bottom component has the following layer structure: (a) an outer thermoformable layer; (b) Cyclic olefin copolymer layer, (c) an inner thermoformable layer; (d) middle class; (e) barrier layer, and (f) a sealing layer; Includes, The aforementioned cover sheet has the following layer structure: (i) a protective layer; (ii) The first barrier layer, (iii) middle class; (iv) The second barrier layer, and (v) a sealing layer; including, The administration packaging according to claim 1 or claim 2.

16. The plastic sheet of the bottom component has the following layer structure having the following layer sequence: (a) an outer thermoformable layer and thereafter, (b) A cyclic olefin copolymer layer and thereafter, (c) An inner thermoformable layer and thereafter, (d) The barrier layer and the following (e) A sealing layer and Includes, The aforementioned cover sheet has the following layer structure: (i) A protective layer and the following (ii) The first barrier layer and the following, (iii) The middle class and the class that follows, (iv) The second barrier layer and the following, (v) Sealing layer and including, The administration packaging according to claim 1 or claim 2.

17. The plastic sheet of the bottom component has the following layer structure having the following layer sequence: (a) an outer thermoformable layer and thereafter, (b) A cyclic olefin copolymer layer and thereafter, (c) An inner thermoformable layer and thereafter, (d) The middle class and the class that follows, (e) The barrier layer and the following (f) A sealing layer and Includes, The aforementioned cover sheet has the following layer structure: (i) A protective layer and the following (ii) The first barrier layer and the following, (iii) The middle class and the class that follows, (iv) The second barrier layer and the following, (v) Sealing layer and including, The administration packaging according to claim 1 or claim 2.

18. A method for manufacturing and filling dosing packages for pharmaceutical products, The administration packaging has a bottom component having a cavity for receiving the pharmaceutical product and a rim surrounding the cavity, The administration packaging has a cover that covers the cavity and completely closes the cavity. The administration packaging has a predetermined break zone for opening the administration packaging by breaking the break zone, The bottom component is formed from a plastic sheet in the form of a multilayer film. The aforementioned cover is a cover sheet in the form of a multilayer film. The plastic sheet of the bottom component consists of at least the following five layers: An outer thermoformable layer comprising or composed of a polymer 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), chain-type low-density polyethylene (LLDPE), and mixtures thereof, A cyclic olefin copolymer (COC) layer, Inner thermoformable layer, barrier layer, A sealing layer comprising a polymer selected from the group consisting of polypropylene (PP), propylene copolymer (CoPP), polypropylene terpolymer (ter-PP), polyethylene (PE), low-density polyethylene (LDPE), chain-type low-density polyethylene (LLDPE), metallocene chain-type low-density polyethylene (mLLDPE), very low-density polyethylene (VLDPE), acid copolymer ionomer, ethylene acrylic acid copolymer (EAA), ethylene methacrylic acid copolymer (EMAA), ethyl methyl acrylate (EMA), ethylene vinyl alcohol (EVOH), or mixtures thereof, Includes, 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. The aforementioned method, - A step of heating a multi-layer plastic sheet at least partially, - A step of forming the bottom component of the administration packaging by stretching the plastic sheet onto and / or within a molding tool, wherein the bottom component has a cavity for receiving the pharmaceutical product and a rim surrounding the cavity, - A step of generating a predetermined fracture zone in the bottom part using the molding tool and / or during the step of forming the bottom part, - The step of filling the cavity with the pharmaceutical product, - The step of covering the cavity with a cover and fixing the cover to the rim so that the cavity is completely closed, including, A method characterized by the following:

19. The cavity includes a chamber and a dosing channel that is in fluid communication with the chamber. The method according to claim 18.

20. The method according to claim 18 or claim 19, wherein the predetermined fracture zone is formed only in the region of the cavity.

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