Laminate methods and products

Abstract

To provide a method for producing strong and durable laminates having improved properties in a cost-efficient manner.SOLUTION: The present invention provides a method for producing a laminate film, the method comprising the steps of: i) providing a base layer that is water-resistant and / or oxygen-resistant; ii) providing a contact layer; and iii) laminating the base layer to the contact layer, preferably by adhesive lamination or coextrusion lamination, wherein the contact layer comprises COC, PA, EVOH, CBC, PVDF, COP, HDPE, or EMAA.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a new laminated film whereby a contact layer is adhesively laminated to a base layer such as a metal foil or whereby a coextruded layer comprising a contact layer and at least one tie layer is adhered to a base layer, and to the use of the laminated film to package APIs (active pharmaceutical ingredients) such as nicotine, fentanyl, lidocaine, and rivastigmine. [Background technology]

[0002] In the pharmaceutical industry, substances including highly active substances such as nicotine, fentanyl, rivastigmine, and lidocaine are packaged as tablets into inhalers, patches, etc., which results in special requirements for the packaging, lamination, or film to seal these substances to ensure that harmful degradation or ingestion does not occur.

[0003] The requirements for packaging, films or laminates are typically as follows: -Mechanically stable laminate that does not separate or deform -Ensuring packaging is child-resistant to increase the safety of potentially dangerous compounds - Inert properties that ensure that compounds from the environment outside the laminate do not migrate through the laminate and come into contact with the sealed material The encapsulated API does not react with or migrate through or into the surfaces it comes into contact with.

[0004] A commercially used polymer that meets some or all of the requirements for extreme chemical resistance and inertness properties is polyacrylonitrile (PAN)-based film, which is sold as a resin under the trademark Barex®, manufactured by Ineos, among others. Barex® is widely used and approved for drug and food applications and is used because of its good barrier to oxygen, nitrogen, and carbon dioxide compared to other common polymers, as well as its excellent chemical resistance to different functional groups such as hydrocarbons, ketones, esters, alcohols, bases, and acids, and / or drugs such as nicotine.

[0005] Furthermore, extruded Barex® resin is heat stable and therefore weldable at temperatures of about 160 to 220°C, making it suitable for use in flexible packaging. However, Barex® is sold at a high price because its manufacture and subsequent extrusion into film is difficult, resulting in high material loss. Furthermore, the water and oxygen resistance of Barex® is not satisfactory for all purposes.

[0006] A solution is also described in the applicant's WO 2017 / 114922, which discloses a laminated film having a coextrusion or coextrusion coating with a tie layer and a contact layer, the contact layer being the innermost layer facing a highly active chemical agent such as rivastigmine, nicotine, fentanyl or lidocaine. The contact layer may comprise a polyamide, a cyclic olefin copolymer, or ethylene vinyl alcohol. The tie layer is coextrusion coated onto the base layer such that the tie layer is in contact with the base layer and the contact layer.

[0007] A further solution is described in WO 2015 / 123211, which discloses a film with a tie layer and a contact layer comprising a COC and PE blend facing a drug such as nicotine. The film can be produced by providing coextrusion layers or by adhesive lamination.

[0008] However, in view of the expanding market and demand for flexible packaging, there is a pressing need to find various solutions and methods for producing strong, durable laminates in a cost-effective manner, with the same or improved properties compared to prior art products. Summary of the Invention

[0009] Against this background, it is an object of the present invention to provide a solution that meets one or more of the above-mentioned needs, namely, inter alia, a solution that provides impermeability and inertness to packaging, while providing a mechanically strong laminate that does not separate, deform, puncture, is sealable and otherwise resistant to mechanical impacts, and further provides alternative methods of producing such products with similar or improved properties.

[0010] One solution involves adhesive lamination. Adhesive lamination allows for high-speed manufacturing, the ability to use a wide variety of films, and thin membranes. Therefore, adhesive lamination is less specialized than, for example, extrusion coating, which incurs higher capital costs. Additionally, adhesive lamination offers higher lamination strength, making it a good alternative to extrusion coating when providing new laminated films using other methods.

[0011] Thus, in a first aspect, this is solved by providing a method for providing a laminated film, said method comprising the following steps: i) providing a substrate that is water-resistant and / or oxygen-resistant ii) providing a contact layer ii) laminating the base layer to the contact layer, preferably by adhesive lamination or extrusion lamination. The contact layer comprises a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

[0012] Preferably, the contact layer is made of a material that is a polymer selected from the group consisting of cyclic olefin copolymers, polyamides, ethylene vinyl alcohol, cyclic block copolymers, polyvinylidene fluoride, cyclic olefin polymers, high density polyethylene, or ethylene-methacrylic acid copolymers and physical variations thereof.

[0013] The contact layer may be one or more layers. Preferably, the contact layer is a single layer. In certain embodiments, the contact layer is a single layer of one material.

[0014] The adhesive lamination can be performed by either solventless lamination or solvent-based lamination, and preferably the lamination is solvent-based. Preferably, the solvent is ethyl acetate or methyl ethyl ketone, although other suitable solvents are contemplated and within the scope. The adhesive is preferably a two-component adhesive based on polyurethane and aromatic or aliphatic amine. Such two-component adhesives are well known in the art. Solvent-based adhesive lamination is preferred because it allows for longer chains, which results in stronger bonding of the laminate.

[0015] Preferably, the base layer and contact layer are directly adhesive laminated, meaning that there are no further layers between the adhesive layers.

[0016] As an alternative to adhesive lamination, extrusion lamination can be used. The extrusion lamination may use a copolymer made from a material selected from a copolymer of ethylene and acrylic acid, a copolymer of ethylene and methacrylic acid, and a terpolymer comprising ethylene, an acrylic acid ester, and a third polymer, the third polymer preferably being glycidyl methacrylate, more preferably maleic anhydride, or alternatively, the extrusion lamination may use PMMA.

[0017] Extrusion lamination with PMMA may be particularly beneficial when the contact layer comprises or is PVDF. An example of a suitable PMMA is Plexiglas® HFI7. Preferably, the PMMA is pure.

[0018] Suitably, the base layer is laminated to at least a first outer layer, preferably the first outer layer comprises polyethylene terephthalate (PET), polyethylene (PE), paper or a combination thereof.

[0019] Typically, the thickness of the contact layer or each sublayer of the contact layer is in the range of 20 to 60 μm, although thicknesses of 15 to 20 μm are also contemplated.

[0020] In one embodiment, the contact layer is a polyamide, and the side of the polyamide layer facing away from the base layer comprises an amorphous polyamide. Preferably, the amorphous polyamide layer and one or more crystalline polyamide layers are coextruded. In this embodiment, the contact layer is not a single layer.

[0021] In embodiments where the contact layer is PA, the contact layer is not corona treated on the amorphous PA side facing away from the substrate. Preferably, the side of the contact layer facing the substrate is corona treated prior to lamination.

[0022] By applying an amorphous PA and / or by not corona treating the side of the contact layer facing away from the substrate, i.e., the sealing side of the contact layer, the polyamide layer becomes weldable / sealable at lower temperatures starting at about 140-160°C, in contrast to commercially used PAs (such as PA6 or PA66 available from BASF), which require much higher temperatures of up to 230°C.

[0023] A good seal / weld is obtained when the amorphous PA layer comprises about 10 to 40% of the thickness of the contact layer, as this is a balance to obtain a contact layer that is sealable at lower temperatures and still facilitates smooth manufacturing.

[0024] In another embodiment, the contact layer is a monolayer comprising or consisting of COC. When the monolayer is a blend, the COC content of the blend is at least 40% (w / w) of the monolayer.

[0025] In some embodiments where the contact layer is a COC layer, the side of the layer facing the base layer is corona treated. Typically, when the contact layer is or comprises COC, the COC layer or each of the layers making up the contact layer has a thickness of 18 to 22 μm, preferably 20 μm.

[0026] In a further embodiment, the contact layer comprises or consists of COC coextruded with the tie layer.

[0027] The tie layer is suitably low density polyethylene (LDPE), particularly when the contact layer is COC.

[0028] In a further embodiment, the contact layer is ethylene vinyl alcohol (EVOH). When the contact layer is EVOH, the layer or layers that make up the contact layer typically have a thickness of 20 to 50 μm, more preferably 25 to 35 μm, and most preferably 30 μm.

[0029] In a further embodiment, the contact layer comprises or is a cyclic block copolymer, and the layer has a thickness of from 20 to 60 μm.

[0030] In a further embodiment, the contact layer comprises or is polyvinylidene fluoride, and the layer has a thickness of 15 to 50 μm.

[0031] In a further embodiment, the contact layer comprises or is a cyclic olefin polymer, and the layer has a thickness of from 20 to 60 μm.

[0032] In a further embodiment, the contact layer comprises or is high density polyethylene, and the layer has a thickness of from 15 to 60 μm.

[0033] In a further embodiment, the contact layer comprises or is an ethylene-methacrylic acid copolymer, and the layer has a thickness of from 15 to 50 μm.

[0034] In a further embodiment, the contact layer comprises or is a polyamide and the layer has a thickness of from 15 to 60 μm.

[0035] In further embodiments, the contact layer is a cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

[0036] It is contemplated that all embodiments and embodiment variations can be used to encapsulate active ingredients, preferably highly active ingredients such as lidocaine, amphetamine, testosterone, fentanyl, oxymorphone, tetrahydrocannabinol, rivastigmine, nicotine, diclofenac, dexdibuprofen, ibuprofen, Dl-camphor, dextromethorphan, ondansetron, donepezil, methylphenidate, isopropyl myristate, i-metol, methyl salicylate, diphenhydramine, tolbuterol, buprenorphine, clonidine, scopolamine, and the like, with fentanyl, nicotine, lidocaine, or rivastigmine being preferred.

[0037] Thus, in a further variation, the laminate film or final laminate film encapsulates the composition and the laminate film is sealed / welded into a pouch, sachet or used as a lidding film to a container.

[0038] Also provided is a laminated film, comprising at least one base layer that is water-resistant and / or oxygen-resistant, and a contact layer bonded to the base layer, the contact layer comprising or consisting of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). The contact layer may be adhesively bonded to the base layer. It is understood that the method used to bond the contact layer to the base layer may be adhesive lamination or extrusion lamination. The film may be manufactured according to the method outlined in the first aspect of the invention.

[0039] The laminated film can be filled with an active chemical substance. The active chemical substance can be any suitable substance. For example, it can be selected from lidocaine, amphetamine, testosterone, fentanyl, oxymorphone, tetrahydrocannabinol, rivastigmine, nicotine, diclofenac, dexdibuprofen, ibuprofen, Dl-camphor, dextromethorphan, ondansetron, donepezil, methylphenidate, isopropyl myristate, i-metol, methyl salicylate, diphenhydramine, tolbuterol, buprenorphine, clonidine, scopolamine, and preferably fentanyl, nicotine, lidocaine, or rivastigmine.

[0040] Also provided is the use of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), or high density polyethylene (HDPE) or ethylene-methacrylic acid copolymer (EMAA) in the contact layer of a film for packaging highly active chemicals.

[0041] A second solution involves co-extrusion. Thus, in a second aspect of the present invention, there is provided a method for providing a laminated film, said method comprising the steps of: i) providing a substrate that is water-resistant and / or oxygen-resistant ii) providing a contact layer iii) coating the base layer with a coextruded layer, said coextruded layer comprising said contact layer and a tie layer; iv) allowing the coextruded layer to adhere to the base layer The contact layer comprises a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

[0042] Preferably, the tie layer comprises: a) One layer, the loading of one layer is at least 3g / m 2 is, or b) multiple layers, at least one of the layers having a loading of at least 3 g / m 2 or the total loading of the layers is at least 3 g / m 2 is.

[0043] The loading of the (individual) tie layers was found to have an effect on seal strength, and the results presented in this application clearly show an increase in seal strength following an increase in the loading of the contact layer portion of the coextrudate. However, at 3 g / m of layers 2 In the region of , there is a rapid decrease in seal strength when the tie layer loading becomes too low, and when there are two or more tie layers, the total loading of the tie layers is less than 3 g / m 2 It is also clear that it exceeds

[0044] In some embodiments, the contact layer is comprised of a material that is a polymer selected from the group consisting of cyclic olefin copolymers, polyamides, ethylene vinyl alcohol, cyclic block copolymers, polyvinylidene fluoride, cyclic olefin polymers, high density polyethylene, or ethylene-methacrylic acid copolymers and physical variations thereof.

[0045] The contact layer may comprise or consist of a polymer selected from the group consisting of cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

[0046] The contact layer must be at least 5 g / m 2 , preferably at least 10 g / m 2 The ion exchange membrane may have a loading of 1000 volts.

[0047] Suitably the tie layer is made up of 1, 2, 3, 4 or 5 layers.

[0048] In some embodiments, all layers of the tie layer are coextruded with the contact layer. The coextruded layers may be coextrusion coated onto the base layer.

[0049] In some embodiments, the tie layer is comprised of one layer that is a copolymer made from a material selected from copolymers of ethylene and acrylic acid, copolymers of ethylene and methacrylic acid, and terpolymers comprising ethylene, an acrylic acid ester, and a third polymer, preferably glycidyl methacrylate, more preferably maleic anhydride.

[0050] In some embodiments, the tie layer comprises at least two layers, a first layer comprising a copolymer according to the above and at least a second or more layers comprising a material selected from EEA, PE, EMA, EAA, or a combination.

[0051] In some embodiments, the tie layer or at least one layer of the tie layers may comprise or consist of PMMA. An example of a suitable PMMA is Plexiglas® HFI7. Such tie layers may be particularly beneficial when the contact layer comprises or consists of PVDF, especially in extrusion coating. Preferably, the PMMA is pure.

[0052] In some embodiments, the contact layer is a polyamide, and the side of the polyamide layer facing away from the base layer comprises an amorphous polyamide.

[0053] Preferably, the layer, for example the polyamide layer, is amorphous. In an alternative embodiment, part of the layer may be amorphous, for example 10 to 40% (w / w).

[0054] The laminate film may enclose the composition, and the laminate film may be sealed into a pouch, sachet, or used as a lidding film on a container.

[0055] Preferably, the method further comprises laminating at least a first outer layer to the base side of the laminate film.

[0056] The total thickness of the laminated film may be in the range of 70 to 140 μm.

[0057] There is also provided a laminated film, the film comprising at least one base layer that is water and / or oxygen resistant, and a coextruded layer, the coextruded layer comprising a tie layer and a contact layer, the contact layer comprising or consisting of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE) or ethylene-methacrylic acid copolymer (EMAA). The film may be obtained by the method outlined in the second aspect of the invention.

[0058] The active chemical substance can be loaded into the laminated film. The active chemical substance can be any suitable substance. For example, it can be selected from lidocaine, amphetamine, testosterone, fentanyl, oxymorphone, tetrahydrocannabinol, rivastigmine, nicotine, diclofenac, dexdibuprofen, ibuprofen, Dl-camphor, dextromethorphan, ondansetron, donepezil, methylphenidate, isopropyl myristate, i-metol, methyl salicylate, diphenhydramine, tolbuterol, buprenorphine, clonidine, scopolamine, and preferably fentanyl, nicotine, lidocaine, or rivastigmine.

[0059] Also provided is the use of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), or high density polyethylene (HDPE) or ethylene-methacrylic acid copolymer (EMAA) in the contact layer of a film for packaging highly active chemicals.

[0060] The invention, including embodiments and variations, is described in more detail below. DETAILED DESCRIPTION OF THE INVENTION

[0061] The term "film" or "laminated film" according to the present invention contemplates a product comprising a base layer laminated, for example by adhesive lamination or extrusion lamination, and a coextruded or coextrusion coated contact layer. Further outer layers, such as PET and paper, may be added.

[0062] "Packaging" is intended in the context of the present invention to mean the final laminated film used to fill a composition or compound, or a container otherwise sealed with a film according to the present invention.

[0063] The term "highly reactive compound or composition" is to be understood as a compound / composition that is reactive with metals, acids, bases, or functional groups such as ketones, alcohols, hydrocarbons and / or esters, and / or is volatile, but easily migrates through barriers.

[0064] The term "oxygen and water resistant" as used in the context of the present invention contemplates a material having an Oxygen Transfer Rate (OTR) and / or Water Vapor Transfer Rate (WVTR) of no more than 1, preferably no more than 0.1, as further detailed below. The term WVTR may also be referred to as Water Vapor Transmission Rate (MVTR). WVTR and MVTR are equivalent.

[0065] The term "mechanical abrasion-resistant layer" used to describe the outer layer should be understood as a material suitable for manufacturing flexible packaging. The mechanical abrasion-resistant layer can be selected from materials such as, but not limited to, polyethylene or polyamide-based sheets, ortho-phthalaldehyde-based sheets, or polyester-based sheets, or combinations. Furthermore, the mechanical abrasion-resistant material, i.e., the first outer layer, can be provided as a biaxially oriented film to impart higher mechanical strength, such as tear strength, to the packaging. The term "biaxially oriented" should be understood to mean that the provided polymer film is stretched in both the longitudinal and transverse directions during manufacturing.

[0066] The term "outside" should be understood in its broadest sense. The term external environment is used to define the side opposite to the side facing the composition or compound sealed by the laminate or package of the present invention. This means that the term external environment is independent of whether additional layers are coated, laminated, or otherwise attached to the film. Thus, the term is used to identify which side of the layer faces.

[0067] According to all embodiments of the present invention, the base layer may be selected from, but is not limited to, a metal foil, preferably an aluminum foil, such as commercially available Alu foil, e.g. from Hydro, or an AlOx-coated PET film, e.g. from Toray Films Europe, or an SiOx-coated PET film, e.g. from Celplast under the trade name Ceramis®, a polymer selected from polyamide, polyvinylidene chloride, silicon- or aluminum oxide-coated polyester, and / or a fluoropolymer.

[0068] According to the present invention, water resistance and / or oxygen resistance is preferably measured at 23°C and 0% RH according to ASTM standard D3985 at 1 cm 3 / m 2 Oxygen Transfer Rate (OTR) of 24 hr / bar or less, and / or 1 g / m according to ASTM standard F1249 at 38°C and 90% RH 2 / 24hr or less, and preferably both the WVTR and OTR are each 0.01 g / m 2 / 24hr or 0.01cm 3 / m 2 / 24hr / bar less.

[0069] In accordance with the present invention, the base layer of the film is selected to provide multiple properties to the laminate film and packaging containing the laminate film. The base layer can provide the desired barrier and support properties to the final laminate / packaging. Additionally, the base layer can be a gas- and water-impermeable base layer, and more preferably a water- and / or oxygen-resistant base layer.

[0070] In embodiments where the contact layer is hygroscopic, the base layer is preferably made from a metal foil such as aluminum. Aluminum is competitively priced and is an excellent barrier to all gases and moisture. Furthermore, like other metal-like materials, aluminum has good crease properties, i.e., it does not unfold once folded, reflects radiant heat, and provides decorative appeal to laminates and packaging.

[0071] Typically, the thickness of the substrate is 5 to 15 μm, preferably 7 to 12 μm, more preferably 8 to 10 μm, such as 9 μm, particularly when the substrate comprises or consists of aluminium. If the substrate comprises or consists of a polymer, for example PET, the thickness may be greater, for example in the range of 1 to 50 μm.

[0072] According to the present invention, the contact layer must be chemically resistant / inert to the APIs, such as so-called active substances and excipients, ultimately packaged, if present. Furthermore, the contact layer must exhibit low absorption of substances that migrate through the film or laminate. The degree of absorption acceptable for a given substance is typically determined by the substance manufacturer, but acceptable values ​​are often in the range of 0 to 1% (w / w). For some products, up to 10% (w / w) is typically acceptable for products with a low initial API content. Absorption is calculated as the weight of API in the package after a set period of storage for a particular product relative to the initial weight of API in the commercial product. Typical shelf lives are about 2 years, e.g., 18 months to 5 years.

[0073] It will be understood that the parameter by which the thickness of the contact layer is reflected will depend, as is conventional in the art, on the method by which the laminate is formed. Thus, for laminates formed by lamination, for example adhesive lamination or extrusion lamination, the parameter used to reflect the thickness of the contact layer is in μm. For laminates in which at least one tie layer and contact layer are coextruded, the parameter used to define the contact layer and tie layer is in g / m. 2 Those skilled in the art can determine the thickness of each layer as needed from the loading and density of the material used.

[0074] The contact layer preferably comprises a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

[0075] It is also envisaged that the contact layer is a blend of one of the polymers defined above in combination with an inferior polymer such as polyethylene (PE), a polyethylene blend or other polymer known to those skilled in the art. In the case of a blend, the contact layer suitably or preferably comprises at least 50% (w / w) of COC, PA, EVOH, CBC, PVDF, COP, HDPE or EMAA.

[0076] It is also contemplated that when the film is adhesively laminated, the contact layer may comprise two or more layers, including one or more tie layers. In such embodiments, the side of the contact layer facing away from the base layer may be designated the seal layer, and the side of the contact layer facing the base layer is designated the tie layer. When the contact layer and / or tie layer are made of two or more layers, these layers may be made by any suitable method, such as coextrusion.

[0077] According to all embodiments of the present invention, the contact layer may be made from a material selected from cyclic olefin copolymers, polyamides, ethylene vinyl alcohol, cyclic block copolymers, polyvinylidene fluoride, cyclic olefin polymers, high-density polyethylene, or ethylene-methacrylic acid copolymers (EMAA), or mixtures thereof, such as the commercial products EVAL® C109B sold by Kuraray, Selar PA 3426 R sold by Dupont®, or COC 6013M-07, COC 8007F-600, 7010F-600 or 9506F500 sold by Topas®, or EVOH available from Nippon Gohsei under the trade name Soarnol®, and the COC film may be provided by Amcor or Plastique Venthenat. Other examples include ViviOn 8210 (CBC) sold by USI corporation, Kynar® 710 (PVDF) sold by Zeus Industrial Products, ZEONOR® 1420R (COP) sold by Zeon Specialty Materials, Inc., CG9620 or CG8410 (HDPE) sold by Borealis AG, and Surlyn® (EMAA) sold by Dupont®. Other variations of the same functionality are within the scope of the present invention.

[0078] Table 1 lists non-exclusive examples of commercially available polymers that can be used as contact layers in accordance with the present invention. [Table 1]

[0079] Preferably, the contact layer consists of only one material, i.e., the contact layer is cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). Preferably, the contact layer is a single layer. Even more preferably, it is a single layer of one material. Despite the challenges associated with providing a single-component contact layer, this may be preferred to avoid scalping, as blends containing PE may permeate and thus result in a sieve-like layer over time.

[0080] It has been found that chemically resistant films and laminates can be obtained when the contact layer contains one of the polymers from the above group, even if the polymers chemically represent different polymer types, even if they have a relatively low RED value. Tests have shown that the resistance of laminated films containing the preferred polymers shows results similar to or better than those of laminates coated / laminated with, for example, the commercial product Barex®. The RED value or HSP parameter is a parameter known to those skilled in the art, and further details can be found, inter alia, in Hansen, C., M., Hansen Solubility Parameters a User's Handbook, 2nd Ed., CRC Press, Boca Raton, 2007.

[0081] EVOH is typically used in lamination due to its excellent oxygen barrier properties and tear strength. Although it is known to be very hydrophilic and hygroscopic (i.e., has a high WVTR), EVOH is well suited as a contact layer in accordance with the present invention.

[0082] Also, polyamide (PA) has typically been used in lamination due to its excellent mechanical properties such as tear strength or as a barrier. With respect to EVOH, it is noteworthy that despite the hydrophilicity of PA, PA can be used as a contact layer to provide a chemically resistant laminate film.

[0083] Due to the hydrophilicity of PA and EVOH, in a preferred embodiment, the laminated film obtained according to the present invention may be tightly packed in a moisture barrier, especially if it has to be stored. The laminated film according to the present invention may be packed immediately after production and should remain safely packed until further use, for example in a filling line.

[0084] In some embodiments, the contact layer is made from a blend of at least two polymers. Using a blend can be a means to reduce costs and to match the physical and chemical properties of the lamination process, for example, lowering or raising the melt temperature to match the layer profile of the tie layer, if present, and the polarity of the blend, improving the adhesive properties of the layers and therefore the robustness of the final product.

[0085] In one variation, the cyclic olefin copolymer, polyamide, ethylene vinyl alcohol, cyclic block copolymer, polyvinylidene fluoride, cyclic olefin polymer, high density polyethylene, or ethylene-methacrylic acid copolymer (EMAA) constitutes at least 50% w / w of the blend of the contact layer, preferably at least 60% w / w, more preferably at least 80% w / w, and most preferably at least 95% w / w of the or each layer of the contact layer. In this variation, the contact layer may be a single layer or may be comprised of two or more layers.

[0086] The tie layer may be selected from ethylene methacrylic acid (EMAA), ethylene acrylic acid (EAA), preferably ethylene acrylic acid (EEA-high acid) having an acrylic acid content of at least 10% (W / W) based on the total weight of the ethylene acrylic acid layer, a terpolymer of ethylene, methacrylic acid and glycidyl methacrylate, a terpolymer of ethylene, an acrylic acid ester and maleic anhydride, preferably ethylene, butyl acrylate and maleic anhydride (t-EBAMA), an acrylic acid ester and maleic anhydride, preferably ethylene butyl acrylate, maleic anhydride (t-EBAMA), ethylene methyl acrylate (EMA), ethylene butyl acrylate (EBA), ethylene ethyl acrylate (EEA), low density polyethylene (LDPE), a metallocene compound, or a combination thereof.

[0087] Preferably, the laminate according to the present invention further comprises a first outer layer preferably made from a material selected from, but not limited to, paper, polyethylene or polyamide based sheets, ortho-phthalaldehyde based sheets, or polyester based sheets, or combinations thereof, such as the commercial product F-PAP sold by Flexpet. When polyester based sheets are used, it is preferred that the first outer layer is a combination of materials.

[0088] Preferably, the first outer layer and the laminating film are laminated to provide a package. Laminating the first outer layer to the laminating film provides a strong laminate when tested under several parameters, and the package can be easily wrapped and sealed / welded.

[0089] Preferably, the laminate film further comprises a second outer layer facing the outside of the first outer layer. Preferably, the second outer layer is a paper layer. The paper layer is typically printed with the product name, color, and / or logo, and the product manufacturer. It is also or alternatively contemplated that the first outer layer can be printed. In some embodiments where the first outer layer is polyethylene, the laminate film further comprises a second outer layer.

[0090] It is contemplated that adhesives and / or polymeric agents may be applied between the various layers. The adhesives and / or polymeric agents used between the first outer layer and the base layer or the second outer layer may be made from the same or different materials as the adhesives used for adhesive lamination of the base and contact layers. Furthermore, the agents applied between these layers may be selected from polymers selected from the group of materials used as tie layers according to the present invention or two-component adhesives extrusion laminated using water-based adhesives, the latter being particularly the case when a paper layer is used.

[0091] Further suitable adhesives are those approved for use in packaging products for human use and are well known to those skilled in the art. Suitable adhesives may be selected from, but are not limited to, polyurethane-based adhesives, epoxy-based adhesives, or acrylic-based adhesives well known to those skilled in the art.

[0092] According to all aspects and embodiments of the present invention utilizing adhesive lamination, the adhesive used in adhesive lamination is a two-component adhesive commonly known in the art. Thus, it is based on a polyurethane and an epoxy, e.g., a polyurethane and an aromatic or aliphatic amine. Exemplary commercially available polyurethane adhesives that can be used in accordance with the present invention are LOCTITE LIOFOL LA 3644-21 MHS / LA 6055 available from Loctite® or Adcote™ 811A EA / MOR-FREE™ 200C coreactant available from Dow.

[0093] When the adhesive lamination is solvent-based, the solvent is suitably selected from ethyl acetate, acetone, and methyl ethyl ketone or other solvents known to those skilled in the art.

[0094] In use, the solvent and two-component adhesive are mixed in the usual manner and in the specific ratios specified by the manufacturer. The base material and hardener are mixed in the ratio recommended by the adhesive supplier—typically 8:1 to 15:1 calculated on a solids basis, although other ratios are contemplated.

[0095] The solvent is added to give a viscosity in the range of 15 to 22 seconds, for example about 17 to 18 seconds, measured by DIN CUP 4 under the DIN 53211 standard, a method well known to those skilled in the art.

[0096] Advantageously, most of the polymers, adhesives and other ingredients that can be used in the present method are conventional and thereby readily available from a variety of suppliers, thereby providing for cost-effective production.

[0097] The method further contemplates the following steps: a) optionally providing a first and / or second outer layer; b) providing a laminated film according to the present invention c) placing a composition containing the compound on the contact layer side of the laminated film; d) sealing the outer layer and / or laminate film, preferably by heat sealing, to provide a hollow interior space for sealing the composition, said hollow space having an inside and an outside, the inside of the film being the contact layer of the adhesive laminate and the outside of the film being the base layer and / or the first and second outer layers. It is contemplated that the first and / or second outer layers may be laminated to the laminate film prior to steps c) and d), for example in one combined lamination step.

[0098] In general, the order in which the different layers of the packaging according to the invention are applied to the base layer is flexible. Thus, the first outer layer may be applied before the adhesive lamination, or vice versa. The order depends on which production line is appropriate in a particular situation.

[0099] Further provided by the present invention are laminated films and packaging made according to the present method.

[0100] According to the present invention, the laminated film according to the present invention has various uses. In one embodiment of the present invention, the laminated film is used to encase a composition comprising a compound selected from nicotine, fentanyl, lidocaine and rivastigmine, preferably the compound is formulated as a patch, such as a transdermal patch.

[0101] According to the present invention, when the composition is a patch, the amount of active ingredient remaining after storage at 40°C for at least 7 days is a maximum of + / - 10% (w / w) compared to the same active ingredient sealed in a similar Barex® patch as Index 100.

[0102] According to the present invention, the resulting laminated film is heat-sealable or weldable. A heat-sealable laminated film can seal itself during heat sealing without deformation. Deformation is undesirable in terms of quality assurance, and the deformation must be carefully accounted for, which is very labor-intensive. Furthermore, legislation in many countries is very strict. Therefore, films and / or laminates with deformation cannot be loaded with active ingredients. Therefore, mechanical properties are very important from the perspective of cost-effective manufacturing. Similarly, it is important that the laminate is tightly packed.

[0103] The resulting laminated film of the present invention must be inert and impermeable to the compound it encapsulates. Thus, in one embodiment of the present invention, after 12 weeks of storage at 40° C., up to 10% (w / w) of the compound has migrated into the laminated film, preferably up to 5% (w / w), even more preferably up to 1.5% (w / w), and most preferably up to 0.5% (w / w).

[0104] The laminated film of the present invention can suitably encapsulate compositions or compounds containing active ingredients selected from the group consisting of nicotine, rivastigmine, fentanyl and lidocaine, which are known to be highly active chemicals / compounds and require special packaging.

[0105] The packaging should preferably comply with international standards such as ISO 8317 (2003), which corresponds to 16 CFR § 1700.20 (for the US) and DIN EN ISO 8317 (2004) (for Europe). "Packaging" is intended in the context of the present invention to mean the complete laminated film, optionally including the first and / or second outer layer used to fill the compound.

[0106] The sealing of the package is achieved in such a way that the contact layer of the laminate film faces the compound or composition, while the rest of the package is protected by the contact layer. In this way, the compound or composition is kept inside the package and is therefore only in direct contact with the contact layer of the laminate film layer.

[0107] The following are specific, non-limiting embodiments of the present invention that have demonstrated favorable properties.

[0108] Adhesive lamination example: Specific laminated films with COC as contact layer: 1) Paper / Adhesive / Aluminum / Adhesive / COC 2) PET / adhesive / aluminum / adhesive / COC 3) Paper / Adhesive / Aluminum / Adhesive / OPA / Adhesive / COC 4) Paper / Adhesive 3g / PET 23μm / Adhesive 3g / Aluminum / Adhesive / COC

[0109] More specifically: 1) Paper 50gsm / Adhesive 3g / Aluminum 9μm / Adhesive 3g / COC 20μm 2) PET 36 μm / adhesive 3 g / aluminum 9 μm / adhesive 3 g / COC 20 μm 3) Paper 40gsm / Adhesive 3g / Aluminum 9μm / Adhesive 3g / OPA 15μm / Adhesive 3g / COC 20μm 4) Paper 40gsm / Adhesive 3g / PET 23μm / Adhesive 3g / Aluminum 9μm / Adhesive 3g / COC 20μm

[0110] Specific laminated films with PA as contact layer: 1) Paper / Adhesive / Aluminum / Adhesive / PA 2) PET / adhesive / aluminum / adhesive / PA 3) Paper / Adhesive / Aluminum / Adhesive / OPA / Adhesive / PA 4) Paper / Adhesive / PET / Adhesive / Aluminum / Adhesive / PA.

[0111] More specifically: 1) Paper 50gsm / Adhesive 3g / Aluminum 9μm / Adhesive 3g / PA 40μm 2) PET 23 μm / adhesive 3 g / aluminum 9 μm / adhesive 3 g / PA 40 μm 3) Paper 40gsm / Adhesive 3g / Aluminum 9μm / Adhesive 3g / oPA 15μm / Adhesive 3g / PA 40μm 4) Paper 40gsm / Adhesive 3g / PET 23μm / Adhesive 3g / Aluminum 9μm / Adhesive 3g / PA 40μm

[0112] Specific laminated films with EVOH as contact layer: 1) PET / PE / aluminum / adhesive / EVOH 2) Paper / Adhesive / Aluminum / Adhesive / EVOH 3) PET / adhesive / aluminum / adhesive / EVOH 4) Paper / Adhesive / Aluminum / Adhesive / OPA / Adhesive / EVOH 5) Paper / Adhesive / PET / Adhesive / Aluminum / Adhesive / EVOH

[0113] More specifically: 1) PET 50μm / PE 14g / Aluminum 9μm / Adhesive 3g / EVOH 30μm 2) Paper 50 gsm / Adhesive 3 g / Aluminum 9 μm / Adhesive 3 g / EVOH 30 μm 3) PET 36 μm / adhesive 3 g / aluminum 9 μm / adhesive 3 g / EVOH 30 μm 4) Paper 40 gsm / Adhesive 3 g / Aluminum 9 μm / Adhesive 3 g / OPA 15 μm / Adhesive 3 g / EVOH 30 μm 5) Paper 40gsm / Adhesive 3g / PET 23μm / Adhesive 3g / Aluminum 9μm / Adhesive 3g / EVOH 30μm

[0114] Example 1: Strength of adhesive lamination The present invention will now be described in more detail with reference to the following non-limiting examples which test the seal strength of illustrative laminate films of the present invention. In all embodiments, seal strength was measured using the DIN 55529 standard.

[0115] Laminated films with 100% COC as the sole contact layer: It contains PET 23 μm / adhesive / al 9 μm / adhesive / COC 20 μm, made by adhesive lamination using a two-component solvent urethane adhesive.

[0116] Laminated film 0.5N / mm 2 The seal was made at 120 to 190°C for 0.5 seconds. The resulting seal strengths were 10 to 15 N / 15 mm, which is equivalent to a similar Barex® laminate with a 20 to 25 micron Barex® layer instead of the COC.

[0117] Films with 100% cast PA as the sole contact layer It contains PET 23 μm / adhesive / al 9 μm / adhesive / CPA 40 μm, made by adhesive lamination using a two-component solvent urethane adhesive.

[0118] Laminated film 0.5N / mm 2 The seal was made at 150 to 200°C for 0.5 seconds. The seal strengths obtained in the temperature range of 150 to 200°C were 25 to 40 N / 15 mm. This strength is equivalent to a similar Barex® laminate with a 50 micron Barex® layer, meaning that the laminate with PA as the contact / sealing layer provides a higher seal strength than Barex®, even with a lower film thickness of the contact / sealing layer.

[0119] Films with 100% EVOH as the sole contact layer: It contains PET 50µm / PE 12gsm / al 9µm / adhesive / EVOH 30µm, manufactured by adhesive lamination using a two-component solvent urethane adhesive.

[0120] Laminated film 0.5N / mm 2 The seal was made at 150 to 200°C for 0.5 seconds. The resulting seal strengths were 25 to 40 N / 15 mm, which is equivalent to that of a similar Barex® laminate with a 50 micron Barex® layer. Thus, the EVOH film provides the same seal strength despite the thinner film thickness of the sealing layer, which also means that higher seal strengths than Barex® can be obtained if desired.

[0121] Example 2: RED&CHI Values

[0122] Tests were conducted to determine the RED and CHI values ​​of PVDF, HDPE and EMAA samples for a range of chemical species.

[0123] RED calculation

[0124] Determination of the HSP value and interaction radius requires that the solubility of a drug be evaluated in at least 16 solvents with a range of polarity and hydrogen bonding properties. The methodology for determining HSP values, interaction radii and RED values ​​is explained in C. M. Hansen: "Hansen Solubility Parameters, A User's Handbook", CRC Press, 2007, Second Edition, and exemplified in EP2895531.

[0125] To assess solubility, each sample was first weighed into a standard test tube and an aliquot of the screening solvent was added. The tubes were then placed on a rotating platform for 24 hours and visually inspected to see if the sample had dissolved / swelled.

[0126] If the sample is soluble, a score of 1 is given; if the sample swells, a score of 2 is given; if the sample cannot be soluble, a score of 3 is given.

[0127] When solubility is plotted in Hansen space (three dimensions: δD = dispersion parameter / δP = polar parameter / δH = hydrogen bonding parameter), where 1 = soluble, 2 = swollen, and 3 = insoluble, the solubility domains can be calculated using a fitting algorithm. The relevant parameters for PVDF, HDPE, and EMAA are summarized in Table 2, and the test results are shown in Table 3. [Table 2]

[0128] The RED and CHI values ​​for samples for a range of chemical species are shown in Table 3. [Table 3]

[0129] It will be understood that the RED value reflects an experimental determination of R, while the CHI represents a theoretical determination based on the volume of API.

[0130] An API with both RED and CHI greater than 1 is considered highly suitable for packaging in a film faced by a contact layer, and an API with one of RED and CHI (typically the CHI value) less than 1 is considered less suitable. An API with both RED and CHI less than 1 is considered even less suitable for packaging in a film with a contact layer of interest.

[0131] As can be seen from both experiment and theoretical calculations, the contact layers tested have broad applicability as contact layers for APIs (values ​​less than 1 are in italics).

[0132] Example 3: Strength of co-extruded example:

[0133] The mechanical properties were tested. Different laminated films were made containing all the outer and base layers to mimic the commercial products. The laminated films were produced by varying the application of the coextrusion as shown in Table 4.

[0134] All laminated films were made of PET23 / AL9 with coextruded HDPE as follows: Tie Layer 2: Nucrel® 0609 HSA (ethylene methacrylic acid) Tie Layer 1: PE MI15 (PE, e.g. Borealis® CA9150) Contact layer: Borealis® CG9620 (HDPE) [Table 4] As can be seen, there was a discrepancy between the target loading and the actual loading, and in fact the discrepancy is believed to be due to the tie layer loading being lower than the target value.

[0135] method: The mechanical properties of the laminated films in Table 4 were tested. In particular, the following properties were tested: -Tear strength -Puncture resistance (front side) -Sealing strength -Lamination strength -Exploratory testing

[0136] All tests are performed according to industry standards with some modifications as detailed below: Tear Strength - Per ASTM D1938-14, no change.

[0137] Puncture Resistance - Follow ASTM F1306 with the following changes: sample diameter is 48 mm instead of 34.9 mm, and piercer tip diameter is 3.0 mm instead of 3.2 mm.

[0138] Sealing strength: No change as per DIN55529. The sealing strength test was carried out under the following conditions: 160°C, 500N pressure, 0.5 seconds.

[0139] Laminate Strength: Followed ASTM D903-98(2010) with the following modifications: sample width was 15mm instead of 25mm, and samples were not conditioned to 23°C + / - 1°C, 50% RH + / - 2%. Instead, all samples were kept in the same place and therefore continuously under the same conditions. Pull speed was set at 100mm / min instead of 305mm / min. The measurement angle was 90° instead of 180°.

[0140] The probe strength test was carried out as follows: a four-sided sealed bag was sealed with a size of 80 mm x 90 mm, including a 5 mm wide sealed area, under the parameters of 160°C, 0.5 seconds and 500 N pressure.

[0141] The bag was held and pierced with a syringe connected to a pressure device. The bag was then inflated to a pressure of 0.2 bar in one test (probe test 1) and to a pressure of 0.25 bar in another test (probe test 2). The success criterion for a given laminate was to withstand the pressure for 30 seconds without bursting.

[0142] The results of all the tests performed are shown in Table 5. [Table 5]

[0143] Consider Tear strength levels range from 1.5 to 6.1 N. The results show that the main influence on tear strength is the thickness of the contact layer, rather than the thickness of the tie layer or the total thickness of the coextruded layers.

[0144] When it comes to puncture resistance, Samples 1 to 9 show puncture resistance of 36.7N to 46.4N (front side). This is only an increase of about 22% even though the coating weight increased by a factor of four from the lowest to the highest loading. This indicates that the substrate is the primary influence on puncture resistance.

[0145] Lamination strength could not be measured because all samples tore when an attempt was made to separate the coextrudates, indicating that in all circumstances the adhesion level of the coextrudates was greater than the tear strength of the coextrudates.

[0146] Regarding seal strength, the results clearly show an increase in seal strength following an increase in the loading of the contact layer portion of the coextrudate. However, when the tie layer loading becomes too low, above 3 g / m per layer, 2 It can also be seen that the seal strength drops sharply in the region of 0.05 mm. This is seen in Sample 1, which has a seal strength of 7.3 N / 15 mm, and Sample 5, which has a seal strength of 12.9 N / 15 mm.

[0147] Sample 1 is 7.4 g / m 2 Sample 5 has a contact layer loading of 14 g / m, which is about the same as Sample 2, but Sample 2 has a significantly higher seal strength. 2 but has a contact layer loading of 12 g / m 2 The seal strength is lower than that of Sample 4, which has a contact layer loading of 20 g / m. 2 Even so, the measured total loading of sample 5 was 17 g / m 2 Note that the tie layer loading was actually 3 g / m 2 This indicates that the difference is less than

[0148] This was also confirmed in the exploration tests where samples 1 and 5 were unable to withstand the internal pressure of 3 g / m 2 These results indicate that tie layer loadings in excess of 0.1% are important in at least some circumstances to achieve desired properties.

[0149] item

[0150] The "A" section relates to adhesive lamination. A1 1. A method for providing a laminated film, comprising: i) providing a substrate that is water-resistant and / or oxygen-resistant; ii) providing a contact layer; iii) laminating said base layer to said contact layer, preferably by adhesive lamination or extrusion lamination; The contact layer comprises a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). A2 The method according to item A1, wherein the contact layer is a polymer selected from the group consisting of cyclic olefin copolymer, polyamide, ethylene vinyl alcohol, cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE) or ethylene-methacrylic acid copolymer (EMAA). A3 The method according to any one of claims A1 to A2, wherein the contact layer is a single layer. A4 The method according to any one of items A1 to A3, wherein the lamination is an adhesive lamination, in particular a solvent-based adhesive lamination. A5 The method according to item A4, wherein the adhesive used for adhesive lamination is a two-component adhesive based on polyurethane and aromatic or aliphatic amine, preferably the solvent is ethyl acetate. A6 The method according to any one of items A1 to A3, wherein the lamination is an extrusion lamination. The method according to claim A6, wherein the extrusion lamination uses a copolymer made of a material selected from a copolymer of ethylene and acrylic acid, a copolymer of ethylene and methacrylic acid, and a terpolymer comprising ethylene, an acrylic acid ester, and a third polymer, the third polymer being preferably glycidyl methacrylate, more preferably maleic anhydride, or alternatively the extrusion lamination uses PMMA. A8 The method of any one of items A1 to A7, wherein the base layer is laminated to at least a first outer layer, preferably the first outer layer comprises polyethylene terephthalate (PET), polyethylene (PE), paper, or a combination thereof. A9 The method of any one of items A1 to A8, wherein the contact layer is a polyamide and the side of the polyamide layer facing away from the base layer comprises amorphous polyamide. A10 The method according to item A9, wherein the amorphous polyamide layer and the polyamide layer are coextruded. A11 The method according to any one of claims A8 to A9, wherein the side of the contact layer facing the base layer is corona treated. The method of any one of items A9 to A11, wherein the amorphous PA layer comprises 10 to 40% of the thickness of the contact layer. A13 The method of any one of paragraphs A1 to A8, wherein the contact layer comprises or consists of COC. A14 The method according to item A13, wherein the contact layer comprises COC, and the COC content is at least 40% (w / w), or the contact layer is a co-extrusion of COC and a tie layer. A15 The method according to any one of items A13 to A14, wherein the COC layer is corona treated. A16 The method according to any one of items A13 to A15, wherein the COC layer has a thickness of 18 to 22 μm, preferably 20 μm. A17 The method of any one of items A1 to A8, wherein the contact layer is ethylene vinyl alcohol and the EVOH layer has a thickness of 25 to 35 μm, preferably 30 μm. A18 The method of any one of items A1 to A8, wherein the contact layer includes or is a cyclic block copolymer, and the layer has a thickness of 20 to 60 μm. A19 The method of any one of items A1 to A8, wherein the contact layer includes or is polyvinylidene fluoride, and the layer has a thickness of 15 to 50 μm. A20 The method of any one of items A1 to A8, wherein the contact layer includes or is a cyclic olefin polymer, and the layer has a thickness of 20 to 60 μm. A21 The method of any one of items A1 to A8, wherein the contact layer includes or is high density polyethylene, and the layer has a thickness of 15 to 60 μm. The method of any one of items A1 to A8, wherein the contact layer comprises or is an ethylene-methacrylic acid copolymer, and the layer has a thickness of 15 to 50 μm. A23 The method of any one of items A1 to A8, wherein the contact layer includes or is a polyamide, and the layer has a thickness of 15 to 60 μm. A24 The method of any one of paragraphs A1 to A23, wherein the laminate film encapsulates the composition, and the laminate film is sealed into a pouch, a sachet, or used as a lidding film on a container. A25 The method of any one of items A1 to A24, wherein the method further comprises laminating at least a first outer layer to the base layer side of the laminate film. A26 The method of any one of items A1 to A25, wherein the thickness of the laminated film is in the range of 70 to 140 μm. A27 1. A laminate film comprising at least one base layer that is water-resistant and / or oxygen-resistant, and a contact layer bonded to said base layer, said contact layer comprising or consisting of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). A28 The laminate film according to item A27, wherein the contact layer is adhesively bonded to the base layer. A29 A laminated film according to Item A27, obtained by the method according to any one of Items A1 to A26. A30 A highly active chemical loaded in a laminate film, said laminate film being described in any one of items A27, A28 or A29. A31 A highly active chemical substance loaded into a laminated film according to item A30, wherein the highly active chemical substance is selected from the group consisting of nicotine, fentanyl, lidocaine and rivastigmine. A32 Use of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), or high density polyethylene (HDPE) or ethylene-methacrylic acid copolymer (EMAA) in the contact layer of a film for packaging highly active chemicals.

[0151] Item "B" relates to coextrusion. B1 1. A method for providing a laminated film, comprising: i) providing a substrate that is water-resistant and / or oxygen-resistant; ii) providing a contact layer; iii) coating the base layer with a coextruded layer, said coextruded layer comprising said contact layer and a tie layer; iv) allowing the coextruded layer and the base layer to adhere to each other; The method, wherein the contact layer comprises a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). B2 The Thai formation has the following: b) One layer, the loading of one layer is at least 3g / m 2 or b) multiple layers, at least one of the layers having a loading of at least 3 g / m 2 or the total loading of the layers is at least 3 g / m 2 The method according to Item B1, B3 The method according to any one of items B1 to B2, wherein the contact layer is a polymer selected from the group consisting of cyclic olefin copolymer, polyamide, ethylene vinyl alcohol, cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). B4 The method of any one of items B1 to B3, wherein the contact layer is a cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). The contact layer has a thickness of at least 5 g / m 2, preferably at least 10 g / m 2 The method of any one of paragraphs B1 to B4, comprising the loading of B6 The method of any one of paragraphs B1 to B4, wherein the tie layer is made up of 1, 2, 3, 4 or 5 layers. B7 The method of claim B6, wherein all layers of the tie layer are coextruded with the contact layer. B8 The method of any one of items B1 to B7, wherein the coextruded layer is coextrusion coated onto the base layer. B9 The method of any one of items B1 to B8, wherein the tie layer is comprised of one layer, the layer being a copolymer made of a material selected from a copolymer of ethylene and acrylic acid, a copolymer of ethylene and methacrylic acid, and a terpolymer comprising ethylene, an acrylic acid ester, and a third polymer, the third polymer being preferably glycidyl methacrylate, more preferably maleic anhydride. B10 The method of any one of items B1 to B8, wherein the tie layer comprises at least two layers, a first layer comprising the copolymer described in item B8, and at least a second or more layers comprising a material selected from EEA, PE, EMA, EAA, or a combination. B11 The method of any of items B1 to B10, wherein the contact layer is polyamide and the side of the polyamide layer facing away from the base layer comprises amorphous polyamide. B12 The method of any one of paragraphs B1 to B11, wherein the laminate film encapsulates a composition and the laminate film is sealed into a pouch, a sachet, or used as a lidding film on a container. B13 The method of any one of items B1 to B12, wherein the method further comprises laminating at least a first outer layer to a base side of the laminate film. B14 The method according to any one of items B1 to B13, wherein the total thickness of the laminated film is in the range of 70 to 140 μm. B15 1. A laminate film comprising at least one base layer that is water and / or oxygen resistant and a coextruded layer, said coextruded layer comprising a tie layer and a contact layer, said contact layer comprising or consisting of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA). B16 The laminated film according to item B15, obtained by the method according to any one of items B1 to B14. B17 The laminated film is described in either one of paragraphs B15 or B16. A highly active chemical loaded in the laminated film. B18 The highly active chemical substance loaded into the laminated film according to item B17, wherein the highly active chemical substance is selected from the group consisting of nicotine, fentanyl, lidocaine, and rivastigmine. B19 Use of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), or high density polyethylene (HDPE) or ethylene-methacrylic acid copolymer (EMAA) in the contact layer of a film for packaging highly active chemicals. B20 The use according to item B19, comprising a base layer, a tie layer, and a contact layer, wherein the contact layer and the tie layer are co-extrusion coated onto the base layer.

Claims

1. 1. A method for providing a laminated film, comprising: i) providing a substrate that is water and / or oxygen resistant; ii) providing a contact layer; iii) laminating said base layer to said contact layer, preferably by adhesive lamination or extrusion lamination; The contact layer comprises a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

2. 10. The method of claim 1, wherein the contact layer is a polymer selected from the group consisting of cyclic olefin copolymer, polyamide, ethylene vinyl alcohol, cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

3. The method of claim 1 or 2, wherein the contact layer is a single layer.

4. 4. The method according to any one of claims 1 to 3, wherein the lamination is an adhesive lamination, in particular a solvent-based adhesive lamination.

5. 5. The method according to claim 4, wherein the adhesive used for adhesive lamination is a two-component adhesive based on polyurethane and aromatic or aliphatic amine, preferably the solvent is ethyl acetate.

6. The method of any one of claims 1 to 3, wherein the lamination is an extrusion lamination.

7. 7. The method of claim 6, wherein the extrusion lamination uses a copolymer made from a material selected from a copolymer of ethylene and acrylic acid, a copolymer of ethylene and methacrylic acid, and a terpolymer comprising ethylene, an acrylic acid ester, and a third polymer, preferably glycidyl methacrylate, more preferably maleic anhydride, or alternatively the extrusion lamination uses PMMA.

8. 8. The method of any one of claims 1 to 7, wherein the base layer is laminated to at least a first outer layer, preferably the first outer layer comprising polyethylene terephthalate (PET), polyethylene (PE), paper, or a combination thereof.

9. 9. The method of claim 1, wherein the contact layer is polyamide and the side of the polyamide layer facing away from the base layer comprises amorphous polyamide.

10. 10. The method of claim 9, wherein the amorphous polyamide layer and the polyamide layer are coextruded.

11. 10. The method of claim 8 or 9, wherein the side of the contact layer facing the base layer is corona treated.

12. 12. The method according to any one of claims 9 to 11, wherein the amorphous PA layer constitutes 10 to 40% of the thickness of the contact layer.

13. 9. The method of claim 1, wherein the contact layer comprises or consists of COC.

14. 14. The method of claim 13, wherein the contact layer comprises COC, the COC content being at least 40% (w / w), or the contact layer is a co-extrusion of COC and a tie layer.

15. 15. The method of claim 13 or 14, wherein the side of the COC layer facing the substrate is corona treated.

16. 16. A method according to any one of claims 13 to 15, wherein the COC layer has a thickness of 18 to 22 μm, preferably 20 μm.

17. 9. The method of any one of claims 1 to 8, wherein the contact layer comprises or is ethylene vinyl alcohol, the EVOH layer having a thickness of 25 to 35 μm, preferably 30 μm.

18. 9. The method of claim 1, wherein the contact layer comprises or is a cyclic block copolymer, the layer having a thickness of 20 to 60 μm.

19. 9. The method of claim 1, wherein the contact layer comprises or is polyvinylidene fluoride, the layer having a thickness of 15 to 50 μm.

20. 9. The method of claim 1, wherein the contact layer comprises or is a cyclic olefin polymer, the layer having a thickness of from 20 to 60 μm.

21. 9. A method according to any one of claims 1 to 8, wherein the contact layer comprises or is high density polyethylene, the layer having a thickness of 15 to 60 μm.

22. 9. A method according to any one of claims 1 to 8, wherein the contact layer comprises or is an ethylene-methacrylic acid copolymer, the layer having a thickness of from 15 to 50 μm.

23. 9. The method of claim 1, wherein the contact layer comprises or is a polyamide, the layer having a thickness of 15 to 60 μm.

24. 24. The method of any one of claims 1 to 23, wherein the laminate film encapsulates the composition, and the laminate film is sealed into a pouch, a sachet, or used as a lidding film on a container.

25. 25. The method of any one of claims 1 to 24, further comprising laminating at least a first outer layer to the base layer side of the laminate film.

26. 26. The method of any one of claims 1 to 25, wherein the thickness of the laminated film is in the range of 70 to 140 μm.

27. A laminated film, 1. A laminated film comprising at least one base layer that is water-resistant and / or oxygen-resistant, and a contact layer bonded to said base layer, said contact layer comprising or consisting of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), high density polyethylene (HDPE), or ethylene-methacrylic acid copolymer (EMAA).

28. 30. The laminate film of claim 27, wherein the contact layer is adhesively bonded to the base layer.

29. 28. A laminate film according to claim 27, obtainable by the method according to any one of claims 1 to 26.

30. 30. A highly active chemical loaded into a laminate film, said laminate film being as defined in any one of claims 27, 28 or 29.

31. 31. The laminated film loaded active chemical of claim 30, wherein the active chemical is selected from the group consisting of nicotine, fentanyl, lidocaine, and rivastigmine.

32. Use of a polymer selected from the group consisting of cyclic olefin copolymer (COC), polyamide (PA), ethylene vinyl alcohol (EVOH), cyclic block copolymer (CBC), polyvinylidene fluoride (PVDF), cyclic olefin polymer (COP), or high density polyethylene (HDPE) or ethylene-methacrylic acid copolymer (EMAA) in the contact layer of a film for packaging highly active chemical substances.

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