Lid Sheet For Use in a Blister Pack

Abstract

A lid sheet for use in a blister form pack for packaging of pharmaceutical and medical products, wherein said lid sheet is a laminate comprising four layers A, B, C and D with the layer sequence A-B-C-D and the layers comprising as follows: (Layer A) a layer A material selected from the group consisting of cellulose material; aluminium foil; plastic film with a temperature resistance of at least 1 second at 220° C.; lacquer with a temperature resistance of at least 1 second at 220° C.; and anti-adhesive coating; (Layer B) a layer B material selected from the group consisting of: (1) at least two non-orientated, mono-orientated or biaxially orientated plastic films displaced at an angle and bonded by means of lamination or hot calendaring or plastic coating with a net-like structure; (2) non-woven material made from a plastic polymer; (3) at least one fibre or a plastic film possessing a net-like web; (4) a foil comprising a material selected from the group consisting of Polysulfone, Polyethylenenaphthalate PEN, polyphenylsulfone (PPSU), polyimide (PI); Polyetherimide (PEI) and Tetrafluoroethylene/ethylene; and (5) a multilayer foil consisting of at least two of the aforementioned materials; (Layer C) aluminium foil; and (Layer D) a heat seal layer.

1 . A lid sheet for use in a blister form pack for packaging of pharmaceutical and medical products, wherein said lid sheet is a laminate comprising four layers A, B, C and D with the layer sequence A-B-C-D and the layers comprising as follows:
 (Layer A) a layer A material selected from the group consisting of cellulose material; aluminium foil; plastic film with a temperature resistance of at least 1 second at 220° C.; lacquer with a temperature resistance of at least 1 second at 220° C.; and anti-adhesive coating;   (Layer B) a layer B material selected from the group consisting of: (1) at least two non-orientated, mono-orientated or biaxially orientated plastic films displaced at an angle and bonded by means of lamination or hot calendaring or plastic coating with a net-like structure; (2)(non-woven material made from a plastic polymer; (3) at least one fibre or a plastic film possessing a net-like web; (4) a foil comprising a material selected from the group consisting of Polysulfone, Polyethylenenaphthalate PEN, polyphenylsulfone (PPSU), polyimide (PI); Polyetherimide (PEI) and Tetrafluoroethylene/ethylene; and (5) a multilayer foil consisting of at least two of the aforementioned materials;   (Layer C) aluminium foil; and   (Layer D) a heat seal layer.   
   
   
       2 . A lid sheet according to  claim 1 , wherein layers A and B and layers B and C are bonded using a laminating aid to achieve a bond strength of at least 2N/15 mm. 
   
   
       3 . A lid sheet according to  claim 1 , wherein the paper of layer A is untreated, coated or satined and has a weight of 15 to 100 g/m2. 
   
   
       4 . A lid sheet according to  claim 1 , wherein the aluminium foil of layer A has a thickness of 6 to 60 μm. 
   
   
       5 . A lid sheet according to  claim 1 , wherein the temperature resistant plastic film of layer A has a thickness of 7 to 25 μm. 
   
   
       6 . A lid sheet according to  claim 1 , wherein the temperature resistant plastic film of layer A is selected from the group consisting of Polyethylenterephthalate (PET), orientated Polyamide (OPA), Polysulfone (PSU), Polyphenylsulfone (PPSU), Polyaryletherketone (PEEK), Polyimide (PI), Polyetherimide (PEI), Tetrafluorethylene/ethylene, and any combination thereof, and wherein said temperature resistant plastic film of layer A has a thickness of 7 to 25 μm. 
   
   
       7 . A lid sheet according to  claim 1 , wherein the plastic films of layer B are individually selected from the group consisting of Polyethylene (PE), in particular VLDPE, LLDPE, LMDPE, LDPE or HDPE, Polypropylene (PP), Polyester, Polyamide (PA), Polystyrene (PS), Polycarbonate (PC), halogen-containing plastics, in particular Polyvinychloride (PVC), Polyvinylidenchloride (PVDC) or Polychlorotrifluoroethylene (PCTFE), Poly-Acrylic-Nitrile (PAN), Tetrafluoroethylene and any combination thereof and wherein said plastic films of layer B has a thickness of 8 to 200 μm. 
   
   
       8 . A lid sheet according to  claim 1 , wherein the plastic coating of the net-like structure of layer B is selected from the group consisting of Polyethylene (PE), Polypropylene (PP), Polyester, Polyamide (PA), halogen-containing plastics, Tetrafluorethylene/ethylene, protein (satin), and any combination thereof, and wherein said plastics coating has a surface weight of 30 to 150 g/m 2 . 
   
   
       9 . A lid sheet according to  claim 1 , wherein the non-woven fibre of layer B is selected from the group consisting of HDPE, Polyester, PET/Polybutylenterephthalate (PBT) with Polyamide 6 or Polyamide 6.6, Polyester with polyolefines, Tetrafluoroethylene/ethylene, and any combination thereof, and wherein the non-woven fibre of layer B has a weight of 10 to 120 g/m 2 . 
   
   
       10 . A lid sheet according to  claim 1 , wherein the foil consisting of at least one fibre or a plastic film of layer B possessing a net-like web comprises a material selected from the group consisting of Polyethylene (PE), Polyprolylene (PP), Polyester, Polyamide (PA), Polystyrene (PS), Polycarbonate (PC), halogen-containing plastics, Poly-Acrylic-Nitrile (PAN), Tetrafluoroethylene/ethylene, and any combination thereof and wherein the foil has a thickness of 8 to 200 μm. 
   
   
       11 . A lid sheet according to  claim 1 , wherein the individual films of the multiplayer foil of layer B are independently selected from the group consisting of Polyethylene (PE), Polypropylene (PP), Polyester, Polyamide (PA), Polystyrene (PS), Polycarbonate (PC), halogen-containing plastics, Poly-Acrylic-Nitrile (PAN), Tetrafluorethylene/ethylene, and any combination thereof and wherein the individual films have a thickness of 8 to 200 μm. 
   
   
       12 . A lid sheet according to  claim 1 , wherein the aluminium foil of layer C has a thickness of 7 to 60 μm. 
   
   
       13 . A blister form pack for packaging of pharmaceutical and medical products comprising
 (a) a base sheet in which blisters are formed to define pockets therein; and   (b) a lid sheet according to  claim 1 , which is sealable to the base sheet except in the region of the blisters and mechanically peelable from the base sheet.   
   
   
       14 . A blister form drug pack according to  claim 13  comprising
 (a) a base sheet in which blisters are formed to define pockets therein for the containment of inhalable drug;   (b) a lid sheet which is sealable to the base sheet except in the region of the blisters and mechanically peelable from the base sheet to enable release of said inhalable drug,   
     wherein said lid sheet has a laminate structure comprising at least the following successive layers:
 (Layer A) an outer lid sheet layer of cellulose material; bonded to 
 (Layer B) a first intermediate lid sheet layer of comprising of a layer B material; bonded directly or indirectly to 
 (Layer C) an aluminium foil lid sheet layer; bonded directly or indirectly to 
 (Layer D) an inner lid sheet heat seal layer. 
 
   
   
       15 . A drug pack according to  claim 14  in the form of an elongate blister strip. 
   
   
       16 . A drug pack according to  claim 14 , wherein the first intermediate lid sheet layer comprises woven polyamide. 
   
   
       17 . A drug pack according to  claim 16 , wherein the woven polyamide layer has a thickness from 50 to 100 micron. 
   
   
       18 . A drug pack according to  claim 17 , wherein bonding of the woven polyamide layer to its adjacent layers is by way of adhesive lamination. 
   
   
       19 . A drug pack according to  claim 17 , wherein bonding of the woven polyamide layer to its adjacent layers is by way of extrusion lamination. 
   
   
       20 . A drug pack according to  claim 14 , wherein the first intermediate lid sheet layer comprises spun-PET. 
   
   
       21 . A drug pack according to  claim 20 , wherein the spun-PET is of weight from 10 to 250 g/m 2 . 
   
   
       22 . A drug pack according to  claim 21 , wherein bonding of the spun-PET layer to its adjacent layers is by way of a lamination technique selected from the group consisting of extrusion lamination, co-extrusion lamination and lacquer lamination. 
   
   
       23 . A drug pack according to  claim 22 , wherein bonding of the spun-PET layer to its adjacent layers is by way of polyethylene (PE) extrusion lamination. 
   
   
       24 . A drug pack according to  claim 14 , wherein the first intermediate lid sheet layer comprises spun-HDPE. 
   
   
       25 . A drug pack according to  claim 24 , wherein the spun-HDPE is of weight from 10 to 80 g/m 2 . 
   
   
       26 . A drug pack according to  claim 24 , wherein bonding of the spun-HDPE layer to its adjacent layers is by way of extrusion lamination. 
   
   
       27 . A drug pack according to  claim 26 , wherein bonding of the spun-HDPE layer to its adjacent layers is by way of polyethylene (PE) extrusion. 
   
   
       28 . A drug pack according to  claim 14 , wherein the first intermediate lid sheet layer comprises cross-laminated HDPE. 
   
   
       29 . A drug pack according to  claim 28 , wherein said cross-laminated HDPE comprises at least two HDPE films cross-laminated to each other at a cross-lamination angle of from 30 to 60°. 
   
   
       30 . A drug pack according to  claim 28 , wherein the cross-laminated HDPE layer has a thickness from 30 to 100 micron, particularly from 50 to 80 micron. 
   
   
       31 . A drug pack according to  claim 14 , wherein the first intermediate lid sheet layer comprises cross-laminated PET. 
   
   
       32 . A drug pack according to  claim 31 , wherein said cross-laminated PET comprises at least two PET films cross-laminated to each other at a cross-lamination angle of from 30 to 60°. 
   
   
       33 . A drug pack according to  claim 31 , wherein the cross-laminated PET layer has a thickness from 30 to 100 micron. 
   
   
       34 . A drug pack according to  claim 14 , wherein the outer paper lid sheet layer comprises paper of grade from 10 to 50 g/m 2 . 
   
   
       35 . A drug pack according to  claim 14 , wherein the thickness of the aluminium foil lid sheet layer is from 10 to 60 micron. 
   
   
       36 . A blister form drug pack comprising
 (a) a base sheet in which blisters are formed to define pockets therein for the containment of inhalable drug;   (b) a lid sheet which is sealable to the base sheet except in the region of the blisters and mechanically peelable from the base sheet to enable release of said inhalable drug,   
     wherein said lid sheet has a laminate structure comprising at least the following successive layers:
 (i) an outer lid sheet layer of cellulose material; bonded directly or via an optional first intermediate layer of polymeric material to 
 (ii) an aluminium foil lid sheet layer; bonded to 
 (iii) an inner lid sheet layer of polymeric material. 
 
   
   
       37 . A drug pack according to  claim 36  in the form of an elongate blister strip. 
   
   
       38 . A drug pack according to  claim 36 , wherein said optional first intermediate layer of polymeric material comprises polyethylene (PE) extrusion layer and the inner lid sheet layer of polymeric material comprises a peelable co-extrusion coating. 
   
   
       39 . A drug pack according to  claim 38 , wherein the peelable co-extrusion coating layer has a weight of from 5 to 50 g/m 2 . 
   
   
       40 . A drug pack according to  claim 36 , wherein no optional first intermediate layer of polymeric material is present and the inner lid sheet layer of polymeric material comprises a peel film. 
   
   
       41 . A drug pack according to  claim 40 , wherein said peel film is selected from the group consisting of a polyethylene (PE) peel film, a polyvinyl chloride (PVC) peel film and a polypropylene (PP) peel film. 
   
   
       42 . A drug pack according to  claim 40 , wherein the peel film is particularly suitable for peelable sealing to an inner base sheet layer comprising polyvinyl chloride (PVC) or polyethylene (PE). 
   
   
       43 . A drug pack according to  claim 40 , wherein the peel film layer is of thickness from 10 to 80 micron. 
   
   
       44 . A drug pack according to  claim 36 , wherein the optional first intermediate layer of polymeric material comprises poly (ethylene terephthalate) (PET) and the inner lid sheet layer of polymeric material comprises polyvinyl chloride (PVC). 
   
   
       45 . A drug pack according to  claim 44 , wherein the PET layer is of thickness from 5 to 30 micron; and the PVC layer is of thickness from 5 to 50 micron. 
   
   
       46 . A drug pack according to  claim 36 , wherein the optional first intermediate layer of polymeric material comprises spun poly (ethylene terephthalate) (spun-PET) and the inner lid sheet layer of polymeric material comprises a peel film. 
   
   
       47 . A drug pack according to  claim 46 , wherein said peel film is selected from the group consisting of a polyethylene (PE) peel film, a polyvinyl chloride (PVC) peel film and a polypropylene (PP) peel film. 
   
   
       48 . A drug pack according to  claim 46 , wherein the peel film is particularly suitable for peelable sealing to an inner base sheet layer comprising polyvinyl chloride (PVC) or polyethylene (PE). 
   
   
       49 . A drug pack according to  claim 46 , wherein the spun-PET layer is of thickness from 10 to 60 micron; and the peel film layer is of thickness from 5 to 50 micron. 
   
   
       50 . A drug pack according to  claim 36 , wherein the optional first intermediate layer of polymeric material comprises cross-laminated high density polyethylene (HDPE) and the inner lid sheet layer of polymeric material comprises a peel film. 
   
   
       51 . A drug pack according to  claim 50 , wherein said cross-laminated HDPE comprises at least two HDPE films cross-laminated to each other at a cross-lamination angle of from 30 to 60°. 
   
   
       52 . A drug pack according to  claim 50 , wherein said cross-laminated HDPE layer is of thickness from 30 to 100 micron; and the peel film layer is of thickness from 5 to 50 micron. 
   
   
       53 . A drug pack according to  claim 50 , wherein said peel film is selected from the group consisting of a polyethylene (PE) peel film, a polyvinyl chloride (PVC) peel film and a polypropylene (PP) peel film. 
   
   
       54 . A drug pack according to  claim 50 , wherein the peel film is particularly suitable for peelable sealing to an inner base sheet layer comprising polyvinyl chloride (PVC) or polyethylene (PE). 
   
   
       55 . A drug pack according to  claim 36 , wherein bonding of the optional first intermediate layer of polymeric material to its adjacent layers is by way of a lamination technique selected from the group consisting of extrusion lamination, co-extrusion lamination and lacquer lamination. 
   
   
       56 . A drug pack according to  claim 36 , wherein the outer paper lid sheet layer comprises paper of grade from 10 to 80 g/m 2 . 
   
   
       57 . A drug pack according to  claim 36 , wherein the thickness of the aluminium foil lid sheet layer is from 10 to 60 micron. 
   
   
       58 . A drug pack according to  claim 14 , wherein the base sheet herein comprises (i) a first base sheet layer of aluminium foil; and (ii) a second base sheet layer of polymeric material of thickness from 10 to 150 micron. 
   
   
       59 . A drug pack according to  claim 58 , wherein the first base sheet layer of aluminium foil typically has a thickness of from 15 to 120 micron. 
   
   
       60 . A drug pack according to  claim 58 , wherein the second base sheet layer of polymeric material has a thickness of from 10 to 120 micron. 
   
   
       61 . A drug pack according to  claim 58 , wherein the second base sheet layer comprises a polymeric material of water vapour permeability of less than 0.6 g/(100 inches 2 ) (24 hours) (mil) at 25° C. 
   
   
       62 . A drug pack according to  claim 61 , wherein the second base sheet layer comprises a material selected from the group consisting of polyvinyl chloride (PVC); polypropylene; polyethylene; polyvinylidene chloride (PVDC); polychlorotrifluoroethylene (PCTFE); cyclic olefin copolymer (COC); and cyclic olefin polymer (COP). 
   
   
       63 . A drug pack according to  claim 58 , wherein the first base sheet layer of aluminium foil is provided with an outer base sheet layer of a polymeric material. 
   
   
       64 . A drug pack according to  claim 63 , wherein, said outer layer base sheet layer comprises oriented polyamide (OPA). 
   
   
       65 . A drug pack according to  claim 40 , wherein the base sheet has a PE peel film provided as an inner base sheet layer. 
   
   
       66 . A drug pack according to  claim 44 , wherein the base sheet is provided with an inner base sheet layer comprising heat seal lacquer. 
   
   
       67 . A drug pack according to  claim 46 , wherein the base sheet is provided with an inner base sheet layer comprising polyvinyl chloride (PVC). 
   
   
       68 . A blister form drug pack according to  claim 46 , wherein one or more of said blisters of the pack contain inhalable drug in dry powder form. 
   
   
       69 . A blister form drug pack according to  claim 68 , wherein said inhalable drug comprises one or more drug actives selected from the group consisting of anti-inflammatory agents, anticholinergic agents, other β 2 -adrenoreceptor agonists, antiinfective agents, antihistamines and any mixtures thereof. 
   
   
       70 . A blister form drug pack according to  claim 69 , wherein said anti-inflammatory agents are selected from the group consisting of corticosteroids, NSAIDs and any mixtures thereof. 
   
   
       71 . A blister form drug pack according to  claim 69 , wherein said corticosteroids are selected from the group consisting of methyl prednisolone, prednisolone, dexamethasone, fluticasone propionate, 6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester, 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioic acid S-(2-oxo-tetrahydro-furan-3S-yl)ester, beclomethasone esters, flunisolide, mometasone esters, triamcinolone acetonide, rofleponide, ciclesonide, butixocort propionate, RPR-106541, and ST-126 and any mixtures thereof. 
   
   
       72 . A blister form drug pack according to  claim 69 , wherein said NSAIDs are selected from the group consisting of sodium cromoglycate, nedocromil sodium, phosphodiesterase (PDE) inhibitors, leukotriene antagonists, inhibitors of leukotriene synthesis, iNOS inhibitors, tryptase and elastase inhibitors, beta-2 integrin antagonists, adenosine receptor agonists or antagonists, cytokine antagonists, inhibitors of cytokine synthesis and any mixtures thereof. 
   
   
       73 . A drug dispenser device comprising a housing; and within said housing an elongate form blister form drug pack according to  claim 68 , wherein the dispenser device includes an internal mechanism for dispensing the inhalable drug from the pockets of the drug pack, said mechanism comprising,
 a) an opening station for receiving a pocket of the drug pack;   b) peeling means positioned to engage the base sheet and the lid sheet of a pocket which has been received in said opening station for peeling apart such base sheet and lid sheet, to open such a pocket, said peeling means including lid driving means for pulling apart the lid sheet and the base sheet of a pocket that has been received at said opening station;   c) an outlet, positioned to be in communication with an opened pocket through which a user can access a drug dose from such an opened pocket;   d) indexing means for individually indexing the distinct pockets of the drug pack.   
   
   
       74 . (canceled) 
   
   
       75 . A blister form pack for packaging of packaging of products, the pack comprising
 (a) a base sheet in which blisters are formed to define pockets therein; and   (b) a lid sheet according to any of  claims 1  to  12 , which is sealable to the base sheet except in the region of the blisters and mechanically peelable from the base sheet.