CA2620754A1 - Cold-formable laminate for blister base parts - Google Patents
Cold-formable laminate for blister base parts Download PDFInfo
- Publication number
- CA2620754A1 CA2620754A1 CA002620754A CA2620754A CA2620754A1 CA 2620754 A1 CA2620754 A1 CA 2620754A1 CA 002620754 A CA002620754 A CA 002620754A CA 2620754 A CA2620754 A CA 2620754A CA 2620754 A1 CA2620754 A1 CA 2620754A1
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- layer
- coc
- opa
- pet
- blend
- Prior art date
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Links
- 239000000203 mixture Substances 0.000 claims abstract description 45
- 239000005030 aluminium foil Substances 0.000 claims abstract description 27
- 238000004806 packaging method and process Methods 0.000 claims abstract description 15
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 13
- 229940127557 pharmaceutical product Drugs 0.000 claims abstract description 13
- 239000000463 material Substances 0.000 claims abstract description 10
- 239000004033 plastic Substances 0.000 claims abstract description 10
- 229920003023 plastic Polymers 0.000 claims abstract description 10
- 239000011248 coating agent Substances 0.000 claims abstract description 6
- 238000000576 coating method Methods 0.000 claims abstract description 6
- 239000004698 Polyethylene Substances 0.000 description 77
- 229920000089 Cyclic olefin copolymer Polymers 0.000 description 72
- 229920000139 polyethylene terephthalate Polymers 0.000 description 43
- 239000005020 polyethylene terephthalate Substances 0.000 description 43
- 239000011888 foil Substances 0.000 description 10
- 238000007789 sealing Methods 0.000 description 10
- 239000004800 polyvinyl chloride Substances 0.000 description 7
- 229920000915 polyvinyl chloride Polymers 0.000 description 7
- 238000004108 freeze drying Methods 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- -1 polyethylene Polymers 0.000 description 4
- 238000007710 freezing Methods 0.000 description 3
- 230000008014 freezing Effects 0.000 description 3
- 239000004952 Polyamide Substances 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 238000003490 calendering Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 238000007765 extrusion coating Methods 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 239000005026 oriented polypropylene Substances 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
- B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
- B32B15/20—Layered products comprising a layer of metal comprising aluminium or copper
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
- B32B27/325—Layered products comprising a layer of synthetic resin comprising polyolefins comprising polycycloolefins
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/36—Layered products comprising a layer of synthetic resin comprising polyesters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
- A61J1/035—Blister-type containers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2311/00—Metals, their alloys or their compounds
- B32B2311/24—Aluminium
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2323/00—Polyalkenes
- B32B2323/04—Polyethylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2323/00—Polyalkenes
- B32B2323/10—Polypropylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2367/00—Polyesters, e.g. PET, i.e. polyethylene terephthalate
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/80—Medical packaging
Landscapes
- Laminated Bodies (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Wrappers (AREA)
- Packages (AREA)
Abstract
A cold-formable laminate made of an aluminium foil (26, 46) covered on both sides with plastics material for producing base parts of blister packagings for pharmaceutical products which are freeze dried in the base part has the layer sequence - layer A (22) / layer B (24) / aluminium foil (26) / layer C (28) / layer D
(30), wherein the layer A is a film 10 to 100 µm thick made of COC/PE blend or coextruded COC-PE, the layers B and C are films 10 to 50 µm thick made of oPA, oPP or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend, coextruded COC-PE or PVC, the layers A and D being different, or - layer A (22) / layer B (24) / aluminium foil (26) / layer C (28) / layer D
(30), wherein the layer A is a film 4 to 20 µm thick made of oPP or PET, the layers B and C are films 10 to 50 µm thick made of oPA or PET and the COC/PE, or layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded - layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layer D is a coating made of PE with a grammage of 8 to 40 g/m2, or layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layers B and C are films 10 to 50 µm thick made of oPA or PET and the COC/PE.
layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded
(30), wherein the layer A is a film 10 to 100 µm thick made of COC/PE blend or coextruded COC-PE, the layers B and C are films 10 to 50 µm thick made of oPA, oPP or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend, coextruded COC-PE or PVC, the layers A and D being different, or - layer A (22) / layer B (24) / aluminium foil (26) / layer C (28) / layer D
(30), wherein the layer A is a film 4 to 20 µm thick made of oPP or PET, the layers B and C are films 10 to 50 µm thick made of oPA or PET and the COC/PE, or layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded - layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layer D is a coating made of PE with a grammage of 8 to 40 g/m2, or layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layers B and C are films 10 to 50 µm thick made of oPA or PET and the COC/PE.
layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded
Description
Cold-formable laminate for blister base parts The invention relates to a cold-formable laminate made of an aluminium foil covered on both sides with plastics material for producing base parts of blister packagings for pharmaceutical products which are freeze dried in wells in the base part.
Cold-formable laminates made of an aluminium foil covered on both sides with plastics material are used, inter alia, for producing base parts of blister packagings for pharmaceutical products. Wells for receiving individual tablets or other forms of individual doses are formed in the base parts. The aluminium foil is used here primarily as a barrier layer against the passage of water vapour and gases and protects the products primarily from absorbing or giving off moisture.
Conventional laminates for producing base parts of blister packagings for pharmaceutical products frequently have the structure oPA / aluminium foil /
sealing layer. Conventional sealing layers consist of 15 to 100 pm PVC, 20 to pm PP or 30 to 50 pm PE. After filling the wells, an optionally peelable outer foil is sealed against the base parts. Conventional outer foils are optionally aluminium foils which are coated with plastics material, covered with film or lacquered.
Freeze-dried pharmaceutical products are a new form of drug delivery system (DDS). With this form of administration, the active ingredient is released in the throat and reaches the blood circulation by way of the mucous membranes.
A first method of producing these DDSs is the production of freeze-dried pharmaceutical products and the subsequent filling of the blisters similarly to the packaging of conventional tablets.
A second method for producing these DDSs consists in introducing the pharmaceutical product in liquid form into the wells which are arranged in the base part of a blister packaging and carrying out the freeze drying directly in the wells. However, in practice it has been shown that laminates made of an aluminium foil coated with plastics material tend to roll in under the influence of the temperature change during the freeze drying process.
As a consequence of the production process, in the method with freeze drying carried out directly in the blister base parts, foil portions with blister base parts are punched after the cold-forming of the laminate and the wells thereof are then filled with the pharmaceutical product present in liquid form. The foil portions with the filled wells are then continuously guided through a freezing tunnel. So no liquid can come from the wells onto the sealing layer, the foil portions have to lie flat during the freezing process, i.e. no distortion may occur.
A laminate which is made of an aluminium foil with plastics material layers arranged on both sides is known from EP-A-0 646 367, the layers having substantially the same thermal coefficients of expansion to avoid distortion of the blister base parts during the freeze drying. This condition is fulfilled with an arrangement of identical plastics material layers on both sides.
The invention is based on the object of providing a laminate of the type mentioned at the outset which is suitable for producing base parts of blister packagings for pharmaceutical products which are freeze dried directly in the base part, without the plastics material layers arranged on both sides of the aluminium foil having to have the same thermal coefficients of expansion.
The object is achieved according to the invention in that the laminate has the layer sequence - layer A / layer B / aluminium foil / layer C / layer D, wherein the layer A
is a film 10 to 100 pm thick made of COC/PE blend or coextruded COC/PE, the layers B and C are films 10 to 50 pm thick made of oPA, oPP or PET and the layer D is a film 10 to 100 pm thick made of COC/PE blend, coextruded COC-PE or PVC, the layers A and D being different, or - layer A / layer B / aluminium foil / layer C / layer D, wherein the layer A
is a film 4 to 20 pm thick made of oPP or PET, the layers B and C are films 10 to 50 pm thick made of oPA or PET and the layer D is a film 10 to 100 pm thick made of COC/PE blend or coextruded COC/PE, or - layer B/ aluminium foil / layer C / layer D, wherein the layers B and C are films 10 to 50 pm thick made of oPA or PET and the layer D is a coating made of PE with a grammage of 8 to 40 g/m2, or - layer B/ aluminium foil / layer C / layer D, wherein the layers B and C are films 10 to 50 pm thick made of oPA or PET and the layer D is a film 10 to 100 pm thick made of COC/PE blend or coextruded COC/PE.
The films of layers A and D made of COC/PE blend, coextruded COC/PE or PVC
preferably have a thickness of 15 to 60 pm, the films of the layers A made of oPP
or PET have a thickness of 6 to 10 pm and the films of layers B and C have a thickness of 12 to 30 pm. If there is a coating, =the layer D has a preferred grammage of 10 to 30 g/m2.
The layer D forms the later sealing layer when sealing an outer foil on a base part of a blister packaging produced from the laminate according to the invention.
Apart from the special layer structure, the different chemical composition and/or the different structure of the two outer layers of the laminate is a fundamental feature of the invention.
The aluminium foil is in a flexible state and has a thickness of 20 to 100 pm, preferably 30 to 60 pm.
The individual layers can be connected by covering with solvent-based, solvent-free or aqueous adhesives, by extrusion covering, hot calendering and/or extrusion coating with and without primer.
Cold-formable laminates made of an aluminium foil covered on both sides with plastics material are used, inter alia, for producing base parts of blister packagings for pharmaceutical products. Wells for receiving individual tablets or other forms of individual doses are formed in the base parts. The aluminium foil is used here primarily as a barrier layer against the passage of water vapour and gases and protects the products primarily from absorbing or giving off moisture.
Conventional laminates for producing base parts of blister packagings for pharmaceutical products frequently have the structure oPA / aluminium foil /
sealing layer. Conventional sealing layers consist of 15 to 100 pm PVC, 20 to pm PP or 30 to 50 pm PE. After filling the wells, an optionally peelable outer foil is sealed against the base parts. Conventional outer foils are optionally aluminium foils which are coated with plastics material, covered with film or lacquered.
Freeze-dried pharmaceutical products are a new form of drug delivery system (DDS). With this form of administration, the active ingredient is released in the throat and reaches the blood circulation by way of the mucous membranes.
A first method of producing these DDSs is the production of freeze-dried pharmaceutical products and the subsequent filling of the blisters similarly to the packaging of conventional tablets.
A second method for producing these DDSs consists in introducing the pharmaceutical product in liquid form into the wells which are arranged in the base part of a blister packaging and carrying out the freeze drying directly in the wells. However, in practice it has been shown that laminates made of an aluminium foil coated with plastics material tend to roll in under the influence of the temperature change during the freeze drying process.
As a consequence of the production process, in the method with freeze drying carried out directly in the blister base parts, foil portions with blister base parts are punched after the cold-forming of the laminate and the wells thereof are then filled with the pharmaceutical product present in liquid form. The foil portions with the filled wells are then continuously guided through a freezing tunnel. So no liquid can come from the wells onto the sealing layer, the foil portions have to lie flat during the freezing process, i.e. no distortion may occur.
A laminate which is made of an aluminium foil with plastics material layers arranged on both sides is known from EP-A-0 646 367, the layers having substantially the same thermal coefficients of expansion to avoid distortion of the blister base parts during the freeze drying. This condition is fulfilled with an arrangement of identical plastics material layers on both sides.
The invention is based on the object of providing a laminate of the type mentioned at the outset which is suitable for producing base parts of blister packagings for pharmaceutical products which are freeze dried directly in the base part, without the plastics material layers arranged on both sides of the aluminium foil having to have the same thermal coefficients of expansion.
The object is achieved according to the invention in that the laminate has the layer sequence - layer A / layer B / aluminium foil / layer C / layer D, wherein the layer A
is a film 10 to 100 pm thick made of COC/PE blend or coextruded COC/PE, the layers B and C are films 10 to 50 pm thick made of oPA, oPP or PET and the layer D is a film 10 to 100 pm thick made of COC/PE blend, coextruded COC-PE or PVC, the layers A and D being different, or - layer A / layer B / aluminium foil / layer C / layer D, wherein the layer A
is a film 4 to 20 pm thick made of oPP or PET, the layers B and C are films 10 to 50 pm thick made of oPA or PET and the layer D is a film 10 to 100 pm thick made of COC/PE blend or coextruded COC/PE, or - layer B/ aluminium foil / layer C / layer D, wherein the layers B and C are films 10 to 50 pm thick made of oPA or PET and the layer D is a coating made of PE with a grammage of 8 to 40 g/m2, or - layer B/ aluminium foil / layer C / layer D, wherein the layers B and C are films 10 to 50 pm thick made of oPA or PET and the layer D is a film 10 to 100 pm thick made of COC/PE blend or coextruded COC/PE.
The films of layers A and D made of COC/PE blend, coextruded COC/PE or PVC
preferably have a thickness of 15 to 60 pm, the films of the layers A made of oPP
or PET have a thickness of 6 to 10 pm and the films of layers B and C have a thickness of 12 to 30 pm. If there is a coating, =the layer D has a preferred grammage of 10 to 30 g/m2.
The layer D forms the later sealing layer when sealing an outer foil on a base part of a blister packaging produced from the laminate according to the invention.
Apart from the special layer structure, the different chemical composition and/or the different structure of the two outer layers of the laminate is a fundamental feature of the invention.
The aluminium foil is in a flexible state and has a thickness of 20 to 100 pm, preferably 30 to 60 pm.
The individual layers can be connected by covering with solvent-based, solvent-free or aqueous adhesives, by extrusion covering, hot calendering and/or extrusion coating with and without primer.
The film combinations preferred for the laminates according to the invention are compiled in Table 1. The abbreviated designations of the plastics materials on which the films are based mean:
oPA oriented polyamide PE polyethylene oPP oriented polypropylene PVC polyvinylchloride PET polyethylene terephthalate COC cycloolefin copolymer COP cycloolefin polymer Table 1: Preferred laminate structures No. Layer A Layer B Al Layer C Layer D
1 25 pm COC/PE blend 15 pm oPA 45 pm 15 pm oPA 25 pm COC/PE coex 2 25 pm COC/PE blend 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE coex 3 25 pm COC/PE blend 25 pm oPA 45 pm 25 pm oPA 25 pm COC/PE coex 4 25 pm COC/PE blend 25 pm oPA 60 pm 25 pm oPA 25 pm COC/PE coex 5 40 pm COC/PE blend 15 pm oPA 45 pm 15 pm oPA 40 pm COC/PE coex 6 40 pm COC/PE blend 15 pm oPA 60 pm 15 pm oPA 40 pm COC/PE coex 7 40 pm COC/PE blend 20 pm oPA 45 pm 20 pm oPA 40 pm COC/PE coex 8 40 pm COC/PE blend 20 pm oPA 60 pm 20 pm oPA 40 pm COC/PE coex 9 25 pm COC/PE blend 25 pm oPA 45 pm 23 pm PET 25 pm COC/PE coex 10 25 pm COC/PE blend 25 pm oPA 60 pm 23 pm PET 25 pm COC/PE coex 11 25 pm COC/PE coex 15 pm oPA 45 pm 15 pm oPA 25 pm COC/PE blend 12 25 pm COC/PE coex 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE blend 13 40 pm COC/PE blend 20 pm oPP 45 pm 20 pm oPP 40 pm COC/PE coex 14 40 pm COC/PE blend 20 pm oPP 60 pm 20 pm oPP 40 pm COC/PE coex 40 pm COC/PE coex 20 pm oPA 45 pm 20 pm oPA 15 pm PVC
16 40 pm COC/PE coex 20 pm oPA 60 pm 20 pm oPA 30 pm PVC
17 25 pm COC/PE blend 23 pm PET 45 pm 23 pm PET 25 pm COC/PE coex 18 25 pm COC/PE blend 23 pm PET 60 pm 23 pm PET 25 pm COC/PE blend 19 6 pm PET 15 pm oPA 45 pm 15 pm oPA 25 pm COC/PE coex 8 pm oPP 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE blend 21 9 pm PET 25 pm oPA 45 pm 25 pm oPA 25 pm COC/PE coex 22 10 pm oPP 25 pm oPA 60 pm 25 pm oPA 25 pm COC/PE blend 23 9 pm PET 25 Nm oPA 45 Nm 25 pm oPA 40 pm COC/PE coex 24 10 pm oPP 25 pm oPA 60 pm 25 pm oPA 40 pm COC/PE blend 25 6 pm PET 15 pm oPA 45 pm 12 pm PET 25 pm COC/PE coex 26 8 pm oPP 15 pm oPA 60 pm 12 pm PET 25 pm COC/PE blend 27 9 pm PET 25 pm oPA 45 pm 23 pm PET 25 pm COC/PE coex 28 10 pm oPP 25 pm oPA 60 pm 23 pm PET 25 pm COC/PE blend 29 9 pm PET 23 pm PET 45 pm 23 pm PET 40 pm COC/PE coex 30 10 pm oPP 23 pm PET 60 Nm 23 Nm PET 40 pm COC/PE blend 31 15 Nm oPA 45 Nm 15 Nm oPA 10 g/m PE
32 15pmoPA 60pm 15NmoPA 10g/m PE
33 25 pm oPA 45 pm 25 pm oPA 15 g/m PE
34 25 pm oPA 60 pm 25 pm oPA 15 g/M2 PE
35 25 pm oPA 45 pm 23 pm PET 15 g/m PE
36 25 pm oPA 60 pm 23 pm PET 15 g/m PE
37 23 p m PET 45 pm 23 pm PET 15 g/m PE
38 23 pm PET 60 pm 23 pm PET 15 g/m PE
39 15 Nm oPA 45 pm 15 Nm oPA 25 pm COC/PE coex 40 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE blend 41 25 pm oPA 45 pm 25 pm oPA 25 pm COC/PE coex 42 25 pm oPA 60 pm 25 pm oPA 25 pm COC/PE blend 43 25 pm oPA 45 pm 25 pm oPA 40 pm COC/PE coex 44 25 pm oPA 60 pm 25 pm oPA 40 pm COC/PE blend 45 15 pm oPA 45 pm 12 pm PET 25 pm COC/PE coex 46 15 pm oPA 60 pm 12 pm PET 25 pm COC/PE blend 47 25 pm oPA 45 pm 23 pm PET 25 pm COC/PE coex 48 25 pm oPA 60 pm 23 pm PET 25 pm COC/PE blend 49 23 pm PET 45 pm 23 pm PET 40 pm COC/PE coex 50 23 pm PET 60 pm 23 pm PET 40 pm COC/PE blend A preferred area of application of the laminate according to the invention is the production of base parts of blister packagings for pharmaceutical products which are freeze dried in wells in the base part.
Further advantages, features and details of the invention emerge from the following description of preferred embodiments and with the aid of the drawings, in which, schematically:
Fig.1 shows a plan view of a base part of a blister packaging;
Fig. 2 shows a section through the base part of Fig. 1 along the line I-I;
Fig. 3 shows a cross section through a first embodiment of a laminate for producing blister base parts;
Fig. 4 shows a cross section through a second embodiment of a laminate for producing blister base parts;
Fig. 5 shows a cross section through a blister packaging made of a base part with a sealed-on outer foil.
A base part 10 of a blister packaging shown in Figs. 1 and 2 consists of a laminate, from which depressions in the form of wells 12 are formed by cold-forming. A single dose 14 in liquid form is located in each well 12.
A first laminate 20 which is shown in Fig. 3 for producing the base part 10 has the following layer structure from the outside to the inside:
22 layer A for example film made of COC/PE blend, 40 pm thick, or film made of PET, 9 pm thick 24 layer B for example film made of oPA, 20 pm thick 26 aluminium foil for example 60 pm thick 28 layer C for example film made of oPA, 20 pm thick 30 layer D for example film made of COC/PE coex, 40 pm thick The layer A is the later outside of a blister base part produced from the laminate 20 and the layer D is the sealing side for sealing on an outer foil.
A second laminate 40 shown in Fig. 4 for producing the base part 10 has the following layer structure from the outside to the inside:
44 layer B for example film made of oPA, 15 pm thick 46 aluminium foil for example 45 pm thick 48 layer C for example film made of oPA, 15 pm thick 50 layer D for example coating of PE, 15 g/m2, or film made of COC/PE coex, 40 pm thick -The layer B is the later outside of a blister base part produced from the laminate 20 and the layer D is the sealing side for sealing on an outer foil.
During freeze drying with a base part 10 shown in Fig. 1, individual doses 14 of a pharmaceutical product in liquid form are introduced into the wells 14. The base part 10 then runs through a freezing station, in which the individual doses 14 rapidly freeze. The base parts 10 with the frozen individual doses 14 are then freeze dried in a chamber under a vacuum. After the freeze drying, the base parts 10 are closed by sealing on an outer foil 16, for example an aluminium foil, which can preferably be peeled from the base part 10, to produce the finished blister packaging 18.
oPA oriented polyamide PE polyethylene oPP oriented polypropylene PVC polyvinylchloride PET polyethylene terephthalate COC cycloolefin copolymer COP cycloolefin polymer Table 1: Preferred laminate structures No. Layer A Layer B Al Layer C Layer D
1 25 pm COC/PE blend 15 pm oPA 45 pm 15 pm oPA 25 pm COC/PE coex 2 25 pm COC/PE blend 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE coex 3 25 pm COC/PE blend 25 pm oPA 45 pm 25 pm oPA 25 pm COC/PE coex 4 25 pm COC/PE blend 25 pm oPA 60 pm 25 pm oPA 25 pm COC/PE coex 5 40 pm COC/PE blend 15 pm oPA 45 pm 15 pm oPA 40 pm COC/PE coex 6 40 pm COC/PE blend 15 pm oPA 60 pm 15 pm oPA 40 pm COC/PE coex 7 40 pm COC/PE blend 20 pm oPA 45 pm 20 pm oPA 40 pm COC/PE coex 8 40 pm COC/PE blend 20 pm oPA 60 pm 20 pm oPA 40 pm COC/PE coex 9 25 pm COC/PE blend 25 pm oPA 45 pm 23 pm PET 25 pm COC/PE coex 10 25 pm COC/PE blend 25 pm oPA 60 pm 23 pm PET 25 pm COC/PE coex 11 25 pm COC/PE coex 15 pm oPA 45 pm 15 pm oPA 25 pm COC/PE blend 12 25 pm COC/PE coex 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE blend 13 40 pm COC/PE blend 20 pm oPP 45 pm 20 pm oPP 40 pm COC/PE coex 14 40 pm COC/PE blend 20 pm oPP 60 pm 20 pm oPP 40 pm COC/PE coex 40 pm COC/PE coex 20 pm oPA 45 pm 20 pm oPA 15 pm PVC
16 40 pm COC/PE coex 20 pm oPA 60 pm 20 pm oPA 30 pm PVC
17 25 pm COC/PE blend 23 pm PET 45 pm 23 pm PET 25 pm COC/PE coex 18 25 pm COC/PE blend 23 pm PET 60 pm 23 pm PET 25 pm COC/PE blend 19 6 pm PET 15 pm oPA 45 pm 15 pm oPA 25 pm COC/PE coex 8 pm oPP 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE blend 21 9 pm PET 25 pm oPA 45 pm 25 pm oPA 25 pm COC/PE coex 22 10 pm oPP 25 pm oPA 60 pm 25 pm oPA 25 pm COC/PE blend 23 9 pm PET 25 Nm oPA 45 Nm 25 pm oPA 40 pm COC/PE coex 24 10 pm oPP 25 pm oPA 60 pm 25 pm oPA 40 pm COC/PE blend 25 6 pm PET 15 pm oPA 45 pm 12 pm PET 25 pm COC/PE coex 26 8 pm oPP 15 pm oPA 60 pm 12 pm PET 25 pm COC/PE blend 27 9 pm PET 25 pm oPA 45 pm 23 pm PET 25 pm COC/PE coex 28 10 pm oPP 25 pm oPA 60 pm 23 pm PET 25 pm COC/PE blend 29 9 pm PET 23 pm PET 45 pm 23 pm PET 40 pm COC/PE coex 30 10 pm oPP 23 pm PET 60 Nm 23 Nm PET 40 pm COC/PE blend 31 15 Nm oPA 45 Nm 15 Nm oPA 10 g/m PE
32 15pmoPA 60pm 15NmoPA 10g/m PE
33 25 pm oPA 45 pm 25 pm oPA 15 g/m PE
34 25 pm oPA 60 pm 25 pm oPA 15 g/M2 PE
35 25 pm oPA 45 pm 23 pm PET 15 g/m PE
36 25 pm oPA 60 pm 23 pm PET 15 g/m PE
37 23 p m PET 45 pm 23 pm PET 15 g/m PE
38 23 pm PET 60 pm 23 pm PET 15 g/m PE
39 15 Nm oPA 45 pm 15 Nm oPA 25 pm COC/PE coex 40 15 pm oPA 60 pm 15 pm oPA 25 pm COC/PE blend 41 25 pm oPA 45 pm 25 pm oPA 25 pm COC/PE coex 42 25 pm oPA 60 pm 25 pm oPA 25 pm COC/PE blend 43 25 pm oPA 45 pm 25 pm oPA 40 pm COC/PE coex 44 25 pm oPA 60 pm 25 pm oPA 40 pm COC/PE blend 45 15 pm oPA 45 pm 12 pm PET 25 pm COC/PE coex 46 15 pm oPA 60 pm 12 pm PET 25 pm COC/PE blend 47 25 pm oPA 45 pm 23 pm PET 25 pm COC/PE coex 48 25 pm oPA 60 pm 23 pm PET 25 pm COC/PE blend 49 23 pm PET 45 pm 23 pm PET 40 pm COC/PE coex 50 23 pm PET 60 pm 23 pm PET 40 pm COC/PE blend A preferred area of application of the laminate according to the invention is the production of base parts of blister packagings for pharmaceutical products which are freeze dried in wells in the base part.
Further advantages, features and details of the invention emerge from the following description of preferred embodiments and with the aid of the drawings, in which, schematically:
Fig.1 shows a plan view of a base part of a blister packaging;
Fig. 2 shows a section through the base part of Fig. 1 along the line I-I;
Fig. 3 shows a cross section through a first embodiment of a laminate for producing blister base parts;
Fig. 4 shows a cross section through a second embodiment of a laminate for producing blister base parts;
Fig. 5 shows a cross section through a blister packaging made of a base part with a sealed-on outer foil.
A base part 10 of a blister packaging shown in Figs. 1 and 2 consists of a laminate, from which depressions in the form of wells 12 are formed by cold-forming. A single dose 14 in liquid form is located in each well 12.
A first laminate 20 which is shown in Fig. 3 for producing the base part 10 has the following layer structure from the outside to the inside:
22 layer A for example film made of COC/PE blend, 40 pm thick, or film made of PET, 9 pm thick 24 layer B for example film made of oPA, 20 pm thick 26 aluminium foil for example 60 pm thick 28 layer C for example film made of oPA, 20 pm thick 30 layer D for example film made of COC/PE coex, 40 pm thick The layer A is the later outside of a blister base part produced from the laminate 20 and the layer D is the sealing side for sealing on an outer foil.
A second laminate 40 shown in Fig. 4 for producing the base part 10 has the following layer structure from the outside to the inside:
44 layer B for example film made of oPA, 15 pm thick 46 aluminium foil for example 45 pm thick 48 layer C for example film made of oPA, 15 pm thick 50 layer D for example coating of PE, 15 g/m2, or film made of COC/PE coex, 40 pm thick -The layer B is the later outside of a blister base part produced from the laminate 20 and the layer D is the sealing side for sealing on an outer foil.
During freeze drying with a base part 10 shown in Fig. 1, individual doses 14 of a pharmaceutical product in liquid form are introduced into the wells 14. The base part 10 then runs through a freezing station, in which the individual doses 14 rapidly freeze. The base parts 10 with the frozen individual doses 14 are then freeze dried in a chamber under a vacuum. After the freeze drying, the base parts 10 are closed by sealing on an outer foil 16, for example an aluminium foil, which can preferably be peeled from the base part 10, to produce the finished blister packaging 18.
Claims (7)
1. Cold-formable laminate made of an aluminium foil (26, 46) covered on both sides with plastics material for producing base parts (10) of blister packagings (18) for pharmaceutical products (14) which are freeze dried in the base part, characterised in that the laminate (20, 40) has the layer sequence - ~layer A (22) / layer B(24) / aluminium foil (26) / layer C(28) / layer D
(30), wherein the layer A is a film 10 to 100 µm thick made of COC/PE
blend or coextruded COC-PE, the layers B and C are films 10 to 50 µm thick made of oPA, oPP or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend, coextruded COC-PE or PVC, the layers A and D being different, or - ~layer A (22) / layer B (24) / aluminium foil (26) / layer C (28) / layer D
(30), wherein the layer A is a film 4 to 20 µm thick made of oPP or PET, the layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded COC/PE, or - ~layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer D is a coating made of PE with a grammage of 8 to 40 g/m2, or - ~layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded COC/PE
(30), wherein the layer A is a film 10 to 100 µm thick made of COC/PE
blend or coextruded COC-PE, the layers B and C are films 10 to 50 µm thick made of oPA, oPP or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend, coextruded COC-PE or PVC, the layers A and D being different, or - ~layer A (22) / layer B (24) / aluminium foil (26) / layer C (28) / layer D
(30), wherein the layer A is a film 4 to 20 µm thick made of oPP or PET, the layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded COC/PE, or - ~layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer D is a coating made of PE with a grammage of 8 to 40 g/m2, or - ~layer B (44) / aluminium foil (46) / layer C (48) / layer D (50), wherein the layers B and C are films 10 to 50 µm thick made of oPA or PET and the layer D is a film 10 to 100 µm thick made of COC/PE blend or coextruded COC/PE
2. Laminate according to claim 1, characterised in that the films of the layers A
(22) and D (30, 50) which are made of COC/PE blend or coextruded COC-PE or PVC have a thickness of 15 to 60 µ.
(22) and D (30, 50) which are made of COC/PE blend or coextruded COC-PE or PVC have a thickness of 15 to 60 µ.
3. Laminate according to claim 1, characterised in that the films of the layers A
(42) which are made of oPP or PET have a thickness of 6 to 10 µ.
(42) which are made of oPP or PET have a thickness of 6 to 10 µ.
4. Laminate according to claim 1, characterised in that the films of the layers B
(24, 44) and C (28, 48) have a thickness of 12 to 30 µ.
(24, 44) and C (28, 48) have a thickness of 12 to 30 µ.
5. Laminate according to claim 1, characterised in that the coating of the layer D (50) has a grammage of 10 to 30 g/m2.
6. Laminate according to claim 1, characterised in that the aluminium foil (26, 46) has a thickness of 20 to 100 µ, preferably 30 to 60 µ.
7. Use of a laminate (20, 40) according to any one of the preceding claims for producing base parts (10) of blister packagings (18) for pharmaceutical products (14) which are freeze dried in wells (12) in the base part (10).
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05405583A EP1775117A1 (en) | 2005-10-12 | 2005-10-12 | Cold formable laminate for the making of blister base portions |
| EP05405583.5 | 2005-10-12 | ||
| EP05405692.4 | 2005-12-08 | ||
| EP05405692A EP1775118A1 (en) | 2005-10-12 | 2005-12-08 | Cold formable laminate for the making of blister base portions |
| PCT/EP2006/009567 WO2007042174A1 (en) | 2005-10-12 | 2006-10-04 | Cold-workable laminate for blister bottom parts |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2620754A1 true CA2620754A1 (en) | 2007-04-19 |
| CA2620754C CA2620754C (en) | 2013-05-14 |
Family
ID=37547701
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2620754A Active CA2620754C (en) | 2005-10-12 | 2006-10-04 | Cold-formable laminate for blister base parts |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP1937473B1 (en) |
| AR (1) | AR058483A1 (en) |
| AU (1) | AU2006301587B2 (en) |
| CA (1) | CA2620754C (en) |
| PL (1) | PL1937473T3 (en) |
| WO (1) | WO2007042174A1 (en) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL196345B1 (en) | 2001-12-14 | 2007-12-31 | Huhtamaki Ronsberg | Packaging and sealing tool for production thereof |
| RU2005118749A (en) * | 2002-11-15 | 2006-12-20 | Хутамаки Ронсберг, Цвайгнидерлассунг Дер Хутамакидойчланд Гмбх Енд Ко. Кг (De) | MULTILAYERED MATERIAL FOR TUBES AND SIMILAR PACKAGES OF FILM TYPE WITH AN INTEGRATED BARRIER LAYER IN IT |
| US7364047B2 (en) | 2004-05-27 | 2008-04-29 | Zweigniederlassung Der Huhtamaki Deutschaland, Gmbh & Co. Kg | Tubular, especially can-shaped, receptacle for the accommodation of fluids, a method of manufacture, and use |
| DE102005006827A1 (en) | 2004-11-04 | 2006-05-24 | Huhtamaki Ronsberg, Zweigniederlassung Der Huhtamaki Deutschland Gmbh & Co. Kg | Process for producing a bottle-like or hose-like container, in particular a tubular bag, with a sealed bottom and a correspondingly produced tubular bag |
| DE202004021343U1 (en) | 2005-04-18 | 2007-10-25 | Huhtamaki Ronsberg, Zweigniederlassung Der Huhtamaki Deutschland Gmbh & Co. Kg | Printed carrier substrate |
| EP3019415B1 (en) | 2013-07-10 | 2017-08-23 | Amcor Flexibles Kreuzlingen AG | Gas and light proof, double-shell blister packs for medicinal contents |
| CN106185030A (en) * | 2016-08-26 | 2016-12-07 | 南通惠得成包装材料有限公司 | A kind of medical PVC composite packaging stiff sheet |
| DE102017115861A1 (en) * | 2017-07-14 | 2019-01-17 | Huhtamaki Flexible Packaging Germany Gmbh & Co. Kg | Push-through packaging as well as strip packaging and laminate for producing the same |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100235089B1 (en) * | 1992-05-14 | 1999-12-15 | Mitsui Chemicals Inc | Ptp or blister packaging articles and packaging material therefor |
| US5343672A (en) | 1992-12-01 | 1994-09-06 | Scherer Ltd R P | Method for manufacturing freeze dried dosages in a multilaminate blister pack |
| DE19644675A1 (en) * | 1996-10-28 | 1998-04-30 | Hoechst Ag | Packaging film useful as backing layer for blister packs |
| US6269671B1 (en) * | 1998-09-16 | 2001-08-07 | Alusuisse Technology & Management Ltd. | Process for manufacturing shaped packaging |
| GB0225621D0 (en) * | 2002-11-02 | 2002-12-11 | Glaxo Group Ltd | Medicament carrier |
| EP1488921A1 (en) * | 2003-06-17 | 2004-12-22 | Alcan Technology & Management Ltd. | Cold-formable laminate |
-
2006
- 2006-10-04 AU AU2006301587A patent/AU2006301587B2/en not_active Ceased
- 2006-10-04 WO PCT/EP2006/009567 patent/WO2007042174A1/en active Application Filing
- 2006-10-04 CA CA2620754A patent/CA2620754C/en active Active
- 2006-10-09 AR ARP060104437A patent/AR058483A1/en unknown
- 2006-10-11 EP EP06806008.6A patent/EP1937473B1/en active Active
- 2006-10-11 PL PL06806008T patent/PL1937473T3/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP1937473B1 (en) | 2014-03-19 |
| AU2006301587B2 (en) | 2010-11-11 |
| WO2007042174A1 (en) | 2007-04-19 |
| AU2006301587A1 (en) | 2007-04-19 |
| AR058483A1 (en) | 2008-02-06 |
| EP1937473A1 (en) | 2008-07-02 |
| CA2620754C (en) | 2013-05-14 |
| PL1937473T3 (en) | 2014-08-29 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |