U.S. patent application number 10/553125 was filed with the patent office on 2006-12-21 for blister pack.
This patent application is currently assigned to ALCAN TECHNOLOGY & MANAGEMENT LTD.. Invention is credited to Erwin Pasbrig.
Application Number | 20060283758 10/553125 |
Document ID | / |
Family ID | 32893019 |
Filed Date | 2006-12-21 |
United States Patent
Application |
20060283758 |
Kind Code |
A1 |
Pasbrig; Erwin |
December 21, 2006 |
Blister pack
Abstract
A blister (10) for pharmaceutical products, diagnostic reagents
or medical implements includes a blister bottom part (12), which is
thermoformed from plastic, of a covering foil (16) made of aluminum
or of an aluminum/plastic composite, and includes an undersealing
trough (18), which is sealed against the rear side of the blister
bottom part (12) and which is cold-formed from an aluminum/plastic
composite film. The aluminum/plastic composite film of the
undersealing trough (18) includes, on the side oriented toward the
blister bottom part (12), a peelable heat-sealable layer that
includes a paint having an application weight ranging from 2 to 20
g/m.sup.2, preferably 7 to 15 g/m.sup.2, a peelable plastic film
having a film thickness ranging from 10 to 40 .mu.m, preferably
from 15 to 30 .mu.m, or a peelable plastic coating having an
application weight ranging from 5 to 40 g/m.sup.2, preferably 7 to
20 g/m.sup.2. The undersealing trough (18) that can be removed from
the blister bottom part (12) by peeling permits the product
contained inside the blister (10) to be seen. In order to achieve
an optimal storage quality of the product even after the
aluminum/plastic composite film of the undersealing trough has been
removed, the plastic of the bottom part is a barrier with a passage
blocking effect against water vapor and/or gases.
Inventors: |
Pasbrig; Erwin; (Singen,
DE) |
Correspondence
Address: |
FISHER, CHRISTEN & SABOL
1725 K STREET, N.W.
SUITE 1108
WASHINGTON
DC
20006
US
|
Assignee: |
ALCAN TECHNOLOGY & MANAGEMENT
LTD.
Neuhausen am Rheinfall
CH
CH-8212
|
Family ID: |
32893019 |
Appl. No.: |
10/553125 |
Filed: |
April 5, 2004 |
PCT Filed: |
April 5, 2004 |
PCT NO: |
PCT/EP04/03577 |
371 Date: |
October 14, 2005 |
Current U.S.
Class: |
206/531 |
Current CPC
Class: |
B32B 27/08 20130101;
B65D 75/327 20130101; A61J 1/035 20130101; B65D 2575/3218
20130101 |
Class at
Publication: |
206/531 |
International
Class: |
B65D 83/04 20060101
B65D083/04; B65D 85/42 20060101 B65D085/42 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 16, 2003 |
EP |
03405270.4 |
Claims
1. A blister pack for pharmaceutical products, diagnostic products
or medical devices, comprising a blister base part (12)
thermoformed from plastics material, a cover film (16) made of
aluminum or an aluminum/plastics material composite and a lower
sealing tray (18), which is sealed against the rear of the blister
base part (12) and cold-formed from an aluminum/plastics material
composite film, the aluminum/plastics material composite film of
the lower sealing tray (18) has, on the side directed toward the
blister base part (12), a peelable heat-sealing layer made of
lacquer with an application weight of 2 to 20 g/m.sup.2, a peelable
plastics material film with a film thickness of 10 to 40 .mu.m, or
a peelable plastics material coating with an application weight of
5 to 40 g/m.sup.2.
2. The blister pack according to claim 1, wherein the peelable
heat-sealing layer consists of a lacquer with an application weight
of 7 to 15 g/m.sup.2.
3. The blister pack according to claim 1, wherein the peelable
plastics material film has a film thickness of 15 to 30 .mu.m.
4. The blister pack according to claim 1, wherein the peelable
plastics material coating has an application weight of 7 to 20
g/m.sup.2.
5. The blister pack according to claim 4, wherein the plastics
material of the blister base part (12) has a barrier with a
penetration barrier effect against steam and/or gases.
6. The blister pack according to claim 5, wherein the blister base
part (12) is constructed from a laminate with the layer sequence
PVC/PVDC, PVC/PE/PVDC, PVC/PCTFE, PVC/PE/PCTFE, PVC/PCTFE/PVC.
PVC/PE, PVC/COC/PE, PVC/COC/PVC, PVC/COC/PVDC, PVC/COC/PP,
PVC/COC/PE. PVC/COC, PP/PVDC, PP/PCTFE, PP/PCTFE/PP, PP/COC/PP,
PP/PET, PP/PE, PP/COC/PE, PP/COC/PCTFE, PP/COC, PET/PP/PVDC,
PET/COC/PP, PET/COC/PVC, PET/COC/PVDC, PET/COC/PE, PET/PVC/PCTFE,
PET/COC, PE/PCTFE, HDPE/PVDC, HDPE/PVC, PE/PCTFE/PE, PE/COC/PVDC,
PE/COC, or from LCP, HDPE, PP, PVC or PET containing LCP.
7. The blister pack according to claim 6, wherein the
aluminum/plastics material composite film of the lower sealing tray
(18), which can be peeled from the rear of the blister base part
(12), is an aluminum film with a thickness of 15 to 80 .mu.m,
which, on the side pointing away from the blister base part (12),
is laminated with a plastics material film made of oriented
polyamide (oPA), polyethylene terephthalate (PET) or oriented
polypropylene (oPP) with a film thickness of 10 to 30 .mu.m, or is
lacquered with a protective lacquer based on the lacquer raw
materials, nitrocellulose, epoxy resin, polyester, polyurethane or
mixtures of said lacquer raw materials with an application weight
of 1 to 20 g/m.sup.2.
8. The blister pack according to claim 7, wherein the peelable
heat-sealing layer which is directed toward the rear of the blister
base part (12) is constructed with the same or similar chemical
base components as the plastics material of the blister base part
(12) forming the sealing face, or mixtures of these base components
with materials which bring about an adhesive or cohesive break.
9. The blister pack according to claim 8, wherein the lacquer
contains, as materials which bring about an adhesive or cohesive
break, acrylates, polybutylates, Morprime, styrene acrylate with
polyolefin groups, PVC/AC with acrylate, PP/butadiene or
polyester/butadiene/styrene.
10. The blister pack according to any claim 9, wherein the peelable
plastics material film which is directed toward the rear of the
blister base part (12) or the peelable plastics material coating
which is directed toward the rear of the blister base part (12) is
constructed on the basis of PVC, PP, metallocene PP, PE,
metallocene PE, PCTFE, PET, EM, ionomers of PE and PE acrylates,
EVA and copolymers with EVA.
11. The blister pack according to claim 10, wherein the peelable
plastics material film is extruded, coextruded or lacquer-laminated
with a peelable coating.
12. The blister pack according to claim 10, wherein the plastics
material coating is coextruded with a peelable layer.
13. The blister pack according to claim 1, wherein the peelable
plastic material film has a film thickness of 15 to 30 .mu.m, or
the peelable plastics material coating has an application weight of
7 to 20 g/m.sup.2.
14. The blister pack according to claim 1, wherein the plastics
material of the blister base part (12) has a barrier with a
penetration barrier effect against steam and/or gases.
15. The blister pack according to claim 5, wherein the blister base
part (12) is constructed from a laminate with the layer sequence
PVC/PVDC, PVC/PE/PVDC, PVC/PCTFE, PVC/PE/PCTFE, PVC/PCTFE/PVC,
PVC/PE, PVC/COC/PE, PVC/COC/PVC, PVC/COC/PVDC, PVC/COC/PP,
PVC/COC/PE, PVC/COC, PP/PVDC, PP/PCTFE, PP/PCTFE/PP, PP/COC/PP,
PP/PET, PP/PE, PP/COC/PE, PP/COC/PCTFE, PP/COC, PET/PP/PVDC,
PET/COC/PP, PET/COC/PVC, PET/COC/PVDC, PET/COC/PE, PET/PVC/PCTFE,
PET/COC, PE/PCTFE, HDPE/PVDC, HDPE/PVC, PE/PCTFE/PE, PE/COC/PVDC,
PE/COC or from LCP, HDPE, PP, PVC OR PET containing LCP.
16. The blister pack according to claim 1, wherein the
aluminum/plastics material composite film of the lower sealing tray
(18), which can be peeled from the rear of the blister base part
(12), is an aluminum film with a thickness of 15 to 80 .mu.m,
which, on the side pointing away from the blister base part (12),
is laminated with a plastics material film made of oriented
polyamide (oPA), polyethylene terephthalate (PET) or oriented
polypropylene (oPP) with a film thickness of 10 to 30 .mu.m, or is
lacquered with a protective lacquer based on the lacquer raw
materials, nitrocellulose, epoxy resin, polyester, polyurethane or
mixtures of said lacquer raw materials with an application weight
of 1 to 20 g/m.sup.2.
17. The blister pack according to claim 1, wherein the peelable
heat-sealing layer which is directed toward the rear of the blister
base part (12) is constructed with the same or similar chemical
base components as the plastics material of the blister base part
(12) forming the sealing face, or mixtures of these base components
with materials which bring about an adhesive or cohesive break.
18. The blister pack according to claim 17, wherein the lacquer
contains, as materials which bring about an adhesive or cohesive
break, acrylates, polybutylates, Morprime, styrene acrylate with
polyolefin groups, PVC/AC with acrylate, PP/butadiene or
polyester/butadiene/styrene.
19. The blister pack according to claim 1, wherein the peelable
plastics material film which is directed toward the rear of the
blister base part (12) or the peelable plastics material coating
which is directed toward the rear of the blister base part (12) is
constructed on the basis of PVC, PP, metallocene PP, PE,
metallocene PE, PCTFE, PET, EM, ionomers of PE and PE acrylates,
EVA and copolymers with EVA.
20. The blister pack according to claim 19, wherein the peelable
plastics material film is extruded, coextruded or lacquer-laminated
with a peelable coating.
21. The blister pack according to claim 19, wherein the plastics
material coating is coextruded with a peelable layer.
22. The blister pack according to claim 7, wherein the aluminum
film has a thickness of 25 to 60 .mu.m.
23. The blister pack according to claim 7, wherein the plastics
material film has a thickness of 15 to 25 .mu.m.
24. The blister pack according to claim 7, wherein the protective
lacquer has a thickness of 7 to 15 g/m.sup.2.
26. The blister pack according to claim 16, wherein the aluminum
film has a thickness of 25 to 60 .mu.m.
27. The blister pack according to claim 16, wherein the plastic
material film has a thickness of 15 to 25 .mu.m.
28. The blister pack according to claim 16, wherein the protective
lacquer has a thickness of 7 to 15 g/m.sup.2.
Description
[0001] The invention relates to a blister pack for pharmaceutical
products, diagnostic products or medical devices, comprising a
blister base part thermoformed from plastics material, a cover film
made of aluminium or an aluminium/plastics material composite and a
lower sealing tray, which is sealed against the rear of the blister
base part and cold-formed from an aluminium/plastics material
composite film.
[0002] In blister packs with a thermoformed blister base part known
under the term "tropical blisters", the cover film consists of
aluminium or an aluminium/plastics material composite, and a lower
sealing tray, which is cold-formed from an aluminium/plastics
material laminate, is selected against the rear of the blister base
part. Therefore: in a tropical blister, the blister base part with
the filling is completely protected by the aluminium films in the
cover layer and in the lower sealing tray against the penetration
of steam and gases from the external atmosphere.
[0003] In the tropical blisters known today, the lower sealing tray
is firmly sealed against the base part. The filling is pressed
through the cover film by pressure on the aluminium/plastics
material laminate and the thermoformed cup of the base part located
below it. As neither the filling nor the individual cup is visible
from outside, there may be problems in pressing out the
filling.
[0004] No perforations may be provided in the case of cover films,
which can be removed by peeling, because of the transverse
diffusion of moisture and oxygen and the risk of the cover film
tearing off. There is therefore a very high risk that not only the
cup provided for opening is exposed when peeling the cover film,
but the adjacent cup is also at least partially opened.
[0005] As the aluminium/plastics material laminate of the lower
sealing tray ensures adequate protection of the filling against
moisture, UV radiation and oxygen during the logistics chain, PVC
or PVC/40 to 60 g/m.sup.2 PVDC is used as the plastics material for
the thermoformed blister. So the guaranteed minimum durability of
the filling is not exceeded, the blister pack has to be used up in
a relatively short time once the filling has been removed for the
first time.
[0006] The invention is based on the object of providing a tropical
blister of the type mentioned at the outset, in which the filling
is visible prior to removal and therefore can be pressed through
the cover film without damaging adjacent regions. In addition, the
durability of the filling is to be ensured for longer for the
remaining pack after the first removal of filling, as a function of
the plastics material used for the thermoformed base part.
[0007] The fact that the aluminium/plastics material composite film
of the lower sealing tray has, on the side directed toward the
blister base part, a peelable heat-sealing layer made of a lacquer
with an application weight of 2 to 20 g/m.sup.2, preferably 7 to 15
g/m.sup.2, a peelable plastics material film with a film thickness
of 10 to 40 .mu.m, preferably 15 to 30 .mu.m, or a peelable
plastics material coating with an application weight of 5 to 40
g/m.sup.2, preferably 7 to 20 g/m.sup.2, leads to the achievement
of the object.
[0008] Obviously, the solution according to the invention may also
be used for the currently used thermoformed plastics materials for
the "lower sealing tray".
[0009] To achieve an optimum durability of the filling, the
plastics material of the blister base part has a barrier with a
penetration barrier effect against steam and/or gases.
[0010] The plastics material of the blister base part with barrier
properties may be constructed from a laminate with the layer
sequence PVC/PVDC, PVC/PE/PVDC, PVC/PCTFE, PVC/PE/PCTFE,
PVC/PCTFE/PVC. PVC/PE, PVC/COC/PE, PVC/COC/PVC, PVC/COC/PVDC,
PVC/COC/PP, PVC/COC/PE. PVC/COC, PP/PVDC, PP/PCTFE, PP/PCTFE/PP,
PP/COC/PP, PP/PET, PP/PE, PP/COC/PE, PP/COC/PCTFE, PP/COC,
PET/PP/PVDC, PET/COC/PP, PET/COC/PVC, PET/COC/PVDC, PET/COC/PE,
PET/PVC/PCTFE, PET/COC, PE/PCTFE, HDPE/PVDC, HDPE/PVC, PE/PCTFE/PE,
PE/COC/PVDC, PE/COC. The blister base part may also, however,
consist of LCP, HDPE, PP, PVC or PET containing LCP.
[0011] The blister base part may also be constructed from the
generally used plastics materials without special barrier
properties, if the limited durability of the filling after removal
of the lower sealing tray is taken into account.
[0012] In the blister pack according to the invention, a
press-through film is preferred as a cover film. However, if a
peelable opening is desired, the proposed solutions can obviously
also be used.
[0013] The peelable heat-sealing layer which is directed toward the
rear of the blister base part, of the aluminium/plastics material
composite film of the lower sealing tray, is expediently
constructed with the same chemical base components as the plastics
material of the blister base part forming the sealing face, or
mixtures of these base components with materials, which bring about
an adhesive or cohesive break.
[0014] Materials which bring about an adhesive or cohesive break
are, for example, acrylates, polybutylates, Morprime, styrene
acrylate with polyolefin groups, PVC/AC plus acrylate, PP/butadiene
or polyester/butadiene/styrene.
[0015] The peelable plastics material film which is directed toward
the rear of the blister base part or the peelable plastics material
coating which is directed toward the rear of the blister base part
is preferably constructed on the basis of PVC, PP, metallocene PP,
PE, metallocene PE, ACLAR.RTM. (PCTFE), PET, EAA, ionomers of PE
and PE acrylates, EVA and copolymers with EVA.
[0016] The peelable plastics material film can be extruded,
coextruded or lacquer-laminated with a peelable coating, and the
plastics material coating can be coextruded with a peelable
layer.
[0017] 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:
[0018] FIG. 1 shows a cross-section through a part of a blister
pack with a peelable lower sealing tray and a tear flap;
[0019] FIG. 2 shows a view of the blister pack of FIG. 1 with a
first embodiment of a tear flap in the viewing direction A;
[0020] FIG. 3 shows a view of the blister pack of FIG. 1 with a
second embodiment of a tear flap in the viewing direction A;
[0021] FIG. 4 shows a view of the blister pack of FIG. 1 with a
third embodiment of a tear flap in the viewing direction A.
[0022] A blister pack 10 shown in FIG. 1 to 4 in the form of a
tropical blister has a base part 12 with individual blisters or
cups 14 formed therefrom to receive a pharmaceutical filling, not
shown in the drawing, such as tablets or capsules, diagnostic
products or medical devices, for example. On the side of the
openings of the cups 14 a cover film 16 tightly sealing the cups 14
is sealed against the base part 12.
[0023] On the side opposing the cover film 16, a further film in
the form of a lower sealing tray 18 extends over the formed cups 14
and is sealed against a peripheral edge 20 of the base part 12 so
as to be peelable. The barrier properties of the lower sealing tray
18 prevent penetration of steam and gases from the external
atmosphere into the filling space of the cups 14.
[0024] In the region of a side edge of the blister pack 10, the
lower sealing tray is not sealed against the base part 12 in a
narrow region 20a, forming a tear flap 22. FIGS. 2 to 4 show
different embodiments of tear flaps 22 or corresponding unsealed
zones. In an exemplary side edge length e of the blister pack 10 of
68 mm, the tear flap of FIG. 2 has a uniform width b.sub.a of 7 mm.
The tear flap of FIG. 3 has a width b.sub.m of for example 2 mm in
the middle and a width ba of 7 mm on the outside. In the tear flap
of FIG. 4, the width b.sub.m is 7 mm in the middle, and the width
b.sub.a is 2 mm on the outer edge:
[0025] In the Table below, examples are compiled of
aluminium/plastics material laminates used according to the
invention as the material to produce the cold-formed lower sealing
tray. The coating/lacquering of the aluminium film which is
directed to the outside is designated "Outside coating" and the
coating/lacquering which is directed toward the plastics material
on the outside of the blister base part for sealing is designated
"inside coating", in each case giving the grams per square metre in
coating/lacquering or the film thickness in lamination of the
plastics material film. The table also contains the plastics
materials selected in accordance with the inside coating/lacquering
of the laminates of the lower sealing tray for the outside of the
blister base part, against which the sealing of the
aluminium/plastics material laminate is carried out. TABLE-US-00001
Outside Outside base Example coating Al film Inside coating part 1
oPA, 25 .mu.m 45 .mu.m HSL (hot-sealing PVDC 2 oPA, 25 .mu.m 60
.mu.m lacquer) based on or 3 oPP, 20 .mu.m 45 .mu.m PVC/AC plus PVC
4 PET film, 45 .mu.m acrylate, 10 g/m.sup.2 23 .mu.m 5 oPA, 25
.mu.m 45 .mu.m HSL based on acrylate with polyolefin groups, 10
g/m.sup.2 6 oPA, 25 .mu.m 45 .mu.m PVC film, 10 .mu.m, peelable 7
oPA, 25 .mu.m 45 .mu.m PVC film 15 .mu.m, peelable 8 oPA, 25 .mu.m
45 .mu.m HSL based on PP 9 oPA, 25 .mu.m 60 .mu.m PP/butadiene, 10
10 oPP, 20 .mu.m 45 .mu.m g/m.sup.2 11 PET film, 45 .mu.m 23 .mu.m
12 oPA, 25 .mu.m 45 .mu.m HSL based on acrylate with polyolefin
groups, 10 g/m.sup.2 13 oPA, 25 .mu.m 45 .mu.m PP film, 20 .mu.m,
peelable 14 oPA, 25 .mu.m 45 .mu.m HSL based on PET 15 oPA, 25
.mu.m 60 .mu.m PVC/AC plus 16 oPP, 20 .mu.m 45 .mu.m acrylate, 10
g/m.sup.2 17 PET film, 45 .mu.m 23 .mu.m 18 oPA, 25 .mu.m 45 .mu.m
HSL based on polyester with acrylate, 10 g/m.sup.2 19 oPA, 25 .mu.m
40 .mu.m HSL based on PVC/AC plus acrylate, 10 g/m.sup.2 20 oPA, 25
.mu.m 45 .mu.m PET film, 12 .mu.m, peelable 21 oPA, 25 .mu.m 45
.mu.m HSL based on PE 22 oPA, 25 .mu.m 60 .mu.m polyester/ 23 oPA,
25 .mu.m 40 .mu.m butadiene/styrene, 24 oPA, 25 .mu.m 36 .mu.m 10
g/m.sup.2 25 oPP, 20 .mu.m 45 .mu.m 26 PET film, 45 .mu.m 23 .mu.m
27 oPA, 25 .mu.m 45 .mu.m HSL based on acrylate with polyolefine
groups, 10 g/m.sup.2 28 oPA, 25 .mu.m 45 .mu.m PE peel film, 40
.mu.m 29 oPA, 25 .mu.m 40 .mu.m HSL based on PVC/AC plus 30 oPA, 25
.mu.m 36 .mu.m acrylate, 10 g/m.sup.2 31 oPA, 25 .mu.m 40 .mu.m HSL
based on 32 oPA, 25 .mu.m 36 .mu.m PP/butadiene, 10 g/m.sup.2 33
oPA, 25 .mu.m 36 .mu.m HSL based on PVC/AC plus acrylate, 10
g/m.sup.2 34 oPA, 25 .mu.m 45 .mu.m HSL based on ACLAR .RTM. 35
oPA, 25 .mu.m 60 .mu.m EVA/acrylate, (PCTFE) 36 oPA, 25 .mu.m 40
.mu.m 10 g/m.sup.2 37 oPA, 25 .mu.m 36 .mu.m 38 oPP, 20 .mu.m 45
.mu.m 39 PET film, 45 .mu.m 23 .mu.m 40 oPA, 25 .mu.m 45 .mu.m HSL
based on ACLAR .RTM./EVA/ acrylate 41 oPA, 25 .mu.m 45 .mu.m HSL
based on EVA/copolymer, 20 g/m.sup.2
* * * * *