U.S. patent application number 13/497538 was filed with the patent office on 2012-08-02 for induction seal disk.
This patent application is currently assigned to BOEHRINGER INGELHEIM INTERNATIONAL GMBH. Invention is credited to Eduard Balthes.
Application Number | 20120193267 13/497538 |
Document ID | / |
Family ID | 43014436 |
Filed Date | 2012-08-02 |
United States Patent
Application |
20120193267 |
Kind Code |
A1 |
Balthes; Eduard |
August 2, 2012 |
INDUCTION SEAL DISK
Abstract
An induction seal disc for a closure (4) of a bottle for storing
medicaments comprises an elastic pressure inlay (9) and an, in
particular, metallic sealing foil (8). Between the pressure inlay
(9) and the sealing foil (8) is disposed a film (10) having low
permeability.
Inventors: |
Balthes; Eduard; (Ingelheim
am Rhein, DE) |
Assignee: |
BOEHRINGER INGELHEIM INTERNATIONAL
GMBH
Ingelheim am Rhein
DE
|
Family ID: |
43014436 |
Appl. No.: |
13/497538 |
Filed: |
September 22, 2010 |
PCT Filed: |
September 22, 2010 |
PCT NO: |
PCT/EP2010/063973 |
371 Date: |
April 10, 2012 |
Current U.S.
Class: |
206/540 ;
215/347 |
Current CPC
Class: |
B32B 15/20 20130101;
B32B 2307/7248 20130101; B32B 7/12 20130101; B32B 2255/06 20130101;
B32B 27/304 20130101; B32B 2307/51 20130101; B32B 2307/75 20130101;
B32B 2439/80 20130101; B32B 27/32 20130101; B32B 15/08 20130101;
B32B 27/322 20130101; B32B 2435/02 20130101; B32B 2307/724
20130101; B32B 2307/7244 20130101; B32B 27/325 20130101; B65D
41/045 20130101; B32B 15/12 20130101; B32B 2307/554 20130101; B32B
27/306 20130101; B32B 2307/758 20130101; B32B 2307/726 20130101;
B32B 27/08 20130101; B32B 7/06 20130101; B32B 2307/7246 20130101;
B32B 27/10 20130101; B32B 2255/28 20130101; B32B 2307/402 20130101;
B65D 53/04 20130101 |
Class at
Publication: |
206/540 ;
215/347 |
International
Class: |
B65D 53/04 20060101
B65D053/04; B65D 41/02 20060101 B65D041/02; B65D 41/04 20060101
B65D041/04; B65D 85/00 20060101 B65D085/00 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 23, 2009 |
EP |
09171085.5 |
Claims
1. Induction seal disc for a closure (4) of a bottle for storing
medicaments, comprising an elastic pressure inlay (9) and a
metallic sealing foil (8), characterised in that between the
pressure inlay (9) and the sealing foil (8) is arranged a low
permeability film (10).
2. Induction seal disc according to claim 1, characterised in that
the film (10) is adhesively bonded to the pressure inlay (9)
embodied as a cardboard inlay (6) and an adhesive layer is applied
between the film (10) and the sealing foil (8).
3. Induction seal disc according to claim 1, characterised in that
the sealing foil (8) and the film (10) are made of aluminium.
4. Induction seal disc according to claim 1, characterised in that
the surface of the cardboard inlay (6), the film (10) and the
sealing foil (8) are all the same size.
5. Induction seal disc according to claim 1, characterised in that
between the film (10) and the sealing foil (8) is provided an
adhesive layer, the area of which is less than the area of the
sealing foil (8), wherein the adhesive layer does not extend to the
edge of the sealing foil (8).
6. Induction seal disc according to claim 1, characterised in that
the adhesive layer consists of a wax (7) with a low
permeability.
7. Induction seal disc according to claim 1, characterised in that
the sealing foil (8) or the closure (4) is of such dimensions that
the sealing foil (8) is held in the closure (4), in the unsealed
state.
8. Induction seal disc according to claim 1, characterised in that
the film (10) and/or the sealing foil (8) is or are coated with a
lacquer or a plastic selected from polyolefin, polyethylene,
polypropylene, ethylenevinyl alcohol, ethylenevinyl acetate, or a
barrier foil selected from cycloolefin copolymer, highly
crystalline polyvinylidene chloride,
polychlorotrifluoroethylene.
9. Induction seal disc according to claim 8, characterised in that
the coating comprises a sorbent which is suitable in particular for
absorbing water, gases and/or flavours.
10. Closure for a bottle for storing medicaments, having an
induction seal disc (5) according to claim 1.
11. Closure according to claim 10, characterised in that the
closure (4) is embodied as a screw closure.
12. Plastic bottle having a closure (4) according to claim 10.
13. Plastic bottle according to claim 11, characterised in that a
sealing surface is formed at the free end of the bottle neck
(2).
14. Plastic bottle according to claim 11, characterised in that the
plastic bottle (1) is filled with a pharmaceutical active substance
formulation in the form of plain or coated tablets or filled
capsules.
Description
[0001] The invention relates to an induction seal disk for a
closure of a bottle for storing medicaments, comprising a cardboard
inlay and an essentially metallic sealing foil, a closure having an
induction seal disk and a plastic bottle with a corresponding
closure.
[0002] In the pharmaceutical industry, pharmaceutical active
substance formulations are sold in the form of plain or coated
tablets or filled capsules in sealed bottles made of glass or
plastics. Between the free end of the neck of the bottle and the
closure there is generally provided an induction seal disc which on
the one hand serves as proof of origin and on the other hand
prevents moisture from getting into the bottle. Induction seal
discs are known in a great many variations and are manufactured
separately. Before the filled bottle is sealed, an induction seal
disc is placed in a corresponding closure which is generally
screwed onto the bottle with a certain torque. Then the sealed
bottle passes through an induction device in which the actual
sealing operation takes place, by the induction of alternating
current in a metal foil of the induction seal disc, which is
converted into heat which either causes the metal foil to bond
directly to a bottle neck made of plastics or causes a
corresponding adhesive to melt, thereby securing the foil to the
bottle neck. On the side of the foil remote from the bottle neck is
provided an elastic pressure inlay which allows the foil or the
sealing layer to be pressed on satisfactorily thanks to the
clamping pressure of the closure. Often, the pressure inlay is
attached to the film by wax or some another adhesive. During
sealing, the wax or the adhesive liquefies as a result of being
heated and diffuses into the correspondingly configured pressure
inlay, or special paper layers are provided that hold the wax or
the adhesive.
[0003] One of the determining factors for the stability of
pharmaceutical active substances is moisture. In view of the
increasing development of active substances which are ever more
effective but ever more sensitive to moisture, reduction and
monitoring of the moisture in packages is essential. The packaging
of medicaments involves a substantial use of plastic bottles which
are sealed for the delivery chain from a manufacturer or bottling
plant to a pharmacy or to the patient by means of the induction
seal, thus sealing the plastic bottles particularly effectively
from moisture during delivery and storage. Surprisingly, it has
been found that it is this particularly high-quality closure method
that results in induction-sealed plastic bottles becoming
particularly leaky in the region of the opening once the bottle has
been opened (so-called in-use permeation). When the bottle is
opened, the sealing foil is pierced and there is only a cardboard
layer and the plastic closure screwed shut to protect the product
from moisture.
[0004] The problem of the invention is to provide an induction seal
disc of the kind mentioned hereinbefore which will still provide an
effective seal against moisture even after the induction seal has
been broken.
[0005] According to the invention the problem is solved by
arranging a film of low permeability between the pressure inlay and
the sealing foil.
[0006] To reduce the in-use permeation, an additional barrier in
the form of the film is introduced into the induction seal disc
associated with the closure, this film preferably being firmly
adhesively bonded to the pressure inlay. During the induction
sealing, the sealing foil is firmly attached to the neck of a
bottle and ensures the low permeation rate during the storage of
the bottle that has thus been sealed. The sealing foil may be
connected to the film by an adhesive or sticky layer which is more
particularly releasable by heating, so that after the sealing
process it is possible to rotate the film relative to the sealing
foil without destroying the sealing foil. After the bottle has been
opened, i.e. after the sealing foil has been pierced, the water
permeation through the main permeation route, namely through the
pressure inlay and the material from which the closure is made, is
completely blocked by the additional film inserted. This method of
improving the in-use permeation is not restricted to a specific
type of bottle or container, and various materials may be used,
particularly aluminium composites and/or polymers, for example
polypropylene. It is also possible to use the induction seal disc
in containers or bottles made of materials other than plastics.
Moreover, the induction seal disc can be used with all common types
of lid, particularly childproof or senior-friendly closures.
[0007] In one embodiment, the film is adhesively bonded to the
pressure inlay in the form of a cardboard inlay and an adhesive
layer is applied between the film and the sealing foil. There is
therefore a strong bond between the cardboard inlay and the film
and a releasable adhesive bond between the film and the sealing
foil.
[0008] Expediently, the sealing foil and the film are made of
aluminium. Other metallic materials or laminates of metal and/or
plastic films are not ruled out, however, and will be selected by
the skilled man according to the particular requirements.
[0009] In order to provide a reliable barrier for reducing water
permeation, the surface of the cardboard inlay, the film and the
sealing foil are advantageously all the same size. The size is
matched to the internal diameter of the closure and the contact
surface of the container that is to be sealed off, in order to
permit a large-area seal.
[0010] The remaining difference between the permeation of the
opened and sealed container can be attributed to the lateral
permeation through the adhesive layer between the film and the
sealing foil. The permeation can be further reduced by the
advantageous provision of an adhesive layer between the film and
the sealing foil, the area of which is less than the area of the
sealing foil, while the adhesive layer does not extend as far as
the edge of the sealing foil. The diameter of the adhesive layer
applied in a circle between the film and the sealing foil is such
that the adhesive layer does not come into contact with the bottle
sealing surface (top edge). Thus, after the bottle has been opened,
the adhesive layer itself cannot contribute to the lateral
permeation between the film and the sealing foil.
[0011] Preferably, the adhesive layer consists of a wax,
particularly with low permeability. The wax melts on sealing and
thereafter permits non-destructive rotation of the film relative to
the sealing foil as the lid is unscrewed and screwed shut. In order
to reduce the permeation through the wax layer between the film and
the sealing foil, a functional material is used as the wax which
not only allows non-destructive opening of the closure, by its
lubricating properties, but also has very low permeation and
additionally minimises the ingress of water, for example as a
result of strong adhesive properties, its low tendency to scoring
and clumping and its elastic properties.
[0012] An alternative embodiment encompasses the omission of the
adhesive layer between the film and the sealing foil. Preferably,
the sealing foil or the closure is of such dimensions that the
sealing foil is held in the closure in the unsealed state. The
sealing foil used is a sufficiently stable foil which can be
prevented from dropping out of the closure during the packaging
process by the fact that the internal diameter of the closure at
the seating of the induction seal disc is somewhat greater than the
internal diameter of the closure that is left free by the thread.
The sealing foil introduced into the closure cannot thereafter fall
out during the packaging process before the sealing operation. In
order to ensure the correct positioning of the film and sealing
foil it is possible to make the film and sealing foil of different
configurations that are optically perceptible, for example by the
application of structures, prints and/or colours. Thus, an optical
check can be carried out to determine whether the film and the
sealing foil are present in the closure during the packaging
process.
[0013] According to a further feature, the film and/or the sealing
foil are coated, particularly with a lacquer or a plastic, for
example polyolefin, polyethylene, polypropylene, ethylenevinyl
alcohol, ethylenevinyl acetate, or a barrier film, for example
cycloolefin copolymer, highly crystalline polyvinylidene chloride,
polychlorotrifluoroethylene. The coating may serve to prevent
metallic abrasion during the repeated opening and closing of the
closure and thus protect the product in the container or bottle. In
addition, a coating can be selected, both for its material or
combinations of material and its thickness, such that the direct
application of the film and the sealing foil to one another is
ensured and any unevenness is cancelled out and in this way the
lateral permeation is further reduced. Coatings used may be, for
example, lacquers, simple polymers, for example polyolefins such as
high or low density polyethylenes (HDPE or LDPE), polypropylene
(PP), or barrier films such as for example cycloolefin copolymer
(COC), highly crystalline polyvinylidene chloride (PVDC) or
polychlorotrifluoroethylene (PCTFE=Aclar.RTM.). In other variants,
barrier properties against water may be combined, for example, with
barrier properties against gases, e.g. oxygen. For this purpose,
suitable barrier plastics such as highly crystalline polyvinylidene
chloride (PVDC) or ethylenevinyl alcohol (EVOH) may be used as
coatings, particularly for coating the film. Moreover, the coating
may be used in controlled manner as a flavour protection, by the
controlled use of suitable barrier plastics such as e.g. PVDC (for
water protection and at the same time for flavour protection) or
ethylenevinyl acetate (EVA, predominantly for flavour protection).
For simultaneously achieving a barrier effect against various
substances, e.g. water and gases and flavours, etc., foil
composites having the corresponding barrier properties may be used.
Foil composites may also be used to improve the mechanical
stability of the film and/or the sealing foil. For the purpose of
improving lateral permeation the film may also be wholly or partly
coated and/or physically modified, e.g. by blasting or vapour
deposition. For this purpose the layers or coatings may also be
surface-treated or physically modified. In another variant the film
may be replaced by an aluminium barrier foil or by a foil
composite. This may itself be coated, pre-treated or physically
modified.
[0014] To improve the in-use permeation properties further, the
coating preferably comprises a sorbent which is suitable in
particular for absorbing water, gases and/or flavours. It may be,
for example, silica gel, a molecular sieve, clay or gypsum.
[0015] The problem is also solved with a closure for a bottle for
storing medicaments with an induction seal disc having the
properties described hereinbefore.
[0016] To safeguard repeated and reliable opening and closing, the
closure is expediently configured as a screw closure. With the
screw closure it is relatively simple to obtain the contact
pressure required for a reliable seal.
[0017] The problem is further solved with a plastic bottle having a
closure as shown above.
[0018] A plastic bottle of this kind can be produced inexpensively
in particular by the blow-moulding method and also by coextrusion
of a plurality of material layers. It is particularly advantageous
if the plastic bottle consists of a polyurethane elastomer, a
cellular polyurethane elastomer, a thermoplastic material,
particularly high or low density polypropylene or polyethylene, or
a laminate.
[0019] The plastics used for the plastic bottle may consist of
polyvinylchloride (PVC), cyclo-olefin-copolymer (COC),
polychlorotrifluoroethylene (PCFE), polyethylene (PE),
polypropylene (PP), polyethylene terephthalate (PET), polycarbonate
(PC), polyester (UP), polyacrylate, polyamide (PA) or another
plastic or a multi-layer composite plastic, consisting for example
of a combination of polychlorotrifluoroethylene (PCTFE), which is
known particularly by the brand name Aclar.RTM. registered as a
trade mark by Honeywell International, Inc., with polyvinylchloride
(PVC) or polyvinyl chloride (PVC) with polyvinylidene chloride
(PVdC).
[0020] Preferably, a sealing surface is formed on the free end of
the bottle neck. The sealing surface is configured so as to provide
a relatively large and flat abutment surface for the sealing foil
and/or the film.
[0021] According to a further feature, the plastic bottle is filled
with a pharmaceutical active substance formulation in the form of
plain or coated tablets or filled capsules.
[0022] It will be understood that the features mentioned above and
about to be explained hereinafter may be used not only in the
particular combination specified but also in other combinations.
The scope of the invention is defined only by the claims.
[0023] The invention is hereinafter explained in more detail by
means of an embodiment by way of example, with reference to the
associated drawings, wherein:
[0024] FIG. 1 shows a plastic bottle with a closure and an
induction seal disc according to the prior art and
[0025] FIG. 2 shows a plastic bottle with a closure and an
induction seal disc according to the invention.
[0026] The plastic bottle 1 according to the prior art is made from
a high density polyethylene (HDPE) and has a capacity of about 150
ml. A thread 3 for a closure 4 is formed on the neck 2 of the
bottle. An induction seal disc 5 is placed in the closure 4 and
consists of a cardboard inlay 6 on which a sealing foil 8 made of
aluminium is attached by means of a wax 7.
[0027] After being filled, the plastic bottle 1 is sealed with the
closure 4 with an induction seal disc 5 contained therein, by the
application of a certain torque, in order to press the cardboard
inlay 6 with the sealing foil 8 adhesively bonded thereto onto the
free end of the neck 2 of the bottle with the corresponding contact
pressure. Then the sealed plastic bottle 1 passes through an
electromagnetic field of a certain power that is irradiated in
close above the closure 4, as a result of which an electric current
is induced in the electrically conductive sealing foil 8, which
dissipates as a result of the electrical resistance of aluminium,
i.e. is converted directly into heat. The heat produced melts the
contact surface at the free end of the bottle neck 2 and bonds the
bottle neck 2 to the sealing foil 8. After leaving a sealing
machine, the heated area cools down and the sealing foil 8 is
welded to the plastic bottle 1. During heating, in the sealing
operation, as well as the plastic the wax 7 between the cardboard
inlay 6 and the sealing foil 8 also melts, after which the
cardboard inlay 6 is detached from the sealing foil 8. This
induction sealing process has already been used successfully for
years in the packaging of pharmaceutical products. HDPE bottles
sealed by this method have low permeation rates of about 0.85 mg of
water per day, for example, in the sealed state, in the case of a
150 ml HDPE bottle, based on 100% [relative humidity] difference in
humidity (inside/outside) and at 25.degree. C. When the plastic
bottle 1 is opened, the sealing foil 8 is pierced. Then the
cardboard inlay 6 pressed against the free end of the bottle neck 2
to form a seal and the tightly screwed closure 4 protect the
product in the plastic bottle 1 from moisture and the permeation
rate is about 7.3 mg of water per day under the conditions stated
above.
[0028] In the plastic bottle 1 according to the invention shown in
FIG. 2 the induction seal disc 5 has been improved by the provision
of a low-permeability film 10 between a pressure inlay 9, which may
also be made of an elastic plastics, for example, and the sealing
foil 8, the film 10 made of aluminium being firmly adhered to the
pressure inlay 9 configured as a cardboard inlay 6 using an
adhesive 11. The sealing foil 8 which is also made of aluminium is
attached to the film 10 with wax. The cardboard inlay 6, the film
10 and the sealing foil 9 are all the same size.
[0029] To reduce the lateral permeation through the layer of wax 7
between the film 10 and the sealing foil 8, a functional material
is used as the wax 7 itself, which safeguards the non-destructive
opening of the closure 4 by its lubricating properties and also has
a low permeability. To reduce the lateral permeation through the
wax 7 still further, the diameter of the circular layer of wax 7
provided between the film 10 and the sealing foil 8 is small enough
so that the wax 7 cannot come into contact with the sealing surface
at the free end of the bottle neck 2. Once the plastic bottle 1 has
been opened, the wax 7 itself cannot contribute to the lateral
permeation between the films 10 and the sealing foil 8.
[0030] During the sealing, the sealing foil 8 is firmly welded to
the bottle neck 2 and, as previously, safeguards the low permeation
rate of the sealed plastic bottle 1 during storage. The wax 7
between the film 10 and the sealing foil 8 melts during sealing, as
a result of the prevailing heat, and enables the film 10 to be
rotated non-destructively relative to the sealing foil 8 during the
opening and closing of the closure 4. Thus the film 10 and sealing
foil 8 remain intact and retain their barrier properties. Once the
plastic bottle 1 has been opened and the sealing foil 8 pierced
accordingly, the water permeation through the main permeation
route, namely via the cardboard inlay 6 and the material from which
the closure 4 is produced, is completely blocked by the additional
film 10.
[0031] The in-use permeation rate of originally about 7.3 mg/d is
reduced to about 2.35 mg/d in the plastic bottle 1 according to the
invention, under the conditions explained hereinbefore.
* * * * *