ACCESSOIRE D'EMBALLAGE-COQUE

BLISTER PACKAGE ADJUNCT

Abrégé français

Un élément annexe destiné à être utilisé avec un emballage coque comportant une pluralité d'alvéoles disposés en un motif établi, chaque alvéole contenant un objet pharmaceutique. L'élément annexe comporte une feuille de support présentant des première et seconde parties latérales assemblées selon une ligne de pliage, une pluralité d'ouvertures s'étendant à travers la première partie latérale dans un motif correspondant à un motif d'alvéoles de l'emballage coque, une première couche de matériau adhésif entourant les ouvertures, une seconde couche de matériau adhésif recouvrant la seconde partie latérale de la feuille de support, un film mince de matière plastique recouvrant la seconde couche de matériau adhésif, une troisième couche de matériau adhésif recouvrant le film de matière plastique, une feuille électronique recouvrant la troisième couche de matériau adhésif et portant des impressions conductrices d'électricité et une puce électronique, les impressions conductrices s'étendant dans un motif correspondant au motif des ouvertures dans la première partie latérale de la feuille de support, et une quatrième couche de matériau adhésif recouvrant la feuille électronique. Chacune des première et quatrième couches de matériau adhésif est recouverte préalablement à l'utilisation de l'élément annexe par une feuille de matériau de déblocage.

Abrégé anglais

An adjunct is provided for use with a blister package having a plurality of blisters arranged in a set pattern, each blister containing a pharmaceutical object. The adjunct includes a backing sheet having first and second side portions joined along a fold line, a plurality of openings extending through the first side portion in a pattern corresponding to a pattern of blisters of the blister package, a first layer of adhesive material surrounding the openings, a second layer of adhesive material covering the second side portion of the backing sheet, a thin film of plastics material covering the second layer of adhesive material, a third layer of adhesive material covering the film of plastics material, an electronics sheet covering the third layer of adhesive material and carrying electrical traces and an electronic chip thereon, the traces extending in a pattern corresponding to the pattern of openings in the first side portion of the backing sheet, and a fourth layer of adhesive material covering the electronics sheet. Each of the first and fourth layers of adhesive material is covered prior to use of the adjunct by a sheet of release material.

Revendications

CLAIMS:
1. An adjunct for use with a blister package having a plurality of blisters
arranged in a set pattern, each blister containing a pharmaceutical object,
said adjunct comprising:
a backing sheet having first and second side portions joined along a
fold line;
a plurality of openings extending through said first side portion in a
pattern corresponding to a pattern of blisters of said blister package;
a first layer of adhesive material surrounding said openings;
a second layer of adhesive covering said second side portion of said
backing sheet;
a thin film of plastics material covering said second layer of
adhesive;
a third layer of adhesive material covering said film of plastics
material;
an electronics sheet covering said third layer of adhesive and
carrying electrical traces and an electronic chip thereon, said traces
extending in a pattern corresponding to said pattern of openings in the
first side portion of said backing sheet; and
a fourth layer of adhesive material covering said electronics sheet;
each of said first and fourth layers of adhesive material being
covered prior to use of said adjunct by a sheet of release material.
2. The adjunct of claim 1. wherein the adhesive material of each of said
adhesive layers is a gel-type adhesive.
3. The adjunct of claim 1 wherein the adhesive material of each of said
adhesive layers is relatively thick.
4. The adjunct of claim 1 wherein the adhesive material of each of said
adhesive layers is flexible.
5. The adjunct of claim 1 wherein the second, third and fourth layers have
weakened zones located in a pattern corresponding to said pattern of
openings in the first side portion of said backing sheet.
6

6. The adjunct of claim 5 wherein the backing sheet has weakened zones
located in a pattern corresponding to said pattern of openings in the first
side portion of said backing sheet.
7. The adjunct of claim 1 wherein the second, third and fourth layers have
openings located in a pattern corresponding to said pattern of openings in
the first side portion of said backing sheet.
8. The adjunct of claim 7 wherein the backing sheet has openings located in
a pattern corresponding to said pattern of openings in the first side
portion of said backing sheet.
9. The adjunct of claim 1 wherein the backing sheet is cardboard having a
thickness of about 0.175mm.
10. The adjunct of claim 1 wherein the first, second, third and fourth
layers
each have a thickness of about 0.05mm.
11. The adjunct of claim 1 wherein the thin film has a thickness of about
0.1mm.
12. The adjunct of claim 1 wherein the electronics sheet has a thickness of
about 0.05mm.
7

Description

CA 02567546 2006-11-09
BLISTER PACKAGE ADJUNCT
This invention relates to blister packages for pharmaceutical products in
general and
more particularly to an adjunct for use with a blister package, especially
during clinical trials
and when monitoring of pharmaceutical usage is important.
BACKGROUND OF THE INVENTION
Pharmaceutical products, such as pills or capsules containing specific
medications are
usually provided in sealed bottles or in blister packages, either "over the
counter" or by
prescription. Often, as well, such products are available only as part of a
clinical trial
undertaken by a pharmaceutical company in order to verify the efficacy of the
medication
and, in particular, to ascertain whether there are any side effects associated
with the
medication. Only after the clinical trials have been completed can the
pharmaceutical
company attempt to obtain regulatory approval for the medication.
When conducting clinical trials it is important that very accurate records be
maintained. The individuals participating in the trials, whether physicians or
patients
(subjects) must record the time that the medication is taken and any side
effects resulting
therefrom. New packaging such as that available through Information Mediary
Corporation
makes the recording of information easier, in that the packaging provides for
electrical
traces printed or otherwise provided on a blister package such that a trace is
broken
whenever a pill or capsule is extracted from the package. This event is
recorded on an
electronic chip included as part of the package, and the information recorded
on the chip
can be downloaded by the physician or other technician once all of the pills
or capsules have
been removed from the package. The data recorded on the chip can be downloaded
directly
to an appropriate reader or can be transmitted wirelessly to a reader some
distance away
from the individual.
The production of blister packages with electronic traces can be expensive and
it can
become difficult to co-ordinate the provision of such packages to a subject of
a clinical test,
or to any individual who is on a strict regimen relating to the taking of
certain medications.
When the blister packages of medication are made at one facility and the
electronics are
manufactured elsewhere there can be difficulties in marrying the two elements
together
such that a physician can ensure that the individual obtains the correct
package of
medication with the correct monitoring electronics associated therewith.
1

CA 02567546 2006-11-09
SUMMARY OF THE INVENTION
The present invention overcomes problems associated with the manufacturing of
electronically monitored blister packages, particularly with respect to such
packages used in
clinical trials. With this invention the physician conducting the trial, or
having a patient on a
strict medication regimen, is provided with a number of package adjuncts which
carry the
necessary electronics and traces. The conducting physician can then provide
the patient or
subject with an adjunct such that when the patient or subject obtains a
blister package of
the correct medication, whether from a pharmacy or other source, the patient
or subject
can then bring the blister package and the adjunct together and assemble them
into a
monitoring unit containing the blister package of medication and the
electronic portion
which provides the required usage information for later retrieval.
The adjunct of this invention includes a cardboard backing sheet or lidstock
which
typically will be printed with appropriate information and instructions for
use. The backing
sheet will have two major portions and will be foldable so that one portion
can overly the
other portion. One of the portions will have a plurality of openings extending
therethrough
arranged in a pattern which corresponds to the pattern of blisters on the
blister package
with which the adjunct is to be used. Surrounding those openings will be a
first layer of
adhesive material covered by a sheet of release paper. When the blister
package is to be
united with the adjunct the sheet of release paper is removed and the blister
package is
pressed against the adhesive layer with the blisters projecting through the
openings in the
backing sheet, such that the blisters are accessible from the opposite side of
the backing
sheet.
On the same side of the backing sheet carrying the adhesive, the other portion
of the
backing sheet will carry several layers. Specifically, there will be a second
layer of adhesive
material, a thin layer of plastic material, a third layer of adhesive
material, an electronics
layer carrying the required pattern of electrical traces and the electronic
chip, and a fourth
layer of adhesive material. The adhesive material utilized with the present
invention is
preferably a gel-type adhesive that is relatively thick in comparison to most
adhesives used
with cardboard an other such materials. The adhesive used herein has desirable
properties
in that it is not rigid but has a fair degree of flexibility associated
therewith. The layers in
contact with the adhesive can shift slightly relative to each other which in
turn means that
the final package can be subjected to various stresses without degrading the
effectiveness
of the electrical traces and the electronic chip. The final package can be
folded, deformed,
2

CA 02567546 2006-11-09
bent and otherwise stressed without the effects thereof being felt by those
layers which are
spaced inwardly from the cardboard backing.
The innermost or fourth layer of adhesive material provided on the other
portion of
the cardboard backing sheet will also have a release paper or sheet thereon.
Once the
blister package has been assembled or applied to the adhesive on the one side
portion of
the backing sheet the release paper on the other side portion is removed and
the portion
carrying the blister package is folded over so as to overly the other portion.
The exposed
adhesive on the other portion will adhere to the back of the blister package
and to the
surrounding cardboard of the one side portion of the cardboard backing sheet,
creating a
final folded package with the blister package sandwiched between the overlying
portions of
the cardboard backing sheet.
The adhesive layers on the other portion of the backing sheet can be provided
with
openings, weakness zones or fracture zones to facilitate the passage of the
pills or capsules
therethrough from the blister package. As a pill or capsule passes through the
layers of
material on the other portion of the backing sheet is will break an electrical
trace on the
electronics layer, triggering a recording event on the electronics chip which
can be later
retrieved as required.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be described in conjunction with the drawings
wherein:
Figure 1 is a plan view of an adjunct in accordance with the present
invention;
Figure 2 is a cross-sectional view showing the various layers;and
Figure 3 shows the steps in assembling the final package.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Figures 1 and 2 show an adjunct 10 of this invention in both plan and cross-
section
respectively. A sheet 12 of cardboard backing material has two major side
portions 14, 16
with a fold line 18 separating the portions. The first side portion 14 is
provided with a
plurality of openings 20 extending therethrough in a patter corresponding to
the pattern of
blisters 22 provided on a blister package 24. The openings 20 are surrounded
by a first
layer 26 of adhesive material, the layer having a surface extent that
generally corresponds
to the surface extent of the blister package 24. Although not shown in Figure
1, but seen in
Figure 3, the adhesive layer 26 will be initially provided with a layer of a
release paper 50
3

CA 02567546 2006-11-09
which protects the adhesive prior to usage thereof.
The second side portion 16 of the cardboard backing sheet is provided with a
plurality of individual layers, one above the other and each being generally
co-extensive
with the entire surface area of the portion 16. Built up on the portion 16 of
the backing
sheet is a second layer 28 of adhesive material, a thin film 30 of plastic
material, a third
layer 32 of adhesive material, an electronics layer 34 carrying thereon the
desired pattern
of electrical traces and an electronics chip, and a fourth layer 36 of
adhesive material. The
adhesive layers preferably are constituted by a gel-type of adhesive which is
relatively thick
in comparison to most adhesives used with cardboard materials. A preferred
adhesive
material is available from Grafix Plastics of Cleveland, OH, USA. Such
adhesive material is
provided as a plastic film coated on both sides with the adhesive material and
appropriate
release papers. In the assembly shown in Figures 1 and 2 the second adhesive
layer 28,
the plastic film 30 and the third adhesive layer 32 will, in fact, be
constituted by the product
obtained from Grafix Plastics as described above.
Typically, the adjunct 10 of this invention will use a cardboard backing sheet
having
a thickness in the order of 7mil (0.175mm), adhesive layers each having a
thickness in the
order of 2mil (0.05mm), a plastic film layer having a thickness in the order
of 4mil (0.1mm)
and an electronics layer printed on paper having a thickness in the order of
2mil (0.05mm).
In order to facilitate usage of the present invention the layers applied to
the side
portion 16, and the cardboard sheet itself, will be preferably provided with
either openings
or zones of weakness 38 corresponding to the pattern of blisters associated
with the blister
package. Thus the various layers applied to portion 16 will not greatly hinder
the passage
of a pill or capsule therethrough.
Figure 3 generally shows the steps to be taken when an individual prepares a
final
package using the adjunct of the present invention. In this view all of the
individual layers
provided on the second portion of the cardboard sheet 12 are represented by
the single
layer 52.
The first step in creating a final package is for the individual to remove the
release
layer 50 from the adhesive material 26, exposing the adhesive for usage. The
blister
package 24, obtained from a pharmacy, a physician, or a technician, is
positioned above the
adhesive layer 26 with the blisters 22 aligned with the openings 20. The
blister package 24
is then pressed against the adhesive layer 26 so that the blisters 22 project
through the
openings 20.
4

CA 02567546 2006-11-09
After the blister package has been adhered to the adhesive layer 26 provided
on the
first portion 14 of the adjunct the release paper 54 covering the fourth layer
of adhesive on
the second portion 16 is removed and the two portions are folded towards each
other
around the fold line 18. That will bring the exposed adhesive of the fourth
layer into contact
with the back of the blister package 24 and with the adjacent surface of the
first portion 14
surrounding the blister package. The end result is a folded package with the
blister package
24 sandwiched securely between the first and second portions of the cardboard
backing
sheet, with the blister 22 exposed through the openings in the first portion
14 and with the
openings or zones of weakness 38 aligned with the blisters 22 as well.
Because the gel-type adhesive used for the various adhesive layers of the
adjunct is
relatively thick and is relatively flexible, without being rigid, there can be
a small amount of
relative movement between the components provided on the adjunct. This
relative
movement means that there is less chance of damage to, in particular, the
electronics layer
34 should the final package be subjected to stress due to flexing, creasing,
dropping or
bending between the time of assembly and the time of data gathering.
By providing a separate adjunct of the present invention potential
difficulties in
providing final packages for clinical trials and other pharmaceutical
preparations can be
avoided. Blister packages of a standard size and configuration can be
manufactured by a
particular pharmaceutical company without concern as to how such packages will
be
provided, if desired, with electronic monitoring elements. Those elements can
be
manufactured elsewhere and assembled to the blister package as desired, by a
physician,
pharmacist or patient. This simplifies greatly the overall manufacturing and
distribution
process. Additionally, the adjunct of the present invention, while increasing
the flexibility of
clinical trials, helps to prevent damage to the final package occasioned by
rough handling of
the final package.
5

Dessin représentatif