CA2567546C - Blister package adjunct - Google Patents

Blister package adjunct Download PDF

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Publication number
CA2567546C
CA2567546C CA2567546A CA2567546A CA2567546C CA 2567546 C CA2567546 C CA 2567546C CA 2567546 A CA2567546 A CA 2567546A CA 2567546 A CA2567546 A CA 2567546A CA 2567546 C CA2567546 C CA 2567546C
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CA
Canada
Prior art keywords
adjunct
layer
adhesive
openings
pattern
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2567546A
Other languages
French (fr)
Other versions
CA2567546A1 (en
Inventor
Michael Petersen
Mykola Sherstyuk
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Intelligent Devices SEZC Inc
Original Assignee
Intelligent Devices Inc Barbados
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Intelligent Devices Inc Barbados filed Critical Intelligent Devices Inc Barbados
Priority to CA2567546A priority Critical patent/CA2567546C/en
Publication of CA2567546A1 publication Critical patent/CA2567546A1/en
Application granted granted Critical
Publication of CA2567546C publication Critical patent/CA2567546C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/04Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
    • B65D83/0445Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments
    • B65D83/0463Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments formed in a band or a blisterweb, inserted in a dispensing device or container
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J2200/00General characteristics or adaptations
    • A61J2200/30Compliance analysis for taking medication
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2203/00Decoration means, markings, information elements, contents indicators
    • B65D2203/10Transponders

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)

Abstract

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.

Description

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.

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 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 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 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

Claims (12)

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. 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.
CA2567546A 2006-11-09 2006-11-09 Blister package adjunct Active CA2567546C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2567546A CA2567546C (en) 2006-11-09 2006-11-09 Blister package adjunct

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA2567546A CA2567546C (en) 2006-11-09 2006-11-09 Blister package adjunct

Publications (2)

Publication Number Publication Date
CA2567546A1 CA2567546A1 (en) 2008-05-09
CA2567546C true CA2567546C (en) 2014-03-11

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2567546A Active CA2567546C (en) 2006-11-09 2006-11-09 Blister package adjunct

Country Status (1)

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CA (1) CA2567546C (en)

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Publication number Publication date
CA2567546A1 (en) 2008-05-09

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