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Patent 2577703 Summary

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(12) Patent: (11) CA 2577703
(54) English Title: CHILD-RESISTANT MEDICAMENT PACKAGE
(54) French Title: EMBALLAGE POUR MEDICAMENTS A L'EPREUVE DES ENFANTS
Status: Expired and beyond the Period of Reversal
Bibliographic Data
(51) International Patent Classification (IPC):
  • B65D 83/04 (2006.01)
(72) Inventors :
  • WILLIAMS, TIMOTHY RICHARD, JR. (United States of America)
(73) Owners :
  • L. PERRIGO COMPANY
(71) Applicants :
  • L. PERRIGO COMPANY (United States of America)
(74) Agent: BORDEN LADNER GERVAIS LLP
(74) Associate agent:
(45) Issued: 2013-07-02
(86) PCT Filing Date: 2005-08-18
(87) Open to Public Inspection: 2006-03-02
Examination requested: 2010-08-05
Availability of licence: N/A
Dedicated to the Public: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2005/029393
(87) International Publication Number: WO 2006023643
(85) National Entry: 2007-02-19

(30) Application Priority Data:
Application No. Country/Territory Date
60/603,489 (United States of America) 2004-08-20

Abstracts

English Abstract


An individual blister pack includes an unsealed area formed along an edge, and
a die cut slot is formed at an angle adjacent edges of the blister pack and
communicates with the unsealed area. The die cut slot allows tearing of the
corner of the blister pack, which exposes an easily accessible corner pull tab
to allow an impenetrable polymeric film to be peeled away from the underlying
foil such that medicament can subsequently be pushed through the foil for
dispensing the medicament from the blister pack. The package, therefore,
provides a tear-peel-push sequence of operation requiring the cognitive skills
of an adult and yet allows an adult an easy manner by which to obtain a finger
hold on the impenetrable film layer for peeling it from the blister pack.


French Abstract

Cette invention concerne un emballage-coque individuel, qui comprend une zone non scellée formée le long d'un bord, et une fente à dentelure formée au niveau d'un angle adjacent aux bords de l'emabllage-coque et communiquant avec la zone non scellée. La fente à dentelure permet à l'utilisateur de détacher le coin de l'emballage-coque en tirant, ce qui libère une languette de coin à tirer facilement accessible, permettant ainsi de détacher ainsi un film polymère impénétrable de la feuille de dessous, pour que le médicament puisse ensuite être poussé à travers la feuille, de façon à sortir de l'emballage-coque. Ainsi, cet emballage offre une séquence d'opérations de type tirer-détacher-pousser, nécessitant les compétences d'un adulte, tout en lui offrant un moyen aisé d'obtenir une alvéole sur la couche de film impénétrable, laquelle se détache ainsi de l'emballage-coque.

Claims

Note: Claims are shown in the official language in which they were submitted.


CLAIMS:
1. A child-resistant blister package comprising:
a first polymeric film defining a pocket for receiving a medicament
therein;
a foil layer covering said pocket;
an impenetrable polymeric film sealed to said first polymeric film for sealing
a
medicament in said pocket;
an unsealed area between said first polymeric film and said impenetrable
polymeric film, said unsealed area extending along one edge of said blister
pack; and
a die cut extending at an acute angle to adjacent edges of said blister pack
and
having only one end intersecting and extending into said unsealed area and an
opposite
end extending toward one edge of said blister pack adjacent said edge on which
said
unsealed area is located, wherein said package can be opened by tearing the
die cut to
remove a comer of the blister pack to expose a tab which can be gripped for
peeling
the impenetrable polymeric film from said package to allow a medicament to be
pushed through the foil layer.
2. The package as defined in claim 1 wherein said die cut extends through
said
first polymeric film and said impenetrable polymeric film.
3. The package as defined in claim 2 wherein said die cut terminates before
reaching said one edge.
4. The package as defined in claim 3 wherein said die cut extends from said
unsealed area at an angle of about 45° to said one edge.
5. The package as defined in claim 4 wherein said unsealed area is
curvilinear.
6. The package as defined in claim 5 wherein said unsealed area is a
semicircle.
7. A child-resistant blister package comprising:
a first polymeric film defining a plurality of spaced-apart pockets for
receiving
medicaments therein;
a foil layer coupled to said first polymeric film to enclose said pockets;
a laminate including an impenetrable polymeric film sealed to said first
polymeric film
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for sealing medicaments in said pockets;
perforations formed through said first film and said laminate to allow
separation of individual blister units;
a plurality of unsealed areas between said first polymeric film and said
laminate and located between pairs of adjacent blister units; and
a die cut extending at an acute angle to adjacent edges of each blister unit
and
having only one end extending into said unsealed area and an opposite end
extending
toward one edge of said blister unit adjacent said edge on which said unsealed
area is
located, wherein said blister unit can be opened by tearing the die cut at the
unsealed
area to remove a corner of the blister unit to expose a tab which can be
gripped for
peeling the impenetrable polymeric film from said unit to allow a medicament
to be
pushed through the foil layer.
8. The package as defined in claim 7 wherein said die cut extends through
said
first polymeric film and said laminate.
9. The package as defined in claim 8 wherein said die cut terminates before
reaching said one edge.
10. The package as defined in claim 9 wherein said die cut extends from
said
unsealed area at an angle of about 45° to said one edge.
11. The package as defined in claim 10 wherein said unsealed areas are
curvilinear.
12. The package as defined in claim 11 wherein said unsealed areas are
circular.
13. A method of manufacturing a blister pack comprising the steps of:
heat sealing a polymeric film having a plurality of pockets containing
medicaments therein with a laminate comprising a foil layer and an
impenetrable film
layer;
while heat sealing said film and laminate, forming unsealed areas between said
film and laminate;
-8-

providing perforations between adjacent pockets for separating individual
blister units from said blister pack; and
die cutting a slot extending from each unsealed area toward an edge of each
blister unit at an acute angle to allow a corner of each blister unit to be
torn away.
14. The method of claim 13 wherein said forming step comprises providing
apertures in a heat sealing tool which prevents sealing of said polymeric film
and
laminate in the areas of said apertures.
15 . A child-resistant tear-peel-push blister package comprising:
a first polymeric film defining a plurality of spaced-apart pockets for
receiving
medicaments therein;
a lidding including a foil layer and an impenetrable polymeric film
selectively
heat sealed to said first polymeric film for sealing medicaments in said
pockets;
perforations formed through said first film and said laminate-lidding to allow
separation of individual blister units;
a plurality of unsealed areas between said first polymeric film and said
lidding
and located between pairs of adjacent blister units; and
a die cut extending at an acute angle to adjacent edges of each blister unit
and
having only one end extending into said unsealed area and an opposite end
extending
toward one edge of said blister unit adjacent said edge on which said unsealed
area is
located, wherein said blister unit can be opened by tearing the die cut at the
unsealed
area to remove a corner of the blister unit to expose a tab which can be
gripped for
peeling the impenetrable polymeric film from said unit to allow a medicament
to be
pushed through the foil layer.
16. The package as defined in claim 15 wherein said die cut extends through
said
first polymeric film and said laminate.
17. The package as defined in claim 16 wherein said die cut terminates
before
reaching said one edge.
18. The package as defined in claim 17 wherein said die cut extends from
said
unsealed area at an angle of about 45° to said one edge.
-9-

19. The package as defined in claim 18 wherein said unsealed areas are
curvilinear.
20. The package as defined in claim 19 wherein said unsealed areas are
circular.
21. The package as defined in claim 15 wherein said polymeric film is a
polyvinylchloride having a thickness of from about 7.5 to about 30 mils.
22. The package as defined in claim 21 wherein said impenetrable film is a
biaxially oriented nylon film of from about 30 to about 60 gauge.
23. The package as defined in claim 22 wherein said foil layer is and
aluminum
foil having a thickness of from about .00035 inches to about .03 inches.
24. The package as defined in claim 22 wherein said lidding further
includes a
paper layer on a side of said impenetrable layer opposite said foil.
25. A child-resistant blister package comprising:
a first polymeric film defining a pocket for receiving a medicament therein;
a foil layer enclosing said pocket;
a laminate including an impenetrable polymeric film sealed to said first
polymeric film for sealing a medicament in said pocket;
an unsealed area between said first polymeric film and said laminate, said
unsealed area extending along one edge of said blister pack; and
a die cut extending at an acute angle to adjacent edges of said blister pack
and
having only one end extending into said unsealed area and an opposite end
extending
toward one edge of said blister pack adjacent said edge on which said unsealed
area is
located, wherein said package can be opened by tearing the die cut to remove a
corner
of the blister pack to expose a tab which can be gripped for peeling the
impenetrable
polymeric film from said package to allow a medicament to be pushed through
the foil
layer.
26. The package as defined in claim 25 wherein said die cut extends through
said
first polymeric film and said laminate.
-10-

27. The package as defined in claim 26 wherein said die cut terminates
before
reaching said one edge.
28. The package as defined in claim 27 wherein said die cut extends from
said
unsealed area at an angle of about 45° to said one edge.
29. The package as defined in claim 28 wherein said polymeric film is a
polyvinylchloride having a thickness of from about 7.5 to about 30 mils.
30. The package as defined in claim 29 wherein said impenetrable film is a
biaxially oriented nylon film of from about 30 to about 60 gauge.
31. The package as defined in claim 30 wherein said foil layer is and
aluminum
foil having a thickness of from about .00035 inches to about .03 inches.
32. The package as defined in claim 31 wherein said laminate further
includes a
paper layer on a side of said impenetrable layer opposite said foil.
-11-

Description

Note: Descriptions are shown in the official language in which they were submitted.


CA 02577703 2012-09-06
CHILD-RESISTANT MEDICAMENT PACKAGE
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C. 119(e) on U.S.
Provisional
Application No. 60/603,489 entitled CHILD-RESISTANT MEDICAMENT
PACKAGE, filed on August 20, 2004, by Timothy Richard Williams, Jr.
BACKGROUND OF THE INVENTION
[0002] The present invention relates to a child-resistant medicament
package and
particularly to an opening feature for a blister-type package.
[0003] Blister packages have become popular for the child-resistant
packaging of
medicaments, such as antihistamines and other medicaments which are available
over
the counter and in common use by adults but which must be taken according to
instructions and are required to be packaged in a child-resistant package.
Existing
packages have been provided with a paper foil backing over which a polymeric
film is
heat-sealed to encase the medicament in what is generally referred to as a
blister pack.
[0004] In order to access the medicament for use, a die cut is usually
formed in spaced
relationship to an edge of the package and aligned with the blister enclosing
the
medicament. The die cut slit allows an adult to tear open the blister pack
with some
effort by tearing through the edge material and then the blister itself for
gaining access
to the medicament contained therein. Typically, a child will not have the
strength
required to open such a package.
[0005] Although this type of package has provided an effective, popular
child-resistant
package for medicaments, they are somewhat difficult to open by adults. U.S.
Patent
No. 6,422,391 discloses a blister pack which is easier for an adult to open
and requires
significant cognitive skills which prevents a child from accessing such a
package. The
391 patent employs a tear-away tab on a blister pack, which subsequently forms
a
notch with a pair of legs which can be easily gripped for subsequent tearing
through the
blister pack itself. This type of package is particularly useful for blister
packs which are
not the push-through type packages which constitute another popular form of
blister
pack construction.
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[0006] In push-through packages, an impenetrable polymeric layer typically
overlies a
foil layer sealing a medicament-holding blister formed on a base layer. The
impenetrable polymeric layer is first peeled away by a tab along an edge which
then
allows a medicament to be pushed through the remaining foil sealing layer for
accessing
the medicament. There exists numerous push-through type packages of such peel-
push
construction, however, they frequently require considerable dexterity for
adults to
initiate the peeling of the impenetrable polymeric layer for subsequent access
to the
medicament.
[0007] When tested, too often children are able to access peel-push
packages, which
have an unsealed area located at one or more corners or an edge of the
individual blister
unit. Also, too often seniors have difficulty opening tear-notch or tear-slit
packages,
which rely on the user having sufficient finger strength to tear through the
cavity to
expose the product.
[0008] A child-resistant bend-peel package is also known in which the
blister sheet is
scored at one corner. The customer is instructed to bend the corner at the
score line,
which will break the blister sheet layer but leave the backing layers attached
to the
blister sheet. The broken corner, comprised of the broken blister sheet which
is still
attached to all backing layers, can then be used to pull all of the backing
layers away
from the remaining blister sheet, thereby exposing the product.
SUMMARY OF THE INVENTION
[0009] The tear-peel-push (TPP) package of the present invention was
designed with the
intention of making it more difficult for children to locate and utilize an
unsealed portion
of the package. At the same time, the tearing strength requirement for seniors
is less
than what is required for packages utilizing a typical tear-notch feature.
[0010] The TPP blister pack of the present invention incorporates a unique
opening
feature once an individual blister pack has been segregated from an array of
blister
packs typically employed for packaging several dosages of a given medicament.
An
unsealed area between the polymeric film forming the blister pack and the
backing
material is formed along an edge of a segregated blister pack. A die cut slot
is formed
at an angle to the edges of the blister pack and communicates with the
unsealed area.
The corner of the blister pack is torn away utilizing the die cut slot which
results in an
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easily accessible corner pull tab which allows an impenetrable polymeric film
to be
peeled away from the underlying foil such that medicament can subsequently be
pushed
through the foil for dispensing the medicament from the blister pack. In one
embodiment of the invention, the unsealed area is formed in a generally
circular pattern
spanning adjacent blister packs in an array of blister packs, while the die
cut is formed
at an angle of about 45 between adjacent edges of the blister pack with one
end of the
die cut intersecting the unsealed area and the other end closely adjacent but
not
extending through the edge of the blister pack.
mom The TPP package of this invention, therefore, provides a tear-peel-
push sequence
of operation which requires the cognitive skills of an adult and which
provides an adult
an easy manner by which to obtain a finger hold on the impenetrable film layer
for
peeling it from the blister pack.
[0012] These and other features, objects and advantages of the present
invention will
become apparent upon reading the following description thereof together with
reference
to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Fig. 1 is a top plan view of the child-resistant blister package,
showing multiple
individual blister units;
[0014] Fig. 2 is a top plan view of one of the individual blister units
shown in Fig. 1;
[0015] Fig. 3 is a bottom plan view of the individual blister unit shown
in Fig. 2;
[0016] Fig. 4 is a plan view of the individual blister unit of Fig. 3,
showing one corner
of the individual blister unit detached at the single cut line;
1j0017] Fig. 5 is a plan view of the individual blister unit of Fig. 4,
showing the paper
sheet and flexible polymeric material layers peeled away exposing the foil
layer;
[0018] Fig. 6 is a plan view of the individual blister unit of Fig. 5,
showing the product
rupturing the foil layer; and
[0019] Fig. 7 is an enlarged cross-sectional view of the individual
blister unit, showing
the material layers and a portion of the unsealed area.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0020] Referring first to Figs. 1 and 7, the child-resistant package as a
whole is
indicated by the reference character 10. Package 10 may contain a single but
more
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CA 02577703 2007-02-19
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typically multiple individual blister units 11. Each unit 11 has a single or
double cavity
12 of any desired shape which conforms to the shape of the product 18
contained within
the package. The individual blister units 11 can be separated by tearing the
package
along perforated cut lines 13. Typically the product 18 is a medicament, such
as a tablet
or caplet, requiring child-resistant packaging.
[0021] Referring to Figs. 2-7, each individual blister unit 11 includes a
single die cut
line 14 and an unsealed area 15 which intersect and provide an opening feature
for
individual blister units 11. The single die cut line 14 penetrates the outer
blister sheet
19 (Fig. 7) and all backing layers 21, 23, and 25. Die cut 14 extends at an
angle of
about 45 to the adjacent edges of each blister unit 11 and has one end 13
which
intersects the unsealed area 15 and an opposite end 17 which terminates in
spaced
relationship to an edge 19 of unit 11 adjacent the edge in which the unsealed
area 15 is
formed. The unsealed area 15 comprises, as best seen in Fig. 7, a gap between
the
lidding 26 and specifically the peel-resistant adhesive 20 and the facing
blister sheet 19,
leaving a gap of approximately .010 inches.
[0022] The unsealed area 15 is formed during the heat sealing of lidding
26 to the blister
sheet 19 by providing circular openings in the lower sealing tool, which
engages the
blister sheet. The circular openings are aligned with the blister pack 10 to
place
unsealed areas 15 centered between individual blister units 11 and toward one
corner of
each blister unit, as seen in Fig. 1. A heated sealing plate engages the
lidding 26 on a
side of blister pack 10 opposite the lower sealing tool and the blister sheet
19. The
circular openings therefore prevent sealing pressure from being applied to the
blister
pack in the circular areas 15 resulting in the unsealed areas 15, as seen in
Figs. 1 and 7.
[0023] When the corner 30 of an individual blister pack 11 is torn away at
die cut 14, as
seen in Fig. 4, a new corner 16 or tab is presented within the unsealed area
15. This
allows a thumb or finger nail to be inserted in the gap between the lidding 26
and blister
sheet 19 for peeling the paper and polymeric film 25 and 23 away from blister
sheet 19,
as seen in Fig. 5, exposing the foil seal layer 21 through which the
medicament 18 can
then be pushed, as illustrated in Fig. 6. As seen in Fig. 5, the unsealed area
15 is
exposed and a portion 21' of the foil 21 remains on the backside of layer 23.
[0024] Backing sheet or lidding 26, as shown in Fig. 7, contains a strong
peel-resistant
heat seal coating 20, a foil barrier sheet 21, a peelable adhesive 22, a
strong flexible
-4-

CA 02577703 2007-02-19
WO 2006/023643
PCT/US2005/029393
polymeric sheet material (e.g. polyester such as polyethylene terephthalate,
etc.) 23, a
strong peel-resistant adhesive layer 24, and a paper sheet 25 which can have
printing on
the outer surface to convey information to the consumer, such as package
contents and
opening instructions. The blister sheet 19 can be a single or multiple layered
material
consisting of various polymeric materials (e.g. polyvinyl chloride, polyvinyl
chloride
and polyvinylidene chloride, etc) formed with cavities 12 to contain
medicaments
between sheet 19 and lidding 26.
[0025] A strong peel-resistant heat seal coating is utilized for layer
20, so that as the
paper sheet 25 and strong flexible polymeric material 23 are pulled back, the
foil layer
21 will not peel back to expose the cavity area 12.
[0026] Backing sheet or lidding 26 need not contain all three layers of
foil 21, strong
(i.e. impenetrable) polymeric sheet 23, and paper sheet 25. The strong
polymeric
material, however, is necessary for the purposes of providing a safety backing
to the
blister sheet 19 so that the product cannot be forced out of the package
without first
peeling away material 23.
[0027] Referring to Fig. 7 and reference characters identified below,
in one
embodiment, the following material types and thicknesses were employed:
[0028] Reference No. 19 - 10 mil (0.010") PVC (polyvinylchloride)
[0029] Reference Nos. 20-25 (Alcoa ID = Safety Pak 226)
[0030] Reference No. 20 - 3.5# Heat Seal Coating (Alcoa ID = C11158)
[0031] Reference No. 21 - 0.001" Foil (Alcoa ID = MALB102.5DR1235-0)
[0032] Reference No. 22 - 1.1# W/B Laminate Adhesive (Alcoa ID =A11960)
[0033] Reference No. 23 - 60 GA. Biaxially oriented nylon film (Alcoa ID =
NYL60E)
[0034] Reference No. 24 - 2.0# Thermoset Adhesive (Alcoa ID = C1360)
[0035] Reference No. 25 - 25# Calend. Bleach Paper (Alcoa ID = 25BLP)
[0036] The following ranges of materials may be employed in other
embodiments:
[0037] Reference No. 19 - 7.5-30 mils
[0038] Reference No. 20 - 2.5 to 4.5 pounds per ream
[0039] Reference No. 21 - 0.00035" to 0.03"
[0040] Reference No. 22 - 0.75 to 1.25 pounds per ream
[0041] Reference No. 23 - 30 to 90 gauge
[0042] Reference No. 24 - 1.5 to 2.5 pounds per ream
[0043] Reference No. 25 - 20 to 30 pounds per ream
-5-

CA 02577703 2012-09-06
[004,11
Although the unsealed areas 15 between adjacent units 11 were generally
circular, any geometric shape to achieve a gap or slot between layer 19 and
lidding 26
for peeling away the impenetrable layer 23 can be employed.
-6-

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

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Event History

Description Date
Time Limit for Reversal Expired 2017-08-18
Letter Sent 2016-08-18
Inactive: Late MF processed 2013-11-05
Letter Sent 2013-08-19
Grant by Issuance 2013-07-02
Inactive: Cover page published 2013-07-01
Pre-grant 2013-04-19
Inactive: Final fee received 2013-04-19
Notice of Allowance is Issued 2012-12-10
Letter Sent 2012-12-10
Notice of Allowance is Issued 2012-12-10
Inactive: Approved for allowance (AFA) 2012-11-28
Amendment Received - Voluntary Amendment 2012-09-06
Inactive: S.30(2) Rules - Examiner requisition 2012-03-06
Letter Sent 2010-08-18
Request for Examination Requirements Determined Compliant 2010-08-05
All Requirements for Examination Determined Compliant 2010-08-05
Request for Examination Received 2010-08-05
Inactive: IPRP received 2008-02-21
Inactive: Cover page published 2007-05-08
Inactive: Notice - National entry - No RFE 2007-04-18
Letter Sent 2007-04-18
Application Received - PCT 2007-03-09
National Entry Requirements Determined Compliant 2007-02-19
Application Published (Open to Public Inspection) 2006-03-02

Abandonment History

There is no abandonment history.

Maintenance Fee

The last payment was received on 2012-07-10

Note : If the full payment has not been received on or before the date indicated, a further fee may be required which may be one of the following

  • the reinstatement fee;
  • the late payment fee; or
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Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
L. PERRIGO COMPANY
Past Owners on Record
TIMOTHY RICHARD, JR. WILLIAMS
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 2007-02-19 6 323
Claims 2007-02-19 5 205
Abstract 2007-02-19 1 70
Drawings 2007-02-19 2 48
Representative drawing 2007-05-04 1 13
Cover Page 2007-05-08 1 46
Claims 2007-02-20 5 414
Description 2012-09-06 6 314
Claims 2012-09-06 5 180
Cover Page 2013-06-12 2 51
Reminder of maintenance fee due 2007-04-19 1 109
Notice of National Entry 2007-04-18 1 192
Courtesy - Certificate of registration (related document(s)) 2007-04-18 1 105
Reminder - Request for Examination 2010-04-21 1 119
Acknowledgement of Request for Examination 2010-08-18 1 179
Commissioner's Notice - Application Found Allowable 2012-12-10 1 163
Maintenance Fee Notice 2013-09-30 1 170
Late Payment Acknowledgement 2013-11-05 1 163
Late Payment Acknowledgement 2013-11-05 1 163
Maintenance Fee Notice 2016-09-29 1 178
PCT 2007-02-19 8 309
PCT 2007-02-20 9 797
Correspondence 2013-04-19 1 31