U.S. patent application number 10/453794 was filed with the patent office on 2004-12-09 for method and article for packaging dosed products.
Invention is credited to Urban, Joseph J..
Application Number | 20040245145 10/453794 |
Document ID | / |
Family ID | 33489612 |
Filed Date | 2004-12-09 |
United States Patent
Application |
20040245145 |
Kind Code |
A1 |
Urban, Joseph J. |
December 9, 2004 |
Method and article for packaging dosed products
Abstract
The present invention provides a child-resistant package for a
dosed-form product having a blister layer, a rupturable layer
disposed adjacent the blister layer, the rupturable layer and the
blister layer together defining at least one cavity, a diaphragm
layer for resisting passage of a dose, the diaphragm layer disposed
adjacent the rupturable layer on a side of the rupturable layer
opposite the blister layer, and a backing layer having at least one
moveable tab corresponding to the at least one cavity, the backing
layer disposed adjacent the diaphragm layer on a side of the
diaphragm layer opposite the rupturable layer. Also included are
methods of packaging dosed products in accordance with the
invention.
Inventors: |
Urban, Joseph J.; (Richboro,
PA) |
Correspondence
Address: |
RATNERPRESTIA
P O BOX 980
VALLEY FORGE
PA
19482-0980
US
|
Family ID: |
33489612 |
Appl. No.: |
10/453794 |
Filed: |
June 3, 2003 |
Current U.S.
Class: |
206/531 ;
206/538 |
Current CPC
Class: |
B65D 75/36 20130101;
B65D 2215/04 20130101 |
Class at
Publication: |
206/531 ;
206/538 |
International
Class: |
B65D 083/04 |
Claims
What is claimed:
1. A child-resistant package for a product comprising: a blister
layer; a rupturable layer disposed adjacent the blister layer, said
rupturable layer and said blister layer together defining at least
one cavity; means for resisting passage of a dose, said means
disposed adjacent said rupturable layer on a side of said
rupturable layer opposite said blister layer; and a backing layer
having at least one moveable tab corresponding to said at least one
cavity, said backing layer disposed adjacent said means for
resisting on a side of said means opposite said rupturable
layer.
2. The child-resistant package of claim 1 wherein said means for
resisting is a diaphragm layer having a slit disposed therein.
3. The child-resistant package of claim 1 wherein said means for
resisting is comprised of plastic.
4. The child-resistant package of claim 1 wherein said backing
layer comprises paper.
5. The child-resistant package of claim 1 wherein said rupturable
layer comprises foil.
6. The child-resistant package of claim 1 wherein said backing
layer comprises plastic.
7. The child-resistant package of claim 1 wherein said means for
resisting is a diaphragm layer formed of a non-woven barrier
material.
8. The child-resistant package of claim 1 wherein said backing
layer is formed of a non-woven barrier material.
9. The child-resistant package of claim 1 where said rupturable
layer is formed of a woven barrier material.
10. A child-resistant package for a product comprising: a blister
layer; a rupturable layer disposed adjacent the blister layer, said
rupturable layer and said blister layer together defining at least
one cavity; a diaphragm layer having at least one slit
corresponding to the at least one cavity in said blister layer,
said diaphragm layer disposed adjacent said rupturable layer on a
side of said rupturable layer opposite said blister layer; and a
backing layer having at least one moveable tab corresponding to the
at least one slit in said diaphragm layer, said backing layer
disposed adjacent said diaphragm layer on a side of said diaphragm
layer opposite said rupturable layer.
11. The child-resistant package of claim 10 wherein said diaphragm
layer comprises paper.
12. The child-resistant package of claim 10 wherein said backing
layer comprises paper.
13. The child-resistant package of claim 10 wherein said diaphragm
layer comprises plastic.
14. The child-resistant package of claim 10 wherein said rupturable
layer comprises foil.
15. The child-resistant package of claim 10 wherein said backing
layer is plastic.
16. The child-resistant package of claim 10 wherein said diaphragm
layer is formed of a non-woven barrier material.
17. The child-resistant package of claim 10 wherein said diaphragm
layer is formed of a woven barrier material.
18. The child-resistant package of claim 10 wherein said backing
layer is formed of a non-woven barrier material.
19. A method for forming a child-resistant package for a product,
said method comprising the steps of: (a) placing a product in a
cavity formed in a blister cover; (b) disposing a barrier adjacent
the blister cover, thereby containing the product between the
blister cover and the barrier; (c) disposing a diaphragm layer
adjacent the barrier layer, said diaphragm layer having at least
one slit corresponding to the at least one cavity; and (d)
disposing a backing layer adjacent the diaphragm layer, said
backing layer having at least one peel-away tab corresponding to
the at least one slit of the diaphragm layer.
20. The method of claim 19 wherein step (b) comprises disposing a
foil layer adjacent the blister cover.
21. The method of claim 19 wherein step (c) comprises disposing a
plastic layer adjacent the barrier layer.
22. The method of claim 19 wherein the backing is formed from any
one or more of film, plastic, non-woven barrier material, woven
barrier material or paper.
23. A method of packaging a dosed product comprising the steps of:
(a) sealing a plurality dosages between a foil layer and a blister
layer; (b) adhering a diaphragm layer to the foil layer such that
slits in the diaphragm correspond to dosages sealed between the
foil and blister layers; and (c) adhering a backing layer to the
diaphragm layer such that a moveable tab in the backing layer
corresponds to each slit in the diaphragm layer.
Description
BACKGROUND OF THE INVENTION
[0001] It is known to use blister packages to contain small
articles such as pharmaceutical or dose form products. These
packages allow the user to access the product by applying pressure
to the blister to force the product from an individual blister or
capsule through a rupturable layer.
[0002] Known blister packages comprise a first sheet of transparent
or translucent thermoformable material such as polyvinyl chloride
or polystyrene having a plurality of flexible blisters or blisters
preformed therein and projecting outwardly from one surface to
define separate compartments for individual doses of a product,
typically a single tablet or capsule, and a second sheet to cover
the product. The second sheet is often made from a rupturable foil
or a paper-foil combination so that the user can push the product
from the blister side out through the foil. This construction did
not offer much in the way of child resistance, and presented a
potential hazard to children.
[0003] In order to render blister packages resistant to access by
children, improved child-resistant blister packages have been
developed. Exemplary structures of such child-resistant blister
packages, as well as exemplary methods of forming such packages,
are disclosed in U.S. Pat. No. 6,161,699 to Gartland, which is
hereby incorporated by reference herein.
[0004] Despite the fact that such child-resistant packages have
improved safety characteristics, there is room for further
improvements. Many of the known package-forming methods and package
constructions, although offering varying degrees of child
resistance, sometimes compromised accessibility. Specifically, in
some cases, known methods and constructions made the product so
inaccessible that even adults had trouble accessing the product.
This later case is especially problematic where older adults or
others who have lost some degree of manual dexterity are the users
of the products.
[0005] Thus, there remains a need for an improved packaging method
and construction that provide the desired level of resistance to a
child while maintaining acceptable levels of accessibility for
adults.
SUMMARY OF THE INVENTION
[0006] The present invention provides a child-resistant package for
a dosed-form product comprising a film blister layer, a rupturable
layer disposed adjacent the film blister layer, the rupturable
layer and the film blister layer together defining at least one
cavity, means for resisting passage of a dose, the means disposed
adjacent the rupturable layer on a side of the rupturable layer
opposite the film blister layer, and a backing layer having at
least one moveable tab corresponding to the at least one cavity,
the backing layer disposed adjacent the means for resisting on a
side of the means opposite the rupturable layer.
[0007] An alternative embodiment of the present invention includes
a child-resistant package for a product comprising a film blister
layer, a rupturable layer disposed adjacent the film blister layer,
the rupturable layer and the film blister layer together defining
at least one cavity, a diaphragm layer having at least one slit
corresponding to the at least one cavity in the film blister layer,
the diaphragm layer disposed adjacent the rupturable layer on a
side of the rupturable layer opposite the film blister layer, and a
backing layer having at least one moveable tab corresponding to the
at least one slit in the diaphragm layer, the backing layer
disposed adjacent the diaphragm layer on a side of the diaphragm
layer opposite the rupturable layer.
[0008] Also included as a part of the invention is a method for
forming a child-resistant package for a product. The method
comprises the steps of: (a) placing a product in a cavity formed in
a blister cover, (b) disposing a barrier adjacent the blister
cover, thereby containing the product between the blister cover and
the barrier, (c) disposing a diaphragm layer adjacent the barrier
layer, the diaphragm layer having at least one slit corresponding
to the at least one cavity; and (d) disposing a backing layer
adjacent the diaphragm layer, the backing layer having at least one
peel-away tab corresponding to the at least one slit of the
diaphragm layer.
[0009] In a more preferred method, the method comprises the steps
of: (a) sealing a plurality dosages between a foil layer and a
blister layer, (b) adhering a diaphragm layer to the foil layer
such that slits in the diaphragm correspond to dosages sealed
between the foil and blister layers, and (c) adhering a backing
layer to the diaphragm layer such that a moveable tab in the
backing layer corresponds to each slit in the diaphragm layer.
BRIEF DESCRIPTION OF THE FIGURES
[0010] The features of the invention believed to be novel and the
elements characteristic of the invention are set forth with
particularity in the appended claims. The figures are for
illustration purposes only and are not drawn to scale. The
invention itself, however, both as to organization and method of
operation, may best be understood by reference to the detailed
description that follows taken in conjunction with the accompanying
drawings in which:
[0011] FIG. 1 is a cross-sectional side view of a portion of one
embodiment of the present invention which includes an optional card
layer on top; and
[0012] FIG. 2 is an expanded view of the embodiment shown in FIG. 1
but without the optional card layer.
DETAILED DESCRIPTION OF THE INVENTION
[0013] The present invention includes child-resistant packages and
methods for packaging dose form products. Generally, the packages
according to the present invention are formed with a plurality of
layers for the packaging of dosed products within a blister or
other compartment formed between two of the layers. The products
which can be packaged in accordance with the present invention
include many types, most notably dose form products such as
pharmaceuticals in pill or capsule form. Other products to which
the present invention can be applied include, without limitation,
medicaments (in pill, tablet, capsule, or lozenge form), drugs,
vitamins, cosmetics, foods, nutriceutical products, pharmaceutical
products, devices, and any other product for which dose-form
consumption, or use, is desired.
[0014] This invention will now be described with reference to
specific embodiments selected for illustration in the figures. It
will be appreciated that the spirit and scope of this invention is
not limited to the embodiments selected for illustration. Instead,
the scope of this invention is defined separately in the appended
claims. Also, it will be appreciated that the drawings are not
rendered to any particular proportion or scale.
[0015] The package of the present invention is formed in layers.
For example, FIG. 1 shows a partial cross-sectional view of a
package 10 that accommodates a dose in each of a plurality of
blister cavities 12. The package is formed by layers 14, 18, 22,
26, and optionally 30, bonded to one another by one or more
adhesives 16, 20, 24, and 28. More specifically, backing layer 14
is disposed against diaphragm layer 18, which in turn is disposed
adjacent a rupturable layer 22 made of foil, paper, or foil-paper
laminate, which in turn is disposed adjacent blister layer 26.
Backing layer 14 is preferably a paper, plastic, foil or polymer
backing layer that is bonded to diaphragm layer 18 by an adhesive
16. In turn, diaphragm layer 18 is bonded to rupturable 22 by an
adhesive 20. In turn, rupturable layer 22 is bonded to a blister
layer 26 by an adhesive 24. Finally, blister layer 26 is optionally
bonded to an optional card layer 30 by an adhesive 28. This
optional card layer 30 would preferably include printed indicia or
information, such as advertising or dosage instructions, among
other pieces of information. A preferred optional card layer is one
provided by Permalith, Inc. under its mark, Permapack.
[0016] Referring to FIG. 2, package 10 is shown in an exploded
view. The first component is an assembly of rupturable layer 22 and
blister layer 26 having a plurality of blister cavities 12. FIG. 2
shows these two layers already adhered to each other with a
suitable adhesive (including but not limited to pressure sensitive,
heat activated or ultrasonic weldable type adhesives as discussed
in more detail below). Optional card layer 30 is not shown in this
embodiment. Assemblies of card layer 30 and blister layer 26 and
rupturable layer 22 are available from Permalith Plastics, LLC of
Pennsauken, N.J., under the mark PERMAPACK.
[0017] The assembly of layers 22 and 26 can contain a dose in each
cavity 12. However, additional layers, as discussed below, prevent
the inadvertent removal of a dose from each cavity 12 which could
occur by simply pressing against the blister layer 26 and forcing a
dose through a tear thus created in the paper or foil layer 22. It
is the remaining layers, in conjunction with rupturable layer 22
and blister layer 26, which together provide package 10 with
child-resistant features according to this invention.
[0018] Disposed below rupturable layer 22, and adjacent to
rupturable layer 22, is diaphragm layer 18. Diaphragm layer 18 is
adhered to rupturable layer 22 with a suitable adhesive (discussed
in more detail below). Diaphragm layer 18 helps to resist the
removal of a dose from a blister cavity 12, but does not unduly
prevent a removal, either. Specifically, diaphragm layer 18
includes a plurality of weakened portions for resisting passage of
doses therethrough. Diaphragm layer 18 is one exemplary embodiment
of means for resisting passage. Alternatively, such means can be
any structure capable of resisting passage and can include a slit,
a perforation, a slot, or any other weakened portion capable of
resisting dose removal without preventing such removal.
[0019] In the embodiments shown in FIGS. 1 and 2, for example,
slits 19 are illustrated, each of which is positioned to correspond
with a blister cavity 12 of the blister layer 26. Slits 19 in
diaphragm layer 18 allow the passage of a dose when a user pushes
on a blister cavity 12 and little or no resistance is felt on the
side of diaphragm layer 18 opposite rupturable layer 22. In other
words, slits 19 allow passage of a dose when the side of the slit
opposite the dose side is substantially unobstructed. When
diaphragm layer 18 is supported by backing layer 14, however,
diaphragm layer 18, even with slits 19, provides significant
resistance to the passage of the dose.
[0020] Backing layer 14 is provided beneath diaphragm layer 18 and
is attached to diaphragm layer 18 with a suitable adhesive
(discussed in more detail below). Backing layer 14 has a plurality
of tabs 15, each of which is positioned to correspond to a slit 19
of diaphragm layer 18 and a blister cavity 12 of blister layer 26.
Each tab 15 of backing layer 14 preferably includes a perforated
portion 15A to permit at least partial removal of the tab 15 from
backing layer 14. Also preferably on tab 15 is a fingernail slot
15B to provide fingernail access for movement of the tab 15 with
respect to backing layer 14. Any specific means of tab removal,
however, is envisioned as within the scope of the present invention
for backing layer 14.
[0021] Blister layer 26 can be made from any suitable blister layer
material known to those skilled in the art, and is preferably a
clear or opaque plastic or foil type material. Exemplary materials
include transparent or translucent thermoformable materials such as
polyvinyl chloride or polystyrene. Rupturable layer 22 is made from
any suitable paper, foil-paper combination or foil material known
to those skilled in the art, and is preferably foil. This layer is
preferably capable of ripping or otherwise tearing so as to allow
removal of the dose. Diaphragm layer 18 can be formed from a
plastic or paper material. Optionally, it is formed from a plastic
material such as TYVEK (Tyvek is a registered trademark of E. I. du
Pont de Nemours and Company for non-woven barrier material), or
another material that has relatively increased tear strength and
puncture resistance. Similarly, backing layer 14 can be formed from
such paper, plastic, foil, polymers or laminates thereof.
[0022] The adhesives used to join the different layers of this
invention as discussed above include any suitable adhesives which
are acceptable for the dosage which is contained therein. Typically
the dosage is a human pharmacological product, although the
invention is not limited thereto. Federal regulations provide for
suitable pharmaceutical packaging adhesives, as delineated in 21
C.F.R. .sctn. 175.105.
[0023] In use, a user of the package 10 lifts a tab 15 from backing
layer 14 using a fingernail or fingertip. The tab 15 lifted is
either completely removed or is left hanging. The user can then
push against the top of a blister cavity 12 on blister layer 26 in
order to push a dose from the blister cavity 12 through rupturable
layer 22, through slit 19 of diaphragm layer 18 and out through the
backing layer 14 at a location where the tab 15 has been
removed.
[0024] By requiring the sequential step of removing a tab 15 before
pushing out the dose corresponding to that particular removed tab,
the present invention provides a child-resistant package while not
requiring much dexterity or force. This latter feature is important
in that it provides a physically, relatively easy means of
accessing a dose, which is preferable for seniors and others having
any type of dexterity or strength problem, while still preventing
children from improperly accessing the dose.
[0025] Also included as a part of the invention is a method for
forming a child-resistant package for a product. The method
comprises the steps of: (a) placing a product in a cavity formed in
a blister cover, (b) disposing a barrier adjacent the blister
cover, thereby containing the product between the blister cover and
the barrier, (c) disposing a diaphragm layer adjacent the barrier
layer, the diaphragm layer having at least one slit corresponding
to the at least one cavity; and (d) disposing a backing layer
adjacent the diaphragm layer, the backing layer having at least one
peel-away tab corresponding to the at least one slit of the
diaphragm layer.
[0026] In a more preferred method, the method comprises the steps
of: (a) sealing a plurality dosages between a foil layer and a
blister layer, (b) adhering a diaphragm layer to the foil layer
such that slits in the diaphragm correspond to dosages sealed
between the foil and blister layers, and (c) adhering a backing
layer to the diaphragm layer such that a moveable tab in the
backing layer corresponds to each slit in the diaphragm layer.
[0027] Although the invention is illustrated and described herein
with reference to specific embodiments, the invention is not
intended to be limited to the details shown. Rather, various
modifications may be made in the details within the scope and range
of equivalents of the claims and without departing from the
invention. Such modifications could include those noted above, such
as the use of an optional cover card, or even additional other
layers not mentioned.
* * * * *