U.S. patent application number 11/369070 was filed with the patent office on 2007-09-06 for peelable pouch containing a single film dosage and process of making same.
This patent application is currently assigned to R.P. Scherer Technologies, Inc.. Invention is credited to David Barndt, Michael S. Bergey, Victor Gherdan.
Application Number | 20070205127 11/369070 |
Document ID | / |
Family ID | 38470569 |
Filed Date | 2007-09-06 |
United States Patent
Application |
20070205127 |
Kind Code |
A1 |
Barndt; David ; et
al. |
September 6, 2007 |
Peelable pouch containing a single film dosage and process of
making same
Abstract
A peelable pouch for containing a single dosage product having a
top layer joined to a bottom layer by a containment seal and a
distributing seal formed with a stress riser separating a primary
compartment from a secondary compartment. The primary compartment
houses the product, sealed from the exterior environment. The
secondary compartment includes a fold-over line. When the pouch is
folded about the fold-over line the tear promoting surface
condition permits a user to easily tear off a portion of the pouch
and expose a portion of the secondary compartment. The product is
accessed by peeling apart the secondary compartment, the
distributing seal, and then peeling open the primary compartment.
Preferred embodiments incorporate variation in the primary and
secondary containment seal thicknesses.
Inventors: |
Barndt; David;
(Richlandtown, PA) ; Bergey; Michael S.;
(Washington Crossing, PA) ; Gherdan; Victor;
(Cherry Hill, NJ) |
Correspondence
Address: |
CARDINAL HEALTH
7000 CARDINAL PLACE
LEGAL DEPARTMENT - INTELLECTUAL PROPERTY
DUBLIN
OH
43017
US
|
Assignee: |
R.P. Scherer Technologies,
Inc.
|
Family ID: |
38470569 |
Appl. No.: |
11/369070 |
Filed: |
March 6, 2006 |
Current U.S.
Class: |
206/484 |
Current CPC
Class: |
B65D 81/3266 20130101;
B65D 2221/00 20130101; B65D 2215/08 20130101; A61J 1/00 20130101;
B65D 75/5805 20130101 |
Class at
Publication: |
206/484 |
International
Class: |
B65D 73/00 20060101
B65D073/00 |
Claims
1. A peelable pouch (50) for containing a single dosage product
(P), comprising: a top layer (100) having a peripheral edge (170),
an interior surface (110), an exterior surface (120), and a top
layer width (180); a bottom layer (200) having a peripheral edge
(270), an interior surface (210), an exterior surface (220), and a
bottom layer width (280), wherein the top layer width (180) and the
bottom layer width (280) are substantially the same; a seal (500)
having a containment seal (510) and a distributing seal (520),
wherein the containment seal (510) has two regions, (A) a primary
compartment seal (512), having a primary compartment lateral seal
thickness (513), and (B) a secondary compartment seal (516), having
a secondary compartment lateral seal thickness (517), and wherein
the distributing seal (520) has a seal width (522) and a
distributing seal length (524); and wherein said distributing seal
(50) is formed with a stress riser (526) that is saw tooth-shaped;
a primary compartment (300) housing the product (P), sealed from
the exterior environment, formed between the top layer (100) and
the bottom layer (200) by the top layer (100) being selectively
joined to the bottom layer (200) by at least a portion of the
containment seal (510) and the distributing seal (520), the primary
compartment (300) having a peripheral boundary (360) along a
portion of the containment seal (510) and a portion of the
distributing seal (520), and having a primary compartment width
(370); a secondary compartment (400) formed between the top layer
(100) and the bottom layer (200) by the top layer (100) being
selectively joined to the bottom layer (200) by a portion of the
containment seal (510) and a portion the distributing seal (520),
the secondary compartment (400) being adjacent to the primary
compartment (300) and separated from the primary compartment (300)
by the distributing seal (520), and the secondary compartment (400)
having a peripheral boundary (450) along a portion of the
containment seal (510) and a portion of the distributing seal
(520), and having a secondary compartment width (470); the
secondary compartment width (470) is greater than the primary
compartment width (370); and a tear promoting surface condition
(600), on the top layer (100) and the bottom layer (200),
intersecting a fold-over line (700) such that when the pouch (50)
is folded about the fold-over line (700) the tear promoting surface
condition (600) permits a user to tear off a portion of the top
layer (100) and the bottom layer (200) to expose a portion of the
secondary compartment (400) so that the user may grip the top layer
(100) and the bottom layer (200) to peel them apart forming an
opening in the primary compartment (300) by separating the
secondary compartment seal (516) and the distributing seal (520),
and gaining access to the product (P).
2. The pouch (50) of claim 1, wherein the initiation point (527) is
located on the secondary compartment peripheral boundary (450).
3. The pouch (50) of claim 1, wherein the secondary compartment
width (470) is sized to cooperate with two human digits.
4. The pouch (50) of claim 1, wherein the secondary compartment
width (470) is between approximately 0.25 inches (0.635 cm) and
approximately 3.0 inches (7.62 cm).
5. The pouch (50) of claim 1, wherein the secondary compartment
lateral seal thickness (517) is substantially the same as the
primary compartment lateral seal thickness (513).
6. The pouch (50) of claim 5, wherein the secondary compartment
lateral seal thickness (517) and the primary compartment lateral
seal thickness (513) are between approximately 0.062 inches
(0.15748 cm) and approximately 0.5 inches (1.27 cm).
7. The pouch (50) of claim 1, wherein the secondary compartment
lateral seal thickness (517) is less than the primary compartment
lateral seal thickness (513).
8. The pouch (50) of claim 7, wherein the secondary compartment
lateral seal thickness (517) is between approximately 0.062 inches
(0.15748 cm) and approximately 0.5 (1.27 cm) inches and the primary
compartment lateral seal thickness (513) is between approximately
0.125 inches (0.3175 cm) and approximately 0.562 inches (1.42748
cm).
9. The pouch (50) of claim 1, wherein the distributing seal width
(522) is substantially uniform.
10. The pouch (50) of claim 9, wherein the distributing seal width
(522) is between 0.062 inches (0.15748 cm) to 0.25 inches (1.27 cm)
wide.
11. The pouch (50) of claim 1, wherein the distributing seal width
(522) varies over the distributing seal length (524).
12. The pouch (50) of claim 1, wherein the top layer (100) has a
proximal edge (130), a distal edge (140), a first lateral edge
(150), and a second lateral edge (160), the bottom layer (200) has
a proximal edge (230), a distal edge (140), a first lateral edge
(150), and a second lateral edge (160), and wherein the top layer
(100) and the bottom layer (200) are formed from a common substrate
folded over at either the proximal edge (100), the distal edge
(140), the first lateral edge (150), or the second lateral edge
(160) creating a folded edge thereby not requiring the containment
seal (510) along the folded edge, whereby the containment seal
(510), the distributing seal (520), and the folded edge define the
primary compartment peripheral boundary (360) to include a proximal
boundary (310), a distal boundary (320), a first lateral boundary
(330), and a second lateral boundary (340), and define the
secondary compartment peripheral boundary (450) to include a
proximal boundary (410), a distal boundary (420), a first lateral
boundary (430), and a second lateral boundary (440), wherein once
the secondary compartment distal boundary (420) is torn away, a
user may easily grip the top layer (100) and the bottom layer (200)
to peel them apart to separate the secondary compartment seal (516)
and the distributing seal (520), thereby gaining access to the
product.
13. The pouch (50) of claim 1, further including a second product
housed in the secondary compartment (400).
14. A peelable pouch (50) for containing a single dosage product
(P), comprising: a top layer (100) having a peripheral edge (170),
an interior surface (110), an exterior surface (120), and a top
layer width (180); a bottom layer (200) having a peripheral edge
(270), an interior surface (210), an exterior surface (220), and a
bottom layer width (280), wherein the top layer width (180) and the
bottom layer width (280) are substantially the same; a seal (500)
having a containment seal (510) and a distributing seal (520),
wherein the containment seal (510) has two regions, (A) a primary
compartment seal (512), having a primary compartment lateral seal
thickness (513), and (B) a secondary compartment seal (516), having
a secondary compartment lateral seal thickness (517), and wherein
the distributing seal (520) has a seal width (522) that is
substantially uniform with a stress riser (526) and is saw
tooth-shaped, and wherein the secondary compartment lateral seal
thickness (517) is less than the primary compartment lateral seal
thickness (513); a primary compartment (300) housing the product
(P), sealed from the exterior environment, formed between the top
layer (100) and the bottom layer (200) by the top layer (100) being
selectively joined to the bottom layer (200) by the primary
compartment seal (512) and the distributing seal (520), the primary
compartment (300) having a peripheral boundary (360) along a
portion of the primary compartment seal (512) and a portion of the
distributing seal (520), and having a primary compartment width
(370); a secondary compartment (400) formed between the top layer
(100) and the bottom layer (200) by the top layer (100) being
selectively joined to the bottom layer (200) by a portion of the
secondary compartment seal (516) and a portion of the distributing
seal (520), the secondary compartment (400) being adjacent to the
primary compartment (300) and is separated from the primary
compartment (300) by the distributing seal (520), the secondary
compartment (400) having a peripheral boundary (450) along a
portion of the secondary compartment seal (516) and a portion of
the distributing seal (520) and wherein the initiation point (527)
is located on the secondary compartment peripheral boundary (450),
and the secondary compartment (400) having a secondary compartment
width (470) wherein the secondary compartment width (470) is
greater than the primary compartment width (370); and a tear
promoting surface condition (600), on the top layer (100) and the
bottom layer (200), intersecting a fold-over line (700) such that
when the pouch (50) is folded about the fold-over line (700) the
tear promoting surface condition (600) permits a user to easily
tear off a portion of the top layer (100) and the bottom layer
(200) to expose a portion of the secondary compartment (400) so
that the user may easily grip the top layer (100) and the bottom
layer (200) to peel them apart forming an opening in the primary
compartment (300) by separating the secondary compartment seal
(516) and the distributing seal (520), and gaining access to the
product (P).
15. A peelable pouch (50) for containing a single dosage product
(P), comprising: a top layer (100) having a peripheral edge (170),
an interior surface (110), an exterior surface (120), and a top
layer width (180); a bottom layer (200) having a peripheral edge
(270), an interior surface (210), an exterior surface (220), and a
bottom layer width (280), wherein the top layer width (180) and the
bottom layer width (280) are substantially the same; a seal (500)
having a containment seal (510) and a distributing seal (520),
wherein the containment seal (510) has two regions, (A) a primary
compartment seal (512), having a primary compartment lateral seal
thickness (513), and (B) a secondary compartment seal (516), having
a secondary compartment lateral seal thickness (517), and wherein
the distributing seal (520) has a seal width (522) that is
substantially uniform between approximately 0.125 inches and
approximately 0.25 inches and is formed with a stress riser (526)
having a substantially saw tooth shape with at least two initiation
points (527), and wherein the secondary compartment lateral seal
thickness (517) is less than the primary compartment lateral seal
thickness (513) which is between approximately 0.062 inches and
approximately 0.5 inches; a primary compartment (300) housing the
product (P), sealed from the exterior environment, formed between
the top layer (100)) and the bottom layer (200) by the top layer
(100) being selectively joined to the bottom layer (200) by the
primary compartment seal (512) and the distributing seal (520), the
primary compartment (300) having a peripheral boundary (360) along
a portion of the primary compartment seal (512) and a portion of
the distributing seal (520), and having a primary compartment width
(370); a secondary compartment (400) formed between the top layer
(100) and the bottom layer (200) being selectively joined to the
bottom layer (200) by a portion of the secondary compartment seal
(516) and a portion of the distributing seal (520), the secondary
compartment (400) being adjacent to the primary compartment (300)
and is separated from the primary compartment (300) by the
distributing seal (520), the secondary compartment (400) having a
peripheral boundary (450) along a portion of the secondary
compartment seal (516) and a portion of the distributing seal (520)
and wherein the initiation point (527) is located on the secondary
compartment peripheral boundary (450), the secondary compartment
(400) having a secondary compartment width (470) that is between
approximately 1.0 inches and approximately 2.0 inches and the
secondary compartment width (470) is greater than the primary
compartment width (370); and a tear promoting surface condition
(600), on the top layer (100) and the bottom layer (200),
intersecting a fold-over line (700) including indicia (710)
substantially on the fold-over line (700) such that when the pouch
(50) is folded about the fold-over line (700) the tear promoting
surface condition (600) permits a user to easily tear off a portion
of the top layer (100) and the bottom layer (200) to expose a
portion of the secondary compartment (400) so that the user may
easily grip the top layer (100) and the bottom layer (200) to peel
them apart forming an opening in the primary compartment (300) by
separating the secondary compartment seal (516) and the
distributing seal (520), and gaining access to the product (P).
Description
REFERENCE TO RELATED DOCUMENTS
[0001] This application is related to a previous application filed
in the United States Patent and Trademark Office by Paul H. Alvater
and Thomas J. Fillis on Aug. 2, 2004, entitled "PEELABLE POUCH
CONTAINING A SINGLE OR MULTIPLE DOSAGE FORMS AND PROCESS OF MAKING
SAME," and given Ser. No. 10/910,675.
TECHNICAL FIELD
[0002] The instant invention relates to product packaging, and
particularly to a process for forming a peelable pouch for
individually housing single doses of a product, particularly for
individually housing single doses of orally consumable film strips,
and to the pouch formed thereby.
BACKGROUND OF THE INVENTION
[0003] Orally consumable films have become important consumer
products for the dispensing of such substances as breath
fresheners, anti-bacterial compounds, and various medicaments; and
are frequently compounded with sweeteners, preservatives, and other
additives. They are commonly made of water-soluble polymers, such
as pullulan, as seen in U.S. Pat. Nos. 5,518,902; 5,411,945; and
4,851,394.
[0004] Presently, orally consumable films are generally distributed
in reclosable packages containing ten or more doses. One dispenser
adaptable for flat sheet orally consumable films is taught in U.S.
Pat. Appl. Pub. No. 2003/0121932A1. This device uses a roller that
can frictionally engage a flat article, such as an orally
consumable strip, and dispense it through a slot in an otherwise
closed container. An alternative packaging and dispensing system is
seen in U.S. Pat. Appl. Pub. No. 2003/0183643A1. In that device,
the orally consumable films are contained in a blister pack having
an openable back portion that opens and closes the blister pack by
means of a resealable pressure sensitive adhesive area. Often such
packages are very small and require the user to grip and remove the
solid dosage product with a single index finger. To ease removal of
such small, thin, lightweight products users often lick their
finger to increase adhesion of the product to the finger.
Obviously, such a procedure has a high probability of contaminating
the other products in the packaging and has the potential of
totally ruining the products from carryover saliva. Such a contact
intensive removal and administration process is entirely
unacceptable for medical products. Further, both the roller and
resealable back blister pack have two serious drawbacks, namely,
they are not particularly designed to prevent the dispensing of
multiple sheets, nor do they have any child-resistant
attributes.
[0005] These drawbacks may not be of much consequence in some of
the frequent uses of orally consumable films, that is, for candy,
breath aids, and the like. In this setting, dosage control and
safety from accidental ingestion by children is not particularly
important. Representative of these packages are those taught in
U.S. Pat. No. 5,354,551. However, these films have been taught as
methods of dosing drugs, as for example in U.S. Pat. No. 5,411,945.
In such applications, dosage control and child resistance become
essential qualities of any practical packaging.
[0006] Packaging of individually contained single dosage forms,
including but not limited to orally consumable films, has become
increasing popular. This is true with both pharmaceutical products
as well as consumer products. One obvious advantage of this in the
pharmaceutical market is that it substantially reduces the risk of
accidental overdose. Additionally, having the product individually
wrapped, or housed, eliminates the risk of contaminating other
doses of the product. Further, consumers appreciate the feeling
obtained when opening an individually wrapped product because they
know that they are the only one that has handled the actual product
since it was packaged.
[0007] Some drawbacks come along with the benefits of individually
packaged products. Perhaps the largest drawback and risk of
individually packaged products is the risk posed to children.
Individually wrapped products, especially small products such as
medications, often resemble candy to a small child. Further,
written warnings as to the contents are ineffective for children
who cannot read. Most importantly, the vast majority of single dose
packaging has not been child-resistant. As such, a demand for
child-resistant single dose packaging has surfaced.
[0008] Present packaging technologies for individually wrapped
candies and non-prescription products such as aspirin are
particularly ineffective for the myriad of products that require
some degree of child-resistant packaging because such candies and
non-prescription product packaging has been designed solely for
ease of opening. Additionally, an entirely new class of packaging
is required for fast dispersing solid dosage products that are
designed to dissolve when exposed to liquid. Most commonly, such
fast dispersing solid dosage products are formed as a thin sheet,
often less than a tenth of an inch in thickness, that is placed in
the mouth to dissolve upon contact with saliva. This method of
administration has become increasingly popular with prescription
medications as well as consumer products such as breath fresheners.
However, the key attribute that has made them popular, namely their
dissolution upon contact with a liquid, has made them particularly
susceptible to damage. Therefore, a process for forming individual,
and individual child-resistant packaging for thin sheet fast
dispersing solid dosage products is particularly needed, as well as
the need for the packaging itself.
[0009] To date, great attention has been focused on designing
child-resistant blister packaging for tablet and capsule products.
These packages have typically been formed of a rigid transparent
top layer which is sealed or otherwise bonded to a backing layer in
a manner that provides a cavity, pouch, or "blister" in which the
medicament is disposed. Advances in such blister packaging have
included the incorporation of features requiring peeling, folding,
stripping, and/or rupturing of various portions of the packaging.
Unfortunately the advances made in child-resistance for such
packaging has little to no relevance to applications for thin sheet
type products, particularly when such products are not rigid.
[0010] What has been needed, and heretofore unavailable, is a
disposable, unit dose pouch for containing thin sheet type products
that is child-resistant, yet senior-friendly, and allows for easy
opening. Such a pouch must be inexpensive and easy to manufacture,
maintain the integrity of the unit dose, and must be resistant to
opening by children. At the same time, the package must be easily
opened by an adult user that may have limited strength,
coordination, or sight.
SUMMARY OF THE INVENTION
[0011] The instant invention provides a novel peelable pouch that
addresses the shortcomings of the prior art. In its most general
design, the pouch comprises a top layer joined to a bottom layer by
at least one containment seal and at least one distributing seal,
thereby creating a primary and a secondary compartment between the
top layer and the bottom layer. The top layer has a peripheral edge
and the bottom layer has a peripheral edge. The primary compartment
houses the product (dosage form), sealed from the exterior
environment, and is formed between the top layer and the bottom
layer by the top layer being selectively joined to the bottom layer
by the containment and distributing seals. The secondary
compartment is separated from the primary compartment by a
distributing seal and may house a second product. For example, one
can readily appreciate that the secondary compartment may house
antibacterial hand washing solution that may be used to clean a
user's hands prior to handling the product in the primary
compartment.
[0012] The inventive peelable pouch also includes a tear promoting
feature on the top layer and the bottom layer located substantially
on a line that traverses a portion of the secondary compartment.
When the pouch is folded about a fold-over line, the tear promoting
surface condition or feature permits a user to easily tear off a
portion of the top and bottom layers to expose a portion of the
secondary compartment interior.
[0013] Once a portion of the secondary compartment has been
exposed, the user pulls the top and bottom layers in opposing
directions to peel the two layers apart separating the containment
and distributing seals, following which, the product may then be
removed from the primary compartment. In a preferred embodiment,
the distributing seal is formed with at least two stress risers. In
another embodiment, the containment seal is formed with variations
in seal thickness. In this embodiment, the containment seal has a
primary compartment seal and a secondary compartment seal with
different thicknesses to provide child resistance and at the same
time improve the ease with which the secondary and, therefore, the
primary compartments may be opened.
[0014] Once a portion of the secondary compartment is exposed, a
user may easily grip the top and bottom layers to peel them apart
and separate the distributing seal thereby gaining access to the
primary compartment and to the product. The secondary compartment
enhances the child-resistance of the pouch and improves the
sterility of the packaging since at least two seals must be
compromised before the product is exposed to the surrounding
environment.
[0015] Thus, there is disclosed a peelable pouch for containing a
single dosage product, comprising:
[0016] a top layer having a peripheral edge, an interior surface,
an exterior surface, and a top layer width;
[0017] a bottom layer having a peripheral edge, an interior
surface, an exterior surface, and a bottom layer width, wherein the
top layer width and the bottom layer width are substantially the
same;
[0018] a seal having a containment seal and a distributing seal,
wherein the containment seal has two regions, (A) a primary
compartment seal, having a primary compartment lateral seal
thickness, and (B) a secondary compartment seal, having a secondary
compartment lateral seal thickness, and wherein the distributing
seal has a seal width and a distributing seal length; and wherein
said distributing seal is formed with at least one stress riser
having at least one initiation point;
[0019] a primary compartment housing the product, sealed from the
exterior environment, formed between the top layer and the bottom
layer by the top layer being selectively joined to the bottom layer
by at least a portion of the containment seal and the distributing
seal, the primary compartment having a peripheral boundary along a
portion of the containment seal and a portion of the distributing
seal, and having a primary compartment width;
[0020] a secondary compartment formed between the top layer and the
bottom layer by the top layer being selectively joined to the
bottom layer by a portion of the containment seal and a portion the
distributing seal, the secondary compartment being adjacent to the
primary compartment and separated from the primary compartment by
the distributing seal, and the secondary compartment having a
peripheral boundary along a portion of the containment seal and a
portion of the distributing seal, and having a secondary
compartment width; the secondary compartment width is greater than
the primary compartment width; and
[0021] a tear promoting surface condition, on the top layer and the
bottom layer, intersecting a fold-over line such that when the
pouch is folded about the fold-over line the tear promoting surface
condition permits a user to tear off a portion of the top layer and
the bottom layer to expose a portion of the secondary compartment
so that the user may grip the top layer and the bottom layer to
peel them apart forming an opening in the primary compartment by
separating the secondary compartment seal and the distributing
seal, and gaining access to the product.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Without limiting the scope of the present invention as
claimed below and referring now to the drawings and figures:
[0023] FIG. 1 shows a representative peelable pouch in elevated
perspective, not to scale;
[0024] FIG. 2 shows a top plan view of a representative peelable
pouch, not to scale;
[0025] FIG. 3 shows a cross-sectional view taken along section line
3-3 in FIG. 2 of a peelable pouch, not to scale;
[0026] FIG. 4 shows a cross-sectional view taken along section line
4-4 in FIG. 3 of a peelable pouch, not to scale;
[0027] FIG. 5 shows a cross-sectional view taken along section line
5-5 in FIG. 3 of a peelable pouch, not to scale;
[0028] FIG. 6 shows a top plan view of an embodiment of the instant
invention with a plurality of stress risers with substantially saw
tooth shape, not to scale;
[0029] FIG. 7 shows a representative peelable pouch in elevated
perspective view having an end portion folded and ready for
tearing, not to scale;
[0030] FIG. 8 shows a representative peelable pouch partially torn
in elevated perspective view, not to scale;
[0031] FIG. 9 shows a representative peelable pouch partially
opened in elevated perspective view, not to scale;
[0032] FIG. 10 shows a representative peelable pouch partially
opened in elevated perspective view, not to scale; and
[0033] FIG. 11 shows a top plan view of a representative peelable
pouch, not to scale.
[0034] Also, in the various figures and drawings, the following
reference symbols and letters are used to identify the various
elements described herein below in connection with the figures and
illustrations.
DETAILED DESCRIPTION OF THE INVENTION
[0035] The peelable pouch of the instant invention provides a
significant advancement in the state of the art. The preferred
embodiments of the inventive dosage delivery system accomplish this
by new and novel arrangements of elements that are configured in
unique and novel ways and which demonstrate previously unavailable
but preferred and desirable capabilities. The detailed description
set forth below in connection with the drawings is intended merely
as a description of the presently preferred embodiments of the
invention, and is not intended to represent the only form in which
the present invention may be constructed or utilized. The
description sets forth the designs, functions, means, and methods
of implementing the invention in connection with the illustrated
embodiments. It is to be understood, however, that the same or
equivalent functions and features may be accomplished by different
embodiments that are also intended to be encompassed within the
spirit and scope of the claims.
[0036] With reference now to FIG. 1, the instant invention is a
peelable pouch (50) containing a single dosage product (P),
preferably a fast dispersing film dosage form. The peelable pouch
(50) includes a top layer (100) joined to a bottom layer (200) by a
seal (500). The seal (500) is a continuous, unitary seal and is
formed with two seal regions, namely, a containment seal (510) and
a distributing seal (520). In FIG. 1, the containment seal (510)
and distributing seal (520) are each shown as a continuous seal, by
way of example only, and not limitation, as the seals may be
separate. The containment seal (510) and distributing seal (520)
create a primary compartment (300) and a secondary compartment
(400) between the top layer (100) and the bottom layer (200),
illustrated best in FIG. 1. The top layer (100) has a peripheral
edge (170) and the bottom layer (200) has a peripheral edge (270).
While the embodiments illustrated in the figures are generally
rectangular in shape, one with skill in the art will recognize that
the peripheral edges (170, 270) may be any shape.
[0037] The top layer (100) has an interior surface (110), in
contact with the primary and secondary compartments (300, 400), and
an exterior surface (120) in contact with the surrounding
environment, shown best in FIG. 3. Similarly, the bottom layer
(200) has an interior surface (210), in contact with the primary
compartment (300) and the secondary compartment (400), and an
exterior surface (220), in contact with the surrounding
environment. The top layer (100) and the bottom layer (200) may be
constructed of virtually any material. Embodiments of the pouch
(50) directed to the medical market are typically constructed of
flexible laminated foil material, and may incorporate a peelable
polymer. These foils or films are well known to those skilled in
the art and are available commercially from a number of suppliers.
Such materials may be impervious to moisture. Alternatively,
embodiments directed toward non-prescription products for the mass
market, such as breath films and other candies may be constructed
of less expensive alternatives.
[0038] The primary compartment (300) houses the product (P), sealed
from the exterior environment, and is formed between the top layer
(100) and the bottom layer (200) by the top layer (100) being
selectively joined to the bottom layer (200) by a portion of the
containment seal (510) and the distributing seal (520), as seen in
FIG. 1. Referring now to FIG. 6, the primary compartment (300) has
a primary compartment width (370) and a primary compartment length
(380), which are measured from a peripheral boundary (360). The
peripheral boundary (360) is created by a portion of each of the
containment and distributing seals (510, 520). As with the
peripheral edges (170, 270), the peripheral boundary (360) of the
primary compartment (300) may be any shape, including a shape
designed to mimic the shape of the product (P), or a shape selected
for ease of use in opening the pouch (50).
[0039] Similar to the primary compartment (300), the secondary
compartment (400) is formed between the top layer (100) and the
bottom layer (200) by the top layer (100) being selectively joined
to the bottom layer (200) by portions of each of the containment
and distributing seals (510, 520). Consequently, the secondary
compartment (400) has a secondary compartment width (470), a
secondary compartment length (480), and a peripheral boundary
(450), which is created by portions of each of the containment and
distributing seals (510, 520). The secondary compartment (400) is
adjacent to the primary compartment (300) and separated from the
primary compartment (300) by the distributing seal (520).
[0040] In the generic rectangular embodiment illustrated in FIGS. 1
through 10, the top layer (100) has a proximal edge (140), a distal
edge (130), a first lateral edge (150), and a second lateral edge
(160), as seen in FIG. 4. The distance from the first lateral edge
(150) to the second lateral edge (160) defines a top layer width
(180), and the distance from the proximal edge (140) to the distal
edge (130) defines a top layer length (190), best illustrated in
FIG. 4. Similarly, the bottom layer (200) has a proximal edge
(240), a distal edge (230), a first lateral edge (250), and a
second lateral edge (260). The distance from the first lateral edge
(250) to the second lateral edge (260) define a bottom layer width
(280), and the distance from the proximal edge (240) to the distal
edge (230) defines a bottom layer length (290), best illustrated in
FIG. 5. In an embodiment of the instant invention, the top and
bottom layer widths (190, 290) are substantially the same, and the
top and bottom layer lengths (190, 290) are substantially the same.
Generally, the containment seal (510) joins the proximal edges
(140, 240), the distal edges (130, 230), the first lateral edges
(150, 250), and the second lateral edges (160, 260), of the top
layer (100) and the bottom layer (200). The distributing seal (520)
together with the containment seal (510), defines the primary
compartment peripheral boundary (360) and secondary compartment
peripheral boundary (450), as seen in FIGS. 1 and 6. In such a
rectangular embodiment, best illustrated in FIG. 11, the primary
compartment peripheral boundary (360) includes a proximal boundary
(320), a distal boundary (310), a first lateral boundary (330), and
a second lateral boundary (340). Likewise, the secondary
compartment peripheral boundary (450) includes a proximal boundary
(410), a first lateral boundary (430), a distal boundary (420), and
a second lateral boundary (440). The containment seal (510), as
illustrated in FIGS. 2 and 11, is generally a single continuous
seal that separates the external environment from the primary and
secondary compartments (300, 400). The distributing seal (520) may
be formed in a variety of shapes that cooperate to separate the
primary and secondary compartments (300, 400).
[0041] With reference to FIGS. 2 and 11, the distributing seal
(520) is formed by the joining of portions of the top and bottom
layers (100, 200) and, as stated above, it separates the primary
compartment (300) from the secondary compartment (400). As seen in
FIG. 2, the distributing seal (520) has a seal length (524) and a
distributing seal width (522), which is the shortest distance
between the primary compartment distal boundary (320) and the
secondary compartment proximal boundary (410). While the
embodiments of the instant invention show a uniformly formed
distributing seal (520) having a substantially uniform distributing
seal width (522), it is not necessary that the distributing seal
(520) have a substantially uniform distributing seal width (522).
By way of example, and not limitation, a pouch (50) having a
distributing seal (520) varying in width (522) is illustrated in
FIG. 11. Those skilled in the art will appreciate the multitude of
distributing seal (520) designs that are possible by variations in
width, as well as, form. For example, an excursion, or excursions,
on the surface of a seal, commonly known as a stress riser (526),
may be formed in the distributing seal (520).
[0042] The stress riser (526) is shaped to have at least one
initiation point (527). The initiation point (527) tends to create
a peel starting region or regions on the distributing seal (520)
during the process of opening the peelable pouch (50), discussed in
more detail later. At the initiation point, or points, (527), the
distributing seal (520) begins its opening response, or peel, to
the tensile stresses created by pulling the top and bottom layers
(100, 200) apart. Generally, the opening response occurs on the
side of the distributing seal (520) in which the initiation point
(527) is located. The separation of the top and bottom layers (100,
200) eventually reaches the distributing seal (520) with the
initiation point (527). By continued application of opposing forces
to each of the top and bottom layers (100, 200), which tend to pull
the layers (100, 200) apart, tensile stresses are focused at the
initiation point (527) rather than diffusely spreading the tension
along the distributing seal length (524). The stress riser (526) is
oriented to extend the initiation point (527) in the direction of
the oncoming separation line between top and bottom layers (100,
200) as the layers (100, 200) are forcibly pulled apart. In other
words, at the distributing seal (520), initial separation of the
top layer (100) from the bottom layer (200) occurs at the
initiation point (527). By concentrating the applied forces at one
or more initiation points (527), rather than across the entire
distributing seal (520), less force is required to initiate the
separation of the distributing seal (520). Therefore, the
separation of the top and bottom layers (100, 200) of the
distributing seal (520) proceeds more predictably and consistently
and ultimately requires less finger, wrist, and forearm
strength.
[0043] In embodiments of the instant invention, the stress riser
(526) has a substantially saw tooth shape where the initiation
point (527) is the region substantially along the tip of the tooth,
as seen in FIGS. 2 and 11. However, it is not necessary that the
stress riser (526) have any particular configuration, only that the
initiation of seal opening, or peel, is enhanced as the initiation
point (527) of the stress riser (526) becomes sharper. In one
embodiment of the instant invention, as seen in FIG. 6, the
distributing seal (520) is formed with a plurality of saw tooth
shaped stress risers (526).
[0044] The selection of an optimal design of the stress riser (526)
or risers might be selected to reflect particular characteristics
of the product (P) contained in the primary compartment (300) or
the polymer covered foil material. The containment and the
distributing seal (510, 520) may be created by virtually any
material joining technology. Most commonly, the containment and
distributing seals (510, 520) will be at least one fusion seal
created under elevated temperature and pressure; however, they may
also be a mechanical or chemical seal. Such a mechanical seal could
include, by way of example and not limitation, crimping and various
retainer clips; and such thermal or chemical seals could include,
by way of example and not limitation, adhesive bonds such as
chemical adhesive or hot melt techniques, or other fusion methods.
The containment and distributing seals (510, 520) are selected to
be strong enough that they cannot be easily separated by a small
child, yet can be opened without difficulty by the elderly.
[0045] Further, while the top (100) and bottom (200) layers have
been illustrated and described as separate distinct articles, one
with skill in the art will recognize that the top layer (100) and
the bottom layer (200) may be formed from a common substrate folded
over at either the proximal edges (140, 240), the distal edges
(130, 230), the first lateral edges (150, 250), or the second
lateral edges (160, 260), creating a folded edge thereby not
requiring the containment seal (510) along the folded edge. In such
an embodiment, the three containment seal (510) edges, the
distributing seal (520), and the folded edge define the primary
compartment peripheral boundary (360).
[0046] The peelable pouch (50) also includes a tear promoting
surface condition (600) on the top layer (100) and the bottom layer
(200) located substantially near a fold-over line (700). The
fold-over line (700) generally intersects, and is substantially
orthogonal to, the tear promoting surface condition (600), and is
illustrated in FIGS. 1 and 6. When the pouch (50) is folded about
the fold-over line (700), as seen in FIG. 7, the tear promoting
surface condition (600) is presented and permits a user to easily
upturn a portion of the pouch (50), as seen in FIG. 8. The upturned
portion may then be easily grasped and pulled to tear off a portion
of the top (100) and bottom (200) layers to expose a portion of the
secondary compartment (400), as seen in FIG. 9.
[0047] Child-resistance is provided by the pouch (50) in that it
may be easily torn only once simultaneous or complex movement
sequences have been performed, which would not be obvious to a
small child. For instance, the pouch (50) is exceedingly difficult
to tear open without first folding it along the fold-over line
(700) and exposing the tear promoting surface condition (600). In
one embodiment, the tear promoting surface condition (600) is a
tear slit (610) that extends through the top layer (100) and the
bottom layer (200) in an area of the seal containment seal (510).
Alternatively, the tear promoting surface condition (600) may
simply be an indentation in the surface of the top and bottom
layers (100, 200), a penetration of any shape extending through the
top and bottom layers (100, 200), areas of reduced thickness of the
top and bottom layers (100, 200), or areas of different material
formed in the top and bottom layers (100, 200). The tear promoting
condition (600) could also encompass a tear string or other
integral tearing structure, as would be known to one skilled in the
art.
[0048] The fold-over line (700) may be identified on the pouch (50)
in any of a number of ways. First, the fold-over line (700) may not
be expressly identified at all, but rather be implicitly identified
by the location and orientation of the tear promoting surface
condition (600). For instance in the embodiment of FIG. 1, most
adults would recognize that the tear promoting surface condition
(600) that does not extend all the way to an edge would most easily
be accessed by folding the pouch (50) lengthwise, or substantially
orthogonal to the tear promoting surface condition (600), as seen
in FIG. 7. Alternatively, the pouch (50) may further include
indicia (710) located substantially on the fold-over line (700) to
indicate how to fold the pouch (50). Such indicia (710) may simply
be a line as shown in FIG. 1, or may incorporate a written message
such as "fold along line and tear," as seen in FIG. 6.
[0049] The tear promoting surface condition (600) is configured to
promote a tear across a portion of the secondary compartment (400).
Therefore, when the pouch (50) is folded about the fold-over line
(700), as seen in FIG. 7, the tear promoting surface condition
(600) presents itself and permits a user to fold the end of the
pouch (50) so that it may be easily gripped, as seen in FIG. 8. The
user may then easily tear off a portion of the top (100) and bottom
(200) layers to expose a portion of the secondary compartment
(400), illustrated in FIG. 10. Once a portion of the secondary
compartment (400) is exposed, a user may easily grip the top layer
(100) and the bottom layer (200) to peel them apart, thereby
separating the secondary compartment seal (516) followed by
separation of the distributing seal (520).
[0050] In an embodiment of the instant invention, the secondary
compartment width (470) is at least 0.25 inches and sized to permit
the user to catch the exposed top and bottom layers (100, 200) with
a raking or picking motion made in opposing directions with two
digits, most likely their two thumbs. The user can then initiate
separation of the secondary compartment seal (516) which ultimately
permits the user to pincher grip the top layer (100) between one or
more fingers and thumb on one hand and the bottom layer (200)
between one or more fingers and thumb on the other hand. By
separating the distributing seal (520), the user creates an opening
in the primary compartment (300), thereby gaining access to the
product (P). The secondary compartment (400) enhances the
child-resistance of the pouch (50) and improves the sterility of
the packaging since at least two seals must be compromised before
the product (P) is exposed to the surrounding environment.
[0051] The separation of the product (P) in the primary compartment
(300) from the secondary compartment (400) permits the
incorporation of perforations (720) across the secondary
compartment (400) in the preferred location for the tear, as
illustrated in FIG. 6. Such perforations (720) make the tear easier
to perform and provide enhanced control over the location of the
tear. The perforations (720) may extend through the top layer (100)
and the bottom layer (200) permitting the exterior atmosphere to
enter the secondary compartment (400) while the product (P) in the
primary compartment (300) remains sealed and protected from
potential contaminants.
[0052] In another embodiment of the instant invention, as seen in
FIG. 6, the containment seal (510) varies in thickness by
compartment. In this embodiment, the containment seal (510) has a
primary compartment seal (512) having a lateral seal thickness
(513) and a proximal seal thickness (514). The containment seal
(510) also has a secondary compartment seal (516) having a lateral
seal thickness (517) and a distal seal thickness (518). In FIG. 6,
each seal region (512, 516, 520) is generally identified. By
forming the primary compartment seal (512) of different thickness
than the secondary compartment seal (516), varying degrees of child
resistance can be realized. By way of example and not limitation,
in an embodiment of the present invention the secondary compartment
lateral seal thickness (517) is less than the primary compartment
lateral seal thickness (513), as seen in FIG. 6. The advantages of
this containment seal (510) design are two-fold.
[0053] First, the child resistance of the primary compartment (300)
is substantially the same as the embodiment of the instant
invention where the primary compartment lateral seal thickness
(513) and the secondary compartment lateral seal thicknesses (517)
are substantially the same. And, secondly, the secondary
compartment (516) may be opened more easily versus the embodiment
of the instant invention where the primary compartment and
secondary lateral seal thicknesses (513,517) are substantially the
same. A reduction in the secondary compartment lateral seal
thickness (517) may reduce the force required to separate the
secondary compartment seal (516) because the reduced secondary
compartment lateral seal thickness (517) reduces the total
secondary compartment seal (516) area. In addition, a reduction in
the secondary compartment lateral seal thickness (517) increases
the secondary compartment width (470). In other words, less seal
may allow the user to grip the open end of the secondary
compartment (400) more easily and, consequently, may allow the user
to peel the secondary compartment (400) open more easily. In an
embodiment of the instant invention, the secondary compartment
lateral seal thickness (517) is between approximately 0.062 inches
(0.15748 cm) and 0.5 inches (1.27 cm) and the secondary compartment
width (470) is between approximately 0.25 (0.0635 cm) inches to
approximately 3.0 inches (7.62 cm). The primary compartment lateral
seal thickness (513) is between about 0.125 inches (0.3175 cm) and
about 0.562 inches (1.42748 cm). The distributing seal width (522)
is between 0.062 inches (0.15748 cm) to 0.25 inches (1.27 cm)
wide.
[0054] In an embodiment of the instant invention, the secondary
compartment (400) may house a second product. For example, one can
readily appreciate that the secondary compartment (400) may house
an antibacterial hand washing solution that may be used to clean a
user's hands prior to handling the product (P) in the primary
compartment (300).
[0055] The Inventors will now disclose how the pouch (50) described
above may be part of a process to place single dosage forms of a
wide variety of product types, in primary compartments. Such a
process would, overall, utilize the steps of providing bulk single
dosage product while concurrently providing two opposing sheets of
pouch material in a suitable packaging machine. A plurality of
single dosage products (P) would be placed between the two opposing
sheets of pouch material comprising a top layer (100) and bottom
layer (200) in a predetermined pattern, creating areas wherein the
top layer (100) and bottom layer (200) of pouch material are
separated by single dosage product (P) and areas where the top
layer (100) and bottom layer (200) of pouch film material may
directly touch.
[0056] The pouches containing the single dosage product (P) would
be formed by applying sealing means to a portion of the top layer
(100) and bottom layer (200) of pouch film material such that
sealing will occur in areas where top layer (100) and bottom layer
(200) of pouch material may directly touch. The result would be to
seal a portion of the top layer (100) and bottom layer (200) of
pouch material to enclose at least one of a plurality of the single
dosage products (P) in at least one closed pouch, sealed from the
environment, thereby creating a plurality of closed pouches further
comprising a secondary compartment (400) and a primary compartment
(300) containing the single dosage product (P). The sealing means
may be a thermal means, or any of a variety of sealing techniques
that would be known to one skilled in the art.
[0057] The remaining stages of the process may include forming a
tear promoting surface condition (600) in each of the plurality of
closed pouches to aid in the later opening of the pouches, and then
cutting the plurality of closed pouches into a plurality of
individual closed pouches (50). The plurality of individual closed
pouches (50) could then be discharged, ready for secondary
packaging. The order of the steps of the process may be varied
somewhat, as would be apparent to one skilled in the art. By way of
example and not limitation, the tear promoting surface condition
(600) could be formed either before or after the sealing step.
[0058] The tear promoting surface condition (600) may further be
formed with a fold-over line (700) that intersects the tear
promoting condition (600) such that when the pouch (50) is folded
along the fold-over line (700) the tear promoting surface condition
(600) presents itself to a user so that it can be easily folded
back, as seen in FIG. 7, for easy gripping. The tear promoting
surface condition (600) permits a user to easily tear off a portion
of the top (100) and bottom layer (200) and expose a portion of the
secondary compartment (400). The location of the fold-over line
(700) may be based upon the type of tear promoting surface
condition (600) that is incorporated into the pouch (50), as well
as the desired level of child-resistance.
[0059] The process may further include the step of imprinting
indicia on the single dosage product (P) before sealing, as well as
further including the step of imprinting indicia (710) on the pouch
material either before or after sealing. Indicia (710) imprinted on
the pouch material could identify the tear promoting surface
condition. Indicia (710) may also identify the product (P) should
the individual pouches (50) be separated from the secondary
packaging, while indicia imprinted on the single dosage product (P)
itself could serve as a safety check for the consumer before use
and as a reassurance that the product (P) had been properly
identified during packaging.
[0060] The pouch (50) as detailed above may be further contemplated
as an embodiment for sealing single dosage film strips of orally
consumable film in individual pouches. Such a process may involve
the steps of first providing bulk orally consumable film strip cast
in roll form, and then unwinding the orally consumable film strip
under tension in a suitable machine. The roll form may further be
formed of a laminate comprising an orally consumable film strip and
a paper backing wherein the film strip and paper backing are
simultaneously unwound.
[0061] The bulk film strip may then be slit or otherwise cut into a
plurality of strips of lesser width, and each of the strips may
then be cut into a plurality of single dosage film strips, each
representing a single dosage product (P).
[0062] The process may then concurrently provide two opposing
sheets of pouch material comprising a top layer (100) and bottom
layer (200) and placing a plurality of single dosage film strips
between the top layer (100) and bottom layer (200) of pouch
material in a predetermined pattern. The pattern could create areas
wherein the top layer (100) and bottom layer (200) of pouch film
material are separated by single dosage film strips and areas where
the top layer (100) and bottom layer (200) of pouch film material
may directly touch.
[0063] The application of sealing means to a portion of the top
layer (100) and bottom layer (200) in areas where the top layer
(100) and bottom layer (200) of pouch material are directly
touching will create a pouch to enclose the single dosage film
strip. The sealing means may be a thermal means.
[0064] The remaining stages of the process includes forming a tear
promoting surface condition (600) in each of the closed pouches and
then cutting the plurality of closed pouches into a plurality of
individual closed pouches (50). The plurality of individual closed
pouches (50) will then be discharged and ready for secondary
packaging. The order of the steps of the process may be varied
somewhat, as would be apparent to one skilled in the art. By way of
example and not limitation, the tear promoting surface condition
(600) could be formed either before or after the sealing step.
[0065] The tear promoting surface condition (600) may further be
formed of a feature on the top layer (100) and the bottom layer
(200). The tear promoting surface condition (600) may be configured
so that a tear that originates therefrom traverses a portion of the
primary compartment (300) thereby removing a portion of the top
(100) and bottom layer (200) to expose a portion of the primary
compartment (300). The fold-over line (700) may intersect the tear
promoting surface condition (600) at virtually any angle despite
the figures illustrating the intersection as substantially
orthogonal.
[0066] The process may further include the step of imprinting
indicia on the single dosage film strip before sealing as well as
further including the step of imprinting indicia (710) on pouch
material either before or after sealing. Indicia (710) imprinted on
the pouch material could identify the dosage form should the
individual pouches be separated from the secondary packaging, while
indicia imprinted on the single dosage film strip itself could
serve as a safety check for the consumer.
INDUSTRIAL APPLICABILITY
[0067] The peelable pouch according to the present invention
answers a long felt need for a low cost disposable package for
housing a single film dosage form. The present invention provides a
package that offers simplicity in manufacture, convenience in
storage, preservation of product, resistance to contamination,
child-resistance, and improved sanitation. In particular, the
inventive package has the capacity to provide a means for safely
delivering thin film dosage forms while at the same time creating
efficient child resistant packaging.
[0068] Numerous alterations, modifications, and variations of the
preferred embodiments disclosed herein will be apparent to those
skilled in the art and they are all anticipated and contemplated to
be within the spirit and scope of the instant invention. For
example, although specific embodiments have been described in
detail, those with skill in the art will understand that the
preceding embodiments and variations can be modified to incorporate
various types of substitute and/or additional or alternative
materials, relative arrangement of elements, and dimensional
configurations.
* * * * *