Note: Descriptions are shown in the official language in which they were submitted.
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New single-dose packaging
The invention relates to an item of packaging for
single-dose films or patches which contain an active
ingredient, comprising an upper packaging-material
element and a lower packaging-material element which
are connected to one another by means of an encircling
sealing face or sealing seam, respectively, in such a
manner that a cavity, enclosed on all sides, for
receiving the film or patch is formed, wherein the
upper packaging-material element and the lower
packaging-material element in the region of the sealing
face or the sealing seam, respectively, display in each
case at least one incision which are congruent, and at
least one incision is intersected by a fold or kink
line.
Transdermal therapeutic systems (TTS) are patch-like
pharmaceutical dosage forms for dispensing active
ingredients to the skin. In the simplest case, TTS
consist of a very thin backing layer, an adhesive
polymer layer which contains an active ingredient, and
optionally of a protective layer which may be peeled
off again and which is removed prior to the application
of the TTS. The backing layer and the polymer layer
have to be very thin, so as to prevent the sensation of
a foreign body when wearing the TTS. On account of this
property, both layers are susceptible to damage when
the packaging is torn open (in the following referred
to as "patch").
The same also applies to film-shaped oral
pharmaceutical dosage forms, also so-called oral thin
films (OTF) or wafers, which are composed of only one
polymer layer (in the following referred to as "film").
There is, in principle, a demand for child-safe
packaging for such types of pharmaceutical dosage forms
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or dispensing forms, respectively, which, however, also
have to be easy for adults to open.
DE 10 2004 047 445 Al discloses a non-resealable item
of packaging for products, in particular pharmaceutical
products, which are hazardous to health, comprising a
first packaging-material element and a second
packaging-material element. The two packaging-material
elements here are disposed so as to be on top of one
another, and the item of packaging displays at least
one first face portion on the periphery or peripheries
of which the two packaging-material elements are
releasably connected to one another, wherein between
the two packaging-material elements at least one
cavity, enclosed on all sides, for receiving the
packaged item is formed. The item of packaging displays
at least one second face portion which is outside the
mentioned first face portion or is adjacent thereto,
and on the periphery or peripheries of which the two
packaging-material elements are releasably connected to
one another, and wherein at least one of the two
packaging-material elements is provided with at least
one structure which runs within the second face portion
and which enables tearing of the packaging-material
element/elements.
DE 10 2006 041 921 Al discloses an item of packaging
for films which contain an active ingredient, which
displays a carrier layer and a cover layer which is
releasably connected thereto. The item of packaging
here displays in paired arrangement two face regions
which lie opposite one another and which are separated
by a web and within which the cover layer is not
connected to the carrier layer, on account of which two
spaces, enclosed on all sides, which are separated from
one another for receiving the mentioned films in a
paired manner are formed. A further face region in
which the carrier layer is not connected to the cover
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layer exists within the mentioned web, on account of
which a cavity, enclosed on all sides, is formed and at
least one perforation line exists within the web.
In these known embodiments, the upper packaging-
material element and the lower packaging-material
element are connected to one another in a releasable
(peelable) manner.
In another embodiment in the case of single-dose items
of packaging, the two packaging-material elements are
connected to one another in a non-releasable manner.
This preferably takes place by way of heat-sealing, but
may also take place by way of any other suitable
sealing method, such as cold-sealing, ultrasonic
sealing, laser sealing, or comparable film-welding
methods which are known to a person skilled in the art,
as long as a non-releasable sealing seam is obtained.
An item of packaging of this type is known from the
German laid-open patent
specification
DE 10 2009 008 217 Al, for example.
In the known embodiments of the item of packaging, the
user has to fold over part of the item of packaging
along a printed marking line, in order to subsequently
open the item of packaging at a likewise marked spot by
tearing along a weakening line. Folding over along the
printed marking line modifies the positioning of a
structure or of an incision in the region of the
sealing face or sealing seam, respectively, of the two
packaging-material elements on the periphery of the
item of packaging and thus enables the item of
packaging to be torn open in order to be able to remove
the contents from the cavity. The structure or the
incision has a length of approx. 3 to 5 'um. The printed
marking line intersects the structure or the incision,
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respectively, in a preferably perpendicular manner or
at a selected angle.
The necessity for the sealing seam and the packaging-
material elements to have to consider the diffusion
behavior of the contents of the item of packaging is
already pointed out in DE 10 2009 008 217 Al. In the
known embodiments the arrangement of the incisions has
to be seen as critical_
The prior art here overlooks the fact that the
packaging significantly contributes toward the
stability of the packaged pharmaceutical dosage form,
since the packaging protects the pharmaceutical dosage
form from light, humidity, oxygen, and microorganisms.
On account of causing a gap in the seal, the mentioned
weakening line weakens the packaging, since more
humidity and oxygen can be diffused through the
interrupted seal into the interior of the packaging. It
is to be noted here that both water vapor and oxygen
are very small molecules and the shelf life of the
medicine prior to application should at least be two
years, ideally even three years or more.
The invention is thus based on the object of providing
a single-dose item of packaging of the generic type
which improves the embodiments described above. In
particular, diffusion of material into the interior of
the packaging is to be prevented.
This object is achieved according to the invention in
that the incision in the upper packaging-material
element and the congruent incision in the lower
packaging-material element is configured such that the
respective terminal point of the incisions displays a
spacing from the cavity which corresponds to at least
the width of the sealing seam. Claim 1 thus achieves
the object set.
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Furthermore, the aspect of child safety is
advantageously achieved such that this invention meets
the requirements of DIN EN 14375 (child-resistant, non-
reclosable packaging for pharmaceutical products -
requirements and tests).
The invention, therefore, relates to an item of
packaging for single-dose films or patches which
contain an active ingredient, comprising an upper
packaging-material element and a lower packaging-
material element which are connected to one another by
means of an encircling sealing face or sealing seam in
such a manner that a cavity, enclosed on all sides, for
receiving the film or patch is formed, wherein
i.) the upper packaging-material element and the lower
packaging-material element in the region of the sealing
face or the sealing seam display in each case at least
one incision which are congruent, and
ii.) at least one incision of i.) is intersected by a
fold or kink line, and
iii.) the incision of i.) in the upper packaging-
material element and the congruent incision in the
lower packaging-material element is configured such
that the respective terminal point of the incisions of
i.) displays a spacing (MI) from the cavity or the
cavity edge, respectively, which corresponds to at
least the width (M2) of the sealing seam.
In a further preferred embodiment of the invention the
width of the sealing seam (M2) is 1 to 25 mm,
preferably 2 to 10 mm, particularly preferably 4 to
8 mm. Accordingly, the spacing M1 according to the
invention of iii.) is at least the length of M2 or
more; it is, however, preferable for M1 not to be equal
to but longer than M2, in particular to display an
additional amount of 20% to 30% in relation to M2. An
example which is not final is illustrated in fig. 1. It
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is furthermore preferable for the sealing seams to be
configured in a uniform manner. For example, if a width
(M2) of the sealing seam of 5 mm is chosen, M1 may be
mm and more, preferably 6 to 10 mm.
5
Design embodiments of the invention are stated in the
dependent claims
The invention thus provides that the terminal points of
the incisions are located at least as far from the
cavity as the maximum width of the remaining sealing
seams. Each item of packaging on at least three sides
displays sealing seams, which consider a width in order
to avoid or prevent, respectively, diffusion for the
time duration of the maximum shelf life.
The outer layer is preferably printable, such that, for
example, product identification marks and aids for
tearing open may be attached.
A second layer, or the central layer in the case of a
triple-layer construction, is composed of a metal foil,
preferably aluminum, having a thickness of 9 - 25
micrometers. This metallic layer makes for tightness of
the packaging in relation to humidity and air.
The inner layer is a sealable plastic layer, wherein
the sealing seam produced by this layer cannot be
reopened.
In one preferred embodiment, the upper packaging-
material element and the lower packaging-material
element have an identical construction. This has the
advantage that only one variety of packaging material
is employed and any mix-up can be precluded.
An expedient embodiment provides that the incision in
the upper packaging-material element and the incision
in the lower packaging-material element is applied in
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the sealing seam such that said incision is oriented so
as to be perpendicular to the nearest outer edge of the
cavity. This ensures that the incision is in contact
with the encircling sealing face or sealing seam,
respectively, at precisely one single point, while in
the case of the known embodiments, contact exists
across a comparatively large distance.
It is furthermore preferable for said incisions to
display sufficient spacing along an incision line from
the introduced film or patch, such that no damage
arises during tearing open. A suitable spacing M3 is
identified in an exemplary manner in fig. 1.
In one particular embodiment, the upper packaging-
material element and the lower packaging-material
element are configured so as to be in one part and here
are folded back along a bending edge.
The connection between the two packaging-material
elements is preferably produced by sealing or welding.
Suitable means and methods for producing the sealing
faces or the sealing seams, respectively, are known to
the person skilled in the art. The seal serves as a
barrier to diffusion and permeation and is generally
impermeable to active ingredients and to air humidity.
Both hot-sealing methods and cold-sealing methods are
considered. Hotmelt adhesives, sealing waxes, sealing
dispersions, or adhesives may be used as a material for
sealing layers, for example
The invention furthermore relates to a method for
manufacturing an item of packaging for single-dose
films or patches which contain an active ingredient,
comprising the steps of
i.) providing an upper packaging-material element and a
lower packaging-material element which are connected to
one another by means of an encircling sealing face or
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sealing seam, respectively, in such a manner that a
cavity, enclosed on all sides, for receiving the film
or patch is formed, wherein
ii.) in each case at least one incision which are
congruent is inflicted on the upper packaging-material
element and the lower packaging-material element in the
region of the sealing face or the sealing seam,
respectively, and
iii.) applying a fold or kink line which intersects at
least one aforementioned incision of ii.),
wherein said incision of ii.) in the upper
packaging-material element and the congruent incision
in the lower packaging-material element is configured
such that the respective terminal point of these
incisions displays a spacing (M1) from the
abovementioned cavity which corresponds to at least the
width (M2) of the sealing seam of i).
The method according to the invention may be further
designed as per one of the preceding or following
features. In particular, at least one incision of ii.)
may be oriented so as to be perpendicular to the
nearest outer edge of the cavity of i.),
The invention furthermore relates to the use of an item
of packaging (1) as claimed in claim 1, for receiving
single doses, such as films, wafers or patches, in
particular TTS patches, which contain an active
ingredient.
Further features and details of the invention are
derived from the claims and the following description
of exemplary embodiments of the invention, which are
illustrated in schematic drawings, in which:
Fig. 1 shows an item of packaging for films which
contain an active ingredient in plan view; and
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Fig. 2 shows the item of packaging of fig. 1, in a
sectional side view.
In fig. 1, an item of packaging 1 according to the
invention is illustrated in plan view. The item of
packaging 1 is a sealed-edge pouch made from an upper
packaging-material element 3 and a lower packaging-
material element 4. A film 2 which contains an active
ingredient is disposed in a cavity 6, enclosed on all
sides, between the upper packaging-material element 3
and the lower packaging-material element 4. The cavity
6 is produced by an encircling sealing face or sealing
seam 5, respectively, which connects the two packaging-
material elements 3, 4 in a non-releasable manner. The
cavity 6 and the sealing face or sealing seam 5,
respectively, display a common outer edge 6a. An
incision 7 is located in the upper packaging-material
element 3 in the sealing face or sealing seam 5,
respectively, and an incision 8 is located in the lower
packaging-material element 4, The two incisions 7 and 8
are congruent. The incision 7 is intersected by a fold
or kink line 10
An imaginary extension of the incisions 7 and 8, which
is identical to the tear-open edge, displays a spacing
M3 from the nearest edge of the film 2 which contains
an active ingredient. In one preferred embodiment, the
spacing M3 is 4 to 5 mm.
In another embodiment, the upper and lower packaging-
material element 3, 4 is configured so as to be in one
part and is folded back around a bending edge 17. Here,
the sealing seam 5 is dispensed with in this region.
The construction of the item of packaging is
illustrated in a sectional illustration, along the line
A-A in fig. 1, in fig 2. The individual parts are
greatly enlarged and drawn so as to be separate in
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order to show the construction more clearly. The upper
packaging-material element 3 is composed of at least
one upper outer layer 11 and an adjoining upper
metallic layer 13.
The lower packaging-material layer 4 is likewise
composed of a lower outer layer 12 and an adjoining
lower metallic layer 14.
The metallic layers 13, 14 are preferably composed of
an aluminum foil having a thickness of 9 to 25
micrometers. The foil ensures that the inserted product
does not come into contact with air and is not exposed
to any humidity.
The upper or the lower packaging-material element 3, 4
displays a sealable layer or sealing layer 9 in at
least the region of the sealing face or the sealing
seam 5, respectively. The sealing layer 9, however, may
also be attached on both, the upper and the lower,
packaging-material elements 3, 4. The sealing face or
sealing seam 5, respectively, which is produced by this
layer 9 cannot be separated again.
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List of reference signs:
1 Packaging
2 Film containing active ingredient
3 Upper packaging-material element
4 Lower packaging-material element
5 Sealing face or sealing seam, respectively
6 Cavity
6a Outer edges of cavity 6a
7 Incision
8 Incision
9 Sealing layer
10 Fold or kink line
11 Upper outer layer
12 Lower outer layer
13 Upper metallic layer
14 Lower metallic layer
15 Terminal point of incision 7
16 Terminal point of incision 8
17 Bending edge
M1 Spacing 1
M2 Spacing 2
M3 Spacing 3