EP2874908B1 - Package for films with a unitary dosage of an active substance as well as the method for manufacturing said package - Google Patents

Description

The invention relates to a package for single-drug-containing films or patches, comprising an upper packaging material element and a lower packaging material element, which are connected to each other by means of a circumferential sealing surface or sealing seam such that a cavity enclosed on all sides for receiving the film or plaster is, wherein the upper packaging material element and the lower packaging material element in the region of the sealing surface or the sealing seam each have at least one section which are congruent, and at least one section is crossed by a fold or crease line.

Transdermal Therapeutic Systems (TTS) are patch-like dosage forms for delivery of active ingredients to the skin. TTS consist in the simplest case of a very thin backing layer, a pressure-sensitive adhesive polymer layer containing an active ingredient and optionally a removable protective layer which is removed before the application of the TTS. The backing layer and polymer layer must be very thin, so that no foreign body feeling is created when wearing the TTS. This property makes both layers vulnerable to being damaged when the package is torn open (hereinafter referred to as "patch").

This also applies to film-shaped oral dosage forms, also known as oral thin films (OTF) or wafers, which consist of only one polymer layer (hereinafter called "film").

In general, there is a need for child-resistant packaging for such types of dosage forms, but which at the same time must be easy for adults to open.

From the DE 10 2004 047 445 A1 is a non-reclosable package for hazardous products, in particular pharmaceutical products, comprising a first packaging material element and a second packaging material element known. In this case, the two packaging material elements are arranged one above the other and the packaging has at least a first surface portion, at the edge or edges of the two packaging material elements are releasably connected to each other, wherein between the two packaging material elements at least one side enclosed cavity for receiving the packaged goods is formed. The packaging has at least one second surface section which lies outside of or adjoins the first surface section and at the edge or edges 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 extends within the second surface portion and which allows tearing of the packaging material element (s).

From the DE 10 2006 041 921 A1 is a package for active substance-containing films, which has a carrier layer and a releasably connected to this cover layer known. The packaging has in a pairwise arrangement two opposite, separated by a web surface areas within which the cover layer is not connected to the carrier layer, whereby two separate, mutually enclosed spaces for pairwise recording of said films are formed. Within said web, there is a further surface area in which the carrier layer is not connected to the cover layer, whereby an all-round enclosed cavity is formed and within the web at least one perforation line is present.

In these known embodiments, the upper packaging material element and the lower packaging material element are releasably (peelably) connected to each other.

In another embodiment, the two packaging material elements are inseparably connected to each other in single-dose packaging. This is preferably done by a heat seal, but can also be done with any other suitable sealing method such as cold sealing, ultrasonic sealing, laser sealing or similar, known in the art foil welding process, as long as a non-detachable sealing seam is obtained.

Such a package is for example from the German patent application DE 10 2009 008 217 A1 known.

In the known embodiments of the packaging, the user must fold over part of the packaging along an imprinted marking line, in order subsequently to open the packaging by tearing along a weakening line at a likewise marked point. The buckling along the printed marking line changes the position of a structure or a cut in the region of the sealing surface or sealing seam of the two packaging material elements to the edge of the packaging and thus allows tearing of the packaging in order to be able to remove the contents from the cavity. The structure or section has a length of about 3 to 5 mm. The printed marker line preferably crosses the pattern or cut at right angles or at a selected angle.

Already in the DE 10 2009 008 217 A1 It points out the need for the sealing seam and the packaging material elements to take into account the diffusion behavior of the contents of the packaging. As critical in the known designs, the arrangement of the cuts can be seen.

The prior art overlooks the fact that the packaging significantly contributes to the stability of the packaged dosage form, because the packaging protects the dosage form from light, moisture, oxygen and microorganisms. The mentioned weakening line weakens the packaging by causing a gap in the seal because the broken seal allows more moisture and oxygen to diffuse into the interior of the package. It should be noted that both water vapor and oxygen are very small molecules and the storage of the drug before use is at least two years, ideally three years or more.

The invention is therefore based on the object to provide a generic single-dose packaging, which improves the embodiments described above. In particular, the diffusion of substances into the interior of the packaging should be prevented.

This object is achieved in that the section in the upper packaging material element and the congruent cut in the lower packaging material element is formed so that the respective end point of the cuts has a distance from the cavity, which corresponds at least to the width of the sealed seam. Therefore, claim 1 solves the task.

Furthermore, the aspect of parental control is advantageously solved, so that this invention meets the required DIN EN 14375 (child-resistant, non-resealable packaging for pharmaceutical products - requirements and tests).

1. i.) das obere Packstoffelement und das untere Packstoffelement im Bereich der Siegelfläche oder der Siegelnaht jeweils mindestens einen Schnitt aufweisen, die deckungsgleich sind, und
2. ii.) mindestens ein Schnitt aus i.) durch eine Falz- oder Knicklinie gekreuzt wird, und
3. iii.) der Schnitt aus i.) im oberen Packstoffelement und der deckungsgleiche Schnitt im unteren Packstoffelement so ausgebildet ist, dass der jeweilige Endpunkt der Schnitte aus i.) einen Abstand (M1) zum Hohlraum bzw. Hohlraumkante aufweist, der mindestens der Breite (M2) der Siegelnaht entspricht.

Therefore, the invention relates to a package for single-drug-containing films or patches, comprising an upper packaging material element and a lower packaging material element, which are connected to each other by means of a circumferential sealing surface or sealing seam, that a cavity enclosed on all sides for receiving the film or plaster being, being

1. i.) The upper packaging material element and the lower packaging material element in the region of the sealing surface or the sealing seam each have at least one section which are congruent, and
2. ii.) at least one cut from i.) is crossed by a fold or crease line, and
3. iii.) the cut from i.) in the upper packaging material element and the congruent cut in the lower packaging material element is designed so that the respective end point of the cuts from i.) has a distance (M1) to the cavity or cavity edge which is at least the width ( M2) corresponds to the sealed seam.

In a further preferred embodiment of the invention, the width of the sealed seam (M2) is 1 to 25 mm, preferably 2 to 10 mm, particularly preferably 4 to 8 mm. Accordingly, the distance M1 from iii) according to the invention is at least the length of M2 or more, but it is preferred that M1 is not equal but longer than M2, in particular has an additional amount of 20% to 30% compared to M2. A non-exhaustive example is in FIG. 1 shown. Furthermore, it is preferred that the sealing seams are uniform. If, for example, a width (M2) of the sealing seam of 5 mm is selected, M1 may be 5 mm or more, preferably 6 to 10 mm.

Embodiments of the invention are specified in the subclaims.

The invention thus provides that the end points of the cuts are at least as far away from the cavity as the maximum width of the remaining sealing seams. Each package has sealed seams on at least three sides that take into account a width to prevent or prevent diffusion for the period of maximum storage.

The outer layer is preferably printable, so that e.g. Product labels and tear-open aids can be attached.

A second or, in the case of a three-layer structure, the middle layer consists of a metal foil, preferably aluminum, with a thickness of 9-25 micrometers. This metal layer ensures the tightness of the packaging against moisture and air.

The inner layer is a sealable plastic layer, wherein the sealed seam produced by this layer can not be opened again.

In a preferred embodiment, the upper packaging material element and the lower packaging material element have an identical structure. This has the advantage that only one type of packaging materials for use and thus a confusion is excluded.

An expedient development provides that the cut in the upper and the cut in the lower packaging material element in the sealed seam is mounted so that it is aligned at right angles to the nearest outer edge of the cavity. This ensures that the cut exactly at a single point with the circulating sealing surface or sealing seam comes into contact, while in the known embodiments, there is a contact over a longer distance.

Furthermore, it is preferred that the said cuts have a sufficient distance along a cutting line to the introduced film or plaster, so that no damage occurs during tearing. In FIG. 1 For example, a suitable distance M3 is shown.

In a particular embodiment, the upper packaging material element and the lower packaging material element are integrally formed and are thereby folded around 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 surfaces or the sealing seams are known to the person skilled in the art. The seal serves as a diffusion and permeation barrier and is generally impermeable to drugs and humidity. Both heat sealing and cold sealing methods are contemplated. As a material for sealing layers, e.g. Hot melt adhesives, sealing waxes, Siegel dispersions or adhesives are used.

1. i.) Bereitstellung eines oberen Packstoff-Elements und eines unteren Packstoff-Elements, die mittels einer umlaufenden Siegelfläche bzw. Siegelnaht derart miteinander verbunden sind, dass ein allseitig umschlossener Hohlraum zur Aufnahme des Films oder Pflaster gebildet wird, wobei
2. ii.) dem oberen Packstoffelement und dem unteren Packstoffelement im Bereich der Siegelfläche bzw. der Siegelnaht jeweils mindestens ein Schnitt zugefügt wird, die deckungsgleich sind, und
3. iii.) Anbringen einer Falz- oder Knicklinie, welche mindestens einen vorgenannten Schnitt aus ii.) kreuzt,

wobei der besagte Schnitt aus ii.) im oberen Packstoffelement und der deckungsgleiche Schnitt im unteren Packstoffelement so ausgebildet ist, dass der jeweilige Endpunkt dieser Schnitte einen Abstand (M1) zum vorgenannten Hohlraum aufweist, der mindestens der Breite (M2) der Siegelnaht aus i.) entspricht.Furthermore, the invention relates to a method for producing a package for single-dose active substance-containing films or patches, comprising the steps

1. i.) providing an upper packaging material element and a lower packaging material element, which are connected to each other by means of a circumferential sealing surface or sealing seam, that an all-round enclosed cavity for receiving the film or plaster is formed
2. ii.) the upper packaging material element and the lower packaging material element in the region of the sealing surface or the sealing seam is added in each case at least one section which are congruent, and
3. iii.) applying a fold or crease line which intersects at least one of the above-mentioned section from ii.),

wherein the said section of ii.) In the upper packaging material element and the congruent section in the lower packaging material element is formed so that the respective end point of these cuts a distance (M1) to the aforementioned cavity, the at least the width (M2) of the sealed seam of i. ) corresponds.

The method according to the invention can be designed further according to one of the preceding and following features. In particular, at least one section from ii.) Can be aligned at right angles to the closest outer edge of the cavity from i.).

Furthermore, the invention relates to the use of a package (1) according to claim 1 for receiving single doses, such as active ingredient-containing films, wafers or patches, in particular TTS patches.

Fig. 1

in Draufsicht eine Verpackung für wirkstoffhaltige Filme;

und Fig. 2

in geschnittener Seitenansicht die Verpackung aus Figur 1;

Further features and details of the invention will become apparent from the claims and the following description of illustrated in schematic drawings embodiments of the invention. Show it:

Fig. 1

in plan view, a package for active substance-containing films;

and FIG. 2

in cut side view of the packaging FIG. 1 ;

In Fig. 1 a packaging 1 according to the invention is shown in plan view. The packaging 1 is a sealed-edge bag made of an upper packaging material element 3 and a lower packaging material element 4. Between the upper packaging material element 3 and the lower packaging material element 4, an active-substance-containing film 2 is arranged in a cavity 6 enclosed on all sides. The cavity 6 is generated by a circumferential sealing surface or sealing seam 5, which connects the two packaging material elements 3, 4 inextricably. The cavity 6 and the sealing surface or sealing seam 5 have a common outer edge 6a. In the sealing surface or sealing seam 5 is located in the upper packaging material element 3, a section 7 and in the lower packaging material element 4 a section 8. The two sections 7 and 8 are congruent. The section 7 is crossed by a fold or crease line 10.

An imaginary extension of the cuts 7 and 8, which is identical to the tear-open edge, has a distance M3 from the nearest edge of the active substance-containing film 2. In a preferred embodiment, the distance M3 is 4 to 5 mm.

In another embodiment, the upper and lower packaging material element 3, 4 is integrally formed and is folded around a bending edge 17. This eliminates the seal 5 in this area.

In Fig. 2 is the structure of the package in a sectional view along the line A - A in Fig. 1 shown. The individual parts are greatly enlarged and drawn separately to illustrate the structure. The upper packaging material element 3 consists of at least one upper, outer layer 11 and a subsequent upper metal layer 13.

The lower packaging material layer 4 likewise consists of a lower, outer, layer 12 and a subsequent lower metal layer 14.

The metal layers 13, 14 are preferably made of an aluminum foil having a thickness of 9 to 25 microns. This film ensures that the inserted product does not come into contact with air and is not exposed to moisture.

At least in the area of the sealing surface or the sealing seam 5, the upper or lower packaging material element 3, 4 has a sealable layer or sealing layer 9. However, the sealing layer 9 can also be applied to both the upper and the lower packaging material elements 3, 4. The sealing surface or sealing seam 5 produced by this layer 9 can not be separated again.

LIST OF REFERENCE NUMBERS

1

packaging

2

active substance-containing film

3

upper packaging material element

4

lower packing material element

5

Sealing surface or sealing seam

6

cavity

6a

Outside edges of the cavity 6

7

cut

8th

cut

9

sealing layer

10

Fold or crease line

11

upper, outer layer

12

lower, outer layer

13

upper metal layer

14

lower metal layer

15

End point of section 7

16

End point of section 8

17

bending edge

M1

Distance 1

M2

Distance 2

M3

Distance 3

Claims (10)

1. An item of packaging (1) for single-dose films or patches (2) which contain an active ingredient, comprising an upper packaging-material element (3) and a lower packaging-material element (4) which are connected to one another by means of an encircling sealing face or sealing seam (5), respectively, in such a manner that a cavity (6), enclosed on all sides, for receiving the film or patch (2) is formed, wherein

   i.) the upper packaging-material element (3) and the lower packaging-material element (4) in the region of the sealing face or the sealing seam (5), respectively, display in each case at least one incision (7, 8) which are congruent, and

   ii.) at least one incision (7, 8) is intersected by a fold or kink line (10), characterized in
   that iii.) the incision (7) in the upper packaging-material element (3) and the congruent incision (8) in the lower packaging-material element (4) is configured such that the respective terminal point (15, 16) of the incisions (7, 8) displays a spacing (M1) from the cavity (6) which corresponds to at least the width (M2) of the sealing seam (5).
2. The item of packaging (1) as claimed in claim 1, characterized in that the incision (7) and the incision (8) are oriented so as to be perpendicular to the nearest outer edge (6a) of the cavity (6).
3. The item of packaging (1) as claimed in claim 1, characterized in that the upper packaging-material element (3) and the lower packaging-material element (4) are configured so as to be in one part and form a bending edge (17).
4. The item of packaging (1) as claimed in claim 1, characterized in that the upper outer layer (11) and/or the lower outer layer (12) are/is configured so as to be printable.
5. The item of packaging (1) as claimed in one of claims 1 to 4, characterized in
   that the sealing face or the sealing seam (5), respectively, is not peelable.
6. The item of packaging (1) as claimed in one of claims 1 to 5, characterized in
   that each packaging-material element (3, 4) displays an outer layer (11, 12) and a metallic layer (13, 14), and at least one of the two packaging-material elements (3, 4) displays a sealing layer (9).
7. The item of packaging (1) as claimed in claim 6, characterized in that the sealing layer is selected from hotmelt adhesives, sealing waxes, sealing dispersions, or adhesives.
8. A method for manufacturing an item of packaging (1) for single-dose films or patches which contain an active ingredient, comprising the steps of:

   i. providing an upper packaging-material element (3) and a lower packaging-material element (4) which are connected to one another by means of an encircling sealing face or sealing seam (5), respectively, in such a manner that a cavity (6), enclosed on all sides, for receiving the films is formed, wherein

   i.) in each case at least one incision (7, 8) which are congruent is inflicted on the upper packaging-material element (3) and the lower packaging-material element (4) in the region of the sealing face or the sealing seam, respectively, and

   ii.) applying a fold or kink line (10) which intersects at least one aforementioned incision (7, 8),

   wherein the incision (7) in the upper packaging-material element (3) and the congruent incision (8) in the lower packaging-material element (4) is configured such that the respective terminal point (15, 16) of the incisions displays a spacing (M1) from the cavity (6) which corresponds to at least the width (M2) of the sealing seam (5).
9. The method for manufacturing an item of packaging (1) for single-dose films which contain an active ingredient, as claimed in claim 8, comprising a further step iv.), wherein at least one incision (7, 8) is oriented so as to be perpendicular to the nearest outer edge (6a) of the cavity (6).
10. 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.

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