KR20150032702A - Pack for individual active-substance-containing films, and method for producing said pack - Google Patents

Abstract

The present invention relates to an upper package element (3) which is connected to each other by a surrounding sealing surface or sealing joint (5) in such a way that a front sealed cavity (6) for receiving a film or patch (2) 1. A packaged article (1) for a single dosage form or patch (2) containing an active ingredient, the article comprising:
- the upper and lower packaging elements (3) and (4) in the sealing surface or sealing joint area (5) each have one or more cuts (7, 8) of the same type in each case,
- one or more incisions (7, 8) crossing the fold line or tear line (10)
The cutouts 8 of the same type in the cutouts 7 and the lower package element 4 in the upper package element 3 are arranged such that the respective ends 15,16 of the cutouts 7,8 are arranged at least in the area of the sealing abutment 7, (M1) from the cavity (6) corresponding to the width (M2) of the container (5).

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a pack for a film containing an active material,

The present invention comprises a top and a bottom packaging element interconnected by a surrounding sealing surface or sealing seam such that a front sealed cavity is formed for receiving the film or patch, Wherein each of the upper and lower packaging elements in the area of the sealing abutment has at least one incision in each case of the same type and wherein one or more incisions are made of a single piece containing the active ingredient crossed by a fold line or a kink line To a packaging article for a dosage form film or patch.

The transdermal therapeutic system (TTS) is a patch-like pharmaceutical dosage form for dispensing the active ingredient to the skin. In the simplest case, the TTS consists of a very thin backing layer, a tacky polymer layer containing the active ingredient, and optionally a protective layer that can be re-peeled and removed before application of the TTS. The back layer and the polymer layer should be very thin to prevent stimulation by foreign substances when wearing TTS. Due to this characteristic, both layers are vulnerable to damage when the package is opened (hereinafter referred to as "patch ").

This also applies to oral pharmaceutical dosage forms (hereinafter referred to as "films ") in the form of films, also referred to as oral thin films (OTF) or wafers, consisting of a single layer of polymer.

In principle, there is a need for pediatric safe packaging for this type of pharmaceutical dosage form or dispensing formulation, but such packaging should also be easy for an adult to open.

German Patent Application No. 10 2004 047 445 A1 discloses a packaging article which can not be resealed for health-hazardous products, especially medicines, comprising a first packaging element and a second packaging element. Wherein the two packaging elements are arranged to be positioned on top of each other, the packaging article having at least one first surface portion, the two packaging elements at the periphery of the first surface portion being removably coupled to each other, One or more cavities are formed on the front side to accommodate the packaged articles. Wherein the packaging article has at least one second surface portion present or adjacent to the first surface portion and the two packaging elements at the periphery of the second surface portion are removably coupled to one another, A structure is provided that can penetrate the interior of the second surface portion and tear the packaging element (s).

German Patent Application No. 10 2006 041 921 A1 discloses a packaging article for a film containing an active ingredient having a carrier layer and a cover layer releasably bonded to the carrier layer. Wherein the packaging article has two surface areas arranged opposite to each other and separated by a web in a paired arrangement and wherein the cover layer is not connected to the carrier layer, , Two spaces separated from each other and frontally closed are formed. There is an additional surface area in the web where the carrier layer is not connected to the cover layer, thereby forming a front sealed cavity, with one or more perforations in the web.

In this known example, the upper and lower packaging elements are connected in a detachable (peelable) manner.

In another example for a single dose packaging article, the two packaging elements are connected in a non-separable manner to each other. This is preferably done by heat sealing, but may be accomplished by any other suitable sealing method known to those skilled in the art, such as cooling sealing, ultrasonic sealing, laser sealing or film welding, as long as a non-releasable sealing joint is obtained.

This type of packaging article is known, for example, from German Patent Application Publication No. 10 2009 008 217 A1.

In the example of a known packaging article, the user must fold a portion of the packaging article along the printed indicia to unseal the packaging article at the marked point by tearing along the line of weakness. Folding along the printed indicia can cause the packaging article to be opened to change the location of the structure or cutout in the area of the sealing surface or sealing abutment of the two packaging elements located at the periphery of the packaging article and thereby remove the contents from the cavity . The structure or incision has a length of about 3 to 5 mm. The printed indicia traverses each of the structures or cuts, preferably vertically or at a selected angle.

The need for the sealing joint and the packaging elements to take into account the diffusion behavior of the contents of a packaged article has already been pointed out in German Patent Application No. 2009 2009 21 21 A1. In the known example, the arrangement of the incisions should be considered significant.

The prior art overlooks the fact that packaging contributes significantly to the stability of the packaged pharmaceutical dosage form, since it protects the pharmaceutical dosage form from light, moisture, oxygen and microorganisms. By creating a gap in the seal, the above-mentioned fragile line weakens the packaging because more moisture and oxygen can diffuse into the packaging through the damaged seal line. Note that both water vapor and oxygen are very small molecules, and that the lifespan of the drug before application is at least two years, ideally even three years or more.

Accordingly, it is an object of the present invention to provide a comprehensive form of a single dose packaging article which improves the examples described above. In particular, it is necessary to prevent the substances from diffusing into the packaging.

This object is achieved in that the same type of incision in the upper package element and in the lower package element is constructed such that each end of the incision has at least a gap from the cavity corresponding to the width of the sealing abutment, Lt; / RTI > Therefore, Claim 1 achieves the above object.

In addition, aspects of pediatric safety are advantageously achieved so that the present invention meets the requirements of DIN EN 14375 (packaging for pediatric safe non-resealable pharmaceuticals - requirements and test methods).

Accordingly, the present invention relates to a method of manufacturing a film or patch, comprising the steps of: providing an active, comprising an upper package element and a lower package element interconnected by a surrounding sealing surface or sealing abutment in such a manner that a front, ≪ / RTI > to a packaging article for a single dosage form or patch containing a < RTI ID = 0.0 >

(i) the upper and lower packaging elements in the sealing surface or seal joint region have, in each case, one or more of the same type of cuts,

(ii) one or more incisions of (i) are crossed by fold lines or fold lines,

(iii) cuts of the same type in the cutouts and the bottoms of the package elements of (i) in the upper package element are formed from the joints or joint edges, at each end of the cutout of (i) at least corresponding to the width M2 of the seal joint Respectively.

In a further preferred embodiment of the invention, the width M2 of the sealing joint is 1 to 25 mm, preferably 2 to 10 mm, particularly preferably 4 to 8 mm. Therefore, the interval M1 of (iii) according to the present invention is at least equal to or longer than the length of M2, but M1 is not equal to M2 and is preferably longer than M2, in particular an additional length of 20% to 30% . A non-limiting example is shown in FIG. Further, it is preferable that the sealing joint is constructed in a certain manner. For example, if the width M2 of the sealing joint is chosen to be 5 mm, M1 may be 5 mm or more, preferably 6 to 10 mm.

Design embodiments of the present invention are described in the dependent claims.

Thus, according to the present invention, the ends of the incisions are located at least as far apart as the maximum width of the remaining sealing abutment from the cavity. Each packaging article has a sealing abutment on three or more sides that takes into account the width to avoid or prevent diffusion during periods of maximum shelf life.

The outer layer is preferably printable so that, for example, a product identification mark and an explanatory note for opening can be attached.

In the case of the second layer, or triple layer structure, the center layer consists of a metal foil, preferably aluminum, having a thickness of 9 to 25 μm. The metal layer provides moisture and airtight packaging to the atmosphere.

The inner layer is a sealable plastic layer, and the seal joint produced by this layer can not be opened again.

In a preferred embodiment, the upper package element and the lower package element have the same structure. This has the advantage that only one kind of packaging material is used, and any confusion can be prevented.

In a preferred embodiment, the cutouts in the upper and lower packaging material elements are applied to the seal joint such that the cutouts are oriented perpendicular to the proximal outer edge of the cavity. This ensures that the incision is in contact with the surrounding sealing surface or sealing abutment, respectively, at precisely one single point, and in contrast to the known examples where contact is made over a relatively wide distance.

Further, it is preferable that the cut-out portion has sufficient spacing along the cut-out from the introduced film or patch so that damage does not occur during the opening. An appropriate interval M3 is illustratively shown in Fig.

In certain embodiments, the top and bottom packaging elements are configured to be present in one portion, wherein they are folded in opposite directions along the bending edge.

The connection between the two packaging elements is preferably produced by sealing or welding. Appropriate means and methods for manufacturing sealing surfaces or sealing joints are known to those of ordinary skill in the art. The seal acts as a barrier to diffusion and permeation and is generally impermeable to active ingredients and atmospheric moisture. Both the heat sealing method and the cooling sealing method are considered. For example, hot melt adhesives, beeswax, sealing dispersants or adhesives can be used as the material for the sealing layer.

In addition,

(i) providing an upper package element and a lower package element interconnected by a surrounding sealing surface or sealing joint, in such a manner that a front sealed cavity is formed for receiving a film or patch;

(ii) at least one incision in each case of the same type being formed on the upper and lower packaging elements, respectively, in the sealing surface or sealing joint region; And

(iii) applying a fold line or tangent line across at least one of the cuts of (ii)

(Ii) in the upper package element and the same type of incision in the lower package element, each end of these incisions being spaced apart from the cavity corresponding to the width (M2) of the sealing abutment of at least (i) M1)

To a method of making a packaged article for a single dose type film or patch containing an active ingredient.

The method according to the present invention may be further devised in accordance with one of the features mentioned above or described below. In particular, one or more cuts of (ii) may be oriented perpendicular to the proximal outer edge of the cavity of (i).

The invention also relates to the use of a packaged article (1) as claimed in claim 1 for containing a single dosage form, e.g. a film, a wafer or a patch, especially a TTS patch, containing the active ingredient.

Additional features and details of the invention are derived from the following description of exemplary embodiments of the invention, which are illustrated in the claims and in the schematic drawings.

Figure 1 shows a top view of a packaging article for a film containing the active ingredient.
Figure 2 shows a side view of the packaging article of Figure 1;

In Fig. 1, a packaging article 1 according to the invention is shown in a top view. The packaging article 1 is a pouch having a sealed edge made from the upper and lower packaging elements 3 and 4. A film 2 containing the active ingredient is placed in the front sealed cavity 6 between the upper and lower packaging elements 3 and 4. The cavities 6 are each formed by a surrounding sealing surface or sealing joint 5 connecting the two packaging elements 3, 4 in a non-separable manner. The cavity 6 and the sealing surface or sealing joint 5 each have a common outer edge 6a. An incision (7) is located in the upper packaging element (3) in the sealing face or sealing joint (5) and the incision (8) is located in the lower packaging element (4). The two incisions 7, 8 have the same shape. A folding line or tear line 10 crosses the incision 7.

The virtual extensions of the incisions 7, 8, like the opened edges, have an interval M3 from the closest edge of the film 2 containing the active ingredient. In a preferred embodiment, the interval M3 is 4 to 5 mm.

In another embodiment, the upper and lower package elements 3, 4 are configured to be present in one section and fold back in the vicinity of the bending edge 17. Here, the sealing joint 5 is provided with the above region.

The structure of the packaging article is shown in Fig. 2 as a sectional view taken along the line A-A in Fig. In order to show the structure more clearly, the individual parts are shown in a very enlarged and separated state. The upper package element 3 consists of one or more upper outer layers 11 and an adjacent upper metal layer 13.

Likewise, the bottom wrapper layer 4 consists of a bottom outer layer 12 and an adjacent bottom metal layer 14.

The metal layers 13,14 are preferably made of aluminum foil having a thickness of 9 to 25 [mu] m. The foil ensures that the inserted product does not come into contact with the atmosphere and is not exposed to moisture at all.

The upper or lower packaging element (3, 4) each have a sealable layer or sealable layer (9) in at least part of the area of the seal surface or seal joint (5). However, the sealing layer 9 may be bonded to both the upper and lower packaging elements 3, 4. Each of the sealing surfaces or sealing joints 5 formed by the layer 9 can not be separated again.

1: Packaging
2: Film containing active ingredient
3: Upper packing element
4: Lower package element
5: sealing surface or sealing joint
6: Co
6a: the outer edge of the cavity 6
7: incision
8: incision
9: sealing layer
10: Folded or broken line
11: upper outer layer
12: Lower outer layer
13: upper metal layer
14: lower metal layer
15: the end of the incision 7
16: the end of the cutout 8
17: Bending edge
M1: Interval 1
M2: Interval 2
M3: Interval 3

Claims (10)

The upper package element 3 connected to each other by a surrounding sealing surface or sealing seam 5 in such a way that a front sealed cavity 6 for receiving the film or patch 2 is formed, 1. A packaged article (1) for a single dosage form or patch (2) containing an active ingredient, the article comprising:
(i) the upper and lower packaging elements 3 and 4 in the sealing face or sealing joint 5 region, respectively, have in each case one or more identical cut-outs 7, 8,
(ii) a fold line or kink line (10) traversing one or more incisions (7, 8)
(iii) cutouts 8 of the same type in the cutouts 7 and the lower package element 4 in the upper package element 3 are arranged such that each end 15, 16 of the cutouts 7, (M1) from the cavity (6) at least corresponding to the width (M2) of the sealing joint (5)
Packaging article (1). The method according to claim 1,
Characterized in that the cut-out portion (7) and the cut-out portion (8) are oriented perpendicular to the proximal outer edge (6a) of the cavity (6). The method according to claim 1,
Characterized in that the upper and lower packaging element (3) and the lower packaging element (4) are arranged to be in one part and form a bending edge (17). The method according to claim 1,
Characterized in that the upper outer layer (11) and / or the lower outer layer (12) are configured to be printable. 5. The method according to any one of claims 1 to 4,
Characterized in that the sealing surface (5) or the sealing surface (5) is not releasable, respectively. 6. The method according to any one of claims 1 to 5,
Characterized in that each packaging element (3, 4) has an outer layer (11, 12) and a metal layer (13, 14) and at least one of the two packaging elements (1). ≪ / RTI > The method according to claim 6,
Characterized in that the sealing layer is selected from hot-melt adhesives, enamels, sealing dispersants or adhesives. (3) and a lower package element (3) connected to each other by a surrounding sealing surface or sealing joint (5) in such a way that (i) a front sealed cavity (6) 4), wherein one or more cuts (7, 8) of the same type in each case are formed on the upper and lower packaging elements (3, 4) in the sealing face or sealing joint region, respectively In which, step; And
(ii) applying a fold line or tangent line (10) across said at least one incision (7, 8)
, ≪ / RTI &
The cutouts 8 of the same type in the cutouts 7 and the lower package element 4 in the upper package element 3 are such that the ends 15,16 of the cutouts have at least a width M2, < / RTI >
A process for producing a packaged article (1) for a single dosage form or patch containing an active ingredient. 9. The method of claim 8,
(Iv) orienting one or more cuts (7, 8) perpendicular to the proximal outer edge (6a) of the cavity (6) (1). The use of the packaged article (1) according to claim 1 for accommodating a single dosage form containing the active ingredient, e.g. a film, a wafer or a patch, in particular a transdermal therapeutic system (TSS) patch.

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