EP2655212A1

EP2655212A1 - Childproof highly-inert bag packaging for individually dosed films containing an active ingredient

Info

Publication number: EP2655212A1
Application number: EP11819089.1A
Authority: EP
Inventors: Markus Krumme; Grace A. BEHREND; Steven Dodd
Original assignee: LTS Lohmann Therapie Systeme AG
Current assignee: LTS Lohmann Therapie Systeme AG
Priority date: 2010-12-23
Filing date: 2011-12-21
Publication date: 2013-10-30
Also published as: CA2822544A1; JP6121336B2; CA2822544C; MX2013007290A; US9637293B2; RU2608068C2; TW201238861A; AR084451A1; AU2011348433B2; JP2014501585A; TWI534052B; KR20130140829A; US9370463B2; AU2011348433A1; BR112013015750A2; US20130301960A1; US20160297592A1; RU2013134156A; MX341099B; WO2012084217A1

Abstract

The invention relates to a childproof packaging for individual doses (1), in particular for preparations for administration in film form, wherein the packaging constitutes a bag produced by sealing, which has at least on each side a covering layer which is provided at least on one side with local weak points (4) which do not touch the edge of the packaging, wherein the local weak points (4) form a cohesive pattern which runs around the individual dose (1) in an arc or a curve and overlaps an angular region of at least 90° when considered from the main area of the individual dose (1).

Description

Child-safe, highly inert pouch packaging for single-cropped

Active substance-containing films

The invention relates to a child-resistant hochinerte

Pouch packaging for single-dose drug-containing films.

For general use, it is often necessary to package drugs as a single dose. The reason lies in the fact that such a single packaging ensures that a defined dose is taken at the desired time instead of one

unintended multiple dosing.

Furthermore, thereby a protection of the drug is achieved from environmental influences. In multi-dose containers, the lifetime of the entire contents is often affected by the repeated opening for single dose withdrawal. This impairment is the stronger, the greater the mechanical and chemical sensitivity of the drug form.

Furthermore, an often-met requirement in terms of drug safety is the protection of uninvolved population groups, especially children

unintentional medication. In this context, natural curiosity is added to children, as these packages are often understood as an invitation to open, and thus alone could be exposed by the hands of children's hands because of the challenge of opening dangerous substances.

CONFIRMATION COPY On the other hand, the easy opening of the packaging is important to the intended target group, mostly older people. This problem is well described by the keyword "child resistant, senior friendly".

Film-shaped dosage forms make a special

Challenge, since the films in terms of chemical (moisture, oxygen) and mechanical loads

are sensitive. Since such film-shaped dosage forms usually have a large area to be suitable for a pharmaceutical, typically oral, application, and a packaging must always enclose all the surfaces of its contents, it is necessary to provide a package for film-shaped

Pharmaceutical forms to make comparably large.

In order to achieve the required protective effects, the use of so-called high-barrier films is often necessary, as they are commercially available, for example in the form of the film Sudafed PE from Pfizer. These have the disadvantage that they are expensive, especially because area related for a packaging at least twice as much packaging material as the product to be packaged must be used to one

To fully comprehend the subject. Thus, an unfavorable ratio of packaging costs to product costs can hardly be avoided, which has a negative effect on the price of the final product.

Up to now, childproof film packaging for pharmaceutical, oral applicable films, which offer the required chemical protection, based on the use of a peelable, heat-sealed bag of two films, each containing a thin aluminum layer, are known. Such film packages sometimes contain a side cuts. This will have the pack in the middle of the

Cut below 90 ° in order to get a crack notch in the side of the pack. Thus, a crack can be brought into the pack, which is an opening aid for

Grasping exposes, which then allows the pulling apart of the two parts of the film.

This packaging principle has the disadvantage that it is very expensive because the time to produce such

Packaging is comparatively long and a relatively high material usage is required.

In addition, there are other technical solutions on the basis of peelable films, paired and unpaired, which describe the optimization of the use of material by optimal utilization of the film surface in the range of grip tabs, as e.g. in WO 2010/025899 AI is described.

All the solutions described have in common that they are based on peelable films, that is, the product

Touching part of the film structure must be peelable. These are usually always polyethylene-based peel layers or similar compositions that have a relatively weak seal seam strength to achieve peelability.

These films have the disadvantage that they are often not inert to drug migration, with the result that the active ingredients migrate in the course of storage in the package and thus are removed from the dosage form. In addition, the strength of the sealed seam is usually reduced by the fact that the sealed polymers are weakened by the incorporation of other components that are not weldable. Such adjuvants require as Side effect reduced sealing seam impermeability for gases such as water vapor and oxygen, which can lead to problems during storage due to the reduced storage stability of the packaging to water absorption of hygroscopic products, as well as to increased degradation of

Oxygen-sensitive products.

WO 2010/091813 A1 describes a pouch packaging for film-shaped dosage forms, which achieves a tearability of the pouch by means of a weakening line. The combination of kinking and tearing at the weakening line allows one side of the package to be opened per line of weakness and thus access to the product from that side of the weave

Bag.

In order to expose two or three sides of the product, two or three pairs of motion of kinking and tearing along the lines of weakness must be performed. This can be particularly bothersome in case of a special need for medication, for example, in pain, "craving" or in special emergencies, or by not obtaining a necessary medication to

damage to health or, in extreme cases, death. Object of the present invention is the above

overcome these disadvantages and a child-safe single-dose packaging based on sealed films for

Provide a single-motion opening

allowed to expose the three sides of the product in one movement.

Preferred embodiments have the additional advantage of having a minimum film consumption per dose, are inert to drug migration, and seal seams which do not have to fulfill maximum seal strength.

The object is achieved by a package according to claim 1, wherein a single dose is housed in a pouch produced by sealing, which has at least on each side an outer cover layer, in particular with a minimum tensile strength of 30 N, the at least one side, preferably both sides with local weakenings that are not the edge of the packaging

touch. The local weakenings form one

contiguous pattern running around the single dose in an arc or curved path that is at the center of the bend or curved path. The local weakenings encompass an angle range of at least 90 ° from the point of view of the single dose,

preferably at least 120 °, more preferably at least 180 °, wherein the local weakenings preferably as

Weakening lines are executed.

The local weakenings are in large part, but at least completely outside the beginning and end areas, in an unsealed area, which also includes the single dose.

At the edge of the packaging is preferably completely enclosed by a continuous sealing seam.

The arc which the local weakenings describe can have different bending radii, but preferably has no corners or bending radii smaller than 1 mm, particularly preferably no bending radii smaller than 1 cm. In this way, an opening of the package is through

Tearing open to the local weakenings favorably influenced by a single movement. In a preferred embodiment, the local

Weakenings designed so that they total or at least apart from their beginning and end areas not more than 5 cm, preferably at most 2 cm, more preferably at most 1 cm, run away from the outer contour of the single dose.

In a further preferred embodiment, the local weakenings run at least partially so that a portion of the single dose is exposed along the weakenings after the packaging has been torn open.

In a preferred embodiment, both sides contain local weakenings to the outer layer, with the areas of weakening preferably on both sides

are congruent.

Preferably, the line of weakness has a shape which allows twice a crack deflection through an angle of at least 45 degrees, more preferably at least 75 degrees, thereby allowing the product to be exposed in the bag package on three sides.

In a preferred embodiment, the weakening is not formed by a cut that covers the whole

Cover layer or both cover layers severed, but by a selective weakening of the cover layer. In a preferred embodiment, crack initiation is enabled only after the bag has been bent over at a defined line. The outer cover layer is preferably printable.

In particular, it has characters that on the

Clearly indicate a tear-open mechanism in order to avoid delays in an emergency caused by a study of

Opening mechanism could arise.

Preferably, the cover layer wears arrows which mark the local weakenings and indicate the tear direction.

In a preferred embodiment, located between the outer cover layer and the single dose on at least one side of the bag, but preferably on both sides, a metal layer, in particular a high density

Metal layer, preferably aluminum, which the

Single dose completely covered and protrudes into the surfaces of the seal.

Such an embodiment has the advantage that the

Bag surfaces are inert to drug migration,

Gas exchange and water vapor are. In a further preferred embodiment, there is between the outer cover layer and the single dose or between the metal layer and the single dose

at least one side of the bag, but preferably on both sides, an inner, in particular product-contacting, sealing layer, which is able to form solid and gas-tight sealing seams, which the outer cover layer

completely covered. Preferably, the outer cover layer, the sealing layer and optionally the metal layer are firmly joined together, in particular in the form of a laminate.

In a preferred embodiment, the sealing layer is present only in the region of the sealing seams, so that the

Cover layer or optionally the metal layer comes into direct contact with the single dose.

This embodiment has the further advantage of having seal seams that are inert to drug migration.

In a preferred embodiment, a

Rissinitiation done by a second weakening in the form of a cut, which is within the bag and can be brought by bending along a crease line across the cut also to the perimeter of the bag. This second weakening particularly preferably has the form of a "sidecut." Of course, this sidecut does not reach the edge of the packaging.

In the case of the second weakening, weakening of the two facing layers is preferably applied by lasering or other suitable ablative process in a mold which allows the tear initiated by the incision to be forced onto the intended web.

Preferably, at this second weakening there are crackers, in particular Y-shaped pieces, for trapping the crack. Preferably, the beginning and / or end portions of the local weakenings are shaped to serve as a scavenger.

Preferably, weakening by a Y-geometry around the second weakening is achieved by lasing. Because of this Y-piece of the weakening line is the capture of the crack after crack in the second weakening possible and the targeted introduction to a defined crack path. It fulfills the function of a cracker.

Another preferred embodiment has one leg of the Y on one side of the cover layer (e.g., the top) and the other leg on the opposite side (e.g., bottom), the superposition of both top and bottom sides completing the Y. This variant allows a particularly short cycle time in the production.

In a preferred embodiment, the packaging and in particular the local weakenings are designed symmetrically. Thus, the bag packaging of right and left-handers can be easily opened and provides a second opening option, should the first attempt of the opening fail. Another preferred embodiment includes a

Mechanism, especially in the form of more

Lines of weakness, which in case of failure offers a second chance to open the packaging. The special design of the weakening produced in particular by laser ablation is advantageous

Curved track, which it by suitable combination of

Curve radius and material of the top layer allows to guide the crack course after initiation so that several sides of the product are exposed in a single movement. For this purpose, a particularly preferred embodiment, as set forth in the drawings, characterized in that the line of weakness in the form of a U three sides of the product After the initiation of the crack by the sidecut and the subsequent capture and steering of the crack on the intended curved path through the Y-pieces of the

Line of weakness occurs.

It is particularly preferred that the line of weakness be congruent on both sides of the bag, with the top and bottom panels of the bag being of the same material. However, it is also covered by the invention that the weakening line is only one-sided

is appropriate. In this case, a facilitation of the function is to be achieved inter alia by suitable material selection, e.g. in that the non-weakened side is made of a material that is less tear-resistant than the locally weakened top.

A preferred method for weakening the cover layer is laser ablation. By using focused laser light of sufficient power, the outer plastic layer can be locally burned off with high precision without injuring any metal layer that may be present. This preserves the barrier effect of a metal foil.

Examples of the packaging according to the invention are in the

Illustrated illustrations and are explained below.

Figure 1 shows a sketchy preferred packaging.

FIGS. 2A and 2B illustrate various crack deflections. FIG. 3 shows a sketch of the opening of a preferred packaging.

Figure 4 shows a sketch of a cover layer, which is provided with characters to represent the opening.

Figure 5 shows top and bottom of a preferred

Embodiment. An example of a package according to the invention for a single dose (1) is shown in FIG. she is

preferably produced by heat sealing of high barrier films. These high barrier films are constructed in particular on the basis of aluminum foils with thicknesses of preferably 9-20 microns, which ensure a high degree of impermeability and inertness.

In order to produce such a bag package, the two aluminum foils are glued or welded together in the region of the sealing seams (3), this being achieved by a laminated heat-sealable plastic layer as the sealing layer, which consists of conventional materials known to the person skilled in the art, preferably from the group PVC, PVDC , PP, Barex (British Petroleum), PE, Aclar (Honeywell), Topaz Advanced Polymers (COP) and Surlyn are and preferably have a thickness of 20-100 microns.

This sealing layer is usually with the

Aluminum layer laminated together and thus by the

Bag structure automatically to the product-contacting layer. The more inert the material, the more advantageous it is for product stability.

On the outside, the packaging film is formed by the outer cover layer, which has a sufficiently high tear strength, so that a manual tearing in places where there are no local weakening zones, without aids is not possible. A preferred material for this is PET with a thickness of 10 - 100 microns, preferably 10 - 50 microns.

A particularly preferred packaging material has the structure (from the inside to the outside): Barex with a thickness of 20-40

Micrometers as a sealing layer at the single dose facing side, as metal layer aluminum with a thickness of 9-25 microns and finally as outer

Topcoat PET with a thickness of 10-100 microns, preferably 10-50 microns. The outer cover layer is optionally printable to mark the product.

Inside the package is the single dose (1) in an unsealed area (2). Where this unsealed area is located, the cover layer, or have both cover layers, weakening lines (4), which surround the single dose (4) partially in the form of an arc.

Considering the focus of the single dose, this arc covers an angular range of more than 180 °. The bow can have various crack deflections. Figures 2A and 2B show 2 possible crack deflections. The crack deflection in FIG. 2A is 85 ° and in FIG. 2B 90 °. An example of an embodiment according to FIG. 2B is one

Packaging consisting of a bag whose top is made of a composite of PET 10-100 microns, preferably 10-50 microns, aluminum 12 microns and Barex 28-50

Micrometer, and by laser with the

Is made of a laminate of 0-12 microns PET, 12 microns AI and 28 microns Barex and is not lasered. The cracking behavior is similar in principle, but it does not quite follow the curve line, but it is easier to manufacture because only one side has to be lasered.

The curve line of the weakening should be designed by suitable choice of radii so that the deflection of the crack by 90 ° takes place reliably. For bag dimensions of For example, 45-65 mm while a radius of curvature of 20 aaa has been found suitable. It may be advantageous that the crack deflection does not have to reach 90 °, but somewhat less, for example 85 ° as shown in Figure 2A. This can be achieved by making the curved line trapezoidal.

The beginning and end regions of the weakening line in the examples are in the sealed region. Without the help of

Cutting tools would not open such a bag package manually, the seal can not be opened, and the film itself can not be torn due to the stability of the outer cover layer and not.

The manual opening succeeds, as in FIG. 3

represented by targeted local weaknesses of

Cover layer within the circumference without touching the circumference of the packaging. Thus, only by buckling the packaging along a crease line (6), the local

Weakening (4) to the edge of the (folded) package, thus allowing tearing, e.g. on the sidecut (5).

As shown in Figure 4, the cover layer

Elements, here arrows, contain, which on the

Opening mechanism, the weakening, or the

Indicate opening direction.

The local weakenings may have different shapes on the top (7) and bottom (8) of the package, as shown in FIG. Thus, e.g. the weakenings (4) are designed so that the Y-shaped areas at the beginning and end of the weakening, which serve to catch the tear, only at a superposition of the two

Packaging halves result. This saves time during production.

Claims

claims

1. Childproof packaging for single doses, in particular for film-shaped dosage forms, characterized in that the packaging is a bag produced by sealing, at least on each side of a

Cover layer which is equipped at least on one side with local weakenings, which the edge of the

Do not touch the packaging, where the local weakenings form a coherent pattern that runs around the single dose in an arc or curve, one from the point of view of the single dose

Angular range of at least 90 ° covered.

2. Packaging according to claim 1, characterized in that the local weakenings extend, at least in large part, in an unsealed area, which also includes the single dose, and preferably as

Weakening lines are formed.

3. Packaging according to one of the preceding claims, characterized in that the arc, which describe the local weakenings, no corners or bending radii smaller than 1 mm, and that the crack deflection is preferably less than 90 °.

4. Packaging according to one of the preceding claims, characterized in that it additionally comprises at least one metal layer and preferably at the single dose side facing at least one sealing layer.

5. Packaging according to one of the preceding claims, characterized in that they additionally at the beginning and / or end of the local weakening a sidecut has, which does not reach to the edge of the package, and are preferably carried out in the beginning and end of the local weakening in the form of a crack trap.

6. Packaging according to one of the preceding claims, characterized in that the local weakenings are designed such that they total, or

at least apart from their starting and ending areas, not more than 5 cm from the outer contour of the single dose.

7. Packaging according to one of the preceding claims, characterized in that the local weakenings are designed symmetrically.

8. Packaging according to one of the preceding claims, characterized in that it has a mechanism

especially in the form of further weakening lines, which in case of failure offers a second chance at the first opening attempt to open the packaging.

9. Packaging according to one of the preceding claims, characterized in that the combination of

Curve radius of local weakening and material of

Top coat allows it to lead the crack course after initiation so that several sides of the product in one

Movement be exposed.

10. Packaging according to one of the preceding claims, characterized in that the weakening line in the form of a U exposes three sides of the product, after the crack initiation by the sidecut and the subsequent

Catching and turning the crack on the intended

Curved track through the Y-pieces of the weakening line is done.