AU734467B2

AU734467B2 - Child-proof peelable bag with sealable edges, method for producing same, and use

Info

Publication number: AU734467B2
Application number: AU63960/98A
Authority: AU
Inventors: Frank Becher; Frank Muller
Original assignee: LTS Lohmann Therapie Systeme AG
Current assignee: LTS Lohmann Therapie Systeme AG
Priority date: 1997-02-21
Filing date: 1998-02-09
Publication date: 2001-06-14
Anticipated expiration: 2018-02-09
Also published as: CA2281593A1; DE19706825A1; EP0961737A1; KR20000071122A; AU6396098A; JP2002503187A; NO994043D0; WO1998036989A1; NO994043L

Description

EDITORIAL NOTE NO. 63960/98 This specification does not contain a page numbered 1.

-2- The invention relates to a peelable side-sealed bag of child-proof design, comprising at least two packaging material web sections sealed flat against each other by a sealing edge and having a gripping aid arranged outside the sealing edge, together with a method for its production and its use.

It is known that, in order to comply with the important "child-proof" property, for example in a bag-type packaging, it is necessary to use at least one but customarily two packaging material webs of high tear-strength to produce the packaging. These must also have an appropriate barrier property relative to the packaged contents. In addition, in order to achieve the necessary barrier function, the sealing edge of the packaging bag must be formed by a strong and tightly sealed weld seam extending uninterrupted around the bag. In such cases, in order to achieve a peel property at tight weld seams, sealants or combinations of sealants specifically adapted to this such as PE-peel, peel coatings, etc. are to be used.

Forms of packaging with a child-proof seal, such as blister strips, blister cards and blister tapes which are suitable for solid medicinal products and can be opened without a tool are also known. The content of these forms of packaging, comprising of products such as tablets, pills or capsules, must be insensitive to pressure, since pressure has to be applied through a covering, usually consisting of aluminium foil, to press them out of the package and remove them.

It is known in professional circles that a number of States are currently considering the introduction of binding legislation mandatorily prescribing childproof packagings for a number of active substances. This applies especiallyto medicinal products which, as a result of the toxic effect of their formulation 25 represent a serious risk if incorrectly taken, and especially in the case of children.

In the case of medicinal products which, because of their structure and use, are flexible and pressure-sensitive, it is impossible to press them through the packaging as described above. On the other hand, it is regarded by the majority of patients as disadvantageous and inconvenient if the opening of a child-proof bag-type packaging requires the assistance of a tool such as, for example, scissors or a knife.

The present invention seeks to provide a packaging for flat, flexible and pressure-sensitive medicinal products which can be opened without a tool but is 13/12/00,gc10781.spe,2 -3also child-proof, during opening of which the exertion of pressure has to be reliably avoided but which requires no auxiliary tools in order to open it.

In accordance with the present invention there is provided a peelable sidesealed bag of child-proof design, including at least two packaging material web sections sealed flat against each other by a sealing edge and having a gripping aid projecting outwards from said sealing edge, wherein the relative flexural rigidity of the packaging material web sections are made to exhibit comparatively distinct differences, and wherein said gripping aid in a first packaging material web section designed with greater flexural rigidity has a line of weakness, extending in the region of said sealing edge, at which said gripping aid is adapted to be bent, thus exposing a gripping tab at the or each other packaging material section designed with lower flexural rigidity.

As a result of the fact that the relative flexural rigidity of the packaging material web sections is designed with a comparatively significant difference, and that in addition the gripping aid of the packaging material web section designed with higher flexural rigidity possesses a line of weakness extending in the region of the sealing edge, it is possible, by selectively bending along the line of weakness, to break open the contents of the two packaging material webs and thus expose a gripping tab for further peeling along the sealed edges.

20 Because the gripping aid does not yield when subjected to tensile stress but only becomes accessible by the trick involving bending for subsequent peeling, security against opening during play is provided, at least for children's hands and without knowledge of the necessary bending function.

One preferred embodiment envisages that a region of the gripping aid close 25 to the sealing edge is free of sealant or unsealed. As a result, in the course of bending a starting point or gripping tab for further peeling along the sealing edges becomes more readily accessible.

It is also preferable that a punched through clearance is provided in the section of the packaging material web of lower flexural rigidity, maintaining a constant distance from the outer contour of the gripping aid and forming a gripping tab, with or without retaining points, depending on the material combination.

The effect of these retention points is that, if the gripping region is bent in the course of play, the peeling tab provided for opening still reliably adheres to the I)S respective other web of packaging material. Only by direct, deliberate bending 13/12/00,gc10781.spe,3 -4over of the tab about the line of weakness in the web of higher flexural rigidity are the retention points in the more flexible web overstretched and broken open. As a result, a gripping tab is formed or exposed.

The retention points may take the form of interruptions in the punched line or, for example, comparatively small sealed areas adjacent to the punched line.

The number, type and size of these retention points are to be selected for each specific material and as a function of the size and geometry of the gripping tab.

The measure serves both to increase child-proof security and to facilitate further handling in the peeling of the side-sealed bag. As a result, in contrast to known child-proof but in many cases unpeelable side-sealed bags according to the prior art, opening without tools or other aids becomes possible, while the desired property of child-proof security is achieved by a special design of the gripping aid, by means of a line of weakness in the packaging web section of higher flexural rigidity and the punching-out of a gripping tab in the packaging material web section of lower flexural rigidity, in accordance with the teaching of the invention.

In accordance with a further aspect of the present invention there is provided a method for the production of a side-sealed bag of the type referred to t earlier, in which a packed material is inserted between halves of a packaging S• having sealing edges and a gripping aid and said halves are welded together, 20 wherein one of said halves is selected from material of comparatively low flexural rigidity and the other half from a material of, comparatively, significantly greater flexural rigidity, or vice versa, and wherein whichever is the material half of greater S flexural rigidity is designed with a line of weakness in the starting region of said gripping aid.

25 In this method, a punched portion is made in the packaging material web too: section designed with lower flexural rigidity, following the outer contour of the gripping aid at a distance, to form a gripping tab.

The peelable side-sealed bag of child-proof design can be used according to the invention for flat, pressure-sensitive forms of medicinal products and especially for transdermal therapeutic systems.

Details, features and advantages of the invention are apparent from the explanation which follows of an example of the embodiment shown diagrammatically in the drawings, in which: 1FIG. 1 shows a circular packaging according to the invention in a plan view; 13/12/00,gc10781.spe,4 FIG. 2 shows a rectangular packaging with the arrangement of a gripping aid in a corner region, again in plan view; FIG. 3 shows a similarly rectangular packaging with a marginal gripping aid; FIG. 4 shows a detailed view with a gripping aid (and in the region of the latter, a punched-out portion for a gripping tab with interruptions in the punch line according to FIG. and FIG. 5 shows examples of retention points for the connection of top and bottom webs, with defined release, in the region of a gripping tab in the form of mini-sealing points.

FIG. 1 shows an example of embodiment of a circular packaging in the form of a side-sealed bag 10 of child-proof design and with particular suitability for the packaging of a circular -ITS (not shown) or another flat form of medicinal product, comprising at least two packaging material web sections 1,2 sealed flat against one another by a sealing edge 3 and a gripping aid 4 projecting outwards from the sealing edge 3 and partially sealed as indicated by the hatching.

It is important here that the relative flexural rigidities of the packaging material web parts 1,2 are designed with comparatively significant differences, and S.that the gripping aid 4 of the packaging material web part 1 designed with greater

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o flexural rigidity has a line of weakness 5 extending in the region of the sealing 20 edge. The line of weakness is characterised by a straight dotted line.

It extends approximately tangentially in the region of the sealing edge 3 and so. is prepared in a known manner, for example by perforation, punched notches, scoring, thermal embrittlement, etc., to form a defined intended breaking point. It is relevant to functioning that one packaging material web section is rigid and the 25 second relatively flexible. The relatively more flexible packaging material web to: section 2 or its retention points 9, 9a to 9c (FIGS. 3 and 5) are overstretched by

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the bending of the relatively more rigid packaging material web section 1 and are thereby separated and the peel tab 8 thus exposed. Which of the two web sections is rigid and which is less rigid is fundamentally unimportant for functional purposes. In the example shown, the lower web 1 has been made the rigid web and the upper web 2 has been made the flexible web, for reasons of better handling and on the basis of experience. In this arrangement, in order to open the bag, the gripping aid 4 is folded over downwards, the upper packaging material web section 2 being stretched parallel to the line of weakness 5. As a result of this 13/12/00,gc10781.spe,5 -6stretching, the retention points 9, 9a to 9c break open, after which the upper web section 2 can be pulled off without problems by peeling, using the gripping aid 8 which is now exposed, if appropriate after the gripping aid 4 has again been folded over upwards, when the lower web section 1 reliably breaks open along the line of weakness The two webs are selected, as far as material is concerned, so that they possess a sealing function or resistance to passage of contents of the bag which is appropriate to the product, which must also apply to the sealant and the completely tightly closed sealing seam of the sealing edges 3.

FIG. 1 also shows that a region 6 of the gripping aid 4 close to the sealing edge 3 is free of sealant.

This sealant-free region 6 is bordered on the outside by a punched-out portion 7, in the present case in a design resembling a bell curve, whereby a gripping tab 8, initially still secured by retention points 9, 9a to 9c (FIGS. 3 and 15 is formed in the upper, more flexible packaging material web 2.

.ool After the gripping aid 4 has been folded up and back to overstretch and

S.

break the retention points 9, 9a to 9c, the gripping tab 8 is exposed and can then S be used for the further peeling of the peelable side-sealed bag 10, the gripping tab 8 being formed in the upper, flexible packaging material web 2. With the aid of

S

this, after the gripping aid 4 has been folded up and back, the gripping tab 8 can very easily be bent up and can then be used for the further peeling of the peelable side-sealed bag Sview, In an especially preferred embodiment, which is not apparent from the plan view, at least one of the packaging material web parts 1,2 is three-dimensionally 25 stamped out or deep drawn in the form of a cavity.

As a precondition for security against undesired access by children, further o provision is made for the packaging material webs 1,2 to possess, in conjunction with one another, a tear strength selected sufficiently high to prevent access by children.

Provision is also made for sealant to be applied to at least one of the two sealing edges 3.

Because full details of sealants and sealing methods of the prior art are known to the person skilled in the art, no additional details thereof are given at this 0 point but qualified sealing in the region of the sealing edges 3 is assumed.

13/12/00,gc10781.spe,6 -7- In this arrangement, at least one of the two packaging material web sections 1,2 may be a monofilm.

According to the example of embodiment shown in FIG. 1, the packaging may be provided for a circular patch, for example a TTS.

Apart from the circular shape of the side-sealed bag 10, any desired shapes are of course possible and may also be necessary depending on the shape of the packaged material.

For example, FIGS. 2 and 3 show rectangular formats, but these may also be polygonal or oval. Using the embodiment of a rectangular side-sealed bag as a model, FIG. 2 shows a gripping aid 4 arranged cornerwise with an obliquely extending line of weakness 5 in the underlying packaging material web section 1, designed with higher flexural rigidity. The sealed-on packaging material web section 2 has a punched-out section 7 extending approximately at right-angles (FIG. 3) forming a gripping tab 8. In the example of embodiment according to FIG. 3, the gripping aid 4, the course of the line of weakness 5 and the punchedout section 7 and the gripping tab 8 resulting therefrom are provided on a narrow 0.

0 side of the rectangular packaging. coco 0 0 o S In order to prevent possible premature exposure of the gripping tab 8 and S, hence unintentional, premature peeling of the packaging material web section 2, o.o 20 interruptions 9 in the cut line may be provided in the course of the punched-out section 7, as shown at a plurality of points in FIG. 3. The positioning, size and arrangement of such interruptions 9 may vary according to the specific material. It can always be defined individually for the respective material combination of the packaging materials 1 and 2 in conjunction with the existing packaging dimensions 25 or their geometry and is relevant to the function of tearing open.

ot To produce retention points 9, 9a to 9c, apart from the examples of

S

embodiment shown in FIG. 3 in the form of interruptions of the cut, alternative embodiments in the form of mini-sealing points in sealed regions within the unsealed surface 6 are possible, as shown in FIG. 5. Such a mini-sealed retention point is shown there at 9a; an embodiment in which a corner is also sealed is shown at 9b; 9c, however, represents a mini-retention point which has been formed by a "nose" in the sealed seam.

For understanding of the function of the peeling of the relatively more elastic S packaging material web section 2, attention is drawn to the fact that the punched- 13/12/00,gc10781.spe,7 -8out section 7 preferably extends close to one marginal sealed seam 3 and the gripping tab 8 defined thereby is not sealed to the underlying region 6 of the packaging material web section 1 but secured only by retention points 9 (FIG. 3).

A further alternative embodiment comprises, as shown in FIG. 4, giving a punched-out portion 7 to the relatively more rigid web 1 so that a gripping tab 8 is formed in this web 1 which, by upward bending and subsequent peeling of the upper web 2 adhering thereto, permits problem-free opening of the packaging For greater ease of comprehension, it is pointed out that the co-ordination of the two packaging material web sections 1,2 is within the discretion of the person skilled in the art.

The following alternatives are conceivable: Lower web rigid/flat Upper web flexible/flat; Lower web rigid/deep drawn Upper web flexible/flat; too.

Lower web rigid/deep drawn :00: 20 Upper web flexible/deep drawn; SoLower web flexible/flat Upper web rigid/flat; S 25 Lower web flexible/flat Upper web rigid/deep drawn; Lower web flexible/deep drawn Upper web rigid/deep drawn.

A method for the production of a peelable side-sealed bag of child-proof design according to the invention, in which a packed material is inserted between halves 1,2 of a packaging 10 having sealing edges 9 and a gripping aid 4 and the v halves 1,2 are welded together, provides in accordance with the invention that one 13/12/00, gc 10781 spe,8 -9of the halves 1 is selected from material of comparatively low flexural rigidity and the other half 2 from a material of, comparatively, significantly greater flexural rigidity, or vice versa, and that whichever is the material half of greater flexural rigidity is designed with a line of weakness 5 in the starting region of the gripping aid 4.

According to the invention, use of the peelable side-sealed bag for flat, pressure-sensitive forms of medicinal products and in particular for transdermal therapeutic systems is envisaged.

Where the terms "comprise", "comprises", "comprised" or "comprising" are used in this specification, they are to be interpreted as specifying the presence of the stated features, integers, steps or components referred to, but not to preclude the presence or addition of one or more other feature, integer, step, component or group thereof.

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Claims

1. A peelable side-sealed bag of child-proof design, including at least two packaging material web sections sealed flat against each other by a sealing edge and having a gripping aid projecting outwards from said sealing edge, wherein the relative flexural rigidity of the packaging material web sections are made to exhibit comparatively distinct differences, and wherein said gripping aid in a first packaging material web section designed with greater flexural rigidity has a line of weakness, extending in the region of said sealing edge, at which said gripping aid is adapted to be bent, thus exposing a gripping tab at the or each other packaging material section designed with lower flexural rigidity.

2. The sealed bag according to Claim 1, wherein a region of said gripping aid close to said sealing edge is free of sealant and is not sealed to the web opposite and adjacent to it.

3. The bag according to Claim 1 or Claim 2, wherein a punched portion 15 is provided in said packaging material web section designed with lower flexural oooorigidity and following the outer contour of said gripping aid at a distance to form a gripping tab.

4. The bag according to any one of Claims 1 to 3, wherein at least one of said packaging material web sections is three dimensionally stamped out or 20 deep drawn in the form of a cavity. o o

5. The bag according to any one of Claims 1 to 4, wherein the material of the at least two packaging material web sections of different flexural rigidity possesses a sealing function or resistance to the passage of contents of the bag which is appropriate to the product. S 25 6. The bag according to any one of Claims 1 to 5, wherein the packaging material web sections possess, in conjunction with one another, a tear strength selected sufficiently high to prevent access by children.

7. The bag according to any one of Claims 1 to 6, wherein sealant is applied to at least one of said two sealing edges.

8. The bag according to any one of Claims 1 to 7, wherein at least one of the at least two packaging material web sections is a monofilm.

9. The bag according to any one of Claims 1 to 8, wherein a region of said gripping aid close to said sealing edge is free of sealant. 13/12/00,gc10781.spe,10 -11 A method for the production of a side-sealed bag according to any one of the preceding Claims, in which a packed material is inserted between halves of a packaging having sealing edges and a gripping aid and said halves are welded together, wherein one of said halves is selected from material of comparatively low flexural rigidity and the other half from a material of, comparatively, significantly greater flexural rigidity, or vice versa, and wherein whichever is the material half of greater flexural rigidity is designed with a line of weakness in the starting region of said gripping aid.

11. The method according to Claim 10, wherein a punched portion, preferably with retaining points, is made in said packaging material web section designed with lower flexural rigidity, following the outer contour of said gripping aid at a distance, to form a gripping tab.

12. Use of a peelable side-sealed bag of child-proof design as claimed in any one of Claims 1 to 9, for flat, pressure sensitive medicinal product forms and 15 especially for transdermal therapeutic systems (TTS).

13. A peelable, side-sealed bag of child-proof design, substantially as described herein with reference to the accompanying drawings.

14. A method according to Claim 10, substantially as described herein with reference to the accompanying drawings. Dated this 14th day of December, 2000. *.*oo SLTS LOHMANN THERAPIE-SYSTEME GMBH By their Patent Attorneys: CALLINAN LAWRIE ter aet tores 13/12/00,gc10781.spe, 11