EP2396241A1 - Childproof, highly inert individual packaging - Google Patents

Childproof, highly inert individual packaging

Info

Publication number
EP2396241A1
EP2396241A1 EP10702621A EP10702621A EP2396241A1 EP 2396241 A1 EP2396241 A1 EP 2396241A1 EP 10702621 A EP10702621 A EP 10702621A EP 10702621 A EP10702621 A EP 10702621A EP 2396241 A1 EP2396241 A1 EP 2396241A1
Authority
EP
European Patent Office
Prior art keywords
packaging
dose
line
layer
sealing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP10702621A
Other languages
German (de)
French (fr)
Other versions
EP2396241B1 (en
Inventor
Markus Krumme
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LTS Lohmann Therapie Systeme GmbH and Co KG
Original Assignee
LTS Lohmann Therapie Systeme GmbH and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to DE200910008217 priority Critical patent/DE102009008217A1/en
Application filed by LTS Lohmann Therapie Systeme GmbH and Co KG filed Critical LTS Lohmann Therapie Systeme GmbH and Co KG
Priority to PCT/EP2010/000638 priority patent/WO2010091813A1/en
Publication of EP2396241A1 publication Critical patent/EP2396241A1/en
Application granted granted Critical
Publication of EP2396241B1 publication Critical patent/EP2396241B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B31B41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B31MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31BMAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00Making flexible containers, e.g. envelopes or bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52Details
    • B65D75/58Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5805Opening or contents-removing devices added or incorporated during package manufacture for tearing a side strip parallel and next to the edge, e.g. by means of a line of weakness
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B31MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31BMAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B2160/00Shape of flexible containers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/4998Combined manufacture including applying or shaping of fluent material

Abstract

The present invention relates to individual dose packagings (1) for transdermal therapeutic systems or film-like forms of administration in the form of a sealing edge bag that can be peeled back with a complete surrounding and continuous sealing surface, comprising two packaging material elements, that are arranged on top of each other and form the upper side and the bottom side of a bag containing the product, wherein at least one layer of the packaging material elements is a metal layer and at least one packaging material element a film laminate with an at least three-layer design; and the outer layer of the at least three-layer film laminate has a minimum tear resistance of 30 N, wherein said outer layer comprises at least one line-shaped weakening (20, 21) that is not touching the edge of the packaging on the upper and bottom side and the line-shaped weakening has a reduced resistance to tear for opening the packaging. The invention further relates to a method for the production thereof.

Description


  Child-proof, highly inert single-pack

  
The present invention relates to highly inert single-dose packages for film-shaped or sheet-like dosage forms and transdermal therapeutic systems (TTS) that are easy to open but yet child-resistant.

  
The present invention also encompasses a method for producing the single-dose packages according to the invention, which is characterized by the economical use of materials.

  
Pharmaceutical packaging has several tasks to accomplish. On the one hand to be ensured by a package as a single dose, for example, that only one dose is taken at a time and a multiple dose is avoided.

  
On the other hand, the drug should also be protected by the packaging from environmental influences such as light and moisture, which often lead to the breakdown of active ingredient and thus the uselessness of the drug. Especially in the case of containers containing several dosage units, the problem arises here that the repeated opening of the container for taking a single dose, the quality of the drug preparation is adversely affected, this impairment is the stronger, the more sensitive the dosage form against mechanical and physical-chemical stress is. In particular, film-shaped dosage forms make special demands on the packaging, since the films are subject to physicochemical influences

  
(e.g., light, moisture, oxygen) are sensitive due to their large surface area and mechanical stresses due to their structure.

  
In addition, the packaging should prevent the medicines from being released to children for accidental ingestion or self-medication.

  
A particular problem with the design of such safe drug packages is that, on the one hand, the package provides maximum security against accidental packaging

  
Self-medication, especially of children to give, driven by curiosity open the packaging and mix the often colored and flavored to cover the bad taste and / or smell of the drugs drugs with sweets or other sweets or take the TTS contained in the game.

  
On the other hand, the opening of the packaging should be so simple that adults and among these, especially the elderly and those with motor impairment, can open these packages without any problems and good compliance with the intake of the drugs is guaranteed.

  
As is clear from the nature of the thing described above

  
Problems arise, a solution of these problems seems to exclude, as children often tackle the task of opening the packaging with great perseverance, ingenuity and intuition, while adult users often omit the required study of manual or explanatory pictograms and unnecessarily to knife and scissors to open grab the packaging, or at worst the medication because of the difficulty in opening the package suspend when these tools are once inaccessible, so that the compliance of the patient drops.

  
Another problem with single-dose packaging for film-shaped or sheet-like dosage forms and transdermal therapeutic systems is that the area of the single dose in relation to the active ingredient content compared to other dosage forms such as tablets or suppositories is quite large and can not be reduced by kinking and wrinkles.

  
The size of the film thus determines the size of the packaging. Furthermore, due to the already discussed sensitivity of the films, the use of expensive high barrier films (high barrier films), which are mechanically strong and possibly allow low permeation of gases and moisture, indexed to ensure the necessary protection of the dosage form.

  
Thus, there is the disadvantage that both the upper and the bottom of the large-area dosage form must be covered with a film, which is associated with a high cost of materials and leads to high packaging costs due to the expensive films, which significantly increase the cost of the single dose and extremely unfavorable ratio of packaging costs to product costs. It should be mentioned that, in particular child-resistant packaging often require additional material costs in the design of the fuse. The following proposals for easy-to-open but child-resistant packaging are known from the prior art.

  
Published patent application DE 10 2004 047 445 A1 discloses a non-resealable package for hazardous products which has two superimposed packaging material elements, a first surface section, at the edge or edges of which the two packaging material elements are detachably connected to one another, wherein at least one on all sides between the two packaging material elements enclosed cavity for receiving the packaged product is formed, and has a second, lying outside the first surface portion or adjacent to this surface portion at the edge or edges of the two packaging material elements are releasably connected together. At least one of the two packaging material elements is provided with at least one structure that extends within the second surface portion and that allows the tearing of the / the packaging material elements.

  
Publication US 2006/0023976 A1 describes retractable pouches for one or more doses of a drug in which two packaging material webs are marginally sealed to one another and which are provided in the region of the sealing edge with a tear-off surface structure which is formed by a fold line is crossed. The edge of the bag must be folded along the fold line so that it can be torn and opened at the surface structure.

   In the published patent application DE 10 2006 041 921 A1, a child-resistant packaging for active substance-containing films is described, which comprises a carrier layer and a covering layer releasably connected thereto and in a pairwise arrangement has two opposite area areas separated by a web, within which the covering layer does not is connected to the carrier layer, whereby two separate, mutually enclosed spaces for pairwise recording of said films are formed. Within this web, there is another surface area in which the carrier layer is not connected to the cover layer, whereby a cavity enclosed on all sides is formed. There is at least one perforation line inside the bridge.

   The disadvantage of this approach is that child-resistant packaging is only given when packaging paired films (film-shaped dosage forms). The separation of the parental control to expose a dosage form leaves the other dosage form still chemically packed tight, but the parental control is no longer given. In this respect, the use of a package according to DE 10 2006 041 921 A1 is only indicated if the interval between taking the first single dose and taking the second single dose is not too great.

  
In the DE 10 2004 047 445 Al, US 2006/0023976 Al and

  
The object of providing a child-resistant packaging which at the same time offers protection of the packaged item from chemical damage is solved by the use of a windable, heat-sealed bag made of two films each containing a thin aluminum layer. The film packaging has a side cut, but does not cut the bag itself. As a result, the bags in the middle of the cut must be folded beyond an angle of 90 ° to create a tear notch in the side of the bag edge. Thus, an opening aid is exposed to touch, with the help of the two films of the bag can be deducted from each other.

  
The solutions described above have in common that they are based on peelable films, i. the product-contacting laminate layer of the film structure must be peelable and can be detached from the overlying layers relatively easily. These layers are practically always polyethylene-based peel layers or similar compositions which have a relatively weak seal seam strength (hence peelable). In addition, these films have the disadvantage that they are often not inert to drug migration, with the result that the active ingredients in the course of storage time migrate into the packaging and thus the dosage form are removed. According to the application, the seal seam strength is usually weakened by the fact that the sealed polymers are weakened by incorporation of other excipients which are not weldable.

   As a side effect, these auxiliaries also result in reduced seal seam impermeability to gases such as water vapor and oxygen, which impairs the storage stability of the packaging and can lead to problems due to water absorption of hygroscopic products, as well as to increased degradation of oxygen-sensitive products.

  
Furthermore, the material consumption for the production of the packaging is further increased by the fact that there must be openings for opening the packaging not sealed sections, which serve as an aid to "peel", wherein the minimum size of the Anfasshilfen is limited by anatomical conditions.

  
The packaging of film or film-shaped drug / dosage forms thus presents a particular challenge since films and films are sensitive to physicochemical (e.g., light, moisture, oxygen) and mechanical stresses. Even if the packaging of individual film or film-shaped dosage forms meets the requirements for the protection of individually packaged product, but it has the disadvantage that it is very expensive in practice, because it requires a high material usage and the corresponding packaging are produced only comparatively slowly can.

  
The object of the present invention is to provide a child-safe single-dose packaging for film or film-like Darreichungsformen and transdermal therapeutic systems (TTS) based on sealed films, ensures the minimum film consumption per single dose, is inert to the packaged, is easy to open and yet a maximum Has tightness of the sealed seam. It is a further object of the present invention to provide a method for producing single-dose packages according to the present invention.

  
The object is achieved by a single-dose packaging according to claim 1 of the present invention and a corresponding method for producing the sealed single doses according to claim 22.

  
The single-dose packaging of the present invention is a tearable end-bag having a completely circumferential and continuous, not interrupted, non-peelable sealing surface, wherein the top and bottom of the sealed-edge bag are formed by two packaging material elements which are arranged one above the other and form a receptacle for the packaged goods.

  
Since the requirement of the peelability of the sealing seams according to the present invention is no longer present, highly inert sealing materials can be used, which in turn has a favorable effect on the durability of the packaged goods.

  
The sealing surface preferably forms the outer boundaries of the packaging, so that there is no possibility of grasping for a possible opening of the bag by "peeling", i. the opening of the bag by loosening the sealing seams from each other or from the adjacent laminate layers, is given. In this way, the opening of the bag is prevented by a weakened sealing seam, which is not peelable actually. At least one layer of the packaging material elements is a metal layer in order to ensure the required high tightness of the single-dose packaging.

  
Furthermore, at least one packaging material element is a film laminate having an at least three-layered construction, the outermost, i. the product facing away layer has a minimum tensile strength of 30 N, so that opening the package by a simple tearing without tools is not possible.

  
Due to the high tensile strength of this first, at least three-ply packaging material layer can be used as a second packaging material element a cheaper film laminate with a lower tensile strength to save costs.

  
In a preferred embodiment, however, the first and second packaging material element have an identical structure.

  
In order to prevent the opening of the packaging, which can not be opened manually due to the tear-resistant outer layer of the laminate and the non-peelable sealing seams, without additional aids, the outermost layer of the at least three-layered film laminate, which is the cause of the tensile strength of the multilayer laminate, has one line-shaped weakening (weakening line) with a reduced tensile strength, wherein when using identical, tear-resistant packaging material directly superimposed lines of weakness are applied on both sides of the single-dose packaging.

  
The weakening line is preferably produced in that the outer layer of the film laminate facing away from the packaged material is removed or significantly reduced in thickness, so that the tensile strength is reduced.

  
In one embodiment, this reduction or removal of the outermost, tear-resistant layer of the film laminates is by laser ablation or laser scoring (scoring by laser), which step can be easily included in the production process. However, other methods such as targeted mechanical removal or chemical etching or detachment of the outer layer to illustrate the line of weakness are conceivable.

  
An alternative embodiment provides that the line of weakness is a broken line, that is to say that the tear-resistant layer has not been removed continuously, but small webs of tear-resistant material remain, which do not hinder scribing and tearing.

  
The advantage of this type of attachment of the line of weakness only in the outermost layer of the laminate is that the highly gas-tight metal layer is not damaged and thus maximum protection of the packaged goods from moisture and oxygen is made possible.

  
In preferred embodiments, since the beginning of the line of weakness does not touch the circumference of the package, the package must first be kinked to expose the beginning of the line of weakness along which the package can be torn open and which dictates the course of the tear.

  
While this two-step operation is readily accomplished by an adult, it is not obvious to children, especially since only the uppermost layer of the film laminate is weakened, but not, as known in the art, the entire film through a well discerning incision, which would also arouse the interest of a child.

  
A particularly preferred embodiment therefore envisages removing the outermost, tear-resistant layer only at the level of the marked bend region which extends orthogonally to the weakening line and merely reducing the layer thickness in the remainder of the weakening line such that further tearing but no initial tearing takes place more is possible.

  
In a further embodiment, the tensile strength of the packaging material element is so high that tearing further only in the region of the weakening line is possible. In this way, a crack propagation into areas of the package in which the mechanically sensitive product is prevented.

  
In a preferred embodiment, the line of weakness extends through both the sealing surface and the unsealed product receiving area, preferably with the line of weakness parallel to the edge of the package and the line of weakness through the unsealed product receiving area at a distance of less than 5mm, preferably less than 3mm , more preferably less than 2 mm, and most preferably less than 1 mm, extends to the sealing surface.

  
Furthermore, it is preferred that the line of weakness extends over at least 50% of the length of the side of the package on which it is disposed, more preferably over at least 65%, more preferably over at least 80%, and most preferably over at least 90% a maximum extent is limited to 95%, since the line of weakness does not affect the edge of the packaging according to the invention.

  
A further embodiment provides that the packaging has two line-shaped weakenings, which preferably extend at a right angle to each other and overlap at a point in a corner region of the packaging.

  
Further, in a preferred form, the product receiving area has a bulge extending into the sealing surface, wherein the line of weakness in the area of the bulge passes through the product receiving area and the bulge does not extend the entire length of one side of the receiving area, but preferably over 95% -50% of the length one side of the receiving area, more preferably over 85% to 55%, more preferably over 75% to 60%, and most preferably over 66% of the length.

  
In one embodiment, the protrusion extends over two sides of the single-dose packaging, so that with two lines of weakness opening of the package can be done via corner and the removal of the packaged goods is facilitated. In addition, these bulges provide the necessary space to open the package by severing the tear lines given by the weakening without destroying the product. The additional space is intended as a safety zone, which prevents unwanted detection and damage of the product in the cracking process, while the product is additionally secured by the narrower boundary of the sealing edge in the rest of the receiving area in its position against slipping within the package.

  
According to a further embodiment, the single-dose packaging has position restrictors for the product in the product receiving area, which are preferably produced by heat-sealing. The position restrictors can be designed as narrow connecting webs between the upper and lower film layers.

  
In order to identify the line of weakness and to facilitate the opening of the package, the line of weakness and / or the crease line may be identified, for example by a color marking or other means common to the marking.

  
The sealed-edge bag of the present invention consists of two packaging material elements arranged one above the other, a first packaging material element and a second packaging material element.

  
The packaging material for the production of the sealed-edge pouches is preferably a packaging material which has low permeation rates for gases and moisture.

  
For the assumption of the different functions that the packaging material has to fulfill, packaging materials with an at least three-layer structure are particularly suitable. In these packaging materials, in which the individual layers or layers of the packaging material are joined together to form a composite, preferably in the form of a laminate, the individual layers of the packaging material assume one or more functions.

  
According to the present invention, the outermost layer of the packaging material element is characterized by a high tensile strength, which can not be destroyed manually without additional tools. However, an existing crack generated at a predetermined weakened point can be widened and crack propagation achieved so that manual tearing without aids is possible. Such a layer is preferably a polyethylene terephthalate layer with a layer thickness of 12-25 μm; however, it is also possible to use other materials and layer thicknesses familiar to the person skilled in the art. The outer layer is further preferably printable such that e.g. Product labels and ripping aids can be attached.

  
In a particular embodiment, the outer layer of the packaging material element is an oriented material, ie a monoaxially stretched material, whose tensile strength is increased in one direction, so that, for example, further tearing without weakening the outer layer is not possible.

  
A second or in three-layered construction, the middle

  
Layer consists of a metal foil, preferably aluminum, with a thickness of 9 - 25 [mu] m. This metal layer ensures the tightness of the packaging against moisture and air. The inner layer is a sealable plastic splint, whereby the sealed seam produced by this layer can not be reopened.

  
The bonding of the laminates is preferably carried out by heat sealing, but can also be carried out with any other suitable sealing method such as cold sealing, ultrasonic sealing, laser sealing or similar, known in the art foil welding method, as long as a non-detachable sealing seam is obtained.

  
The sealing seams or sealing surfaces preferably have one

  
Width of 0.1 mm to 10 cm, more preferably a width of 1 mm to 2 cm, and most preferably a width of 2 mm to 8 mm, and they preferably extend over the entire length and width of the packaging material elements. In particularly exposed areas, the sealing seam width can also be greater. To further complicate the opening of the package, at least one of the sealing seams may be wider than the other sealing seams.

  
Plastics include materials known to the person skilled in the art, such as polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polypropylene (PP), polyethylene (PE), Barex® (BP Chemicals, copolymer of acrylonitrile and butadiene) Surlyn® (R) >

  
Aclar (TM) (Honeywell; polychlorofluoroethylene high barrier films [PCTFE]) and Topas <(R)> - COC (Ticona; cyclo-olefin copolymer films), the layer thickness typically being 20-100 μm and Plastics are particularly suitable, which are highly dense, inert to the drug of the packaged dosage form and / or adsorb this only slightly. Surlyn <(R)> is a high elongation plastic ionomer that contains metal ions in the molecular chain and thus has cross-linking.

  
A preferred Aclar <(R)> film is Aclar <(R)> 33. Aclar <(R)> 33 is a copolymer consisting essentially of chlorotrifluoroethylene.

  
TOPAS <(R)> - COC are amorphous, transparent copolymers based on cyclic and linear olefins, which are free of ionic

  
Ingredients are. A preferred TOPAS <(R)> COC film is made from ethylene and norbornene.

  
A preferred Barex film is a film prepared by graft copolymerizing 73-77 parts by weight of acrylonitrile and 23-27 parts by weight of methyl acrylate in the presence of 8-10 parts by weight of butadiene-acrylonitrile copolymer containing about 70% by weight of butadiene.

  
A particularly preferred high barrier film laminate for use as a packaging material consists of a Barex <(R)> layer (20-40 / im), an aluminum foil (9-25 [mu] m) and a PET layer (10 - 30 [ mu] m).

  
The thickness of the multilayer film laminate is preferably in the range of 35 to 300 μm, more preferably 50 to 200 μm.

  
The tear strength of the packaging material is at least 30 N, preferably at least 40 N, and particularly preferably at least 50 N. The tear strength of the packaging material is preferably below 2000 N, more preferably below 200 N, and most preferably below 100 N, measured from the two together connected packaging material elements which form the packaging.

  
If different film laminates are used as the first and second packaging material element, the minimum tearability of the second film laminate is below that of the first film laminate, wherein it is preferably> 30 N, particularly preferably> 50 N.

  
The tear strength of the packaging material must not be too low, because then sufficient protection of the packaged goods can no longer be guaranteed and there is the danger that the packaging will be opened unintentionally and / or the packaged goods will be damaged. This can be determined by simple experiments. The tear resistance of the packaging material is less than 20 N, preferably less than 5 N, particularly preferably less than 1 N, measured on the two interconnected packaging material elements which form the packaging.

  
The tear strength and the tear propagation resistance of the packaging material can be determined by means of known tensile testing machines using a sample holder for tearing tests (Type No. 00740) (eg obtainable from FRANK Prüfgerate GmbH, D-69488 Birkenau).

  
To enable or facilitate the tearing of the packaging material, the tear strength is a multiple of the tear propagation resistance. Preferably, the ratio of tensile strength to tear strength in the range of 20: 1 to 500: 1, more preferably in the range of 50: 1 to 250: 1, based on the tensile strength and Wei ter terreissfestigkeit the two interconnected packaging material elements.

  
The tear strength in the region of the weakening line is less than 20 N, preferably less than 5 N, particularly preferably less than 1 N, measured on the two interconnected packaging material elements which form the packaging.

  
The single-dose packaging according to the invention will be explained further below with reference to the figures. The figures are merely illustrative of the invention without, however, limiting it to what is shown.

  
FIG. 1 shows a preferred embodiment of the single-dose packaging according to the invention in plan view with bulges in the product receiving region and

  
Positional restrictors across two sides of the package and two orthogonally extending lines of weakness extending over the region of the bulges.

  
Figure 2 shows a single dose package as in Figure 1 but with only one line of weakness along one side of the package.

  
FIG. 3 shows the sequence of the buckling and cracking operations for opening the single-dose packaging from FIG. 1.

  
The packaging (1) according to the invention is a sealed-edge bag made of two packaging material elements arranged one above the other, of which one packaging element forms the cover layer and the other packaging material element forms the underlay, between which the product (5), preferably a trans-therapeutic system or a film or film-like Darreichungsform is arranged. The two packaging material elements are sealed together in such a way that the product (5) is surrounded by a circumferential, continuous sealing edge (3) which is not peelable. This results in a product receiving area (4) closed on all sides, in which the product (5) is contained.

  
The sealed-edge bag (1) has a front edge (8), a trailing edge (9) and two preferably parallel side edges (10, 10 ').

  
Furthermore, the sealed-edge bag has weakening lines (20, 21) with reduced tensile strength along which the packaging material elements can be torn open.

  
Moreover, in FIG. 1, the sealing edge bag has bulges on the front edge and on the side edge 10 ', through which the tear line defined by the weakening lines runs, so that the product (5) is not damaged. A displacement of the product is prevented by the position restrictors (35, 35 ').

  
The parental control of the packaging is achieved in that the lines of weakness for tearing the package can be exposed only by overcoming a child safety device. This backup is that the lines of weakness do not extend to the edge and tear the otherwise tear-resistant material of the packaging material only after exposing the beginning of the weakening line by folding the package along a crease line, which may optionally be given, and the product can be removed. Due to the tensile strength of the packaging material, manual tearing of the packaging in other areas is not possible.

  
Since weakening only removes or reduces the uppermost layer of the laminates in a very small area in relation to the packaging surface, the resistance and tightness of the packaging is only minimally impaired.

  
According to the invention, the weakening line for tearing the packaging material should have no edge contact with the packaging, so that this structure does not develop until the packaging has been folded along a structure extending through this structure

  
Line, for example, along the line A-A '(FIG. 3), exposing the beginning of the weakening range for tearing.

  
The said weakening line, which allows the tearing of the packaging material element (s), may be present in one of the two packaging material elements, for example if the second packaging material element has a lower tensile strength, or in both, the latter embodiment being preferred. In this case, the

  
Line of weakness for tearing the packaging material in both packaging material elements arranged congruently.

  
The inventive combination of packaging material and embodiment of the childproof device, it is possible to make the package so that the opening only by an orderly sequence of at least two steps is possible: (i) folding or folding of the packaging along a

  
Line, whereby the weakening structure is accessible to tearing;

  
(Ii) tearing the packaging on the now marginal weakening structure and tear along this structure.

  
This handling is associated with considerable difficulties for children, especially toddlers, especially since the line of weakness is not easily recognizable, since there is only a slight material removal and no incision. For adults, however, it is possible without problems and without the aid of tools. In a particularly preferred embodiment, the single-dose packaging is childproof according to DIN EN 14375 and / or according to ASTM D3475-03a.

  
The present invention also relates to a method for producing a single-dose packaging for transdermal therapeutic systems or film-shaped dosage forms. This method is characterized by the fact that it is particularly material-saving in comparison to the known methods. Since there are no peelable seals and the package is torn directly along the line of weakness, no additional surfaces are required for a child-resistant packaging, the Anfasshilfen and the like expose, as they are known from DE 10 2004 047 445 Al. The individual packages are directly adjacent to each other and an additional, beyond the size of the packaged material consumption is only due to the strength of the sealing surfaces and in certain embodiments by the bulges and position restrictors.

   A blend through a complex outer shape is also not available. The preparation of the single-dose packages according to the invention can thus be carried out without loss of packaging material.

  
The method for producing a single-dose packaging according to one of the preceding claims comprises the steps of: providing a first packaging material web having at least a three-layer structure;

  
- Providing a second packaging material web;

  
- Positioning of the packaged goods on one of the two packaging material webs; - superimposing and connecting the two packaging material webs in such a way that for each packaged goods a compartment closed on all sides for receiving the packaged goods is formed, at the edge or edges of the two packaging material elements are permanently connected to each other; Applying at least one line of weakness by removing the uppermost, tear-resistant film layer of the multilayer film laminate, wherein the line of weakness extends through both the sealing surface and the unsealed product receiving area, but does not touch the edge of the packaging.

  
- Separating the successive packaging units by a cut or perforation along a line which extends transversely to the web direction of the packaging material webs in the region of the sealing surface. The above-mentioned sequence of process steps is not mandatory; For example, the weakening lines for tearing the packaging material can also be attached only in a later step.

  
Preferably, the permanent connection between the

  
Packing material elements by heat sealing at temperatures in the range between 50 <0> C and 200 <0> C, in particular 50 <0> C to 90 <0> C generated. However, the intractable connection between the two packaging material webs can also be produced by other heat-sealing or cold-sealing methods, such as ultrasonic sealing, laser sealing or the like.

  
For example, the packaging can be efficiently made from tape by serial production on rotary sealing machines.

  
In a preferred embodiment, the line of weakness is produced during manufacture by laser ablation or laser scoring, with the use of tear-resistant film laminates for the first and second packaging element, the lines of weakness being directly congruent.

  
Another embodiment provides that position restrictors, preferably by heat sealing, are arranged in the product receiving area.

Claims

claims
1. A single-dose packaging for transdermal therapeutic systems or film-shaped dosage forms in the form of a tearable end-sealable bag having a completely circumferential and continuous sealing surface, comprising two packaging material elements arranged one above the other and forming the top and bottom of a bag containing the product, at least one layer of the packaging material elements comprising Metal layer is and at least one packaging material element is a film laminate having an at least three-layer structure; and the outermost layer of the at least three-layered film laminate has a minimum tensile strength of 30 N, this outermost layer having at least one line-shaped non-contacting edge of the packaging
Weakening has congruent on the top and bottom and the linear weakening to open the package has a reduced tensile strength.
2. Single-dose packaging according to claim 1, characterized in that in the region of the weakening line, the outer, the packaged material facing away layer of the film laminate is removed or significantly reduced in thickness.
3. Single-dose packaging according to one of the preceding claims, characterized in that the weakening line is produced by laser ablation of the outer layer of the film laminate (s) of the packaging material elements.
4. Single-dose packaging according to one of the preceding claims, characterized in that the linear weakening extends through both the sealing surface and the unsealed product-receiving region.
5. Single-dose packaging according to one of the preceding claims, characterized in that the packaging has two line-shaped weakenings, which preferably extend at a right angle to each other and overlap in one point.
6. Single-dose package according to one of the preceding claims, characterized in that the line of weakness is a broken line.
7. Single-dose package according to one of the preceding claims, characterized in that the line of weakness through the product receiving area at a distance of less than 5 mm, preferably less than 3 mm, more preferably less than 2 mm, and most preferably less than 1 mm Sealing surface runs.
8. Single-dose packaging according to one of the preceding claims, characterized in that the weakening line is optically marked.
9. Single-dose packaging according to one of the preceding claims, characterized in that the sealed seam is not peelable.
10. Single-dose packaging according to one of the preceding claims, characterized in that the first and second packaging material element have the same structure.
11. Single dose packaging according to one of the preceding claims, characterized in that the product receiving area has a reaching into the sealing surface bulge, wherein the line of weakness (s) run in the region of the bulge through the receiving area and preferably not the bulge over the entire length of one side of the receiving area runs.
12. Single-dose packaging according to one of the preceding claims, characterized in that the bulge about
95% -50% of the length of one side of the receiving region, preferably 85% to 55%, more preferably 75% to 60%, and most preferably 66%
13. Single dose package according to one of the preceding
Claims, characterized in that the packaging has position restrictors for the product in the product receiving area.
14. Single-dose packaging according to one of the preceding claims, characterized in that the position restrictors are produced by heat-sealing, narrow connecting webs between the upper and lower film layers.
15. Single dose package according to one of the preceding
Claims, characterized in that the tear strength of the packaging material is between 30 N and 2000 N, preferably between 40 N and 200 N, and more preferably between 50 N and 100 N, measured on the two interconnected packaging material elements forming the unit dose package.
16. Single-dose package according to one of the preceding claims, characterized in that the tear propagation resistance is less than 20 N, preferably less than 5 N, and particularly preferably less than 1 N, measured on the two interconnected packaging material elements which form the single-dose packaging.
17. Single-dose packaging according to one of the preceding claims, characterized in that the ratio of tear strength to tear strength in the range of 20: 1 to 500: 1, more preferably in the range of 50: 1 to 250: 1, based on the tensile strength and tear strength of two interconnected packaging material elements forming the unit dose package.
18. Single dose package according to one of the preceding
Claims, characterized in that the tensile strength in the region of the weakening line is <20 N, preferably <5 N, and particularly preferably <1 N, measured on the two interconnected packaging material elements forming the single-dose packaging.
19. Packaging according to one of the preceding claims, characterized in that at least one of the packaging material elements, preferably both packaging material elements, is formed from an at least three-layered film / are.
20. Single-dose packaging according to one of the preceding claims, characterized in that the minimum tearability of the second film laminate below that of the first
Foil laminate, wherein it is preferably> 30 N, more preferably> 50 N, is.
21. Packaging according to one of the preceding claims, characterized in that the packaged therein packaged goods children without tools is not accessible and in particular childproof according to DIN EN 14375 and / or according to ASTM D3475-03a.
22. A method for producing a single-dose packaging according to one of the preceding claims, comprising the steps: - Providing a first packaging material web with at least three-layer structure;
- Providing a second packaging material web;
- Positioning of the packaged goods on one of the two packaging material webs; - superimposing and connecting the two packaging material webs in such a way that for each packaged goods a compartment closed on all sides for receiving the packaged goods is formed, at the edge or edges of the two packaging material elements are permanently connected to each other; Attaching at least one line of weakness by removing the uppermost, tear-resistant film layer of the multilayer film laminate, wherein the line of weakness extends through both the sealing surface and the unsealed product-receiving area. - Separating the successive packaging units by a cut or a perforation along a line which runs transversely to the web direction of the packaging material webs in the region of the sealing surface.
23. The method according to claim 22, characterized in that the weakening line is produced by laser ablation or laser scoring.
24. The method according to any one of the preceding claims, characterized in that the first and second film laminate are constructed at least three layers and the weakening lines are mounted directly opposite one another.
25. The method according to any one of the preceding claims, characterized in that the packaging material webs are connected to each other by means of sealing seams or sealing surfaces, in particular using a sealing wax.
26. The method according to any one of the preceding claims, characterized in that position restrictors are arranged in the product receiving area, preferably by Heisssiegelung.
27. Use of the single-dose packaging according to any one of claims 1 - 21 for the packaging of transdermal therapeutic systems or film-shaped dosage forms.
EP10702621.3A 2009-02-10 2010-02-03 Childproof, highly inert individual packaging Active EP2396241B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
DE200910008217 DE102009008217A1 (en) 2009-02-10 2009-02-10 Child-proof, highly inert single-pack
PCT/EP2010/000638 WO2010091813A1 (en) 2009-02-10 2010-02-03 Childproof, highly inert individual packaging

Publications (2)

Publication Number Publication Date
EP2396241A1 true EP2396241A1 (en) 2011-12-21
EP2396241B1 EP2396241B1 (en) 2017-06-07

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ID=42046212

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EP10702621.3A Active EP2396241B1 (en) 2009-02-10 2010-02-03 Childproof, highly inert individual packaging

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US (2) US9145248B2 (en)
EP (1) EP2396241B1 (en)
JP (1) JP5738200B2 (en)
KR (1) KR20110124288A (en)
CN (1) CN102307793B (en)
AU (1) AU2010213197B2 (en)
BR (1) BRPI1008174B1 (en)
CA (1) CA2751998C (en)
DE (1) DE102009008217A1 (en)
ES (1) ES2638773T3 (en)
HK (1) HK1162011A1 (en)
IL (1) IL214410D0 (en)
MX (1) MX2011008384A (en)
PH (1) PH12015500229A1 (en)
RU (1) RU2517131C9 (en)
WO (1) WO2010091813A1 (en)
ZA (1) ZA201105522B (en)

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Also Published As

Publication number Publication date
HK1162011A1 (en) 2014-11-28
BRPI1008174A2 (en) 2016-03-01
RU2011137191A (en) 2013-03-20
CA2751998C (en) 2016-08-09
DE102009008217A1 (en) 2010-08-19
KR20110124288A (en) 2011-11-16
US9145248B2 (en) 2015-09-29
BRPI1008174B1 (en) 2019-04-24
AU2010213197A1 (en) 2011-09-01
PH12015500229A1 (en) 2015-04-13
RU2517131C9 (en) 2015-03-20
WO2010091813A1 (en) 2010-08-19
CN102307793B (en) 2014-02-19
EP2396241B1 (en) 2017-06-07
RU2517131C2 (en) 2014-05-27
US20150321438A1 (en) 2015-11-12
ZA201105522B (en) 2012-10-31
JP2012517387A (en) 2012-08-02
CN102307793A (en) 2012-01-04
IL214410D0 (en) 2011-09-27
AU2010213197B2 (en) 2015-04-30
MX2011008384A (en) 2011-09-06
ES2638773T3 (en) 2017-10-24
CA2751998A1 (en) 2010-08-19
US20120006707A1 (en) 2012-01-12
US9597852B2 (en) 2017-03-21
JP5738200B2 (en) 2015-06-17

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