EP2687458A1 - Package for films with a unitary dosage of an active substance - Google Patents

Package for films with a unitary dosage of an active substance Download PDF

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Publication number
EP2687458A1
EP2687458A1 EP20120005237 EP12005237A EP2687458A1 EP 2687458 A1 EP2687458 A1 EP 2687458A1 EP 20120005237 EP20120005237 EP 20120005237 EP 12005237 A EP12005237 A EP 12005237A EP 2687458 A1 EP2687458 A1 EP 2687458A1
Authority
EP
European Patent Office
Prior art keywords
packaging
packaging material
material element
sealing
layer
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.)
Ceased
Application number
EP20120005237
Other languages
German (de)
French (fr)
Inventor
Erfindernennung liegt noch nicht vor Die
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 AG
Original Assignee
LTS Lohmann Therapie Systeme AG
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
Application filed by LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Priority to EP20120005237 priority Critical patent/EP2687458A1/en
Priority to JP2015522029A priority patent/JP6422436B2/en
Priority to PL13736824T priority patent/PL2874908T3/en
Priority to CA2878330A priority patent/CA2878330C/en
Priority to AU2013292245A priority patent/AU2013292245B2/en
Priority to KR20157000819A priority patent/KR20150032702A/en
Priority to ES13736824.7T priority patent/ES2605432T3/en
Priority to CN201380044805.XA priority patent/CN104640781B/en
Priority to BR112015000813-5A priority patent/BR112015000813B1/en
Priority to PCT/EP2013/063922 priority patent/WO2014012787A1/en
Priority to EP13736824.7A priority patent/EP2874908B1/en
Priority to RU2015105053A priority patent/RU2633954C2/en
Priority to MX2015000790A priority patent/MX351124B/en
Publication of EP2687458A1 publication Critical patent/EP2687458A1/en
Priority to HK15110625.5A priority patent/HK1209713A1/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B11/00—Wrapping, e.g. partially or wholly enclosing, articles or quantities of material, in strips, sheets or blanks, of flexible material
    • B65B11/50—Enclosing articles, or quantities of material, by disposing contents between two sheets, e.g. pocketed sheets, and securing their opposed free margins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B65B61/18—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for making package-opening or unpacking elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5805—Opening 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5827—Tear-lines provided in a wall portion

Definitions

  • the invention relates to a package for single-dose active substance-containing films, comprising an upper packaging material element and a lower packaging material element, which are connected to each other by means of a circumferential sealing surface or sealing seam, that an all-round enclosed cavity for receiving the film is formed, wherein the upper packaging material element and the lower packaging material element in the region of the sealing surface or the sealing seam each have at least one section which are congruent, and at least one section is crossed by a fold or crease line.
  • TTS Transdermal Therapeutic Systems
  • TTS consist in the simplest case of a very thin backing layer, a pressure-sensitive adhesive polymer layer containing an active ingredient and optionally a removable protective layer which is removed before the application of the TTS.
  • the backing layer and polymer layer must be very thin, so that no foreign body feeling is created when wearing the TTS. This property makes both layers vulnerable to being damaged when the package is torn open.
  • film-shaped oral dosage forms which consist of only one polymer layer.
  • From the DE 10 2004 047 445 A1 is a non-reclosable package for hazardous products, in particular pharmaceutical products comprising a first packaging material element and a second packaging material element known.
  • the two packaging material elements are arranged one above the other and the packaging has at least a first surface portion, at the edge or edges of the two packaging material elements are releasably connected to each other, wherein between the two packaging material elements at least one side enclosed cavity for receiving the packaged goods is formed.
  • the packaging has at least one second surface section which lies outside or adjoins the first surface section and at the edge or edges of which the two packaging material elements are detachably connected to one another and wherein at least one of the two packaging material elements is provided with at least one structure which extends within the second surface portion and which allows tearing of the packaging material element (s).
  • From the DE 10 2006 041 921 A1 is a package for active substance-containing films, which has a carrier layer and a releasably connected to this cover layer known.
  • the package has in a pairwise arrangement two opposite, separated by a web surface areas within which the cover layer is not connected to the carrier layer, whereby two separate, mutually enclosed spaces for pairwise recording of said films are formed.
  • Within said web there is a further surface area in which the carrier layer is not connected to the cover layer, whereby an all-round enclosed cavity is formed and within the web at least one perforation line is present.
  • the upper packaging material element and the lower packaging material element are releasably (peelably) connected to each other.
  • the two packaging material elements are inseparably connected to each other in single-dose packaging. This is preferably done by a heat seal, but can also be done with any other suitable sealing method such as cold sealing, ultrasonic sealing, laser sealing or similar, known in the art foil welding process, as long as a non-detachable sealing seam is obtained.
  • Such a package is for example from the German patent application DE 10 2009 008 217 A1 known.
  • the user must fold over part of the packaging along an imprinted marking line, in order subsequently to open the packaging at a likewise marked location by tearing along a weakening line.
  • the buckling along the printed marking line changes the position of a structure or a cut in the region of the sealing surface or sealing seam of the two packaging material elements to the edge of the packaging and thus allows tearing of the packaging in order to be able to remove the contents from the cavity.
  • the structure or section has a length of about 3 to 5 mm.
  • the printed marker line preferably crosses the pattern or cut at right angles or at a selected angle.
  • the prior art overlooks the fact that the packaging significantly contributes to the stability of the packaged dosage form, because the packaging protects the dosage form from light, moisture, oxygen and microorganisms.
  • the mentioned weakening line weakens the packaging by causing a gap in the seal because the broken seal allows more moisture and oxygen to diffuse into the interior of the package. It should be noted that both water vapor and oxygen are very small molecules and the storage of the drug before use is at least two years, ideally three years or more.
  • the invention is therefore based on the object to provide a generic single-dose packaging, which improves the embodiments described above.
  • This object is achieved in that the section in the upper packaging material element and the congruent cut in the lower packaging material element is formed so that the respective end point of the cuts has a distance from the cavity, which corresponds at least to the width of the sealed seam.
  • the invention thus provides that the end points of the cuts are at least as far away from the cavity as the maximum width of the remaining sealing seams.
  • Each package has sealed seams on at least three sides that take into account a width to prevent or prevent diffusion for the period of maximum storage.
  • the outer layer is preferably printable, so that e.g. Product labels and tear-open aids can be attached.
  • the middle layer consists of a metal foil, preferably aluminum, with a thickness of 9-25 micrometers. This metal layer ensures the tightness of the packaging against moisture and air.
  • the inner layer is a sealable plastic layer, wherein the sealed seam produced by this layer can not be opened again.
  • the upper packaging material element and the lower packaging material element have an identical structure. This has the advantage that only one type of packaging materials for use and thus a confusion is excluded.
  • An expedient development provides that the section in the upper and the cut in the lower Fackstoflelement in the sealed seam is mounted so that it is aligned at right angles to the nearest outer edge of the cavity. This ensures that the cut comes in contact with the peripheral sealing surface or sealing seam at exactly one point, whereas in the known embodiments there is contact over a longer distance.
  • the upper packaging material element and the lower packaging material element are integrally formed and are thereby folded around a bending edge.
  • connection between the two packaging material elements is preferably produced by sealing or welding. Suitable means and methods for producing the sealing surfaces or the sealing seams are known to the person skilled in the art.
  • the seal serves as a diffusion and permeation barrier and is generally impermeable to active substances and atmospheric moisture. Both heat-sealing and cold-sealing methods are possible.
  • a material for sealing layers for example, hot melt adhesives, sealing paints, sieve dispersions or adhesives can be used.
  • packaging 1 according to the invention is shown in plan view.
  • the packaging 1 is a sealed-edge bag made of an upper packaging material element 3 and a lower packaging material element 4. Between the upper packaging material element 3 and the lower packaging material element 4, an active substance-containing film 2 is arranged in a cavity 6 enclosed on all sides.
  • the cavity 6 is generated by a circumferential sealing surface or sealing seam 5, which connects the two packaging material elements 3, 4 inextricably.
  • the cavity 6 and the mirror surface or sealing seam 5 have a common outer edge 6a.
  • In the sealing surface or sealing seam 5 is located in the upper packaging material element 3, a section 7 and in the lower packaging material element 4 a section 8.
  • the two sections 7 and 8 are congruent.
  • the section 7 is crossed by a fold or crease line 10.
  • An imaginary extension of the sections 7 and 8, which is identical to the tear-open edge, has a distance M3 from the nearest edge of the fuel-containing film 2.
  • the distance M3 is 4 to 5 mm.
  • the upper and lower packaging material element 3, 4 is integrally formed and is folded around a bending edge 17. This eliminates the Siegeinaht 5 in this area.
  • Fig. 2 is the construction of the package in a sectional view along the line A - A in Flg. 1 shown.
  • the individual parts are greatly enlarged and drawn separately to illustrate the structure.
  • the upper packaging material element 3 consists of at least one upper, outer layer 11 and a subsequent upper metal layer 13.
  • the lower packaging material layer 4 likewise consists of a lower, outer, layer 12 and a subsequent lower metal layer 14.
  • the metal layers 13, 14 are preferably made of an aluminum foil having a thickness of 9 to 25 microns. This foil ensures that the inserted Product does not come into contact with air and is not exposed to moisture.
  • the upper or lower packaging material element 3, 4 has a sealable layer 9.
  • the sealable layer 9 can also be applied to both the upper and the lower packaging material elements 3, 4. The sealing surface or sealing seam 5 produced by this layer 9 can not be separated again.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Wrappers (AREA)
  • Bag Frames (AREA)
  • Basic Packing Technique (AREA)

Abstract

The packaging structure (1) has an upper packaging element (3) and lower packaging elements (4) that are interconnected with each other by a circumferential sealing surface and/or sealing seam (5). The cavity (6) is formed for receiving the film (2). The case section (7) is formed in upper packaging element and the case section (8) in the lower packaging element by crossing a folding or bending line (10), such that the terminal points (15,16) of sections are placed at a distance (M1) from the cavity corresponding to the width (M2) of the sealing seam.

Description

Die Erfindung betrifft eine Verpackung für einzeldosierte wirkstoffhaltige Filme, umfassend ein oberes Packstoff-Element und ein unteres Packstoff-Element, die mittels einer umlaufenden Siegelfläche bzw. Siegelnaht derart miteinander verbunden sind, dass ein allseitig umschlossener Hohlraum zur Aufnahme des Films gebildet wird, wobei das obere Packstoffelement und das untere Packstoffelement im Bereich der Siegelfläche bzw. der Siegelnaht jeweils mindestens einen Schnitt aufweisen, die deckungsgleich sind, und mindestens ein Schnitt durch eine Falz- oder Knicklinie gekreuzt wird.The invention relates to a package for single-dose active substance-containing films, comprising an upper packaging material element and a lower packaging material element, which are connected to each other by means of a circumferential sealing surface or sealing seam, that an all-round enclosed cavity for receiving the film is formed, wherein the upper packaging material element and the lower packaging material element in the region of the sealing surface or the sealing seam each have at least one section which are congruent, and at least one section is crossed by a fold or crease line.

Transdermale Therapeutische Systeme (TTS) sind pflasterähnliche Arzneiformen zur Abgabe von Wirkstoffen an die Haut. TTS bestehen im einfachsten Fall aus einer sehr dünnen Rückschicht, einer haftklebenden Polymerschicht, die einen Wirkstoff enthält und ggf. einer wieder ablösbaren Schutzschicht, die vor der Applikation des TTS entfernt wird. Rückschicht und Polymerschicht müssen sehr dünn sein, damit beim Tragen des TTS kein Fremdkörpergefühl entsteht. Durch diese Eigenschaft sind beide Schichten anfällig, beim Aufreißen der Verpackung beschädigt zu werden.Transdermal Therapeutic Systems (TTS) are patch-like dosage forms for delivery of active ingredients to the skin. TTS consist in the simplest case of a very thin backing layer, a pressure-sensitive adhesive polymer layer containing an active ingredient and optionally a removable protective layer which is removed before the application of the TTS. The backing layer and polymer layer must be very thin, so that no foreign body feeling is created when wearing the TTS. This property makes both layers vulnerable to being damaged when the package is torn open.

Dieses gilt auch für folienförmige orale Arzneiformen, die nur aus einer Polymerschicht bestehen.This also applies to film-shaped oral dosage forms, which consist of only one polymer layer.

Grundsätzlich besteht ein Bedarf an kindersicheren Verpackungen für beide Arten von Arznei- bzw. Dameichungsformen, die aber gleichzeitig von Erwachsenen leicht zu öffnen sein müssen.In general, there is a need for child-resistant packaging for both types of drugs, but which must be easy for adults to open at the same time.

Aus der DE 10 2004 047 445 A1 ist eine nicht wiederverschliessbare Verpackung für gesundheitsgefährdende Erzeugnisse insbesondere pharmazeutische Erzeugnisse, umfassend ein erstes Packstoff-Element und eine zweites Packstoff-Element bekannt. Dabei sind die beiden Packstoff-Elemente übereinanderliegend angeordnet und die Verpackung weist mindestens einen ersten Flächenabschnitt auf, an dessen Rand oder Rändern die beiden Packstoff-Elemente lösbar miteinander verbunden sind, wobei zwischen den beiden Packstoff-Elementen mindestens ein allseitig umschlossener Hohlraum zur Aufnahme des Packgutes gebildet wird. Die Verpackung weist mindestens einen zweiten Flächenabschnitt auf, der außerhalb des genannten ersten Flächenabschnitts liegt oder an diesen angrenzt, und an dessen Rand oder Rändern die beiden Packstoff-Elemente lösbar miteinander verbunden sind und wobei zumindest eines der beiden Packstoff-Elemente mit mindestens einer Struktur versehen ist, die innerhalb des zweiten Flächenabschnitts verläuft und die das Einreißen des/der Packstoff-Elements/Elemente ermöglicht.From the DE 10 2004 047 445 A1 is a non-reclosable package for hazardous products, in particular pharmaceutical products comprising a first packaging material element and a second packaging material element known. In this case, the two packaging material elements are arranged one above the other and the packaging has at least a first surface portion, at the edge or edges of the two packaging material elements are releasably connected to each other, wherein between the two packaging material elements at least one side enclosed cavity for receiving the packaged goods is formed. The packaging has at least one second surface section which lies outside or adjoins the first surface section and at the edge or edges of which the two packaging material elements are detachably connected to one another and wherein at least one of the two packaging material elements is provided with at least one structure which extends within the second surface portion and which allows tearing of the packaging material element (s).

Aus der DE 10 2006 041 921 A1 ist eine Verpackung für wirkstoffhaltige Filme, die eine Trägerschicht und eine mit dieser lösbar verbundene Deckschicht aufweist, bekannt. Die Verpackung weist dabei in einer paarweisen Anordnung zwei gegenüberliegende, durch einen Steg voneinander getrennten Flächenbereiche auf, innerhalb weicher die Deckschicht nicht mit der Trägerschicht verbunden ist, wodurch zwei voneinander getrennte, allseitig umschlossene Räume zur paarweisen Aufnahme der genannten Filme gebildet werden. Innerhalb des genannten Stegs ist ein weiterer Flächenbereich vorhanden, in welchem die Trägerschicht nicht mit der Deckschicht verbunden ist, wodurch ein allseitig umschlossener Hohlraum gebildet wird und innerhalb des Stegs mindestens eine Perforationslinie vorhanden ist.From the DE 10 2006 041 921 A1 is a package for active substance-containing films, which has a carrier layer and a releasably connected to this cover layer known. The package has in a pairwise arrangement two opposite, separated by a web surface areas within which the cover layer is not connected to the carrier layer, whereby two separate, mutually enclosed spaces for pairwise recording of said films are formed. Within said web, there is a further surface area in which the carrier layer is not connected to the cover layer, whereby an all-round enclosed cavity is formed and within the web at least one perforation line is present.

Bei diesen bekannten Ausführungen sind das obere Packstoffelement und das untere Packstoffelement lösbar (peelbar) miteinander verbunden.In these known embodiments, the upper packaging material element and the lower packaging material element are releasably (peelably) connected to each other.

In einer anderen Ausführung werden bei Einzeldosisverpackungen die beiden Packstoffelemente unlösbar miteinander verbunden. Dieses geschieht vorzugsweise durch eine Heißsiegelung, kann aber auch mit jedem anderen geeigneten Siegelverfahren wie Kaltsiegeln, Ultraschallsiegeln, Lasersiegeln oder vergleichbaren, dem Fachmann bekannten Folienschweißverfahren erfolgen, solange eine nichtlösbare Siegelnaht erhalten wird.In another embodiment, the two packaging material elements are inseparably connected to each other in single-dose packaging. This is preferably done by a heat seal, but can also be done with any other suitable sealing method such as cold sealing, ultrasonic sealing, laser sealing or similar, known in the art foil welding process, as long as a non-detachable sealing seam is obtained.

Eine derartige Verpackung ist z.B. aus der deutschen Offenlegungsschrift DE 10 2009 008 217 A1 bekannt.Such a package is for example from the German patent application DE 10 2009 008 217 A1 known.

Bei den bekannten Ausführungen der Verpackung muss der Nutzer einen Teil der Verpackung entlang einer aufgedruckte Markierungslinie umknicken, um anschließend an einer ebenfalls markierten Stelle die Verpackung durch Reißen entlang einer Schwächungslinie zu öffnen. Das Umknicken entlang der aufgedruckten Markierungslinie verändert die Lage einer Struktur oder eines Schnittes im Bereich der Siegelfläche bzw. Siegelnaht der beiden Packstoffelementen an den Rand der Verpackung und ermöglicht so ein aufreißen der Verpackung, um den Inhalt aus dem Hohlraum entnehmen zu können. Die Struktur oder der Schnitt hat eine Länge von ca. 3 bis 5 mm. Die aufgedruckte Markierungslinie kreuzt die Struktur bzw. den Schnitt vorzugsweise rechtwinklig oder unter einem ausgewählten Winkel.In the known embodiments of the packaging, the user must fold over part of the packaging along an imprinted marking line, in order subsequently to open the packaging at a likewise marked location by tearing along a weakening line. The buckling along the printed marking line changes the position of a structure or a cut in the region of the sealing surface or sealing seam of the two packaging material elements to the edge of the packaging and thus allows tearing of the packaging in order to be able to remove the contents from the cavity. The structure or section has a length of about 3 to 5 mm. The printed marker line preferably crosses the pattern or cut at right angles or at a selected angle.

Bereits in der DE 10 2009 008 217 A1 wird auf die Notwendigkeit hingewiesen, dass die Siegelnaht und die Packstoffefemente dass Diffusionsverhalten des Inhalts der Verpackung berücksichtigen müssen. Als kritisch ist bei den bekannten Ausführungen die Anordnung der Schnitte zu sehen.Already in the DE 10 2009 008 217 A1 It points to the need for the sealing seam and the packaging material elements to take into account the diffusion behavior of the contents of the packaging. As critical in the known designs, the arrangement of the cuts can be seen.

Der Stand der Technik übersieht hierbei, dass die Verpackung wesentlich zur Stabilität der verpackten Arzneiform beiträgt, denn die Verpackung schützt die Arzneiform vor Licht, Feuchte, Sauerstoff und Mikroorganismen. Die erwähnte Schwächungslinie schwächt dadurch, dass sie eine Lücke in der Siegelung herbeiführt, die Verpackung, weil durch die unterbrochene Siegelung mehr Feuchtigkeit und Sauerstoff in das Innere der Verpackung diffundieren kann. Hierbei ist zu beachten, dass sowohl Wasserdampf als auch Sauerstoff sehr kleine Moleküle sind und die Lagerung des Arzneimittels vor der Anwendung mindestens zwei Jahre, idealerweise aber drei Jahre und mehr betragen soll.The prior art overlooks the fact that the packaging significantly contributes to the stability of the packaged dosage form, because the packaging protects the dosage form from light, moisture, oxygen and microorganisms. The mentioned weakening line weakens the packaging by causing a gap in the seal because the broken seal allows more moisture and oxygen to diffuse into the interior of the package. It should be noted that both water vapor and oxygen are very small molecules and the storage of the drug before use is at least two years, ideally three years or more.

Der Erfindung liegt daher die Aufgabe zugrunde, eine gattungsgemäße Einzeldosisverpackung zu schaffen, welche die oben beschriebenen Ausführungen verbessert.The invention is therefore based on the object to provide a generic single-dose packaging, which improves the embodiments described above.

Diese Aufgabe wird erfindungsgemäß dadurch gelöst, dass der Schnitt im oberen Packstoffelement und der deckungsgleiche Schnitt im unteren Packstoffelement so ausgebildet ist, dass der jeweilige Endpunkt der Schnitte einen Abstand zum Hohlraum aufweist, der mindestens der Breite der Siegelnaht entspricht.This object is achieved in that the section in the upper packaging material element and the congruent cut in the lower packaging material element is formed so that the respective end point of the cuts has a distance from the cavity, which corresponds at least to the width of the sealed seam.

Ausgestaltungen der Erfindung sind in den Unteransprüchen angegeben.Embodiments of the invention are specified in the subclaims.

Die Erfindung sieht somit vor, dass die Endpunkte der Schnitte mindestens so weit von dem Hohlraum entfernt sind, wie die maximale Breite der übrigen Siegelnähte. Jede Verpackung weist mindestens an drei Seiten Siegelnähte auf, die eine Breite berücksichtigen, um eine Diffusion für den Zeitraum der maximalen Aufbewahrung zu vermeiden bzw. zu verhindern.The invention thus provides that the end points of the cuts are at least as far away from the cavity as the maximum width of the remaining sealing seams. Each package has sealed seams on at least three sides that take into account a width to prevent or prevent diffusion for the period of maximum storage.

Die äußere Schicht ist vorzugsweise bedruckbar, so dass z.B. Produktkennzeichnungen und Aufreißhilfen angebracht werden können.The outer layer is preferably printable, so that e.g. Product labels and tear-open aids can be attached.

Eine zweite bzw. bei dreischichtigem Aufbau die mittlere Schicht besteht aus einer Metallfolie, vorzugsweise Aluminium, mit einer Dicke von 9 - 25 Mikrometer. Diese Metallschicht sorgt für die Dichtigkeit der Verpackung gegenüber Feuchtigkeit und Luft..
Die innere Schicht ist eine siegelfähige Kunststoffschicht, wobei die durch diese Schicht erzeugte Siegelnaht nicht wieder geöffnet werden kann.A second or, in the case of a three-layer structure, the middle layer consists of a metal foil, preferably aluminum, with a thickness of 9-25 micrometers. This metal layer ensures the tightness of the packaging against moisture and air.
The inner layer is a sealable plastic layer, wherein the sealed seam produced by this layer can not be opened again.

In einer bevorzugten Ausführungsform besitzen das obere Packstoffelement und das untere Packstoffelement einen identischen Aufbau. Dieses hat den Vorteil, dass nur eine Sorte von Packstoffen zum Einsatz und damit eine Verwechslung ausgeschlossen wird.In a preferred embodiment, the upper packaging material element and the lower packaging material element have an identical structure. This has the advantage that only one type of packaging materials for use and thus a confusion is excluded.

Eine zweckmäßige Weiterbildung sieht vor, dass der Schnitt im oberen und der Schnitt im unteren Fackstoflelement in der Siegelnaht so angebracht ist, dass er rechtwinklig zur nächstliegenden Außenkante des Hohlraums ausgerichtet ist. Hiermit ist gewährleistet, dass der Schnitt genau an einem einzigen Punkt mit der umlaufenden Siegelfläche bzw. Siegelnaht in Berührung kommt, während bei den bekannten Ausführungen eine Berührung über eine längere Strecke vorliegt.An expedient development provides that the section in the upper and the cut in the lower Fackstoflelement in the sealed seam is mounted so that it is aligned at right angles to the nearest outer edge of the cavity. This ensures that the cut comes in contact with the peripheral sealing surface or sealing seam at exactly one point, whereas in the known embodiments there is contact over a longer distance.

In einer besonderen Ausführung sind das obere Packstoffelement und das untere Packstoffelement einteilig ausgebildet und werden dabei um eine Biegekante geklappt.In a particular embodiment, the upper packaging material element and the lower packaging material element are integrally formed and are thereby folded around a bending edge.

Die Verbindung zwischen den beiden Packstoffelementen wird vorzugsweise durch Siegeln oder Schweißen erzeugt. Geeignete Mittel und Verfahren zum Erzeugen der Siegelflächen bzw. der Siegelnähte sind dem Fachmann bekannt. Die Siegelung dient als Diffusions- und Permeationsbarriere und ist im allegemeinen undurchlässig für Wirkstoffe und Luftfeuchtigkeit, Es kommen sowohl Heißsiegelverfahren als auch Kaltsiegelverfahren in Betracht. Als Material für Siegelschichten können z.B, Schmelzkleber, Siegellacke, Siegeldispersionen oder Klebstoffe verwendet werden.The connection between the two packaging material elements is preferably produced by sealing or welding. Suitable means and methods for producing the sealing surfaces or the sealing seams are known to the person skilled in the art. The seal serves as a diffusion and permeation barrier and is generally impermeable to active substances and atmospheric moisture. Both heat-sealing and cold-sealing methods are possible. As a material for sealing layers, for example, hot melt adhesives, sealing paints, sieve dispersions or adhesives can be used.

Weitere Merkmale und Einzelheiten der Erfindung ergeben sich aus den Ansprüchen und der nachfolgenden Beschreibung von in schematischen Zeichnungen dargestellten Ausführungsbeispielen der Erfindung. Es zeigen:

Fig. 1 und
in Draufsicht eine Verpackung für wirkstoffhaltige Filme;
Fig. 2
in geschnittener Seitenansicht die Verpackung aus Figur 1;
Further features and details of the invention will become apparent from the claims and the following description of illustrated in schematic drawings embodiments of the invention. Show it:
Fig. 1 and
in plan view, a package for active substance-containing films;
Fig. 2
in cut side view of the packaging FIG. 1 ;

In Fig. 1 ist erfindungsgemäße Verpackung 1 in Draufsicht dargestellt. Bei der Verpackung 1 handelt es sich um einen Siegelrandbeutel aus einem oberen Packstoffelement 3 und einem unteren Packstoffelement 4. Zwischen dem oberen Packstoffelement 3 und dem unteren Packstoffelement 4 ist ein wirkstoffhaltiger Film 2 in einem allseitig umschlossenen Hohlraum 6 angeordnet. Der Hohlraum 6 wird durch eine umlaufende Siegelfläche bzw. Siegelnaht 5 erzeugt, die die beiden Packstoffelemente 3, 4 unlösbar verbindet. Der Hohlraum 6 und die Spiegelfläche bzw. Siegelnaht 5 weisen eine gemeinsame Außenkante 6a auf. In der Siegelfläche bzw. Siegelnaht 5 befindet sich in dem oberen Packstoffelement 3 ein Schnitt 7 und in dem unteren Packstoffelement 4 ein Schnitt 8. Die beiden Schnitte 7 und 8 sind deckungsgleich. Der Schnitt 7 wird durch eine Falz- oder Knicklinie 10 gekreuzt.In Fig. 1 packaging 1 according to the invention is shown in plan view. The packaging 1 is a sealed-edge bag made of an upper packaging material element 3 and a lower packaging material element 4. Between the upper packaging material element 3 and the lower packaging material element 4, an active substance-containing film 2 is arranged in a cavity 6 enclosed on all sides. The cavity 6 is generated by a circumferential sealing surface or sealing seam 5, which connects the two packaging material elements 3, 4 inextricably. The cavity 6 and the mirror surface or sealing seam 5 have a common outer edge 6a. In the sealing surface or sealing seam 5 is located in the upper packaging material element 3, a section 7 and in the lower packaging material element 4 a section 8. The two sections 7 and 8 are congruent. The section 7 is crossed by a fold or crease line 10.

Eine gedachte Verlängerung der Schnitte 7 und 8, die identisch ist mit der Aufreißkante, weist einen Abstand M3 von der nächstliegenden Kante des varkstoffhaltigen Films 2 auf. In einer bevorzugten Ausführung beträgt der Abstand M3 4 bis 5 mm.An imaginary extension of the sections 7 and 8, which is identical to the tear-open edge, has a distance M3 from the nearest edge of the fuel-containing film 2. In a preferred embodiment, the distance M3 is 4 to 5 mm.

Bei einer anderen Ausführung ist das obere und untere Packstoffelement 3, 4 einteilig ausgebildet und wird um eine Biegekante 17 geklappt. Dabei entfällt die Siegeinaht 5 in diesem Bereich.In another embodiment, the upper and lower packaging material element 3, 4 is integrally formed and is folded around a bending edge 17. This eliminates the Siegeinaht 5 in this area.

In Fig. 2 ist der Aufbau der Verpackung in geschnittener Darstellung entlang der Linie A - A in Flg. 1 dargestellt. Die einzelnen Teile sind stark vergrößert und getrennt gezeichnet, um den Aufbau zu verdeutlichen. Das obere Packstoffelement 3 besteht mindestens aus einer oberen, äußeren Schicht 11 und einer nachfolgenden oberen Metallschicht 13.In Fig. 2 is the construction of the package in a sectional view along the line A - A in Flg. 1 shown. The individual parts are greatly enlarged and drawn separately to illustrate the structure. The upper packaging material element 3 consists of at least one upper, outer layer 11 and a subsequent upper metal layer 13.

Die untere Packstoffschicht 4 besteht ebenfalls aus einer unteren, äußeren, Schicht 12 und einer nachfolgenden unteren Metallschicht 14.The lower packaging material layer 4 likewise consists of a lower, outer, layer 12 and a subsequent lower metal layer 14.

Die Metallschichten 13, 14 bestehen verzugsweise aus einer Aluminiumfolie mit einer Dicke von 9 bis 25 Mikrometer. Diese Folie sorgt dafür, dass das eingelegte Produkt nicht mit Luft in Berührung kommt und keinerlei Feuchtigkeit ausgesetzt ist.The metal layers 13, 14 are preferably made of an aluminum foil having a thickness of 9 to 25 microns. This foil ensures that the inserted Product does not come into contact with air and is not exposed to moisture.

Mindestens im Bereich der Siegelfläche bzw. der Siegelnaht 5 weist das obere oder das untere Packstoffelement 3, 4 eine siegelfähige Schicht 9 auf. Die siegelfähige Schicht 9 kann aber auch auf beiden, dem oberen und dem unteren, Packstoffelementen 3, 4 angebracht sein. Die durch diese Schicht 9 erzeugte Siegelfläche bzw. Siegelnaht 5 kann nicht wieder getrennt werden.At least in the area of the sealing surface or the sealing seam 5, the upper or lower packaging material element 3, 4 has a sealable layer 9. However, the sealable layer 9 can also be applied to both the upper and the lower packaging material elements 3, 4. The sealing surface or sealing seam 5 produced by this layer 9 can not be separated again.

Bezugszeichenliste:LIST OF REFERENCE NUMBERS

11
Verpackungpackaging
22
wirkstoffhaltiger Filmactive substance-containing film
33
oberes Packstoffelementupper packaging material element
44
unteres Packstoffelementlower packing material element
55
Siegelfläche bzw. SiegelnahtSealing surface or sealing seam
66
Hohlraumcavity
6a6a
Außenkanten des Hohlraums 6Outside edges of the cavity 6
77
Schnittcut
88th
Schnittcut
99
Siegelschichtsealing layer
1010
Falz- oder KnicklinieFold or crease line
1111
obere, äußere Schichtupper, outer layer
1212
untere, äußere Schichtlower, outer layer
1313
obere Metallschichtupper metal layer
1414
untere Metallschichtlower metal layer
1515
Endpunkt von Schnitt 7End point of section 7
1616
Endpunkt von Schnitt 8End point of section 8
1717
Biegekantebending edge
M1M1
Abstand 1Distance 1
M2M2
Abstand 2Distance 2
M3M3
Abstand 3Distance 3

Claims (6)

Verpackung (1) für einzeldosierte wirkstoffhaltige Filme (2), umfassend ein oberes Packstoff-Element (3) und ein unteres Packstoff-Element (4), die mittels einer umlaufenden Siegelfläche bzw. Siegelnaht (5) derart miteinander verbunden sind, dass ein allseitig umschlossener Hohlraum (6) zur Aufnahme des Films (2) gebildet wird, wobei - das obere Packstoffelement (3) und das untere Packstoffelement (4) im Bereich der Siegelfläche bzw. der Siegelnaht (5) jeweils mindestens einen Schnitt (7, 8) aufweisen, die deckungsgleich sind, und - mindesten ein Schnitt (7, 8) durch eine Falz- oder Knicklinie (10) gekreuzt wird,
dadurch gekennzeichnet,
dass der Schnitt (7) im oberen Packstoffelement (3) und der deckungsgleiche Schnitt (8) im unteren Packstoffelement (4) so ausgebildet ist, dass der jeweilige Endpunkt (15,16) der Schnitte (7, 8) einen Abstand (M1) zum Hohlraum (6) aufweist, der mindestens der Breite (M2) der Siegelnaht (5) entspricht. Packaging (1) for single-dose active substance-containing films (2), comprising an upper packaging material element (3) and a lower packaging material element (4), which are connected to each other by means of a circumferential sealing surface or sealing seam (5) such that one on all sides enclosed cavity (6) for receiving the film (2) is formed, wherein - The upper packaging material element (3) and the lower packaging material element (4) in the region of the sealing surface or the sealing seam (5) each have at least one section (7, 8) which are congruent, and at least one cut (7, 8) is crossed by a fold or crease line (10),
characterized,
that the cut (7) is formed in the upper packaging material element (3) and the congruent section (8) in the lower packaging material element (4), that the respective end point (15,16) of the sections (7, 8) at a distance (M1) to the cavity (6) which corresponds at least to the width (M2) of the sealing seam (5). Verpackung (1) nach Anspruch 1,
dadurch gekennzeichnet,
dass der Schnitt (7) und der Schnitt (8) rechtwinklig zur nächstliegenden Außenkante (6a) des Hohlraums (6) ausgerichtet Ist.Packaging (1) according to claim 1,
characterized,
in that the cut (7) and the cut (8) are aligned at right angles to the nearest outer edge (6a) of the cavity (6). Verpackung (1) nach Anspruch 1,
dadurch gekennzeichnet,
dass das obere Packstoffelement (3) und das untere Packstoffelement (4) einteilig ausgebildet sind und eine Biegekante (17) bilden.Packaging (1) according to claim 1,
characterized,
that the upper packing material element (3) and the lower packing material element (4) are formed in one piece and form a bending edge (17). Verpackung (1) nach Anspruch 1,
dadurch gekennzeichnet,
dass die obere äußere Schicht (11) und/oder die untere äußere Schicht (12) bedruckbar ausgebildet sind/ist.Packaging (1) according to claim 1,
characterized,
that the upper outer layer (11) and / or the lower outer layer (12) is / are designed to be printable. Verpackung (1) nach einem der Ansprüche 1 bis 4,
dadurch gekennzeichnet,
dass die Siegelfläche bzw. die Siegelnaht (5) nicht peelbar ist.Packaging (1) according to one of claims 1 to 4,
characterized,
that the sealing surface or the sealing seam (5) is not peelable. Verpackung (1) nach einem der Ansprüche 1 bis 5,
dadurch gekennzeichnet,
dass jedes Packstoffelement (3, 4) eine äußere Schicht (11, 12) und eine Metallschicht (13, 14) und mindestens eine der beiden Packstoffelemente (3, 4) eine Siegelschicht (9) aufweist.Packaging (1) according to one of claims 1 to 5,
characterized,
in that each packaging material element (3, 4) has an outer layer (11, 12) and a metal layer (13, 14) and at least one of the two packaging material elements (3, 4) has a sealing layer (9).
EP20120005237 2012-07-17 2012-07-17 Package for films with a unitary dosage of an active substance Ceased EP2687458A1 (en)

Priority Applications (14)

Application Number Priority Date Filing Date Title
EP20120005237 EP2687458A1 (en) 2012-07-17 2012-07-17 Package for films with a unitary dosage of an active substance
CN201380044805.XA CN104640781B (en) 2012-07-17 2013-07-02 For single dose the film containing active material packaging part and for manufacturing the method for this packaging part
BR112015000813-5A BR112015000813B1 (en) 2012-07-17 2013-07-02 new single dose packaging
CA2878330A CA2878330C (en) 2012-07-17 2013-07-02 New single-dose packaging
AU2013292245A AU2013292245B2 (en) 2012-07-17 2013-07-02 Pack for individual active-substance-containing films, and method for producing said pack
KR20157000819A KR20150032702A (en) 2012-07-17 2013-07-02 Pack for individual active-substance-containing films, and method for producing said pack
ES13736824.7T ES2605432T3 (en) 2012-07-17 2013-07-02 Packaging for films containing active substance in unit dose and procedure for manufacturing this container
JP2015522029A JP6422436B2 (en) 2012-07-17 2013-07-02 New single dose packaging
PL13736824T PL2874908T3 (en) 2012-07-17 2013-07-02 Package for films with a unitary dosage of an active substance as well as the method for manufacturing said package
PCT/EP2013/063922 WO2014012787A1 (en) 2012-07-17 2013-07-02 Pack for individual active‑substance‑containing films, and method for producing said pack
EP13736824.7A EP2874908B1 (en) 2012-07-17 2013-07-02 Package for films with a unitary dosage of an active substance as well as the method for manufacturing said package
RU2015105053A RU2633954C2 (en) 2012-07-17 2013-07-02 Packaging for films containing single-dosed active substance and method of its manufacture
MX2015000790A MX351124B (en) 2012-07-17 2013-07-02 Pack for individual active-substance-containing films, and method for producing said pack.
HK15110625.5A HK1209713A1 (en) 2012-07-17 2015-10-28 Pack for individual active-substance-containing films, and method for producing said pack

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20120005237 EP2687458A1 (en) 2012-07-17 2012-07-17 Package for films with a unitary dosage of an active substance

Publications (1)

Publication Number Publication Date
EP2687458A1 true EP2687458A1 (en) 2014-01-22

Family

ID=46640511

Family Applications (2)

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EP20120005237 Ceased EP2687458A1 (en) 2012-07-17 2012-07-17 Package for films with a unitary dosage of an active substance
EP13736824.7A Active EP2874908B1 (en) 2012-07-17 2013-07-02 Package for films with a unitary dosage of an active substance as well as the method for manufacturing said package

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP13736824.7A Active EP2874908B1 (en) 2012-07-17 2013-07-02 Package for films with a unitary dosage of an active substance as well as the method for manufacturing said package

Country Status (13)

Country Link
EP (2) EP2687458A1 (en)
JP (1) JP6422436B2 (en)
KR (1) KR20150032702A (en)
CN (1) CN104640781B (en)
AU (1) AU2013292245B2 (en)
BR (1) BR112015000813B1 (en)
CA (1) CA2878330C (en)
ES (1) ES2605432T3 (en)
HK (1) HK1209713A1 (en)
MX (1) MX351124B (en)
PL (1) PL2874908T3 (en)
RU (1) RU2633954C2 (en)
WO (1) WO2014012787A1 (en)

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JP2015217970A (en) * 2014-05-19 2015-12-07 大日本印刷株式会社 Package

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ES2605432T3 (en) 2017-03-14
RU2633954C2 (en) 2017-10-19
CN104640781A (en) 2015-05-20
CA2878330C (en) 2020-04-14
CA2878330A1 (en) 2014-01-23
JP6422436B2 (en) 2018-11-14
BR112015000813A2 (en) 2017-06-27
PL2874908T3 (en) 2017-05-31
CN104640781B (en) 2016-11-09
EP2874908A1 (en) 2015-05-27
EP2874908B1 (en) 2016-09-07
RU2015105053A (en) 2016-09-10
AU2013292245B2 (en) 2016-08-18
MX351124B (en) 2017-10-02
AU2013292245A1 (en) 2015-02-05
WO2014012787A1 (en) 2014-01-23
JP2015524290A (en) 2015-08-24
BR112015000813B1 (en) 2021-01-26
KR20150032702A (en) 2015-03-27
HK1209713A1 (en) 2016-04-08
MX2015000790A (en) 2015-05-07

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