EP2874908A1 - Emballage pour films unidose contenant une substance active et son procédé de fabrication - Google Patents

Emballage pour films unidose contenant une substance active et son procédé de fabrication

Info

Publication number
EP2874908A1
EP2874908A1 EP13736824.7A EP13736824A EP2874908A1 EP 2874908 A1 EP2874908 A1 EP 2874908A1 EP 13736824 A EP13736824 A EP 13736824A EP 2874908 A1 EP2874908 A1 EP 2874908A1
Authority
EP
European Patent Office
Prior art keywords
packaging material
material element
sealing
packaging
cut
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
EP13736824.7A
Other languages
German (de)
English (en)
Other versions
EP2874908B1 (fr
Inventor
Thomas Hille
Gabriel WAUER
Helena GALLINGER
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 EP13736824.7A priority Critical patent/EP2874908B1/fr
Priority to PL13736824T priority patent/PL2874908T3/pl
Publication of EP2874908A1 publication Critical patent/EP2874908A1/fr
Application granted granted Critical
Publication of EP2874908B1 publication Critical patent/EP2874908B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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-drug-containing films or patches, 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 such that a cavity enclosed on all sides for receiving the film or plaster is, 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 (hereinafter referred to as "patch").
  • film-shaped oral dosage forms also known as oral thin films (OTF) or wafers, which consist of only one polymer layer (hereinafter
  • DE 10 2004 047 445 A1 discloses a non-resealable packaging for hazardous products, in particular pharmaceutical products, comprising a first packaging material element and a second packaging material element.
  • 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 Eiemente are releasably connected to each other, wherein between the two packaging material elements at least one enclosed on all sides cavity for receiving the packaged goods is formed.
  • the packaging has at least one second surface section which lies outside of or adjoins the first surface section and at the edge or edges of which the two packaging material elements are releasably connected to one another and wherein at least one of the two packaging material elements is provided with at least one structure is that extends within the second surface portion and which allows tearing of the / the packaging material / elements.
  • a package for active substance-containing films which has a carrier layer and a covering layer releasably connected thereto.
  • the packaging 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.
  • the user 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.
  • 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.
  • the diffusion of substances into the interior of the packaging should be prevented.
  • Darier the invention relates to a package for single-drug-containing films or patches, 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 formed on all sides cavity for receiving the film or plaster being, being
  • 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
  • the cut from i.) in the upper packaging material element and the congruent cut in the lower packaging material element is designed so that the respective end point of the cuts from i.) has a distance (M1) to the cavity or cavity edge which is at least the width (M2) corresponds to the sealed seam.
  • the width of the sealed seam (M2) is 1 to 25 mm, preferably 2 to 10 mm, particularly preferably 4 to 8 mm. Accordingly, the distance M1 from iii) according to the invention is at least the length of M2 or more, but it is preferred that M1 is not equal but longer than M2, in particular has an additional amount of 20% to 30% compared to M2. A non-exhaustive example is shown in FIG. Furthermore, it is preferred that the sealing seams are uniform. If, for example, a width (M2) of the sealing seam of 5 mm is selected, M1 may be 5 mm or more, preferably 6 to 10 mm. Embodiments of the invention are specified in the subclaims.
  • 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 cut in the upper and the cut in the lower packaging material element 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 exactly at a single point with the circulating sealing surface or sealing seam comes into contact, while in the known embodiments, there is a contact over a longer distance.
  • the said cuts have a sufficient distance along a cutting line to the introduced film or plaster, so that no damage occurs during tearing.
  • a suitable distance M3 is exemplified.
  • 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 drugs and humidity. Both heat sealing and cold sealing methods are contemplated.
  • As a material for sealing layers e.g. Hot melt adhesives, sealing waxes, Siegel dispersions or adhesives are used.
  • the invention relates to a method for producing a package for single-dose active substance-containing films or patches, comprising the steps i.) Providing 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 such that an all-round cavity for receiving the film or plaster is formed, wherein ii.) in each case at least one section is added to the upper packaging material element and the lower packaging material element in the region of the sealing surface or the sealing seam, which are congruent, and
  • Has cavity which corresponds at least to the width (M2) of the sealed seam of i.).
  • the method according to the invention can be designed further according to one of the preceding and following features.
  • the invention relates to the use of a package (1)
  • Claim 1 for receiving single doses such as active substance films, wafers or patches, in particular TTS patches.
  • Figure 1 is a plan view of a package for active substance-containing films.
  • FIG. 2 shows a sectional side view of the packaging from FIG. 1;
  • FIG. 1 a 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 sealing 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 cuts 7 and 8, which is identical to the tear-open edge, has a distance M3 from the nearest edge of the active substance-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 seal 5 in this area.
  • 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 also consists of a lower, outer,
  • the metal layers 13, 14 are preferably made of an aluminum foil having a thickness of 9 to 25 microns. This film 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 or sealing layer 9.
  • the sealing 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.

Landscapes

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

Abstract

L'invention concerne un emballage (1) destiné à des films ou des emplâtres (2) unidose contenant une substance active, comprenant un élément de matériau d'emballage supérieur (3) et un élément de matériau d'emballage inférieur (4) qui sont reliés l'un à l'autre au moyen d'une surface de scellement ou d'un cordon de scellement (5) périphérique de façon à former une cavité (6) fermée de tous les côtés destinée à recevoir le film ou l'emplâtre (2), dans lequel - l'élément de matériau d'emballage supérieur (3) et l'élément de matériau d'emballage inférieur (4) présentent chacun dans la zone de la surface de scellement ou du cordon de scellement (5) au moins une entaille (7, 8) coïncidente, et - au moins une entaille (7, 8) qui croise un trait de pliage ou flexion (10). L'entaille (7) de l'élément de matériau d'emballage supérieur (3) et l'entaille (8) coïncidente de l'élément de matériau d'emballage inférieur (4) sont formées de telle façon que chaque extrémité (15, 16) des entailles (7, 8) présente par rapport à la cavité (6) une distance (M1) qui correspond au moins à la largeur (M2) du cordon de scellement (5).
EP13736824.7A 2012-07-17 2013-07-02 Emballage pour films contenant une dose unitaire d' une substance active ainsi que le procédé pour fabriquer cet emballage Active EP2874908B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP13736824.7A EP2874908B1 (fr) 2012-07-17 2013-07-02 Emballage pour films contenant une dose unitaire d' une substance active ainsi que le procédé pour fabriquer cet emballage
PL13736824T PL2874908T3 (pl) 2012-07-17 2013-07-02 Opakowanie na dozowane pojedynczo, zawierające substancję czynną listki oraz sposób wytwarzania tego opakowania

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20120005237 EP2687458A1 (fr) 2012-07-17 2012-07-17 Emballage pour films contenant une dose unitaire d' une substance active.
EP13736824.7A EP2874908B1 (fr) 2012-07-17 2013-07-02 Emballage pour films contenant une dose unitaire d' une substance active ainsi que le procédé pour fabriquer cet emballage
PCT/EP2013/063922 WO2014012787A1 (fr) 2012-07-17 2013-07-02 Emballage pour films unidose contenant une substance active et son procédé de fabrication

Publications (2)

Publication Number Publication Date
EP2874908A1 true EP2874908A1 (fr) 2015-05-27
EP2874908B1 EP2874908B1 (fr) 2016-09-07

Family

ID=46640511

Family Applications (2)

Application Number Title Priority Date Filing Date
EP20120005237 Ceased EP2687458A1 (fr) 2012-07-17 2012-07-17 Emballage pour films contenant une dose unitaire d' une substance active.
EP13736824.7A Active EP2874908B1 (fr) 2012-07-17 2013-07-02 Emballage pour films contenant une dose unitaire d' une substance active ainsi que le procédé pour fabriquer cet emballage

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP20120005237 Ceased EP2687458A1 (fr) 2012-07-17 2012-07-17 Emballage pour films contenant une dose unitaire d' une substance active.

Country Status (13)

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

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102009008217A1 (de) * 2009-02-10 2010-08-19 Lts Lohmann Therapie-Systeme Ag Kindergesicherte, hochinerte Einzelverpackung
DE102014104692A1 (de) * 2014-04-02 2015-10-08 Huhtamaki Flexible Packaging Germany, Zweigniederlassung Der Huhtamaki Flexible Packaging Germany Gmbh & Co. Kg Verpackung
JP2015217970A (ja) * 2014-05-19 2015-12-07 大日本印刷株式会社 包装体
DE102021100782B3 (de) * 2021-01-15 2022-07-14 Lts Lohmann Therapie-Systeme Ag. Otf-verbindung durch nähen

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Publication number Priority date Publication date Assignee Title
US3809220A (en) * 1972-07-24 1974-05-07 Becton Dickinson Co Child safety package
US5511665A (en) * 1994-10-31 1996-04-30 G. D. Searle & Co. Child-resistant package
US6199698B1 (en) * 1999-12-03 2001-03-13 Alusuisse Technology & Management, Ltd. Pharmaceutical packaging with separation means
JP3984225B2 (ja) * 2002-02-08 2007-10-03 ザ プロクター アンド ギャンブル カンパニー 子供用安全袋
DE102004047445B4 (de) 2004-09-30 2007-05-31 Lts Lohmann Therapie-Systeme Ag Nichtwiederverschließbare Verpackung für gesundheitsgefährdende Erzeugnisse, Verwendung der Verpackung, sowie Verfahren zu deren Herstellung
DE102004062864A1 (de) * 2004-12-21 2006-06-22 Boehringer Ingelheim Pharma Gmbh & Co. Kg Folienbehälter
US20060283747A1 (en) * 2005-06-07 2006-12-21 Gloria Lam Family Partnership, Llc Condiment package with advertising for others
DE102006041921A1 (de) 2006-09-07 2008-03-27 Lts Lohmann Therapie-Systeme Ag Verpackung für wirkstoffhaltige Filme und Verfahren für deren Herstellung
CA2657689A1 (fr) * 2008-03-27 2009-09-27 Bruce D. Detwiler Emballages dechirables pour produit pharmaceutique, et methode
CN101712384A (zh) * 2008-09-30 2010-05-26 三洋电机株式会社 药品包装机
DE102009008217A1 (de) 2009-02-10 2010-08-19 Lts Lohmann Therapie-Systeme Ag Kindergesicherte, hochinerte Einzelverpackung
MX354293B (es) * 2010-12-23 2018-02-21 Lts Lohmann Therapie Systeme Ag Empaque de una sola dosis que sella de manera hermética.

Non-Patent Citations (1)

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Title
See references of WO2014012787A1 *

Also Published As

Publication number Publication date
AU2013292245B2 (en) 2016-08-18
AU2013292245A1 (en) 2015-02-05
EP2874908B1 (fr) 2016-09-07
BR112015000813B1 (pt) 2021-01-26
CN104640781A (zh) 2015-05-20
RU2015105053A (ru) 2016-09-10
CN104640781B (zh) 2016-11-09
HK1209713A1 (en) 2016-04-08
JP2015524290A (ja) 2015-08-24
BR112015000813A2 (pt) 2017-06-27
EP2687458A1 (fr) 2014-01-22
MX2015000790A (es) 2015-05-07
RU2633954C2 (ru) 2017-10-19
MX351124B (es) 2017-10-02
WO2014012787A1 (fr) 2014-01-23
CA2878330A1 (fr) 2014-01-23
ES2605432T3 (es) 2017-03-14
PL2874908T3 (pl) 2017-05-31
CA2878330C (fr) 2020-04-14
JP6422436B2 (ja) 2018-11-14
KR20150032702A (ko) 2015-03-27

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