EP2396241B1 - Emballage individuel hautement inerte doté d'une sécurité enfant - Google Patents
Emballage individuel hautement inerte doté d'une sécurité enfant Download PDFInfo
- Publication number
- EP2396241B1 EP2396241B1 EP10702621.3A EP10702621A EP2396241B1 EP 2396241 B1 EP2396241 B1 EP 2396241B1 EP 10702621 A EP10702621 A EP 10702621A EP 2396241 B1 EP2396241 B1 EP 2396241B1
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- Prior art keywords
- packaging
- packaging material
- line
- weakness
- dose
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Images
Classifications
-
- 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
-
- 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
-
- 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
- B31—MAKING 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
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B70/00—Making flexible containers, e.g. envelopes or bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING 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
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2160/00—Shape of flexible containers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING 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
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B2160/00—Shape of flexible containers
- B31B2160/10—Shape of flexible containers rectangular and flat, i.e. without structural provision for thickness of contents
-
- Y—GENERAL 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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/4998—Combined manufacture including applying or shaping of fluent material
Definitions
- the present invention relates to high-inert single-dose packages for film-shaped or sheet-like dosage forms and transdermal therapeutic systems (TTS), which are easy to open, yet child resistant, and have the features of the preamble of claim 1.
- the present invention also encompasses a method for producing the single-dose packages according to the invention, which is characterized by an 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 dosing 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.
- film-shaped dosage forms make special demands on the packaging, since the films are resistant to physical-chemical influences (eg light, moisture, oxygen) due to the large surface area and mechanical stresses are sensitive due to their structure.
- 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 should provide maximum safety against inadvertent self-medication, especially by children who, driven by curiosity, open the packages and frequently colored and to mask the bad taste and / or odor mix and consume the flavored medications with sweets or other sweets or apply the included TTS in the game.
- both the top and the bottom of the large-scale 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 an 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.
- US 2006/0023976 A1 and DE 10 2006 041 921 A1 known film packages, the object of providing a child-resistant packaging, which also provides protection of the packaged goods from chemical interference, by the use of a windable, made by heat sealing bag of two Solved films, each containing a thin layer of aluminum.
- the film packaging has a side cut, but does not cut the bag itself. As a result, the bags must be folded in the middle of the cut through an angle of 90 ° to produce 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.
- auxiliaries also cause reduced seal seam tightnesses for gases such as water vapor and oxygen, which impairs the storage stability of the packaging and leads to problems due to water absorption of hygroscopic products as well as increased degradation of oxygen-sensitive products.
- the material consumption for the production of the package is further increased by the fact that the opening of the package not sealed sections must be present, which serve as gripping aid for "peeling", wherein the minimum size of the Anfbus Anlagenn is limited by anatomical conditions.
- the object of the present invention is to provide a child-safe single-dose packaging for film-shaped or film-shaped dosage forms and transdermal therapeutic systems (TTS) based on sealed films, which ensures minimum film consumption per single dose, is inert to the packaged, is easy to open and yet has a maximum tightness of the sealed seam.
- TTS transdermal therapeutic systems
- the unit dose package of the present invention is a tearable end-sealable bag having a completely circumferential and continuous, non-interrupted, non-peelable sealing surface, the top and bottom sides of the sealed-edge bag being formed by two packaging material elements disposed one above the other and forming a receptacle for the package.
- the sealing surface preferably forms the outer boundaries of the packaging, so that there is no gripping possibility for a possible opening of the bag by "peeling", ie the opening of the bag by loosening the sealing seams from each other or from the adjacent laminate layers 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 density of the single-dose packaging.
- at least one packaging material element is a film laminate having an at least three-layered structure whose outermost layer, ie the layer facing away from the product, has a minimum tear strength of 30 N, so that it is not possible to open the packaging by simple tearing without auxiliary means. Due to the high tear 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.
- said outermost layer of the at least three-layered film laminate which is the cause of the tensile strength of the multilayer laminate, a line-shaped weakening (weakening line) with a reduced tear strength, wherein when using identical, tear-resistant packaging material elements directly superimposed lines of weakness are applied on both sides of the single-dose packaging.
- the weakening line is preferably produced by the fact that the outer, the packaged material facing away layer of the film laminate removed or significantly reduced in thickness, so that the tensile strength is reduced.
- 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.
- the line of weakness is a broken line, that is, that the tear-resistant layer has not been consistently removed, but small ridges of tear-resistant material remain, which do not hinder the tearing 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 violated and so maximum protection of the packaged material from moisture and oxygen is possible.
- the package since the beginning of the line of weakness does not affect the circumference of the package, the package must first be folded to expose the beginning of the line of weakness along which the package can be torn open and which dictates the course of the crack. While this two-step process is easy for an adult to manage, it is not obvious to children, especially the top one Layer of the film laminate is weakened, but not, as known in the art, the entire film through a well-recognizable incision, which would also arouse the interest of a child.
- a particularly preferred embodiment therefore provides for the outermost, tear-resistant layer to be removed only at the level of the marked bend region which is orthogonal to the weakening line and for the rest of the weakening line to reduce the layer thickness only so far that further tearing but no initial tearing takes place more is possible.
- 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.
- 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.
- the line of weakness be at least 50% of the length of the side of the package on which it is arranged extends, more preferably over at least 65%, more preferably over at least 80%, and most preferably over at least 90%, with a maximum extension limited to 95%, since the line of weakness does not affect the edge of the package 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.
- 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.
- the protrusion extends over two sides of the unit 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.
- 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 course of the crack while the product is additionally secured against slipping within the packaging by the narrower boundary of the sealing edge in the remaining receiving area in its position.
- 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.
- the line of weakness and / or the crease line can be characterized, for example by a color marking or other conventional means of identification.
- 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.
- packaging materials with an at least three-layer structure are particularly suitable.
- 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, take over the individual layers of the packaging material one or more functions.
- the outermost layer of the packaging material element is characterized by a high tear resistance, which can not be destroyed manually without additional tools.
- a high tear resistance which can not be destroyed manually without additional tools.
- 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 ⁇ m ; however, it is also possible to use other materials and layer thicknesses familiar to the person skilled in the art.
- the outer layer is also preferably printable, so that, for example, product labels and tearing aids can be attached.
- 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, tearing without weakening the outer layer is not possible.
- the middle layer consists of a metal foil, preferably aluminum, with a thickness of 9-25 ⁇ m . 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 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 comparable, known in the art foil welding process, as long as a non-detachable seal seam is obtained.
- the seal seams or sealing surfaces preferably have a 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 seal seam width can also be larger. To further complicate the opening of the package, at least one of the sealing seams may be wider than the other sealing seams.
- plastics known materials such as polyvinyl chloride come to the skilled artisan (PVC), polyvinylidene chloride (PVDC), polypropylene (PP), polyethylene (PE), Barex ® (BP Chemicals; copolymer of acrylonitrile and butadiene), Surlyn ®, Aclar TM (Honeywell, high-barrier films made from polychlorofluoroethylene [PCTFE]) and Topas ® -COC (Ticona; cyclo-olefin copolymer films) into consideration, typically the layer thickness of 20-100 ⁇ m, and plastics are particularly suitable, which are highly dense, compared with the Active ingredient of the packaged dosage form behave inert and / or adsorb this only slightly.
- PVDC polyvinylidene chloride
- PP polypropylene
- PE polyethylene
- Barex ® BP Chemicals; copolymer of acrylonitrile and butadiene
- Surlyn ® Aclar
- Surlyn ® is a high elongation plastic ionomer that contains metal ions in the molecular chain and thus has cross-linking.
- a preferred Aclar ® - film is Aclar ® 33.
- Aclar ® 33 is a copolymer consisting of chlorotrifluoroethylene substantially.
- TOPAS ® - COC are amorphous, transparent copolymers based on cyclic and linear olefins that are free of ionic ingredients.
- a preferred TOPAS ® - COC - film is prepared 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 packaging material element consists of a Barex ® layer (20 - 40 ⁇ m), an aluminum foil (9-25 ⁇ m) and a PET layer (10-30 ⁇ m).
- the thickness of the multilayer film laminate is preferably in the range of 35 to 300 ⁇ m , more preferably 50 to 200 ⁇ m .
- 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 below 2000 N, more preferably below 200 N, and most preferably below 100 N, measured on the two interconnected packaging material elements which form the packaging.
- 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 no sufficient protection of the packaged goods can be more guaranteed and there is a risk that the package opened unintentionally and / or the packaged goods is damaged. This can be determined by simple experiments.
- the tear propagation 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) (available, for example, from FRANK für Mikroorganismen GmbH, D-69488 Birkenau).
- the tear strength is a multiple of the tear propagation resistance.
- the ratio of tear strength to tear propagation resistance is in the range of 20: 1 to 500: 1, more preferably in the range of 50: 1 to 250: 1, based on the tear strength and tear propagation resistance 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.
- FIG. 1 shows a preferred embodiment of the single dose packaging according to the invention in plan view with protrusions of the product receiving area and position restrictors on two sides of the package and two orthogonal weakening lines that extend over the region of the bulges.
- FIG. 2 shows a single-dose packaging as in FIG. 1 but only with a line of weakness along one side of the package.
- FIG. 3 indicates the order of kinking and cracking operations for opening the unit dose package FIG. 1 ,
- the packaging (1) according to the invention is a sealed edge bag made of two superimposed packaging material elements, of which one packaging material element forms the cover layer and the other packaging material element the underlay, between which the product (5), preferably a transdermal therapeutic system or a film or film-like Darreichungsform is arranged.
- the two packaging material elements are sealed to one another 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 ').
- the sealed-edge bag has weakening lines (20, 21) with reduced tear strength, along which the packaging material elements can be torn open.
- the sealed-edge bag points in FIG. 1 Arches on the front edge and on the side edge 10 ', through which the line defined by the lines of weakness 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 the otherwise tear-resistant material of the packaging material elements only after the exposure of the beginning of the weakening line by folding the package along a crease line, which can optionally be given, torn open 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.
- 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, child-proof packaging does not require any additional surfaces to expose the tabs and the like as they do DE 10 2004 047 445 A1 are known.
- the individual packages are directly adjacent to each other and an additional, beyond the size of the packaged material consumption is only by the strength of the sealing surfaces and in certain embodiments by the Bulges and position restrictors conditional. 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 above-mentioned sequence of process steps is not mandatory;
- the weakening lines for tearing the packaging material can also be attached only in a later step.
- the insoluble bond between the packaging material elements is preferably produced by heat sealing at temperatures in the range between 50.degree. C. and 200.degree. C., in particular 50.degree. C. to 90.degree.
- the non-detachable 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.
- the packaging can be efficiently made from tape by serial production on rotary sealing machines.
- 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 material element, the lines of weakness are mounted directly opposite congruent.
- Another embodiment provides that in the product receiving area position restrictors, preferably by heat sealing, are arranged.
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Packages (AREA)
- Wrappers (AREA)
- Bag Frames (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Basic Packing Technique (AREA)
Claims (15)
- Emballage de doses individuelles pour des systèmes thérapeutiques transdermiques ou pour des formes d'administration en forme de feuilles se présentant sous la forme d'un sachet déchirable à bords scellés (1), comprenant deux éléments de matériau d'emballage, lesquels sont disposés l'un au-dessus de l'autre et forment la face supérieure et la face inférieure d'un sachet, lequel contient le produit (5), dans lequel au moins une couche de l'élément de matériau d'emballage est une couche métallique,
caractérisé en ce
qu'au moins un élément de matériau d'emballage est une feuille stratifiée avec une structure constituée d'au moins trois couches et la couche extérieure de la feuille stratifiée constituée d'au moins trois couches présente une résistance minimale à la déchirure de 30 N ;
dans lequel cette couche extérieure présente au moins un affaiblissement (20, 21) en forme de ligne, qui n'entre pas en contact avec le bord de l'emballage (1), de manière coïncidente sur la face supérieure et la face inférieure ; et l'affaiblissement (20, 21) en forme de ligne présente une résistance réduite à la déchirure en vue de l'ouverture de l'emballage (1) ; et en ce que les éléments de matériau d'emballage sont scellés ensemble tout autour du produit au moyen d'une surface de scellage ou d'un joint de scellage (3) continu(e), non pelable et entourant complètement sur toute la circonférence. - Emballage de doses individuelles selon la revendication 1,
caractérisé en ce que
la couche extérieure de la feuille stratifiée, laquelle se situe à l'opposé de la marchandise emballée (5), est soit supprimée, soit son épaisseur est considérablement réduite au niveau de la ligne d'affaiblissement (20, 21). - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
la ligne d'affaiblissement (20, 21) est produite par l'ablation au laser de la couche extérieure de la ou des feuilles stratifiées des éléments de matériau d'emballage. - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
l'affaiblissement (20, 21) en forme de ligne se prolonge aussi bien à travers la surface de scellage (3) qu'à travers la zone non scellée de réception du produit (4). - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
l'emballage présente deux affaiblissements (20, 21) en forme de ligne, lesquels se prolongent de préférence dans un angle droit l'un vis-à-vis de l'autre et se chevauchent en un point. - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
la ligne d'affaiblissement (20, 21) est une ligne interrompue. - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
la ligne d'affaiblissement (20, 21) se prolonge à travers la zone de réception du produit (4), à une distance inférieure à 5 mm, de préférence inférieure à 3 mm, en particulier de préférence inférieure à 2 mm et, de manière préférée entre toutes, inférieure à 1 mm, par rapport à la surface de scellage (3). - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
la ligne d'affaiblissement (20, 21) est caractérisée de manière optique. - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
le premier et le deuxième élément de matériau d'emballage possèdent une structure identique. - Emballage de doses individuelles selon l'une des revendications précédentes,
caractérisé en ce que
la zone de réception du produit (4) présente un bombement s'étendant jusque dans la surface de scellage (3), où la ou les lignes d'affaiblissement (20, 21) courent dans la zone du bombement à travers la zone de réception du produit (4) et, de préférence, le bombement ne se prolonge pas sur toute la longueur d'une face de la zone de réception du produit (4). - Procédé destiné à la production d'un emballage de doses individuelles selon l'une des revendications précédentes, comprenant les phases suivantes :- la préparation d'une première bande de matériau d'emballage avec une structure constituée d'au moins trois couches ;- la préparation d'une deuxième bande de matériau d'emballage ;- le positionnement de la marchandise emballée (5) sur l'une des deux bandes de matériau d'emballage ;- la superposition et la jonction des deux bandes de matériau d'emballage de telle manière que, pour chaque marchandise emballée (5), un compartiment, fermé de toute part et destiné à la réception de la marchandise emballée (5), est formé, au bord ou aux bords duquel les deux éléments de matériau d'emballage sont reliés l'un à l'autre, sur leur périphérie, de manière inséparable ;- la mise en place d'au moins une ligne d'affaiblissement (20, 21) par la suppression de la couche formant feuille la plus externe, résistante à la déchirure, de la feuille stratifiée multicouche, la ligne d'affaiblissement (20, 21) se prolongeant aussi bien à travers la surface de scellage (3) qu'à travers la zone non scellée de réception du produit (4), sans toutefois toucher le bord de l'emballage devant être produit ;- la séparation des unités d'emballage qui se succèdent par une découpe ou une perforation réalisée le long d'une ligne qui se prolonge, dans la zone de la surface de scellage (3), transversalement à la direction de bande des bandes de matériau d'emballage.
- Procédé selon la revendication 11,
caractérisé en ce que
la ligne d'affaiblissement (20, 21) est produite par une ablation au laser ou par un entaillage au laser. - Procédé selon l'une des revendications précédentes,
caractérisé en ce que
la première et la deuxième feuille stratifiée présentent une structure constituée d'au moins trois couches et les lignes d'affaiblissement (20, 21) sont mises en place directement à l'opposé l'une de l'autre. - Procédé selon l'une des revendications précédentes,
caractérisé en ce que
les bandes de matériau d'emballage sont reliées l'une à l'autre au moyen de joints de scellage des surfaces de scellage (3), en particulier en recourant à un agent de scellage. - Utilisation de l'emballage de doses individuelles selon l'une des revendications 1 à 10 en vue de l'emballage de systèmes thérapeutiques transdermiques ou pour des formes d'administration en forme de feuilles.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE200910008217 DE102009008217A1 (de) | 2009-02-10 | 2009-02-10 | Kindergesicherte, hochinerte Einzelverpackung |
PCT/EP2010/000638 WO2010091813A1 (fr) | 2009-02-10 | 2010-02-03 | Emballage individuel hautement inerte doté d'une sécurité enfant |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2396241A1 EP2396241A1 (fr) | 2011-12-21 |
EP2396241B1 true EP2396241B1 (fr) | 2017-06-07 |
Family
ID=42046212
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP10702621.3A Active EP2396241B1 (fr) | 2009-02-10 | 2010-02-03 | Emballage individuel hautement inerte doté d'une sécurité enfant |
Country Status (17)
Country | Link |
---|---|
US (2) | US9145248B2 (fr) |
EP (1) | EP2396241B1 (fr) |
JP (1) | JP5738200B2 (fr) |
KR (1) | KR20110124288A (fr) |
CN (1) | CN102307793B (fr) |
AU (1) | AU2010213197B2 (fr) |
BR (1) | BRPI1008174B1 (fr) |
CA (1) | CA2751998C (fr) |
DE (1) | DE102009008217A1 (fr) |
ES (1) | ES2638773T3 (fr) |
HK (1) | HK1162011A1 (fr) |
IL (1) | IL214410A0 (fr) |
MX (1) | MX2011008384A (fr) |
PH (1) | PH12015500229A1 (fr) |
RU (1) | RU2517131C9 (fr) |
WO (1) | WO2010091813A1 (fr) |
ZA (1) | ZA201105522B (fr) |
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DE102011107939A1 (de) * | 2011-07-19 | 2013-01-24 | Lts Lohmann Therapie-Systeme Ag | Einzeldosisverpackung für transdermale therapeutische Systeme oder folienförmige Darreichungsformen |
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AR084451A1 (es) * | 2010-12-23 | 2013-05-15 | Lohmann Therapie Syst Lts | Envase tipo bolsa altamente inerte a prueba de niños, para peliculas que contienen sustancias activas, de una sola dosis |
EP2687458A1 (fr) * | 2012-07-17 | 2014-01-22 | LTS LOHMANN Therapie-Systeme AG | Emballage pour films contenant une dose unitaire d' une substance active. |
-
2009
- 2009-02-10 DE DE200910008217 patent/DE102009008217A1/de not_active Withdrawn
-
2010
- 2010-02-03 BR BRPI1008174-7A patent/BRPI1008174B1/pt active IP Right Grant
- 2010-02-03 ES ES10702621.3T patent/ES2638773T3/es active Active
- 2010-02-03 CN CN201080007209.0A patent/CN102307793B/zh active Active
- 2010-02-03 EP EP10702621.3A patent/EP2396241B1/fr active Active
- 2010-02-03 AU AU2010213197A patent/AU2010213197B2/en not_active Ceased
- 2010-02-03 WO PCT/EP2010/000638 patent/WO2010091813A1/fr active Application Filing
- 2010-02-03 CA CA2751998A patent/CA2751998C/fr active Active
- 2010-02-03 RU RU2011137191/12A patent/RU2517131C9/ru not_active IP Right Cessation
- 2010-02-03 KR KR20117020863A patent/KR20110124288A/ko not_active Application Discontinuation
- 2010-02-03 MX MX2011008384A patent/MX2011008384A/es active IP Right Grant
- 2010-02-03 JP JP2011548592A patent/JP5738200B2/ja active Active
-
2011
- 2011-07-27 ZA ZA2011/05522A patent/ZA201105522B/en unknown
- 2011-08-02 IL IL214410A patent/IL214410A0/en unknown
- 2011-08-09 US US13/136,746 patent/US9145248B2/en active Active
-
2012
- 2012-03-14 HK HK12102569.3A patent/HK1162011A1/xx unknown
-
2015
- 2015-02-02 PH PH12015500229A patent/PH12015500229A1/en unknown
- 2015-07-18 US US14/803,039 patent/US9597852B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
US20150321438A1 (en) | 2015-11-12 |
HK1162011A1 (en) | 2012-08-17 |
PH12015500229A1 (en) | 2015-04-13 |
US9145248B2 (en) | 2015-09-29 |
JP2012517387A (ja) | 2012-08-02 |
US20120006707A1 (en) | 2012-01-12 |
CN102307793A (zh) | 2012-01-04 |
ES2638773T3 (es) | 2017-10-24 |
ZA201105522B (en) | 2012-10-31 |
EP2396241A1 (fr) | 2011-12-21 |
WO2010091813A1 (fr) | 2010-08-19 |
RU2517131C2 (ru) | 2014-05-27 |
CN102307793B (zh) | 2014-02-19 |
CA2751998C (fr) | 2016-08-09 |
JP5738200B2 (ja) | 2015-06-17 |
AU2010213197A1 (en) | 2011-09-01 |
BRPI1008174A2 (pt) | 2016-03-01 |
BRPI1008174B1 (pt) | 2019-04-24 |
RU2517131C9 (ru) | 2015-03-20 |
KR20110124288A (ko) | 2011-11-16 |
CA2751998A1 (fr) | 2010-08-19 |
AU2010213197B2 (en) | 2015-04-30 |
IL214410A0 (en) | 2011-09-27 |
DE102009008217A1 (de) | 2010-08-19 |
RU2011137191A (ru) | 2013-03-20 |
MX2011008384A (es) | 2011-09-06 |
US9597852B2 (en) | 2017-03-21 |
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