EP2850018B1 - Device for holding a medicine blister - Google Patents

Device for holding a medicine blister Download PDF

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Publication number
EP2850018B1
EP2850018B1 EP13722402.8A EP13722402A EP2850018B1 EP 2850018 B1 EP2850018 B1 EP 2850018B1 EP 13722402 A EP13722402 A EP 13722402A EP 2850018 B1 EP2850018 B1 EP 2850018B1
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EP
European Patent Office
Prior art keywords
blister
punching
tablet
capsule
cover film
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.)
Active
Application number
EP13722402.8A
Other languages
German (de)
French (fr)
Other versions
EP2850018A1 (en
Inventor
Thomas Hogh JENSEN
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.)
Boehringer Ingelheim International GmbH
Original Assignee
Boehringer Ingelheim International GmbH
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Publication date
Application filed by Boehringer Ingelheim International GmbH filed Critical Boehringer Ingelheim International GmbH
Priority to EP13722402.8A priority Critical patent/EP2850018B1/en
Publication of EP2850018A1 publication Critical patent/EP2850018A1/en
Application granted granted Critical
Publication of EP2850018B1 publication Critical patent/EP2850018B1/en
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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
    • A61J1/035—Blister-type containers
    • 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
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • 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
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/04—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
    • B65D83/0445—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments
    • B65D83/0463—Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments formed in a band or a blisterweb, inserted in a dispensing device or container
    • 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
    • B65D2583/00—Containers or packages with special means for dispensing contents
    • B65D2583/04—For dispensing annular, disc-shaped or spherical or like small articles or tablets
    • B65D2583/0404—Indications, e.g. directions for use
    • B65D2583/0409—Indications, e.g. directions for use of dates or follow-numbers

Definitions

  • the invention relates to a device for receiving and storing blister packs, in particular blister packs, by which the integrity of the blister is ensured, and which is characterized in that individual medicament units, such as e.g. Tablets or capsules can be removed individually from the blister and removed from the device.
  • blister packs in particular blister packs
  • individual medicament units such as e.g. Tablets or capsules
  • a tablet is to be understood as meaning not only compressed powder, powder mixture or granules with and without a coating but also correspondingly filled capsules or dragees.
  • the invention relates to a device for receiving blister packs, in particular medicament blisters, the blister pack containing a medicament capsule consisting of gelatin or hydroxypropylmethylcellulose (HPMC) into which a powder or a granulate is filled.
  • a medicament capsule consisting of gelatin or hydroxypropylmethylcellulose (HPMC) into which a powder or a granulate is filled.
  • HPMC hydroxypropylmethylcellulose
  • the claimed device ensures that for the patient a regular removal of the product is made possible, wherein the drug is protected by the blister pack until shortly before use against external influences.
  • Tablet dispensers which are devices in which cases tablets are stored, and which have the functionality of providing a single tablet by operating a release agent, are known in the art ( WO2004 / 026728 . EP0822151 ).
  • devices which are suitable for receiving a blister pack, and having a means or one or more stamps, by means of which the tablets can be pressed individually from the blister, so that these pressed from the blister tablets accessible to the patient ( US4074806 . DE4134237 . WO8909042 ).
  • Such a device which further includes a means for punching the cover sheet of the blister is also in US5431283 disclosed.
  • a blister in particular a drug blister is meant a film container with two to form a receiving chamber for a product, in particular a pharmaceutical drug formulation, circumferentially interconnected, in particular square-shaped films.
  • the film containers serve to protect pharmaceutical active ingredient formulations from environmental influences from the outside, which under certain circumstances may influence the pharmaceutical quality of the active substance formulation.
  • Drugs for medicaments consist of a bottom foil or bottom plate which contains several e.g. having circular or oval cavities arranged.
  • the individual wells each contain a tablet or capsule containing the drug formulation.
  • a blister pack is understood to mean a cold-formed or thermoformed blister bottom portion having cavities for receiving a drug, e.g. the tablets or capsules, wherein the bottom part is sealed to a cover sheet.
  • the cover film and the bottom film can also be composed of one or more layers of different or the same materials.
  • the cover sheet is z with the bottom sheet. B. connected by gluing, welding or sealing sealed.
  • the cover film and / or the carrier film is usually formed as metal and / or plastic and / or paper foil. These materials can be present in multiple layers.
  • Typical metal foils include, for example, aluminum foils and aluminum composite foils made of aluminum and, for example, a plastic.
  • plastic films can polyvinyl chloride (PVC) cycloolefin copolymer (COC), polychlorotrifluoroethylene (PCFE), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), polyester (UP), polyacrylate, polyamide (PA) or other plastics.
  • PVC polyvinyl chloride
  • COC cycloolefin copolymer
  • PCFE polychlorotrifluoroethylene
  • PE polyethylene
  • PP polypropylene
  • PET polyethylene terephthalate
  • PC polycarbonate
  • UP polyester
  • PA polyacrylate
  • PA polyamide
  • a blister consists of a cover foil of aluminum and a bottom foil for receiving the pharmaceutical product in the cavities of the bottom foil.
  • the deep-drawn bottom foil may also be an aluminum foil.
  • blisters can be designed in the form of a push-through blister.
  • a push-through blister is to be understood as a blister in which the individual removal of medicaments from the blister, such as e.g. Capsules, tablets and dragees by expressing the tablets, capsules or dragees containing wells (cavities) can be removed.
  • the blister can be configured such that the integrity of the blister cavity, and thus the cover sheet, is maintained even if an attempt is made to obtain the drug by a squeezing operation on the well, but this is not possible.
  • Such blisters which do not allow the product to become accessible by pressing on the cavity, are not push-through blisters (also referred to below as non-blister blisters).
  • non-push-through blisters Blisters which, due to their technical design, do not allow the drug, eg the tablet, to be accessible by pressing on the cavity (well), but rather have a different opening mechanism (non-push-through blisters), are known in the art.
  • non-push-through blisters provide increased protection for the drug from external environmental influences and / or meet specific child safety requirements because the drug is not accessible by simply pressing on the blister cavity.
  • Such blisters are for example in US 3941248 . US 4243144 . US 3811564 . US 3,921,805 . US 6422391 . US 3924746 and WO 2006/067096 disclosed.
  • the object is achieved by a device which is suitable for receiving and storing a blister pack (4), in particular a blister for medicaments, and for extracting a tablet or capsule (12) from the blister pack (4), which is characterized in that the device comprises a means (3) by means of which by pressing a button (10) the cover foil of a blister cup (5) is punched around the tablet or capsule (12) and subsequently the tablet or capsule (12) from the blister cup (5) can be removed.
  • the term "key” is understood to mean a movable field which can be actuated by mechanical actuation, e.g. caused by a finger triggering the agent (3).
  • the means (3) comprises a tool, e.g.
  • blister packaging is to be understood as equivalent to blister packs and represents a pharmaceutical blister in a particular manner.
  • a blister consists of a bottom film which is welded to a cover film, the blister having cavities suitable for holding a tablet or Capsule or dragee serve.
  • the cavities can be generated, for example, by shaping (deep-drawing) the bottom foil and are also called blister pots in the following.
  • Blisters, in the special drug blister thus consist of a thermoformed bottom sheet containing blister pens as formations in which the drug (tablet or capsule) are inserted, the filled blister pots are sealed by sealing with a cover sheet.
  • the cover sheet thus has an almost flat level, while the bottom sheet has deformations (blister pens).
  • the invention comprises a device of the type described above or below, which is characterized in that the device has an upper part (1) and a lower part (2), the lower part (2) being trough-shaped for receiving a blister ( 4) is formed and holding elements (6) serving as (uniform) support structure (6), and which is adapted to fix the blister (4) in the lower part (2), wherein when inserting the blister, the formations of the blister pots (5) to the lower part (2) and thus the blister (4) is fixed against lateral displacement and the web height of the support structure (6) at least the embossing depth of the blister cup (5) corresponds.
  • holding elements (6) are understood to mean means which ensure that the blister pots in the lower part of the device are protected and positioned against displacement of the blister in the lower part, that the blister poppet is cut open by the use of the punching means (3) .
  • the holding elements also serve as a support structure (6), so that in the application of the punching means (3), which causes a directed mechanical force on the cover sheet in the direction of the blister cup, it is avoided that the blister cup is pressed against the lower part.
  • the holding elements (6) can have the shape of a wall which partially or completely surrounds the blister pots.
  • the lower part can have further means (8a), (8b) for fixing the blister in the lower part.
  • the fixing means (8a), (8b) serve the purpose of preventing the blister from accidentally falling out, e.g. is protected while turning on the open device on the head.
  • the fixing means may have the form of webs on the longitudinal side of the lower part, under which the blister can be inserted or clamped in the lower part. Conveniently, the insertion or clamping of the blister takes place in the lower part by bending the blister in the longitudinal direction and simultaneous positioning of the blister edge under the fixing means (8a), (8b).
  • the fixing means (8a), (8b) in connection with the holding elements (6) that the device according to the invention can be used for blisters having different blister outer dimensions, provided the distance between the blister cups and the size of the blister cups are comparable between the blisters with different Blisterau salchen.
  • the device consisting of an upper part and a lower part, be designed such that the lower part consists of a trough-shaped bottom part and a matching insert.
  • the insert serves to receive the blister and accordingly has retaining elements (6) which serve as a (uniform) support structure (6).
  • the insert contains the fixing means (8a), (8b) for fixing the blister.
  • the insert may include a support structure (9) which ensures that the assembled top and bottom insert with blister loaded in the holding position, i. is held in the position before triggering the punching means (3), and the cutting edge and / or the teeth spaced from the cover sheet of the blister (4) is positioned.
  • the invention comprises a
  • the device comprises an upper part (1) and a lower part (2), the upper part (1) containing means (3) for punching out the tablet or capsule (12), and the punching means (3) is formed wall-shaped with a cutting edge and / or teeth, so that upon actuation of the means (3) the cut edge and / or teeth cuts open the cover foil of a blister cup (5).
  • Equivalent according to the invention are the terms "means (3) for punching out” the tablet or capsule (12) and “punching means”.
  • this punching means is formed wall-shaped with a cutting edge directed to the cover sheet.
  • the cutting edge is provided with pointed teeth. This embodiment requires that upon actuation of the punching means (3) first puncturing / perforating the cover sheet with subsequent tearing open / cut the cover sheet along the cutting line of the punching means.
  • the invention comprises a device of the type described above or below, which is characterized in that prior to actuation of the means (3) for punching the tablet or capsule, the holding position of the cutting edge and / or teeth of the punching means (3) by a support structure (9) and / or a web (7) spaced from the cover sheet of the blister (4) inserted into the device, and after actuation of the punching means (3), the cut edge and / or the teeth of the cover sheet circular, partially circular, semicircular, arcuate or oval and spaced from the tablet or capsule (12) cuts the cover sheet.
  • the punching means (3) is positioned in the holding position without contact with the cover film of the inserted blister.
  • stop position is the starting position (rest position) of the punching means, ie to understand the position of the punching means before pressing the punching means.
  • the cutting edge and / or the teeth of the punching means is spaced at least 1 mm from the cover sheet. More preferably, the distance is at least 2 mm. More preferably, the distance is 1-3 mm. More preferably, the distance is 1-2 mm.
  • the device according to the invention additionally includes a cover for the upper part, which is designed such that it prevents accidental actuation of a button for triggering the punching means (3).
  • the lid is thus designed such that the operation fields for the punching means (3) not
  • the invention comprises a device of the type described above or below, which is characterized in that after pressing the punching means (3), the cut edge and / or the teeth penetrates the cover sheet 1 to a maximum of 2 mm.
  • a further preferred embodiment of the device according to the invention is when the wall-shaped cutting edge and / or teeth of the punching means (3) has a free inner diameter which is greater than the diameter / outer circumference of the tablet or capsule.
  • the invention comprises a device of the type described above or below, which is characterized in that the device is suitable for receiving a blister (4) of at least 2 rows and the upper part (1) has a web (7). contains, which presses the blister in the lower part with the device closed, so that it is ensured that the cutting edge and / or teeth of the punching means in the rest position spaced from the cover sheet of the blister (4). Also included according to the invention is a kit consisting of the device according to the invention and a double-row blister, or a kit of the device, and parts of divisible blisters, so that the sum of the blister pens is even.
  • the invention comprises a device of the type described above or below, which is characterized in that the upper part (1) including the means (3) for punching out the tablet or the capsule (12) from the blister (4). and the web (7) for spacing the punching means (3) of the upper part (1) from the cover sheet of the blister is made of a single plastic part, the means (3) for punching out the tablet or capsule (12) being movable with the cover in that the circular, part-circular, semicircular, arcuate or oval means are separated by a gap from the cover to a connection point so that the punching means is connected to the cover on only one side, the connection point being in the form of an axis, and the axis optionally has a material weakening in the axis line, and the punching means (3) by pressing on the same elastic abs Enken leaves.
  • an embodiment is also included, which is characterized in that the upper part contains the punching means (3) in the form of a wing or flap, wherein the wing or the flap is connected on one side, the axis of the upper part.
  • the connection between the punching means and the upper part is configured elastically.
  • an embodiment is also included, which is characterized in that the upper part including the punching means (3) represents a single part, which is made of plastic, preferably by means of injection molding.
  • the invention comprises a device of the kind described above or below, characterized in that the device has the capacity for receiving the necessary medication of a patient, which the patient needs in 7 days, the drug being taken twice a day is administered in the evening and in the morning and the button for triggering the means for punching the tablet or capsule by a symbol (11a) or (11b) is marked, so that an association of the medication to a dose in the morning or evening is possible , and characterized in that the device signatures (13), which an association of the medication, on a particular day of the week, eg Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday is required.
  • the invention comprises a device of the type described above or below, which is characterized in that the blister (4) contains a pharmaceutical formulation containing dabigatran etexilate.
  • the invention comprises a device of the type described above or below, which is characterized in that the blister (4) contains as medicament inhalation capsules, preferably inhalation capsules containing the active ingredient tiotropium.
  • the invention comprises the use of a means (3) for punching the cover sheet of a blister cup (5) so that a tablet or capsule (12) can be removed from the blister cup (5) after the punching operation.
  • the invention also comprises the use of a means (3) for punching the cover foil of a blister cup (5), so that a tablet or capsule (12) can be removed from the blister cup (5) after the punching process, characterized in that this means ( 3) in a device suitable for storing a medicament blister (4).
  • a device suitable for storing a medicament blister (4) is made of plastic, for example made of polyolefin, polyethylene, polypropylene, polycarbonate.
  • the device consists of 2 parts (upper part and lower part) and 3 parts (upper part and lower part, wherein the lower part consists of a trough-shaped bottom part and an insert for receiving the blister).
  • the invention additionally comprises a lid for the device.
  • the invention also comprises a manufacturing method for the device, characterized in that the individual parts of the device are produced by means of injection molding.
  • the device according to the invention is shown consisting of an upper part and a lower part, wherein after opening the device, a blister can be inserted into the device.
  • the opened device is shown.
  • the punching means (3) Integrated into the upper part (1) are the punching means (3).
  • the device contains the same number of punching means, which corresponds to the number of blister pots (5) containing the blister (s) (optionally split blister) to be picked up.
  • a blister or a part of a divisible blister can be inserted into the lower part by insertion into the fixing means (8a), (8b), so that the blister pots (5) are protected by the Halteelmente (6) before moving in the lower part.
  • the support structure (6) serves in addition to its function as a holding element as a means to protect the blister pans from deformation.
  • FIG 3 the closed device is shown, pressing on an actuating panel / button (10), which has the shape of a wing, the integrated punching means in the cover sheet of the inserted blister (not visible) can be pressed.
  • the operations / buttons (10) are provided with symbols that allow the patient to recognize whether the appropriate medication (tablet or capsule) should be taken in the morning (11a) or in the evening (11b).
  • the upper part may additionally contain signatures (13), which allows an association of the medication at a specific time of administration, eg weekday.
  • Figure 4 the opened device is shown with a blister after performing the punching process. After punching the cover sheet and opening the device, the tablet or capsule can then be removed from the blister cup.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Mechanical Engineering (AREA)
  • Medical Informatics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Description

Die Erfindung bezieht sich auf eine Vorrichtung zur Aufnahme und Aufbewahrung von Blisterverpackungen, insbesondere Arzneimittelblister, durch die die Integrität des Blisters sichergestellt ist, und die dadurch gekennzeichnet ist, dass einzelne Arzneimitteleinheiten, wie z.B. Tabletten oder Kapseln einzeln aus dem Blister herausgelöst und aus der Vorrichtung entnommen werden können.The invention relates to a device for receiving and storing blister packs, in particular blister packs, by which the integrity of the blister is ensured, and which is characterized in that individual medicament units, such as e.g. Tablets or capsules can be removed individually from the blister and removed from the device.

Viele pharmazeutische Produkte werden in Form von Tabletten in Blistern auf den Markt gebracht, wobei einige dieser Tabletten relativ klein und insbesondere von älteren Personen, die eine verringerte Beweglichkeit ihrer Hände besitzen, schwer zu handhaben sind. Eine leicht zu handhabende spezielle Vorrichtung, die geeignet ist, eine einzelne Tablette aus einem Blister herauszulösen, vereinfacht das Handling der Tablette.Many pharmaceutical products are marketed in the form of tablets in blisters, some of which are relatively small in size and difficult to handle, particularly by elderly persons who have reduced mobility of their hands. An easy-to-use special device that is capable of extracting a single tablet from a blister simplifies the handling of the tablet.

Unter einer Tablette ist im Sinne der Erfindung nicht nur verpresstes Pulver, PulverGemisch oder Granulat mit und ohne einen Überzug sondern auch entsprechend gefüllte Kapseln oder Dragees zu verstehen. In einer speziellen Ausführungsform betrifft die Erfindung eine Vorrichtung zur Aufnahme von Blisterverpackungen, insbesondere Arzneimittelblister, wobei die Blisterverpackung eine Arzneimittelkapsel enthält, welche aus Gelatine oder Hydroxypropylmethylcellulose (HPMC) besteht, in welche ein Pulver oder ein Granulat gefüllt ist.For the purposes of the invention, a tablet is to be understood as meaning not only compressed powder, powder mixture or granules with and without a coating but also correspondingly filled capsules or dragees. In a specific embodiment, the invention relates to a device for receiving blister packs, in particular medicament blisters, the blister pack containing a medicament capsule consisting of gelatin or hydroxypropylmethylcellulose (HPMC) into which a powder or a granulate is filled.

Es besteht somit der Bedarf, eine Vorrichtung zur Aufnahme von Blisterverpackungen der eingangs genannten Art bereitzustellen, die bei einem einfachen Aufbau es ermöglicht,

  1. (i) einerseits dass das Arzneimittel, z.B. Tablette, entsprechend den pharmazeutischen Anforderungen des Arzneimittels geschützt im Blister aufbewahrt werden kann und andererseits,
  2. (ii) dass das Arzneimittel durch einfache Betätigung aus dem Blister mithilfe der Vorrichtung entnommen werden kann.
There is thus a need to provide a device for receiving blister packs of the type mentioned, which allows a simple structure,
  1. (i) on the one hand that the medicament, eg tablet, can be kept protected in the blister in accordance with the pharmaceutical requirements of the medicament and, on the other hand,
  2. (ii) that the drug can be removed from the blister by simple operation with the aid of the device.

Insbesondere wird durch die beanspruchte Vorrichtung sichergestellt, dass für den Patienten eine regelmäßige Entnahme des Produktes ermöglicht wird, wobei das Arzneimittel durch die Blisterverpackung bis kurz vor der Anwendung gegenüber äußeren Einflüssen geschützt ist.In particular, it is ensured by the claimed device that for the patient a regular removal of the product is made possible, wherein the drug is protected by the blister pack until shortly before use against external influences.

Erfindungsgemäß wird die Aufgabe durch die Merkmale des Anspruchs 1 gelöst. Die Unteransprüche stellen vorteilhafte Ausgestaltungen der Erfindung dar.According to the invention the object is achieved by the features of claim 1. The subclaims represent advantageous embodiments of the invention.

Stand der TechnikState of the art

Tablettenspender, die Vorrichtungen darstellen, in deren Gehäuse Tabletten bevorratet werden, und die die Funktionalität aufweisen, dass durch Betätigung eines Freigabemittels eine einzelne Tablette zur Verfügung gestellt wird, sind im Stand der Technik bekannt ( WO2004/026728 , EP0822151 ). Ebenso sind im Stand der Technik Vorrichtungen bekannt, die zur Aufnahme einer Blisterverpackung geeignet sind, und die ein Mittel bzw. einen oder mehrere Stempel aufweisen, mit Hilfe derer die Tabletten einzelnen aus dem Blister gedrückt werden können, so dass diese aus dem Blister gedrückte Tabletten dem Patienten zugänglich sind ( US4074806 , DE4134237 , WO8909042 ).Tablet dispensers, which are devices in which cases tablets are stored, and which have the functionality of providing a single tablet by operating a release agent, are known in the art ( WO2004 / 026728 . EP0822151 ). Likewise, in the prior art devices are known which are suitable for receiving a blister pack, and having a means or one or more stamps, by means of which the tablets can be pressed individually from the blister, so that these pressed from the blister tablets accessible to the patient ( US4074806 . DE4134237 . WO8909042 ).

Eine solche Vorrichtung, die ferner ein Mittel zum Stanzen der Deckfolie des Blisters enthält, wird auch in US5431283 offenbart.Such a device, which further includes a means for punching the cover sheet of the blister is also in US5431283 disclosed.

Unter einem Blister, im speziellen einem Arzneimittelblister versteht man einen Folienbehälter mit zwei zur Ausbildung einer Aufnahmekammer für ein Füllgut, insbesondere eine pharmazeutische Wirkstoffformulierung, umlaufend miteinander verbundenen, insbesondere viereckförmigen Folien. Die Folienbehälter dienen unter anderem dazu, pharmazeutische Wirkstoffformulierungen vor Umwelteinflüssen von außen zu schützen, die unter Umständen die pharmazeutische Qualität der Wirkstoffformulierung beeinflussen können.Under a blister, in particular a drug blister is meant a film container with two to form a receiving chamber for a product, in particular a pharmaceutical drug formulation, circumferentially interconnected, in particular square-shaped films. Among other things, the film containers serve to protect pharmaceutical active ingredient formulations from environmental influences from the outside, which under certain circumstances may influence the pharmaceutical quality of the active substance formulation.

Blister für Arzneimittel bestehen aus einer Bodenfolie oder Bodenplatte, die mehrere z.B. kreisförmig oder oval angeordnete Kavitäten aufweist. Die einzelnen Kavitäten enthalten jeweils eine Tablette oder Kapsel, die die Wirkstoffformulierung enthält. Typischerweise versteht man unter einer Blisterverpackung ein kaltverformtes oder thermogeformtes Blisterbodenteil, welches Kavitäten zur Aufnahme eines Arzneimittels, z.B. die Tabletten oder Kapseln, enthält, wobei das Bodenteil mit einer Deckfolie abgedichtet verbunden ist.Drugs for medicaments consist of a bottom foil or bottom plate which contains several e.g. having circular or oval cavities arranged. The individual wells each contain a tablet or capsule containing the drug formulation. Typically, a blister pack is understood to mean a cold-formed or thermoformed blister bottom portion having cavities for receiving a drug, e.g. the tablets or capsules, wherein the bottom part is sealed to a cover sheet.

Die Deckfolie und die Bodenfolie können dabei auch aus einer oder mehreren Schichten verschiedener oder gleicher Materialien aufgebaut sein. Die Deckfolie wird mit der Bodenfolie z. B. durch Kleben, Schweißen oder Versiegeln abgedichtet verbunden. Die Deckfolie und/oder die Trägerfolie ist in der Regel als Metall- und/oder Kunststoff und/oder Papierfolie ausgebildet. Diese Materialien können in mehreren Schichten vorhanden sein. Typische Metallfolien umfassen beispielsweise Aluminiumfolien und Aluminiumverbundfolien, die aus Aluminium und z.B. einem Kunststoff gefertigt sind. Als Material für die Kunststofffolien kann Polyvinylchlorid (PVC) Cycloolefin-Copolymer (COC), Polychlortrifluorethylen (PCFE), Polyethylen (PE), Polypropylen (PP), Polyethylenterephtalat (PET), Polycarbonat (PC), Polyester (UP), Polyacrylat, Polyamid (PA) oder andere Kunststoffe verwendet werden. Häufig besteht ein Blister aus einer Deckfolie aus Aluminium und einer Bodenfolie zur Aufnahme des pharmazeutischen Produktes in den Kavitäten der Bodenfolie.The cover film and the bottom film can also be composed of one or more layers of different or the same materials. The cover sheet is z with the bottom sheet. B. connected by gluing, welding or sealing sealed. The cover film and / or the carrier film is usually formed as metal and / or plastic and / or paper foil. These materials can be present in multiple layers. Typical metal foils include, for example, aluminum foils and aluminum composite foils made of aluminum and, for example, a plastic. As a material for the plastic films can polyvinyl chloride (PVC) cycloolefin copolymer (COC), polychlorotrifluoroethylene (PCFE), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), polyester (UP), polyacrylate, polyamide (PA) or other plastics. Often a blister consists of a cover foil of aluminum and a bottom foil for receiving the pharmaceutical product in the cavities of the bottom foil.

Die tiefgezogene Bodenfolie kann ebenfalls eine Aluminiumfolie sein. Ebenso können die Bodenfolien aus Polyvinylchlorid (PVC), Polyvinylidenchlorid (PVDC), Polypropylen (PP), Polyethylenterephthalat (PET), Polyethylen (PE) sowie Verbundfolien wie PVC/ACLAR® (PCTFE), PVC/PVDC und COC oder FORMPACK® (Al-Al Blister) bestehen.The deep-drawn bottom foil may also be an aluminum foil. Similarly, the bottom foils of polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polypropylene (PP), polyethylene terephthalate (PET), polyethylene (PE) and composite films such as PVC / ACLAR® (PCTFE), PVC / PVDC and COC or FORMPACK® (Al -Al blisters) exist.

In einer spezifischen Ausführung können Blister in Form eines Durchdrückblisters ausgestaltet sein. Unter einem Durchdrückblister ist dabei ein Blister zu verstehen, bei dem die Einzelentnahme von Medikamenten aus dem Blister, wie z.B. Kapseln, Tabletten und Dragees durch Ausdrücken der die Tabletten, Kapseln oder Dragees enthaltenden Näpfe (Kavitäten) entnommen werden können. Dagegen kann in einer weiteren speziellen Ausführungsform der Blister derart ausgestaltet sein, dass die Integrität der Blisterkavität und folglich der Deckfolie auch dann erhalten bleibt, wenn versucht wird, durch einen Drückvorgang auf den Napf das Arzneimittel zu erlangen, jedoch dies nicht möglich ist. Derartige Blister, die es nicht ermöglichen, dass das Produkt durch Drücken auf die Kavität zugängig wird, sind keine Durchdrückblister (im folgenden auch Nicht-Durchdrückblister bezeichnet).In a specific embodiment, blisters can be designed in the form of a push-through blister. A push-through blister is to be understood as a blister in which the individual removal of medicaments from the blister, such as e.g. Capsules, tablets and dragees by expressing the tablets, capsules or dragees containing wells (cavities) can be removed. In contrast, in another specific embodiment, the blister can be configured such that the integrity of the blister cavity, and thus the cover sheet, is maintained even if an attempt is made to obtain the drug by a squeezing operation on the well, but this is not possible. Such blisters, which do not allow the product to become accessible by pressing on the cavity, are not push-through blisters (also referred to below as non-blister blisters).

Blister, die aufgrund ihrer technischen Auslegung es nicht ermöglichen, dass das Arzneimittel, z.B. die Tablette durch Drücken auf die Kavität (Napf) zugängig ist, die vielmehr einen anderen Öffnungsmechanismus aufweisen (Nicht-Durchdrückblister), sind im Stand der Technik bekannt. Beispielsweise gewähren derartige Nicht-Durchdrückblister einen erhöhten Schutz für das Arzneimittel gegen äußere Umwelteinflüsse und/oder erfüllen spezielle Anforderungen bezüglich Kindersicherheit, da das Arzneimittel nicht durch einfaches Drücken auf die Blisterkavität zugängig ist. Derartige Blister sind beispielsweise in US 3941248 , US 4243144 , US 3811564 , US 3921805 , US 6422391 , US 3924746 und WO 2006/067096 offenbart.Blisters which, due to their technical design, do not allow the drug, eg the tablet, to be accessible by pressing on the cavity (well), but rather have a different opening mechanism (non-push-through blisters), are known in the art. For example, such non-push-through blisters provide increased protection for the drug from external environmental influences and / or meet specific child safety requirements because the drug is not accessible by simply pressing on the blister cavity. Such blisters are for example in US 3941248 . US 4243144 . US 3811564 . US 3,921,805 . US 6422391 . US 3924746 and WO 2006/067096 disclosed.

Es ist Aufgabe der Erfindung, eine Vorrichtung der eingangs genannten Art bereit zu stellen, die zur Aufnahme und Aufbewahrung eines Blisters geeignet ist, und die ein Mittel zum Öffnen der einzelnen Kavitäten eines Blisters enthält, wobei die Funktionalität des Öffnungsmechanismus auch für Nicht-Durchdrückblister anwendbar ist.It is an object of the invention to provide a device of the type mentioned, which is suitable for receiving and storing a blister, and which contains a means for opening the individual cavities of a blister, wherein the functionality the opening mechanism is also applicable to non-push-through blister.

Beschreibung der ErfindungDescription of the invention

Erfindungsgemäß wird die Aufgabe durch eine Vorrichtung gelöst, die zur Aufnahme und Aufbewahrung einer Blisterverpackung (4), insbesondere eines Blisters für Arzneimittel, und zum Herauslösen einer Tablette oder Kapsel (12) aus der Blisterverpackung (4), geeignet ist, die dadurch gekennzeichnet ist, dass die Vorrichtung ein Mittel (3) enthält, mit Hilfe dessen durch Betätigen einer Taste (10) die Deckfolie eines Blisternapfs (5) um die Tablette oder Kapsel (12) gestanzt wird und darauffolgend die Tablette oder Kapsel (12) aus dem Blisternapf (5) entnommen werden kann. In Sinne der vorliegenden Erfindung ist hierbei unter Taste ein bewegliches Feld zu verstehen, welches durch mechanische Betätigung z.B. mittels eines Fingers das Auslösen des Mittels (3) bewirkt. Das Mittel (3) umfasst hierbei ein Werkzeug, z.B. eine Schnittkante, die dazu dient, die Deckfolie aufzuschneiden. Im Sinne der vorliegenden Erfindung ist Blisterverpackung gleichbedeutend mit Blister zu verstehen und stellt im besonderen Maße einen Arzneimittelblister dar. Gemäß üblicher Definition besteht ein Blister aus einer Bodenfolie, welche mit einer Deckfolie verschweißt ist, wobei der Blister Kavitäten aufweist, die zur Aufnahme einer Tablette oder Kapsel oder auch Dragee dienen. Die Kavitäten sind hierbei beispielsweise durch Ausformung (Tiefziehen) der Bodenfolie generierbar und werden im folgenden auch Blisternäpfe genannt. Blister, im speziellen Arzneimittelblister, bestehen somit aus einer tiefgezogenen Bodenfolie, die Blisternäpfe als Ausformungen enthält, in die das Arzneimittel (Tablette oder Kapsel) eingelegt sind, wobei die gefüllten Blisternäpfe durch versiegeln mit einer Deckfolie verschlossen sind. Die Deckfolie weißt somit ein nahezu ebenförmiges Niveau auf, während hingegen die Bodenfolie Verformungen (Blisternäpfe) aufweist.According to the invention, the object is achieved by a device which is suitable for receiving and storing a blister pack (4), in particular a blister for medicaments, and for extracting a tablet or capsule (12) from the blister pack (4), which is characterized in that the device comprises a means (3) by means of which by pressing a button (10) the cover foil of a blister cup (5) is punched around the tablet or capsule (12) and subsequently the tablet or capsule (12) from the blister cup (5) can be removed. For the purposes of the present invention, the term "key" is understood to mean a movable field which can be actuated by mechanical actuation, e.g. caused by a finger triggering the agent (3). The means (3) comprises a tool, e.g. a cutting edge, which serves to cut open the cover sheet. For the purposes of the present invention, blister packaging is to be understood as equivalent to blister packs and represents a pharmaceutical blister in a particular manner. According to the usual definition, a blister consists of a bottom film which is welded to a cover film, the blister having cavities suitable for holding a tablet or Capsule or dragee serve. The cavities can be generated, for example, by shaping (deep-drawing) the bottom foil and are also called blister pots in the following. Blisters, in the special drug blister, thus consist of a thermoformed bottom sheet containing blister pens as formations in which the drug (tablet or capsule) are inserted, the filled blister pots are sealed by sealing with a cover sheet. The cover sheet thus has an almost flat level, while the bottom sheet has deformations (blister pens).

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass die Vorrichtung ein Oberteil (1) und ein Unterteil (2) aufweist, wobei das Unterteil (2) wannenförmig zur Aufnahme eines Blisters (4) ausgebildet ist und Halteelemente (6) aufweist, die als (gleichförmige) Stützstruktur (6) dient, und die geeignet ist, um den Blister (4) im Unterteil (2) zu fixieren, wobei beim Einlegen des Blisters die Ausformungen der Blisternäpfe (5) zum Unterteil (2) zeigen und somit der Blister (4) auch gegen seitliches Verschieben fixiert ist und die Steghöhe der Stützstruktur (6) mindestens der Prägungstiefe des Blisternapfs (5) entspricht.In a further embodiment according to the invention, the invention comprises a device of the type described above or below, which is characterized in that the device has an upper part (1) and a lower part (2), the lower part (2) being trough-shaped for receiving a blister ( 4) is formed and holding elements (6) serving as (uniform) support structure (6), and which is adapted to fix the blister (4) in the lower part (2), wherein when inserting the blister, the formations of the blister pots (5) to the lower part (2) and thus the blister (4) is fixed against lateral displacement and the web height of the support structure (6) at least the embossing depth of the blister cup (5) corresponds.

Unter Halteelemente (6) im Sinne der Erfindung sind Mittel zu verstehen, die bedingen, dass die Blisternäpfe im Unterteil der Vorrichtung derart gegen ein Verschieben des Blisters im Unterteil geschützt und positioniert sind, dass durch die Anwendung des Stanzmittels (3) der Blisternapf aufgeschnitten wird. Die Haltelemente dienen auch als Stützstruktur (6), so dass bei der Anwendung des Stanzmittels (3), welches eine gerichtete mechanische Kraft auf die Deckfolie in Richtung des Blisternapfs bewirkt, es vermieden wird, dass der Blisternapf gegen das Unterteil gedrückt wird. In einer speziellen Ausführungsform können die Haltelemente (6) die Ausformung einer Wandung haben, die die Blisternäpfe teilweise oder vollständig umschließen.For the purposes of the invention, holding elements (6) are understood to mean means which ensure that the blister pots in the lower part of the device are protected and positioned against displacement of the blister in the lower part, that the blister poppet is cut open by the use of the punching means (3) , The holding elements also serve as a support structure (6), so that in the application of the punching means (3), which causes a directed mechanical force on the cover sheet in the direction of the blister cup, it is avoided that the blister cup is pressed against the lower part. In a special embodiment, the holding elements (6) can have the shape of a wall which partially or completely surrounds the blister pots.

In einer weiteren Ausführungsform kann das Unterteil weitere Mittel (8a), (8b) zur Fixierung des Blisters im Unterteil aufweisen. Die Fixierungsmittel (8a), (8b) dienen dem Zweck, dass der Blister gegen versehentliches Herausfallen, z.B. beim auf den-Kopf Drehen der geöffneten Vorrichtung geschützt ist. Das Fixierungsmittel kann dabei die Form von Stegen an der Längsseite des Unterteils haben, unter die der Blister in das Unterteil eingeschoben oder eingeklemmt werden kann. Zweckmäßiger Weise erfolgt das Einschieben oder Einklemmen des Blisters in das Unterteil durch Biegen des Blisters in Längsrichtung und gleichzeitiger Positionierung der Blisterkante unter das Fixierungsmittel (8a), (8b). In vorteilhafter Art und Weise wird durch das Fixierungsmittel (8a), (8b) in Verbindung mit den Haltelementen (6) sichergestellt, dass die erfindungsgemäße Vorrichtung für Blister mit unterschiedlichen Blisteraußenmaßen einsetzbar ist, sofern der Abstand zwischen den Blisternäpfen sowie die Größe der Blisternäpfe vergleichbar zwischen den Blistern mit unterschiedlichen Blisteraußenmaßen ist.In a further embodiment, the lower part can have further means (8a), (8b) for fixing the blister in the lower part. The fixing means (8a), (8b) serve the purpose of preventing the blister from accidentally falling out, e.g. is protected while turning on the open device on the head. The fixing means may have the form of webs on the longitudinal side of the lower part, under which the blister can be inserted or clamped in the lower part. Conveniently, the insertion or clamping of the blister takes place in the lower part by bending the blister in the longitudinal direction and simultaneous positioning of the blister edge under the fixing means (8a), (8b). In an advantageous manner, it is ensured by the fixing means (8a), (8b) in connection with the holding elements (6) that the device according to the invention can be used for blisters having different blister outer dimensions, provided the distance between the blister cups and the size of the blister cups are comparable between the blisters with different Blisteraußenmaßen.

In einer weiteren Ausführungsform kann die Vorrichtung, bestehend aus einem Oberteil und einem Unterteil, derart ausgestaltet sein, dass das Unterteil aus einem wannenförmigen Bodenteil und einem passenden Einsatz besteht. Dabei dient der Einsatz zur Aufnahme des Blisters und weist dementsprechend Halteelemente (6), die als (gleichförmige) Stützstruktur (6) dient, auf. Ebenso enthält der Einsatz die Fixierungsmittel (8a), (8b) zur Fixierung des Blisters. Gegebenenfalls kann der Einsatz eine Stützstruktur (9) enthalten, die sicherstellt, dass die zusammengesetzte Vorrichtung aus Oberteil und Bodenteil mit Einsatz, in dem ein Blister eingelegt ist, in der Halteposition, d.h. in der Position vor Auslösen des Stanzmittels (3), gehalten wird und die Schnittkante und/oder die Zähne beabstandet von der Deckfolie des Blisters (4) positioniert ist.In a further embodiment, the device, consisting of an upper part and a lower part, be designed such that the lower part consists of a trough-shaped bottom part and a matching insert. The insert serves to receive the blister and accordingly has retaining elements (6) which serve as a (uniform) support structure (6). Likewise, the insert contains the fixing means (8a), (8b) for fixing the blister. Optionally, the insert may include a support structure (9) which ensures that the assembled top and bottom insert with blister loaded in the holding position, i. is held in the position before triggering the punching means (3), and the cutting edge and / or the teeth spaced from the cover sheet of the blister (4) is positioned.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eineIn a further embodiment of the invention, the invention comprises a

Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass die Vorrichtung ein Oberteil (1) und ein Unterteil (2) aufweist, wobei das Oberteil (1) Mittel (3) zum Ausstanzen der Tablette oder Kapsel (12) enthält, und das Ausstanzmittel (3) wandförmig mit einer Schnittkante und/oder Zähnen ausgebildet ist, so dass beim Betätigen des Mittels (3) die Schnittkante und/oder Zähne die Deckfolie eines Blisternapfs (5) aufschneidet. Erfindungsgemäß gleichbedeutend sind die Begriffe "Mittel (3) zum Ausstanzen" der Tablette oder Kapsel (12) und "Stanzmittel". Bevorzugt ist dieses Stanzmittel wandförmig mit einer zur Deckfolie gerichteten Schnittkante ausgebildet. In einer speziellen Ausführungsform ist die Schnittkante mit spitzzulaufenden Zähnen versehen. Diese Ausführungsform bedingt, dass beim Betätigen des Stanzmittels (3) zuerst eine Punktierung/Perforierung der Deckfolie mit nachfolgendem aufreißen/aufschneiden der Deckfolie entlang der Schnittlinie des Stanzmittels erfolgt.Device of the type described above or below, characterized in that the device comprises an upper part (1) and a lower part (2), the upper part (1) containing means (3) for punching out the tablet or capsule (12), and the punching means (3) is formed wall-shaped with a cutting edge and / or teeth, so that upon actuation of the means (3) the cut edge and / or teeth cuts open the cover foil of a blister cup (5). Equivalent according to the invention are the terms "means (3) for punching out" the tablet or capsule (12) and "punching means". Preferably, this punching means is formed wall-shaped with a cutting edge directed to the cover sheet. In a special embodiment, the cutting edge is provided with pointed teeth. This embodiment requires that upon actuation of the punching means (3) first puncturing / perforating the cover sheet with subsequent tearing open / cut the cover sheet along the cutting line of the punching means.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass vor Betätigung des Mittels (3) zum Ausstanzen der Tablette oder der Kapsel die Halteposition der Schnittkante und/oder Zähnen des Ausstanzmittels (3) durch eine Stützstruktur (9) und/oder einen Steg (7) beabstandet von der Deckfolie des in die Vorrichtung eingelegten Blisters (4) ist, und nach Betätigen des Stanzmittels (3) die Schnittkante und/oder die Zähne die Deckfolie kreisförmig, teilkreisförmig, halbkreisförmig, bogenförmig oder oval und beabstandet zu der Tablette oder Kapsel (12) die Deckfolie aufschneidet.
Erfindungsgemäß wird durch die Stützstruktur (9) und/oder Steg (7) sichergestellt, dass das Stanzmittel (3) bei Nicht-Betätigen desselben kontaktfrei zur Deckfolie des eingelegten Blisters in der Halteposition positioniert ist. Unter Halteposition ist hierbei die Ausgangsstellung (Ruhestellung) des Stanzmittels, d.h. die Position des Stanzmittels vor betätigen des Stanzmittels zu verstehen. Bevorzugt ist dabei sichergestellt, dass die Schnittkante und/oder die Zähne des Stanzmittels mindestens 1 mm von der Deckfolie beabstandet ist. Weiter bevorzugt beträgt der Abstand mindestens 2 mm. Weiter bevorzugt beträgt der Abstand 1-3 mm. Weiter bevorzugt beträgt der Abstand 1-2 mm. In einer weiteren Ausführungsform beinhaltet die erfindungsgemäße Vorrichtung zusätzlich einen Deckel für das Oberteil, welcher derart ausgestaltet ist, dass dieser eine versehentliche Betätigung einer Taste zum Auslösen des Stanzmittels (3) verhindert. Der Deckel ist folglich derart ausgestaltet, dass die Betätigungsfelder für das Stanzmittel (3) nichtIn a further embodiment of the invention, the invention comprises a device of the type described above or below, which is characterized in that prior to actuation of the means (3) for punching the tablet or capsule, the holding position of the cutting edge and / or teeth of the punching means (3) by a support structure (9) and / or a web (7) spaced from the cover sheet of the blister (4) inserted into the device, and after actuation of the punching means (3), the cut edge and / or the teeth of the cover sheet circular, partially circular, semicircular, arcuate or oval and spaced from the tablet or capsule (12) cuts the cover sheet.
According to the invention, it is ensured by the support structure (9) and / or web (7) that the punching means (3) is positioned in the holding position without contact with the cover film of the inserted blister. Under stop position here is the starting position (rest position) of the punching means, ie to understand the position of the punching means before pressing the punching means. It is preferably ensured that the cutting edge and / or the teeth of the punching means is spaced at least 1 mm from the cover sheet. More preferably, the distance is at least 2 mm. More preferably, the distance is 1-3 mm. More preferably, the distance is 1-2 mm. In a further embodiment, the device according to the invention additionally includes a cover for the upper part, which is designed such that it prevents accidental actuation of a button for triggering the punching means (3). The lid is thus designed such that the operation fields for the punching means (3) not

zugängig sind, bevor nicht der Deckel geöffnet oder entfernt wird.are accessible before the lid is opened or removed.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass nach Betätigen des Stanzmittels (3) die Schnittkante und/oder die Zähne die Deckfolie 1 bis maximal 2 mm durchdringt.
Eine erfindungsgemäß weitere bevorzugte Ausführungsform der Vorrichtung ist, wenn die wandförmige Schnittkante und/oder Zähne des Stanzmittels (3) einen freien Innendurchmesser aufweist, der größer als der Durchmesser / des äußeren Umfangs der Tablette oder Kapsel ist.In a further embodiment of the invention, the invention comprises a device of the type described above or below, which is characterized in that after pressing the punching means (3), the cut edge and / or the teeth penetrates the cover sheet 1 to a maximum of 2 mm.
A further preferred embodiment of the device according to the invention is when the wall-shaped cutting edge and / or teeth of the punching means (3) has a free inner diameter which is greater than the diameter / outer circumference of the tablet or capsule.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass die Vorrichtung für die Aufnahme eines mindestens 2-reihigen Blister (4) geeignet ist und das Oberteil (1) einen Steg (7) enthält, der bei geschlossener Vorrichtung den Blister in das Unterteil drückt, so dass sichergestellt ist, dass die Schnittkante und/oder Zähne des Stanzmittels in der Ruhe-Position beabstandet von der Deckfolie des Blisters (4) ist.
Erfindungsgemäß umfasst ist auch ein Kit bestehend aus der erfindungsgemäßen Vorrichtung und einem zweireihigen Blister, beziehungsweise einem Kit aus der Vorrichtung und Teilen von teilbaren Blistern, so dass die Summe der Blisternäpfe geradzahlig ist.In a further embodiment of the invention, the invention comprises a device of the type described above or below, which is characterized in that the device is suitable for receiving a blister (4) of at least 2 rows and the upper part (1) has a web (7). contains, which presses the blister in the lower part with the device closed, so that it is ensured that the cutting edge and / or teeth of the punching means in the rest position spaced from the cover sheet of the blister (4).
Also included according to the invention is a kit consisting of the device according to the invention and a double-row blister, or a kit of the device, and parts of divisible blisters, so that the sum of the blister pens is even.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass das Oberteil (1) inklusive der Mittel (3) zum Ausstanzen der Tablette oder der Kapsel (12) aus dem Blister (4) sowie dem Steg (7) zur Beabstandung der Stanzmittel (3) des Oberteils (1) von der Deckfolie des Blisters aus einem einzigen Kunststoffteil gefertigt ist, wobei die Mittel (3) zum Ausstanzen der Tablette oder der Kapsel (12) beweglich mit dem Deckel verbunden sind, indem die kreisförmigen, teilkreisförmigen, halbkreisförmigen, bogenförmigen oder ovalen Mittel durch einen Spalt vom Deckel bis auf eine Verbindungsstelle getrennt sind, so dass das Stanzmittel nur an einer Seite mit dem Deckel verbunden ist, wobei die Verbindungstelle die Form einer Achse hat, und die Achse gegebenenfalls eine Materialschwächung in der Achsenlinie aufweist, und sich das Stanzmittel (3) durch Drücken auf dasselbe elastisch absenken lässt.In a further embodiment of the invention, the invention comprises a device of the type described above or below, which is characterized in that the upper part (1) including the means (3) for punching out the tablet or the capsule (12) from the blister (4). and the web (7) for spacing the punching means (3) of the upper part (1) from the cover sheet of the blister is made of a single plastic part, the means (3) for punching out the tablet or capsule (12) being movable with the cover in that the circular, part-circular, semicircular, arcuate or oval means are separated by a gap from the cover to a connection point so that the punching means is connected to the cover on only one side, the connection point being in the form of an axis, and the axis optionally has a material weakening in the axis line, and the punching means (3) by pressing on the same elastic abs Enken leaves.

Erfindungsgemäß ist auch eine Ausführungsform umfasst, die dadurch gekennzeichnet ist, dass das Oberteil das Stanzmittel (3) in Form eines Flügels oder Klappe enthält, wobei der Flügel oder die Klappe einseitig, achsenförmig mit dem Oberteil verbunden ist. Erfindungsgemäß bevorzugt ist die Verbindung zwischen dem Stanzmittel und dem Oberteil elastisch ausgestaltet. Erfindungsgemäß ist auch eine Ausführungsform umfasst, die dadurch gekennzeichnet ist, dass das Oberteil inklusive dem Stanzmittel (3) ein einziges Teil darstellt, welches aus Kunststoff gefertigt ist, bevorzugt mittels Spritzgießens.According to the invention an embodiment is also included, which is characterized in that the upper part contains the punching means (3) in the form of a wing or flap, wherein the wing or the flap is connected on one side, the axis of the upper part. Preferably according to the invention, the connection between the punching means and the upper part is configured elastically. According to the invention, an embodiment is also included, which is characterized in that the upper part including the punching means (3) represents a single part, which is made of plastic, preferably by means of injection molding.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass die Vorrichtung die Kapazität für die Aufnahme der notwendigen Medikamentation eines Patienten aufweist, die der Patient in 7 Tagen benötigt, wobei das Medikament zweimal täglich, jeweils abends und morgens verabreicht wird und die Taste zum Auslösen des Mittels zum Ausstanzen der Tablette oder Kapsel durch ein Symbol (11a) bzw. (11b) gekennzeichnet ist, so dass eine Zuordnung der Medikamentation zu einer Gabe am Morgen oder am Abend ermöglicht ist, sowie dadurch gekennzeichnet, dass die Vorrichtung Signaturen (13) aufweist, welche eine Zuordnung der Medikamentation, die an einem bestimmten Wochentag, z.B. "Montag", "Dienstag", "Mittwoch", "Donnerstag", "Freitag", "Samstag", "Sonntag" benötigt wird, ermöglicht wird.In a further embodiment of the invention, the invention comprises a device of the kind described above or below, characterized in that the device has the capacity for receiving the necessary medication of a patient, which the patient needs in 7 days, the drug being taken twice a day is administered in the evening and in the morning and the button for triggering the means for punching the tablet or capsule by a symbol (11a) or (11b) is marked, so that an association of the medication to a dose in the morning or evening is possible , and characterized in that the device signatures (13), which an association of the medication, on a particular day of the week, eg Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday is required.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass der Blister (4) eine pharmazeutische Formulierung enthaltend Dabigatran etexilate enthält.In a further embodiment of the invention, the invention comprises a device of the type described above or below, which is characterized in that the blister (4) contains a pharmaceutical formulation containing dabigatran etexilate.

In einer weiteren erfindungsgemäßen Ausführungsform umfasst die Erfindung eine Vorrichtung der oben oder unten beschriebenen Art, die dadurch gekennzeichnet ist, dass der Blister (4) als Medikament Inhalationskapseln, bevorzugt Inhalationskapseln, die den Wirkstoff Tiotropium enthalten, enthält.In a further embodiment of the invention, the invention comprises a device of the type described above or below, which is characterized in that the blister (4) contains as medicament inhalation capsules, preferably inhalation capsules containing the active ingredient tiotropium.

Ebenso umfasst die Erfindung die Verwendung eines Mittels (3) zum Stanzen der Deckfolie eines Blisternapfs (5), so dass eine Tablette oder Kapsel (12) nach dem Stanzvorgang aus dem Blisternapf (5) entnommen werden kann.Likewise, the invention comprises the use of a means (3) for punching the cover sheet of a blister cup (5) so that a tablet or capsule (12) can be removed from the blister cup (5) after the punching operation.

Die Erfindung umfasst ebenso die Verwendung eines Mittels (3) zum Stanzen der Deckfolie eines Blisternapfs (5), so dass eine Tablette oder Kapsel (12) nach dem Stanzvorgang aus dem Blisternapf (5) entnommen werden kann, dadurch gekennzeichnet, dass dieses Mittel (3) in einer Vorrichtung, die geeignet zur Aufbewahrung eines Arzneimittelblisters (4) ist, enthalten ist.
Erfindungsgemäß ist die beanspruchte Vorrichtung aus Kunststoff, z.B. aus Polyolefin, Polyethylen, Polypropylen, Polycarbonat gefertigt. Bevorzugt besteht die Vorrichtung aus 2 Teilen (Oberteil und Unterteil) bzw. 3 Teilen (Oberteil und Unterteil, wobei das Unterteil aus einem wannenförmigen Bodenteil und einem Einsatz zur Aufnahme des Blisters besteht). Gegebenenfalls umfasst die Erfindung zusätzlich einen Deckel für die Vorrichtung. Die Erfindung umfasst ebenso ein Herstellverfahren für die Vorrichtung, dadurch gekennzeichnet, dass die einzelnen Teile der Vorrichtung mittels Spritzgießens hergestellt werden.The invention also comprises the use of a means (3) for punching the cover foil of a blister cup (5), so that a tablet or capsule (12) can be removed from the blister cup (5) after the punching process, characterized in that this means ( 3) in a device suitable for storing a medicament blister (4).
According to the claimed device is made of plastic, for example made of polyolefin, polyethylene, polypropylene, polycarbonate. Preferably, the device consists of 2 parts (upper part and lower part) and 3 parts (upper part and lower part, wherein the lower part consists of a trough-shaped bottom part and an insert for receiving the blister). Optionally, the invention additionally comprises a lid for the device. The invention also comprises a manufacturing method for the device, characterized in that the individual parts of the device are produced by means of injection molding.

Die Erfindung wird im Folgenden anhand eines Ausführungsbeispielss unter Bezugnahme auf die zugehörigen Zeichnungen näher erläutert. Es zeigt:

  • Abb.1 Draufsicht auf eine erfindungsgemäße Vorrichtung zur Aufnahme einer Blisterverpackung und zum Herauslösen einer Tablette oder Kapsel aus der Blisterverpackung.
  • Abb.2 Geöffnete erfindungsgemäße Vorrichtung, wobei ein Blister gemäß angegebener Pfeile in das Unterteil der Vorrichtung geschoben und im Unterteil fixiert wird.
  • Abb.3 Geschlossene erfindungsgemäße Vorrichtung (mit eingelegtem Blister - nicht sichtbar), wobei durch Betätigen einer Taste das Stanzmittel ausgelöst wird.
  • Abb.4 Nach Stanzvorgang geöffnete Vorrichtung, welche einen Blister enthält, wobei die Deckfolie eines Blisternapfs durch den Stanzvorgang aufgeschnitten ist und die freigelegte Kapsel aus dem Blisternapf entnommen werden kann.
The invention will be explained in more detail below with reference to an exemplary embodiment with reference to the accompanying drawings. It shows:
  • Fig.1 Top view of an inventive device for receiving a blister pack and for extracting a tablet or capsule from the blister pack.
  • Fig.2 Open device according to the invention, wherein a blister is pushed according to indicated arrows in the lower part of the device and fixed in the lower part.
  • Fig.3 Closed device according to the invention (with inserted blister - not visible), wherein the punching means is triggered by pressing a button.
  • Fig.4 After punching open device containing a blister, wherein the cover sheet of a Blisternapfs is cut by the punching operation and the exposed capsule can be removed from the Blisternapf.

Bezugszeichenliste:LIST OF REFERENCE NUMBERS

  • (1) Oberteil der Vorrichtung(1) Top part of the device
  • (2) Unterteil der Vorrichtung(2) Bottom part of the device
  • (3) Ausstanzmittel / Mittel mit Schnittkante und/oder Zähnen zum Aufschneiden der Deckfolie eines Blisternapfs(3) Punching means / cut edge means and / or teeth for slicing the cover sheet of a blister pint
  • (4) Blisterverpackung / Blister / Arzneimittelblister(4) blister pack / blister / drug blister
  • (5) Blisternapf(5) blister pot
  • (6) Halteelemente / Stützstruktur(6) Retaining elements / support structure
  • (7) Steg im Oberteil zur Beabstandung des Ausstanzmittels von der Deckfolie des Blisters in der Ruheposition(7) Bar in the upper part for spacing the punching means from the cover foil of the blister in the rest position
  • (8a) Steg zur Fixierung des Blisters am Unterteil der Vorrichtung(8a) web for fixing the blister to the lower part of the device
  • (8b) Steg zur Fixierung des Blisters am Unterteil der Vorrichtung(8b) web for fixing the blister to the lower part of the device
  • (9) Stützstruktur zur Beabstandung des Ausstanzmittels von der Deckfolie des Blisters in der Ruheposition des Ausstanzmittels(9) A support structure for spacing the punching means from the cover sheet of the blister in the rest position of the punching means
  • (10) Betätigungsfeld / Taste, mit Hilfe dessen /deren sich das Stanzmittel durch Drücken auf dasselbe/dieselbe elastisch absenken lässt(10) Operation panel / key by means of which the punching means can be elastically lowered by pressing on the same
  • (11a) Symbol als Kennzeichnung, so dass eine Zuordnung der Medikamentationsgabe zu einer Tageszeit (z.B. Sonne = vormittags) möglich ist(11a) symbol as a label, so that an assignment of the medication dose at a time of day (for example sun = morning) is possible
  • (11b) Symbol als Kennzeichnung, so dass eine Zuordnung der Medikamentationsgabe zu einer Tageszeit (z.B. Mond = abends/vor der Nachtruhe) möglich ist(11b) symbol as a label, so that an attribution of medication at a time of day (for example, moon = in the evening / before sleep) is possible
  • (12) Tablette oder Kapsel(12) tablet or capsule
  • (13) Signatur, welche eine Zuordnung der Medikamentation zu einem bestimmten Wochentag, z.B.: "Monday", "Tuesday", "Wednesday", "Thursday", "Friday", "Saturday", "Sunday" ermöglicht(13) Signature that allows medication to be assigned to a particular day of the week, such as Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday

In Abbildung 1 ist die erfindungsgemäße Vorrichtung bestehend aus einem Oberteil und einem Unterteil dargestellt, wobei nach Öffnen der Vorrichtung ein Blister in die Vorrichtung eingelegt werden kann.In illustration 1 the device according to the invention is shown consisting of an upper part and a lower part, wherein after opening the device, a blister can be inserted into the device.

In Abbildung 2 ist die geöffnete Vorrichtung dargestellt. In das Oberteil (1) integriert sind die Stanzmittel (3). Typischerweise enthält die Vorrichtung die gleiche Anzahl an Stanzmittel, die der Zahl der Blisternäpfe (5) entspricht, die der oder die aufzunehmenden Blister (gegebenenfalls geteilten Blister) enthalten. Ein Blister oder ein Teil eines teilbaren Blisters kann dabei in das Unterteil durch Einschieben in das Fixierungsmittel (8a), (8b) eingelegt werden, so dass die Blisternäpfe (5) durch die Halteelmente (6) vor verschieben in dem Unterteil geschützt werden. Die Stützstruktur (6) dient dabei neben ihrer Funktion als Halteelement auch als Mittel, um die Blisternäpfe vor Deformation zu schützen.In Figure 2 the opened device is shown. Integrated into the upper part (1) are the punching means (3). Typically, the device contains the same number of punching means, which corresponds to the number of blister pots (5) containing the blister (s) (optionally split blister) to be picked up. A blister or a part of a divisible blister can be inserted into the lower part by insertion into the fixing means (8a), (8b), so that the blister pots (5) are protected by the Halteelmente (6) before moving in the lower part. The support structure (6) serves in addition to its function as a holding element as a means to protect the blister pans from deformation.

In Abbildung 3 ist die geschlossene Vorrichtung abgebildet, wobei durch Drücken auf ein Betätigungsfeld / Taste (10), welche die Form eines Flügels hat, das integrierte Stanzmittel in die Deckfolie des eingelegten Blisters (nicht sichtbar) gedrückt werden kann. Die Betätigungsfelder / Tasten (10) sind mit Symbolen versehen, die es dem Patienten ermöglichen zu erkennen, ob die entsprechende Medikamentation (Tablette oder Kapsel) morgens (11a) oder abends (11b) eingenommen werden soll. Das Oberteil kann zusätzlich Signaturen (13) enthalten, die eine Zuordnung der Medikamentation zu einem bestimmten Einnahmezeitpunkt, z.B. Wochentag ermöglicht.In Figure 3 the closed device is shown, pressing on an actuating panel / button (10), which has the shape of a wing, the integrated punching means in the cover sheet of the inserted blister (not visible) can be pressed. The operations / buttons (10) are provided with symbols that allow the patient to recognize whether the appropriate medication (tablet or capsule) should be taken in the morning (11a) or in the evening (11b). The upper part may additionally contain signatures (13), which allows an association of the medication at a specific time of administration, eg weekday.

In Abbildung 4 ist die geöffnete Vorrichtung mit einem Blister nach Durchführung des Stanzvorgangs abgebildet. Nach Stanzen der Deckfolie und Öffnen der Vorrichtung kann dann die Tablette oder Kapsel aus dem Blisternapf entnommen werden.In Figure 4 the opened device is shown with a blister after performing the punching process. After punching the cover sheet and opening the device, the tablet or capsule can then be removed from the blister cup.

Claims (10)

  1. Device for accommodating and storing a blister pack (4), particularly a blister for medicaments, and for releasing a tablet or capsule (12) from the blister pack (4), wherein the device contains a means (3) by which the cover film of a blister well (5) is punched around the tablet or capsule (12), and the tablet or capsule (12) can subsequently be taken out of the blister well (5) characterised in that the means (3) punches the cover film by the actuation of a button.
  2. Device according to claim 1, characterised in that the device comprises an upper part (1) and a lower part (2), the lower part (2) being of a tub-like configuration for accommodating a blister (4) and comprising retaining elements (6), which acts as a uniform support structure (6), and which is suitable for fixing the blister (4) within the lower part (2), wherein the mouldings of the blister wells (5) point towards the lower part (2) as the blister is inserted and thus the blister (4) is also secured against lateral movement and the base height of the support structure (6) corresponds at least to the depth of indentation of the blister well (5).
  3. Device according to claim 1 or 2, characterised in that the device comprises an upper part (1) and a lower part (2), the upper part (1) containing means (3) for punching out the tablet or capsule (12), and the punching means (3) being in the shape of a wall with a cutting edge and/or teeth, so that when the means (3) is actuated the cutting edge and/or teeth cut open the cover film of a blister well (5).
  4. Device according to claim 3, characterised in that before the actuation of the means (3) for punching out the tablet or the capsule the holding position of the cutting edge and/or teeth of the punching means (3) is spaced by a support structure (9) and/or a strut (7) from the cover film of the blister (4) placed in the device, and after actuation of the punching means (3) the cutting edge and/or the teeth make a circular, segment-shaped, semicircular, arcuate or oval cut in the cover film at a spacing from the tablet or capsule (12).
  5. Device according to claim 4, characterised in that after actuation of the punching means (3) the cutting edge and/or the teeth penetrate the cover film by from 1 to at most 2 mm.
  6. Device according to one of claims 1 to 5, characterised in that the device is suitable for accommodating an at least 2-row blister (4) and the upper part (1) contains a strut (7) which when the device is closed presses the blister into the lower part, thus ensuring that in the resting position the cutting edge and/or teeth of the punching means are spaced from the cover film of the blister (4).
  7. Device according to one of claims 1 to 6, characterised in that the upper part (1) including the means (3) for punching the tablet or the capsule (12) out of the blister (4) and the strut (7) for spacing the punching means (3) of the upper part (1) from the cover film of the blister is made from a single plastics part, the means (3) for punching out the tablet or the capsule (12) being movably attached to the cover, while the circular, segment-shaped, semicircular, arcuate or oval means are separated from the cover by a slot, apart from a connecting point, so that the punching means is attached to the cover only on one side, the connecting point in the form of a pivot having a material attenuation, and the punching means (3) being capable of being resiliently lowered onto it by pressing.
  8. Device according to one of claims 1 to 7, characterised in that the device has the capacity to hold the requisite patient medication that the patient will need for 7 days, the medicament being administered twice a day, in the morning and evening, and the button for actuating the means for punching out the tablet or capsule is characterised by a symbol (11 a) or (11 b), so that the medication can be assigned to a morning or evening administration, and characterised in that the device comprises markings (13) which permit allocation of the medication that is needed on a particular day of the week, e.g. "Monday", "Tuesday", "Wednesday", "Thursday", "Friday", "Saturday", "Sunday".
  9. Device according to one of claims 1 to 8, characterised in that the blister (4) contains a pharmaceutical formulation containing dabigatran etexilate.
  10. Device according to one of claims 1 to 8, characterised in that the blister (4) contains inhalation capsules as the medicament, preferably inhalation capsules which contain the active substance tiotropium.
EP13722402.8A 2012-05-14 2013-05-10 Device for holding a medicine blister Active EP2850018B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP13722402.8A EP2850018B1 (en) 2012-05-14 2013-05-10 Device for holding a medicine blister

Applications Claiming Priority (3)

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EP12167813 2012-05-14
PCT/EP2013/059717 WO2013171129A1 (en) 2012-05-14 2013-05-10 Device for accommodating a drug blister
EP13722402.8A EP2850018B1 (en) 2012-05-14 2013-05-10 Device for holding a medicine blister

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EP2850018A1 EP2850018A1 (en) 2015-03-25
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EP (1) EP2850018B1 (en)
JP (1) JP6233853B2 (en)
DK (1) DK2850018T3 (en)
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HU (1) HUE030466T2 (en)
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EP2850018B1 (en) 2012-05-14 2016-07-13 Boehringer Ingelheim International GmbH Device for holding a medicine blister
WO2019020202A1 (en) 2017-07-28 2019-01-31 Abbott Products Operations Ag A package for medicines

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HUE030466T2 (en) 2017-05-29
EP2850018A1 (en) 2015-03-25
WO2013171129A1 (en) 2013-11-21
JP2015517351A (en) 2015-06-22
ES2588902T3 (en) 2016-11-07
US9610218B2 (en) 2017-04-04
US20150136640A1 (en) 2015-05-21
DK2850018T3 (en) 2016-10-03
PL2850018T3 (en) 2017-01-31
JP6233853B2 (en) 2017-11-22

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