EP3341303B1 - Blister - Google Patents

Blister Download PDF

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Publication number
EP3341303B1
EP3341303B1 EP16757603.2A EP16757603A EP3341303B1 EP 3341303 B1 EP3341303 B1 EP 3341303B1 EP 16757603 A EP16757603 A EP 16757603A EP 3341303 B1 EP3341303 B1 EP 3341303B1
Authority
EP
European Patent Office
Prior art keywords
blister pack
macro
medicinal product
macro blister
blister
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
EP16757603.2A
Other languages
German (de)
English (en)
Other versions
EP3341303A1 (fr
Inventor
Olaf Stange
Johannes-Walter Höhl
Reiner Diederich
Klaus DRÖDER
Christoph Herrmann
Franz Dietrich
Philipp BLUMENTHAL
Kai STÜHM
Paul BOBKA
Christopher Schmidt
Sebastian THIEDE
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.)
Bayer Pharma AG
Original Assignee
Bayer Pharma AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Pharma AG filed Critical Bayer Pharma AG
Priority to PL16757603T priority Critical patent/PL3341303T3/pl
Priority to SI201630587T priority patent/SI3341303T1/sl
Priority to RS20200001A priority patent/RS59742B1/sr
Publication of EP3341303A1 publication Critical patent/EP3341303A1/fr
Application granted granted Critical
Publication of EP3341303B1 publication Critical patent/EP3341303B1/fr
Priority to HRP20200192TT priority patent/HRP20200192T1/hr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B61/00—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages
    • B65B61/04—Auxiliary devices, not otherwise provided for, for operating on sheets, blanks, webs, binding material, containers or packages for severing webs, or for separating joined packages
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B9/00—Enclosing successive articles, or quantities of material, e.g. liquids or semiliquids, in flat, folded, or tubular webs of flexible sheet material; Subdividing filled flexible tubes to form packages
    • B65B9/02—Enclosing successive articles, or quantities of material between opposed webs
    • B65B9/04—Enclosing successive articles, or quantities of material between opposed webs one or both webs being formed with pockets for the reception of the articles, or of the quantities of material
    • B65B9/045—Enclosing successive articles, or quantities of material between opposed webs one or both webs being formed with pockets for the reception of the articles, or of the quantities of material for single articles, e.g. tablets
    • 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
    • B65D2203/00—Decoration means, markings, information elements, contents indicators
    • B65D2203/06—Arrangements on packages concerning bar-codes
    • 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
    • B65D83/08—Containers or packages with special means for dispensing contents for dispensing thin flat articles in succession
    • B65D83/0805—Containers or packages with special means for dispensing contents for dispensing thin flat articles in succession through an aperture in a wall

Definitions

  • the present invention is a novel blister containing drug portions, a process for its preparation, a method for providing drug portions for patients and a system for producing packaged drug portions, which are intended for distribution to patients.
  • Blister packs are preferred packages for drug portions such as tablets and capsules.
  • the tablets or capsules are in an arrangement of individual wells (cavities) in a plastic or aluminum foil.
  • the cavities are usually sealed by an aluminum foil.
  • the medicine portions can be removed individually and are protected against dirt and humidity.
  • Another advantage of drug portions in blister packs is the easy recognition of the remaining number of available drug portions.
  • Blister packs, devices for their production, and devices for packaging medicament portions in blister packs have been adequately described in the prior art (see, for example, US Pat US4384649A . GB2184086A . EP2272763A1 . EP0849055A1 . EP0257990A2 . EP0210823A1 . DE3803979A1 . CN203003955U ).
  • a typical size of a blister is in Fig. 1a the published patent GB2184086A 15 individual drug portions are present in an areal arrangement of approximately 6-8 cm ⁇ 4-6 cm.
  • blisters are placed in another package prior to delivery to the patient.
  • This secondary packaging is typically a folding box, which usually contains, in addition to a number of about 1 to 10 blisters, a leaflet with usage and safety information.
  • this problem is solved by separating the process of primary packaging, secondary packaging and labeling of drug portions into two areas.
  • macro blisters are generated, which are a variety of Contain medicine portions.
  • These macroblisters do not contain and / or carry country-specific and / or customer-specific information. They represent an intermediate stage in which the medicament portions can be transported and stored.
  • secondary-packaged and labeled drugs are generated from the macro-blisters, which are suitable for distribution to specific customers / patients, for example, in a particular country. They contain or carry all country-specific and / or customer-specific markings, leaflets, warnings, etc. that are required.
  • WO20090261 (A1 ) describes a process in which conventional blisters are initially packaged and stored unmarked for later unpacking, labeling and repackaging before being sent to their final destination. The fact that the blisters are only provided with information when their final destination is known, allows a flexible handling of the blisters. However, that is in WO20090261 (A1 ) due to the steps of packaging, unpacking and repackaging comparatively cumbersome. Even dealing with the relatively small conventional blisters requires complex technical solutions. These disadvantages do not have the present invention.
  • WO2014130941 discloses a blister sheet from which six blisters are cut out.
  • a first object of the present invention are thus macroblisters according to claim 1, which allow a more flexible and / or less expensive packaging and provision of drug portions.
  • a macroblister in the sense of the present invention is characterized in that it is larger than the blisters, which are passed on to patients.
  • a macro blister will be broken up into smaller units at a later date.
  • the smaller blister units are for distribution to customers / patients. They are also referred to below as blister packs.
  • a blister pack is understood to mean a composite of flat film layers which cover one another and are connected to one another.
  • One of the film layers forms the so-called base.
  • She has at least one depression or open “bladder” that can absorb a portion of medication.
  • a second layer of film, called a cover seals the bladder.
  • a blister is understood to mean a blister pack which has at least one bladder, this bladder being filled with a medicament portion and closed.
  • FIG. 1 shows an example of a utility blister.
  • Figures 2 and 3 show examples of a macroblister.
  • a macroblister of the invention may include punches, indentations, perforations, and the like to facilitate machine handling.
  • the macroblister according to the invention has markings indicating, for example, where it can / should be divided later. These markings are preferably machine-readable markings. As markings are conceivable folds, punches, perforations, notches, printed lines, milled grooves u.v.m.
  • a macroblister according to the present invention contains a number T of at least 60 drug portions.
  • a medication portion is understood to be a solid dosage form of a drug that can be taken by a patient as a single unit.
  • medicament portions are tablets, pills, dragees and capsules.
  • the macroblister contains at least 100 drug portions.
  • the macroblister contains at least 150 drug portions.
  • the macroblister contains at least 200 drug portions.
  • the macroblister contains between 250 and 350 drug portions.
  • the macroblister contains a number of drug portions corresponding to the number of use blisters to be split into at a later time.
  • the macroblister according to the invention has a surface extension in the range from 200 mm ⁇ 200 mm (0.04 m 2 ) to 1200 mm ⁇ 1200 mm (1.44 m 2 ).
  • the macroblister according to the invention has an areal extent of at least 0.09 m 2 .
  • the macroblister according to the invention has an areal extent in the range from 0.1225 m 2 to 0.96 m 2 .
  • the macroblister according to the invention can in principle have any desired shape, such as, for example, round, hexagonal, quadrangular or triangular. It can be symmetrical or unbalanced. Advantageous are those forms that simplify mechanical processing and / or processing. Therefore, the macroblister preferably has a rectangular shape, but the corners may be rounded (see, for example, the macroblisters of FIGS Figures 2 and 3 ).
  • the macroblister has an areal extent which is suitable for placing a single macroblister or two, three or four macroblisters side by side on a transport pallet so that the base area of the transport pallet is almost completely filled without a macroblister over the outer borders of the transport pallet protrudes.
  • a preferred transport pallet is the Euro pallet. Europallet is understood to mean the transport pallet standardized by EN 13698-1 with a footprint of 1200 mm x 800 mm.
  • the macroblister has an areal extent ranging from 1000 mm x 700 mm (0.7 m 2 ) to 1199 mm x 799 mm (0.958001 m 2 ), so that a single macroblister covers the area of the Euro pallet almost filled.
  • the macroblister has a surface extent in the range of 500 mm ⁇ 700 mm (0.35 m 2 ) to 599 mm ⁇ 799 (0.478601 m 2 ) or a surface extent in the range of 1000 mm ⁇ 350 ( 0.35 m 2 ) mm to 1199 mm x 399 mm (0.478401 m 2 ), so that two macroblisters placed next to each other almost completely fill the base area of the Euro pallet.
  • the macroblister has a surface extent in the range of 333 mm x 700 mm (0.2331 m 2 ) to 399 mm x 799 mm (0.318801 m 2 ) or a surface area of 1000 mm x 233 mm ( 0.233 m 2 ) to 1199 mm x 266 mm (0.297654 m 2 ), so that three macroblisters placed next to each other almost completely fill the base area of the Euro pallet.
  • the macroblister has a surface extent in the range of 250 mm x 700 mm (0.175 m 2 ) to 299 mm x 799 (0.238901 m 2 ) mm or a surface extension of 1000 mm x 175 mm (0.175 m 2 ) up to 1199 mm x 199 mm (0.238601 m 2 ), so that four macroblisters placed next to each other almost completely fill the base of the Euro pallet.
  • Analog dimensions can also be determined for other transport pallets.
  • a further subject of the present invention is thus a stack comprising at least 2 macroblisters according to the invention.
  • the stack comprises a number of 10 to 200 macroblisters.
  • the stack comprises a number of 50 to 150 macroblisters.
  • the stack comprises a number of 100 to 150 macroblisters.
  • the individual macroblisters can be stored in the stack above or next to each other so that the bubbles in which the drug portions are located always point in one direction.
  • the macroblisters are alternately stacked on the dorsal side and the dorsal side on the ventral side, the side of the vault denoting that side on which the bladders lie and the dorsal side designating that side which is opposite to the ventral side and flatter.
  • a macroblister according to the invention can identify support structures which lead to a stabilization in the stacking and / or which are intended to prevent the impression of bubbles during stacking.
  • the macroblisters according to the invention are stored in transport boxes, which in turn can be adapted in their size to transport pallets.
  • Another object of the present invention is a transport box containing macroblister.
  • the transport box according to the invention preferably contains a stack of macroblisters according to the invention.
  • a transport box is understood to mean a box-shaped body whose one bottom surface and the four side surfaces adjoining thereto include a volume for receiving the macroblisters.
  • a transport box according to the invention has a lid, with which the volume can be closed reversibly with respect to the outside world, so that a material exchange between the volume and the outside world is prevented or, with respect to gaseous substances, at least limited.
  • Fig. 5 shows an example of a transport box according to the invention.
  • the transport box has a size of 580 mm x 200 mm x 308 mm (0.035728 m 3 ) to 2320 mm x 800 mm x 1230 mm (2.28288 m 3 ).
  • the transport boxes can also be stacked on top of and / or next to one another on a transport pallet.
  • Another object of the present invention is a transport pallet on which at least two transport boxes according to the invention are mounted.
  • the transport boxes may have support structures and / or separation layers to stabilize containing macroblisters.
  • the transport box has a marking such as a machine-readable optical code or an RFID chip for determining the content. It is also conceivable to equip a transport box with GPS, GSM or other receivers / transmitters, which allow localization. Also, a seal is conceivable.
  • the transport box can be equipped with means for thermal and / or electrical insulation and / or with means for tempering their contents. Also means that protects the contents from falling, are conceivable.
  • the macroblister according to the invention has a preferably machine-readable identification, via which information relating to the medicament portions contained can be obtained. Further information on machine-readable markings is given below.
  • the macroblister according to the invention has free surfaces which can be provided with country and / or customer-specific information and markings. According to the invention, country-specific and / or customer-specific and / or use-specific information and markings are only applied at one time to the macroblister or to the blister packs obtained from the macroblister, at which the location and purpose of the medicament portions are established. In a preferred embodiment, the macroblister according to the invention therefore has no country and customer-specific information and markings.
  • a method for producing a macroblister is the subject of the present invention.
  • the method comprises introducing drug portions into the wells of a macro-blister package and then sealing the wells.
  • the medicament portions are introduced into a blister web and the blisters are subsequently closed.
  • the blister sheet is divided into the macroblisters according to the invention. Under a blister sheet is understood a film layer, are introduced in the bubbles for receiving drug portions.
  • the method further comprises applying at least one machine-readable tag to the macroblister.
  • at least one machine-readable tag is applied that is not visible to the naked human eye. Further information on machine-readable markings can be found below.
  • the macroblisters according to the invention are usually produced in the vicinity of the production site for medicament portions.
  • quality assurance measures For the production and primary packaging of pharmaceuticals, certain quality assurance measures must be taken in many countries.
  • GMP Good Manufacturing Practice
  • a macro blister pack usually represents the primary packaging for drug portions.
  • the drug portions Before being introduced into a macro blister pack, the drug portions are available as unpackaged substances whose handling is more demanding according to the GMP guideline than the handling of the packaged portions in the form of the macro blisters.
  • the medicament portions are therefore introduced into the macro blister packs directly after their preparation.
  • preparation includes not only the preparation of the drugs but also the preparation of the dosage form (e.g., tablet, capsule) from the drugs (e.g., by tablet pressing, encapsulation, etc.).
  • the drugs packaged in the macroblister can then be processed under less severe conditions.
  • the macroblisters thus produced are stored until it is clear to which customers / patients the medication portions are to be passed on. Only then is a use-specific identification, the macroblister according to the invention are in a plurality of conventional Blisters (blister packs) and these blister packs are placed in secondary packaging.
  • secondary packaging is meant a package in which one or more blister packs can usually be introduced together with a leaflet.
  • the secondary packaging containing one or more blister packs, and preferably one or more leaflets with leaflets, is the unit that a patient receives from a physician, pharmacist, druggist, or other distributor of drugs. It is to be understood by the use of one or more drug portions for the treatment of a disease, for prophylaxis, for the improvement of well-being, for contraception and the like.
  • the medicament portions in the secondary packaging are intended for a hospital or a doctor, wherein the hospital staff or the doctor extracts individual medicament portions for the transfer to patients from the secondary packaging.
  • the secondary packaging is usually a folding box, preferably made of cardboard.
  • Fig. 6 shows some examples of secondary packaging containing multiple blister packs.
  • a macroblister is produced by introducing medicament portions into the cavities of a macroblister package and subsequently closing the cavities. It is usually closed in each case a drug portion in a cavity.
  • the known devices for introducing drug portions into conventional blisters can be used, wherein the devices may need to be adapted to the size of the macroblister. Such an adaptation is an everyday activity for a mechanical engineer.
  • medicament portions are introduced into blister webs, from which macroblisters are then produced by cutting, punching or similar separation methods.
  • step (B) the macroblisters thus produced are stored until it is clear where and for what purpose the medicament portions are to be used.
  • the warehouse may be located at the site where the macro blister has been created.
  • the bearing can also be located at the site where the macro blisters are broken into blister packs. Also conceivable is a store in a location that corresponds neither to the location of the macroblister generation nor to the location of the breakup.
  • Conceivable is / are e.g. one or more warehouses in which the macroblisters, stacks of macroblisters, transport boxes and / or transport pallets according to the invention are kept available in the vicinity of possible places of use ("central warehouse").
  • central warehouse is a further subject of the present invention.
  • Also conceivable is a combination of one or more central warehouses and warehouses at the locations of the production of the macroblisters and / or the division of the macroblisters.
  • a warehouse can also be a mobile warehouse such as a container.
  • the storage can also be understood as the transport box described above, in which the macroblisters are not further processed for a period of time. What matters is that pharmaceuticals in the form of a macro-blister are kept in a flexible state that allows the macroblister to produce differently packaged and labeled drugs for different uses, countries, regions, markets, customers and / or the like as needed.
  • the method according to the invention comprises the additional step of transporting the macroblisters from the place of creation of the macroblisters (step (A)) to the location of dividing the macroblisters (step (C)).
  • the transport does not have to be done directly between these places; it is conceivable that the macroblisters are first transported from the location of macroblister production to a warehouse and later transported from that warehouse to the dicing location.
  • step (C) the macroblisters are divided into a number N of utility blisters.
  • the splitting of a macroblister into a number N of blister packs can be done by known methods. Conceivably, e.g. Laser cutting, mechanical cutting, punching, etching, electron beam machining, ultrasound and water jet. These and other methods are e.g. described in DIN standards 8588, 8589 and 8590.
  • the splitting can be done both manually and automatically. A combination of manual and automated steps is also conceivable.
  • the number N of blister packs into which a macroblister is divided is at least 10.
  • the number N of blister packs into which a macroblister is divided is at least 20.
  • the number N of blanks in which a macroblister is divided is exactly the number T the drug portions in the macro blister.
  • each blister contains exactly one drug portion (see, eg Fig. 6 (a) ).
  • Such a blister is also referred to below as a single blister. With such a single blister it is possible, for example, for a patient to be able to carry a single portion of medicament in packaged form in order to be able to take them when needed. It is not necessary to carry a conventional blister containing multiple drug portions, although typically only a single portion of medication is used. This reduces the risk that the blister pack and the drug portions contained therein may be damaged or lost.
  • the blister packs which contain only a single portion of medication, are therefore advantageous because drug portions can be handed over to a patient in packaged form.
  • pre-engineered blister blanks have an advantage over blister packs containing a perforation for the customer to cut off individual blisters themselves: the blanks produced by machine can be made to have no sharp corners or edges while tearing along a perforation Usually inevitably sharp corners and edges arise.
  • the blister packs have no sharp corners or edges.
  • a sharp corner or edge means a corner or edge that can be used to burst a conventional inflated balloon by banging the corner or edge from below against the air balloon in the air.
  • a blister contains exactly one dosage.
  • Dosage is the dose of a drug to be administered as part of a therapy.
  • the dose refers to the amount of a substance that is delivered to an organism.
  • the dosage is exactly one portion of medication.
  • the dosage is spread over several drug portions. two, three, four, five or six drug portions per dosage.
  • Another object of the present invention is a stack-shaped arrangement of individual blisters.
  • Such a stack comprises at least two individual blisters.
  • the individual blisters are stacked in the stack above or next to each other. In this case, the stacking can take place such that the bubbles always point in the same direction or the individual blisters are alternately arranged on the dorsal side and dome side on the dorsal side. Additional support structures next to the bubbles be attached to prevent the bubbles are pressed and / or damaged.
  • FIG. 6 (b) shows preferred embodiments of Einzelblisterstapeln.
  • a stack according to the invention is in a secondary packaging, which has an opening in the lower region through which a single individual blister of the secondary packaging can be removed, with the individual blisters lying behind moving up due to gravity.
  • Fig. 6 (a) is such an embodiment exemplified (left side, the secondary packaging carries the inscription 28).
  • step (D) the blister packs are placed in secondary packages.
  • a secondary packaging contains at least one blister.
  • the number n of blister packs that are put in a secondary package is usually between 1 and 200.
  • a blister pack contains at least one portion of medication. Typical amounts of drug portions per use blister are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 21, 28, 30, 31, 32, 64, 50 and 100. However, other quantities are also conceivable.
  • the use blister from step (C) has a size dependent on the number of contained drug portions. Typically, a footprint of at least 35 mm x 35 mm (12.25 cm 2 ) is estimated for each individual portion of medication, as shown in FIG Fig. 7 is illustrated.
  • the method according to the invention has the advantage that, as in the past, large batch sizes of packaged medicaments can be produced, but that the use of macroblisters allows greater flexibility in further processing and in further logistics.
  • the macro blisters are made in one country or state and divided in another country or state.
  • the macroblisters are prepared in the country or state in which the drug portions are also prepared.
  • the macroblisters are divided in the country or state in which the transfer to the patients is intended.
  • the macro blisters are produced at the same location where the fragmentation and packaging takes place in secondary packaging.
  • the macro blisters can be produced and stored in advance. If necessary, the medicine portions are marked custom and / or country-specific and brought to their final form.
  • Information about the portion of the medication, the date of the packaging, an expiry date, a batch number, the place of packaging and other information may be possible.
  • step (B) of the method according to the invention Information about the portion of the medication, the date of the packaging, an expiry date, a batch number, the place of packaging and other information may be possible.
  • step (B) It is conceivable to apply information to the macroblisters after storage in step (B) and before dividing in step (C) of the method according to the invention. It is possible to obtain information about the containing medicine portions, specific information of the country in which the medicine portions are to be used, and other information.
  • step (C) It is conceivable to apply information to the blister packs produced in step (C). It is possible to obtain information about the containing medicine portions, specific information of the country in which the medicine portions are to be used, and other information.
  • country and / or customer-specific information is applied to the blister packs or the areas of the macroblisters only immediately before and / or after the splitting of macroblisters, from which blanks are produced by blending.
  • the method according to the invention comprises a step in which country and / or customer-specific information is applied to the macroblister, this step occurring after step (B).
  • the application of information to a macroblister and / or a blister can be carried out by methods that are common in the labeling of blisters. Examples are inkjet printing, laser marking, pad printing and the introduction of structures such as a Braille font.
  • the macroblister is provided with at least one machine-readable code.
  • machine-readable codes are RFID codes or optical codes such as stacked codes (e.g., codeblock, code 49 or PDF417), matrix codes (e.g., QR code, DataMatrix, MaxiCode or Aztec code), and dot codes.
  • matrix codes e.g., QR code, DataMatrix, MaxiCode or Aztec code
  • dot codes e.g., QR code, DataMatrix, MaxiCode or Aztec code
  • an optical two-dimensional code such as the matrix code is used, more preferably a DataMatrix code.
  • each code per medicament portion is applied to the macroblister, so that each individual medicament portion is identified.
  • This allows the individual recognition and tracking of each individual portion of medication on their way from the macro blister on the blister, possibly a doctor, pharmacist and / or a hospital to the patient. This designation makes it possible to track and verify the identity of the drug until a patient presses the drug portion from the user blister.
  • a single drug portion in a blister can be provided with an individual label. It is also conceivable to attach the identification on the back side. An attachment of a marking on the abdominal and the dorsal side is conceivable.
  • each of the N regions on the macroblister, from which a blister is generated in the fragmentation in step (C), receives an individual identifier.
  • the macroblister is provided with at least one marking which is invisible to the naked eye in visible light (electromagnetic radiation of wavelength 380 nm to 780 nm) for humans.
  • This label can be applied to both sides of the macroblister.
  • a mark is applied on the ventral side of the blister, while, for example, a readable mark on the opposite back side is applied at a later time.
  • inks for example inks can be used, which can be made visible only in ultraviolet light (electromagnetic radiation of the wavelength from 10 nm to less than 380 nm).
  • Such an invisible marking has the advantage that it can be read by machines and thus the macro blisters can be processed, without the marking the further course of the production of blister packs, their packaging in a secondary packaging and distribution to a hospital, a doctor, a pharmacy and / or a patient. Since it is invisible to the naked eye by a human being, it does not "disturb" anyone further and at a later stage, when it is no longer usable, can be provided with readable information, e.g. overprinted or pasted over.
  • the invisible marking thus serves in one embodiment of the present invention predominantly the processing of macroblisters.
  • a macroblister on the ventral side is provided with an optically machine-readable marking in each of the areas from which the blanks are produced, the marking being invisible to the naked human eye.
  • a “device” is used here synonymously with the term “device”.
  • a “device” is a device that has appropriate means to perform the procedures that characterize the device.
  • a “drug delivery device in a macro-blister package” is a device that has means for inserting drug portions into a macro-blister package.
  • a device may include a plurality of machine units that perform various processes such as gripping, transporting, filling, printing, cutting, etc.
  • the system according to the invention comprises a device for generating a macroblister.
  • a macroblister can be created by introducing drug portions into the blisters of a blister sheet, closing the blisters, and separating a macroblister from the blister sheet.
  • a macroblister can be produced by first separating a sheet from a blister sheet, filling the blisters of the sheet with medicament portions, and closing the blisters.
  • the device (A) according to the invention has the corresponding functions for carrying out said steps.
  • the macroblister generating device and the macroblast splitting device are provided at spatially separated locations.
  • the device of step (C) is more than 100 km away from the device of step (A).
  • the device of step (C) is located in a different country than the device of step (A).
  • steps (C) and (D) are usually located in the same country / state and preferably also at the same location.
  • step (B) may be located at the site where the apparatus of step (A) is located. It is also conceivable that the bearing in step (B) is located at the location where the device of step (C) is located.
  • a warehouse is located at the location where step (A) is executed, and another warehouse at the location where step (C) is performed. Also, a central warehouse, a mobile warehouse or the combination of different bearings, as discussed above, are conceivable.
  • the system of the invention comprises means for transporting the macroblister from step (A) from the location where step (A) has taken place or from the location of the warehouse from step (B) to the location where step (C) takes place.
  • devices for splitting blisters are also known. It is conceivable to use such devices in the system according to the invention and in the method according to the invention. If necessary, adaptation to the size of the macroblister according to the invention is necessary, which, however, can easily be accomplished by a person skilled in mechanical engineering.
  • a device for applying country and / or customer-specific information to a macroblister and / or to a blister is another object of the system according to the invention. This device is preferably located at a different location than the device for generating the macroblister.

Landscapes

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

Claims (17)

  1. Macroblister comprenant un corps plat, dans lequel sont pratiquées des cavités destinées à recevoir des portions de médicament individuelles, dans lequel les cavités sont remplies avec des portions de médicament individuelles et sont fermées avec un film, dans lequel le macroblister contient un nombre T de portions de médicament, caractérisé en ce que T vaut au moins 60 et le corps plat présente une extension comprise dans la plage de 200 mm x 200 mm à 1200 mm x 1200 mm.
  2. Macroblister selon la revendication 1, caractérisé en ce qu'il présente une extension plate d'au moins 0,09 m2.
  3. Macroblister selon une revendication 1 ou 2, caractérisé en ce qu'il contient au moins 100 portions de médicament.
  4. Macroblister selon l'une quelconque des revendications 1 à 3, caractérisé en ce qu'il présente au moins une identification lisible à la machine.
  5. Macroblister selon l'une quelconque des revendications 1 à 4, caractérisé en ce qu'il présente au moins une identification lisible à la machine, de préférence sur le côté renflé, par laquelle des informations concernant les portions de médicament contenues peuvent être obtenues.
  6. Macroblister selon l'une quelconque des revendications 1 à 5, caractérisé en ce qu'un code optique bidimensionnel lisible à la machine est respectivement appliqué dans la région de chaque portion de médicament contenue.
  7. Empilement comprenant au moins deux des macroblisters selon l'une quelconque des revendications 1 à 6.
  8. Boîte de transport comprenant au moins un macroblister selon l'une quelconque des revendications 1 à 6.
  9. Palette de transport, sur laquelle au moins un macroblister selon l'une quelconque des revendications 1 à 6 ou au moins une boîte de transport selon la revendication 8 est déposé(e).
  10. Procédé de fabrication d'un macroblister selon l'une quelconque des revendications 1 à 6, comprenant les étapes suivantes :
    - introduire des portions de médicament dans les bulles d'un emballage macroblister,
    - fermer les bulles avec un film.
  11. Procédé de fabrication d'un macroblister selon l'une quelconque des revendications 1 à 6 comprenant les étapes suivantes :
    - introduire des portions de médicament dans les bulles d'une bande de blister,
    - fermer les bulles avec un film,
    - séparer le macroblister de la bande de blister.
  12. Procédé de fourniture de portions de médicament pour un ou plusieurs patient(s), comprenant les étapes suivantes :
    (A) produire un macroblister selon l'une quelconque des revendications 1 à 6,
    (B) soutenir le macroblister,
    (C) partager le macroblister en un nombre N de blisters d'usage, N étant un nombre entier supérieur à 8,
    (D) introduire un nombre n de blisters d'usage de l'étape (C) dans un emballage secondaire, n étant un nombre entier supérieur ou égal à 1.
  13. Procédé selon la revendication 12, dans lequel on applique sur le macroblister et/ou les blisters d'usage, après l'étape (B) et avant l'étape (D), des informations spécifiques au pays et/ou au client.
  14. Procédé selon une revendication 12 ou 13, dans lequel chaque blister d'usage contient un nombre de portions de médicament, qui correspond exactement à un dosage.
  15. Procédé selon l'une quelconque des revendications 12 à 14, dans lequel on introduit un empilement de n = 2 à 64 blisters d'usage dans un emballage secondaire.
  16. Système de production de portions de médicament emballées, qui sont destinées à être transmises à des patients, comprenant
    (A) un appareil pour produire un macroblister selon l'une quelconque des revendications 1 à 6, contenant les portions de médicament,
    (B) un appui pour soutenir le macroblister,
    (C) un appareil pour partager le macroblister en un nombre N de blisters d'usage, N étant un nombre entier supérieur à 8,
    (D) un appareil pour introduire un nombre n de blisters d'usage dans un emballage secondaire, n étant un nombre entier supérieur ou égal à 1.
  17. Système selon la revendication 16, dans lequel l'appareil pour produire le macroblister et l'appareil pour partager le macroblister se trouvent en des lieux différents.
EP16757603.2A 2015-08-25 2016-08-18 Blister Active EP3341303B1 (fr)

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Application Number Priority Date Filing Date Title
PL16757603T PL3341303T3 (pl) 2015-08-25 2016-08-18 Opakowanie blistrowe
SI201630587T SI3341303T1 (sl) 2015-08-25 2016-08-18 Pretisni omot
RS20200001A RS59742B1 (sr) 2015-08-25 2016-08-18 Blister pakovanje
HRP20200192TT HRP20200192T1 (hr) 2015-08-25 2020-02-05 Blister pakiranje

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EP15182316.8A EP3135602A1 (fr) 2015-08-25 2015-08-25 Blister
PCT/EP2016/069560 WO2017032674A1 (fr) 2015-08-25 2016-08-18 Emballage alvéolaire

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EP3341303A1 EP3341303A1 (fr) 2018-07-04
EP3341303B1 true EP3341303B1 (fr) 2019-11-20

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EP15182316.8A Ceased EP3135602A1 (fr) 2015-08-25 2015-08-25 Blister
EP16757603.2A Active EP3341303B1 (fr) 2015-08-25 2016-08-18 Blister

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EP15182316.8A Ceased EP3135602A1 (fr) 2015-08-25 2015-08-25 Blister

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JP (1) JP6878410B2 (fr)
KR (1) KR102566585B1 (fr)
CN (1) CN107922096B (fr)
AU (1) AU2016312905B2 (fr)
BR (1) BR112018003539B1 (fr)
CA (1) CA2996434C (fr)
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CO (1) CO2018001990A2 (fr)
CR (1) CR20180117A (fr)
DK (1) DK3341303T3 (fr)
EA (1) EA039570B1 (fr)
ES (1) ES2770301T3 (fr)
HK (1) HK1247170A1 (fr)
HR (1) HRP20200192T1 (fr)
HU (1) HUE048689T2 (fr)
IL (1) IL257271A (fr)
LT (1) LT3341303T (fr)
MX (1) MX2018002347A (fr)
PE (1) PE20181095A1 (fr)
PH (1) PH12018500389A1 (fr)
PL (1) PL3341303T3 (fr)
PT (1) PT3341303T (fr)
RS (1) RS59742B1 (fr)
SG (1) SG11201801362QA (fr)
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BR112018003539A2 (pt) 2018-09-25
AU2016312905B2 (en) 2021-12-09
SG11201801362QA (en) 2018-03-28
PE20181095A1 (es) 2018-07-09
US20180319519A1 (en) 2018-11-08
DK3341303T3 (da) 2020-02-17
US10889393B2 (en) 2021-01-12
JP2018526289A (ja) 2018-09-13
CA2996434A1 (fr) 2017-03-02
EA039570B1 (ru) 2022-02-11
KR102566585B1 (ko) 2023-08-11
CN107922096A (zh) 2018-04-17
AU2016312905A1 (en) 2018-03-01
ES2770301T3 (es) 2020-07-01
CL2018000495A1 (es) 2018-06-22
SV2018005638A (es) 2019-02-22
EA201890579A1 (ru) 2018-08-31
CA2996434C (fr) 2023-10-03
MX2018002347A (es) 2018-04-11
SI3341303T1 (sl) 2020-06-30
CN107922096B (zh) 2020-09-01
BR112018003539B1 (pt) 2022-11-16
CR20180117A (es) 2018-05-11
HRP20200192T1 (hr) 2020-05-01
IL257271A (en) 2018-03-29
EP3341303A1 (fr) 2018-07-04
HUE048689T2 (hu) 2020-08-28
PL3341303T3 (pl) 2020-05-18
JP6878410B2 (ja) 2021-05-26
WO2017032674A1 (fr) 2017-03-02
KR20180042262A (ko) 2018-04-25
PH12018500389A1 (en) 2018-08-29
LT3341303T (lt) 2020-02-10
EP3135602A1 (fr) 2017-03-01
RS59742B1 (sr) 2020-02-28
PT3341303T (pt) 2020-02-06
CO2018001990A2 (es) 2018-05-10
HK1247170A1 (zh) 2018-09-21

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