EP3135602A1 - Blisterpackung - Google Patents

Blisterpackung Download PDF

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Publication number
EP3135602A1
EP3135602A1 EP15182316.8A EP15182316A EP3135602A1 EP 3135602 A1 EP3135602 A1 EP 3135602A1 EP 15182316 A EP15182316 A EP 15182316A EP 3135602 A1 EP3135602 A1 EP 3135602A1
Authority
EP
European Patent Office
Prior art keywords
macroblister
blister
portions
makroblister
drug
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP15182316.8A
Other languages
German (de)
English (en)
French (fr)
Inventor
Erfindernennung liegt noch nicht vor Die
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
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 EP15182316.8A priority Critical patent/EP3135602A1/de
Priority to CN201680049852.7A priority patent/CN107922096B/zh
Priority to PT167576032T priority patent/PT3341303T/pt
Priority to SI201630587T priority patent/SI3341303T1/sl
Priority to LTEP16757603.2T priority patent/LT3341303T/lt
Priority to JP2018510434A priority patent/JP6878410B2/ja
Priority to KR1020187005127A priority patent/KR102566585B1/ko
Priority to PE2018000305A priority patent/PE20181095A1/es
Priority to US15/754,858 priority patent/US10889393B2/en
Priority to CA2996434A priority patent/CA2996434C/en
Priority to CR20180117A priority patent/CR20180117A/es
Priority to DK16757603.2T priority patent/DK3341303T3/da
Priority to AU2016312905A priority patent/AU2016312905B2/en
Priority to EP16757603.2A priority patent/EP3341303B1/de
Priority to PL16757603T priority patent/PL3341303T3/pl
Priority to PCT/EP2016/069560 priority patent/WO2017032674A1/de
Priority to MX2018002347A priority patent/MX2018002347A/es
Priority to BR112018003539-4A priority patent/BR112018003539B1/pt
Priority to SG11201801362QA priority patent/SG11201801362QA/en
Priority to HUE16757603A priority patent/HUE048689T2/hu
Priority to RS20200001A priority patent/RS59742B1/sr
Priority to ES16757603T priority patent/ES2770301T3/es
Priority to EA201890579A priority patent/EA039570B1/ru
Publication of EP3135602A1 publication Critical patent/EP3135602A1/de
Priority to IL257271A priority patent/IL257271A/en
Priority to PH12018500389A priority patent/PH12018500389A1/en
Priority to SV2018005638A priority patent/SV2018005638A/es
Priority to CONC2018/0001990A priority patent/CO2018001990A2/es
Priority to CL2018000495A priority patent/CL2018000495A1/es
Priority to HK18106715.1A priority patent/HK1247170A1/zh
Priority to HRP20200192TT priority patent/HRP20200192T1/hr
Ceased legal-status Critical Current

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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 contain a large number of drug portions.
  • 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.
  • the drug portions are brought into a state that allows maximum flexibility in terms of later use (location, time and purpose).
  • the inventive separation of the previous process costs can be reduced at the same time, because due to the flexible use of macroblister overcapacities can be avoided.
  • even small batches can be produced very effectively and cost-reduced.
  • a first subject of the present invention are thus macroblisters, which allow a more flexible and / or cost-effective 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 labels conceivable are folds, punches, perforations, notches, printed lines, milled grooves and much more
  • a macroblister according to the present invention contains a number T of at least 100 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 150 drug portions.
  • the macroblister contains at least 200 drug portions.
  • the macroblister contains between 250 and 350 drug portions.
  • 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 a surface 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. It is also conceivable, however, to have a stack in which the individual macroblisters alternately point in one direction and the other direction, as shown by way of example in FIG Fig. 4 is shown.
  • 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 transmitters. Also, a seal is 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 that can be filled with country and / or customer-specific information and labels. 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. After sealing, the blister is in the inventive Macro blister parts.
  • 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 invention are divided into a plurality of conventional blisters (blister), and these blanks are introduced into 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.
  • One drug portion in each cavity is closed in each case.
  • 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.
  • central warehouse Such a 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 blister packs into which a macroblister is divided is exactly the number T of the medicament portions in the macroblister.
  • 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.
  • 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 which may be mounted adjacent to the bubbles, are intended to prevent the bubbles from being crushed 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 can be removed from the secondary packaging, wherein the individual blisters lying above rise as a result of 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.
  • step (A) of the method according to the invention It is conceivable to apply information to a macro blister pack before, during or after it is filled with medicament portions in step (A) 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) 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 Marking on the opposite back side is applied at a later date.
  • 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 macro blister can be created by first a sheet is separated from a blister sheet, the blisters of the sheet are filled with drug portions and the blisters are closed.
  • 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 introducing drug portions in a blister pack are 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.
  • 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.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP15182316.8A 2015-08-25 2015-08-25 Blisterpackung Ceased EP3135602A1 (de)

Priority Applications (30)

Application Number Priority Date Filing Date Title
EP15182316.8A EP3135602A1 (de) 2015-08-25 2015-08-25 Blisterpackung
SI201630587T SI3341303T1 (sl) 2015-08-25 2016-08-18 Pretisni omot
BR112018003539-4A BR112018003539B1 (pt) 2015-08-25 2016-08-18 Embalagem do tipo blister
PCT/EP2016/069560 WO2017032674A1 (de) 2015-08-25 2016-08-18 Blisterpackung
LTEP16757603.2T LT3341303T (lt) 2015-08-25 2016-08-18 Lizdinės plokštelės pakelis
JP2018510434A JP6878410B2 (ja) 2015-08-25 2016-08-18 ブリスタ包装
KR1020187005127A KR102566585B1 (ko) 2015-08-25 2016-08-18 블리스터 패키징
PE2018000305A PE20181095A1 (es) 2015-08-25 2016-08-18 Envase blister
US15/754,858 US10889393B2 (en) 2015-08-25 2016-08-18 Macro blister packaging
CA2996434A CA2996434C (en) 2015-08-25 2016-08-18 Blister packaging
CR20180117A CR20180117A (es) 2015-08-25 2016-08-18 Envase blister
DK16757603.2T DK3341303T3 (da) 2015-08-25 2016-08-18 Blisterpakning
PT167576032T PT3341303T (pt) 2015-08-25 2016-08-18 Embalagem tipo blíster
EP16757603.2A EP3341303B1 (de) 2015-08-25 2016-08-18 Blisterpackung
PL16757603T PL3341303T3 (pl) 2015-08-25 2016-08-18 Opakowanie blistrowe
CN201680049852.7A CN107922096B (zh) 2015-08-25 2016-08-18 泡罩包装
MX2018002347A MX2018002347A (es) 2015-08-25 2016-08-18 Envase blister.
AU2016312905A AU2016312905B2 (en) 2015-08-25 2016-08-18 Blister packaging
SG11201801362QA SG11201801362QA (en) 2015-08-25 2016-08-18 Blister packaging
HUE16757603A HUE048689T2 (hu) 2015-08-25 2016-08-18 Blisztercsomagolás
RS20200001A RS59742B1 (sr) 2015-08-25 2016-08-18 Blister pakovanje
ES16757603T ES2770301T3 (es) 2015-08-25 2016-08-18 Envase blíster
EA201890579A EA039570B1 (ru) 2015-08-25 2016-08-18 Блистерная упаковка
IL257271A IL257271A (en) 2015-08-25 2018-01-31 bubble wrap
PH12018500389A PH12018500389A1 (en) 2015-08-25 2018-02-21 Blister packaging
SV2018005638A SV2018005638A (es) 2015-08-25 2018-02-22 Envase blister
CONC2018/0001990A CO2018001990A2 (es) 2015-08-25 2018-02-23 Envase blíster
CL2018000495A CL2018000495A1 (es) 2015-08-25 2018-02-23 Envase blíster
HK18106715.1A HK1247170A1 (zh) 2015-08-25 2018-05-24 泡罩包裝
HRP20200192TT HRP20200192T1 (hr) 2015-08-25 2020-02-05 Blister pakiranje

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP15182316.8A EP3135602A1 (de) 2015-08-25 2015-08-25 Blisterpackung

Publications (1)

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EP3135602A1 true EP3135602A1 (de) 2017-03-01

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Family Applications (2)

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

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EP16757603.2A Active EP3341303B1 (de) 2015-08-25 2016-08-18 Blisterpackung

Country Status (29)

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US (1) US10889393B2 (zh)
EP (2) EP3135602A1 (zh)
JP (1) JP6878410B2 (zh)
KR (1) KR102566585B1 (zh)
CN (1) CN107922096B (zh)
AU (1) AU2016312905B2 (zh)
BR (1) BR112018003539B1 (zh)
CA (1) CA2996434C (zh)
CL (1) CL2018000495A1 (zh)
CO (1) CO2018001990A2 (zh)
CR (1) CR20180117A (zh)
DK (1) DK3341303T3 (zh)
EA (1) EA039570B1 (zh)
ES (1) ES2770301T3 (zh)
HK (1) HK1247170A1 (zh)
HR (1) HRP20200192T1 (zh)
HU (1) HUE048689T2 (zh)
IL (1) IL257271A (zh)
LT (1) LT3341303T (zh)
MX (1) MX2018002347A (zh)
PE (1) PE20181095A1 (zh)
PH (1) PH12018500389A1 (zh)
PL (1) PL3341303T3 (zh)
PT (1) PT3341303T (zh)
RS (1) RS59742B1 (zh)
SG (1) SG11201801362QA (zh)
SI (1) SI3341303T1 (zh)
SV (1) SV2018005638A (zh)
WO (1) WO2017032674A1 (zh)

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US10896301B2 (en) 2015-07-07 2021-01-19 Avery Dennison Retail Information Services, Llc RFID-based methods and systems for monitoring medication compliance
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US20180012117A1 (en) * 2016-07-07 2018-01-11 Avery Dennison Retail Information Services, Llc Medication containers incorporating wireless communication devices and methods for manufacturing such containers
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FR3103325B1 (fr) 2019-11-15 2022-04-08 Centre Nat Rech Scient Dispositif de production d’énergie comprenant un réservoir
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CN107922096A (zh) 2018-04-17
US10889393B2 (en) 2021-01-12
DK3341303T3 (da) 2020-02-17
EA201890579A1 (ru) 2018-08-31
AU2016312905A1 (en) 2018-03-01
CR20180117A (es) 2018-05-11
HK1247170A1 (zh) 2018-09-21
SV2018005638A (es) 2019-02-22
JP2018526289A (ja) 2018-09-13
AU2016312905B2 (en) 2021-12-09
MX2018002347A (es) 2018-04-11
EP3341303A1 (de) 2018-07-04
EA039570B1 (ru) 2022-02-11
ES2770301T3 (es) 2020-07-01
HRP20200192T1 (hr) 2020-05-01
BR112018003539B1 (pt) 2022-11-16
BR112018003539A2 (pt) 2018-09-25
IL257271A (en) 2018-03-29
EP3341303B1 (de) 2019-11-20
WO2017032674A1 (de) 2017-03-02
PT3341303T (pt) 2020-02-06
CA2996434C (en) 2023-10-03
US20180319519A1 (en) 2018-11-08
SI3341303T1 (sl) 2020-06-30
CA2996434A1 (en) 2017-03-02
RS59742B1 (sr) 2020-02-28
LT3341303T (lt) 2020-02-10
KR20180042262A (ko) 2018-04-25
CO2018001990A2 (es) 2018-05-10
PH12018500389A1 (en) 2018-08-29
PL3341303T3 (pl) 2020-05-18
HUE048689T2 (hu) 2020-08-28
CN107922096B (zh) 2020-09-01
PE20181095A1 (es) 2018-07-09
JP6878410B2 (ja) 2021-05-26
CL2018000495A1 (es) 2018-06-22
KR102566585B1 (ko) 2023-08-11
SG11201801362QA (en) 2018-03-28

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