EP3341303B1 - Blister pack - Google Patents
Blister pack Download PDFInfo
- 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
Links
- 238000000034 method Methods 0.000 claims description 29
- 238000009517 secondary packaging Methods 0.000 claims description 20
- 238000004806 packaging method and process Methods 0.000 claims description 17
- 238000004519 manufacturing process Methods 0.000 claims description 14
- 230000003287 optical effect Effects 0.000 claims description 5
- 210000001015 abdomen Anatomy 0.000 claims description 4
- 238000007789 sealing Methods 0.000 claims description 4
- 229940126601 medicinal product Drugs 0.000 claims 12
- 239000003814 drug Substances 0.000 description 122
- 229940079593 drug Drugs 0.000 description 84
- 238000003860 storage Methods 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 238000009826 distribution Methods 0.000 description 5
- 238000002360 preparation method Methods 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 238000000926 separation method Methods 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 239000002775 capsule Substances 0.000 description 4
- 239000011888 foil Substances 0.000 description 4
- 238000009516 primary packaging Methods 0.000 description 4
- 239000003826 tablet Substances 0.000 description 4
- 230000006978 adaptation Effects 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 238000005520 cutting process Methods 0.000 description 3
- 238000011194 good manufacturing practice Methods 0.000 description 3
- 238000002372 labelling Methods 0.000 description 3
- 239000011159 matrix material Substances 0.000 description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- 208000002352 blister Diseases 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000005670 electromagnetic radiation Effects 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 238000013467 fragmentation Methods 0.000 description 2
- 238000006062 fragmentation reaction Methods 0.000 description 2
- 238000011089 mechanical engineering Methods 0.000 description 2
- 238000004080 punching Methods 0.000 description 2
- 238000000275 quality assurance Methods 0.000 description 2
- 241000282412 Homo Species 0.000 description 1
- 230000003187 abdominal effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000013256 coordination polymer Substances 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000010292 electrical insulation Methods 0.000 description 1
- 238000010894 electron beam technology Methods 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 238000005530 etching Methods 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000007373 indentation Methods 0.000 description 1
- 239000000976 ink Substances 0.000 description 1
- 238000007641 inkjet printing Methods 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 238000010330 laser marking Methods 0.000 description 1
- 230000004807 localization Effects 0.000 description 1
- 238000003754 machining Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000007649 pad printing Methods 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 238000007639 printing Methods 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 238000009475 tablet pressing Methods 0.000 description 1
- 238000005496 tempering Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 230000036642 wellbeing Effects 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/28—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
- 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)
Description
Gegenstand der vorliegenden Erfindung ist ein neuartiger Blister enthaltend Arzneimittelportionen, ein Verfahren zu dessen Herstellung, ein Verfahren zur Bereitstellung von Arzneimittelportionen für Patienten und ein System zur Erzeugung von verpackten Arzneimittelportionen, die zur Weitergabe an Patienten bestimmt sind.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.
Blisterverpackungen sind bevorzugte Verpackungen für Arzneimittelportionen wie beispielsweise Tabletten und Kapseln. In einem Blister liegen die Tabletten oder Kapseln in einer Anordnung aus einzelnen Vertiefungen (Kavitäten) in einer Kunststoff- oder Aluminiumfolie vor. Die Kavitäten sind üblicherweise durch eine Aluminiumfolie versiegelt. Die Arzneimittelportionen lassen sich einzeln entnehmen und sind gegenüber Schmutz und Luftfeuchtigkeit geschützt. Ein weiterer Vorteil von Arzneimittelportionen in Blisterverpackungen besteht in dem einfachen Erkennen der Restanzahl an verfügbaren Arzneimittelportionen.Blister packs are preferred packages for drug portions such as tablets and capsules. In a blister, 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.
Blisterverpackungen, Vorrichtungen zu ihrer Herstellung sowie Vorrichtungen zur Verpackung von Arzneimittelportionen in Blisterverpackungen sind im Stand der Technik hinreichend beschrieben (siehe z.B.
Eine typische Größe eines Blisters ist in
Typischerweise werden Blister vor der Weitergabe an den Patienten noch in eine weitere Verpackung eingebracht. Diese Sekundärverpackung ist typischerweise eine Faltschachtel, die neben einer Anzahl von etwa 1 bis 10 Blistern üblicherweise noch einen Beipackzettel mit Gebrauchs- und Sicherheitsinformationen enthält.Typically, 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.
Die heutigen Produktionssysteme zur Verpackung von Arzneimittelportionen sind einem zunehmenden Veränderungsdruck ausgesetzt: mehr und mehr Arzneimittel werden für spezielle Indikationen entwickelt, es gibt spezifische Verabreichungsformen und Dosierungen. Länderspezifische Anforderungen an die Zulassung der Arzneimittel erfordern zudem spezielle Verpackungen, Beipackzettel und Aufdrucke. Ferner können verpackte Arzneimittel aus Zulassungsgründen nicht beliebig lange gelagert werden.Today's production systems for the packaging of drug portions are subject to increasing pressure to change: more and more drugs are being developed for specific indications, there are specific dosage forms and dosages. Country-specific requirements for drug approval also require special packaging, package leaflets and imprints. Furthermore, packaged drugs can not be stored indefinitely for regulatory purposes.
Alle diese Faktoren führen zu einer sinkenden Losgröße. Diesem Trend können die derzeit eingesetzten Verpackungsanlagen, die auf große Losgrößen ausgelegt sind, nicht uneingeschränkt folgen. Dies ist vor allem durch den hohen Rüstaufwand zum Produkt- und/oder Formatwechsel begründet, der kleine Losgrößen damit schnell unwirtschaftlich werden lässt.All these factors lead to a sinking lot size. The currently used packaging systems that are designed for large batch sizes can not fully follow this trend. This is mainly due to the high set-up effort for product and / or format change, which makes small batches quickly become uneconomical.
Es besteht demnach ein Bedarf an einer Lösung, wie dem beschriebenen Veränderungsdruck bei den heutigen Produktionssystemen zur Verpackung von Arzneimittelportionen begegnet werden kann.Thus, there is a need for a solution to how to address the described pressure to change in today's drug package packaging production systems.
Erfindungsgemäß wird dieses Problem dadurch gelöst, dass der Prozess des Primärverpackens, Sekundärverpackens und Kennzeichnens von Arzneimittelportionen in zwei Bereiche getrennt wird. Im ersten Bereich werden so genannte Makroblister erzeugt, die eine Vielzahl an Arzneimittelportionen enthalten. Diese Makroblister enthalten und/oder tragen keine länderspezifischen und/oder kundenspezifischen Informationen. Sie stellen ein Zwischenstadium dar, in dem die Arzneimittelportionen transportiert und gelagert werden können. Im zweiten Bereich werden aus den Makroblistern sekundärverpackte und gekennzeichnete Arzneimittel erzeugt, die zur Weitergabe an spezifische Kunden/Patienten beispielsweise in einem bestimmten Land geeignet sind. Sie enthalten oder tragen alle länderspezifischen und/oder kundenspezifischen Kennzeichnungen, Beipackzettel, Warnhinweise etc., die erforderlich sind.According to the invention, this problem is solved by separating the process of primary packaging, secondary packaging and labeling of drug portions into two areas. In the first area so-called 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. In the second area, 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.
Durch diese erfindungsgemäße Trennung ist es möglich, Arzneimittelportionen wie gehabt in großen Losgrößen zu produzieren und in Primärverpackungen zu verpacken. Die Herrichtung der verpackten Arzneimittelportionen zur Weitergabe an Kunden/Patienten erfolgt jedoch anders als gehabt räumlich und zeitlich zu der Erzeugung der Makroblister getrennt, und zwar zu einem Zeitpunkt und/oder an einem Ort, zu dem/an dem genauere Kenntnisse darüber herrschen, wie viele Arzneimittelportionen für welchen Zweck benötigt werden.As a result of this separation according to the invention, it is possible to produce medicament portions as before in large batch sizes and pack them in primary packaging. However, the reconstitution of the packaged drug portions for delivery to customers / patients will be spatially and temporally separate to the generation of the macroblisters at a time and / or location where more detailed knowledge of how many are Medicament portions are needed for what purpose.
Durch die Erzeugung der Makroblister werden die Arzneimittelportionen in einen Zustand gebracht, der eine maximale Flexibilität hinsichtlich der späteren Verwendung (Ort, Zeit und Zweck) erlaubt. Durch die erfindungsgemäße Trennung des bisherigen Prozesses können gleichzeitig Kosten reduziert werden, denn aufgrund des flexiblen Einsatzes der Makroblister können Überkapazitäten vermieden werden. Zudem können auch kleine Losgrößen sehr effektiv und kostenreduziert produziert werden.
Ein erster Gegenstand der vorliegenden Erfindung sind damit Makroblister gemäß Anspruch 1, die eine flexiblere und/oder kostengünstigere Verpackung und Bereitstellung von Arzneimittelportionen erlauben.A first object of the present invention are thus macroblisters according to
Ein Makroblister im Sinne der vorliegenden Erfindung zeichnet sich dadurch aus, dass er größer ist als die Blister, die an Patienten weitergegeben werden. Ein Makroblister wird erst zu einem späteren Zeitpunkt in kleinere Einheiten zerteilt. Die kleineren Blistereinheiten dienen der Weitergabe an Kunden/Patienten. Sie werden nachfolgend auch als Gebrauchsblister bezeichnet.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.
Unter einer Blisterverpackung wird ein Verbund aus flachen Folienlagen verstanden, die einander bedecken und miteinander verbunden sind. Eine der Folienlagen bildet die so genannte Basis. Sie hat mindestens eine Vertiefung oder offene "Blase", die eine Arzneimittelportion aufnehmen kann. Eine zweite Folienlage, die als Abdeckung bezeichnet wird, dient zur Versiegelung der Blase.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.
Unter einem Blister wird eine Blisterverpackung verstanden, die mindestens eine Blase aufweist, wobei diese Blase mit einer Arzneimittelportion befüllt und verschlossen ist.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.
Ein erfindungsgemäßer Makroblister kann Stanzungen, Einkerbungen, Perforationen und dergleichen enthalten, um eine maschinelle Be- und Verarbeitung zu erleichtern.A macroblister of the invention may include punches, indentations, perforations, and the like to facilitate machine handling.
In einer bevorzugten Ausführungsform weist der erfindungsgemäße Makroblister Kennzeichnungen auf, die beispielsweise angeben, wo er später zerteilt werden kann/soll. Vorzugsweise handelt es sich bei diesen Kennzeichnungen um maschinenlesbare Kennzeichnungen. Als Kennzeichnungen denkbar sind Falzungen, Stanzungen, Perforationen, Einkerbungen, aufgedruckte Linien, eingefräste Nuten u.v.m.In a preferred embodiment, 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.
Ein Makroblister im Sinne der vorliegenden Erfindung enthält eine Anzahl T von mindestens 60 Arzneimittelportionen.A macroblister according to the present invention contains a number T of at least 60 drug portions.
Unter einer Arzneimittelportion wird eine feste Darreichungsform eines Arzneimittels verstanden, die von einem Patienten als einzelne Einheit genommen werden kann. Beispiele für Arzneimittelportionen sind Tabletten, Pillen, Dragees und Kapseln.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. Examples of medicament portions are tablets, pills, dragees and capsules.
In einer bevorzugten Ausführungsform der vorliegenden Erfindung enthält der Makroblister mindestens 100 Arzneimittelportionen.In a preferred embodiment of the present invention, the macroblister contains at least 100 drug portions.
In einer bevorzugten Ausführungsform der vorliegenden Erfindung enthält der Makroblister mindestens 150 Arzneimittelportionen.In a preferred embodiment of the present invention, the macroblister contains at least 150 drug portions.
In einer bevorzugten Ausführungsform der vorliegenden Erfindung enthält der Makroblister mindestens 200 Arzneimittelportionen.In a preferred embodiment of the present invention, the macroblister contains at least 200 drug portions.
In einer besonders bevorzugten Ausführungsform der vorliegenden Erfindung enthält der Makroblister zwischen 250 und 350 Arzneimittelportionen.In a particularly preferred embodiment of the present invention, the macroblister contains between 250 and 350 drug portions.
In einer besonders bevorzugten Ausführungsform der vorliegenden Erfindung enthält der Makroblister eine Anzahl an Arzneimittelportionen, die der Anzahl der Gebrauchsblister eintspricht, in die zu einem späteren Zeitpunkt zerteilt wird.In a particularly preferred embodiment of the present invention, the macroblister contains a number of drug portions corresponding to the number of use blisters to be split into at a later time.
Der erfindungsgemäße Makroblister weist eine flächige Ausdehnung im Bereich von 200 mm x 200 mm (0,04 m2) bis 1200 mm x 1200 mm (1,44 m2) auf.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 ).
In einer weiteren bevorzugten Ausführungsform weist der erfindungsgemäße Makroblister eine flächige Ausdehnung von mindestens 0,09 m2 auf.In a further preferred embodiment, the macroblister according to the invention has an areal extent of at least 0.09 m 2 .
In einer besonders bevorzugten Ausführungsform weist der erfindungsgemäße Makroblister eine flächige Ausdehnung im Bereich von 0,1225 m2 bis 0,96 m2 auf.In a particularly preferred embodiment, the macroblister according to the invention has an areal extent in the range from 0.1225 m 2 to 0.96 m 2 .
Der erfindungsgemäße Makroblister kann prinzipiell jede beliebige Form wie beispielsweise rund, sechseckig, viereckig oder dreieckig aufweisen. Er kann symmetrisch oder unsymmetrisch sein. Vorteilhaft sind solche Formen, die eine maschinelle Be- und/oder Verarbeitung vereinfachen. Daher weist der Makroblister vorzugsweise eine rechteckige Form auf, bei der die Ecken jedoch abgerundet sein können (siehe beispielhaft die Makroblister der
In einer weiteren bevorzugten Ausführungsform weist der Makroblister eine flächige Ausdehnung auf, die geeignet ist, einen einzelnen Makroblister oder zwei, drei oder vier Makroblister nebeneinander auf einer Transportpalette zu platzieren, so dass die Grundfläche der Transportpalette nahezu vollständig ausgefüllt wird, ohne dass ein Makroblister über die äußeren Umrandungen der Transportpalette hinausragt.In a further preferred embodiment, 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.
Eine bevorzugte Transportpalette ist die Europalette. Unter Europalette wird die durch EN 13698-1 genormte Transportpalette mit einer Grundfläche von 1200 mm x 800 mm verstanden.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.
Weitere bevorzugte Transportpaletten sind Chemiepaletten (siehe "CP - Paletten für die Chemische Industrie", Handbuch für Verpackungen. VCI - Verband der Chemischen Industrie e.V., April 2004, Ausgabe 6).Other preferred transport pallets are chemical pallets (see "CP Pallets for the Chemical Industry", Handbook for Packaging VCI - Chemical Industry Association e.V., April 2004, Issue 6).
In Bezug auf die Europalette hat der Makroblister also beispielsweise eine flächige Ausdehnung im Bereich von 1000 mm x 700 mm (0,7 m2) bis 1199 mm x 799 mm (0,958001 m2), so dass ein einzelner Makroblister die Grundfläche der Europalette nahezu ausfüllt.Thus, for example, with regard to the Euro pallet, 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.
In einer anderen möglichen Ausprägung hat der Makroblister eine flächige Ausdehnung im Bereich von 500 mm x 700 mm (0,35 m2) bis 599 mm x 799 (0,478601 m2) oder eine flächige Ausdehnung im Bereich von 1000 mm x 350 (0,35 m2) mm bis 1199 mm x 399 mm (0,478401 m2), so dass zwei nebeneinander platzierte Makroblister die Grundfläche der Europalette nahezu vollständig ausfüllen.In another possible embodiment, 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.
In einer anderen möglichen Ausprägung hat der Makroblister eine flächige Ausdehnung im Bereich von 333 mm x 700 mm (0,2331 m2) bis 399 mm x 799 mm (0,318801 m2) oder eine flächige Ausdehnung von 1000 mm x 233 mm (0,233 m2) bis 1199 mm x 266 mm (0,297654 m2), so dass drei nebeneinander platzierte Makroblister die Grundfläche der Europalette nahezu vollständig ausfüllen.In another possible embodiment, 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.
In einer anderen möglichen Ausprägung hat der Makroblister eine flächige Ausdehnung im Bereich von 250 mm x 700 mm (0,175 m2) bis 299 mm x 799 (0,238901 m2) mm oder eine flächige Ausdehnung von 1000 mm x 175 mm (0,175 m2) bis 1199 mm x 199 mm (0,238601 m2), so dass vier nebeneinander platzierte Makroblister die Grundfläche der Europalette nahezu vollständig ausfüllen.In another possible embodiment, 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.
Analoge Maße lassen sich auch für andere Transportpaletten ermitteln.Analog dimensions can also be determined for other transport pallets.
Mehrere erfindungsgemäße Makroblister werden üblicherweise über- und/oder nebeneinander gestapelt, um sie zu transportieren und/oder zu lagern. Ein weiterer Gegenstand der vorliegenden Erfindung ist damit ein Stapel umfassend mindestens 2 erfindungsgemäße Makroblister. In einer bevorzugten Ausführungsform umfasst der Stapel eine Anzahl von 10 bis 200 Makroblistern. In einer weiteren bevorzugten Ausführungsform umfasst der Stapel eine Anzahl von 50 bis 150 Makroblistern. In einer weiteren bevorzugten Ausführungsform umfasst der Stapel eine Anzahl von 100 bis 150 Makroblistern.Several macroblisters according to the invention are usually stacked above and / or next to one another in order to be transported and / or stored. A further subject of the present invention is thus a stack comprising at least 2 macroblisters according to the invention. In a preferred embodiment, the stack comprises a number of 10 to 200 macroblisters. In another preferred embodiment, the stack comprises a number of 50 to 150 macroblisters. In another preferred embodiment, the stack comprises a number of 100 to 150 macroblisters.
Die einzelnen Makroblister können in dem Stapel so über- oder nebeneinander gelagert werden, dass die Blasen, in denen sich die Arzneimittelportionen befinden, stets in eine Richtung weisen.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.
Denkbar ist aber auch eine Stapelung, in der die einzelnen Makroblister alternierend jeweils in die eine Richtung und die andere Richtung weisen, wie dies beispielhaft in
Ein erfindungsgemäßer Makroblister kann Stützstrukturen ausweisen, die zu einer Stabilisierung bei der Stapelung führen und/oder, die ein Eindrücken von Blasen bei der Stapelung verhindern sollen.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.
Es ist auch denkbar, dass die erfindungsgemäßen Makroblister in Transportboxen gelagert werden, die wiederum in ihrer Größe an Transportpaletten angepasst sein können. Ein weiterer Gegenstand der vorliegenden Erfindung ist eine Transportbox enthaltend Makroblister. Vorzugsweise enthält die erfindungsgemäße Transportbox einen erfindungsgemäßen Stapel von Makroblistern.It is also conceivable that 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.
Unter einer Transportbox wird ein kastenförmiger Körper verstanden, dessen eine Bodenfläche und die daran angrenzenden vier Seitenflächen ein Volumen zur Aufnahme der Makroblister einschließen. Üblicherweise weist eine erfindungsgemäße Transportbox einen Deckel auf, mit dem das Volumen reversibel gegenüber der Außenwelt geschlossen werden kann, so dass ein Materieaustausch zwischen dem Volumen und der Außenwelt verhindert oder, in Bezug auf gasförmige Substanzen, zumindest eingeschränkt wird.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. Usually, 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.
In einer bevorzugten Ausführungsform hat die Transportbox eine Größe von 580 mm x 200 mm x 308 mm (0,035728 m3) bis 2320 mm x 800 mm x 1230 mm (2,28288 m3).In a preferred embodiment, 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 ).
Wie in
Ein weiterer Gegenstand der vorliegenden Erfindung ist eine Transportpalette, auf der mindestens zwei erfindungsgemäße Transportboxen gelagert sind.Another object of the present invention is a transport pallet on which at least two transport boxes according to the invention are mounted.
Die Transportboxen können Stützstrukturen und/der Trennschichten aufweisen, um enthaltende Makroblister zu stabilisieren. Vorzugsweise weist die Transportbox eine Kennzeichnung wie beispielsweise einen maschinenlesbaren optischen Code oder einen RFID-Chip zur Bestimmung des Inhalts auf. Denkbar ist auch die Ausstattung einer Transportbox mit GPS, GSM oder anderen Empfängern/Sendern, die eine Lokalisierung ermöglichen. Auch eine Verplombung ist denkbar.The transport boxes may have support structures and / or separation layers to stabilize containing macroblisters. Preferably, 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.
Die Transportbox kann mit Mittel zur thermischen und/oder elektrischen Isolierung und/oder mit Mittel zur Temperierung ihres Inhalts ausgestattet sein. Auch Mittel, die den Inhalt vor Stürzen schützt, sind denkbar.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.
In einer bevorzugten Ausführungsform weist der erfindungsgemäße Makroblister eine vorzugsweise maschinenlesbare Kennzeichnung auf, über die Informationen hinsichtlich der enthaltenen Arzneimittelportionen gewonnen werden können. Nähere Informationen zu maschinenlesbaren Kennzeichnungen sind weiter unten aufgeführt.In a preferred embodiment, 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.
Der erfindungsgemäße Makroblister weist freie Flächen auf, die mit länder- und/oder kundenspezifischen Informationen und Kennzeichnungen versehen werden können. Länder- und/oder kunden- und/oder verwendungsspezifische Informationen und Kennzeichnungen werden erfindungsgemäß erst zu einem Zeitpunkt auf den Makroblister oder auf die aus dem Makroblister gewonnen Gebrauchsblistern aufgebracht, an dem der Einsatzort und Einsatzzweck der Arzneimittelportionen feststehen. In einer bevorzugten Ausführungsform weist der erfindungsgemäße Makroblister daher keine länder- und kundenspezifischen Informationen und Kennzeichnungen auf.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.
Ferner ist ein Verfahren zur Erzeugung eines Makroblisters Gegenstand der vorliegenden Erfindung. Das Verfahren umfasst das Einbringen von Arzneimittelportionen in die Kavitäten einer Makroblisterverpackung und das anschließende Verschließen der Kavitäten. In einer alternativen Ausführungsform werden die Arzneimittelportionen in eine Blisterbahn eingebracht und die Blister anschließend verschlossen. Nach dem Verschließen wird die Blisterbahn in die erfindungsgemäßen Makroblister zerteilt. Unter einer Blisterbahn wird eine Folienlage verstanden, in der Blasen zur Aufnahme von Arzneimittelportionen eingebracht sind.Further, 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. In an alternative embodiment, the medicament portions are introduced into a blister web and the blisters are subsequently closed. After sealing, 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.
In einer bevorzugten Ausführungsform umfasst das Verfahren ferner das Aufbringen mindestens einer maschinenlesbaren Kennzeichnung auf dem Makroblister. In einer bevorzugten Ausführungsform wird eine optisch maschinenlesbare Kennzeichnung aufgebracht, die für das bloße menschliche Auge nicht sichtbar ist. Weitere Informationen zu maschinenlesbaren Kennzeichnungen sind weiter unten im Text zu finden.In a preferred embodiment, the method further comprises applying at least one machine-readable tag to the macroblister. In a preferred embodiment, an optically machine-readable mark is applied that is not visible to the naked human eye. Further information on machine-readable markings can be found below.
Die erfindungsgemäßen Makroblister werden üblicherweise in der Nähe der Produktionsstelle für Arzneimittelportionen erzeugt. Für die Herstellung und Primärverpackung von Arzneistoffen müssen in vielen Ländern gewisse Qualitätssicherungsmaßnahmen ergriffen werden. Als Stichwort sei hier auf die Richtlinien zur Qualitätssicherung verwiesen, die unter dem Namen "Good Manufacturing Practice" (GMP) bekannt sind. Eine Makroblisterverpackung stellt üblicherweise die Primärverpackung für Arzneimittelportionen dar. Vor ihrem Einbringen in eine Makroblisterverpackung liegen die Arzneimittelportionen als unverpackte Substanzen vor, an deren Handhabung gemäß GMP-Richtlinie höhere Anforderungen gestellt werden als an die Handhabung der verpackten Portionen in Form der Makroblister. In einer bevorzugten Ausführungsform werden die Arzneimittelportionen daher direkt im Anschluss an ihre Herstellung in die Makroblisterverpackungen eingebracht. Dabei umfasst der Begriff Herstellung nicht nur die Herstellung der Arzneistoffe sondern auch die Herstellung der Darreichungsform (z.B. Tablette, Kapsel) aus den Arzneistoffen (z.B. mittels Tablettenpressung, Verkapselung etc.).The macroblisters according to the invention are usually produced in the vicinity of the production site for medicament portions. For the production and primary packaging of pharmaceuticals, certain quality assurance measures must be taken in many countries. As a keyword, reference is made here to the guidelines for quality assurance, which are known as "Good Manufacturing Practice" (GMP). A macro blister pack usually represents the primary packaging for 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. In a preferred embodiment, the medicament portions are therefore introduced into the macro blister packs directly after their preparation. The term "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.).
Die in den Makroblistern verpackten Arzneistoffe können dann unter weniger strengen Bedingungen prozessiert werden.The drugs packaged in the macroblister can then be processed under less severe conditions.
Die so erzeugten Makroblister werden gelagert, bis feststeht, an welche Kunden/Patienten die Arzneimittelportionen weitergegeben werden sollen. Erst dann erfolgt eine verwendungsspezifische Kennzeichnung, die erfindungsgemäßen Makroblister werden in eine Mehrzahl von konventionellen Blistern (Gebrauchsblister) zerteilt, und diese Gebrauchsblister werden in Sekundärverpackungen eingebracht.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.
Unter Sekundärverpackung wird eine Verpackung verstanden, in die ein oder mehrere Gebrauchsblister üblicherweise zusammen mit einem Beipackzettel eingebracht werden können. Die Sekundärverpackung enthaltend einen oder mehrere Gebrauchsblister sowie vorzugsweise einen oder mehrere Beipackzettel mit Gebrauchsinformationen ist diejenige Einheit, die ein Patient von einem Arzt, Apotheker, Drogist oder einem anderen Vertreiber von Arzneimitteln zur Verwendung bekommt. Dabei ist unter Verwendung die Einnahme einer oder mehrerer Arzneimittelportionen zur Behandlung einer Krankheit, zur Prophylaxe, zur Verbesserung des Wohlbefindens, zur Schwangerschaftsverhütung und dergleichen zu verstehen.By 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.
Ebenso ist denkbar, dass die Arzneimittelportionen in den Sekundärverpackungen für ein Krankhaus oder einen Arzt bestimmt sind, wobei das Krankenhauspersonal oder der Arzt einzelne Arzneimittelportionen für die Weitergabe an Patienten aus den Sekundärverpackungen entnimmt.Likewise, it is conceivable that 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.
Die Sekundärverpackung ist üblicherweise eine Faltschachtel, vorzugsweise aus Karton.
Die Bereitstellung von Arzneimittelportionen in Makroblistern ist ein weiterer Gegenstand der vorliegenden Erfindung.The provision of drug portions in macroblisters is another object of the present invention.
Die Erfindung betrifft damit auch ein Verfahren zur Bereitstellung von Arzneimittelportionen für einen oder mehrere Patienten, umfassend die Schritte
- (A) Erzeugen eines Makroblisters enthaltend Arzneimittelportionen,
- (B) Lagerung des Makroblisters,
- (C) Zerteilen des Makroblisters in eine Anzahl N von Gebrauchsblistern, wobei N eine ganze
Zahl größer als 8 ist, - (D) Einbringen einer Anzahl n von Gebrauchsblistern aus Schritt (C) in eine Sekundärverpackung, wobei n eine ganze Zahl größer oder gleich 1 ist.
- (A) generating a macroblister containing drug portions,
- (B) storage of the macroblister,
- (C) dividing the macroblister into a number N of utility blanks, where N is an integer greater than 8,
- (D) introducing a number n of blanks from step (C) into a secondary package, where n is an integer greater than or equal to 1.
In Schritt (A) des erfindungsgemäßen Verfahrens wird ein Makroblister erzeugt, indem Arzneimittelportionen in die Kavitäten einer Makroblisterverpackung eingebracht und die Kavitäten danach verschlossen werden. Es wird üblicherweise jeweils eine Arzneimittelportion in einer Kavität verschlossen. Hierfür können die bekannten Vorrichtungen zum Einbringen von Arzneimittelportionen in konventionelle Blister verwendet werden, wobei die Vorrichtungen gegebenenfalls auf die Größe der Makroblister angepasst werden müssen. Eine solche Anpassung ist für einen Fachmann des Maschinenbaus eine alltägliche Tätigkeit.In step (A) of the method according to the invention, 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. For this purpose, 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.
Ebenso ist denkbar, dass Arzneimittelportionen in Blisterbahnen eingebracht werden, aus denen dann Makroblister durch Schneiden, Stanzen oder ähnliche Trennmethoden erzeugt werden.It is also conceivable that medicament portions are introduced into blister webs, from which macroblisters are then produced by cutting, punching or similar separation methods.
In Schritt (B) werden die so erzeugten Makroblister gelagert bis feststeht, wo und für welchen Zweck die Arzneimittelportionen verwendet werden sollen. Dabei kann sich das Lager an dem Standort befinden, an dem die Makroblister erzeugt worden sind. Das Lager kann sich aber auch an dem Standort befinden, an dem die Makroblister in Gebrauchsblister zerteilt werden. Denkbar ist auch ein Lager an einem Ort, der weder dem Standort der Erzeugung der Makroblister noch dem Standort der Zerteilung entspricht.In 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. However, 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.
Denkbar ist/sind z.B. ein oder mehrere Lager, in denen die erfindungsgemäßen Makroblister, Stapel von Makroblistern, Transportboxen und/oder Transportpaletten in der Nähe von möglichen Verwendungsorten bereitgehalten werden ("Zentrallager"). Ein solches Zentrallager ist ein weiterer Gegenstand der vorliegenden Erfindung. Denkbar ist auch eine Kombination von einem oder mehreren Zentrallagern und Lagern an den Orten der Erzeugung der Makroblister und/oder des Zerteilens der Makroblister.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"). 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.
Unter Lager soll hier aber nicht nur ein Lagerraum oder eine Lagerhalle verstanden werden. Ein Lager kann auch ein mobiles Lager wie beispielsweise ein Container sein.Under storage here but not just a storage room or a warehouse to be understood. A warehouse can also be a mobile warehouse such as a container.
Als Lager kann auch die oben beschriebene Transportbox verstanden werden, in der die Makroblister für einen Zeitraum nicht weiter prozessiert werden. Entscheidend ist, dass man Arzneistoffe in Form eines Makroblisters in einem flexiblen Zustand behält, der es erlaubt, aus dem Makroblister bei Bedarf verschieden verpackte und gekennzeichnete Arzneistoffe für verschiedene Verwendungen, Länder, Regionen, Märkte, Kunden und/oder dergleichen zu erzeugen.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.
In einer bevorzugten Ausführungsform umfasst das erfindungsgemäße Verfahren den zusätzlichen Schritt des Transports der Makroblister von dem Ort der Erzeugung der Makroblister (Schritt (A)) zu dem Ort des Zerteilens der Makroblister (Schritt (C)). Der Transport muss nicht unmittelbar zwischen diesen Orten erfolgen; es ist denkbar, dass die Makroblister zunächst von dem Ort der Erzeugung der Makroblister zu einem Lager transportiert werden und zu einem späteren Zeitpunkt von diesem Lager zu dem Ort des Zerteilens weitertransportiert werden.In a preferred embodiment, 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.
In Schritt (C) werden die Makroblister in eine Anzahl N von Gebrauchsblistern zerteilt.In step (C), the macroblisters are divided into a number N of utility blisters.
Das Zerteilen eines Makroblisters in eine Anzahl N von Gebrauchsblistern kann mit bekannten Methoden erfolgen. Denkbar sind z.B. Laser-Schnitt, mechanischer Schnitt, Stanzen, Ätzen, Elektronenstrahlbearbeitung, Ultraschall und Wasserstrahl. Diese und weitere Methoden sind z.B. in den DIN-Normen 8588, 8589 und 8590 beschrieben.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.
Das Zerteilen kann sowohl manuell als auch automatisiert ausgeführt werden. Auch eine Kombination aus manuellen und automatisierten Schritten ist denkbar.The splitting can be done both manually and automatically. A combination of manual and automated steps is also conceivable.
In einer bevorzugten Ausführungsform des erfindungsgemäßen Verfahrens beträgt die Anzahl N von Gebrauchsblistern, in die ein Makroblister zerteilt wird, mindestens 10.In a preferred embodiment of the method according to the invention, the number N of blister packs into which a macroblister is divided is at least 10.
In einer besonders bevorzugten Ausführungsform des erfindungsgemäßen Verfahrens beträgt die Anzahl N von Gebrauchsblistern, in die ein Makroblister zerteilt wird, mindestens 20.In a particularly preferred embodiment of the method according to the invention, the number N of blister packs into which a macroblister is divided is at least 20.
In einer weiteren besonders bevorzugten Ausführungsform des erfindungsgemäßen Verfahrens beträgt die Anzahl N von Gebrauchsblistern, in die ein Makroblister zerteilt wird, genau der Anzahl T der Arzneimittelportionen in dem Makroblister. Damit enthält jeder Gebrauchsblister genau eine Arzneimittelportion (siehe z.B.
Im Krankenhaus werden Patienten durch das Krankenhauspersonal oftmals einzelne, unverpackte Arzneimittelportionen in kleinen Behältnissen zur Einnahme übergeben. Es ist denkbar, dass es dabei zu Verwechselungen kommt. Ebenso ist denkbar, dass ein solches Behältnis aus Versehen umgeschüttet wird und der Inhalt auf den Boden fällt. Es ist denkbar, dass damit die verschütteten Arzneimittelportionen aus hygienischen Gründen nicht mehr verwendbar sind. Es ist aber auch denkbar, dass die verschütteten Arzneimittelportionen den Patienten nicht mehr zuordenbar sind.In the hospital, patients are often given individual, unpackaged medicine portions in small containers to be taken by the hospital staff. It is conceivable that this will lead to confusion. It is also conceivable that such a container is accidentally spilled and the contents fall to the ground. It is conceivable that the spilled drug portions are no longer usable for hygienic reasons. However, it is also conceivable that the spilled medicament portions are no longer attributable to the patient.
Die Gebrauchsblister, die nur eine einzelne Arzneimittelportion enthalten, sind damit von Vorteil, da Arzneimittelportionen einem Patienten in verpackter Form übergeben werden können.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.
Ferner haben im Vorfeld maschinell erzeugte Einzelblister einen Vorteil gegenüber Gebrauchsblistern, die eine Perforation enthalten, damit der Kunde selbst einzelne Blister abtrennen kann: die maschinell erzeugten Einzelblister können so erzeugt werden, dass sie keine scharfen Ecken oder Kanten aufweisen, während durch Reißen entlang einer Perforation üblicherweise zwangsläufig scharfe Ecken und Kanten entstehen.Furthermore, 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.
In einer weiteren bevorzugten Ausführungsform weisen die Gebrauchsblister keine scharfen Ecken oder Kanten auf. Unter einer scharfen Ecke oder Kante wird eine Ecke oder Kante verstanden, mit der man einen konventionellen, aufgeblasenen Luftballon zum Platzen bringen kann, indem ein Mensch die Ecke oder Kante von unten gegen den in der Luft befindlichen Luftballon schlägt.In a further preferred embodiment, 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.
In einer weiteren bevorzugten Ausführungsform enthält ein Gebrauchsblister genau eine Dosierung. Als Dosierung wird die Dosis eines Medikaments verstanden, die im Rahmen einer Therapie zu verabreichen ist. Die Dosis bezeichnet die Menge eines Stoffes, die einem Organismus zugeführt wird. Üblicherweise beträgt die Dosierung genau eine Arzneimittelportion. Es gibt aber auch Arzneistoffe, bei denen eine Dosierung mehrere Arzneimittelportionen umfasst. Es ist beispielsweise denkbar, dass eine Arzneimittelportion zu groß werden würde, um eine Dosierung zu umfassen. Um die Einnahme des Arzneistoffes z.B. durch Verschlucken zu erleichtern, wird die Dosierung auf mehrere Arzneimittelportionen verteilt Denkbar sind z.B. zwei, drei, vier, fünf oder sechs Arzneimittelportionen pro Dosierung.In a further preferred embodiment, 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. Usually, the dosage is exactly one portion of medication. However, there are also drugs in which a dosage comprises several portions of drugs. For example, it is conceivable that a portion of medication would become too large to include a dosage. To prevent the ingestion of the drug, e.g. By swallowing, the dosage is spread over several drug portions. two, three, four, five or six drug portions per dosage.
Ein weiterer Gegenstand der vorliegenden Erfindung ist eine stapelförmige Anordnung von Einzelblistern. Ein solcher Stapel umfasst mindestens zwei Einzelblister. Die Einzelblister sind in dem Stapel über- oder nebeneinander gestapelt. Dabei kann die Stapelung so erfolgen, dass die Blasen stets in dieselbe Richtung weisen oder die Einzelblister alternierend Rückenseite an Rückenseite und Bauchseite an Bauchseite angeordnet sind. Zusätzliche Stützstrukturen, die neben den Blasen angebracht sein können, sollen verhindern, dass die Blasen eingedrückt und/oder beschädigt werden.
In Schritt (D) werden die Gebrauchsblister in Sekundärverpackungen eingebracht. Dabei enthält eine Sekundärverpackung mindestens einen Gebrauchsblister. Die Zahl n an Gebrauchsblistern, die in eine Sekundärverpackung eingebracht werden, beträgt üblicherweise zwischen 1 und 200.In step (D) the blister packs are placed in secondary packages. In this case, 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.
Ein Gebrauchsblister enthält mindestens eine Arzneimittelportion. Typische Mengen von Arzneimittelportionen pro Gebrauchsblister sind 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 21, 28, 30, 31, 32, 64, 50 und 100. Es sind aber auch andere Mengen denkbar.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.
Der Gebrauchsblister aus Schritt (C) hat eine von der Zahl der enthaltenen Arzneimittelportionen abhängige Größe. Üblicherweise wird für jede einzelne Arzneimittelportion eine Grundfläche von mindestens 35 mm x 35 mm (12,25 cm2) veranschlagt, wie dies in
Das erfindungsgemäße Verfahren bietet den Vorteil, dass wie bisher große Losgrößen an verpackten Arzneimitteln hergestellt werden können, dass die Verwendung von Makroblistern jedoch eine höhere Flexibilität in der weiteren Be- und/oder Verarbeitung und bei der weiteren Logistik erlaubt.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.
Erst dann, wenn der Verwendungszweck und der Ort, an dem die Arzneimittelportionen zum Einsatz kommen sollen, feststehen, werden sie in ihre finale, für den Kunden/Patienten bestimmte Form gebracht.Only then, when the intended use and the place where the medicine portions are to be used are determined, they are brought into their final form intended for the customer / patient.
In einer bevorzugten Ausführungsform werden die Makroblister in einem Land oder Staat hergestellt und in einem anderen Land oder Staat zerteilt.In a preferred embodiment, the macro blisters are made in one country or state and divided in another country or state.
In einer besonders bevorzugten Ausführungsform werden die Makroblister in dem Land oder Staat hergestellt, in dem auch die Arzneimittelportionen hergestellt werden.In a particularly preferred embodiment, the macroblisters are prepared in the country or state in which the drug portions are also prepared.
In einer weiteren besonders bevorzugten Ausführungsform werden die Makroblister in dem Land oder Staat zerteilt, in dem die Weitergabe an die Patienten vorgesehen ist.In a further particularly preferred embodiment, the macroblisters are divided in the country or state in which the transfer to the patients is intended.
Es ist aber auch denkbar, dass die Makroblister an demselben Standort hergestellt werden, an dem auch die Zerteilung und Verpackung in Sekundärverpackungen stattfindet. In einem solchen Fall können die Makroblister auf Vorrat erzeugt und gelagert werden. Die Arzneimittelportionen werden dann bei Bedarf kund- und/oder länderspezifisch gekennzeichnet und in ihre finale Form gebracht.However, it is also conceivable that the macro blisters are produced at the same location where the fragmentation and packaging takes place in secondary packaging. In such a case, 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.
Es ist denkbar, auf eine Makroblisterverpackung Informationen aufzubringen, bevor, während oder nachdem sie in Schritt (A) des erfindungsgemäßen Verfahrens mit Arzneimittelportionen befüllt wird.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.
Denkbar sind Informationen über die Arzneimittelportionen, das Datum der Verpackung, ein Verfallsdatum, eine Chargennummer, der Verpackungsort und andere Informationen.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.
Es ist denkbar, auf die Makroblister vor ihrer Lagerung in Schritt (B) des erfindungsgemäßen Verfahrens Informationen aufzubringen. Denkbar sind Informationen über die Arzneimittelportionen, das Datum der Verpackung, ein Verfallsdatum, eine Chargennummer, der Verpackungsort und andere Informationen.It is conceivable to apply information to the macroblisters prior to their storage in 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.
Es ist denkbar, auf die Makroblister nach der Lagerung in Schritt (B) und vor dem Zerteilen in Schritt (C) des erfindungsgemäßen Verfahrens Informationen aufzubringen. Denkbar sind Informationen über die enthaltenden Arzneimittelportionen, spezifische Informationen des Landes, in dem die Arzneimittelportionen eingesetzt werden sollen, und andere Informationen.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.
Es ist denkbar, auf die in Schritt (C) erzeugten Gebrauchsblister Informationen aufzubringen. Denkbar sind Informationen über die enthaltenden Arzneimittelportionen, spezifische Informationen des Landes, in dem die Arzneimittelportionen eingesetzt werden sollen, und andere Informationen.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.
Erfindungsgemäß werden länder- und/oder kundenspezifische Informationen erst unmittelbar vor und/oder nach dem Zerteilen von Makroblistern auf die Gebrauchsblister bzw. die Bereiche der Makroblister aufgebracht, aus denen die Gebrauchsblister durch Zerteilung erzeugt werden.According to the invention, 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.
In einer bevorzugten Ausführungsform umfasst das erfindungsgemäße Verfahren einen Schritt, in dem länder- und/oder kundenspezifische Informationen auf den Makroblister aufgebracht werden, wobei dieser Schritt nach Schritt (B) erfolgt.In a preferred embodiment, 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).
Das Aufbringen von Informationen auf einen Makroblister und/oder einen Gebrauchsblister kann mittels Verfahren, wie sie bei der Beschriftung von Blistern üblich sind, erfolgen. Beispiele sind Tintenstrahldruck, Laserbeschriftung, Tampondruck und das Einbringen von Strukturen wie beispielsweise einer Braille-Schrift.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.
In einer bevorzugten Ausführungsform der vorliegenden Erfindung wird der Makroblister mit mindestens einem maschinenlesbaren Code versehen. Beispiele für maschinenlesbare Codes sind RFID-Codes oder optische Codes wie gestapelte Codes (z.B. Codablock, Code 49 oder PDF417), Matrix-Codes (z.B. QR-Code, DataMatrix, MaxiCode oder Aztec-Code) sowie Punktcodes. Vorzugsweise wird ein optischer zweidimensionaler Code wie der Matrix-Code verwendet, besonders bevorzugt ein DataMatrix Code.In a preferred embodiment of the present invention, the macroblister is provided with at least one machine-readable code. Examples of 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. Preferably, an optical two-dimensional code such as the matrix code is used, more preferably a DataMatrix code.
In einer bevorzugten Ausführungsform wird jeweils ein Code pro Arzneimittelportion auf den Makroblister aufgebracht, so dass jede einzelne Arzneimittelportion gekennzeichnet ist. Dies erlaubt die individuelle Wiedererkennung und Verfolgung jeder einzelnen Arzneimittelportion auf ihrem Weg vom Makroblister über den Gebrauchsblister, ggf. über einen Arzt, Apotheker und/oder ein Krankenhaus bis hin zum Patienten. Durch diese Kennzeichnung ist es möglich, die Identität des Arzneistoffs bis zu dem Zeitpunkt, an dem ein Patient die Arzneimittelportion aus dem Gebrauchsblister drückt zu verfolgen und zu verifizieren.In a preferred embodiment, in each case one 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.
Individuelle Kennzeichnungen sind insbesondere für die personalisierte Medizin von Vorteil.Individual markings are particularly beneficial for personalized medicine.
In
In einer weiteren bevorzugten Ausführungsform erhält jedes der N Bereiche auf dem Makroblister, aus denen bei der Zerteilung in Schritt (C) ein Gebrauchsblister generiert wird, eine individuelle Kennzeichnung.In a further preferred embodiment, each of the N regions on the macroblister, from which a blister is generated in the fragmentation in step (C), receives an individual identifier.
In einer weiteren bevorzugten Ausführungsform wird der Makroblister mit mindestens einer Kennzeichnung versehen, die in sichtbarem Licht (elektromagnetische Strahlung der Wellenlänge von 380 nm bis 780 nm) für den Menschen mit dem bloßen Auge nicht erkennbar ist. Diese Kennzeichnung kann auf beiden Seiten des Makroblisters aufgebracht werden. Bevorzugt wird eine Kennzeichnung auf der Bauchseite des Blisters aufgebracht, während beispielsweise eine lesbare Kennzeichnung auf der gegenüberliegenden Rückenseite zu einem späteren Zeitpunkt aufgetragen wird.In a further preferred embodiment, 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. Preferably, 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.
Für die "unsichtbare" Kennzeichnung können beispielsweise Tinten verwendet werden, die nur im ultravioletten Licht (elektromagnetische Strahlung der Wellenlänge von 10 nm bis weniger als 380 nm) erkennbar gemacht werden können.For the "invisible" marking, 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).
Eine solche unsichtbare Kennzeichnung hat den Vorteil, dass sie von Maschinen gelesen und so die Makroblister prozessiert werden können, ohne dass die Kennzeichnung den weiteren Ablauf von der Erzeugung der Gebrauchsblister, deren Verpackung in eine Sekundärverpackung und Weitergabe an ein Krankenhaus, einen Arzt, eine Apotheke und/oder einen Patienten beeinflusst. Da sie mit bloßem Auge durch einen Menschen nicht zu sehen ist, "stört" sie auch nicht weiter und kann zu einem späteren Zeitpunkt, wenn sie keine Verwendung mehr findet, mit lesbaren Informationen z.B. überdruckt oder überklebt werden.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.
Die unsichtbare Kennzeichnung dient damit in einer Ausführungsform der vorliegenden Erfindung vorwiegend der Prozessierung der Makroblister.The invisible marking thus serves in one embodiment of the present invention predominantly the processing of macroblisters.
In einer bevorzugten Ausführungsform wird ein Makroblister auf der Bauchseite mit jeweils einer optisch maschinenlesbaren Kennzeichnung in jedem der Bereiche versehen, aus denen die Gebrauchsblister erzeugt werden, wobei die Kennzeichnung für das bloße menschliche Auge unsichtbar ist.In a preferred embodiment, 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.
Ein weiterer Gegenstand der Erfindung ist ein System zur Erzeugung von verpackten Arzneimittelportionen, die zur unmittelbaren Weitergabe an Patienten bestimmt sind, umfassend
- (A) ein Gerät zum Erzeugen eines Makroblisters,
- (B) ein Lager zur Lagerung des Makroblisters,
- (C) ein Gerät zum Zerteilen des Makroblisters in eine Anzahl N von Gebrauchsblistern, wobei N eine ganze
Zahl größer als 8 ist, - (D) ein Gerät zum Einbringen einer Anzahl n von Gebrauchsblistern in eine Sekundärverpackung, wobei n eine ganze Zahl größer oder gleich 1 ist.
- (A) a device for generating a macroblister,
- (B) a store for storing the macroblister,
- (C) means for dividing the macroblister into a number N of utility blanks, where N is an integer greater than 8,
- (D) a device for inserting a number n of blanks into a secondary package, where n is an integer greater than or equal to 1.
Der Begriff "Gerät" wird hier synonym zu dem Begriff "Vorrichtung" verwendet. Ein "Gerät" ist eine Vorrichtung, die entsprechende Mittel aufweist, um die Verfahren durchzuführen, die das Gerät charakterisieren. Zum Beispiel ist ein "Gerät zum Einbringen von Arzneimittelportionen in eine Makroblisterverpackung" eine Vorrichtung, die Mittel aufweist, um Arzneimittelportionen in eine Makroblisterverpackung einzubringen. Ein Gerät kann mehrere maschinelle Einheiten aufweisen, die verschiedene Prozesse ausführen wie beispielsweise greifen, transportieren, befüllen, bedrucken, schneiden etc.The term "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. For example, 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.
Das erfindungsgemäße System umfasst ein Gerät zum Erzeugen eines Makroblisters. Wie oben beschrieben, kann ein Makroblister dadurch erzeugt werden, dass Arzneimittelportionen in die Blasen einer Blisterbahn eingebracht werden, die Blasen verschlossen werden und von der Blisterbahn ein Makroblister abgetrennt wird. Ebenso kann ein Makroblister erzeugt werden, indem aus einer Blisterbahn zunächst ein Bogen abgetrennt wird, die Blasen des Bogens mit Arzneimittelportionen befüllt werden und die Blasen verschlossen werden. Das erfindungsgemäße Gerät (A) weist die entsprechenden Funktionen zur Ausführung der genannten Schritte auf.The system according to the invention comprises a device for generating a macroblister. As described above, 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. Likewise, 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.
In einer Ausführungsform der vorliegenden Erfindung liegen das Gerät zum Erzeugen des Makroblisters und das Gerät zum Zerteilen des Makroblisters an räumlich voneinander getrennten Orten vor.In one embodiment of the present invention, the macroblister generating device and the macroblast splitting device are provided at spatially separated locations.
Unter räumlicher Trennung wird verstanden, dass die betroffenen Geräte nicht mehr Teil eines einzelnen Produktionsstandortes bzw. Verpackungsstandortes sind, sondern verschiedenen Produktionsstandorten/Verpackungsstandorten angehören. Beispielsweise befindet sich das Gerät aus Schritt (C) mehr als 100 km von dem Gerät des Schritts (A) entfernt. Beispielsweise befindet sich das Gerät des Schritts (C) in einem anderen Land/Staat als das Gerät des Schritts (A).Spatial separation means that the affected devices are no longer part of a single production site or packaging location, but belong to different production sites / packaging locations. For example, the device of step (C) is more than 100 km away from the device of step (A). For example, the device of step (C) is located in a different country than the device of step (A).
Die Geräte der Schritte (C) und (D) befinden sich üblicherweise im selben Land/Staat und vorzugsweise auch am selben Standort.The devices of steps (C) and (D) are usually located in the same country / state and preferably also at the same location.
Das in Schritt (B) genannte Lager kann sich an dem Standort befinden, an dem sich das Gerät des Schritts (A) befindet. Ebenso ist denkbar, dass sich das Lager in Schritt (B) an dem Standort befindet, an dem sich das Gerät des Schritts (C) befindet.The bearing referred to in 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.
Es ist auch denkbar, dass sich ein Lager an dem Standort befindet, an dem Schritt (A) ausgeführt wird, und ein weiteres Lager an dem Standort, an dem Schritt (C) ausgeführt werden/wird. Auch ein Zentrallager, ein mobiles Lager oder die Kombination verschiedener Lager, wie weiter oben diskutiert, sind denkbar.It is also conceivable that 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.
In einer bevorzugten Ausführungsform umfasst das erfindungsgemäße System Mittel zum Transport des Makroblisters aus Schritt (A) vom Standort, wo Schritt (A) stattgefunden hat oder vom Standort des Lagers aus Schritt (B) zum Standort, wo Schritt (C) stattfindet.In a preferred embodiment, 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.
Geräte zum Einbringen von Arzneimittelportionen in eine Blisterverpackung sind bekannt. Es ist denkbar, derartige Geräte in dem erfindungsgemäßen System und in dem erfindungsgemäßen Verfahren einzusetzen. Gegebenenfalls ist eine Anpassung an die Größe der erfindungsgemäßen Makroblister nötig, die jedoch von einem Fachmann des Maschinenbaus ohne Weiteres bewerkstelligt werden kann.Devices for introducing drug portions in a blister pack are known. It is conceivable such devices in the system according to the invention and in the inventive Use method. 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.
Ferner sind auch Geräte zum Zerteilen von Blistern bekannt. Es ist denkbar, solche Geräte in dem erfindungsgemäßen System und in dem erfindungsgemäßen Verfahren einzusetzen. Gegebenenfalls ist eine Anpassung an die Größe des erfindungsgemäßen Makroblisters nötig, die jedoch von einem Fachmann des Maschinenbaus ohne Weiteres bewerkstelligt werden kann.Furthermore, 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.
In einer weiteren bevorzugten Ausführungsform ist ein Gerät zum Aufbringen von länder- und/oder kundenspezifischen Informationen auf einen Makroblister und/oder auf einen Gebrauchsblister ein weiterer Gegenstand des erfindungsgemäßen Systems. Dieses Gerät befindet sich vorzugsweise an einem anderen Standort als das Gerät zum Erzeugen des Makroblisters.In a further preferred embodiment, 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.
Die Erfindung wird nachstehend durch weitere Beispiele erläutert, wobei die Erfindung nicht auf die Beispiele beschränkt wird.
-
zeigt ein Beispiel eines Gebrauchsblisters a) in der Aufsicht, b) von vorne und c), d) von den Seiten. Der Gebrauchsblister umfasst einen flächigen Körper 1, inFigur 1den Kavitäten 2 zur Aufnahme von Arzneimittelportionen eingebracht sind. In den Kavitäten befinden sich einzelne Arzneimittelportionen (inFig. 1 nicht zu sehen). Die Kavitäten sind durch eine Folie 3 versiegelt. -
zeigt ein Beispiel einer Ausführungsform eines Makroblisters a) in der Aufsicht, b) von vorne und c) in einer Seitenansicht. Der Makroblister umfasst einen flächigen Körper 1, inFigur 2den Kavitäten 2 zur Aufnahme von Arzneimittelportionen eingebracht sind. In den Kavitäten befinden sich einzelne Arzneimittelportionen (inFig. 2 nicht zu sehen). Die Kavitäten sind durch eine Folie 3 verschlossen. -
zeigt ein weiteres Beispiel einer Ausführungsform eines Makroblisters a) in der Aufsicht, b) von vorne und c) in einer Seitenansicht. InFigur 3 sind beispielhaft Schnittlinien 4a und 4b gezeigt, die angeben, wo der Makroblister zerteilt werden kann, um eine Mehrzahl an "konventionellen" Blistern (Gebrauchsblister), die für die Weitergabe an Patienten bestimmt sind, zu erhalten.Figur 3 -
Figur 4 zeigt einen erfindungsgemäßen Stapel von Makroblistern. Die Makroblister sind alternierend Rücken an Rücken und Bauch an Bauch gestapelt. -
Fig. 5 zeigt ein Beispiel einer erfindungsgemäßen Transportbox. Die Transportbox ist so ausgestaltet, dass zwei Transportboxen nebeneinander auf einer Europalette platziert werden können, so dass die Grundfläche der Europalette nahezu vollständig abgedeckt wird. Die Größe der Transportbox beträgt etwa 1160 mm x 400 mm x 615 mm (0,28536 m3). Es können 100 bis 150 Makroblister in der Transportbox gelagert werden. Wenn ein Makroblister 280 Arzneimittelportionen enthält, ergeben sich bei 150 Makroblistern pro Transportbox insgesamt 42000 Arzneimittelportionen pro Transportbox. Drei Europaletten mit jeweils zwei Transportboxen enthalten damit eine Gesamtmenge von 252000 Arzneimittelportionen. -
Fig. 6 (a) zeigt einige Beispiele von Sekundärverpackungen, die mehrere Gebrauchsblister enthalten. In diesem Beispiel enthält jeder Gebrauchsblister eine einzelne Arzneimittelportion. Die Sekundärverpackungen enthalten jeweils 28, 14 und 7 Gebrauchsblister/Arzneimittelportionen. -
Fig. 6 (b) zeigt bevorzugte Ausführungsformen von gestapelten Einzelblistern. Die Einzelblister weisen einen flächigen Grundkörper (1) auf, in den eine Blase (2) eingebracht ist, in der eine Arzneimittelportion enthalten ist (in derFigur 6 (b) nicht zu erkennen). Zusätzlich sind Stützstrukturen in Form von Stützstegen (5) oder Stütznoppen (6) vorhanden. Ferner trägt jeder Einzelblister einen maschinenlesbaren optischen zweidimensionalen Code (7). Der linke und der mittlere Stapel enthalten jeweils 4 Einzelblister, die so übereinander angeordnet sind, dass die Blasen in dieselbe Richtung (hier nach oben) weisen. Im rechten Stapel sind vier Einzelblister alternierend Rückenseite an Rückenseite, Bauchseite an Bauchseite gestapelt. -
Fig. 7 zeigt schematisch den Flächenbedarf einer einzelnen Arzneimittelportion in einem Blister. -
Fig. 8 zeigt einen Gebrauchsblister, der eine Arzneimittelportion enthält und einen Matrixcode auf der Bauchseite trägt. -
Fig. 9 zeigt schematisch eine Vorrichtung zur Erzeugung von Makroblistern. Im ersten Schritt (links) werden einzelne Arzneimittelportionen in Kavitäten einer Folienlage eingebracht und die Kavitäten dann verschlossen. Der Folienverbund wird dann zu Makroblistern geschnitten (Mitte) und die Makroblister werden in Transportboxen verlagert (rechts). -
Fig. 10 zeigt schematisch die Prozessierung von Makroblistern zur Erzeugung von Gebrauchsblistern. Die Makroblister werden den Transportboxen (links) entnommen. Es werden Informationen aufgedruckt, dann werden die Makroblister zerteilt (Mitte). Die so erzeugten Gebrauchsblister werden zusammen mit einem Beipackzettel in den Sekundärverpackungen verpackt (rechts).
-
FIG. 1 shows an example of a utility blister a) in the top view, b) from the front and c), d) from the sides. The blister comprises aflat body 1, are introduced into thecavities 2 for receiving drug portions. In the cavities are individual drug portions (inFig. 1 not to be seen). The cavities are sealed by afoil 3. -
FIG. 2 shows an example of an embodiment of a macroblister a) in the top view, b) from the front and c) in a side view. The macroblister comprises aplanar body 1, in whichcavities 2 for receiving medicament portions are introduced. In the cavities are individual drug portions (inFig. 2 not to be seen). The cavities are closed by afilm 3. -
FIG. 3 shows a further example of an embodiment of a macroblister a) in the top view, b) from the front and c) in a side view. InFIG. 3 Shown are, by way of example, 4a and 4b, which indicate where the macroblister can be divided to obtain a plurality of "conventional" blisters (blister packs) intended for delivery to patients.section lines -
FIG. 4 shows a stack of macroblisters according to the invention. The macroblisters are alternately stacked back to back and belly to belly. -
Fig. 5 shows an example of a transport box according to the invention. The transport box is designed so that two transport boxes can be placed next to each other on a Euro pallet so that the base of the Euro pallet is almost completely covered. The size of the transport box is approximately 1160 mm x 400 mm x 615 mm (0.28536 m 3 ). You can store 100 to 150 macro blisters in the transport box. If a macro-blister contains 280 medicine portions, 150 macro blisters per transport box result in a total of 42,000 drug portions per transport box. Three Euro pallets with two transport boxes each contain a total of 252,000 medicine portions. -
Fig. 6 (a) shows some examples of secondary packaging containing multiple blister packs. In this example, each use blister contains a single portion of medication. The secondary packs contain 28, 14 and 7 user blister packs / drug portions, respectively. -
Fig. 6 (b) shows preferred embodiments of stacked Einzelblistern. The individual blisters have a flat basic body (1), in which a bladder (2) is introduced, in which a drug portion is contained (in theFIG. 6 (b) not recognizable). In addition, support structures in the form of support webs (5) or support knobs (6) are present. Furthermore, each Einzelblister carries a machine-readable optical two-dimensional code (7). The left and middle stacks each contain 4 individual blisters arranged one above the other so that the bubbles point in the same direction (up here). In the right stack four Einzelblister are alternately stacked back to back, belly on the side of the stomach. -
Fig. 7 shows schematically the area requirement of a single drug portion in a blister. -
Fig. 8 shows a blister containing a drug portion and carrying a matrix code on the ventral side. -
Fig. 9 schematically shows an apparatus for generating macroblisters. In the first step (left), individual drug portions are introduced into cavities of a film layer and the cavities are then closed. The foil composite is then cut into macro blisters (center) and the macro blisters are moved into transport boxes (right). -
Fig. 10 shows schematically the processing of macroblisters for generating blanks. The macro blisters are taken from the transport boxes (left). Information is printed, then the macro blisters are cut (middle). The blister packs produced in this way are packed together with a leaflet in the secondary packaging (right).
Claims (17)
- Macro blister pack, comprising a flat body, in which cavities for receiving individual medicinal product portions are formed, wherein the cavities are filled with individual medicinal product portions and sealed by a film, wherein the macro blister pack contains a number T of medicinal product portions, characterized in that T is at least 60 and the flat body has an extent in the range from 200 mm x 200 mm to 1200 mm x 1200 mm.
- Macro blister pack according to Claim 1, characterized in that it has a planar extent of at least 0.09 m2.
- Macro blister pack according to Claim 1 or 2, characterized in it contains at least 100 medicinal product portions.
- Macro blister pack according to any one of Claims 1 to 3, characterized in that it has at least one machine-readable marking.
- Macro blister pack according to any one of Claims 1 to 4, characterized in that it has at least one machine-readable marking, preferably on the belly side, via which information regarding the contained medicinal product portions can be obtained.
- Macro blister pack according to any one of Claims 1 to 5, characterized in that a machine-readable optical two-dimensional code is applied in the region of each contained medicinal product portion.
- Stack comprising at least two of the macro blister packs according to any one of Claims 1 to 6.
- Transport box containing at least one macro blister pack according to any one of Claims 1 to 6.
- Transport pallet, on which at least one macro blister pack according to any one of Claims 1 to 6 or at least one transport box according to Claim 8 is stored.
- Method for producing a macro blister pack according to any one of Claims 1 to 6, comprising the following steps:- introducing medicinal product portions into the bubbles of a macro blister pack packaging,- sealing the bubbles with a film.
- Method for producing a macro blister pack according to any one of Claims 1 to 6, comprising the following steps:- introducing medicinal product portions into the bubbles of a blister web,- sealing the bubbles with a film,- separating off the macro blister pack from the blister web.
- Method for providing medicinal product portions for one or more patients, comprising the following steps(A) producing a macro blister pack according to any one of Claims 1 to 6,(B) storing the macro blister pack,(C) dividing the macro blister pack into a number N of ready-for-use blister packs, where N is an integer greater than 8,(D) introducing a number n of ready-for-use blister packs from step (C) into a secondary packaging, where n is an integer greater than or equal to 1.
- Method according to Claim 12, wherein, after step (B) and before step (D), country- and/or customer-specific information is applied to the macro blister pack and/or the ready-for-use blister packs.
- Method according to Claim 12 or 13, wherein each ready-for-use blister pack contains a number of medicinal product portions corresponding precisely to a dosage.
- Method according to any one of Claims 12 to 14, wherein a stack of n = 2 to 64 ready-for-use blister packs is introduced into a secondary packaging.
- System for producing packaged medicinal product portions intended to be passed on to patients, comprising(A) an apparatus for producing a macro blister pack according to any one of Claims 1 to 6 containing the medicinal product portions,(B) a store for storing the macro blister pack,(C) an apparatus for dividing the macro blister pack into a number N of ready-for-use blister packs, where N is an integer greater than 8,(D) an apparatus for introducing a number n of ready-for-use blister packs into a secondary packaging, where n is an integer greater than or equal to 1.
- System according to Claim 16, the apparatus for producing the macro blister pack and the apparatus for dividing the macro blister pack being provided at different locations.
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL16757603T PL3341303T3 (en) | 2015-08-25 | 2016-08-18 | Blister pack |
SI201630587T SI3341303T1 (en) | 2015-08-25 | 2016-08-18 | Blister pack |
RS20200001A RS59742B1 (en) | 2015-08-25 | 2016-08-18 | Blister pack |
HRP20200192TT HRP20200192T1 (en) | 2015-08-25 | 2020-02-05 | Blister pack |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP15182316.8A EP3135602A1 (en) | 2015-08-25 | 2015-08-25 | Blister pack |
PCT/EP2016/069560 WO2017032674A1 (en) | 2015-08-25 | 2016-08-18 | Blister packaging |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3341303A1 EP3341303A1 (en) | 2018-07-04 |
EP3341303B1 true EP3341303B1 (en) | 2019-11-20 |
Family
ID=53969312
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP15182316.8A Ceased EP3135602A1 (en) | 2015-08-25 | 2015-08-25 | Blister pack |
EP16757603.2A Active EP3341303B1 (en) | 2015-08-25 | 2016-08-18 | Blister pack |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP15182316.8A Ceased EP3135602A1 (en) | 2015-08-25 | 2015-08-25 | Blister pack |
Country Status (29)
Country | Link |
---|---|
US (1) | US10889393B2 (en) |
EP (2) | EP3135602A1 (en) |
JP (1) | JP6878410B2 (en) |
KR (1) | KR102566585B1 (en) |
CN (1) | CN107922096B (en) |
AU (1) | AU2016312905B2 (en) |
BR (1) | BR112018003539B1 (en) |
CA (1) | CA2996434C (en) |
CL (1) | CL2018000495A1 (en) |
CO (1) | CO2018001990A2 (en) |
CR (1) | CR20180117A (en) |
DK (1) | DK3341303T3 (en) |
EA (1) | EA039570B1 (en) |
ES (1) | ES2770301T3 (en) |
HK (1) | HK1247170A1 (en) |
HR (1) | HRP20200192T1 (en) |
HU (1) | HUE048689T2 (en) |
IL (1) | IL257271A (en) |
LT (1) | LT3341303T (en) |
MX (1) | MX2018002347A (en) |
PE (1) | PE20181095A1 (en) |
PH (1) | PH12018500389A1 (en) |
PL (1) | PL3341303T3 (en) |
PT (1) | PT3341303T (en) |
RS (1) | RS59742B1 (en) |
SG (1) | SG11201801362QA (en) |
SI (1) | SI3341303T1 (en) |
SV (1) | SV2018005638A (en) |
WO (1) | WO2017032674A1 (en) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10678382B2 (en) | 2014-04-22 | 2020-06-09 | Avery Dennison Retail Information Services, Llc | Methods and systems for monitoring medication compliance |
US10762753B2 (en) | 2014-12-12 | 2020-09-01 | Avery Dennison Retail Information Services, Llc | Methods and systems for determining the time at which a seal was broken |
US10896301B2 (en) | 2015-07-07 | 2021-01-19 | Avery Dennison Retail Information Services, Llc | RFID-based methods and systems for monitoring medication compliance |
US10913594B2 (en) | 2015-07-07 | 2021-02-09 | Avery Dennison Retail Information Services, Llc | Smart ejection trays for use with medication containers |
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 |
CN108785271B (en) * | 2018-08-22 | 2021-02-26 | 李怡曈 | Capsule medicine board |
KR20210047731A (en) | 2019-10-22 | 2021-04-30 | 쓰리애플즈코스메틱스 주식회사 | Safe cutting type blister package |
FR3103325B1 (en) | 2019-11-15 | 2022-04-08 | Centre Nat Rech Scient | Device for producing energy comprising a reservoir |
KR20230037026A (en) | 2020-07-10 | 2023-03-15 | 트리아스텍 인코포레이티드 | High-precision additive manufacturing devices and high-throughput additive manufacturing systems |
CH717886A1 (en) * | 2020-09-21 | 2022-03-31 | Alpla Werke Alwin Lehner Gmbh & Co Kg | Plastic container and method for determining a property of a plastic container. |
USD993311S1 (en) * | 2021-07-20 | 2023-07-25 | F. Hoffmann-La Roche Ag | Package leaflet |
EP4286835A1 (en) * | 2022-05-30 | 2023-12-06 | Uhlmann Pac-Systeme GmbH & Co. KG | Method and packaging machine for making and testing blister packs |
Family Cites Families (37)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5243354B2 (en) * | 1972-11-08 | 1977-10-29 | ||
DE2950469C2 (en) * | 1979-12-14 | 1983-12-01 | I.M.A. Industria Macchine Automatiche S.p.A., Ozzano Emilia, Bologna | Device for the automatic cutting of rectangular panels with rounded corners |
US4384649A (en) | 1980-12-11 | 1983-05-24 | E. R. Squibb & Sons, Inc. | Dispensing package |
US4612755A (en) | 1985-07-24 | 1986-09-23 | Minnesota Mining And Manufacturing Company | Blister pack laminating device and method |
GB8519036D0 (en) | 1985-07-29 | 1985-09-04 | Jefferies F W | Blister pack machine |
US4750318A (en) | 1986-08-21 | 1988-06-14 | Idemitsu Petrochemical Co., Ltd. | Blister packaging apparatus |
DE3803979A1 (en) | 1988-02-05 | 1989-08-17 | Stephan Dieter | METHOD FOR PRODUCING PACKAGING BLISTER PACKAGING AND TOOL FOR SEALING BLISTER PACKAGING |
US20050016134A1 (en) * | 2003-07-22 | 2005-01-27 | Prebelli Industries, Inc. | Cutting machine for package manufacturing |
US5551567A (en) * | 1994-04-29 | 1996-09-03 | Mcneil-Ppc, Inc. | Blister package containing gripping means |
CH689305A5 (en) * | 1994-08-23 | 1999-02-15 | Alusuisse Lonza Services Ag | Blister. |
US5740717A (en) | 1996-12-19 | 1998-04-21 | Mcneil-Ppc, Inc. | Blister package scoring machine |
US6516949B2 (en) | 1995-10-31 | 2003-02-11 | Mcneil-Ppc, Inc. | Blister pill package with safety backing |
DE10030318C1 (en) * | 2000-06-27 | 2002-02-28 | Byk Gulden Lomberg Chem Fab | Pharmaceutical packaging for eradication therapy |
GB0020964D0 (en) * | 2000-08-25 | 2000-10-11 | Reckitt & Colmann Prod Ltd | Improvements in or relating to containers |
CN2631947Y (en) * | 2003-06-13 | 2004-08-11 | 林德平 | Photoelectric register set of roller heat-sealing bubble cap packer |
CA2567250A1 (en) * | 2004-05-18 | 2005-11-24 | Silverbrook Research Pty Ltd | Authentication of an object using a signature encoded in a number of data portions |
US8024911B2 (en) * | 2006-02-16 | 2011-09-27 | Mcneil Ab | Method for blister packing |
EP1985550A1 (en) * | 2007-04-27 | 2008-10-29 | UHLMANN PAC-SYSTEME GmbH & Co. KG | Packaging unit for medicines and method for its manufacture |
DE502007001135D1 (en) * | 2007-05-03 | 2009-09-03 | Uhlmann Pac Systeme Gmbh & Co | Process for the production of multi-day packages with various medicines |
DE202007009046U1 (en) | 2007-06-27 | 2007-08-30 | Zürcher, Ralf | Mobile phone, has transmitting and receiving unit and communication unit accommodated in separate housings and movable independent of each other, where housing of transmitting and receiving unit has shielding for electromagnetic radiation |
US9460948B2 (en) * | 2007-09-04 | 2016-10-04 | Ncr Corporation | Data management |
BRPI0817300A2 (en) | 2007-09-26 | 2015-06-16 | Pioneer Hi Bred Int | Apparatus for storing, uniquely identifying and cataloging for the recovery of a seed or a part thereof; method for storing, uniquely identifying and cataloging seeds with a package. |
ATE541784T1 (en) * | 2007-09-26 | 2012-02-15 | Ima Spa | METHOD FOR PACKAGING ARTICLES, IN PARTICULAR PHARMACEUTICAL ARTICLES |
US20090202635A1 (en) * | 2008-02-08 | 2009-08-13 | Stephen Michael Scott | Delivery System, Application, and Method |
ES2336880B1 (en) | 2008-04-02 | 2011-02-10 | Marti Garcia Sala | BLISTER TYPE DISPENSING MACHINE. |
KR20110116156A (en) * | 2009-02-06 | 2011-10-25 | 바이엘 파마 악티엔게젤샤프트 | Method for the production of a stack of medicament pouches used for storing and supplying medicament wafers, medicament pouch template for producing said stack, and use of the medicament pouch template |
US9189728B2 (en) * | 2009-07-23 | 2015-11-17 | I-Property Holding Corp. | Method for the authentication of dosage forms |
ATE549272T1 (en) * | 2009-10-02 | 2012-03-15 | Uhlmann Pac Systeme Gmbh & Co | PACKAGING FOR PHARMACEUTICAL PRODUCTS AND METHOD AND DEVICE FOR THE PRODUCTION THEREOF |
EP2383705B1 (en) * | 2010-04-30 | 2012-10-31 | MediSeal GmbH | Forgery-proof blister pack |
IT1400272B1 (en) * | 2010-06-04 | 2013-05-24 | Ima Safe S R L Unipersonale | PADS DISTRIBUTION MACHINE AND ITS PROCEDURE |
ITBO20100519A1 (en) * | 2010-08-11 | 2012-02-12 | Swisslog Italia Spa | DEVICE AND PROCEDURE FOR SINGULARIZING PRODUCTS |
US20120228190A1 (en) * | 2011-03-11 | 2012-09-13 | Anthony Joonkyoo Yun | Multi-dose nutritional supplements for the promotion of joint health |
US9138378B2 (en) * | 2011-07-06 | 2015-09-22 | Sonoco Development, Inc. | Blister package and method of forming same |
CN203003955U (en) | 2012-10-29 | 2013-06-19 | 上海派莎实业有限公司 | Hob type blister cutting device |
US20140230376A1 (en) * | 2013-02-18 | 2014-08-21 | Qem, Inc. | System, Method, and Apparatus for Forming and Filling Pill Compartments |
US20160001948A1 (en) | 2013-02-22 | 2016-01-07 | Meadwestvaco Corporation | Packaging system, sleeve and slide card |
ES2626779T3 (en) * | 2014-09-08 | 2017-07-26 | Edwin Kohl | Installation and procedure for repackaging different medicines from their respective original blisters to filling blisters |
-
2015
- 2015-08-25 EP EP15182316.8A patent/EP3135602A1/en not_active Ceased
-
2016
- 2016-08-18 ES ES16757603T patent/ES2770301T3/en active Active
- 2016-08-18 SG SG11201801362QA patent/SG11201801362QA/en unknown
- 2016-08-18 PL PL16757603T patent/PL3341303T3/en unknown
- 2016-08-18 US US15/754,858 patent/US10889393B2/en active Active
- 2016-08-18 KR KR1020187005127A patent/KR102566585B1/en active IP Right Grant
- 2016-08-18 PE PE2018000305A patent/PE20181095A1/en unknown
- 2016-08-18 PT PT167576032T patent/PT3341303T/en unknown
- 2016-08-18 HU HUE16757603A patent/HUE048689T2/en unknown
- 2016-08-18 DK DK16757603.2T patent/DK3341303T3/en active
- 2016-08-18 BR BR112018003539-4A patent/BR112018003539B1/en active IP Right Grant
- 2016-08-18 WO PCT/EP2016/069560 patent/WO2017032674A1/en active Application Filing
- 2016-08-18 LT LTEP16757603.2T patent/LT3341303T/en unknown
- 2016-08-18 CA CA2996434A patent/CA2996434C/en active Active
- 2016-08-18 CN CN201680049852.7A patent/CN107922096B/en active Active
- 2016-08-18 SI SI201630587T patent/SI3341303T1/en unknown
- 2016-08-18 JP JP2018510434A patent/JP6878410B2/en active Active
- 2016-08-18 CR CR20180117A patent/CR20180117A/en unknown
- 2016-08-18 RS RS20200001A patent/RS59742B1/en unknown
- 2016-08-18 EP EP16757603.2A patent/EP3341303B1/en active Active
- 2016-08-18 MX MX2018002347A patent/MX2018002347A/en unknown
- 2016-08-18 AU AU2016312905A patent/AU2016312905B2/en active Active
- 2016-08-18 EA EA201890579A patent/EA039570B1/en unknown
-
2018
- 2018-01-31 IL IL257271A patent/IL257271A/en unknown
- 2018-02-21 PH PH12018500389A patent/PH12018500389A1/en unknown
- 2018-02-22 SV SV2018005638A patent/SV2018005638A/en unknown
- 2018-02-23 CL CL2018000495A patent/CL2018000495A1/en unknown
- 2018-02-23 CO CONC2018/0001990A patent/CO2018001990A2/en unknown
- 2018-05-24 HK HK18106715.1A patent/HK1247170A1/en unknown
-
2020
- 2020-02-05 HR HRP20200192TT patent/HRP20200192T1/en unknown
Non-Patent Citations (1)
Title |
---|
None * |
Also Published As
Similar Documents
Publication | Publication Date | Title |
---|---|---|
EP3341303B1 (en) | Blister pack | |
EP1045799B1 (en) | Primary packaging unit for film-like or oblate-like administered shapes | |
DE10030318C1 (en) | Pharmaceutical packaging for eradication therapy | |
DE60123114T2 (en) | PACKAGING TO RECEIVE A BLISTER PACK | |
CH642026A5 (en) | EMPTY PACKING FOR INSERTING BLISTER STRIPES AND BLISTER PACK. | |
DE6930390U (en) | PACKAGE FOR A MEDICINAL PRODUCT. | |
KR20120135482A (en) | Administration methods and packagings for oral medications | |
EP2651766B1 (en) | Method for filling a cavity, in particular a blister of a blister packaging, with a liquid | |
DE602004008704T2 (en) | Blister pack for the visually impaired | |
EP3147233A1 (en) | Single blister packages for optimized stacking | |
EP1880953A1 (en) | Tablet blister pack | |
EP2393467A1 (en) | Method for the production of a stack of medicament pouches used for storing and supplying medicament wafers, medicament pouch template for producing said stack, and use of the medicament pouch template | |
DE202022002735U1 (en) | Stackable blister card for a patient's weekly medication needs and packaging unit for medication with such a blister card | |
EP3924267B1 (en) | Child-proof packaging | |
WO2013171129A1 (en) | Device for accommodating a drug blister | |
EP3125851B1 (en) | Use of a container for storing contraceptive tablets | |
CH513055A (en) | Drug pack | |
DE102023102804A1 (en) | Stackable blister card for a patient's weekly medication needs and packaging unit for medication with such a blister card and method for producing such a packaging unit | |
DE1969225U (en) | DOSAGE PACK FOR PHARMACEUTICAL PREPARATIONS. | |
DE202020004267U1 (en) | Blister markers (blister markers) for pharmaceutical blister packs | |
WO2017072328A1 (en) | Method for marking film-type dosage forms | |
EP0725015A1 (en) | Package for tablets contained in a blister pack | |
DE102009008026A1 (en) | Method for producing stack of medicament pockets that is utilized for storing and providing medicament wafers for e.g. contraception, involves stacking pockets so that markings are arranged in marking sections of pockets within each stack |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
|
17P | Request for examination filed |
Effective date: 20180326 |
|
AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
AX | Request for extension of the european patent |
Extension state: BA ME |
|
RIN1 | Information on inventor provided before grant (corrected) |
Inventor name: STANGE, OLAF Inventor name: BLUMENTHAL, PHILIPP Inventor name: BOBKA, PAUL Inventor name: DIEDERICH, REINER Inventor name: DIETRICH, FRANZ Inventor name: STUEHM, KAI Inventor name: HOEHL, JOHANNES-WALTER Inventor name: SCHMIDT, CHRISTOPHER Inventor name: DROEDER, KLAUS Inventor name: THIEDE, SEBASTIAN Inventor name: HERRMANN, CHRISTOPH |
|
RAV | Requested validation state of the european patent: fee paid |
Extension state: MA Effective date: 20180326 |
|
GRAP | Despatch of communication of intention to grant a patent |
Free format text: ORIGINAL CODE: EPIDOSNIGR1 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: GRANT OF PATENT IS INTENDED |
|
INTG | Intention to grant announced |
Effective date: 20190429 |
|
GRAS | Grant fee paid |
Free format text: ORIGINAL CODE: EPIDOSNIGR3 |
|
GRAA | (expected) grant |
Free format text: ORIGINAL CODE: 0009210 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE PATENT HAS BEEN GRANTED |
|
AK | Designated contracting states |
Kind code of ref document: B1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
AX | Request for extension of the european patent |
Extension state: BA ME |
|
REG | Reference to a national code |
Ref country code: GB Ref legal event code: FG4D Free format text: NOT ENGLISH |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: EP |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R096 Ref document number: 502016007661 Country of ref document: DE |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: FG4D Free format text: LANGUAGE OF EP DOCUMENT: GERMAN |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: REF Ref document number: 1203950 Country of ref document: AT Kind code of ref document: T Effective date: 20191215 |
|
REG | Reference to a national code |
Ref country code: RO Ref legal event code: EPE |
|
REG | Reference to a national code |
Ref country code: HR Ref legal event code: TUEP Ref document number: P20200192T Country of ref document: HR |
|
REG | Reference to a national code |
Ref country code: PT Ref legal event code: SC4A Ref document number: 3341303 Country of ref document: PT Date of ref document: 20200206 Kind code of ref document: T Free format text: AVAILABILITY OF NATIONAL TRANSLATION Effective date: 20200129 |
|
REG | Reference to a national code |
Ref country code: DK Ref legal event code: T3 Effective date: 20200212 |
|
REG | Reference to a national code |
Ref country code: FI Ref legal event code: FGE |
|
REG | Reference to a national code |
Ref country code: SE Ref legal event code: TRGR |
|
REG | Reference to a national code |
Ref country code: NL Ref legal event code: FP |
|
REG | Reference to a national code |
Ref country code: EE Ref legal event code: FG4A Ref document number: E018574 Country of ref document: EE Effective date: 20200106 |
|
REG | Reference to a national code |
Ref country code: NO Ref legal event code: T2 Effective date: 20191120 |
|
REG | Reference to a national code |
Ref country code: SK Ref legal event code: T3 Ref document number: E 33136 Country of ref document: SK |
|
REG | Reference to a national code |
Ref country code: MA Ref legal event code: VAGR Ref document number: 42682 Country of ref document: MA Kind code of ref document: B1 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: GR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20200221 |
|
REG | Reference to a national code |
Ref country code: HR Ref legal event code: T1PR Ref document number: P20200192 Country of ref document: HR |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: AL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20191120 |
|
REG | Reference to a national code |
Ref country code: ES Ref legal event code: FG2A Ref document number: 2770301 Country of ref document: ES Kind code of ref document: T3 Effective date: 20200701 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R097 Ref document number: 502016007661 Country of ref document: DE Ref country code: HR Ref legal event code: ODRP Ref document number: P20200192 Country of ref document: HR Payment date: 20200730 Year of fee payment: 5 |
|
REG | Reference to a national code |
Ref country code: HU Ref legal event code: AG4A Ref document number: E048689 Country of ref document: HU |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: SM Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20191120 |
|
PLBE | No opposition filed within time limit |
Free format text: ORIGINAL CODE: 0009261 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT |
|
26N | No opposition filed |
Effective date: 20200821 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MC Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20191120 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: LU Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20200818 |
|
VSFP | Annual fee paid to validation state [announced via postgrant information from national office to epo] |
Ref country code: MA Payment date: 20200919 Year of fee payment: 5 |
|
REG | Reference to a national code |
Ref country code: HR Ref legal event code: ODRP Ref document number: P20200192 Country of ref document: HR Payment date: 20210812 Year of fee payment: 6 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: CY Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20191120 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20191120 |
|
REG | Reference to a national code |
Ref country code: HR Ref legal event code: ODRP Ref document number: P20200192 Country of ref document: HR Payment date: 20220817 Year of fee payment: 7 |
|
P01 | Opt-out of the competence of the unified patent court (upc) registered |
Effective date: 20230507 |
|
REG | Reference to a national code |
Ref country code: HR Ref legal event code: ODRP Ref document number: P20200192 Country of ref document: HR Payment date: 20230728 Year of fee payment: 8 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: TR Payment date: 20230814 Year of fee payment: 8 Ref country code: RO Payment date: 20230728 Year of fee payment: 8 Ref country code: NO Payment date: 20230809 Year of fee payment: 8 Ref country code: IT Payment date: 20230726 Year of fee payment: 8 Ref country code: ES Payment date: 20230905 Year of fee payment: 8 Ref country code: EE Payment date: 20230719 Year of fee payment: 8 Ref country code: CZ Payment date: 20230727 Year of fee payment: 8 Ref country code: CH Payment date: 20230902 Year of fee payment: 8 Ref country code: AT Payment date: 20230725 Year of fee payment: 8 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: SK Payment date: 20230724 Year of fee payment: 8 Ref country code: SI Payment date: 20230725 Year of fee payment: 8 Ref country code: SE Payment date: 20230726 Year of fee payment: 8 Ref country code: RS Payment date: 20230725 Year of fee payment: 8 Ref country code: PL Payment date: 20230727 Year of fee payment: 8 Ref country code: HU Payment date: 20230811 Year of fee payment: 8 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: MT Payment date: 20230816 Year of fee payment: 8 Ref country code: LV Payment date: 20230719 Year of fee payment: 8 |
|
REG | Reference to a national code |
Ref country code: HR Ref legal event code: ODRP Ref document number: P20200192 Country of ref document: HR Payment date: 20240725 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: NL Payment date: 20240725 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: IS Payment date: 20240723 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: BG Payment date: 20240730 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: FI Payment date: 20240821 Year of fee payment: 9 Ref country code: IE Payment date: 20240723 Year of fee payment: 9 Ref country code: LT Payment date: 20240718 Year of fee payment: 9 Ref country code: DE Payment date: 20240717 Year of fee payment: 9 Ref country code: HR Payment date: 20240725 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: DK Payment date: 20240813 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: GB Payment date: 20240718 Year of fee payment: 9 Ref country code: PT Payment date: 20240819 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: BE Payment date: 20240724 Year of fee payment: 9 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: FR Payment date: 20240726 Year of fee payment: 9 |