EP3341303B1 - Blister pack - Google Patents

Description

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. 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.

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.

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.

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.

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.

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.

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.

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.

By creating the macroblisters, the drug portions are brought into a state that allows maximum flexibility in terms of later use (location, time and purpose). The inventive separation of the previous process costs can be reduced at the same time, because due to the flexible use of macroblister overcapacities can be avoided. In addition, even small batches can be produced very effectively and cost-reduced. 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.

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.

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. Examples of medicament portions are tablets, pills, dragees and capsules.

In a preferred embodiment of the present invention, the macroblister contains at least 100 drug portions.

In a preferred embodiment of the present invention, the macroblister contains at least 150 drug portions.

In a preferred embodiment of the present invention, the macroblister contains at least 200 drug portions.

In a particularly preferred embodiment of the present invention, the macroblister contains between 250 and 350 drug portions.

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.

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 a further preferred embodiment, the macroblister according to the invention has an areal extent of at least 0.09 m ² .

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 .

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 ).

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.

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.

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).

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 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 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 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.

Analog dimensions can also be determined for other transport pallets.

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.

The individual macroblisters can be stored in the stack above or next to each other so that the bubbles in which the drug portions are located always point in one direction.

It is also conceivable, however, to have a stack in which the individual macroblisters alternately point in one direction and the other direction, as shown by way of example in FIG Fig. 4 is shown. Preferably, 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.

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.

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.

Fig. 5 shows an example of a transport box according to the invention.

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 ).

As in Fig. 5 (b) 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. 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.

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 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.

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.

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 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.

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.).

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.

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.

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.

The secondary packaging is usually a folding box, preferably made of cardboard. Fig. 6 shows some examples of secondary packaging containing multiple blister packs.

The provision of drug portions in macroblisters is another object of the present invention.

1. (A) Erzeugen eines Makroblisters enthaltend Arzneimittelportionen,
2. (B) Lagerung des Makroblisters,
3. (C) Zerteilen des Makroblisters in eine Anzahl N von Gebrauchsblistern, wobei N eine ganze Zahl größer als 8 ist,
4. (D) Einbringen einer Anzahl n von Gebrauchsblistern aus Schritt (C) in eine Sekundärverpackung, wobei n eine ganze Zahl größer oder gleich 1 ist.

The invention thus also relates to a method for providing drug portions for one or more patients, comprising the steps

1. (A) generating a macroblister containing drug portions,
2. (B) storage of the macroblister,
3. (C) dividing the macroblister into a number N of utility blanks, where N is an integer greater than 8,
4. (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 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.

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 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.

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.

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.

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 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 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.

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 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 a further particularly preferred embodiment of the method according to the invention, the number N of blanks in which a macroblister is divided is exactly the number T the drug portions in the macro blister. Thus, 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.

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.

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.

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 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 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.

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. In a preferred embodiment, 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. In Fig. 6 (a) is such an embodiment exemplified (left side, the secondary packaging carries the inscription 28).

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.

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.

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 a preferred embodiment, the macro blisters are made in one country or state and divided in another country or state.

In a particularly preferred embodiment, the macroblisters are prepared in the country or state in which the drug portions are also prepared.

In a further particularly preferred embodiment, the macroblisters are divided in the country or state in which the transfer to the patients is intended.

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.

It is conceivable to apply information to a macro blister pack before, during or after it is filled with medicament portions in step (A) of the method according to the invention.

Information about the portion of the medication, the date of the packaging, an expiry date, a batch number, the place of packaging and other information may be possible.

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.

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.

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.

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 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).

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 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 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.

Individual markings are particularly beneficial for personalized medicine.

In Fig. 8 It is shown how a single drug portion in a blister (both macroblister and 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.

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 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.

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).

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.

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.

1. (A) ein Gerät zum Erzeugen eines Makroblisters,
2. (B) ein Lager zur Lagerung des Makroblisters,
3. (C) ein Gerät zum Zerteilen des Makroblisters in eine Anzahl N von Gebrauchsblistern, wobei N eine ganze Zahl größer als 8 ist,
4. (D) ein Gerät zum Einbringen einer Anzahl n von Gebrauchsblistern in eine Sekundärverpackung, wobei n eine ganze Zahl größer oder gleich 1 ist.

Another object of the invention is a system for the production of packaged drug portions, which are intended for immediate distribution to patients, comprising

1. (A) a device for generating a macroblister,
2. (B) a store for storing the macroblister,
3. (C) means for dividing the macroblister into a number N of utility blanks, where N is an integer greater than 8,
4. (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.

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.

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 one embodiment of the present invention, the macroblister generating device and the macroblast splitting device are provided at spatially separated locations.

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).

The devices of steps (C) and (D) are usually located in the same country / state and preferably also at the same location.

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.

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 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.

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.

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 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.

• Figur 1 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, in den Kavitäten 2 zur Aufnahme von Arzneimittelportionen eingebracht sind. In den Kavitäten befinden sich einzelne Arzneimittelportionen (in Fig. 1 nicht zu sehen). Die Kavitäten sind durch eine Folie 3 versiegelt.
• Figur 2 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, in den Kavitäten 2 zur Aufnahme von Arzneimittelportionen eingebracht sind. In den Kavitäten befinden sich einzelne Arzneimittelportionen (in Fig. 2 nicht zu sehen). Die Kavitäten sind durch eine Folie 3 verschlossen.
• Figur 3 zeigt ein weiteres Beispiel einer Ausführungsform eines Makroblisters a) in der Aufsicht, b) von vorne und c) in einer Seitenansicht. In Figur 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 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 der Figur 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).

The invention will now be illustrated by further examples, but the invention is not limited to the examples.

• 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 a flat body 1, are introduced into the cavities 2 for receiving drug portions. In the cavities are individual drug portions (in Fig. 1 not to be seen). The cavities are sealed by a foil 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 a planar body 1, in which cavities 2 for receiving medicament portions are introduced. In the cavities are individual drug portions (in Fig. 2 not to be seen). The cavities are closed by a film 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. In FIG. 3 Shown are, by way of example, section lines 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.
• 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 the FIG. 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)

1. 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.
2. Macro blister pack according to Claim 1, characterized in that it has a planar extent of at least 0.09 m².
3. Macro blister pack according to Claim 1 or 2, characterized in it contains at least 100 medicinal product portions.
4. Macro blister pack according to any one of Claims 1 to 3, characterized in that it has at least one machine-readable marking.
5. 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.
6. 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.
7. Stack comprising at least two of the macro blister packs according to any one of Claims 1 to 6.
8. Transport box containing at least one macro blister pack according to any one of Claims 1 to 6.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.

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