EP1985550A1 - Packaging unit for medicines and method for its manufacture - Google Patents

Abstract

The packaging unit has a receiving frame (11), in which a number of recesses is arranged. The recesses are arranged in a sample, and a number of separated packaging sections (10) are inserted and fastened in the recesses. Each packaging section includes a base layer (16) with a recess, which serve for receiving of medicines, and a sealing foil (21) closes the recess of a base layer. Marking codes are applied on the sealing foils, and a cover foil (23) is arranged above the receiving frame and sealing foils. An independent claim is also included for a method for manufacturing of a packaging unit for medicines.

Description

The invention relates to a packaging unit for pharmaceuticals, with which for a plurality of days at different times of the day various drugs can be provided, and to a method for their preparation.

In the treatment of chronically ill people, the consequent, consistent use of medication often leaves much to be desired. This is especially the case if several tablets have to be taken several times a day. On the one hand to create a reminder to take the medication and on the other hand to provide a reliable overview of what medications are already taken, is in the DE 10 2004 034 024 A1 a blister pack is described in which the drug stations are arranged in a divided by weekdays and intake times matrix with seven rows and at least three columns. The individual drug stations are designed as trough-shaped depressions of a thin plastic layer, and all tablets, which are provided for a time of administration, are taken together in such a depression. All drug stations are covered with a blister foil and the sections for the individual intake times are each separated with perforations, so that a simple separation of individual intake sections for certain times of day and certain days of the week is possible.

A method for producing such a packaging unit for the weekly medication needs of a patient is for example off DE 10 2004 020 510 A1 known. Here are strip-shaped, wound into rolls Vorratsblisterverpackungen containing the individual drugs, moved at different output stations on the above-described packaging unit in the transverse direction and pushed by plungers from the strip-shaped supply blister pack in the trough-shaped recesses of the packaging unit before the trained as a weekly blister packaging unit integral with a Sealing film is sealed.

However, the above-mentioned packaging unit and the associated filling method have some disadvantages. Particularly serious is that certain tablets may not be stored together in a receptacle, as they influence each other. An inclusion of certain drug combinations in the above mentioned Packaging unit is therefore not possible from the outset. In addition, the filling process is relatively cumbersome and also critical from a contamination point of view, since during the ejection process of the tablets by means of the plunger an amount of tablet dust is generated, which deposits on the plungers and in the trough-shaped depressions.

The present invention is therefore an object of the invention to provide a packaging unit for pharmaceuticals, which includes the need for a patient for a longer period of time, in which all possible drug combinations can be used and which is easily prepared with the exclusion of contamination risk, and a corresponding Process for their preparation. This object is solved by the features of claim 1 or claim 9.

According to the invention, the pharmaceutical packaging unit has a receiving frame in which a plurality of recesses arranged in a pattern are arranged. In addition, it has a plurality of separated, inserted into the recesses and fixed therein packaging sections, each packaging section having a bottom layer with at least one recess, which serves to receive a drug, and a sealing film for closing the recess.

By this arrangement, an order of delivery times arranged packaging unit for drugs created with any number of different drugs can be stored without having to fear drug interactions during storage or contamination of the drug.

The packaging unit preferably has a cover film, which is arranged above the receiving frame and the sealing films. The cover sheet may serve to secure the packaging sections in the recesses but is commonly used to simultaneously peel off all the sealing films of a desired portion of the packaging unit. For this purpose, the cover film is adhesively bonded both to edge regions of the sealing films and to webs of the receiving frame, wherein the adhesive force of the cover film on the sealing films is greater than the adhesive force of the sealing films at the edges of the recesses of the soil layers. As a result, it is achieved that at the same time peel off the cover sheet release the sealing films from the packaging sections and thus can be accessed at once for all drugs that are provided for a single administration.

For this purpose, the receiving frame is preferably subdivided by means of perforations into subregions, wherein the cover film should also have perforations which correspond to the perforations of the receiving frame.

If this effect is to be achieved, the packaging sections must be secured in the recesses by mechanical fastening means such as lugs, by gluing, welding or sealing, in order to avoid unintentional withdrawal of the packaging sections from the recesses.

A method for producing the pharmaceutical packaging unit according to the invention comprises the following steps: producing a receiving frame in which a plurality of recesses arranged in a pattern are arranged; Producing a plurality of separated packaging sections, each packaging section having a bottom layer with at least one depression serving to receive a drug and a sealing film for closing the depression; and inserting the separated packaging sections into the recesses and securing them therein.

Thus, a packaging unit according to the invention for pharmaceuticals is produced in a particularly simple manner, the method providing only a single filling of a blister pack with medicaments. The tablets contained in the strip-shaped supply blister packs do not have to be removed again from the supply blister packaging during the filling of the packaging unit according to the invention in an intermediate step.

Advantageously, the forming of the plurality of separated packaging sections comprises the steps of: forming a longitudinally and transversely extending bottom sheet, thereby forming a plurality of depressions; Delivering drugs to the wells; Closing the wells by means of a sealing foil adhered to lands of the bottom sheet between the wells; and cutting the packaging web produced thereby into separated packaging sections.

A particularly simple way of cutting the packaging web into separated packaging sections comprises the following steps: cutting the packaging web in the longitudinal direction by means of a longitudinal cutter; Winding the longitudinal strips of the packaging web to Roll; and unwinding the rolls and cutting the longitudinal strips in the transverse direction by means of a cross cutter.

The insertion of the packaging sections in the recesses takes place advantageously by means of a movable suction or gripping device.

For easy quality control, the suction or gripping device is preferably monitored by means of a camera.

Fig. 1

ist eine schematische Draufsicht auf die Struktur einer erfindungsgemäßen Verpackungseinheit für Arzneimittel;

Fig. 2

ist eine Querschnittsansicht einer ersten Ausführungsform der erfindungsgemäßen Verpackungseinheit;

Fig. 3

ist eine Querschnittsansicht einer zweiten Ausführungsform der erfindungsgemäßen Verpackungseinheit;

Fig. 4

ist ein Ablaufdiagramm des erfindungsgemäßen Verfahrens zur Herstellung der Verpackungseinheit; und

Fig. 5

ist eine schematische Ansicht einer Vorrichtung, die beim erfindungsgemäßen Herstellungsverfahren verwendet wird.

Further details, features and advantages of the present invention will become apparent from the following description with reference to the drawings.

Fig. 1

is a schematic plan view of the structure of a packaging unit according to the invention for drugs;

Fig. 2

is a cross-sectional view of a first embodiment of the packaging unit according to the invention;

Fig. 3

is a cross-sectional view of a second embodiment of the packaging unit according to the invention;

Fig. 4

is a flow diagram of the inventive method for producing the packaging unit; and

Fig. 5

Fig. 10 is a schematic view of an apparatus used in the manufacturing method of the present invention.

Fig. 1 shows a schematic plan view of an example of a packaging unit according to the invention 1. The packaging unit 1 comprises a plurality of segments 3, each of which is associated with a particular time of day of a particular day of the week and can accommodate several drugs stored separately from each other. The segments 3 are arranged in rows and columns and preferably separated by perforations 2, wherein in the illustrated embodiment, the first line 4, for example, for the weekday "Monday", the second line 5 for the day of the week "Tuesday", etc. The division into columns Corresponds to the different intake times for medication during a certain day of the week, for example, the first column 6 of the intake time is assigned "morning", the second column 7 of the intake time "noon", the third column 8 of the intake time "evening" and the fourth column 9 of the intake time "night". In the present case, each segment 3 comprises four packaging sections 10, which in turn are arranged symmetrically in rows and columns within the segments 3, so that a uniform pattern of the packaging sections 10 results over the entire length and width of the packaging unit 1. The packaging sections 10 are inserted into recesses 12 of a receiving frame 11 and fixed there.

It is also possible that a packaging section 10 has a plurality of recesses in the longitudinal and / or transverse direction, in each of which identical tablets are stored. This can speed up the manufacturing process of the packaging unit 1 in particularly frequently used tablets by e.g. a packaging section 10 formed as a strip is inserted as a whole in the receiving frame 11.

Thus, in the example of the Fig. 1 the possibility to include four different tablets for each administration time in the packaging unit 1, but any other arrangement and number of packaging units per segment is conceivable. For example, there may be a matrix of 3 x 3 packing sections 10 per segment 3, such as in FIG Fig. 5 is shown. An irregular arrangement of the packaging sections 10 (eg in a circular arrangement) is also conceivable, as is the configuration of the packaging sections 10 in various sizes or shapes or any modification of the number of days for which drugs are received in the packaging unit 1. A particular form of the embodiment of the packaging unit 1 could be a monthly blister, preferably if only one administration time is to be considered daily.

In Fig. 2 is a section of a packaging unit 1 according to the invention with two juxtaposed packing sections 10 within a segment 3 in cross-sectional view. The receiving frame 11 is preferably made of plastic or cardboard, and the individual packaging sections 10 are inserted into the recesses 12 in the receiving frame 11 and anchored there via mechanical fasteners 14 such as lugs, for example, embrace the lower surface of the receiving frame 11 at the edge of the recesses 12. Thereby, a mechanical attachment of the packaging sections 10 in the receiving frame 11 is ensured, which exerted an upward Pressure withstands. However, the attachment of the packaging sections 10 in the recesses 12 of the receiving frame 11 can be done by any suitable mechanical means. For example, an arrangement of retaining lugs is conceivable, which engage in corresponding grooves on the inside of the recesses 12 of the receiving frame 11. Alternatively, a lid formed identically to the take-up frame 11 may be laid or folded from above with corresponding recesses (not shown) from above onto the take-up frame 11 and the packaging sections 10, which serves to secure the wrapping sections 10.

The individual packaging sections 10 are formed from a bottom layer 16 into each of which a large depression for receiving a drug is formed. The bottom layer 16 is preferably made of transparent or optionally colored PVC film, of polypropylene or of an aluminum composite layer.

Unlike in Fig. 2 illustrated embodiment, the individual packaging sections 10 and the receiving frame 11 may also have a greater height or smaller width. The webs 18 of the receiving frame, which limit the recesses 12, may also have respective planar projections 19 in their middle region, as in FIG Fig. 3 is shown.

Each packaging section 10 is closed with a sealing film 21, which is adhesively bonded to the sections of the bottom layer 16 projecting laterally from the recesses 12. Suitable sealing foil 21 are, for example, aluminum foils, paper-laminated foils or polypropylene foils. It is particularly preferred that the sealing film 21 can be relatively easily detached from this adhesive compound (peelable film), which can be achieved by a suitable choice of the heat-sealing lacquer. The sealing film 21 has no perforation in the covering area of the depression, so that a secure and permanent closure of the drug is ensured until use. In addition, an identification code may be applied to the sealing film 21, e.g. imprinted, with which the contents of the packaging section 10 can be properly identified.

A cover sheet 23, which covers the entire packaging unit 1, is adhesively sealed to edge portions of the sealing films 21 and to the webs 18 of the receiving frame 11. The cover sheet 23 is preferably an aluminum foil provided with polyethylene Aluminum foil, plastic film, etc. If the individual packaging sections 10 project only slightly beyond the surface of the receiving frame 11, the cover film 23 can be sealed directly onto the straight webs 18 and the edge regions of the sealing films 21. For a larger projection, the embodiment of Fig. 3 be advantageous with the flat projections 19 on the webs 18. The cover sheet 23 also preferably has a perforation 24 in the region of the perforation 2 of the receiving frame 11.

The adhesive force of the cover film 23 on the sealing films 21 is preferably greater than the adhesive force of the sealing films 21 at the edges of the recesses of the bottom layers 16. This achieves that when the cover film 23 is pulled off the webs 18 of the mounting frame 11, the sealing films 21 simultaneously detach from the packaging sections 10 and thus be able to access all drugs that are intended for a single administration time at once. For this purpose, on the one hand, it is important that the cover film is tearproof and, on the other hand, the packaging sections 10 are fastened in the recesses 12 almost inextricably. For this purpose, in addition to the abovementioned mechanical fastening, welding, gluing or sealing of the edge regions of the bottom layer 16 to the receiving frame 11 can also be used.

It is also conceivable to force the medicaments from the individual packaging sections 10 manually from the underside through the sealing foil 21. A cover sheet 23 is not necessary in this case.

As a further fastening alternative of the packaging sections 10 in the recesses 12 of the receiving frame 11, an attachment due to the adhesive connection between the cover film 23 and the webs 18 and the lateral edge regions of the sealing film 21 is conceivable. In this case, the adhesion of the cover sheet 23 to the substrate must be particularly high. In addition, it is then recommended that the cover film 23 has a further perforation in the region of the packaging sections, so that the medicaments can be pressed from below, both by the sealing film 21 and by the cover film 23.

The cover film 23 may additionally be labeled with a list of the medicaments contained in each of the packaging sections 10. Likewise it is conceivable, an additional Provide hinged lid on which information about the medicines are printed.

A flowchart of a preferred method for producing the packaging unit according to the invention is shown in FIG Fig. 4 shown. First, the receiving frame 11 is prepared, wherein the grid described above with the recesses 12 and preferably with perforations 2 between the different segments 3 is provided for the different intake times (step 30).

Subsequently or simultaneously, a plurality of separated packaging sections 10 are produced in step 32. Each packing section 10 serves to receive a medicament and comprises a bottom layer 16 with at least one depression in which the medicament is received, and a sealing film 21 for closing the depression. A preferred method for producing the separated packaging sections 10 consists of several steps, which are described below.

First, recesses for receiving the drugs are formed in a bottom sheet that extends widely in the longitudinal and transverse directions (step 34). For this purpose, the bottom sheet is unwound from a roll, heated in a heating station and provided in a subsequent forming station with the wells. Subsequently, the cavities are filled with medicaments (step 36) and preferably a filling control with coupled product ejection. In the subsequent step 38, the depressions are sealed by means of a sealing foil 21 which is adhered to webs 18 of the bottom web between the depressions (step 38). For this purpose, the sealing film 21 is unwound from a roll, applied in a sealing station on the webs 18 of the bottom sheet between the wells and then cooled in a cooling station.

Subsequently, the large-area packaging web thus produced is cut into separated packaging sections 10 (step 40). The cutting of the packaging web into separated packaging sections initially comprises cutting the packaging web in the longitudinal direction by means of a longitudinal cutter (step 42). In the slitter, the packaging web is cut in the running direction of the packaging web. The cut is preferably carried out in each case with a circular blade on a shaft. This shaft is usually below the packaging web. Above the packaging web is a shaft with one round disk per circular blade. The cut surface is between Round knives and the round disc formed. Hold-down press the packaging web from above against the guide to achieve a straight cut. The slitter is usually driven by a motor via a toothed belt.

As a result, longitudinal strips of the packaging web are produced, which are then wound up into rolls (step 44). In step 46, the longitudinal strips, which may also have a plurality of depressions in the transverse direction, are unwound from the roll and cut transversely by means of a cross cutter, whereby the separated packaging sections 10 already described above are produced. The structure of the cross cutter may correspond to the structure of the slitter.

Thus, one obtains individual separated packaging sections 10, in each of which at least one depression a drug is stored, which is securely packaged by the sealing film 21 and protected from environmental influences, as is the case with a conventional blister pack. These separated packaging sections 10 are now inserted into the recesses 12 in the receiving frame 11 (step 48). This can be done by means of a movable suction or gripping device.

An example of a transversely movable suction device 49 is shown in FIG Fig. 5 shown. In this schematically illustrated embodiment, a vertically movable suction arm 50, which is controlled by a control device (not shown), provided to receive a separated packaging section 10 and insert into the respective desired recess 12 in the receiving frame 11. In this case, a movement in the transverse direction along a rail 52 is conceivable, but also any other guided movement, which can be controlled by the control device, can be used here.

It is also possible to use a plurality of suction arms 50 in parallel, which are actuated separately in order to simultaneously insert a plurality of packaging sections 10 into the recesses 12. The transport of the receiving frame 11 is preferably clocked, wherein the filling of the packaging unit 1 with the separated packaging sections 10 is line-wise. In the presence of several suction arms 50, a simultaneous filling of several rows or segments 3 can also take place. For this purpose, it may also be useful if the suction arms 50 are also movable along the running direction of the packaging unit.

A camera installed in the area of the suction device 49 and preferably moved along 54 is used to monitor the suction and, if necessary, to monitor the correct storage of the packaging sections 10 in the recesses 12 of the receiving frame 11. It is also possible during application of the packaging sections 10 before the first sealing process applied to the sealing films 21, for example by printing Identification code by means of a code reader (not shown) to check. Thus, the correct content of the entire packaging unit 1 can be checked in a simple manner.

Subsequently, a cover sheet 23 is applied to the receiving frame 11 and the sealing films 21 (step 56), which may have perforations 24.

Thus, a pharmaceutical packaging unit is easily provided in which the need of a patient for medicines for several days is sorted by intake times, the individual tablets are always safely packed in the separated packaging sections 10 and thus both a contamination of the tablets is avoided a safe manufacturing process is ensured.

Claims (17)

Packaging unit for pharmaceuticals, with: a receiving frame (11) in which a plurality of patterned recesses (12) are arranged; and a plurality of separated, in the recesses (12) inserted and fixed therein packaging portions (10), wherein each packaging section (10) has a bottom layer (16) with at least one recess, which serves to receive a drug, and a sealing film (21) Has closure of the recess. Packaging unit according to claim 1, characterized in that identification codes are applied to the sealing films (21). Packaging unit according to claim 1 or 2, characterized in that it comprises a cover sheet (23) which is arranged above the receiving frame (11) and the sealing films (21). Packaging unit according to one of the preceding claims, characterized in that the receiving frame (11) by means of perforations (2) is subdivided into subregions. Packaging unit according to claim 3 or 4, characterized in that the cover film (23) is adhesively bonded both to edge regions of the sealing films (21) and with webs (18) of the receiving frame (11). Packaging unit according to claim 5, characterized in that the adhesive force of the cover film (23) on the sealing films (21) is greater than the adhesive force of the sealing films (21) at the edges of the recesses of the soil layers (16). Packaging unit according to one of claims 3 to 6, characterized in that the cover sheet (23) has perforations (24) corresponding to the perforations (2) of the receiving frame (11). Packaging unit according to one of the preceding claims, characterized in that the packaging sections (10) in the recesses (12) by mechanical fastening means (14), by gluing, welding or sealing are attached. Method of manufacturing a pharmaceutical packaging unit, comprising the following steps: - making (30) a receiving frame (11) in which a plurality of patterned recesses (12) is arranged; - producing (32) a plurality of separated packaging sections (10), each packaging section (10) having a bottom layer (16) with at least one recess for receiving a medicament and a sealing film (21) for closing the recess; and - Inserting (48) of the separated packaging sections (10) in the recesses (12) and attaching them therein. A method according to claim 9, characterized in that the manufacturing (32) of the plurality of separated packaging sections (10) comprises the following steps: - molds (34) of a longitudinally and transversely extending bottom sheet, whereby a plurality of recesses is formed; - delivering (36) drugs into the wells; - sealing (38) the recesses by means of a sealing foil (21) adhered to webs (18) of the bottom sheet between the recesses; and - Cutting (40) of the packaging web produced thereby in separated packaging sections (10). Method according to claim 10, characterized in that the cutting (40) of the Packaging web in separated packaging sections (10) comprises the following steps: - Cutting (42) of the packaging web in the longitudinal direction by means of a slitter; - winding (44) the longitudinal strips of the packaging web into rolls; and - Unwinding of the rolls and cutting (46) of the longitudinal strips in the transverse direction by means of a cross cutter. A method according to claim 10 or 11, characterized in that the insertion (48) of the packaging sections (10) in the recesses (12) by means of at least one movable suction or gripping device (49). A method according to claim 12, characterized in that the suction or gripping device (49) by means of a camera (54) is monitored. Method according to one of Claims 9 to 13, characterized by the step of checking, by means of a code reader, identification codes applied after the insertion (48) of the separated packaging sections (10) into the recesses (12) on the sealing films (21) of the packaging unit. Method according to one of claims 9 to 14, characterized by the step of also applying a cover sheet (23) over the receiving frame (11) and the sealing films (21), so that the cover sheet (23) both with edge regions of the sealing films (21) and is adhesively connected to webs (18) of the receiving frame (11). A method according to claim 15, characterized by the step of introducing perforations (24) into the cover film (23). Method according to one of Claims 9 to 16, characterized by the step of introducing perforations (2) into the receiving frame (11).

Images