US20080295460A1

US20080295460A1 - Method of Manufacturing Packaging Comprising Pharmaceutical Products

Info

Publication number: US20080295460A1
Application number: US12/110,840
Authority: US
Inventors: Siegfried Drost; Gunter Felk; Georg Pfau; Hans-Werner Bongers-Ambrosius; Heino Prinz; Richard Mertens
Original assignee: Uhlmann Pac Systeme GmbH and Co KG
Current assignee: Uhlmann Pac Systeme GmbH and Co KG
Priority date: 2007-05-03
Filing date: 2008-04-28
Publication date: 2008-12-04
Also published as: US20080271417A1; DE502007001135D1; EP2000410B1; EP1988019B1; EP1988019A1; DE502007000406D1; EP2000410A1

Abstract

The method for producing a multi-day package containing various drugs has the following steps. A bottom layer is formed with a plurality of wells arranged in a pattern. A predetermined number of different drugs are arranged in predetermined positions at various dispensing stations of a filling device. The desired drugs are picked in a controlled manner from their predetermined positions at each dispensing station by at least one movable suction or gripper device, and the drugs are placed in predetermined wells. Finally, a sealing film is applied to the bottom layer to seal off the wells.

Description

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority based on European patent application EP 07 008 966.9, filed May 3, 2007.

FIELD OF THE INVENTION

The invention pertains to methods for producing multi-day packages which contain various medicaments for several days and for several administration times.

DESCRIPTION OF THE PRIOR ART

The multiple blister pockets of conventional blister packs are intended to hold a single type of medicament. A device for filling these conventional blister packs is described in, for example, DE 199 26 893 C2.
In the treatment of patients with chronic diseases, however, there is often room for improvement with respect to the patient's ability to take his or her medicaments consistently in accordance with the prescribed therapy. This is especially true when different sets of tablets must be taken at different times of day. To provide a memory aid which helps the patient take his or her medicaments correctly and also to ensure a reliable overview as to which medicaments have already been taken, DE 10 2004 034 024 A1 describes a blister pack in which the drug pockets are arranged in a matrix divided into days of the week and administration times with seven lines and at least three columns. The individual drug pockets are designed as tub-like wells formed in a thin layer of plastic, and all the tablets which are to be taken at a particular time of day are put together in one of these wells. All the drug pockets are covered with blister film, and the sections assigned to the individual administration times are separated from each other by perforations, so that the individual administration sections for certain times of day and certain days of the week can be easily separated from the rest of the pack.
A method for producing a packaging unit of this type to accommodate the patient's medicaments for a week is known from, for example, DE 10 2004 020 510 A1. Strip-like supply blister packs containing the individual medicaments are wound up into rolls. At various dispensing stations, the strips are conveyed over the above-described packaging unit in the transverse direction, and plungers are used to push the medicaments out of the strip-like supply blister pack into the tub-like wells of the packaging unit. The packaging unit, designed as a “one-week blister”, is sealed as a whole with sealing film.
The above-mentioned production method is relatively cumbersome, however, because of the complicated mechanisms required and the double packaging step of the tablets. The method is also critical from a contamination standpoint, because, when the tablets are pushed out by the plungers, tablet dust is created, which settles on the plungers and in the tub-like wells.
Another production method is known from DE 10 2005 047 429 A1. Here a system for filling one-week blister packs is disclosed, which is intended primarily for situations in which comparatively small numbers of patients are involved (e.g., in clinical centers). Standard commercial blister packs are stored in stacks in sector magazines, each of which can be rotated to release a blister holding the desired type of tablet. The blister pocket, from which the tablet is to be taken, is then opened by punching out the blister cap. The blister cap is then removed by a suction pipette integrated into the punching tool, whereupon the suction pipette is also used to remove the tablet from the blister pocket and to load it into the one-week blister pack. The overall method is extremely complicated.
It is an object of the present invention to provide a method for producing a multi-day package holding various drugs, which method excludes contamination and which can be carried out easily and also very quickly.

SUMMARY OF THE INVENTION

According to an embodiment of the invention, the method for producing a multi-day package with various drugs includes the following steps: forming a bottom layer with a plurality of wells arranged in a pattern; arranging supply-blister sheets with a predetermined number of different drugs in predetermined positions at various dispensing stations of a filling device, wherein the supply-blister-pockets are sealed by a temporary sealing film, which is applied adhesively to the webs of the base layer between the supply-blister pockets; partially removing the temporary sealing film from the webs of the base layer of the supply-blister sheets; picking the desired drugs from their predetermined positions by at least one movable suction or gripper device; depositing the drugs in the predetermined wells; and applying a sealing film to the bottom layer to seal off the wells.
Thus, a multi-day package containing various drugs is produced in an especially simple manner, quickly, and without risk of contamination, wherein the drugs are kept protected in the supply-blister pockets even during long periods of storage.
The production of the supply-blister sheets preferably comprises the following steps: forming a base layer extending a considerable distance in the longitudinal and transverse directions, as a result of which the plurality of supply-blister pockets is obtained; and loading the drugs into the supply-blister pockets.
It can be advantageous to cut the supply-blister sheet into supply-blister sections before the step of removing the temporary sealing film and to arrange the blister sections wound up on a roll at the dispensing stations transversely to the transport direction of the multi-day package. As a result, effective access to individual, seldom-used tablets is possible. The supply-blister sections are not necessarily limited to a single strip-like row of supply-blister pockets but can have instead several supply-blister pockets next to each other, so that the simultaneous removal of medicaments from several supply-blister pockets by several suction or gripper devices is possible not only transversely, but also longitudinally to the transport direction of the multi-day package.
To simplify quality control, the suction or gripper device is preferably monitored by a camera or by means of sensors.
By means of the additional step of introducing perforations into the bottom layer and into the sealing film between the wells, the possibility is obtained of being able to separate individual sections for specific administration times of specific days from the multi-day package.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional details, features, and advantages of the present invention can be derived from the following description, which makes reference to the attached drawings.

FIG. 1 is a schematic top view of a multi-day package containing various drugs after the sealing film has been partially removed;

FIG. 2 is a cross-sectional view through the multi-day package of FIG. 1;

FIG. 3 is a flow chart of the inventive method for producing the multi-day package;

FIG. 4 is a flow chart of an alternative to the inventive method for producing the multi-day package;

FIG. 5 is a schematic diagram of a filling device which can be used in the inventive production method; and

FIG. 6 is a schematic diagram of a filling device which can be used in an alternative production method.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a schematic top view of an example of a multi-day package 1. The packaging unit 1 comprises several segments 3, each of which is assigned to a certain time of day of a certain day of the week and can hold several types of medicaments. The segments 3 are arranged in columns and rows and are preferably separated by perforations 2, wherein, in the exemplary embodiment shown here, the first row 4 stands, for example, for “Monday”, the second row 5 for “Tuesday”, etc. The division into columns corresponds to the different administration times of the medicaments during the course of a specific day of the week, wherein, for example, the first column 6 is assigned to the administration time “morning”, the second column 7 to the administration time “noon”, the third column 8 to the administration time “evening”, and the fourth column 9 to the administration time “night”. It is also possible to package medicaments for more than 7 or less than 7 days in the multi-day package (e.g., a blister pack for a whole month) or to include only certain administration times.
FIG. 2 is a cross-sectional view of part of an inventive packaging unit 1 with several adjacent segments 3. The segments 3 are formed out of a bottom layer 11, into which relatively large wells 10 are formed, each of which can hold several medicaments. The bottom layer 11 consists preferably of PVC film, either transparent or of any desired color, or it can consist of polypropylene or a layer laminate with aluminum. The wells 10 can also have a shape different from the tub-like form shown in FIG. 2 and can also be arranged in almost any regular or irregular pattern, possibly a circular pattern, for example.
Each well 10 is closed by a sealing film 12, which is bonded adhesively to the webs 14 of the bottom layer located between the wells 10. Aluminum foil, paper-lined foil, or polypropylene film can be used as the sealing film 12. The sealing film 12 has no perforations in the areas where it covers the wells 10, so that a secure and long-lasting seal is provided for the drug until it is needed. The perforations 2 in the webs 14 of the bottom layer 11, which form the boundaries of the wells 10, and those in the sealing film 12 can be seen between the individual segments 3.
When the sealing film 12 is pulled from the webs 14 around a well 10, it is therefore possible to access all of the medicaments intended for a certain administration time at once. For this purpose it is important for the sealing film 12 to be relatively tear-proof.
The sealing film 12 can also be imprinted with a list of the medicaments contained in the individual wells 10. It is also conceivable that an additional hinged cover could be provided, on which information about the medicaments is presented.
A flow chart of the inventive method for producing the multi-day package is shown in FIG. 3.
First, wells 10 to hold the drugs are formed in a bottom layer 11 (step 32). For this purpose, the bottom layer 11 is pulled from a roll, possibly heated in a heating station, and then provided with the wells 10 in a following forming station.
Then a predetermined number of different drugs are arranged (step 34) in predetermined positions at various dispensing stations of the filling station. The steps to be carried out for this purpose in the case of the embodiment according to FIG. 3 are explained in the following.
First, in step 35, a base layer of considerable size in the longitudinal and transverse directions is formed, as a result of which a large number of supply-blister pockets 16 is obtained. For this purpose, the base layer is unwound from a roll, possibly heated in a heating station, and provided with the supply-blister pockets 16 in a forming station. Then the supply-blister pockets 16 are filled with drugs (step 36); the results are subjected to quality control, and defective products are ejected. In the following step 38, the supply-blister pockets 16 are closed by a temporary sealing film, which is applied adhesively to the webs of the base layer between the supply-blister pockets 16. For this purpose, the temporary sealing film is unwound from a roll, applied in a sealing station to the webs of the base layer between the supply-blister pockets 16, and then cooled in a cooling station.
Then the large supply-blister sheet thus produced is cut into individual supply-blister sections (step 40). The cutting of the supply-blister sheet into separate supply-blister sections comprises preferably the cutting of the supply-blister sheet in the longitudinal direction by means of a longitudinal cutter. In the longitudinal cutter, the supply-blister sheet is cut in the direction in which the supply-blister sheet is traveling. The cuts are made preferably by circular knives mounted on a shaft. This shaft will usually be located underneath the supply-blister sheet. Above the supply-blister sheet there is a shaft on which a round disk is mounted opposite each of the circular knives. The cut edge is formed between the circular knife and the round disk. Hold-downs press the supply-blister sheet from above against the guide to ensure a straight cut. The longitudinal cutter is usually driven by a motor and a toothed belt.
As a result, supply-blister sections are produced from the supply-blister sheet, and these sections are then wound up into rolls. A supply-blister section can be in the form of a strip, but it can also have several supply-blister pockets 16 adjacent to each other in the transverse direction. After that, the supply-blister sections are unwound from the roll, and the temporary sealing film is removed (step 42).
Then the medicaments are picked up in a controlled manner by means of at least one mobile suction or gripper device 50 and placed in the wells 10 (step 44).
FIG. 5, which shows a schematic diagram of a filling device for the inventive method, illustrates an example of a suction device 50 which can move in the transverse direction. In this schematic diagram of an exemplary embodiment, the suction device 50 is a suction arm, which can move vertically and which is driven by a control unit (not shown). The device is designed to pick up individual tablets from the supply-blister pockets 16 from which the sealing film 12 has previously been removed and to place them in the individual desired wells 10 formed in the bottom layer 11. Movement in the transverse direction along a rail 52 is also conceivable, but any other guided movement which can be controlled by the control unit can be used here.
It is also possible to use several suction arms 50 in parallel, which are actuated separately, in order to place several tablets in the wells 10 simultaneously. The bottom layer 11 is preferably transported in interval fashion, and the multi-day package I will be filled with the individual tablets row by row. If several suction arms 50 are present, it is also possible to fill several rows or segments 3 simultaneously. For this purpose it can also be advisable for the suction arms 50 to be movable in the transport direction of the multi-day package as well.
A camera 54, which is installed in the area of the suction device and which preferably moves along with it, serves to monitor both the suction process and the correct placement of the tablets in the wells 10 of the bottom layer 11. Other sensors are also suitable for monitoring the picking and placing of the tablets.
The last step is the sealing of the multi-day package with the sealing film 12 (step 46).
In addition to the inventive method, the arrangement 34 of a predetermined number of drugs in predetermined positions at other dispensing stations of the filling device can occur in a different way which is shown in FIG. 4 and FIG. 6.
In this case, the holders of a sorting plate 56 arranged in correspondence with the pattern of the wells 10 in the multi-day package are filled with drugs. This variant is especially effective when several suction or gripper devices 50, which can be arranged above the sorting plate 56 in correspondence with the pattern of the holders, are actuated individually at the dispensing station, and when a large number of these drugs is to be loaded into each multi-day package. The placing of the drugs onto the sorting plate 56 is preferably accomplished by means of a vibrating chute. To ensure that all of the holders of the sorting plate 56 are filled, a brushing movement with a brush device 58 is then preferably carried out, which also takes care of removing excess tablets from the sorting plate 56.
By means of the filling device shown in FIG. 6, where, for reasons of clarity the sorting plate 56 is shown reduced in size and where only two suction devices 50 of the matrix arrangement of suction devices 50 corresponding to the pattern of wells 10 in the multi-day package are shown, it is therefore possible to pick the medicaments from the sorting plate 56 in any desired pattern and to place them in the corresponding wells 10 in the multi-day package, whereupon the empty holders are refilled.
It is possible to apply the inventive and the alternative embodiment of the method in combination, that is, at different dispensing stations of the same filling device.
Thus, in an especially simple and rapid manner, a multi-day package for various medicaments is created, in which the medicaments are sorted by administration times.

Claims

1. A method for producing a multi-day package containing various drugs comprising the following steps:

forming a bottom layer with a plurality of levels arranged in a pattern;

arranging supply-blister sheets at various dispensing stations of a filling device, wherein, at predetermined positions at each dispensing station, the supply-blister sheets have supply-blister pockets to hold a number of different medicaments, and wherein the pockets of the supply-blister sheets are sealed by a temporary sealing film, which is applied adhesively to the webs of the base layer between the supply-blister pockets;

partially removing the temporary sealing film from the supply-blister sheet to release a predetermined number of drugs to at least one suction or gripper device;

picking the desired drugs in a controlled manner from their predetermined positions at each dispensing station by at least one movable suction or gripper device, and placing the drugs in predetermined wells; and

applying a sealing film to the bottom layer to seal off the wells.

2. The method of claim 1 wherein the production of the supply-blister sheet includes the following steps:

forming a base layer extending a considerable distance in the longitudinal and transverse directions, as a result of which the plurality of supply-blister pockets is obtained; and

loading the drugs into the supply-blister pockets.

3. The method of claim 2 further comprising the additional step that, before the step of removing the temporary sealing film from the supply-blister sheet, the supply-blister sheet is cut into supply-blister sections, and the supply-blister sections are arranged on rolls at the dispensing station transversely to the transport direction of the multi-day package.

4. The method of claim 1 wherein several suction or gripper devices are actuated individually in at least one dispensing station.

5. The method of claim 4 wherein the suction or gripper devices are arranged in correspondence with the pattern of the wells in the multi-day package and are moved parallel to each other transversely to the transport direction of the multi-day package.

6. The method of claim 1 wherein the at least one suction or gripper device is monitored by means of a camera or by sensors.

7. The method of claim 1 comprising the additional step of introducing perforations into the bottom layer and into the sealing film between the wells.