Abstract:
A device for the individual packaging of pharmaceutical tablets comprising a charging template ( 1 ) with recesses ( 5 ) for receiving tablets ( 11 ) of dosage at given times, the recesses ( 5 ) have recess bases ( 6 ) for openable by a displaceable arranged control template ( 2 ) to pass on the tablet ( 11 ), a tablet container ( 3 ), physically arranged below the charging template ( 1 ) such as to be displaced relative to the charging template ( 1 ) and having compartments for transfer of the tablets ( 11 ), and a weighing scale positioned beneath the charging template ( 1 ) and above the tablet container ( 3 ) for checking the weight of the tablets ( 11 ) assigned to the charging template ( 1 ).

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     Applicant claims priority under 35 U.S.C. §119 of German Application No. 20 2005 008 656.8 filed Jun. 3, 2005 and German Application No. 10 2006 007 136.0 filed Feb. 16, 2006. Applicant also claims priority under 35 U.S.C. §365 of PCT/DE2006/000947 filed Jun. 6, 2006. The international application under PCT article 21(2) was not published in English. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to a device for individual packaging of medication tablets according to a multi-dose system. In the following connection, the term “medication tablets” comprises solid, oral forms of medication, in other words whole or parts of tablets, coated tablets, film tablets, capsules, etc. In the following, these are always (also) meant when the term “tablets” is used. 
     2. The Prior Art 
     In supplying medications to nursing home residents and also other aged or chronically ill citizens, the problem occurs that several medications frequently have to be taken at different times of day. In the case of nursing home residents, the medications are made available by the care personnel. This work is generally not very much appreciated by the care personnel, because the activity is time-consuming and prone to error. Therefore, individual packaging is already available in pharmacies, where individual packs, tailored to the specific persons, generally for a week at a time, so-called weekly packs, are produced. However, placing the individual tablets into the packs by hand is not only time-consuming, and the corresponding costs are not covered by the profit margin of the medications, but also, this process is prone to error. 
     One speaks of a multi-dose system if different tablets are prepared in individual compartments of a tablet container, individually, for a specific person, for an extended period of administration, for example a week. The contrast to this is a unit-dose system, having only a single type of tablet in a tablet pack. The term “tablet compartment” is to be understood generally in the present connection; for example, it also comprises small tablet bags. 
     Within the scope of the invention, medication cassettes, preferably having a flip-open or push-open lid (lower lid) or tablet blister packs (also with a plurality of tablet compartments) are possible tablet containers. In the case of blister packs, the compartments of which are generally sealed with a removable sealing film/foil, these are usually disposable packaging. 
     SUMMARY OF THE INVENTION 
     The invention is based on the task of creating a device that makes it possible to improve the efficiency of the production of individual packagings tailored to a specific person, in each instance, and, in particular, to preclude incorrect charging, using an EDP control. 
     For the device for individual packaging of tablets, as stated initially, the invention is described as follows. The solution is particularly characterized by a charging template having at least one nest for defined insertion of tablets to be taken on pre-determined days, e.g. weekdays, and/or times of day, e.g. in the morning (once or twice), at noon, in the evening, at night, whereby the nest(s) possess nest bottoms for passing the inserted tablets on, which bottoms are to be opened, preferably vertically towards the bottom (allowing the tablet to fall through), and by a tablet container disposed spatially underneath the charging template, to be displaceable relative to the latter, which container possesses compartments assigned to specific days and/or times of day, to be brought into coverage with the nest bottoms, for take-over of the tablets present in the nest(s). Some improvements and further embodiments of the invention are indicated as follows. 
     The region of the device according to the invention in which tablets are laid into the nests and then transferred from the charging template into a tablet container is also referred to as the charging region (or tablet feed station). Preferably, the charging region should already comprise all the means for preventing incorrect charging. If several and/or different tablets are to be laid into a nest, correspondingly many charging passes should follow one another in the charging region. After correct and complete charging of a tablet container has been determined, the container should be passed to a packaging station and sealed. If the container is a tablet blister pack, it can be brought into a sealing station, particularly a heat-sealing station. 
     The charging template according to the invention generally possesses seven nest columns for the insertion of tablets for the seven days of the week, and four or five nest rows that correspond to the times of day. Preferably, only one row of nests is supplied only with the same tablets, in other words only with one and the same type of tablet, and only for one time of day (in the morning on an empty stomach and/or after breakfast, at noon, in the evening, or at night), at every pass, i.e. work cycle. Zero or one tablet (one piece) should get into each nest per pass. 
     In order to avoid incorrect charging, it can additionally be advantageous to indicate, on the one hand, what nest is to be charged—because it can happen that a medication does not have to be taken every day—and, on the other hand, to check whether the individual tablet has gotten into the right nest. In order to prevent a tablet from being placed where no administration is to take place, each nest can be structured so that it can be closed off individually, so that insertion of a tablet is only possible on those days on which the medication is to be administered at the time of day of administration that is currently being worked on. 
     A photoeye can be used to detect whether a tablet has gotten into a nest in which it does not belong. Then, an alarm can be triggered by way of EDP, and the further process of charging can be stopped until this tablet has been removed again. An LED lamp or the like on every nest is possible for the display; photoeyes, preferably on or in every nest, and/or a scale are possible for checking whether or not a tablet was inserted. The photoeye, in each instance, should preferably be switched in such a manner that the LED goes out when a tablet gets into a nest. If a tablet too many falls into a nest, this becomes evident by means of activating the scale. In this way, it is assured that precisely zero or one single tablet gets into each nest of a row of nests, i.e. every compartment of a row of blister pack compartments, in accordance with the doctor&#39;s orders. Accordingly, two or more passes are required per row of nests or compartments, if two or more tablets are to be placed into at least one compartment. Of course, a new pass is also required for a new type of tablet. 
     The nests of the charging template according to the invention possess bottoms that can be opened in order to empty the nests into the compartments of a tablet container placed underneath. The tablet container, in each instance, and the charging template are positioned relative to one another in such a manner that the tablets placed into the nests, in each instance, drop precisely into the tablet compartments of the container that correspond to the time of administration that was pre-determined initially. Small electric motors are suitable for setting the relative movement, in each instance. Fundamentally, it lies within the scope of the invention to supply the nests, and thereby the tablet compartments, by time of day or by day, in each instance (in other words by rows, or by columns, or also individually). 
     For opening and closing the nest bottoms, a control template is preferred, within the scope of the invention, which closes the nest bottoms in one position and possesses openings that are to be brought into coverage with the nests in another position, so that the passage from the nest into the tablet compartment positioned underneath it, if applicable, is released. 
     In order to check whether the nests of a row (or column), i.e. the corresponding tablet compartments are charged with the correct number of tablets, after the tablets have been inserted, a (precision) scale is assigned to the charging template or the tablet container. The scale can be used to check whether precisely the correct number of tablets was inserted during the pass, in each instance. 
     In order to avoid incorrect charging, it can be advantageous, according to a further invention, to configure the tablet container in such a manner that it can only be introduced into the process in a single, defined position. This configuration can preferably be implemented by means of different dimensions of the tablet compartments (cavities) for individual times of administration, or other geometrical characteristics of the container. 
     It can be advantageous, within the scope of the invention, to configure the nest bottom, in each instance, as a scale pan. Since the scale that is used must be extraordinarily sensitive, a delay can occur during the weight determination if the nest and/or the inserted tablet is/are exposed to an air draft. Possibly, the weight value that is determined can be falsified as a result. According to a further invention, this problem is solved in that a cover, for example of glass, is moved over the nests before the weighing process, in each instance, is triggered. Then, an air draft can no longer influence the weight measurement. 
     If applicable, the weighing process is triggered after the nests are covered. If the weight is correct, the charging template, together with the cover, is displaced relative to the control template, in the tablet container, in order to transfer the tablets. This has the additional advantage that it is not possible to throw in any objects that do not belong in the container, during the transfer process; in other words, the aforementioned nest cover also represents security against sabotage and security against incorrect charging.—If it turns out, during the weighing process, that the prescribed weight is not present, an alarm is triggered and the cover is moved back again, to correct the content of the nests. 
     By means of the invention, a device for individual packaging of tablets is created, which is designed in such a manner that it is accessible to EDP control. For this purpose, a computer can be supplied with the relevant data (e.g. name and medication) of every individual patient. Furthermore, each individual preparation (each type of tablet) can be detected by the computer as it is delivered, for example by means of scanning. The computer can then control, i.e. regulate the entire system, for example the lamps and photoeyes on the aforementioned nests, the scale, in each instance, and the drives for relative movements of the various components of the device according to the invention, as well as the mechanical feed and removal of the tablets to be distributed, if applicable. 
     Once precisely all of the (possibly various) tablets that the patient, in each instance, is supposed to take during the week (or during any other time period that is being prepared), have been filled into the tablet container, the latter is closed. If the container is a blister pack, it is brought from the charging station to a packaging station, preferably configured with a heat-sealing station. A labeling, preferably individually on each tablet compartment, can be applied to the tablet container, for example, on a sealing film/foil; it should contain the name of the patient, the administration date and/or the administration time for every administration occasion. Preferably, medication documentation is additionally attached to the finished tablet container, so that it can be removed, e.g. with perforation. 
     In order to guarantee a prescribed position of the sealing film/foil on the blister pack, if applicable, it can be advantageous, according to a further invention, to provide the sealing film/foil with positioning aids. Preferably, fitting pins can be used for this purpose, which are situated in the blister accommodation for the sealing process. If applicable, punched holes should be situated in the (removable) sides of the sealing film/foil, which correspond with the fitting pins. When the film/foil is laid down, the punched holes are placed onto the fitting pins, so that all the films/foils are to be positioned in precisely the same way. After the sealing process, the positioning aids can be removed. 
     The aforementioned documentation can disclose the patient&#39;s address and the complete administration plan, including possible preparations that are not packaged (injection solutions, syrups, drops, ointments, suppositories, etc.), for example on its page 1. The medications to be administered separately can be emphasized, for example with colors. Furthermore, images of all of the tablets contained in the container, with their dimensions and weights, can be contained in the documentation, for example on page 2. If applicable, individual tablets can then be removed, in targeted manner, if the physician has changed the long-term medication. 
     Furthermore, free space can be left in the documentation (for example on page 3), for entering measurement values of the patient (e.g. blood pressure, blood sugar, etc.). Finally, all of the known adverse medication effects from all of the patient&#39;s medications can be listed in a short form (for example on page 4). After the documentation is removed from the tablet container, it should preferably be filed in the patient&#39;s record, or fixed in place on the patient&#39;s bed or in the patient&#39;s room. 
     According to a further invention, the transport of the tablets to/from the charging region of the charging template can take place mechanically, for example under EDP control—possibly by means of a warehouse robot or automatic commissioning device. In this operation, the tablets of a preparation can be situated—even loosely—in a special (preferably airtight) storage container, which is opened by machine when it is introduced into the charging region, after it has reached its pre-determined position, and is supposed to be sealed in airtight manner again, after completion of the individual metering pass, in each instance, by machine, and automatically transported away. 
     The individual parts of the device according to the invention, with charging template and, if applicable, control template, with the displacement drives, positioning device of the tablet container, and scale, in each instance, possess the indicated, specific spatial assignment with regard to one another, and can be built into a table, in such a manner that an ergonomically high-quality workstation is obtained. An EDP system for control, a printer for imprinting the labeling, particularly blister pack films/foils, and for the production of the aforementioned documentation, as well as one or more scanners for recognizing the delivery and removal of the medications, can be assigned to the device. 
     According to a further invention, that part of the packaging work which can also be performed manually, within the scope of the task stated initially, of precluding incorrect charging, is preferably carried out by hand, at least in a smaller operation, such as a pharmacy. If applicable, the tablet container is manually inserted into the device according to the invention, the charged tablet container is closed manually, and, if applicable, also provided with the relevant labeling, by hand, for example by gluing it on. If the tablet container is a blister pack, it can be set into the sealing die by hand, and the imprinted sealing film/foil can be laid on manually. At the conclusion, the documentation can be glued on manually. The capacity of such a partially manual workstation is approximately 1,000 tablet containers per week. This is sufficient even in the case of large pharmacies that have to supply many nursing homes. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Details of the invention will be explained for the case of a blister pack as the tablet container, using the schematic representation of an exemplary embodiment. The figures show: 
         FIG. 1  a charging device shown in perspective, with closed nest bottoms, without a tablet container as yet; 
         FIG. 2  a charging device according to  FIG. 1 , with opened nest bottoms; 
         FIG. 3  an arrangement according to  FIG. 1 , with blister pack and scale, in vertical section; 
         FIG. 4  a control template to be assigned to the charging template, in each instance, with built-in scale; 
         FIG. 5  a blister pack shown in perspective; 
         FIG. 6  a tablet storage container; and 
         FIGS. 7 to 9  workstation equipped according to the invention; and 
         FIG. 10  the nest of the charging template resting on a scale. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       FIG. 1 to 3  show a charging template  1 , a control template  2 , a tablet container, i.e. blister pack  3 , and a scale  4 . The two templates  1 ,  2  should be displaceable, relative to one another, and should lie flat on top of one another, preferably with planar surfaces (as planar plates). The charging template  1  possesses tablet nests  5  that (in  FIG. 1 ) are closed off by the surface of the control template  2  that lies underneath, at the nest bottom  6 . The control template  2  therefore forms the nest bottom  6 , but possesses openings, i.e. holes  7  that are to be brought into coverage with the nests  5 , by means of relative displacements of the templates  1  and  2 , in the displacement direction  8 , using a drive  9  ( FIG. 2 ). 
     The tablet container, i.e. blister pack  3 , for example according to  FIG. 3 , can possess rows and columns of tablet compartments  10 . According to  FIG. 3 , a blister pack  3  is positioned underneath the control template  2  that acts like a control slide, and underneath its openings  7 , in such a manner that its individual tablet compartments  10  of a weekly row of containers or blister packs stand vertically underneath one of the openings  7  and one nest  5  that is open on the bottom, in each instance. The control template  2  can be moved, relative to the charging template  1 , using the drive  9 . The tablets  11  inserted into the nests  5  drop through the openings  7  into the tablet compartment  10 , in each instance, if applicable. 
     In order to ensure that the individual tablets  11  get into precisely the prescribed nest  5  of the charging template  1 , the nests  5  can each have a photoeye  12  assigned to them. Furthermore, a light display  13  can light up on each nest  5  that is supposed to even be charged during the metering pass, in each instance. The photoeye  12  can be assigned to the space close to the nest bottom  6 , for example at a height of 1 mm above the bottom, so that it reliably detects even the smallest tablets. If it registers an inserted tablet  11 , it is supposed to turn off the lighted light display  13  on the nest in question—by way of related electronics. If the photoeye  12  cannot determine how many tablets were placed into a nest  5 , the scale  4  (precision scale) can be used to check whether the correct number of tablets got into a nest  5 , i.e. into a row of nests or row of compartments, during the filling process, in each instance. As an aside: The weight of an industrially produced tablet is a characteristic of the preparation, in each instance. There is hardly any preparation whose tablet weighs precisely as much as the tablet of a different preparation. 
     Filling of the nests  5  should preferably take place manually. However, an automatic commissioning device  14  can be provided for delivering the tablets. This device can comprise special storage containers  21  for every medication of every patient. This container should be equipped with means, for example a flap  22 , for automatic, preferably airtight closing and opening (accessible to the operator). Preferably, a dehumidifier chamber  23  is provided within the storage container  21 , which can accommodate a desiccant, such as silica gel, and is supposed to bind humidity within the storage container  21 , if applicable. It is practical if the desiccant is equipped with a color indicator that shows whether the desiccant has been exhausted and therefore must be replaced. After the flap  22  is opened (direction of arrow), tablets  11 , preferably a pre-determined number, can get out of the container  21  onto a tray  24 , from where it is to be placed into a nest  5  (by the operator). 
     The automatic commissioning device  14  can also be used for automatic delivery and removal of tablet storage containers  21  and can be assigned to the charging template  1  within a tablet delivery station  19 . 
     In an exemplary embodiment, a storage container  21  consists essentially of two tubes, particularly plastic tubes, which can be pushed into one another in the manner of a telescope, and can be firmly closed off at their ends with a rectangular plate, particularly also made of plastic. If applicable, the outer tube, which is always visible, should bear one or more cams that fit into corresponding recesses in the end piece of the inner tube, so that the container can be opened or closed by means of rotating the two end pieces relative to one another (bayonet closure). To protect the stored tablets, the outer tube should be pressed against a silicone seal by means of the clamping force of this closure, thus making it possible to seal it in airtight manner. The storage container should possess a removal opening with an insert, preferably a deep-drawn plastic part, which is adapted to the bulk volume of the tablets to be stored. This prevents the stored tablets from grinding against one another during transport procedures, like in a ball mill. 
       FIG. 4  shows a modification of the control template  2 , according to the invention, where a scale  4  is coupled with the template, forming the nest bottoms  6  when the charging template  1 , i.e. its nests  5 , is/are filled. Preferably, the nest bottoms should rest on the scale  4 . This scale registers whether one tablet  11  too much or too little got into a nest  5 , for example using an indicator  15 . 
       FIG. 5  shows, in the lower part, a blister pack  3  having four rows and seven columns of tablet compartments  10 , as an example, namely one row each for four different times of day (morning, noon, evening, night), and one column each for the seven days of a week. Within the scope of the invention, blister packs having five and more rows for correspondingly many administration times per day and/or blister packs having more than seven columns for administration periods having a length of more than one week are also possible. 
     If the prescribed tablets  11  have been properly filled into the tablet compartments  10 , and a blister pack is to be filled, the latter is brought into a heat-sealing station, where the individual blister pack compartments  10  are to be sealed with a sealing film/foil  16 . The film/foil  16  can possess perforations  17  that allow the compartments  10  to be opened individually. The details described above can be imprinted onto the film/foil  16 ; furthermore, documentation  18  of the type indicated can be attached to the (sealed) blister pack. 
     In the following, a preferred exemplary embodiment is described, which was designed for operation with EDP control. 
     Only a single preparation, in other words only the same tablets, should be situated within a charging region, i.e. a tablet delivery station  19 , spatially above the charging template  1  of  FIG. 1 to 3 , at any one time. In the case of the tablet container according to the invention, e.g. a blister pack  3 , the preparation can be identified with the customer number of the patient, in each instance, the central pharmaceutical number, and the batch identifier, in machine-readable form, for example with a barcode. Specifically in the case of the EDP operation made possible according to the invention, these data are detected when the preparation, in each instance (tablet or tablet container) is brought in. If applicable, the administration plan for the individual patients should also be stored in the memory of the EDP that controls the system according to the invention. In connection with the aforementioned stored data, the entire selection and filling process described can then be carried out in the device according to the invention, without the risk of incorrect charging. 
     According to  FIGS. 1 to 3 , a tablet container, i.e. blister pack  3 , which is still empty, for one week, for example, is spatially placed underneath charging and control template  1 ,  2 , on a scale  4 , by way of a mechanical feed, a so-called container positioner  20 . The charging template  1  is then situated above the blister pack  3 ; it can be displaced relative to the blister pack  3 . The nests  5  are situated in the template  1 ; the tablets  11 , in each instance, are to be placed into them. Each nest  5  is provided with a photoeye  12 , with which it can be detected whether at least one tablet  11  was placed in. Furthermore, a signal lamp  13  can be assigned to each nest  5 , which is supposed to indicate to the operator the nests into which the current type of tablet is to be placed, if applicable, and goes out once a tablet has been placed in. 
     If all of the tablets of the preparation being worked on have now been placed into the nests  5  for an administration time (e.g. the morning), the charging template  1  is displaced, relative to the control template  2  (or the latter is displaced relative to the former), using the drive  9 . As a result, the tablets  11  fall out of the nests  5  into the compartments  10  of the blister pack  3  that correspond to the administration time in question. At the same time, the scale  4  can be used to check whether the correct number of tablets was filled in. 
     Alternatively, the charging template  1  can also be mounted in fixed manner, and the scale  4  can be positioned underneath the template ( FIG. 4 ). Then, the weighing process is already carried out when the tablets are placed into the nests  5 . That part of the control template  2  that is situated underneath the charging nests  5  can be configured as a precision scale ( 4 ), if applicable. In the case of this arrangement, transfer of the tablets  11  into the blister pack  3  is triggered when all of the nests  5  to be charged have been served with the correct number of at most one tablet (weight). 
     If the preparation being worked on must be placed in again, two or more times for the same point in time or, in addition, for another point in time of the weekday in question, the nest bottoms  6  of the charging template  1  are closed again and the metering pass begins again. In order to transfer the tablets from the nests  5 , the blister pack  3  can be brought into the desired or required relative position underneath the charging template  1 , in each instance, using the container positioner  20 . 
     Once all of the tablets of a preparation for the week in question are in the blister pack  3 , the operator or the automatic commissioning device can be prompted (for example by way of the related EDP control) to remove the preparation from the system. Removal can be documented by scanning the barcode of the tablets or tablet container, in each instance. Once removal of the previously dosed tablets has been completed, the next preparation can be moved into the system. After this has been done, the procedure described can begin again. 
       FIG. 6  shows an exemplary embodiment of a tablet storage container  21  that is preferably to be used in the device according to the invention. This container consists essentially of two tubes to be inserted into one another in the manner of a telescope, namely an outer tube  25  and an inner tube  26 . The one end of the two tubes is closed off by means of a plate  27 , in each instance, which should be rectangular, for example in order to prevent rolling. A bayonet closure  28  is provided to connect, close, and separate the two tubes  25 ,  26 . The interior enclosed by the tubes  25 ,  26  inserted into one another, which is supposed to accommodate the tablets, in each instance, can be sealed to be airtight, using a silicone seal  29  against which the outer tube  26 , for example with its open end, is to be pressed by the clamping force of the closure  28 . An insert  30  can be situated in the interior of the container, the volume of which is adapted to the bulk volume of the tablets to be stored. 
     An exemplary embodiment of the system layout for a workstation  40  for individual blister pack packaging according to the invention will be explained using  FIGS. 7 to 9 .  FIG. 7  shows a worktable  41  with a device for manual charging of the tablet containers positioned on it. The device includes a power supply  42 , a PC  43 , and a control  44 , as well as a display  45 . Furthermore, a metering unit  46 , a scanner  47 , and a heat-sealing press  48 , as well as a printer  49 , are situated at the workstation. The metering unit  46  includes a scale, three photoeyes, and a closure slide. 
     Details of the device according to  FIG. 7  become evident in the exploded view according to  FIG. 8 , in which the same parts are numbered as in  FIG. 7 . In addition,  FIG. 8  shows a tablet gripper  50  as well as a blister pack  3  with the related blister pack accommodation, i.e. die  51 . The parts and  51  are shown once again on a larger scale, and individually, in detail Z according to  FIG. 9 . In this drawing, the pins  52  can also be seen, which serve to position the blister pack and the film/foil, respectively, and are positioned asymmetrically, in order to achieve the result that film/foil and blister pack can only be set onto the die  51  in a single position. 
       FIG. 10  shows the bottoms of the nest  5  of the charging template  1  resting on a scale  4   a  when being filled through hole  7  and having display  15 . 
     REFERENCE SYMBOL LIST 
     
         
           1 =charging template 
           2 =control template 
           3 =tablet container 
           4 =scale 
           5 =nest 
           6 =nest bottom 
           7 =hole, opening 
           8 =displacement direction 
           9 =drive 
           10 =tablet compartment 
           11 =tablet 
           12 =photoeye 
           13 =light display 
           14 =automatic commissioning device 
           15 =display 
           16 =sealing film/foil 
           17 =perforation 
           18 =documentation 
           19 =tablet delivery station 
           20 =positioner 
           21 =storage container 
           22 =flap 
           23 =dehumidifier chamber 
           24 =tablet 
           25 =outer tube 
           26 =inner tube 
           27 =rectangular plate 
           28 =bayonet closure 
           29 =silicone seal 
           30 =insert 
           40 =workstation 
           41 =worktable 
           42 =power supply 
           43 =PC 
           44 =control 
           45 =display 
           46 =metering unit with scale, photoeye, and closure slide 
           47 =scanner 
           48 =heat-sealing press 
           49 =printer 
           50 =tablet gripper 
           51 =blister pack accommodation, die 
           52 =positioning pins