Abstract:
The present invention relates to a dosing dispenser for the alternating removal of two or more, possibly different solid forms of pharmaceutical substances to be taken, such as for example tablets, film tablets, coated tablets and/or capsules, which differ in their quantitative and/or qualitative composition.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    This is a continuation of copending patent application Ser. No. 09/239,485 filed on Jan. 28, 1999.  
     
    
     
       INTRODUCTION  
         [0002]    The present invention relates to a dosing dispenser for the alternating delivery of two or more, possibly different, solid forms of pharmaceutical substances to be taken. Examples of different solid forms include tablets, film tablets, coated tablets and/or capsules, which may differ in their quantitative and/or qualitative composition.  
         BACKGROUND  
         [0003]    There are numerous examples of medicines for which, in the course of treatment, solid forms of different compositions are to be taken at different times, for example in the morning, evening or on different days. The composition of the formulation may differ with respect to the dosage of the active substances, and it is also possible that the different formulations contain completely or partially different active substances. Examples of such medicines are combinations of daytime/nighttime tablets in the area of painkillers and cough remedies, the two formulations containing partially or completely different active substances.  
           [0004]    Also in widespread use are preparations for which different dosages of an active substance or a variety of active substances are contained in one pack. One example of this is oral contraceptives, in particular, and another is urological medicines. These packs may be both so-called starter packs, with which a switch to the next highest dose is made after a few days, or monthly or calendar packs, with the aid of which physiological, cyclical increases in hormone levels are simulated.  
           [0005]    Also popular are medicine packs which contain both active and placebo formulations to encourage compliance or to make it easier for the patient to take the correct dosage. As a result, in the case of contraceptives for example, tablets can be taken on a continuous daily schedule continually, although for a certain time no hormones are to be supplied (for example combination of 21 active and 7 placebo tablets—U.S. Pat. No. 4,958,736).  
           [0006]    For other groups of active substances too, for example for the use of biphosphonates for the treatment of osteoporosis, there are treatment regimens in which even the daily variation between active and placebo formulations is envisaged (U.S. Pat. No. 4,812,311).  
           [0007]    To encourage patient compliance, or to avoid mistakes in taking the medicine, the different tablets, (film tablets, coated tablets, capsules etc.) are sometimes produced in different colours and/or are provided with embossed markings or imprints etc. In addition, they may be arranged in “dosage rows” on blister strips and under certain circumstances are provided with numbers or indications of the day. Nevertheless, dosing errors can occur, since elderly patients, in particular, have problems with reading lettering and there are often special requirements with respect to the correct regimen for taking medicine, and to this extent instances of uncertainty can be observed among patients.  
           [0008]    Greater certainty is offered by the so-called calendar packs, for example for contraceptives in the form of blister packs or dosage discs, on which, for example, the days of the week are marked. Dosage rows, (ascending or descending), wherein the arrangement of a certain number of tablets of the same dosage, followed by a number of tablets of the next dosage is technically still quite simple to achieve and provides some level of certainty, daily dosing regimens requiring varying administration of two or more different formulations requires something more sophisticated. In this case special arrangements of the tablets on the blister pack and indications in the form of arrows etc. are required, although this likewise cannot rule out mix-ups.  
         SUMMARY OF THE INVENTION  
         [0009]    The present invention is directed to a reliable dosing dispenser with which two or more possibly different individual pharmaceutical formulations with quantitatively and/or qualitatively different compositions can be taken alternately one after the other.  
           [0010]    The object is achieved according to the invention by the features set forth in the specification and the claims. The novel device is characterized by at least two separate storage containers for quantitatively and/or qualitatively different solid pharmaceutical substances to be taken, said storage containers which are arranged in a housing, which housing may have different forms. In the bottom of the housing there may be either a catching device or at least one ejecting opening or both for the forms of medicine to be taken. It is also possible for the catching device to be arranged outside the housing, for example in the form of a tray or similar vessel. Pharmaceutical substances may, for example, be in the form of tablets, film tablets, coated tablets and/or capsules. The ejecting opening has in this case the cross section of the largest form which the medicine takes. The cross section of the housing is preferably rectangular, oval or circular, although combinations of these shapes are also feasible, for example one side of the dosing dispenser may be rectangular, the other side may be rounded off. Other forms, such as polygonal, radial or trapezoidal housings, for example, can likewise be used.  
           [0011]    The storage containers for the forms of medicine end proximate to a movable dosing slide, which is located above the bottom surface in the interior of the housing. This slide is constructed in to correspond with the respective housing, such as a rectangular or oval design, for example in the form of a bar or plate, or for a cylindrical housing in a circular design, as a dosage disc. It has as many receiving openings for the respective pharmaceutical substances from the storage containers as there are storage containers. The height of the dosing slide (thickness) is adapted to the height of the forms of medicine, thereby preventing accidental adding of a second form of medicine to the dose. Furthermore, preferably arranged on the dosing slide are lugs which fix an end position and secure the forms of medicine to prevent accidental ejection from the housing, as well as determine the filling and removal positions (click-stop positions).  
           [0012]    The storage containers are elongated and preferably tubular and, depending on the form of medicine, their cross section may be round, oblong-shaped and/or elliptical. To prevent accidental emptying upwards, they may be closed at the top, for example by fitting on plugs.  
           [0013]    According to a design variant, the storage containers may be closed at the bottom by a movably mounted plate or some other equivalent device when the dosing slide moves during emptying, in particular if three or more different forms of medicine are to be administered, and opened again during the filling operation when the dosing slide is moved back.  
           [0014]    Preferred storage containers are those in which the different formulations are kept separately, which are filled once at the manufacturers or are designed to be exchangeable or refillable (refill pack).  
           [0015]    The device according to the invention may also be combined with mechanical, electromechanical and/or electronic devices which  
           [0016]    a) block the removal of the next dose for a certain time, for example by means of a built-in clock or the like, and/or  
           [0017]    b) indicate the day, time of day, number, dosage or the like (by means of a day counter or a morning or evening indication) of the formulations just taken or the formulations to be taken next. In the simplest case, this may take place by inscriptions on the dosing slide which become visible in an alternating manner through an opening in the housing wall. In this example the changing of the indication takes place automatically when the dosing slide is pushed back and forth.  
           [0018]    With the device according to the invention, the forms of medicine can be removed in a controlled sequence, with mix-ups avoided. In addition, the dosing dispenser according to the invention has the advantage that renewed filling is possible. For this purpose, if appropriate, a further slide which regulates the feeding of the forms of medicine is to be arranged in an analogous way above the storage containers.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]    Preferred design variants of the dosing dispenser according to the invention are described in more detail with reference to FIGS.  1  to  6 , in which:  
         [0020]    [0020]FIG. 1A shows top view of a rectangular dosing dispenser for the alternating delivery of two different formulations, having one ejecting opening between the storage containers.  
         [0021]    [0021]FIG. 1B shows side cross sectional view of the rectangular dosing dispenser for the alternating delivery of two different formulations, having one ejecting opening between the storage containers.  
         [0022]    [0022]FIG. 1C shows bottom view of the rectangular dosing dispenser for the alternating delivery of two different formulations, having one ejecting opening between the storage containers.  
         [0023]    [0023]FIG. 1D shows bottom cross sectional view of the rectangular dosing dispenser for the alternating delivery of two different formulations, having one ejecting opening between the storage containers.  
         [0024]    [0024]FIG. 2A shows a top view of a cylindrical dosing dispenser for the alternating delivery of two different formulations, having one ejecting opening between the storage containers.  
         [0025]    [0025]FIG. 2B shows a bottom view of a cylindrical dosing dispenser for the alternating delivery of two different formulations, having one ejecting opening between the storage containers.  
         [0026]    [0026]FIG. 2C shows a bottom cross sectional view of a cylindrical dosing dispenser for the alternating delivery of two different formulations, having one ejecting opening between the storage containers.  
         [0027]    [0027]FIG. 3A shows a top view of a rectangular dosing dispenser for the alternating delivery of three different formulations, having two ejecting openings.  
         [0028]    [0028]FIG. 3B shows a side view of the rectangular dosing dispenser for the alternating delivery of three different formulations, having two ejecting openings.  
         [0029]    [0029]FIG. 3C shows a bottom view of the rectangular dosing dispenser for the alternating delivery of three different formulations, having two ejecting openings.  
         [0030]    [0030]FIG. 3D shows a bottom cross sectional view of the rectangular dosing dispenser for the alternating delivery of three different formulations, having two ejecting openings.  
         [0031]    [0031]FIG. 3E shows a top view of a rectangular dosing dispenser for the alternating delivery of three different formulations, having three ejecting openings.  
         [0032]    [0032]FIG. 3F shows a side view of the rectangular dosing dispenser for the alternating delivery of three different formulations, having three ejecting openings.  
         [0033]    [0033]FIG. 3G shows a bottom view of the rectangular dosing dispenser for the alternating delivery of three different formulations, having three ejecting openings.  
         [0034]    [0034]FIG. 3H shows a bottom cross sectional view of a rectangular dosing dispenser for the alternating delivery of three different formulations, having three ejecting openings.  
         [0035]    [0035]FIG. 4A shows a top view of a cylindrical dosing dispenser for the alternating delivery of three different formulations, having two ejecting openings.  
         [0036]    [0036]FIG. 4B shows a bottom view of a cylindrical dosing dispenser for the alternating delivery of three different formulations, having two ejecting openings.  
         [0037]    [0037]FIG. 4C shows a bottom cross sectional view of a cylindrical dosing dispenser for the alternating delivery of three different formulations, having two ejecting openings.  
         [0038]    [0038]FIG. 5A shows a side view of a rectangular dosing dispenser for the alternating delivery of three different formulations, having one ejecting opening.  
         [0039]    [0039]FIG. 5B shows a bottom view of a rectangular dosing dispenser for the alternating delivery of three different formulations, having one ejecting opening.  
         [0040]    [0040]FIG. 5C shows a bottom cross sectional view of a rectangular dosing dispenser for the alternating delivery of three different formulations, having one ejecting opening.  
         [0041]    [0041]FIG. 6A shows a side view of a rectangular dosing dispenser for the alternating delivery of more than three different formulations, having a collecting tray.  
         [0042]    [0042]FIG. 6B shows a top view of a rectangular dosing dispenser for the alternating delivery of more than three different formulations, having a collecting tray.  
         [0043]    [0043]FIG. 6C shows a top view of a rectangular dosing dispenser for the alternating delivery of more than three different formulations, having a collecting tray showing one orientation of storage containers with respect to receiving openings.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0044]    With reference to FIGS.  1 A- 1 D, two forms of pharmaceutical substance are accommodated in two separate tubular storage containers  1  and  2 , which are located in a common housing  34  and are linearly arranged. The cross section of the tubes is adapted to the respective form of medicine. In this arrangement, the two storage containers may have the same cross section, but may also have different cross sections. The two storage containers end in an open manner on the dosing slide  31 , which is located in the same housing  34 . This dosing slide  31  has two receiving openings  11  and  12  for the forms of medicine, which correspond to the cross sections of the storage containers  1  and  2  and are arranged in such a way that, in the filling position, in each case one form of medicine slides into the corresponding dosing slide  31  and, in the emptying position, it falls downwards or is ejected out of the latter. The dosing slide  31  is covered at the bottom by a baseplate  40 , which has an ejecting opening  21 , which corresponds to the cross section of the form of medicine or to the cross section of the largest form of medicine (in the case of different formats). By moving the dosing slide  31  back and forth, in each case a bore  11  or  12  of the slide  31  is filled, while the content of the other bore is discharged through the opening  21  in the baseplate  40 .  
         [0045]    The dosing slide  31  is secured against accidental ejection from the housing  34  by suitable lugs  41 . The two filling and removal positions are also fixed by these lugs. The ejection of the forms of medicine in the emptying position may be assisted, for example, by a spring-loaded spherical cap  33 , which in the emptying position protrudes slightly from above into the corresponding receiving opening of the dosing slide  31 . During the movement of the dosing slide, the spherical cap  33  slides resiliently back upwards against the resistance of a spring. Such a device also supports the exact positioning of the dosing slide  31 . The tubular storage containers  1  and  2  may be closed upwards against accidental emptying of the content, in the simplest case by pressing in plugs  32 .  
         [0046]    In another variant, in the upper part of the housing there is provided above the storage containers a further dosing slide, which for filling is drawn partially out of the housing and thus permits the simultaneous or successive filling of the two tubes.  
         [0047]    In analogy with the variant according to FIGS.  1 A- 1 D, according to FIGS.  2 A- 2 C a cylindrical housing  34  is used. Used as the dosing means is a circular dosage disc  31 , which is likewise provided with two receiving openings  11  and  12 , which correspond to the cross section of the forms of medicine to be discharged. Dosing and ejection are performed by turning the dosage disc  31  back and forth whereby receiving openings are alternately brought into communication with storage containers  1  and  2  and ejecting opening  21 . If appropriate, the end positions of the disc are marked again by correspondingly protruding lugs  42  on the disc; alternatively, the dosage disc  31  may also have a greater diameter over part of its circumference, the sides of the tongue bounding the stop positions.  
         [0048]    FIGS.  3 A- 3 D represent an extended version of the variant according to FIGS.  1 A- 1 D in which three storage tubes  1 ,  2  and  3  are accommodated in a rectangular housing  34  and the dosing slide  31  contains three receiving openings  11 ,  12  and  13 , provided in a suitable way, for the controlled removal of different formulations, which are arranged, for example, in such a way that in the starting position the receiving openings  11  and  12  are filled. When the dosing slide  31  is then drawn out into the first click-stop position, the emptying of the receiving opening  11  takes place through ejecting opening  21 . In the second click-stop position, the bore  12  is emptied through the second ejecting opening  22  and at the same time the receiving opening  13  is filled. After the dosing slide  31  has been brought back into the starting position again, the content of the bore  13  is ejected through the opening  21  in the baseplate  40 . In this position of the dosing slide  31 , the receiving openings  11  and  12  are simultaneously filled again, etc. In a further variant according to FIGS.  3 E- 3 H, three ejecting openings  21 ,  22  and  23  are used.  
         [0049]    As far as the arresting of the dosing slide  31  etc. is concerned, the dosing slide is secured against accidental ejection from the housing  34  by suitable lugs  41 .  
         [0050]    In FIGS.  4 A- 4 C, the dosing dispenser for the alternating dosing of three different formulations according to the variant as shown in FIGS.  3 A- 3 C is modified to the extent that the three tubular storage containers  1 ,  2  and  3  are accommodated in a cylindrical housing  34  and again a circular dosage disc  31  is used as the dosing slide. The three receiving openings  11 ,  12  are  13  are arranged on a circular path, but at corresponding intervals, as in the case shown by FIGS.  3 A- 3 D.  
         [0051]    According to FIGS.  5 A- 5 C, as in the case of the variant shown by FIGS.  3 A- 3 D, three storage containers  1 ,  2  and  3  for the forms of medicine are arranged next to one another in a row. All three open out onto a dosing slide  31 , which has three receiving openings  11 ,  12  and  13 . By contrast with the variant  3   a , the baseplate  40  contains only one ejecting opening  21 . In the starting position, all three receiving openings  11 ,  12  and  13  of the dosing slide  31  are filled simultaneously from the various storage tubes  1 ,  2  and  3 . As soon as the dosing slide  31  is moved out of this starting position in the direction of the ejecting opening  21 , a movably mounted closureplate  32   a  closes the openings of the three storage containers  1 ,  2  and  3  in the downward direction, so that further sliding of the forms of medicine into the dosing slide  31  or a cavity possibly formed by the movement of the dosing slide is not possible. The dosing slide  31  may be drawn out of the housing  34  in three click-stopped stages, the forms of medicine being ejected one after the other at the individual stages out of the individual receiving openings  11 ,  12  and  13  through the opening  21 . Once all three receiving openings  11 ,  12  and  13  in the dosing slide  31  have been emptied, the latter is pushed back again into the starting position. During this operation, the closure plate  32   a  beneath the three tubes  1 ,  2  and  3  is pushed back, for example by a mechanical follower or a lug on the dosing slide, and thus exposes the openings of the three tubes again. The three bores  11 ,  12  and  13  in the dosing slide  31  are re-filled etc.  
         [0052]    In analogy with the variant shown in FIG. 5, a further variant is concerned with a cylindrical housing  34 , in which the three storage tubes  1 ,  2  and  3  are arranged circularly and not linearly. The circular dosing slide  31  again contains three receiving openings  11 ,  12  and  13 . The base contains one ejecting opening  21 . As soon as the dosing slide  31  is moved out of the starting position, the three storage tubes  1 ,  2  and  3  are closed by means of a movable closure disc or the like, etc. Otherwise, the procedure described with respect to FIG. 5 applies.  
         [0053]    FIGS.  6 A- 6 C offer a variant for more than three different forms of medicine. In FIGS.  6 A- 6 C, this is presented in the example of five different formulations.  
         [0054]    The five different forms of medicine are located in five storage containers  1  to  5 . These are arranged diagonally in a rectangular housing. The tubes  1  to  5  open out onto a dosing slide  31 , which is in the form of a plate in which, in the starting position, the receiving openings  11  to  15  for the different forms of medicine are located exactly beneath the storage containers  1  to  5 . The dosing slide  31  may be drawn out forwards from the housing  34  in a click-stop manner in five stages, the individual receiving openings  11  to  15  being emptied one after the other. The forms of medicine fall into a common catching device, for example a catching tray  20 . The dosing slide  31  is subsequently pushed back into the starting position and the receiving openings  11  to  15  are filled again.  
         [0055]    The dosing slide  31  must have an adequate length (“depth”), so that even in the fifth click-stop position, i.e. when the dosing slide  31  has been drawn out from the housing on one side to such an extent that all the receiving openings  11  to  15  are visible, unintentional further sliding of the forms of medicine out of the storage containers  1  to  5  is prevented. Alternatively, the five storage containers may also be closed by a closureplate  32   a  between the lower end of the containers and the dosing slide  31  as soon as the dosing slide  31  is removed from the starting position.  
         [0056]    The invention is not restricted to the exemplary embodiments described here. In particular, for example, two or more tubes per removal station are also possible.  
       List of Reference Numerals  
       [0057]    [0057] 1 =storage container for form of medicine  1   
         [0058]    [0058] 2 =storage container for form of medicine  2   
         [0059]    [0059] 3 =storage container for form of medicine  3   
         [0060]    [0060] 4 =storage container for form of medicine  4   
         [0061]    [0061] 5 =storage container for form of medicine  5   
         [0062]    n=storage container for form of medicine n  
         [0063]    [0063] 11 =receiving opening for form of medicine  1  in the dosing slide  
         [0064]    [0064] 12 =receiving opening for form of medicine  2  in the dosing slide  
         [0065]    [0065] 13 =receiving opening for form of medicine  3  in the dosing slide  
         [0066]    [0066] 14 =receiving opening for form of medicine  4  in the dosing slide  
         [0067]    [0067] 15 =receiving opening for form of medicine  5  in the dosing slide  
         [0068]    m=receiving opening for form of medicine m in the dosing slide  
         [0069]    [0069] 20 =catching means  
         [0070]    [0070] 21 =ejecting opening  
         [0071]    [0071] 22 =ejecting opening  
         [0072]    [0072] 23 =ejecting opening  
         [0073]    [0073] 31 =dosing slide  
         [0074]    [0074] 32 =plugs  
         [0075]    [0075] 32   a =closure for storage container  
         [0076]    [0076] 33 =spring-loaded spherical cap  
         [0077]    [0077] 34 =housing  
         [0078]    [0078] 35 =dosing dispenser  
         [0079]    [0079] 40 =baseplate  
         [0080]    [0080] 41 =lugs  
         [0081]    [0081] 42  lugs