Abstract:
A dispenser for storing/dispensing pharmaceutical dosages that are provided in a stamp-like (flat) dosage form. In some embodiments, the present dispenser includes a housing for retaining a plurality of stacked, individual “stamp-like” pharmaceutical dosages. Disposed within the housing beneath the dosages is a bias element, such as a helical spring, that urges the dosages towards a dosage delivery port of the housing. From the dosage delivery port, dosages are dispensed through an aperture. In other embodiments, the instant dispenser includes a cylindrical main body for retaining pharmaceutical dosages having a stamp-like dosage form that are collectively organized in a roll. A dosage delivery port depending from the cylindrical main body receives dosages one at a time therefrom. The present dispenser is configured, in various embodiments, for manual, mechanically assisted, or automated dispensing. Moreover, the present dispenser includes, when appropriately automated, control electronics that (1) alert a user of a scheduled dosage, and/or (2) dispense a dosage at a prescribed time or at a prescribed time interval, and/or (3) maintain a dosage record.

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to medication dispensers. More particularly, the resent invention relates to reusable medication dispensers for dispensing medications having a relatively “flat” dosage form. 
     BACKGROUND OF THE INVENTION 
     “Child-proof” medicine containers are a standard method for dispensing prescription drugs. The popularity of such containers is due, of course, to the difficulty that opening such containers presents to children. Ironically, these containers also pose difficulties for groups of people who are most likely to require the medicine that is stored therein. In particular, the aged, the handicapped, stroke victims, arthritis sufferers, individuals that have tremors and those recovering from accidents, surgery or serious disease conditions, among other individuals, may have trouble opening such child-proof medicine containers. 
     In response to this problem, specialized medication dispensers have been developed. Medication dispensers typically include one or more chambers for storing medicine(s) and various mechanisms for dispensing the medication. In some cases, the dispensers include motors so that when a user pushes a button, a pill is dispensed (see, e.g., U.S. Pat. No. 5,810,198). Some medicine dispensers include electronics that warn a user when it is time to take a pill, some restrict the dispensing of medication to certain prescribed times, and others automatically control delivery of multiple medications (see, e.g., U.S. Pat. Nos. 5,752,620, 4,310,103, and 5,752,621). 
     Most medication dispensers are designed to dispense small solid dosage forms such as tablets or capsules. If the final dosage form of a medication deviates from those common forms, dispensing may be problematic or impossible via standard dispensers. With the advent of new dosage forms, new types of medication dispensers are required. 
     SUMMARY OF THE INVENTION 
     A dispenser for dispensing medications having a flat or “stamp-like” final dosage form is disclosed. In some embodiments, a dispenser in accordance with the present teachings includes a housing for retaining a plurality of stacked individual pharmaceutical dosages. Within the housing and beneath the dosages is a bias element, such as a helical spring, that urges the dosages towards a dispensing end of the housing. The housing also includes a dosage delivery port that receives the pharmaceutical dosages one at a time from the interior of the housing. 
     In other embodiments, a dispenser in accordance with the present teachings includes a cylindrical main body for retaining a plurality of stamp-like dosages that are collectively organized in a roll. A dosage delivery port depending from the cylindrical main body receives dosages one at a time therefrom. 
     The dispensing operation for both stacked and rolled dosages can be carried out manually, manually with mechanical assist, or automatically via appropriate actuating mechanisms. In further embodiments, the present dispenser includes electronics that (1) alert a user of a scheduled dosage, and/or (2) dispense a dosage at a prescribed time or at a prescribed time interval, and/or (3) maintain a dosage record. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1A depicts an electrostatically deposited pharmaceutical dosage form. 
     FIG. 1B depicts a strip of stamp-like dosage forms. 
     FIG. 1C depicts an individual stamp-like dosage form. 
     FIGS. 2A and 2B depict an embodiment of a dispenser in accordance with the present teachings. 
     FIG. 3 depicts a further embodiment of a dispenser in accordance with the present teachings wherein the dosages are contained within a removable magazine. 
     FIG. 4 depicts an additional embodiment of a dispenser wherein the dosages are dispensed via a manual actuator. 
     FIGS. 5A and 5B depict yet another embodiment of a dispenser in accordance with the present teachings wherein the pharmaceutical dosages are dispensed via a mechanized actuator. 
     FIG. 6 depicts pharmaceutical dosages having a stamp-like dosage form wherein the dosages are collectively organized in the form of a roll. 
     FIG. 7 depicts an embodiment of a dispenser in accordance with the present teachings for manually dispensing the rolled dosages of FIG.  6 . 
     FIG. 8 depicts a further embodiment of a dispenser that is configured for mechanized dispensing of the rolled dosages of FIG.  6 . 
     FIG. 9 depicts an illustrative electronically-driven mechanized actuator for dispensing the rolled dosages of FIG.  6 . 
     FIG. 10 depicts a simplified block diagram of electronics for imparting dosing, alarm and dose monitoring capabilities to the present dispenser. 
    
    
     DETAILED DESCRIPTION 
     The assignee of the present application has described a method and an apparatus for making a pharmaceutical unit dosage form or a diagnostic form using electrostatic deposition of biologically- or pharmaceutically-active ingredients. See, International Application PCT/US99/12772, incorporated by reference herein. 
     In accordance with PCT/US99/12772, unit dosage forms are fabricated by electrostatically depositing pharmaceutically-active powder(s) onto a pharmaceutical-grade substrate and then bonding a cover layer to the substrate over the powder(s). FIG. 1A depicts such a unit dosage form  100 . The unit dosage form comprises pharmaceutically-active powder  104  that is disposed between substrate  102  and cover layer  106 . Active powder  104  is advantageously disposed underneath bubble  108  in cover layer  106 . 
     In some embodiments, unit dosage forms  100  are incorporated into a secondary package to form any of a number of different “final” or “finished” dosage forms that are disclosed in PCT/US99/12772 or elsewhere. One final dosage form described in PCT/US99/12772 is referred to (therein and herein) as a “stamp” or “stamp-type” or “stamp-like” dosage form. The designation “stamp” acknowledges the resemblance of a diced (i.e., individual) dosage to a postage stamp. 
     In one embodiment, a stamp-like final dosage form comprises a unit dosage form  100  that is sealed between two polymer-based outer layers  152  and  156  (i.e., the “secondary package”). (See FIGS. 1B and 1C.) Typically, many of such unit dosage forms  100  are sealed within the secondary package forming a strip  150  of such stamp-like dosage forms, as depicted via an “exploded” view in FIG.  1 B. FIG. 1C depicts an individual dosage form  150 C, such as results from dicing strip  150  to separate the individual dosages. In embodiments in which unit dosage form  100  includes bubble  108  (FIG.  1 A), layer  156  that overlies cover layer  106  advantageously includes bubble  158  that receives bubble  108 . 
     Stamp-like dosage forms have shapes that are characteristically flat. The diced stamp-like dosage form  150 A is advantageously rectangular as shown in FIG. 1C, but it can also be circular or have any suitable shape, as desired. As will become clearer later in this Specification, stamp-like dosages forms may advantageously be organized into a 1×N strip. In embodiments in which stamp-like dosage forms are not diced into individual dosages (e.g., when they are organized in a 1×N strip), the secondary package advantageously has perforations (not shown) between adjacent dosage forms to facilitating removing an individual dosage from the collection thereof. 
     It will be appreciated that due to its physical configuration, the stamp-like dosage form, whether diced into individual dosage forms or grouped in a strip (both referenced hereinafter by the call out “150”), is not suitable for use in the typical prior art medication dispensers, such as are discussed in the Background section. The present invention provides several embodiments of a dispenser  200  that is suitable for dispensing pharmaceutical dosages that are configured in stamp-like dosage form  150 . 
     As used herein, the term “stamp-like dosage form” includes, in addition to dosage form  150  described above, other final dosage forms that are relatively flat in shape, but that may or may not be electrostatically deposited. In other words, it is not intended that the appended Claims be limited in scope to dosages that are formed via electrostatic deposition and/or to dosages that are sealed into a secondary package. That is, any dosage form that may suitably be dispensed from the present dispenser is considered to be a stamp-like dosage form as that term is used within this Description and the appended Claims. Those skilled in the art will be able to recognize other dosage forms that may suitably be used in conjunction with the present dispenser. Moreover, it will be recognized that while in some embodiments, the dosage comprises a single therapeutic agent, in other embodiments, the dosage comprises multiple therapeutic agents as may be used by patients on more than one therapy. Hereinafter, the term “dosage” and “dosage form” will be used synonymously. 
     FIGS. 2A (exterior view) and  2 B (interior view) depict a first embodiment of medicine dispenser  200  for dispensing pharmaceuticals having a stamp-like final dosage form. Dispenser  200  comprises housing  202  having dosage delivery port  204 . The dosage delivery port  204  receives pharmaceutical dosages  150 , one at a time, from the interior of dispenser  200  through portal  206  located at dispensing end  208  of housing  202 . 
     Dosages are urged towards portal  206  via a bias element  210 . In the illustrated embodiments, bias element  210  is a helical spring that is placed in compression by dosages  150 . 
     The interior of housing  202  must be suitably configured to retain dosages  150  in a substantially orderly stack so that each dosage  150  is capable of being delivered to portal  206  and then to dosage delivery port  204 . In one embodiment, guides (not shown) within housing  202  maintain dosages  150  in stacked arrangement. In another embodiment, the open space within housing  202  takes the form of a shaft (not depicted) that restricts the movement of stacked dosages  150  to only one direction, which is upwards toward dispensing end  208 . 
     Dosage delivery port  204  has a receiving surface  212  that receives dosages  150 , one at a time, from portal  206 . Receiving surface  212  leads to aperture  214 , which is the site from which dosages  150  are dispensed from dispenser  200 . 
     In the embodiment illustrated in FIGS. 2A and 2B, dosages  150  are manually advanced to receiving surface  212  and from there to aperture  214 . To facilitate such manual operation, dosage delivery port  204  includes access way  218  through which a user can engage, with a finger, a dosage that is cued in portal  206 . Access way  218  is formed in top  216  of housing  202 . 
     Access way  218  is advantageously narrower across than dosages  150 . In particular, in the illustrated embodiment, top  216  extends inwardly beyond the side edges of receiving surface  212  thereby forming lips  220 . Channels  222  are defined between lip  220  and receiving surface  212  on both sides of dosage delivery port  204 . The “side” edges of dosages  150  engage channels  222  so that, among any other benefits, dosages will not fall out of dispenser  200  if it is inverted. 
     Moreover, the resilience of bias element  210  forces the top-most dosage  150  against the underside of lips  220 . Such upward pressure reduces the likelihood that dosages  150  could fall out of dispenser  200 . 
     Dispenser  200  advantageously includes ergonomic features. For example, in the illustrated embodiment, housing  202  includes ergonomic handgrip  224  configured to minimize strain on a user&#39;s hand/wrist. 
     In a second embodiment depicted in FIG. 3, dispenser  200  includes magazine  326  that stores a stack of dosages  150 . Magazine  326 , which is advantageously removable from housing  202 , ensures that dosages  150  remain in an orderly stack within housing  202  for problem-free dispensing. Additionally, it is easier and more convenient to load magazine  326  with dosages  150  (when the magazine is removed from housing  202 ), than to load a plurality of such dosages directly into the interior of housing  202  as is required for the embodiment depicted in FIGS. 2A and 2B. 
     In the illustrated embodiment, bias element  210  is disposed within magazine  326 . In other embodiments, magazine  326  is physically configured so that bias element  210  is not contained within magazine  326 , but, rather, is disposed beneath it. This is accomplished in one embodiment by providing an opening (not shown) in the bottom of magazine  326  that receives bias element  210  and allows it to engage the bottom of the stack of dosages  150 . In another embodiment (not depicted), the bottom of magazine  326  is configured to slide within the sidewalls thereof. As dosages are removed from magazine  326  through portal  206 , the force imparted by bias element  210  forces the movable bottom of the magazine, and the overlying dosages  150 , upwardly. The slideable bottom of magazine  326  nears dispensing end  208  of housing  202  as the full complement of dosages  150  is dispensed therefrom. 
     In the previous embodiments, dosages  150  are manually advanced to receiving surface  212  and from there to aperture  214 . FIG. 4 depicts an embodiment of dispenser  200  according to the present teachings in which a plunger  428  advances a dosage  150  from portal  206  to dosage delivery port  204 . 
     Plunger  428  does not include any mechanism that provides a mechanical advantage or that changes the direction of a manually applied actuating force. A user simply pushes plunger  428 , which, in turn, advances dosage  150  from portal  206  into dosage delivery port  204 . Plunger  428  is suitably configured, as desired, to advance a dosage either part of the way or completely through aperture  214  of dosage delivery port  204 . Dispenser  200  depicted in FIG. 4 can be used with or without magazine  326 . 
     FIGS. 5A and 5B depict an embodiment of dispenser  200  comprising a mechanized actuator  530 . Actuator  530  includes arm  532  that is operatively connected to solenoid  534  or like device. A power supply (not shown) supplies power to solenoid  534 . When a user pushes button  536 , power is sent to solenoid  534 , which in turn drives arm  532  into dosage  150  thereby moving it from portal  206  into dosage delivery port  204 . To provide sufficient space for actuator  530 , housing  202  may be somewhat larger than for the previously described embodiments. Magazine  326  is advantageously used for storing dosages  150  within housing  202 . 
     In some embodiments (not depicted), the mechanized actuator is manually “powered” (i.e., the actuating force is supplied by a user). In such embodiments, actuator  530  comprises mechanical linkages (not depicted) that drive arm  532  into dosage  150  using a force that is applied by a user to button  536 . Alternatively, other actuating arrangements that will occur to those skilled in the art may suitably be used. 
     The previous embodiments of dispenser  200  were directed to diced stamp-like dosage forms (see, FIG.  1 C). In further embodiments, the present dispenser is configured for dispensing a strip of stamp-like dosage forms  150 . 
     FIG. 6 depicts a roll  600  of stamp-like dosage forms  150 . Perforations  602  separate each individual dosage  150  to facilitate separating such dosages. In other embodiments (not shown), individuals dosage forms can be disposed on a carrier sheet (e.g., using a weak adhesive), rather than being linked by their secondary package to adjacent dosage forms as depicted in FIG.  6 . 
     FIG. 7 depicts an embodiment of medicine dispenser  700  for dispensing a roll  600  of dosages  150 . Dispenser  700  comprises housing  702  having cylindrical main body  706  suitable for receiving roll  600 . Dosage delivery port  704  depends from cylindrical main body  706 . Dosages  150  are received at dosage delivery port  704  one at a time from cylindrical main body  706 . Dosage delivery port  704  includes aperture  714 , which is the site from which dosages  150  are dispensed from dispenser  700 . 
     In the embodiment illustrated in FIG. 7, dosages  150  are manually advanced to dosage delivery port  704  and to aperture  714 . To facilitate such manual operation, dosage delivery port  704  includes access way  718  through which a user can engage, with a finger, a dosage that is cued in dosage delivery port  704 . Access way  718  is formed in top  716  of housing  702 . 
     Access way  718  in top  716  is advantageously narrower across than pharmaceutical dosages  150 . In particular, in the illustrated embodiment, top  716  extends inwardly beyond the side edges of aperture  714  forming lips  720 . The “side” edges of dosages  150  advantageously underlie lips  720  so that, among any other benefits, the end of roll  600  nearest aperture  714  will remain within the dispenser until such time as dosage  150  is dispensed. 
     A side  722  of housing  702  is advantageously removable or otherwise allows access to the interior of housing  702  to allow insertion of roll  600  of dosages  150 . In some embodiments, housing  702  contains a removable cartridge (not shown) that receives roll  600  for storage therein. 
     In the previous embodiment, dispenser  700  did not include any mechanism for advancing dosages  150  toward the dosage delivery port/aperture. In such an embodiment, dosages are dispensed, for example, by inserting a finger through access way  718 , engaging dosage  150 , and sliding it forward towards aperture  714 . FIG. 8 (exterior view) and FIG. 9 (interior view) depict an embodiment of dispenser  700  according to the present teachings comprising a drive mechanism  730  for advancing dosages  150  toward dosage delivery port  704  and aperture  714  for dispensing. 
     The illustrative dispenser  700  depicted in FIG. 8 is very similar in external configuration to the dispenser depicted in FIG.  7 . Since dispenser  700  of FIG. 8 has drive mechanism  730 , access way  718  for manually engaging dosages  150  is not required. The dispenser of FIG. 8 includes button  744  that activates the drive mechanism. 
     In an illustrative depicted in FIG. 9, drive mechanism  730  comprises first roller  732 A, second roller  732 B and motor  740 , interrelated as shown. Each roller comprises two wheels (e.g.,  734 B and  736 B) that are rigidly connected by an axle (e.g.,  738 B). Drive shaft  742  is connected to motor  740  and turns when the motor is energized. A power supply (not shown) supplies power to motor  740 . 
     Wheels  734 A and  736 A (the latter not shown) of roller  732 A engage undersurface  604  (see FIG. 6) of the carrier sheet or secondary package of the dosage forms. Likewise, wheels  734 B and  736 B of roller  732 B engage top surface  606  (see FIG. 6) of the secondary package of the dosage forms. Drive shaft  742  operatively engages wheel  734 A. 
     When a user pushes button  744 , power is sent to motor  740 . The motor rotates drive shaft  742 , which, in turn, drives wheel  734 A. Wheel  734 A, which must maintain sufficient frictional engagement with undersurface  604 , drives dosage forms  150  towards through dosage delivery port  704  and aperture  714 . Sufficient frictional engagement is maintained by sandwiching dosage forms  150  between the first and second roller  732 A and  732 B. 
     In some embodiments, drive mechanism  730  is manually “powered” (i.e., the actuating force is supplied by a user). In one such embodiment (not depicted), the drive mechanism comprises the two rollers as shown, but not motor  740 . Rather, a crank engages, either directly, or through mechanical linkages, one of the rollers. As the crank is turned by hand, the rollers advance dosages  150  through aperture  714 . In another embodiment (not depicted), roll  600  of dosages  150  can be wound around a hub, the hub having a crank engaged thereto. As a user turns the crank, the hub turns, thereby advancing dosages  150 . 
     The operation of dispensers  200  and  700  can be enhanced by one or more advanced dispensing features. Such features include, among others, alerting the user to dispense a dosage, timed dispensing, and compliance record keeping. To that end, in further embodiments in accordance with the present teachings, dispensers  200  and  700  include dosing/alarm/monitoring electronics  800 , a figurative embodiment of which is depicted in FIG.  10 . 
     In the embodiment depicted in FIG. 10, electronics  800  includes processor  802 , memory  804 , timer  806  and alarm  808 . “Dosing” electronics (i.e., the functionality required for timed dosing) and “monitoring” electronics (i.e., the functionality required for dosage monitoring and recording) include processor  802 , memory  804  and timer  806 . 
     In some embodiments, memory  804  is used to store program code for operating the processor  802 , to store a user-defined dosing schedule and to store compliance/monitoring data. Memory  804  may comprise at least two separate memory devices since the program code should be in permanent memory while the dosing schedule and compliance data advantageously reside in programmable/erasable memory. 
     The dosing schedule, which is advantageously programmed by a user into memory  804 , can specify that a dosage is to be dispensed at a specific time (e.g., 8:00 a.m.) or, alternatively, can specify that dosages are to be delivered according to a time interval (e.g., every 4 hours). Timer  806  is used in conjunction with the dosing schedule to implement timed dosing. 
     In accordance with the dosing schedule, processor  802  sends an appropriate actuating signal to the actuator/drive mechanism  530 / 730  (more properly, to the actuator or mechanism “driver,” not depicted). The signal energizes actuator/drive mechanism  530 / 730  and a dosage is dispensed. Processor  802  advantageously updates the compliance record with information concerning the dispensed dosage (e.g., the time dispensed, etc.). Compliance data can be read out of memory  804  in known fashion. 
     To automatically dispense dosages according to a defined schedule, dispenser  200  or  700  must include sufficient automation (e.g., actuators, power supply, etc.) Thus, dosing electronics can only be used with suitably automated embodiments of the present dispenser. On the other hand, “alarm” electronics, which in some embodiments includes timer  806  and alarm  808 , can be used in conjunction with substantially non-automated embodiments of the present dispenser. 
     It is understood that the functionality represented by processor  802 , memory  804  and the timer and alarm may be suitably combined into fewer than four discrete devices. Those skilled in the art will know how to implement such dosing, alarm and monitoring electronics. 
     It is to be understood that the above-described embodiments are merely illustrative of the invention and that many variations can be devised by those skilled in the art without departing from the scope of the invention. It is therefore intended that such variations be included within the scope of the following claims and their equivalents.