Abstract:
A dispenser for dispensing solid dosing forms which include a storage compartment and a releasing portion at the bottom of the storage compartment. The releasing portion is adapted to receive a releasing device which dispenses a single solid dosage form while providing security against the release of multiple solid dosage forms as well as clogging which may prevent the release of a single solid dosage form.

Description:
[0001]    This application claims the benefit of U.S. Provisional Patent Application No. 60/293,687 filed on May 25, 2001, the entirety of which is hereby incorporated by reference as if fully set forth herein. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention is directed to a dispenser for dispensing a solid dosage form such as a tablet to a user. The dispenser is easily held in the hand and enables the user to uniformly dispense a single solid dosage form and prevents against undesirable clogging or inadvertent release of multiple solid dosage forms. The dispenser also provides a substantially water vapor imperable environment to prevent moisture from contacting the solid dosage form when the dispenser is not in use.  
         BACKGROUND OF THE INVENTION  
         [0003]    Dispensers for releasing solid dosage forms such as tablets, capsules, caplets and the like are known in the art. Various structures have been developed to ensure a single solid dosage form is released when the dispenser is activated by the user. Examples of such devices are disclosed in U.S. Pat. Nos. 2,683,554; 3,191,803; 3,332,576; 4,354,619; 4,402,425; 4,492,316; 4,653,668; 5,018,664; 5,108,006; 5,174,471; 5,657,901; and 5,816,441.  
           [0004]    It is desirable for a solid dosage form dispenser to consistently release only a single dosage form at a time until all of the solid dosage forms contained within the dispenser are released. One problem with prior dispensers is that upon occasion more than one solid dosage form is released at a time. The release of multiple solid dosage forms presents a number of difficulties to the user. First, the extra or additional solid dosage forms must be handled by the user. The user may have to discard the extras or return them to the dispenser which takes time and is annoying to the user. If the user chooses to return the solid dosage form to the dispenser, the dispenser must be opened which is often disadvantageous because many solid dosage forms are sensitive to moisture and in some cases may be hygroscopic. For some applications, it may be desirable to provide a dispenser which can not be opened or which can not be easily opened by the user. These types of dispensers may be preferred for highly water sensitive solid dosage forms and/or for medications whose administration must be very carefully controlled. Accordingly, the user would have to find another place to store the extra or discard the same.  
           [0005]    Another disadvantage of typical solid dosage form dispensers is that the compartment for storing the solid dosage forms can become clogged, especially in proximity to the opening where the solid dosage form is discharged from the storage compartment. This presents a number of problems to the user. For example, the user must then open the pill dispenser, empty the contents and hope that the clog can be eliminated without damage to the solid dosage forms. The opening of the container for the removal or elimination of a clog can result in damage to some of the solid dosage forms as well as contamination by the excessive handling of the contents of the dispenser.  
           [0006]    If the dispenser can not be opened because it is of the permanent sealed type or can not be easily opened, then the user is at least temporarily without access to the solid dosage form and has to return the same to the retailer who may then have to return the same to the manufacturer, all of which results in disruption, loss of time and increase cost of the dispenser.  
           [0007]    A further disadvantage of typical dispensers for releasing solid dosage forms is that they do not provide a substantially water vapor impermeable environment for the solid dosage forms especially when the dispenser is not in use. By preventing significant contact with water vapor, the solid dosage forms within the dispenser have an extended shelf life and can therefore be dispensed over longer periods of time without loss of efficacy.  
           [0008]    It would therefore be a significant advance in the art of providing dispensers for the distribution of solid dosage forms if a dispenser could be provided which distributes a single solid dosage form at a time and prevents against dispensing of multiple solid dosing forms as well as clogging so that the user is assured of receiving the proper solid dosage form a single dose at a time.  
           [0009]    It would be a further advance in the art to provide a dispenser which provides substantial protection against moisture.  
           [0010]    It would be a still further advance in the art to provide a dispenser which is relatively to simple to manufacture and which provides all of the features necessary to ensure distribution of a single solid dosage form upon activation by the user.  
         SUMMARY OF THE INVENTION  
         [0011]    The present invention is generally directed to a dispenser for dispensing a solid dosage form in which a single solid dosage form is dispensed at a time and the dispenser prevents against dispensing multiple solid dosage forms as well as clogging which can result in the inability of the dispenser to deliver any solid dosage forms.  
           [0012]    In a particular aspect of the present invention, there is provided a dispenser for dispensing a solid dosage form comprising:  
           [0013]    a) a housing comprising a storage compartment for storing a solid dosage form and having a first opening, a solid dosage form releasing portion operatively connected to the storage compartment for receiving and supporting a solid dosage form received through the first opening and having a second opening for receiving a solid dosage form releasing device, and a third opening for releasing the solid dosage form from the dispenser;  
           [0014]    b) said solid dosage form releasing device comprising:  
           [0015]    1) reversible moving means for reversibly moving the releasing device from a passive position to an active position for releasing a single solid dosage form from the dispenser through the third opening; and  
           [0016]    2) disengaging means for disengaging the solid dosage form from the solid dosage form releasing portion. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0017]    The following drawings in which like reference characters indicate like parts are illustrative of embodiments of the invention and are not intended to limit the invention as encompassed by the claims forming part of application.  
         [0018]    [0018]FIG. 1 is a perspective view of an embodiment of a solid dosage form dispensing device of the present invention where the releasing device is in the active position;  
         [0019]    [0019]FIG. 2 is a perspective view similar to FIG. 1 showing the bottom portion of the dispensing device with an opening for releasing a single solid dosage form;  
         [0020]    [0020]FIG. 3 is a side view of the solid dosage form dispensing device shown in FIG. 1;  
         [0021]    [0021]FIG. 4 is a front view of the solid dosage form dispensing device shown in FIG. 1;  
         [0022]    [0022]FIG. 5 is an exploded view of the solid dosage form dispensing device shown in FIG. 1;  
         [0023]    [0023]FIG. 6 is a cross-sectional view of the solid dosage form dispensing device of FIG. 1 showing the solid dosage form releasing device in the passive position;  
         [0024]    [0024]FIG. 7A is a cross-sectional view similar to FIG. 6 showing the solid dosage form releasing device in the active position for the release of a single solid dosage form;  
         [0025]    [0025]FIG. 7B is a cross-sectional view of a portion of the solid dosage form releasing device particularly adapted to disengage the single solid dosage form so that it may be released from the dispensing device;  
         [0026]    [0026]FIG. 8 is a top view of the solid dosage form dispensing device shown in FIG. 1 with the lid removed;  
         [0027]    [0027]FIG. 9 is a cross-sectional view taken through line  9 - 9  of FIG. 8 showing one embodiment of the manner in which a single solid dosage form is secured to the releasing device prior to release therefrom;  
         [0028]    [0028]FIG. 10 is a cross-sectional view similar to FIG. 9 showing another embodiment of the manner in which a single solid dosage form is secured to the releasing device;  
         [0029]    [0029]FIG. 11 is a partial cross-sectional view of seal formed between the lid and the housing of the dispensing device taken from FIG. 7A;  
         [0030]    [0030]FIG. 12 is a partial cross-sectional view of the seal formed between the cap and housing taken from FIG. 6;  
         [0031]    [0031]FIG. 13 is a cross-sectional view of the solid dosage form releasing device shown best in FIG. 5;  
         [0032]    [0032]FIG. 14 is a top view of the solid dosage form releasing device shown in FIG. 13; and  
         [0033]    [0033]FIG. 15 is a bottom perspective view of the solid dosage form releasing device shown in FIG. 13. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0034]    The present invention is generally directed to a solid dosage form dispensing device for dispensing a single solid dosage form to a user upon activation of the device. As used herein, the term “solid dosage form” shall mean any dosage form that is in the form of a solid including, but not limited to, tablets, caplets, capsules including those made from hard or soft materials such as gelatin or natural or synthetic gelatin substitutes, lozenges, combinations thereof and the like.  
         [0035]    The solid dosage form may contain medications whether prescription or nonprescription as well as, vitamins, nutraceuticals, cough medications, mineral and/or herb supplements whether natural or synthetic, combinations thereof and the like. It will be understood that the content of the solid dosage form (e.g. the type of active agent) is non-limiting with respect to the dispenser described herein and any active agent contained within a solid dosage form may be dispensed in accordance with the present invention.  
         [0036]    Referring to the drawings and first to FIGS.  1 - 4  there is shown a preferred embodiment of the solid dosage form dispenser (hereinafter dispenser) generally shown by the reference numeral  2 . The dispenser  2  has a housing  4  including an upper portion defining a storage compartment  6  (see FIG. 5). The storage compartment is either permanently sealed or has a removable lid  8  which allows access to the storage compartment and enables the dispenser to be refilled as necessary. It will be understood that in one embodiment of the present invention, the pill dispenser has a unitary construction in which the solid dosage form is permanently packaged at a manufacturing facility and is not thereafter opened by the user. Instead, once the user has dispensed all of the solid dosage forms contained therein, the dispenser may be discarded. In other embodiments of the invention as described in detail hereinafter, the lid is releasably secured to the housing through a moisture preventing seal system to keep moisture away from the solid dosage forms stored within the storage compartment  6 .  
         [0037]    Referring again to FIGS.  1 - 4 , the lower portion of the dispenser  2  is in the form of a solid dosage form releasing portion  12  having a side opening  14  for insertion of a solid dosage form releasing device  16  as hereinafter described and a bottom opening  20  for releasing a solid dosage form to the user. As shown in FIG. 5, the solid dosage releasing portion  12  and the releasing device  16  may be secured within a removable protective cover  46  operatively secured in place about the releasing portion  12  through engagement with a flange  74  as hereinafter described. The cover  46  is removed when the user wishes to dispense a solid dosage form and then resecured to the dispenser when the dispenser is not being used. As will be explained in detail hereinafter, the cover  46  may be releasably secured to the housing  4  in a manner which provides a moisture preventing seal system to further assist in maintaining the stored solid dosage forms in a substantially moisture free environment.  
         [0038]    The solid dosage releasing device  16  as shown best in FIG. 5 comprises a housing  22  which in the embodiment shown in FIG. 5 is in the form of a U-shaped wall enclosure  24  having a forward opened portion  26 . It will be understood that the enclosure  24  may have other shapes. Extending from the wall enclosure  24  at said opened portion  26  are a pair of opposed flexible arms  28 A and  28 B. These arms are adapted to engage an opposed wall  50  of the releasing portion  12  as best shown in FIGS. 6 and 7. As explained in detail hereinafter, the flexible arms  28 A and  28 B are movable from a compressed position when the releasing device  16  is moved to the active position for releasing a single solid dosage form to a passive position when the releasing device  16  is at rest.  
         [0039]    Also extending from the U-shaped wall enclosure  24  at the forward opened portion  26  is an optional stopper  30  which prevents access to the single solid dosage form which is suspended above the bottom opening  20  when the releasing device  16  is in the passive position. As explained in detail hereinafter, when the releasing device  16  is in the passive position, the next available solid dosage form is suspended above the stopper  30  in a predetermined orientation ready to be released when the releasing device  16  is moved to the active position and the stopper  30  is moved away from the bottom opening  20 .  
         [0040]    The wall enclosure  24  has a bottom opening  18  (See FIGS. 13 and 15) which is coincident with the bottom opening  20  of the releasing portion  12  when the releasing device  16  is moved to the active position to provide a clear pathway for the release of a single dosage form in the predetermined orientation.  
         [0041]    Within the U-shaped wall enclosure  24 , there is provided a pair of cam devices  33  (See FIGS. 7B, 13 and  14 ) which serve to release the suspended single dosage form from the dispenser when the releasing device  16  is moved to the active position.  
         [0042]    As shown best in FIGS. 5 and 7A, an optional solid dosage form agitation device  32  is provided within the U-shaped wall enclosure  24 . The agitation device  32  has an upper irregular surface  36  which contacts the bottom most solid dosage forms contained within the storage compartment  6  to thereby provide sufficient agitation or tumbling action so that the solid dosage forms in contact therewith do not jam or otherwise obstruct the pathway leading from the storage compartment  6  when the releasing device  16  is moved to the releasing portion  12 .  
         [0043]    The U-shaped wall enclosure  24  may also be provided with a mechanism which prevents the releasing device from being inserted too far into the side opening  14  and thus damaging the arms  28 A and  28 B. As shown specifically in FIG. 5, a projection  60  is provided at the end of the wall enclosure  24  which press fits into a notch  62  when the releasing device  16  is secured in the proper position within the side opening  14 .  
         [0044]    Between the storage compartment  6  and the bottom opening  20  there is provided a delivery assembly for the delivery of a single solid dosage form at a predetermined orientation which facilitates the release of only a single solid dosage form and prevents jamming.  
         [0045]    Referring to FIGS.  6 - 10 , the delivery assembly shown generally by the numeral  51  includes a top opening  42  through which the solid dosage forms pass into a pathway  52  which extends from the storage compartment  6  to the bottom opening  20  of the dispenser  2 . The pathway  52  is preferably dimensioned to allow only a single dosage form to pass through at a time. The pathway  52  is bounded by a pair of upwardly extending walls  54   a  and  54   b  having a distance therebetween less than twice the amount of a preselected dimension of a solid dosage form  38  so that only a single solid dosage form may enter. Toward the lower portion  56  of the walls  54   a  and  54   b  are a pair of inwardly extending projections,  58   a  and  58   b  best shown in FIGS. 9 and 10, which further narrow the width of the pathway  52  to a width slightly greater than the preselected dimension of the solid dosage form and are thereby used to support the single solid dosage form within the pathway  52  so that it may be released therefrom when the user moves the releasing device  16  from the passive to the active position.  
         [0046]    As shown in FIG. 6, a solid dosage form  38  moves from the storage compartment  6  to a desirable predetermined orientation. The single solid dosage form is shown in the pathway  52  in said desirable orientation in FIG. 8.  
         [0047]    As used herein the term “predetermined position” shall mean any position in which only a single dosage form is positioned within the delivery assembly and delivered through the bottom opening of the dispenser. By way of example, the predetermined position may be a position as shown specifically in the drawing figures in which the longest dimension of the solid dosage form extends axially in the pathway of the delivery assembly. The present device also encompasses, for example, an orientation in which the longest dimension of the solid dosage form extends radially within the pathway.  
         [0048]    When in the predetermined position, the single solid dosage form  38  within the pathway  52  is bounded by the upwardly extending walls  54   a  and  54   b  having inwardly extending projections  58   a  and  58   b . in one embodiment of the invention as shown specifically in FIG. 9 the dosage form  38  has a pair of opposed convex faces  57   a  and  57   b  in which the widest portion thereof is in the middle of the solid dosage form  38 . The narrow surfaces below the middle portion of the solid dosage form are particularly suited to be engaged by the corresponding projections  58   a  and  58   b . As a result the dosage form  38  is suspended in the position shown in FIG. 9 with the bottom portion thereof positioned above the optional stopper  30  which is in position for closing off the bottom opening  20  of the dispensing device  2  if desired.  
         [0049]    The release of the dosage form  38  from the predetermined position shown in FIG. 9 takes place by spreading the walls  54   a  and  54   b  away from each other so that the projections  58   a  and  58   b  disengage from the convex surfaces  57   a  and  57   b  of the solid dosage form  38 . The spreading of the walls  54   a  and  54   b  is made possible by the cam device  33  within releasing device  16 .  
         [0050]    As shown in FIG. 14, each of the cam devices  33  is comprised of base  35  and a tapered end  37 . The tapered end  37  is adapted to contact the lower portion  56  of the walls  54   a  and  54   b  shown in FIG. 9 when the releasing device is moved by the user to the active position. As the lower end of the walls  54   a  and  54   b  engage the tapered end  37  of the respective cam devices  33 , they are caused to move a sufficient distance away from each other to release the dosage form from contact with the projections  58   a  and  58   b . At the same time and by the same movement of the releasing device  16 , the stopper  30  if present moves away from the bottom opening  20  to provide an unimpeded pathway for the release of the dosage form so that it may drop from the dispensing device as shown in FIG. 7A.  
         [0051]    In a further embodiment of the invention as shown best in FIG. 10, the projections  58   a  and  58   b  do not engage the sides of the dosage form  38  but instead provide a platform on which the solid dosage form rests when the releasing device  16  is in the passive position. This embodiment of the invention may be used for solid dosage forms having generally planar opposed faces. When the releasing device  16  is moved to the active position, the cam devices  33  engage the lower portion  56  of the walls  54   a  and  54   b  as previously described and thereby release the dosage form  38  by moving the projections  58   a  and  58   b  away from each other. The optional stopper  30  is simultaneously moved away from the bottom opening  20  of the dispensing device  2  to provide an unimpeded pathway for the release of the single solid dosage form to the user.  
         [0052]    The preferred releasing device  16  of the present invention will be described with reference to FIGS. 5 and 13- 15  as set forth below. The releasing device  16 , as previously indicated, includes a pair of flexible arms  28 A and  28 B which provide a spring-like action enabling the releasing device  16  to be moved from a passive position as specifically shown in FIG. 6 to an active position (shown in FIG. 7A) where the arms  28 A and  28 B are compressed and under tension. The optional stopper  30  blocks the bottom opening  20  (see FIG. 6) in the releasing portion  12  when the releasing device  16  is in the passive position. When the releasing device  16  is moved to the active position, the stopper  30  is retracted thereby removing the obstruction to the bottom opening  20  allowing a single dosage form to fall therethrough and thereby be released form the dispenser  2  as the cam devices  33  engage the walls  54   a  and  54   b  as previously described.  
         [0053]    There is also provided in a preferred embodiment of the invention an agitation device  32  having an irregular surface  36  which as shown best in FIG. 7A engages solid dosage forms at the bottom of the storage compartment  6  which are in proximity to the top opening  42  of the storage compartment. The agitation or disruption of the bottommost solid dosage forms within the storage compartment prevents the solid dosage forms from becoming lodged in the top opening  42 . The agitation device  32  provides further assurance of the entry of a single solid dosage form into the pathway  52  each time the releasing device  16  is activated.  
         [0054]    In operation, the dispenser  2  of the present invention as best shown in FIG. 3 has the releasing device  16  in the passive position in which the bottom opening  20  of the releasing portion  12  is obstructed by the optional stopper  30  extending from the releasing device  16 . When the user wishes to obtain a single solid dosage form, the releasing device  16  is pushed inwardly into the releasing portion  12  from the position shown in FIG. 6 to the position shown in FIG. 7A. As the releasing device  16  is moved inwardly into the releasing portion  12 , the cam devices  33  engage the walls  58   a  and  58   b  causing the projections  56   a  and  56   b  to disengage from the solid dosage form  38 . At the same time, the optional agitation device  32  begins to contact and tumble the solid dosage forms contained in proximity to the top opening  42  in the storage compartment  6 . This ensures that another single solid dosage form in proximity to the top opening  42  will enter at the predetermined orientation into the delivery assembly  51  without becoming jammed against other solid dosage forms.  
         [0055]    As shown in FIG. 7A, once the solid dosage form (identified by the reference numeral  38 ) is released through the bottom opening  20 , the user releases pressure from the releasing device  16  thereby moving the releasing device  16  to the position shown in FIG. 6 with the flexible arms  28 A and  28 B moving from the compressed position to the relaxed position of FIG. 6.  
         [0056]    In a further preferred form of the invention, within the releasing portion  12  there is provided a ramp  40  having an incline for urging the solid dosage forms resting thereon toward the bottom opening  42  of the storage compartment  6 . The inclined ramp  40  further ensures a constant supply of solid dosage forms for release by the dispenser.  
         [0057]    The dispensing device of the present invention can be made from any suitable plastic material. Of particular importance is the employment of a suitable plastic for the formation of the flexible arms  28 A and  28 B. The arms should be sufficiently flexible so that when a moderate force is applied by the user, the arms may be compressed and have sufficient memory and durability that they can return to a relaxed position a sufficient number of times to release all of the solid dosage forms that may be contained in the pill dispenser or any refills provided.  
         [0058]    In accordance with another preferred aspect of the present invention, the dispensing device  2  is rendered substantially impermeable to water vapor when the device is in the passive position (i.e. when the user is not dispensing a solid dosage form from the device.). It will be understood that when the device is in the active position and a solid dosage form is being released, water vapor (moisture in ambient air) can enter the device through the bottom opening  20 . In this aspect of the invention, water vapor is at least substantially prevented from entering the device when the user is not actively releasing a solid dosage form therefrom and a cover  46  is operatively secured to the dispenser.  
         [0059]    In this regard, it is also advantageous to provide a cover  46  to protect the releasing portion  12  and the releasing device  16  as well as to keep moisture from entering the dispenser  2  through the bottom portion thereof and particularly through the opening  14  in the releasing portion  12 .  
         [0060]    Referring to FIGS. 5, 6 and  12 , a cover  46  is releasably secured to the lower portion of the housing  4  in a manner which substantially prevents moisture from entering the device. The cover must be removed when the user desires to dispense a solid dosage form. As shown best in FIG. 12, the cover  46  is releasably secured to the housing  4 , preferably through a multiple seal barrier, as described hereinafter. The cover  46  is provided with at least two, preferably more than two projections  70  (three projections  70   a ,  70   b , and  70   c  are shown in FIG. 12. Between each pair of projections is a trough  72   a  and  72   b , respectively which provides a place of contact for a corresponding flange  74  located on the surface of the housing  4 . Contact of the flange  74  to the trough surface ( 72   a  as specifically shown in FIG. 12) provides a seal which prevents the influx of moisture into the device.  
         [0061]    In addition, the housing  4  may be provided with a tapered surface  76  which provides individual sealing surfaces for each of the remaining projections (e.g.  70   b  and  70   c  as shown specifically in FIG. 12) and thus provides additional barriers against the influx of moisture.  
         [0062]    As previously indicated, the dispenser  2  may be provided as a unitary or integral structure with a lid permanently secured to the top portion of the housing  4 . Alternatively, the lid  8  may be removable for the purpose of adding a new supply of solid dosage forms to the dispenser. The desirability of either a unitary construction or a removable lid will depend in part on the type of solid dosage form and its sensitivity to moisture.  
         [0063]    As previously explained, the lid  8 , if present, may be permanently sealed to the upper portion of the housing  4  or may be releasably secured thereto. If the dispensing device is constructed with a lid which can be removed from the housing, it is desirable to provide at least one moisture preventing sealing interface to assist in preventing unwanted moisture from contacting the solid dosage forms which may be present in the storage compartment.  
         [0064]    Referring to the embodiment of the invention shown specifically in FIGS. 7A and 11, the lid  8  has a pair of projections  80   a  and  80   b  defining corresponding trough surfaces  82   a  and  82   b . There is also provided an indentation  84  defined by an inwardly tapering surface  86 , a downwardly extending surface  88  and an outwardly extending surface  90  below which is a projection  92 . The corresponding inner surface  100  of the housing  4  has a contour which provides sealing contact with the lid  8  at the projections  80   a  and  80   b , along at least one of the surfaces  86 ,  88  and  90  and with the projection  92 . Thus there are at least three sealing surfaces in a preferred embodiment of the invention to prevent moisture from entering the dispensing device  2  through the lid  8 .  
         [0065]    The embodiments shown herein are for illustrative purposes only and modifications thereof which would be apparent to one of ordinary skill in the art or within the full scope of the invention.