Abstract:
A hermetically sealed container and a medicament bearing insert assembly therefor are disclosed. The medicament bearing insert assembly is protected by a severable overcap. A pocket within the insert assembly is provided with a pierceable membrane. Rupture of the membrane by a built-in plunger causes the medicament to drop out of the pocket and into the container where it is mixed with the container contents.

Description:
FIELD OF THE INVENTION  
         [0001]    This invention relates to a hermetically sealed container which includes a body filled with a liquid and, more particularly, to an insert for such a container adapted to store and thereafter dispense a medicament such as a tablet into the liquid in the container.  
         BACKGROUND OF THE INVENTION  
         [0002]    Hermetically sealed containers can be readily produced by the so-called blow/fill/seal techniques. Utilizing such techniques, a container body is first blow molded from an extruded parison segment, then charged (or filled) with a desired liquid, and thereafter sealed with a preformed closure insert. See, for example, the container structure disclosed in U.S. Pat. No. 4,596,110 to Weiler.  
           [0003]    The liquid in the container body is typically dispensed through the insert and then mixed with another liquid or solid deposit prior to being ingested or otherwise used. A disadvantage associated with the mixing of a deposit or the like into the liquid dispensed from the container prior to ingestion or use is the increased risk of contamination inherent in the handling, manipulation and mixing of the deposit such as a tablet or the like in a non-sterile environment.  
           [0004]    There is thus presently a need for a hermetically sealed container where the liquid or solid deposit intended to be mixed with the liquid in the container is stored in the container and mixed with the liquid in the container prior to being dispensed from the container to eliminate the risk of contamination and to simplify the mixing and dispensing procedure.  
         SUMMARY OF THE INVENTION  
         [0005]    A hermetically sealed container of the present invention incorporates a preformed medicament bearing insert assembly adapted and structured to store and thereafter dispense a solid medicament, such as a medicinal tablet or the like, into a liquid contained in the body of the container.  
           [0006]    More particularly, the insert assembly defines a base member with sealed cavity having a rupturable unitary membrane therewith and a solid medicament contained in the cavity. A plunger provided in the insert assembly is adapted to penetrate the membrane so that the medicament can drop into the body of the container when the plunger is activated. The plunger can be axially slidable or threaded, as desired. The membrane is not completely severed from the base member, however, to dispense the medicament.  
           [0007]    The medicament can be a tablet, a capsule, a pill, an aliquot of a powder, and the like.  
           [0008]    The insert assembly is encapsulated within a hermetically sealed container molded of a thermoplastic material and having a body portion, a neck portion, and an severable overcap unitary therewith. The neck portion defines a socket for the insert assembly. The severable overcap is delineated from the neck portion by a peripheral frangible web, and protects the insert assembly during storage and handling from premature activation. When the overcap is removed or severed from the container by a twisting action, the plunger, which is part of the insert assembly, can be activated to release the medicament into the body of the container by urging the plunger against the membrane so as to partially sever the membrane from the insert assembly.  
           [0009]    Other advantages and features of the present invention will be more readily apparent from the following detailed description of the preferred embodiment of the invention, the accompanying drawings, and the appended claims. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    In the Drawings,  
         [0011]    [0011]FIG. 1 is a perspective view of a hermetically sealed container embodying the present invention;  
         [0012]    [0012]FIG. 2 is an enlarged, partial front elevational view, partially broken away and shows the insert received in a socket provided in the neck portion of the container;  
         [0013]    [0013]FIG. 3 is a cross-sectional view of the container socket and insert;  
         [0014]    [0014]FIG. 4 is a cross-sectional view of the container socket and insert structure where the plunger of the insert assembly has pierced the membrane thereof preparatory to medicament release;  
         [0015]    [0015]FIG. 5 is a cross-sectional view of the container socket and insert assembly depicting the plunger in a position where the medicament is released from the insert assembly into the body of the container;  
         [0016]    [0016]FIG. 6 is an enlarged, partial front sectional view of an alternate insert assembly embodying the present invention;  
         [0017]    [0017]FIG. 7 is a view similar to FIG. 6 and showing a medicament being dispensed;  
         [0018]    [0018]FIG. 8 is an enlarged, front sectional view of an alternate container embodying the present invention;  
         [0019]    [0019]FIG. 9 is an enlarged partial front elevational view, partially broken away, and showing the dispensing nozzle of the container; and  
         [0020]    [0020]FIG. 10 is a perspective view depicting the container of FIG. 1 in its dispensing position with the overcap and dispensing cap removed therefrom and the medicament in the liquid dissolved in the contents of the container. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0021]    The invention disclosed herein is, of course, susceptible of embodiment in many different forms. Shown in the drawings and described below in detail are preferred embodiments of the container of the present invention. It is to be understood, however, that the present disclosure is an exemplification of the principles of the invention and does not limit the invention to the illustrated embodiments.  
         [0022]    For ease of description, the container of the present invention will be described in a normal (upright) operating position and terms such as upper, lower, horizontal, etc., will be used with reference to this position. It will be understood, however, that the container and the insert assembly of the present invention may be manufactured, stored, transported, used, and sold in an orientation other than the position described.  
         [0023]    A formed, filled, and hermetically sealed thermoplastic container  10  embodying the insert assembly structure of the present invention is illustrated in FIG. 1. Container  10  is preferably fabricated, using a method similar to the method disclosed in U.S. Pat. No. 4,596,110 to Weiler, from conventional molding materials such as polyethylene, polypropylene, and the like, compatible with the contemplated container contents.  
         [0024]    Container  10  is but one example of such a container, inasmuch as a wide variety of container shapes and sizes can be fabricated. Container  10  includes a hollow body portion  12  having a bottom portion  14  and a top portion  16 . The container body portion  12  is filled with a suitable liquid contents or solution  13 . A medicament containing insert assembly  46  is received in a socket  44  provided in a neck portion  38  of the container  10 . A severable overcap  48  envelops the upper part of insert assembly  46 . The bottom portion  14  of the container  10  terminates in a dispensing nozzle  18  which is in fluid flow communication with the container body portion  12  and the liquid contents  13  therein.  
         [0025]    As shown in FIGS. 1, 2 and  3 , at the top portion  16 , the container body portion  12  terminates in the neck portion  38  unitary therewith which includes a generally cylindrical throat portion  40  defining a hollow passageway  42 . Socket  44  is defined by throat portion  40  and is unitary therewith. Socket  44  is sized to receive the insert assembly  46 . Severable overcap  48  envelops insert assembly  46  and is delineated from the socket  44  by a frangible web  49 . Preferably, overcap  48  includes two spaced apart unitary and diametrically opposed grasping wings  50  and  52  to facilitate removal of the overcap  48  when the container  10  is prepared for use.  
         [0026]    Insert assembly  46  is a separately fabricated assembly adapted to be inserted, immobilized and subsequently sealed within the socket  44  of the container  10  using a top insertion method disclosed in, for example, U.S. Pat. No. 4,596,110 to Weiler and U.S. Pat. No. 4,707,966 to Weiler et al. The insert assembly  46  may be made of the same type of material as the container  10 , i.e., polyethylene or polypropylene, but can also be molded from a different material such as acrylonitrile-butadiene-styrene (ABS), and the like.  
         [0027]    Referring to FIGS. 2 and 3, the insert assembly  46  includes a base member  54  which is immobilized and sealed in the socket  44  of the container  10 . The base member  54  defines a medicament pocket  70  and includes first and second collars  56  and  58 , first and second shoulders  60  and  62  and a hollow neck  64 . The shoulder  60  extends between the collars  56  and  58  while the shoulder  62  extends between the collar  58  and the neck  64 . The base member  54  includes an outer surface  66  and defines a generally cylindrical inner passageway  68  which extends through the collars  56  and  58  and the neck  64  and defines the pocket  70  which terminates in a proximal generally circular aperture  72  occluded by a rupturable membrane  76 .  
         [0028]    Interior face  77  of rupturable membrane  76  seals the interior of the pocket  70  from the container  10 . The rupturable membrane  76  is unitary with and is made of the same material as the base member  54 . The thickness of the material forming the membrane  76  is selected to provide both good sealing and piercing characteristics.  
         [0029]    Medicament  78  is stored in the pocket  70  and is sealed from the container body  12  by the membrane  76 . Medicament  78  can be, for example, a capsule, a tablet, a pill, or an aliquot of powder, as desired.  
         [0030]    The neck  64  of the base member  54  additionally includes a distal flange  80  extending radially outwardly from the outer surface  66  adjacent the distal opening  74 . The neck  64  also includes first and second annular ribs  82  and  84  extending outwardly from, and circumferentially around, the outer surface  66 . The rib  82  is positioned parallel to, and spaced from, the flange  80  so as to define a groove  86  therebetween. The rib  84  is positioned parallel to, and spaced from, the shoulder  62  so as to define a groove or pocket  88  therebetween.  
         [0031]    The insert assembly  46  also includes a plunger  90  movably received in passageway  68  defined in base member  54 . Plunger  90  includes a generally cylindrically shaped head unitary with body portion  93  which extends into the passageway  68  of the member  54 . The proximal end  94  of plunger  90  has a distal radial end face  96  and an outer surface  98  which abuts and slides against the inner surface of the base member  54  that defines the passageway  68 .  
         [0032]    The solid medicament  78  is stored in the pocket  70  so that it is retained between the end face  96  of the plunger  90  and the membrane  76 . The radial end face  96  also can include a pair of spaced-apart prongs  86  and  88  extending outwardly therefrom which define a cradle for the medicament  78 . An elongate piercing blade  104  extends from the radial end face  96  outwardly toward the membrane  76 . Outer face  106  of blade  104  slides along passageway  68  of the base member  54 . The blade  104  terminates in a pointed tip  108  which is adapted to pierce and partially sever the membrane  76  when the plunger  90  is urged against the membrane  76 .  
         [0033]    Cap  109  of plunger  90  is unitary with the proximal end  94  of plunger body portion  93  and comprises an annular flange  110  which extends radially outwardly from the outer surface  98  of the plunger body portion  93  adjacent the proximal end  94  thereof. A circumferential wall  112  depends generally downwardly from the flange  110 . The wall  112  is spaced from and generally parallel to the outer surface  98  of the plunger body portion  93  and defines a circumferential hollow sleeve  114  between the wall  112  and the outer surface  98 . Annular flange  110  provides a stop as the plunger  90  is urged against the membrane  76 . The membrane  76  is not fully severed from the base member  54  when medicament  78  is dispensed so as to keep the membrane  76  from dropping into the container  10  along with the medicament  78 .  
         [0034]    The wall  112  includes an inner surface  116  and a peripheral distal end  118 . A finger  120  extends circumferentially and radially inwardly from the inner surface  116  adjacent the peripheral distal end  118  thereof and abuts retaining rib  82 .  
         [0035]    As shown in FIGS. 1, 9 and  10 , the nozzle  18  at the bottom of container  10  is hollow, generally frustoconical in shape, and at distal end  20  defines an axial dispensing aperture  22 . A unitary but removable dispensing cap member  26  is attached to the bottom distal end  20  of the nozzle  18 . Dispensing member  26  includes a generally cylindrically shaped twist-off cap  27  including a circumferential lip or edge  28  which is unitary with the lip  24  of the nozzle  18 . The lip  24  is delineated from the lip  28  by a circumferential frangible web  30  unitary therewith.  
         [0036]    Dispensing member  26  additionally includes a flat lower base  32  which is unitary with the cap  27  and wings  34  and  36  extending upwardly from opposite ends of the base  32  and on opposite sides of the nozzle  18  in a diametrically opposed relationship.  
         [0037]    The use and operation of the container  10  and the insert assembly  46  thereof for storing, dispensing and thereafter mixing the medication  78  with a liquid  13  in the container body  12  will now be described with reference to FIGS.  2 - 5 ,  9  and  10 .  
         [0038]    Initially, the overcap  48  is severed and removed from the container  10  to obtain access to the insert assembly  46  and the plunger  90  thereof. This is achieved by grasping the wings  50  and  52  of the overcap  48  and then exerting a substantially simultaneous twisting and lifting motion to the overcap  48  so as to break the unitary frangible web  49  (FIG. 2) between overcap  48  and container top portion  16 .  
         [0039]    [0039]FIG. 3 shows the container  10  with the overcap  48  removed therefrom. The plunger  90  of the insert assembly  46  is in its normal upright locked position where the finger  120  on the cap  109  of the plunger  90  is lodged in the pocket  86  defined on the neck  64  of the member  54  between flange  80  and retaining rib  82 .  
         [0040]    [0040]FIG. 4 depicts the top of the container  10  and the insert assembly  46  after the plunger  90  has been partially depressed downwardly in the direction of the base member  54 . The finger  120  has been dislodged from the pocket  86  and has passed over the rib  82  on the neck  64  into a position where the finger  120  is located between the ribs  82  and  84  on the neck  64 . The depression of the plunger  90  also causes the downward movement of the elongate blade  104  extending outwardly from the end of the head  92  which, in turn, causes the tip  108  thereof to contact and pierce the membrane  76 .  
         [0041]    The continued downward axial movement of the plunger  90  in the direction of the base member  54  into the position of FIG. 5 where the finger  120  of the plunger  90  is lodged in the pocket  88  on the neck  64  of the base member  54  causes the further downward movement of the plunger body portion  93  through the pocket  70  which, in turn, causes the medicament  78  to be pushed out of the pocket  70  through the now open aperture  72  in the base member  54  and into the container body  12  where the medicament  78  is dissolved and mixed in the liquid  13 . The pierced membrane remains with the base member  54 , however.  
         [0042]    The container  10  at this point can be shaken to allow the composition of the medicament  78  to be thoroughly distributed in the liquid  13 . The container  10  then can be turned upside down into a position where the dispensing nozzle  18  faces up and the dispensing member  26  is severed and removed from the nozzle  18  by grasping the wings  34  and  36  thereof and then exerting a simultaneous twisting and lifting motion to break the frangible web  30 . The container  10  is then returned to the dispensing position of FIG. 7 for dispensing the liquid mixture.  
         [0043]    [0043]FIGS. 6 and 7 depict an alternate insert assembly, generally designated  246 , which includes a plunger  290  with a plunger body portion  293  provided with external threads  295  that engage mating internal threads  297  formed in the base member  254  along the inner surface which defines a central passageway  268  thereof. In such a case, the plunger body portion  293  is urged against the membrane  276  by turning rather than pushing to partially sever the membrane  276  from base member  254 .  
         [0044]    The insert assembly  246  also differs in structure from the insert assembly  46  in that the outer surface  298  of plunger body portion  293  includes a knurled flange portion  299  which extends radially outwardly therefrom adjacent the proximal end  294  and allows the plunger body portion  293  to be easily grasped and turned.  
         [0045]    A second flange portion  301  extends radially outwardly from the outer surface  298  in a parallel and spaced relationship relative to the knurled flange portion  299 . The flange portion  301  defines a radial shoulder  303  which, as shown in FIG. 7, is adapted to abut against the shoulder  262  defined at the proximal end  263  of the base member  254  to limit the depth to which the plunger body portion  293  can be threaded into the passageway  268  defined in the base member  254 .  
         [0046]    The membrane  276  differs in structure from the membrane  176  associated with the insert assembly  46  in that the membrane  276  includes a peripheral portion  277  which is thinner than a central portion  279  thereof to further enhance the piercing of the membrane  276  by the tip or edge  208  of the piercing blade  204  which extends downwardly from the distal end face  296  of the plunger body portion  293 .  
         [0047]    The plunger  290  of the insert assembly  246  additionally differs in structure from the plunger  90  of the insert assembly  46  in that the plunger  290  includes an interior cavity  305  which terminates in an opening  307  in the distal end face  296  thereof. The opening  307  defines a cradle for the medicament tablet  278  housed in the pocket  270  in a manner similar to the cradle defined by the prongs  86  and  88  of the base member  54  of the insert assembly  46 .  
         [0048]    The other elements and features of the alternate insert assembly  246  are similar to the elements and features of the insert assembly  46 .  
         [0049]    [0049]FIG. 8 depicts yet a further alternate container embodiment  310  including an insert assembly  346  which is similar in structure and function to the insert assembly  246  shown in FIGS. 6 and 7. The container embodiment  310  further includes a severable overcap  348  with grasping wings  350  and  351  unitary therewith. Overcap  348  is similar in structure to the overcap  48  shown in FIGS. 1 and 2, except that the thermoplastic material forming the overcap  348  also defines a container top portion  422  and stays together with body portion  393  of plunger  390  as body portion  393  is turned. In this particular embodiment, overcap  348  need not be removed in order to activate plunger  390 . Flange portions  399  and  401  receive therebetween inwardly extending flange or ring  425  of the material that forms overcap  348 .  
         [0050]    The thermoplastic material forming the overcap  348  is brought into intimate and abutting relationship with the outer surface of the plunger  390  and the groove  426  defined therein by flange portions  399  and  401  during the molding of the container  310  and, more particularly, after the insertion and sealing of the insert assembly  346  as is known in the art and shown in U.S. Pat. No. 4,596,110 to Weiler and U.S. Pat. No. 4,707,966 to Weiler et al.  
         [0051]    As a result, the overcap  348  is permanently secured to the plunger  390  such that, when the overcap  348  is twisted to break the unitary frangible web  349 , the plunger  390  turns with the overcap  348 . The subsequent turning of the overcap  348 , in turn, causes the downwardly movement of the plunger  390  into piercing and severing contact with the membrane  376  in the same manner as described above with respect to the plunger embodiment  290  to dispense medicament  378 .  
         [0052]    What has thus been disclosed and described are containers including alternate insert assemblies which house and subsequently dispense a medicament into the container body thus eliminating the risk of contamination which can result when medicaments are handled or exposed to non-sterile environments prior to being mixed with a carrier liquid.