Patent Abstract:
A container and more specifically a container such as a capsule used to deliver dosages of pharmaceuticals, medicines, vitamins, etc. to an individual is discussed. In one embodiment, the invention includes a container comprising: a cap; a body slidably engagable inside the cap; and a fluid gap positioned between the cap and the body adjacent an end of the cap, wherein a first channel of the cap and a first channel of the body form a snap fit joint and a second channel of the cap and a second channel of the body form a fluid stop joint whereby a sealing fluid is substantially restricted to the fluid gap by the fluid stop joint.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of co-pending U.S. application Ser. No. 11/485,686, filed Jul. 13, 2006, as a continuation-in-part application and also claims the benefit of U.S. Provisional Patent Application No. 60/706,604, filed 9 Aug. 2005, which are hereby incorporated herein. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     1. Technical Field  
         [0003]     The invention relates generally to a container and more specifically to a container such as a capsule used to deliver dosages of pharmaceuticals, medicines, vitamins, etc. to an individual.  
         [0004]     2. Related Art  
         [0005]     Standard containers for pharmaceuticals or other powdered, granular, or liquid substances, so-called telescope-type capsules, include a tubular-shaped or cylindrically-shaped first part, namely the cap part, which is closed on one end and open on the other end. A tightly fitting second part of similar shape, but of smaller diameter, can be telescopically inserted into the cap part, the second part being referred to as the main part or body part.  FIG. 1  shows an illustrative conventional capsule  100  including a cap  110  and a body  140 . Cap  110  includes an open end  112  and a closed end  114 . Similarly, body  140  includes an open end  142  and a closed end  144 . Open end  142  of body  140  is of a slightly smaller diameter than open end  112  of cap  110  such that body  140  may be partially inserted into cap  110 . A separation of cap  110  and body  140  is prevented by friction and/or various modifications of an exterior surface of body  140  and/or an opposed inner surface of cap  110 . For example, U.S. Pat. No. 5,769,267 to Duynslager et al., which is hereby incorporated by reference, discloses a two-piece telescoping capsule having corresponding connection units on the cap part and body as well as protrusions on an inner surface of the cap part to increase friction between the cap part and the body.  
         [0006]     Usually, the containers are supplied to a filling apparatus in a “prelock” condition in which the body part is telescoped only partially into the cap. The two parts are separated in the filling machine and then fully closed after the filling operation.  
         [0007]     In addition to various locking mechanisms intended to secure the various parts of a multi-part capsule after filling, the parts may alternatively or additionally be sealed by various methods. Generally, such sealing includes the spraying with a liquid or dipping of the capsule parts in a liquid. Such liquid may itself provide adhesive and/or sealing properties. Alternatively, such liquid may result in the partial dissolution or disintegration of portions of the capsule parts, whereby the capsule parts are fused or sealed upon evaporation of the liquid. Illustrative liquid sealing methods and solutions are disclosed in U.S. Pat. No. 4,893,721 to Bodenmann et al., which is hereby incorporated by reference. The particular liquid chosen will depend, in part, upon the composition of the capsule parts, but may include, for example, water or an alcohol.  
         [0008]     Capsules may be constructed from a variety of film-forming agents such as gelatin, hydroxypropylmethylcellulose (HPMC), pullulan, etc. A number of defects have been observed in known devices, particularly deformations and microcracks in capsule walls. Deformations may result from a thinning and/or weakening of a capsule wall due to an excess of sealing fluid, which necessarily at least partially dissolves or disintegrates a material of the capsule wall.  
         [0009]     Microcracks generally take the form of small breaks or discontinuities and almost always appear near a locking structure cap, i.e., portions of the cap and body providing a friction fit to prevent opening of the capsule. Microcracks result from stresses upon the capsule parts combined with a locally low loss on drying (LOD), i.e., low moisture content, and thus brittleness. Stresses may result, for example, from an internal capsule pressure, e.g., from the closing and/or heating of the capsule, or stresses placed upon the capsule parts themselves due to the force required to insert the capsule body into the capsule cap. The locally low LOD or brittleness may result, for example, from the presence of an alcohol vapor, which acts as a dehumidifier, in a gap between the cap and the body or from the drying of the capsule material, also attributable to an alcohol in the sealing fluid.  
         [0010]     It has been observed that pullulan is particularly susceptible to these defects. Pullulan capsules experience higher than normal rates of failure after a sealing process, due, at least in part, to the fact that pullulan dissolves in room temperature water. Gelatin forms a phase intermediate between a solid and a liquid upon application of water, wherein the chain structure of the gelatin remains intact. In contrast, upon the application of water, pullulan transitions from a solid to a liquid. As a result, the strength of pullulan is lost locally near the sealing area. In this case, deformations may be common, resulting in the bending, swelling, or rupturing of capsules. Examples of failure include improper sealing, deformation, etc. As a result, current capsule designs are not well suited to allow for the liquid sealing of a pullulan-based multi-piece capsule.  
         [0011]     There is, therefore, a need in the art for a multi-piece capsule design that can be sealed, such as with a conventional alcohol/water spray, and is not susceptible to deformation or failure of the capsule due to a liquid sealing process.  
       SUMMARY OF THE INVENTION  
       [0012]     A container and more specifically a container such as a capsule used to deliver dosages of pharmaceuticals, medicines, vitamins, etc. to an individual is disclosed. In one embodiment, the invention includes a container comprising: a cap; a body slidably engagable inside the cap; and a fluid gap positioned between the cap and the body adjacent an end of the cap, wherein a first channel of the cap and a first channel of the body form a snap fit joint and a second channel of the cap and a second channel of the body form a fluid stop joint whereby a sealing fluid is substantially restricted to the fluid gap by the fluid stop joint.  
         [0013]     A first aspect of the invention provides a container comprising: a cap; a body slidably engagable inside the cap; and a fluid gap positioned between the cap and the body adjacent an end of the cap, wherein a first channel of the cap and a first channel of the body form a snap fit joint characterized as free of contact with a sealing fluid and a second channel of the cap and a second channel of the body form a fluid stop joint whereby a sealing fluid is substantially restricted to the fluid gap by the fluid stop joint.  
         [0014]     A second aspect of the invention provides a container comprising: a cap having a first channel and a second channel; a body slidably engagable inside the cap, the body having a first channel engagable with the first channel of the cap in a first position and the second channel of the cap in a second position, a second channel engagable with the second channel of the cap in the second position, and a third channel forming an entry gap adjacent an open end of the cap; and a fluid gap between the cap and the body adjacent an end of the cap.  
         [0015]     A third aspect of the invention provides a container comprising: a cap having a first channel and a second channel; a body slidably engagable inside the cap, the body having a first channel engagable with the first channel of the cap in a first position and the second channel of the cap in a second position, a second channel engagable with the second channel of the cap in the second position, and a third channel forming an entry gap adjacent an open end of the cap; a fluid gap positioned between the cap and the body adjacent an end of the cap; and a pressure release channel, wherein the first channel of the cap and the first channel of the body form a snap fit joint, the second channel of the cap and the second channel of the body form a fluid stop joint for substantially restricting sealing fluid to the fluid gap, and the pressure release channel is located substantialily within the snap fit joint.  
         [0016]     A fourth aspect of the invention provides a container comprising: a cap having a first channel and a second channel; a body slidably engagable inside the cap, the body having a first channel engagable with the second channel of the cap and a second channel forming an entry gap adjacent an open end of the cap; and a fluid gap between the cap and the body adjacent an end of the cap, wherein the second channel of the cap and a portion of the body between an open end of the body and the first channel of the body form a pre-lock joint in a first position and the second channel of the cap and the first channel of the body form a fluid stop joint for substantially restricting a sealing fluid to the fluid gap in a second position.  
         [0017]     A fifth aspect of the invention provides a method of sealing a multi-part container comprising: providing a container having: a cap; a body slidably engagable inside the cap; and a fluid gap positioned between the cap and the body adjacent an end of the cap; closing the container such that a first channel of the cap and a first channel of the body are in contact and a second channel of the cap and a second channel of the body are in contact; applying a sealing fluid to the fluid gap; and drying the container.  
         [0018]     The illustrative aspects of the present invention are designed to solve the problems herein described and other problems not discussed, which are discoverable by a skilled artisan. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]     The embodiments of this invention will be described in detail, with reference to the following figures, which are not drawn to scale, wherein like designations denote like elements, and wherein:  
         [0020]      FIG. 1  shows a conventional two-piece capsule device.  
         [0021]      FIG. 2  shows a partial cross-sectional view of an embodiment of the invention.  
         [0022]     FIGS.  3 A-D show cross-sectional views of various embodiments of the invention.  
         [0023]      FIG. 4  shows a partial cross-sectional view of an alternative embodiment of the invention.  
         [0024]      FIG. 5  shows a partial cross-sectional view of a second alternative embodiment of the invention.  
         [0025]     FIGS.  6 A-C show cross-sectional views of third and fourth alternative embodiments of the invention.  
         [0026]      FIG. 7  shows a partial cross-sectional view of an embodiment of the invention in a prelock position.  
         [0027]     FIGS.  8 A-B show cross-sectional side views of an alternative embodiment of the invention in prelock and closed positions, respectively.  
         [0028]     FIGS.  9 A-B show cross-sectional side views of an alternative embodiment of the invention in prelock and closed positions, respectively.  
         [0029]     FIGS.  10 A-B show cross-sectional side views of an alternative embodiment of the invention in prelock and closed positions, respectively.  
         [0030]     FIGS.  11 A-B show cross-sectional side views of an alternative embodiment of the invention in prelock and closed positions, respectively.  
         [0031]     FIGS.  12 A-B show cross-sectional side views of an alternative embodiment of the invention in prelock and closed positions, respectively.  
         [0032]      FIG. 13  shows a flow diagram of a method of filling and sealing a container of the invention. 
     
    
     DETAILED DESCRIPTION  
       [0033]     Referring to  FIG. 2 , a first illustrative embodiment of the present invention is shown. Container  200  comprises cap  210  and body  240 . Each of cap  210  and body  240  includes an open end  212  and  242 , respectively. Open end  212 ,  242  may be of any number of cross-sectional shapes, including, for example, circular, ovoid, hexagonal, or square. In one preferred embodiment, each open end  212 ,  242  is circular in cross-section. Open end  242  is of a slightly smaller diameter than open end  212 , such that body  240  may be at least partially inserted into cap  210 . Optionally, open end  242  may include an inward taper  243  to facilitate insertion of body  240  into cap  210 , although such a feature is not essential.  
         [0034]     Opposite open end  212 ,  242 , each of cap  210  and body  240  includes a closed end  214 ,  244 . While somewhat dependent upon the cross-sectional shape of the open end, a closed end may be of any number of shapes, including, for example, hemispherical or pyrimidal. The closed ends of cap  210  and body  240  may have the same or different shapes. In one preferred embodiment, each closed end is hemispherical in shape.  
         [0035]     The cross-sectional shapes of cap  210  and body  240  at points between their open and closed ends may be different than the cross-sectional shapes at either their open ends or closed ends. That is, the cross-sectional shape of cap  210  and/or body  240  may change between their open ends and closed ends. However, since body  240  is ultimately to be at least partially inserted into cap  210 , no cross-sectional shape of either should impede such insertion.  
         [0036]     In order to prevent the separation of cap  210  and body  240  after capsule  200  is assembled, container  200  includes a snap fit joint  270  comprising corresponding channels  220  and  250  on cap  210  and body  240 , respectively. By “corresponding,” it is meant that channels  220 ,  250  are of compatible shape and size such that one may rest atop the other. However, channels  220 ,  250  need not be identical in shape or size. For example, channel  220  may have a V-shape while channel  250  may have a U-shape. Channels  220 ,  250  are each preferably continuous along a circumference of cap  210  and body  240 , respectively, although one or both may also be discontinuous or segmented. Snap fit joint  270  preferably includes a radially-oriented interference gap  271  between cap  210  and body  240  of between about 20 μm and about 60 μm, and more preferably about 40 μm. Snap fit joint  270  preferably has a height (i.e., a length along an axis of container  200 ) of between about ⅙ and about ½, and more preferably between about ⅕ and about ⅓ the height of container  200  when fully closed. For example, for a size 2 container having a closed height of about 18 mm, a height of snap fit joint  272  would be between about 1 mm and about 5 mm, and more preferably between about 1.2 mm and about 2 mm. Other sizes may also be possible.  
         [0037]     A small amount of sealing fluid  290  may enter fluid gap  260 , resulting in the partial dissolution or disintegration of a portion of cap  210  and body  240  and then a fusing of cap  210  and body  240  upon evaporation and/or removal of sealing fluid  290 . As such, the fusing of cap  210  and body  240  provides a seal that is tamperproof or tamper evident, i.e., opening container  200  after such fusing requires destruction of the seal. Fluid gap  260  preferably has a width, i.e., between an internal surface of cap  210  and an external surface of body  240 , between about 20 μm and about 120 μm, and more preferably about  40  μm. Fluid gap  260  preferably has a height (i.e., a length along an axis of container  200 ) of between about 1/10 and about ⅓, and more preferably between about ⅛ and about 2/9 a height of container  200  when fully closed. For example, for a size 2 container  200  having a closed height of about 18 mm, fluid gap  260  preferably has a height between about 2 mm and about 5 mm, and more preferably about 3 mm and about 4 mm. Other sizes may also be possible. The volume of fluid gap  260  is smaller than analogous features of known devices. This smaller volume results in less sealing fluid  290  between cap  210  and body  240  and therefore less deformation of either cap  210  or body  240  following the sealing of container  200 . Fluid gap  260  is preferably substantially uniform in width, i.e., cap  210  is preferably equally spaced from body  240  along a length of fluid gap  260 . The uniformity of fluid gap  260  thus results in less sealing fluid  290  at the open end  212  of cap  210 , as compared to the conical-shaped gaps of known devices, wherein the gap is greater nearer open end  112  ( FIG. 1 ) of cap  110  ( FIG. 1 ).  
         [0038]     In order to prevent excess sealing fluid  290  from entering far into fluid gap  260  between cap  210  and body  240  and weakening one or both of cap  210  and body  240 , container  200  may optionally further include a fluid stop joint  272  comprising corresponding channels  222  and  252  on cap  210  and body  240 , respectively. Channels  222 ,  252  are each preferably continuous along a circumference of cap  210  and body  240 , respectively, although one or both may also be discontinuous or segmented. Fluid stop joint  272  preferably includes a gap  273  between cap  210  and body  240  of between about −20 μm and about +10 μm, and more preferably about 0 μm. Fluid stop joint  272  preferably has a height (i.e., a length along an axis of container  200 ) of between about 1/9 and about 1/9, more preferably between about 1/26 and about 1/20, and most preferably about 1/21 a height of container  200  when fully closed. For example, for a size 2 container  200  having a height of about 18 mm when fully closed, fluid stop joint  272  would have a height between about 0.2 mm and about 3.5 mm, more preferably between about 0.7 mm and about 0.9 mm, and most preferably about 0.86 mm. Other sizes may also be possible.  
         [0039]     In a particularly preferred embodiment, container  200  includes both snap fit joint  270  and fluid stop joint  272 . Such an arrangement uncouples the stress and brittleness (due to locally low LOD) defects of known devices. That is, rather than stress and brittleness affecting the same portion of container  200 , a container  200  of this embodiment that includes both a snap fit joint  270  and a fluid stop joint  272  restricts stresses to snap fit joint  270  and eliminates or reduces brittleness by restricting sealing fluid  290  (and therefore alcohol vapors) to fluid gap  260 . In addition, with such an arrangement, fluid stop joint  272  inhibits or stops the capillary action of sealing fluid  290 , resulting in less sealing fluid  290  between cap  210  and body  240  and faster, more efficient drying of container  200 .  
         [0040]     Container  200  may optionally further include one or more pressure release channels  280  on body  240  for allowing the escape of gas within container  200  upon the insertion of body  240  into cap  210 . In one embodiment, pressure release channel  280  comprises a depression within a surface of body  240 . Pressure release channel  280  may have any number of cross-sectional shapes, including, for example, ovoid and circular. In one embodiment, pressure release channel  280  is preferably ovoid in cross-section. Preferably, pressure release channel  280  is located substantially within the area of snap fit joint  270  and is not located within fluid stop joint  272 . Such an arrangement provides a particular advantage over known capsules when used in conjunction with snap fit joint  270  and fluid stop joint  272 . In known devices, pressure release channels permit gas to escape from a capsule during the drying process, wherein the capsule is heated. The escape of gas during this step causes the formation of gas channels within the sealing area, which compromise the integrity of the seal, permitting the leaking of capsule contents and/or failure of the seal. By restricting pressure release channel  280  to the area of snap fit joint  270  and including fluid stop joint  272 , gas is allowed to escape from within container  200  as it is closed but is prevented from escaping by fluid stop joint  272  once container  200  is fully closed. As such, gas does not escape from container  200  during the drying process and gas channels (not shown) do not form in the sealing area. The result is an uninterrupted seal providing increased strength and integrity.  
         [0041]     In addition, it has been found that deformation of body  240  and/or cap  210  may be prevented or reduced by utilizing a body  240  and/or cap  210  of increased thickness. Known containers typically include caps and bodies having wall thicknesses of approximately 100 μm. Utilizing a cap and/or body having a wall thickness of approximately 130 μm has been shown to significantly decrease container deformation.  
         [0042]     FIGS.  3 A-D show cross-sectional views of various alternative embodiments of the invention having different cross-sectional shapes. The shapes of both cap  210  and body  240  are circular in  FIG. 3A , ovoid in  FIG. 3B , hexagonal in  FIG. 3C , and square in  FIG. 3D . It should be noted, of course, that cap  210  and body  240  may have different cross-sectional-shapes, provided that the different shapes do not impede the insertion of body  240  into cap  210 .  
         [0043]     Referring now to  FIG. 4 , an alternative embodiment of the present invention is shown, wherein container  200  further includes an additional channel  254  on body  240 . Additional channel  254  may have dimensions similar to those of channels  220 ,  250  or channels  222 ,  252  and is preferably located adjacent open end  212  of cap  210 . Such location of additional channel  254  results in an entry gap  262  between body  240  and open end  212  of cap  210 . Entry gap  262  preferably has a width (i.e., a space between body  240  and cap  210 ) between about 90 μm and about 200 μm, more preferably between about 110 μm and 150 μm, and most preferably about 140 μm. The inclusion of additional channel  254  provides at least three advantages. First, entry gap  262  improves the capillary action of sealing fluid  290 , drawing sealing fluid  290  into fluid gap  260 . Second, entry gap  262  enables better removal of excess sealing fluid  290 , particularly when suction is used. Third, upon heating container  200 , sealing fluid  290  is forced out of fluid gap  260  and retained within entry gap  262  rather than forming a droplet along an edge of open end  212 , as is common with known devices. The formation of such a droplet contributes to capsule deformation in known devices.  
         [0044]      FIG. 5  shows yet another alternative embodiment of a container  200  of the present invention, wherein open end  242  of body  240  is elongated such that open end  242  contacts an inner surface of cap  210  upon complete insertion of body  240  into cap  210 . Open end  242  may still include inward taper  243 . Elongated open end  242  provides a number of advantages over known designs. First, the formation of gas channels in sealing fluid  290 , caused by the escape of gas from inside container  200  upon heating, is reduced or prevented. Second, internal pressure is substantially reduced following closing of container  200 .  
         [0045]     Referring now to FIGS.  6 A-B, two additional alternative embodiments of a container  200  of the present invention are shown in partial cross-section. In  FIG. 6A , a pillar  216  has been included on an inner surface  211  of cap  210  near open end  212 . Such pillars  216  are preferably not-continuous along inner surface  211  of cap  210 , but rather are located periodically along inner surface  211 . Such an arrangement results in “pillared areas,” as on the left side of  FIG. 6A  and capillary channels  218  as on the right side of  FIG. 6A . Pillar  216  significantly reduces a gap  261  between cap  210  and body  240  and effectively restricts fluid gap  260  to a location further from open end  212 . As noted above, fluid gap  260  preferably has a width between about 20 μm and about 120 μm, and more preferably about 40 μm. However, pillar  216  preferably changes this width to between an interference of about 30 μm and a gap of about 5 μm, and preferably to an interference of about 25 μm. The inclusion of one or more such pillars provides a number of benefits over known designs. First, pillars  216  result in less total sealing fluid  290  at open end  212 , resulting in less dissolution or disintegration and therefore less deformation at open end  212 . Second, where pillars  216  are located, little or no sealing fluid  290  is present at open end  212 . Third, pillars  216  increase the strength of cap  210 , specifically, and container  200 , generally, in an area that is typically the weakest location in known designs. Fourth, the capillary channels  218  formed between pillars  216  enhance the capillary action of sealing fluid  290 , drawing it further into fluid gap  260 .  
         [0046]     In  FIG. 6B , pillar(s)  216  is/are located further inwardly from open end  212 . Such an arrangement provides the increased strength noted above while permitting more sealing fluid  290  immediately beneath open end  212  than the embodiment in  FIG. 6A . Such an arrangement may be beneficial, for example, where a stronger seal is required at open end  212 . Pillars  216  may similarly be located elsewhere along an inner surface of cap  210  or an exterior surface of body  240  where increased strength, increased friction, and/or reduced sealing fluid are desirable, such as within fluid stop joint  272  ( FIGS. 2-4 ).  
         [0047]      FIG. 6C  shows a cross-sectional view of a particularly preferred embodiment, wherein container  200  includes a plurality of evenly-spaced pillars  216  on the inner surface  211  of cap  210 , forming a plurality of evenly-spaced capillary channels  218 . Most preferably, container  200  includes six evenly-spaced pillars  216 , as shown. Gap  261  between each pillar  216  and body  240  is significantly reduced as compared to fluid gap  260 . It should be recognized that one or more pillars  216  may similarly be located on an exterior surface  241  of body  240 .  
         [0048]     As noted above, capsules are often supplied to a filling apparatus in a prelock condition in which the body part is telescoped only partially into the cap.  FIG. 7  shows an embodiment of the present invention in such a prelock condition. Specifically, body  240  is telescopically inserted into cap  210  to the point at which channel  250  of body  240 , which corresponds to channel  220  of cap  210  when container  200  is fully closed, contacts channel  222  of cap  210 . That is, when inserted to the prelock position, the channel of body  240  that ultimately makes up part of snap fit joint  270  is instead inserted only as far as channel  222 , the cap  210  component of fluid stop joint  272 . Other prelock positions are possible, of course. For example, body  240  may be inserted into cap  210  such that channel  222  of cap  210  contacts an exterior surface (rather than channel  250 ) of body  240 .  
         [0049]     In such an embodiment, i.e., one that includes both a snap fit joint  270  and a fluid stop joint  272 , the force necessary to disassociate cap  210  and body  240  from the prelock position may be reduced compared to known devices. This decrease in required force is attributable, in part, to the uncoupling of the stress and fluid stop functions noted above. In other words, while known devices typically utilize a single joint to both secure the cap and body and limit the egress of a sealing fluid, those functions are separate in an embodiment of the present invention having both a snap fit joint  270  and a fluid stop joint  272 . As a result, the dimensions of channels making up snap fit joint  270  and fluid stop joint  272  (i.e.,  220 ,  250  and  222 ,  252 , respectively) may be adjusted such that an interaction of channels  222  and  250 , as shown in  FIG. 7 , is a more loose connection than that resulting from the interaction of channels  220  and  250  and/or channels  222  and  252 , as shown in  FIGS. 2-4 . The result, in a particularly preferred embodiment, is a container  200  with a lower prelock strength, as compared to known devices.  
         [0050]     Prelock strength may similarly be lowered using any of a number of cap and body arrangements according to the invention. For example, FIGS.  8 A-B show cross-sectional side views of a capsule  300  according to an alternative embodiment of the invention in a prelock and closed configuration, respectively. In FIGS.  8 A-B, body  340  is shown having three channels: first channel  350 , second channel  352 , and third channel  354 , similar to the arrangement shown in  FIGS. 4-5 . However, first channel  350  is both higher and shallower than shown in  FIGS. 4-5 . Cap  310  includes a first channel  320  and second channel  322 . As shown in FIGS.  8 A-B, first channel  320  of cap  310  is substantially triangular in cross-section, although this is not essential.  
         [0051]     The increased height and decreased depth of first channel  350  of body  340  results in a looser connection between first channel  350  of body  340  and second channel  322  of cap  310  when in a prelock position, such as that shown in  FIG. 8A . More specifically, an interference between body  340  and second channel  322  of cap  310  is between about −20 μm and about 50 μm, preferably between about −10 μm and 30 μm, and most preferably about 19 μm. Accordingly, a force required to remove cap  310  from body  340 , when in a prelock position such as that shown in  FIG. 8A , is preferably between about 5 grams and about 55 grams, preferably between about 5 grams and about 40 grams, and most preferably between about 10 grams and about 30 grams (as an average from a measurement of 10 parts).  
         [0052]     In  FIG. 8B , capsule  300  is shown in a closed position, wherein first channel  320  of cap  310  and first channel  350  of body  340  form a snap fit joint  370  and second channel  322  of cap  310  and second channel  352  of body  340  form a fluid stop joint  372 . As in other embodiments described above, snap fit joint  370  includes an interference between cap  310  and body  340  of between about −20 μm and about 60 μm, and more preferably about 40 μm.  
         [0053]     FIGS.  9 A-B show cross-sectional side views of a capsule  400  according to another alternative embodiment of the invention. Here, body  440  contains only two channels  452 ,  454 . As compared to the embodiment in FIGS.  8 A-B, the first channel  350  (FIGS.  8 A-B) has been removed. As such, in the prelock position of  FIG. 9A , second channel  422  of cap  410  rests not within a channel, as in the embodiments described above, but adjacent a portion of body  440  between channel  452  and the inner taper  443  of the open end of body  440 . As can be seen in  FIG. 9A , open ends of cap  410  and/or body  440  may be deflected due to frictional contact in the prelock position. The degree of such deflection will depend, in part, upon the rigidities of cap  410  and body  440  and the degree of frictional contact therebetween.  
         [0054]     In a prelock position, an interference between second channel  422  of cap  410  and body  440  is between about 5 μm and about 80 μm, preferably between about 0 μm and 30 μm, and most preferably about 19 μm. Accordingly, a force required to remove cap  410  from body  440 , when in a prelock position such as that shown in  FIG. 9A , is preferably between about 5 grams and about 55 grams, preferably between about 5 grams and about 40 grams, and most preferably between about 10 grams and about 30 grams (as an average from a measurement of  10  parts).  
         [0055]     In a closed position, as shown in  FIG. 9B , second channel  422  of cap  410  rests within channel  452  of body  440 , forming fluid stop joint  472 , as in the embodiments described above. However, unlike the embodiments above, snap fit joint  470  is formed by channel  420  of cap  410  deflecting and being deflected by a portion of body  440  between first channel  452  and inward taper  443 . The degree of such deflection will depend, in part, upon the rigidities of cap  410  and body  440  and the amount of frictional contact therebetween. However, in general, less force is required to remove cap  410  from body  440  in the closed position of  FIG. 9B  than in the embodiments described above. Snap fit joint  470  includes an interference between cap  410  and body  440  of between about −20 μm and about 80 μm, and more preferably about 40 μm.  
         [0056]     Referring now to FIGS.  10 A-B, cross-sectional side views of yet another alternative embodiment of a capsule  500  according to the invention are shown. As in the embodiment shown in FIGS.  8 A-B, body  540  includes three channels: first channel  550 , second channel  552 , and thrid channel  554 . However, second channel  552  of body  540  is both higher and shallower than first channel  550  of body  540 . Similarly, second channel  522  of cap is both higher and shallower than first channel  520  of cap  510  and, more importantly, is both higher and shallower than first channel  550  of body  540 . As a result, in the prelock position shown in  FIG. 10A , second channel  522  of cap  510  does not rest within first channel  550  of body  540 . This results in a looser connection between cap  510  and body  540  in a prelock position. More particularly, in a prelock position, there is an interference between second channel  522  of cap  510  and body  540  of between about 5 μm and about 80 μm, preferably between about 0 μm and 30 μm, and most preferably about 19 μm Accordingly, a force required to remove cap  510  from body  540 , when in a prelock position such as that shown in  FIG. 10A , is preferably between about 5 grams and about 55 grams, preferably between about 5 grams and about 40 grams, and most preferably between about 10 grams and about 30 grams (as an average from a measurement of 10 parts).  
         [0057]      FIG. 10B  shows capsule  500  in a closed position. As noted above, first channel  520  of cap  510  and first channel  550  of body  540  are similar in shape, as are second channel  522  of cap  510  and second channel  552  of body  540 . Thus, snap fit joint  570  and fluid stop joint  572  are formed as in the embodiments of  FIGS. 2, 4 ,  5 ,  7 , and  8 A-B, with correspondingly-shaped channels in the cap and body and unlike the embodiment of FIGS.  9 A-B. As a consequence, the force required to remove cap  510  from body  540  in the closed position of  FIG. 10B  is higher than in the embodiment of  FIG. 9B .  
         [0058]     FIGS.  11 A-B show cross-sectional side views of yet another alternative embodiment of a capsule  600  according to the invention. Body  640  includes two channels: first channel  650  and second channel  652 . However, unlike other embodiments described above, second channel  652  includes a first portion  652 A having a first depth and a second portion  652 B having a second depth less than the first depth. First portion  652 A is located closer to an open end of body  640  than is second portion  652 B.  
         [0059]      FIG. 11A  shows capsule  600  in a prelock position, wherein second channel  622  of cap  610  rests within first channel  650  of body  640 .  FIG. 11B  shows capsule  600  in a closed position, wherein first channel  620  of cap  610  rests within first channel  650  of body  640 , forming snap fit ring  670 , and second channel  622  of cap  610  rests within second channel  652  of body  640 , forming fluid stop ring  672 . More specifically, second channel  622  of cap  610  rests within first portion  652 A of second channel  652  of body  640 . In such an arrangement, second portion  652 B provides a void beneath an open end of cap  610 , into which a quantity of sealing fluid (not shown) may be contained. Capsule  600  is, therefore, particularly advantageous in ensuring adequate sealing of capsule  600  using a sealing fluid.  
         [0060]     In known capsules, variations in cross-sectional shape and/or thicknesses of the cap and/or body walls can result in the cap and body touching at areas adjacent an open end of the cap, thereby prevening the entry of sealing fluid beneath the cap and providing a thorough seal. By including second portion  652 B, an adequate seal is ensured by the provision of a void beneath an open end of cap  610  into which the sealing fluid may enter.  
         [0061]     It should be recognized that the arrangement of first and second channels on one or both of a cap and body may be applied to any number of capsule arrangements. For example, U.S. Pat. No. 4,893,721 to Bodenmann et al., which is hereby incorporated by reference, describes a tamperproof capsule having a cap and a body of approximately the same length, the diameter of each being substantially less than its length.  
         [0062]     FIGS.  12 A-B show a capsule  700  according to such an embodiment. In  FIG. 12A , cap  710  and body  740  are shown in a prelock position. Cap  710  has a length L 1  approximately equal to a length L 2  of body  740 . Similarly, each of L 1  and L 2  is greater than the diameters of cap  710 , D 1 , and body  740 , D 2 . As described above, D 2  is necessarily equal to or slightly less than D 1 . In  FIG. 12B , cap  710  and body  740  of capsule  700  are shown in a closed position, wherein the similarities in length of L 1  and L 2  are more clearly observable.  
         [0063]     In any of the embodiments of the invention, the cap and body may be comprised of any number of materials known in the art including, for example, gelatin, hydroxypropylmethylcellulose, polyvinyl alcohol, hydroxypropyl starch, and pullulan. Pullulan is a particularly preferred material. The cap and body may each be comprised of more than one material and may each be of different materials or combinations of materials.  
         [0064]     As noted above, the cap and the body may be further sealed using a sealing fluid  290  ( FIGS. 2-5B ) capable of at least partially dissolving and/or disintegrating a portion of the cap and/or body. Preferably, such dissolving and/or disintegrating occurs in an area between the cap and body, most preferably in an area adjacent an open end  212  ( FIG. 2 ) of the cap. Any sealing fluid known in the art may be used, based upon the composition of the cap and body. Where the cap and/or body includes pullulan, a preferred sealing fluid contains at least one of water and an alcohol. A particularly preferred sealing fluid contains water and ethanol. As described below with respect to  FIG. 13 , excess sealing fluid may be removed by evaporation or suction.  
         [0065]     Referring now to  FIG. 13 , a flow diagram is shown of a method of filling and sealing a container of the present invention. At step S 1 , a container according to one embodiment of the present invention is provided in a prelock position, such as that shown in  FIGS. 7, 8A ,  9 A,  10 A,  11 A, and  12 A. The container may be of any number of shapes and configurations, including those of the embodiments described above.  
         [0066]     At step S 2 , the container is opened such that cap  210  ( FIG. 7 ) and body  240  ( FIG. 7 ) are not in contact. Once opened, a substance may be added to either or both of cap  210  ( FIG. 7 ) and body  240  ( FIG. 7 ) at step  53 . The container of the present invention may be used to contain any number of substances to be delivered to an individual, including, for example, a pharmaceutical, a medicine, or a vitamin. The substance may take one or more of a number of forms, including, for example, a powder, a liquid, or a solid. Preferably, the substance is added only to body  240  ( FIG. 7 ).  
         [0067]     At step S 4 , the container is closed, whereby body  240  is inserted into cap  210 , as shown, for example, in  FIG. 2 . At step S 5 , a sealing fluid  290  ( FIG. 2 ) is applied to fluid gap  260  ( FIG. 2 ) between the body and the cap. Sealing fluid at least partially dissolves and/or disintegrates at least one of the cap and the body. At-step S 6 , excess sealing fluid is optionally removed. Such removal may be accomplished, for example, by the application of a suction force to the container. Finally, at step S 7 , the container is dried to substantially remove any remaining sealing fluid and fuse the at least partially dissolved and/or disintegrated portions of the cap and the body. The drying step may include, for example, heating the container. When heating is employed in the drying step, the container is preferably heated to between about 35° C. and about 55° C.  
         [0068]     It should be noted, of course, that a container of the present invention may be provided in an open rather than a prelock position. As such, step S 2  is unnecessary. Similarly, a container of the present invention may be provided in a closed position with a substance already contained therein. As such, steps S 2  through S 4  are unnecessary.  
         [0069]     While this invention has been described in conjunction with the specific embodiments outlined above, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the embodiments of the invention as set forth above are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention as defined in the following claims.

Technology Classification (CPC): 0