(cid:38)(cid:68)(cid:83)(cid:86)(cid:88)(cid:74)(cid:72)(cid:79)(cid:3)(cid:40)(cid:91)(cid:75)(cid:76)(cid:69)(cid:76)(cid:87)(cid:3)(cid:20)(cid:19)(cid:21)(cid:23)
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`US. Patent
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`Dec. 24, 1991
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`Sheet 1 o} 4
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`5,074,426
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`US. Patent
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`Dec. 24, 1991
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`Sheet 2 of 4
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`5,074,426
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`Page 3 of 9
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`Page 3 of 9
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`US. Patent
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`Dec. 24, 1991
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`Sheet 3 of 4
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`5,074,426
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`US. Patent
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`Dec. 24, 1991
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`Sheet 4 of 4
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`5,074,426
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`Page 5 of 9
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`1
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`DIVIDABLE CAPSULE
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`5,074,426
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`2
`manufactured with integrally molded webs between
`and connecting adjacent capsule bodies, while the cap-
`sule caps might also have such integrally molded con-
`nection elements.
`The disadvantage of this arrangement is that conven-
`tional capsule bodies and caps cannot be used. and the
`need for integrally molded interconnection elements
`considerably complicates manufacture.
`It is thus an object ofthe present invention to provide
`a dividable capsule which is easily separated by a pull or
`bending into capsule units which are of familiar and
`palatable shape.
`It is a further object of the present invention to pro—
`vide a dividable capsule which may utilize conventional
`capsule bodies or caps.
`It is still a further object ofthe inventiou to provide a
`dividable capsule which is relatively easy and straight-
`forward to manufacture and which permits the use of
`conventional capsule filling equipment.
`In accordance with the invention. the above objects
`are accomplished by providing a dividable capsule
`which is comprised of first and second capsule‘units.
`each of which is cylindrical about an axis along the
`major part of its length. and wherein the capsule units
`are detachably joined to each other in such manner that
`the longitudinal axes of the respective capsule units are
`approximately co-linear. As used herein, the term “cy-
`lindrical“ encompasses tubular shapes having circular
`cross-sections as well as more oval cross-sections such
`as elliptical cylinders.
`While a cylindrical shape is preferred. capsules of
`other shapes are contemplated. Thus. those having oc-
`tagonal, hexagonal. square. or other geometrical cross
`sections are operable. Capsule shapes which resemble
`tablets (i.e.. which are not significantly elongated] can
`be made.
`The capsule units are detachably joined to each other
`by various expedients including connection by adhe-
`sive. an annular band. and locking mechanical means.
`The invention will be better appreciated by referring
`to the accompanying drawings in which:
`FIGS. 1—4 are illustrations of a dividable capsule in
`accordance with several embodiments of the invention.
`FIGS. 5-? illustrate a method ofmaking the dividable
`capsules of the invention.
`FIG..8 relates to a method ofmalting the embodiment
`of FIG. 3.
`FIG. 9 illustrates the assembly of a dividable capsule
`in accordance with a further embodiment of the inven-
`tton.
`
`FIG. 10 illustrates the dividable capsule shown in
`FIG. 9 as assembled.
`FIG. 1! shows the assembly ofa dividable capsule in
`accordance with still a further embodiment of the in-
`vention.
`FIG. 12 shows the dividable capsule of FIG. I] as
`assembled.
`FIG. 13 shows the assembly of a dividable capsule in
`accordance with still a further embodiment of the in-
`ventiort.
`FIG. 14 shows the embodiment of FIG. 13 as assem-
`bled.
`FIG. 15 shows the assembly ofa dividable capsule in
`accordance with still a further embodiment of the in-
`vention.
`FIG. 16 shows the dividable capsule of FIG. 15 as
`assembled.
`
`This application is a continuation~in~part of Ser. No.
`CDT/300.23. filed Jan. 29, I989. now abandoned. which
`was a continuation of Ser. No. 06/930,601. filed Nov.
`13, 1986. now abandoned.
`The present invention is directed to capsules which
`are dividable by the user into accurate individual dos-
`age units.
`It is desirable for a patient to be able to administer
`medicine to him or herself in varying dosages. Thus. a
`patient may begin medication in larger dosages, and
`then proceed to smaller dosages. or vice versa. as treat-
`ment progresses. Also. different dosages may be desir-
`able for different individuals. Some drugs require moni~
`toring of drug blood level until the patient is stabilized
`and dividable dosage forms provide a non-c0mplicated
`procedure for achieving this.
`In the case of tablets, the need for variable dose ad-
`ministration is easily met, since tablets are breakable
`into smaller units and sometimes may be scored to facili-
`tate breaking into accurate dosage units.
`In the case ofa capsule however, breaking or division
`is not ordinarily possible without destroying the integ-
`rity of the capsule and losing some or all of the contents.
`While providing capsules in varying sizes is possible.
`it may not be feasible to predict in advance how many
`capsules in which sizes are necessary for a given patient.
`In addition, production of capsules in varying sizes
`complicates the manufacturing process and adds to the
`patients cost in the event the dosage must be changed.
`Additionally, dividable capsules are desirable since
`they may be used to separate drugs which are interac-
`tive. for example. propoxyphene in its hydrochloride or
`other suitable salt form and aSpirin or sodium me~
`clofenamate and codeine sulfate. Further, they may be
`arranged so as to formulate a portion of the capsule to
`be slow releasing while the other portion furnishes drug
`in a readily available fast-dissolving form, or to include
`two or three sections all having modified release prop-
`erties which will afford optimal drug blood levels or by
`attaching a separate section which has enteric proper-
`ties.
`
`While dividable capsules are known in the prior art, it
`is believed that the capsules provided by the present
`invention afford advantages not heretofore realized.
`European Patent Publication No. 0 141 397 discloses
`a dividable capsule which when undivided is in the
`shape of a conventional capsule. The capsule is divid-
`able along a plane running along the entire length of the
`capsule and bisectin g it by twisting the two "half cap-
`sule“ parts away from each other. The result is two
`capsule units. each of which has a cross—section in the
`shape of a semi-circle and a flat. planar surface which
`previously had been connected to the flat, planar sur-
`face of the other capsule unit.
`the
`The disadvantage of this configuration is that
`unfamiliar shape of the "half-capsule", which includes a
`flat surface. may be unpalatable for the patient to swal-
`low. Additionally, due to the unusual shape of each
`capsule unit. it is not possible to use conventional cap-
`sule filling equipment to fill the capsule units with medi-
`cine.
`
`United Kingdom Published Patent App]. No.
`2.148.84IA discloses dividable capsules which are
`formed with integrally molded connection elements.
`For example. a number of capsule bodies would be
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`10
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`FIG. 17 shows the assembly of a dividable capsule
`which is comprised of three units.
`FIG. 18 shows the dividable capsule of FIG. 17 as
`assembled.
`FIG. 19 shows the assembly of a dividable capsule
`wherein the units are of different diameters.
`FIG. 20 shows the capsule of FIG. 19 as assembled.
`FIGS. 21—23 show the assembly ofthe body portions
`of two units with further locking embodiments of the
`invention.
`
`FIG. 24 shows the assembly of the body portions of
`two units with a further locking embodiment of the
`invention.
`
`FIGS. 25 and 26 show the assembly of the body por-
`tions of two units with still another locking embodiment
`of the invention.
`Referring to FIG. I, dividable capsule 2 is shown. It
`is comprised of capsule units 4 and 6, each of which is
`filled with a desired medicinal preparation 8.
`The overall shape of capsule 2 is similar to that ofa
`conventional capsule. That is. each of the capsule units
`4 and 6 is comprised of a shell which is cylindrical about
`an axis over the major portion of its length and rounded
`at one end.
`In addition to the conventional capsule, the one end
`of the capsule units may also be rectangular or squared
`if desired.
`The capsule units are juxtaposed longitudinally so
`that the cylindrical axes of the respective capsule units
`are approximately co-Iinear and are detachably secured
`to each other in this configuration.
`The capsule units are secured by an adhesive and/or
`an annular band. In the embodiment of FIG. 1. band 10
`is provided which is a thin plastic band of the type
`sometimes used to secure the bodies and caps of con-
`ventional capsules together. The band is perforated at
`13 to permit easy Separation of the capsule units from
`each other.
`In the embodiment of FIG. 2. the band is an annular
`sleeve 12 having constrictive segments 14 to provide a
`friction ftt. For example, the constrictive segments may
`be dimples or other raised areas.
`The capsules depicted in FIGS. 1 and 2 may be taken
`as shown to provide a full dose or may be separated
`from each other by the user to provide a couvenient half
`dose.
`It should be noted that while the capsules shown in
`the illustrative embodiments are bisectable capsules
`which prOVide accurate half doses. if desired. the cap-
`sales may be dividable in some other proportion. for
`example, one-third to two-thirds. Conceivably, the cap-
`sule could be a series of segments held together as
`shown and used for dose titration purposes.
`A method of making the dividable capsules is shown
`in FIGS. 5-7. Referring to FIG. 5. capsule units 4 and 6
`are shown. These may be the caps of conventional cap-
`sules. typically comprised of a capsule body and capsule
`cap, and are frequently made ofhard gelatin. but may be
`made of other suitable material. Instead of the capsule
`caps. capsule bodies may be used, and as these are
`longer. it may be desirable to cut them. for example, to
`two-thirds length.
`Referring to FIG. 6. the capsule units are filled with
`a desired medicinal preparation. This. for example, may
`be in the form of pellets. granules. or viscous or liquid
`substance. Additionally.
`the filling step may be per~
`formed with the automatic filling machines customarily
`used to fill conventional capsules.
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`4
`The capsule units would be filled to within a small
`distance of the top. for example about one-sixteenth of
`an inch, and as shown in FIG. 7. a thin layer 9 of adhe-
`sive paste would be applied to the top to seal in the
`medicinal preparation.
`The capsule units would then be turned inwardly
`towards each other with the adhesive paste layers abut-
`ting each other, and adhesive paste would be applied to
`the inside and outside of the joint area, after which the
`joint would be air dried.
`After this. a band or sleeve as shown in FIG S. l and
`2 would be added.
`The adhesive paste used as described above. by way
`of illustration, could be a polymer solution as follows:
`
`HPMC Bill
`PEG 3350
`Aicoho], Denatured
`Water
`
`[1% win-
`2.4% wru-
`15.497:
`10.19? tar/w
`
`Further embodiments of the dividable capsule of the
`invention are shown in FIGS. 3 and 4. In these embodi-
`ments, the capsule units are as shown in FIG. 8. and
`each comprises a body portion and a cap. wherein the
`cap has a flat surface and is fitted to snugly fit over the
`body portion.
`The caps are bonded to each other with adhesive
`paste 30 as shown in FIG. 3 or by it separately molded
`section which is sealed to the capsule section by means
`of solvent welding.
`In the embodiment shown in FIG. 4, a band 31 having
`constrictive segments 32 is also added. It is possible that
`in this embodiment one may diSpense with the adhesive
`paste.
`FIGS. 9-16 illustrate further embodiments of the
`invention wherein locking mechanical means is used to
`join the two capsule units.
`Referring to FIG. 9. capsule units 40 and 44 are
`shown filled with medicinal preparation 46. Capsule
`unit 40 is enclosed by cap 42 while capsule unit 44 is
`closed by adhesive layer 48 or by a friction fit with or
`without use ofa solvent seal.
`Intermediate molded locking part 50 is used to secure
`the two capsule units together. Locking part 50 has
`open cylindrical receptacle 53 and annular groove 55.
`Cap 42 of capsule unit 40 is held snugly in annular
`groove 55. The molded piece may be made ofthe same
`material as the capsule units and the dividable capsule as
`assembled is shown in FIG. 10.
`Referring to the embodiment of FIG. 11. capsule unit
`51 is closed by cap 52 and intermediate molded piece 56
`serves both as a closure for capsule unit 54 and as a
`connecting means to secure the two capsule units to-
`gether.
`Molded piece 56 has open cylindrical receptacles 57
`and 59, which are separated by flat surface 61. Recepta-
`cle 57 is sized so as to snugly receive cap 52 of capsule
`unit 51 while receptacle 59 is sized so as to receive
`capsule unit 54 in such manner that flat surface 6] acts
`as a closure for the medicinal preparation in capsule unit
`54.
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`10
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`ES
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`the receptacles 57 and 59 may have
`Additionally,
`fricrion fit features such as dimples to enhance the tight-
`ness with which the capsule units are held together. The
`assembled capsule units are shown in FIG. 12.
`A further embodiment to the inventiOn is shown in
`FIG. 13 wherein cylindrical capsule unit parts 60 and 64
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`are shown. Each of these capsule unit parts is filled with
`a desired medicinal preparation, and the capsule unit
`parts are sealed with rounded or flat caps 62 and 66
`respectively. The other end of capsule unit 60 is pro-
`vided with a female member 68 which may for example
`be cylindrical receptacle. while capsule unit 64 is pro—
`vided with a male member '79. which for example may
`be a cylindrical projection resembling a spike. The male
`and female members are sized so as to provide a tight
`friction fit. which may be enhanced by the provision of 10
`additional locking means such as one or more dimples
`on one of the members and a corresponding number of
`detents on the other of the members. Capsule unit parts
`60 and 64 may be made of hard gelatin or other known
`material used for capsule bodies. The assembled divid-
`able capsule is shown at FIG. 14.
`FIGS. 15 and 16 illustrate a dividable capsule which
`is similar to that shown in FIGS. 13 and 14. except that
`the locking receptacle and projection are larger in di-
`ameter.
`
`15
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`20
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`FIG. 13' illustrates a dividable capsule which is com-
`prised of three units instead of two. The units are body
`mil/cap 107, body 102/cap 108. and body 101/cap 110.
`As shown. cap 110 has a cylindrical receptacle 106
`therein. and the units are detachably joined to each
`other by cylindrical projections 103 and 104, which fit
`into receptacles 105 and 106. Alternatively. center cap-
`sule unit 101/110 could have a receptacle at each end
`for receiving projections associated with the end cap-
`sule units or could have a projection at each end for
`insertion into receptacles which would be associated
`with the end units. In FIG. 18, the capsule shown in
`FIG. 17 is depicted in assembled form.
`The embodiment illustrated in FIGS. 19 and 20 is
`
`similar to the embodiment of FIGS. 15 and 16, except
`that one ofthe capsule units is of greater diameter than
`the other.
`'
`The embodiments shown in FIGS. 21-23 comprise
`any dividable capsule described above with the body
`portion of the units to be joined together designed to
`improve centration. These conical
`shaped locking
`means. a male and corresponding female member. seat
`together to allow tolerance in the machinery of the
`individual units. Thus even ifthe machinery ofthe units
`cause irregular alignments. the units will still seat
`to-
`gether in an easier manner.
`The locking embodiment shown in FIG. 24 also
`shows the body portion of two units to be assembled.
`This design not only improves centration as described
`for FIGS. 21-23 but also improves the facility of pulling
`apart both units when used by the patient.
`FIGS. 25 and 26 also show further improvements on
`the locking means of the body portions of the capsule
`units in FIGS. 21-23 by adding nubs. slots or rings.
`The embodiments shown in FIGS. 13 to 26 may be
`particularly advantageous in that the dividable capsule
`can be easily separated by a pulling, bending or twisting
`motion without the necessity of breaking or tearing a
`part of the capsule. This relatively easy method of sepa-
`ration is congruent with more practical and trouble-free
`manufacture.
`Thus. there has been described a dividable capsule
`and illustrative embodiments thereof in accordance
`with the invention. While the description has been in
`connection with such illustrative embodiments,
`it
`should be appreciated that variations will occur to those
`skilled in the art and that it is intended that the scope of
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`the invention be limited only by the claims appended
`hereto and equivalents.
`We claim:
`1. A capsule which is dividable by the user into accu~
`rate individual dosage units for administering a medi-
`cine or medicines to the user in varying dosages, com-
`prising first and second capsule units. each for holding a
`desired medicinal preparation. each of said first and
`second capsule units being of cylindrical shape at least
`along most of its length, the cylindrical shaped portion
`of' each capsule unit having a longitudinal axis, and said
`first and second capsule units having first and second
`ends, wherein the first ends are rounded and the second
`end of each said capsule unit is sealed by a closure and
`wherein said closures of said respective capsule units
`abut each other and are detachably joined to each other
`in such manner that the perimeters of each capsule unit
`abut each other and their respective longitudinal axes
`are approximately colinear when the units are joined.
`2. The dividable capsule of claim 1 wherein said clo-
`sures are joined together by adhesive.
`3. The dividable capsule of claim 1 wherein said clo-
`sures are joined together by an annular band.
`4. The dividable capsule of claim 1 wherein said clo-
`sures are detachably joined together by locking me-
`chanical means.
`5. The dividable capsule of claim 2 where. in addition
`to said adhesive. said closures are joined together by an
`annular band.
`6. The dividable capsule of claim 2 wherein said clo-
`sures comprise adhesive layers.
`’7. The dividable capsule of claim 2 wherein said clo-
`sures comprise caps.
`8. The dividable capsule of claim 3 wherein said clo-
`sures comprise adhesive layers.
`9. The dividable capsule of claim 3 wherein said clo-
`sures comprise caps.
`10. The dividable capsule of claim 3 wherein said
`annular band has constrictive regions.
`11. The dividable capsule of claim 3 wherein said
`annular band has perforations.
`12. The dividable capsule of claim 4 wherein the
`second end of one of said capsule units is closed by a cap
`and wherein said locking mechanical means includes a
`hollow cylindrical member open at one end into which
`said cap fits.
`13. The dividable capsule of claim 12 wherein the
`second end of the other of said capsule units is closed by
`an adhesive layer.
`14. The dividable capsule of claim 12 wherein the
`second end of the other of said capsule units is closed by
`a closure which is a plane member which is integrally
`formed With said hollow cylindrical member.
`15. A capsule which is dividable by the user into
`accurate individual dosage units for administering a
`medicine or medicines to the user in varying dosages.
`comprising first and second capsule units. each for hold-
`ing a desired medicinal preparation, each of said first
`and second capsule units being of cylindrical shape at
`least along most of its length. the cylindrical shaped
`portion of each capsule unit having a longitudinal axis.
`and said first and second capsule units having first and
`second ends. wherein the first ends are rounded and the
`second end of each said capsule unit is sealed by a clo-
`sure and wherein said closures of said respective cap-
`sule units abut each other and are detachably joined
`together by locking mechanical means, which comprise
`interlocking male and female member, and said male
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`member including a conically shaped projection and
`satd female member including a conically shaped recep-
`tacle for locking said members together. and wherein
`the perimeters of each capsule unit abut each other and
`their respective longitudinal axes are approximately
`colinear when the units are joined.
`16. The dividable capsule of claim 15 having up to
`
`three projections and receptacles on the male and fe-
`male members.
`17. The dividable capsule of claim 15 wherein the
`5 comically shaped projection and receptacle contain
`thereon nubs, 51018 Dr rings-
`'
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`lo
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