AU603614B2

AU603614B2 - Dividable capsule

Info

Publication number: AU603614B2
Application number: AU80505/87A
Authority: AU
Inventors: Frank William Goodhart; Chaur-Ming Jan
Original assignee: Warner Lambert Co LLC
Current assignee: Warner Lambert Co LLC
Priority date: 1986-11-13
Filing date: 1987-10-29
Publication date: 1990-11-22
Anticipated expiration: 2007-10-29
Also published as: ES2023943B3; JPS63135174A; BR8706068A; DE3772023D1; AU8050587A; EP0274345B1; ATE65907T1; EP0274345A1; KR880005915A; GR3002447T3

Abstract

A capsule (20) which is dividable into accurate individual dosage units by the user is comprised of at least first and second capsule units (24, 22), each being cylindrical about a longitudinal axis along the major part of its length. The capsule units are detachably joined in such manner that the longitudinal axes of the two capsule units are approximately co-linear. The capsule units may be detachably joined by adhesive, banding, or locking mechanical means, and the capsule may be comprised of two or more units.

Description

COMMONWEALTH OF AUSTRALIA FORM PATENTS ACT 1952 'OR 1 S SPEC I F I CATION FOR OFFICE USE:

COMPLETE

Class Int.Class Application Number: Lodged: Complete Specification Lodged: Tsdocument ai Accepted: i m e nner Published: amendentsnder P b s e Section 49 and is correct for 4printing.

Priority: 'Related Art: SName of Applicant: WARNER-LAMBERT COMPANY Address of Applicant: 2800 Plymouth Road, Ann Arbor, Michigan, United States of America .:.*.Actual Inventor: Frank William Goodhart and Chaur-Ming Jan A. "ddress for Service: SHELSTON WATERS, 55 Clarence Street, Sydney Complete Specification for the Invention entitled: "DIVIDABLE CAPSULE" The following statement is a full description of this invention, including the best method of performing it known to me/us:- 1 SHELSTON WATEfRS PATENT ATTORNEYS CLARENCE STREET, SYDNEY

AUSTRALIA

Cables: 'Valid' Sydney Telex: 24422 Abstract of the Disclosure A capsule which is dividable into accurate individual dosage units by the user is comprised of first and second capsule units, each being cylindrical about a longitudinal axis along the major part of its length. The capsule units are detachably joined in such manner that the longitudinal axes of the two capsule units are approximately co-linear. The capsule units may be detachably joined by adhesive, banding, or locking mechanical means, and the capsule may be comprised of two or more units.

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0O*O 5 The present invention is directed to capsules which are dividable by the user into accurate individual dosage 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 treatment progresses. Also, different dosages may be desirable for different individuals. Some drugs require monitoring of drug blood level until the patient is stabilized and dividable dosage forms provide a non-complicated procedure for achieving this.

In the case of tablets, the need for variable dose administration is easily met, since tablets are breakable into smaller units and sometimes may be scored to facilitate breaking into accurate dosage units.

In the case of a capsule however, breaking or division is not ordinarily possible without destroying the integrity of the capsule and losing some or all of the 20 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 0 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 interactive, for example, propoxyphene in its hydrochloride or other suitable salt form and aspirin or sodium meclofenamate 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 properties which will afford optimal drug blood levels or by attaching a separate section which has enteric properties.

4 L_ 3 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 dividable along a plane running along the entire length of the capsule and bisecting it by twisting the two "half capsule" 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 has been connected to the flat, planar surface of the other capsule unit.

The disadvantage of this configuration is that the o unfamiliar shape of the "half-capsule", which includes a flat surface, may be unpalatable for the patient to swallow. Additionally, due to the unusual shape of each capsule unit, it is not possible to use conventional SOcapsule filling equipment to fill the capsule units with medicine.

United Kingdom Published Patent Appl. No. 2,148,841A discloses dividable capsules which are formed with integrally molded connection elements. For example, a number of capsule bodies would be manufactured with integrally molded webs between and connecting adjacent *.9 Scapsule bodies, whiU. the capsule caps might also have such integrally molded connection elements.

The disadvantage of this arrangement is that conventional capsule bodies and caps cannot be used, and the need for integrally molded interconnection elements considerably complicates manufacture.

It is thus an object of the present invention to substantially ameliorate at least some of the disadvantages of the prior art.

In accordance with the invention there is provided a capsule which is dividable by the user into accurate individual dosage units, comprising first and second i 4 capsule units, each capusle unit having first and second ends, each capusle unit capable of holding a desired medicinal preparation, the second end of each capusle unit sealed by a closure, each of said first and second capusule units being of substantially cylindrical shape along its length, the substanitally cylindrical shaped portion of each capusle unit having a longitudinal axis, and said first and second capsule units being detachably joined to each other in such manner that when joined said second ends face each other and said respective longitudinal axes are approximately co-linear. As used herein, the term "cylindrical" encompasses tubular shapes having circular cross-sections as well as more oval cross-sections such as elliptical cylinders.

A second aspect of the invention provides a method of making a capsule which is dividable by the user into accurate dosage units comprising the steps of: providing first and second capsule units, each being o of substantially cylindrical shape along its length, wherein the substantially cylindrical shaped portion of each capsule unit has a longitudinal axis, filling said first and second capsule units with a desired medicinal preparation, closing said first and second capsule units, and detachably joining said first and second capsule o0 units to each other in such manner that said respective longitudinal axes of said first and second capsule units are approximately co-linear with each other.

For preference the first ends of each unit are rounded.

While a cylindrical shape is preferred, capsules of other shapes are contemplated. Thus, those having octagonal, hexagonal, square, or other geometrical cross sections are operable. Capsule shapes which resemble tablets which are not significantly elongated) can be made.

4a The capsule units are detachably joined to each other by various expedients including connection by adhesive, and annular band, and locking mechanical means.

The invention will be better appreciated by referring to the accompanying drawings in which: Figures 1-4 are illustrations of a dividable capsule in accordance with several embodiments of the invention.

Figures 5-7 illustrate a method of making the dividable capsules of the invention.

Figure 8 relates to a method of making the embodiment of Figure 3.

Figure 9 illustrates the assembly of a dividable capsule in accorance with a further embodiment of the invention.

*go Figure 10 illustrates the dividable capsule shown in Figure 9 as assembled.

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59 r e~m~iin~c~is*mc~a~-auuY1~*l 5 Figure 11 shows the assembly of a dividable capsule in accordance with still a further embodiment of the invention.

Figure 12 shows the dividable capsule of Figure 11 as assembled.

Figure 13 shows the assembly of a dividable capsule in accordance with still a further embodiment of the invention.

Figure 14 shows the embodiment of Figure 13 as assembled.

Figure 15 shows the assembly of a dividable capsule in accordance with still a further embodiment of the invention.

Figure shows the dividable capsule of Figure 15 as assembled.

6* Figure 17 shows the assembly of a dividable capsule which is comprised of three units.

Figure 18 shows the dividable capsule of Figure 17 as 66 assembled.

Figure 19 shows the assembly of a dividable capsule wherein the units are of different diameters.

Figure 20 shows the capsule of Figure 19 as assembled.

Referring to Figure 1, 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.

@6 0" The overall shape of capsule 2 is similar to that of a conventional capsule. That is, each of the capsule 0 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.

66 e The capsule units are juxtaposed longitudinally so *a that the cylindrical axes of the respective capsule units are approximately co-linear 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 Figure 1, band is provided which is a thin plastic band of the type jl 6 sometimes used to secure the bodies and caps of conventional capsules together. The band is perforated at 13 to permit easy separation of the capsule units from each other.

In the embodiment of Figure 2, the band is an annular sleeve 12 having constrictive segments 14 to provide a friction fit. For example, the constrictive segments may be dimples or other raised areas.

The capsules depicted in Figures 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 convenient 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 capsules may be dividable in some other proportion, for example, S one-third to two-thirds. Conceivably, the capsule could @0.e be a series of segments held together as shown and used for dose titration purposes.

sea 00.. A method of making the dividable capsules is shown in Figures 5-7. Referring to Figure 5, capsule units 4 and 6 are shown. These may be the caps of conventional capsules, typically comprised of a capsule body and capsule cap, and are frequently made of hard gelatin, but may be made of other suitable material. Instead of the capsule caps, capsule bodies may be used, and as these are *0 longer, it may be desirable to cut them, for example, to two-thirds length.

o oo Referring to Figure 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 e liquid substance. Additionally, the filling step may be performed with the automatic filling machines customarily used to fill conventional capsules.

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 Figure 7, a thin layer 9 of adhesive paste would be applied to the top to seal in the medicinal 7 2 preparation.

The capsule units would then be turned inwardly towards each other with the adhesive paste layers abutting 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 Figures 1 and 2 would be a added.

The adhesive paste used as described above, by way of .0 illustration, could be a polymer solution as follows: HPMC E-15 12% w/w PEG 3350 2,4% w/w Alcohol, Denatured 75.4% Water 10.2% w/w Further embodiments of the dividable capsule of the invention are shown in Figures 3 and 4. In these embodiments, the capsule units are as shown in Figure 8, and each comprises a body portion and a cap, wherein the cap has a flat surface and is fitted to snugly fit over 0. the body portion.

The caps are bonded to each other with adhesive paste as shown in Figure 3 or by a separately molded section which is sealed to the capsule section by means of solvent welding.

In the embodiment shown in Figure 4, a band 31 having constrictive segments 32 is also added. It is possible that in this embodiment one may dispense with the adhesive S* paste.

Figures 9-16 illustrate further embodiments of the invention wherein locking mechanical means is used to join the two capsule units.

Referring to Figure 9, capsule units 40 and 44 are shown filled with medicinal preparation 46. Capsule unit is enclosed by cap 42 while capsule unit 44 is closed by adhesive layer 48 or by a friction fit with or without use of a solvent seal.

3 l i r. 8 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 The molded piece may be made of the same material as the capsule units and the dividable capsule as assembled is shown in Figure Referring to the embodiment of Figure 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 together.

Molded piece 56 has open cylindrical receplacles 57 and 59, which are separated by flat surface 61.

Receptacle 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 61 acts as a closure for medicinal preparation in capsule unit 54.

000 Additionally, the receptacles 57 and 59 may have 2Q friction fit features such as dimples to enhance the tightness with which the capsule units are held together.

The assembled capsule units are shown in Figure 12.

A further embodiment to the invention is shown in Figure 13 wherein cylindrical capsule unit parts 60 and 64 are shown. Each of these capsule unit parts is filled •o with a desired medicinal preparation, and the capsule unit parts are sealed with rounded or flat caps 62 and 66 o respectively. The other end of capsule unit 60 is provided with a female member 68 which may for example be 34.o. cylindrical receptacle, while capsule unit 64 is provided e with a male member 70, 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 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 9 of hard gelatin or other known material used for capsule bodies. The assembled dividable capsule is shown at Figure 14.

Figures 15 and 16 illustrate a dividable capsule which is similar to that shown in Figures 13 and 14, except that the locking receptacle and projection are larger in diamter.

Figure 17 illustrates a dividable capsule which is comprised of three units instead of two. The units are body 100/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 capsule unit 101/110 could have a receptacle at each end for

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receiving projections associated with the end capsule units or could have a projection at each end for insertion E into receptacles which would be associated with the end units. In Figure 18, the capsule shown in Figure 17 is depicted in assembled form.

The embodiment illustrated in Figures 19 and 20 is similar to the embodiment of Figures 15 and 16, except that one of the capsule units is of greater diameter that the other.

The embodiments shown in Figures 13 to 20 may be e J r Ow particularly advantageous in that the dividable capsule Scan be easily separated by a pulling or twisting motion S without the necessity of breaking or tearing a part of the capsule.

o 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 the inventi'n be limited only by the claims appended hereto and equivalents.

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Claims

1. A capsule which is dividable by the user into accurate individual dosage units, comprising first and second capsule units, each capusle unit having first and second ends, each capusle unit capable of holding a desired medicinal preparation, the second end of each capusle unit sealed by a closure, each of said first and second capusule units being of substantially cylindrical shape along its length, the substanitally cylindrical shaped portion of each capusle unit having a longitudinal axis, and said first and second capsule units being detachably joined to each other in such manner that when joined said second ends face each other and said respective longitudinal axes are approximately co-linear.

2. The dividable capsule of claim 1 wherein the first ends of said capsule units are rounded.

3. The dividable capsule of claim 1 wherein said closures are joined together by adhesive.

4. The dividable capsule of claim 1 wherein said closures are joined together by an annular band.

The dividable capsule of claim 1 wherein said capsule units are detachably joined together by locking mechanical means.

6. The dividable capsule of claim 1 wherein said closures are detachably joined together by locking mechanical means.

7. The dividable capsule of claim 3 where, in addition to said adhesive, said closures are joined together by an annular band.

8. The dividable capsule of claim 3 wherein said closures comprise adhesive layers.

9. The dividable capsule of claim 4 wherein said closures comprise adhesive layers.

The dividable capsule of claim 3 wherein said closures comprise caps.

11. The dividable capsule of claim 4 wherein said closures comprise caps. -11-

12. The dividable capsule of claim 4 wherein said annular band has constrictive regions.

13. The dividable capsule of claim 4 wherein said annular band has perforations.

14. The dividable capsule of claim 5 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.

The dividable capsule of claim 14 wherein the second end of the other of said capsule units is closed by an adhesive layer.

16. The dividable capsule of claim 14 wherein the second s. end of the other of said capsule units is closed by a oes closure which is a plane member which is integrally formed with said hollow cylindrical member. *SS S

17. The dividable capsule of claim 5 wherein said locking ge ~mechanical means comprises interlocking male and female so to members which are disposed at said respective second ends of said capsule units.

18. The dividable capsule of claim 17 wherein said male member includes a projection of said female member P.S. includes a receptacle.

19. The dividable capsule of claim 17 wherein said male and female members are arranged so as to have a friction S9*, fit when interlocked.

The dividable capsule of claim 18 wherein one of said projection and receptacle has at least a raised area while the other has a recessed area into which said raised area fits for locking said projection and receptacle together.

21. A method of making a capsule which is dividable by the user into accurate dosage units comprising the steps of: providing first and second capsule units, each being of substantially cylindrical shape along its length, wherein the substantially cylindrical shaped portion of each capsule unit has a longitudinal axis, I I 12 filling said first and second capsule units with a desired medicinal preparation, closing said first and second capsule units, and detachably joining said first and second capsule units to each other in such manner that said respective longitudinal axes of said first and second capsule units are approximately co-linear with each other.

22. A dividable capsule substantially as herein described with refrence to any one of the accompanying drawings.

23. A method for making a dividable capsule substantially as herein described with reference to any one of the accompanying drawings. DATED this 1st day of August, 1990 WARNER-LAMBERT COMPANY Attorney: PETER HEATHCOTE Fellow Institute of Patent Attorneys of Australia of SHELSTON WATERS e 9 KS., S *S Vr oj^