GB1596008A

GB1596008A - Sealed capsule

Info

Publication number: GB1596008A
Application number: GB1232278A
Authority: GB
Original assignee: Capsugel AG
Current assignee: Capsugel AG
Priority date: 1977-03-29
Filing date: 1978-03-29
Publication date: 1981-08-19
Also published as: BE865440A; CH624007A5; DE2713873A1; DE2713873C2

Abstract

The capsule consists of a cap (8) and a body (10) which are telescopically fitted together and mutually locked. A hole (18) pierced in the top of the cap makes it possible to introduce the pharmaceutical preparation (22) as far as a level lower than that of the upper edge (12) of the body. Gelatin is then introducd by means of a curved needle (26) when the capsule is set in rotation around its axis in order to form a continuous layer on the surface of the preparation, and in order to fill the entire inside of the cap, including its hole (18). The gelatin plug (34) coats the upper edge (12) of the body, and ensures perfect leaktightness of the assembly. It also improves the mechanical strength of the capsule. This capsule is used for packaging pharmaceutical preparations and other liquid products. <IMAGE>

Description

(54) A SEALED CAPSULE (71) We, CAPSUGEL AG, a corporation organized under the laws of Switzerland, of Engelgasse 11, CH-4010 Basel, Switzerland, do hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement: This invention relates to a capsule, for example a locking capsule. filled with liquid or other viscous material, in particular a pharmaceutical preparation, and having a body part and a cap part telescoped thereon.

Two basically different types of capsules for pharmaceutical preparations are commonly used: a i'hard-shell" locking capsule and a "soft-shell" capsule. Conventional hard-shell locking capsules are formed mostly of gelatine, have a body part (lower portion) and a cap part (upper portion) telescopically engaging the body part, and contain pharmaceutical preparations in solid form, such a powder or pellets. Conventional soft-shell capsules are formed of gelatine and additionally plastisizers, and usually contain pharmaceutical preparations in liquid form, such as suspensions. pastes and oils. The two types of capsules, which are intended predominantly for oral administration, are filled in different manners.

Thus the hard-shell locking capsule can be filled by the manufacturer of the pharmaceutical preparation himself, for instance by filling the body part with the solid pharmaceutical preparation, then telescopicaly fitting a cap part onto the body part, with any trapped air being vented through a gap between the body and cap parts, and then if required, providing the resulting capsule with a band sealing the free end of the cap part with respect to the outer wall of the body part.

In contrast, the filling of conventional soft-shell capsules with liquid pharmaceutical preparations is relatively complex as the soft-shell capsules are formed, only at the time of their being filled, from two joined halves enclosing between them the liquid pharmaceutical preparation. These operations require a specific technique and are usually not performed by the manufacturer of the pharmaceutical preparation himself, which causes considerable disadvantages, especially in view of the high demands made on quality and safety that have to be observed in the manufacture of finished medicament capsules.

Until now, so far as we are aware, there has been no simple method for filling medicament capsules with liquid pharmaceutical preparations at the site of manufacture of the pharmaceutical preparation assuming that this site is different from- the place of manufacture of the capsule parts. In the case of soft-shell capsules, this-cannot be realized in view of the complex technique.

In the case of hard-shell capsules, sealing problems are encountered because the liquid pharmaceutical preparation penetrates into the space between the external surface of the body part and the internal surface of the cap part, and it is necessary to protect against such leaking by providing a band around the capsule. In practice. there is a need not only for capsules filled with liquid pharmaceutical preparations. but quite generally for capsules being filled with any liquid or other viscous materials, e.g. liquid or pasty materials. Such materials can be, for example, stain-removing agents, solvents, volatile oils. liquid spices. silicon oils or chicken fat. Locking capsules are particularly advantageously used for containing materials that must be carefully stored (e.g.

air-tight). must remain ready for use, and are required in small amounts, i.e. in portions. The materials may, for example.

become thinly liquid when they are heated and thickly liquid or even pasty when they are cooled.

According to the present invention, there is provided a sealed capsule filled with a liquid or other viscous material, the capsule comprising a body part having an open end and a closed end region, and a cap part having an open end region and a closed end region and being telescopically mounted on the body part, wherein the open end region of the body part received in the cap part is sealed with respect to the adjacent area of the internal surface of the cap part with a sealing composition which is provided in the interior of the capsule and is inert with respect to and insoluble in the liquid or other viscous material, and wherein the capsule has an aperture for the introduction of the sealing composition into the interior of the capsule. which aperture is itself sealed.

The sealing composition may be a pasty, solidifiable sealing composition inert with respect to and insoluble in the liquid or other viscous material. The sealed capsule according to the present invention, being sealed from inside, should be reliably tight as the sealing composition enters into a positive bond with the free end of the body part. Besides, in practice, the open end region of the body part is generallv located in most of the locking capsules in that area of the cap part where the cylindrical side wall of the cap changes over to the curved closed end, an area, in other words. displaying a high mechanical stability so that the sealing composition remain free from mechanical stresses to a large extent.

There are various. simple procedures for applying the sealing compodition. as will be explained hereinbelow. The sealing composition, and the liquid or other viscous material as well, can be introduced into the joined capsule through an aperture, which aperture can be closed with sealing composition after the capsule has been filled or can be welded by locally heating the joined capsule.

Advantageously. the entire interior of the closed end region of the cap part. including the area of the free end of the body part, is filled with sealing composition. In this man ner, a good mechanical stabilization of the filled capsule is obtained; additionally there is the advantage that the sealing composition sealing the area between the free end of the body part and the internal surface of the cap part can enter into a bond with the material of the locking capsule and rest against the internal surface of the cap part over a large area. which can improve the sealing of the filled capsule. Also. with this arrangement the filled capsule is free from air pockets, which makes it possible to store for a prolonged period materials that would perish upon contact with air.

Conveniently, as indicated above, in a preferred embodiment of the filled capsule the aperture is formed in the closed end region of the cap part.

Starting from a pre-fabricated, complete, but empty hard-shell capsule, a filled capsule may be produced in the following way.

The prefabricated capsule is first provided with an aperture at that end belonging to the cap part. Then, the capsule is filled with, for example, pasty material through the aperture, in its upright position, to a level below the free end of the body part. The free end of the body part is then sealed with respect to the internal surface of the cap part by introducing the sealing composition above the fill, so that the sealing composition forms an uninterrupted layer across the entire cross-section above the fill, which layer completely encloses the pasty material and prevents it from leaking through the aperture in the cap.This filling and sealing of the capsule does not require any complex technology, and thus the use of liquid or other viscous materials, which may be thinly liquid or even pasty, is possible at the site of the manufacturer of the manufacturer of the respective material itself.

In a preferred embodiment. a plug of sealing composition is applied to the aperture of the capsule and extends over the aperture. The plug provides for a positive bond between the sealing composition and the cap and can thus ensure that the space above the pharmaceutical preparation or other fill remains filled with sealing composition in the event of any shrinkage caused by solification of the sealing composition, and that no cracks are formed that might lead to leakage.

An alternative embodiment of the filled capsule is that in which the aperture is provided in the closed end of the body part.

which aperture is sealed with sealing composition. With this embodiment, sealing composition can first be introduced through the aperture. while the- capsule is in theupright position with the body part pointing upwardly, to a level above the open end of the body part, after which the liquid or other viscous material is introduced through the same aperture to a level below the aperture, whereupon the aperture is then sealed with sealing composition. This filling procedure is particularly simple in that it is not necessary to form above the liquid or other viscous material a coherent layer of sealing composition covering the cn)ss- section of the capsule. The sealing composition introduced first into the cap part. which could as an alternative be introduced through an aperture in the bottom of the cnp part. fills the bottom region of the cap to a level above the free end of the body pirt and thus seals the capsule in this area. I he sealing composition applied additionally after the introduction of the liquid or other viscous material only has to seal the aperture in the body part, so that there is no danger that the aperture will not be totally closed during introduction of the sealing composition owing to the initially tough and viscous consistency of the sealing composition.

A development of the last-mentioned embodiment of the capsule is that in which a further cap part is telescoped on the body part of the capsule filled with liquid or other viscous material. and sealing composition is contained in the area of the aperture between the closed end of the further cap part and the body part. This further cap part stabilizes the capsule additionally, and consequently makes the seal even more secure.

In a preferred development of the capsule provided with a further cap part, the area between the further cap part and the firstmentioned cap part closing the open end of the body part is sealed with a band. When for instance both cap parts are made of a material resistant to gastric juice there is obtained a delayed-release capsule. A still further preferred embodiment of the capsule provided with a further cap, is that in which an additional cap part is telescoped on the first-mentioned cap part closing the open end of the body part. which additional cap part is sealed with respect to the further cap part by means of a band.In this manner a capsule can be provided in which it is unimportant whether the further cap part or the additional cap part are exactly true to dimensions. and in which these caps are not in direct contact with the liquid or other viscous material and can consequently be made of another material which solely depends on the prevailing conditions.

Another aspect of the present invention provides a method for the production of a sealed capsule formed of a body part having an open end region and a closed end region and a cap part which has an open end region and a closed end region and which is telescopically fitted on the body part, the capsule being filled with a liquid or other viscous material. which method comprises filling the closed capsule in which the cap part is mounted on the body part. with the liquid or other viscous material through an aperture in the capsule. sealing the open end region of the body part received in the cap part with respect to the adjacent area of the internal surface of the cap part from the inside with a pasty, solidifiable sealing composition which is inert with respect to and insoluble in the liquid or other viscous material, and sealing the aperture.

This method according to the present invention is simple to put into effect. and provides for the reliable sealing of capsules filled with liquid or other viscous material, since these sealed capsules are sealed from the inside with sealing composition which positively engages the open end region of the body part. This open end region of the body part is preferably located in that area of the cap part where the cylindrical side wall of the cap part changes over to the curved closed end of the cap part, namely an area which is mechanically very firm and undergoes therefore little deformation which in turn ensures that the sealing composition remains free from mechanical stresses to a large extent.

In accordance with a preferred embodiment of the method of the present invention, the capsule is aligned with its axis approximately vertical with the cap part uppermost, and the liquid or other viscous material is introduced through an aperture in the closed end of the cap part to a level below the open end of the body part, after which through the aperture the space above the liquid or other viscous material is filled with the sealing composition. In this embodiment, the areas of the internal surface of the capsule which are in contact with the sealing composition do not contact the liquid or other viscous material. This ensures that the sealing composition enters reliably into a bond with the open end of the body part and the internal surface of the cap part.Another advantage achieved with this embodiment is that it is possible to keep the amount of introduced liquid or other viscous material uninfluenced by variations of the capsule volume caused by irregularities in capsule dimensions. Irregularities in the capsules can be compensated by varying the amount of sealing composition used.

Preferably, the aperture is formed on the axis of the capsule and the capsule is slowly rotated about its axis during introduction of the sealing composition. In this manner. it is particularly simple to introduce the pasty sealing composition such that it forms a continuous layer above the liquid or other viscous material. which layer closes the body part of the capsule in the upward direction and seals it with respect to the cap part.

In an advantageous embodiment of the last-mentioned arrangement the sealing composition is introduced by extruding the composition from an orifice. and the orifice is moved. during the extrusion, from an area adjacent the free end of the body part. after at least one revolution of the capsule. first radially inwardly towards the axis of the capsule and then upwardly out of the aperture.

In accordance with another preferred embodiment of the method of the present invention a plug is applied in the region of the aperture. extending thereover and con sisting of sealing composition. This plug provides for a positive bond between the sealing composition and the cap part and can ensure that during any shrinkage occurring, possibly during solification of the sealing composition, no cavities are formed, the space above the pharmaceutical preparation remains filled with the sealing composition and no cracks are formed that might cause leakage.

In the last-mentioned embodiment of the method of the present invention, the liquid or other viscous material is introduced prior to the sealing composition. An alternative embodiment of the method according to the present invention is that in which the sealing composition is introduced prior to the liquid or other viscous material. In this alternative embodiment there is no need to see to it, when introducing the liquid or other viscous material, that material does not come into contact with the open end of the body part and the adjacent internal surface of the cap part. Such a contact area to be sealed with the liquid or other viscous material would lead to limitations as regards the usable sealing compositions that have to enter into a regular bond with the material of the capsule.Moreover, some of the sealing compositions enter reliably into a bond with the material of the capsule only when it has not been wetted previously with the liquid or other viscous material.

In the aforementioned alternative embodiment, the capsule is advantageously aligned with its axis vertical with the body part uppermost, and is filled to above the open end of the body part with sealing composition; then the capsule through an aperture in the closed end of the body part is filled with the liquid or other viscous material to a point below the aperture, and the aperture is sealed thereafter. The sealing composition can be introduced into the capsule either from above, or from below through an aperture in the cap part. which aperture. upon withdrawal of a needle through which the sealing composition is introduced, is automatically sealed.

It is also convenient to introduce the sealing composition through the aperture in the closed end of the body part. These last-mentioned embodiments are particularlv simple in that it is not necessary with them to form above the liquid or other viscous material a coherent layer of sealing composition covering the cross-section of the capsule. The sealing composition introduced first into the interior of the cap part fills the bottom of the cap to above the free end of the body part and thus seals the capsule in this area. After the introduction of the liquid or other viscous material, the additionally applied sealing composition onlv has to seal the aperture formed in the body part; there is no danger owing to the initially glutinous, viscous consistency of the sealing composition that the aperture is not totally closed.

It is of advantage to compress radially the capsule after introducing the liquid or other viscous material so that that material rises to a level directly below the aperture. then to apply over the aperture a drop of the sealing composition to cover the aperture, and directly thereafter to release the capsule of the compressive force. The drop is drawn slightly into the capsule so that the sealing composition penetrates into the upper end of the body part and positively engages the rim defining the aperture thereby ensuring a reliable seal.

In another embodiment of the method of the present invention the aperture is sealed by fitting a further cap part on the body part of the locking capsule filled with the liquid or other viscous material, after the sealing composition has been provided in the further cap part at its closed end, or on the body part in the area of the aperture at the outer surface thereof. The sealing composition can be smeared across the area before the further cap part is fitted so that a large-area seal is provided. A capsule produced in this manner is particularly stable mechanically.

while the sealing composition itself is to a large extent protected from mechanical deformation.

A A capsule produced according to the last-mentioned embodiment can be provided on its external surface between the two cap parts with a band whereby the capsule can be made resistant to gastric juice provided the two cap parts are made of a material resistant to gastric juice, to obtain a delayed release preparation when a liquid pharmaceutical preparation is present within the capsule.It is also possible to fit an additional cap part over the original cap part, whereby a capsule resistant to gastric juice is also obtained provided the further cap part and the additional cap part are resistant to gastric juice: the further cap part and the additional cap part can be made from a material other than that of the body part and the inner cap part, and there is no need for dimensional accuracv for the further and additional cap parts as these cap parts can be sealed by means of a band.

Generally, the sealing composition is advantageously introduced at an increased temperature depending on the viscosit- desired. Immediately after introducing the sealing composition into the capsule the temperature of the composition substantially falls to the temperature of the capsule.

which is the ambient temperature. and solidifies almost at once.

When the material of the locking capsule is gelatine, the scaling composition is prefer ably gelatine as well. This gelatine when introduced in its pasty state, by heating it for instance to the temperature required for the desired viscosity, enters into a intimate bond with the material of the capsule which has not come into contact with the liquid or other viscous material in the areas to be sealed, prior to sealing, so that the finished capsule should be reliably sealed and mechanically stable.

As pasty material for sealing may be used, for example, also dimethyl cellulose, starch, shellac, a solution of cationic polyacrylate in isopropyl alcohol and acetone, as well as other lacquers which are common for banding locking capsules, or for the production of a cover for locking capsules resistant to gastric juice. Usable are all materials that enter into an intimate bond with the material of the capsule, do not dissolve in the liquid or other viscous material and show minor shrinkage upon setting or solidifying.

When the liquid or other viscous material is a pharmaceutical preparation the sealing composition must be edible and non-toxic.

When materials are used that undergo considerable shrinkage upon solidification, it is advantageous to allow the filled capsule to dry or to set in an atmosphere of inert gas such that no oxygen is drawn into the interior of the capsule upon reduction of the volume. as oxygen can be detrimental for some types of liquid pharmaceutical preparations. When using gelatine as sealing composition the formation of bubbles was observed sometimes at the interior of the capsule. caused by mostly harmless water vapour formed upon solidification of the gelatine. When using gelatine it is advantageous to employ a mixture of solid gelatine particles and aqueous gelatine since such a mixture displays little shrinkage.

The present invention allows a simple manufacture of capsules, e.g. locking capsules, filled with for instance a liquid pharmaceutical preparation, which manufacture can be continuous and fast. The capsule filled with liquid or other viscous material and sealing composition can be further processed immediately after having been filled since the capsule has a sufficient stability on account of its own rigidity even if the sealing composition has not solidified completely. Suitable for use in the present invention are all conventional. prefabricated, hard-shell locking capsules.The finished locking capsules can have different appearances depending on the different areas - cap part, body part, aperture covered with sealing composition, interior space of the locking capsule filled with sealing composition, when they are differently coloured and/or show a different transparency of the materials, so that they can be widely varied in their aesthetic appearances. It is to be understood that the locking capsules can be provided with an aperture at the time of their manufacture, or just before they are filled.

For the manufacture of the capsules according to the present invention continuously operating apparatuses can be employed after having been adjusted slightly, such as are used for filling locking capsules with pulverulent pharmaceutical preparations (e.g. an apparatus in accordance with DT-OS 2 048 948). These apparatuses need not comprise a station where the supplied, joined locking capsule is separated into body part and cap part; instead, the station where the cap part is fitted again on the body part once filled with a pulverulent pharmaceutical preparation can have a mandrel with which the aperture in the locking capsule is formed. This station is then followed by filling stations in which the filling of the locking capsule with pharmaceutical preparations and the sealing composition is effected.The movement of the orifice through which the sealing composition is extruded and applied. can be effected for example in that a needle at the end of which the orifice is formed is retained by a pivotable mounting moving alongside a cam surface.

For a better understanding of the present invention and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings in which: Figures la to le are vertical sections through a capsule at various stages of filling and sealing, in accordance with the present invention; and Figures 2 to 5 are vertical sections through four different modified embodiments of filled sealed capsules in accordance with the present invention.

Referring firstly to Figure la. there is shown a locking capsule 6 have a cap part 8 and a body part 10, both of these parts having an open end and a closed end region.

The body part 10 is provided in the proximity of the open end 12 with a groove 14.

which is engaged by a corresponding groove 16 of the cap part 8 so that the cap part 8 and the body part 10 are rigidly mechanically joined. In the closed end of the cap part 8 an aperture 18 is formed, by means of drilling, for instance.

Figure ib shows a distal end region of a needle 20 being passed clearly through the aperture 18. Through this needle 20 a liquid pharmaceutical preparation 22 is introduced into the body part 10. with the capsule 6 in a vertical position, to a level about 1 mm below the upper end 12 of the body part 10.

Care has to be taken, in this connection, that the liquid pharmaceutical preparation 22 does not contact either the rim of the aperture 18, the free end 12 of the body part 10, or the internal surface of the cap 8 in the area of the free end 12 of the body part 10.

The needle 20 is withdrawn from the aperture 18 after filling the majority of the body part 10 with liquid pharmaceutical preparation 22, and then in accordance with Figure Ic, there is inserted through aperture 18 a needle 26 having a bent tip 24 in a manner such that its orifice 28 is spaced by only a small distance from the free end 12 of the body part 10. The capsule 6 is then slowly rotated about its own axis a-a and from the orifice 28 of the needle 26 a highly viscous, heated gelatine is extruded as a sealing composition which in the form of a bead 30 is positioned in the area of the free end 12 of the body part 10 and the adjacent internal surface of the side wall of the cap part 8 and penetrates in part into any slight gap between the cap part 8 and the body part 10.During this process the gelatine cools at once and solidifies rapidly so that the bead 30 which initially partly dissolves the adjacent areas of the capsule 6 consisting likewise of gelatine, enters into a bond with the material of the capsule which solidfies rapidly and seals the cap part 8 with respect to the body part 10.

Then as shown in Figure 1d the needle 26 is rotated about a transverse axis such that, while the capsule 6 is rotated about its axis a-a, the orifice 28 of the needle 26 moves from the area of the free end 12 of the body part 10 obliquely upwardly and in the direction to axis a-a. The pasty gelatine which is continuously extruded from orifice 28 is placed spirally, ring by ring, on the bead 30 and forms an uninterrupted layer filling the interior of the cap part 8 directly above the pharmaceutical preparation 22.In this connection it has to be observed that the layer is not spaced above the level of the pharmaceutical preparation 22, which could cause air to be enclosed between the layer and the pharmaceutical preparation 22, nor is the layer immersed in the pharmaceutical preparation, which could cause the latter to be enclosed above the layer thus leading to leakage during further filling of the cap part 8 with sealing composition, as described hereinafter.

Subsequently, in accordance with Figure le, the needle 26 is moved, while the capsule 6 is still rotated about its axis a-a, such that the orifice 28 moves first upwardly inside the cap part 8 and then out through the aperture 18. The entire space within the cap 8 is thus filled with gelatine and the air expelled from the cap 8 is vented through the aperture 18. The extrusion of gelatine from the orifice 28 is terminated as soon as the orifice 28 has been removed from the cap 8 and a plug 32 of gelatine formd in and over the aperture 16.The now finished capsule is completely filled with gelatine 34 above the pharmaceutical preparation 22 which ensures that the gelatine 34 enters into a rigid bond directly with the material of the cap part 8 being likewise of gelatine and of the open end 12 of the body part 10, which in turn reliably seals the capsule 6 and, as soon as the gelatine 34 has solidified, provides in addition for a mechanical stabilization of the capsule.

Figure 2 shows an embodiment of a sealed capsule 6' filled with a liquid pharmaceutical preparation 22, which capsule has been filled in a manner somewhat different from that described above in relation to Figure 1.

The capsule 6' has its body part 10' uppermost and has at the closed end of its body part 10' an aperture 18'; the capsule 6' is first filled through the aperture 18' with sufficient gelatine to fill the cap part 8' wih a continuous gelatine body 36, to a level above the open end 12' of the body part 10' this gelatine body 36 sealing the cap part 8' with respect to the body part 10'. Then the pharmaceutical preparation 22 is introduced through the aperture 18' to a level just below the aperture 18'. It is observed-that the rims of the aperture 18' remain free of pharmaceutical preparation. The aperture 18' is thereafter closed with gelatine 32'.

This closing is advantageously effected in that the locking capsule 6', after the pharmaceutical preparation 22 has been introduced, is compressed radially, i.e. at its side walls, whereby the level of the pharmaceutical preparation 22 rises until no air remains inside the capsule 6'. At the aperture 18' a spherical surface of the liquid pharmaceutical preparation is formed as a consequence of the surface tension of the pharmaceutical preparation, which does not wet those regions defining the aperture itself. At this stage a drop of gelatine is applied in the region of the aperture 18', so as to cover the aperture 18'.The capsule 6' is then released from radial pressure so that the drop of gelatine applid over the aperture 18' is drawn inside the aperture and provides for a positive bond with the rim of the aperture, this providing in turn a reliable seal of the aperture 18' when the drop of gelatine solidifies.

Figure 3 shows an embodiment of a sealed capsule 6" somewhat modified with respect to that illustrated in Figure 2. The filling of the capsule proceeds identically to the filling of the capsule 6'. according to Figure 2. up to and including the filling step. Then the aperture 18" in the body part 10' is closed by telescoping another cap part 38 onto the body part 10', which cap part 38 is provided at the inside of its closed end with a drop of gelatine 32". This drop 32" is pressed to a flat configuration when the further cap part 38 is fitted over the body part 10' and closes the aperture 18' by its large-area contact with the inner side of the further cap part 38, on the one hand, and, on the other hand, with the outer side on the body part 10'. The further cap part 38 provides the capsule 6" additionally with greater stability.The capsule may in this case as well be advan tageously somewhat compressed radially before telescoping on the further cap part 38.

In the embodiment of capsule illustrated in Figure 4, the capsule illustrated in Figure 3 is provided between the open end of the cap part 8' and the further cap part 38 with a band 40 to provide a seal towards the exterior so that the body part 10' is not in direct contact with the gastric juice when the capsule is administered.

The embodiment illustrated in Figure 5 differs from that illustrated in Figure 3 in that an additional cap part 42 is telescoped on the cap part 8', which cap part 42 is sealed by means of a band 44 with respect to the further cap part 38. The capsule formed in this manner is exceptionally solid; also as the cap parts 38 and 42 do not come into contact with the pharmaceutical preparation 22 but are merely telescoped on the parts provided with closed curved portions, the cap parts 38 and 42 need not be manufactured with great dimensional accuracy; the capsule can for instance be a delayedrelease capsule if the caps 38 and 42 are made of an accordingly slowly dissolving material.

WHAT WE CLAIM IS: 1. A sealed capsule filled with a liquid or other viscous material, the capsule comprising a body part having an open end and a closed end region. and a cap part having an open end region and a closed end region and being telescopically mounted on the body part, wherein the open end region of the body part received in the cap part is sealed with respect to the adjacent area of the internal surface of the cap part with a sealing composition which is provided in the interior of the capsule and is inert with respect to and insoluble in the liquid or other viscous material, and wherein the capsule has an aperture for the introduction of the sealing composition into the interior of the capsule, which aperture is itself sealed.

2. A capsule as claimed in claim 1, wherein the liquid or other viscous material is a pharmaceutical preparation.

3. A capsule as claimed in claim 1 or 2, wherein the sealing composition is a set composition which was applied as a pasty, solidifiable composition.

4. A capsule as claimed in claim 1, 2 or 3, wherein the entire interior of the closed end region of the cap part, including the area of the free end of the body part. is filled with the sealing composition.

5. A capsule as claimed in any preceding claim, wherein the aperture is formed in the closed end region of the cap part.

6. A capsule as claimed in claim 5, which includes a plug of sealing composition, applied to the aperture and extending over said aperture.

7. A capsule as claimed in any one of claims 1 to 4, wherein the aperture is formed in the closed end region of the body part and is sealed with sealing composition.

8. A capsule as claimed in claim 7, which includes a further cap part fitted over the closed end region of the body part, there being sealing composition present in the area of the aperture between the closed end of the further cap part and the body part.

9. A capsule as claimed in claim 8, wherein the area between the further cap part and the first-mentioned cap part is sealed with a band.

10. A capsule as claimed in claim 8 or 9, which includes an additional cap part fitted over the closed end region of the firstmentioned cap part, the additional cap being sealed with respect to the further cap by means of a band.

11. A capsule according to claim 5, substantially as hereinbefore described with reference to, and as illustrated in, Figures la to le of the accompanying drawings.

12. A capsule according to claim 7, substantially as hereinbefore described with reference to and as illustrated in, Figure 2 of the accompanying drawings.

13. A capsule according to claim 8, substantially as hereinbefore described with reference to, and as illustrated in, Figure 3 of the accompanying drawings.

14. A capsule according to claim 9, substantially as herein before described with reference to, and as illustrated in, Figure 4 of the accompanying drawings.

15. A capsule according to claim 10, substantially as hereinbefore described with reference to, and as illustrated in, Figure 5 of the accompanying drawings.

16 A method for the production of a sealed capsule formed of a body part having an open end region and a closed end region and a cap part which has an open end region and a closed end region and which is telescopically fitted on the body part. the capsule being filled with a liquid or other viscous material, which method comprises filling the closed capsule in which the cap part is mounted on the body part, with the liquid or other viscous material through an aperture in the capsule, sealing the open end region of the body part received in the cap part with respect to the adjacent area of the internal surface of the cap part from the inside with a pasty, solidifiable sealing composition which is inert with respect to

**WARNING** end of DESC field may overlap start of CLMS **.

Claims

**WARNING** start of CLMS field may overlap end of DESC **. aperture 18' by its large-area contact with the inner side of the further cap part 38, on the one hand, and, on the other hand, with the outer side on the body part 10'. The further cap part 38 provides the capsule 6" additionally with greater stability. The capsule may in this case as well be advan tageously somewhat compressed radially before telescoping on the further cap part 38. In the embodiment of capsule illustrated in Figure 4, the capsule illustrated in Figure 3 is provided between the open end of the cap part 8' and the further cap part 38 with a band 40 to provide a seal towards the exterior so that the body part 10' is not in direct contact with the gastric juice when the capsule is administered. The embodiment illustrated in Figure 5 differs from that illustrated in Figure 3 in that an additional cap part 42 is telescoped on the cap part 8', which cap part 42 is sealed by means of a band 44 with respect to the further cap part 38. The capsule formed in this manner is exceptionally solid; also as the cap parts 38 and 42 do not come into contact with the pharmaceutical preparation 22 but are merely telescoped on the parts provided with closed curved portions, the cap parts 38 and 42 need not be manufactured with great dimensional accuracy; the capsule can for instance be a delayedrelease capsule if the caps 38 and 42 are made of an accordingly slowly dissolving material. WHAT WE CLAIM IS:

1. A sealed capsule filled with a liquid or other viscous material, the capsule comprising a body part having an open end and a closed end region. and a cap part having an open end region and a closed end region and being telescopically mounted on the body part, wherein the open end region of the body part received in the cap part is sealed with respect to the adjacent area of the internal surface of the cap part with a sealing composition which is provided in the interior of the capsule and is inert with respect to and insoluble in the liquid or other viscous material, and wherein the capsule has an aperture for the introduction of the sealing composition into the interior of the capsule, which aperture is itself sealed.

and insoluble in the liquid or other viscous material, and sealing the aperture.

17. A method as claimed in claim 16, which includes filling the entire interior of the closed end region of the cap part, including the area of the open end of the body part, with the sealing composition.

18. A method as claimed in claim 16 or 17, wherein the capsule with its axis extending vertically or substantially vertically is filled through an aperture in the closed end region of the upwardly pointing cap part with the liquid or other viscous material to a level slightly below the open end of the body part, and wherein the space above the liquid or other viscous material is then filled through the aperture with the sealing composition.

19. A method as claimed in claim 18, wherein the aperture is formed on the axis of the capsule, and the capsule is rotated slowly about its axis during filling of the sealing composition.

20. A method as claimed in claim 19, wherein the sealing composition is introduced by extruding it through an orifice, and wherein, during filling, the orifice is moved away from the area adjacent the open end of the body part. after at least one revolution of the capsule, first radially inwardly in the direction of the axis of the capsule and then in an upward direction out of the aperture.

21. A method as claimed in claim 18. 19 or 20. which includes applying a plug of sealing composition to the aperture and extending over the aperture.

22. A method as claimed in claim 16 or 17. wherein the sealing composition is introduced before the liquid or other viscous material is introduced.

23. A method as claimed in claim 22.

wherein the capsule with its axis vertical or substantially vertical is filled with the sealing composition to a level above the open end of the body part. with the cap part pointing downwardly, and then, through an aperture in the closed end of the body part, is filled with the liquid or other viscous material to a level below the aperture, whereafter the aperture is sealed.

24. A method as claimed in claim 23, wherein the sealing composition is introduced through the same aperture in the closed end of the body part used for introducing the liquid or other viscous material.

25. A method as claimed in claim 23 or 24, wherein after the liquid or other viscous material has been introduced into the capsule, the capsule is radially compressed so that the liquid or other viscous material rises to a level directly below the aperture, then sufficient sealing composition is applied in the region of the aperture to cover it, and immediately thereafter the capsule is released of the compression.

26. A method as claimed in claim 23 or 24, wherein the aperture is sealed by fitting a further cap part on the closed end region of the body part of the already filled capsule, after sealing composition has been applied to the inside surface of the further cap part, at the closed end region thereof, or to the outside surface of the body part in the area of the aperture.

27. A method as claimed in any one of claims 16 to 26, wherein the sealing composition is introduced at an elevated temperature corresponding to the desired viscosity.

28. A method as claimed in any one of claims 16 to 27, wherein the capsule is made of gelatine and the sealing composition is formed of gelatine.

29. A method according to claim 16 for producing filled capsules, substantially as hereinbefore described with reference to the accompanying drawings.