GB1582385A

GB1582385A - Method of producing a sealed hard gelatine capsule containing a liquid

Info

Publication number: GB1582385A
Application number: GB4601577A
Authority: GB
Original assignee: Robert Bosch GmbH
Current assignee: Robert Bosch GmbH
Priority date: 1976-11-05
Filing date: 1977-11-04
Publication date: 1981-01-07
Also published as: FR2369969A1; CH623004A5; DE2650649A1; IT1088265B; JPS5359022A

Abstract

Prefabricated hollow hard gelatin containers are used for packaging liquid medicaments. These containers can be produced as sealed, one-part hard gelatin capsules. It is also possible to use two-part hard gelatin capsules (1) which have been sealed at the separating point before filling. Liquid medicaments are introduced into the hard gelatin capsules (1) with hollow needles (5). The hollow needles (5) are inserted in openings provided in the hard gelatin capsules (1). However, they can also be used in order to produce openings in the hard gelatin capsules (1). The openings in the hard gelatin capsules (1) are sealed with a quickly drying sealing compound after the filling operation. <IMAGE>

Description

(54) METHOD OF PRODUCING A SEALED HARD GELATINE CAPSULE CONTAININGA A LIQUID (71) We, ROBERT BOSCH GmbH, a German company of 7000 Stuttgart, Germany 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 follow- ing statement:- This invention relates to a method of producing a sealed hard gelatine capsule containing a liquid, and to a sealed hard gelatine capsule containing a liquid when produced by such a method.

According to the invention there is provided a method of producing a sealed hard gelatine capsule containing a liquid, comprising the steps of making at least one opening in the hard gelatine capsule, introducing the liquid into the capsule through the or each opening, and sealing the or each opening after the liquid has been introduced into the capsule.

The opening/s m the capsule is/are preferably made by the same member through which the liquid is introduced into the capsule.

The method of the invention has particular application to the production of hard gelatine capsules containing liquid in the form of a medicinal substance. Such capsules may be one-piece capsules or comprise two parts or halves of which one may be inside the other.

Liquid medicinal substances have already been introduced into soft gelatine capsules, the liquid being introduced into the capsules during manufacture of the capsules as described, for example, in British Patent Specification No. 564538.

However, only pulverulent medicinal substances, such as pellets or small tablets, have been introduced into hard gelatine capsules consisting of two parts of different diameter insertable one within the other. The capsules, delivered in a complete form, are first of all separated into two parts and then, after introducing material into the lower part, the upper part is again inserted as described, for example, in German Patent Specification No.

1117471.

The method in accordance with the invention meets the demand which has existed in the pharmaceutical industry for some time for hard gelatine capsules containing liquid medicinal substances. The main reason for this demand is that, in the production of soft gelatine capsules, substantially more gelatine is used since, due to the method of production, there is more waste than with the production of hard gelatine capsules.

Furthermore, in using soft gelatine capsules, there is also the disadvantage that introduction and production have to take place in one working operation. For this reason, the pharmaceutical firms as well as the industries specializing in the introduction of medicinal substances into capsules, have to be involved in the manufacture of the capsules themselves which is not the case when using hard gelatine capsules since these are produced by special capsule manufacturing firms which deliver them to the pharmaceutical industry or to the "filling" industry.

Now, hard gelatine capsules can be used not only for solid medicinal rubstances but, in accordance with the method of the inven tin, for liquid medicinal substances so that a substantially more economical and more simple storage arrangement is involved than was previously the case when using soft gelatine capsules for liquid medicinal substances and hard gelatine capsules for solid medicinal substances. Quite apart from that, it is much simpler for the pharmaceutical manufacturer and for the pharmaceutical "filling" industry since they are only involved with the introduction of material into the capsules and no longer with the manufacture of the capsules themselves. Nor do they need to obtain soft gelatine capsules already containing liquid, from specialized firms.

Furthermore, as opposed to the introduction of powder into two-part hard gelatine capsules, there is the further advantage in introducing liquid into hard gelatine capsules in accordance with the invention, that, for the same capsule volume, a "larger quantity of liquid-- can be introduced into the hard gelatine- capsules. Moreover, there is a further advantage that the kind of introduction on which the invention is based requires shorter times for the introduction of the same amount of liquid.

-However, for the production of hard gelatine capsules containing liquid, the same twopart' hard gelatine capsules can be used which can also be used for powder or the like.

Hereby, in addition to the advantage to the manufacturer who does not have to produce special, capsules for - liquid medicinal substances, there is a further advantge for the pharmaceutical manufacturer and for the pharmaceutical "filling" industry of further simplification in the storage arrangements.

After liquid has been introduced into the capsule, the opening/s may be sealed by a mass of closure material the colour of which being such as to identify the liquid in the capsule.

If a sealed two-part hard gelatine capsule is produced, the joint between the two parts of the capsule may also be sealed with a closure material which may be the same, or a similar, material to that used for sealing the opening is in the capsule.

In order that the invention may be clearly understood -and readily carried into effect, embodiments thereof will now be described with reference to the accompanying drawing, in which: Figure 1 shows apparatus for the supplying of two-part hard gelatine capsules into which liquid is to be introduced; Figure 2 shows apparatus for making an opening in a hard gelatine capsule, and for introducing liquid into-the capsule; Figure 3 shows apparatus for sealing the opening; Figure 4 shows apparatus -comprising -a hollow needle designed for -introducing liquid by vacuum; and Figure 5 shows apparatus for striping a hard gelatine capsule at the closure joint.

Figure 1 shows the-delivery of, for example, two-part hard gelatine capsules 1 to a rotary receiving device 2, which has compartments in the form of bores 3 for the reception of the hard gelatine capsules 1. A disc 4 or the like which serves as a support for the hard gelatine capsules 1 is arranged beneath the receiving device 2. The receiving device 2 may be rotated either step-by-step or continuously.

On rotation of the receiving device 2, the hard gelatine capsules 1 are delivered to the various operating stations.

One such operating station is illustrated in Figure 2. At this station, an opening is made in the hard gelatine capsules 1 and liquid is introduced into -the capsules through the opening. A hollow needle 5 is provided for this purpose, the needle 5 being in -communi- cation with a cylinder 6 or the like which is connected to means' (not shown) for supplying the liquid to be introduced. As can be further appreciated from Figure 2, the hollow needle 5 (illustrated in dotted lines) is. introduced into the hard gelatine capsii'les' in which it forms an opening. Liquid is then introdúced into the hard gelatine capsule 1 throngh the hollow needle 5.

Finally, the hard gelatine capsule 1 containing liquid arrives at the - sealing station which is illustrated in Figure 3. At this station, a drop 10 of a quick drying closure material from a storage container 9 is applied to the opening produced by the hollow needle 5 in each hard gelatine capsule 1. 'The closure 'material' may be of a colour suitable for identifying the liquid in the capsule and may even be in contrast to the colour of the cap sule.

Figure 4 shows a station for introducing liquid into the capsules by means of a vacuum.

For this purpose, an outer hollow needle 5 is provided in which is arranged a further inner hollow needle 7. Moreover, the inner dia meter of the outer hollow needle 5 is greater than the outer diameter of the inner hollow needle 7 so that two ducts exist, one for the liquid and one for the vacuum. Moreover, a sealing disc 8 is provided on the hollow needle 5.

For the packaging of liquid medicinal sub stances one-piece hard gelatine capsules specially designed for the purpose can be used or alternatively the two-part hard gelatine capsules shown in the drawings and designed for the packaging of powders or the like, can be used. In that case, it is necessary to seal the two-part capsules at the closure joints, for example by striping. This can take place before or after making an opening, introducing liquid -and closing the hard gelatine capsules 1.

One possible apparatus for striping the closure joints of the hard gelatine capsules 1 is shown in Figure 5. In the illustrated -arr- angement, a rod 11 is provided which can be inserted into the bore 3 from below to raise; the joint in the hard gelatine capsule 1 above the surface of the receiving device 2. Further more, the arrangement is so designed that-the closure material can be applied, from a storage container 14, for example by way of two rotating discs 12 and 13, -on to the closure joint 15 of the hard gelatine -capsule 1, the hard gelatine capsule 1 being rotated by means of the disc 13.

The same, or a similar, closure material is used for sealing the closure joint 15-as is used for sealing the opening in each hard gelatine capsule.

The illustrated embodiments represent, in only a diagrammatic manner, possibilities for carrying out the method in accordance with the invention. Thus, for example, other forms of hollow needle for filling the liquid into the hard gelatine capsules 1 can be used. Likewise, other forms of apparatus may be used for striping the hard gelatine capsules 1.

Although in the embodiments described, only one opening is produced in each of the capsules, it is to be understood that a plularity of openings may also be made in each capsule into which liquid is to be introduced.

WHAT WE CLAIM IS 1. A method of producing a sealed hard gelatine capsule containing a liquid, comprising the steps of making at least one opening in the hard gelatine capsule, introducing the liquid into the capsule through the or each opening, and sealing the or each opening after the liquid has been introduced into the capsule.

2. A method according to Claim 1, in which the or each opening in the capsule is made by a member through which the liquid is introduced into the capsule.

3. A method according to claim 2, in which the member comprises a hollow needle.

4. A method according to claim 2, in which the member comprises an inner hollow needle arranged within an outer hollow needle to provide a pair of ducts, one duct being through the inner hollow needle and the other duct being between the inner and outer hollow needles, the liquid being introduced into one duct and a vacuum being applied to the other duct.

5. A method according to any of the preceding claims, in which the or each opening is sealed by a mass of closure material, the colour of the closure material being such as to identify the liquid in the capsule.

6. A method according to claim 5, in which the colour of the closure material is in contrast to the colour of the capsule.

7. A method according to claim 5 or claim 6, in which the mass of closure material is applied to the or each opening by a device which is arranged at a sealing station positioned after a station at which the liquid is introduced into the capsule.

8. A method according to claim 7, in which the steps of making the or each opening in the capsule and introducing the liquid into the capsule are performed at one and the same station.

9. A method according to claim 7 or claim 8, in which the capsule is moved from one station to the other by a rotary device.

10. A method according to claim 9, in which the rotary device has compartments and more than one said capsule is delivered to the rotary device so that the capsules are received sequentially by each compartment in turn as the device rotates and the capsules are conveyed one at a time to each station.

11. A method according to claim 10, in which the rotary device rotates continuously between the stations or in step-by-step fashion.

12. A method according to claim 10 or claim 11, in which the compartments are bores extending through the rotary device, and the capsules are supported in the bores by a support member arranged beneath the rotary device.

13. A method according to any of the preceding claims, of producing one or more sealed two-part hard gelatine capsules, which also comprises the step of sealing the joint between the two parts of the or each capsule by the application thereto of a closure material either before or after the aforementioned steps.

14. A method according to claim 13, in which the same, or a similar, closure material is used for sealing the joint as is used for sealing the or each opening.

15. A method according to claim 13 or claim 14, in which the closure material is applied to the joint from a storage container by a pair of rotating discs, one of the rotating discs rotating the capsule as it applies the closure material to the joint thereof.

16. A method according to any of claims 13 to 15, when appendant to claim 12, in which the joint is sealed by raising the capsule in the bore so that the joint is above the rotary device, and the closure material is applied to the joint.

17. A method according tO claim 16, in which the capsule is raised in the bore by inserting a rod into the bore from below the rotary device.

18. A method according to any of the preceding claims, in which the liquid is, or contains, a medicinal substance.

19. A methd of producing one or more sealed hard gelatine capsules, substantially as herein described with reference to the accompanying drawing.

20. A sealed hard gelatine capsule containing liquid, produced by the method according to any of the preceding claims.

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

Claims

**WARNING** start of CLMS field may overlap end of DESC **. of hollow needle for filling the liquid into the hard gelatine capsules 1 can be used. Likewise, other forms of apparatus may be used for striping the hard gelatine capsules 1. Although in the embodiments described, only one opening is produced in each of the capsules, it is to be understood that a plularity of openings may also be made in each capsule into which liquid is to be introduced. WHAT WE CLAIM IS

1. A method of producing a sealed hard gelatine capsule containing a liquid, comprising the steps of making at least one opening in the hard gelatine capsule, introducing the liquid into the capsule through the or each opening, and sealing the or each opening after the liquid has been introduced into the capsule.