The invention relates to a hard-shell capsule of a type used to deliver dosages of pharmaceuticals, medicines, vitamins, dietary supplements, etc. . . . to an individual. The invention is suitable for any dosage form but is most particularly adapted to liquid dosages.
In general, hard-shell capsules are made of two separately moulded parts, namely a body and a cap. In the manufacturing process, the cap is placed on the body in a pre-closed position providing a sufficient retention force for the transfer of pre-assembled capsules to the filling machine with no risk of separation.
In the filling machine, successive capsules are automatically processed according to the following steps:
In the fully closed final position, the force to disengage the cap from the body is much higher than in the pre-closed position.
During the final joining of the capsules after filling, there is a risk that the cap is not properly fixed on the body, due to the air pressure increase inside the capsule upon closing. It is thus desirable that the air excess is allowed to escape from the inner volume of the capsule when the final assembling is processed. Therefore, it has been proposed to provide capsules with means allowing air escape.
The invention relates to such hard-shell capsules comprising:
Such a capsule is known in the prior art, for example from U.S. 2007-0184077 A1, wherein the air-vents are formed by oval dimples extending across the locking ring.
However, due to the structure of the dimples, the air escape is only allowed on a small range of engagement positions between the pre-closed position and the fully closed final position. On the remaining travel of the cap until the full engagement, the air pressure builds up in the capsule. This may cause some deformations of the capsule and the fill product, especially in case it is a liquid dosage, may leak out of the capsule before a tight sealing is made. Such leakage may occur during the transfer between the filling machine and a sealing machine, especially if the capsules are not vertically transferred.
It is an object of the invention to solve the aforementioned problem and propose a capsule design suitable to minimize the risks of leakage of the capsule after filling.
It is a further object to propose a capsule design which is adapted to the large scale manufacturing processes.
This is achieved by the hard-shell capsule according to the invention, which comprises:
A capsule according to the invention may have one or more of the following features:
According to a first embodiment of the invention, the air-vent axially extends from the open end into the locking ring.
According to a second embodiment of the invention, the air-vent axially extends across the locking ring, from the open end into an area comprised between the locking ring and the contact section.
Advantageously, a capsule according to the invention may include a liquid dosage accommodated in the inner volume.
Preferred embodiments of the invention will now be described in more details, by way of example only, with reference to the accompanying drawings, which are not drawn to scale and wherein:
Referring to
The body 2 and the cap 3 are adapted to be telescopically joined by partial insertion of the body 2 into the cap 3 until a fully closed or engaged final position and thus define a closed inner volume therebetween for accommodating a dosage. The herein described invention is most particularly adapted to liquid dosages but is suitable for any other dosage form, such as powder.
The tubular body 2 is elongated in an axial direction, corresponding to the insertion axis X-X, and has an open end 5 and a closed end 7. In the example shown, the body 2 includes a generally cylindrical wall 9 axially extending from the open end 5 to the closed end 7. The generally cylindrical wall 9 is circular in cross-section, although it may have various shapes in cross-section such as oval, and the closed end 5 is dome-shaped although it may also have various shapes. In particular embodiments, the closed end 5 may be hemispherical in shape.
The body 2 has an annular channel formed as a narrowed portion on an intermediate section of the cylindrical wall 9. This annular channel constitutes a spray ring 11 which defines a gap between the body 2 and the cap 3 in the fully closed final position for allowing a sealing fluid to be sprayed between the body and the cap, i.e. in an overlap region of the body and the cap.
The cylindrical wall 9 of the body 2 comprises a further narrowed portion (or channel), formed over an axial section of the body located between the spray ring 11 and the open end 5. This narrowed portion constitutes a locking ring 12 for receiving a complementary member of the cap 3, as it will be described in the following.
As visible on
The body 2 further comprises air-vents 14 formed as axial recesses on the outer surface of the body so as to ensure fluid communication between the inner volume and the atmosphere during the closure of the capsule, as it will be explained in more details in the foregoing.
Similarly to the body 2, the cap 3 has an open end 15, a closed end 17 and a generally cylindrical wall 19 extending therebetween. The generally cylindrical wall 19 has a corresponding shape to the body 2 such that the cap 3 can be slidably and telescopically engaged on the body 2 in the axial direction X-X from a disengaged position into the fully closed final position—shown on FIG. 1—. In particular, the open end 15 of the cap is generally circular in-cross section and of a slightly larger diameter than open end 5 of the body, whereby the body 2 can be inserted in the cap 3 through the open end 15.
The cap 3 includes an annular ridge 21 inwardly protruding from the generally cylindrical wall 19. The annular ridge 21 radially extends with respect to the common insertion axis X-X. In the example shown, the annular ridge 21 has an overall V-shape in cross-section and the locking ring 12 is substantially U-shaped in cross-section with a depth d1, both being adapted to mutual engagement with close fit. The depth d1 of the locking ring 12 is defined as the radial distance between the bottom surface of the locking ring and the outer generally cylindrical surface of the wall 9. The mutual engagement of the locking ring 12 and ridge 21 is obtained by an elastic deformation of the cylindrical walls 9, 19 during the insertion of the body 2 in the cap 3. The diameter of the ridge 21, defined as the distance between the apex 22 of the V-shaped cross-section and the axis X-X, is slightly smaller than the inner diameter of the bottom surface of the locking ring 12, whereby the ridge 21 and the locking ring 12 are resiliently biased into mutual engagement. In this respect, the locking ring 12 and the ridge 21 constitute complementary snap-fit means for locking the cap 3 on the body 2 in the fully closed final position. For the sake of clarification, the locking ring 12 and the ridge 21 need not to be identical in shape or size to define complementary snap-fit means, but rather need to be compatible in shape and size for mutual engagement with close fit.
The ridge 21 is preferably continuous along an inner circumference although it could be envisaged to provide a segmented ridge instead.
On
The body 2 and the cap 3 are also configured such that the cap has a stable pre-closed position on the body, corresponding to a partially engaged position shown on
Again, on
Referring now to
As more specifically visible on
The air-vents 14 are axially elongated and extend from the open end 5 toward the contact section 33 into the locking ring 12, whereby they do not interfere with the contact section 33. In other words, in the fully closed final position, the contact section 33 is not interrupted by any air-vent 14 along the circumference of body 2.
It should be noted that each air-vent 14 has a depth d2—defined as the radial distance between the bottom surface of the air-vent and the outer generally cylindrical surface of the wall 9—which is less than the depth d1 of the locking ring. The locking ring 12 is thus recessed within the recess formed by the air-vent 14. Due to this feature, the contact area 35 between the body 2 and the cap 3 defined by engagement of the ridge 21 within the locking ring 12 in the fully closed final position is not interrupted by the air-vents 14. Similarly to the contact section 33, this contact area 35 is continuous over the periphery of the body 2 in the closed position and not by-passed by the air-vents 14.
Although the body 2 could be provided with one single air-vent, the body 2 is preferably provided with a plurality of air-vents 14, as shown on the Figures representing preferred embodiments, which are peripherally distributed on the body. More preferably, the air-vents 14 are all identical, formed at the same axial location, and regularly distributed (at even angle) around the axis X-X. This permits to obtain an even distribution of the efforts and stresses on the capsule parts due to the air pressure build-up during joining, and thus minimize the risks of unwanted deformations.
It has been determined that a preferred number of such air-vents 14 on the body is within the range of 4 to 10, and most preferably equal to 8.
With reference to
As previously explained, the manufacturing process of the capsule 1 typically comprises, after the step of separately moulding the body 2 and the cap 3, a step of placing these two parts 2, 3 in a pre-closed position—illustrated on FIGS. 2A and 3A—for safe transfer to a filling station. In the filling station, the capsule 1 is reopened by separation of the capsule parts 2, 3 (by application of a relatively low separation effort). The body is kept in a vertical position, filled with the dosage (with liquid dosage in the most advantageous applications of the invention), and then the cap 3 is re-engaged on the body 2 to the fully closed final position—illustrated on
As visible on
During the closure of the capsule 1 after filling, i.e. in the process of moving the cap 3 on the body 2 from the pre-closed position (
The air escape is allowed until a very late stage of mutual engagement i.e. until the ridge 21 falls into the locking ring 12, while the capsule 1 is very efficiently closed and made air-tight as soon as the closed position is reached. This is very beneficial for ensuring both that the capsule will not be leaking during the transfer to a sealing machine and that no deformation (and subsequently leak) will occur at a later stage due to the pressure build-up in the capsule.
Once filled and closed as described above, the capsule is ready for transfer to a sealing machine. As visible on
A second illustrative embodiment of the invention is shown on
This embodiment only differs from the first one in that the body 102 of the capsule 101 has air-vents 114 which axially extend across the locking ring 12, from the open end 5 of the body 102 into an area comprised between the locking ring 12 and the contact section 33. Although they are of an increased length by comparison with the air-vents 14, the air-vents 114 are similarly designed so as to not interfere with the contact surface 33. It means that the contact surface 33 is continuous over the circumference of the body 102 and not interrupted by the air-vents 114. This is made clear on
It will be appreciated that the other features of the capsule described with reference to the first embodiment may similarly apply to this second embodiment and need not to be repeated. This is also the case for the description of the air-vents function, which is similar to the description made with reference to the first embodiment and will accordingly not be repeated.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2009/051880 | 5/7/2009 | WO | 00 | 11/10/2010 |
Publishing Document | Publishing Date | Country | Kind |
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WO2009/138920 | 11/19/2009 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
5769267 | Duynslager et al. | Jun 1998 | A |
20070036830 | Vanquickenborne et al. | Feb 2007 | A1 |
20070184077 | Vanquickenborne et al. | Aug 2007 | A1 |
Number | Date | Country |
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WO9717049 | May 1997 | WO |
Entry |
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Stegemann, S. Hard gelatin capsules today—and tomorrow. Capsugel, 2nd edition, 2002. |
Number | Date | Country | |
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20110064802 A1 | Mar 2011 | US |
Number | Date | Country | |
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61052277 | May 2008 | US |