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WO2008141861A1 - Gélule destinée à contenir une substance et procédé de fabrication d'une telle gélule - Google Patents

Gélule destinée à contenir une substance et procédé de fabrication d'une telle gélule Download PDF

Info

Publication number
WO2008141861A1
WO2008141861A1 PCT/EP2008/054186 EP2008054186W WO2008141861A1 WO 2008141861 A1 WO2008141861 A1 WO 2008141861A1 EP 2008054186 W EP2008054186 W EP 2008054186W WO 2008141861 A1 WO2008141861 A1 WO 2008141861A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
cover element
medium
lid
fixed
Prior art date
Application number
PCT/EP2008/054186
Other languages
German (de)
English (en)
Inventor
Ralf Schmied
Torsten Grass
Original Assignee
Robert Bosch Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Robert Bosch Gmbh filed Critical Robert Bosch Gmbh
Priority to EP08735917A priority Critical patent/EP2152222A1/fr
Publication of WO2008141861A1 publication Critical patent/WO2008141861A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/072—Sealing capsules, e.g. rendering them tamper-proof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074—Filling capsules; Related operations

Definitions

  • the present invention relates to a capsule for receiving a medium, in particular a powdery or liquid medium, and a method for producing such a capsule.
  • Capsules for receiving powdered or liquid media are known, for example, from the pharmaceutical field.
  • the known capsules in this case have an oval-cylindrical shape and comprise a lower capsule part and a capsule upper part, which is inserted over the lower capsule part. Inside the capsule, for example, the drug is arranged.
  • the known capsules are made of gelatin or the like, for example. produced and release after taking the drug in the digestive tract. Recently, applications are increasingly in demand, in which liquid media should be arranged in such capsules. In the case of the conventional capsules, however, the problem arises that the liquid can escape relatively easily through the gap, which is present in the overlapping region between the capsule upper part and the capsule lower part, to the outside.
  • the known capsules have the disadvantage that they can be opened relatively easily by the capsule shell can be removed from the capsule base. This results in the possibility of manipulation of the medium received in the capsule. In order to avoid such manipulations, it would be conceivable to fix, for example, at the interface between the capsule top and the capsule base an annular circumferential band. However, this is on the one hand relatively expensive and on the other hand may result in problems in taking the capsules due to difficult swallowing of the capsule.
  • DE 101 37 054 A1 also discloses a method for welding plastic capsules for inhalers, which are used in particular in inhalers.
  • capsules are not suitable for medication use.
  • the capsule according to the invention for receiving a medium with the features of
  • Claim 1 has the advantage that it ensures a secure recording of the medium in the capsule.
  • the capsule comprises a capsule lower part, in which the medium is arranged, a capsule upper part and a lid member.
  • the lid member closes the opening of the capsule lower part, so that the medium therein is enclosed and can not get to the outside.
  • the capsule top can then be arranged in a known manner on the capsule base, for example by sliding.
  • the capsule according to the invention has a lid element directly on the capsule lower part and a capsule upper part, which practically provides a second slipped-over cover for the capsule lower part.
  • the cover element can be attached by means of any joining method on the capsule base to close the capsule bottom tightly.
  • the lid member is disposed on an upper edge of the capsule lower part.
  • the opening of the capsule lower part is directly on the upper
  • Cover element arranged on an inner peripheral portion of the capsule lower part.
  • the lid member comprises a step portion, wherein the step portion of the lid member comprises a horizontal surface for fixing to the upper edge of the capsule lower part and a vertical surface for fixing to the inner peripheral portion of the capsule lower part. This allows a particularly secure fixation and sealing of the
  • Capsule lower parts are achieved by the lid member.
  • the cover element has a spherical segment shape, in particular a hemispherical shape, wherein a dome-like projecting region of the spherical segment shape is directed towards the inside of the capsule lower part. It can thereby be achieved that the capsule lower part closed with the cover element still has sufficient flexibility when the cover element is fixed to the capsule lower part. On the other hand, if the cover element is formed only in a planar manner, the capsule lower part is relatively stiff after a fixation of the cover element on the capsule lower part. There is a risk that in a further handling the capsule or the
  • Capsule bottom is easily damaged.
  • the capsule top is fixed to the capsule base. This can be done for example by gluing or welding. This can ensure that the capsule is sealed tamper-proof.
  • the upper part of the capsule is particularly preferably fixed to the lower part of the capsule at two opposite areas, for example by means of spot welding or the like.
  • the cover element, the lower part of the capsule and the upper part of the capsule are made of the same material.
  • the parts of the capsule are preferably made of gelatin.
  • a method of joining the cover element to the capsule base can then be accomplished, for example, by gluing or welding with ultrasound, heat or friction or the like. be enabled.
  • the capsule has no visible geometric or dimensional changes to the outside.
  • the capsule can thus comply with the known dimensions.
  • Capsule having the features of the independent method claim comprises the steps of filling a capsule lower part with a medium, closing the filled capsule lower part by means of a lid element and disposing a capsule top part on the capsule lower part.
  • the capsule shell can, for example, by placing or plugging or sliding over o. be arranged on the capsule base.
  • the cover element is more preferably separated out of a flat band and at the same time fixed on the capsule lower part.
  • the cover element may be made of a flat strip material, e.g. welded or punched out, and directly onto the capsule base e.g. be fixed by gluing or welding.
  • the cover element is particularly preferably fixed to the lower part of the capsule by means of welding, in particular by means of ultrasonic welding, or by gluing.
  • the lid member is fixed to the upper edge of the capsule lower part and / or the lid member at an inner peripheral portion of the capsule lower part.
  • one or two-point welds are particularly preferably carried out.
  • the spot welds are arranged opposite each other.
  • FIG. 1 shows a schematic sectional view of a capsule lower part with cover according to a first embodiment of the invention
  • Figure 2 is a perspective view of a capsule of the first
  • FIG. 3 shows a schematic sectional view of a capsule lower part according to a second exemplary embodiment of the present invention
  • FIG. 4 shows a schematic sectional view of a capsule lower part according to a third exemplary embodiment of the present invention
  • FIG. 5 shows a schematic sectional view of a capsule lower part according to a fourth exemplary embodiment of the present invention
  • FIG. 6 is a perspective view of a capsule according to a fifth embodiment of the present invention.
  • Figure 7 is a perspective view of a capsule according to a sixth
  • FIG. 8 shows a schematic sectional view of an apparatus for producing a capsule according to the first exemplary embodiment
  • Figure 9 is a schematic sectional view of an alternative device for
  • Figure 10 is a schematic sectional view of an apparatus according to another alternative for producing a capsule according to the first embodiment
  • Figure 11 is a schematic sectional view of an apparatus for producing a capsule according to the first exemplary embodiment.
  • the capsule 1 comprises a capsule lower part 3 and a capsule upper part 4.
  • the capsule lower part 3 in this case has a substantially cylindrical
  • the capsule base 3 has an upper edge 3a at the opposite end to the hemispherical termination.
  • An inner peripheral region of the capsule lower part 3 is identified by the reference symbol 3b.
  • the capsule lower part 3 is filled with a medium 2, which, for example, a powdered or a liquid medicament or an oil o.a. can be.
  • the capsule 1 further comprises a cover 5, which is fastened on the capsule lower part 3 and closes this medium-tight.
  • the lid is placed on the upper edge 3a of the capsule lower part 3 and welded to the upper edge. As a result, the tightness of the capsule lower part 3 with cover 5 is ensured.
  • the lid can alternatively be glued or with any other
  • Joining method can be mounted on the upper edge 3a of the capsule base.
  • the capsule base 3 is thus first provided, then this is filled with the medium 2 and then the lid 5 is fixed on the upper edge 3a of the capsule lower part. In a next step then becomes
  • the capsule 1 has the known from other applications form, but the tightness of the capsule 1 by using the lid 5 is significantly improved.
  • the lid 5 is not visible from the outside.
  • a medium which has been able to escape between the inner wall of the capsule upper part 4 and the outer wall of the capsule lower part 3 in the prior art is held securely in the capsule lower part 3 by the cover 5 in the present invention.
  • the handling of the lower capsule part 3 is further simplified when it is filled with the medium 2.
  • the lid 5 is preferably in a next step after filling the capsule lower part 3 with the medium 2 on the capsule part. 3 applied.
  • the subsequent handling can be significantly simplified, since in particular no longer the orientation of the capsule lower part 3 in the subsequent handling must be strictly adhered to, since the lower part of the capsule 3 is sealed by the lid 5.
  • the capsule lower part 3, the capsule upper part 4 and the cover 5 are preferably made of the same material, in particular gelatin. In this way, a simple attachment of the lid 5 on the capsule lower part 3, for example, by moistening the upper edge 3 and sticking the lid 5, are made possible.
  • the upper edge 3 a of the capsule lower part 3 and a surface of the lid 5 form a flat end surface.
  • the capsule shell 4 can be easily pushed onto the capsule base 3, without the risk of damage to the lid 5 is present. Otherwise, this embodiment corresponds to the previous embodiment, so that reference can be made to the description given there.
  • Figure 4 shows a capsule part 3 according to a third embodiment of the present invention, wherein the same or functionally identical parts are denoted by the same reference numerals as in the preceding embodiments.
  • the lid 5 of the third embodiment has an annular horizontal surface 5a and an annular vertical surface 5b.
  • the lid 5 thus has a gradation, wherein the horizontal surface 5 a in the fixed state of the lid with an upper edge 3 a of the capsule lower part 3 is connected and the vertical
  • FIG. 5 shows a lower part of a capsule according to a fourth exemplary embodiment of the present invention, wherein in turn identical or functionally identical parts are designated by the same reference numerals as in the preceding exemplary embodiments.
  • the fourth embodiment is constructed similarly to the second embodiment, wherein the lid 5 is fixed to an inner peripheral portion 3b of the capsule lower part 3.
  • the lid 5 of the fourth embodiment has a hollow spherical portion shape with a protruding portion 5c being disposed inside the capsule base 3.
  • the sealed with the lid 5 capsule base 3 thus no longer has a flat surface in the region of the lid, but a part-spherical recess corresponding to the shape of the spherical segment shape of the lid 5.
  • the use of such a spherical segment shape as a cover 5 has the advantage that after attachment of the lid 5 on the capsule base still sufficient flexibility of the capsule part 3 is maintained.
  • Capsule bottoms occur. This stiffening is not present in the closed capsule lower part of the fourth embodiment.
  • FIG. 6 shows a capsule 1 according to a fifth exemplary embodiment of the present invention.
  • the capsule 1 of the fifth embodiment substantially corresponds to that of the first embodiment, wherein additionally the capsule upper part 4 is fixed to the capsule lower part 5 by means of a first connection point 6 and a second connection point 7.
  • the capsule top and the capsule bottom are firmly connected to each other, so that a removal of the capsule shell of the capsule base is possible only with destruction of the two connection points 6, 7.
  • the two connection points 6, 7 are arranged at opposite positions at approximately the same height.
  • the capsule 1 is particularly tamper-proof, ie, the capsule top can not be removed from the capsule base without destroying the connection points 6, 7.
  • FIG. 7 shows a capsule 1 according to a sixth embodiment of the present invention, which substantially corresponds to the capsule of the fifth embodiment.
  • the capsule of the sixth embodiment instead of connecting points in each case a first connecting line 8 and a second connecting line 9.
  • the two connecting lines 8, 9 are arranged opposite one another and fix the capsule upper part 4 securely on the lower capsule part 3.
  • this embodiment corresponds to the previous exemplary embodiment, so that reference can be made to the description given there.
  • Figures 8 to 11 show schematic devices with which a production of a capsule according to the invention is possible.
  • Figures 8 to 11 show the process of attachment of the lid 5 on the capsule part 3.
  • the apparatus of Figure 8 comprises a holder 11, on which the filled capsule base 3 is held, a movable plunger 12 and a Stationary sonotrode 13.
  • the lid 5 is thereby separated from a gelatin band 15, which is guided between the sonotrode 13 and the holder 11, and simultaneously welded onto the upper edge 3 a of the capsule lower part 3.
  • the capsule lower part 3 is pushed by means of the movable plunger 12, as indicated by the arrow A, up against the gelatin ribbon 15 until the gelatin ribbon 15 comes into contact with the sonotrode 13.
  • the gelatin strip 13 is welded to the upper edge 3 a of the capsule lower part 3 and at the same time separates the upwardly pressing capsule base
  • Figure 9 shows an alternative of a manufacturing method, wherein in this embodiment, a plunger 22 is stationary and a sonotrode 23 is movable.
  • the movable sonotrode 23 as indicated by the arrow B, pressed down, so that the gelatin ribbon 15 is pressed onto the upper edge 3 a of the capsule lower part 3.
  • the lid 5 is also simultaneously separated out of the gelatin band 15 and welded onto the upper edge 3a of the capsule lower part.
  • FIG. 10 shows a further alternative for producing a sealed capsule lower part, wherein in this method, in turn, the sonotrode 23 is movable and the plunger 22 is stationary.
  • the sonotrode 23 has a central opening 23a which bears a negative pressure, so that, as indicated by the arrows C, the gelatin ribbon 15 is sucked against the sonotrode 23.
  • the gelatin band 15 can be held on the sonotrode 23.
  • a die 24 is provided, through which then the gelatin ribbon is pushed through the movable sonotrode 23.
  • the lid is again separated from the gelatin ribbon 15 and simultaneously welded onto the upper edge 3 a of the capsule lower part 3.
  • the method shown in Figure 11 is similar to the method shown in Figure 10, in contrast, the die 24 has a plurality of holes 25 through which a
  • Adhesive can be supplied.
  • the reference numeral 26 denotes a movable punch, which, as indicated by the arrow D, is movable downwards.
  • the gelatin ribbon 15 is sucked in again, as indicated by the arrows C, against the plunger 26 by means of a negative pressure and the plunger shears a lid out of the gelatin ribbon 15 as soon as it is level with the die 24.
  • the punch 26 is guided further downwards, so that the lid sheared off from the gelatin strip 15 comes into contact with the adhesive supplied through the bores 25 on its outer circumference.
  • the outer peripheral edge of the lid is wetted with adhesive, and the punch 26 is further moved downward until the lid is in contact with an inner peripheral portion 3b of the capsule base 3.
  • the movement of the punch 26 is such that a
  • the capsules according to the invention are used in particular in the pharmaceutical sector for the intake of conclusive medicaments or oils. But there are others too

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Gélule destinée à contenir une substance (2), qui comporte une partie inférieure (3) dans laquelle la substance (2) est contenue, une partie supérieure (4) et un élément bouchon (5). La partie inférieure et la partie supérieure de la gélule forment une enveloppe externe de la gélule et l'élément bouchon ferme la partie inférieure (3) de la gélule de manière étanche. La présente invention concerne en outre un procédé de fabrication d'une telle gélule.
PCT/EP2008/054186 2007-05-22 2008-04-08 Gélule destinée à contenir une substance et procédé de fabrication d'une telle gélule WO2008141861A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08735917A EP2152222A1 (fr) 2007-05-22 2008-04-08 Gélule destinée à contenir une substance et procédé de fabrication d'une telle gélule

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102007023399.1 2007-05-22
DE102007023399A DE102007023399A1 (de) 2007-05-22 2007-05-22 Kapsel zur Aufnahme eines Mediums sowie Verfahren zur Herstellung einer derartigen Kapsel

Publications (1)

Publication Number Publication Date
WO2008141861A1 true WO2008141861A1 (fr) 2008-11-27

Family

ID=39581856

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/054186 WO2008141861A1 (fr) 2007-05-22 2008-04-08 Gélule destinée à contenir une substance et procédé de fabrication d'une telle gélule

Country Status (3)

Country Link
EP (1) EP2152222A1 (fr)
DE (1) DE102007023399A1 (fr)
WO (1) WO2008141861A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3545937A1 (fr) * 2018-03-28 2019-10-02 Harro Höfliger Verpackungsmaschinen GmbH Capsule pour cupules pour cachets et système de capsules

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3167867A1 (fr) * 2015-11-16 2017-05-17 Capsugel Belgium NV Forme posologique inviolable
EP3167868A1 (fr) * 2015-11-16 2017-05-17 Capsugel Belgium NV Forme posologique inviolable

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE7709877U1 (de) * 1977-03-29 1978-09-21 Capsugel Ag Mit viskosem Stoff insbesondere fluessigem Arzneimittel gefuellte Steckkapsel
DE3227432C1 (de) * 1982-07-22 1983-10-27 Etablissement Dentaire Ivoclar, Schaan Mischbehaelter
WO1994009745A1 (fr) * 1992-11-05 1994-05-11 R.P. Scherer Corporation Structure de capsule
WO2004010978A1 (fr) * 2002-07-25 2004-02-05 Glaxo Group Limited Forme posologique pharmaceutique a multicomposants

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2722807A1 (de) * 1977-05-20 1978-11-23 Capsugel Ag Verfahren zum herstellen einer mit viskosem stoff gefuellten steckkapsel
US4738724A (en) * 1983-11-04 1988-04-19 Warner-Lambert Company Method for forming pharmaceutical capsules from starch compositions
IT1207675B (it) 1987-04-27 1989-05-25 Mg 2 Spa To farmaceutico macchina per l'umettatura di un coperchio da fissare su un fondello riempito per esempio con un prodot-
US4936074A (en) * 1988-11-17 1990-06-26 D. M. Graham Laboratories, Inc. Process for preparing solid encapsulated medicament
DE10137054A1 (de) 2001-07-28 2003-02-13 Boehringer Ingelheim Pharma Verfahren zum Verschweißen von medizinischen Kapseln für die Inhalation, Inhalationskapseln und Apparat zum Verschweißen

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE7709877U1 (de) * 1977-03-29 1978-09-21 Capsugel Ag Mit viskosem Stoff insbesondere fluessigem Arzneimittel gefuellte Steckkapsel
DE3227432C1 (de) * 1982-07-22 1983-10-27 Etablissement Dentaire Ivoclar, Schaan Mischbehaelter
WO1994009745A1 (fr) * 1992-11-05 1994-05-11 R.P. Scherer Corporation Structure de capsule
WO2004010978A1 (fr) * 2002-07-25 2004-02-05 Glaxo Group Limited Forme posologique pharmaceutique a multicomposants

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3545937A1 (fr) * 2018-03-28 2019-10-02 Harro Höfliger Verpackungsmaschinen GmbH Capsule pour cupules pour cachets et système de capsules
CN110314096A (zh) * 2018-03-28 2019-10-11 德国翰辉包装机械有限责任公司 用于插塞胶囊的胶囊套管和套管系统
CN110314096B (zh) * 2018-03-28 2022-06-14 德国翰辉包装机械有限责任公司 用于插塞胶囊的胶囊套管和套管系统
US11369546B2 (en) 2018-03-28 2022-06-28 Harro Hoefliger Verpackungsmachinen Gmbh Capsule socket for two-piece capsules and socket system

Also Published As

Publication number Publication date
EP2152222A1 (fr) 2010-02-17
DE102007023399A1 (de) 2008-11-27

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