EP0225565A2 - Divisible capsule - Google Patents

Divisible capsule Download PDF

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Publication number
EP0225565A2
EP0225565A2 EP86116604A EP86116604A EP0225565A2 EP 0225565 A2 EP0225565 A2 EP 0225565A2 EP 86116604 A EP86116604 A EP 86116604A EP 86116604 A EP86116604 A EP 86116604A EP 0225565 A2 EP0225565 A2 EP 0225565A2
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EP
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Prior art keywords
partial
capsules
capsule
divisible
capsule according
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Granted
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EP86116604A
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German (de)
French (fr)
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EP0225565A3 (en
EP0225565B1 (en
Inventor
Bernhard Dr. Freund
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Boehringer Ingelheim International GmbH
Boehringer Ingelheim GmbH
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Boehringer Ingelheim International GmbH
Boehringer Ingelheim GmbH
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Priority to AT86116604T priority Critical patent/ATE63215T1/en
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Publication of EP0225565A3 publication Critical patent/EP0225565A3/en
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    • 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

Definitions

  • the invention relates to a divisible capsule and to processes for its production.
  • Hard gelatin capsules are preferably used for dosing solidifying, highly viscous, powdered, granulated and, in special cases, tablet-shaped pharmaceutical preparations.
  • divisible forms for more flexible dosing are known in other galenical preparations, e.g. Divisible tablets, divisible soft gelatin capsules, the development of an inexpensively manufactured divisible hard gelatin capsule failed due to the special characteristics of this galenic form.
  • a divisible capsule which consists of two elongated partial capsules each with a semicircular cross section, which after filling with a drug are connected to form a capsule of the usual shape.
  • the special feature of the divisible hard gelatin capsule described is the specially shaped partial capsule of conventional length, but with a semicircular cross-section, the area of which is slightly smaller than half the circular cross-sectional area of the fully assembled capsule
  • the separable capsule can be in the following embodiments:
  • the two partial capsules (2) are inserted in an outer capsule (6a) with at least twice the length of a partial capsule (2), the outer capsule not being provided with a safety closure (Fig. I), so that the capsule can be opened and closed is possible without damage.
  • the two small partial capsules (2) are connected by a cylindrical envelope (6b) made of a pharmaceutically acceptable material (Fig. IIa, b, c).
  • This covering can consist of a tubular cylinder (6b) made of hard gelatin with a circular or elliptical cross-section, the cross-section of which is somewhat larger than that of the partial capsules (2), the partial capsule being connected in the form of a plug (Fig. IIa).
  • the separable capsule (1) can be divided by simply pulling apart the partial capsules (2), the safety closures (7) preventing the shell of the partial capsules (2) from being opened during the dividing process.
  • the cylinder (6c) can be provided with a predetermined breaking point (8), for example by perforation or an easily tearable band or thread for easy division of the capsule.
  • the partial capsules (2) can be glued to the cylinder (6c).
  • the material of the cylinder can be such that it becomes immediately soft and flexible when used with a liquid, for example saliva, so that even a divided capsule can be swallowed without problems.
  • the partial capsules (2) are covered by a covering (6d) made of a pharmaceutically acceptable, shrinkable film.
  • the covering can be designed in such a way that it completely or partially surrounds the outer surface of the partial capsules.
  • the breaking point (9) is formed by the shrinking process on the end faces (5) of the subcapsules and can, if necessary, be taken by further measures, e.g. Perforation, further weakened.
  • the upper and lower parts of each partial capsule (2) even after the division, are firmly connected to one another by the covering made of the shrunk film, so that the capsule cannot be opened without being destroyed.
  • the use of the so-called "safety capsules" is not necessary for reasons of pharmaceutical safety.
  • a larger number of capsules can be combined to form a unit by means of a shrinkable covering, so that the patient cancels out appropriate portions depending on the dosage required.
  • the partial capsules (2) are connected via the end faces (5) of their lower and upper parts or their side parts by a pharmaceutically acceptable adhesive (10).
  • a pharmaceutically acceptable adhesive 10
  • Fig. III and IV Corresponding adhesives are known from the prior art.
  • the gelatin capsules can also be connected using ultrasound techniques.
  • a particular advantage of the divisible capsule according to the invention is that the partial capsule is available, for example, under the trade name "Suprokapsel". Elaborate special shapes of the partial capsules are not necessary.
  • the partial capsules can thus be filled and sealed using the standardized, commercially available filling machines.
  • the individual subcapsules can be made of different materials in a separable capsule.
  • the time at which the active ingredient is released can be influenced by a suitable selection of the composition of these materials.
  • Corresponding materials are known from the prior art. This is of particular interest if the active substances in combination preparations are to be released in a predeterminable sequence. By dividing the capsule, an individual adjustment of the dosage to the patient is also possible. Appropriate coloring of the capsules almost eliminates the risk of confusion by the patient.
  • Drug combinations that react chemically with each other i.e. are incompatible can be filled separately in a simple manner and then combined to form a capsule with two partial capsules.
  • the divisible capsules consisting of at least two partial capsules, can be produced as follows:
  • a separable capsule according to embodiment A is produced by inserting the two partial capsules into the lower part of the outer capsule and then applying the upper closure part.
  • a known technique can be used, as is used when inserting film-coated tablets in capsules.
  • a separable capsule of embodiment B is produced, for example, as follows:
  • the already filled partial capsules are aligned on a vibrating trough and placed transversely on a conveyor belt.
  • Two opposing belts transport the partial capsules to a filling station, in the middle of which the cylindrical shell (6b, c) is laid out.
  • Two tappets or the narrowing band side parts push the partial capsules into the cylindrical casing (6b, c) from both sides.
  • the cylindrical covering (6c) can be made with an easily tearable band or thread (8) or with a predetermined breaking point (8), e.g. in the form of a perforation.
  • a pharmaceutically acceptable adhesive can be applied before the partial capsules are put together, so that the partial capsules are firmly connected to the casing.
  • a separable capsule which is surrounded by a shrinkable film as a covering (6d), can be produced as follows:
  • the already filled partial capsules are placed on a conveyor belt on a belt made of a shrinkable film and aligned if necessary, then the film is guided through auxiliary devices in such a way that the film lies in a funnel shape around the partial capsules until they are completely enveloped by the film, where the top and bottom of the shrinkable film can partially overlap.
  • the film is welded to a tube that is close to the capsules; subsequently auxiliary devices, e.g. a perforation (9) can be attached for a later better division.
  • auxiliary devices e.g. a perforation (9) can be attached for a later better division.
  • shrinking takes place, whereby the partial capsule and the wrapping combine to form a solid unit. After dividing the capsule chains into a desired subset with two or more subcapsules, shrinking is again possible in order to remove any burrs that may have arisen during the division.
  • a separable capsule of embodiment C is produced as follows:
  • the filled partial capsules are brought together as described under b), the end faces together and connected to one another with a drop of a pharmacologically acceptable adhesive.
  • a pharmacologically acceptable adhesive is suitable for the adhesive: gelatin, gelatinized starch, hydroxypropylmethyl cellulose, hydroxypropyl cellulose, cellulose ether, polyvinylpyrrolidone, polyacrylates.
  • methods other than that described under b) can also be used to bring the two partial capsules together.

Abstract

A divisible capsule for highly viscous, pulverulent, granulated or tablet-shaped drug formulations and process for the preparation thereof.

Description

Die Erfindung betrifft eine teilbare Kapsel sowie Verfahren zu ihrer Herstellung.The invention relates to a divisible capsule and to processes for its production.

Für die Dosierung erstarrender, hochviskoser, pulverförmiger, granulierter und in Sonderfällen auch tablettenförmiger Arzneimittelzubereitungen werden vorzugsweise Hartgelatine-Kapseln eingesetzt.Hard gelatin capsules are preferably used for dosing solidifying, highly viscous, powdered, granulated and, in special cases, tablet-shaped pharmaceutical preparations.

Während bei anderen galenischen Zubereitungen teilbare Formen zur flexibleren Dosierbarkeit bekannt sind, wie z.B. teilbare Tabletten, teilbare Weichgelatine-Kapseln, scheiterte die Entwicklung einer kostengünstig herstellbaren teilbaren Hartgelatine-Kapsel an den besonderen Eigenarten dieser galenischen Form.While divisible forms for more flexible dosing are known in other galenical preparations, e.g. Divisible tablets, divisible soft gelatin capsules, the development of an inexpensively manufactured divisible hard gelatin capsule failed due to the special characteristics of this galenic form.

Ein einfaches Teilen der länglichen Hartgelatine-Kapsel in zwei Hälften ähnlich wie bei Tabletten mit Bruchrillen, ist aus naheliegenden Gründen nicht möglich, da bei einem Öffnen der Hartgelatine-Kapsel eine exakte Dosierung des Arzneimittels nicht mehr gewährleistet ist und die zurückbleibende zweite Dosis nicht mehr sicher aufbewahrt werden kann. Zudem sind viele Kapseln mit einem Sicherheitsverschluß versehen, der sich nur unter Zerstörung der Kapsel öffnen läßt.For obvious reasons, it is not possible to simply split the elongated hard gelatin capsule in half, similar to tablets with broken grooves, since opening the hard gelatin capsule no longer guarantees an exact dosage of the drug and the second dose that remains is no longer safe can be kept. In addition, many capsules are provided with a safety lock that can only be opened by destroying the capsule.

Aus der DE-OS 33 40 262 ist eine teilbare Kapsel bekannt, die aus zwei länglichen mit je halbkreisförmigem Querschnitt bestehenden Teilkapseln besteht, die nach dem Füllen mit einem Arzneimittel zu einer Kapsel üblicher Form verbunden werden. Das besondere Merkmal der beschriebenen teilbaren Hartgelatine-Kapsel ist die besonders geformte Teilkapsel üblicher Länge, aber mit einem halbkreisförmigen Querschnitt, dessen Fläche etwas kleiner ist als die Hälfte der kreisförmigen Querschnittsfläche der fertig montierten KapselFrom DE-OS 33 40 262 a divisible capsule is known, which consists of two elongated partial capsules each with a semicircular cross section, which after filling with a drug are connected to form a capsule of the usual shape. The special feature of the divisible hard gelatin capsule described is the specially shaped partial capsule of conventional length, but with a semicircular cross-section, the area of which is slightly smaller than half the circular cross-sectional area of the fully assembled capsule

Im Gegensatz zu der in der DE-OS beschriebenen Ausführungsform sind die im Handel erhältlichen Kapselformen im allgemeinen standardisiert, wobei die oben beschriebenen Ausführungsformen gegebenenfalls als Sonderanfertigungen hergestellt werden müßten. Dies ist nur durch beträchtliche zusätzliche Aufwendungen an den Maschinen möglich.In contrast to the embodiment described in DE-OS, the commercially available capsule forms are generally standardized, the embodiments described above possibly having to be manufactured as custom-made products. This is only possible through considerable additional expenditure on the machines.

Es ist die Aufgabe der vorliegenden Erfindung, eine teilbare Kapsel unter Verwendung herkömmlichen Kapselmaterials bereitzustellen, sowie Verfahren zu deren Herstellung.It is the object of the present invention to provide a divisible capsule using conventional capsule material, as well as methods for its production.

Es ist eine weitere Aufgabe der vorliegenden Erfindung, eine galenische Form zur Applikation von Arzneimittel­kombinationen bereitzustellen, die inkompatibel sind. Eine weitere Aufgabe ist die Schaffung eines Arzneimitteldepots mit verzögerter Freisetzungsrate.It is a further object of the present invention to provide a pharmaceutical form for the application of drug combinations that are incompatible. Another task is to create a drug depot with a delayed release rate.

Es wird eine teilbare Kapsel (1) aus mindestens zwei länglichen Teilkapseln (2) mit kreisförmigen oder ellipsoiden Querschnitt entlang der Achse aa vorgeschlagen, wobei die Teilkapseln (2) aus einem Unterteil (3) und einem hierauf aufgesteckten Oberteil (4) bestehen und längs einer gemeinsamen Längsachse angeordnet sind und

  • a) über ihre Stirnseiten (5) oder ihre Längsseiten (Fig. IV) durch ein pharmazeutisch unbedenkliches Klebemittel verbunden sind,
    oder
  • b) eine gemeinsame, die Teilkapseln ganz oder teilweise umschließende Umhüllung (6) aufweisen.
The invention proposes a separable capsule (1) consisting of at least two elongated partial capsules (2) with a circular or ellipsoidal cross-section along the axis aa, the partial capsules (2) consisting of a lower part (3) and an upper part (4) attached to them and along a common longitudinal axis are arranged and
  • a) are connected via their end faces (5) or their long sides (Fig. IV) by a pharmaceutically acceptable adhesive,
    or
  • b) a common covering (6) which completely or partially encloses the partial capsules.

Erfindungsgemäß kann die teilbare Kapsel in folgenden Ausführungsformen vorliegen:According to the invention, the separable capsule can be in the following embodiments:

A) Die beiden Teilkapseln (2) sind in einer äußeren Kapsel (6a) mit mindestens doppelter Länge einer Teilkapsel (2) eingesteckt, wobei die äußere Kapsel nicht mit einem Sicherheitsverschluß versehen ist (Abb I), so daß ein Öffnen und Schließen der Kapsel ohne Beschädigung möglich ist.A) The two partial capsules (2) are inserted in an outer capsule (6a) with at least twice the length of a partial capsule (2), the outer capsule not being provided with a safety closure (Fig. I), so that the capsule can be opened and closed is possible without damage.

B) In einer weiteren Ausführungsform sind die beiden kleinen Teilkapseln (2) durch eine zylinderförmige Umhüllung (6b) aus einem pharmazeutisch unbedenklichen Material verbunden (Abb. IIa,b,c).B) In a further embodiment, the two small partial capsules (2) are connected by a cylindrical envelope (6b) made of a pharmaceutically acceptable material (Fig. IIa, b, c).

Diese Umhüllung kann aus einem rohrförmigen Zylinder (6b) aus Hartgelatine mit kreisförmigen oder elliptischen Querschnitt bestehen, dessen Querschnitt etwas größer ist als der der Teilkapseln (2), wobei die Teilkapsel steckförmig verbunden sind (Abb. IIa). Die teilbare Kapsel (1) kann durch einfaches Auseinanderziehen der Teilkapseln (2) geteilt werden, wobei die Sicherheitsverschlüsse (7) verhindern, daß die Hülle der Teilkapseln (2) beim Teilungsvorgang geöffnet werden.This covering can consist of a tubular cylinder (6b) made of hard gelatin with a circular or elliptical cross-section, the cross-section of which is somewhat larger than that of the partial capsules (2), the partial capsule being connected in the form of a plug (Fig. IIa). The separable capsule (1) can be divided by simply pulling apart the partial capsules (2), the safety closures (7) preventing the shell of the partial capsules (2) from being opened during the dividing process.

In einer besonderen Ausführungsform kann der Zylinder (6c) mit einer Sollbruchstelle (8), beispielsweise durch Perforation oder einem leicht reißbaren Band oder Faden zur einfachen Teilung der Kapsel versehen werden. In diesem Fall können die Teilkapseln (2) mit dem Zylinder (6c) verklebt sein.In a special embodiment, the cylinder (6c) can be provided with a predetermined breaking point (8), for example by perforation or an easily tearable band or thread for easy division of the capsule. In this case, the partial capsules (2) can be glued to the cylinder (6c).

Das Material des Zylinders kann so beschaffen sein, daß es durch Benutzung mit einer Flüssigkeit, beispielsweise Speichel, sofort weich und flexibel wird, so daß auch eine geteilte Kapsel problemlos zu schlucken ist.The material of the cylinder can be such that it becomes immediately soft and flexible when used with a liquid, for example saliva, so that even a divided capsule can be swallowed without problems.

In noch einer anderen Ausführungsform sind die Teilkapseln (2) von einer Umhüllung (6d) aus einer pharmazeutisch unbedenklichen, schrumpffähigen Folie überzogen. Die Umhüllung kann derart gestaltet sein, daß sie die äußere Fläche der Teilkapseln vollständig oder teilweise umschließt. Die Bruchstelle (9) ist durch den Schrumpfungsprozess an den Stirnseiten (5) der Teilkapseln vorgebildet und kann gegebenenfalls durch weitere Maßnahme, z.B. Perforation, weiter geschwächt werden. Bei dieser Ausführungsform sind bei jeder Teilkapsel (2), auch nach der Teilung, Ober- und Unterteil durch die Umhüllung aus der geschrumpften Folie fest miteinander verbunden, so daß die Kapsel ohne Zerstörung nicht geöffnet werden kann. Bei dieser Ausführungsform ist die Verwendung der sogenannten "Sicherheitskapseln" aus Gründen der Arzneimittelsicherheit nicht erforderlich.In yet another embodiment, the partial capsules (2) are covered by a covering (6d) made of a pharmaceutically acceptable, shrinkable film. The covering can be designed in such a way that it completely or partially surrounds the outer surface of the partial capsules. The breaking point (9) is formed by the shrinking process on the end faces (5) of the subcapsules and can, if necessary, be taken by further measures, e.g. Perforation, further weakened. In this embodiment, the upper and lower parts of each partial capsule (2), even after the division, are firmly connected to one another by the covering made of the shrunk film, so that the capsule cannot be opened without being destroyed. In this embodiment, the use of the so-called "safety capsules" is not necessary for reasons of pharmaceutical safety.

Eine größere Anzahl von Kapseln kann durch eine schrumpffähige Umhüllung zu einer Einheit zusammengefaßt sein, so daß der Patient je nach benötigter Dosierung entsprechende Teilmengen abbricht.A larger number of capsules can be combined to form a unit by means of a shrinkable covering, so that the patient cancels out appropriate portions depending on the dosage required.

C) In einer anderen Ausführungsform sind die Teilkapseln (2) über die Stirnseiten (5) ihrer Unter- bzw. Oberteile oder ihrer Seitenteile durch ein pharmazeutisch unbedenkliches Klebemittel (10) verbunden. (Abb. III und IV). Entsprechende Klebstoffe sind aus dem Stand der Technik bekannt. Anstelle eines Klebestoffes können die Gelatinekapseln auch durch Ultraschalltechniken verbunden werden.C) In another embodiment, the partial capsules (2) are connected via the end faces (5) of their lower and upper parts or their side parts by a pharmaceutically acceptable adhesive (10). (Fig. III and IV). Corresponding adhesives are known from the prior art. Instead of an adhesive, the gelatin capsules can also be connected using ultrasound techniques.

Ein besonderer Vorteil der erfindungsgemäßen teilbaren Kapsel ist, daß die Teilkapsel beispielsweise unter dem Handelsnamen "Suprokapsel" erhältlich ist. Aufwendige Sonderformen der Teilkapseln sind nicht erforderlich. Die Teilkapseln können somit unter Verwendung der standardisierten handelsüblichen Abfüllautomaten gefüllt und verschlossen werden.A particular advantage of the divisible capsule according to the invention is that the partial capsule is available, for example, under the trade name "Suprokapsel". Elaborate special shapes of the partial capsules are not necessary. The partial capsules can thus be filled and sealed using the standardized, commercially available filling machines.

Falls erforderlich oder gewünscht, können die einzelnen Teilkapseln in einer teilbaren Kapsel aus verschiedenen Materialien bestehen. Durch eine geeignete Auswahl der Zusammensetzung dieser Materialien kann der Zeitpunkt der Wirkstofffreigabe beeinflußt werden. Entsprechende Materialien sind aus dem Stand der Technik bekannt. Dies ist besonders dann von Interesse, wenn bei Kombinationspräparaten die Wirkstoffe in zeitlich vorherbestimmbarer Reihenfolge freigesetzt werden sollen. Durch eine Teilung der Kapsel ist zusätzlich eine individuelle Anpassung der Dosierung an den Patienten möglich. Durch eine geeignete Farbgebung der Kapseln kann das Verwechslungsrisiko durch den Patienten nahezu ausgeschlossen werden.If necessary or desired, the individual subcapsules can be made of different materials in a separable capsule. The time at which the active ingredient is released can be influenced by a suitable selection of the composition of these materials. Corresponding materials are known from the prior art. This is of particular interest if the active substances in combination preparations are to be released in a predeterminable sequence. By dividing the capsule, an individual adjustment of the dosage to the patient is also possible. Appropriate coloring of the capsules almost eliminates the risk of confusion by the patient.

Arzneimittelkombinationen, die chemisch miteinander reagieren d.h. inkompatibel sind, können in einfacher Weise getrennt abgefüllt und anschließend zu einer Kapsel mit zwei Teilkapseln vereinigt werden.Drug combinations that react chemically with each other i.e. are incompatible, can be filled separately in a simple manner and then combined to form a capsule with two partial capsules.

Erfindungsgemäß können die teilbaren Kapseln, bestehend aus mindestens zwei Teilkapseln, wie folgt hergestellt werden:According to the invention, the divisible capsules, consisting of at least two partial capsules, can be produced as follows:

a) Eine teilbare Kapsel gemäß der Ausführungsform A wird durch Einlegen der beiden Teilkapseln in das Unterteil der äußeren Kapsel und anschließendem Aufbringen des Verschlußoberteils hergestellt. Hierbei kann auf eine bekannte Technik zurückgegriffen werden, wie sie beim Einlegen von Filmtabletten in Kapseln angewendet wird.a) A separable capsule according to embodiment A is produced by inserting the two partial capsules into the lower part of the outer capsule and then applying the upper closure part. Here, a known technique can be used, as is used when inserting film-coated tablets in capsules.

b) Eine teilbare Kapsel der Ausführungsform B wird beispielsweise wie folgt hergestellt:b) A separable capsule of embodiment B is produced, for example, as follows:

Die bereits gefüllten Teilkapseln werden auf einer Rüttelrinne ausgerichtet und quer auf einem Transportband abgelegt. Zwei gegenüberliegende Bänder transportieren die Teilkapseln vor eine Füllstation, in deren Mitte die zylinderförmige Hülle (6b,c) bereitgelegt wird. Zwei Stößel oder die sich verengenden Bandseitenteile schieben von beiden Seiten die Teilkapseln in die zylinderförmige Hülle (6b,c). Die zylinderförmige Umhüllung (6c) kann mit einem leicht reißbaren Band oder Faden (8) oder aber mit einer Sollbruchstelle (8), z.B. in Form einer Perforation, versehen sein. In diesem Fall kann vor dem Zusammenstecken der Teilkapseln ein pharmazeutisch unbedenklicher Kleber aufgetragen werden, so daß die Teilkapseln mit der Hülle fest verbunden werden.The already filled partial capsules are aligned on a vibrating trough and placed transversely on a conveyor belt. Two opposing belts transport the partial capsules to a filling station, in the middle of which the cylindrical shell (6b, c) is laid out. Two tappets or the narrowing band side parts push the partial capsules into the cylindrical casing (6b, c) from both sides. The cylindrical covering (6c) can be made with an easily tearable band or thread (8) or with a predetermined breaking point (8), e.g. in the form of a perforation. In this case, a pharmaceutically acceptable adhesive can be applied before the partial capsules are put together, so that the partial capsules are firmly connected to the casing.

Eine teilbare Kapsel, die von einer schrumpffähigen Folie als Umhüllung (6d) umgeben ist, kann wie folgt hergestellt werden:A separable capsule, which is surrounded by a shrinkable film as a covering (6d), can be produced as follows:

Die bereits gefüllten Teilkapseln in werden auf einem Transportband auf ein Band aus einer schrumpffähigen Folie gelegt und wenn nötig ausgerichtet, anschließend wird die Folie durch Hilfsvorrichtungen so geführt, daß sich die Folie trichterförmig um die Teilkapseln legt, bis diese völlig von der Folie umhüllt sind, wobei sich die Ober- und Unterseite der schrumpffähigen Folie teilweise überlappen können. Im gleichen Arbeitsgang wird die Folie zu einer an die Teilkapseln eng anliegenden Röhre verschweißt; nachfolgend können Hilfseinrichtungen, z.B. eine Perforation (9), zu einer späteren besseren Teilung angebracht werden. Daran anschließend wird geschrumpft, wobei sich Teilkapseln und Umhüllung zu einer festen Einheit verbinden. Nach einer Teilung der Kapselketten in eine gewünschte Teilmenge mit zwei oder mehr Teilkapseln kann noch einmal geschrumpft werden, um eventuell bei der Teilung entstandene Grate zu beseitigen.The already filled partial capsules are placed on a conveyor belt on a belt made of a shrinkable film and aligned if necessary, then the film is guided through auxiliary devices in such a way that the film lies in a funnel shape around the partial capsules until they are completely enveloped by the film, where the top and bottom of the shrinkable film can partially overlap. In the same operation, the film is welded to a tube that is close to the capsules; subsequently auxiliary devices, e.g. a perforation (9) can be attached for a later better division. Subsequently, shrinking takes place, whereby the partial capsule and the wrapping combine to form a solid unit. After dividing the capsule chains into a desired subset with two or more subcapsules, shrinking is again possible in order to remove any burrs that may have arisen during the division.

c) Eine teilbare Kapsel der Ausführungsform C wird wie folgt hergestellt:c) A separable capsule of embodiment C is produced as follows:

Die gefüllten Teilkapseln werden wie unter b) beschrieben, mit den Stirnseiten zueinandergeführt und mit einem Tropfen eines pharmakologisch unbedenklichen Klebers miteinander verbunden. Für den Kleber eignen sich folgende pharmazeutische Hilfsstoffe: Gelatine, verkleisterte Stärke, Hydroxypropylmethylcellulose, Hydroxypropylcellulose, Celluloseäther, Polyvinylpyrrolidon, Polyacrylate. Es ist jedoch selbstverständlich, daß auch andere Verfahren, als das unter b) beschrieben, zum Zusammenführen der beiden Teilkapseln Verwendung finden können.The filled partial capsules are brought together as described under b), the end faces together and connected to one another with a drop of a pharmacologically acceptable adhesive. The following pharmaceutical auxiliaries are suitable for the adhesive: gelatin, gelatinized starch, hydroxypropylmethyl cellulose, hydroxypropyl cellulose, cellulose ether, polyvinylpyrrolidone, polyacrylates. However, it goes without saying that methods other than that described under b) can also be used to bring the two partial capsules together.

Claims (10)

1. Teilbare Kapsel für erstarrende, hochviskose, pulverförmige und/oder granulierte Arzneimittelzubereitungen, dadurch gekennzeichnet, daß diese aus mindestens zwei länglichen Teilkapseln (2), mit kreisförmigem oder ellipsoidem Querschnitt entlang der Achse aa, wobei die Teilkapseln in an sich bekannter Weise aus einem Unterteil (3) und einem hierauf aufgesteckten Oberteil (4) bestehen und längs einer gemeinsamen Längsachse angeordnet sind und a) über ihre Stirnseiten (5) oder über ihre Seitenteile durch ein pharmazeutisch unbedenkliches Klebemittel verbunden sind,
oder b) eine gemeinsame, die Teilkapseln (2) ganz oder teilweise umschließende Umhüllung (6) aufweisen. 1. Divisible capsule for solidifying, highly viscous, powdery and / or granulated pharmaceutical preparations, characterized in that they consist of at least two elongated partial capsules (2), with a circular or ellipsoidal cross section along the axis aa, the partial capsules in a manner known per se from one The lower part (3) and an upper part (4) attached thereon are arranged along a common longitudinal axis and a) are connected via their end faces (5) or via their side parts by a pharmaceutically acceptable adhesive,
or b) a common, the partial capsules (2) completely or partially enclosing envelope (6). 2. Teilbare Kapsel nach Anspruch 1, dadurch gekennzeichnet, daß die Teilkapseln (2) von einer, gegebenenfalls wieder verschließbaren, äußeren Kapsel (6a) umhüllt sind.2. Divisible capsule according to claim 1, characterized in that the partial capsules (2) of an optionally resealable outer capsule (6a) are encased. 3. Teilbare Kapsel nach Anspruch 1, dadurch gekennzeichnet, daß die Teilkapseln (2) von einer zylinderförmigen Umhüllung (6b,c,d) aus einem pharmazeutisch unbedenklichen Material umgeben sind, wobei die zylinderförmige Umhüllung Vorrichtungen, wie z.B. eine Perforation, einen reißbaren Faden oder Band, zur besseren Teilung der Kapsel enthalten kann (8).3. Divisible capsule according to claim 1, characterized in that the partial capsules (2) are surrounded by a cylindrical envelope (6b, c, d) made of a pharmaceutically acceptable material, the cylindrical envelope devices, such as e.g. Perforation, a tearable thread or tape, for better division of the capsule may contain (8). 4. Teilbare Kapsel nach Anspruch 3, dadurch gekennzeichnet, daß die zylinderförmige Umhüllung (6d) aus einem geschrumpften, pharmazeutisch unbedenklichen Material besteht.4. Divisible capsule according to claim 3, characterized in that the cylindrical envelope (6d) consists of a shrunk, pharmaceutically acceptable material. 5. Teilbare Kapsel nach Anspruch 1, dadurch gekennzeichnet, daß die Teilkapseln über ihre Stirnseiten durch einen pharmakologisch unbedenklichen Kleber verbunden sind.5. Divisible capsule according to claim 1, characterized in that the partial capsules are connected via their end faces by a pharmacologically acceptable adhesive. 6. Verfahren zur Herstellung einer teilbaren Kapsel nach Anspruch 2, dadurch gekennzeichnet, daß die Teilkapseln (2) in das Unterteil der äußeren Kapsel (6a) gefüllt werden und dieses anschließend mit dem dazugehörigen Oberteil verschlossen wird.6. A method for producing a divisible capsule according to claim 2, characterized in that the partial capsules (2) are filled into the lower part of the outer capsule (6a) and this is then closed with the associated upper part. 7. Verfahren zur Herstellung einer teilbaren Kapsel nach Anspruch 3, dadurch gekennzeichnet, daß die Teilkapseln (2) über ihre Stirnseiten steckförmig durch eine zylinderförmige Umhüllung (6b) verbunden werden.7. A method for producing a divisible capsule according to claim 3, characterized in that the partial capsules (2) are plug-connected via their end faces by a cylindrical sheath (6b). 8. Verfahren zur Herstellung einer teilbaren Kapsel nach Anspruch 3, dadurch gekennzeichnet, daß die Teilkapseln (2) über ihre Stirnseiten steckförmig durch eine zylinderförmige Umhüllung (6c) unter Zugabe eines Klebemittels verbunden werden, wobei die Umhüllung (6c) Vorrichtungen (8) zur späteren Teilung enthält.8. A method for producing a divisible capsule according to claim 3, characterized in that the partial capsules (2) are plug-connected via their end faces by a cylindrical sheath (6c) with the addition of an adhesive, the sheath (6c) devices (8) for later division contains. 9. Verfahren zur Herstellung einer teilbaren Kapsel nach Anspruch 4, dadurch gekennzeichnet, daß die Teilkapseln auf eine schrumpffähige Folie gelegt werden, die Folie zu einer Röhre verschweißt, anschließend geschrumpft, mit Vorrichtungen zur besseren Teilung versehen wird und dann gegebenenfalls in Teilmengen mit zwei oder mehreren Teilkapseln geteilt wird.9. A method for producing a separable capsule according to claim 4, characterized in that the partial capsules are placed on a shrinkable film, the film is welded to a tube, then shrunk, provided with devices for better division and then optionally in partial quantities with two or is divided into several subcapsules. 10. Verfahren zur Herstellung einer teilbaren Kapsel nach Anspruch 5, dadurch gekennzeichnet, daß die Teilkapseln über ihre Stirnseiten entlang einer gemeinsamen Längsachse durch einen pharmazeutisch unbedenklichen Kleber verbunden werden.10. A method for producing a separable capsule according to claim 5, characterized in that the partial capsules are connected via their end faces along a common longitudinal axis by a pharmaceutically acceptable adhesive.
EP86116604A 1985-12-06 1986-11-28 Divisible capsule Expired - Lifetime EP0225565B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT86116604T ATE63215T1 (en) 1985-12-06 1986-11-28 DIVIDEABLE CAPSULE.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19853543154 DE3543154A1 (en) 1985-12-06 1985-12-06 DIVISIBLE CAPSULE
DE3543154 1985-12-06

Publications (3)

Publication Number Publication Date
EP0225565A2 true EP0225565A2 (en) 1987-06-16
EP0225565A3 EP0225565A3 (en) 1988-06-15
EP0225565B1 EP0225565B1 (en) 1991-05-08

Family

ID=6287800

Family Applications (1)

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EP86116604A Expired - Lifetime EP0225565B1 (en) 1985-12-06 1986-11-28 Divisible capsule

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Country Link
EP (1) EP0225565B1 (en)
JP (1) JPS62133960A (en)
AT (1) ATE63215T1 (en)
DE (2) DE3543154A1 (en)
ES (1) ES2021579B3 (en)
GR (1) GR3001923T3 (en)

Cited By (3)

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WO1996018370A1 (en) * 1994-12-16 1996-06-20 Warner-Lambert Company Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
US6245350B1 (en) 1994-12-16 2001-06-12 Warner-Lambert Company Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
US11944707B2 (en) 2017-07-10 2024-04-02 Gel Cap Technologies, LLC Dual release dosage form capsule and methods, devices and systems for making same

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AU603614B2 (en) * 1986-11-13 1990-11-22 Warner-Lambert Company Dividable capsule
DE3727894A1 (en) * 1987-08-21 1989-03-02 Stephan Dieter CAPSULE FOR PHARMACEUTICAL ACTIVE INGREDIENTS OF A DRUG
NZ536267A (en) * 2002-04-10 2007-06-29 Fred H Miller Multi-phase, multi-compartment and multi-ingredient capsular system
US20060141001A1 (en) 2004-11-19 2006-06-29 Finkelmeier Steven D Pharmaceutical product
BRPI0618687A2 (en) 2005-11-18 2011-09-06 Glaxo Group Ltd machine and method for assembling pharmaceutical and pharmaceutical type product
DE102006031441B4 (en) * 2006-07-05 2011-12-29 Hans Matt Oral creatine supplement, and method of making the same
DE102008006197B4 (en) * 2008-01-26 2020-06-04 Man Energy Solutions Se Fuel supply system of an internal combustion engine
FR2962647B1 (en) * 2010-07-19 2013-05-24 Duo Ge DEVICE AND INSTALLATION FOR ASSEMBLING AT LEAST TWO MEDICINAL CAPSULES BY COLLAGE

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DE8120453U1 (en) * 1981-07-13 1982-02-04 Alsitan-Gesellschaft Wilh. E. Ronneburg & Co, 8000 München CAPSULE FOR MEDICINAL PRODUCTS
EP0112183A2 (en) * 1982-12-20 1984-06-27 Warner-Lambert Company A method of providing a seal on a capsule
EP0191438A2 (en) * 1985-02-11 1986-08-20 Klinge Pharma GmbH Double capsule for receiving medicines

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US1815902A (en) * 1927-07-16 1931-07-28 Nat Aniline & Chem Co Inc Device for administering medicaments
DE3340262A1 (en) * 1983-11-08 1985-05-23 Sanol Schwarz GmbH, 4019 Monheim DIVISIBLE HARD GELATINE CAPSULE AND METHOD FOR THE PRODUCTION THEREOF

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FR1454013A (en) * 1965-08-18 1966-07-22 Pluripharm Presentation of two combined medicinal products
DE2719156A1 (en) * 1977-04-29 1978-11-02 Rainer Dr Med Liedtke Two-chamber hard gelatin medicine capsule - with caps of different solubility closing ends of common tube with central partition
DE8120453U1 (en) * 1981-07-13 1982-02-04 Alsitan-Gesellschaft Wilh. E. Ronneburg & Co, 8000 München CAPSULE FOR MEDICINAL PRODUCTS
EP0112183A2 (en) * 1982-12-20 1984-06-27 Warner-Lambert Company A method of providing a seal on a capsule
EP0191438A2 (en) * 1985-02-11 1986-08-20 Klinge Pharma GmbH Double capsule for receiving medicines

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996018370A1 (en) * 1994-12-16 1996-06-20 Warner-Lambert Company Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
US6080426A (en) * 1994-12-16 2000-06-27 Warner-Lamberg Company Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
US6245350B1 (en) 1994-12-16 2001-06-12 Warner-Lambert Company Process for encapsulation of caplets in a capsule and solid dosage forms obtainable by such process
CN1132566C (en) * 1994-12-16 2003-12-31 沃尼尔·朗伯公司 Process for encapsulation of caplets in capsule and solid dasage forms obtainable by such process
US11944707B2 (en) 2017-07-10 2024-04-02 Gel Cap Technologies, LLC Dual release dosage form capsule and methods, devices and systems for making same

Also Published As

Publication number Publication date
GR3001923T3 (en) 1992-11-23
DE3543154C2 (en) 1988-04-14
DE3543154A1 (en) 1987-06-11
DE3679156D1 (en) 1991-06-13
EP0225565A3 (en) 1988-06-15
ATE63215T1 (en) 1991-05-15
JPS62133960A (en) 1987-06-17
EP0225565B1 (en) 1991-05-08
ES2021579B3 (en) 1991-11-16

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