EP0225565A2 - Capsule divisible - Google Patents

Capsule divisible 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
Authority
EP
European Patent Office
Prior art keywords
partial
capsules
capsule
divisible
capsule according
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
EP86116604A
Other languages
German (de)
English (en)
Other versions
EP0225565B1 (fr
EP0225565A3 (en
Inventor
Bernhard Dr. Freund
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boehringer Ingelheim International GmbH
Boehringer Ingelheim GmbH
Original Assignee
Boehringer Ingelheim International GmbH
Boehringer Ingelheim 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 Boehringer Ingelheim International GmbH, Boehringer Ingelheim GmbH filed Critical Boehringer Ingelheim International GmbH
Priority to AT86116604T priority Critical patent/ATE63215T1/de
Publication of EP0225565A2 publication Critical patent/EP0225565A2/fr
Publication of EP0225565A3 publication Critical patent/EP0225565A3/de
Application granted granted Critical
Publication of EP0225565B1 publication Critical patent/EP0225565B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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

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.

Landscapes

  • 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)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Developing Agents For Electrophotography (AREA)
  • Cosmetics (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
EP86116604A 1985-12-06 1986-11-28 Capsule divisible Expired - Lifetime EP0225565B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT86116604T ATE63215T1 (de) 1985-12-06 1986-11-28 Teilbare kapsel.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3543154 1985-12-06
DE19853543154 DE3543154A1 (de) 1985-12-06 1985-12-06 Teilbare kapsel

Publications (3)

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

Family

ID=6287800

Family Applications (1)

Application Number Title Priority Date Filing Date
EP86116604A Expired - Lifetime EP0225565B1 (fr) 1985-12-06 1986-11-28 Capsule divisible

Country Status (6)

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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996018370A1 (fr) * 1994-12-16 1996-06-20 Warner-Lambert Company Procede d'encapsulation de comprimes-capsules dans une capsule et formes galeniques solides obtenues par ce procede
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

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU603614B2 (en) * 1986-11-13 1990-11-22 Warner-Lambert Company Dividable capsule
DE3727894A1 (de) * 1987-08-21 1989-03-02 Stephan Dieter Kapsel fuer pharmazeutisch wirksame inhaltsstoffe einer droge
EP1499303A4 (fr) * 2002-04-10 2007-07-25 Fred H Miller Systeme capsulaire a plusieurs compartiments et plusieurs phases
JP2008520726A (ja) * 2004-11-19 2008-06-19 スミスクライン・ビーチャム・コーポレイション 医薬製品
EA012998B1 (ru) 2005-11-18 2010-02-26 Глэксо Груп Лимитед Машина и способ сборки фармацевтических и им подобных изделий
DE102006031441B4 (de) * 2006-07-05 2011-12-29 Hans Matt Orales Creatin-Supplement, sowie Verfahren zur Herstellung desselben
DE102008006197B4 (de) * 2008-01-26 2020-06-04 Man Energy Solutions Se Kraftstoffversorgungsanlage einer Brennkraftmaschine
FR2962647B1 (fr) * 2010-07-19 2013-05-24 Duo Ge Dispositif et installation d'assemblage d'au moins deux capsules medicamenteuses par collage

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1815902A (en) * 1927-07-16 1931-07-28 Nat Aniline & Chem Co Inc Device for administering medicaments
FR1454013A (fr) * 1965-08-18 1966-07-22 Pluripharm Mode de présentation de deux médicaments associés
DE2719156A1 (de) * 1977-04-29 1978-11-02 Rainer Dr Med Liedtke Zwei-kammer arzneikapsel
DE8120453U1 (de) * 1981-07-13 1982-02-04 Alsitan-Gesellschaft Wilh. E. Ronneburg & Co, 8000 München Kapsel fuer arzneimittel
US4478658A (en) * 1982-12-20 1984-10-23 Warner-Lambert Company Method for sealing non-enteric capsules
DE3340262A1 (de) * 1983-11-08 1985-05-23 Sanol Schwarz GmbH, 4019 Monheim Teilbare hartgelatine-kapsel und verfahren zu ihrer herstellung
DE8503747U1 (de) * 1985-02-11 1985-05-09 Klinge Pharma GmbH, 8000 München Doppel-Kapsel zur Aufnahme von Medikamenten

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996018370A1 (fr) * 1994-12-16 1996-06-20 Warner-Lambert Company Procede d'encapsulation de comprimes-capsules dans une capsule et formes galeniques solides obtenues par ce procede
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 (zh) * 1994-12-16 2003-12-31 沃尼尔·朗伯公司 在胶囊中填充囊芯的方法和由该方法制得的固体剂型
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
DE3543154A1 (de) 1987-06-11
DE3543154C2 (fr) 1988-04-14
EP0225565B1 (fr) 1991-05-08
ATE63215T1 (de) 1991-05-15
ES2021579B3 (es) 1991-11-16
DE3679156D1 (de) 1991-06-13
EP0225565A3 (en) 1988-06-15
JPS62133960A (ja) 1987-06-17
GR3001923T3 (en) 1992-11-23

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