EP0084529B1 - Zweiteilige hartschalige gelatinekapsel und verfahren zur herstellung - Google Patents

Zweiteilige hartschalige gelatinekapsel und verfahren zur herstellung Download PDF

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Publication number
EP0084529B1
EP0084529B1 EP81902190A EP81902190A EP0084529B1 EP 0084529 B1 EP0084529 B1 EP 0084529B1 EP 81902190 A EP81902190 A EP 81902190A EP 81902190 A EP81902190 A EP 81902190A EP 0084529 B1 EP0084529 B1 EP 0084529B1
Authority
EP
European Patent Office
Prior art keywords
body member
shaped body
cap member
gelatin capsule
capsule
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.)
Expired
Application number
EP81902190A
Other languages
English (en)
French (fr)
Other versions
EP0084529A1 (de
EP0084529A4 (de
Inventor
Joseph A. Pace
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.)
Catalent Pharma Solutions Inc
Original Assignee
Catalent Pharma Solutions Inc
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 Catalent Pharma Solutions Inc filed Critical Catalent Pharma Solutions Inc
Priority to AT81902190T priority Critical patent/ATE23975T1/de
Publication of EP0084529A1 publication Critical patent/EP0084529A1/de
Publication of EP0084529A4 publication Critical patent/EP0084529A4/de
Application granted granted Critical
Publication of EP0084529B1 publication Critical patent/EP0084529B1/de
Expired 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
    • A61J3/072—Sealing capsules, e.g. rendering them tamper-proof

Definitions

  • Liquid leach and leakage problems have plagued procedures intended for filling and sealing of liquid-containing capsules intended for oral use. Complicated filling and sealing procedures, tried in an effort to remedy the difficulties, have failed to enable production, at low cost, of consistently reliable, leak proof, practical quantity production of such products.
  • US-A-3285408 discloses such a capsule with a U-shaped body member having a closed lower end and open free end terminating in an upper edge, a cap member for receiving the open free end of said U-shaped member said cap member including a continuous interior rim therein. After insertion of the liquid, the upper edge of said U-shaped body member is abuttingly engaged against the interior rim formed in said cap member.
  • the cap member has cylindrical portion adjacent to its closed end which extends approximately one sixth the length of the cap and is of a diameter somewhat smaller than the outer diameter of the open end of the body member. The press fit produced on the joining of the cap and body members provides a strong gripping action which resists separation of parts.
  • an improved capsule is provided by applying ultrasonic energy to the region where the upper edge of the U-shaped body member abuts the interior rim so as to form a substantially continuous interior ultrasonic weld between the upper edge and the interior rim.
  • the invention also includes a capsule obtainable by this method, and preferably the cap member of the capsule is shorter in length than the U-shaped body member.
  • gelatin is used herein to designate the material of which the capsule of the invention is made, comprises a non-synthetic, substantially tasteless and odourless dried protein, readily soluble, digestible and compatible, when taken orally, and dissolving readily when swallowed. Formed by boiling the bones, shins, and tendons of animals.
  • Figure 5 is a medial vertical sectional view of the upper portions of the capsule cap and body member so welded together and thus ultrasonically sealed 360°.
  • the hard-shelled soluble and digestible gelatin capsule comprises a U-shaped body member 10 wherein may be positioned liquids or pharmaceutical products, and a cap member 11 having a dome end portion 12 and having an outwardly stepped circumferential rim portion 13 formed to telescopically register, on assembly with the free upper end portion 14 of the body member.
  • the cap member is provided with a depending skirt portion 15 below the stepped rim portion 13; on assembly of the parts (Fig. 1) the stepped rim portion 13 of the cap overlies the free upper end 14 of the body member 10 in closing relation, the depending skirt portion 15 of the cap member telescopically registering with and contiguously overlying the upper portion 16 of the body member.
  • the cap member 11 and body member 10 of the capsule are shown in closed relation in Fig. 1 and positioned in a fixture 17 in Fig. 2, with the stepped rim cap portion 13 and adjacent depending apron portion thereof disposed outwardly of the fixture 17.
  • An ultrasonic horn 21 is positioned over the assembled parts (Fig. 4) in overlying relation to the stepped rim portion 13 of the cap and adjacent apron portion 15 telescopically registered with the upper portion 16 of the body member within the horn.
  • the horn Upon being energized by any well-known ultrasonic means, the horn will ultrasonically hermetically seal for 360° to thereby weld, as noted at 23 (Fig. 5) and unify the outwardly stepped portion 13 of the cap member to the upper end 14 of the body member.
  • the fixture 17 may be turnable or other practical form of a multi-unit fixture wherein a large number of capsules may be simultaneously so formed and sealed.

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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)
  • Package Closures (AREA)
  • Lining Or Joining Of Plastics Or The Like (AREA)
  • Closures For Containers (AREA)

Claims (8)

1. Verfahren zur Herstellung einer zweiteiligen, hartschaiigen, lösbaren und verdaubaren Gelatinekapsel, umfassend folgende Schritte:
Ausbilden eines U-förmigen Kapselteils (10) mit einem unten geschlossenen Ende und einem offenen freien Ende, das in einer oberen Kante (14) endet,
Ausbilden eines Kappenteils zur Aufnahme des offenen freien Endes des U-förmigen Kapselteils (10), wobei das Kappenteil (12) einen kontinuierlichen inneren Rand (13) aufweist, der gegen die obere Kante (14) des U-förmigen Kapselteils (10) anstößt, gekennzeichnet durch
Aufbringen einer Ultraschallenergie auf die Zone, wo die ober Kante (14) des U-förmigen Kapselteils (10) gegen den inneren Rand (13) anstößt, so daß eine im wesentlichen kontinuierliche innere Ultraschallschweißung zwischen der oberen Kante und dem inneren Rand ausgebildet wird.
2. Verfahren nach Anspruch 1 mit dem weiteren Verfahrensschritt; daß ein Randleistenabschnitt (15) am Kappenteil (12) ausgebildet wird, der sich von dem inneren Rand (13) nach unten erstreckt. 3. Zweiteilige, hartschalige, lösbare und verdaubare Gelatinekapsel, gefertigt nach dem Verfahren nach Anspruch 1 und 2.
4. Kapsel nach Anspruch 3, bei der das Kappenteil (12) eine kürzere Länge als das U-förmige Kapselteil (10) aufweist.
EP81902190A 1981-07-30 1981-07-30 Zweiteilige hartschalige gelatinekapsel und verfahren zur herstellung Expired EP0084529B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT81902190T ATE23975T1 (de) 1981-07-30 1981-07-30 Zweiteilige hartschalige gelatinekapsel und verfahren zur herstellung.

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1981/001019 WO1983000477A1 (en) 1981-07-30 1981-07-30 Two-piece hardshell gelatin capsule and method for manufacture

Publications (3)

Publication Number Publication Date
EP0084529A1 EP0084529A1 (de) 1983-08-03
EP0084529A4 EP0084529A4 (de) 1984-11-22
EP0084529B1 true EP0084529B1 (de) 1986-12-03

Family

ID=22161339

Family Applications (1)

Application Number Title Priority Date Filing Date
EP81902190A Expired EP0084529B1 (de) 1981-07-30 1981-07-30 Zweiteilige hartschalige gelatinekapsel und verfahren zur herstellung

Country Status (5)

Country Link
EP (1) EP0084529B1 (de)
JP (1) JPS58501157A (de)
AT (1) ATE23975T1 (de)
DE (1) DE3175671D1 (de)
WO (1) WO1983000477A1 (de)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4581875A (en) * 1983-06-20 1986-04-15 Cosden Technology, Inc. Process for forming tamper-resistant tamper-indicative capsules
CN101953816B (zh) * 2010-09-08 2015-01-07 浙江昂利康胶囊有限公司 药用空心胶囊、制备方法及其制造设备

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US525845A (en) * 1894-09-11 Riley p
US2102885A (en) * 1935-10-21 1937-12-21 John O Carroll Individual cosmetic container structure
DE1217024B (de) * 1961-07-10 1966-05-18 Hoefliger & Karg Fuell- und Schliessmaschine fuer zweiteilige Kapseln
US3173840A (en) * 1962-04-30 1965-03-16 Lilly Co Eli Separation-resistant capsule
US3285408A (en) * 1964-10-16 1966-11-15 Lilly Co Eli Capsule with integral locking band
US3258115A (en) * 1965-05-12 1966-06-28 Scherer Corp R P Two-piece hard gelatin capsule
US3438824A (en) * 1965-05-14 1969-04-15 Cavitron Corp Method and apparatus for joining a closure to a container by high frequency radial vibrations
US3556884A (en) * 1966-05-02 1971-01-19 Lusteroid Container Co Inc Plastic tube construction
US3549440A (en) * 1967-10-26 1970-12-22 United Glass Ltd Method for sealing a membrane to the mouth of a container utilizing induced radio frequency current
US3927195A (en) * 1974-01-31 1975-12-16 Lilly Industries Ltd Production of capsules

Also Published As

Publication number Publication date
JPS58501157A (ja) 1983-07-21
ATE23975T1 (de) 1986-12-15
EP0084529A1 (de) 1983-08-03
DE3175671D1 (en) 1987-01-15
WO1983000477A1 (en) 1983-02-17
EP0084529A4 (de) 1984-11-22

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