EP1022991B1 - Ampoules contenant un liquide injectable - Google Patents

Ampoules contenant un liquide injectable Download PDF

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Publication number
EP1022991B1
EP1022991B1 EP98949359A EP98949359A EP1022991B1 EP 1022991 B1 EP1022991 B1 EP 1022991B1 EP 98949359 A EP98949359 A EP 98949359A EP 98949359 A EP98949359 A EP 98949359A EP 1022991 B1 EP1022991 B1 EP 1022991B1
Authority
EP
European Patent Office
Prior art keywords
ampoule
liquid
ampoules
holding
trap
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 - Lifetime
Application number
EP98949359A
Other languages
German (de)
English (en)
Other versions
EP1022991A1 (fr
EP1022991A4 (fr
Inventor
Yosef Ron Oded Shapira
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.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
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 Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Priority to SI9830938T priority Critical patent/SI1022991T1/sl
Publication of EP1022991A1 publication Critical patent/EP1022991A1/fr
Publication of EP1022991A4 publication Critical patent/EP1022991A4/fr
Application granted granted Critical
Publication of EP1022991B1 publication Critical patent/EP1022991B1/fr
Priority to CY20131100340T priority patent/CY1113957T1/el
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/09—Ampoules
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules

Definitions

  • the present invention is in the field of ampoules holding an injectable liquid
  • Ampoules are commonly used as primary packaging for liquid drugs and other fluids. After filling, the ampoule is hermetically sealed so that the contents do not interact with the environment. Glass is the preferred material for the manufacture of ampoules due to its chemical inertness which minimizes its interaction with the contents. Attempts to replace glass with other materials, such as plastic, in the manufacture of ampoules have failed due to leakage, cost, or interactions of these material with the contents.
  • a glass ampoule is opened by breaking the ampoule at a constriction located at the bottom of its stem.
  • the glass in the region of the constriction may be weakened apriori or be wakened ad hoc with the aid of an instrument such as a tile, in order to facilitate opening.
  • glass particles are shed from the cut edges into the contents during opening. Particles of a small size are able to penetrate via opening of a syringe needle during withdrawal of liquid from the ampoule and thus may be hazardous when the contents are injected into an individual
  • D1 296 18 100 discloses an ampoule with an arched, concave bottom portion and a circumferential restriction.
  • an ampoule having a bottom formed by a V-shaped circumferential constriction in the side wall of the ampoule which serves as a trap for precipitated solid particulate contaminants and a pocket-like side wall portion which serves as a liquid sump when the ampoule is tilted, whereby essentially contaminant free liquid can be withdrawn from the ampoule.
  • Particles in the trap are separate from the bulk of the liquid in the ampoule so that the liquid may be aspirated into a syringe free of particles.
  • the aforementioned hazards posed by these contaminants are thereby substantially reduced or eliminated.
  • Fig. 1 shows, a sealed ampoule 1 according to the present invention containing a liquid 2 for injection.
  • the ampoule 1 is formed so as to possess a V-shaped circumferential constriction 3 close to its bottom wall 4, dividing between a trap 5 and a circumferential pocket 6 and a second circumferential constriction 7 at the bottom of its stem 8.
  • Fig. 2 shows that the ampoule of Fig. 1 is opened by applying a torque to its stem 8, causing the stem to break at the constriction 7.
  • Fig. 3 shows the ampoule and the detached stem 8 after opening.
  • the ampoule is held tilted so that particulate contaminants 9, such as glass particles shed into the liquid 2 from cut edges 10 and 11 during opening of the ampoule and which have sedimented through the liquid 2, collect in the trap 5 formed between the constriction 3 and the bottom 4.
  • the syringe needle 13 is inserted so that its tip lies in pocket 6, which in the tilted state serves as liquid sump.
  • the liquid 2 is aspirated into the syringe while particles 9 in the trap 5 are not drawn into the syringe needle and consequently the liquid aspirated into the syringe 12 is free of particles which remain in the trap 5 together with an insignificantly small volume of liquid 2.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Ceramic Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Water Treatment By Sorption (AREA)

Claims (1)

  1. Une ampoule (1) contenant un liquide (2) pour injection comprenant :
    une partie inférieure (5) retenant les contaminants particulaires solides précipités (9) ; et
    une partie de paroi latérale en forme de poche (6), qui, lorsque l'ampoule (1) est inclinée, sert de bassin de liquide, au moyen duquel un liquide essentiellement exempt de contaminants (2) peut être extrait de l'ampoule (1), caractérisé en ce que la partie de paroi latérale en forme de poche (6) est formée par un resserrement circonférentiel en forme de V (3) présent sur la paroi latérale de l'ampoule (1).
EP98949359A 1997-09-22 1998-09-17 Ampoules contenant un liquide injectable Expired - Lifetime EP1022991B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
SI9830938T SI1022991T1 (sl) 1997-09-22 1998-09-17 Ampule s tekoäśino za injektiranje
CY20131100340T CY1113957T1 (el) 1997-09-22 2013-04-25 Φυσιγγα διατηρησης υγρου με δυνατοτητα εγχυσης

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US93534297A 1997-09-22 1997-09-22
US935342 1997-09-22
PCT/US1998/019377 WO1999015096A1 (fr) 1997-09-22 1998-09-17 Ampoules contenant un liquide injectable

Publications (3)

Publication Number Publication Date
EP1022991A1 EP1022991A1 (fr) 2000-08-02
EP1022991A4 EP1022991A4 (fr) 2004-04-07
EP1022991B1 true EP1022991B1 (fr) 2013-02-13

Family

ID=25466945

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98949359A Expired - Lifetime EP1022991B1 (fr) 1997-09-22 1998-09-17 Ampoules contenant un liquide injectable

Country Status (8)

Country Link
EP (1) EP1022991B1 (fr)
AU (1) AU9569798A (fr)
CY (1) CY1113957T1 (fr)
DK (1) DK1022991T3 (fr)
ES (1) ES2408697T3 (fr)
PT (1) PT1022991E (fr)
SI (1) SI1022991T1 (fr)
WO (1) WO1999015096A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101341897B1 (ko) 2012-07-10 2013-12-16 대한약품공업 주식회사 플라스틱 앰플
KR101761570B1 (ko) * 2017-01-19 2017-07-26 주식회사 네스필러피케이지 플라스틱 앰플

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1744947A (en) * 1928-10-17 1930-01-28 Owen J Bowman Bottle
US1770093A (en) * 1929-02-15 1930-07-08 Cream Separator Bottle Inc Milk bottle
US2494456A (en) * 1946-03-18 1950-01-10 Kathleen S Still Container
US2644599A (en) * 1951-04-24 1953-07-07 Royden A Blunt Bottle
US3198194A (en) * 1963-05-13 1965-08-03 Upjohn Co Admixing storage container with means preventing inadvertent removal of closure means
US3674028A (en) * 1969-06-04 1972-07-04 Ims Ltd Multi-mix
DE29618100U1 (de) * 1996-10-18 1997-01-23 Bünder Glas GmbH, 32257 Bünde Ampulle

Also Published As

Publication number Publication date
EP1022991A1 (fr) 2000-08-02
DK1022991T3 (da) 2013-04-29
SI1022991T1 (sl) 2013-07-31
WO1999015096A1 (fr) 1999-04-01
CY1113957T1 (el) 2016-07-27
ES2408697T3 (es) 2013-06-21
AU9569798A (en) 1999-04-12
PT1022991E (pt) 2013-05-06
EP1022991A4 (fr) 2004-04-07

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