WO1999015096A1 - Ampoules holding an injectable liquid - Google Patents

Ampoules holding an injectable liquid Download PDF

Info

Publication number
WO1999015096A1
WO1999015096A1 PCT/US1998/019377 US9819377W WO9915096A1 WO 1999015096 A1 WO1999015096 A1 WO 1999015096A1 US 9819377 W US9819377 W US 9819377W WO 9915096 A1 WO9915096 A1 WO 9915096A1
Authority
WO
WIPO (PCT)
Prior art keywords
ampoule
liquid
ampoules
trap
holding
Prior art date
Application number
PCT/US1998/019377
Other languages
French (fr)
Inventor
Yosef Ron Oded Shapira
Original Assignee
Teva Pharmaceutical Industries Ltd.
Teva Pharmaceuticals Usa, 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 Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals Usa, Inc. filed Critical Teva Pharmaceutical Industries Ltd.
Priority to SI9830938T priority Critical patent/SI1022991T1/en
Priority to AU95697/98A priority patent/AU9569798A/en
Priority to ES98949359T priority patent/ES2408697T3/en
Priority to DK98949359.8T priority patent/DK1022991T3/en
Priority to EP98949359A priority patent/EP1022991B1/en
Publication of WO1999015096A1 publication Critical patent/WO1999015096A1/en

Links

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 materials 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 a priori or be weakened ⁇ d hoc with the aid of an instrument such as a file, 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.
  • an ampoule having a trap for the collection of particulate contaminants.
  • an ampoule is provided having a bottom 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 separated 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. DESCRIPTION OF THE DRAWINGS
  • FIG. 1 shows a magnified drawing of an ampoule of the present invention
  • Fig. 2 shows the method of opening the ampoule of Fig. 1 ;
  • Fig. 3 shows removal of the contents of the ampoule of Fig. 1 after opening (small ampoule);
  • Fig. 4 shows removal of the contents of the ampoule of Fig. 1 after opening (bigger ampoule > 10 ml.).
  • 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 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 1 1 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)

Abstract

An ampoule (1) having a bottom portion (4) serving as trap (5) for precipitated solid particulate contaminants, and a circumferential constriction (3) sidewall portion which when the ampoule is titled serves as a liquid sump, whereby essentially contaminant free liquid can be withdrawn from the ampoule.

Description

AMPOULES HOLDING AN INJECTABLE LIQUID
FIELD OF THE INVENTION
The present invention is in the field of ampoules holding an injectable liquid.
BACKGROUND OF THE INVENTION
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 materials 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 a priori or be weakened αd hoc with the aid of an instrument such as a file, in order to facilitate opening. Invariably, 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.
SUMMARY OF THE INVENTION
It is the purpose of the present invention to provide an ampoule having a trap for the collection of particulate contaminants. In accordance with the present invention an ampoule is provided having a bottom 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 separated 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. DESCRIPTION OF THE DRAWINGS
The invention will be described with reference to the following drawings in which: Fig. 1 shows a magnified drawing of an ampoule of the present invention;
Fig. 2 shows the method of opening the ampoule of Fig. 1 ; Fig. 3 shows removal of the contents of the ampoule of Fig. 1 after opening (small ampoule); and
Fig. 4 shows removal of the contents of the ampoule of Fig. 1 after opening (bigger ampoule > 10 ml.).
DETAILED DESCRIPTION OF A SPECIFIC EMBODIMENT
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 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 1 1 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. For withdrawing liquid from the ampoule 1 into a syringe 12, the syringe needle 13 is inserted so that its tip lies in pocket 6, which in the tilted state serves as liquid sump. In this configuration, 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.

Claims

CLAIMS:
1. An ampoule having a bottom portion serving as trap for precipitated solid particulate contaminants and a pocket-like side wall portion which when the ampoule is tilted serves as a liquid sump, whereby essentially contaminant free liquid can be withdrawn from the ampoule.
2. An ampoule according to Claim 1. wherein said sump is formed by a circumferential constriction.
PCT/US1998/019377 1997-09-22 1998-09-17 Ampoules holding an injectable liquid WO1999015096A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
SI9830938T SI1022991T1 (en) 1997-09-22 1998-09-17 Ampoules holding an injectable liquid
AU95697/98A AU9569798A (en) 1997-09-22 1998-09-17 Ampoules holding an injectable liquid
ES98949359T ES2408697T3 (en) 1997-09-22 1998-09-17 Ampoules containing an injectable liquid
DK98949359.8T DK1022991T3 (en) 1997-09-22 1998-09-17 Vials containing an injectable liquid
EP98949359A EP1022991B1 (en) 1997-09-22 1998-09-17 Ampoules holding an injectable liquid

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US93534297A 1997-09-22 1997-09-22
US08/935,342 1997-09-22

Publications (1)

Publication Number Publication Date
WO1999015096A1 true WO1999015096A1 (en) 1999-04-01

Family

ID=25466945

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/019377 WO1999015096A1 (en) 1997-09-22 1998-09-17 Ampoules holding an injectable liquid

Country Status (8)

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

Cited By (2)

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

Citations (6)

* 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
US3842836A (en) * 1969-06-04 1974-10-22 Ims Ltd Multi-mix

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE29618100U1 (en) * 1996-10-18 1997-01-23 Buender Glas Gmbh ampoule

Patent Citations (6)

* 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
US3842836A (en) * 1969-06-04 1974-10-22 Ims Ltd Multi-mix

Cited By (2)

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

Also Published As

Publication number Publication date
AU9569798A (en) 1999-04-12
EP1022991A1 (en) 2000-08-02
PT1022991E (en) 2013-05-06
DK1022991T3 (en) 2013-04-29
CY1113957T1 (en) 2016-07-27
EP1022991B1 (en) 2013-02-13
ES2408697T3 (en) 2013-06-21
SI1022991T1 (en) 2013-07-31
EP1022991A4 (en) 2004-04-07

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