AMPOULES HOLDING AN INJECTABLE LIQUID

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portion which when the ampoule is titled serves as a liquid sump, whereby essentially contaminant free liquid can be withdrawn from the ampoule.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portion which serves as a liquid sump when the ampoule is tilted, whereby essentially contaminant free liquid can be withdrawn from the ampoule.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.

Inventors: SHAPIRA YOSEF RON ODED, SHAPIRA, YOSEF, RON, ODED
Applicants: TEVA PHARMA, TEVA PHARMACEUTICAL INDUSTRIES LTD., TEVA PHARMACEUTICALS USA, INC.
Application year: 1998
Main classification: A61B19
IPC codes: A61J1, B65D1