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Drug container

A technology for medicines and containers, which is applied to the field of containers for liquid medicines, can solve the problems of not being able to completely prevent air bubbles, promoting protein deterioration, and insufficient injection volume.

Active Publication Date: 2011-02-23
TERUMO KK
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] For air bubbles, in the case of prefilled syringes that are used for injection or pump injection immediately after opening, handling becomes complicated because air bubbles are released before use
[0009] In addition, in the case of injecting a very small amount of medicine such as insulin preparations, there is a problem that the injection volume is insufficient due to the mixing of air bubbles, and the discharge volume is inaccurate due to the contraction of the air bubbles under pressure.
[0010] In addition, in the case of storing and transporting water-soluble protein preparations in a solution state, there is a problem in that the aqueous solution becomes trapped due to vibration during transport, etc. The state of stirring, coupled with the load brought by the surface tension of the air bubbles to the molecular structure of the protein, promotes the deterioration of the protein and deteriorates the preservation
[0012] However, because it is used directly connected to a pump or an injection device, in order to press out the liquid medicine from the container, it is necessary to have a resin seal (gasket) that slides while maintaining a liquid-tight seal with the liquid medicine container. There is a resin septum or the like as a path for discharging the liquid medicine from the liquid medicine container through which the connection end of the connection needle or the injection needle is pierced, so the generation of air bubbles caused by the entry of outside air into the container cannot be completely prevented.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0080] exist Figure 10 The measurement device used in this experimental example is shown in .

[0081] In a commercially available polypropylene syringe 501 (TERUMO SYRINGE, manufactured by Terumo Co., Ltd.) of empty 10 ml (indicating that it is sold on the market as a capacity of 10 ml, the same below), fill it with 4 so that there is no gas part. The stored water was cooled at °C, and a pressure gauge 502 (PG-35 manufactured by Nidec Copal Electronics Co., Ltd.) was connected through a luer connector 505 .

[0082] The packing of this commercially available syringe is a soft polyolefin-based elastomer mixed with a styrene-based elastomer.

[0083] The push piece fixing pin 504 is used to fix the push piece so that its relative position with the outer cylinder does not change, preventing the pressure applied to the water from decreasing due to the movement of the gasket. Brass or stainless steel is used for materials of auxiliary parts other than the syringe such as the pr...

experiment example 2

[0089] After moving to an oven at 50°C for 1 hour, adjust the pressure to the set value, and then use the same syringe under the same measurement conditions as in Experimental Example 1, except for long-term storage while correcting the set pressure every day. experimented. The results are shown in Table 2.

[0090] (Table 2) Bubble change with time at 50°C

[0091]

[0092] According to the results of Experimental Example 2, by continuously applying a pressure of 20 kPa or more to the aqueous liquid in the syringe, the air bubbles in the syringe disappeared, and the disappearance speed became faster as the pressure increased, and it was confirmed that the bubbles disappeared in about 2 days.

[0093] Also, even assuming that the set pressure is set to 20 kPa, the pressure decreases over time. used in this experiment example Figure 10 In the measurement device, since the volume inside the syringe is basically constant, the generation or disappearance of a very small amo...

experiment example 3

[0103] Change the storage temperature to room temperature, except to use commercially available syringes of various volumes (5ml: VITAJECT manufactured by Terumo Corporation; 10ml: TERUMO SYRINGE manufactured by Terumo Corporation; 20ml: KC1MEDIJECT manufactured by Terumo Corporation) In addition, by the same method as in Experimental Example 2, it was confirmed that the air bubbles disappeared when stored under pressure at 25 kPa.

[0104] Among the constituent members of each syringe, the outer cylinder was made of polypropylene, and the packing was made of olefin-based elastomer including styrene-based elastomer.

[0105] The results are shown in Table 3.

[0106] (Table 3) Disappearance of air bubbles in polypropylene syringes of various capacities

[0107]

[0108]

[0109] From the results of Experimental Example 3, it was confirmed that air bubbles were present in all the syringes when the temperature was raised from the refrigerated storage state at 4° C. to roo...

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PUM

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Abstract

The invention provides a drug container. In a drug container filled with a liquid drug, bubbles are formed during prolonged storage even in the case where the liquid drug is filled in a gas-free state after removing dissolved gas therefrom. To solve this problem, bubbles formed in the container during storage are removed and the formation of bubbles in the container is prevented. A drug container, in which a liquid drug is enclosed, provided at least in a part thereof with a resin member coming into contact with the liquid drug as described above, characterized in that a pressurizing member removable from the drug container, by which the liquid drug as described above is maintainedin a pressurized state, is provided and the liquid drug as described above is filled in a substantially bubble-free state.

Description

technical field [0001] The invention relates to a container for storing and transporting liquid medicines. In particular, it relates to a container and a prefilled syringe that do not require the liquid drug to be transferred to another injection device during use. Background technique [0002] In recent years, due to problems such as contamination when dissolving or exchanging the container, prefilled syringes that have both functions as a container and as an injection tool have come into use. Unlike vial containers, prefilled syringes have the advantage of being able to be used for injection immediately after opening because there is no need to exchange the drug into an injection device such as a syringe or a pump. [0003] In addition, in protein preparations such as insulin, a gasket (gasket) is also developed at one end of the vial, and the vial is used in conjunction with a dedicated pump or injection device, so that the internal solution can not come into contact wit...

Claims

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Application Information

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IPC IPC(8): A61M5/28
CPCA61M2005/3104A61M2005/312A61M5/28A61M5/36A61M5/31505A61M2005/3121
Inventor 松本淳
Owner TERUMO KK
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