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Multi-layer film and medicine container using the same

a multi-layer film and medicine container technology, applied in the field of multi-layer film and medicine container using the same, can solve the problems of deterioration of properties such as strength and flexibility of the medicine container, decrease in the content of the medicine, interference with pre-mixing, etc., and achieve the effect of improving heat resistance and improving flexibility of the multi-layer film

Inactive Publication Date: 2005-09-22
OTSUKA PHARM FAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0017] According to the multi-layer film with such a layer configuration and the medicine container using the same of the present invention, it is made possible to suppress adsorption of the medicine by the barrier layer and to impart excellent strength and excellent flexibility by the seal layer covering the barrier layer, the flexible layer and the surface layer while maintaining the miscibility with the barrier layer.
[0021] By using the material obtained by mixing the ethylene-α-olefin copolymer having a predetermined density with the high-density polyethylene, as shown in (a), and the laminate of the layer of the ethylene-α-olefin copolymer having a predetermined density and the layer of the high-density polyethylene, as shown in (b), the heat resistance can be improved without impairing the flexibility of the multi-layer film (and the medicine container using the same).
[0022] In the multi-layer film shown in (a), the ethylene-α-olefin copolymer having a density of 0.860 to 0.930 g / cm3 used in the flexible layer may be a mixture of an ethylene-α-olefin copolymer having a density of 0.860 to 0.910 g / cm3 and an ethylene-α-olefin copolymer having a density of 0.910 to 0.940 g / cm3. By using the above mixture as the material of the flexible layer, the flexibility of the multi-layer film can be further improved.
[0024] As described above, by using those obtained by polymerizing using the metallocene catalyst as the ethylene-α-olefin copolymer used in the flexible layer and the barrier layer, the gas barrier properties and moisture barrier properties can be improved while satisfactorily maintaining the flexibility and impact resistance of the multi-layer film (medicine container using the same).
[0026] Since the multi-layer film of the present invention is used in a medical pliable plastic container such as medicine container, the thickness of the seal layer is preferably set in order to lower the adsorption ability of the medicine accommodated in the container and to improve various characteristics (for example, durability) of the container. Specifically, the thickness of the seal layer is preferably set within a range from 5 to 40 μm in case of attaching great importance to the effect of preventing adsorption of the medicine, while the thickness of the seal layer is preferably set within a range from 40 to 80 μm in case of attaching more great importance to the durability of the container.

Problems solved by technology

However, since a certain medicine such as nitroglycerin is easily adsorbed into polyethylene, a problems such as decrease in content of the medicine arises in case of administration of mixed injection, which interferes with pre-mixing.
However, the cyclic olefin polymer has characteristics such as less adsorption of nitroglycerin but has drawbacks such as hardness and brittleness, there by causing a problem that properties such as strength and flexibility of the medicine container are deteriorated.
Furthermore, since the cyclic olefin polymer is inferior in miscibility and adhesion with the other resin, the medicine container is likely to be delaminated and lowered in strength.
In case the cyclic olefin polymer and the other resin are bonded using an adhesive resin, a problem such as dissolution into a medicine arises.
Therefore, the safety is not secured.

Method used

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  • Multi-layer film and medicine container using the same
  • Multi-layer film and medicine container using the same
  • Multi-layer film and medicine container using the same

Examples

Experimental program
Comparison scheme
Effect test

example 1

(Example 1)

[0097] The resin A, the resin C, a mixed resin containing the resin E and the resin A in a weight ratio of 3:1 [mixing ratio of a cyclic olefin polymer (CO) :75% by weight] and the resin A were respectively used as the surface layer, the flexible layer, the barrier layer and the seal layer.

[0098] The surface layer, the flexible layer, the barrier layer and the seal layer were laid one upon another in this order, and then a multi-layer film having a total thickness of 230 μm (each of constituent layers formed from the side of the surface layer in the above order has a thickness of 20 μm, 170 μm, 30 μm or 10 μm) was formed by a water-cooling coextrusion inflation method.

[0099] Using the resulting multi-layer film, a medicine bag (medicine container) 10 shown in FIG. 1 was produced. Polyethylene was used as the material of a port member 20. Sealing of the port member 20 was conducted at 140 to 150° C. for 3 seconds, while sealing of a peripheral portion 22 was conducted at...

example 2

(Example 2)

[0100] The resin A, a mixed resin containing the resin C and the resin D in a weight ratio of 95:5 [mixing ratio of a high-density polyethylene (HDPE): 5% by weight], a mixed resin containing the resin F and the resin C in a weight ratio of 3:1 [mixing ratio of CO: 75% by weight] and the resin B were respectively used as the surface layer, the flexible layer, the barrier layer and the seal layer.

[0101] The surface layer, the flexible layer, the barrier layer and the seal layer were laid one upon another in this order, and then a multi-layer film having a total thickness of 230 μm (each of constituent layers formed from the side of the surface layer in the above order has a thickness of 20 μm, 175 μm, 20 μm or 15 μm) was formed by a water-cooling coextrusion inflation method.

[0102] In the same manner as in Example 1, except that the above multi-layer film was used, a medicine bag 10 shown in FIG. 1 was produced.

example 3

(Example 3)

[0103] In the same manner as in Example 2, except that the barrier layer was made of a mixed resin containing the resin F and the resin C in a weight ratio of 3:2 [mixing ratio of CO: 60% by weight], a multi-layer film (total thickness: 230 μm) was formed and a medicine bag was produced.

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Abstract

Disclosed is a multi-layer film comprising: a surface layer having a thickness of 10 to 50 ƒÊm made of an ethylene-ƒ-olefin copolymer halving a density of 0.935 to 0.950 g / cm3, a flexible layer having a thickness of 100 to 200 ƒÊm made of an ethylene-ƒ-olefin copolymer having a density of 0.860 to 0.930 g / cm3, a barrier layer having a thickness of 10 to 80 ƒÊm made of a mixed resin containing 60 to 95% by weight of a cyclic olefin polymer and 5 to 40% by weight of an ethylene-ƒ-olefin copolymer having a density of 0.900 to 0.965 g / cm3, and a seal layer having a thickness of 5 to 80 ƒÊm made of an ethylene-ƒ-olefin copolymer having a density or 0.910 to 0.950 g / cm3. This multi-layer film is suited for use as a material for production of a medicine container 10 because it suppresses adsorption of a medicine by the barrier layer and is also superior in strength and flexibility.

Description

TECHNICAL FIELD [0001] The present invention relates to a multi-layer film which suppresses adsorption of a medicine and a liquid medicine, and a medicine container using the same. BACKGROUND ART [0002] For use in continuous infusion, some medicines are administered in the state of being mixed with an infusion solution. For use in continuous infusion, it has been studied to previously form a medicine for injection into an aqueous dilute solution (namely, pre-mixing). [0003] Bottles and ampuls made of chemically stable glass have hitherto been used as a medicine container which accommodates an infusion solution. Recently, for the purpose of weight reduction of the medicine container and improvement in handling property, infusion bags and infusion bottles made of a pharmaceutically acceptable plastic have widely been used. Among various known pharmaceutically acceptable plastics, polyethylene is remarkably superior in handling property because of its high safety and flexibility in the...

Claims

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Application Information

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IPC IPC(8): B32B27/32B65D1/00
CPCB32B27/32Y10T428/269Y10T428/1334Y10T428/24967Y10T428/1317Y10T428/13Y10T428/2495Y10T428/1352B32B27/08B32B2307/306B32B2307/31B32B2307/558B32B2307/7242B32B2307/7246B32B2439/40Y10T428/31913
Inventor MANABE, YUKIOKAMOTO, HIDESHIKAWAKAMI, KEIICHI
Owner OTSUKA PHARM FAB INC
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