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Medical multi-layered container and plural chamber container

A container and multi-layer film technology, which is applied in the field of medical multi-layer containers and medical multi-layer multi-chamber containers, can solve problems that have not been studied before, and achieve the effect of reducing drug changes

Active Publication Date: 2006-06-07
NIPRO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] As for these medical containers, although it is described in these prior arts that the containers are used for autoclaving or high temperature sterilization such as hot water sterilization, it has not been studied whether these containers can be irradiated with gamma rays
Also, it has not been investigated whether multi-compartment containers can be gamma sterilized, in which solid and liquid medications are stored separately and, at the point of use, both are mixed with each other

Method used

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  • Medical multi-layered container and plural chamber container
  • Medical multi-layered container and plural chamber container
  • Medical multi-layered container and plural chamber container

Examples

Experimental program
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preparation example Construction

[0045] As for the preparation method of the multilayer film, one method is to utilize dry lamination method, extrusion coating method, co-extrusion lamination method (T-die method, inflation method), thermal lamination method or a combination of these methods. Pressing method to laminate these layers. In addition to these methods, it is also possible to employ a method in which a thermoplastic saturated norbornene type polymer is dissolved in a suitable solvent, i.e., a heterocyclic hydrocarbon type solvent (cyclopentene, cyclohexane, methylcyclohexanedecalin or analogues), aromatic hydrocarbon solvents (toluene, xylene, ethylbenzene or similar), chlorinated hydrocarbon solvents (chloroform, chlorobenzene or similar) and their mixtures, or solvents in which these solvents are mixed with other solvents , apply the resulting solution, and then dry.

[0046] In addition, lamination can be performed by using an adhesive or bonding resin between layers. As such adhesives, polyure...

Embodiment 1

[0064] Cyclic polyolefin (trade name: Zeonor; from Zeon Corporation, COP) and medium-density polyethylene (density: 0.938, MDPE) were extruded together at 250°C using a co-extruder, thereby forming 2 layers Membrane (former: 30 μm; latter: 20 μm). On the medium-density polyethylene layer of the 2-layer film thus formed, a polyethylene terephthalate film (thickness: 12 μm; from Mitsubishi Chemical, PET) and a polyolefin-type adhesive resin (LLDPE) were sequentially laminated. Medium-density polyethylene film (density: 0.938; thickness: 40 μm, MDPE), from which a multilayer film (front panel A) was prepared. The thickness of the adhesive resin (LLDPE) was 20 μm.

[0065] Next, cyclic polyolefin (trade name: Zeonor; from Zeon Corporation, COP) and medium-density polyethylene (density: 0.938, MDPE) were extruded together at 250° C. by using a co-extruder, whereby A 2-layer film (former: 30 μm; latter: 20 μm) was formed. Aluminum foil (thickness: 20 μm; from Sun Alumi, Al) and p...

Embodiment 2

[0084] A tubular article (100 mm×150 mm) of linear low-density polyethylene (0.923; thickness: 250 μm) was produced. A drug discharge port is provided at its end. The resulting tubular article was firmly bonded at 145°C for 3.0 seconds, after which a small piece made of a polymer blend comprising polyethylene and polypropylene was inserted into its end. The resulting tubular article was weakly bonded at 150°C for 3.5 seconds, thereby forming a medical fluid-containing chamber. After such a medical fluid-containing chamber is formed, the chamber is filled with a solution and then steam sterilized. In addition, when the drug-containing chamber manufactured in Example 1 was in a bag-shaped product (140 mm×115 mm), it was sterilized by gamma rays, and then filled with a solid drug preparation under aseptic conditions. Thereafter, at 150° C., the remaining one-end innermost layer (which has been firmly bonded at the three-way end) and the outermost layer containing the medical fl...

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Abstract

A multi-layered medical container formed by a multi-layered film, in which an innermost layer is a layer comprising a cyclic polyolefin or a polymer blend containing the cyclic polyolefin, and a layer, which is adhered to the above-described layer, having a linear polyolefin or polyamide is provided. Also, a multi-layered medical plural chamber container which includes a body divided by a peelable seal portion into a medical liquid-containing chamber that stores the medical liquid and a medicament-containing chamber that stores the medicament is provided.

Description

Background of the invention [0001] The present invention relates to a medical multi-layer container and a medical multi-layer multi-chamber container, in particular to a medical multi-layer container and a medical multi-layer multi-chamber container which prevent components from being eluted from the container and an adhesive layer. [0002] In general, as containers for storing medicines, containers formed of linear polyolefin monolayer films or multilayer films containing linear polyolefin layers, polymers having moisture-proof or gas-barrier properties have been widely used. In addition, in recent years, in the medical field, the application of a multilayer film in which films are bonded to each other by an adhesive has been approved by the revised Japanese Pharmacopoeia, and then, medical containers having many properties have been developed, and therefore, can be used in These containers contain various types of medications. [0003] However, due to the nature of the con...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J1/10A61J1/00A61J1/16
CPCA61J1/10A61J1/2093B32B7/12B32B15/08B32B15/20B32B27/08B32B27/32B32B27/34B32B27/36B32B2250/44B32B2307/7242B32B2307/7265B32B2307/75B32B2439/80B32B2535/00A61J1/2024Y10T428/1352B32B1/00A61J1/00
Inventor 大森健司本田稔岩池真茂木昌司
Owner NIPRO CORP