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Plastic container comprising cyclic polyolefin layer




Title: Plastic container comprising cyclic polyolefin layer.
Abstract: The present invention provides and a plastic container and multilayered films, which comprises a heat-sealable seal layer, a cyclic polyolefin layer, and an outermost layer, wherein the seal layer comprises polypropylene, the cyclic polyolefin layer comprises a cyclic polyolefin polymer or a cyclic polyolefin copolymer, and the outermost layer comprises a layer containing polypropylene, and which further comprises a resin composition layer comprises a blended product of a propylene polymer and a styrene elastomer. The plastic container of the present invention can suppresses a reduction in the medicament content of a liquid-state medicament and is excellent in terms of shock resistance, handling ability during the filling of the container with the medicament, and the moldability and transparency of the container. ...


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USPTO Applicaton #: #20120271270
Inventors: Kazuhiko Ozaki, Munetomo Matsuda, Tetsurou Nishimura, Kenjirou Takayanagi, Hiroshi Kanedo


The Patent Description & Claims data below is from USPTO Patent Application 20120271270, Plastic container comprising cyclic polyolefin layer.

TECHNICAL FIELD

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The present invention relates to a plastic container suitable for containing a liquid-state medicament and a multilayered film used for this container.

BACKGROUND

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ART

A reduction in the content of a certain kind of medicament is suppressed using a container composed of cyclic polyolefin. The suppression of a reduction in the content of a certain kind of medicament is disclosed in JP Patent Publication (Kokai) No. 5-293159 A (1993) (Patent Document 1) and JP Patent Publication (Kokai) No. 2003-24415 A (Patent Document 2), for example. However, cyclic polyolefin is rigid and fragile, and further, it is poor in terms of heat-sealing properties. Thus, cyclic polyolefin has been problematic in that a practical bag cannot be directly formed with the cyclic polyolefin itself. In order to solve this problem, JP Patent Publication (Kokai) No. 2002-301796 A (Patent Document 3) and JP Patent Publication (Kohyo) No. 2005-525952 A (Patent Document 4), for example, have proposed a multilayered film comprising a specific ethylene-α-olefin copolymer and cyclic polyolefin and a container constituted with the same.

Moreover, if a constituted multilayered film is rigid and inflexible, it causes problems such as low shock resistance and poor handling ability during the filling of a container with a medicament.

On the other hand, it has been known that a pyrazolone derivative represented by the formula (I) as shown below has, as a medical use, an action to normalize brain function (Patent Document 5; JP Patent Publication (Kokoku) No. 5-31523 B (1993)), an action to suppress generation of lipid peroxide (Patent Document 6; JP Patent Publication (Kokoku) No. 5-35128 B (1993); the compound of Example 1), an antiulcer action (Patent Document 7; JP Patent Publication (Kokai) No. 3-215425 A (1991)), an action to suppress an increase in blood sugar (Patent Document 8; JP Patent Publication (Kokai) No. 3-215426 A (1991)), and the like:

(wherein R1 represents a hydrogen atom, an aryl, an alkyl containing 1 to 5 carbon atoms, or an alkoxycarbonylalkyl containing 3 to 6 carbon atoms in total; R2 represents a hydrogen atom, an aryloxy, an arylmercapto, an alkyl containing 1 to 5 carbon atoms, or a hydroxyalkyl containing 1 to 3 carbon atoms; or R1 and R2 together represent an alkylene containing 3 to 5 carbon atoms; R3 represents a hydrogen atom, an alkyl containing 1 to 5 carbon atoms, a cycloalkyl containing 5 to 7 carbon atoms, a hydroxyalkyl containing 1 to 3 carbon atoms, a benzyl, naphthyl or phenyl, or a phenyl substituted with 1 to 3 identical or different substituents selected from the group consisting of an alkoxy containing 1 to 5 carbon atoms, a hydroxyalkyl containing 1 to 3 carbon atoms, an alkoxycarbonyl containing 2 to 5 carbon atoms in total, an alkylmercapto containing 1 to 3 carbon atoms, an alkylamino containing 1 to 4 carbon atoms, a dialkylamino containing 2 to 8 carbon atoms in total, a halogen atom, a trifluoromethyl, a carboxyl, a cyano, a hydroxyl group, a nitro, an amino, and an acetamide).

Moreover, since June 2001, the compound represented by the formula (I) has been commercially available as a brain-protecting agent (generic name: “Edaravone”; product name: “Radicut”; manufactured and distributed by Mitsubishi Tanabe Pharma Corporation). This “Edaravone” has been reported to have high reactivity with active oxygen (Non-Patent Documents 1 and 2). Thus, Edaravone is a free radical scavenger that acts to scavenge various types of free radicals including active oxygen as a typical example, so as to prevent cell injury.

At present, Radicut is commercially available as a Radicut injection 30 mg in the form of a 20 ml of solution containing 30 mg of 3-methyl-1-phenyl-2-pyrazoline-5-one (Edaravone) filled into a glass ampule. Furthermore, International Publication WO2007/55312 (Patent Document 9) reports a plastic container filled with an aqueous solution containing Edaravone, coloration of which is suppressed. However, a plastic container capable of suppressing a reduction in the content of Edaravone due to adhesion of Edaravone to the plastic container has not yet been disclosed.

[Patent Document 1] JP Patent Publication (Kokai) No. 5-293159 A (1993)

[Patent Document 2] JP Patent Publication (Kokai) No. 2003-24415 A

[Patent Document 3] JP Patent Publication (Kokai) No. 2002-301796 A

[Patent Document 4] JP Patent Publication (Kohyo) No. 2005-525952 A

[Patent Document 5] JP Patent Publication (Kokoku) No. 5-31523 B (1993)

[Patent Document 6] JP Patent Publication (Kokoku) No. 5-35128 B (1993)

[Patent Document 7] JP Patent Publication (Kokai) No. 3-215425 A (1991)

[Patent Document 8] JP Patent Publication (Kokai) No. 3-215426 A (1991)

[Non-Patent Document 1] Kawai, H., et al., J. Pharmacol. Exp. Ther., 281(2), 921, 1997

[Non-Patent Document 2] Wu, TW. et al., 67(19), 2387, 2000

[Patent Document 9] International Publication WO2007/55312

DISCLOSURE OF THE INVENTION

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Problems to be Solved by the Invention

It is an object of the present invention to provide a plastic container which suppresses a reduction in the content of a liquid-state medicament and is excellent in terms of shock resistance, handling ability during the filling of the container with the medicament, and the moldability and transparency of the container, and a multilayered film used for the aforementioned container.

Means for Solving the Problems

The multilayered film of the present invention for achieving the aforementioned object comprises a heat-sealable seal layer, a cyclic polyolefin layer, and an outermost layer, wherein the seal layer comprises polypropylene, the cyclic polyolefin layer comprises a cyclic polyolefin polymer or a cyclic polyolefin copolymer, and the outermost layer comprises a layer containing polypropylene, and the present multilayered film further comprises a resin composition layer comprising a blended product of a propylene polymer and a styrene elastomer. However, the multilayered film of the present invention excludes a five-layered plastic film only composed of a seal layer-an adhesive layer-a barrier layer-an adhesive layer-a material layer, wherein each of the seal layer and the material layer consists of only a polypropylene elastomer having a melting point of 165° C., each of the adhesive layers consists of only MODIC manufactured by Mitsubishi Chemical Corporation, and the barrier layer consists of only a cyclic polyolefin polymer having a glass transition temperature of 136° C.

Moreover, the plastic container according to the present invention for achieving the aforementioned object is molded by heat-sealing the peripheral portions of the multilayered films which comprise a heat-sealable seal layer, a cyclic polyolefin layer, and an outermost layer wherein the seal layer comprises polypropylene, the cyclic polyolefin layer comprises a cyclic polyolefin polymer or a cyclic polyolefin copolymer, and the outermost layer comprises a layer containing polypropylene, and which further comprises a resin composition layer comprising a blended product of a propylene polymer and a styrene elastomer, in a state in which the seal layers are laminated on each other such that they face each other. The plastic film of the present invention is molded, so that the seal layer thereof becomes the inner surface thereof. Specifically, the seal layer is allowed to directly come into contact with a liquid-state medicament which is contained in this container.

The plastic container or multilayered film according to the present invention preferably comprises a resin composition layer or a polyethylene layer on the surfaces of both sides of the cyclic polyolefin layer. In addition, for such resin composition layer, a resin composition having a fusion peak temperature only in a temperature range from 120° C. or higher to 170° C. or lower and also having a heat of fusion from 5 J/g or more to 20 J/g or less is preferably used.

The cyclic polyolefin in the cyclic polyolefin layer used for the plastic container or multilayered film according to the present invention is preferably a ring-opening polymer hydrogenation product of dicyclopentadiene or a derivative thereof. Moreover, another preferred embodiment of the cyclic polyolefin is cyclic polyolefin having a glass transition temperature (Tg) of 80° C. to 120° C. A further preferred embodiment of the cyclic polyolefin is cyclic polyolefin having a melt flow rate (230° C., 21.2 N) value of 1 to 20 (g/10 minutes).

As a seal layer used for the plastic container or multilayered film according to the present invention, polypropylene having a melt flow rate (230° C., 21.2 N) value of 1 to 4 (g/10 minutes) is preferable. Furthermore, another preferred embodiment of the seal layer is a seal layer having a bending elasticity of 400 to 600 MPa. A further preferred embodiment of the seal layer is polypropylene having the maximum fusion peak temperature of 125° C. to 135° C. A still further preferred embodiment of the seal layer is propylene having the highest fusion peak temperature of 150° C. to 160° C. The maximum fusion peak temperature and the highest fusion peak temperature used in the present specification will be described. There are cases in which multiple endothermic peaks are observed in differential scanning calorimetry (DSC). The maximum fusion peak temperature means a temperature at which the largest endothermic peak is observed, and the highest fusion peak temperature means a temperature at which the highest temperature peak is observed in a temperature range in which such endothermic peaks are observed.

The outermost layer used for the plastic container or multilayered film according to the present invention is preferably polypropylene having a melt flow rate (230° C., 21.2 N) value of 1 to 4 (g/10 minutes). Another preferred embodiment of the outermost layer is polypropylene having a bending elasticity of 400 to 600 MPa. A further preferred embodiment of the outermost layer is polypropylene having a fusion peak temperature of 160° C. to 170° C.

In the present invention, a multilayered film having a tensile elasticity of 300 MPa or less and a plastic container molded using this multilayered film are preferable.

The plastic container according to the present invention can be preferably sterilized at 115° C. for 30 minutes or more. In another preferred embodiment, the plastic container according to the present invention can be sterilized at 121° C. for 15 minutes or more.

The active ingredient of a liquid-state medicament placed in the plastic container according to the present invention is preferably a pyrazolone derivative represented by the formula (I) as shown below, a physiologically acceptable salt thereof, a hydrate thereof, or a solvate thereof:




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stats Patent Info
Application #
US 20120271270 A1
Publish Date
10/25/2012
Document #
File Date
12/31/1969
USPTO Class
Other USPTO Classes
International Class
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Drawings
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20121025|20120271270|plastic container comprising cyclic polyolefin layer|The present invention provides and a plastic container and multilayered films, which comprises a heat-sealable seal layer, a cyclic polyolefin layer, and an outermost layer, wherein the seal layer comprises polypropylene, the cyclic polyolefin layer comprises a cyclic polyolefin polymer or a cyclic polyolefin copolymer, and the outermost layer comprises |Mitsubishi-Tanabe-Pharma-Corporation
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