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Plastic container comprising cyclic polyolefin layer

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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 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.

Browse recent Mitsubishi Tanabe Pharma Corporation patents - Tokyo, JP
Inventors: Kazuhiko Ozaki, Munetomo Matsuda, Tetsurou Nishimura, Kenjirou Takayanagi, Hiroshi Kanedo
USPTO Applicaton #: #20120271270 - Class: 604408 (USPTO) - 10/25/12 - Class 604 
Surgery > Container For Blood Or Body Treating Material, Or Means Used Therewith (e.g., Needle For Piercing Container Closure, Etc.) >Bag Type

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

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TECHNICAL FIELD

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

BACKGROUND 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

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:

(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). In another preferred embodiment, the active ingredient of a liquid-state medicament is 3-methyl-1-phenyl-2-pyrazolin-5-one.

The plastic container according to the present invention is preferably in the form of an infusion bag.

Moreover, the plastic container according to the present invention is preferably placed together with an oxygen absorber into a poorly air-permeable container.

When the active ingredient of a liquid-state medicament placed in the plastic container according to the present invention is the pyrazolone derivative represented by the above-described formula (I), a physiologically acceptable salt thereof, a hydrate thereof, or a solvent thereof, a reduction percentage in the content of the active ingredient after the preservation thereof at 60° C. for 4 weeks is preferably 4% or less. On the other hand, a reduction percentage in the content of the active ingredient after sterilization is preferably 4% or less.

BEST MODE FOR CARRYING OUT THE INVENTION

The plastic container and the multilayered film provided by the present invention have a structure in which they comprise at least a cyclic polyolefin layer and a resin composition layer between an outermost layer and a seal layer. The disposition is not limited. Preferably, the resin composition layers or the polyethylene layers are disposed on both sides of the cyclic polyolefin layer. More preferably, the resin composition layers are disposed on both sides of the cyclic polyolefin layer. The resin composition layer that can be disposed on the outermost layer side of this cyclic polyolefin layer may be identical to or different from the resin composition layer that can be disposed on the seal layer side thereof. The same applies to the polyethylene layer.

Polyethylene that constitutes the polyethylene layer used in the present invention may be a copolymer of ethylene with α-olefin such as propylene, 1-butene, 4-methyl-1-pentene or 1-octene, as well as an ethylene homopolymer. In addition, the above-mentioned copolymer may be either a linear or branched copolymer. Moreover, a mixed resin of the ethylene homopolymer and the above-mentioned α-olefin may also be used. Furthermore, regardless of whether it is high-density or low-density, such polyethylene can be selected from a wide range of polyethylenes, as appropriate. From the viewpoint of flexibility and transparency, linear low-density polyethylene is advantageously used.

Specific examples of polyethylene preferably used in the present invention include an ethylene homopolymer (product name: HARMOREC (registered trademark)), an α-olefin copolymer (product name: TOUGHMER (registered trademark)), and an ethylene-1-octene copolymer (product name: MORETEC (registered trademark)). A more preferred example of polyethylene is a mixed resin of HARMOREC (registered trademark) and TOUGHMER (registered trademark).

The thickness of this polyethylene layer is not particularly limited. It is preferably from 10 μm or more to 150 gm or less.

A resin composition that constitutes the resin composition layer used in the present invention preferably has a fusion peak temperature only in a temperature range from 120° C. or higher to 170° C. or lower and also has a heat of fusion from 5 J/g or more to 20 J/g or less. This resin composition plays a role in improving the adhesion between a cyclic polyolefin polymer or a cyclic polyolefin copolymer and a polyolefin layer and also in improving the flexibility of the multilayered film as a whole. This resin composition has a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower that is derived from the crystalline component of the resin. If such fusion peak temperature is lower than 120° C., a multilayered film resistant to sterilization at 121° C. cannot be constituted. On the other hand, if such fusion peak temperature exceeds 170° C., the molding temperature is too high to produce a multilayered film with good appearance. Moreover, if the heat of fusion is less than 5 J/g, a multilayered film resistant to sterilization at 121° C. cannot be constituted. On the other hand, if it exceeds 20 J/g, the adhesion with a cyclic polyolefin polymer or a cyclic polyolefin copolymer becomes poor, and delamination (delami) easily occurs after completion of the sterilization. As a result, there is a fear that the appearance becomes deteriorated or desired preservability cannot be obtained.

Furthermore, when the resin composition has a fusion peak temperature in a temperature range of lower than 120° C., since a component having such fusion peak is melted during sterilization, the heat resistance of the resin composition is lost, and as a result, deformation, whitening and the like occur on the multilayered film. Examples of a resin having a fusion peak temperature in a temperature range of lower than 120° C. include high pressure method polyethylene or linear low-density polyethylene having a density of 0.93 or less, and an ethylene-α-olefin copolymer having a density of 0.90 or less.

The method for producing the resin composition of the present invention is not particularly limited, as long as the produced resin composition satisfies the above-described conditions, namely, as long as it has a fusion peak temperature only in a temperature range from 120° C. or higher to 170° C. or lower and also has a heat of fusion from 5 J/g or more to 20 J/g or less. For example, there can be applied a method, which comprises: first producing a crystalline propylene homopolymer having a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower, or a propylene-ethylene copolymer containing a small amount of ethylene (approximately 3% by weight or less) by continuous polymerization; and then producing a copolymer consisting of substantially amorphous propylene that does not have a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower and approximately 10% to 20% by weight of ethylene; so as to totally obtain a resin composition having a heat of fusion from 5 J/g or more to 20 J/g or less. There can also be applied a method, which comprises: producing a crystalline propylene homopolymer having a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower, or a propylene-ethylene copolymer of propylene and a small amount of ethylene (approximately 3% by weight or less), and a copolymer of propylene and approximately 10% to 20% by weight of ethylene, separately; and then blending them; so as to totally obtain a resin composition having a heat of fusion from 5 J/g or more to 20 J/g or less.

The above-described method for producing a resin composition by continuous polymerization is disclosed, for example, in JP Patent Publication (Kokai) Nos. 2001-172454 A and 2003-292700 A.

Further, there are produced: a crystalline propylene homopolymer having a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower, a propylene-ethylene copolymer containing a small amount of ethylene (approximately 3% by weight or less); a crystalline propylene homopolymer having a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower, or a propylene-ethylene copolymer containing a small amount of ethylene (approximately 3% by weight or less), produced by continuous polymerization. Thereafter, a copolymer consisting of amorphous or semi-crystalline propylene that does not have a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower and approximately 10% to 20% by weight of ethylene is produced to obtain a propylene polymer composition. A propylene copolymer having a fusion peak temperature in a temperature range from 120° C. or higher to 170° C. or lower, selected from among the thus obtained propylene polymer compositions, are blended with a styrene elastomer, so as to obtain a blended product.

The above-described styrene elastomer indicates a hydrogenated derivative of a vinyl aromatic hydrocarbon-conjugated diene block copolymer. It is one or two or more types of hydrogenated derivatives of such block copolymer represented by the formula: a(b-a)n, (a-b)n, or a-b-c (wherein (a) represents a polymer block of monovinyl-substituted aromatic hydrocarbon; (b) represents a random copolymer block of a monovinyl-substituted aromatic hydrocarbon and a conjugated diene, or an elastomeric polymer block of conjugated diene; (c) represents a block of a monovinyl-substituted aromatic hydrocarbon and .a conjugated diene, which is a taper block in which the monovinyl-substituted aromatic hydrocarbon is gradually increased; and n represents an integer of 1 to 5).



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stats Patent Info
Application #
US 20120271270 A1
Publish Date
10/25/2012
Document #
13537639
File Date
06/29/2012
USPTO Class
604408
Other USPTO Classes
428349, 206570, 206205, 220 6211
International Class
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Drawings
0



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