US2018207131A1PendingUtilityA1

Plastic container comprising cyclic polyolefin layer

Assignee: MITSUBISHI TANABE PHARMA CORPPriority: Nov 22, 2007Filed: Mar 20, 2018Published: Jul 26, 2018
Est. expiryNov 22, 2027(~1.3 yrs left)· nominal 20-yr term from priority
A61P 3/08A61P 3/10A61P 39/06A61P 25/28A61J 1/10A61K 31/4152B32B 2307/31Y10T428/2826B32B 27/08A61K 9/0019B32B 2307/558A61P 1/04B32B 2307/7265B32B 2250/24B32B 2307/30B32B 27/302B32B 27/325B32B 2307/7242B32B 2307/51B32B 2307/546B32B 2439/80B32B 2307/412B32B 2307/308B32B 2270/00B32B 27/32B32B 2307/50A61J 1/1468
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 19 . (canceled) 
     
     
         20 . A pharmaceutical formulation in a unit dosage form comprising 3-methyl-1-phenyl-2-pyrazolin-5-one;
 wherein the unit dosage form is a solution stored in a plastic container, and   wherein the container comprises:
 a multilayered film having six or more layers, wherein the six or more layers are:
 an innermost heat-sealable seal layer consisting essentially of polypropylene, 
 a first resin composition layer disposed on the innermost heat-sealable seal layer consisting essentially of a resin composition comprising a blended product of a propylene polymer and a styrene elastomer, 
 a cyclic polyolefin barrier layer disposed on the first resin composition layer consisting of a polymer consisting of repeating units represented by the formula (1) and repeating units represented by the formula (1′): 
 
   
       
         
           
           
               
               
           
         
         
           
             
               wherein each of Ra, Ra′, Rb and Rb′, identically or differently, represents a hydrogen, a hydrocarbon residue, a halogen, an ester, a nitrile or a pyridyl; or Ra and Rb may bind to one another to form a ring; or Ra′ and Rb′ may bind to one another to form a ring; each of m and m′ represents an integer of 1 or greater; and each of n and n′ represents an integer of 0 or 1 or greater, 
             
             two or more additional resin composition layers disposed on the cyclic polyolefin barrier layer consisting essentially of a resin composition comprising a blended product of a propylene polymer and a styrene elastomer, 
             and 
             an outermost layer disposed on the additional resin composition layers consisting essentially of a polypropylene layer; 
           
           wherein the plastic container is molded by heat sealing peripheral portions of the multilayered films. 
         
       
     
     
         21 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the cyclic polyolefin barrier layer has a glass transition temperature (Tg) of 80° C. to 120° C. 
     
     
         22 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the melt flow rate (230° C., 21.2 N) value of the cyclic polyolefin barrier layer is 1 to 20 (g/10 minutes). 
     
     
         23 . The pharmaceutical formulation in a unit dosage form according to  claim 22 , wherein the melt flow rate (230° C., 21.2 N) value of the seal layer and/or the outermost layer is 1 to 4 (g/10 minutes). 
     
     
         24 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the maximum fusion peak temperature of the seal layer is 125° C. to 135° C. 
     
     
         25 . The pharmaceutical formulation in a unit dosage form according to  claim 24 , wherein the highest fusion peak temperature of the seal layer is 150° C. to 160° C. 
     
     
         26 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the fusion peak temperature of the outermost layer is 160° C. to 170° C. 
     
     
         27 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the plastic container can be sterilized at 115° C. for 30 minutes or more. 
     
     
         28 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the plastic container can be sterilized at 121° C. for 15 minutes or more. 
     
     
         29 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the plastic container is in the form of an infusion bag. 
     
     
         30 . The pharmaceutical formulation in a unit dosage form according to  claim 29 , wherein the plastic container can be sterilized at 115° C. for 30 minutes or more. 
     
     
         31 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the unit dosage form comprises 30 mg of 3-methyl-1-phenyl-2-pyrazolin-5-one. 
     
     
         32 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the 3-methyl-1-phenyl-2-pyrazolin-5-one is contained in a concentration of 0.06 mg/mL or higher to 2 mg/mL or lower. 
     
     
         33 . The pharmaceutical formulation in a unit dosage form according to  claim 32 , wherein the 3-methyl-1-phenyl-2-pyrazolin-5-one is contained in a concentration of 0.1 mg/mL or higher to 0.6 mg/mL or lower. 
     
     
         34 . The pharmaceutical formulation in a unit dosage form according to  claim 33 , wherein the 3-methyl-1-phenyl-2-pyrazolin-5-one is contained in a concentration of about 0.3 mg/mL. 
     
     
         35 . The pharmaceutical formulation in a unit dosage form according to  claim 20 , wherein the 3-methyl-1-phenyl-2-pyrazolin-5-one is contained in an injection solution. 
     
     
         36 . The pharmaceutical formulation in a unit dosage form according to  claim 35 , wherein the injection solution is saline.

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