# US 8,465,819 B2 · Drug solution container package and method for manufacturing the same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,465,819 B2 - Document ID: US8465819B2 - Status: Granted - Kind: B2 - Application number: 11/911,644 - Filed: 2006-04-19 - Published: 2009-02-05 - Granted: 2013-06-18 - Earliest claimed: 2005-04-28 - Assignees: Otsuka Pharmaceutical Factory, Inc. - Applicants: Isamu Tateishi; Hitoshi Mori; Yasushi Morimoto - Inventors: Isamu Tateishi; Hitoshi Mori; Yasushi Morimoto - Web page: https://patentgrep.com/patent/US8465819B2 ## CPC - B32B 27/32: comprising polyolefins {(comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30)} - A61J 1/10: Bag-type containers - A61M 2207/00: Methods of manufacture, assembly or production - Y10T 428/1352: Polymer or resin containing [i.e., natural or synthetic] - Y10T 428/1379: Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit - Y10T 428/1383: Vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit is sandwiched between layers [continuous layer] - B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract A drug solution container package, which can restrain degradation of a drug solution, proliferation of microbes, etc. accompanying the transmission of oxygen in a high degree while maintaining characteristics required of plastic drug solution containers such as heat resistance, impact resistance, pliability, transparency, and resistance against elution of plastic forming material, and to provide a method for manufacturing the drug solution container package. A drug solution is first contained and sealed in a plastic drug solution container having an oxygen gas transmission rate (25° C., 60% RH) of not less than 200 cm3/m2·24 h·atm within twelve hours after being subject to steam or hot water sterilization, and having an oxygen gas transmission rate (25° C., 60% RH) of not more than 100 cm3/m2·24 h·atm when the oxygen gas transmission rate is in a steady state, and thereafter the plastic drug solution container is steam sterilized or hot water sterilized and then contained and sealed along with an oxygen scavenger in an outer pouch having an oxygen barrier property. ## Claims ### Claim 1 A drug solution container package comprising: a plastic drug solution container containing a drug solution, the container being sealed and sterilized by steam or hot water; an oxygen scavenger; and an outer pouch having an oxygen barrier property for containing and sealing the plastic drug solution container and the oxygen scavenger, wherein a plastic forming the plastic drug solution container has an oxygen gas transmission rate of not less than 200 cm3/m2·24 h·atm at a temperature of 25° C. and a humidity of 60% RH within twelve hours after being subjected to steam sterilization or hot water sterilization, and has an oxygen gas transmission rate of not more than 100 cm3/m2·24 h·atm at a temperature of 25° C. and a humidity of 60% RH when the oxygen gas transmission rate is in a steady state, wherein the plastic forming the plastic drug solution container is a multilayer film having a sealing layer at an inner surface side of the plastic drug solution container, a protective layer on an outer surface side of the plastic drug solution container, and an intermediate layer between the sealing layer and the protective layer, wherein the intermediate layer is formed from a polyol-based plastic and wherein the multilayer film includes a low water absorption layer, formed of a low water absorption plastic having a water absorption rate of not more than 0.01%, between the sealing layer and the intermediate layer. ### Claim 2 (depends on 1) The drug solution container package according to claim 1, wherein the steam sterilization is a process of heating the plastic drug solution container for 10 to 60 minutes under an inert gas atmosphere at a temperature of 100 to 121° C. and in a steam saturated state. ### Claim 3 (depends on 1) The drug solution container package according to claim 1, wherein the polyol-based plastic of the intermediate layer is an ethylene-vinyl alcohol copolymer with an ethylene content of 10 to 45 mole %. ### Claim 4 (depends on 1) The drug solution container package according to claim 1, wherein, of the multilayer film, a water vapor transmission rate of the entirety of layers disposed at the outer surface side of the plastic drug solution container with respect to the intermediate layer is 1 to 50 g/m2·24 h at a temperature of 25° C. and a humidity of 90% RH. ### Claim 5 (depends on 1) The drug solution container package according to claim 1, wherein the low water absorption plastic is a cyclo olefin polymer. ### Claim 6 (depends on 1) The drug solution container package according to claim 1, wherein the plastic forming the plastic drug solution container has an oxygen gas transmission rate of 500 to 1000 cm3/m2·24 h·atm at a temperature of 25° C. and a humidity 60% RH within twelve hours after being subjected to steam sterilization or hot water sterilization. ### Claim 7 (depends on 1) The drug solution container package according to claim 1, wherein the plastic forming the plastic drug solution container has an oxygen gas transmission rate of 0.5 to 70 cm3/m2·24 h·atm at a temperature of 25° C. and a humidity of 60% RH when the oxygen gas transmission rate is in a steady state. ### Claim 8 (depends on 1) The drug solution container package according to claim 1, wherein the plastic drug solution container is formed of a plastic that requires at least two days for the oxygen gas transmission rate to attain the steady state after steam sterilization or hot water sterilization. ### Claim 9 (depends on 1) The drug solution container package according to claim 1, wherein the drug solution contained and sealed in the plastic drug solution container is a drug solution that contains an oxidizable substance. ### Claim 10 (depends on 1) The drug solution container package according to claim 1, wherein the outer pouch has a water vapor transmission rate of 0.5 to 30 g/m2·24 h at a temperature of 25° C. and a humidity of 90% RH. ### Claim 11 A method for manufacturing a plastic drug solution container package, wherein plastic forming the plastic drug solution container is a multilayer film having a sealing layer at an inner surface side of the plastic drug solution container, a protective layer on an outer surface side of the plastic drug solution container, and an intermediate layer between the sealing layer and the protective layer, wherein the multilayer film includes a low water absorption layer, formed of a low water absorption plastic having a water absorption rate of not more than 0.01%, between the sealing layer and the intermediate layer, and wherein after making a drug solution contained and sealed in the plastic drug solution container formed of the plastic, which has an oxygen gas transmission rate of not less than 200 cm3/m2·24 h·atm at a temperature of 25° C. and a humidity of 60% RH within twelve hours after being subjected to steam sterilization or hot water sterilization and oxygen gas transmission rate of not more than 100 cm3/m2·24 h·atm at a temperature of 25° C. and a humidity of 60% RH when the oxygen gas transmission rate is in a steady state, the plastic drug solution container is steam sterilized or hot water sterilized, and then the sterilized plastic drug solution container and an oxygen scavenger are contained and sealed in an outer pouch having an oxygen barrier property to form a plastic drug solution container package, wherein the intermediate layer is formed from a polyol-based plastic. ### Claim 12 (depends on 11) The method for manufacturing a drug solution container package according to claim 11, wherein the steam sterilization is a process of heating the plastic drug solution container for 10 to 60 minutes under an inert gas atmosphere at a temperature of 100 to 121° C. in a steam saturated state. ### Claim 13 (depends on 11) The method for manufacturing a drug solution container package according to claim 11, wherein the outer pouch has a water vapor transmission rate of 0.5 to 30 g/m2·24 h at a temperature of 25° C. and a humidity of 90% RH. ### Claim 14 (depends on 11) The method for manufacturing a drug solution container package according to claim 11, wherein before the plastic drug solution container and the oxygen scavenger are contained and sealed in the outer pouch, a space between the plastic drug solution container and the outer pouch is filled with an inert gas.