LEMA MARTINEZ, Carmen,LUEMKEMANN, Joerg,WERK, Tobias,ZUMSTEIN, Thomas,KULLMANN, Daniel
申请号：
EPEP2019/082342
公开号：
WO2020/109195A1
申请日:
2019.11.25
申请国别(地区):
EP
年份:
2020
代理人:
摘要：
A method of manufacturing a flexible container (1) housing a drug substance, comprises: forming a first compartment (11) of the container (1) out of a flexible sheet-like material, filling a liquid (2) into the first compartment (11) of the container (1), sealing the first compartment (11), forming a second compartment (12) of the container (1) out of the flexible sheet-like material, filling a dry drug formulation (3) into the second compartment (12), and sealing the second compartment (12). The method further involves lyophilizing the drug formulation inside a tubular cartridge such that the dry drug formulation (3) is generated and held in the tubular cartridge, wherein filling the dry drug formulation (3) into the second compartment (12) comprises: introducing the tubular cartridge holding the dry drug formulation (3) through an opening of the second compartment (12) of the container (1) such that an open end of the tubular cartridge is positioned distant from the opening of the second compartment (12), providing the dry drug formulation (3) out of the open end of the tubular cartridge into the second compartment (12), and withdrawing the tubular cartridge out of the opening of the second compartment (12) of the container (1). The first compartment (11) is separated from the second compartment (12) by a frangible seal (14) which opens when the first compartment (11) is compressed.Un procédé de fabrication d'un contenant souple (1) recevant une substance médicamenteuse comprend : la formation d'un premier compartiment (11) du contenant (1) à partir d'un matériau stratiforme souple, le remplissage d'un liquide (2) dans le premier compartiment (11) du contenant (1), le scellage du premier compartiment (11), la formation d'un second compartiment (12) du contenant (1) à partir du matériau stratiforme souple, le remplissage avec une formulation de médicament sec (3) du second compartiment (12), et le scellage du second compartiment (12). Le procédé comprend en outre l
