KNOPOV, VICTOR,WITTE, RICHARD P.,KARMALI, PRIYA,LEE, ROBIN,WEBB, DAVID
申请号:
CA2853685
公开号:
CA2853685C
申请日:
2012.11.02
申请国别(地区):
CA
年份:
2019
代理人:
摘要:
Sterile preparation of a lipid-drug nanoparticle includes transferring anaqueous drug solutionfrom a first holding unit to a mixing unit and adding a solution of lipids ina water-miscibleorganic solvent from a second holding unit to the aqueous drug solution, usinginjection meansso as to form a gradient of the organic solvent concentration in the solutionin the mixing unit.The resulting lipid-drug mixture is diluted with an aqueous buffer to form aliposomesuspension, which is then concentrated using a transflow filter to remove theorganic solvent.The concentrated liposome suspension is collected in a single use bed forsubsequent asepticdispensing. Apparatus used to carry out the process contains components whichare sterilized anddisposable so as to be adapted for single batch usage.