EP 0826063 A1 19980304 - SINGLE-VIAL FORMULATIONS OF DNA/LIPID COMPLEXES
Title (en)
SINGLE-VIAL FORMULATIONS OF DNA/LIPID COMPLEXES
Title (de)
EINZELFLÄSCHEHENE FORMULIERUNGEN VON DNA (LIPID-KOMPLEXEN)
Title (fr)
FORMULATIONS EN AMPOULE UNIDOSE DE COMPLEXES ADN/LIPIDES
Publication
Application
Priority
- US 9605035 W 19960411
- US 42846395 A 19950425
Abstract (en)
[origin: WO9634109A1] The invention relates to single-vial formulations of plasmid DNA/cationic lipid complexes for human clinical use prepared by various different processes, for example, by the process comprising the steps of: (a) autoclave sterilizing a cationic lipid solution at a concentration sufficiently high to substantially prevent lipid degradation during said autoclave sterilization; (b) diluting the sterilized cationic lipid solution of step (a) to a degree sufficient to substantially prevent lipid aggregation during step (d) below; (c) filter sterilizing a plasmid DNA solution; (d) adding the sterilized plasmid DNA solution of step (c) to the diluted sterilized cationic lipid solution of step (b) at an ionic strength that is lower than isotonicity to form DNA/lipid complexes; and (e) adjusting the DNA/lipid complexes of step (d) to near isotonicity.
IPC 1-7
IPC 8 full level
A61K 9/127 (2006.01); A61K 31/70 (2006.01); A61K 38/17 (2006.01); A61K 38/20 (2006.01); A61K 47/18 (2006.01); A61K 48/00 (2006.01); C12N 15/09 (2006.01); C12N 15/88 (2006.01)
CPC (source: EP)
A61K 9/1272 (2013.01); A61K 31/711 (2013.01); A61K 38/1774 (2013.01); A61K 38/2013 (2013.01); A61K 47/543 (2017.07); A61K 48/00 (2013.01); C12N 15/88 (2013.01)
Citation (search report)
See references of WO 9634109A1
Designated contracting state (EPC)
AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE
DOCDB simple family (publication)
WO 9634109 A1 19961031; CA 2214029 A1 19961031; EP 0826063 A1 19980304; JP H11504631 A 19990427
DOCDB simple family (application)
US 9605035 W 19960411; CA 2214029 A 19960411; EP 96911722 A 19960411; JP 53255996 A 19960411