公开(公告)号：EP1105096B1

公开(公告)日：2003-10-29

申请号：EP99942292.6

申请日：1999-08-18

申请人： SKYEPHARMA CANADA INC.

发明人： MISHRA, Awadhesh K. ,  PACE, Gary W. ,  VACHON, Michael, G.

IPC分类号： A61K9/107 ,  A61K31/05

CPC分类号： A61K9/1075 ,  A61K9/0019 ,  A61K31/05 ,  A61K47/14 ,  A61K47/24 ,  A61K47/28 ,  Y02A50/473 ,  Y10S514/816 ,  Y10S514/817 ,  Y10S514/818 ,  Y10S514/938

摘要： Irritation upon injection of a formulation containing propofol is reduced or substantially eliminated by administering a stable, sterile, and antimicrobial aqueous dispersion comprising a water-insoluble microdroplet matrix of mean diameter from about 50 nm to about 1000 nm consisting essentially of about 1% to about 15% of propofol, up to about 7% of a propofol-soluble diluent, and about 0.8% to about 4% of a surface stabilizing amphiphilic agent. The aqueous phase includes a pharmaceutically acceptable water-soluble polyhydroxy tonicity modifier. The propofol-containing dispersion is devoid of additional bactericidal or bacteriostatic preservative agents.