RT Journal Article
SR Electronic
T1 The Influence of Manufacturing Parameters on the Formation and Growth on Autoclaving of a 40% V/V Bis-Perfluorobutylethene Emulsion
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 12
OP 15
VO 46
IS 1
A1 Shireesh Apte
A1 Salvatore Turco
YR 1992
UL http://journal.pda.org/content/46/1/12.abstract
AB The influence of different process variables on the number of large particles before and after autoclaving of a 40% V/V Bis-Perfluorobutylethene emulsion stabilized by egg yolk lecithin, made isotonic with blood, was examined. The concentration of emulsifier, emulsification and autoclaving time and temperature, fill volume and the cooling gradient applied to the emulsion after autoclaving all affect the number of large droplets and hence the stability and acceptability of the finished product. This work suggests that validation of equipment and process to very exacting specifications and strict adherence to specified manufacturing protocol is essential for the reproducible production of fluorocarbon emulsions acceptable for intravenous administration.