Heavy metal contamination of nanosuspensions produced by high-pressure homogenisation.
High pressure homogenisation is a method for the production of nanosuspensions. In this process crystalline drug particles are pressed with high pressure through a narrow homogenisation gap. Due to the conditions in the gap it seems possible that metal erosion can occur. In this study the heavy metal (Fe) contamination of nanosuspensions produced by high pressure homogenisation was determined. Therefore nanosuspensions were analysed by atom absorption spectroscopy concerning their load of iron which is chosen as reference metal. The results show that the erosion of metal is below 1 ppm and will not cause any toxicological problems.
Krause
K P
KP
Department of Pharmaceutics, Biopharmaceutics and Biotechnology, Free University of Berlin, Kelchstr. 31, D-12196, Berlin, Germany.
Kayser
O
O
Mäder
K
K
Gust
R
R
Müller
R H
RH
D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods; D004340:Drug Contamination / Q000517:prevention & control*; D007501:Iron / Q000032:analysis / Q000592:standards; D019216:Metals, Heavy / Q000032:analysis* / Q000592:standards; D013054:Spectrophotometry, Atomic; D013535:Suspensions / Q000737:chemistry* / Q000592:standards
D019216:Metals, Heavy; D013535:Suspensions; D007501:Iron