Abstract
Lipofundin MCT LCT ∗ ∗ in Germany: Lipofundin™ MCT, B. Braun Melsungen A G emulsions for parenteral nutrition were characterized in terms of particle size (bulk population), presence of large particles (⪢ 1 μm) and droplet charge (zeta potential as measure of electrostatic stabilization). Photon Correlation Spectroscopy (PCS), microscopy and Laser Diffractometry (LD) were employed as sizing techniques and compared to each other. Zeta potentials were determined by Laser Doppler Anemometry (LDA). The characterization data showed a good batch-to-batch reproducibility. The physical stability of Lipofundin MCT LCT was monitored over a period of 2 years. The mean diameter of the bulk droplet population did not increase. No formation of larger droplets was found by microscopy and LD. A negligible coalescence could only be detected by the very sensitive PCS measurements (two time window analysis). The zeta potential stayed above −45 mV providing sufficient electrostatic stabilization during the whole storage period.
Published Version
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