Parenteral nutrition admixtures for pediatric patients compounded with highly refined fish oil-based emulsion: Assessment of physicochemical stability – Letter to Editor

Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices

“…Chemical and therapeutic safety was confirmed for 12 of the admixtures in the original study, although without transferability to other parenteral nutrition admixtures [12,13]. This point was addressed in a subsequent study because laser diffraction cannot detect a large-diameter tail induced by coalescence, which would only be observed during a destabilization process [15]. A complete physical stability analysis should therefore include visual inspection, microscopic observation, pH and zeta potential measurements, and the determination of globule size and characteristics by photon correlation spectroscopy [16].…”

“…Inline analysis, which can detect large droplets during the process, would minimize such risks. Additional methods should be used, especially the determination of the zeta potential, in order to make statements about stability [15]. Such effects have been demonstrated by stability check-ups, which reveal the challenges between the characterization of the current size distribution and the further stability of the emulsion [2].…”