Objective Premature newborns and infants suffering from digestive and extradigestive pathologies often need parenteral nutrition to cover their nutritional needs. Our objective is to assess the galenic stability of four all-in-one parenteral nutrition admixtures (PNAs) intended for neonates.
Methods A retrospective analysis of 238 prescriptions a given day per week over 6 months was conducted. Four formulae were then elaborated, testing different conditions. Galenic stability was assessed during 7 days through visual inspection, calcium concentration measurement, pH measurement, Zeta potential and particle size measurement.
Results No signs of creaming or coalescence or phase separation were observed. Calcium concentrations remained stable for the four formulae. pH ranged from 5.4 to 6 and remained stable. Zeta potential ranged from −32 to −38 mV and remained stable during the whole study for the four formulae. Droplet size distribution curves followed a Gauss curve and were strictly identical to the control (Medialipide) distribution curve. The De Brouckere mean diameter of globules was 0.38 µm and the maximum diameter was 0.78 µm.
Conclusions Although further physicochemical analyses should be performed to complete our results, the four all-in-one PNAs we studied can be considered as stable from a galenic point of view and meet French recommendations based on current European Pharmacopoeia and US Pharmacopoeia <729> chapter criteria. For clinical practice, we set the lower limit of lipid percentage at 4% and the use-by date at 3 days between 2°C and 8°C and 24 h between 25°C and 30°C.
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