Physicochemical stable standard all-in-one parenteral nutrition admixtures for infants and children in accordance with the ESPGHAN/ESPEN guidelines.

Abstract

Because there are almost no standard all-in-one parenteral nutrition admixtures available for infants and children, the aim was to develop standard two-compartment parenteral nutrition bags for different weight categories based on the ESPGHAN/ESPEN (European Society of Paediatric Gastroenterology, Hepatology and Nutrition/European Society for Clinical Nutrition and Metabolism) guidelines. The 1 g/kg/d lipid version for the 3 to 10 kg weight category (PED1) was assessed for short- and long-term physicochemical stability with the ability to add additional electrolytes (PED1+E). The lipid compartment A and the all-in-one admixture of A + B + vitamins + trace elements were assessed physically by visual inspection, Sudan red test, pH measurement, and lipid droplet size distribution. Chemical stability for compartment A was evaluated by quantitative analyses of non-esterified fatty acids and peroxide content. The glucose-amino acid-electrolyte compartment B was evaluated physically by visual inspection, measuring particle contamination and pH. Chemical stability was assessed by discoloration, quantitative analyses of glucose, and the amino acids L-cysteine, L-tyrosine, and L-tryptophan. No phase separation or coalescence occurred, and the mean droplet size diameter did not exceed 0.5 µm. Peroxide content and non-esterified fatty acids concentration of compartment A remained well below the limit of acceptation. No precipitation was detected for compartment B; only a slight yellow discoloration was noted at 80 d. Concentrations of glucose, L-tyrosine, and L-tryptophan remained stable; only L-cysteine decreased significantly from its initial concentration. The two-compartment PED1 and PED1+E admixtures are stable up to 80 d 2° to 8°C + 24 h room temperature (RT) with an additional 7 d 2° to 8°C + 48 h RT after mixing and addition of vitamins and trace elements.