Production and stability study of a hospital parenteral nutrition solution for neonates

Abstract

Standard parenteral nutrition solutions are mixtures comprising interacting components that may degrade themselves over time. The objective of this study was to investigate the physicochemical and microbiological stability of a hospital preparation for parenteral nutrition in neonatology. The analyses were performed throughout the storage of the preparations at 2-8 °C (up to 4 months). The extent of stability was based on the determination of amino acids dosage, visual and physicochemical properties (glucose and electrolytes concentrations, pH and osmolality measurements, particle counting) and microbiological analysis (sterility test). A thermal degradation of ascorbic acid was conducted to evaluate the antioxidant properties of the parenteral mixture. Physicochemical and microbiological controls were found to comply with the specifications. Amino acids showed a good stability throughout the 4months storage except for cysteine, which was progressively degraded to cystine, conferring a yellow coloration to parenteral solutions. Parenteral nutrition standards solutions remain stable for 4 months at 2-8 °C, ensuring safe administration in preterm infants.

Keywords: Amino acids; High-performance liquid chromatographic; Neonatology; Parenteral nutrition; Stability-indicating method study.

Fig. 1

(A) Linear profiles of (•) cystine (r = 0.936, p < 0.0001) and (○) cysteine (r = 0.984, p < 0.0001) concentrations in parenteral nutrition solution as a function of time of storage at 2–8 °C (n = 9 experimental determinations). Profile of cysteine concentration was calculated as the difference of initial concentration of cysteine in the parenteral nutrition solution and the experimental cystine concentrations determined throughout the time of storage. (B) Box plot: Cystine concentration for 118 days of storage at 2–8 °C (n = 9 experimental determinations). * p < 0.05; *** p < 0.01 as compared to day 1 group (Wilcoxon's test).

Fig. 2

(A) UV–visible spectra of aqueous solutions of glucose, amino acids, glucose and amino acids, supplemented or not with ascorbic acid. (B) Photographs of aqueous solutions of glucose, amino acids, glucose and amino acids, supplemented or not with ascorbic acid.