Stability Study and Clinical Evaluation of Lipid Injectable Emulsion in Parenteral Nutrition Admixtures Used for Preterm Neonates.

ABSTRACT

BACKGROUND: Intravenous administration of parenteral nutrition (PN) admixtures containing 4-oil lipid injectable emulsion (ILE) in preterm neonates is usually prohibited because of limited clinical data. The authors evaluated the stability, safety, and efficacy of PN admixtures containing 4-oil ILE, for the first time, in preterm neonates. METHODS: A series of PN admixtures were prepared for consecutive administration in preterm neonates over a period of 15 days. Admixture stability was assessed after 24 hours of storage at 25 and 37 °C via visual inspection and measurement of mean droplet size (MDS). Safety and efficacy of the admixtures in preterm neonates were assessed via serum triglyceride levels and body weight increase measurements, respectively. RESULTS: PN admixtures were stable at 25 °C and had MDS ˂500 nm. After 15 days, there was a significant increase in body weight (P ≤ .0001) and level of serum triglycerides (P ≤ .0001), compared with the level before PN administration. CONCLUSIONS: PN admixtures containing 4-oil ILE were stable at 25 °C and showed instability at 37 °C. Therefore, it is recommended to keep the temperature during administration of PN admixtures at 25 °C. PN admixtures were well tolerated and safe over a period of 8 days while providing a balanced fatty acid supply. Tight monitoring of serum triglyceride level is essential, particularly in neonates of low birth weight and/or young gestational age, to avoid hypertriglyceridemia. Hence, the use of these PN admixtures is expected to be beneficial in terms of being cost-effective and reducing the contamination risks.