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Stability of MCT/LCT-based total nutrient admixtures for neonatal use over 30 hours at room temperature: applying

David F Driscoll1, Anthony P Silvestri, Bruce R Bistrian

  • 1Nutrition/Infection Laboratory, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.

JPEN. Journal of Parenteral and Enteral Nutrition
|May 15, 2010
PubMed

Insights

Higher amino acid (AA) concentrations in neonatal total nutrient admixtures (TNAs) significantly improve emulsion stability, as measured by the PFAT5 parameter. This finding is crucial for ensuring the safety and efficacy of parenteral nutrition in infants.

Area of Science:

  • Parenteral nutrition
  • Lipid emulsion stability
  • Neonatal intensive care

Background:

  • United States Pharmacopeia <729> limits large fat globules (>5 microm) in lipid emulsions to <0.05% PFAT5.
  • Previous studies showed stability in adult TNAs and some neonatal TNAs with 2-3% amino acid (AA).
  • This study assessed stability in neonatal TNAs with varying AA concentrations (<2% or >=3%).

Purpose of the Study:

  • To evaluate the impact of different amino acid (AA) concentrations on the stability of neonatal total nutrient admixtures (TNAs).
  • To determine the most sensitive indicator of stability for neonatal TNAs.
  • To ensure compliance with United States Pharmacopeia <729> standards for lipid emulsion safety.

Main Methods:

  • Tested eight neonatal TNA formulations with varying AA (1-4%), glucose (5-10%), and MCT/LCT (2-4%) concentrations.
  • Assessed stability using the PFAT5 parameter over 30 hours at 25°C.
  • Measured mean droplet size (MDS) and pH at the beginning and end of the study.

Main Results:

  • Formulations with 1% and 1.5% AA showed PFAT5 levels >0.05% in 71% of samples, indicating instability.
  • Formulations with 3% and 4% AA consistently maintained PFAT5 levels <0.05% (100% of samples), meeting stability requirements.
  • Significant differences (P < .001) in PFAT5, MDS, and pH were observed between low and high AA groups.

Conclusions:

  • Amino acid (AA) concentration is the primary determinant of stability in neonatal total nutrient admixtures (TNAs).
  • The PFAT5 parameter is a highly sensitive indicator for assessing TNA stability.
  • Higher AA levels (>=3%) are essential for ensuring the stability of neonatal TNAs.
Abstract

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