Influence of the relative composition of trace elements and vitamins in physicochemical stability of total parenteral nutrition formulations for neonatal use

Nutr J. 2012 Apr 17:11:26. doi: 10.1186/1475-2891-11-26.

Abstract

Objective: The present study aimed to evaluate the influence of the relative composition of trace elements and vitamins in physicochemical stability of neonatal parenteral nutrition.

Material and methods: Three formulations for neonatal administration were selected; the main variable was the presence of trace elements and vitamins. The analyses where carried out immediately after preparation and at 24 h, 48 h, 72 h and 7 days after preparation. Three methods were selected to determine globule size: light obscuration, dynamic light scattering and optical microscopy. Complementary evaluation including visual inspection, determination of pH and osmolarity, peroxide levels and measurements of zeta potential were also performed.

Results: There was an observable alteration in color and phase separation in the PN stored at 25°C and 40°C. Neither globule size pattern, nor any other physicochemical characteristic evaluated appeared to be considerably altered in any of the analyzed formulations even after 7 days of storage at 5°C. Globule size in all the PN studied was consistent with the established limit, below 500 nm by DLS measurement, and PFAT5 was below 0.05% under all storage temperatures.

Conclusion: Concomitant presence of trace elements and vitamins in the same neonatal formulation did not alter the evaluated aspects of stability.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Chemical Phenomena
  • Chemistry, Pharmaceutical / methods
  • Drug Stability
  • Drug Storage
  • Fat Emulsions, Intravenous / chemistry
  • Humans
  • Hydrogen-Ion Concentration
  • Osmolar Concentration
  • Parenteral Nutrition Solutions / chemistry*
  • Parenteral Nutrition Solutions / pharmacology
  • Parenteral Nutrition, Total
  • Particle Size
  • Peroxides / analysis
  • Trace Elements / analysis*
  • Trace Elements / pharmacology
  • Vitamins / analysis*
  • Vitamins / pharmacology

Substances

  • Fat Emulsions, Intravenous
  • Parenteral Nutrition Solutions
  • Peroxides
  • Trace Elements
  • Vitamins