Long-term physico-chemical stability of standard parenteral nutritions for neonates.
OBJECTIVE
Two ready-to-use parenteral nutritions (PN) have been developed, for the first days of life of the premature newborn, along with syringes of lipid emulsion with or without vitamins. Long-term physico-chemical stability for storage in wards was assessed.


METHODS
Physico-chemical stability of PN: visual inspection, particle size, pH, osmolarity measurement, amino acids, glucose, and electrolytes dosages. Physico-chemical stability of lipid emulsion: visual inspection, globule size, peroxide level and vitamins A, E, and C dosages. Stability was studied for 12 weeks on refrigerated (2-8 °C) and room temperature (30 ± 2 °C) samples.


RESULTS
No precipitation was detected in any PN. A brown coloration was observed in PN stored for four weeks at room temperature but not in the refrigerator. Concentrations of all the nutrients remained constant over the 12 week-study period. Phase separation of the lipid emulsion occurred after three weeks, but particle size complied with the USP limits for 12 weeks. Peroxide content increased only in the samples without vitamins at room temperature. Vitamins remained stable for one week under refrigeration.


CONCLUSIONS
The PN did not present a detectable change of the tested properties when refrigerated for 12 weeks. The lipid emulsion with vitamins is stable for one week when refrigerated.
Bouchoud
Lucie
L
Pharmacy, Geneva University Hospitals, Gabrielle-Perret-Gentil 4, 1211 Geneva 14, Switzerland. lucie.bouchoud@hcuge.ch
Sadeghipour
Farshid
F
Klingmüller
Martin
M
Fonzo-Christe
Caroline
C
Bonnabry
Pascal
P
D000596:Amino Acids / Q000378:metabolism; D055598:Chemical Phenomena; D019587:Dietary Supplements / Q000592:standards; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards*; D005217:Fat Emulsions, Intravenous / Q000737:chemistry; D006801:Humans; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D010288:Parenteral Nutrition / Q000592:standards*; D014815:Vitamins / Q000378:metabolism*
D000596:Amino Acids; D005217:Fat Emulsions, Intravenous; D014815:Vitamins