Objective:

this study aims to investigate the physical stability of standard formulations for parenteral nutrition, with and without lipids, in one bag for preterm babies.

Method:

standard formulations for first-day and for second-day parenteral nutrition of preterm babies weighing 1,000 grams were prepared in triplicate. Standard all-in-one formulas for first-day and for second-day parenteral nutrition were compared with equivalent standard lipid-free formulations. The standard formulas contain glucose, amino acids, lipids, calcium gluconate, potassium chloride, sodium chloride, and vitamins. Stability was evaluated using visual inspection, particle size analysis, and pH measurement. The physical instability of the all-in one parenteral nutrition formulas was reported as creaming, coalescence, or cracking, whereas the instability of the lipid-free parenteral nutrition formulas was described as turbidity, precipitation, gas formation, or colour changes. Two independent evaluators assessed the visual changes under light and against a dark-light background, as well as using the Tyndall beam effect. Particle size was measured using a particle size analyzer. Chemical compatibility was checked using a pH-meter.

Result:

the result showed that the all-in-one (AIO) parenteral nutrition formulas develop reversible creaming on day three, while the lipid-free ones remain clear. As regards pH and particle size, none of the four AIO and lipid-free formulas developed significant changes (ΔpH < 0.05 and particle size < 400 nm) until after seven days.

Conclusion:

all four formulas are stable following examination with visual inspection, a pH-meter, and a particle size analyzer.

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