Standard parenteral nutrition stability study
2 Pharmacy Faculty, University of Poitiers
3 Pediatrics department, Poitiers University Hospital, France
The DGOS instruction of 20 March 2015 on the management of risks associated with parenteral nutrition in pediatrics activity and French Society of Neonatology recommend in the absence of pharmaceutical specialty to prescribe standard formulas. In Poitiers University Hospital, two standard formulas were defined for premature infants of less than 32 weeks: PREM 1 used for the first day of life is composed of glucose, calcium gluconate, amino acid and water and PREM 2 used for the following days contains the same elements as PREM 1 plus phosphate, potassium chloride and magnesium sulfate. The objective of this work was to study the stability of these two formulas stored at 4°C.
Materials and Methods
Controls were performed from day 0 to day 42. Chemical stability was evaluated by analyse of sodium, potassium, glucose, total proteins, magnesium and calcium. Physical stability was evaluated by measuring the pH, osmolality and turbidimetry. Bacteriological stability was controled after inoculation and incubation of blood culture bottles.
Concentrations of sodium, potassium, calcium, magnesium, glucose and protein may be considered stable for 42 days. The pH and osmolality were stable for 42 days. Bacteriological samples were always negative.
Changes from baseline concentrations above 10% were found for some parameters. These results can be explained because methods of analyses were developed for biological matrices different than parenteral nutrition. However, the standard formulas PREM 1 and PREM 2 showed acceptable stability for 42 days.