Article Text
Abstract
Background and Importance Paediatric patients receiving parenteral nutrition (PN) are particularly vulnerable to aluminum exposure, a known contaminant in PN formulations.
Aim and Objectives This study aimed to quantify the aluminum concentrations in paediatric PN admixtures prepared using commercially available multichamber bags (MCBs) for paediatrics and compare them with the aluminium content in compounded PN (CPN) with an equivalent composition of ingredients.
Material and Methods We conducted aluminium content testing on the three commercially available MCB formulations (Numeta® G13, G16, and G19). Simultaneously, we analysed CPN preparations with identical compositions. For the MCB preparations, we utilised two batches of each MCB presentation, both with and without lipids. For CPN, we created three distinct formulations for each MCB presentation: one utilising Primene® as the amino acid source, another using Aminoven-Infant®, and a third modifying the source of electrolytes (using either Aminoven-Infant® or Primene®). CPN was prepared using iv electrolytes compounded by an external pharmacy and commercially available electrolytes. The macronutrients employed for CPN included Aminoven-Infant® or Primene® for amino acids, Glucose 70% for carbohydrates, and Smoflipid® 20% for the lipid source. Aluminium content was quantified using spectrometry. Mann-Whitney tests were employed to compare means.
Results Overall, we tested 30 PN preparations (12 MCB and 18 CPN). The mean aluminium content was significantly higher in the CPN preparations compared to MCB, measuring 20.68 and 9.83 µg/L, respectively (see table 1).
Data expressed as µg/L[SD]
Conclusion and Relevance This study underscores significant differences in aluminium content between commercially available MCBs and CPN preparations, emphasising safety concerns in neonatal and paediatric patients. The findings underscore the need for efforts to harmonise discrepancies across manufacturers and sources of contamination, ultimately enhancing the quality and safety of paediatric PN formulations.
Conflict of Interest No conflict of interest.