Aluminum content in intravenous solutions for administration to neonates: role of product preparation and administration methods.
BACKGROUND
Aluminum loading can reach toxic levels depending on the amount of aluminum intake in intravenous solutions (IV). Premature infants are at a higher risk of aluminum toxicity because of their reduced urinary aluminum elimination. All steps involved in the preparation of intravenous solutions for premature neonates in intensive care units were evaluated to determine to what degree, if any, they increased the aluminum load and should be considered when assessing the daily aluminum intake (<5 mcg/kg) established by the U.S. Food and Drug Administration (FDA).


METHODS
Products and medical devices used for the IV administration of solutions to preterm neonates were analyzed for their aluminum content. Commercial formulations, bags after compounding, and medications before and after their preparation, as well as infusion sets (including burettes) and syringes, were evaluated for their contribution to the aluminum levels in the final solution. The determination was carried out by atomic absorption spectrometry.


RESULTS
Currently available products used to prepare parenteral nutrition solutions as well as injectable medications usually administered to premature neonates present aluminum contamination. Bags, burettes, and syringes were also contaminated by aluminum to some degree, which may be leached during use.


CONCLUSIONS
Commercial products are the main source of aluminum in parenteral nutrition; nevertheless, manipulation, containers, and administration sets increased aluminum levels by about 40%. Because this is a significant rate, these sources should be taken into account when calculating the amount of aluminum delivered to the patient in order to comply with FDA standards.
de Oliveira
Sandra R
SR
Department of Chemistry, Federal University of Santa Maria, Santa Maria, Brazil.
Bohrer
Denise
D
Garcia
Solange C
SC
do Nascimento
Paulo Cícero
PC
Noremberg
Simone
S
D000535:Aluminum / Q000032:analysis*; D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination; D004864:Equipment and Supplies; D006801:Humans; D007231:Infant, Newborn; D007263:Infusions, Parenteral; D007363:Intensive Care Units, Neonatal; D010288:Parenteral Nutrition / Q000592:standards*; D019999:Pharmaceutical Solutions / Q000592:standards*; D012016:Reference Values; D013054:Spectrophotometry, Atomic; D013594:Syringes; D014481:United States; D014486:United States Food and Drug Administration
D019999:Pharmaceutical Solutions; D000535:Aluminum