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An Assessment of aluminum contamination in neonatal parenteral nutrition solutions based on measured versus labeled
Haya I Aljohar1, Rania A Nawawi2, Nora S Albanyan3
1Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
Insights
Aluminum contamination in parenteral nutrition (PN) solutions poses a toxicity risk for infants in Saudi Arabia. This study found concerning aluminum levels in PN ingredients and final products, necessitating urgent safety improvements.
Area of Science:
- Pediatric Nutrition
- Clinical Chemistry
- Toxicology
Background:
- Parenteral nutrition (PN) is crucial for infants with intestinal failure.
- Aluminum exposure from PN can lead to toxicity in pediatric and neonatal patients.
- Concerns exist regarding PN solution compliance with US FDA aluminum regulations in Saudi Arabia.
Purpose of the Study:
- To quantify aluminum concentrations in PN solutions and ingredients used for infants in Saudi Arabia.
- To assess the risk of aluminum toxicity in vulnerable pediatric populations.
- To identify specific PN components contributing to elevated aluminum levels.
Main Methods:
- Inductively coupled plasma mass spectrometry (ICP-MS) was employed to determine aluminum levels.
- Analysis of 38 PN samples, including 15 individual components and final PN solutions.
- Triplicate measurements were conducted for each sample to ensure accuracy.
Main Results:
- Significant aluminum concentrations were found in various PN ingredients, notably calcium gluconate (462.7 mcg/L) and potassium phosphate (141.64 mcg/L).
- Final PN solutions exhibited higher aluminum levels than their constituent ingredients.
- Elevated aluminum levels (exceeding 0.6 ng/ml) were observed in pediatric patients receiving long-term PN, correlating with potential toxicity.
Conclusions:
- Current PN solutions in Saudi Arabia contain aluminum levels that pose a significant risk of toxicity to pediatric patients.
- Reducing aluminum contamination in PN ingredients and final products is critical for ensuring infant safety.
- Further regulatory oversight and formulation adjustments are imperative to mitigate aluminum-induced adverse effects.
Abstract:
Aluminum can potentially cause toxicity in pediatrics and neonates receiving parenteral nutrition. Some PN solutions and ingredients in Saudi Arabia do not comply with US FDA regulations regarding aluminum exposure. This study aims to determine the aluminum concentration in samples of PN solutions and ingredients used to feed infants in Saudi Arabia. The aluminum in the samples was determined using inductively coupled plasma mass spectrometry. The concentration of metal contaminants in each sample was determined in triplicate. The aluminum content of 38 samples was investigated, 15 of which originated from components included in the prepared PN solutions. Among the 15 samples, the least measurable aluminum content was detected in potassium chloride solutions (0.81 mcg/L). In contrast, the greatest amount of aluminum was detected in potassium phosphate and calcium gluconate (141,64 mcg/L and 462.7 mcg/L), respectively. The results showed that the final PN solution (PNS) product contained more aluminum levels than the content ingredients; in addition, the study found a statistically significant relationship among 18 pediatric patients at KFMC who had intestinal failure and needed long-term parenteral nutrition. Specifically, their high aluminum levels, exceeding the normal range of 0.6 ng/ml, indicate that the current use of PN solutions will likely cause toxicity due to aluminum contamination in additives. Hence, reducing aluminum in PN solutions is imperative to ensure patient safety.
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