Introduction: Aluminum contamination of parenteral nutrition solutions has been documented for three decades. It can result in elevated blood, bone, and whole body aluminum levels associated with neurotoxicity, reduced bone mass and mineral content, and perhaps hepatotoxicity. The primary aluminum source among parenteral nutrition components is glass-packaged calcium gluconate, in which aluminum concentration the past three decades has averaged~ 4000 [mu]g/L, compared to < 200 [mu]g/L in plastic container-packaged calcium gluconate. A concern about plastic packaging is leaching of plasticizers, including phthalates, which have the potential to cause endocrine (male reproductive system) disruption and neurotoxicity.
Methods: Aluminum was quantified in samples collected periodically over more than two years from three calcium gluconate sources used to prepare parenteral nutrition solutions; two packaged in glass (from France and the US) and one in plastic (from Germany); in a recently released plastic-packaged solution (from the US);and in the two glass containers. Phthalate concentration was determined in selected samples of each product and leachate of the plastic containers.
Results: The initial aluminum concentration was ~ 5000 [mu]g/L in the two glass-packaged products and ~ 20 [mu]g/L in the plastic-packaged product, and increased ~ 30, 50 and 100% over 2 years, respectively. The aluminum concentration in a recently released Calcium Gluconate Injection USP was ~ 320 [mu]g/L. Phthalates were not detected in any calcium gluconate solutions or leachates.
Conclusion: Plastic packaging greatly reduces the contribution of aluminum to parenteral nutrition solutions from calcium gluconate compared to the glass-packaged product.
Digital Object Identifier (DOI)
Yokel, Robert A. and Unrine, Jason M., "Aluminum and Phthalates in Calcium Gluconate; Contribution from Glass and Plastic Packaging" (2017). Pharmaceutical Sciences Faculty Publications. 69.