Aluminum Exposure in Neonatal Patients Using the Least Contaminated Parenteral Nutrition Solution Products

Abstract

Aluminum (Al) is a contaminant in all parenteral nutrition (PN) solution component products. Manufacturers currently label these products with the maximum Al content at the time of expiry. We recently published data to establish the actual measured concentration of Al in PN solution products prior to being compounded in the clinical setting [1]. The investigation assessed quantitative Al content of all available products used in the formulation of PN solutions. The objective of this study was to assess the Al exposure in neonatal patients using the least contaminated PN solutions and determine if it is possible to meet the FDA “safe limit” of less than 5 μg/kg/day of Al. The measured concentrations from our previous study were analyzed and the least contaminated products were identified. These concentrations were entered into our PN software and the least possible Al exposure was determined. A significant decrease (41%–44%) in the Al exposure in neonatal patients can be achieved using the least contaminated products, but the FDA “safe limit” of less than 5 μg/kg/day of Al was not met. However, minimizing the Al exposure may decrease the likelihood of developing Al toxicity from PN.

Pediatric intestinal failure: Predictors of metabolic bone disease

“…Vitamin D content of PN, which at our center typically consists of 400 IU per 5 mL of pediatric vitamin mix, has not been studied specifically for its impact on MBD [16]. Aluminum, a contaminant of PN, has been shown to inhibit bone mineralization [33], though variability between formulations is likely not significant, as all available PN formulations in the United States exceed Food and Drug Administration limits [39].…”

Physical Compatibility of Calcium Chloride and Sodium Glycerophosphate in Pediatric Parenteral Nutrition Solutions

“…Various publications have raised concern over the aluminum load in PN and the potential consequences of prolonged exposure 8 . ‐ 10 Aluminum toxicity prompted one group to publish limited saturation data for PN containing calcium chloride and sodium phosphate, thus suggesting a potential PN alternative with a lower aluminum load 11 . Regardless of the calcium salt used in PN, it is often difficult to reach calcium and phosphorus serum concentrations in preterm neonates that mimic third‐trimester fetal requirements.…”

Preparación de las nutriciones parenterales pediátricas

“…Es importante conocer el contenido de aluminio de las soluciones para intentar disminuir su aporte sobre todo en neonatología y en pacientes con NP largo plazo. Varios autores han medido la cantidad de aluminio en los productos de NP concluyendo que los aportes de gluconato cálcico, sales de fosfato y multioligoelementos son los que más aluminio aportan (43)(44)(45)(46). Recientemente el grupo de trabajo de farmacia SENPE/SEFH ha estudiado la cantidad de aluminio en los productos del mercado español, encontrando que los que mayor cantidad de aluminio contiene son las sales de fosfato, especialmente las presentaciones de vidrio (datos pendientes de publicar).…”