Aluminum exposure in neonatal patients using the least contaminated parenteral nutrition solution products.

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.

Aluminum in pediatric parenteral nutrition products: measured versus labeled content.

OBJECTIVE: Aluminum is a contaminant in all parenteral nutrition solutions. Manufacturers currently label these products with the maximum aluminum content at the time of expiry, but there are no published data to establish the actual measured concentration of aluminum in parenteral nutrition solution products prior to being compounded in the clinical setting. This investigation assessed quantitative aluminum content of products commonly used in the formulation of parenteral nutrition solutions. The objective of this study is to determine the best products to be used when compounding parenteral nutrition solutions (i.e., those with the least amount of aluminum contamination). METHODS: All products available in the United States from all manufacturers used in the production of parenteral nutrition solutions were identified and collected. Three lots were collected for each identified product. Samples were quantitatively analyzed by Mayo Laboratories. These measured concentrations were then compared to the manufacturers' labeled concentration. RESULTS: Large lot-to-lot and manufacturer-to-manufacturer differences were noted for all products. Measured aluminum concentrations were less than manufacturer-labeled values for all products. CONCLUSIONS: The actual aluminum concentrations of all the parenteral nutrition solutions were significantly less than the aluminum content based on manufacturers' labels. These findings indicate that 1) the manufacturers should label their products with actual aluminum content at the time of product release rather than at the time of expiry, 2) that there are manufacturers whose products provide significantly less aluminum contamination than others, and 3) pharmacists can select products with the lowest amounts of aluminum contamination and reduce the aluminum exposure in their patients.