• Christos Athanasiou, Sophia Hatziantoniou, Maria Skouroliakou, and Sophia Markantonis-Kyroudis.
• Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Athens, Athens, Greece.
• JPEN J Parenter Enteral Nutr. 2014 Sep 1; 38 (7): 867-72.

BackgroundThe purpose of this study was to describe the methodology to assess the stability of all-in-one (AIO) parenteral nutrition admixtures, containing glucose, proteins, and lipids, to the standards of U.S. Pharmacopoeia (USP <729>). The influence of calcium and commercially available lipid emulsions and amino acid solutions were also examined.MethodsFour batches of 5 AIO admixtures containing calcium were compounded with commercially available lipid emulsions and amino acid solutions. Two of them contained calcium. Their stability was tested under conditions simulating clinical use. All the admixtures were assessed for criteria set by the USP <729>: (1) mean droplet diameter (MDD) and (2) percentage of volume weighted particles with diameter > 5 μm (PFAT5).ResultsAll admixtures were within the specifications set by the USP with respect to the MDD at 0, 24, and 48 hours, but only those batches lacking calcium met the benchmarks set by the pharmacopoeia, with respect to PFAT5, on the day of preparation.ConclusionsThe presence of calcium destabilized the admixtures, while the use of different commercial ingredients altered the admixtures' characteristics. Only 1 batch of the AIO admixtures studied was found to be compliant with USP <729> standards.© 2013 American Society for Parenteral and Enteral Nutrition.

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