Assessment of the physicochemical stability of all-in-one parenteral emulsions for neonates according to USP specifications

Abstract

Background: The 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. Methods: Four 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). Results: All 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. Conclusions: The 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.