Physical Stability of Medium‐Chain Triglyceride/Long‐Chain Triglyceride Emulsion Injections From 5 Manufacturers in High‐Concentration Electrolyte–Based Total Nutrient Admixtures

Abstract

Background Lipid emulsion injections for parenteral nutrition are an important source of energy and essential fatty acids. Yet stability and compounding challenges remain. We compared the physicochemical stability of 5 commercial medium‐chain triglyceride/long‐chain triglyceride (MCT/LCT)–based lipid emulsions compounded in total nutrient admixtures (TNAs). Methods Stability of the MCT/LCT‐based TNAs was assessed when compounded with high concentrations of electrolytes. We measured mean droplet diameter (MDD), percentage of fat residing in globules ≥5 μm (PFAT5), pH, and osmolality immediately after compounding (time 0) and 6, 12, 18, 24, 36, 48, 60, and 72 hours later. Repeated‐measures analyses of variance were used to evaluate changes in stability over time, and post hoc tests were used to assess group differences. Results Over 72 hours, MDD of TNAs ranged from 0.206 to 0.713 μm, PFAT5 from 0.58% × 10−3to 43.18% × 10−3, pH from 5.769 to 5.879, and osmolality from 1304 to 1357 mOsm/kg. MDDs and PFAT5s showed a tendency to increase gradually over the first 24 hours and then decrease or remained stable after that. We identified some significant differences in MDDs and PFAT5s among the 5 MCT/LCT‐based TNAs, although all met the United States Pharmacopeia <729> standards. Conclusions The stability of some commercial MCT/LCT‐based TNAs under high concentrations of electrolytes exhibits differences over the 72 hours after compounding. Clinicians should pay attention, therefore, to possible performance differences of injectable lipid emulsions produced by different manufacturers when compounded in TNAs under high electrolyte concentrations.

S3-Leitlinie Heimenterale und heimparenterale Ernährung der Deutschen Gesellschaft für Ernährungsmedizin (DGEM)

“…Elektrolyte neigen zu Inkompatibilitäten (Ausfällungen, mehrwertige Kationen und negativ geladene Lipidemulgatoren, die zur Destabilisierung der Emulsion führen.) Ihre korrekte Beimischung in die entsprechende Makroelementkomponente ist entscheidend [172,217,422,442,443,446]. In ausgewählten Fällen mit hohem Kalziumbedarf sind möglicherweise auch organische, anstatt anorganische Komponenten vorzuziehen [172,217,443,445].…”

“…Die Extrapolation von Daten ist in diesen äußerst komplexen und metastabilen Gemischen in der Regel schwierig oder unmöglich, es können erhebliche Unterschiede, z. B. in der Fettstabilität, unter Zusatz von Spurenelementen oder hohen Elektrolytkonzentrationen auftreten 172 422 . Diese Beutel werden wegen der limitierten Stabilität in der Regel am Tag der Anwendung oder für die Verwendung innerhalb von maximal 7 Tagen einmal wöchentlich gemäß den Stabilitätsdaten hergestellt.…”

A Narrative Review: Analysis of Supplemental Parenteral Nutrition in Adults at the End of Life

“… Emulsifying agents. They maintain stability due to the establishment of repulsive forces between the phases, which prevent the fusion of fat droplets [ 87 ]. The use of emulsifiers such as phospholipids, glycerol and lysoderivatives of lecithin in the emulsion is relevant, as they cause negative repulsive forces on the surface that help maintain lipid stability [ 88 ].…”