Phytosterol determination in lipid emulsions for parenteral nutrition

Abstract

ObjectiveThe presence of phytosterols in vegetal lipid emulsions has been associated with alterations of liver function tests. Determination of phytosterols content, currently undeclared, would allow the development of strategies to prevent or treat these alterations. Method3-4 non-consecutive batches of 6 lipid emulsions from different providers (Clinoleic™, Intralipid™, Lipofundina™, Lipoplus™, Omegaven™ and Smoflipid™) were analyzed. Differences in total phytosterol assay between providers and batches were statistically studied by a one-way ANOVA and Kruskal-Wallis non-parametric approximation and post hoc Scheffe test (p < 0.05) ResultsThe absence of phytosterols was confirmed in Omegaven™, emulsion based on fish oil. The highest assay of phytosterols (422.4 ± 130.5 µg/mL) has been related with the highest percentage of soya bean oil in Intralipid. In the remaining emulsions, concentrations were from 120 to 210 µg/mL related to the percentage of soya bean oil. Statistically significant differences of phytosterol content in lipid emulsions were observed among different providers (F = 23.59; p = 0.000) as well as among non-consecutive batches. Clinolenic™ (F = 23.59; p = 0.000), Intralipid™ (F = 978.25; p = 0.000), Lipofundina™ TCL/TCM (F = 5.43; p = 0.045), Lipoplus™ (F = 123.53; p = 0.000) and Smoflipid™ (16.78; p = 0.000). Except for Lipofundina™ TCL/TCM, the differences between batches were marked. ConclusionsLipid emulsions, registered on Spanish pharmaceutical market, contain variable quantities of phytosterols dependent on commercial brand and batch.