Phytosterol determination in lipid emulsions for parenteral nutrition

• Published in: Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria Vol. 42; no. 3; p. 116
• Main Authors: Llop Talaverón, Josep M, Novak, Ana, Suñé Negre, Josep M, Badia Tahull, María, Leiva Badosa, Elisabet, Ticó Grau, Josep R
• Format: Journal Article
• Language: English
• Published: Spain 01.05.2018
• Subjects: Chromatography, High Pressure Liquid; Drug Compounding; Emulsions; Fat Emulsions, Intravenous - analysis; Fish Oils - analysis; Parenteral Nutrition - methods; Phospholipids; Phytosterols - analysis; Plant Oils; Prospective Studies; Soybean Oil
• ISSN: 2171-8695
• DOI: 10.7399/fh.10954

The 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. 3-4 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 Scheffé test (p < 0.05)Results: The 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. Lipid emulsions, registered on Spanish pharmaceutical market,  contain variable quantities of phytosterols dependent on commercial brand and  batch.