AN EVALUATION OF THE SAFETY OF MIXED MICELLES IN HEALTHY-SUBJECTS

Background: Fat and water soluble vitamins are an essential part of IV nutrition (IVN). However, they are unstable in solution and may adher e to the bags and tubing containing the IVN. This study has examined t he safety and side-effect profile of mixed micelles (mixed bile-salt l ecithin micelles) used to solubilize water and fat soluble vitamins fo r IV administration. Methods: Two groups of six healthy male subjects received either placebo or mixed micelles daily for 5 days by IV infus ion in a randomized crossover design with a 9-day washout period separ ating the two treatment periods. Results: Infusion of mixed micelles r esulted in a significant increase in serum glycocholic acid from a med ian of 26.5 mu g/dL (interquartile range 18 to 38) to 115 mu g/dL (70 to 155) postinfusion. Glycocholic acid may have a lytic effect on cell membranes; however, in this study there was no evidence of hemolysis or increase in serum transaminases during mixed micelle infusion. Ther e was no increase in reported side effects during mixed micelle infusi on compared with placebo. Conclusion: Mixed micelles can be used safel y for the solubilization of fat- and water-soluble vitamins and drugs that are to administered by IV injection.