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An Evaluation of the Safety of Mixed Micelles in Healthy Subjects
Author(s) -
Ballinger A.B.,
Forget D.,
Le Brun A.,
Farthing M.J.G.
Publication year - 1996
Publication title -
journal of parenteral and enteral nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.935
H-Index - 98
eISSN - 1941-2444
pISSN - 0148-6071
DOI - 10.1177/0148607196020002110
Subject(s) - micelle , lecithin , chemistry , glycocholic acid , placebo , crossover study , cholestasis , chromatography , interquartile range , medicine , pharmacology , bile acid , aqueous solution , biochemistry , organic chemistry , alternative medicine , pathology , cholic acid
Background: Fat and water soluble vitamins are an essential part of IV nutrition (IVN). However, they are unstable in solution and may adhere to the bags and tubing containing the IVN. This study has examined the safety and side‐effect profile of mixed micelles (mixed bile‐salt lecithin micelles) used to solubilize water and fat soluble vitamins for IV administration. Methods: Two groups of six healthy male subjects received either placebo or mixed micelles daily for 5 days by IV infusion in a randomized crossover design with a 9‐day washout period separating the two treatment periods. Results: Infusion of mixed micelles resulted in a significant increase in serum glycocholic acid from a median of 26.5 μg/dL (interquartile range 18 to 38) to 115 μg/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. There was no increase in reported side effects during mixed micelle infusion compared with placebo. Conclusion: Mixed micelles can be used safely for the solubilization of fat‐ and water‐soluble vitamins and drugs that are to administered by IV injection. (Journal of Parenteral and Enteral Nutrition 20 :110–112, 1996)