An evaluation of the safety of mixed micelles in healthy subjects.
BACKGROUND
Fat and water soluble vitamins are an essential part of i.v. 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 i.v. administration.


METHODS
Two groups of six healthy male subjects received either placebo or mixed micelles daily for 5 days by i.v. 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 micrograms/dL (interquartile range 18 to 38) to 115 micrograms/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.


CONCLUSIONS
Mixed micelles can be used safely for the solubilization of fat- and water-soluble vitamins and drugs that are to administered by i.v. injection.
Ballinger
A B
AB
Digestive Diseases Research Centre, Medical College of St Bartholomew's Hospital, London.
Forget
D
D
Le Brun
A
A
Farthing
M J
MJ
D000293:Adolescent; D000328:Adult; D001647:Bile Acids and Salts; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008823:Micelles; D008875:Middle Aged; D010288:Parenteral Nutrition / Q000009:adverse effects / Q000379:methods*; D010713:Phosphatidylcholines; D012995:Solubility; D014815:Vitamins / Q000008:administration & dosage
D001647:Bile Acids and Salts; D008823:Micelles; D010713:Phosphatidylcholines; D014815:Vitamins