Biliary excretion of hydroxyethyl starch in man

Area of Science:

• Pharmacokinetics
• Drug Metabolism
• Gastroenterology

Background:

• Hydroxyethyl starch (HES) is a plasma volume expander.
• Understanding the elimination pathways of HES is crucial for assessing its safety and efficacy.
• Biliary excretion is a potential route for drug and metabolite clearance.

Purpose of the Study:

• To quantify the extent of biliary excretion of hydroxyethyl starch (HES) in humans.
• To determine the recovery of HES in feces following intravenous administration.

Main Methods:

• Intravenous administration of 500 ml of a 6% HES solution to nine healthy male volunteers.
• Quantification of HES in fecal samples using a specific gas chromatograph mass spectrometer selected ion monitoring procedure.
• Collection of fecal samples over a 14-day period post-administration.

Main Results:

• The average recovery of the administered hydroxyethyl starch (HES) dose in feces was less than 1%.
• This minimal fecal recovery suggests limited biliary excretion of HES in healthy human subjects.
• The study provides quantitative data on the biliary elimination of HES.

Conclusions:

• Biliary excretion accounts for a very small fraction of the total elimination of hydroxyethyl starch (HES) in humans.
• The findings suggest that HES is primarily eliminated through other routes, such as renal excretion.
• This study contributes to the understanding of HES pharmacokinetics and its potential for accumulation.