'מערכת אימד'For the first time, a highly sensitive assay allowed comprehensive pharmacokinetics studies of PEG-3350 in humans. These studies confirmed that orally administered PEG-3350 is minimally absorbed, rapidly
excreted and primarily eliminated via faeces.
R. W. PELHAM, L. C. NIX, R. E. CHAVIRA, M. VB. CLEVELAND & P. STETSON
Aliment Pharmacol Ther. 28, 256–265
doi:10.1111/j.1365-2036.2008.03727.x
Abstract
Background
The pharmacokinetics of polyethylene glycol 3350 (PEG-3350) have not been fully described because of lack of a sufficiently sensitive analytical method.
Aim
To describe the pharmacokinetics of PEG-3350 in humans.
Methods
A highly sensitive, high performance liquid chromatography with mass spectrometry (HPLC⁄MS⁄MS) method was developed for PEG-3350 in urine, plasma and faeces with quantification limits of 30 ng⁄mL,
100 ng⁄mL and 500 lg ⁄g respectively. Noncompartmental pharmacokinetics methods were used and the effects of gender, age, renal status and dosing frequency were examined after the oral administration of
17 g to healthy volunteers.
Results
Peak PEG-3350 plasma concentrations occurred at 2–4 h and declined to nonquantifiable levels usually within 18 h after single and multiple doses, with a half-life of about 4–6 h. Steady state was reached within
5 days of dosing. Mean urinary excretion of the administered dose ranged from 0.19% to 0.25%. Age, gender or mild kidney impairment did not alter the pharmacokinetics of PEG-3350. Mean faecal excretion of
the administered dose was 93% in young subjects.
Conclusions
For the first time, a highly sensitive assay allowed comprehensive pharmacokinetics studies of PEG-3350 in humans. These studies confirmed that orally administered PEG-3350 is minimally absorbed, rapidly
excreted and primarily eliminated via faeces.