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Related Experiment Videos

Sevelamer, a phosphate-binding polymer, is a non-absorbed compound.

Melissa A Plone1, John S Petersen, David P Rosenbaum

  • 1GelTex Pharmaceuticals, Inc., 153 Second Avenue, Waltham, MA 02451, USA. mplone@geltex.com

Clinical Pharmacokinetics
|June 27, 2002
PubMed
Summary

Sevelamer hydrochloride, a phosphate binder, was studied for absorption in rats and humans. Results show sevelamer is a non-absorbed compound with minimal systemic distribution.

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Area of Science:

  • Pharmacokinetics
  • Drug Metabolism and Disposition
  • Gastroenterology

Background:

  • Sevelamer hydrochloride is a widely used phosphate binder for managing hyperphosphatemia.
  • Understanding the absorption, distribution, and excretion (ADME) profile is crucial for assessing drug safety and efficacy.

Purpose of the Study:

  • To investigate the pharmacokinetic properties of sevelamer hydrochloride.
  • To determine the extent of absorption, distribution, and excretion of sevelamer in preclinical (rat) and clinical (human) studies.

Main Methods:

  • Radiolabeled sevelamer ([3H] in rats, [14C] in humans) was administered orally.
  • Studies included single-dose and 28-day pretreatment regimens.
  • Excretion via urine and feces, and tissue distribution were analyzed.

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Main Results:

  • In rats, fecal recovery of radioactivity was >98%, with <0.1% in tissues.
  • In humans, no detectable radioactivity was found in blood.
  • Fecal recovery in humans averaged >99%, with minimal to undetectable urinary excretion.

Conclusions:

  • Sevelamer hydrochloride demonstrates negligible systemic absorption in both rats and humans.
  • The drug is primarily eliminated through feces, consistent with its intended non-absorbed mechanism of action.