Drugs in R & D

, Volume 4, Issue 3, pp 149–158

Hydroxyethyl Starch (HES) [130/0.4], a New HES Specification

Pharmacokinetics and Safety after Multiple Infusions of 10% Solution in Healthy Volunteers
  • Josef Waitzinger
  • Frank Bepperling
  • Günther Pabst
  • Jens Opitz
Original Research Article

DOI: 10.2165/00126839-200304030-00002

Cite this article as:
Waitzinger, J., Bepperling, F., Pabst, G. et al. Drugs R&D (2003) 4: 149. doi:10.2165/00126839-200304030-00002

Abstract

Objective: To investigate the pharmacokinetics and safety of a daily infusion of 500mL of hydroxyethyl starch (HES) [130/0.4] 10% solution on 10 consecutive days.

Study design and participants: An open, one-way, multiple-dose study was performed in 12 healthy male volunteers. Daily infusions over 30 minutes of 500mL of HES (130/0.4) 10% solution were performed on 10 consecutive days. Plasma and urine HES concentrations were determined repeatedly during the study until 72 hours after the last infusion.

Results: Maximum plasma HES concentrations, assessed with geometric means of 7.7 and 7.4 mg/mL, respectively, as well as the time courses of the plasma concentrations were similar on days 1 and 10 of treatment. Plasma HES concentrations 24 hours after the last infusion were 0.48 mg/mL (mean). Total plasma clearance was calculated as 23.7 and 21.8 mL/min on days 1 and 10, respectively. Urinary recoveries of 69% on day 1 and of 70% on day 10 were in good agreement.

Conclusion: The results clearly demonstrated that there is no relevant accumulation in plasma after repetitive infusion of the medium-molecular weight HES (130/0.4) solution, which exhibits a high renal excretion rate over 10 days. Local as well as systemic tolerability of 10 repeated doses was good.

Copyright information

© Adis Data Information BV 2003

Authors and Affiliations

  • Josef Waitzinger
    • 1
  • Frank Bepperling
    • 2
  • Günther Pabst
    • 1
  • Jens Opitz
    • 2
  1. 1.AAI Deutschland GmbH & Co KGNeu-UlmGermany
  2. 2.FRESENIUS Kabi AG Deutschland GmbHBad HomburgGermany