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Related Experiment Videos

2-Hydroxypropyl-beta-cyclodextrin (HP-beta-CD): a toxicology review.

Sarah Gould1, Robert C Scott

  • 1Safety Assessment, AstraZeneca UK Limited, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, United Kingdom. sarah.gould@astrazeneca.com

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
|July 16, 2005
PubMed
Summary

2-Hydroxylpropyl-beta-cyclodextrin (HP-beta-CD) demonstrates good tolerability in animal studies, especially orally, with limited toxicity. Human trials also show it

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Area of Science:

  • Pharmacology and Toxicology
  • Drug Delivery Systems

Background:

  • 2-Hydroxylpropyl-beta-cyclodextrin (HP-beta-CD) is a water-soluble cyclodextrin derivative.
  • It serves as an alternative to traditional cyclodextrins, potentially offering improved safety.
  • Understanding HP-beta-CD's toxicological profile is crucial for its pharmaceutical applications.

Purpose of the Study:

  • To comprehensively review the toxicity of HP-beta-CD.
  • To present novel toxicity data alongside existing literature.
  • To examine the metabolism and pharmacokinetics of HP-beta-CD in humans and animals.

Main Methods:

  • Literature review of existing HP-beta-CD toxicity studies.
  • Inclusion of novel toxicity data from various studies.
  • Review of metabolism and pharmacokinetic data from human and animal studies.

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Main Results:

  • HP-beta-CD is well-tolerated orally in rats, mice, and dogs with limited toxicity.
  • Short-term studies showed minor biochemical changes; longer-term studies (up to 3 months) revealed reversible hematological changes without histopathological damage.
  • Intravenous administration caused reversible histopathological changes in lungs, liver, and kidneys; carcinogenicity studies indicated rat-specific tumors, and reversible urinary tract changes without functional impairment. No embryo-fetal developmental effects were observed.

Conclusions:

  • HP-beta-CD exhibits a favorable safety profile, particularly with oral administration.
  • Reversible changes observed with intravenous dosing suggest careful administration is needed.
  • HP-beta-CD is well-tolerated in humans, with diarrhea as the primary adverse event and no documented kidney function issues.