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A review of 5-hydroxymethylfurfural (HMF) in parenteral solutions
Abstract:
The chemical formation, toxicity, and pharmacokinetics of 5-hydroxymethylfurfural (HMF) and certain other decomposition products found in parenteral solutions are reviewed. Heat sterilization-induced hexose decomposition to furan derivatives is promoted at low pH. Based upon infusion studies with rats and dogs, HMF does not appear to be acutely toxic at concentrations ordinarily encountered in parenteral infusion solutions (e.g., 10 mg/liter). Dosages of parenterally administered HMF exceeding 75 mg/kg body wt have led to some toxic effects, including increased activity of hepatic enzymes, altered serum-protein fractions, increased relative spleen weight, and hepatic fatty degeneration. Approximately 50% of parenterally administered HMF is oxidized and eliminated by the kidneys. From a clinical standpoint, the amount of HMF formed as a result of the heat sterilization of parenteral solutions containing hexoses does not seem to pose any significant toxicologic problem.
Insights
5-hydroxymethylfurfural (HMF) from heat-sterilized parenteral solutions is generally safe at typical concentrations. Higher HMF doses in animal studies showed some toxicity, but clinical relevance is low.
Area of Science:
- Pharmaceutical Chemistry
- Toxicology
- Pharmacokinetics
Background:
- Parenteral solutions can contain 5-hydroxymethylfurfural (HMF) and other hexose decomposition products.
- Heat sterilization, especially at low pH, promotes hexose decomposition into furan derivatives like HMF.
Purpose of the Study:
- To review the chemical formation, toxicity, and pharmacokinetics of HMF in parenteral solutions.
- To assess the clinical significance of HMF in heat-sterilized parenteral formulations.
Main Methods:
- Literature review on HMF formation and decomposition pathways.
- Analysis of infusion studies in rats and dogs to determine HMF toxicity and pharmacokinetics.
Main Results:
- HMF is not acutely toxic at concentrations typically found in parenteral solutions (e.g., 10 mg/L).
- Parenteral HMF doses above 75 mg/kg in animals caused toxic effects like altered liver enzymes and spleen weight.
- Approximately 50% of administered HMF is metabolized and excreted renally.
Conclusions:
- HMF formation during heat sterilization of parenteral solutions is unlikely to pose a significant toxicologic risk.
- The observed toxicity in animal studies occurs at doses far exceeding typical clinical exposure levels.