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Related Experiment Videos

Safety of propellants.

D J Alexander1

  • 1Glaxo Research and Development Ltd, Ware, Herts, UK.

Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine
|January 3, 1996
PubMed
Summary

1,1,1,2 tetrafluoroethane (HFA134a) is a safe alternative propellant for metered dose inhalers (MDIs). Extensive toxicological studies confirm HFA134a

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Area of Science:

  • Pharmaceutical Science
  • Toxicology
  • Environmental Science

Background:

  • Chlorofluorocarbon (CFC) propellants in metered dose inhalers (MDIs) require replacement due to environmental regulations.
  • 1,1,1,2 tetrafluoroethane (HFA134a) was identified as a potential CFC alternative.

Purpose of the Study:

  • To conduct comprehensive toxicological assessments of HFA134a for pharmaceutical use.
  • To evaluate the safety of HFA134a as an MDI propellant.

Main Methods:

  • Genotoxicity assays
  • Animal inhalation studies (rats, dogs)
  • Reproductive toxicology assessments
  • Local tolerability and safety pharmacology studies
  • Oncogenicity studies (rats, mice)

Main Results:

  • HFA134a demonstrated no genotoxicity or oncogenic potential.
  • No significant toxicity observed in long-term inhalation studies in rats and dogs.
  • No adverse effects on reproduction, development, or local tolerance were found.
  • High systemic concentrations were observed across species.

Conclusions:

  • Extensive toxicological data supports HFA134a's suitability as a replacement for CFC propellants in MDIs.
  • HFA134a exhibits a favorable safety profile at high multiples of anticipated patient exposure.

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