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Related Experiment Videos

Continuing patient care with metered-dose inhalers.

A Woodcock1

  • 1Department of Respiratory Physiology, Wythenshawe Hospital, Manchester, UK.

Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine
|February 2, 1996
PubMed
Summary

New hydrofluoroalkane (HFA) inhalers are replacing older chlorofluorocarbon (CFC) metered-dose inhalers (MDIs) for asthma treatment. Clinical trials show HFA inhalers are safe and effective, offering comparable asthma symptom relief to existing CFC inhalers.

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Area of Science:

  • Pulmonary Medicine
  • Pharmaceutical Science
  • Environmental Health

Background:

  • International asthma guidelines favor inhaled over oral therapies due to superior efficacy and safety profiles.
  • Metered-dose inhalers (MDIs) are the preferred delivery system for most asthma patients, accounting for 85% of global sales.
  • Chlorofluorocarbon (CFC) propellants in current MDIs are being phased out globally under the Montreal Protocol, necessitating reformulation.

Purpose of the Study:

  • To evaluate the safety and efficacy of new hydrofluoroalkane (HFA) propellants as replacements for CFCs in MDIs.
  • To compare the performance of HFA-propelled asthma medications against existing CFC-based formulations.

Main Methods:

  • Reformulation of existing MDI products using HFA 134a propellant, involving adjustments to surfactants, valves, and seals.

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  • High-pressure manufacturing processes were developed for HFA inhalers, as HFA 134a is a gas at room temperature.
  • Toxicological assessments and clinical trials were conducted on HFA 134a formulations of salbutamol, salmeterol, and fluticasone propionate (FP).

    • Main Results:

    • Single-dose studies demonstrated that 200 micrograms of HFA 134a salbutamol provided equivalent protection against histamine-induced bronchoconstriction in asthmatic adults and children compared to CFC preparations.
    • A 4-week study indicated similar effects on morning peak flow between HFA and CFC formulations.
    • Patients perceived the HFA and CFC formulations as equivalent in a 4-week trial.

    Conclusions:

    • Hydrofluoroalkane (HFA) 134a is a well-tolerated and effective propellant for MDIs, suitable for replacing CFCs.
    • HFA-propelled inhalers offer comparable safety and efficacy to traditional CFC inhalers for asthma management.
    • The reformulation and clinical testing support the transition to HFA-based MDIs for asthma patients.