Brand Name

Proventil HFA, Ventolin HFA

Dosage Form

Inhalation

Strength

90mcg per actuation

Manufacturer

  • Key Pharmaceutical (Proventil HFA)
  • GlaxoSmithKline (Ventolin HFA)

Conditions Studied
Study 1:
  • Control group: Three Ventolin brand inhalers and three Proventil brand inhalers stored at room temperature
  • Experimental group: Three Ventolin brand inhalers and three Proventil brand inhalers stored in the trunk of a care in Tuscon, Arizona. Inhalers were exposed to temperatures from -3.4 degrees to 87.9 degrees Celsius
  • Product performance was evaluated at room temperature (i.e. the inhalers were allowed to cool to room temperature before evaluation)
Study 2:
  • Study the performance of both brands of inhalers when actuated at 4, 22, 47 and 60 degrees Celsius.

Temperature (degrees Celsius)

See above for conditions described

Humidity (%).

Not specified

Countries Studied In

Arizona, USA and simulated conditions in a laboratory

Definition of Stability

Not specified

Conclusions and Length of Stability
  • Study 1:
    • The products exposed to extreme temperatures had an increase in propellant-leak rate
    • Emitted particle size, dose per actuation, respirable mass, and non-respirable mass were unaffected
  • Study 2:
    • The amount of drug delivered from Proventil HFA at 60 degrees Celsius was 14.8% less than the amount delivered at 4 degrees Celsius
    • The amount of drug delivered from Ventolin HFA at 60 degrees Celsius was 8% less than the amount delivered at 4 degrees Celsius
  • Author's Conclusions: Despite exposure to extreme temperatures exceeding the manufacturers' recommended storage conditions, drug delivery from Proventil HFA and Ventolin HFA MDIs was not significantly altered. However, drug delivery did change appreciably when the inhalers were tested at different temperatures outside recommended storage conditions.

Reference
Hoye WL, Mogalian EM, Myrdal PB. Effects of extreme temperatures on drug delivery of albuterol sulfate hydrofluoroalkane inhalation aerosols. Am J Health Syst Pharm 2005 Nov 1;62(21):2271-7. PMID: 16239418.

MeSH entry terms
  • 2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol
  • Salbutamol
  • Levalbuterol
  • Levalbuterol Hydrochloride
  • Hydrochloride, Levalbuterol
  • Levosalbutamol Hydrochloride
  • Hydrochloride, Levosalbutamol
  • Sultanol
  • Ventolin
  • Xopenex
  • Albuterol Sulfate
  • Proventil
MeSH reference: http://www.ncbi.nlm.nih.gov/mesh/68000420

Written by: Alex Evans, PharmD
Reviewed by:
Last updated: May 5, 2013