Effects of extreme temperatures on drug delivery of albuterol sulfate hydrofluoroalkane inhalation aerosols.
OBJECTIVE
The effects of extreme temperatures on drug delivery of two albuterol sulfate hydrofluoroalkane, metered-dose inhalers (MDIs) were evaluated.


METHODS
Three Proventil HFA and three Ventolin HFA MDIs were stored at room temperature and served as controls while three of each product were placed in the trunk of a vehicle in Tucson, Arizona. The temperature in the vehicle was monitored for six months. Product performance for each of the MDIs was evaluated at room temperature. An additional study was performed to investigate the performance of the two products when actuated at 4, 22, 47, and 60 degrees C.


RESULTS
The products subjected to extreme environmental temperatures had a modest increase in propellant-leak rate, but the emitted-particle size, dose per actuation, respirable mass, and non-respirable mass were unaffected. The inhalers tested at temperatures outside the recommended storage conditions exhibited a decrease in particle size, dose per actuation, shot weight, and non-respirable mass as temperature increased. Conversely, increased temperature caused an increase in respirable mass.


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.
Hoye
William L
WL
College of Pharmacy, University of Arizona, Tucson, Az 85721, USA. hoye@pharmacy.arizona.edu
Mogalian
Erik M
EM
Myrdal
Paul B
PB
D000336:Aerosols; D000420:Albuterol / Q000008:administration & dosage / Q000737:chemistry*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D003080:Cold Temperature; D004355:Drug Stability; D004356:Drug Storage; D004777:Environment; D006361:Heating; D006845:Hydrocarbons, Fluorinated / Q000737:chemistry*; D036501:Metered Dose Inhalers; D010316:Particle Size
D000336:Aerosols; D001993:Bronchodilator Agents; D006845:Hydrocarbons, Fluorinated; D000420:Albuterol