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Systemic Concentrations of Salbutamol and HFA-134a After Inhalation of Salbutamol Sulfate in a Chlorofluorocarbon-Free System

1996; Lippincott Williams & Wilkins; Volume: 18; Issue: 3 Linguagem: Inglês

10.1097/00007691-199606000-00004

1536-3694

Lester I. Harrison, Ann Cline, Timothy Wells, Joseph P. Jacobson, Katherine M. Cooper, Shaw F. Chang, Janyce R. Nelson, Bruce P. Ekholm, Joel Morganroth,

Asthma and respiratory diseases

The objective of this study was to determine if salbutamol was absorbed from a new salbutamol sulfate chlorofluorocarbon (CFC)-free metered-dose inhaler (MDI). Measurement of HFA-134a, the CFC-free propellant, was included to provide proof of delivery of this MDI. Eight healthy men received two inhalations (90 micrograms salbutamol base equivalents per inhalation ex adapter) from the CFC-free inhaler (MDI A) in period 1 and from a reference CFC inhaler (MDI V) in period 2. Eight postdose samples were collected for the determination of salbutamol serum levels over a 4-h period. Salbutamol levels were not quantifiable in most samples. Four subjects given MDI A and two given MDI V had a few transient salbutamol levels, which occurred in the first hour after dosing, within a narrow range of 1-2 ng/ml and close to the lower limit of detection (1 ng/ml). No pharmacokinetic analyses were possible. Blood samples were also collected after MDI A for propellant quantitation. HFA-134a levels were seen in all subjects, verifying absorption. We conclude that the transient salbutamol serum levels can be attributed to the two-inhalation dose and not to either propellant system.