title: Systemic concentrations of salbutamol and HFA-134a after inhalation of salbutamol sulfate in a chlorofluorocarbon-free system.
abstract: 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.
authors: Department of Drug Metabolism, 3M Pharmaceuticals, St. Paul, Minnesota 55144-1000, USA.
authors: L I
authors: LI
authors: Harrison
authors: A
authors: A
authors: Cline
authors: T M
authors: TM
authors: Wells
authors: J P
authors: JP
authors: Jacobson
authors: K M
authors: KM
authors: Cooper
authors: S F
authors: SF
authors: Chang
authors: J R
authors: JR
authors: Nelson
authors: B P
authors: BP
authors: Ekholm
authors: J
authors: J
authors: Morganroth
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000328:Adult; D000335:Aerosol Propellants; D000420:Albuterol / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005617:Chlorofluorocarbons, Methane; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D005466:Fluorocarbons
chemical_list: D000318:Adrenergic beta-Agonists; D000335:Aerosol Propellants; D000420:Albuterol; D005617:Chlorofluorocarbons, Methane; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons