INTRODUCTION: The present study generated preliminary data on the acceptability and pharmacokinetics of nicotine administered by a simple metered-dose inhaler (MDI). METHODS: We conducted a nonrandomized, open-label cross-over trial of 10 current smokers. On Day 1, a single cigarette was smoked ad libitum. On Day 2, participants took 10 puffs (20 inhalations) of 50 microg nicotine/puff through the inhaler, and on Day 3, they took 10 puffs (20 inhalations) of 100 microg nicotine/puff, each over 5 min. Nicotine pharmacokinetics, changes in heart rate and blood pressure, and the acceptability of the inhalers were measured and recorded. RESULTS:Nicotine administered by an MDI produced a median maximum plasma concentration that was about 50% of that obtained by smoking a cigarette (12.5 vs. 25.9 ng/ml) and took twice the time to reach that concentration, 6 versus 3 min. Self-rated satisfaction and reduced urge to smoke were similar for the MDIs and a cigarette. DISCUSSION: The results suggest that nicotine can be delivered effectively by the pulmonary route using a standard MDI. The inhaler appears to provide a satisfaction level and reduction in the urge to smoke relatively similar to that provided by smoking a cigarette. These conclusions require verification in a larger controlled study.
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INTRODUCTION: The present study generated preliminary data on the acceptability and pharmacokinetics of nicotine administered by a simple metered-dose inhaler (MDI). METHODS: We conducted a nonrandomized, open-label cross-over trial of 10 current smokers. On Day 1, a single cigarette was smoked ad libitum. On Day 2, participants took 10 puffs (20 inhalations) of 50 microg nicotine/puff through the inhaler, and on Day 3, they took 10 puffs (20 inhalations) of 100 microg nicotine/puff, each over 5 min. Nicotine pharmacokinetics, changes in heart rate and blood pressure, and the acceptability of the inhalers were measured and recorded. RESULTS:Nicotine administered by an MDI produced a median maximum plasma concentration that was about 50% of that obtained by smoking a cigarette (12.5 vs. 25.9 ng/ml) and took twice the time to reach that concentration, 6 versus 3 min. Self-rated satisfaction and reduced urge to smoke were similar for the MDIs and a cigarette. DISCUSSION: The results suggest that nicotine can be delivered effectively by the pulmonary route using a standard MDI. The inhaler appears to provide a satisfaction level and reduction in the urge to smoke relatively similar to that provided by smoking a cigarette. These conclusions require verification in a larger controlled study.
Authors: Irina Esterlis; Effie M Mitsis; Jeffery C Batis; Frederic Bois; Marina R Picciotto; Stephanie M Stiklus; Tracy Kloczynski; Edward Perry; John P Seibyl; Sherry McKee; Julie K Staley; Kelly P Cosgrove Journal: Int J Neuropsychopharmacol Date: 2010-10-29 Impact factor: 5.176
Authors: Axel Teichert; Patrick Brossard; Loyse Felber Medlin; Larissa Sandalic; Mikael Franzon; Chris Wynne; Murray Laugesen; Frank Lüdicke Journal: Nicotine Tob Res Date: 2018-03-06 Impact factor: 4.244