New nicotine cigarette gives rapid lung delivery of nicotine

After tests by Health New Zealand Ltd and Christchurch Clinical Studies Trust in Christchurch NZ in 2009, this product is now ready for commercialization as a smoking substitute or as a stop smoking medicine.

SRNT 2010_ PosterAbstract_ Rose.doc 

This device was tested for Duke University (the patent holders), in 2009 on nine healthy smokers. Results were announced by Principal Investigator Dr Jed Rose, of Duke University at the 16th Annual Conference of the Society for Research on Nicotine and Tobacco (SRNT), Baltimore, Maryland, USA on 27 February 2010. The inventors are Rose, his brother Dr Seth Rose, an organic chemistry professor; Dr Jim Turner, a co-inventor of the nicotine inhaler; and Dr Raju Murugesan, a pharmacologist at Duke. Dr Laugesen and Dr Chris Wynne of Christchurch Clinical Studies Trust were co-authors for this SRNT paper, entitled 

Pulmonary delivery of Nicotine Pyruvate: Pharmacokinetic and Sensory Characteristics

The device depends on a chemical reaction at room temperature, with no heating or lighting up. The nicotine pyruvate cigarette is expected to reach the market by 2013 or 2015. It is yet to be manufactured and miniaturized down to the size of a tobacco cigarette. It is not an electronic cigarette. The smoker only inhales one molecule – nicotine pyruvate, which dissolves into nicotine and pyruvate on reaching the lungs.

Pyruvate is a normally found in the blood, and inhaling NP is not expected to raise this level appreciably

Nicotine levels will be raised briefly with every puff taken, though not as much as from smoking tobacco cigarettes.

 To see the graph click on  Plasma Nicotine Rise.ppt

Nine healthy smokers took 10 puffs over the first five minutes. When nicotine in plasma was measured by taking blood at the end of the 10th puff, the nicotine level in the plasma for NP 20 and NP 30 (nicotine pyruvate 20 and 30 micrograms per puff)  increased to 5 to 8 ng per ml, a third to a half as high as with a regular tobacco cigarette, and as rapidly.  The NP cigarette was less harsh and much more rapid in raising plasma nicotine. In contrast the NV (Medicinal nicotine inhaler) resulted in a much slower rise to 1 ng/mL after 35 minutes.

http://www.healthnz.co.nz/SRNT%202010_%20PosterAbstract_%20Rose.doc

Poster, Society for Research on Nicotine and Tobacco 16th annual conference, Baltimore, 27 February 2011

PULMONARY DELIVERY OF NICOTINE PYRUVATE: SENSORY AND PHARMACOKINETIC CHARACTERISTICS

Jed E. Rose*, James E. Turner, Thangaraju Murugesan, Frederique M. Behm, Duke University Medical Center, Durham, NC, USA; Chris J. Wynne, Christchurch Clinical Studies Trust, Christchurch NZ; and Murray Laugesen, Health New Zealand Ltd Christchurch NZ

Abstract

This study conducted an initial evaluation of a prototype nicotine pyruvate (NP) aerosol generation system.  Plasma nicotine levels and subjective responses after NP inhalation were compared to responses after placebo (room air) and after inhalations from the Nicotrol/Nicorette nicotine vapor inhaler (NV).  Nine healthy adult daily cigarette smokers, overnight abstinent from nicotine, were exposed to 5 conditions in 5 ½  hours.  In each condition, participants inhaled 10 puffs of 35 mL volume, comprising either NP, in ascending dose from 10 to 20 to 30 μg/puff, NV (10 μg /puff) or room air (placebo).  Participants and study technicians were blinded as to medication sequences.  In each condition, blood for plasma nicotine assay was withdrawn 5 minutes before inhalation, and at 0, 1, 2, 5, 10, 20 and 30 minutes after the 10th puff.  Smoking withdrawal symptoms were first recorded before the puffs, and then again 5 to 10 minutes after the 10th puff, along with an inhaler evaluation questionnaire.  Plasma nicotine concentrations were maximal when first measured on completing ten inhalations of 20 µg/puff or 30 µg/puff nicotine pyruvate (5.0 and 8.3 ng/mL increase in plasma nicotine, respectively), with concomitant decreases in craving for cigarettes relative to placebo.  Satisfaction ratings were higher than for placebo.  Acceptability, as assessed by ratings of harshness/irritation, was higher for the NP 20 condition than the NV control condition.  Safety indices showed no adverse changes following use.  The results of this double-blind, randomized, cross-over study demonstrate that nicotine pyruvate inhalations produce rapid increases in plasma nicotine concentrations.  In addition, nicotine pyruvate inhalation was well tolerated, and at the 20 μg/puff dose, significantly alleviated craving for cigarettes when compared with placebo.  At this dose, peak nicotine concentrations were higher and harshness/irritation was rated lower than with the Nicotrol/Nicorette nicotine vapor inhaler.  Further trials of this promising nicotine inhalation technology are warranted to assess its safety and efficacy in smoking cessation treatment or harm reduction approaches.

Funding

Supported by funding from the Duke University Department of Psychiatry and Behavioral Sciences (ML, CJW), and a grant from Philip Morris USA (JER, JET, TM, FMB).  The company had no role in the design or conduct of the study, data analysis or publication of results.

Plasma Nicotine Rise chart for nicotine pyruvate (NP) aerosol generation system

http://www.healthnz.co.nz/Plasma%20Nicotine%20Rise.ppt

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