Philip Morris buys patent for nicotine aerosol technology, may be better than e-cigarettes

[Bill Godshall]

Philip Morris International just announced that it has purchased a nicotine aerosol technology from inventor Jed Rose. http://www.pmi.com/eng/media_center/press_releases/Pages/201105261249.aspx

These new nicotine aerosol products may be even better cigarette substitutes than electronic cigarettes, and have the potential to save the lives of tens of millions of smokers. Below are preliminary findings from Murray Laugesen's Health New Zealand website.

This could be a game changer for tobacco harm reduction worldwide.

Bill Godshall
Smokefree Pennsylvania


http://www.healthnz.co.nz/News2010.htm


1 March 2010 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 2010

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

 

[sqirl1]

I have a feeling it's going to suck. Phillip Morris is probably going to make it so it doesn't last long at all so you'll keep buying more and more. they'll probably charge out the ... for it too. and of course they have plenty of bribe money so the FDA will approve their crap without question.

 

[cliff5550]

One of my greatest fears as a vaper is Big Tobacco getting its claws into ecigs. Prices will increase, chemicals will be added, small vendors will be closed by government regulators, and we're all back to square one.

 

[Thulium]

I have a feeling it's going to suck. Phillip Morris is probably going to make it so it doesn't last long at all so you'll keep buying more and more. they'll probably charge out the ... for it too. and of course they have plenty of bribe money so the FDA will approve their crap without question.

I kinda have that same feeling, but that is because for me the presence of visible vapor is more important than nicotine delivery. However, Phillip Morris' existing distribution network for tobacco products would make these smoke-free alternatives available to smokers who don't have access to electronic vaporizers or for whom e-cigarettes don't satisfy. In other words, more alternatives > fewer, so I look at PM's steps to market smoke-free alternatives as a step in the right direction...even if I personally doubt their safety and effectiveness compared to e-cigs.

 

[Vocalek]

1. Keep in mind that the device in question is not an electronic cigarette as we know it. Read the description of how it works.

2. While there could be some negative consequences of BT getting involved, there are also some possible positive outcomes. If the FDA makes the standards extremely high for QC, pharma-grade testing, complex labeling requirements and packaging, etc., the smaller e-cigarette companies will be driven out of business by financial considerations. BT has the technical knowledge and the funding to work with FDA to keep products on the market.

 

[Capers]

... for me the presence of visible vapor is more important than nicotine delivery.

Same here. Nicotine, schmicotine; I want the vapor! I like to take a slow drag, let it roll out. Maybe some vapor rings. I also like how the vapor has a cooling effect on the skin (since I live in Las Vegas!).

However, from the perspective of someone who wants to quit, not swap out the ritual for a healthier alternative, it may be a great option.

 

[sqirl1]

1. Keep in mind that the device in question is not an electronic cigarette as we know it. Read the description of how it works.

2. While there could be some negative consequences of BT getting involved, there are also some possible positive outcomes. If the FDA makes the standards extremely high for QC, pharma-grade testing, complex labeling requirements and packaging, etc., the smaller e-cigarette companies will be driven out of business by financial considerations. BT has the technical knowledge and the funding to work with FDA to keep products on the market.

not a bad point! this way E-cig companies can just say "phillip morris is doing the exact same thing just with a different carrier and without heat, you want to mess with us you GOT to mess with them so screwwwwww youuuu!" I still won't be buying it. Even when I buy tobacco products I always support the little guy, and if anybody on heres gotta have an analog or whatever other real tobacco product they choose, I highly encourage them to do the same

 

[maureengill]

sqirl....I swear you read my mind

I have a feeling it's going to suck. Phillip Morris is probably going to make it so it doesn't last long at all so you'll keep buying more and more. they'll probably charge out the ... for it too. and of course they have plenty of bribe money so the FDA will approve their crap without question.

 

[davelog]

The time to sweat will be if/when they acquire the patents on personal vaporizers. Then they'll bury it like they're going to do with this thing. This is competition elimination, Biz 101.

 

[Debian Dog]

Please remember it was the Bush era that pushed Phillip Morris to even be regulated because they were gettig F'ed over with lawsuits ever other month skyrocketing the cost of cigarettes. Sen. John McCain to put the industry under FDA control. PM bowed to the pressure and sad OK fine have the FDA regulate us.
Why does Philip Morris want the FDA to regulate cigarettes? - By Samuel Loewenberg - Slate Magazine

 

[sqirl1]

The time to sweat will be if/when they acquire the patents on personal vaporizers. Then they'll bury it like they're going to do with this thing. This is competition elimination, Biz 101.

I'm not thinking thats going to happen. they never tried to do anything to get rid of swedish snus, which I think is just as big a threat to them as PVs, plus, their new thing isnt a vaporizer of any kind so.....

 

[Vocalek]

They are not stupid. They realize that the tobacco cigarette business is disappearing in first world countries. Reduced risk products are the way of the future.

 

[b00stzx3]

Doesn't worry me...every day there seems to be more and more progress towards developing rebuildable atomizers... Bulli, Ato-mizer...etc. With that done and commercially available batteries/connectors.... Big Tobacco still won't get one cent from me and Maryland won't get another dime of tobacco taxes (they already tax the crap out of us here anyways!!).

Now securing and commercialing all e-liquid ingredients...that's a different story...

 

[sqirl1]

E-liquid should be the least of our problems regardless of who we're dealing with, and here's why: without nicotine, E-liquid can basically be ANYTHING. it's just propylene glycol and/or vegetable glycerin mixed with a flavoring agent. they can't mess with that. if anything you get 0 nic e-liquid, get a box of nicotine patches, squeeze the nicotine out of them, and BOOM, you got an e-liquid just as good as before

 

[cruisedoc]

It may be that they purchased the tech from RJR, who test marketed such aerosol product in the 90's. It was called Premier. I heard they sold the technology to the Chinese in the late 90's.

 

[Bill Godshall]

sgirl1 wrote

I have a feeling it's going to suck. Phillip Morris is probably going to make it so it doesn't last long at all so you'll keep buying more and more. they'll probably charge out the ... for it too. and of course they have plenty of bribe money so the FDA will approve their crap without question.

The only way PM can turn a profit on its investment (of buying the patent) is to make/sell lots of the products at a lower cost than cigarettes. Besides, PM won't be forcing anyone to buy the products, and folks don't have to buy them if they don't want to. Also, similar to e-cigarettes, these new nicotine aerosol products are not regulated by Chapter IX of the FSPTCA. So PM doesn't need FDA's permission to market these products unless/until the FDA finalizes a yet-to-be-proposed regulation that applies Chapter IX to currently unregulated tobacco products.

cliff5550 wrote

One of my greatest fears as a vaper is Big Tobacco getting its claws into ecigs. Prices will increase, chemicals will be added, small vendors will be closed by government regulators, and we're all back to square one.

If/when PM, Reynolds or Lorillard begin marketing e-cigarettes, e-cigarette prices will drop, sales will skyrocket, consumers will have more choices of products, and every convenience store in the country will be selling them. Makers/sellers of inferior quality and excessively priced products may go out of business, but that's progress. Unless/until the FDA finalizes a yet-to-be-proposed regulation that applies Chapter IX to currently unregulated tobacco products, there will remain a free market for unregulated e-cigarette products. If/when the FDA proposes a regulation to apply Chapter IX to currently unregulated tobacco products, PM will have a vested financial interest in joining forces with other e-cigarette companies, consumers and tobacco harm reduction advocates in opposing that counterproductive regulatory proposal.

Debian Dog wrote

Please remember it was the Bush era that pushed Phillip Morris to even be regulated because they were gettig F'ed over with lawsuits ever other month skyrocketing the cost of cigarettes. Sen. John McCain to put the industry under FDA control. PM bowed to the pressure and sad OK fine have the FDA regulate us.
Why does Philip Morris want the FDA to regulate cigarettes? - By Samuel Loewenberg - Slate Magazine

As one who led the successful campaign to defeat Sen. McCain's legislation (that was agreed to and lobbied for by Big Tobacco, State AGs, and CTFK/ACS/AHA/AMA) in the US Senate in 1998 (to immunize tobacco companies from lawsuits and to regulate tobacco products by FDA in exchange for $468 Billion dollars from Big Tobacco to the federal and state governments), I consider it unfair and wrong to claim that PM succumbed to McCain (as it was McCain who succumbed to lobbying by Big Tobacco, State AGs and CTFK/ACS/AHA/AMA).

 

[RatInDaHat]

i want to see the patent.

 

[DC2]

No vapor = Fail

 

[jj2]

No vapor = Fail

You got that right!!!!

 

[MasterofChaos]

Here's a link to the patent (I believe, anyway)

United States Patent: 6121289

This thing is nothing like an E-cig, and has none of its attributes, in particular the flavoring and the vapor.

I don't think this is anything to worry about, its just a glorified nic inhaler.