The Ruyan (nicotine) e-cigarette

The Ruyan e-cigarette

Health New Zealand Ltd Information Sheet.

This nicotine inhaler mimics the smoking experience closely, apparently providing nicotine absorption from the lungs within a few puffs. It gives the satisfaction of drawback. It is likely to be popular as a nicotine alternative to smoking among those than can afford it.

Safety See PortlandPosterMarch08.doc

Description The Ruyan (pronounced Roo yen) e-cigarette, like a tobacco cigarette, can rapidly deliver nicotine into the lungs, but without the carcinogens and toxicants. The white segment contains a re-chargeable battery (charged overnight from the mains), the dark coloured middle part contains a vapourising chamber. The mouthpiece and nicotine cartridge are one piece, and a new one inserted after 300-350 puffs The nicotine is dissolved in propylene glycol. (PG).

The e-cigarette appears to imitate smoking more closely, more satisfyingly, and as safely as any product yet invented. Tests of safety and efficacy are now needed, before Medsafe will permit its sale in New Zealand.

Marketing. For a You-tube depiction of the e-cigarette in action see: www.youtube.com/watch?v=qEmdU7j9K2s Since 2004, 300,000 units are sold annually in China, and more recently, thousands in Austria and Turkey. It is aimed at the smoker concerned about the health effects of smoking. It is being marketed by one importer in the UK as a way to socialise and “smoke” without having to go outside. As long as tobacco cigarettes are the norm, potential switchers will be dual users initially. Replica varieties abound.

Mechanism. According to the patent, CA 2518174 (inventor Hon Lik, China), lip pressure sensed by the mouthpiece primes the electric circuit. The user draws in diluting air, which after a momentary delay switches off the electric pump and heater after each puff. Nicotine is vaporised ultrasonically at high temperature (atomised) in a fine aerosol (0.2- 3 µm diameter) of non-toxic propylene glycol, which condenses in room air into a visible puff of mist. (PG is used for this effect in stage productions). The particles are small enough (0.2- 3um) to rapidly reach the alveoli of the lungs. A few percent of the solvent weight is flavour, but without tobacco. The white vapour mist exhaled is not smoke, so it can be “smoked” indoors. Drawback activates a red glow at the tip – produced by the rechargeable battery, not by combustion.

Table 1. Nicotine content and delivery from one days' smoking of either manufactured tobacco cigarettes; or the Ruyan e-Cigarette, using one nicotine cartridge; or the Nicorette^TM inhaler.
	Nicotine content of: 1) 20 cigarettes or 2) one e-Cig cartridge** 3) Nicorette inhaler cartridge mg	Nicotine delivery per puff mg	Nicotine Delivery per: 1) 1 cigarette 2) 1 'e-smoke' 3) 1 20 min session of Nicorette inhaler use mg	Nicotine Delivery per 300 puffs: 1) 20 cigarettes 2) 1 e-Cigarette cartridge 3) 5-10 Nicorette cartridges mg
(1) Factory-made cigarettes	A	B=C/15**	C Nicotine 99% absorbed^#	D=c*20
Factory-made single cigarette	13*20= 260 mg in unburnt cigarette	0.1	1.5 mg	30 mg absorbed
(2) Ruyan e-Cigarettes	A	B=A/300***	C=b*15 99% absorbed^#	D=C*20
Ruyan 1.6% nicotine solution Label:16 mg	1.6%*1 g of extractable solution in cartridge = 16 mg	0.053 mg	0.80 mg	16 mg absorbed
Ruyan 1.1% nicotine solution Label = 11 mg	11 mg	0.037 mg	0.56 mg	11 mg absorbed
Ruyan 0.6%. solution Label = 6 mg	6 mg	0.02 mg	0.3 mg	6 mg absorbed
Ruyan 0.0% solution 0 mg	00 mg	0		0 absorbed
Nicorette(r) inhaler. Nicotine inhaled into mouth and throat - half absorbed, and more slowly.
Nicorette inhaler 20 puffs per 20 minute session: 40 to 80 puffs per cartridge	10 mg per cartridge	0.0625 to 0.125 absorbed per puff	1.25 -2.5 absorption per session, 5 mg absorbed / cartridge, 2-4 sessions / cartridge	19- 38 mg absorbed
Assumptions One e-Cigarette cartridge= 20 cigarettes. * Assumes 15 puffs per cigarette *** Assumes 300 puffs per e-Cigarette cartridge. ^# Assumes that >98% of nicotine is extractable on inhalation^.[1]

Dosimetry It is available in cigarette, pipe and cigar forms. The nicotine in the cartridge comes in four strengths for inhalation, varying in delivery from 0 to 16 mg nicotine per day. (Table 1)

Table 1 suggests that the 16 mg cartridge provides nicotine on a per puff basis equal to half that of a factory- made tobacco cigarette, and the 11 mg and 6 mg cartridges provide a third and one fifth respectively.

Topography No studies have been made of smoking inhalation patterns with the e-cigarette.

The e-cigarette: Each puff provides an estimated 2.8-3.3 mg of PG (propylene glycol), and 0.003 to 0.194 mg nicotine. The total nicotine content available for inhalation per e-cartridge is on testing does not exceed and is slightly less than the label (16 mg, 11 mg, 6 mg, 0 mg).[2]

For manufactured cigarettes: One manufactured NZ cigarette contains 13 mg nicotine.[3] The amount 1.5 mg of nicotine absorbed per cigarette represents a range of 1.0 to 2.5 mg absorbed from factory-made cigarettes,[4] exceeds the smoke machine yields printed on cigarette packets.[5]

Nicorette inhaler.[6] Nicotine absorption is from the mouth, where half of it reaches the blood. The inhaler contains 10 mg of nicotine, so at most 5 mg is absorbed. The manufacturer says the cartridge lasts four sessions. If true, only 2.5 cartridges are needed per day, for 10 sessions of 20 puffs over 20 minutes, repeated hourly, whereas the manufacturer recommends 6 to 12 cartridges. Each session of 20 puffs, results in absorption of 1.25 mg, with maximum effect 15 minutes after stopping. We assume one cartridge lasts for 40 to 80 puffs. One session of 20 puffs results in nicotine equal to half to one cigarette’s nicotine. Four puffs are equal to one cigarette puff. As the half life of nicotine is 2 hours, slow absorption means lower levels of blood nicotine.

Biological effect On drawback on the e-cigarette,, nicotine is inhaled within a few breaths and apparently gives a light headed effect within 20 seconds.

Cost The price for New Zealand has not been set for New Zealand. One to two days supply gives 300 puffs. The rechargeable battery lasts for 1300 puffs, and is recharged from the mains overnight. New Zealand price has not been decided.

Legal status The e-cigarette is not yet on sale in New Zealand, as it is not registered as a medicine. Its smoke is not obnoxious, and does not come under the bans on tobacco smoking. Ruyan says it is a cigarette substitute, not a smoking cessation aid. No therapeutic claims is being made for it as a smoking cessation aid. If it should be legal to sell it, it would be permissible to advertise it in New Zealand, as long as no claim to stop smoking is made. It could perhaps be advertised as “Ruyan – a satisfying, safer smoke.”

Contra-indications:

Non smokers. Nicotine-naïve non-smokers may experience the same effects as first-time smokers – coughing, gagging, and on inhaling into the lungs, nausea, dizziness or vomiting.

Pregnancy As this device can deliver high doses of nicotine, it is contra-indicated in pregnancy, unless the woman has not been able to quit smoking by other means.

Cardiovascular effects Nicotine in high dose is not advisable for those with heart disease or irregular heart rhythm as it could possibly trigger heart beat irregularities.

Children or adults if they were able to unscrew the filter, would be at risk of nicotine poisoning if they put the filter in their mouth, as one cartridge contains as much nicotine as in 5 cigarettes.. The filter can be screwed in very tightly or loosely, and if screwed even moderately tightly can be difficult even for adults to open. The lethal nicotine dose for adults is 40-60 mg of nicotine, and 10 mg in children. (For comparison a lethal dose for children is also obtainable from one cigarette (11 mg if hand-rolled to contain 0.6 g of tobacco, or 13 mg of nicotine if factory-made.).

Labelling The product is addictive, and a warning will be needed. Future regulations may require a warning such as, “This nicotine product is addictive, but does not carry the other risks of cigarette smoking”. and a label on the filters, “ Keep away from children”.

[1] Feng S, Plunkett SE, Lam K, Kapur S, Muhammad R, Jin Y, et al. A new method for estimating the retention of selected smoke constituents in the respiratory tract of smokers during cigarette smoking. Inhal Toxicol 2007;19(2):169-79.

[2] ESR Porirua Nicotine content of the Ruyan e-cigarette cartridges, report to Health NZ. Ltd. Sept 2007...

[3] Blakely T et al. NZ Publ Hlth Report 1997; 4: 34-5, 85.

[4] Fagerstrom. K The nicotine market : Nic Tob Res 2005; 7: 1-8.

[5] Djordjevic et al. Doses of nicotine and lung carcinogens delivered to cigarette smokers. JNCI 2000; 92: 106-111.