title: Protocol proposal for, and evaluation of, consistency in nicotine delivery from the liquid to the aerosol of electronic cigarettes atomizers: regulatory implications.
abstract: To propose a protocol and evaluate the consistency in nicotine delivery to the aerosol of different types of electronic cigarette (EC) atomizers, as required by regulatory authorities.
  
  
  
  Three cartomizer and four tank-type atomizer products were tested (three samples per product). The aerosol from three 20-puff sessions from each sample was collected using a smoke machine. Three cartridges from a nicotine inhaler and three tobacco cigarettes were also tested.
  
  
  
  Analytical laboratory in Greece.
  
  
  
  Aerosol nicotine levels were measured. Relative standard deviation (RSD, i.e. coefficient of variation) was calculated separately for each cartomizer and replacement atomizer head sample (intrasample RSD) and between different samples (intersample RSD). The percentage difference from the mean, which is used to assess the quality of medicinal nebulizers, was also calculated.
  
  
  
  The aerosol nicotine levels were 1.01-10.61 mg/20 puffs for ECs, 0.12-0.18 mg/20 puffs for the nicotine inhaler and 1.76-2.20 mg/cigarette for the tobacco cigarettes. The intrasample RSDs were 3.7-12.5% for ECs and 14.3% for the nicotine inhaler and 11.1% for the tobacco cigarettes. The intersample RSDs were higher in cartomizers (range: 6.9-37.8%) compared with tank systems (range: 6.4-9.3%). All tank-type atomizers and one cartomizer were within 75-125% of the mean, as dictated for medicinal nebulizers.
  
  
  
  Electronic cigarettes that use tank-type atomizers appear to deliver nicotine in more consistent quantities (within the acceptable limits for medicinal nebulizers and similar to the nicotine inhaler) than electronic cigarettes that use cartomizers. The protocol for testing nicotine delivery consistency described in this paper could be used effectively for regulatory purposes.
authors.affiliation: Department of Cardiology, Onassis Cardiac Surgery Center, Sygrou, Kallithea, Greece.|Department of Pharmacy, University of Patras, Rio-Patras, Greece.
authors.forename: Konstantinos E
authors.initials: KE
authors.lastname: Farsalinos
authors.affiliation: Skylab-Med Laboratories of Applied Industrial Research and Analysis S.A., Amyklon, Halandri, Greece.
authors.forename: Nikoletta
authors.initials: N
authors.lastname: Yannovits
authors.affiliation: Skylab-Med Laboratories of Applied Industrial Research and Analysis S.A., Amyklon, Halandri, Greece.
authors.forename: Theoni
authors.initials: T
authors.lastname: Sarri
authors.affiliation: Department of Cardiology, Onassis Cardiac Surgery Center, Sygrou, Kallithea, Greece.
authors.forename: Vassilis
authors.initials: V
authors.lastname: Voudris
authors.affiliation: Department of Pharmacy, University of Patras, Rio-Patras, Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Poulas
mesh_terms: D000336:Aerosols; D066300:Electronic Nicotine Delivery Systems / Q000592:standards*; D004867:Equipment Design; D006115:Greece; D006801:Humans; D009538:Nicotine / Q000008:administration & dosage*; D018722:Nicotinic Agonists / Q000008:administration & dosage*; D011640:Public Policy / Q000331:legislation & jurisprudence*; D062789:Tobacco Products / Q000592:standards
chemical_list: D000336:Aerosols; D018722:Nicotinic Agonists; D009538:Nicotine
keywords: Aerosol; electronic cigarette; nicotine; regulation