Puffing Machine Studies Driven by Referenced Topography Data

Table 3.4 (below) shows the emission studies that referenced other research group’s topography values to gather information and report emissions data.

46

Table 3.4: Emission studies that referenced previous electronic cigarette topography protocols.

Electronic study for topography used to

drive puffing machine

US Department of Health and Human Services (1988) [54]

47

(1) Vansickel and Eissenberg (2011) [50]

(2) Perkins and Karelitz [59]

(3) Perkins et al. (2012) [60]

Williams et al.

(2015) [61] * 60 4.3 NR NR NR Hua et al. (2011) [55]

Notes: NR – Not Reported

* - Studies that used topography to drive puffing machines.

Vansickel and Eissenberg [50] characterized the nicotine delivery profile, subjective, and cardiovascular effects electronic cigarettes have on their users. Eight electronic cigarettes users, 3 women and 8 Caucasian, participated in the study. The subjects used their own refillable electronic cigarettes and chose a prefilled flavor and nicotine concentration cartridge. No brands of electronic cigarettes or e-liquids were specified in the study. The subjects were only included in the study if they had at least 3 months experience using an electronic cigarette and consumed either 2 – 3mL of e-liquid or 2 cartridges on a daily basis. Upon arrival to the laboratory the subjects were instructed to take 10 puffs with an interpuff of 30 seconds found in Table 3.4 (above). Blood samples were then collected after the session. This study also had an ad lib smoking session were subjects reported the number of puffs consumed. More information about that test is in Chapter 3.2.1 (below).

Goniewicz et al. [51] investigated four toxic and carcinogenic compounds: carbonyls, volatile organic compounds, nitrosamines, and heavy metals found in electronic cigarette aerosol. The electronic cigarettes tested in this study are identified in Table 3.5 (below).

Table 3.5: Electronic cigarettes used in Goniewicz et al. study.

Brand Model Type

Joye 510 Rechargeable

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Janty eGo Rechargeable

Janty Dure Rechargeable

DSE 901 Rechargeable

Trendy 808 Rechargeable

Nicore M401 Rechargeable

Mild 201 Rechargeable

Colinss Age Refillable

Premium PR111 Refillable

Ecis 510 Rechargeable

Dekang Pen Rechargeable

Intellicig Evolution Rechargeable

The flavors used were: Marlboro, Regular, Trendy and Camel. The smoking machine Palaczbot developed from the Technical University of Lodz in Poland was used to generate electronic cigarette aerosol. The puffing topography characteristics used in this study, found in Table 3.4 (above), came from a previously measure topography study Goniewicz et al. [39] conducted. A total of 150 puffs were collected in 10 puffing sessions.

The Goniewicz et al. [52] study investigated how much nicotine concentration was in the United Kingdom’s most popular electronic cigarettes. Two disposable electronic cigarettes were tested:

Totally Wicked and Vapouriz, while five non disposable models were tested: Green Smoke, E-Lites, Smokers Angel and Vapestick. Nicotine concentrations varied but did not supply that information in mg/mL units. The same smoking machine in Goniewicz et al. [39] was used to generate the electronic cigarette aerosol with the same puffing topography characteristics identified in Table 3.4 (above). A total of 300 puffs were collected in 20 puffing sessions.

The Farsalinos et al. [23] study mentioned in the previous no reference topography profile Chapter 3.1.1 (above) used a combination of puffing topography characteristics identified in Table 3.4 (above). The 4 second puff duration every 30 seconds was referenced from a previous Farsalinos et al. [49] study, “Evaluation of Electronic Cigarette Use (Vaping) Topography and Estimation of Liquid Consumption: Implications for Research Protocol Standards Definition and for Public Health Authorities’ Regulation”.

Kosmider et al. [53] evaluated various characteristics, nicotine solvents and battery voltage, to understand how they affect carbonyl compounds found in electronic cigarettes. The refillable

49 model used was the eGo-3 Twist electronic cigarette. This specific type has a maximum puff duration time for one single puff of 10 seconds. This should be noted for future studies in case a researcher observes subjects puffing longer than 10 seconds. Six different brands of e-liquids with different flavors 18mg/mL nicotine concentrations, with the exception of the LiQueen e-liquid with a 24mg/mL nicotine concentration, were tested in this study: E-Juice Island Tobacco flavor, DK-TAB Classic Tobacco flavor, Mild Mild Black flavor, LiQueen Sunny Banana flavor, and E-Liquid with Camel and Strong Hit flavors. The electronic cigarette aerosol was generated using the smoking machine Palaczbot developed at the University of Technology in Lodz, Poland. The puffing topography characteristics used, found in Table 3.4 (above), were referenced from the Goniewicz et al. [39] “Nicotine levels in electronic cigarettes” study.

Marini et al. [26] was mentioned in the previous no reference topography profile Chapter 3.1.1 (above). Multiple tests were conducted in this study. The test was interested in deposited particle dosage evaluation and used a median puff volume of 42.5mL, identified in Table 3.4 (above). This value was chosen after the US Department of Health and Human Services in 1988 document puff volumes between 21 and 66mL.

Talih et al. [29] was mentioned in the previous no reference topography profile Chapter 3.1.1 (above). It used a combination of puffing topography characteristics for the testing conditions found in Table 3.4 (above). The puffing duration values of 2 seconds, 4 seconds and 8 seconds were referenced from two research groups: Hua et al. [55] and Farsalinos et al. [49]

The Williams et al. [56] study evaluated and compared the performance of disposable electronic cigarettes versus disposable electronic hookahs. The electronic cigarettes tested were: Blu Cig, NJOY King, and the V2 Cig. No information was supplied about what flavor or nicotine concentrations were tested. The apparatus used to generate the electronic cigarette aerosol was the puffer box developed at the University of Kentucky. The device was calibrated to take 4.3 second puffs which was referenced from the Hua et al. [55] study, found in Table 3.4 (above).

El-Hellani et al. [33] was mentioned in the previous no reference topography profile Chapter 3.1.1 (above). This study used a combination of puffing topography characteristics for their tests found in Table 3.4 (above). The 4 second puff duration tested was referenced from both Hua et al. [55]

and Farsalinos et al. [49]

50 The Farsalinos et al. [48] study mentioned in the previous standard topography profile protocols in Chapter 3.1.2 (above) used a combination of puffing topography characteristics. In the first study 7 vapers were recruited through an online forum. They were invited to attend a clinical session where they were asked to puff 4 puffs for 4 seconds every 30 seconds. This profile, identified in Table 3.4 (above), was used from Jensen et al. [36]. This study was specifically interested investigating dry puff conditions. No information regarding whether the vapers had experience smoking electronic cigarettes was provided.

Goel et al. [35] study was mentioned in the previous no reference topography profile Chapter 3.1.1 (above). This study used a combination of puffing topography characteristics found in Table 3.4 (above). The 20 second interpuff value was used from the Farsalinos et al. [49] study.

Offermann [57] investigated both direct and indirect exposure of electronic cigarette aerosol. No information was supplied about the electronic cigarette type, brand, flavor, and nicotine concentration. This research conducted multiple studies. The first test was interested in the direct exposure assessment. The study does not explicitly supply any information about how the electronic cigarette aerosol was generated however, it was inferred that subjects partook in the study. No information was provided about how many subjects participated and how they were selected for the study. The puffing topography characteristics, identified in Table 3.4 (above), were 175 puffs/day and a puff volume of 70mL. The second test was interested in the indirect exposure assessment. A small office space environment was used with an electronic cigarette user and non-user. The electronic cigarette user puffed 125 puffs in 8 hours with the same 70mL puff volume.

It was assumed that 100% of the exhaled aerosol was inhaled from the non-user. Both the tests referenced the Goniewicz et al. [51] study.

Perkins et al. [58] assessed the reinforcement of enhancing effects of acute nicotine in electronic cigarettes. There were 28 subjects, 12 men and 16 women, who participated in the study. In order for the subjects to be eligible for the study they needed to consume at least 10 conventional cigarettes per day. No information was supplied indicating if the subjects used electronic cigarettes previous to the study. The refillable electronic cigarette used in this study was the PrimeVapor.

The e-liquids tested were the Rawhide Red Tobacco and Freeport Menthol. This study used a combination of puffing topography characteristics in the different trials tested, defined in Table 3.4 (above). The referenced topographies are from Vansickel and Eissenberg [50], Perkins and

51 Karelitz [59], and Perkins et al. [60]. All electronic cigarette aerosol was generated using the CReSS Pocket device manufactured from Borgwaldt KC, Inc. This study captured topography data discussed in Chapter 3.2.3 (below).

Williams et al. [61] tested four different electronic cigarettes to identify different metals such as tin, copper, zinc, silver, nickel and chromium present in the aerosol produced from these devices.

Three of the electronic cigarettes were refillable and the fourth model was disposable. No information regarding what brand, flavor or nicotine concentration was specified. The puffer box developed at the University of Kentucky was used to generate the electronic cigarette aerosol. The 4.3 second puff duration used was referenced from the Hua et al. [55] research study and is identified in Table 3.4 (above).