AbstractThe U.S. Food and Drug Administration has regulatory authority over tobacco products, including conventional cigarettes and next generation products (NGPs) such as e-cigarettes and tobacco heating products (THPs). There is a desire by the industry, regulator and animal, protection organizations to incorporate non-animal test methods for tobacco product and NGP assessment. When assessing respiratory effects in vitro, reliable exposure systems that deliver aerosols to cellular/tissue cultures (such as human reconstructed airways or lung slices) at the air–liquid interface are needed. Using nicotine dosimetry, we report the characterization of a Vitrocell VC1 in our laboratories (IIVS, USA). Nicotine, generated from a 3R4F reference cigarette or NGP (e-cigarette and THP) aerosols at source and the exposure interface (culture media), was assessed using ultra-high-performance liquid chromatography–tandem mass spectrometry. These data were compared to published dosimetry data for the same products, generated at a different laboratory (BAT R&D, Southampton, UK), on different exposure systems (VC10 and Borgwaldt RM20S) to confirm repeatability. The nicotine content of 3R4F and NGP aerosols at VC1 source generation was established. Results demonstrated no statistical difference between laboratories (IIVS and BAT; p = 0.903) when comparing puff-by-puff nicotine concentrations from the three products. Culture media nicotine assessment demonstrated no significant difference between replicate wells in the exposure module (p = 0.855), indicating uniform delivery. This study demonstrates successful Vitrocell VC1 aerosol generation and delivery across multiple nicotine product categories, as characterized using nicotine as a dosimetry marker. The data suggest the VC1 established in our laboratory can reproducibly generate and deliver tobacco product and NGP aerosols for future in vitro assessment and matches the performance of reported exposure systems.
Applied In Vitro Toxicology – Mary Ann Liebert
Published: Jun 1, 2018