Advanced in vitro exposure systems.

Characterization of a Vitrocell VC1 Using Nicotine Dosimetry: An Essential Component Towards Standardised In Vitro Aerosol Exposure of Tobacco and Next Generation Nicotine Delivery Products

11. Mar. 2018

IIVS at SOT 2018

D. Sheehan1, M. Aragon1, J. Adamson2, M. Gaca2, H. Raabe1, and H. Behrsing1.
1Institute for In Vitro Sciences, Inc., Gaithersburg, MD; and 2British American Tobacco, Southampton, United Kingdom.

This study demonstrates successful Vitrocell VC1 aerosol generation and delivery across multiple nicotine product categories (3R4F cigarette smoke, e-liquid and THP), as characterised using nicotine as a dosimetry marker. The data suggests the VC1 can reproducibly generate and deliver tobacco product and NGP aerosols for future in vitro assessment and matches the performance of reported exposure systems.

Abstract
The US-FDA 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 at the air-liquid interface are needed. Using nicotine dosimetry, we report the characterisation 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 UPLC-MS/MS. This data was compared to published dosimetry data for the same products, generated at a different laboratory (BAT R&D, UK), on different exposure systems (VC10 and Borgwaldt RM20S) to confirm repeatability. The nicotine content of 3R4F and NGP aerosols at VC1 source generation were 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 characterised using nicotine as a dosimetry marker. The data suggests the VC1 established in our lab can reproducibly generate and deliver tobacco product and NGP aerosols for future in vitro assessment and matches the performance of reported exposure systems.

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