Manual smoking machine with high tech features

The VC 1 smoking machine is used for a controlled aerosol generation of combustion cigarettes as well as of next generation devices such as Heated Tobacco Products (HTP) and electronic nicotine delivery systems (ENDS). Special attention was given to guarantee very flexible programming of the smoking parameters. The properties of the aerosol are maintained due to small dead volumes of the system.

VITROCELL® Smoking Machine VC 1 2.0  (PDF)

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Robert Leverette¹, Thomas Shutsky¹, John Wertman¹, Katarina Aleksa², Dhatri Lakshmanan², Rebecca Payne³, Kristen Jordan^1
1Scientific & Regulatory Affairs, RAI Services Company, Winston-Salem, NC, USA; 
²Labstat International Inc. Kitchener, ON, Canada;
³Labcorp Early Development Laboratories Ltd., Harrogate, UK

This poster shows whole aerosol exposures of combustible and next generation tobacco products, including Electronic Nicotine Delivery Systems. A Vitrocell® VC10® robot generated and delivered aerosols to the Mammalian 6/48 aerosol dilution and exposure system, with up to 7 concurrent doses plus a clean air control. Dosimetry module allowed the capture and quantification of deposited aerosol constituents (nicotine, glycerol and carbonyls). The study utilized the Neutral Red Uptake (NRU) assay in which mammalian cells were exposed to either combined TPM + GVP (submerged culture) or Whole Aerosol (ALI).

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Regular leak tests are mandatory in aerosol research. A leak caused by a forgotten connection or defective o-ring may have a significant influence on the aerosol exposure process. We recommend to carry out a leak test prior to the experiment and as part of cleaning or service routine.

VITROCELL Application Note

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Rob Bedford¹, Emma Rothwell¹, Sophie Martin¹, Cian O’Hanlon¹, Andrew McCune² and Michael Hollings^1
1Genetic and Molecular Toxicology and ²Immunology and Immunotoxicology, Covance Laboratories Ltd., Harrogate, UK

- Exposure to 3R4F resulted in increased levels of IL-4, MDC, GM-CSF, IL-12/IL23p40, IL-10 and IFN-γ in the recovery media. Approximately three-fold increases in MDC, GM-CSF, IL-12/IL23p40 and IFNγ were observed whilst two-fold increases were observed for IL-4 and IL-10. In comparison, no marked effect was observed in the module media.

- In contrast to the response observed from 3R4F exposure, fewer changes in cytokine production were observed following THP and E-cigarette exposure. IFNγ demonstrated a two-fold increase in levels measured in the recovery media at doses 1 and 2 for THP. IL-12/IL23p40 also demonstrated a 1.5-fold increase in recovery media following exposure to THP. In addition, IFN-γ and IL-8 were increased following exposure to E-cigarette at dose 2. IL-1β also demonstrated a 1.5-fold increase in the recovery and module media following exposure to E-cigarette.

- A number of cytokines were reduced following exposure to THP and E-cigarette. For example, GM-CSF, MIP1α, VEGF and MCP-1.

- These results demonstrate the difference in cytokine profiles of MucilAir tissues following exposure to different nicotine-containing products.

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https://doi.org/10.1007/s11626-020-00517-7

Xuefei Cao¹, Jayme P. Coyle², Rui Xiong¹, Yiying Wang¹, Robert H. Heflich¹, Baiping Ren¹, William M. Gwinn³, Patrick Hayden⁴, Liying Rojanasakul²

¹ Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd., AR Jefferson, USA
² Allergy and Clinical Immunology Branch, Health Effects Laboratory Division, National Institute for Occupational Safety and Health, Centers forDisease Control and Prevention,Morgantown,WV, USA
³ Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Durham, NC, USA
⁴ BioSurfaces Inc., Ashland, MA, USA

One important element for validating any new assay for making regulatory decisions is determining its performance relative to an accepted standard. Conducting in vivo inhalation toxicity studies using whole-body or nose-only exposure systems is expensive and time-consuming and typically requires a large number of animals. The goal of using alternative methods, like human in vitro ALI airway cultures, ultimately is to replace inhalation toxicity testing in animals with in vitro approaches. Transition from animal- to human-based models is ultimately expected to lead to faster and better predictive toxicity assessments and therapeutic development at lower cost.  This study shows the development and validation of alternative in vitro methods for acute toxicity testing, including acute inhalation toxicity testing.
 

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