Method development and validation of dissolution testing for nicotine release from smokeless tobacco products using flow-through cell apparatus and UPLC-PDa.
Introduction:
This text describes a study that investigates the characteristics of extracts from tobacco-free nicotine pouches and compares them to a reference snus product and a reference cigarette. The study uses several in vitro assays to evaluate the mutagenic, cytotoxic, genotoxic, and oral irritation potential of these products.
Key points:
* The study used four tobacco-free nicotine pouches, a reference snus product, and a reference cigarette.
* Extracts were prepared from the products and tested in the Neutral Red Uptake (NRU) cytotoxicity assay, Bacterial Reverse Mutation (ames) assay, and in vitro Mammalian Cell Micronucleus (ivMN) assay.
* The products were also tested for oral irritation potential using the EpiGingival ™ 3D tissue model.
* Results from the ames, ivMN, and NRU assays showed that the tobacco-free nicotine pouches were non-mutagenic, non-genotoxic, and non-cytotoxic, while the reference cigarette was mutagenic, cytotoxic, and genotoxic.
* Results from Complete artificial Saliva (CaS) extracts of these products also failed to be classified as irritants in the EpiGingival ™ 3D tissue model.
Main message:
The study found that tobacco-free nicotine pouches have favorable characteristics compared to a reference cigarette and are non-irritating to oral tissue. These findings suggest that tobacco-free nicotine pouches may have reduced harm potential compared to traditional tobacco products. however, further research is needed to confirm these results and to fully understand the potential health impacts of these products.
Citation
Miller, J. h., Danielson, T., Pithawalla, Y. B., Brown, a. P., Wilkinson, C., Wagner, K., & aldeek, F. (2020). Method development and validation of dissolution testing for nicotine release from smokeless tobacco products using flow-through cell apparatus and UPLC-PDa. Journal of Chromatography. B, analytical Technologies in the Biomedical and Life Sciences, 1141, 122012–122012. https://doi.org/10.1016/j.jchromb.2020.122012
Miller, J. h., Danielson, T., Pithawalla, Y. B., Brown, a. P., Wilkinson, C., Wagner, K., & aldeek, F. (2020). Method development and validation of dissolution testing for nicotine release from smokeless tobacco products using flow-through cell apparatus and UPLC-PDa. Journal of Chromatography. B, analytical Technologies in the Biomedical and Life Sciences, 1141, 122012–122012. https://doi.org/10.1016/j.jchromb.2020.122012
