Introducing a Novel Biorelevant In Vitro Dissolution Method for the assessment of Nicotine Release from Oral Tobacco-Derived Nicotine (OTDN) and Snus Products

Introduction:
This text provides an overview of a study that introduces a novel biorelevant in vitro dissolution method for the assessment of nicotine release from oral tobacco-derived nicotine (OTDN) and snus products. The study aims to develop a method that can distinguish between different products and predict in vivo behavior.

Key Points:

* The study uses a µDISS Profiler as a surrogate for the US Pharmacopeia standard apparatuses and a custom-made sinker to determine nicotine release from an OTDN pouch product (ZYN®Dry Smooth) and a snus product (General®Pouched Snus White Portion Large) in biorelevant volumes (10 mL) of artificial saliva.
* The nicotine release observed in vitro does not significantly differ from the nicotine extracted in vivo for both products.
* The custom-made sinker is designed to accommodate both loose and pouched oral tobacco/nicotine products, making the proposed in vitro dissolution method suitable for assessing nicotine release from OTDN and snus pouches.
* The method was able to predict in vivo nicotine extraction, indicating its potential use as a (biorelevant) monograph for product equivalence studies.

Main Message:
The study successfully developed an in vitro dissolution method that can distinguish between OTDN and snus pouches and predict in vivo nicotine extraction. This method could serve as a valuable tool for regulatory assessments and product development in the tobacco industry.

Knopp, Matthias M., Nikolai K. Kiil-Nielsen, anna E. Masser, and Mikael Staaf. “Introducing a Novel Biorelevant In Vitro Dissolution Method for the assessment of Nicotine Release from Oral Tobacco-Derived Nicotine (OTDN) and Snus Products.” Separations 9, no. 2 (February 15, 2022): 52. https://doi.org/10.3390/separations9020052.