Abstract
The rate at which oral tobacco-derived nicotine (OTDN) and snus pouches release nicotine into saliva is crucial to determine product performance. As no standardized method is available for this purpose, this study sought to develop a biorelevant dissolution method that could both discriminate between different products and predict in vivo behavior. Using a μDISS Profiler™ as a surrogate for the US Pharmacopoeia standard apparatuses and a custom-made sinker, nicotine release from an OTDN pouch product (ZYN® Dry Smooth) and a snus product (General® Pouched Snus White Portion Large) was determined in biorelevant volumes (10 mL) of artificial saliva. In addition, nicotine extraction in vivo was measured for both products. Strikingly, the method showed distinct dissolution curves for OTDN and snus pouches, and the nicotine release observed in vitro did not significantly differ from the nicotine extracted in vivo. The custom-made sinker was designed to accommodate both loose and pouched oral tobacco/nicotine products, and thus the proposed in vitro dissolution method is suitable to assess nicotine release from OTDN and snus pouches. Apart from providing individual dissolution curves, the method was also able to predict in vivo nicotine extraction. Thus, this method could serve as a (biorelevant) monograph for product equivalence studies.
Highlights
Oral tobacco-derived nicotine (OTDN) pouch products are growing in popularity, but cigarettes remain the most common tobacco product worldwide [1]
Several different in vitro nicotine release methods have been proposed that are able to discriminate between different Smokeless tobacco products (STPs), but common for these methods is that they all seem to substantially overpredict the nicotine release in vivo [13,20]
Calculations of the difference and similarity factor showed distinct nicotinerelease curves for the two different products, verifying that the method can discriminate between different product categories
Summary
Oral tobacco-derived nicotine (OTDN) pouch products are growing in popularity, but cigarettes remain the most common tobacco product worldwide [1]. Cigarettes are a huge health burden in terms of tobacco-related morbidity and mortality, and smoking tobacco is the factor contributing to most preventable deaths worldwide [2]. The hazards of cigarettes are a result of the inhaled combustion products formed during smoking and have less to do with their tobacco and nicotine content [3]. Smokeless tobacco products (STPs) expose the user to no combustion products and epidemiological data on the STP Swedish snus have shown the use of Swedish snus to be significantly less harmful, in terms of morbidity and mortality, compared to cigarettes [4,5,6]. OTDN pouches are an enticing alternative to traditional tobacco-based products, in terms of harm reduction
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