Abstract
In recent years, oral tobacco-derived nicotine (OTDN) pouches have emerged as a new oral tobacco product category. They are available in a variety of flavors and do not contain cut or ground tobacco leaf. The on!® nicotine pouches fall within this category of OTDN products and are currently marketed in seven (7) flavors with five (5) different nicotine levels. Evaluation of the nicotine release from these products is valuable for product assessment and product-to-product comparisons. In this work, we characterized the in vitro release profiles of nicotine from the 35 varieties of on!® nicotine pouches using a fit-for-purpose dissolution method, employing the U.S. Pharmacopeia flow-through cell dissolution apparatus 4 (USP-4). The nicotine release profiles were compared using the FDA’s Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. The cumulative release profiles of nicotine show a dose dependent response for all nicotine levels. The on!® nicotine pouches exhibit equivalent percent nicotine release rates for each flavor variant across all nicotine levels. Furthermore, the nicotine release profiles from on!® nicotine pouches were compared to a variety of other commercially available OTDN pouches and traditional pouched smokeless tobacco products. The percent nicotine release rates were found to be dependent on the product characteristics, showing similarities and differences in the nicotine release profiles between the on!® nicotine pouches and other compared products.
Highlights
Over recent years, oral tobacco products have provided alternatives to smoking cigarettes [1,2]
We demonstrated the ability of this method to be used as an important tool for tobacco product assessment and product-to-product comparisons, and that the nicotine release profile is dependent on the form and cut of the studied traditional smokeless tobacco products [28]
The nicotine release profiles from on!® nicotine pouches were compared to a variety of oral tobacco-derived nicotine (OTDN) pouches and traditional smokeless tobacco products to better understand the nicotine release rates within and across product categories
Summary
Oral tobacco products have provided alternatives to smoking cigarettes [1,2]. Traditional smokeless tobacco products come in three different types, including chewing tobacco (loose leaf, plug, or twist), snuff (finely ground tobacco that can be dry, moist, or packaged in pouches (e.g., snus)), and dissolvable (finely ground tobacco pressed into shapes such as tablets and sticks) products [6]. Modern oral tobacco-derived nicotine (OTDN) products have been commercialized in various solid forms, including lozenges, gums, and dissolving tablets [8,9,10]. Nicotine pouches have emerged as a new category of OTDN products. These products are preportioned pouches similar to snus but replace the tobacco leaf with non-tobacco filler and tobacco-derived nicotine
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