Dissolution Testing of Nicotine Release from OTDN Pouches: Product Characterization and Product-to-Product Comparison

In recent years, oral tobacco-derived nicotine (OTDN) pouches have emerged as a new tobacco product category. They are available in variety of flavors and do not contain cut or ground leaf. The on!® fall within this category OTDN products currently marketed seven (7) with five (5) different levels. Evaluation the release from these is valuable for assessment product-to-product comparisons. work, we characterized vitro profiles 35 varieties using fit-for-purpose dissolution method, employing U.S. Pharmacopeia flow-through cell apparatus 4 (USP-4). were compared FDA’s Guidance Industry: Dissolution Testing Immediate Release Solid Oral Dosage Forms. cumulative show dose dependent response all exhibit equivalent percent rates each flavor variant across Furthermore, to other commercially traditional pouched smokeless products. found be on characteristics, showing similarities differences between