Event name:
Tobacco Science Research Conference 2024Session Date:
September 8, 2024 –
Session Speakers:
Session: Dissolution Testing of White Fox Brand Modern Oral Nicotine Pouches.
Speaker: – Ed Carmines, Chris Woodruff, Lise Fraissinet, Mengliang Bao
Date: September 8th, 2024 – Atlanta, GA
About The Poster:
White Fox is an oral nicotine pouch product that does not contain cut, ground, powdered or leaf tobacco. The nicotine source is synthetic. Dissolution testing was performed as part of a PMTA development program in order to demonstrate that the products are appropriate for the protection of public health (APPH). The nicotine release profiles for the portfolio of White Fox brand nicotine pouches were characterized using the U.S. Pharmacopeia flow-through cell dissolution apparatus 4 (USP-4). Samples of all the study products were placed in the apparatus flow-through cells at a constant temperature of 37°C. A pump delivered a constant flow of artificial saliva for 100 minutes. The flow was sampled throughout the release period. The method followed the approach of Miller et al. 2020. Nicotine release profiles were compared by calculating the difference factor (f1) and similarity factor (f2) by adopting methodology referenced in Guidance for Industry from FDA’s Center for Drug Evaluation and Research (CDER). The tested products varied in size, flavor, and nicotine content. The excipients are the same in all of the products. About 20% of the nicotine was released over the first 30 minutes for all of the products. By 100 minutes the release was about 40%. The dissolution rate was about 0.4% per minute. All of the products were considered statistically equivalent to each other. The release rates were markedly slower than market comparators ZYN and VELO.