Poster Presented at TSRC 2022 by Helen Cyrus-Miller, Karin M. Gilligan and Willie McKinney, Ph.D.
Abstract
The market for oral tobacco pouches has been increasing in recent years as adult tobacco consumers are seeking alternatives to traditional tobacco products. The use of oral tobacco products is considered by many to reduce risks of harm caused by smoking cigarettes. Nicotine pouches that do not contain tobacco leaves have emerged as a new category of oral tobacco products. These oral tobacco-derived nicotine (OTDN) products are pre-portioned pouchessimilar to snus, except that the tobacco leaf is replaced with non-tobacco filler and food grade ingredients. Since the nicotine in the OTDN is added, there are several questions about its release from the pouch. We utilized dissolution test systems to measure the release of nicotine to characterize and compare oral tobacco products.
To determine the nicotine release profile of BIDI® Pouch compared to other pouch products, the FDA’s Guidance for Industry was followed throughout the testing and comparison process. We tested three BIDI® Pouch flavors and three comparator products. The nicotine release profile of three BIDI® Pouch flavors and three comparator products, including General Snus, were determined using the FDA’s Guidance for Industry, Dissolution Testing of Immediate Release Solid Oral Dosage Forms.
Similar to Swedish Match General Snus, BIDI® Pouch products released 38% of the total pouch nicotine at 20 minutes. The two other comparator products released ~90% of the total pouch nicotine at 20 minutes. The similarity of the BIDI® Pouch release to Swedish Match Snus is important for three reasons. First, BIDI® Pouch products are the only OTDN products in this study that deliver nicotine like a tobacco containing pouch. Second, Swedish Match is authorized by the FDA to market and make reduced exposure claims about its snus products. Finally, as the BIDI® Pouch products nicotine release closely replicate the Swedish Match General Snus, it could be inferred that the pharmacokinetic profiles would be similar as well.