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Abstract
Background: Oral nicotine pouch (ONP) use is rising. The sales of ONPs in 2019 were 126 million units, increasing to 808 million units in 2022. Understanding ONP in vitro release is critical for assessing exposure to ONP products.
Methods: The commercial brand ON! ONPs with nicotine label claims of 2, 4, and 8 mg, were evaluated in vitro for cumulative nicotine release using the bidirectional transmucosal apparatus (BTA) for 90 minutes. Nicotine quantification was performed by HPLC-PDA. For pH determination, ONP samples were prepared in water or artificial saliva (pH 6.8) with measurements for 30 minutes. BTA results were compared to ON! ONP in vivo data to access relevance.
Results: The cumulative release across all ON! ONP nicotine concentrations were greater than 85% and maximum release occurred within 30 minutes. The pH of ON! original flavor ONPs in water was 8.4 to 9.4. The pH in artificial saliva was 7.3 to 8.5. The pH remained constant over sampling time. The 8 mg ON! ONPs were found to have a lower pH than 2 and 4 mg. The 4mg ON! original ONPs had a higher pH than 4 mg ON! mint. The BTA and in vivo data both showed maximum nicotine concentrations around 30 minutes.
Conclusion: In vitro nicotine release was acceptable under United States Pharmacopeia guidelines. ON! ONPs do not utilize pH change during nicotine delivery and pH is influenced by flavor. More in vivo data is required to establish an in vitro in vivo correlation for ONPs.
Publication Date
2025
Keywords
Oral Nicotine Pouches, Nicotine Release Apparatus, In-Vitro, Nicotine Exposure
Disciplines
Medicinal Chemistry and Pharmaceutics | Other Analytical, Diagnostic and Therapeutic Techniques and Equipment | Other Pharmacy and Pharmaceutical Sciences | Pharmacy and Pharmaceutical Sciences | Substance Abuse and Addiction
Faculty Advisor/Mentor
Matthew S. Halquist
Is Part Of
VCU Graduate Research Posters
Included in
Medicinal Chemistry and Pharmaceutics Commons, Other Analytical, Diagnostic and Therapeutic Techniques and Equipment Commons, Other Pharmacy and Pharmaceutical Sciences Commons, Substance Abuse and Addiction Commons