A comparison of select smokeless tobacco and tobacco-free nicotine pouches utilizing validated methods for nicotine dissolution using the dissolution apparatus 1 and dissolution apparatus 4

This study presents the results of a method validation for nicotine dissolution using the United States Pharmacopeia (USP) basket apparatus (Apparatus 1). Furthermore, dissolution profiles of select oral tobacco products (OTP) and tobacco-free nicotine pouches (TFNP) were generated and compared with a validated method using the USP flow-through cell apparatus (Apparatus 4). Nicotine quantification at each fraction collection time from each apparatus was achieved using a single method of analysis. This study provides robust data for the validation of nicotine dissolution using Apparatus 1 (App1). Additionally, justification is provided for using App1 or Apparatus 4 (App4) when determining the nicotine dissolution profiles for any of the products included in this study. Lastly, nicotine release profiles generated from both apparatuses are compared using the difference factor (f1) and similarity factor (f2) according to the United States Food and Drug Administration (FDA) Guidance for Industry: Dissolution testing of immediate release solid oral dose forms (FDA CDER, 1997). • Validated USP Apparatus 1 method for nicotine dissolution of multiple products. • Compared nicotine release profiles using USP Apparatus 1 and Apparatus 4. • Demonstrated apparatus-dependent equivalency based on product matrix. • Confirmed both methods are suitable for regulatory nicotine release testing.