Pharmaceutical Development and Analytical Method Validation of a Nicotine Polacrilex-Containing Pouch Formulation

Abstract

Nicotine Polacrilex is a most commonly used active pharmaceutical ingredient in the treatment of tobacco dependence as a nicotine replacement therapy (NRT) in adult patients. This paper demonstrates the pharmaceutical development and analytical method validation of a novel nicotine polacrilex-containing pouch formulation through buccal nicotine delivery. This formulation was designed to deliver 2 mg of nicotine per pouch through controlled buccal absorption, providing a smokeless, tar-free alternative to cigarettes.

Keywords: Nicotine polacrilex, nicotine replacement therapy, pouch formulation, buccal drug delivery, HPLC method validation, ICH Q2, smoking cessation, tobacco dependence.