Nicotine Bitartrate Dihydrate: Role in NRT Manufacturing
Nicotine replacement therapy (NRT) depends on more than simply delivering nicotine. The active ingredient must be supplied in a form that can be incorporated accurately into a finished dosage form, with appropriate control over identity, purity, assay, impurities, and physical properties. Nicotine bitartrate dihydrate is one such nicotine salt used in pharmaceutical products, including certain nicotine lozenges. Current UK product information, for example, identifies nicotine bitartrate dihydrate as the active substance in several marketed lozenge products. For pharmaceutical manufacturers, understanding the salt form is useful because the amount of nicotine stated on a finished product label is not necessarily the same as the mass of nicotine salt used to manufacture it. This distinction matters during formulation, analytical testing, purchasing, and batch release. What Is Nicotine Bitartrate Dihydrate? Nicotine bitartrate dihydrate is a salt form of nicotine associated with t...