DESCRIPTION

NICOTROL® Inhaler (nicotine inhalation system) consists of a mouthpiece and a plastic cartridge delivering 4 mg of nicotine from a porous plug containing 10 mg nicotine. The cartridge is inserted into the mouthpiece prior to use. Nicotine is a tertiary amine composed of a pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile, hygroscopic liquid obtained from the tobacco plant. Nicotine has a characteristic pungent odor and turns brown on exposure to air or light. Of its two stereoisomers, S(-) nicotine is the more active. It is the prevalent form in tobacco, and is the form in the NICOTROL Inhaler. The free alkaloid is absorbed rapidly through skin, mucous membranes, and the respiratory tract.

Chemical Name: S-3-(1-methyl-2-pyrrolidinyl) pyridine

Molecular Formula: C₁₀H₁₄N₂

Molecular Weight: 162.23

Ionization Constants: pKa1 = 7.84, pKa2 = 3.04 at 15° C

Octanol-Water Partition Coefficient: 15:1 at pH 7

Nicotine is the active ingredient; inactive components of the product are menthol and a porous plug which are pharmacologically inactive. Nicotine is released when air is inhaled through the Inhaler.