Nicotrol® NS (nicotine nasal spray) is an aqueous solution of nicotine intended for administration as a metered spray to the nasal mucosa.

Nicotine is a tertiary amine composed of 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 NICOTROL NS (nicotine nasal spray) . 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

Each 10 mL spray bottle contains 100 mg nicotine (10 mg/mL) in an inactive vehicle containing disodium phosphate, sodium dihydrogen phosphate, citric acid, methylparaben, propylparaben, edetate disodium, sodium chloride, polysorbate 80, aroma and water. The solution is isotonic with a pH of 7. It contains no chlorofluorocarbons.

After priming the delivery system for NICOTROL NS (nicotine nasal spray) , each actuation of the unit delivers a metered dose spray containing approximately 0.5 mg of nicotine. The size of the droplets produced by the unit is in excess of 8 microns. One NICOTROL NS unit delivers approximately 200 applications.

Last reviewed on RxList: 3/10/2009
This monograph has been modified to include the generic and brand name in many instances.