Cetylpyridinium Chloride

Category

Antimicrobial Preservative; Cationic Surfactant; Solubilizing Agents; Wetting Agents

Grade

Pharmceutical Excipients

Description

Cetylypyridinium chloride is a white powder with a characteristic odor. It is slightly soapy to the touch.

UNII

D9OM4SK49P

Chemical Name

1-Hexadecylpyridinium chloride; 1-Hexadecylpyridinium chloride monohydrate;

Synonyms

C16-alkylpyridinium chloride; Cepacol; Cepacol chloride; Ceta- miun; cetylpridinii chloridum; cetyl pyridium chloride; Dobendan; hexadecylpyridinium chloride; 1-hexadecylpyridinium chloride; Medilave; Pristacin; Pyrisept

Administration route

Inhalation and oral

Dosage Form

Inhalation and oral preparations

Stability and Storage Conditions

Cetylpyridinium chloride is stable under normal conditions. It should be stored in well-closed containers.

Source and Preparation

Cetylpyridinium chloride is prepared from cetyl chloride by treatment with pyridine.

Applications

Cetylpyridinium chloride is a quaternary ammonium cationic surfactant, used in pharmaceutical and cosmetic formulations as an antimicrobial preservative. It is used therapeutically as an antiseptic agent; used alone or in combination with other drugs for oral and throat care; used in nonparenteral formulations licensed in the UK; and used in oral and inhalation preparations at concentrations of 0.02-1.5.mg. Mouthwashes containing cetylpyridinium chloride have been shown to inhibit plaque formation, although efficacy is variable owing to limited published data.

Safety

Cetylpyridinium chloride is used widely in mouthwashes as a bactericidal antiseptic. It is generally regarded as a relatively nontoxic material when used at a concentration of 0.05% w/v, although minor side effects such as mild burning sensations on the tongue have been reported. At higher concentrations, cetylpyridinium chloride may damage the mucous membranes in the mouth. It is harmful when ingested or inhaled. It can cause eye irritation, and is irritant to the respiratory system and the skin. LD50 (rat, IP): 0.006 g/kg LD50 (rat, IV): 0.03 g/kg LD50 (rat, oral): 0.2 g/kg LD50 (rat, SC): 0.25 g/kg LD50 (mouse, IP): 0.01 g/kg LD50 (mouse, oral): 0.108 g/kg LD50 (rabbit, oral): 0.4 g/kg LD50 (rabbit, IV): 0.036 g/kg

Incompatibilities

Incompatible with strong oxidizing agents and bases. It is also incompatible with methylcellulose. Magnesium stearate suspensions in cetylpyridinium chloride have been shown to significantly reduce its antimicrobial activity.This is due to the absorption of cetylpyridinium chloride on magnesium stearate.The cetylpyridinium chloride ion also interacts with gelatin, resulting in reduced bioavailability.