Chemical Properties
solid
General Description
Odorless yellow to dark brown-green solid. Floats on water.
Air & Water Reactions
Insoluble in water.
Reactivity Profile
Carnauba wax react with acids to liberate heat. Heat is also generated by interaction with caustic solutions. Strong oxidizing acids may cause a vigorous reaction that is sufficiently exothermic to ignite the reaction products. Flammable hydrogen is generated by mixing with alkali metals and hydrides.
Health Hazard
Hot wax can burn skin and eyes.
Definition
The wax derived from Copernicia cerifera, Prunae.
Production Methods
Carnauba wax is obtained from the leaf buds and leaves of the
Brazilian carnauba palm, Copernicia cerifera. The leaves are dried
and shredded, and the wax is then removed by the addition of hot
water.
Pharmaceutical Applications
Carnauba wax is widely used in cosmetics, certain foods, and
pharmaceutical formulations. Cosmetically, carnauba wax is
commonly used in lip balms.
Carnauba wax is the hardest and highest-melting of the waxes
commonly used in pharmaceutical formulations and is used
primarily as a 10% w/v aqueous emulsion to polish sugar-coated
tablets. Aqueous emulsions may be prepared by mixing carnauba
wax with an ethanolamine compound and oleic acid. The carnauba
wax coating produces tablets of good luster without rubbing.
Carnauba wax may also be used in powder form to polish sugarcoated
tablets.
Carnauba wax (10–50% w/w) is also used alone or with other
excipients such as hypromellose, hydroxypropyl cellulose, alginate/
pectin-gelatin, Eudragit, and stearyl alcohol to produce sustainedrelease
solid-dosage formulations.
Carnauba wax has been experimentally investigated for use in
producing microparticles in a novel hot air coating (HAC) process
developed as an alternative to conventional spray-congealing
techniques.(11) In addition, carnauba wax has been used to produce
gel beads for intragastric floating drug delivery and has been
investigated for use in nanoparticulate sunscreen formulations.
Safety
Carnauba wax is widely used in oral pharmaceutical formulations,
cosmetics, and certain food products. It is generally regarded as an
essentially nontoxic and nonirritant material. However, there
have been reports of allergic contact dermatitis from carnauba wax
in mascara.
The WHO has established an acceptable daily intake of up to 7
mg/kg body-weight for carnauba wax.
storage
Carnauba wax is stable and should be stored in a well-closed
container, in a cool, dry place.
Regulatory Status
GRAS listed. Accepted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (oral capsules
and tablets). Included in nonparenteral medicines licensed in the
UK. Included in the Canadian List of Acceptable Non-medicinal
Ingredients.