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Candelilla Wax

Excipient (pharmacologically inactive substance)

What is it?

Candelilla wax is harvested from the leaves of the small Candelilla shrub native to Mexico and the southwestern part of the U.S. It is a yellow-brown wax, which is hard, brittle, aromatic, and opaque to translucent. It may be mixed with other waxes to harden them, and in the pharmaceutical industry it is used as a glazing agent and a binder. Binders are added to tablet formulations to add cohesiveness to powders and provide the necessary bonding to form a compact tablet mass. In other words, binders are essential to achieve the “hardness” of the tablet. Candelilla wax has been used in lip balms and lotions, too. Candelilla wax is on the FDA Generally Regarded as Safe List (GRAS). There is no evidence in the available information on candelilla wax that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that follow current good manufacturing practice conditions of use.

[1] Code of Federal Regulations, Title 21, Volume 3, Revised as of April 1, 2013. CITE: 21CFR184.1976 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=184.1976 Accessed 1/14/2014.

[2] Dave RH. Overview of pharmaceutical excipients used in tablets and capsules. Drug Topics (online). Advanstar. 10/24/2008 http://drugtopics.modernmedicine.com/drugtopics/Top+News/Overview-of-pharmaceutical-excipients-used-in-tabl/ArticleStandard/Article/detail/561047. Accessed 01/14/2014

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