Triacetin

Excipient (pharmacologically inactive substance)

What is Triacetin?

Triacetin (C9H14O6), also known as glyceryl triacetate, is pharmaceutical excipient used in manufacturing of capsules and tablets, and has been used as a humectant, plasticizer, and solvent. It is a liquid, and has been approved by the FDA as a food additive. Triacetin is a water-soluble short-chain triglyceride that may also have a role as a parenteral nutrient according to animal studies.[1][2] It is also used in the perfume and cosmetic industries.

Triacetin is listed on the FDA Generally Regarded As Safe (GRAS) List. According to the FDA, triacetin has been found to be non-toxic in long-term feeding tests in rats at levels that were several orders of magnitude greater than those to which consumers are exposed.[2] Additionally, in a toxicology report from 2002, triacetin and a group of related triglycerides did not represent a hazard to human health based on the anticipated daily intake of 7.8 mg/day/adult, and other available data. One case of skin toxicity (allergic contact eczema) due to industrial use in cigarette filter production has been reported.[1][3]

There is no evidence in the available information on triacetin that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.[2]

[1] 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 March 19, 2012.

[2] FDA’s SCOGS database; propylene glycol; SCOGS-Report Number: 30; http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASSubstancesSCOGSDatabase/ucm261045.htm. Accessed March 19, 2012.

[3] SIDS. Screening Information Data Set for High Production Volume Chemicals. (2005) p. 169 Triacetin. http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~uyt6aD:1Accessed March 17, 2012

Top Medications Containing Triacetin

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