Ethylcellulose
Excipient (pharmacologically inactive substance)
What is Ethylcellulose?
Ethylcellulose is a free-flowing, white to light tan powder used in the pharmaceutical and food manufacturing industries. It is prepared from wood pulp or cotton by treatment with alkali and ethylation of the alkali cellulose with ethyl chloride. Ethylcellulose is used in pharmaceutical industry as a coating agent, flavoring fixative, tablet binder and filler, film-former, and as a viscosity-increasing agent. Ethyl cellulose is also used in the food industry as an emulsifier.[1] [2]
There is very limited data detailing possible side effects of ethylcellulose; however it is included in the FDA generally regarded as safe (GRAS) Database of Substances (SCOGS) Reviews.[3]
[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 08/19/2011
[2] Food and Agriculture Organization of the United States. Prepared at the 26th JECFA (1982), published in FNP 25 ( 1982) and FNP. 52 (1992). Accessed March 31, 2012. Ethylcellulose. http://www.fao.org/ag/agn/jecfa-additives/specs/Monograph1/Additive-178.pdf
[3] FDA’s SCOGS database; Ethylcellulose; SCOGS-Report Number: 25; http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&id=365 Accessed March 31, http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=scogsListing&id=119
Top Medications Containing Ethylcellulose
- Amoxicillin and Clavulanate Potassium 875 mg / 125 mg (Lek Pharmaceuticals)
- Bupropion Hydrochloride Extended-Release (XL) 300 mg (Anchen Pharmaceuticals, Inc.)
- Bupropion Hydrochloride Extended-Release (XL) 150 mg (Anchen Pharmaceuticals, Inc.)
- Bupropion Hydrochloride Extended-Release (XL) 300 mg (Watson Pharmaceuticals)
- Bupropion Hydrochloride Extended-Release (XL) 150 mg (Watson Pharmaceuticals)
- Divalproex Sodium Extended-Release 500 mg (Mylan Pharmaceuticals Inc.)
- Divalproex Sodium Extended-Release 250 mg (Mylan Pharmaceuticals Inc.)
- Divalproex Sodium Extended-Release 500 mg (Anchen Pharmaceuticals, Inc.)
- Kadian 30 mg (Actavis)
- Kadian 20 mg (Actavis)
- Kadian 50 mg (Actavis)
- Kadian 100 mg (Actavis)
- Metoprolol Succinate Extended-Release 50 mg (Wockhardt USA)
- Norflex 100 mg (3M Pharmaceuticals)
- Orphenadrine Citrate Extended Release 100 mg (Global Pharmaceuticals)
- Toprol-XL 50 mg (AstraZeneca Pharmaceuticals)
- Toprol-XL 25 mg (AstraZeneca Pharmaceuticals)
- Toprol-XL 100 mg (AstraZeneca Pharmaceuticals)
- Ultram ER 200 mg (Ortho McNeil Pharmaceutical)
- Ultram ER 100 mg (Ortho McNeil Pharmaceutical)
