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Polysorbate 80

Excipient (pharmacologically inactive substance)

What is Polysorbate 80?

Polysorbate 80 (C64H124O26) is a common excipient and solubilizing agent used in the pharmaceutical industry. Polysorbate 80 (also known as polyoxyethylene-sorbitan-20 mono-oleate, or Tween 80) is used in the pharmaceutical and cosmetic industry in lotions, medical preparations (e.g., vitamin oils, vaccines, and intravenous preparations) and as an excipient in tablets.[1]

A solubilizing agent acts as a surfactant and increases the solubility of one agent in another. A substance that would not normally dissolve in a particular solution is able to dissolve with the use of a solubilizing agent.

Polysorbate 80 is used as a solubilizing agent in IV formulations of the antiarrhythmic drug amiodarone. Rare case reports of liver toxicity have been published suggesting polysorbate 80 may contribute to liver toxicity with the IV formulation of amiodarone. The package labeling of amiodarone warns that polysorbate 80 is also known to leach DEHP (dioctyl phthalate) from PVC and dosing recommendations should be followed closely. [2][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] Rätz Bravo AE, Drewe J, Schlienger RG, et al. Hepatotoxicity during rapid intravenous loading with amiodarone: Description of three cases and review of the literature. Crit Care Med. 2005;33:128-34.

[3] Amiodarone Hydrochloride (amiodarone hydrochloride) Injection, Solution. Apotex Inc. Accessed October 24, 2011. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=990c1cb3-3370-75e0-ff2a-bb51379f5dab

Top Medications Containing Polysorbate 80

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