Peringatan Keamanan

Acute oral toxicity (LD50): 25000 mg/kg in Mouse MSDS

In general, study results of the polysorbates demonstrated no carcinogenicity and genotoxicity. In repeated-dose toxicity studies, diarrhea was observed as the major symptom of toxicity L1856. Some studies, however, show conflicting findings.

In a 2-year dietary study of polysorbate 80 in rats, a higher incidence of adrenal medullary pheochromocytomas was found, mainly in male rats L1856.

Polysorbate 80 is used as a solubilizing agent in IV infusions 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 must be followed closely L1852.

It was found that maternal toxicities such as loose stool, suppression of weight gain and reduced intake were seen, and poor lactation was noted in some studies of mother rats administered 7.5% solutions of polysorbates L1856.

Polysorbate 80

DB11063

small molecule approved

Deskripsi

Polysorbate, a substance formulated by the reaction of sorbitan fatty acid ester (a nonionic surfactant) with ethylene oxide, is used in many foreign countries, including the U.S. and the EU, where it acts as an emulsifier, a solubilizer in many foods, including bread, cake mix, salad dressing, shortening oil and chocolate L1856.

Polysorbate 80 is a hydrophilic nonionic surfactant. It is utilized as a surfactant in soaps and cosmetics and also as a lubricant in eye drops. In food or pharmaceutical products, it can act as an emulsifier. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration or vaccinations.L1852

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.L1852

It is also known as an emulsifier, which helps ingredients mix together and prevent separation, and water-containing small amounts of salts, and is included in several vaccines licensed in the USA.L1844

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) -
Volume Distribusi -
Klirens (Clearance) -

Absorpsi

Poorly absorbed L1856.

Metabolisme

Polysorbates undergo degradation by auto-oxidation, producing reactive peroxides, in addition to hydrolysis L1848. Exposure to light of polysorbate 80 aqueous solution leads autoxidation of the alkyl polyoxyethylene chain leading to the production of hydroperoxide derivatives. The peroxides cause oxidative damage to the protein molecule that makes up the formulation. The residual peroxides and the rate of peroxide generation as a result of light exposure are found to vary for polysorbate 80 of different grades/from different sources A32234.

Rute Eliminasi

Data eliminasi belum tersedia.

Interaksi Obat

0 Data
Tidak ada data.

Referensi & Sumber

Artikel (PubMed)
  • PMID: 16400901
    Coors EA, Seybold H, Merk HF, Mahler V: Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions. Ann Allergy Asthma Immunol. 2005 Dec;95(6):593-9. doi: 10.1016/S1081-1206(10)61024-1.
  • PMID: 14967540
    Sun W, Xie C, Wang H, Hu Y: Specific role of polysorbate 80 coating on the targeting of nanoparticles to the brain. Biomaterials. 2004 Jul;25(15):3065-71. doi: 10.1016/j.biomaterials.2003.09.087.
  • PMID: 21348312
    Zhao YM, Xia AX, Wei YH, Ruan YP, Li FZ: Polysorbate-80 modified neurotoxin nanoparticle with its transport and cytotoxicity against blood-brain barrier. Yao Xue Xue Bao. 2010 Oct;45(10):1312-6.
  • PMID: 10537361
    van Tellingen O, Beijnen JH, Verweij J, Scherrenburg EJ, Nooijen WJ, Sparreboom A: Rapid esterase-sensitive breakdown of polysorbate 80 and its impact on the plasma pharmacokinetics of docetaxel and metabolites in mice. Clin Cancer Res. 1999 Oct;5(10):2918-24.
  • PMID: 14560928
    Zhang H, Yao M, Morrison RA, Chong S: Commonly used surfactant, Tween 80, improves absorption of P-glycoprotein substrate, digoxin, in rats. Arch Pharm Res. 2003 Sep;26(9):768-72.
  • PMID: 19401168
    Wang CX, Huang LS, Hou LB, Jiang L, Yan ZT, Wang YL, Chen ZL: Antitumor effects of polysorbate-80 coated gemcitabine polybutylcyanoacrylate nanoparticles in vitro and its pharmacodynamics in vivo on C6 glioma cells of a brain tumor model. Brain Res. 2009 Mar 19;1261:91-9. doi: 10.1016/j.brainres.2009.01.011. Epub 2009 Jan 20.

Contoh Produk & Brand

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International Brands
  • Tween-80

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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