Product Details
Category
Absorption enhancer; Antioxidant; Emulsifying Agents; Granulation Aid; Ointment Base; Solubilizing Agents; Surfactant; Suspending Agents; Tablet Binder
Molecular Formula
C33O5H54(CH2CH2O)20-22
Grade
Pharmceutical Excipients
Description
Vitamin E polyethylene glycol succinate is a synthetic product. It is available as a white to light-brown, waxy solid and is practically tasteless.
Chemical Name
4-O-(2-Hydroxyethyl)-1-O-[2, 5, 7, 8-tetramethyl-2-(4, 8, 12-trimethyltridecyl)-3, 4-dihydrochromen-6 yl]butanedioate [9002-96-4] and [30999-06-5]
Synonyms
Speziol TPGS Pharma; tocofersolan; tocophersolan; tocopherol polyethylene glycol succinate; D-a-tocopheryl polyethylene glycol 1000 succinate; TPGS; vitamin E polyethylene glycol 1000 succinate; vitamin E TPGS; VEGS
Administration route
Ophthalmic or drops; oral; topical
Dosage Form
Ophthalmic solution or drops; oral capsules, solution, tablet; topical solution or drops
Stability and Storage Conditions
Vitamin E polyethylene glycol succinate is stable at ambient room temperature for up to 4 years. It reacts with alkalis and acids. Aqueous solutions of vitamin E polyethylene glycol succinate are stable over a pH range of 4.5-7.5 and can be further stabilized with propylene glycol.
Source and Preparation
Vitamin E polyethylene glycol succinate is prepared by esterification of the acid group of crystalline D-a-tocopheryl acid succinate by polyethylene glycol 1000.
Applications
Vitamin E polyethylene glycol succinate is an esterified vitamin E (tocopherol) derivative primarily used as a solubilizer or emulsifying agent because of its surfactant properties. Structurally, it is amphipathic and hydrophilic, unlike the tocopherols, and therefore it is a water-soluble derivative that can be used in pharmaceutical formulations such as capsules, tablets, hot-melt extrusion, microemulsions, topical products, and parenterals. One of the most important applications is its use as a vehicle for lipid-based drug delivery formulations. It can also be used as a source of vitamin E. Vitamin E polyethylene glycol succinate has been characterized with respect to its mechanism of action and studied as a glycoprotein inhibitor.
Safety
Vitamin E polyethylene glycol succinate has been used at levels of 280 mg/capsule in the product Agenerase (amprenavir), which was dosed at 8 capsules (2240 mg vitamin E TPGS) per day.An additional assessment of the safety of vitamin E polyethylene glycol succinate has been published, which includes a report showing no-observed-adverse-effect-level (NOAEL) in rats of 1000 mg/kg/day.
Incompatibilities
Vitamin E polyethylene glycol succinate is incompatible with strong acids and strong alkalis.