Natural source, water soluble form of Vitamin E. Vitamin E TPGS is widely used as an excipient in drug formulations and is rapidly expanding into the beverage and functional food markets. Structure – property relationship suggests that it uniquely meets the need for enhancing drug solubility, permeability, safety and enhancing the bioavailability.
Emulsifier - TPGS has amphiphilc properties and is therefore used as emulsifier for nutraceuticals and pharmaceuticals (Lehr 2005). Emulsifier for injectable formulations
Vehicle for lipid - based drug delivery - Vitamin E TPGS is an important extension to a range of drug delivery products
Source of natural Vitamin E - used in pharmaceutical formulations as well as dietary supplements Extensively used in solid, topical and ophthalmic dosage forms
Vitamin E TPGS is amphiphile, that is it has a dual nature. Part of the molecule exhibits hydrophilicity and the other lipophilicity. General accepted view is that the polyethylene glycol portion serves as the hydrophilic polar head (water soluble), while the tocopherol succinate portion serves as the lipophilic alkyl tail (water insoluble).
Vitamin E TPGS is stable when exposed to oxygen, heat, light, or oxidizing agents. It is unstable to alkali. Vitamin E TPGS is known to be stable excipient with a shelf-life of 4 years when stored in the original unopened container at room temperature. Vitamin E TPGS is stable under the conditions of heat sterilization. Stability data will be available soon.
Regarding the safety of Vitamin E TPGS, various studies have been conducted in the last decades. EFSA (European Food Safety Authority) has conducted studies to assess the safety and bioavailability of Vitamin E TPGS for use in food particularly for nutritional / medical purposes. From toxicology studies, an overall no-observed-adverse-effect level (NOAEL) of 1000 mg / kg body weight per day can be derived. Vitamin E TPGS is not genotoxic. Also approved by US-FDA (United States - Food and Drug Administration).