Tocopherols excipient

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Comments tocopherols excipient is described in the USPNF 23 as a vegetable oil solution containing not less than 50.0% of total tocopherols, of which not less than 80.0% consists of varying amounts of beta, delta, and gamma tocopherols. 

Various mixtures of tocopherols, and mixtures of tocopherols with other excipients, are commercially available and individual manufacturers should be consulted for specific information on their products. The EINECS number for a-tocopherol is 215-798-8. The EINECs number for d-a.-tocopherol is 200-412-2 and the EINECS number for dl-a-tocopherol is 233-466-0. 

The simplest lipid-based formulations contain only one excipient such as Gelucire 44/14, oleic acid, o -tocopherol, corn oil, peanut oil, sesame oil, medium-chain triglyceride, or medium-chain mono- and diglycerides. There are at least 10 commercially available one-lipid excipient oral formulations, and they all happen to be in soft capsules. 

The next level of complexity in lipid-based formulations is those that contain two excipients. Some typical combinations are sesame oil with a-tocopherol, medium-chain triglyceride with ethanol, and propylene glycol esters of fatty acids with glyceryl monooleate. There are at least 6 commercially available oral formulations with two lipid excipients. 

Vitamin E is available as tocopheryl polyethylene glycol succinate (TPGS). Tocopherol is esterified via succinate to polyethylene glycol. This substance can be dissolved in a high concentration in water under micelle formation. For the formation of micelles no excipient (but a preservative) is needed because the TPGS has surfactant properties (Fig. 5.2). 

It is also important, with regard to excipients as to what chemical form is used. OL-alfa-Tocopherol acts as antioxidant in an alcohol-water mixture the esters have no effect. 

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