Eastman pharmaceutical excipient approved in Japan

Eastman Chemical Company's Eastman Vitamin E TPGS (d-alpha-tocopheryl polyethylene glycol 1000 succinate) has been approved as a pharmaceutical excipient for oral drug formulations in Japan by the Japanese government's Ministry of Health, Labour and Welfare.

A multifunctional excipient that acts as a drug solubiliser and a bioavailability enhancer, increasing the absorption of water-insoluble drugs as well as the efficacy of drugs that are otherwise difficult for the body to absorb, Eastman Vitamin E TPGS is safe for oral consumption and is already used as a pharmaceutical excipient in Europe and the US. Oral delivery methods enhance drug efficacy by improving the solubilisation or emulsification of the drug in the finished dosage form and/or through formation of a self-emulsifying drug delivery system (SEDDS) in the stomach, and studies have shown that in some instances they can improve the permeability of a drug across cell membranes by inhibiting P-glycoprotein (P-gp), thus enhancing absorption of a drug through the intestinal wall and into the bloodstream. It has been formulated in various oral drug applications, including immunosuppressants, HIV protease inhibitors and anti-cancer drugs.

'The approval in Japan is a significant milestone for pharmaceutical manufacturers, as pharmaceutical companies operating worldwide can now commercialise products in Japan using this drug delivery technology,' said Dr. Julian Parratt, pharmaceutical business development manager, Eastman Europe.