Solubilising excipient gets green light in Japan

Related tags Pharmacology

Eastman Chemical Co's Vitamin E TPGS has been approved as a
pharmaceutical excipient for oral drug formulations in Japan by the
Japanese government's Ministry of Health, Labour and Welfare.

Eastman's Vitamin E TPGS ((d-alpha-tocopheryl polyethylene glycol 1000 succinate) is 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. Already used as a pharmaceutical excipient in Europe and the United States, Eastman Vitamin E TPGS has been formulated in various oral drug applications including immunosuppressants, HIV protease inhibitors and anticancer drugs. For example, the excipient is a key component in GlaxoSmithKline's HIV protease inhibitor Agenerase (amprenavir). Dr Julian Parratt, pharmaceutical business development manager at Eastman Chemical Company Europe, said: "Pharmaceutical companies operating worldwide can now commercialise products in Japan using this drug delivery technology." Approval of an excipient in all three of the world's top drug markets - North America, Japan and Europe - makes it easier for companies to develop drug products that use it because the same formulation can be filed for approval in each territory. For oral delivery, Eastman Vitamin E TPGS enhances 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. Studies have shown that in some instances Eastman Vitamin E TPGS functions to 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. External links to companies or organisations mentioned in thisstory: Eastman Chemical Company

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