Eastman to Manufacture Vitamin E TPGS NF Drug Solubilizer at Llangefni, Wales Plant
By the end of March, 2000, Eastman Chemical Co. (Kingsport, TN) will close down its Rochester, NY "distillation product industries" (DPI) fine chemical plant and move production of the last product made at Rochester, Vitamin E TPGS NF, to Eastman's Peboc Division in Llangefni, Wales. "Vitamin E TPGS NF is the last product being produced at Rochester," said excipients market manager David Wyatt. The first Vitamin E TPGS NF will roll off Peboc's production lines by early April, assuring a continuous supply of the excipient to pharmaceutical manufacturers. "Eastman has developed a comprehensive transition plan to ensure continuity of supply and allow our excipients customers a reasonable time to evaluate the new Peboc material," Wyatt added.
"Eastman announced last March that it was phasing out the DPI [Rochester] plant some time this year," said company spokeswoman Katherine Watkins. "Projected growth for products made in Rochester didn't warrant operating a separate facility," she added, so products made in Rochester were farmed out to Easman's other manufacturing facilities. The building and land housing the Rochester plant belong to Eastman Kodak. According to Watkins Eastman Chemical is considering options for disposing of the plant's equipment.
Vitamin E TPGS NF, d-alpha-tocopheryl polyethylene glycol 1000 succinate, is prepared by esterifying the acid group of crystalline vitamin E succinate with polyethylene glycol 1000, resulting in a type of nonionic surfactant: large, oily vitamin E residue attached to a highly water-soluble polyethylene glycol arm. As expected, the material solubilizes drugs and enhances their physiologic adsorption. According to studies Vitamin E TPGS NF's solubilizing properties can reduce the cost of administering expensive drugs.
VItamin E TPGS NF has been used as a thermal binder, binder for granulation using hot-melt extrusion, oxidation inhibitor and process aid for hot-melt extrusion, solubilizing agent (griseofulvin), and absorption enhancer (for HIV protease inhibitors).
April Target for Peboc Product
Material from Peboc is expected to be available in April 2000. New cGMP capacity has been installed at the facility and is currently being commissioned. To ensure supply continuity, Peboc has previously validated and produced vitamin E TPGS NF in an existing cGMP manufacturing area to back up the new facility.
The Peboc Division is Eastman's dedicated fine chemical facility in Europe for the production of cGMP fine and custom chemicals for the pharmaceutical industry. Recent site improvements include doubled cGMP capacity, remodeled and expanded quality control laboratories and a new 11,000-square-foot technology center comprising state-of-the-art laboratory suites.
Eastman has invested significant capital at Peboc Division to add capacity and enhance capabilities for R&D, manufacturing and scale-up of products used to full cGMP. In August 1998 a multimillion-dollar investment in a new cGMP plant came onstream, including catalytic pressure hydrogenation capability. The high-pressure Hastelloy batch autoclave extends long-established Eastman expertise in catalytic hydrogenation to the Peboc Division site. A second manufacturing facility refurbishment, scheduled for completion in first-quarter 2000, involves vitamin E TPGS production.
For more information: Katherine Watkins, Eastman Corporate Communications, PO Box 431, Kingsport, TN 37662. Tel: 423-229-3078. Fax: 423-229-1008.
By Angelo DePalma