Isochem highlights Vitamin E TPGS capacity

Isochem will have manufactured ten tonnes of the multi-purpose drug excipient vitamin E TPGS by the end of the year, marking the end of what it says has been a successful first 12 months of commercial scale production.

Vitamin E TPGS is widely used in the drug industry as a solubilizer to improve the bioavailablity of otherwise insoluble active pharmaceutical ingredients (APIs).

The compound’s other primary application is to enhance permeability of drug actives in solid dose formulations. For example, it is used in the manufacture of GlaxoSmithKline's (GSKs) HIV protease inhibitor Agenerase (amprenavir) to aid absorption and improve its therapeutic efficacy.

While pharmaceutical grade vitamin E TPGS is made by a number of chemicals firms, it was Eastman’s withdrawal from the market in late April that made the excipient an attractive proposition for organisations like Isochem and competitors such as China's Suzhou Textiles.

Additional capacity guarantees supply

Isochem, a subsidiary of French agrochemicals organisation Groupe SNPE, makes its version of vitamin E TPGS at its US Food and Drug Administration (FDA) approved good manufacturing practice (GMP) accredited facility in Gennevilliers, near Paris.

Company sales director Xavier Jeanjean told in-PharmaTechnologist.com that a major use of the product was in the formulation of the non-steroidal anti-inflammatory ibuprofen, but was unable to provide further details for reasons of commercial confidentiality.

Jeanjean said that: “Our experience as a manufacturer of pharmaceutical actives gives us some key advantages,” highlighting the optimised supply security and additional manufacturing capacity offered by a second cGMP accredited plant as a particular strength.

He explained that, as a result, Isochem can rapidly increase vitamin E TPGS output and keep pace with the changing demand of its customers, but declined to speculate on the future development of the market.