Catalent named as US Trokendi XR delivery tech supplier
The new drug - Trokendi XR – is an extended-release formulation of the drug topiramate, which was approved as a treatment for epilepsy by the US Food and Drug Administration (FDA) in August.
While details of the contract have not been disclosed it is understood that Supernus asked the New Jersey contractor to provide the delivery technology for Trokendi XR, which it originally developed using its own Microcontrol XR.
Catalent spokesman Nick Johnson told Outsourcing-pharma.com that: “The extended release properties of Trokendi XR result from the development of coated particles contained within the capsule.”
He explained that the coated particles slowly release the topiramate over an extended period, creating what he claims is “the first and only once-daily dose of this active ingredient.”
Johnson added that the delayed-release technology “is manufactured out of our Winchester, KY facility which specialises in fluid bed processing and other technologies relating to complex and controlled release dose forms including capsules and coated beads.”
In June, Catalent announced it had started work on a $35m (€26m) expansion plan that will add 90,000 sqft of manufacturing space dedicated to the production of controlled-release technology.
Johnson also confirmed that supplies of the drug already on US pharmacy shelves utilize the Catalent technology, explaining that: “Commercial supplies of Trokendi XR have already commenced under our agreement.”
News of the Catalent contract follows just a few weeks after Taiwan-based active pharmaceutical ingredient (API) manufacturer Scinopharm was unveiled as the ingredient supplier for the new product.
