Comprehensive tests are said to be underway on a scale version of the machine, built by Harro Hoefliger, that is designed to demonstrate the technology and generate valid data on specific pharmaceutical products which can be used in product license applications.
This first machine will be extensively run, thoroughly tested and commissioned and then installed in the Farmasierra facility in Madrid, Spain, in early 2005. Farmasierra is FMC's first choice European pharmaceutical contract manufacturer and the installation of the first machine will facilitate a programme of pharmaceutical product development in the NROBE technology.
NROBE was originally developed by BioProgress and consists of powdered drug being lightly compressed and enrobed between two films and sealed to provide a non-friable, coated dosage form.
It is now expected that the first full scale NROBE machine will then be ordered by FMC and delivered to Farmasierra during 2005 to enable full commercial production to commence.
Robin Mitchell, business director of the FMC BioPolymer business unit that is focusing on the commercialisation of the NROBE technology, said the company is now testing a range of pharmaceutical products on the first machine.
Benefits of the system are claimed to include improved dissolution of active versus conventional oral dosage forms; areduced requirement for problematic excipients; enabling moisture sensitive actives to be coated without using aqueous based coating systems; reduced formulation time; and improved manufacturing efficiencies
A demonstration of the technology is available here.