present on P V proteins of the paramyt...|gentaur.com>Pk TAG present on P V proteins of the paramyt...|gentaur.com
Continuous oral solid dosing processes are combined in the Xelum production platform to streamline manufacturing.
Bosch’s device combines charging, dosing of several ingredients, and blending with granulation, drying, and discharging in one unit.
Fritz-Martin Scholz, Xelum product manager at Bosch, told us that the biggest challenge of continuous production systems is the precise dosing of the starting materials.
“Active ingredients and excipients have to be continuously dosed in a constant mass flow rate of milligrams per second. However, all available dosing systems show fluctuations over time. Back mixing is the only way to compensate for these fluctuations, which broadens the product’s residence time distribution in the system, making traceability more difficult,” said Scholz.
He further explained that the Xelum device has what is known as the X-key approach, which allows active ingredients and excipients to be dosed as discrete masses and not as continual mass flow, meaning even the smallest amounts of active ingredients can be precisely dosed.
“Failure susceptibility is reduced by the step-by-step dosing and mixing of the X-key packages. They continuously run through the process chain and are removed successively,” Scholz told us.
The Xelum platform also relies on fluid bed processors, according to Scholz who said that usually platforms like Xelum use twin screw granulators. In the fluid bed, granulation and drying take place in the same process chamber – eliminating the need to transfer wet granulate, which positively affects the systems’ reliability.
Scholz also said that with this platform, “scale-up becomes obsolete, which reduces development time and API usage, since scale-up tests are no longer necessary.”
According to Bosch, the Xelum R&D solution was launched at Achema 2018 in Frankfurt, Germany, where it was presented to selected customers only. At CPhI in Madrid it is on open display for the first time and is shortlisted for the CPhI Pharma Award.