At Achema 2018 in mid-June at Frankfurt, Bosch Packaging Technology will introduce its latest R&D device for the continuous production of oral solid dosage (OSD) forms. The platform ensures a short time to market and optimum dosing of active pharmaceutical ingredients (APIs). “The new laboratory device is based on our Xelum production platform that we presented last year,” says Fritz-Martin Scholz, product manager at the Bosch subsidiary Hüttlin. “The separated process steps of batch production take place one after the other and without interruption. This leads to shorter cycle times, lower production costs and high flexibility.” With the Xelum R&D, Bosch offers a platform that offers an ideal start to continuous manufacturing.
Precise and reliable dosing
As opposed to the common complex mass flow rate, excipients and active ingredients are dosed as a discrete mass in the Xelum R&D. This makes it possible to dose even smallest amounts of APIs of less than 1%. The system doses, mixes and granulates individual packages, so-called X-keys, which continuously run through the process chain and are removed successively from the machine as packages into bins. “This way we reduce not only process complexity, but also the system’s failure susceptibility, while increasing both accuracy and quality of the end product. Moreover, the product is traceable at all times,” says Scholz. Depending on requirements, up to four loss-in-weight feeders can be used.
Since the Xelum R&D uses the same components for dosing, mixing and granulating as the Xelum production platform from Bosch, process parameters are identical and can be directly transferred 1:1. “Scale-up becomes obsolete, which reduces development time and API usage, since elaborate tests are no longer necessary,” Scholz explains. Material flow from dosing to emptying takes place in a closed process (bin-to-bin) to ensure the highest safety.
The benefits of the fluid bed
Current continuous production systems for wet granulation mostly use twin screw granulators. The Xelum system relies on fluid bed processors – based on a proven technology developed by the Bosch subsidiary Hüttlin. In the fluid bed, granulation and drying take place in the same process chamber. “This eliminates the need to transfer wet granules, which in turn has a positive effect on the system’s reliability,” Scholz emphasizes. Pharmaceutical manufacturers obtain granulates with the desired characteristics – including unimodal particle size distribution, as well as excellent flow and tableting properties combined with high production yields.
The controls of the Xelum R&D correspond to a modern production system. All relevant process parameters are continuously recorded. Both the production and the product transfer, as well as the cleaning process are recipe-controlled and ensure reproducible results. The user-friendly handling of the system is complemented by a DoE (Design of Experiment) software support. Bosch Packaging Technology will be at Achema in Hall 3.1 Stand C71