A solution for low-dose feeding in continuous pharmaceutical processes.

Continuous feeding of small quantities of powder is increasingly applied in pharmaceutical manufacturing. With that regard, what is crucial is not only the feasibility, but also the accuracy and stability. To enable stable processing, low amounts of various agents, e.g., lubricants, can be used. Even more important is the exact dosage of highly potent active pharmaceutical ingredients (APIs), which require feed rates within the range of grams per hour. Conventional feeders cannot supply powder at such rates, especially when the material properties are challenging. In this work, a novel micro-feeder was integrated into a continuous manufacturing line and its capability to supply API at feed rates down to one gram per hour was tested. The micro-feeder system is based on the principle of active volumetric displacement: a piston pushes the powder out of the cartridge upwards to the end of a plate, where a scraper places it into the process inlet. In this study, a hot melt extrusion process was used, during which the API was dissolved in a polymer matrix. Samples of the strand were analysed with regard to their content by means of HPLC. The results showed that the novel micro-feeder system can feed powder with good accuracy and reproducibility, indicating its high potential for continuous process implementation.