(366c) Drug Product Continuous Powder Feeding for Low-Percentage Formulation Components

Drug product formulations typically contain low-percentage components, such as lubricants, glidants, disintegrants and sometimes drug substance. For continuous manufacturing these materials require relatively low mass feed rates. Low-end limitations of twin-screw feeders commonly used for cDC led to the investigation of a novel feeding device that uses brief, frequent pulses of compressed gas to temporarily fluidize and propel powder through a narrow, adjustable gap. For cDC relevance, the device was outfitted with an appropriately sized hopper, and additional modifications were made including vibration and agitation to disrupt powder bridging. A series of experiments were conducted with common low-percentage pharmaceutical excipients, and additionally with cohesive drug substance. An initial target of 60 grams per hour was identified which most materials could achieve, and some materials were able to be fed below 10 grams per hour. Preliminary results are promising; however, additional development of this technology is needed prior to integrating into a continuous manufacturing process train.