Manufacturing and Bioprocessing
2019 PharmSci 360
Spray-drying is an established platform to manufacture solid dispersions of active pharmaceutical ingredients yielding enhancements in bioavailability of many poorly water soluble bioclassification system II (BCSII) pharmaceuticals. The development of a spray-dried dispersion (SDD) intermediate consists of four-unit operations: 1) spray solution preparation, 2) solution atomization/spray-drying, 3) spray-dried powder collection and 4) residual solvent removal. This last process is also known as secondary drying. Control over this process ensures the product meets ICH residual solvent requirements and minimizes the potential impact of residual solvents on the physico-chemical stability of the SDD. The objectives of this research are 1) to address the challenges associated with secondary drying a cohesive and poorly flowing SDD via an agitated dryer, 2) to introduce a solution to improve the SDD flowability by addition of SiO2 and 3) to present the opportunity to implement process analytical technology (PAT) on a SDD-SiO2 mixture with enhanced flow characteristics.