Efficient Scale-Up Strategy for Spray-Dried Amorphous Dispersions

October 16, 2013


DuBose, D.B., D.M. Settell, and J.M. Baumann, “Efficient Scale-Up Strategy for Spray-Dried Amorphous Dispersions,” Drug Dev. Delivery, 13:8(2013)54-62.


The increase in low-solubility drugs coming out of discovery labs has fueled the need for new formulation and processing approaches to address bioavailability challenges. Amorphous dispersions, manufactured using spray-drying and hot-melt extrusion, have emerged as a platform technology for mitigating bioavailability challenges. Spray-drying offers particular flexibility in formulation, because it allows use of polymers with high melting temperatures and offers rapid drying kinetics. The availability of small-scale spray-drying equipment and analytical techniques makes it possible to conduct feasibility and process-development work in a bulk sparing manner. In addition, the spray-drying process can be efficiently scaled from milligram to metric ton quantities and has demonstrated commercial viability, making this process broadly applicable in the development and commercialization of amorphous dispersions.

Previous articles contributed by Bend Research have focused on amorphous formulation selection and phase-appropriate formulation and process development approaches.1,2 This paper is focused on scale-up methodology for spray-dried dispersions (SDDs). Two critical focus areas guide scale-up: (1) atomization of the feed solution into droplets and (2) droplet drying. The following describes these focus areas and methodologies for efficient scale-up of the spray-drying process while maintaining the critical-to-quality attributes (CQAs) of the SDD.


Bioavailability Enhancement