Abstract
Spray drying can generate very fine powders for inhalable drugs and
improve the bio-availability of solid dosage drugs using amorphous solid
dispersion. However, spray drying is quite challenging to optimize and
scale up. Many interacting parameters have a considerable impact on the
product yield, residual solvent content, and particle size. We have
demonstrated a novel model-aided workflow to optimize and transfer the
process across three different Spray dryers for a sticky product. The
material produced in this work has a very low Glass transition
temperature resulting in adhesion of the product to the wall.
Mechanistic models and CFD models have been developed across three
different pieces of equipment. Mathematical models have been used to
understand & optimize the impact of operating conditions on the product
yield across the scale. The understanding developed using the workflow
has enabled the production of API with greater than 80% yield across
the scales.