Scale-up of a DPI carrier-based formulation and blending process optimization

Ddry powder carrier-based formulation of a model active pharmaceutical ingredient (API), which includes coarse and fine lactose grades, is in development.
The initial development work was conducted at a small scale low-shear mixer in order to demonstrate proof of concept. A scale-up of the blending process was necessary to support clinical trials.
This work focuses on the blending process scale-up and optimization, which was performed according to a design of experiments (DOE) approach considering the following variables:

• particle size distribution (PSD) of the micronized API,
• blending time per step and
• API concentration.