Investigation of the Dfferences in Material Properties Between Amorphous Dispersions Created By Conventional Methods and High-Shear Co-Precipitation

High-shear co-precipitation is a technique for the manufacturing of API-polymer amorphous solid dispersions, and is an alternative to the typical spray-drying and hot-melt extrusion processes. The technique relies on the rapid contacting of a solution of polymer and API with a common anti-solvent, resulting in a stable suspension where the precipitated amorphous solid dispersion is below its glass transition temperature.

In this work we present the characterization and analysis of a co-precipitated solid dispersion exhibiting significant differences in properties compared to equivalent dispersions, prepared via spray-drying and hot-melt extrusion. These differences extend across the full spectrum of “fundamental” characteristics, including morphology, true density, glass transition temperature and enthalpy, as well as indirect, “performance-based” properties, such as compactability and dissolution. A large collection of “orthogonal” techniques is brought to bear in the analysis of the material and the elucidation of the physical processes underlying these differences in properties.