| Abstract Scope |
Mechanical properties of the active pharmaceutical ingredient have significant impact on manufacturability and product quality of water-soluble solid oral dosage forms. Depending on the mechanical properties, molecular crystals can deform, chip, fragment and/or develop disorder due to external stress, impacting drug substance and/or drug product unit operations, and end-product attributes, stability and dissolution. This presentation will discuss methodology used in the characterization of mechanical properties of API by nanoindentation, the influence of crystal structure and intermolecular interactions on the mechanical properties, particle informatics tool that can be used to understand particle breakage and resulting surface chemistry, as well as the influence on powder properties and pharmaceutical unit operations, including agitated drying process, twin screw granulation and compression. |