Novel Non-Crystalline Materials Analysis: New Strategies to De-risk Amorphous Material Formulation D

The latest approaches for characterizing non-crystalline (amorphous) materials and determining physical stability under typical storage conditions. Amorphous forms consist of disordered arrangements of molecules that do not possess a distinguishable crystal lattice. Different forms of a drug substance can have different chemical and physical properties, including melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapor pressure, and density. These properties can have a direct effect on the ability to process and/or manufacture the drug substance and the drug product, as well as on drug product stability, dissolution, and bioavailability. Instability of non-crystalline materials is of particular concern to regulatory bodies within companies and national agencies.