Screening For Amorphous Drug Substance

In the pharmaceutical industry, “amorphous” is often used broadly to describe not only truly disordered materials with no long-range structure, but also disordered crystalline and microcrystalline solids. Despite this loose definition, amorphous forms have become increasingly important, with several APIs formulated this way to enhance performance.

Amorphous materials can offer dramatically higher solubility — sometimes up to 1600 times greater than their crystalline counterparts — potentially improving bioavailability. Because of these advantages, solid form screening should evaluate both crystalline and amorphous options.

An effective early-stage strategy involves three key steps: assessing API solubility, screening for viable amorphous forms, and evaluating their stability, all aimed at selecting the optimal form while reducing development time.