Non-Crystalline (Amorphous) Materials Characterization, Stability Prediction, Development

Non-Crystalline (Amorphous) Materials Characterization, Stability Prediction, Development

We offer specialized characterization and development services for non-crystalline (amorphous) materials, helping you tackle the challenges of poor solubility and bioavailability in active pharmaceutical ingredients (APIs). Through advanced techniques like spray drying, hot melt extrusion, cryogrinding, and particle engineering, we guide the development of amorphous dispersions that enhance the dissolution rate and stability of challenging compounds. Our expertise includes determining the amorphous nature of materials, assessing chemical and physical stability, and identifying potential crystallization risks, using cutting-edge tools such as Total Diffraction Analysis and in-house analytical software based on Debye diffraction theory. With our state-of-the-art methodologies, we also evaluate the degree of API mixing within carrier matrices, ensuring optimal stability for amorphous dispersions while aiding in regulatory alignment for FDA filings with cGMP testing. By partnering with us, you gain a science-driven approach to solid-state amorphous systems that optimizes formulation design, mitigates risks, and accelerates the market readiness of your products.