Quantitative Measures of Crystalline Fenofibrate in Amorphous Solid Dispersion Formulations by X-Ray Microscopy.

In the pharmaceutical industry, amorphous solid dispersion can be utilized to enhance the solubility, hence bioavailability, of poorly solubility active pharmaceutical ingredients owing to the higher free energy of the amorphous state. Measuring the concentration, size and spatial distribution of crystalline API particles that may be present in amorphous solid dispersions (ASD) is critical to understanding product performance and developing improved formulations. In this study X-Ray Microscopy (XRM) was used to nondestructively measure these attributes in ASDs.