Formulation and Quality – Chemical
2019 PharmSci 360
Much of our research focuses on using synchrotron X-ray Pair Distribution Function (SXPDF) techniques to probe atom-atom distances in amorphous materials and dispersions. Not all amorphous materials are equivalent, and the PDF patterns reflect the degree of disorder in the materials. SXPDF can provide important regulatory information regarding the sameness of various formulations or lots prepared using different techniques (e.g. spray drying and melt extrusion). SXPDF can also detect neighboring drug molecules in a drug-polymer dispersion. If present, the dispersion is more likely to crystallize as compared to dispersions where no drug domains are detected. This information is extremely important, especially when assessing the risk of a formulation undergoing unwanted changes during manufacturing, scale-up, or storage. We will present data for the examples noted above, as well as our latest research advances in this area.