Solid form screening is an integral part of many pre-formulation research and development activities at various companies, including screening of polymorphs, salts, cocrystals, amorphous and amorphous dispersions. It is well documented that the molecular packing of both the active substance and excipients in the solid state influences the pharmaceutical efficacy of drugs. On the one hand, the diversity of solid forms increases and on the other, it is used as a key element in product design, including single-component and multi-component systems. This highlights the importance of very carefully characterizing the composition of the solid form of the drug. At the same time, the rapid development of solid-state analytical instruments, data analysis, computational methods, and process analysis techniques made it possible to more accurately characterize the solid substance as part of complex dosage forms. An essential part of risk-based drug development is an early discovery of the ideal solid form based on clinical significance. All these developments suggest that understanding the diversity of solid forms and choosing the most informative and useful solid-state analytical methods play an important role in the overall drug development process. This paper critically addresses these challenges and highlights the elements that are important for viable and meaningful analytical characterization. Read the whitepaper to learn more.
