By Bhupatsinh Vihol
The topic of pharmaceutical solids is broad and complex. The criticality of a thorough understanding of the solid-state physiochemistry of a new drug is unquestioned from a scientific, quality, and regulatory point of view. Even though chemical properties may remain the same in solid state, the compound may not always act in the same way. These differences could affect how a drug works in the human body. Appropriate instrumentation, analytical methods, and scientific expertise are necessary, not only to generate information during form screening, but also for troubleshooting problems that may arise with solid drug substance, finished dose production, and throughout the product’s life cycle.
Generally, a combination of advanced techniques is required to perform a rigorous solid-state characterization. This will utilize the higher-level principles of chemistry, physics, and mathematics. Beyond the obvious science, the secret to performing a thorough solid-state characterization involves, integrating all data that may be generated across various instruments at different laboratories and properly interpreting the collective data set to adjust the drug’s formulation. This requires a deft team of analytical scientists who bring with them the experience from working on a variety of formulations and new formulation technologies, as well as a wide array of instrumentation. It is also critical that these scientists have a strong command of manufacturing processes to proactively anticipate and mitigate the typical problems that arise not just at lab or pilot scale, but also in a commercial production environment.