By Dr. Timothy Aschl, Global Product Manager – Powder Rheology, Anton Paar
Ensuring the usability of pharmaceutical powders is an integral but taxing part of the drug manufacturing process. Multiple factors may affect the physical and chemical characteristics of powders and the subsequent quality of the drug products made from them. Caking is one such effect, and a well-known problem in the industry.
Translational shear cell testing can be used to understand how and why caking occurs and how to prevent it. However, it is notoriously time-consuming. It also often fails to consider humidity and temperature – two factors that can have profound effects on other required testing, as well as powder storage, mixing, and processing, and the safety and efficacy of the final drug product. As a result, some companies have forsaken the practice, which may be costing them more time and money in the long run.
Technological advancements in ring shear cell testing equipment have shortened the process exponentially, while recently also accounting for humidity and temperature. The ability to test more quickly and accurately, and subsequently implement better-informed powder management practices, should entice companies who shied away from it to reconsider their approach.