Discrete Element Method to Understand Particle Behavior in Agitated Filter Dryers

Ahmed Taha, University of Illinois at Urbana-Champaign

Usage Details

In the pharmaceutical industry, the goal is to produce a drug product (DP) that is efficacious and safe for the patient in a cost-effective and timely manner.  To ensure this, a target product profile (TPP) is created to define the critical quality attributes (CQAs) of the DP that then guide the determination of the active pharmaceutical ingredient (API) CQAs.  For synthetically produced, small molecular weight drug substances, in particular those formulated in oral solid dosage forms, the CQAs include aspects related to both purity and chemical and physical stability as well as those associated with powder properties, which can affect DP processing and performance.  To ensure that the API CQAs are met, it is crucial to understand the impact of the processing parameters on these attributes.

Although a critical step of the synthesis compared to other unit operations, drying is often overlooked and not fully understood until later in the development cycle.  This frequently occurs since many of the issues are only discovered when manufacture occurs at larger scale or the process is transferred to a different equipment train.  Unfortunately, this approach carries high risk since the API drying step, which is normally the last step in the synthesis, can greatly impact the API CQAs.  To mitigate this risk, it is important to have a firm understanding of the impacts of the drying process parameters on the API CQAs early in the development process.