Challenges and opportunities in modeling pharmaceutical manufacturing processes

• Methods for modeling solids-based pharmaceutical processes are discussed.
• Recent advances in flowsheet modeling for pharmaceutical processes are described.
• A flowsheet model of a continuous feeding and blending process is presented.
• Flowsheet simulation results are compared with experimental findings.

The pharmaceutical industry currently faces economic and regulatory challenges associated with process development. Process modeling tools can play a role in developing robust and economically efficient manufacturing processes. However pharmaceutical companies have lagged behind other specialty chemical manufacturers in the adoption of these tools. This is in part due to the challenges associated with modeling solids-based processes. However recent advances in the modeling of particulate processes have created opportunities to apply process modeling tools, including flowsheet modeling, to pharmaceutical manufacturing processes. This work will provide an overview of the challenges associated with modeling particulate processes and discuss recent developments in pharmaceutical process modeling. In addition, a case study involving a continuous feeding and blending process will be presented where many of the modeling approaches discussed in this work are applied.