A first principle model for simulating the ribbon solid fraction during pharmaceutical roller compaction process

Solid fraction is a key intermediate product attribute which significantly affects the granule characteristics prepared in a roller compaction (RC) process. Implementing the quality by design (QbD) in pharmaceutical manufacturing requires quantitative insight into the impacts of process parameters and material properties on product attributes. Despite the efforts made towards modeling of RC process in pharmaceutical applications, the predictive capabilities of the current approaches still depend on model calibration using extensive experimental data.

Highlights
• Modeled Johanson’s equations for pharmaceutical roller compaction process.

• Developed a material profiling workflow for model parameter determination.

• Established a global pressure range to measure powder compressibility coefficient.

• Validated the model predictive capabilities with historical roller compaction data.

• Predicted the process space design for the target solid fraction of new compounds.

In this paper, a practical approach is presented that incorporates the process parameters and material properties into a set of first principal equations based on Johanson’s theory. A material profiling procedure was devised in order to fully capture the powder behavior during roller compaction. The results showed that the model is capable to predict the solid fraction with a relative error of 1–7%. This approach may help expedite development timeline and reduce material usage while improving efficiency. Continue on a first principle model for simulating the ribbon solid fraction during pharmaceutical roller compaction process