(M1030-09-60) A Material Sparing Approach for Predicting Ribbon Solid Fraction at Diverse Roll Compaction Speeds

Purpose: Roller compaction is a critical step in the pharmaceutical manufacturing process, and understanding its nuances aids in optimizing product quality and manufacturing efficiency. This work presents a study on the modeling of pharmaceutical roller compaction process with a specific emphasis on applying the Johanson model and a progressive exploration of the effect of roller speed on final model prediction. This study aims to bridge the gap between theoretical predictions and practical manufacturing conditions, thereby improving the understanding of the process up to production scale.

Methods: In this study, we employed a systematic approach to examine the impact of various roller speeds on the variation of ribbon solid fractions. Microcrystalline cellulose (MCC), lactose, and their blends were compressed using a gap-controlled roll compactor at four different roll speeds. The ribbon solid fraction after elastic recovery was measured to determine the correction factor of Johanson model predictions on the solid fraction. Leveraging the Johanson model, precise control of roller speed facilitated the determination of corresponding dwell time for each roller speed setting. Separately, yield stress or plasticity for the studied blends was determined from the simulated ribbons.

Results: It was found that roll speed had notable influence on solid fraction variation depending on blend characteristics. Blends with higher plasticity was more sensitive to the roll speed and led to reduction in ribbon solid fraction with increasing roll speed. Interestingly, the correlation between Johanson model predicted correction factor and roll speed had a strongly linear relationship with the blend’s plasticity parameter (P_y). These results thus allow for different roll speeds as an input parameter in Johanson model to obtain accurate prediction of ribbon solid fraction with known plasticity property of the blend.

Conclusion: In conclusion, our findings not only underscore the value of the Johanson model for simulating roller compaction but also emphasize the crucial role of roller speed, demonstrating its direct impact on model prediction accuracy. This work has the potential to guide the development of more sophisticated and accurate models, enabling enhanced control and optimization in pharmaceutical manufacturing.

Dwell time calculated the pressure-time curve from Johanson's roller compaction model

Correction factor of Johanson's roller compaction model vs. the roller compaction dwell time under different type of materials

The slope and intercet of correction factor vs. The material's plasticity parameter (Py)