Powder blending is a critical step in pharmaceutical manufacturing that can impact product quality such as tablet tensile strength. This study utilized the Discrete Element Method (DEM) to investigate blending in a 5-liter mini-batch and a 2-liter Turbula blender. DEM parameters were calibrated using small-scale powder characterization tests, so that the particle behavior in the DEM simulations matches the measured behavior. The research explored the effects of blender designs and process conditions on blending and lubricant dispersion. A predictive model for tablet tensile strength was developed. The model takes the lubricant’s dispersion via the lubrication energy into account. The model is then used to predict the tablet tensile strength depending on the chosen process parameters, blending speed, duration, and fill level. DEM simulations enabled scaling between the two blenders, providing valuable insights for a semi-continuous manufacturing process based on mini-batch blending. The findings contribute to a deeper understanding of blending mechanics, offering potential enhancements in pharmaceutical manufacturing efficiency and product consistency.

• Research Center Pharmaceutical Engineering GmbH, Graz, Austria

• Pharmaceutical Technical Development Synthetic Molecules, F. Hoffmann-La Roche, Basel, Switzerland

• IPPT, Graz University of Technology, Graz, Austria

• API
• Oral Solid Dosage

1. Blender
2. DEM
3. Direct compression
4. Powder blending
5. semi-continuous process