A correction factor for bridging compaction simulator and different roller compactors

Area of Science:

• Pharmaceutical Engineering
• Chemical Engineering
• Materials Science

Background:

• Roller compaction (RC) is a crucial dry granulation method for large-scale pharmaceutical production.
• Developing RC processes on industrial equipment is impractical due to high material requirements.
• Compaction simulators (CS) offer a material-sparing alternative for laboratory-scale RC development.

Purpose of the Study:

• To establish a reliable method for translating compaction parameters from CS to RC.
• To identify a correction factor (Kp) to bridge the gap between uniaxial die compression pressure in CS and roll pressure in RC.
• To reduce uncertainties in critical quality attributes like ribbon solid fraction and mechanical strength during RC process development.

Main Methods:

• Correlating compressibility profiles from CS and industrial roller compactors.
• Determining a correction factor (Kp = uniaxial die compression pressure/roll pressure).
• Validating the determined Kp value across different roller compactor models.

Main Results:

• A Kp value of 0.5 was identified for the Alexanderwerk WP120.
• This Kp value was successfully validated for the Gerteis Mini-Pactor and Bepex Pharmapactor.
• The study demonstrated a more reliable translation of compaction pressure from CS to RC.

Conclusions:

• The identified Kp value serves as a valuable starting point for optimizing RC processes.
• This approach facilitates minor adjustments for achieving optimal roll force on various roller compactors.
• Improved process translation enhances the efficiency and reliability of pharmaceutical dry granulation development.