A correction factor for BRIDGING compaction simulator and different roller compactors

Area of Science:

• Pharmaceutical Sciences
• 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 development, using only grams of material.

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 process scale-up.

Main Methods:

• Correlating compressibility profiles from CS and industrial roller compactors.
• Determining a Kp value by comparing uniaxial die compression pressure to roll pressure.
• Validating the determined Kp value across different roller compactor models (Alexanderwerk WP120, Gerteis Mini-Pactor, Bepex Pharmapactor).

Main Results:

• A consistent Kp value of 0.5 was identified for translating CS data to roller compactor performance.
• This Kp value facilitates more accurate prediction of ribbon solid fraction and mechanical strength.
• The study demonstrated the Kp value's applicability across multiple commercial roller compactor systems.

Conclusions:

• The identified Kp factor enables more reliable and efficient formulation and process development for roller compaction using a material-sparing approach.
• This method significantly reduces scale-up uncertainties and optimizes the development of pharmaceutical granules.
• The Kp value serves as a valuable starting point for optimizing roller compaction processes on various equipment.