Roller compaction scale-up using roll width as scale factor and laser-based determined ribbon porosity as critical...

Area of Science:

• Pharmaceutical Engineering
• Materials Science

Background:

• Mechanistic modeling of roller compaction for scale-up is complex.
• Traditional scale-up methods face challenges in maintaining consistent process conditions.

Purpose of the Study:

• To investigate an innovative equipment approach for roller compaction scale-up.
• To assess the scale-independence of ribbon porosity using fixed roll diameter and varying roll width.
• To establish reproducible process settings between development and commercial scales.

Main Methods:

• Utilized a non-destructive laser-based technique for at-line ribbon porosity measurement.
• Compared porosity data from small-scale (Mini-Pactor®) and large-scale (Macro-Pactor®) roller compactors.
• Validated laser technique against the established volume displacement oil intrusion method.

Main Results:

• Ribbon porosity was found to be scale-independent when comparing average porosities.
• Higher standard deviation in large-scale compactor porosity attributed to minor densification variations across roll width.
• Process settings (roll force, gap size) were directly transferable from Mini-Pactor® to Macro-Pactor®.

Conclusions:

• The proposed equipment approach ensures scale-reproducible ribbon porosity.
• Direct transferability of process settings facilitates smoother tech transfer from formulation development to commercial production.
• This method reduces the number of batches needed for commercial process parameter establishment.