A modified mechanistic approach for predicting ribbon solid fraction at different roller compaction speeds.

Area of Science:

• Pharmaceutical Manufacturing
• Materials Science
• Chemical Engineering

Background:

• Roller compaction is vital for pharmaceutical production, but accurate modeling remains challenging.
• The Johanson model is a foundational tool for predicting compaction behavior.
• Predicting ribbon solid fraction is key to process control and drug product quality.

Purpose of the Study:

• To refine the Johanson model for roller compaction by incorporating roll speed and formulation effects.
• To improve the predictive accuracy of ribbon solid fraction in pharmaceutical manufacturing.
• To establish a mechanistic approach for optimizing roller compaction parameters.

Main Methods:

• Integrated a dwell time parameter into the classical Johanson model.
• Analyzed the impact of varying roll speeds (1-15 RPM) on ribbon solid fraction.
• Correlated model correction factors with powder mechanical properties (yield stress, elastic modulus).

Main Results:

• Developed a floating correction factor dependent on roll speed and formulation composition.
• Demonstrated a strong correlation between the correction factor and powder deformability (yield stress, elastic modulus).
• Validated the modified model with a multicomponent drug formulation, showing minimal prediction differences (±0.4-1.3%).

Conclusions:

• The modified Johanson model offers precise prediction of ribbon solid fraction using mechanical properties.
• This approach enhances control and accuracy in pharmaceutical roller compaction.
• Provides valuable insights for optimizing late-stage pharmaceutical manufacturing processes.