Continuous twin screw granulation: Robustness of lactose/MCC-based formulations

Area of Science:

• Pharmaceutical Technology
• Chemical Engineering
• Materials Science

Background:

• Continuous twin screw granulation is advancing, but the influence of active pharmaceutical ingredient (API) properties on granule quality remains understudied.
• Understanding API impact is crucial for optimizing granulation processes and ensuring consistent product quality.

Purpose of the Study:

• To investigate the effect of diverse active pharmaceutical ingredient (API) properties on continuous twin screw granulation performance.
• To compare the behavior of API-containing formulations with a placebo formulation.
• To assess the potential of using a robust placebo and surrogate APIs in drug product development.

Main Methods:

• Four API formulations (5-10% drug load) with varied characteristics and a placebo (lactose, MCC, HPMC) were prepared.
• API selection involved material characterization and in silico descriptors.
• A design of experiments evaluated the impact of liquid to solid (L/S) ratio and screw speed.

Main Results:

• Formulations with diverse APIs showed similar response behavior and processability to the placebo at an optimized L/S ratio.
• The robust placebo formulation demonstrated comparable performance across different API types.
• APIs with similar properties exhibited predictable behavior at specific L/S ratios.

Conclusions:

• A robust placebo formulation can effectively represent API-containing formulations in continuous twin screw granulation, reducing development time.
• The use of surrogate APIs with similar properties can be a viable strategy in early-stage drug product development.
• These findings can expedite patient access to innovative medicines by streamlining the development process.