Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an...

Area of Science:

• Pharmaceutical Manufacturing
• Materials Science

Background:

• Pellet production involves granulation, extrusion, and spheronisation, with granulation quality critically impacting final product characteristics.
• Optimal liquid requirement in wet granulation is a crucial parameter, but often difficult to determine early in the process.

Purpose of the Study:

• To identify an alternative parameter for predicting optimal liquid requirements in wet granulation.
• To ensure high-quality pellet production through improved process control.

Main Methods:

• Experiments were conducted using lactose and microcrystalline cellulose formulations.
• Granules were analyzed using a Powder Vertical Shear Rig to determine compression density (ρpress).
• Compression density was correlated with powder properties and moisture content.

Main Results:

• Compression density (ρpress) was identified as a reliable alternative parameter for predicting liquid requirements (R² = 0.995).
• This predictive capability was validated for unknown formulation compositions.
• High-quality pellets with desirable shape and size distribution were successfully produced.

Conclusions:

• Compression density (ρpress) effectively predicts liquid requirements, streamlining the pellet manufacturing process.
• The applicability of ρpress was demonstrated for both placebo and active pharmaceutical ingredient (API) formulations.
• This finding offers a valuable quality control metric for pharmaceutical pellet production.