Real-time image-based investigation of spheronization and drying phenomena using different pellet formulations

Area of Science:

• Pharmaceutical Technology
• Process Analytical Technology (PAT)

Background:

• Extrusion-spheronization (ES) is crucial for pharmaceutical pellet production.
• Real-time monitoring of ES and drying processes is essential for quality control.

Purpose of the Study:

• To apply photometric stereo imaging for real-time characterization of pharmaceutical pellets during ES and drying.
• To evaluate the utility of imaging for assessing pellet size distribution, shape, and surface brightness.

Main Methods:

• Photometric stereo imaging was used at-line during spheronization and fluid bed drying.
• Pellet samples were analyzed at 20 time points during spheronization.
• Particle size distribution and surface brightness were calculated from images.

Main Results:

• Imaging provided real-time data on pellet size, shape, and surface brightness during spheronization and drying.
• Changes in particle size and brightness during drying correlated with moisture reduction and drug solid-state transitions.
• The technique enabled characterization of different formulations' behavior.

Conclusions:

• Photometric stereo imaging is a rapid and effective tool for real-time monitoring of ES and drying processes.
• This PAT approach provides valuable insights into pellet characteristics and formulation behavior.
• The method allows for the analysis of wet samples, offering comprehensive process understanding.