Granule size control and targeting in pulsed spray fluid bed granulation

Area of Science:

• Chemical Engineering
• Materials Science
• Pharmaceutical Technology

Background:

• Fluid bed granulation is a key process in pharmaceutical manufacturing.
• Controlling granule size is critical for drug product performance.
• Pulsed liquid feeding offers a novel approach to manipulate granulation outcomes.

Purpose of the Study:

• To investigate the impact of pulsed liquid feed on granule size.
• To enhance understanding of pulsed liquid feed for granule size targeting.
• To explore the influence of duty cycle and atomization pressure on granulation.

Main Methods:

• Utilized a laboratory-scale top-spray fluid bed granulator.
• Investigated pulsed liquid feed with varying duty cycle lengths and atomization pressures.
• Maintained constant liquid feed rate, amount, and inlet air temperature.

Main Results:

• Pulsed liquid feed significantly influenced granule size.
• Duty cycle length was critical, controlling intermittent drying and rewetting.
• Atomization pressure effects on granule size were dependent on relative humidity, linked to binder evaporation.
• Granule size could be controlled by adjusting duty cycle length, especially in higher humidity.

Conclusions:

• Pulsed liquid feed is an effective method for targeting granule size in fluid bed granulation.
• Duty cycle length is a key parameter for controlling granule nucleation and growth.
• This technique offers enhanced control over end-product particle attributes.