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Foam granulation: new developments in pharmaceutical solid oral dosage forms using twin screw extrusion machinery
M R Thompson1, S Weatherley, R N Pukadyil
1MMRI/ CAPPA-D, Department of Chemical Engineering, McMaster University, Hamilton, Ontario, Canada. mthomps@mcmaster.ca
Drug Development and Industrial Pharmacy
|November 17, 2011
Summary
Foam granulation in a twin screw extruder offers improved process stability and uniform wetting for pharmaceutical powder formulations. This continuous wet granulation technique uses less binder and maintains lower exit temperatures compared to liquid injection.
Area of Science:
- Pharmaceutical Technology
- Chemical Engineering
- Materials Science
Background:
- Continuous wet granulation is crucial for pharmaceutical powder formulations.
- Traditional liquid binder addition methods face challenges with uniform wetting and process control.
- Foamed binders offer potential advantages in liquid-to-solid ratios and distribution.
Purpose of the Study:
- To investigate foam granulation using a twin screw extruder as a novel continuous wet granulation method.
- To compare the performance of foam granulation against traditional liquid injection in a twin screw extruder.
- To evaluate process stability, granule properties, and energy consumption.
Main Methods:
- A twin screw extruder was configured for foam granulation.
- Granulation trials were performed on α-lactose monohydrate using a methylcellulose binder.
- Foam granulation was compared directly with liquid binder injection under various operating conditions (high powder output rates and screw speeds).
Main Results:
- Foam granulation demonstrated improved process stability and required less binder compared to liquid injection.
- The foam granulation process maintained low, stable exit temperatures, unlike liquid injection where temperatures increased with flow rate.
- Foam granulation resulted in more uniform wetting and larger granule growth, even when liquid injection produced dry powder.
Conclusions:
- Twin screw extruder-based foam granulation is a viable and advantageous continuous wet granulation technique for pharmaceutical applications.
- The method offers enhanced process control, improved granule characteristics, and reduced binder requirements.
- Foam granulation presents a promising alternative to conventional liquid binder addition methods in continuous manufacturing.
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