Related Experiment Video
Updated: May 13, 2026
09:16
Measurement of Particle Size Distribution in Turbid Solutions by Dynamic Light Scattering Microscopy
Published on: January 9, 2017
Real-time particle size analysis using focused beam reflectance measurement as a process analytical technology tool
Vijay Kumar1, Michael K Taylor, Amit Mehrotra
1College of Pharmacy & Health Sciences, Department of Pharmaceutical Sciences, Campbell University, 205 Day Dorm Road, Rm 105A, Buies Creek, NC 27506, USA.
AAPS Pharmscitech
|February 26, 2013
Summary
Focused beam reflectance measurement (FBRM) provided real-time particle size analysis for a continuous granulation process. FBRM data correlated significantly with sieve analysis, showing similar bimodal distributions, but process parameters did not impact particle characteristics.
Area of Science:
- Pharmaceutical Manufacturing
- Process Analytical Technology (PAT)
- Particle Engineering
Background:
- Continuous manufacturing processes offer advantages in pharmaceutical production.
- Process Analytical Technology (PAT) tools are crucial for real-time monitoring and control.
- Understanding particle size distribution (PSD) is vital for drug product performance.
Purpose of the Study:
- To implement Focused Beam Reflectance Measurement (FBRM) for inline, real-time particle size analysis.
- To establish the relationship between FBRM chord length distribution (CLD) and sieve-determined particle size distribution (PSD).
- To investigate the impact of granulator and mill operational parameters on granulation characteristics.
Main Methods:
- Utilized Focused Beam Reflectance Measurement (FBRM) for inline particle size analysis.
- Employed a central composite response surface statistical design to optimize process parameters.
- Performed nested sieve analysis for comparative particle size determination.
- Evaluated bulk density, tapped density, Compressibility Index, and Flowability Index.
Main Results:
- A significant correlation (R²=0.886, p<0.0001) was found between FBRM chord length and sieve particle size.
- Both FBRM and sieve analysis revealed similar bimodal particle size distributions across all batches.
- Granulator screw speed and mill impeller speed did not significantly affect CLD, PSD, or powder flow properties within the studied ranges.
Conclusions:
- FBRM is a viable PAT tool for real-time particle size monitoring in continuous granulation.
- The studied process parameters (granulator and mill speeds) showed minimal impact on the final granulation characteristics.
- Further optimization may require exploring a wider range of process parameters or different operational strategies.
