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Simultaneous Comparison of Two Roller Compaction Techniques and Two Particle Size Analysis Methods.

Tuomas Saarinen¹, Osmo Antikainen², Jouko Yliruusi²

¹Faculty of Pharmacy, Division of Pharmaceutical Chemistry and Technology, University of Helsinki, P.O. Box 56, Viikinkaari 5E, 00014, Helsinki, Finland. tuomas.saarinen@helsinki.fi.

AAPS Pharmscitech

|May 26, 2017

Summary

Gas-assisted roller compaction (GARC) produced larger granules with better flowability than conventional roller compaction (CRC). Sieve analysis (SA) accurately characterized wide distributions, while the fast imaging technique (FS) was quicker but simplified results.

Keywords:

fast imaging particle size analysis flowability gas-assisted roller compaction microcrystalline cellulose roller compaction sieve analysis

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Area of Science:

Pharmaceutical Technology
Materials Science
Chemical Engineering

Background:

Dry granulation is crucial for powder processing in pharmaceuticals.
Conventional roller compaction (CRC) is a widely used granulation method.
Optimizing granulation processes requires understanding granule properties and analysis techniques.

Purpose of the Study:

To compare gas-assisted roller compaction (GARC) with CRC for granule production.
To evaluate the impact of process variables on granule attributes.
To assess the applicability of sieve analysis (SA) and fast imaging (FS) for particle size analysis.

Main Methods:

Manufactured 34 granulation batches using GARC and CRC.
Varied process parameters: roll pressure, roll speed, and sieve size.
Measured granule size and flow characteristics.
Compared SA and FS for particle size distribution analysis.

Main Results:

All produced granules were acceptable.
GARC granules were slightly larger and exhibited superior flowability (e.g., tablet weight variation ~2%) compared to CRC.
SA accurately determined wide/bimodal distributions, while FS provided narrower/unimodal distributions.
Both SA and FS estimated mean granule sizes effectively.
FS was significantly faster (2-3 orders of magnitude) than SA.

Conclusions:

GARC offers an advantageous alternative to CRC, yielding granules with improved characteristics.
The choice between SA and FS depends on the required accuracy and speed for particle size analysis.
Accurate granule characterization is essential for optimizing pharmaceutical manufacturing processes.