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Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
Published on: July 4, 2014
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100% visual inspection of tablets produced with continuous direct compression and coating
Shirin Barimani1, Rok Šibanc1, Dejan Tomaževič2
1Heinrich-Heine-Universitaet Duesseldorf, Institute of Pharmaceutics and Biopharmaceutics, Universitaetsstraße 1, 40225 Duesseldorf, Germany.
International Journal of Pharmaceutics
|January 13, 2022
Summary
Continuous tablet coating ensures consistent visual appearance. Automated inspection revealed minimal defects, demonstrating high process control and homogeneity in semi-batch drum coaters for pharmaceutical manufacturing.
Area of Science:
- Pharmaceutical Technology
- Process Engineering
- Quality Control
Background:
- Tablet visual appearance is critical for patient acceptance and is primarily determined by the coating layer.
- High process control and homogeneity are essential for consistent tablet coating.
- Continuous manufacturing trends necessitate compatible coating technologies.
Purpose of the Study:
- To evaluate the intra-lot and lot-to-lot variability of tablet coating using a semi-batch drum coater integrated with continuous production.
- To assess the effectiveness of automated 100% visual inspection in identifying coating defects.
Main Methods:
- Production of 180 kg of tablets via continuous direct compaction (25 kg/h throughput).
- Coating of tablets in 12 lots using a semi-batch drum coater.
- 100% visual inspection of all coated tablets (all 6 sides) using an automated inspection and sorting machine.
Main Results:
- Lot-to-lot variability was very low across all evaluated criteria.
- In the worst-case scenario, only 1 in approximately 300 tablets was rejected for color mismatch.
- Edge chipping defects were observed, highlighting potential limitations of routine sampling methods.
Conclusions:
- The semi-batch drum coater demonstrated excellent process control and homogeneity when integrated with continuous tablet manufacturing.
- Automated visual inspection effectively identified coating defects, although some mechanical defects like edge chipping may require further attention.
- The study confirms the feasibility of achieving consistent tablet quality in continuous manufacturing processes.
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