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Early detection of capping risk in pharmaceutical compacts
Xiaochi Xu1, Chaitanya Krishna Prasad Vallabh1, Stephen W Hoag2
1Photo-Acoustics Research Laboratory, Department of Mechanical and Aeronautical Engineering, Clarkson University, Potsdam, NY 13699-5725, USA.
International Journal of Pharmaceutics
|October 28, 2018
Summary
Ultrasonic testing detects tablet capping risks before visible damage occurs. This non-destructive method analyzes mechanical properties and acoustic waves to predict defects during pharmaceutical manufacturing.
Area of Science:
- Pharmaceutical Manufacturing
- Materials Science
- Non-destructive Testing
Background:
- Capping is a prevalent mechanical defect in tablet production, impacting product quality.
- Predicting capping based on process variables and formulation is crucial for the pharmaceutical industry.
Purpose of the Study:
- To present a non-destructive contact ultrasonic approach for detecting capping risk in pharmaceutical compacts.
- To identify early indicators of invisible capping using extracted mechanical properties.
Main Methods:
- Utilized a contact ultrasonic approach on pharmaceutical compacts.
- Analyzed X-ray cross-section images and acoustic waveform data.
- Correlated ultrasonic properties with measured porosity and tensile strength.
Main Results:
- Extracted mechanical properties serve as early indicators for invisible capping.
- Acoustic wave propagation is significantly modulated by internal cracks and capping at high compaction speeds/pressures.
- Quantified the effects of compaction speed and pressure on compact properties and acoustic characteristics.
Conclusions:
- Ultrasonic testing can predict capping risk and monitor tablet mechanical integrity.
- This method aids in defining manufacturing design spaces and reducing quality variations.
- Applicable for online monitoring in continuous tablet manufacturing.
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