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Published on: July 4, 2014
Investigating dissolution performance critical areas on coated tablets: a case study using terahertz pulsed imaging.
Louise Ho1, Ronny Müller, Cornelia Krüger
1School of Pharmacy, University of Otago, PO Box 56, Dunedin, New Zealand. lchh2@cam.ac.uk
Journal of Pharmaceutical Sciences
|July 2, 2009
Summary
Identifying weak spots in tablet film coatings is crucial for product quality. Terahertz pulsed imaging (TPI) effectively located these critical areas, revealing thinner coatings and rougher surfaces on the central band, which impacted dissolution performance.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Process Analytical Technology
Background:
- Film coating quality is critical for tablet performance and dissolution.
- Weak spots in tablet coatings can significantly compromise product batch quality and efficacy.
- Understanding coating uniformity is essential for successful pharmaceutical manufacturing.
Purpose of the Study:
- To investigate the utility of terahertz pulsed imaging (TPI) for identifying weak spots in tablet film coatings.
- To correlate identified coating defects with tablet dissolution performance.
- To evaluate TPI as a non-destructive tool for process development in tablet coating.
Main Methods:
- Utilized circular, biconvex tablets for the study.
- Employed terahertz pulsed imaging (TPI) to analyze film coating characteristics.
- Conducted dissolution tests to assess the impact of coating variations on drug release.
Main Results:
- TPI identified the tablet central band as having the thinnest coating, lowest density, and highest roughness.
- Dissolution tests confirmed the central band's coating as the rate-limiting factor for drug release (MDT 7.4 h vs. 10.4 h).
- TPI demonstrated its capability to detect critical coating defects non-destructively.
Conclusions:
- Terahertz pulsed imaging (TPI) is a valuable non-destructive technique for identifying weak spots in tablet film coatings.
- Coating uniformity, particularly in the central band, significantly influences tablet dissolution performance.
- TPI shows potential as a process analytical tool for optimizing tablet coating development.
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