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Optimization of the inter-tablet coating uniformity for an active coating process at lab and pilot scale
Sarah Just1, Gregor Toschkoff, Adrian Funke
1Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.
International Journal of Pharmaceutics
|September 24, 2013
Summary
Optimizing active coating processes for fixed-dose combination tablets using statistical design of experiments significantly improved coating uniformity. Key factors like spray rate and pan speed are crucial for consistent drug delivery of candesartan cilexetil and nifedipine.
Area of Science:
- Pharmaceutical Technology
- Process Engineering
- Drug Delivery Systems
Background:
- Fixed-dose combination (FDC) tablets offer improved patient compliance by combining multiple active pharmaceutical ingredients (APIs).
- Achieving uniform drug distribution in FDCs, particularly with APIs like candesartan cilexetil and nifedipine, is critical for consistent therapeutic efficacy and safety.
- Active coating processes require precise control to ensure inter-tablet coating uniformity.
Purpose of the Study:
- To enhance inter-tablet coating uniformity in an active coating process for FDCs containing candesartan cilexetil and nifedipine.
- To identify and optimize critical process parameters at both laboratory and pilot scales using statistical design of experiments.
- To ensure the developed active coating process meets pharmacopoeial requirements for uniformity of dosage units.
Main Methods:
- Statistical design of experiments (DoE) was employed to investigate process parameters.
- Lab scale experiments examined pan load, pan speed, spray rate, and number of spray nozzles.
- Pilot scale experiments investigated pan load, pan speed, spray rate, spray time, and spray pressure.
Main Results:
- A low spray rate and high pan speed were found to improve coating uniformity at both scales.
- The number of spray nozzles was the most influential variable at lab scale, with four nozzles yielding lower coefficient of variation (CV) values (2.3-6.4%) compared to two nozzles (4.5-13.4%).
- Pilot scale achieved CV values ranging from 2.7% to 11.1%, demonstrating process robustness.
Conclusions:
- The optimized active coating process effectively enhances inter-tablet coating uniformity for FDCs.
- The process parameters identified are suitable for achieving pharmacopoeial compliance (CV ≤ 6.25%) for uniformity of dosage units.
- This study provides a validated approach for scalable active coating of complex FDC formulations.
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