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Enhancing drug processibility through dry coating: Comparison at lab and pilot scales.
Siddharth Tripathi1, M Sebastian Escotet-Espinoza1, James Tarabokija1
1New Jersey Center for Engineered Particulates (NJCEP), New Jersey Institute of Technology, Newark, NJ, USA; Merck & Co., Inc., Rahway, NJ, USA.
Dry coating fine pharmaceutical powders with nano-silica improves powder flow and tablet quality. Surface area coverage-based silica amounts enhance properties more than the standard 1 wt%, showing potential for continuous manufacturing.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Chemical Engineering
Background:
- Dry coating fine pharmaceutical powders with nano-silica enhances bulk properties and blend processability.
- This technique shows potential for improving tablet manufacturing efficiency.
Purpose of the Study:
- Investigate industrial applicability of dry coating.
- Evaluate silica amount selection based on surface area coverage (SAC) versus 1 wt%.
- Assess continuous dry coating feasibility using a pilot-scale conical screen mill (comil-U10) versus lab-scale batch high-intensity vibratory mixer (HIVM).
- Examine downstream processing improvements via feedability and tabletability studies.
Main Methods:
- Tested six pharmaceutical powders (d50 ~ 3-35 microm) with varying silica amounts.
- Characterized powder properties using flow energy (FFC), Hausner's ratio, compressibility, and permeability.
- Evaluated continuous dry coating with comil-U10 and batch dry coating with HIVM.
- Assessed feedability and tabletability of dry-coated materials.
Main Results:
- SAC-based silica selection outperformed 1 wt% for bulk property enhancement.
- Flow energy (FFC) proved the most reliable flowability indicator.
- Comil processing improved flowability for three materials, though finer powders performed better with HIVM.
- Dry-coated materials exhibited superior feed rate stability and reduced flow variability.
- Tablets from dry-coated formulations showed improved quality compared to those with blended silica.
Conclusions:
- Scalable comil-based dry coating offers benefits for continuous tableting manufacturing.
- This method may eliminate the need for granulation.
- Optimizing silica amount via SAC is crucial for effective dry coating.
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