Engineered particles demonstrate improved flow properties at elevated drug loadings for direct compression manufacturing

[Display omitted] Optimizing powder flow and compaction properties are critical for ensuring a robust tablet manufacturing process. The impact of flow and compaction properties of the active pharmaceutical ingredient (API) becomes progressively significant for higher drug load formulations, and for...

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Bibliographic Details
Published in:International journal of pharmaceutics 2017-05, Vol.523 (1), p.133-141
Main Authors: Trementozzi, Andrea N., Leung, Cheuk-Yui, Osei-Yeboah, Frederick, Irdam, Erwin, Lin, Yiqing, MacPhee, J. Michael, Boulas, Pierre, Karki, Shyam B., Zawaneh, Peter N.
Format: Article
Language:English
Subjects:
Carboxymethylcellulose Sodium - chemistry
Cellulose - chemistry
Compaction profile
Flow function
Microscopy, Electron, Scanning
Particle morphology
Particle Size
Particle size distribution
Permeability
Powders - chemistry
Rheology
Silicon Dioxide - chemistry
Stearic Acids - chemistry
Tablets - chemistry
Technology, Pharmaceutical
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Summary:[Display omitted] Optimizing powder flow and compaction properties are critical for ensuring a robust tablet manufacturing process. The impact of flow and compaction properties of the active pharmaceutical ingredient (API) becomes progressively significant for higher drug load formulations, and for scaling up manufacturing processes. This study demonstrated that flow properties of a powder blend can be improved through API particle engineering, without critically impacting blend tabletability at elevated drug loadings. In studying a jet milled API (D50=24μm) and particle engineered wet milled API (D50=70μm and 90μm), flow functions of all API lots were similarly poor despite the vast difference in average particle size (ffc10) compared with the jet milled API blends. Investigation of the compaction properties of both wet and jet milled powder blends also revealed that both jet and wet milled material produced robust tablets at the drug loadings used. The ability to practically demonstrate this uncommon observation that similarly poor flowing APIs can lead to a marked difference upon blending is important for pharmaceutical development. It is especially important in early phase development during API selection, and is advantageous particularly when material-sparing techniques are utilized.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2017.03.011