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Decoding Fine API Agglomeration as a Key Indicator of Powder Flowability and Dissolution: Impact of Particle
Sangah Kim1, Mirna Cheikhali1, Rajesh N Davé2
1New Jersey Center for Engineered Particulates, New Jersey Institute of Technology, Newark, New Jersey, 07102, USA.
Pharmaceutical Research
|June 13, 2022
Summary
Dry coating fine powders significantly reduces agglomeration, improving flowability, bulk density, and drug dissolution. This particle engineering technique enhances powder processability and dissolution rates for BCS Class II drugs.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- Fine Active Pharmaceutical Ingredient (API) agglomeration poses challenges in powder processing.
- Particle engineering, specifically dry coating, offers a potential solution for mitigating API agglomeration.
- The impact of dry coating on powder processability and dissolution of cohesive APIs is not well understood.
Purpose of the Study:
- To investigate API agglomeration before and after dry coating.
- To assess the impact of dry coating on powder processability, including flowability and bulk density.
- To evaluate the effect of dry coating on the dissolution rates of BCS Class II drugs.
Main Methods:
- Assessed ibuprofen, fenofibrate, and griseofulvin (5-20 µm) before and after dry coating with hydrophobic (R972P) or hydrophilic (A200) nano-silica.
- Evaluated agglomeration, flowability (FFC), bulk density (BD), surface energy, wettability, and dissolution.
- Utilized the granular Bond number (Bog) to quantify powder cohesion through particle-scale measures and contact models.
Main Results:
- Dry coating significantly improved powder processability: FFC increased, BD rose by 25-100%, and the agglomerate ratio (AR) decreased by over an order of magnitude.
- Enhanced API dissolution rates were observed, even with hydrophobic silica coating.
- A power-law correlation was established between AR, Bog, FFC, and BD, with AR below 5 indicating improved processability and dissolution.
Conclusions:
- API agglomeration is a critical indicator of powder processability and dissolution.
- Dry coating effectively reduces agglomeration, enhancing powder characteristics and drug dissolution.
- Reduced agglomeration post-dry coating counteracts potential negative impacts of increased surface hydrophobicity on dissolution.
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