Abstract：
:Next to the coating formulation, process conditions play important roles in determining coating quality. This study aims to develop an operational window that separates layering from agglomeration regimes and, furthermore, the one that leads to the best coating quality in a fluidized bed coater. The bed relative humidity and the droplet size of the coating aerosol were predicted using a set of engineering models. The coating quality was characterized using a quantitative image analysis method, which measures the coating thickness distribution, the total porosity, and the pore size in the coating. The layering regime can be achieved by performing the coating process at a certain excess of the viscous Stokes number (DeltaSt(v)). This excess is dependent on the given bed relative humidity and droplet size. The higher the bed relative humidity, the higher is the DeltaSt(v) required to keep the process in the layering regime. Further, it is shown that using bed relative humidity and droplet size alone is not enough to obtain constant coating quality. The changes in bed relative humidity and droplet size have been identified to correlate to the fractional area of particles sprayed per unit of time. This parameter can effectively serve as an additional parameter to be considered for a better control on the coating quality. High coating quality is shown to be achieved by performing the process close to saturation and spraying droplets small enough to obtain high spraying rate, but not too small to cause incomplete coverage of the core particles.
journal_name
AAPS PharmSciTechjournal_title
AAPS PharmSciTechauthors
Laksmana FL,Hartman Kok PJ,Vromans H,Frijlink HW,Van der Voort Maarschalk Kdoi
10.1208/s12249-009-9250-1subject
Has Abstractpub_date
2009-01-01 00:00:00pages
732-42issue
3issn
1530-9932journal_volume
10pub_type
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