Development and application of a process window for achieving high-quality coating in a fluidized bed coating process.
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.
Laksmana
F L
FL
Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands. F.L.Laksmana@gmail.com
Hartman Kok
P J A
PJ
Vromans
H
H
Frijlink
H W
HW
Van der Voort Maarschalk
K
K
D000465:Algorithms; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D005079:Excipients; D006358:Hot Temperature; D006813:Humidity; D007091:Image Processing, Computer-Assisted; D010316:Particle Size; D016062:Porosity; D013608:Tablets, Enteric-Coated; D013696:Temperature; D014783:Viscosity
D005079:Excipients; D013608:Tablets, Enteric-Coated