Development and application of a process window for achieving high-quality coating in a fluidized bed coating process
| Autor: | Henderik W. Frijlink, Fesia L. Laksmana, Herman Vromans, P. J. A. Hartman Kok, van der Kees Voort Maarschalk |
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| Přispěvatelé: | Pharmaceutical Technology and Biopharmacy, Biopharmaceuticals, Discovery, Design and Delivery (BDDD) |
| Jazyk: | angličtina |
| Rok vydání: | 2009 |
| Předmět: |
Materials science
Hot Temperature porosity Bed relative humidity aerosol Chemistry Pharmaceutical Pharmaceutical Science Aquatic Science engineering.material Fluidized bed coating Stokes number Excipients Coating Drug Discovery Image Processing Computer-Assisted drug delivery system Process window Relative humidity Composite material quality control Porosity Ecology Evolution Behavior and Systematics Droplet size Chromatography Ecology Temperature article humidity Humidity food and beverages General Medicine particle size Aerosol process development Fluidized bed material coating viscosity engineering Particle size Tablets Enteric-Coated Agronomy and Crop Science Algorithms Research Article Coating quality |
| Zdroj: | Aaps pharmscitech, 10(3), 732-742. SPRINGER |
| ISSN: | 1530-9932 |
| Popis: | 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 (ΔStv). This excess is dependent on the given bed relative humidity and droplet size. The higher the bed relative humidity, the higher is the ΔStvrequired 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. © 2009 American Association of Pharmaceutical Scientists. |
| Databáze: | OpenAIRE |
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