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AAPS PharmSciTech ; 18(1): 182-193, 2017 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-26935562

RESUMO

The aim of the present work was to develop a PAT strategy for the supervision of hot melt coating processes. Optical fibers were placed at various positions in the process chamber of a fluid bed device. Experiments were performed to determine the most suitable position for in-line process monitoring, taking into account such requirements as a good signal to noise ratio, the mitigation of dead zones, the ability to monitor the product over the entire process, and reproducibility. The experimental evidence suggested that the position at medium fluid bed height, looking towards the center, i.e., normal to particle movement, proved to be the most reliable position. In this study, the advantages of multipoint monitoring are shown, and an in-line-implementation was created. This enabled the real-time supervision of the process, including the fast detection of inhomogeneities and disturbances in the process chamber, and the compensation of sensor malfunction. In addition, a model for estimating the particle size distribution via NIR was successfully created. This ensures that the quality of the product and the endpoint of the coating process can be determined correctly.


Assuntos
Espectroscopia de Luz Próxima ao Infravermelho/métodos , Tecnologia Farmacêutica/métodos , Tamanho da Partícula , Reprodutibilidade dos Testes
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