European Journal of Pharmaceutics and Biopharmaceutics 2014-11-01

In-line spatial filtering velocimetry for particle size and film thickness determination in fluidized-bed pellet coating processes.

Friederike Folttmann, Klaus Knop, Peter Kleinebudde, Miriam Pein

Index: Eur. J. Pharm. Biopharm. 88(3) , 931-8, (2015)

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Abstract

A spatial filtering velocimetry (SFV) probe was applied to monitor the increase in particle size during pellet Wurster coating processes in-line. Accuracy of the in-line obtained pellet sizes was proven by at-line performed digital image analysis (DIA). Regarding particle growth, high conformity between both analytical methods (SFV/DIA) was examined for different coating processes. The influence of ring buffer size and the process of filling the buffer were investigated. With buffer sizes of 30,000-50,000 particles best results were obtained in this study. Investigated process parameters, such as inlet air volume and spray rate, had different effects on the impact of the SFV probe. While the particle rate (the number of particles detected by the SVF probe per second) was highly dependent on the inlet air volume, different spray rates of up to ・}1 g/min did not affect the detected particle growth. Artefacts and delays in SFV particle sizing appeared especially at the beginning of the coating processes. The slope of the particle growth during the final spraying period was therefore used to determine coating thickness.