Fluidised bed granulation processes enable the conversion of fine, poorly-flowing tableting blends into a granulated feed that performs well in the tablet press. Such processes are complex, with mixing, wetting, granule growth and drying all taking place within the same piece of equipment. As a result it can be difficult to control the properties of the exiting granules, which are influenced by a number of factors, including raw material quality, processing conditions and design features of the processing equipment. Granulation scale-up is widely recognised as being particularly challenging.
The Quality by Design (QbD) approach, now widely adopted across the industry and required by regulators for generic submissions, calls for a detailed understanding of the factors that influence the Critical Quality Attributes (CQAs) of a finished tablet. These CQAs include dose uniformity, hardness and stability – parameters that can only be measured post-tableting. In contrast, granule size, which has been shown to correlate directly with certain CQAs, enables measurement much earlier in the tablet production process1. Granule sizing can therefore be extremely valuable for scoping the design space of a granulation process and for achieving reliable scale-up.
This article looks at the benefits of replacing traditional sieve analysis with modern laser diffraction particle sizing and spatial filter velocimetry (SFV) techniques, to monitor and control granulation processes efficiently.
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