A collaborative research project between Freeman Technology and GEA Pharma Systems is progressing the development of continuous tablet manufacturing.
The two firms aim to identify metrics that provide a sound basis for the effective control of continuous manufacturing processes.
For the research GEA’s ConsiGma 1 continuous granulation unit is being used to produce granules for tableting, which are then characterised using Freeman Technology’s FT4 Powder Rheometer.
Direct correlations are observed between the flow properties of the granules and critical quality attributes of finished tablets, such as hardness. These correlations highlight the potential of dynamic powder testing as an at-line Process Analytical Technology (PAT) for continuous tablet manufacture.
Building on early success in applying powder flowability data to scope the design space for the ConsiGma 1, current goals are to establish links between wet granule flow properties and observed tablet weight variability at production speeds. Often sub-optimal granules are associated with low manufacturing speeds and/or high weight variability in the finished product. A partial aim of the current work is to show how dynamic powder characterisation can be used to optimise continuous granulation so as to avoid these problems.
Both companies are investing significant resource in the project and it is expected to deliver further substantive results over the next quarter.