Granulation is the process of converting fine powders into larger granules that are more easily compressed. It is an important unit operation for tablet or capsule production to ensure consistent bioavailability, increase blend density, improve compatibility to processing techniques such as compaction and filling, and improve product appearance. Because granulation results in dust-free granules, there is also reduced exposure to dusts and process-related hazards.
A 2015 review by Shanmugam is an excellent introduction to the variety of techniques used to produce granules. Granulation processes fall into two broad categories: wet granulation or dry granulation. Wet granulation uses a liquid to produce granules of excipient and API, and this can be achieved using a variety of equipment such as mixers, fluidized beds, compactors, or twin-screw granulators. Even though wet granulation has additional steps of drying and screening, it has excellent content uniformity for low potency API’s, and is more widely used than dry granulation.
As an important step in oral solid dose manufacturing, wet granulation approaches and technologies are constantly evolving to improve the process. It is a complex process with Critical Quality Attributes (CQA) that span chemical properties of composition, stability, and crystallinity and physical properties of content uniformity, granule size distribution, density, hardness, moisture, and compressibility. Critical Process Parameters (CPP) that influence the CQA’s are shear rate, duration of processing, the decision to use wet or dry granulation, and excipient choice. Control strategies for granulation focus on using Process Analytical Technology (PAT) to monitor and adjust CQA’s and CPP’s in real time. Blend uniformity and granule size distribution are the CQA’s most frequently measured by spectroscopic PAT. Integration of PAT to granulation equipment for measurement of content uniformity and granule size distribution has measurement-based considerations including sampled volume, speed of measurement, and risk of wet particle adhesion on the probe window. The ability to integrate consistent sample introduction and hands-free automated window cleaning improves content uniformity measurements and supports process intensification strategies.
The µSolis™ device was designed to collect samples from a powder or granule stream, create a uniform volume for presentation to a spectroscopic PAT probe, and then wipe the material away from the probe window. The µSolis™ integrates at the output of industry-leading granulation equipment including for blend uniformity measurements at the output, with potential to divert out of specifications blends.
The Rado™ can be installed inside granulators for in-situ spectroscopic measurements without probe fouling.
Continuous OSD
Our process interfaces and process simulators support inline PAT measurements across the entire CM OSD train.
Blending
Real-time BU prediction for R&D (RTD) and manufacturing (out of spec diversion) through representative sampling enabled by uSolis™.
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