Making Tablets From Potent APIs: Selecting The Appropriate Technology

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Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

TRM Filter d.o.o.

As a result, wet granulation is preferred. There are four main options:

• 1. an integrated line consisting of a high-shear granulator and a fluid bed;

• 2. fluid bed spray granulator;

• 3. continuous granulation and drying; or

• 4. single-pot processing.

The advantage of option 1 is that it allows the most efficient granulator to be combined with the most efficient dryer to achieve high throughput. High-shear granulation also avoids any issues with material separation, which can be challenging when micronized APIs are used. Another advantage is the robustness of the granulation process which provides, for example, the ability to compensate for fluctuations in raw material quality by adjusting the process parameters.

A downside is the fact that this configuration typically involves a relatively long downtime during product changeover. It also requires a high-quality granulator. Systems with good impellers, for example, ensure rapid and even distribution of the granulation liquid. This avoids subsequent problems with uneven drying and extended time needed to mill the granules after drying.

Fluid bed spray granulation (option 2) is a single-pot operation, which is a huge advantage when handling potent substances. This process also creates material with high inter-granular porosity and excellent compression behavior. Using the FlexStream system developed by GEA Pharma Systems, granules also show excellent flow properties, ensuring homogeneous filling of the dies during compression. For cleaning, the filters can be wetted down and taken out with minimal risk of contaminating operators or the environment. The remaining part of the processor can be cleaned in place.

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