How To Make Tablets From Potent APIs

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Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

TRM Filter d.o.o.

GEA Pharma Systems AG

In this case, the entire material required for a batch is loaded into an IBC in the dispensing area, typically under a laminar-flow booth. The IBC is moved into the granulation area – where it’s docked using a split butterfly valve joint to (say) a discharge station. The raw material is then loaded into the granulator either by gravity or a vacuum conveyor, with a mill to remove lumps in between.

If a disposable solution is preferred, one answer is – the Hicoflex flexible container system from GEA Pharma Systems. Excipients are handled in a conventional container, while the API is weighed inside a glovebox, and then transferred via a funnel into a Hicoflex bag below. Both containers are connected via an integrated mill to the granulator inlet.

Granulator and Tablet Press

Various options exist for the granulation stage, but the use of potent APIs restricts the choice somewhat. Potent APIs generally mean that only a small percentage of the formulation is API, and such recipes are not well suited to dry methods such as roller compaction; the machines are difficult to build in a contained way, and there are often problems achieving an even distribution of the API.

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

• 1. an integrated line consisting of a highshear granulator and a fluid bed

• 2. fluid bed spray granulator

• 3. continuous granulation and drying

• 4. single-pot processing

Advantage of option 1 is – it allows the most efficient granulator to be combined with the most efficient dryer to achieve high throughput. High-shear granulation also avoids issues with material separation that can be challenging when micronized APIs are used. Another advantage is the robustness of the granulation process, which provides (say) 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 needs a high-quality granulator. Systems with good impellers, ensure fast and even distribution of the granulation liquid. This avoids problems of uneven drying and long time to mill the granules after drying.

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