Making Tablets From Potent APIs: Selecting The Appropriate Technology

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Continuous lines such as GEA’s Consigma (option 3) offer a good alternative to conventional batch systems. The only potential problems are, first, that most existing recipes have been developed for batch machines, and, second, that automatic cleaning for existing continuous granulation and drying systems is not yet a proven technology. Continuous systems do offer significant advantages, however, so it is a good idea to watch for future developments.

The ideal solution for the granulation of potent API is offered by the single pot (option 4). This combines the process advantages of a high-shear granulator with minimal surface area and a built-in opportunity for CIP to provide extremely fast changeover.

After granulation, the outer phase needs to be added. This is easiest if the dry granules are discharged via an integrated dry mill into an IBC. After the addition of the outer phase a homogeneous mix is achieved by tumbling the IBC in a container blender. This IBC can also be used to feed the tablet press.

For compression of potent materials GEA’s Modul range of tablet presses offers an unbeaten solution.

* The author is Senior Pharmaceutical Technologist, GEA Pharma Systems, Hürth/Germany.

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