How To Make Tablets From Potent APIs

Related Vendors

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

TRM Filter d.o.o.

GEA Pharma Systems AG

Fluid Bed Spray Granulation

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 intergranular porosity and excellent compression behaviour. 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.

Additional Information

Tablet Manufacturing

How To Make Tablets From Potent APIs

Zydus Cadila

Granulation: UP 75 and UP 10 (for R&D) single-pot processors.

Material handling: includes IBCs with Buck MC 100 valve, Vibroflow and blending prism, Hicoflex for discharging API from isolator and charging into single-pot processor, IBC filling station at discharge of single-pot processor, post hoist blender and Buck MC valve on tablet press, IBC wash station, WIP drain frame.

Tablet press: Modul P with HC ECM.

Cosmas

Granulation: Flexstream size 3 fluid bed processor in 10 bar design.

Material handling: 100-l IBCs with Buck MC 100 valve, Vibroflow and blending prism, IBC filling station at discharge of fluid bed processor, post hoist blender, Buck MC valve on tablet press, IBC wash station, WIP drain frame.

Tablet press: Modul P with C ECM.

Natco Pharma

Granulation: integrated line comprising PMA 150, integrated wet mill, wet product transfer line from high shear mixer to fluid bed dryer, Flexstream size 3 fluid bed processor, integrated dry mill and vacuum transfer system for dried granules from fluid bed processor to IBC.

Material handling: IBCs with Buck MC 100 valve, Vibroflow and blending prism, Hicoflex for discharging API from isolator and charging into PMA 150, IBC filling station at discharge of FBP, post hoist, Buck valve on tablet press, IBC wash station, WIP drain frame.

Tablet press: Modul P with HC ECM.

Ranbaxy Laboratories

Granulation: UP 75 and UP 10 single-pot processors.

Material handling: IBC with Buck valve, Hicoflex for discharging API from isolator and charging into single-pot processor, IBC filling station at discharge of single-pot processor, post hoist blender, post hoist, Buck valve on tablet press, IBC wash station, WIP drain frame.

Tablet press: Modul P with wash off line ECM

Continuous Tablet Manufacturing - An Alternative

Continuous lines such as GEA’s Consigma (option 3) offer a good alternative to conventional systems. The 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.

* The author is a Senior Pharmaceutical Technologist, GEA Pharma–Systems, Hürth/Germany. Phone: +49 0 63 49 / 9 27 - 7 06

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