Making Tablets From Potent APIs: Selecting The Appropriate Technology

Related Vendors

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

TRM Filter d.o.o.

IBCs (intermediate bulk containers) with split butterfly valves are the material handling systems most commonly used for potent APIs. Split butterfly valves offer a proven solution for make-and-break connections. They are available in different performance levels.

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 is docked using a split butterfly valve connection to, say, a discharge station. The raw material is then loaded into the granulator by either gravity (if the room height allows) 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.

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