Tablet Tooling Considerations For Scale Up And Post-Approval Changes

By Jeremy Edson

As a tableting process is moved from one tablet press to another, tablets may change with respect to hardness, friability, disintegration, dissolution and other properties. Although there are many factors which will ultimately determine the speed at which a given product can be run on a tablet press, the primary variables that must be considered are those which affect tablet weight and tablet integrity (i.e., hardness, friability). Tablet weight consistency is inherently linked to the total time the die spends under the feeder, while tablet integrity depends on compression force and the time interval over which compression occurs. Experience has shown that both tablet weight consistency and integrity improve as feed times and compression times (dwell) increases.

In this article we explore how noting if tablet weight consistency or integrity play the more dominant role plays a factor in determining production output rates.