Scale-up and implementation
into commercial production
of a technologically
complex drug product

Summary

The project concerned scaling up and implementing the production of an oral film-coated tablet. Technical difficulties resulted primarily from the specific properties of the active substance, which constituted approximately 90% of the tablet composition. The active substance molecule was a cross-linked polymer with elastic properties and a high affinity for water, significantly increasing the volume of the active substance.

This meant a non-standard approach to the tablet compression and film-coating stages was necessary. Thanks to its use, it was possible to determine the optimal process parameters and validate the manufacturing process on an industrial scale.