Bilayer Tablet Manufacturing: An Overview

By Dr. Éanna Ó Maitiú, Technical Operations Manager, AbbVie – Cork, Ireland

Bilayer tablets offer a number of advantages for patients – their unique formulation enables the controlled delivery of one or more active pharmaceutical ingredients (APIs) within a single tablet, improving patient compliance and simplifying a medication regimen. By potentially reducing the number of doses needed to treat a patient, as well as improving the release profile of an API and allowing for incompatible APIs to exist in combination, bilayer tablets represent an integral advancement in patient treatment.

Because of the comparatively novel and bespoke nature of these drugs, additional formulation activity is often required to commercialize them. This investment frequently extends to equipment and process optimization, resulting in an array of unique technical challenges. At AbbVie, researchers have worked toward mitigating these issues by identifying a range of technology solutions, from tablet delamination to cross-contamination layers, layer separation, weight and depth control, and achieving acceptable yields and throughput.