Extrusion-Spheronization in OSD Manufacturing

In this article, we’ll explore how extrusion-spheronization (E-S) is applied in manufacturing, the sophisticated dose forms the process helps create, and why it supports the controlled delivery of active pharmaceutical ingredients (APIs) and ultimately improves patient outcomes.

Manufacturing of oral solid dose (OSD) APIs leveraging E–S has gained favor because of the number of patient-centered benefits it provides formulators and drug developers. Because oral delivery is preferred, E-S is proving to be a versatile tool in finished drug product development, suitable for even the most complex OSD formulations and APIs, including new molecular entities (NMEs) and—life-cycle management extensions.

Formulations engineered using E-S offer a predictable vehicle to control the distribution and delivery of therapeutic agents around the body. The method is most often applied to create amorphous solid dispersions (ASDs) of particles containing API. This allows for great latitude in designing the treatment’s oral delivery profile including E fixed-dose combinations, combined, modified release tablets and capsule forms, and multi-unit