By Simon Chen
In this blog, we explore why and how the technique of extrusion-spheronization offers pharmaceutical companies a robust, proven way to manufacture today’s most complex therapies. We also discuss the key considerations for drug developers who are looking to select a contract manufacturer as a partner to deliver this technique.
It’s the right choice for encapsulated solid dose formulations
In the right hands, with the right capabilities, extrusion spheronization is a well-understood process ready to manufacture today’s and tomorrow’s complex and potent capsule-delivered solid dose therapeutics.
Extrusion-spheronization’s reputation as a versatile and economic manufacturing technique is well-earned. It’s viable for most of today’s-solid dose development paths and is proving to be an effective formulation and manufacturing technology for everything from New Molecular Entities (NMEs), Abbreviated New Drug Applications (ANDAs), life-cycle management (LCM) extensions, to OTC marketing strategies.
Because of its broad drug-engineering utility, extrusion-spheronization can also support emerging 505(B)(2) development pathways. This includes tailoring compounds and developing fixed-dose combinations (FDCs) to create new best-in-class, patient preferred products.