Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics.
Manufacturing oral solid dose (OSD) APIs into spheres via extrusion-spheronization (E-S) is not new. What is new is that in the right hands, with the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of bot
Spheronization’s Expanding Influence As a Drug Manufacturing Driver
Widely acknowledged as a predictable vehicle for the control, distribution and transportation of therapeutic agents around the body, E-S engineered formulations make a variety of common and emerging controlled release dose forms possible. These include fixed-dose combinations (FDCs), combined, modified release single-capsule forms and emerging multi-unit particulate system (MUPS) tablet designs.
Ultimately E-S spheres offer a variety of physical attributes that innovators can leverage to control drug delivery, enhance therapeutic performance and the patient-centricity of today’s complex, combined and modified release OSDs.
Extrusion-Spheronization is extremely viable for complex OSD development
E-S is proving to be an extremely versatile manufacturing technique and a viable route for many of today’s most attractive but often complex OSD development paths, including New Molecular Entities (NMEs) and life-cycle management (LCM) extensions.
Because of its broad utility in OSD engineering, E-S also supports emerging (505(b)2 development pathways – tailoring compounds for pediatric/geriatric applications or developing FDCs to create a new best-in-class product. Done correctly with best-practice techniques and technology, pharmaceutical companies can leverage a better process and take advantage of its many benefits, including high-throughput manufacturing, less waste in process and better yield.