In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME)

• Main Authors: Walkiria Schlindwein (Author), Mariana Bezerra (Author), Juan Almeida (Author), Andreas Berghaus (Author), Martin Owen (Author), Gordon Muirhead (Author)
• Format: Book
• Published: MDPI AG, 2018-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework. Hot melt extrusion (HME) is used as continuous manufacturing process and UV–Vis spectroscopy as an in-line moni...