Optimizing extrusion processes and understanding conformational changes in itraconazole amorphous solid dispersions using in-line UV-Vis spectroscopy and QbD principles

• Main Authors: Hetvi Triboandas (Author), Mariana Bezerra (Author), Juan Almeida (Author), Matheus de Castro (Author), Bianca Aloise Maneira Corrêa Santos (Author), Walkiria Schlindwein (Author)
• Format: Book
• Published: Elsevier, 2024-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

This paper presents a comprehensive investigation of the manufacturing of itraconazole (ITZ) amorphous solid dispersions (ASDs) with Kolllidon® VA64 (KVA64) using hot-melt extrusion (HME) and in-line process monitoring, employing a Quality by Design (QbD) approach. A sequential Design of Experiments...