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

ABSTRACT: 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 (DoE) strategy was utilized to optimize the manufacturing process, with in-line UV-Vis spectroscopy providing real-time monitoring. The first DoE used a fractional factorial screening design to evaluate critical process parameters (CPPs), revealing that ITZ concentration had the most significant impact on the product quality attributes. The second DoE, employing a central composite design, explored the interactions between feed rate and screw speed, using torque and absorbance at 370 nm as resp

SUBMITTER: Triboandas H 

PROVIDER: S-EPMC11647160 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature