Enhancing Process Control and Quality in Amorphous Solid Dispersions Using In-Line UV-Vis Monitoring of L* as a Real-Time Response.

ABSTRACT: Background: This study demonstrates the application of the sequential design of experiments (DoE) approach within the quality by design (QbD) framework to optimize extrusion processes through screening, optimization, and robustness testing. Methods: An in-line UV-Vis process analytical technology (PAT) system was successfully employed to monitor critical quality attributes (CQAs) of piroxicam amorphous solid dispersion (ASD) extrusion products, specifically lightness (L*). Results: L* measurement proved highly effective for ensuring the quality and uniformity of ASDs, offering real-time insights into their physical appearance and process stability. Small variations in L* acted as early indicators of processing issues, such as phase separation or bubble formation, enabl

SUBMITTER: Bezerra M 

PROVIDER: S-EPMC11859203 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature