Quality-by-Design Toolkit for Plant-Derived Excipients in Injectable Nanomedicines

This project contains the registered protocol and supporting materials for a systematic review and meta-analysis (PRISMA-2020 compliant) evaluating plant-derived excipients in parenteral nanomedicines. It includes: (1) the full systematic review protocol; (2) validated Quality-by-Design (QbD) design-space models for lecithin, chitosan, and hyaluronic acid; (3) Python/R scripts for AI-enhanced control strategies and machine learning prediction of critical quality attributes; and (4) raw and analyzed data from prospective validation experiments (e.g., irinotecan liposomes, n=3 batches). All materials support regulatory-ready implementation of botanical excipients in injectable nanomedicines under ICH Q8–Q10 frameworks.