Data Sheet 1_Quality by design driven development of a Monteverdia ilicifolia herbal medicine: from plant to granules.pdf

The initial stages involved hazard identification and risk assignment to identify potentially critical factors, which were subsequently challenged by DoE. The processes were compared based on physicochemical, operational, and technological responses related to Critical Quality Attributes (CQAs), which impact product efficacy and safety. Finally, the optimized condition was subjected to process validation to ensure reproducibility under routine manufacturing conditions.</p>Results and Discussion<p>The stages of harvesting, drying, milling, extraction, concentration, spray drying, and granulation were evaluated.

Among the nine factors assessed during lab-scale extraction, “drug-to-extract ratio” (1% and 2%) and “degree of fragmentation of the herbal drug” (shredded and powdered) showed consistent significant effects. Upon scale-up of the extraction process, “agitation” (0–400 rpm) also proved to be a determining factor at larger scale. For the spray drying and granulation stages, the addition of maltodextrin (0%–60%), feed rate (3.9–8.1 mL/min), and inlet temperature (120°C–200 °C) were significant for at least one CQA.

In conclusion, the application of the QbD approach enabled the identification of the main elements related to the production of herbal medicines from espinheira-santa, satisfying the process capability.</p>