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oai:figshare.com:article/33992872 2026-09-25T05:17:33Z category_851 portal_316 item_type_3 month_year_09_2026

Data Sheet 1_Quality by design driven development of a Monteverdia ilicifolia herbal medicine: from plant to granules.pdf Alberto Araujo de Caux (25107517) José Cláudio Klier Monteiro Filho (25107520) Ruan Barbosa da Silva e Medeiros (25107523) Marili Villa Nova Rodrigues (20958082) Marcos Nopper Alves (9997172) Marcus Bruno Soares Forte (6925055) Maria Isabel Rodrigues (6625142) Rodney Alexandre Ferreira Rodrigues (3119697) Natural Products Chemistry critical quality attributes design of experiments espinheira-santa medicinal plant process validation risk assessment scale-up spray drying Introduction<p>Monteverdia ilicifolia (Mart. Ex Reiss.) Biral, popularly known as espinheira-santa, is a medicinal plant recommended in Brazilian primary healthcare due to its well-recognized antidyspeptic, antacid, and gastric protective properties. Despite its clinical relevance, the development of herbal medicine from this species remains challenging, particularly due to the intrinsic variability of plant derived materials. However, most studies focus on isolated stages of the process, and there is a lack of integrated approaches that evaluate the entire production chain. In this context, Quality by Design (QbD) emerges as a promising framework to systematically understand, control, and optimize this process. Thus, the objective of this study was to use QbD in the evaluation of the production processes of an herbal medicine made from M. ilicifolia, aiming to ensure its quality.</p>Methods<p>The production processes were investigated through process mapping, risk assessment, design of experiments (DoE), and process validation. 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> 2026-09-25T05:17:33Z Dataset Dataset 10.3389/fntpr.2026.1887810.s001 https://figshare.com/articles/dataset/Data_Sheet_1_Quality_by_design_driven_development_of_a_Monteverdia_ilicifolia_herbal_medicine_from_plant_to_granules_pdf/33992872 CC BY 4.0