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The application of the Quality by Design (QbD) concept to extracts obtained from Crocus sativus perianth with potential anticancer activity will ensure the safety, efficiency, and quality control of the entire technological process, as well as determine the critical factors affecting the quality of extracts. Potentially critical points of the production of the plant extracts, including the cultivation and processing of the plant materials, the extraction process, and the choice of solvents, were identified using the Ishikawa diagram and FMEA risk assessment methods as well as the corrective actions proposed. The Herbal Chemical Marker Ranking System (HerbMars) approach was used to justify the Q-markers choice of Crocus, which takes into account bioavailability, pharmacological activity, and the presence of the selected standard. An experimental design (DoE) was used to assess the influence of potentially critical factors on the efficiency of the compound extraction from raw materials with water or ethanol. The presence of 16 compounds in Crocus perianth was determined by HPLC and their quantitative assessment was established. Selected compounds (ferulic acid, mangiferin, crocin, rutin, isoquercitrin) can be used for the quality control of Crocus perianth. In addition, the stigmas from the Volyn region met the requirements of ISO 3632 for saffron as a spice (category I). The cytotoxic activity against melanoma (IGR39) and triple-negative breast cancer (MDA-MB-231) cell lines of the hydroethanolic extract of C. sativus perianth was significantly more pronounced than the water extract, probably due to the chemical composition of the constituent components. The results show that the QbD approach is a powerful tool for process development for the production of quality herbal drugs.

Application of Quality by Design Approach to the Pharmaceutical Development of Anticancer Crude Extracts of Crocus sativus Perianth