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

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