Romanian Society of Pharmaceutical Sciences

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QUALITY BY DESIGN APPROACH FOR THE DEVELOPMENT OF SALINOMYCIN AND GEMCITABINE COMBINATION THERAPY LIPOSOMES FOR COLORECTAL CANCER

LUCIA RUXANDRA TEFAS, IOANA TOMA *, IOAN TOMUȚĂ

Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, “Iuliu Hațieganu” University of Medicine and Pharmacy, 41 V. Babeș Street, 400012, Cluj-Napoca, Romania

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An ideal cancer treatment would eradicate all types of malignant cells, both rapidly replicating and quiescent stem-like cancer cells. Therefore, a combination of drugs capable of targeting all subtypes of cancer cells could offer a better outcome in cancer. Nano-delivery systems for combination therapy represent more secure and efficient platforms for the delivery of anticancer drugs to tumours. Nanocarrier drug development is a complex process which requires careful design and evaluation at various levels to ensure their safety and efficacy. In this sense, the Quality by Design (QbD) approach could help develop a robust, highquality nanocarrier formulation by understanding the properties of the product and the manufacturing process. In this study, the QbD approach was used in the development of liposomes co-loaded with a combination of anticancer drugs, salinomycin (SAL) and gemcitabine (GEM) for colorectal cancer therapy. While GEM is a conventional anticancer drug, SAL has shown selectivity towards cancer stem cells. The implementation of the QbD approach involved the identification of the quality target product profile (QTPP) and critical quality attributes (CQAs) of the liposomes. Based on risk analysis, the Design of Experiments (DoE) methodology was employed to evaluate the impact of critical formulation factors on the liposomes’ properties, in a time and cost-effective manner, in order to obtain SAL and GEM co-loaded liposomes with desired characteristics.