Pharmaceutical Development and Design of Thermosensitive Liposomes Based on the QbD Approach |
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| Authors: | Dorina Gabriella Dobó ,Zsó fia Né meth,Bence Sipos,Martin Cseh,Edina Pallagi,Dá niel Berkesi,Gá bor Kozma,Zoltá n Kó nya,Ildikó Csó ka |
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| Affiliation: | 1.Faculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u 6, H-6720 Szeged, Hungary; (Z.N.); (B.S.); (M.C.); (E.P.); (I.C.);2.Department of Applied and Environmental Chemistry, Faculty of Science and Informatics, Institute of Chemistry, University of Szeged, 1, Rerrich Béla tér, H-6720 Szeged, Hungary; (D.B.); (G.K.); (Z.K.) |
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| Abstract: | This study aimed to produce thermosensitive liposomes (TSL) by applying the quality by design (QbD) concept. In this paper, our research group collected and studied the parameters that significantly impact the quality of the liposomal product. Thermosensitive liposomes are vesicles used as drug delivery systems that release the active pharmaceutical ingredient in a targeted way at ~40–42 °C, i.e., in local hyperthermia. This study aimed to manufacture thermosensitive liposomes with a diameter of approximately 100 nm. The first TSLs were made from DPPC (1,2-dipalmitoyl-sn-glycerol-3-phosphocholine) and DSPC (1,2-dioctadecanoyl-sn-glycero-3-phosphocholine) phospholipids. Studies showed that the application of different types and ratios of lipids influences the thermal properties of liposomes. In this research, we made thermosensitive liposomes using a PEGylated lipid besides the previously mentioned phospholipids with the thin-film hydration method. |
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| Keywords: | quality by design quality planning initial risk assessment critical factors thermosensitive liposomes thin-film hydration method |
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