Next Article in Journal
Anti-Fn14 Antibody-Conjugated Nanoparticles Display Membrane TWEAK-Like Agonism
Next Article in Special Issue
Pharmacological and Biological Study of Microencapsulated Probucol-Secondary Bile Acid in a Diseased Mouse Model
Previous Article in Journal
Rifampicin–Liposomes for Mycobacterium abscessus Infection Treatment: Intracellular Uptake and Antibacterial Activity Evaluation
Previous Article in Special Issue
Dexibuprofen Therapeutic Advances: Prodrugs and Nanotechnological Formulations
 
 
Article

An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development

1
Faculty of Pharmacy, Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, 6. Eötvös u, H-6720 Szeged, Hungary
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
*
Author to whom correspondence should be addressed.
Academic Editor: Armin Mooranian
Pharmaceutics 2021, 13(7), 1071; https://doi.org/10.3390/pharmaceutics13071071
Received: 10 June 2021 / Revised: 4 July 2021 / Accepted: 6 July 2021 / Published: 13 July 2021
(This article belongs to the Special Issue Advances in Micro/Nanotechnology in Drug Delivery)
Liposomal formulation development is a challenging process. Certain factors have a critical influence on the characteristics of the liposomes, and even the relevant properties can vary based on the predefined interests of the research. In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters of an “intermediate” active pharmaceutical ingredient-free liposome formulation prepared via the thin-film hydration method, collect the Critical Quality Attributes of the future carrier system and show the process of narrowing a general initial RA for a specific case. The theoretical liposome design was proved through experimental models. The investigated critical factors covered the working temperature, the ratio between the wall-forming agents (phosphatidylcholine and cholesterol), the PEGylated phospholipid content (DPPE-PEG2000), the type of the hydration media (saline or phosphate-buffered saline solutions) and the cryoprotectants (glucose, sorbitol or trehalose). The characterisation results (size, surface charge, thermodynamic behaviours, formed structure and bonds) of the prepared liposomes supported the outcomes of the updated RA. The findings can be used as a basis for a particular study with specified circumstances. View Full-Text
Keywords: Quality by Design; initial risk assessment; updated risk assessment; critical factors; “intermediate” liposome formulation; thin-film hydration method; liposome characterisation Quality by Design; initial risk assessment; updated risk assessment; critical factors; “intermediate” liposome formulation; thin-film hydration method; liposome characterisation
Show Figures

Figure 1

MDPI and ACS Style

Németh, Z.; Pallagi, E.; Dobó, D.G.; Kozma, G.; Kónya, Z.; Csóka, I. An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development. Pharmaceutics 2021, 13, 1071. https://doi.org/10.3390/pharmaceutics13071071

AMA Style

Németh Z, Pallagi E, Dobó DG, Kozma G, Kónya Z, Csóka I. An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development. Pharmaceutics. 2021; 13(7):1071. https://doi.org/10.3390/pharmaceutics13071071

Chicago/Turabian Style

Németh, Zsófia, Edina Pallagi, Dorina Gabriella Dobó, Gábor Kozma, Zoltán Kónya, and Ildikó Csóka. 2021. "An Updated Risk Assessment as Part of the QbD-Based Liposome Design and Development" Pharmaceutics 13, no. 7: 1071. https://doi.org/10.3390/pharmaceutics13071071

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop