Dialysis is a key factor modulating interactions between critical process parameters during the microfluidic preparation of lipid nanoparticles

Li, 2022, Tailoring combinatorial lipid nanoparticles for intracellular delivery of nucleic acids, proteins, and drugs, Acta Pharm. Sin. B, 12, 2624, 10.1016/j.apsb.2022.04.013 Sheoran, 2022, Lipid-based nanoparticles for treatment of cancer, Heliyon, 8, 10.1016/j.heliyon.2022.e09403 Allen, 2013, Liposomal drug delivery systems: from concept to clinical applications, Adv. Drug Deliv. Rev., 65, 36, 10.1016/j.addr.2012.09.037 Belliveau, 2012, Microfluidic synthesis of highly potent limit-size lipid nanoparticles for in vivo delivery of SiRNA, Mol. Ther. - Nucleic Acids, 1, 10.1038/mtna.2012.28 Evers, 2018, State-of-the-art design and rapid-mixing production techniques of lipid nanoparticles for nucleic acid delivery, Small Methods, 2, 1700375, 10.1002/smtd.201700375 Maeki, 2018, Advances in microfluidics for lipid nanoparticles and extracellular vesicles and applications in drug delivery systems, Adv. Drug Deliv. Rev., 128, 84, 10.1016/j.addr.2018.03.008 Colombo, 2018, Transforming nanomedicine manufacturing toward quality by design and microfluidics, Adv. Drug Deliv. Rev., 128, 115, 10.1016/j.addr.2018.04.004 Bao, 2018, Engineering docetaxel-loaded micelles for non-small cell lung Cancer: a comparative study of microfluidic and bulk nanoparticle preparation, RSC Adv., 8, 31950, 10.1039/C8RA04512G Kimura, 2020, Development of a microfluidic-based post-treatment process for size-controlled lipid nanoparticles and application to SiRNA delivery, ACS Appl. Mater. Interfaces, 12, 34011, 10.1021/acsami.0c05489 Streck, 2019, The distribution of cell-penetrating peptides on polymeric nanoparticles prepared using microfluidics and elucidated with small angle X-ray scattering, J. Colloid Interface Sci., 555, 438, 10.1016/j.jcis.2019.08.007 Ali, 2021, Microfluidics for development of lipid nanoparticles: paving the way for nucleic acids to the clinic, ACS Appl. Bio Mater., 13, 8 Balbino, 2013, Continuous flow production of cationic liposomes at high lipid concentration in microfluidic devices for gene delivery applications, Chem. Eng. J., 226, 423, 10.1016/j.cej.2013.04.053 You, 2018, Targeted brain delivery of rabies virus glycoprotein 29-modified deferoxamine-loaded nanoparticles reverses functional deficits in parkinsonian mice, ACS Nano, 12, 4123, 10.1021/acsnano.7b08172 Bhise, 2017, Nanostructured lipid carriers employing polyphenols as promising anticancer agents: quality by design (QbD) approach, Int. J. Pharm., 526, 506, 10.1016/j.ijpharm.2017.04.078 Akbari, 2022, 1 Terada, 2021, Characterization of lipid nanoparticles containing Ionizable cationic lipids using design-of-experiments approach, Langmuir, 37, 1120, 10.1021/acs.langmuir.0c03039 Ly, 2022, Optimization of lipid nanoparticles for SaRNA expression and cellular activation using a design-of-experiment approach, Mol. Pharm., 19, 1892, 10.1021/acs.molpharmaceut.2c00032 Fu, 2018, Targeted transport of Nanocarriers into brain for Theranosis with rabies virus glycoprotein-derived peptide, Mater. Sci. Eng. C, 87, 155, 10.1016/j.msec.2017.12.029 Yenduri, 2022, Impact of critical process parameters and critical material attributes on the critical quality attributes of liposomal formulations prepared using continuous processing, Int. J. Pharm., 619, 10.1016/j.ijpharm.2022.121700 Suñé-Pou, 2019, Improved synthesis and characterization of cholesteryl Oleate-loaded cationic solid lipid nanoparticles with high transfection efficiency for gene therapy applications, Colloids Surf. B: Biointerfaces, 180, 159, 10.1016/j.colsurfb.2019.04.037 Rawal, 2019, Quality-by-design concepts to improve nanotechnology-based drug development, Pharm. Res., 36, 1, 10.1007/s11095-019-2692-6 Peraman, 2015, Analytical quality by design: a tool for regulatory flexibility and robust analytics, Int. J. Anal. Chem., 2015, 10.1155/2015/868727 Zagalo, 2022, Quality by design (QbD) approach in marketing authorization procedures of non-biological complex drugs: a critical evaluation, Eur. J. Pharm. Biopharm., 178, 1, 10.1016/j.ejpb.2022.07.014 Grangeia, 2020, Quality by Design in Pharmaceutical Manufacturing: a systematic review of current status, challenges and future perspectives, Eur. J. Pharm. Biopharm., 147, 19, 10.1016/j.ejpb.2019.12.007 Politis, 2017, 43, 889 Taha, 2020, Critical quality attributes in the development of therapeutic nanomedicines toward clinical translation, Drug Deliv. Transl. Res., 10, 766, 10.1007/s13346-020-00744-1 Fan, 2021, Analytical characterization of liposomes and other lipid nanoparticles for drug delivery, J. Pharm. Biomed. Anal., 192, 10.1016/j.jpba.2020.113642 Danaei, 2018, Impact of particle size and polydispersity index on the clinical applications of Lipidic Nanocarrier systems, Pharmaceutics, 10, 1, 10.3390/pharmaceutics10020057 Li, 2017, Nanosystem trends in drug delivery using quality-by-design concept, J. Control. Release, 256, 9, 10.1016/j.jconrel.2017.04.019 Beg, 2019, Quality-by-design approach as a systematic tool for the development of Nanopharmaceutical products, Drug Discov. Today, 24, 717, 10.1016/j.drudis.2018.12.002 Agrahari, 2018, Facilitating the translation of nanomedicines to a clinical product: challenges and opportunities, Drug Discov. Today, 23, 974, 10.1016/j.drudis.2018.01.047 Lball, 2017, Achieving long-term stability of lipid nanoparticles: examining the effect of PH, temperature, and lyophilization, Int. J. Nanomedicine, 12, 305 Okuda, 2022, On the size-regulation of RNA-loaded lipid nanoparticles synthesized by microfluidic device, J. Control. Release, 348, 648, 10.1016/j.jconrel.2022.06.017 Hibino, 2019, The use of a microfluidic device to encapsulate a poorly water-soluble drug CoQ10 in lipid nanoparticles and an attempt to regulate intracellular trafficking to reach mitochondria, J. Pharm. Sci., 108, 2668, 10.1016/j.xphs.2019.04.001 Kulkarni, 2019, Fusion-dependent formation of lipid nanoparticles containing macromolecular payloads, Nanoscale, 11, 9023, 10.1039/C9NR02004G Roces, 2020, Manufacturing considerations for the development of lipid nanoparticles using microfluidics, Pharm., 12, 1095 Tiboni, 2021, Microfluidics for nanomedicines manufacturing: an affordable and low-cost 3D printing approach, Int. J. Pharm., 599, 10.1016/j.ijpharm.2021.120464 Riewe, 2020, Antisolvent precipitation of lipid nanoparticles in microfluidic systems – a comparative study, Int. J. Pharm., 579, 10.1016/j.ijpharm.2020.119167 Breiman, 1984, Classification and regression trees, Classif. Regres. Trees, 1 Giuliani, 2017, The application of principal component analysis to drug discovery and biomedical data, Drug Discov. Today, 22, 1069, 10.1016/j.drudis.2017.01.005 Kastner, 2014, High-throughput manufacturing of size-tuned liposomes by a new microfluidics method using enhanced statistical tools for characterization, Int. J. Pharm., 477, 361, 10.1016/j.ijpharm.2014.10.030 Samari-Kermani, 2021, Ionic strength and zeta potential effects on colloid transport and retention processes, Colloid Interface Sci. Commun., 42, 10.1016/j.colcom.2021.100389 Rane, 2005, Polydispersity index: how accurately does it measure the breadth of the molecular weight distribution?, Chem. Mater., 17, 926, 10.1021/cm048594i Das, 2019, Superparamagnetic magnesium ferrite/silica core-shell nanospheres: a controllable SiO2 coating process for potential magnetic hyperthermia application, Adv. Powder Technol., 30, 3171, 10.1016/j.apt.2019.09.026 Bastogne, 2017, Quality-by-Design of Nanopharmaceuticals – a state of the art, Nanomed. Nanotechnol. Biol. Med., 13, 2151, 10.1016/j.nano.2017.05.014 Tomba, 2013, Latent variable modeling to assist the implementation of quality-by-design paradigms in pharmaceutical development and manufacturing: a review, Int. J. Pharm., 457, 283, 10.1016/j.ijpharm.2013.08.074