Scanning Electron-Raman Cryomicroscopy for Characterization of Nanoparticle-Albumin Drug Products

Yilmaz, Huzeyfe; Ahmed, Snober; Rodriguez, Jason D.; Willett, Daniel R.

doi:10.1021/acs.analchem.2c03826

Scanning Electron-Raman Cryomicroscopy for Characterization of Nanoparticle-Albumin Drug Products

Journal Article · 24 January 2023 · Analytical Chemistry

DOI:https://doi.org/10.1021/acs.analchem.2c03826· OSTI ID:2425792

^[1]; Ahmed, Snober ^[1]; Rodriguez, Jason D. ^[1]; ^[1]

Division of Complex Drug Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis 63110, Missouri, United States

Not provided.

Research Organization:: Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)

Sponsoring Organization:: USDOE Office of Science (SC)

DOE Contract Number:: SC0014664

OSTI ID:: 2425792

Journal Information:: Analytical Chemistry, Journal Name: Analytical Chemistry Journal Issue: 5 Vol. 95; ISSN 0003-2700

Publisher:: American Chemical Society (ACS)

Country of Publication:: United States

Language:: English

References (46)

Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials Zheng, Nan; Sun, Dajun D.; Zou, Peng The AAPS Journal, Vol. 19, Issue 3 https://doi.org/10.1208/s12248-017-0044-1	journal	January 2017
Raman-in-SEM, a multimodal and multiscale analytical tool: Performance for materials and expertise Wille, Guillaume; Bourrat, Xavier; Maubec, Nicolas Micron, Vol. 67 https://doi.org/10.1016/j.micron.2014.06.008	journal	December 2014
Advanced characterizations of nanoparticles for drug delivery: investigating their properties through the techniques used in their evaluations Mahmood, Syed; Mandal, Uttam Kumar; Chatterjee, Bappaditya Nanotechnology Reviews, Vol. 6, Issue 4 https://doi.org/10.1515/ntrev-2016-0050	journal	August 2017
Critical Evaluation of the Use of Laser Diffraction for Particle-Size Distribution Analysis Eshel, G.; Levy, G. J.; Mingelgrin, U. Soil Science Society of America Journal, Vol. 68, Issue 3 https://doi.org/10.2136/sssaj2004.7360	journal	May 2004
Impact of Nanotechnology on Drug Delivery Farokhzad, Omid C.; Langer, Robert ACS Nano, Vol. 3, Issue 1 https://doi.org/10.1021/nn900002m	journal	December 2008
Direct Observation of the Release of Nanoplastics from Commercially Recycled Plastics with Correlative Raman Imaging and Scanning Electron Microscopy Zhang, Wen; Dong, Zhiqiang; Zhu, Ling ACS Nano, Vol. 14, Issue 7 https://doi.org/10.1021/acsnano.0c02878	journal	May 2020
Albumin as a drug carrier: Design of prodrugs, drug conjugates and nanoparticles Kratz, Felix Journal of Controlled Release, Vol. 132, Issue 3, p. 171-183 https://doi.org/10.1016/j.jconrel.2008.05.010	journal	December 2008
DLS and zeta potential – What they are and what they are not? Bhattacharjee, Sourav Journal of Controlled Release, Vol. 235 https://doi.org/10.1016/j.jconrel.2016.06.017	journal	August 2016
Electron microscopy of pharmaceutical systems Klang, Victoria; Valenta, Claudia; Matsko, Nadejda B. Micron, Vol. 44 https://doi.org/10.1016/j.micron.2012.07.008	journal	January 2013
Nanomedicines: addressing the scientific and regulatory gap Tinkle, Sally; McNeil, Scott E.; Mühlebach, Stefan Annals of the New York Academy of Sciences, Vol. 1313, Issue 1 https://doi.org/10.1111/nyas.12403	journal	March 2014
Characterization of Complex Drug Formulations Using Cryogenic Scanning Electron Microscopy (Cryo‐SEM) Liang, Jing; Koo, Bonhye; Wu, Yong Current Protocols, Vol. 2, Issue 4 https://doi.org/10.1002/cpz1.406	journal	April 2022
An NMR Protocol for In Vitro Paclitaxel Release from an Albumin-Bound Nanoparticle Formulation Suh, Min Sung; Patil, Sharadrao M.; Kozak, Darby AAPS PharmSciTech, Vol. 21, Issue 5 https://doi.org/10.1208/s12249-020-01669-1	journal	May 2020
Insights into In Vitro Binding of Parecoxib to Human Serum Albumin by Spectroscopic Methods Shang, Shujun; Liu, Qingling; Gao, Jiandong Journal of Biochemical and Molecular Toxicology, Vol. 28, Issue 10 https://doi.org/10.1002/jbt.21582	journal	June 2014
Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date Bobo, Daniel; Robinson, Kye J.; Islam, Jiaul Pharmaceutical Research, Vol. 33, Issue 10 https://doi.org/10.1007/s11095-016-1958-5	journal	June 2016
How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities Tyner, Katherine M.; Zheng, Nan; Choi, Stephanie The AAPS Journal, Vol. 19, Issue 4 https://doi.org/10.1208/s12248-017-0084-6	journal	April 2017
Interaction of taxol with human serum albumin Purcell, M.; Neault, J. F.; Tajmir-Riahi, H. A. Biochimica et Biophysica Acta (BBA) - Protein Structure and Molecular Enzymology, Vol. 1478, Issue 1 https://doi.org/10.1016/S0167-4838(99)00251-4	journal	March 2000
Structural investigations on nanoemulsions, solid lipid nanoparticles and nanostructured lipid carriers by cryo-field emission scanning electron microscopy and Raman spectroscopy Saupe, Anne; Gordon, Keith C.; Rades, Thomas International Journal of Pharmaceutics, Vol. 314, Issue 1 https://doi.org/10.1016/j.ijpharm.2006.01.022	journal	May 2006
Bioequivalence assessment of high-capacity polymeric micelle nanoformulation of paclitaxel and Abraxane® in rodent and non-human primate models using a stable isotope tracer assay Hwang, Duhyeong; Vinod, Natasha; Skoczen, Sarah L. Biomaterials, Vol. 278 https://doi.org/10.1016/j.biomaterials.2021.121140	journal	November 2021
Cellular uptake and transport of gold nanoparticles incorporated in a liposomal carrier Chithrani, Devika B.; Dunne, Michael; Stewart, James Nanomedicine: Nanotechnology, Biology and Medicine, Vol. 6, Issue 1 https://doi.org/10.1016/j.nano.2009.04.009	journal	February 2010
Revealing the structure of high-water content biopolymer networks: Diminishing freezing artefacts in cryo-SEM images Efthymiou, Christina; Williams, Martin A. K.; McGrath, Kathryn M. Food Hydrocolloids, Vol. 73 https://doi.org/10.1016/j.foodhyd.2017.06.040	journal	December 2017
The effect of poloxamer 188 on nanoparticle morphology, size, cancer cell uptake, and cytotoxicity Yan, Fei; Zhang, Chao; Zheng, Yi Nanomedicine: Nanotechnology, Biology and Medicine, Vol. 6, Issue 1 https://doi.org/10.1016/j.nano.2009.05.004	journal	February 2010
The evolving landscape of drug products containing nanomaterials in the United States D'Mello, Sheetal R.; Cruz, Celia N.; Chen, Mei-Ling Nature Nanotechnology, Vol. 12, Issue 6 https://doi.org/10.1038/nnano.2017.67	journal	April 2017
Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography–Inductively Coupled Plasma–Mass Spectrometric Approach Neu, Heather M.; Alexishin, Sergei A.; Brandis, Joel E. P. Molecular Pharmaceutics, Vol. 16, Issue 3 https://doi.org/10.1021/acs.molpharmaceut.8b01215	journal	January 2019
Odyssey of a cancer nanoparticle: From injection site to site of action Nichols, Joseph W.; Bae, You Han Nano Today, Vol. 7, Issue 6 https://doi.org/10.1016/j.nantod.2012.10.010	journal	December 2012
The Uniqueness of Albumin as a Carrier in Nanodrug Delivery Spada, Alessandra; Emami, Jaber; Tuszynski, Jack A. Molecular Pharmaceutics, Vol. 18, Issue 5 https://doi.org/10.1021/acs.molpharmaceut.1c00046	journal	March 2021
Viscosity affected by nanoparticle aggregation in Al2O3-water nanofluids Duan, Fei; Kwek, Dingtian; Crivoi, Alexandru Nanoscale Research Letters, Vol. 6, Issue 1 https://doi.org/10.1186/1556-276X-6-248	journal	March 2011
Utilising atomic force microscopy for the characterisation of nanoscale drug delivery systems Sitterberg, Johannes; Özcetin, Aybike; Ehrhardt, Carsten European Journal of Pharmaceutics and Biopharmaceutics, Vol. 74, Issue 1 https://doi.org/10.1016/j.ejpb.2009.09.005	journal	January 2010
The aspect ratio effect of drug nanocrystals on cellular internalization efficiency, uptake mechanisms, and in vitro and in vivo anticancer efficiencies Tian, Baishun; Zhang, Xiujuan; Yu, Caitong Nanoscale, Vol. 7, Issue 8 https://doi.org/10.1039/C4NR06743F	journal	January 2015
New developments in particle characterization by laser diffraction: size and shape Ma, Zhenhua; Merkus, Henk G.; de Smet, Jan G. A. E. Powder Technology, Vol. 111, Issue 1-2 https://doi.org/10.1016/S0032-5910(00)00242-4	journal	August 2000
Physicochemical Characterization of Iron Carbohydrate Colloid Drug Products Zou, Peng; Tyner, Katherine; Raw, Andre The AAPS Journal, Vol. 19, Issue 5 https://doi.org/10.1208/s12248-017-0126-0	journal	July 2017
Analytical considerations for measuring the globule size distribution of cyclosporine ophthalmic emulsions Petrochenko, Peter E.; Pavurala, Naresh; Wu, Yong International Journal of Pharmaceutics, Vol. 550, Issue 1-2 https://doi.org/10.1016/j.ijpharm.2018.08.030	journal	October 2018
Nanotechnology and medicine Emerich, Dwaine F.; Thanos, Christopher G. Expert Opinion on Biological Therapy, Vol. 3, Issue 4 https://doi.org/10.1517/14712598.3.4.655	journal	July 2003
Nanotechnology: What it can do for drug delivery Park, Kinam Journal of Controlled Release, Vol. 120, Issue 1-2 https://doi.org/10.1016/j.jconrel.2007.05.003	journal	July 2007
Highly sensitive detection of paclitaxel by surface-enhanced Raman scattering Cottat, Maximilien; Lidgi-Guigui, Nathalie; Hamouda, Frédéric Journal of Optics, Vol. 17, Issue 11 https://doi.org/10.1088/2040-8978/17/11/114019	journal	October 2015
Evaluation of the impact of freezing preparation techniques on the characterisation of alginate hydrogels by cryo-SEM Aston, Robyn; Sewell, Kim; Klein, Travis European Polymer Journal, Vol. 82 https://doi.org/10.1016/j.eurpolymj.2016.06.025	journal	September 2016
Cryo-electron microscopy of vitreous sections of native biological cells and tissues Al-Amoudi, Ashraf; Norlen, Lars P. O.; Dubochet, Jacques Journal of Structural Biology, Vol. 148, Issue 1 https://doi.org/10.1016/j.jsb.2004.03.010	journal	October 2004
Challenges in Development of Nanoparticle-Based Therapeutics Desai, Neil The AAPS Journal, Vol. 14, Issue 2 https://doi.org/10.1208/s12248-012-9339-4	journal	March 2012
Aspect Ratio Determines the Quantity of Mesoporous Silica Nanoparticle Uptake by a Small GTPase-Dependent Macropinocytosis Mechanism Meng, Huan; Yang, Sui; Li, Zongxi ACS Nano, Vol. 5, Issue 6 https://doi.org/10.1021/nn103344k	journal	May 2011
Comparative Evaluation of U.S. Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization Sun, Dajun; Rouse, Rodney; Patel, Vikram Nanomaterials, Vol. 8, Issue 1 https://doi.org/10.3390/nano8010025	journal	January 2018
Core size determination and structural characterization of intravenous iron complexes by cryogenic transmission electron microscopy Wu, Yong; Petrochenko, Peter; Chen, Lynn International Journal of Pharmaceutics, Vol. 505, Issue 1-2 https://doi.org/10.1016/j.ijpharm.2016.03.029	journal	May 2016
Shear‐stress preconditioning and tissue‐engineering‐based paradigms for generating arterial substitutes Baguneid, Mohamed; Murray, David; Salacinski, Henryk J. Biotechnology and Applied Biochemistry, Vol. 39, Issue 2 https://doi.org/10.1042/BA20030148	journal	April 2004
Cryo-electron microscopy of vitrified specimens Dubochet, Jacques; Adrian, Marc; Chang, Jiin-Ju Quarterly Reviews of Biophysics, Vol. 21, Issue 2 https://doi.org/10.1017/S0033583500004297	journal	May 1988
Freeze-Substitution and Freeze-Drying Steinbrecht, Rudolf Alexander; Müller, Martin Cryotechniques in Biological Electron Microscopy https://doi.org/10.1007/978-3-642-72815-0_7	book	January 1987
Equivalence of complex drug products: advances in and challenges for current regulatory frameworks Hussaarts, Leonie; Mühlebach, Stefan; Shah, Vinod P. Annals of the New York Academy of Sciences, Vol. 1407, Issue 1 https://doi.org/10.1111/nyas.13347	journal	April 2017
Carotene location in processed food samples measured by Cryo In-SEM Raman Lopez-Sanchez, Patricia; Schumm, Stephan; Pudney, Paul D. A. The Analyst, Vol. 136, Issue 18 https://doi.org/10.1039/c0an01023e	journal	January 2011
Nanomaterials: Applications in Cancer Imaging and Therapy Barreto, José A.; O’Malley, William; Kubeil, Manja Advanced Materials, Vol. 23, Issue 12 https://doi.org/10.1002/adma.201100140	journal	February 2011

Similar Records

Excipient-related impurities in liposome drug products

Journal Article · 2024 · International Journal of Pharmaceutics · OSTI ID:2581066

Failure Mode Identification of Insulin Drug Products – Impact of Relevant Stress Conditions on the Quality of the Drug

Journal Article · 2022 · Journal of Pharmaceutical Sciences · OSTI ID:1981798

Related Subjects

Chemistry

Scanning Electron-Raman Cryomicroscopy for Characterization of Nanoparticle-Albumin Drug Products

Citation Formats

References (46)

Similar Records

Related Subjects