Characterization of Nanoparticles Intended for Drug Delivery

1. Front Matter

   Pages i-xii

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2. Introduction and Discussion

   1. Front Matter

      Pages 1-1

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3. Introduction and Discussion

   1. Unique Benefits of Nanotechnology to Drug Delivery and Diagnostics

      • Scott E. McNeil

      Pages 3-8

   2. Challenges for Nanoparticle Characterization

      • Scott E. McNeil

      Pages 9-15

   3. Considerations When Submitting Nanotherapeutics to FDA/CDER for Regulatory Review

      • Katherine Tyner, Nakissa Sadrieh

      Pages 17-31

4. Assays to Determine Physical and Chemical Properties

   1. Front Matter

      Pages 33-33

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5. Assays to Determine Physical & Chemical Properties

   1. Measuring the Hydrodynamic Size of Nanoparticles in Aqueous Media Using Batch-Mode Dynamic Light Scattering

      • Vincent A. Hackley, Jeffrey D. Clogston

      Pages 35-52

   2. Characterization of Nanoparticles by Matrix Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry

      • Uma Ramalinga, Jeffrey D. Clogston, Anil K. Patri, John T. Simpson

      Pages 53-61

   3. Zeta Potential Measurement

      • Jeffrey D. Clogston, Anil K. Patri

      Pages 63-70

   4. Size Measurement of Nanoparticles Using Atomic Force Microscopy

      • Jaroslaw Grobelny, Frank W. DelRio, Namboodiri Pradeep, Doo-In Kim, Vincent A. Hackley, Robert F. Cook

      Pages 71-82

   5. Biological Tissue and Cell Culture Specimen Preparation for TEM Nanoparticle Characterization

      • Kunio Nagashima, Jiwen Zheng, David Parmiter, Anil K. Patri

      Pages 83-91

   6. SEM X-Ray Microanalysis of Nanoparticles Present in Tissue or Cultured Cell Thin Sections

      • Jiwen Zheng, Kunio Nagashima, David Parmiter, Jason de la Cruz, Anil K. Patri

      Pages 93-99

   7. Detecting and Measuring Free Gadolinium in Nanoparticles for MRI Imaging

      • Jeffrey D. Clogston, Anil K. Patri

      Pages 101-108

   8. Lipid Component Quantitation by Thin Layer Chromatography

      • Jeffrey D. Clogston, Anil K. Patri

      Pages 109-117

6. Assays for Sterility

   1. Front Matter

      Pages 119-119

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7. Assays for Sterility

   1. Detection and Quantitative Evaluation of Endotoxin Contamination in Nanoparticle Formulations by LAL-Based Assays

      • Barry W. Neun, Marina A. Dobrovolskaia

      Pages 121-130

   2. Analysis of Microbial Contamination in Nanoparticle Formulations

      • Timothy M. Potter, Marina A. Dobrovolskaia

      Pages 131-134

8. Assays for In Vitro Detection and Quantitation

   1. Front Matter

      Pages 135-135

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9. Assays for In Vitro Detection and Quantitation

   1. Gold Nanoparticle Quantitation via Fluorescence in Solution and Cell Culture

      • Parag Aggarwal, Marina A. Dobrovolskaia

      Pages 137-143

   2. Quantitation of Nanoparticles in Serum Matrix by Capillary Electrophoresis

      • King C. Chan, Timothy D. Veenstra, Haleem J. Issaq

      Pages 145-153

In recent years, there have been many exciting breakthroughs in the application of nanotechnology to medicine. In Characterization of Nanoparticles Intended for Drug Delivery, expert researchers explore the latest advances in the field, providing a set of basic methods for the characterization of nanomaterials for medical use. Chapters provide methods to characterize the physiochemical properties (size, aggregation, and surface chemistry) and in vitro immunological and biological characteristics of nanomaterials. Composed in the highly successful Methods in Molecular Biology™ series format, each chapter contains a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips on troubleshooting and avoiding known pitfalls. Comprehensive and informative, Characterization of Nanoparticles Intended for Drug Delivery is an essential survey of methods that are crucial to the preclinical characterization of nanomedicines.

• Assays for sterility
• Assays for toxicity
• Atomic force microscopy
• Nanomedicine
• Physicochemical properties
• Thin layer chromatography

From the reviews:

“This book details the latest advances in methodology for determining physiochemical, immunological, and toxicological properties of nanoparticles for use in medicine. … The chapter author are the very qualified experts responsible for developing the majority of the protocols for nanoparticle characterization … . serves an audience of researchers in the scientific community, pharmaceutical drug developers, and regulatory agencies. … This is an excellent resource for understanding the unique challenges in the development and in vitro evaluation of nanoparticle-based therapeutic agents.” (Rachel R. Chennault, Doody’s Review Service, June, 2011)

• SAIC-Frederick, Inc., Nanotechnology Characterization Lab, National Cancer Institute at Frederick, Frederick, USA

  Scott E. McNeil

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