Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy

ISBN-13: 9781420084146 / Angielski / Twarda / 2014 / 172 str.

Emil W. Ciurczak; Gary E. Ritchie

Opis

Since the completion of the first edition of this book, major developments have occurred in the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy. A new initiative from the U.S. Food and Drug Administration (FDA) to modernize regulations of pharmaceutical manufacturing and drug quality has helped position NIR spectroscopy as an effective tool for pharmaceutical testing. Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy: Second Edition reflects these developments and brings readers an up-to-date summary of how this technique is being applied to pharmaceutical manufacturing. Topics include:

• The origins and principles of NIR spectroscopy, including early instrumentation, spectroscopic theory, and light-particle interaction
• The physics of each instrument type, the strengths and weaknesses of each, and the manufacturers that produce them
• The possible advantages of using NIR methods for monitoring or controlling blending, as well as practical concerns for mixing processes
• NIR spectroscopy as applied to traditional granulation, drug layering, and film coating of beads or granules
• Pharmaceutical assays, including qualitative analysis, quantitative analysis, determination of actives in tablets and capsules, and considerations for intact dosage form analysis
• Steps involved in the validation and acceptance of an NIR spectroscopy method, including quality assurance, qualification and verification of instruments, and the International Conference on Harmonization (ICH) guidelines
• Medical applications, including those related to blood glucose measurements, tissue and major organ analysis, fetal analysis, and cancer research

Providing comprehensive coverage of NIR spectroscopy, from theory, mathematics, application, and mechanics of NIR analysis, the book supplies ample references to facilitate further research into this burgeoning field.

Spis treści

Basic principles and theory. History. Early instrumentation. Spectroscopic theory. Light-particle interaction. Instrumentation. Filter-based instruments. Scanning grating monochromators. Interferometer-based instruments. Acousto-optic tunable filters. Photodiode arrays. Specialty and custom instruments. Optical parameter instrumentation. Strengths and shortcomings of traditional types of equipment. Blend uniformity analysis. Mixing. Discussion of reported work. Sampling and data handling. Segregation, Demixing, and Particle Size. Granulation, Drying, and Coating. Monitoring Granulation and Drying. Coating and Pelletization. Pharmaceutical assays. Qualitative analysis. Quantitative analysis. Determination of actives in tablets and capsules. Considerations for intact dosage form analysis. Validation issues. International conference on harmonization. Historical perspective. Medical applications. Blood glucose. Blood oxygenation. Tissue. Major organs. Blood chemistry. Fetuses and newborns. Cancer and precancer. Photon migration in tissues. Review articles. Index.

O autorze

Emil W. Ciurczak has degrees in Chemistry from Rutgers and Seton Hall Universities and has been in the pharmaceutical industry since 1970, performing method development. In 1983, he introduced NIR spectroscopy for pharmaceutical applications. He has consulted for numerous instrument companies. He has published over four dozen articles in refereed journals, over 150 magazine columns, and presented nearly two hundred technical papers. Since 2005, Emil has been Contributing Editor for Pharmaceutical Manufacturing magazine and wrote for Spectroscopy; (1987-2007). He has taught at colleges since 1979 and presented short courses in the US, Europe, South America, and Asia. He a consultant in the field of NIR and holds a dozen patents for NIR-based devices and software. He was a member of the PAT sub-committee (Validation) for the FDA and is a member of the PAT Expert Committee for the USP. He was the 2004 recipient of the EAS Achievements in NIR Award.

Benoît Igne is a principal scientist at GlaxoSmithKline, King of Prussia, Pennsylvania. From 2010 to 2014, he worked as an industrial research coordinator at Duquesne University, Pittsburgh, Pennsylvania. He received his Ph.D. in Agricultural Engineering from Iowa State University, Ames, Iowa in 2009. He specializes in the implementation of Process Analytical Technologies.