Amorphous Solid Dispersions / Advances in Delivery Science and Technology (PDF)
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This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems.
Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.
Dr. Harpreet K. Sandhu is a principal scientist at Merck, Inc. in the formulation sciences group. Prior to this, she was at Hoffmann-La Roche Inc., where she held positions of increasing responsibility in the area of oral formulation development. She received her Ph.D. in physical pharmacy from the University of Connecticut in Storrs and an M.B.A. from Rutgers University in Newark, New Jersey. Her research interests have been shaped by her ardent desire to meet the growing challenges of poor aqueous solubility. During her tenure at Roche, she led the development of multiple programs covering simple formulations to the most complex delivery systems and mentored junior scientists, graduate students and postdocs.
Dr. Duk Soon Choi is a vice president at Kashiv Pharmaceuticals in Bridgewater, New Jersey. His responsibilities include the leadership of the preformulation and chemistry teams. Dr. Choi's research focuseson active pharmaceutical
Dr. Hitesh P. Chokshi is a senior leader in pharmaceutical research and early development at Roche Innovation Center, New York. He joined Roche in Nutley as a preformulation scientist after completing his Ph.D. and postdoctoral research at the University of Georgia in Athens, Georgia, and University of Kansas in Lawrence, respectively. Hitesh has held diverse scientific and leadership responsibilities at Roche for the development of new medicines: small molecules, peptides, and biologics. His research includes pharmaceutical profiling, development and characterization of fit-for-purpose dosage forms for toxicological and clinical studies as well as for the market. He has a special interest in amorphous solid dispersion (ASD) design and characterization, establishing predictive in-vitro models to de-risk bioequivalence, and in quality by design (QbD) solid state characterization of drug substances and dosage forms.
Dr. A. Waseem Malick is a retired pharmaceutical R&D executive who has had an extensive career in the industry, previously serving as vice president and global head of pharmaceutical and analytical R&D at Hoffmann-La Roche. He received his Ph.D. in pharmaceutics from the University of Michigan, Ann Arbor, and an M.S. in pharmaceutics from Columbia University, New York. His research interests include drug product development, formulation and drug delivery research. He has published 110 research papers and 169 abstracts and has presentedextensively in the area of drug delivery research. He was elected as fellow of the American Association of Pharmaceutical Scientists (AAPS) and has received several honors and awards. He serves on the board of directors of several non-profit organizations and on the Science Board of Advisors at New York University. He also has an adjunct professor appointment at the University of Rhode Island in Kingston.
- 2014, 2014, 699 Seiten, Englisch
- Herausgegeben: Navnit Shah, Harpreet Sandhu, Duk Soon Choi, Hitesh Chokshi, A. Waseem Malick
- Verlag: Springer-Verlag GmbH
- ISBN-10: 1493915983
- ISBN-13: 9781493915989
- Erscheinungsdatum: 21.11.2014
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- Größe: 16 MB
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