Amorphous Solid Dispersions, Softcover reprint of the original 1st ed. 2014 Theory and Practice Advances in Delivery Science and Technology Series

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.

1 Fundamentals of Amorphous Systems:  Thermodynamic Aspects.- 2 Theoretical Considerations in Developing Amorphous Solid Dispersions.- 3 Overview of Amorphous Solid Dispersion Technologies.- 4 Excipients for Amorphous Solid Dispersions.- 5 Miniaturized Screening Tools for Polymer and Process Evaluation.- 6 HME for Solid Dispersions: Composition and Design Considerations.- 7 HME for Solid Dispersions: Scale up and Late Stage Development.- 8 Spray Drying: Scale UP and Manufacturing.- 9 Design and Development of HPMCAS based spray dried dispersions.- 10 MBP Technology: Composition and Design Considerations.- 11 MBP Technology: Process Development and Scale up.- 12 Pharmaceutical Development of MBP Solid Dispersions: Case Studies.- 13 Downstream Processing Considerations.- 14 Structural Characterization of Amorphous Solid Dispersions.- 15 Dissolution of Amorphous Solid Dispersions: Theory and Practice.- 16 Stability of Amorphous Solid Dispersion.- 17 Regulatory Considerations in Development of Amorphous Solid Dispersions.- 18 KinetiSol® based Amorphous Solid Dispersions.- 19 Amorphous Solid Dispersion Using Supercritical Fluid Technology.- 20 Supersolubilization by Using Non-Salt Forming Acid-Base Interaction.- 21 Stabilized Amorphous Solid Dispersions with Small Molecule Excipients.- 22 Mesoporous ASD – Fundamentals.- 23 Mesoporous Silica Drug Delivery Systems.

Dr. Navnit Shah is president and CSO of Kashiv Pharmaceuticals in Bridgewater, New Jersey. Prior to joining Kashiv, he was a distinguished scientist at Hoffmann-La Roche Inc., where he headed the oral dosage form development group for many years. He received his Ph.D. in pharmaceutics from St. John’s University in Queens, New York, and he has published 120 abstracts and more than eighty scientific papers in the drug delivery area, particularly in the field of amorphous solid dispersion. He is inventor and co-inventor on nineteen issued patents and thirteen patent applications. He is the recipient of numerous awards, including AAPS Fellow, Thomas Alva Edison Patent Award, St John's University Distinguished Alumni Award, New Jersey Biomedical Research Leadership Award, and the New Jersey Inventor of the Year award by New Jersey Inventors Hall of Fame (NJIHoF). He is an adjunct professor at the University of Rhode Island in Kingston and has mentored several graduate students for their M.S. & Ph.D. research.

 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 p