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.
Author(s): Navnit Shah, Harpreet Sandhu, Duk Soon Choi, Hitesh Chokshi, A. Waseem Malick (eds.)
Series: Advances in Delivery Science and Technology
Edition: 1
Publisher: Springer-Verlag New York
Year: 2014
Language: English
Pages: 699
Tags: Pharmaceutical Sciences/Technology
Front Matter....Pages i-xxii
Front Matter....Pages 1-1
Fundamentals of Amorphous Systems: Thermodynamic Aspects....Pages 3-34
Theoretical Considerations in Developing Amorphous Solid Dispersions....Pages 35-90
Overview of Amorphous Solid Dispersion Technologies....Pages 91-122
Excipients for Amorphous Solid Dispersions....Pages 123-161
Front Matter....Pages 163-163
Miniaturized Screening Tools for Polymer and Process Evaluation....Pages 165-195
Hot-Melt Extrusion for Solid Dispersions: Composition and Design Considerations....Pages 197-230
HME for Solid Dispersions: Scale-Up and Late-Stage Development....Pages 231-260
Spray Drying: Scale-Up and Manufacturing....Pages 261-302
Design and Development of HPMCAS-Based Spray-Dried Dispersions....Pages 303-322
MBP Technology: Composition and Design Considerations....Pages 323-350
MBP Technology: Process Development and Scale-Up....Pages 351-371
Pharmaceutical Development of MBP Solid Dispersions: Case Studies....Pages 373-394
Downstream Processing Considerations....Pages 395-417
Front Matter....Pages 419-419
Structural Characterization of Amorphous Solid Dispersions....Pages 421-485
Dissolution of Amorphous Solid Dispersions: Theory and Practice....Pages 487-514
Stability of Amorphous Solid Dispersion....Pages 515-544
Regulatory Considerations in Development of Amorphous Solid Dispersions....Pages 545-563
Front Matter....Pages 565-565
KinetiSol ® -Based Amorphous Solid Dispersions....Pages 567-577
Amorphous Solid Dispersion Using Supercritical Fluid Technology....Pages 579-591
Front Matter....Pages 593-593
Supersolubilization by Using Nonsalt-Forming Acid-Base Interaction....Pages 595-611
Front Matter....Pages 593-593
Stabilized Amorphous Solid Dispersions with Small Molecule Excipients....Pages 613-636
Mesoporous ASD: Fundamentals....Pages 637-663
Mesoporous Silica Drug Delivery Systems....Pages 665-693
Back Matter....Pages 695-699
