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.

From Polymers to Colloids: Engineering the Dynamic Properties of Hairy Particles, by D. Vlassopoulos and G. Fytas * Nonlinear Rheological Properties of Dense Colloidal Dispersions Close to a Glass Transition Under Steady Shear, by M. Fuchs * Micromechanics of Soft Particle Glasses, by R. T. Bonnecaze and M. Cloitre * Quantitative Imaging of Concentrated Suspensions Under Flow, by L. Isa, R. Besseling, A. B. Schofield and W. C. K. Poon * Soft and Wet Materials: From Hydrogels to Biotissues, by J. P. Gong and Y. Osada

From Polymers to Colloids: Engineering the Dynamic Properties of Hairy Particles, by D. Vlassopoulos and G. Fytas * Nonlinear Rheological Properties of Dense Colloidal Dispersions Close to a Glass Transition Under Steady Shear, by M. Fuchs * Micromechanics of Soft Particle Glasses, by R. T. Bonnecaze and M. Cloitre * Quantitative Imaging of Concentrated Suspensions Under Flow, by L. Isa, R. Besseling, A. B. Schofield and W. C. K. Poon * Soft and Wet Materials: From Hydrogels to Biotissues, by J. P. Gong and Y. Osada

From Polymers to Colloids: Engineering the Dynamic Properties of Hairy Particles, by D. Vlassopoulos and G. Fytas * Nonlinear Rheological Properties of Dense Colloidal Dispersions Close to a Glass Transition Under Steady Shear, by M. Fuchs * Micromechanics of Soft Particle Glasses, by R. T. Bonnecaze and M. Cloitre * Quantitative Imaging of Concentrated Suspensions Under Flow, by L. Isa, R. Besseling, A. B. Schofield and W. C. K. Poon * Soft and Wet Materials: From Hydrogels to Biotissues, by J. P. Gong and Y. Osada

Amorphous solid dispersion (ASD) is a powerful formulation technology to improve oral absorption of poorly soluble drugs. Despite their being in existence for more than half a century, controlling ASD performance is still regarded as difficult because of ASD’s natural non-equilibrium. However, recent significant advances in ASD knowledge and technology may enable a much broader use of ASD technology. This Special Issue, which includes 3 reviews and 6 original articles, focuses on recent progresses in ASD technology in hopes of helping to accelerate developmental studies in the pharmaceutical industry. In striving for a deep understanding of ASD non-equilibrium behavior, the Special issue also delves into and makes progress in the theory of soft-matter dynamics.

Hot-melt extrusion (HME) - melting a substance and forcing it through an orifice under controlled conditions to form a new material - is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.

Providing a roadmap from early to late stages of drug development, this book overviews amorphous solid dispersion technology – a leading platform to deliver poorly water soluble drugs, a major hurdle in today’s pharmaceutical industry. • Helps readers understand amorphous solid dispersions and apply techniques to particular pharmaceutical systems • Covers physical and chemical properties, screening, scale-up, formulation, drug product manufacture, intellectual property, and regulatory considerations • Has an appendix with structure and property information for polymers commonly used in drug development and with marketed drugs developed using the amorphous sold dispersion approach • Addresses global regulatory issues including USA regulations, ICH guidelines, and patent concerns around the world