Amorphous Solid Dispersions PDF Download

Author: Navnit Shah
Publisher: Springer
ISBN: 1493915983
Category : Medical
Languages : en
Pages : 702

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Book Description
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: Ann Newman
Publisher: John Wiley & Sons
ISBN: 1118455207
Category : Science
Languages : en
Pages : 502

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Book Description
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

Author: Stephen R. Byrn
Publisher: John Wiley & Sons
ISBN: 1119264448
Category : Science
Languages : en
Pages : 432

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Book Description
Presents a detailed discussion of important solid-state properties, methods, and applications of solid-state analysis Illustrates the various phases or forms that solids can assume and discussesvarious issues related to the relative stability of solid forms and tendencies to undergo transformation Covers key methods of solid state analysis including X-ray powder diffraction, thermal analysis, microscopy, spectroscopy, and solid state NMR Reviews critical physical attributes of pharmaceutical materials, mainly related to drug substances, including particle size/surface area, hygroscopicity, mechanical properties, solubility, and physical and chemical stability Showcases the application of solid state material science in rational selection of drug solid forms, analysis of various solid forms within drug substance and the drug product, and pharmaceutical product development Introduces appropriate manufacturing and control procedures using Quality by Design, and other strategies that lead to safe and effective products with a minimum of resources and time

Author: Norman H. March
Publisher: Springer Science & Business Media
ISBN: 1475791569
Category : Science
Languages : en
Pages : 547

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Book Description
This book has its origins in the 1982 Spring College held at the Interna tional Centre for Theoretical Physics, Miramare, Trieste. The primary aim is to give a broad coverage of liquids and amorphous solids, at a level suitable for graduate students and research workers in condensed-matter physics, physical chemistry, and materials science. The book is intended for experimental workers with interests in the basic theory. While the topics covered are many, it was planned to place special emphasis on both static structure and dynamics, including electronic transport. This emphasis is evident from the rather complete coverage of the determination of static structure from both diffraction experiments and, for amorphous solids especially, from model building. The theory of the structure of liquids and liquid mixtures is then dealt with from the standpoint of, first, basic statistical mechanics and, subsequently, pair potentials constructed from the electron theory of simple metals and their alloys. The discussion of static structure is completed in two chapters with rather different emphases on liquid surfaces and interfaces. The first deals with the basic statistical mechanics of neutral and charged interfaces, while the second is concerned with solvation and double-layer effects. Dynamic structure is introduced by a comprehensive discussion of single-particle motion in liquids. This is followed by the structure and dynamics of charged fluids, where again much basic statistical mechanics is developed.

Author: Dennis Douroumis
Publisher: John Wiley & Sons
ISBN: 1118307879
Category : Science
Languages : en
Pages : 404

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Book Description
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.

Author: Nima Yazdanpanah
Publisher: Royal Society of Chemistry
ISBN: 1839161310
Category : Technology & Engineering
Languages : en
Pages : 579

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Book Description
Continuous crystallization is an area of intense research, with particular respect to the pharmaceutical industry and fine chemicals. Improvements in continuous crystallization technologies offer chemical industries significant financial gains, through reduced expenditure and operational costs, and consistent product quality. Written by well-known leaders in the field, The Handbook of Continuous Crystallization presents fundamental and applied knowledge, with attention paid to application and scaling up, and the burgeoning area of process intensification. Beginning with concepts around crystallization techniques and control strategies, the reader will learn about experimental methods and computational tools. Case studies spanning fine and bulk chemicals, the pharmaceutical industry, and employing new mathematical tools, put theory into context.

Author: Harry Levine
Publisher: Royal Society of Chemistry
ISBN: 1847550118
Category : Technology & Engineering
Languages : en
Pages : 397

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Book Description
During the past decade, the importance of amorphous water-soluble substances has been increasingly recognised within the food and pharmaceutical industries. In response, Amorphous Food and Pharmaceutical Systems brings together current leading experts to contribute to this unique cross-disciplinary account of the subject. Coverage includes: water-compatible amorphous solids (physical, chemical behaviour), low water content systems (water as plasticizer); applications in food and pharmaceutical sciences and industries (processing and stability) along with state-of-the-art technology in food and pharmaceutical systems. This timely publication will be welcomed by academic and industrial researchers and professionals in the pharmaceuticals, food, materials and polymer sciences.

Author: Rolf Hilfiker
Publisher: John Wiley & Sons
ISBN: 3527697853
Category : Science
Languages : en
Pages : 645

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Book Description
"Polymorphism in the Pharmaceutical Industry - Solid Form and Drug Development" highlights the relevance of polymorphism in modern pharmaceutical chemistry, with a focus on quality by design (QbD) concepts. It covers all important issues by way of case studies, ranging from properties and crystallization, via thermodynamics, analytics and theoretical modelling right up to patent issues. As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development. It emphasizes why solid-state issues are important, the approaches needed to avoid problems and the opportunities offered by solid-state properties. The authors include true polymorphs as well as solvates and hydrates, while providing information on physicochemical properties, crystallization thermodynamics, quantum-mechanical modelling, and up-scaling. Important analytical tools to characterize solid-state forms and to quantify mixtures are summarized, and case studies on solid-state development processes in industry are also provided. Written by acknowledged experts in the field, this is a high-quality reference for researchers, project managers and quality assurance managers in pharmaceutical, agrochemical and fine chemical companies as well as for academics and newcomers to organic solid-state chemistry.

Author: Ajit S Narang
Publisher: Springer
ISBN: 3319202065
Category : Medical
Languages : en
Pages : 700

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Book Description
In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Author: Christoph Schick
Publisher: Springer
ISBN: 3319313290
Category : Technology & Engineering
Languages : en
Pages : 796

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Book Description
In the past decades, the scan rate range of calorimeters has been extended tremendously at the high end, from approximately 10 up to 10 000 000 °C/s and more. The combination of various calorimeters and the newly-developed Fast Scanning Calorimeters (FSC) now span 11 orders of magnitude, by which many processes can be mimicked according to the time scale(s) of chemical and physical transitions occurring during cooling, heating and isothermal stays in case heat is exchanged. This not only opens new areas of research on polymers, metals, pharmaceuticals and all kinds of substances with respect to glass transition, crystallization and melting phenomena, it also enables in-depth study of metastability and reorganization of samples on an 1 to 1000 ng scale. In addition, FSC will become a crucial tool for understanding and optimization of processing methods at high speeds like injection molding. The book resembles the state-of-the art in Thermal Analysis & Calorimetry and is an excellent starting point for both experts and newcomers in the field.