Amorphous Solid Dispersions
Amorphous Solid Dispersions

Author: Navnit Shah

Publisher: Springer

Published: 2014-11-21

Total Pages: 702

ISBN-13: 1493915983

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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.

Pharmaceutical Amorphous Solid Dispersions
Pharmaceutical Amorphous Solid Dispersions

Author: Ann Newman

Publisher: John Wiley & Sons

Published: 2015-03-09

Total Pages: 502

ISBN-13: 1118455207

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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

Hot-Melt Extrusion
Hot-Melt Extrusion

Author: Dennis Douroumis

Publisher: John Wiley & Sons

Published: 2012-04-24

Total Pages: 404

ISBN-13: 1118307879

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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.

Practical Guide to Hot-Melt Extrusion
Practical Guide to Hot-Melt Extrusion

Author: Mohammed Maniruzzaman

Publisher: Smithers Rapra

Published: 2015-07-22

Total Pages: 249

ISBN-13: 1910242128

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Over the past few decades, hot-melt extrusion (HME) techniques have been shown to exhibit remarkable potential for the manufacture of various pharmaceutical products. HME is an emerging processing technology used primarily for the manufacture of pharmaceutical solid dispersions, combining the advantages of a solvent-free process with fewer production steps making it suitable for easy to scale-up and continuous manufacturing applications. A single unit HME based operation, employing heat and mechanical shear, has displayed a significant potential to retain the stability even of thermo-labile therapeutics e.g., proteins. HME has now explicitly been established from a quality-by-design viewpoint for in-line data monitoring as per the recent guidelines issued by the US Food and Drugs Administration (FDA).This book will focus primarily on the foregoing subject areas and will be of significant interest to a broad/interdisciplinary readership across the industries and academia for, (but not limited to) the following reasons:- Emerging HME processes and applications for multiple drug delivery.- Solid-state engineering, solubility enhancement, controlled release, taste masking and sustained release case studies from a continuous manufacturing view-point.- Means to explore the potential of continuous manufacture of co-crystals for promoting solvent free production methods.- Scale-up case study and issue considerations and studies on the regulatory guidelines (FDA) for continuous manufacturing involving emerging HME techniques.

Recent Progress in Solid Dispersion Technology
Recent Progress in Solid Dispersion Technology

Author: Kohsaku Kawakami

Publisher: MDPI

Published: 2019-10-01

Total Pages: 202

ISBN-13: 3039215019

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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.

Pharmaceutical Solid Dispersion Technology
Pharmaceutical Solid Dispersion Technology

Author: Muhammad J. Habib

Publisher: CRC Press

Published: 2000-10-05

Total Pages: 114

ISBN-13: 9781566768139

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There has not, until now, been a single up-to-date volume to provide those in drug R&D with practical information on all aspects of solid dispersion technology for drugs. This forthcoming volume finally provides such a guide and reference. The unified presentation by a team of specialists in this field is designed for practical application. Theoretical concepts are covered for a fuller understanding of current techniques. All significant recent developments are included.

Practical Approaches to Method Validation and Essential Instrument Qualification
Practical Approaches to Method Validation and Essential Instrument Qualification

Author: Chung Chow Chan

Publisher: John Wiley & Sons

Published: 2011-03-01

Total Pages: 363

ISBN-13: 1118060318

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Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Developing Solid Oral Dosage Forms
Developing Solid Oral Dosage Forms

Author: Yihong Qiu

Publisher: Academic Press

Published: 2009-03-10

Total Pages: 976

ISBN-13: 008093272X

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Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: - Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms - Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies - New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development - The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards - It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter - A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Practical Guide to ICP-MS and Other Atomic Spectroscopy Techniques
Practical Guide to ICP-MS and Other Atomic Spectroscopy Techniques

Author: Robert Thomas

Publisher: CRC Press

Published: 2023-09-29

Total Pages: 604

ISBN-13: 1000915514

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Written by one of the very first practitioners of ICP-MS, Practical Guide to ICP-MS and Other Atomic Spectroscopy Techniques: A Tutorial for Beginners presents ICP-MS in a completely novel and refreshing way. By comparing it with other complementary atomic spectroscopy (AS) techniques, it gives the trace element analysis user community a glimpse into why the technique was first developed and how the application landscape has defined its use today, 40 years after it was first commercialized in 1983. What’s new in the 4th edition: Updated chapters on the fundamental principles and applications of ICP-MS New chapters on complementary AS techniques including AA, AF, ICP-OES, MIP-AES, XRF, XRD, LIBS, LALI-TOFMS Strategies for reducing errors and contamination with plasma spectrochemical techniques Comparison of collision and reaction cells including triple/multi quad systems Novel approaches to sample digestion Alternative sample introduction accessories Comprehensive glossary of terms used in AS New vendor contact information The book is not only suited to novices and beginners, but also to more experienced analytical scientists who want to know more about recent ICP-MS developments, and where the technique might be heading in the future. Furthermore, it offers much needed guidance on how best to evaluate commercial AS instrumentation and what might be the best technique, based on your lab’s specific application demands.

Practical Dispersion
Practical Dispersion

Author: R. F. Conley

Publisher: John Wiley & Sons

Published: 1996-12-17

Total Pages: 468

ISBN-13: 9780471186403

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Ein Handbuch für die Praxis der Dispersionstechnologie: Weitverstreute Daten aus der Literatur, technische Details und ausgewählte theoretische Grundlagen wurden zu einer übersichtlichen, gut verständlichen Darstellung aufbereitet, die nicht mit Mathematik und komplizierten Zusammenhängen überfrachtet ist. An zahlreichen Beispielen wird erklärt, wie sich verschiedene Dispersionszustände in den Eigenschaften des Produkts widerspiegeln; die Wirkung eines Dispersionsmittels wird auf stoffliche Aspekte, nicht Handelsnamen zurückgeführt. Der Anwender wird in die Lage versetzt, 'seine' Dispersionen gezielt zu verändern, um mechanischen, chemischen und ökologischen Anforderungen der Kunden gerecht zu werden. Mit Herstellerlisten für die technische Ausrüstung! Geschrieben in erster Linie für die industrielle Praxis - weniger für akademische Forschung und Lehre.