Polymorphism In Pharmaceutical Solids

Author: Harry G. Brittain
Editor: CRC Press
ISBN: 1420073222
File Size: 53,14 MB
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Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science. This edition focuses on pharmaceutical aspects of polymorphism a

Polymorphism In Pharmaceutical Solids

Author: Harry G. Brittain
Editor: CRC Press
ISBN: 9780824702373
File Size: 33,96 MB
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"Presents a comprehensive examination of polymorphic behavior in pharmaceutical development-demonstrating with clear, practical examples how to navigate complicated crystal structures. Edited by the recipient of the American Association of Pharmaceutical Scientists' 1998 Research Achievement Award in Analysis and Pharmaceutical Quality."

Polymorphism In The Pharmaceutical Industry

Author: Rolf Hilfiker
Editor: John Wiley & Sons
ISBN: 3527340408
File Size: 53,92 MB
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"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.

Polymorphism In Pharmaceutical Solids

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ISBN: 9780367193317
File Size: 67,89 MB
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Polymorphism

Author: Rolf Hilfiker
Editor: John Wiley & Sons
ISBN: 3527607722
File Size: 80,12 MB
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Edited by one of the leading experts in the field, this handbook emphasizes why solid-state issues are important, which approaches should be taken to avoid problems and exploit the opportunities offered by solid state properties in the pharmaceutical and agricultural industries. With its practical approach, this is at once a guideline for development chemists just entering the field as well as a high-quality source of reference material for specialists in the pharmaceutical and chemical industry, structural chemists, physicochemists, crystallographers, inorganic chemists, and patent departments.

Physical Characterization Of Pharmaceutical Solids

Author: Harry G. Brittain
Editor: Marcel Dekker
ISBN: 9780824793722
File Size: 67,32 MB
Format: PDF
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This unique reference provides the first systematic coverage available in a single-source volume on the application of materials science techniques to the pharmaceutical field-offering a comprehensive program for the physical characterization of raw materials, drug substances, and formulated products.

Solid State Characterization Of Pharmaceuticals

Author: Richard A. Storey
Editor: John Wiley & Sons
ISBN: 1119970172
File Size: 27,84 MB
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The field of solid state characterization is central to the pharmaceutical industry, as drug products are, in an overwhelming number of cases, produced as solid materials. Selection of the optimum solid form is a critical aspect of the development of pharmaceutical compounds, due to their ability to exist in more than one form or crystal structure (polymorphism). These polymorphs exhibit different physical properties which can affect their biopharmaceutical properties. This book provides an up-to-date review of the current techniques used to characterize pharmaceutical solids. Ensuring balanced, practical coverage with industrial relevance, it covers a range of key applications in the field. The following topics are included: Physical properties and processes Thermodynamics Intellectual guidance X-ray diffraction Spectroscopy Microscopy Particle sizing Mechanical properties Vapour sorption Thermal analysis & Calorimetry Polymorph prediction Form selection

Solid State Chemistry Of Drugs

Author: Stephen R. Byrn
Editor: Ssci Incorporated
ISBN:
File Size: 39,46 MB
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Polymorphism In Molecular Crystals 2e

Author: Joel Bernstein
Editor: International Union of Crystal
ISBN: 0199655448
File Size: 60,30 MB
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Most people are familiar with the fact that diamond and graphite are both composed only of carbon; yet they have very different properties which result from the very different structures of the two solids - they are polymorphs of carbon. Understanding the relationship between the structures and the properties of materials is of fundamental importance in developing and producing new materials with improved or new properties. The existence of polymorphic systems allows the direct study of the connection between structures and properties. This book provides grounding on the fundamental structural and energetic basis for polymorphism, the preparation and characterization of polymorphic substances and its importance in the specific areas of pharmaceuticals, pigments and high energy (explosive) materials. The closing chapter describes the intellectual property implications and some of the precedent patent litigations in which polymorphism has played a central role. The book contains over 2500 references to provide a ready entry into the relevant literature.

Advanced Pharmaceutical Solids

Author: Jens T. Carstensen
Editor: CRC Press
ISBN: 1482270544
File Size: 10,41 MB
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This extensive reference/text explores the principles, instrumentation, processes, and programs of pharmaceutical solid science as well as new aspects on one-component systems, micromeritics, polymorphism, solid-state stability, cohesion, powder flow, blending, single- unit sustained release, and tablet coating. Reveals unique approaches in phar

Profiles Of Drug Substances Excipients And Related Methodology

Author:
Editor: Elsevier
ISBN: 9780080522630
File Size: 39,13 MB
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Whilst following in the footsteps of previous volumes by presenting comprehensive reviews of drug substances and additional materials, this title also heralds a significant expansion of the scope of the series. Traditional contributions will now also be augmented by publication of critical review chapters that summarize information related to the characterization of drug substances and excipients. This change is required to better meet the needs of the pharmaceutical communtiy and to allow the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series will encompass review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodologoy related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. - Presents comprehensive reviews covering all aspects of drug development and formulation of drugs - Now encompassing critical review chapters - Meets the information needs of the drug development community

Control And Prediction Of Solid State Of Pharmaceuticals

Author: Rajni Miglani Bhardwaj
Editor: Springer
ISBN: 3319275550
File Size: 76,33 MB
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This thesis investigates a range of experimental and computational approaches for the discovery of solid forms. Furthermore, we gain, as readers, a better understanding of the key factors underpinning solid-structure and diversity. A major part of this thesis highlights experimental work carried out on two structurally very similar compounds. Another important section involves looking at the influence of small changes in structure and substituents on solid-structure and diversity using computational tools including crystal structure prediction, PIXEL calculations, Xpac, Mercury and statistical modeling tools. In addition, the author presents a fast validated method for solid-state form screening using Raman microscopy on multi-well plates to explore the experimental crystallization space. This thesis illustrates an inexpensive, practical and accurate way to predict the crystallizability of organic compounds based on molecular structure alone, and additionally highlights the molecular factors that inhibit or promote crystallization.

Analytical Profiles Of Drug Substances And Excipients

Author:
Editor: Academic Press
ISBN: 9780080861197
File Size: 19,41 MB
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Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the AmericanAssociation of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.

Guidance For Industry

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ISBN:
File Size: 71,57 MB
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Pharmaceutical Crystals

Author: Tonglei Li
Editor: John Wiley & Sons
ISBN: 1119046297
File Size: 39,73 MB
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An important resource that puts the focus on understanding and handling of organic crystals in drug development Since a majority of pharmaceutical solid-state materials are organic crystals, their handling and processing are critical aspects of drug development. Pharmaceutical Crystals: Science and Engineering offers an introduction to and thorough coverage of organic crystals, and explores the essential role they play in drug development and manufacturing. Written contributions from leading researchers and practitioners in the field, this vital resource provides the fundamental knowledge and explains the connection between pharmaceutically relevant properties and the structure of a crystal. Comprehensive in scope, the text covers a range of topics including: crystallization, molecular interactions, polymorphism, analytical methods, processing, and chemical stability. The authors clearly show how to find solutions for pharmaceutical form selection and crystallization processes. Designed to be an accessible guide, this book represents a valuable resource for improving the drug development process of small drug molecules. This important text: Includes the most important aspects of solid-state organic chemistry and its role in drug development Offers solutions for pharmaceutical form selection and crystallization processes Contains a balance between the scientific fundamental and pharmaceutical applications Presents coverage of crystallography, molecular interactions, polymorphism, analytical methods, processing, and chemical stability Written for both practicing pharmaceutical scientists, engineers, and senior undergraduate and graduate students studying pharmaceutical solid-state materials, Pharmaceutical Crystals: Science and Engineering is a reference and textbook for understanding, producing, analyzing, and designing organic crystals which is an imperative skill to master for anyone working in the field.

Developing Solid Oral Dosage Forms

Author: Yihong Qiu
Editor: Academic Press
ISBN: 0128026375
File Size: 40,73 MB
Format: PDF, Kindle
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Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives

Profiles Of Drug Substances Excipients And Related Methodology

Author: Harry G. Brittain
Editor: Academic Press
ISBN: 0128203242
File Size: 65,71 MB
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Profiles of Drug Substances, Excipients, and Related Methodology, Volume 45, presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. The series encompasses review articles, with this release focusing on Azilsartan Medoxomil, Piroxicam, Carbetapentane Citrate, Emtricitabine, Etrlotinib, Isotretinoin and Meloxicam. Contains contributions from leading authorities Informs and updates on all the latest developments in the field of drug substances, excipients and methodologies

Industrial Crystallization

Author: Alison Lewis
Editor: Cambridge University Press
ISBN: 1316299082
File Size: 21,97 MB
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Bridging the gap between theory and practice, this text provides the reader with a comprehensive overview of industrial crystallization. Newcomers will learn all of the most important topics in industrial crystallization, from key concepts and basic theory to industrial practices. Topics covered include the characterization of a crystalline product and the basic process design for crystallization, as well as batch crystallization, measurement techniques, and details on precipitation, melt crystallization and polymorphism. Each chapter begins with an introduction explaining the importance of the topic, and is supported by homework problems and worked examples. Real world case studies are also provided, as well as new industry-relevant information, making this is an ideal resource for industry practitioners, students, and researchers in the fields of industrial crystallization, separation processes, particle synthesis, and particle technology.