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Physical Characterization Of Pharmaceutical Solids
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Book Synopsis Solid State Characterization of Pharmaceuticals by : Richard A. Storey
Download or read book Solid State Characterization of Pharmaceuticals written by Richard A. Storey and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 557 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Physical Characterization of Pharmaceutical Solids by : Harry G. Brittain
Download or read book Physical Characterization of Pharmaceutical Solids written by Harry G. Brittain and published by CRC Press. This book was released on 1995-07-19 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Solid-State Properties of Pharmaceutical Materials by : Stephen R. Byrn
Download or read book Solid-State Properties of Pharmaceutical Materials written by Stephen R. Byrn and published by John Wiley & Sons. This book was released on 2017-07-12 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Physical Characterization of Pharmaceutical Solids by : H. G. Brittain
Download or read book Physical Characterization of Pharmaceutical Solids written by H. G. Brittain and published by . This book was released on 1995 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Polymorphism written by Rolf Hilfiker and published by John Wiley & Sons. This book was released on 2006-08-21 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmaceutical Excipients by : David E. Bugay
Download or read book Pharmaceutical Excipients written by David E. Bugay and published by CRC Press. This book was released on 1999-02-23 with total page 688 pages. Available in PDF, EPUB and Kindle. Book excerpt: Meeting the need for a hands-on guide elucidating the role of molecular spectroscopy in the physical characterization of pharmaceutical solids, two experts from the industry gather theoretical discussions of infrared, Raman, and nuclear magnetic resonance spectroscopy. They provide recommendations on spectral data acquisition techniques and include 600 spectra for 300 of the most commonly used excipients. Complete with references, equations, tables, and a CAS registry number index, the book covers the drug development process, including chemical identification of substances, investigative studies, competitor analysis, problem solving activities, reproduction of spectral data, and more.
Book Synopsis Innovative Dosage Forms by : Yogeshwar Bachhav
Download or read book Innovative Dosage Forms written by Yogeshwar Bachhav and published by John Wiley & Sons. This book was released on 2019-12-04 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
Book Synopsis Developing Solid Oral Dosage Forms by : Yihong Qiu
Download or read book Developing Solid Oral Dosage Forms written by Yihong Qiu and published by Academic Press. This book was released on 2009-03-10 with total page 976 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Pharmaceutical Excipients by : Otilia M. Y. Koo
Download or read book Pharmaceutical Excipients written by Otilia M. Y. Koo and published by John Wiley & Sons. This book was released on 2016-10-03 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients
Book Synopsis Amorphous Solid Dispersions by : Navnit Shah
Download or read book Amorphous Solid Dispersions written by Navnit Shah and published by Springer. This book was released on 2014-11-21 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Solid State Development and Processing of Pharmaceutical Molecules by : Michael Gruss
Download or read book Solid State Development and Processing of Pharmaceutical Molecules written by Michael Gruss and published by John Wiley & Sons. This book was released on 2021-11-15 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: Solid State Development and Processing of Pharmaceutical Molecules A guide to the lastest industry principles for optimizing the production of solid state active pharmaceutical ingredients Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors—noted experts on the topic—examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: Provides a guide for the effective development of solid drug forms Compares different characterization methods for solid state APIs Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs Includes information on automation, process control, and machine learning as an integral part of the development and production workflows Covers in detail the regulatory and quality control aspects of drug development Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production.
Book Synopsis Polymorphism in the Pharmaceutical Industry by : Rolf Hilfiker
Download or read book Polymorphism in the Pharmaceutical Industry written by Rolf Hilfiker and published by John Wiley & Sons. This book was released on 2019-01-04 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
Book Synopsis Polymorphism in Pharmaceutical Solids by : Harry G. Brittain
Download or read book Polymorphism in Pharmaceutical Solids written by Harry G. Brittain and published by CRC Press. This book was released on 1999-03-03 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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."
Book Synopsis Handbook of Stability Testing in Pharmaceutical Development by : Kim Huynh-Ba
Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Download or read book Dosage Form Design Parameters written by and published by Academic Press. This book was released on 2018-07-25 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. - Examines the history and recent developments in drug dosage forms for pharmaceutical sciences - Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism - Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Book Synopsis Pharmaceutical Salts and Co-crystals by : Johan Wouters
Download or read book Pharmaceutical Salts and Co-crystals written by Johan Wouters and published by Royal Society of Chemistry. This book was released on 2011-11-04 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: From crystal structure prediction to totally empirical screening, the quest for new crystal forms has become one of the most challenging issues in the solid state science and particularly in the pharmaceutical world. In this context, multi-component crystalline materials like co-crystals have received renewed interest as they offer the prospect of optimized physical properties. As illustrated in this first book_ entirely dedicated to this emerging class of pharmaceutical compounds_ the outcome of such endeavours into crystal engineering have demonstrated clear impacts on production, marketing and intellectual property protection of active pharmaceutical ingredients (APIs). Indeed, co-crystallization influences relevant physico-chemical parameters (such as solubility, dissolution rate, chemical stability, melting point, hygroscopicity, à) and often offers solids with properties superior to those of the free drug. Combining both reports of the latest research and comprehensive overviews of basic principles, with contributions from selected experts in both academia and industry, this unique book is an essential reference, ideal for pharmaceutical development scientists and graduate students in pharmaceutical science.
Book Synopsis Handbook of Pharmaceutical Salts Properties, Selection, and Use by : P. Heinrich Stahl
Download or read book Handbook of Pharmaceutical Salts Properties, Selection, and Use written by P. Heinrich Stahl and published by John Wiley & Sons. This book was released on 2008-08-04 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.