Polymorphism In The Pharmaceutical Industry

Author : Rolf Hilfiker
Publisher : John Wiley & Sons
ISBN 13 : 3527697853
Total Pages : 618 pages
Book Rating : 4.54/5 ( download)

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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 618 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.

Author : Rolf Hilfiker
Publisher : John Wiley & Sons
ISBN 13 : 3527607722
Total Pages : 433 pages
Book Rating : 4.23/5 ( download)

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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.

Author : Rolf Hilfiker
Publisher : John Wiley & Sons
ISBN 13 : 3527340408
Total Pages : 512 pages
Book Rating : 4.08/5 ( download)

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Download or read book Polymorphism in the Pharmaceutical Industry written by Rolf Hilfiker and published by John Wiley & Sons. This book was released on 2019-04-29 with total page 512 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.

Author : Joel Bernstein
Publisher : Oxford University Press
ISBN 13 : 0198506058
Total Pages : 429 pages
Book Rating : 4.58/5 ( download)

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Download or read book Polymorphism in Molecular Crystals written by Joel Bernstein and published by Oxford University Press. This book was released on 2002 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: Polymorphism - the multiplicity of structures or forms - is a term that is used in many disciplines. In chemistry it refers to the existence of more than one crystal structure for a particular chemical substance. The properties of a substance are determined by its composition and by its structure. In the last two decades, there has been a sharp rise in the interest in polymorphic systems, as an intrinsically interesting phenomenon and as an increasingly important component in the development and marketing of a variety of materials based on organic molecules (e.g. pharmaceuticals, dyes and pigments, explosives, etc.). This book summarizes and brings up to date the current knowledge and understanding of polymorphism of molecular crystals, and concentrates it in one comprehensive source. The book will be an invaluable reference for students, researchers, and professionals in the field.

Author : Michael Gruss
Publisher : John Wiley & Sons
ISBN 13 : 352734635X
Total Pages : 578 pages
Book Rating : 4.56/5 ( download)

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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.

Author : Richard A. Storey
Publisher : John Wiley & Sons
ISBN 13 : 1119970172
Total Pages : 557 pages
Book Rating : 4.70/5 ( download)

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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

Author : Harry G. Brittain
Publisher : CRC Press
ISBN 13 : 9780824702373
Total Pages : 448 pages
Book Rating : 4.79/5 ( download)

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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."

Author : Mary T. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 111928550X
Total Pages : 1435 pages
Book Rating : 4.02/5 ( download)

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Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
ISBN 13 : 3527343962
Total Pages : 470 pages
Book Rating : 4.66/5 ( download)

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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.

Author : Kung-Chung Liu
Publisher : Springer Nature
ISBN 13 : 981138102X
Total Pages : 513 pages
Book Rating : 4.27/5 ( download)

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Download or read book Innovation, Economic Development, and Intellectual Property in India and China written by Kung-Chung Liu and published by Springer Nature. This book was released on 2019-09-06 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.