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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: Rolf Hilfiker
Publisher: John Wiley & Sons
ISBN: 3527697853
Category : Science
Languages : en
Pages : 645
Get Book Here
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: Rolf Hilfiker
Publisher: John Wiley & Sons
ISBN: 3527607722
Category : Science
Languages : en
Pages : 433
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Book Description
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: Michael Gruss
Publisher: John Wiley & Sons
ISBN: 352734635X
Category : Science
Languages : en
Pages : 578
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Book Description
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: 1119970172
Category : Science
Languages : en
Pages : 557
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Book Description
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: 9780824702373
Category : Medical
Languages : en
Pages : 448
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Book Description
"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: Joel Bernstein
Publisher: Oxford University Press
ISBN: 0198506058
Category : Business & Economics
Languages : en
Pages : 429
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Book Description
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:
Publisher: Academic Press
ISBN: 012814422X
Category : Medical
Languages : en
Pages : 816
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Book Description
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
Author: Adeboye Adejare
Publisher: Academic Press
ISBN: 0128223898
Category : Science
Languages : en
Pages : 1032
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Book Description
The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics. - Contains a comprehensive source of principles of drug discovery and development topics, especially for scientists that are new in the pharmaceutical industry such as those with trainings/degrees in chemistry and engineering - Provides a detailed source for formulation scientists and compounding pharmacists, from produg to excipient issues - Updates this excellent source with the latest information to verify facts and refresh on basics for professionals in the broadly defined pharmaceutical industry
Author: Robert Allen Carlton
Publisher: Springer Science & Business Media
ISBN: 1441988319
Category : Science
Languages : en
Pages : 333
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Book Description
Microscopy plays an integral role in the research and development of new medicines. Pharmaceutical Microscopy describes a wide variety of techniques together with numerous practical applications of importance in drug development. The first section presents general methods and applications with an emphasis on the physical science aspects. Techniques covered include optical crystallography, thermal microscopy, scanning electron microscopy, energy dispersive x-ray spectrometry, microspectroscopy (infrared and Raman), and particle size and shape by image analysis. The second section presents applications of these techniques to specific topics of pharmaceutical interest, including studies of polymorphism, particle size and shape analysis, and contaminant identification. Pharmaceutical Microscopy is designed for those scientists who must use these techniques to solve pharmaceutical problems but do not need to become expert microscopists. Consequently, each section has exercises designed to teach the reader how to use and apply the techniques in the book. Although the focus is on pharmaceutical development, workers in other fields such as food science and organic chemistry will also benefit from the discussion of techniques and the exercises. Provides comprehensive coverage of key microscopy techniques used in pharmaceutical development Helps the reader to solve specific problems in pharmaceutical quality assurance Oriented and designed for pharmaceutical scientists who need to use microscopy but are not expert microscopists Includes a large number of practical exercises to give the reader hands-on experience with the techniques Written by an author with 21 years of experience in the pharmaceutical industry
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
