Polymorphism In The Pharmaceutical Industry

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Polymorphism in the Pharmaceutical Industry

Rolf Hilfiker,Markus von Raumer
Polymorphism in the Pharmaceutical Industry Book PDF

Author : Rolf Hilfiker,Markus von Raumer
Publisher : John Wiley & Sons
Page : 618 pages
File Size : 49,7 Mb
Release : 2019-01-04
Category : Science
ISBN : 9783527697854

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Polymorphism in the Pharmaceutical Industry by Rolf Hilfiker,Markus von Raumer Pdf

"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 the Pharmaceutical Industry

Rolf Hilfiker,Markus von Raumer
Polymorphism in the Pharmaceutical Industry Book PDF

Author : Rolf Hilfiker,Markus von Raumer
Publisher : John Wiley & Sons
Page : 512 pages
File Size : 42,5 Mb
Release : 2019-04-29
Category : Science
ISBN : 9783527340408

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Polymorphism in the Pharmaceutical Industry by Rolf Hilfiker,Markus von Raumer Pdf

"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

Rolf Hilfiker
Polymorphism Book PDF

Author : Rolf Hilfiker
Publisher : John Wiley & Sons
Page : 433 pages
File Size : 49,8 Mb
Release : 2006-08-21
Category : Science
ISBN : 9783527607723

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Polymorphism by Rolf Hilfiker Pdf

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.

Solid State Development and Processing of Pharmaceutical Molecules

Michael Gruss
Solid State Development and Processing of Pharmaceutical Molecules Book PDF

Author : Michael Gruss
Publisher : John Wiley & Sons
Page : 578 pages
File Size : 52,6 Mb
Release : 2021-11-15
Category : Science
ISBN : 9783527346356

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Solid State Development and Processing of Pharmaceutical Molecules by Michael Gruss Pdf

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.

Polymorphism in Pharmaceutical Solids

Harry G. Brittain
Polymorphism in Pharmaceutical Solids Book PDF

Author : Harry G. Brittain
Publisher : CRC Press
Page : 448 pages
File Size : 46,8 Mb
Release : 1999-03-03
Category : Medical
ISBN : 0824702379

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Polymorphism in Pharmaceutical Solids by Harry G. Brittain Pdf

"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."

Solid State Characterization of Pharmaceuticals

Richard A. Storey,Ingvar Ymén
Solid State Characterization of Pharmaceuticals Book PDF

Author : Richard A. Storey,Ingvar Ymén
Publisher : John Wiley & Sons
Page : 557 pages
File Size : 55,7 Mb
Release : 2011-03-31
Category : Science
ISBN : 9781119970170

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Solid State Characterization of Pharmaceuticals by Richard A. Storey,Ingvar Ymén Pdf

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

Chemical Engineering in the Pharmaceutical Industry

Mary T. am Ende,David J. am Ende
Chemical Engineering in the Pharmaceutical Industry Book PDF

Author : Mary T. am Ende,David J. am Ende
Publisher : John Wiley & Sons
Page : 1435 pages
File Size : 46,5 Mb
Release : 2019-04-08
Category : Technology & Engineering
ISBN : 9781119285502

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Chemical Engineering in the Pharmaceutical Industry by Mary T. am Ende,David J. am Ende Pdf

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.

Remington

Adeboye Adejare
Remington Book PDF

Author : Adeboye Adejare
Publisher : Academic Press
Page : 1032 pages
File Size : 47,8 Mb
Release : 2020-11-03
Category : Science
ISBN : 9780128223895

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Remington by Adeboye Adejare Pdf

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

Polymorphism in Molecular Crystals

Joel Bernstein
Polymorphism in Molecular Crystals Book PDF

Author : Joel Bernstein
Publisher : Oxford University Press
Page : 429 pages
File Size : 42,6 Mb
Release : 2002
Category : Science
ISBN : 9780198506058

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Polymorphism in Molecular Crystals by Joel Bernstein Pdf

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.

Innovative Dosage Forms

Yogeshwar Bachhav
Innovative Dosage Forms Book PDF

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Page : 470 pages
File Size : 43,6 Mb
Release : 2019-12-04
Category : Science
ISBN : 9783527343966

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Innovative Dosage Forms by Yogeshwar Bachhav Pdf

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.

Solid-State Properties of Pharmaceutical Materials

Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen
Solid State Properties of Pharmaceutical Materials Book PDF

Author : Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen
Publisher : John Wiley & Sons
Page : 432 pages
File Size : 41,7 Mb
Release : 2017-07-12
Category : Science
ISBN : 9781119264446

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Solid-State Properties of Pharmaceutical Materials by Stephen R. Byrn,George Zografi,Xiaoming (Sean) Chen Pdf

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

Pharmaceutical Microscopy

Robert Allen Carlton
Pharmaceutical Microscopy Book PDF

Author : Robert Allen Carlton
Publisher : Springer Science & Business Media
Page : 333 pages
File Size : 43,6 Mb
Release : 2011-05-04
Category : Science
ISBN : 9781441988317

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Pharmaceutical Microscopy by Robert Allen Carlton Pdf

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

Innovation, Economic Development, and Intellectual Property in India and China

Kung-Chung Liu,Uday S. Racherla
Innovation Economic Development and Intellectual Property in India and China Book PDF

Author : Kung-Chung Liu,Uday S. Racherla
Publisher : Springer Nature
Page : 513 pages
File Size : 50,6 Mb
Release : 2019-09-06
Category : Law
ISBN : 9789811381027

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Innovation, Economic Development, and Intellectual Property in India and China by Kung-Chung Liu,Uday S. Racherla Pdf

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.

Handbook of Pharmaceutical Salts Properties, Selection, and Use

P. Heinrich Stahl
Handbook of Pharmaceutical Salts Properties Selection and Use Book PDF

Author : P. Heinrich Stahl
Publisher : John Wiley & Sons
Page : 392 pages
File Size : 55,7 Mb
Release : 2008-08-04
Category : Medical
ISBN : 3906390586

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Handbook of Pharmaceutical Salts Properties, Selection, and Use by P. Heinrich Stahl Pdf

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.

Dosage Form Design Parameters

Anonim
Dosage Form Design Parameters Book PDF

Author : Anonim
Publisher : Academic Press
Page : 810 pages
File Size : 49,6 Mb
Release : 2018-07-25
Category : Medical
ISBN : 9780128144220

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Dosage Form Design Parameters by Anonim Pdf

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