UID:
almafu_9959327388702883
Format:
1 online resource
ISBN:
9783527697830
,
3527697837
,
9783527697847
,
3527697845
Content:
"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.
Note:
Solid State and Polymorphism of the Drug Substance in the Context of Quality by Design and ICH Guidelines Q8-Q12 / Markus Raumer, Rolf Hilfiker -- Alternative Solid Forms: Salts / PH Stahl, Bertrand Sutter, Arnaud Grandeury, Michael Mutz -- Alternative Solid Forms: Co-crystals / Johan Wouters, Dario Braga, Fabrizia Grepioni, Luc Aerts, Luc Quéré -- Thermodynamics of Polymorphs and Solvates / Gerard Coquerel -- Toward Computational Polymorph Prediction / Sarah L Price, Louise S Price -- Hygroscopicity and Hydrates in Pharmaceutical Solids / Susan M Reutzel-Edens, Doris E Braun, Ann W Newman -- The Amorphous State / Marc Descamps, Emeline Dudognon, Jean-François Willart -- Approaches to Solid-Form Screening / Rolf Hilfiker, Fritz Blatter, Martin Szelagiewicz, Markus Raumer -- Nucleation / Marco Mazzotti, Thomas Vetter, David R Ochsenbein, Giovanni M Maggioni, Christian Lindenberg -- Crystallization Process Modeling / Marco Mazzotti, Thomas Vetter, David R Ochsenbein -- Crystallization Process Scale-Up, a Quality by Design (QbD) Perspective / Andrei A Zlota -- Processing-Induced Phase Transformations and Their Implications on Pharmaceutical Product Quality / Seema Thakral, Ramprakash Govindarajan, Raj Suryanarayanan -- Surface and Mechanical Properties of Molecular Crystals -- Analytical Tools to Characterize Solid Forms / Rolf Hilfiker, Susan M De Paul, Timo Rager -- Industry Case Studies / Ralph Diodone, Pirmin C Hidber, Michael Kammerer, Roland Meier, Urs Schwitter, Jürgen Thun -- Pharmaceutical Crystal Forms and Crystal-Form Patents: Novelty and Obviousness1 / Joel Bernstein, Jill MacAlpine.
Additional Edition:
Print version: Polymorphism in the pharmaceutical industry. Weinheim, Germany : Wiley-VCH Verlag GmbH & Co., [2019] ISBN 3527340408
Additional Edition:
ISBN 9783527340408
Language:
English
Keywords:
Electronic books.
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9783527697847
