Polymorphism in the pharmaceutical industry : solid form and drug development

種類:

電子ブック

責任表示:

edited by Rolf Hilfiker

出版情報:

2019

著者名:

• Hilfiker, Rolf
• Raumer, Markus von

ISBN:

9783527697830 [3527697837]    
9783527697847 [3527697845]    

注記:

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 Qua
Includes bibliographical references and index.
"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 i
Online resource; title from PDF title page (EBSCO, viewed December 28, 2018).

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