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Polymorphism in the Pharmaceutical Industry: Solid Form and Drug Development

Polymorphism in the Pharmaceutical Industry: Solid Form and Drug Development

Rolf Hilfiker, Markus von Raumer

ISBN: 978-3-527-69785-4

Oct 2018

392 pages


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"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 and regulatory applications.
As such, the book underscores the importance of solid-state chemistry within chemical and pharmaceutical development in general and polymorphism in particular. 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 described in detail, and a case study on solid-state development processes in industry is 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.
1) The Drug Substance Solid-State and Polymorphism in the Context of Quality by Design and ICH Guidelines Q8 to Q12
2) Alternative Solid Forms: Salts
3) Alternative Solid Forms: Cocrystals
4) Thermodynamics of Polymorphism and Solvates
5) Could a Computer Predict Polymorphs for the Pharmaceutical Industry?
6) Hygroscopicity and Hydrates in Pharmaceutical Solids
7) The Amorphous State
8) Approaches to Form Screening
9) Nucleation
10) Crystallization Process Modeling
11) Crystallization Process Scale-Up, a Quality by Design (QbD) Perspective
12) Processing-Induced Phase Transformations and their Implications on Pharmaceutical Product Quality
13) Surfaces and Mechanical Properties of Molecular Crystals
14) Analytical Tools to Characterize Solid-State Forms
15) Industry Case Studies
16) Pharmaceutical Crystal Forms and Crystal Form Patents: Novelty and Obviousness