Polymorphism in the Pharmaceutical Industry
Solid Form and Drug Development
1. Edition February 2019
XVI, 496 Pages, Hardcover
191 Pictures (82 Colored Figures)
Handbook/Reference Book
Short Description
Focused on quality by design concepts, this must-have reference for researchers in industry and academia describes theoretical basics of polymorphism and analytical characterization techniques as well as patent issues.
Further versions
"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.
2) Alternative Solid Forms: Salts
3) Alternative Solid Forms: Co-Crystals
4) Thermodynamics of Polymorphs and Solvates
5) Towards Computational Polymorph Prediction
6) Hygroscopicity and Hydrates in Pharmaceutical Solids
7) The Amorphous State
8) Approaches to Solid 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) Surface and Mechanical Properties of Molecular Crystals
14) Analytical Tools to Characterize Solid Forms
15) Industry Case Studies
16) Pharmaceutical Crystal Forms and Crystal Form Patents: Novelty and Obviousness
Markus von Raumer is director and group leader of Preformulation and Preclinical Galenics at Idorsia Pharmaceuticals Ltd. in Allschwil, Switzerland. He obtained his PhD in physical chemistry from the University of Fribourg (Switzerland) and then did postdoctoral work in the field of mass spectrometry at the University of Warwick (UK). In 1997 he became head of laboratory of Physical Chemistry at Novartis in Basel, Switzerland. Two years later he moved to Solvias AG in Basel where he was project manager for Solid-State Development until 2008. He then joined Actelion Pharmaceuticals Ltd. in Allschwil where he built up and led the Material Science lab until 2017.
