Polymorphism in the Pharmaceutical Industry (eBook)

Rolf Hilfiker is vice president and head of the department Solid-State Development at Solvias AG in Kaiseraugst, Switzerland. He obtained his PhD in physical chemistry from Basel University (Switzerland) and then did postdoctoral work at Stony Brook University (New York). He returned to Basel University as a research fellow and then moved to Ciba-Geigy (now Novartis) in Basel. In 1997 he became head of the Stability & Kinetics group at Novartis. In 1999 he participated in a management buyout to form Solvias AG. He has taught physical chemistry in New York and Basel, as well as numerous courses in solid-state development in Europe, Asia, and the US. 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.

1) Solid-State and Polymorphism of the Drug Substance in the Context of Quality by Design and ICH Guidelines Q8 to Q12
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