Polymorphism: In the Pharmaceutical Industry

Polymorphism – the multiplicity of structures or forms – is used in many disciplines. In chemistry it refers to the existence of more than one crystal structure for a particular chemical substance. The last two decades of the 20th century witnessed a sharp increase in the interest in polymorphic systems, as an intrinsically interesting phenomenon and as an increasingly important component in the development and marketing of a variety of materials based on organic molecules. As a result, every pharmaceutical, agrochemical and specialist chemical company needs "polymorphism know–how", so as to be aware of the compounds they sell and of patent issues.
Edited by one of the leading experts in the field, this up–to–date handbook fills a need by emphasizing exactly why solid–state issues are important. It demonstrates which approaches should be taken to avoid problems and to exploit the opportunities offered by solid–state properties in the pharmaceutical, agricultural and fine chemical industries.
With its practical approach, this is at once a guideline for development chemists just entering this rapidly expanding field as well as a high–quality source of reference material for specialists in the pharmaceutical and chemical industry, structural chemists, physicochemists, crystallographers, inorganic chemists, and patent departments.


Relevance of Solid–state Properties for Pharmaceutical Products
Thermodynamics of Polymorphs
Characterization of Polymorphic Systems using Thermal Analysis
Solid–state NMR Spectroscopy
Vibrational Spectroscopic Methods in Pharmaceutical Solid–state Characterization
Crystallography for Polymorphs
Light Microscopy
The Importance of Solvates
Physical Characterization of Hygroscopicity in Pharmaceutical Solids
The Amorphous State
Approaches to Polymorphism Screening
Salt Selection
Processing–induced Phase Transformations and their Implications on Pharmaceutical Product Quality
Polymorphism and Patents from A Chemist′s Point of View
Scientific Considerations of Pharmaceutical Solid Polymorphism in Regulatory Applications

After gaining his PhD in physical chemistry from Basel University, Switzerland, Rolf Hilfiker did his postdoc at Stony Brook, USA. He returned to Basel as a research fellow, initially at the university and then at Ciba–Geigy. In 1997 he became head of Stability & Kinetics group at Novartis, joining Solvias two years later where he is currently head of the department Solid–State Development. Dr. Hilfiker has taught physical chemistry in New York and Basel, and is a recipient of the Jacottet–Küng Award and a Treubel Fellowship.
He is author of more than 50 scientific publications in various areas of physical chemistry.


"...the book should be warmly welcomed and widely read. I shall frequently want to refer to it myself, and it will be particularly valuable to students learning about the subject. The latter advantage is especially important, given that most undergraduate courses in chemistry seem to ignore polymorphism, in spite of the fact that it is a ubiquitous phenomenon and is of critical industrial importance. The text of the book is generally clearly written and the illustrations are very helpful. The index is useful and the table of contents is very clearly set out. I recommend the book to a wide range of readership in the pharmaceutical industry and in academia – indeed, to all chemists interested in the characterization of solid organic compounds."
Angewandte Chemie