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Handbook of Pharmaceutical Salts


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Table of Contents

Introduction (Camille G. Wermuth and P. Heinrich Stahl).

Chapter 1. The Physicochemical Background: Fundamentals of Ionic Equilibria (Michael B. Maurin, David J. W. Grant, and P. Heinrich Stahl).

Chapter 2. Solubility and Dissolution of Weak Acids, Bases, and Salts (Madhu Pudipeddi, Abu T. M. Serajuddin, David J. W. Grant, and P. Heinrich Stahl).

Chapter 3. Evaluation of Solid-State Properties of Salts (Danielle Giron and David J. W. Grant).

Chapter 4. Pharmaceutical Aspects of the API Salt Form (P. Heinrich Stahl and Finlay S. Skinner).

Chapter 5. Biological Effects of the API Salt Form (Friedlieb Pfannkuch, Harald Rettig, and P. Heinrich Stahl).

Chapter 6. Salt-Selection Strategies (Abu T. M. Serajuddin and Madhu Pudipeddi).

Chapter 7. A Procedure for Salt Selection and Optimization (Michael J. Bowker).

Chapter 8. High-Throughput Strategies and Techniques for Salt Screening (Nicole Wyttenbach, Bertrand Sutter, and Pirmin Hidber).

Chapter 9. Large-Scale Aspects of API Salt Manufacture (Piotr H. Karpinski).

Chapter 10. Patent Aspects of API Salt Formation (Hans-Gunther Foraita).

Chapter 11. Regulatory Aspects of API Salts (Maria Arfwedson and Alan Chalmers, Jun-ichi Kondo and P. Heinrich Stahl, and Mansoor A. Khan and Vilayat A. Sayeed).

Chapter 12. Selected Procedures for the Preparation of Pharmaceutically Acceptable Salts (Camille G. Wermuth and P. Heinrich Stahl).

Chapter 13. Monographs on Acids and Bases (P. Heinrich Stahl and Camille G. Wermuth).

Appendix (P. Heinrich Stahl).



About the Author

P. Heinrich Stahl (Author/Editor) studied PharmaceuticalSciences in Freiburg, Germany, and completed his Ph. D. thesis onthe synthesis of purine heterocycles under the supervision of KurtWalter Merz. This was followed by a postdoctoral fellowship at theSloan-Kettering-Institute for Cancer Research, New York. In 1969,he joined in Basel, Switzerland. At CIBA, Basel, Switzerland, hefocused his attention on pharmaceutical technology and solvedproblems in tablet granulate drying. Subsequent to the merger ofthe Ciba and Geigy companies, he built up the Preformulation Groupfor API characterization at the interface between medicinalchemistry, dosage form development, and analytics. After anassignment to the Summit, N.J., research site of Ciba-Geigy, hereturned to Basel to take over the responsibility for specialformulation topics. Since 1995 he was responsible for the globalcoordination of early compound evaluation. After his retirement in1997, he still continues his research at the Biocenter in Basel,focusing on the in vitro modeling of passive drug transport acrosslipid double-layers. Dr. P. H. Stahl is an IUPAC Fellow and amember of the International Association for PharmaceuticalTechnology, of the Pharmaceutical Society of Germany, and of theSwiss Society of Industrial Pharmacists. He has co-authoredmultiple scientific and technological papers, patents, and bookchapters. He is an active consultant to several pharmaceuticalcompanies. Camille G. Wermuth (Author/Editor) PharmD, PhD, Founder,President and Chief Scientific Officer of Prestwick Chemicalis, aformer Professor of Organic and Medicinal Chemistry at the Facultyof Pharmacy at the Louis Pasteur University in Strasbourg, France.Pr. Wermuth's research combines synthesis and molecular modeling,and concentrates mainly on CNS diseases. He is the author andco-author of over 300 peer-reviewed scientific papers and ofseveral books or book chapters, and holds over 60 patents. Pr.Wermuth has been awarded the Charles Mentzer Prize of theSociete Francaise de Chimie Therapeutique, theLeon Velluz Prize of the French Academy of Science, and thePrix de l'Ordre des Pharmaciens by the French Academy of Pharmacy.He is Corresponding Member of the German Pharmaceutical Society,and was nominated Commandeurs des Palmes Academiques. He hasbeen nominated President of the Division of Chemistry and HumanHealth of the International Union of Pure and Applied Chemistry(IUPAC).


"...the editors have produced a rare commodity, a body of knowledge on an important area, summarized in single volume.In a nutshell, this long-overdue volume belongs on the personal shelf of every pharmaceutical scientist working with new chemical entities." (Pharmaceutical Development and Technology)

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