Solid-State Chemistry of Drugs
Stephen R. Byrn, Ralph R. Pfeiffer, and Joseph G. Stowell
SSCI’s second edition has been reorganized and substantively rewritten and includes new science and state-of-the-art methodologies, many new illustrations and references, a Glossary, and a forty-page Index. This text is a comprehensive review of molecular structure in solid drugs, methods of analysis, solid-state physical transformations, and solid-state reactions.
Mechanics and Physical Principles for Powders and Compacts
Everett N. Hiestand
This text is a concise overview of relevant technologies and fundamental concepts in processing of solids, powders, and compacts, prediction of tableting and other material properties, and formulation of solid dosage forms.
Specification of Drug Substances and Products: Development and Validation of Analytical Methods
Thomas W. Rosanske (Editor), Shelley R. Rabel Riley (Editor)
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.
Solid-State Properties of Pharmaceutical Materials
Stephen R. Byrn, George Zografi, Xiaoming (Sean) Chen
Presents a detailed discussion of important solid-state properties, methods, and applications of solid-state analysis.
- Illustrates the various phases or forms that solids can assume and discusses various issues related to the relative stability of solid forms and tendencies to undergo transformation
- Covers key methods of solid state analysis including X-ray powder diffraction, thermal analysis, microscopy, spectroscopy, and solid state NMR
- Reviews critical physical attributes of pharmaceutical materials, mainly related to drug substances, including particle size/surface area, hygroscopicity, mechanical properties, solubility, and physical and chemical stability
- Showcases the application of solid state material science in rational selection of drug solid forms, analysis of various solid forms within drug substance and the drug product, and pharmaceutical product development
- Introduces appropriate manufacturing and control procedures using Quality by Design, and other strategies that lead to safe and effective products with a minimum of resources and time.