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Author Byrn, Stephen R., author

Title Solid state properties of pharmaceutical materials / Stephen R. Byrn, George Zografi, Xiaoming (Sean) Chen
Published Hoboken, NJ : Wiley, 2017
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Description 1 online resource
Contents Solid-State Properties of Pharmaceutical Materials; Contents; Preface; Acknowledgments; 1 Solid-State Properties and Pharmaceutical Development; 1.1 Introduction; 1.2 Solid-State Forms; 1.3 ICH Q6A Decision Trees; 1.4 "Big Questions" for Drug Development; 1.5 Accelerating Drug Development; 1.6 Solid-State Chemistry in Preformulation and Formulation; 1.7 Learning Before Doing and Quality by Design; 1.8 Performance and Stability in Pharmaceutical Development; 1.9 Moisture Uptake; 1.10 Solid-State Reactions; 1.11 Noninteracting Formulations: Physical Characterizations; References; 2 Polymorphs
2.1 Introduction2.2 How Are Polymorphs Formed?; 2.3 Structural Aspect of Polymorphs; 2.3.1 Configurational Polymorphs; 2.3.2 Conformational Polymorphs; 2.4 Physical, Chemical, and Mechanical Properties; 2.4.1 Solubility; 2.4.2 Chemical Stability; 2.4.3 Mechanical Properties; 2.5 Thermodynamic Stability of Polymorphs; 2.5.1 Monotropy and Enantiotropy; 2.5.2 Burger and Rambergers Rules; 2.5.3 vant Hoff Plot; 2.5.4 DG/Temperature Diagram; 2.6 Polymorph Conversion; 2.6.1 Solution-Mediated Transformation; 2.6.2 Solid-State Conversion; 2.7 Control of Polymorphs; 2.8 Polymorph Screening
2.9 Polymorph PredictionReferences; 3 Solvates and Hydrates; 3.1 Introduction; 3.2 Pharmaceutical Importance of Hydrates; 3.3 Classification of Pharmaceutical Hydrates; 3.4 Water Activity; 3.5 Stoichiometric Hydrates; 3.6 Nonstoichiometric Hydrates; 3.7 Hydration/Dehydration; 3.8 Preparation and Characterization of Hydrates and Solvates; References; 4 Pharmaceutical Salts; 4.1 Introduction; 4.2 Importance of Pharmaceutical Salts; 4.3 Weak Acid, Weak Base, and Salt; 4.4 pH-Solubility Profiles of Ionizable Compounds; 4.5 Solubility, Dissolution, and Bioavailability of Pharmaceutical Salts
4.6 Physical Stability of Pharmaceutical Salts4.7 Strategies for Salt Selection; References; 5 Pharmaceutical Cocrystals; 5.1 Introduction; 5.2 Cocrystals and Crystal Engineering; 5.3 Solubility Phase Diagrams For Cocrystals; 5.4 Preparation of Cocrystals; 5.5 Dissolution and Bioavailability of Cocrystals; 5.6 Comparison of Pharmaceutical Salts and Cocrystals; References; 6 Amorphous Solids; 6.1 Introduction; 6.2 The Formation of Amorphous Solids; 6.3 Methods of Preparing Amorphous Solids; 6.4 The Glass Transition Temperature; 6.5 Structural Features of Amorphous Solids
6.6 Molecular Mobility6.6.1 Overview of Molecular Mobility; 6.6.2 Viscosity and Molecular Mobility; 6.6.3 Relaxation Time; 6.6.4 Fragility in Supercooled Liquids; 6.6.5 Diffusive Relaxation Time in the Glassy State; 6.6.6 Secondary Relaxations in Amorphous Solids; 6.7 Mixtures of Amorphous Solids; 6.7.1 Overview; 6.7.2 Thermodynamics of Molecular Mixing in Amorphous Solids; 6.7.3 The Glass Transition Temperature and Molecular Mobility of Miscible Amorphous Mixtures; References; 7 Crystal Mesophases and Nanocrystals; 7.1 Introduction; 7.2 Overview of Crystal Mesophases; 7.3 Liquid Crystals
Summary 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 discussesvarious 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
Notes Includes index
Bibliography Includes bibliographical references and index
Notes Print version record and CIP data provided by publisher
Subject Pharmaceutical Preparations -- chemistry
Chemistry Techniques, Analytical
Dosage Forms
Pharmaceutical Preparations -- analysis
Solid dosage forms -- Properties
Solid state chemistry
MEDICAL -- Pharmacology.
Solid state chemistry.
Form Electronic book
Author Chen, Xiaoming (Sean), author
Zografi, George, author
LC no. 2017008527
ISBN 1118145305
1119264405
1119264448
1119264456
9781118145302
9781119264408
9781119264446
9781119264453