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Full Description
Updated and expanded information on the properties of pharmaceutical solids and their impact on drug product performance, quality, and stability
Solid-State Materials in Pharmaceutical Chemistry provides readers with a comprehensive and up-to-date resource for understanding and controlling the solid-state properties of pharmaceutical materials, enabling the development of safe and effective medicines including small molecule compounds, peptides, proteins, and nucleotides. This new edition covers the significant transformations in the landscape of pharmaceutical research, development, and manufacturing since the previous edition was published, presenting both novel challenges and unprecedented opportunities.
New chapters in this edition cover physical and chemical properties of RNA therapeutics, a frontier to many life-saving medicines and vaccines including Covid vaccines, and final stage drug substance manufacturing and control, addressing challenges in API process development including impurity purging, chiral separation, final form preparation, particle size reduction, and nitrosamine control. Readers will also find other updated topics including bulk and surface properties of solids, lipid nanoparticles, applications of pharmaceutical solvates in impurity purging and final form preparation, pharmaceutical cocrystal engineering to enable chiral separation, the emerging technique of microcrystal electron diffraction in solid form characterization, poor wettability of APIs, oral delivery of peptides such as semaglutide, injectable drug-device combination products, and N-nitrosamine control in drug product.
This updated and revised Second Edition still features:
Physical and chemical properties of solid-state pharmaceuticals such as amorphous forms, mesophases, polymorphs, hydrates/solvates, salts, co-crystals, nano-particles, and solid dispersions
Characterization techniques for solid form identification and physical attribute analysis such as X-Ray powder diffraction, thermal analysis, microscopy, spectroscopy, solid state NMR, particle analysis, water sorption, mechanical property testing, solubility, and dissolution
Applications of pharmaceutical chemistry and physical characterization techniques in developing and testing drug substances and drug products for small molecules and biopharmaceuticals
This book is an essential resource on the subject for formulation scientists, process chemists, medicinal chemists, and analytical chemists. The book will also appeal to quality control, quality assurance, and regulatory affair specialists and advanced undergraduate and graduate students in pharmaceutical chemistry, drug delivery, material science, crystal engineering, pharmaceutics, and biopharmaceutics.
Contents
Biography of Authors xv
Preface xvii
Preface to the First Edition xvii
Acknowledgment xix
1 Solid-State Properties and Pharmaceutical Development 1
2 Polymorphs 27
3 Pseudopolymorphs: Hydrates and Solvates 49
4 Pharmaceutical Salts 65
5 Pharmaceutical Cocrystals 81
6 Amorphous Solids 97
7 Crystal Mesophases and Nanocrystals 121
8 X-Ray Crystallography and Crystal-Packing Analysis 131
9 X-Ray Powder Diffraction 139
10 Differential Scanning Calorimetry and Thermogravimetric Analysis 159
11 Microscopy 181
12 Vibrational Spectroscopy 203
13 Solid-State NMR Spectroscopy 227
14 Particle and Powder Analysis 247
15 Hygroscopic Properties of Solids 267
16 Mechanical Properties of Pharmaceutical Materials 287
17 Solubility and Dissolution 307
18 Physical Stability of Solids 329
19 Chemical Stability of Solids 349
20 Solid-State Properties of Proteins 375
21 Physical and Chemical Properties of RNA Therapeutics 389
22 Solid Form Selection of Active Pharmaceutical Ingredients 411
23 Final Stage Drug Substance Manufacturing and Control 431
24 Solid-State Mixture Analysis 455
25 Drug Product Development 479
26 Quality by Design 511
Index 527
