药物剂型科学与技术_实用药品生产文献

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药物剂型科学与技术 307条(本栏目收费,不能显示细节,电话15274084725)

Chapter 1 Preformulation Studies 1 Trevor M. Jones 1

1.1 Introduction 1 1

1.2 Solubility 3 3

1.2.1 Absolute (Intrinsic) Solubility 3 3

1.2.2 Molecular Dissociation pKa 4 4

1.2.3 Solubility in Various Solvents 4 4

1.2.4 Solubility Rate (Dissolution) 5 5

1.3 Diffusion 5 5

1.4 Partition Coefficient 6 6

1.5 Permeability 7 7

1.6 The Biopharmaceutical Classification System 8 8

1.7 Moisture Uptake/Sorption 9 9

1.7.1 Classification of Hygroscopicity 10 10

1.8 Polymorphism and Crystallinity 12 12

1.8.1 Differential Scanning Calorimetry (DSC) 13 13

1.8.2 Thermogravimetric Analysis (TGA) 13 13

1.8.3 Powder X-ray Diffraction 13 13

1.8.4 Crystallinity 14 14

1.9 Stability 14 14

1.9.1 Chemical Degradation in Solution 15 15

1.9.2 Hydrolytic Degradation 16 16

1.9.3 Stability in Solvents Used in Formulation and/or Manufacture 16 16

1.9.4 Dimerization and Polymerisation 16 16

1.9.5 Photostability 16 16

1.9.6 pH-dependent Stability 17 17

1.9.7 Oxidative Stability 17 17

1.9.8 Stability–Compatibility 18 18

1.10 Solid-state Physico–Technical Properties 18 18

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