Vor Ort
Merkzettel Warenkorb
Produktbild: Essentials of Pharmaceutical Preformulation

Essentials of Pharmaceutical Preformulation

85,99 €

inkl. gesetzl. MwSt., Versandkostenfrei

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

04.01.2013

Verlag

John Wiley & Sons Inc

Seitenzahl

268

Maße (L/B/H)

24,4/16,7/1,5 cm

Gewicht

522 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-0-470-97636-4

Beschreibung

Produktdetails

Einband

Taschenbuch

Erscheinungsdatum

04.01.2013

Verlag

John Wiley & Sons Inc

Seitenzahl

268

Maße (L/B/H)

24,4/16,7/1,5 cm

Gewicht

522 g

Auflage

1. Auflage

Sprache

Englisch

ISBN

978-0-470-97636-4

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

Noch keine Bewertungen vorhanden

Verfassen Sie die erste Bewertung zu diesem Artikel

Helfen Sie anderen Kundinnen und Kunden durch Ihre Meinung.

Kundinnen und Kunden meinen

Bewertungen (0)
Die Leseprobe wird geladen.
  • Produktbild: Essentials of Pharmaceutical Preformulation
  • Preface xiii

    List of Abbreviations xv

    1 Basic Principles of Preformulation Studies 1

    1.1 Introduction 1

    1.2 Assay design 2

    1.2.1 Assay development 31.3 Concentrations 5

    1.3.1 Units of concentration 5

    1.4 UV spectrophotometry 9

    1.4.1 Method development for UV assays 11

    1.5 Thin-layer chromatography (TLC) 14

    1.5.1 TLC method development 15

    1.5.2 High-performance TLC 17

    1.6 High-performance liquid chromatography 19

    1.6.1 Normal- and reverse-phase HPLC 20

    1.6.2 HPLC method development 21

    1.7 Differential scanning calorimetry 22

    1.7.1 Interpreting DSC data 23

    1.7.2 Modulated-temperature DSC 27

    1.7.3 DSC method development 30

    1.8 Dynamic vapour sorption 32

    1.8.1 DVS method development 32

    1.9 Summary 33

    References 33

    Answer to study question 34

    Additional study questions 35

    2 Ionisation Constants 36

    2.1 Introduction 36

    2.2 Ionisation 36

    2.2.1 Percent ionisation 42

    2.3 Buffers 44

    2.4 Determination of pKa 44

    2.4.1 Determination of pKa by potentiometric titration 45

    2.4.2 Determination of pKa in nonaqueous solvents 45

    2.4.3 Other factors affecting measurement of pKa 47

    2.5 Summary 48

    References 48

    Answers to study questions 49

    Additional self-study questions and answers 50

    3 Partition Affinity 52

    3.1 Introduction 52

    3.2 Partitioning 52

    3.2.1 Effect of partitioning 54

    3.2.2 Determination of log P 55

    3.2.3 Effect of salt formation on partitioning 62

    3.3 Summary 63

    References 63

    Answers to study questions 64

    4 Solubility 65

    4.1 Introduction 65

    4.2 Intrinsic solubility 67

    4.2.1 Ideal solubility 69

    4.2.2 Solubility as a function of temperature 73

    4.2.3 Solubility and physical form 74

    4.2.4 Measurement of intrinsic solubility 77

    4.2.5 Calculation of pKa from solubility data 83

    4.3 Summary 83

    References 84

    Answer to study question 84

    Additional self-study questions and answers 84

    5 Dissolution 86

    5.1 Introduction 86

    5.2 Models of dissolution 86

    5.3 Dissolution testing 87

    5.3.1 Intrinsic dissolution rate (IDR) 92

    5.3.2 IDR as a function of pH 93

    5.3.3 IDR and the common ion effect 94

    5.4 Summary 96

    References 96

    6 Salt Selection 98

    6.1 Introduction 98

    6.2 Salt formation 99

    6.2.1 Selection of a salt-forming acid or base 104

    6.2.2 Salt screening 108

    6.3 Salt solubility 110

    6.3.1 Solubility of basic salts 111

    6.3.2 Solubility of acidic salts 112

    6.3.3 The importance of pHmax 114

    6.4 Dissolution of salts 117

    6.4.1 Modification of pHm 120

    6.5 Partitioning of salts 121

    6.6 Summary 123

    References 124

    Answers to study questions 126

    7 Physical Form I - Crystalline Materials 127

    7.1 Introduction 127

    7.2 Crystal formation 127

    7.2.1 Crystal formation from the melt 128

    7.2.2 Crystal growth from solution 129

    7.3 Crystal structure 130

    7.4 Polymorphism 131

    7.4.1 Thermodynamics of polymorphism 133

    7.4.2 Physicochemical properties of polymorphs 137

    7.5 Pseudopolymorphism 139

    7.6 Polymorph screening 141

    7.7 Characterisation of physical form 141

    7.7.1 Characterisation of polymorphs 142

    7.7.2 Characterisation of pseudopolymorphs 149

    7.8 Summary 152

    References 152

    Answers to study questions 153

    8 Physical Form II - Amorphous Materials 156

    8.1 Introduction 156

    8.2 Formation of amorphous materials 156

    8.3 Ageing of amorphous materials 160

    8.4 Characterisation of amorphous materials 162

    8.4.1 Measurement of ageing 164

    8.5 Processing and formation of amorphous material 168

    8.5.1 Spray-drying 168

    8.5.2 Freeze-drying 168

    8.5.3 Quench-cooling 169

    8.5.4 Milling 170

    8.5.5 Compaction 171

    8.6 Amorphous content quantification 171

    8.6.1 Calibration standards 172

    8.6.2 DSC for amorphous content quantification 173

    8.6.3 DVS for amorphous content quantification 175

    8.7 Summary 177

    References 178

    Answers to study questions 179

    9 Sta