Table of Contents

 

 

 

 

Preface

ix

 

Introduction

xi

 

Book Outline

xv

 

About the Author

xvii

1

What is Clinical Pharmaceutics?

1

 

Introduction

1

 

Physical Concepts

2

 

The Nature of the Dosage Form and Outcomes

18

 

Quality of Effect

19

 

Ingredients in Dosage Forms and their Influence on Outcomes

22

 

Conclusion

23

 

References

24

2

Excipients: Not Always Inert

27

 

Introduction

27

 

Usually But Not Always Inert

27

 

E-Numbers

31

 

Cross-Reactivity

33

 

Dyes Used in Lymph Node Identification

33

 

Non-Ionic Surfactants

33

 

Polyoxyethylene Glycols (PEGs)

35

 

Adjuvants as Therapeutic Substances

35

 

Talc as Therapeutic Agent and Excipient

37

 

Active Excipients in Multiple Therapies

39

 

Conclusions

39

 

References

39

3

Thinking Chemically

41

 

Introduction

41

 

The Chemistry of Drugs and Clinical Pharmaceutics

42

 

Chemical Nomenclature

47

 

Surface-Active Drugs

49

 

Acids and Bases

49

 

Structural Similarities Between Drugs

52

 

Cross-Reactivity

52

 

Beta-Lactam Antibiotics and the Formation of Oligomers

56

 

The Bisphosphonates

57

 

Hydrophobic and Hydrophilic Statins

58

 

Photochemical Reactions and Photoinduced Reactions

59

 

Chelation and Tetracyclines

64

 

Sugammedex: a Cyclodextrin Derivative

64

 

Conclusions

66

 

References

67

4

Looking at Formulations

69

 

Introduction

69

 

Protein Drugs and Formulations

70

 

Monoclonal Antibodies (MAbs)

73

 

Amphotericin B Formulations

74

 

A Doxorubicin Formulation: Doxil

78

 

A Propofol Formulation: Diprivan

78

 

Long-Acting Depot Injections

80

 

Raft-Producing Oral Formulations

83

 

Etoposide (Vepesid, VP 16 and Etoposide Phosphate)

84

 

Paclitaxel

86

 

Eutectic Mixtures of Local Anaesthetics

87

 

Ciclosporin (Cyclosporin)

87

 

Lupron Depot; Prostap SR and Prostap 3

90

 

Zoladex

90

 

Fluoroquinolone Eye Drops

91

 

Lonsys: Lontophoretic Transdermal Device for Fentanyl

93

 

Parenterals

93

 

Chloramphenicol

95

 

Materials Used in Drug Delivery

95

 

Conclusions

97

 

References

98

5

Adverse Events and Formulations and Devices

101

 

Introduction

101

 

Dosage Form Type

103

 

Reactions to Impurities

105

 

Abnormal Bioavailability, High or Low

114

 

Testing for Adverse Effects

114

 

Nanosystems

116

 

Conclusions

118

 

References

119

6

Paediatric, Geriatric and Special Formulations

121

 

Introduction

121

 

Extemporaneous Formulations

122

 

Effect of Formulation and Presentation: a Case from the Literature

124

 

Extemporaneous Formulations and Performance

126

 

The Elderly and their Medication

126

 

Enteral Feeding

128

 

Drug Interactions with Nutrient Formulations

131

 

Conclusions

131

 

References

131

7

Generic Medicines: Conventional Drugs and Biologicals

133

 

Introduction

133

 

Regulatory Statements on Generic Products

134

 

Generics: a Question of Quality

135

 

Specific Conditions and Generics

137

 

Reading and Deconstructing the Literature on Bioequivalence

139

 

Antiretroviral Drugs

139

 

Bioequivalence of Ophthalmic Products

141

 

The Case of Sevoflurane

141

 

Generic Biologicals (Biologics)

144

 

Conclusions

146

 

References

148

8

The Future: Delivery Systems for Modern Therapeutics

151

 

Introduction

151

 

Personalised Medicine and Medicines

151

 

Drug Delivery and Personalised Medicines

152

 

Technologies

155

 

Nanotechnology

160

 

Cell-Based Therapies

165

 

Gene Therapy

168

 

Conclusions

169

 

References

169

 

Index

173