Drug Delivery Approaches (eBook, ePUB)

Perspectives from Pharmacokinetics and Pharmacodynamics
Redaktion: Berner, Bret; Roberts, Michael S.; Benson, Heather A. E.; Gordi, Toufigh

• Format: ePub

Produktbeschreibung

Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: * A thorough introduction to the utility of mathematical models in drug development and delivery * An exploration of the techniques and applications of physiologically based models to drug delivery * Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery * A review of integrated transdermal delivery and pharmacokinetics in development * An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms * Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 464
• Erscheinungstermin: 4. August 2021
• Englisch
• ISBN-13: 9781119772750
• Artikelnr.: 62420879

Autorenporträt

Bret Berner, PhD, is a pharmaceutical consultant in drug delivery, formulation, and pharmacokinetics. He was formerly Director of Basic Pharmaceutics Research at Ciba-Geigy, Vice President of Development at Cygnus Therapeutics, and Chief Scientific Officer at Depomed. Toufigh Gordi, PhD, is a Senior Director of clinical pharmacology at Rigel Pharmaceuticals, with extensive experience in using pharmacokinetic and pharmacodynamic modeling to advance candidate drug molecules from preclinical through late phase confirmatory clinical studies. Heather A. E. Benson, PhD, is Associate Professor in Curtin Medical School at Curtin University, Australia where she leads the Skin Delivery Research Group Michael S. Roberts, PhD, is Professor of Therapeutics and Pharmaceutical Science at the University of South Australia and Professor of Clinical Pharmacology and Therapeutics at the University of Queensland.

Inhaltsangabe

Preface xv

1 Introduction: Utility of Mathematical Models in Drug Development and Delivery 1
Toufigh Gordi and Bret Berner

1.1 Introduction 1

1.2 Use of Mathematical Models in Drug Development 2

1.3 Noncompartmental Analysis 3

1.4 Pharmacokinetic (PK) Models 5

1.5 Physiologically Based Pharmacokinetic (PBPK) Models 7

1.6 Pharmacokinetic/Pharmacodynamic (PK/PD) Models 9

1.7 Systems Pharmacology Models 12

1.8 Utility of PK/PD Analysis and Models in Drug Development 14

1.8.1 Drug Delivery and PK/PD 26

1.8.2 Drug Properties and Mechanism of Release from the Dosage Form 27

1.8.2.1 Temporal Pattern of Delivery 30

1.9 Discussion 32

References 34

2 Physiologically Based Models: Techniques and Applications to Drug Delivery 43
Richard N. Upton, Ashley M. Hopkins, Ahmad Y. Abuhelwa, Jim H. Hughes and David J.R. Foster

2.1 Introduction 43

2.2 Types of Pharmacokinetic Models 43

2.3 Commercial vs. Bespoke PBPK Models 45

2.4 Data Sources 46

2.5 Applications of PBPK Models 46

2.6 Techniques of PBPK Modeling 48

2.6.1 The "Language" of PBPK Models 48

2.6.2 Oral Absorption Models 49

2.6.3 Drug Metabolism and Drug-Drug Interactions 56

2.6.4 Drug Transporters 58

2.6.5 Renal Elimination 59

2.6.6 Protein Binding 59

2.6.7 Accounting for Size 61

2.6.8 Accounting for Age 63

2.6.9 Interspecies Scaling 64

2.6.10 Between-Subject Variability 65

2.6.11 Sensitivity Analysis 66

2.6.12 Pharmacodynamics 66

2.7 Summary 68

References 68

3 Oral Delivery and Pharmacokinetic Models 75
Wojciech Krzyzanski

3.1 Introduction 75

3.2 Compartmental Models 76

3.2.1 First-Order Absorption 76

3.2.2 Zero-Order Absorption 78

3.2.3 Absorption Delay 78

3.2.4 Parallel Inputs 80

3.2.5 Discontinuous Absorption 81

3.2.6 Compartmental Absorption and Transit 81

3.2.7 Gastrointestinal Transit Time 82

3.2.8 Other Compartmental Models 82

3.3 Empirical Models 82

3.3.1 Gamma Model 83

3.3.2 Weibull Model 83

3.3.3 Inverse Gaussian Model 85

3.4 Physiologically Based Pharmacokinetic Models of Drug Absorption 85

3.4.1 Traditional and Segregated-Flow Models 86

3.5 Advanced PBPK Models 88

3.5.1 Advanced Compartmental Absorption and Transit Model 88

3.5.2 Advanced Dissolution Absorption and Metabolism Model 89

3.6 Intestinal First-pass Drug Metabolism 90

3.6.1 Well-stirred Gut Model 90

3.6.2 QGut Model 91

3.7 Spatiotemporal Models of Drug Absorption 91

3.7.1 Dispersion Model 92

3.7.2 Translocation Model 92

3.8 Conclusions 93

References 94

4 Oral Site-Directed Drug Delivery and Influence on PK 99
Peter Scholes, Vanessa Zann, Wu Lin, Chris Roe and Bret Berner

4.1 Introduction 99

4.2 GI Anatomy and Physiology 99

4.2.1 Anatomy 100

4.2.2 Regional Variations in Physiology Affecting Drug Delivery 101

4.2.2.1 Fluid Volume and pH 101

4.2.2.2 Enzymes, GutWall Metabolism, Tissue Permeability, and Transporters 102

4.2.2.3 Gender and Age Effects 111

4.2.2.4 GI Transit 112

4.2.2.5 Effect of Food 114

4.2.2.6 Enterohepatic Circulation 115

4.3 Biopharmaceutics Classification System (BCS) 116

4.3.1 Background and Regulatory Perspective