Das Werk vermittelt einen Überblick über die Grundlagen der Medikamentenverabreichung und die wichtigsten Prozesse bei der Entwicklung von Systemen zur kontrollierten Medikamentenverabreichung. Im ersten Teil wird das Konzept der Medikamentenverabreichung erläutert, und es werden die Herausforderungen, Chancen und grundlegenden Prozesse bei der Entwicklung von Systemen zur kontrollierten Verabreichung vorgestellt. Im zweiten Teil geht es um eine umfassende Auseinandersetzung mit den üblichen Verabreichungswegen bei der kontrollierten Medikamentenverabreichung. Dabei wird in jedem Kapitel die…mehr
Das Werk vermittelt einen Überblick über die Grundlagen der Medikamentenverabreichung und die wichtigsten Prozesse bei der Entwicklung von Systemen zur kontrollierten Medikamentenverabreichung. Im ersten Teil wird das Konzept der Medikamentenverabreichung erläutert, und es werden die Herausforderungen, Chancen und grundlegenden Prozesse bei der Entwicklung von Systemen zur kontrollierten Verabreichung vorgestellt. Im zweiten Teil geht es um eine umfassende Auseinandersetzung mit den üblichen Verabreichungswegen bei der kontrollierten Medikamentenverabreichung. Dabei wird in jedem Kapitel die für den jeweiligen Verabreichungsweg relevante Physiologie erläutert, und es werden insbesondere die Grenzen der Verabreichung aufgezeigt. Im letzten Teil liegt der Schwerpunkt auf den besonderen Herausforderungen bei der kontrollierten Medikamentenverabreichung und fortschrittlichen Verabreichungstechnologien ? auch bei Verabreichungssystemen für biologische Wirkstoffe mit ihren ganz eigenengewaltigen Herausforderungen.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Heather A.E. Benson, PhD is an Associate Professor at the Curtin Medical School, 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 a Professor of Clinical Pharmacology and Therapeutics at the University of Queensland, Australia. Adrian C. Williams, PhD is Professor of Pharmaceutics and Research Dean at University of Reading, England, UK. Xiaowen Liang, PhD is the UQ Development Fellow at The University of Queensland, Australia.
Inhaltsangabe
Preface xvii
List of Contributors xix
Part I Product Design, the Essence of Effective Therapeutics 1
1 Challenges and Innovations of Controlled Drug Delivery 3 Heather A.E. Benson and Michael S. Roberts
1.1 Background 3
1.2 Parenteral Dosage Forms 3
1.2.1 Intravenous Route (IV) 4
1.2.2 Intramuscular Route (IM) 5
1.2.3 Subcutaneous Route (SC) 5
1.2.4 Other Parenteral Routes 5
1.3 Oral Route and Delivery Systems 6
1.4 Nasal Drug Delivery 6
1.5 Pulmonary Drug Delivery 7
1.6 Transdermal Drug Delivery 7
1.7 Ocular Drug Delivery 9
1.8 Drug Delivery System Development Process 11
1.9 Conclusion 12
References 12
2 Challenges in Design of Drug Delivery Systems 15 S. Narasimha Murthy, Shivakumar H.N, and Sarasija Suresh
2.1 Drug Properties to be Considered in Design of Controlled Release Products 19
2.2 Physicochemical Factors that Need to be Considered in Design of CRDDS 19
2.2.1 Dose Size 19
2.2.2 MolecularWeight/Size 19
2.2.3 Aqueous Solubility 21
2.2.4 Lipid Solubility and Partition Coefficient 25
2.2.5 Physicochemical Stability 26
2.3 Biopharmaceutical Properties that Deserve Consideration in Design of Controlled Release Products 26
2.3.1 Biological Half-life 26
2.3.2 Absorption 27
2.3.3 Metabolism 30
2.3.4 Presystemic Clearance 32
2.3.5 Margin of Safety 32
2.3.6 Adverse Effects 33
2.3.7 Therapeutic Need 33
2.3.8 Role of Circadian Rhythm 34
2.4 Conclusion 35
References 35
3 Drug Delivery of the Future (?) 39 Adrian Williams
3.1 Introduction 39
3.2 Therapeutic Indicators 40
3.3 Drugs of the Future 43
3.4 Delivering the Drugs of the Future 45
3.5 A View to the Longer Term? 47
3.6 Conclusion 50
References 50
4 The Pharmaceutical Drug Development Process: Selecting a Suitable Drug Candidate 37 Lionel Trottet
4.1 The Oral Drug Candidate: How to Get There and Questions to Answer 53
4.2 Challenges for Selecting a Topical Drug Candidate 55
4.3 Percutaneous Flux as a Surrogate Measurement of Skin Tissue Concentration 57
4.4 Learnings from Past Topical Drug Development of Factors Affecting Efficacy 58
4.5 Dermal Pharmacokinetics/Pharmacodynamics 62
4.6 Assessment of Systemic Exposure 63
4.7 Screening Cascade Approach to Select a Dermal Drug Candidate 64
4.7.1 Efficacy (Lack of Target Engagement) 64
4.7.2 Developability 65
4.7.3 Local Safety 65
4.7.4 Systemic Safety 65
4.8 Opportunities for Repurposing Molecules into Dermally Active Treatments for Cosmeceutical or Pharmaceutical Approaches 66
4.9 Conclusion 66
References 67
5 Preformulation and Physicochemical Characterization Underpinning the Development of Controlled Drug Delivery Systems 73 Ronak Savla and Julien Meissonnier
5.1 When Is a Controlled Drug Delivery System Needed? 73
5.2 Optimizing Drug Characteristics 74
5.3 Defining the Product Profile 75
5.4 Preformulation and Physicochemical Characterization Underpinning Development of CDD 77
Part I Product Design, the Essence of Effective Therapeutics 1
1 Challenges and Innovations of Controlled Drug Delivery 3 Heather A.E. Benson and Michael S. Roberts
1.1 Background 3
1.2 Parenteral Dosage Forms 3
1.2.1 Intravenous Route (IV) 4
1.2.2 Intramuscular Route (IM) 5
1.2.3 Subcutaneous Route (SC) 5
1.2.4 Other Parenteral Routes 5
1.3 Oral Route and Delivery Systems 6
1.4 Nasal Drug Delivery 6
1.5 Pulmonary Drug Delivery 7
1.6 Transdermal Drug Delivery 7
1.7 Ocular Drug Delivery 9
1.8 Drug Delivery System Development Process 11
1.9 Conclusion 12
References 12
2 Challenges in Design of Drug Delivery Systems 15 S. Narasimha Murthy, Shivakumar H.N, and Sarasija Suresh
2.1 Drug Properties to be Considered in Design of Controlled Release Products 19
2.2 Physicochemical Factors that Need to be Considered in Design of CRDDS 19
2.2.1 Dose Size 19
2.2.2 MolecularWeight/Size 19
2.2.3 Aqueous Solubility 21
2.2.4 Lipid Solubility and Partition Coefficient 25
2.2.5 Physicochemical Stability 26
2.3 Biopharmaceutical Properties that Deserve Consideration in Design of Controlled Release Products 26
2.3.1 Biological Half-life 26
2.3.2 Absorption 27
2.3.3 Metabolism 30
2.3.4 Presystemic Clearance 32
2.3.5 Margin of Safety 32
2.3.6 Adverse Effects 33
2.3.7 Therapeutic Need 33
2.3.8 Role of Circadian Rhythm 34
2.4 Conclusion 35
References 35
3 Drug Delivery of the Future (?) 39 Adrian Williams
3.1 Introduction 39
3.2 Therapeutic Indicators 40
3.3 Drugs of the Future 43
3.4 Delivering the Drugs of the Future 45
3.5 A View to the Longer Term? 47
3.6 Conclusion 50
References 50
4 The Pharmaceutical Drug Development Process: Selecting a Suitable Drug Candidate 37 Lionel Trottet
4.1 The Oral Drug Candidate: How to Get There and Questions to Answer 53
4.2 Challenges for Selecting a Topical Drug Candidate 55
4.3 Percutaneous Flux as a Surrogate Measurement of Skin Tissue Concentration 57
4.4 Learnings from Past Topical Drug Development of Factors Affecting Efficacy 58
4.5 Dermal Pharmacokinetics/Pharmacodynamics 62
4.6 Assessment of Systemic Exposure 63
4.7 Screening Cascade Approach to Select a Dermal Drug Candidate 64
4.7.1 Efficacy (Lack of Target Engagement) 64
4.7.2 Developability 65
4.7.3 Local Safety 65
4.7.4 Systemic Safety 65
4.8 Opportunities for Repurposing Molecules into Dermally Active Treatments for Cosmeceutical or Pharmaceutical Approaches 66
4.9 Conclusion 66
References 67
5 Preformulation and Physicochemical Characterization Underpinning the Development of Controlled Drug Delivery Systems 73 Ronak Savla and Julien Meissonnier
5.1 When Is a Controlled Drug Delivery System Needed? 73
5.2 Optimizing Drug Characteristics 74
5.3 Defining the Product Profile 75
5.4 Preformulation and Physicochemical Characterization Underpinning Development of CDD 77
5.4.1 Feasibility and Risk Assessment 78
5.4.2 Solubility and Dissolution Rate 79
5.4.3 Permeability 82
5.4.4 Drug and Drug Product Particle Sizes 83
5.4.5 Solid-State Chemistry 84
5.4.6 Stability 85
5.4.7 Excipient Compatibility 8
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