3D Printing of Pharmaceutical and Drug Delivery Devices

Edited by Dimitrios A. Lamprou, (PhD MBA) is the Chair of Biofabrication and Advanced Manufacturing & Director at MSc Industrial Pharmaceutics at Queen’s University Belfast. He is a subject matter expert in Emerging Biopharmaceutical & Pharmaceutical Technologies. Has been named in the Stanford University’s list of World’s Top 2% Scientists, for several consecutive years. Dennis Douroumis, PhD is Professor in Pharmaceutical Technology and Process Engineering at the University of Greenwich, UK. He has published very widely on pharmaceutical technology and has received awards and honors including an Eminent Fellowship of the Academy of Pharmaceutical Sciences. Sheng Qi, PhD is Professor in Pharmaceutics at the School of Pharmacy, University of East Anglia. She has published very widely on pharmaceutical 3D printing and industrial pharmaceutics, and has a strong record of both clinical and industrial partnerships.

About the Editors xv

List of Contributors xvii

Series Preface xxi

Preface xxiii

1 Materials for 3D Printing 1
Thomas McDonagh, Bin Zhang and Sheng Qi

1.1 Introduction 1

1.2 Material Processability Considerations for Pharmaceutical 3DP 2

1.3 Classification of Common Materials Used in Pharmaceutical 3DP 14

1.4 Conclusions and Future Perspectives 19

2 The Use of Microstructure Design and 3D Printing for Tailored Drug Release 29
Bin Zhang, Thomas McDonagh, Joey Yan, Andy Glendale, Richard Bib, Peter Belton and Sheng Qi

2.1 Introduction 29

2.2 3D-Printing Technologies 30

2.3 3D Design for Drug-Loaded Device 33

2.4 3D Designs Influence Drug Release 36

2.5 Challenges and Perspective 39

3 3D Printing of Oral Solid Dosage Forms Using Selective Laser Sintering 43
Atabak, Tabriz Ghanizadeh, Hannah Kuofie, James Scoble, Sam Boulton and Dennis Douroumis

3.1 Introduction 43

3.2 Operational Principles of Selective Laser Sintering 46

3.3 3D-Printed Oral Dosages 50

3.4 Advantages of SLS 59

3.5 Conclusions 61

4 3D Printing for Medical Device Applications 65
Jian-Feng Zhang, Bernabe Tucker, John Tipton, Mahrokh Dadsetan, Scott Jones, Andrea Engel, Theresia Kuntz and Cecile Boudot

4.1 Introduction 65

4.2 3D Printers 66

4.3 Biomaterials for 3D-Printed Medical Devices 69

4.4 3D-Printed Personalised Medical Devices 76

4.5 Regulatory 81

4.6 Future Perspectives 83

5 3D Printed Implants for Long-Acting Drug Delivery 89
Aikaterini Dedeloudi, Sune Andersen, Peyton Hopson and Dimitrios A. Lamprou

5.1 Introduction 89

5.2 Types of 3D-Printed Scaffolds 90

5.3 Critical Parameters in Designing 3D-Printed Implantable Scaffolds 94

5.4 Critical Parameters in Selecting Materials for 3D-Printed Scaffolds 97

5.5 Manufacturing Techniques for Implantable Scaffolds 100

5.6 Drug Release Mechanism of Long-Acting 3D-Printing Polymeric Implantable Systems 105

5.7 Outlining Regulatory Framework for 3D-Printed Implantable Scaffolds 106

5.8 Conclusions 108

6 Wound Dressings by 3D Printing 115
Joshua Boateng

6.1 Wound Healing Process 115

6.2 Case Studies 122

6.3 Summary/Conclusions 126

7 3D Printing of Hydrogels 131
Poornima Ramburrun and Yahya E. Choonara

7.1 Introduction 131

7.2 Applications of 3D-Printed Hydrogels 132

7.3 Types of Hydrogel Materials for 3D Printing 133

7.4 3D Printing Techniques for Hydrogels 136

7.5 Printability and Printing Parameters 138

7.6 Clinical Translation 145

7.7 Conclusions 146

8 Analytical Characterisation of 3D-Printed Medicines 151
Ana Luiza Lima, Lívia L. Sá-Barreto and Marcilio Cunha-Filho

8.1 Introduction 151

8.2 Preformulation 153

8.3 In-Process Characterisations 159

8.4 Final Product 166

8.5 Conclusions 171

9 Adoption of 3D Printing in Pharmaceutical Industry 179
Thomas Kipping

9.1 Partnering and Growing 181

9.2 Regulatory Strategy 182

9.3 Business Model 184

9.4 Regulatory Strategy 185

9.5 Partnering and Growing 185

9.6 Business Model and Strategy 185

10 Clinical Benefits of 3D Printing in Healthcare 187
Atheer Awad, Iria Seoane-Viaño, Abdul W. Basit and Alvaro Goyanes

10.1 Introduction 187

10.2 3D Printing Technologies 189

10.3 Preclinical Applications of 3D Printing 190

10.4 Clinical Applications of 3D Printing 195

10.5 Challenges, Regulatory View and Future Applications 202

10.6 Conclusion 203

11 Regulatory Aspects of 3D-Printed Medicinal Products 211
Maria Malamatari, Ka-Wai Wan and Fotios Baxevanis

11.1 Introduction 211

11.2 Current Regulatory Framework 212

11.3 Quality Aspects of 3D-Printed Medicinal Products 213

11.4 3D-Printed Paediatric Medicinal Products 218

11.5 3D-Printed Systems With Tailored Release Profiles 220

11.6 Conclusions 221

Disclaimer 221

References 222

Index 227