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 xvList of Contributors xviiSeries Preface xxiPreface xxiii1 Materials for 3D Printing 1Thomas McDonagh, Bin Zhang and Sheng Qi1.1 Introduction 11.2 Material Processability Considerations for Pharmaceutical 3DP 21.3 Classification of Common Materials Used in Pharmaceutical 3DP 141.4 Conclusions and Future Perspectives 192 The Use of Microstructure Design and 3D Printing for Tailored Drug Release 29Bin Zhang, Thomas McDonagh, Joey Yan, Andy Glendale, Richard Bib, Peter Belton and Sheng Qi2.1 Introduction 292.2 3D-Printing Technologies 302.3 3D Design for Drug-Loaded Device 332.4 3D Designs Influence Drug Release 362.5 Challenges and Perspective 393 3D Printing of Oral Solid Dosage Forms Using Selective Laser Sintering 43Atabak, Tabriz Ghanizadeh, Hannah Kuofie, James Scoble, Sam Boulton and Dennis Douroumis3.1 Introduction 433.2 Operational Principles of Selective Laser Sintering 463.3 3D-Printed Oral Dosages 503.4 Advantages of SLS 593.5 Conclusions 614 3D Printing for Medical Device Applications 65Jian-Feng Zhang, Bernabe Tucker, John Tipton, Mahrokh Dadsetan, Scott Jones, Andrea Engel, Theresia Kuntz and Cecile Boudot4.1 Introduction 654.2 3D Printers 664.3 Biomaterials for 3D-Printed Medical Devices 694.4 3D-Printed Personalised Medical Devices 764.5 Regulatory 814.6 Future Perspectives 835 3D Printed Implants for Long-Acting Drug Delivery 89Aikaterini Dedeloudi, Sune Andersen, Peyton Hopson and Dimitrios A. Lamprou5.1 Introduction 895.2 Types of 3D-Printed Scaffolds 905.3 Critical Parameters in Designing 3D-Printed Implantable Scaffolds 945.4 Critical Parameters in Selecting Materials for 3D-Printed Scaffolds 975.5 Manufacturing Techniques for Implantable Scaffolds 1005.6 Drug Release Mechanism of Long-Acting 3D-Printing Polymeric Implantable Systems 1055.7 Outlining Regulatory Framework for 3D-Printed Implantable Scaffolds 1065.8 Conclusions 1086 Wound Dressings by 3D Printing 115Joshua Boateng6.1 Wound Healing Process 1156.2 Case Studies 1226.3 Summary/Conclusions 1267 3D Printing of Hydrogels 131Poornima Ramburrun and Yahya E. Choonara7.1 Introduction 1317.2 Applications of 3D-Printed Hydrogels 1327.3 Types of Hydrogel Materials for 3D Printing 1337.4 3D Printing Techniques for Hydrogels 1367.5 Printability and Printing Parameters 1387.6 Clinical Translation 1457.7 Conclusions 1468 Analytical Characterisation of 3D-Printed Medicines 151Ana Luiza Lima, Lívia L. Sá-Barreto and Marcilio Cunha-Filho8.1 Introduction 1518.2 Preformulation 1538.3 In-Process Characterisations 1598.4 Final Product 1668.5 Conclusions 1719 Adoption of 3D Printing in Pharmaceutical Industry 179Thomas Kipping9.1 Partnering and Growing 1819.2 Regulatory Strategy 1829.3 Business Model 1849.4 Regulatory Strategy 1859.5 Partnering and Growing 1859.6 Business Model and Strategy 18510 Clinical Benefits of 3D Printing in Healthcare 187Atheer Awad, Iria Seoane-Viaño, Abdul W. Basit and Alvaro Goyanes10.1 Introduction 18710.2 3D Printing Technologies 18910.3 Preclinical Applications of 3D Printing 19010.4 Clinical Applications of 3D Printing 19510.5 Challenges, Regulatory View and Future Applications 20210.6 Conclusion 20311 Regulatory Aspects of 3D-Printed Medicinal Products 211Maria Malamatari, Ka-Wai Wan and Fotios Baxevanis11.1 Introduction 21111.2 Current Regulatory Framework 21211.3 Quality Aspects of 3D-Printed Medicinal Products 21311.4 3D-Printed Paediatric Medicinal Products 21811.5 3D-Printed Systems With Tailored Release Profiles 22011.6 Conclusions 221Disclaimer 221References 222Index 227

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 xvList of Contributors xviiSeries Preface xxiPreface xxiii1 Materials for 3D Printing 1Thomas McDonagh, Bin Zhang and Sheng Qi1.1 Introduction 11.2 Material Processability Considerations for Pharmaceutical 3DP 21.3 Classification of Common Materials Used in Pharmaceutical 3DP 141.4 Conclusions and Future Perspectives 192 The Use of Microstructure Design and 3D Printing for Tailored Drug Release 29Bin Zhang, Thomas McDonagh, Joey Yan, Andy Glendale, Richard Bib, Peter Belton and Sheng Qi2.1 Introduction 292.2 3D-Printing Technologies 302.3 3D Design for Drug-Loaded Device 332.4 3D Designs Influence Drug Release 362.5 Challenges and Perspective 393 3D Printing of Oral Solid Dosage Forms Using Selective Laser Sintering 43Atabak, Tabriz Ghanizadeh, Hannah Kuofie, James Scoble, Sam Boulton and Dennis Douroumis3.1 Introduction 433.2 Operational Principles of Selective Laser Sintering 463.3 3D-Printed Oral Dosages 503.4 Advantages of SLS 593.5 Conclusions 614 3D Printing for Medical Device Applications 65Jian-Feng Zhang, Bernabe Tucker, John Tipton, Mahrokh Dadsetan, Scott Jones, Andrea Engel, Theresia Kuntz and Cecile Boudot4.1 Introduction 654.2 3D Printers 664.3 Biomaterials for 3D-Printed Medical Devices 694.4 3D-Printed Personalised Medical Devices 764.5 Regulatory 814.6 Future Perspectives 835 3D Printed Implants for Long-Acting Drug Delivery 89Aikaterini Dedeloudi, Sune Andersen, Peyton Hopson and Dimitrios A. Lamprou5.1 Introduction 895.2 Types of 3D-Printed Scaffolds 905.3 Critical Parameters in Designing 3D-Printed Implantable Scaffolds 945.4 Critical Parameters in Selecting Materials for 3D-Printed Scaffolds 975.5 Manufacturing Techniques for Implantable Scaffolds 1005.6 Drug Release Mechanism of Long-Acting 3D-Printing Polymeric Implantable Systems 1055.7 Outlining Regulatory Framework for 3D-Printed Implantable Scaffolds 1065.8 Conclusions 1086 Wound Dressings by 3D Printing 115Joshua Boateng6.1 Wound Healing Process 1156.2 Case Studies 1226.3 Summary/Conclusions 1267 3D Printing of Hydrogels 131Poornima Ramburrun and Yahya E. Choonara7.1 Introduction 1317.2 Applications of 3D-Printed Hydrogels 1327.3 Types of Hydrogel Materials for 3D Printing 1337.4 3D Printing Techniques for Hydrogels 1367.5 Printability and Printing Parameters 1387.6 Clinical Translation 1457.7 Conclusions 1468 Analytical Characterisation of 3D-Printed Medicines 151Ana Luiza Lima, Lívia L. Sá-Barreto and Marcilio Cunha-Filho8.1 Introduction 1518.2 Preformulation 1538.3 In-Process Characterisations 1598.4 Final Product 1668.5 Conclusions 1719 Adoption of 3D Printing in Pharmaceutical Industry 179Thomas Kipping9.1 Partnering and Growing 1819.2 Regulatory Strategy 1829.3 Business Model 1849.4 Regulatory Strategy 1859.5 Partnering and Growing 1859.6 Business Model and Strategy 18510 Clinical Benefits of 3D Printing in Healthcare 187Atheer Awad, Iria Seoane-Viaño, Abdul W. Basit and Alvaro Goyanes10.1 Introduction 18710.2 3D Printing Technologies 18910.3 Preclinical Applications of 3D Printing 19010.4 Clinical Applications of 3D Printing 19510.5 Challenges, Regulatory View and Future Applications 20210.6 Conclusion 20311 Regulatory Aspects of 3D-Printed Medicinal Products 211Maria Malamatari, Ka-Wai Wan and Fotios Baxevanis11.1 Introduction 21111.2 Current Regulatory Framework 21211.3 Quality Aspects of 3D-Printed Medicinal Products 21311.4 3D-Printed Paediatric Medicinal Products 21811.5 3D-Printed Systems With Tailored Release Profiles 22011.6 Conclusions 221Disclaimer 221References 222Index 227

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 xvList of Contributors xviiSeries Preface xxiPreface xxiii1 Materials for 3D Printing 1Thomas McDonagh, Bin Zhang and Sheng Qi1.1 Introduction 11.2 Material Processability Considerations for Pharmaceutical 3DP 21.3 Classification of Common Materials Used in Pharmaceutical 3DP 141.4 Conclusions and Future Perspectives 192 The Use of Microstructure Design and 3D Printing for Tailored Drug Release 29Bin Zhang, Thomas McDonagh, Joey Yan, Andy Glendale, Richard Bib, Peter Belton and Sheng Qi2.1 Introduction 292.2 3D-Printing Technologies 302.3 3D Design for Drug-Loaded Device 332.4 3D Designs Influence Drug Release 362.5 Challenges and Perspective 393 3D Printing of Oral Solid Dosage Forms Using Selective Laser Sintering 43Atabak, Tabriz Ghanizadeh, Hannah Kuofie, James Scoble, Sam Boulton and Dennis Douroumis3.1 Introduction 433.2 Operational Principles of Selective Laser Sintering 463.3 3D-Printed Oral Dosages 503.4 Advantages of SLS 593.5 Conclusions 614 3D Printing for Medical Device Applications 65Jian-Feng Zhang, Bernabe Tucker, John Tipton, Mahrokh Dadsetan, Scott Jones, Andrea Engel, Theresia Kuntz and Cecile Boudot4.1 Introduction 654.2 3D Printers 664.3 Biomaterials for 3D-Printed Medical Devices 694.4 3D-Printed Personalised Medical Devices 764.5 Regulatory 814.6 Future Perspectives 835 3D Printed Implants for Long-Acting Drug Delivery 89Aikaterini Dedeloudi, Sune Andersen, Peyton Hopson and Dimitrios A. Lamprou5.1 Introduction 895.2 Types of 3D-Printed Scaffolds 905.3 Critical Parameters in Designing 3D-Printed Implantable Scaffolds 945.4 Critical Parameters in Selecting Materials for 3D-Printed Scaffolds 975.5 Manufacturing Techniques for Implantable Scaffolds 1005.6 Drug Release Mechanism of Long-Acting 3D-Printing Polymeric Implantable Systems 1055.7 Outlining Regulatory Framework for 3D-Printed Implantable Scaffolds 1065.8 Conclusions 1086 Wound Dressings by 3D Printing 115Joshua Boateng6.1 Wound Healing Process 1156.2 Case Studies 1226.3 Summary/Conclusions 1267 3D Printing of Hydrogels 131Poornima Ramburrun and Yahya E. Choonara7.1 Introduction 1317.2 Applications of 3D-Printed Hydrogels 1327.3 Types of Hydrogel Materials for 3D Printing 1337.4 3D Printing Techniques for Hydrogels 1367.5 Printability and Printing Parameters 1387.6 Clinical Translation 1457.7 Conclusions 1468 Analytical Characterisation of 3D-Printed Medicines 151Ana Luiza Lima, Lívia L. Sá-Barreto and Marcilio Cunha-Filho8.1 Introduction 1518.2 Preformulation 1538.3 In-Process Characterisations 1598.4 Final Product 1668.5 Conclusions 1719 Adoption of 3D Printing in Pharmaceutical Industry 179Thomas Kipping9.1 Partnering and Growing 1819.2 Regulatory Strategy 1829.3 Business Model 1849.4 Regulatory Strategy 1859.5 Partnering and Growing 1859.6 Business Model and Strategy 18510 Clinical Benefits of 3D Printing in Healthcare 187Atheer Awad, Iria Seoane-Viaño, Abdul W. Basit and Alvaro Goyanes10.1 Introduction 18710.2 3D Printing Technologies 18910.3 Preclinical Applications of 3D Printing 19010.4 Clinical Applications of 3D Printing 19510.5 Challenges, Regulatory View and Future Applications 20210.6 Conclusion 20311 Regulatory Aspects of 3D-Printed Medicinal Products 211Maria Malamatari, Ka-Wai Wan and Fotios Baxevanis11.1 Introduction 21111.2 Current Regulatory Framework 21211.3 Quality Aspects of 3D-Printed Medicinal Products 21311.4 3D-Printed Paediatric Medicinal Products 21811.5 3D-Printed Systems With Tailored Release Profiles 22011.6 Conclusions 221Disclaimer 221References 222Index 227