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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5446_Библиотеки_им_академика_М_И_Перельмана
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x Contents
5.5 Manufacturing Techniques for Implantable Scaffolds 100
5.5.1 Hot-Melt Extrusion 102
5.5.2 Compression 102
5.5.3 Injection Moulding 103
5.5.4 Solvent Casting 104
5.5.5 3D Printing 104
5.5.6 Scale-Up in 3D-Printing Process for the Manufacturing of Scaffolds 104
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
5.7.1 Commercial Implantable Scaffolds 107
5.8 Conclusions 108
References 108
6 Wound Dressings by 3D Printing 115
Joshua Boateng
6.1 Wound Healing Process 115
6.1.1 Haemostasis/Coagulation 117
6.1.2 Inflammation 117
6.1.3 Proliferation 117
6.1.4 Re-epithelisation/Remodelling 117
6.1.5 Wound Classification 117
6.1.6 Wound Dressings 118
6.1.7 3D Printing 118
6.1.8 3D-Printed Dressings 121
6.2 Case Studies 122
6.3 Summary/Conclusions 126
References 128
7 3D Printing of Hydrogels 131
Poornima Ramburrun and Yahya E. Choonara
7.1 Introduction 131
7.2 Applications of 3D-Printed Hydrogels 132
7.2.1 Tissue Engineering 132
7.2.2 Wound Healing 133
7.2.3 Drug Delivery 133
7.3 Types of Hydrogel Materials for 3D Printing 133
7.3.1 Natural Polymers 134
7.3.2 Synthetic Polymers 134
7.3.3 Natural-Synthetic Hybrid Polymers 135
7.3.4 Ionically Charged Polymers 135
7.3.5 Crosslinked Polymers 135
7.3.6 Method of Hydrogel Preparation 136
7.4 3D Printing Techniques for Hydrogels 136
7.4.1 Laser-Based 3D Printing 137
7.4.1.1 Stereolithography 137
7.4.1.2 Two-Photon Polymerisation 137
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Contents xi
7.4.1.3 Laser-Induced Forward Transfer 137
7.4.2 Extrusion-Based Printing 138
7.4.3 Inkjet-Based Printing 138
7.5 Printability and Printing Parameters 138
7.5.1 Bioink Design 139
7.5.1.1 Materials Selection, Concentration and Viscosity 140
7.5.1.2 Rheological Properties 140
7.5.1.3 Shear-Thinning 141
7.5.1.4 Viscoelasticity and Yield Stress 141
7.5.1.5 Cell Encapsulation 141
7.5.2 Crosslinking Techniques 142
7.5.2.1 Thermal Crosslinking 143
7.5.2.2 Physical Ionic Crosslinking 143
7.5.2.3 Chemical Crosslinking 143
7.5.2.4 Photocrosslinking 143
7.5.3 3D Printing Parameters 144
7.5.3.1 Temperature 144
7.5.3.2 Pressure 144
7.5.3.3 Speed 145
7.6 Clinical Translation 145
7.6.1 Regulatory Considerations 145
7.6.2 Manufacturing Considerations 145
7.6.3 Limitations and Future Direction 146
7.7 Conclusions 146
References 148
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
8.2.1 Thermal Analysis 153
8.2.2 X-Ray Powder Diffraction (XRPD) 156
8.2.3 Infrared Spectroscopy 157
8.2.4 Hot-Stage Microscopy (HSM) 158
8.2.5 Customizsd Sample Preparation for the Preformulation Protocol 159
8.3 In-Process Characterisations 159
8.3.1 Mechanical Analysis 160
8.3.2 Rheological Analysis 162
8.3.3 Drug Characterisation 166
8.4 Final Product 166
8.4.1 Morphological Analysis 166
8.4.2 X-Ray Computed Microtomography (XμCT) 167
8.4.3 Terahertz Pulsed Imaging (TPI) 168
8.4.4 Mercury Porosimetry 169
8.4.5 Helium Pycnometry 170
8.5 Conclusions 171
References 171
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xii Contents
9 Adoption of 3D Printing in Pharmaceutical Industry 179
Thomas Kipping
9.1 Partnering and Growing 181
9.2 Regulatory Strategy 182
9.2.1 Product Development 183
9.2.2 Manufacturing 183
9.3 Business Model 184
9.3.1 In-House Pipeline Products 184
9.3.2 Co-Development 184
9.4 Regulatory Strategy 185
9.5 Partnering and Growing 185
9.6 Business Model and Strategy 185
9.6.1 Closing Remarks 186
References 186
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
10.2.1 Binder Jetting 189
10.2.2 Vat Photopolymerization 189
10.2.3 Powder Bed Fusion 189
10.2.4 Material Jetting 190
10.2.5 Material Extrusion 190
10.2.5.1 Fused Deposition Modelling 190
10.2.5.2 Semi-Solid Extrusion 190
10.2.5.3 Direct Powder Extrusion 190
10.3 Preclinical Applications of 3D Printing 190
10.3.1 Immediate and Modified Release Oral Printlets 191
10.3.2 3D-Printed Drug Delivery Devices for Other Routes of
Administration 194
10.4 Clinical Applications of 3D Printing 195
10.4.1 Personalised Medications 195
10.4.2 Improved Acceptability and Medication Compliance 197
10.4.2.1 Paediatric Patients 197
10.4.2.2 Adult and Geriatric Patients 199
10.4.3 Mass Manufacturing 201
10.4.4 Decentralised On-Demand Fabrication 201
10.4.5 Veterinary Applications 201
10.5 Challenges, Regulatory View and Future Applications 202
10.6 Conclusion 203
References 204
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
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Contents xiii
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
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About the Editors
Dimitrios A. Lamprou
Dimitrios A. Lamprou
is Full Professor (Chair) of Biofabrication and Advanced
Manufacturing at Queen’s University Belfast. Dimitrios has been recognized as world
leader in 3D Printing and has also been named in the Stanford University’s of World’s Top
2% Scientists. He is currently the author of over 150 peer-reviewed publications and of
over 350conference abstracts, and has given over 150 Invited Talks to institutions and
conferences across the world. His research and academic leadership have been recognized
in a range of awards, including the Royal Pharmaceutical Society of Great Britain Science
Award and the Scottish Universities Life Sciences Alliance Leaders Scheme Award.
Dennis Douroumis
Dr. Dennis Douroumis is a professor in Pharmaceutical Technology and Process Engineering
at the University of Greenwich, UK
His research activities focus on emerging technologies including: (a) 3D printing tech-
nologies for pharmaceutical dosage forms or novel medical devices (microneedles, biore-
sorbable scaffolds), (b) Continuous manufacturing processes for the development of
medicinal products, and (c) Nanomaterial synthesis and surface modification for cancer
treatment.
Dennis has established several national and international collaborations with world-class
colleagues/researchers including industrial funded projects and several EU/UK grants. He
received the prestigious award of Eminent Fellowship of the Academy of Pharmaceutical
Sciences for the excellence in the pharmaceutical sciences over a prolonged period with an
emphasis on advocacy and leadership. He has also received an award for his “Outstanding
Scientific Contribution” in Pharmaceutical Processes and invited to deliver the Award
Lecture, sponsored by AstraZeneca.
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xvi About the Editors
Sheng Qi
Sheng Qi
is Professor of Pharmaceutical Material Science and Technology at the School
of Pharmacy of the University of East Anglia (UEA). She runs a dynamic research group
with most projects co-created and developed with relevant industrial partners/collaborators
to address real-world clinically unmet needs. Sheng has great interests in material science
and processing, and passion in innovation. By working closely with industrial partners as
well as cross-discipline collaborators, her research has contributed to product development
and innovations in many industrial sectors, from pharmaceutical, medical device to food,
cosmetic, agri-tech and sustainable packaging. Within the field of pharmaceutical 3D print-
ing, her efforts focus on the development of a fundamental understanding on how to adapt
industrial 3D printing methods to safely process pharmaceutical materials and manufacture
pharmaceutical products. She founded and leads the UEA Health and Social partner
(UEAHSCP) PointofCare 3DPrintingResearch Group. The research group create the
network for academic scientists to work closely with clinicians, pharmacists, and patients
in Norfolk and Suffolk to identify and develop efficient and cost-effective uses of 3D print-
ing in acute hospital environments for improving patient care.
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List of Contributors
Sune Andersen, Research & Development Department, Janssen, Beerse, Belgium
Atheer Awad, UCL School of Pharmacy, University College London, London, UK and
Department of Clinical, Pharmaceutical and Biological Sciences, University of Hertfordshire,
Hatfield, UK
Abdul Basit, UCL School of Pharmacy, University College London, London, UK and
FABRX Ltd., Henwood House, Henwood Ashford, Kent, UK and FABRX Artificial
Intelligence, Carrete ra de Escairón, Currelos (O Saviñao), Spain
Fotios Baxevanis, Medicines & Healthcare Products Regulatory Agency, London, UK
Peter Belton, School of Chemistry, University of East Anglia, Norwich, UK
Richard Bibb, School of Design & Creative Arts, Loughborough University,
Loughborough, UK
Joshua Boateng, School of Science, Faculty of Engineering and Science, University of
Greenwich, Medway Campus, Kent, UK
Cecile Boudot, Evonik Corporation, Birmingham, Alabama, US
Sam Boulton, Faculty of Engineering and Science, University of Greenwich, Medway
Campus, Kent, UK
Yahya E. Choonara, Wits Advanced Drug Delivery Platform Research Unit, School of
Therapeutic Sciences, Faculty of Health Sciences, Department of Pharmacy and
Pharmacology, University of the Witwatersrand, Johannesburg, South Africa
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xviii List of Contributors
Marcilio Cunha-Filho, Laboratory of Food, Drugs, and Cosmetics (LTMAC), School of
Health Sciences, University of Brasilia, Brasília, Brazil
Mahokh Dadsetan, Evonik Corporation, Birmingham, Alabama, US
Aikaterini Dedeloudi, School of Pharmacy, Queen’s University Belfast, Belfast, UK
Dennis Douroumis, Faculty of Engineering and Science, University of Greenwich,
Medway Campus, Kent, UK and Delta Pharmaceutics Ltd., Kent, UK
Andrea Engel, Evonik Corporation, Birmingham, Alabama, US
Atabak Tabriz Ghanizadeh, Faculty of Engineering and Science, University of
Greenwich, Medway Campus, Kent, UK and Delta Pharmaceutics Ltd., Kent, UK
Andy Gleadall, School of Mechanical, Electrical and Manufacturing Engineering,
Loughborough University, Loughborough, UK
Alvaro Goyanes, UCL School of Pharmacy, University College London, London, UK,
FABRX Ltd., Henwood House, Henwood Ashford, Kent, UK, FABRX Artificial
Intelligence, Carrete ra de Escairón, Currelos (O Saviñao), Spain and Departamento de
Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma Group (GI-1645),
Facultad de Farmacia, iMATUS and Health Research Institute of Santiago de
Compostela, Universidade de Santiago de Compostela, Santiago de Compostela, Spain
Peyton Hopson, Advanced Engineering and Technology Department, Johnson &
Johnson, Jacksonville, Florida, US
Scott Jones, Evonik Corporation, Birmingham, Alabama, US
Thomas Kipping, Life Science, Process Solutions and Formulation Materials, Merck
Life Science KGaA, Darmstadt, Germany
Theresia Kuntz, Evonik Operations GmbH, Kirschenallee, Darmstadt, Germany
Hannah Kuofie, Faculty of Engineering and Science, University of Greenwich, Medway
Campus, Kent, UK
Dimitripos A. Lamprou, School of Pharmacy, Queen’s University Belfast, Belfast, UK
Ana Luiza Lima, Laboratory of Food, Drugs, and Cosmetics (LTMAC), School of
Health Sciences, University of Brasilia, Brasília, Brazil
Maria Malamatari, Medicines & Healthcare Products Regulatory Agency, London, UK
Thomas McDonagh, School of Pharmacy, University of East Anglia, Norwich, UK
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List of Contributors xix
Sheng Qi, School of Pharmacy, University of East Anglia, Norwich, UK
Poornima Ramburrun, Wits Advanced Drug Delivery Platform Research Unit, School
of Therapeutic Sciences, Faculty of Health Sciences, Department of Pharmacy and
Pharmacology, University of the Witwatersrand, Johannesburg, South Africa
Lívia L. Sá-Barreto, Faculty of Ceilandia, University of Brasilia (UnB), Brasília, Brazil
James Scoble, Faculty of Engineering and Science, University of Greenwich, Medway
Campus, Kent, UK
Iria Seosne-Viaño, UCL School of Pharmacy, University College London, London, UK
and Department of Pharmacology, Pharmacy and Pharmaceutical Technology, Paraquasil
Group (GI-2109), Faculty of Pharmacy, iMATUS and Health Research Institute of
Santiago de Compostela, Universidade de Santiago de Compostela, Santiago de
Compostela, Spain
John Tipton, Evonik Corporation, Birmingham, Alabama, US
Bernanbe Tucker, Evonik Corporation, Birmingham, Alabama, US
Ka-Wai Wan, Medicines & Healthcare Products Regulatory Agency, London, UK
Joey Yan, School of Mechanical, Electrical and Manufacturing Engineering,
Loughborough University, Loughborough, UK
Bin Zhang, School of Pharmacy, University of East Anglia, Norwich, UK
Jian-Feng Zhang, Evonik Corporation, Birmingham, Alabama, US
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