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https://t.me/med1917
3D Printing of Pharmaceutical and Drug Delivery Devices: Progress from Bench to Bedside, First Edition.
Edited by Dimitrios A. Lamprou, Dennis Douroumis and Sheng Qi.
© 2024 John Wiley & Sons Ltd. Published 2024 by John Wiley & Sons Ltd.
Index
4D printing, see four-dimensional
printing
acrylonitrile butadiene styrene (ABS)
powder, 46, 73
active implantable scaffolds, 90–92, 108
acute wounds, 117–118
alcohol derived polymers, 14
alcohol ingestion, 221
alginates, 17
amplitude sweep analysis, 163
analytical characterisation, 151–177
final products, 166–171
FTIR spectroscopy, 55, 127, 157–158,
215–217
infrared spectroscopy, 55, 127,
157–158, 166, 215–217
in-process characterisation, 159–166
morphology, 46–50, 95–97, 123–124,
158–159, 166–168
preformulation studies, 153–159
quality parameters, 151–171
regulatory aspects, 215–218
rheology, 5–7, 140–141, 162–166, 217
sampling, 153–163, 166–171
scanning electron microscopy, 50,
54–55, 127, 166–168, 216–217
thermal analysis, 3–4, 153–155, 159,
163–165, 216–217
X-ray computed microtomography,
167–168, 192–194, 217
X-ray powder diffraction, 156–157,
159, 216–217
animal studies, 80, 127, 188–195,
201–202
antibacterial dressings, 122–127
Aprecia, 180–181, 189, 201, 212
attenuated total reflectance (ATR), 127,
215, 217
binder jetting (BJ),
clinical benefits, 189, 201
microstructured tailored release,
30–33, 39
https://t.me/med1917
228 Index
oral solid dosage forms, 43–46
powder bed fusion, 7–12
regulations, 214–216
technology elevation, 181
biodegradable hydrogels, 124, 131–136,
140, 145
biodegradable scaffolds, 92–93, 97–100,
124
bioinks, 136–144
biomaterials,
hydrogels, 124, 131–146
scaffolds, 79–81, 90–105, 124,
132–133, 139
selection, 69–78
wounds dressing/healing, 115–127
biomimetics, 79, 83–84, 98, 122, 131–
134, 146
bioresorbable polymers, 69–73, 83
BJ, see binder jetting
Braille patterns, 199–200
breaking stresses, 161–162
business models and strategies, 184–186
CAD, see computer-aided design
cancer, 90, 92, 104, 107–108
Candurin
®
gold sheen, 50–51
capsules, 35, 44, 187, 191–201, 218
Carbopol
®
, 16
cellulose derived polymers, 17
Center for Drug Evaluation and Research
(CDER), 182, 212
ceramics, 75–76, 79–80, 92, 98–100
chemical crosslinking, 143
chewable products, 7–8, 133, 188–190,
195–199, 218
chitosan, 17, 122–125
chocolate-based products, 197–198
chronic diseases, 90–93, 97–99, 104,
107–108
chronic wounds, 117–122
classification,
common materials, 14–19
hydrogels, 133–135
scaffolds, 90–91
wounds, 117–120
clinical benefits, 187–210
acceptability improvements, 197–201
animal studies, 188–195, 201–202
challenges, 202–203
chewable products, 188–190, 195–199
clinical trials, 188–199
compliance, 197–201
customised/personalised products,
187–190, 194–197, 201–203
future perspectives, 202–203
for geriatric patients, 195–201
GI tract targeted delivery, 188,
191–194
healthcare, 187–210
immediate release products, 188,
190–194, 201
mass manufacturing, 201
modified release products, 191–194
oral solid dosage forms, 188–201
for paediatric patients, 195–199
portability, 188–189, 201–203
preclinical applications, 190–195
printing technologies, 189–204
printlets, 188–201
rectal dosage forms, 194–195
regulations, 202–203
selective laser sintering, 189, 198–200
suppositories, 194–195
vaginal dosage forms, 194–195
veterinary applications, 201–202
clinical trials, 179, 188–199
CMA, see critical material attributes
co-development strategies, 184–185
collaborations, 181–186
commercial implantable scaffolds,
107–108
complex printing, 59
complex release mechanisms, 35–36,
38–39
compliance, 197–201
composite scaffolds, 100
composite wound dressings, 122–125
compression, 101–103, 160
computed microtomography, 167–168,
192–194, 217
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Index 229
computer-aided design (CAD), 34–35,
44, 67–68, 89, 106, 121, 211
contaminant protection, wounds,
118–120
continuous manufacturing, 101–102,
105, 179, 183
control, fault detection and intervention,
183
covalent bonding, 135–136, 143
COVID-19 pandemic, 83, 212–213
critical material attributes (CMA),
47–48, 100–108
critical parameters, 47–48, 52–54,
94–108, 215
critical quality attributes (CQA), 47–48,
52–54, 214–217
crospovidone, 56–58
crosslinked polymers, 133, 135–146
Crump, Scott, 44, 68
customised/personalised products,
analysis, 151–152, 159, 166–167
clinical benefits, 187–190, 194–197,
201–203
device printing, 66, 69, 75–84, 89,
102, 106
FabRX, 5–6, 184–185
hydrogels, 131–135, 145–146
implants, 89, 101–102, 104–108
industrial technology, 181–182
microstructured tailored release,
29–37, 40
oral solid dosage forms, 44, 52–53, 56,
59–61
preformulation protocol, 159
regulatory aspects, 220–221
selective laser sintering, 44, 52–56,
59–61
wound dressings, 121, 125–126, 133
debridement, 118–119
decentralised on-demand fabrication, 201
decision tree modelling, 56
Deckard, Carl, 44, 46
deformation, 58, 162–166
dentistry, 79–80, 197–198
deposition-based technologies, see
individual methods
device printing, 65–114, 118–126,
132–133, 139
biomaterials, 69–78, 92–100, 105
ceramics, 75–76, 79–80, 92, 98–100
computer-aided design, 34–35, 44,
67–68, 89, 106, 121, 211
customised products, 66, 75–76,
79–81
dentistry, 79–80
digital light projection, 68, 73–76, 83
four-dimensional printing, 74–75, 84,
93–94
fused filament fabrication, 65–76,
79–80, 83
future perspectives, 83–84
implants, 79–81, 89–114
metals, 75–76, 92, 98–100
miniaturised extrusion, 65–76, 79–80,
83
polymers, 65–84, 92–106, 122–125
regulatory aspects, 81–83
scaffolds, 78–79, 89–108, 118–126,
132–133, 139
stereolithography, 65–68, 73–80, 83,
101
tissue engineering, 78–79, 89–108
diabetes, 116–118
diethyl fumarate, 75
differential scanning calorimetry (DSC),
153–154, 159, 216
differential thermal analysis (DTA), 153
diffusion, 105–106
digital light processing/projection (DLP),
33, 68, 73–76, 83, 152, 155, 198–199
direct ink writing, 30–32
direct powder deposition, 5
direct powder extrusion (DPE), 190
dressings, wounds, 115–129
drop on demand, 44–46, 138, 152–154,
159, 162–163, 190
drug release,
analysis, 151–177
binder jetting, 43–46
https://t.me/med1917
230 Index
clinical benefits, 188–201
fused deposition modelling, 43–47, 61
hydrogels, 131–134, 137–138, 142–
146
long-acting for implants, 89–114
microstructured tailored, 33–40
powder bed fusion, 11–12, 43–61
quality parameters, 151–171
scaffolds, 90–108
selective laser sintering, 43–66
semi-solid extrusion, 7–8
wound dressings/healing, 125–127
DSC, see differential scanning calorim-
etry
DTA, see differential thermal analysis
DuraForm
®
, 49, 54–55
elastic deformation, 161–162
electrical signals, 132, 135–138
elongation tests, 160–161
Emergency Use Authorization (EUA), 83
Emerging Technology Program (ETP),
182
energy absorbance, 10–11
energy density, 50–51, 56–57
entangled crosslinked polymers, 135, 141
epithelisation/remodelling, 115–117, 122
ethyl cellulose, 51–52
ethylene vinyl acetates, 15
ETP, see Emerging Technology Pro-
gram
EUA, see Emergency Use Authoriza-
tion
Eudragits, 14–15, 51–52
EU regulatory aspects, 82, 213
extrusion-based technologies, 43–47,
59–61, 121–127, 136–144, 152, 190,
214–221
see also individual techniques
exudate absorbance, 118–120
fabrication, see manufacturing prac-
tices/techniques
FabRX, 5–6, 184–185
far-infrared spectrum, 168–169
fatigue tests, 50–51
fault detection and intervention, 183
FDA, see Food and Drug Administra-
tion
FDDS, see floating drug delivery
systems
FDM, see fused deposition modelling
Federal Food, Drug, and Cosmetic Act
(FD&C), 81
FFF, see fused filament fabrication
fibroblast cells, 116–117, 123
filament impregnation, 4
final product analysis, 166–171
first-in-human (FIH) trials, 188, 191
first-order release mechanisms, 36–37
fishbone diagrams, 47–48, 214–215
floating drug delivery systems (FDDS),
56
flowability, 9–10
Food and Drug Administration (FDA),
39, 44, 81–83, 180–184, 212–214
four-dimensional (4D) printing, 74–75,
84, 93–94
Fourier-Transform Infrared Spectroscopy
(FTIR), 55, 127, 157–158, 215–217
fracture analysis, 161–162
frequency sweeps, 162–165
functional excipient classification, 14–18
fused deposition modelling (FDM),
analysis, 152, 155–166
clinical benefits, 190–194, 197–198
fused filament fabrication, 68
implantable scaffolds, 101–102
microstructured tailored release,
30–35, 38–40
operational principles, 68
oral solid dosage forms, 43–47, 61
regulations, 214–215, 219–220
semi-solid extrusion, 5
thermal extrusion, 2, 4–5
fused filament fabrication (FFF), 65–76,
79–80, 83, 104
gastrointestinal (GI) tract, 89, 188,
191–194
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Index 231
gelatin, 12, 17, 122, 127, 140, 191–192,
198
genipin, 122–123, 143
geriatric patients, 60, 133, 146, 195–201
global regulatory agencies, 81–83
Good Manufacturing Practice (GMP),
106–107, 145, 180, 203, 215
graft polymers, 16
granulation tissue formation, 115–119,
122–123, 127, 133
granule deposition, 5
growth and partnering, 181–185
guided bone regeneration, 81
haemostasis, 115–117
HDM, see Humanitarian Device
Exemption
healing, wounds, 115–129, 133, 145–146
Health Canada, 212
healthcare benefits, see clinical benefits
helium pycnometry, 170–171
hot-melt extrusion (HME), 2–5, 14–16,
39, 101–102, 124–125, 159, 166
hot-stage microscopy (HSM), 158–159
HPMC, see hydroxypropyl methylcel-
lulose
Hull, Charles/Chuck W., 11, 43–44, 67
Humanitarian Device Exemption (HDE),
82
human trials, 188, 191, 199
hybrid polymer hydrogels, 133, 135, 141
hydrogels, 131–149
biodegradable, 124, 131–136, 140, 145
bioinks, 136–144
biomaterials, 124, 131–146
biomimetics, 131–134, 146
classification, 133–135
clinical translation, 145–146
crosslinked polymers, 133–146
drug release, 131–134, 137–138,
142–146
extrusion-based printing, 136, 138–144
fabrication, 131–132, 136–147
future perspectives, 146
hybrid polymers, 133, 135, 141
injectable scaffolds, 93
inkjet printing, 136–138
ionically charged polymers, 132–136,
143
laser-based printing, 136–138, 144
manufacturing practices, 145–146
oral solid dosage forms, 131–146
photocrosslinking, 143–144
preparation methods, 136
pressure, 144
printability, 138–146
regulatory frameworks, 145
scaffolds, 93, 124, 132–133, 139
stereolithography, 136–137, 144
temperature, 132, 138, 143–144
tissue engineering, 93, 132–134,
137–140, 144–146
wound dressings/healing, 124–126,
133, 145–146
hydrogen bonding, 135–136
hydrophobic interactions, 135–136, 140
hydroxypropyl methylcellulose (HPMC),
50–51, 56–58
ibuprofen, 52, 58
ICH, see International Council on
Harmonisation
IDE, see Investigational Device Exemp-
tion
immediate release products,
clinical benefits, 188–194, 201
manufacture, 183
material classification, 14–16
material processability, 2, 5–8, 12
regulatory aspects, 214, 220–221
selective laser sintering, 50, 58–60
tailored for, 35
implantable dentistry devices, 79–81
implantable scaffolds, 79–83, 89–108
absorption, 97
active, 90–92, 108
advantages, 105–106
biomaterials, 79–83, 90–105, 124,
132–133
biomimetics, 79, 83–84, 98
https://t.me/med1917
232 Index
cellular adhesion, 96–97
ceramics, 92, 98–100
commercial, 107–108
composite materials, 100
compression, 101–103
computer-aided design, 89, 106
critical parameters, 94–108
degradation rates, 97
design, 94–97
drug release, 90–108
geometry, 94–95
hot-melt extrusion, 101–102
injection moulding, 101, 103–104
kinetic profiles, 105–106
long-acting release, 89–108
manufacturing techniques, 100–108
material selection, 97–100
mechanical properties, 94, 96
metals, 92, 98–100
natural polymers, 98–99
passive, 90–92, 105, 108
physiological parameters, 94, 96–97
polymers, 92–106
pore features, 94–95
porosity, 94–95
quality, 106–107
regulatory frameworks, 106–107
scaled up 3D printing processes,
104–105
solvent-casting, 101, 104
structural characteristics, 94–96
surface properties, 94, 96
synthetic polymers, 98–100
thermoplastics, 98–100
tissue engineering, 89–108
wettability, 94–96
inactive functional excipients, 2–6, 18
industrial adoption, 179–186
business models/strategies, 184–186
co-development strategies, 184–185
partnering and growth, 181–185
product development, 183–184
regulatory strategy, 180–186
infection, wounds, 118–120, 125
inflammation, wounds, 115–117
inflammatory diseases, 90, 97–99
infrared (IR) spectroscopy, 55, 127,
157–158, 166, 215–217
in-house pipeline products, 184
injectable scaffolds, 92–93, 99
injection moulding, 101, 103–104
injury, wound healing, 115–118
inkjet printing, 30–32, 35, 136–138, 190
innovative scaffolds, 93–94, 104–106
in-process characterisation, 159–166
International Council on Harmonisation
(ICH), 106–107, 213, 215–217
International Organisation for Standardi-
zation (ISO), 106–107
Investigational Device Exemption (IDE),
81
in vitro regulations, 213, 221
ionically charged hydrogels, 132–136,
143
IR, see infrared
Irbesartan, 56–57
Ishikawa diagrams, 47–48, 214–215
ISO Standards, 106–107
keratinocytes, 123
Kodama, Hideo, 43–44
Kollicoat
®
IR, 16, 52
Kollidon, 12–14, 50–57, 60, 157
laser-based printing, 11, 48, 136–138,
144, 189
see also selective laser sintering,
laser-induced forward transfer, l, 137–138
laser selection, 46–49, 54–56
LCD, see liquid crystal displays
LED, see light emitting diodes
Lego
™
brick-shaped formulations, 198
levofloxacin, 125–126
lidocaine, 125–126
lifesaving equipment, 83
light, hydrogels, 132, 143–144
light emitting diodes (LED), 68
linear viscoelastic response, 162
lipid-based excipients, 17–18
liquid crystal displays (LCD), 33, 68
https://t.me/med1917
Index 233
long-acting drug release implants,
89–114
active scaffolds, 90–92, 108
advantages, 105–106
injectable scaffolds, 92–93, 99
innovative scaffolds, 93–94, 104–106
passive scaffolds, 90–92, 105, 108
scaffolds, 89–108
manufacturing practices/techniques
see also individual techniques,
continuous manufacturing, 101–102,
105, 179, 183
device overview, 65–84
hydrogels, 131–132, 136–147
implantable scaffolds, 100–108
materials overview, 1–28
microstructured tailored release, 29–42
oral solid dosage forms, 43–64
wound dressings/healing, 118–127
maple syrup urine disease (MSUD),
195–197
mass manufacturing, 201
material extrusion, see individual
techniques
material jetting, 44–46, 152–154, 159,
162–163, 190
materials, 1–28
classification, 14–19
device printing, 69–78, 92–100, 105
future perspectives, 19
hydrogels, 133–146
implantable scaffolds, 92–100, 105
powder bed fusion, 7–12, 15, 19
processability, 2–14, 18
semi-solid extrusion, 5–8, 14–19
stereolithography, 5, 11–13, 19
thermal extrusion, 2–6, 14–19
wounds dressing/healing, 115–127
MCC, see microcrystalline cellulose
MCP-1, see monocytes chemoattract-
ant protein 1
Meaningful Regulation, 202–203
mechanical considerations,
analysis, 160–162
extrusion, 4–7
hydrogel properties, 142–144
scaffold properties, 94, 96
Medicines and Healthcare Products
Regulatory Agency (MHRA), 185,
212–213, 221
melt-based technology,
concepts, 48, 182–185, 189
hot-melt extrusion, 2–5, 14–16, 39,
101–102, 124–125, 159, 166
mercury porosimetry, 169–170
metals, 75–76, 92, 98–100
methacrylic polymers, see Eudragits
metronidazole, 56
MHRA, see Medicines and Healthcare
Products Regulatory Agency
micro-computed tomography (micro-
CT), 167–168, 192–194, 217
microcrystalline cellulose (MCC), 54
microstructured tailored drug release,
29–42
binder jetting, 30–33, 39
CAD, 34–35
challenges, 39–40
cleaning, 40
complex release, 35–36, 38–39
controlling, 36–38
direct ink writing, 30–32
fused deposition modelling, 30–32,
34–35, 38–40
hot-melt extrusion, 39
influences, 36–39
inkjet printing, 30–32, 35
modified release, 38–39
parameter-based design, 35–39
polypills, 35–36
printing parameters, 35–39
semi-solid extrusion, 30–32
stereolithography, 30–33, 39
sterilization, 40
vat polymerisation, 30–33, 39
mid-infrared (MIR) spectroscopy, 157
miniaturised extrusion, 65–76, 79–80, 83
modified release products, 38–39, 99,
166, 191–194, 220–221
https://t.me/med1917
234 Index
moisture,
hydrogels, 132–133
wounds, 118–120, 122–124
monocytes chemoattractant protein 1
(MCP-1), 116–117
Moon patterns, 199–200
morphological analysis, 46–50, 95–97,
123–124, 158–159, 166–168
MSUD, see maple syrup urine disease
natural materials, 16–18, 72, 98–99,
133–135
natural polymers, 72, 98–99, 133–135
near-infrared (NIR) spectroscopy,
157–158, 166, 215–217
neodymium-doped yttrium aluminium
garnet (Nd:YAG) lasers, 46, 48
nerve guided conduits (NGC), 78
non-biodegradable hydrogels, 131
non-biodegradable scaffolds, 92, 98–100,
105
non-bioresorbable polymers, 72–73, 76,
80
non-destructive techniques, 215–216
off-the-shelf devices, 66
oral solid dosage forms, 43–66, 131–146,
188–201
binder jetting, 43–46
capsules, 35, 44, 187, 191–201, 218
clinical benefits, 188–201
critical parameters, 47–48, 52–54
customised products, 44, 52–53, 56,
59–61
energy density, 50–51, 56–57
extrusion-based technologies, 43–47,
59, 61
fused deposition modelling, 43–47, 61
hydrogels, 131–146
manufacturing challenges, 47–49
material jetting, 44–46
particle size distribution, 50–51
porosity, 50
powder bed fusion, 11–12, 43–61
printlets, 51–52, 188–201
quality, 47–48, 52–54
selective laser sintering, 43–66
semi-solid extrusion, 7–8
stereolithography, 43–45
thermal extrusion, 43–47, 59, 61
vat polymerisation, 43
organogels, 93
orthopaedic devices, 81
packing density, 10
paediatric patients, 60, 133, 146, 195–
199, 218–220
PAM, see pressure-assisted micro
syringes
paracetamol, 50–55
parameter-based design, 35–39
particle size distribution, 50–51
partnering and growth, 181–185
passive diffusion, 105–106
passive implantable scaffolds, 90–92,
105, 108
PAT, see process analytical technology
PBF, see powder bed fusion
pectins, 17
personalised products, see customised/
personalised products
personal protective equipment (PPE), 83,
212–213
pH, 18, 132, 135
pharmaceutical industry adoption,
179–186
photo absorbers, 58
photopolymerisation,
see also stereolithography
analysis, 152, 154, 159, 162, 189
crosslinking, 16, 143–144
hydrogels, 133–146
overview, 11–13
regulatory aspects, 214
tailored release, 33
two-photon, 30, 33, 76, 137
physical ionic crosslinking, 143
physio-chemical properties, hydrogels,
142–144
physiological parameters, scaffolds, 94,
96–97
placebo products, 198–199
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Index 235
plasticisers, 18
PMA, see Premarket Approval
point-of-care (POC) framework, 185,
188, 195, 201–203, 212–213
poly-jetting, 44–46, 152–154, 159,
162–163, 190
polymerisation, see photopolymerisa-
tion
polymers,
analysis, 153–165
classification, 14–16
device printing, 65–84, 92–106,
122–125
hydrogels, 131–146
implantable scaffolds, 92–106
long-acting drug release, 92–106
microstructured tailored drug release,
29–35
powder bed fusion, 7–13, 43–61,
69–73, 76–80
printing overview, 1–18
selective laser sintering, 7–12, 43–61,
69–73, 76–80
semi-solid extrusion, 5–8, 14–19
stereolithography, 11–13, 67–69,
73–80
thermal extrusion, 2–6
wound dressings/healing, 118–127
polypharmacy, 29, 60, 201
polypills, 35–36, 60–61
pore features, 94–95
porosimetry, 169–171
porosity, 50, 94–95
powder,
characteristics, 46–47
energy absorbance, 10–11
flowability, 9–10
material parameters, 49–50
packing density, 10
powder bed fusion (PBF), 7–13, 43–61,
69–73, 76–80
see also selective laser sintering
analysis, 152, 157
binder jetting, 7–10, 12
clinical benefits, 189, 198–200
device examples, 11–12
energy absorbance, 10–11
flowability, 9–10
materials for, 7–12, 15, 19
oral solid dosage forms, 11–12, 43–61
packing density, 10
processability, 7–12
spreading mechanisms, 7–11
PPE, see personal protective equip-
ment
preclinical applications, 190–195
preformulation studies, 153–159
Premarket Approval (PMA), 81
pressure, hydrogels, 144
pressure-assisted micro syringes (PAM),
see semi-solid extrusion
printability,
hydrogels, 138–145
microstructured tailored release, 35–39
printlets, 51–52, 188–201
processability considerations, 2–14, 18
process analytical technology (PAT),
106–107, 182, 215–217
product adoption/development, 183–184
proliferation, wounds, 115–119, 122–
123, 127, 133
prototyping, 44, 50, 121, 180–181,
215–217
pycnometry, 170–171
quality,
drug release analysis, 151–171
hydrogels, 146
implantable scaffolds, 106–107
oral solid dosage forms, 47–48, 52–54
regulatory aspects, 213–218
selective laser sintering, 47–48, 52–54
Quality by Design (QbD), 52–54,
214–215
quality control (QC), 145–146, 166–171,
182, 185, 203–204
Quality Management System (QMS),
106–107
Quality Target Product Profiles (QTTP),
214
quick response (QR) codes, 182, 201–
203
https://t.me/med1917
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