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128 T. Karanwad et al.

build (cubical structures) process, using a Sinterstation SLS 3D printer. Mercury porosimetry was employed to ascertain the percentage porosity of the cubical parts. In vitro release demonstrated the accomplishment of a controlled release pattern of methylene blue through variation of selected SLS process parameters (Leong et al.

2001).

Alterations in the design of drug delivery carriers and manipulation of the porosity of dense objects could help alter the characteristics of SODFs. The upcoming years have demanded variations in process parameters, which could help modulate drug delivery. Cheah et al. (2002) successfully fabricated cylindrical composite structures using the SLS platform technology for possible applications in drug delivery. The aim of this study was to design and build cylindrical structures with varying porosities, with a denser outer layer and a porous inner layer, which acted as a diffusion barrier layer and drug encapsulation center, respectively. Polyamide (PA) powder [Duraform

™

(PA)] was used as a matrix former, and methylene blue was used as a model drug. The in vitro release demonstrated the ability of these composite structures to retard the model drug release in a simulated ﬂuid (Cheah et al.

2002). Leong et al. (2006) successfully attempted to build porous microstructures

that could be used as controlled drug delivery devices based on the aforementioned principle. They used couple of biodegradable polymers [Polycaprolactone (PCL) and poly (−L) lactic acid (PLLA)], and fabrication was done with the help of the Sinterstation 2500 SLS 3D printing system (Leong et al.

2006). In both studies,

researchers investigated the effects of critical process parameters, such as laser power, laser scanning speed, and part bed temperature (print bed temperature) on printability (Cheah et al.

2002; Leong et al. 2006).

After 2006, owing to the fact-based assumption that high-energy input in terms of lasers in SLS 3D printing technology may result in the degradation of drugs used during the fabrication of any dosage form using this technique, the role of SLS was restricted to tissue engineering scaffolds and other related biomedical applications. Thus, no single study has been conducted over an extended period of 10 years, related to the fabrication of drug-loaded SODFs. Fina et al. (2017) demonstrated the suitability of SLS-mediated fabrication of drug-loaded formulations (tablets), which they termed as printlets (Fina et al.

2017).

All studies related to SLS-mediated fabrication of drug-loaded formulations using several pharmaceutical grade polymers are considered pharmaceutical applications of the SLS 3D printing platform. Since 2017, researchers have explored SLS AM technology in the ﬁeld of pharmaceuticals. Thus, investigations by various researchers related to the pharmaceutical applications of SLS are summarized below in tabular format (Tables

4.1 and 4.2), along with a detailed explanation of the

research outcomes obtained in each study.

4 Selective Laser Sintering (SLS) in Pharmaceuticals 129

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(Giri and

Maniruzza-

man

This version of the

Sintratec Kit features

2023)

a 2.3-watt blue diode

laser (λ-445 nm))

Trenﬁeld et

al. (2022a)

This version of the

Sintratec Kit features

a 2.3-watt blue diode

laser (λ-445 nm))

(Khuroo et al.

2022)

This version of the

Sintratec Kit features

a 2.3-watt blue diode

laser (λ-445 nm)

(Santitewagun

et al. 2022)

This version of the

Sintratec Kit features

a 2.3-watt blue diode

laser (λ-445 nm)

(Shahbazi et

al. 2022)

This version of the

Sintratec Kit features

a 2.3-watt blue diode

laser (λ-445 nm)

(continued)

Scanning Calorimetry (DSC), Powder X-ray

Diffraction (PXRD), Wide-Angle X-ray Scattering

(WAXS), Hot Stage Microscopy (HSM), Scanning

Electron Microscopy (SEM), X-ray

Micro-Computed Tomography (Micro-CT),

Reverse Phase High-Performance Liquid

Chromatography (RP-HPLC), USP- II

DSC, Thermogravimetric Analysis (TGA),

PXRD, Digital Caliper, TBH 200, SEM,

Micro-CT, UV-visible spectrophotometer

DSC, Fourier Transform Infrared Spectroscopy

(FT-IR), RP-HPLC, Ultra Performance Liquid

Chromatography-Mass Spectrometer (UPLC-MS)

DSC, PXRD, Micro-CT, Terahertz Time-domain

Spectroscopy (THz-TDS)

SODFs Characterization techniques Printers References

Tabl et s Polarized Light Microscopy (PLM), Differential

Gold

Polymers and

excipients

Candurin

Sheen

Active

pharmaceutical

ingredients

Tab le 4 .1 Various applications of SLS 3D printing in SODFs

Acetaminophen Kollidon SR,

Tabl et s Near-infrared spectroscopy,

Gold

Eudragit L100-55,

Candurin

Sheen

Theophylline

Anhydrous USP

Printlets Hardness tester, USP-II, SEM, Micro-CT, PXRD,

Croscarmellose

sodium, Kollicoat

Isoniazid,

Acepromazine

NXT

Ruby Red

IR, Candurin

Amorphous

Indomethacin Kollidon VA 64,

Solid

Dispersions

Gold

Candurin

Sheen,

(ASDs) pellet

Magnesium

Dissolution apparatus, Rheometer, Nuclear

aluminometasilicate,

Silicon dioxide

– Normal maize starch 3D printed

Magnetic Resonance (NMR), DSC, XRD, SEM

structures

130 T. Karanwad et al.

diode laser (5 W)

(λ-808 nm)

(Madžarevi

This version of the

et al. 2021)

Sintratec Kit features a

2.3-watt blue diode

laser (λ-445 nm)

(Kulinowski

et al. 2022)

This version of the

Sintratec Kit features a

2.3-watt blue diode

laser (λ-445 nm)

cet

(Vasiljevi

This version of the

al. 2022)

Sintratec Kit features a

2.3-watt blue diode

laser (λ-445 nm)

(Wei et al.

2022)

Homogenized spot

melting (HSM) printer

Blue diode

(λ-450 nm)

(Lekurwale

et al. 2022)

Lisa, features an IR/Red

Printlets SEM, DSC,

Polymers and excipients SODFs Characterization techniques Printers References

Active pharmaceutical

ingredients

Tab le 4 .1 (continued)

Metronidazole Polyamide 12 (PA12), Sodium

FT-IR, Hardness tester,

USP-III, USP- IV,

UV-Vis Spectrophotometer

Diffuse Reﬂectance Infrared Fourier

Transform Spectroscopy

Multiparticulate

units

chloride

cellulose, Eudragit L 100–55,

Caffeine, Ibuprofen Poly(ethylene) oxide, Ethyl

(DRIFT), PXRD, HPLC, Helium

pycnometer

Surface tension and Melt rheology,

Single and

Gold Sheen

Candurin

PEG 4000, PEG 600, PEG

Indomethacin,

ultraviolet (UV) absorption of

powders, Dissolution apparatus,

UV-Vis Spectrophotometer

multilayer

printlets

8000, PEG 10000, Eudragit

EPO, Hydroxypropyl

Methylcellulose (HPMC),

Low-substituted

Hydroxypropyl Cellulose

Berberine

hydrochloride

(L-HPC), Carboxymethyl

starch sodium, Croscarmellose

sodium, Lactose, Tartrazine

lake.

DSC, FT-IR This version of Sinterit

(Tablets)

– Kollicoat IR, IR-absorbing dye Printlets

Porosimeter (MIP), SEM, FT-IR,

DSC, DT apparatus, UV-Vis

Tabl et s Hardness tester, Mercury Intrusion

Vivapharm E3, Mannitol

Parteck M 200, Candurin

Irbesartan Crospovidone, HPMC,

Spectrophotometer

Gold Sheen, Kollidon VA 64

Fine, Crospovidone NF,

AEROSIL 200

4 Selective Laser Sintering (SLS) in Pharmaceuticals 131

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(continued)

Trenﬁeld et al.

(2022b)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Gueche et al.

(2021c)

This version of

Sharebot SnowWhite

laser

features a

(14 Watt)

(λ-10.6 μm)

Kulinowski et

al. (2021)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Thakkar et al.

(2021b)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Thakkar et al.

(2021a)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Thakkar et al.

(2021c)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

(NIR),

Raman spectroscopy,

Printlets/discs XRPD, Near Infrared Spectroscopy

Gold

(HPC)-SSL, HPC-SL,

HPC-L, Candurin

Itraconazole Hydroxypropyl cellulose

HPLC,

PXRD, Thermo- gravimetric analysis

SODFs DSC, FT-IR,

Kollidon VA 64,

Succinic acid,

sheen

Ibuprofen,

Ibuprofen sodium

(TGA),

USP-II, UHPLC

Tartaric acid,

Fumaric acid,

Maleic acid,

Malic acid

SEM, Micro-CT,

PXRD, USP-II

Paracetamol Charcoal Printlet Morphologi G3s System,

UV-Vis Spectrophotometer,

HPLC-MS,

HPLC-UV/Vis

Printlet

(Tablet)

gold sheen,

Candurin

Sodium phosphate

Nifedipine Kollidon VA 64,

mDSC, PXRD,

VWR digital caliper

DSC, SEM,

HSM, PXRD,

Printlet

(Tablet)

Gold Sheen

Sodium chloride

Candurin

monobasic,

Sodium hydroxide,

Indomethacin Kollidon VA 64,

DVS, USP-II,

WAXS, Zetasizer nano ZS

Hot melt extrusion (HME), Dino Lite

Microscopy, PLM, SEM,

Texture analyser (TA-XT2), XPRD,

mDSC,

Printlet

(Tablet)

Gold Sheen,

Candurin

Magnesium

aluminometasilicate,

Indomethacin Kollidon VA 64,

FT-IR, Raman Mapping, HPLC,

USP-II

Silicon dioxide

132 T. Karanwad et al.

Gueche et al.

(2021a)

Gueche et al.

(2021d)

Yang et al.

(2021)

Hamed et al.

(2021)

This version of

Sharebot SnowWhite

Sotax DT 150,

laser

features a

(14 W)

FT-IR, UHPLC

(λ-10.6 μm)

This version of

Sharebot SnowWhite

Laser granulometry,

SODFs SEM,

laser

features a

(14 W)

FT-IR, DSC, XRPD,

Size exclusion chromatography

(SEC)

3500, Jinke Trading,

blue diode laser

(λ-10.6 μm)

(λ-450 nm)

XRD, DSC, USP-II,

UV-Visible Spectrophotometer

Multilayered

Printlets

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

HPLC, USP-II,

SEM, Micro-CT,

FT-IR, DSC,

XRD

ASDs Printlet

(Tablet)

NXT Ruby

Polymer and excipients SODFs Characterization techniques Printers References

Active pharmaceutical

ingredients

Tab le 4 .1 (continued)

Paracetamol Kollidon VA 64 SODFs XPRD, SEM,

Kollidon VA 64,

Kollidon VA 64 (Fine),

Duraform PA12

Paracetamol,

Paracetamol Fine

Polyvinyl alcohol,

Eudragit EPO,

Eudragit RLPO,

Polyethylene glycol,

Carboxy methyl sodium,

Indomethacin,

Tinidazole, Nifedipine,

Astragalus

polysaccharide,

Metoprolol tartrate,

Ethyl cellulose,

Hydroxypropyl

methylcellulose,

Kollicoat MAE 100P,

Stearic acid

Diclofenac sodium,

Paracetamol, Ibuprofen

Lopinavir Kollicoat IR,

SuperTab 14 SD,

Candurin

Red,

Talc

4 Selective Laser Sintering (SLS) in Pharmaceuticals 133

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Davis Jr et al.

(2021)

This version of the

Sintratec Kit features

DSC, HME,

WAXS, FT-IR,

a2.3-wattbluediode

laser (λ-445 nm)

Silid-state Nuclear Magnetic

Resonance (ssNMR), HPLC

Trenﬁeld et al.

(2020)

This version of the

Sintratec Kit features

HPLC,

a2.3-wattbluediode

laser (λ-445 nm)

XRD, TGA,

Tablet hardness tester,

Awad et al.

This version of the

Erweka friability tester

Tablet hardness tester (TBH 200),

(2020b)

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

SEM, USP-II

Allahham et

al. (2020)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

SEM, Micro-CT,

FT-IR, DSC,

XRD,

Tablet hardness tester,

Erweka friabilator

Mohamed et

al. (2020)

This version of the

Sintratec Kit features

DSC, XRD,

a2.3-wattbluediode

Micro-CT, FT-IR,

laser (λ-445 nm)

NIR, HPLC

(continued)

ASDs Printlet

(Tablet)

Gold Sheen,

Kollidon VA 64,

FujiSil (Colloidal Silicon

Dioxide),

Candurin

Ritonavir Copovidone,

Polyprintlets Reﬂectance NIR spectrometer,

Polyethylene oxide (PEO)

Monohydrate and dihydrate

Sodium phosphate salts

Amlodipine and

Gold Sheen

100,000,

Candurin

Lisinopril dihydrate

Orodispersible

Printlet (ODTs)

(Tablet)

ODTs HPLC, USP-II,

Gold Sheen

Candurin

Paracetamol Kollidon VA 64

β-Cyclodextrin Cavamax W

Ondansetron

Kollidon VA 64, Candurin

Gold Sheen, Mannitol

Hydrochloride USP

(Parteck Delta)

Printlet (Tablet) USP-II, SEM,

Kollidon VA 64,

Microcrystalline cellulose,

Aluminum lake,

Super Tab 14SD,

Food Blue No. 1,

Clindamycin

palmitate

hydrochloride

Iron oxide,

Sodium hydroxide and

Monobasic potassium

phosphate

134 T. Karanwad et al.

Januskaite et

al. (2020)

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Ali et al.

(2019)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Awad et al.

(2019)

This version of the

Sintratec Kit features

a2.3-wattbluediode

Trenﬁeld et

laser (λ-445 nm)

This version of the

al. (2018)

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Fina et al.

(2018c)

This version of the

Sintratec Kit features

a2.3-wattbluediode

laser (λ-445 nm)

Printlet (Tablet) Visual preference survey This version of the

Polymers and excipients SODFs Characterization techniques Printers References

Active pharmaceutical

ingredients

Tab le 4 .1 (continued)

– Kollicoat IR,

Gold Sheen

Candurin

UV-visible spectroscopy,

FT-IR, SEM,

Printlet (Tablet) USP-II,

NXT Ruby

Candurin

Red,

Diclofenac sodium Kollidon VA 64,

Micro-CT, XRD

SuperTab 14 SD,

Monobasic Potassium

DSC, TGA

XRD, SEM,

Miniprintlet/Dual

Miniprintlets

Kollicoat IR,

phosphate,

Ethyl cellulose N

Potassium hydroxide

Paracetamol

Ibuprofen

HPLC,

UV-visible spectroscopy

HPLC,

Printlet (Tablet) Near-infrared spectroscopy

L100-55,

Paracetamol Eudragit RL, Eudragit

Raman spectroscopy and mapping,

XRPD

Tablet hardness tester 200,

SEM,

Printlet (Tablet) Digital caliper,

HPMC Vivapharm E

Gold Sheen

Candurin

HPMC Vivapharm E

Paracetamol Kollidon VA 64,

Micro-CT,

HPLC

4 Selective Laser Sintering (SLS) in Pharmaceuticals 135

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

2017)

Fina et al.

(

This version of the

Sintratec Kit features

a2.3-wattbluediode

Digital caliper, SEM, Micro-CT,

Tablet hardness tester, HPLC,

Printlet (Tablet) DSC, P-XRD,

Salmoria et al.

laser (λ-445 nm)

This version of SLS

USP-II

2017b)

(

laser

printers features a

analyzer (TA), UV-visible

spectroscopy, Dissolution apparatus

(9 W)

(λ-10.6 μm)

Salmoria et al.

This version of SLS

2017a)

(

laser

printers features a

SEM, DSC,

UV-visible spectroscopy

(9 W)

(λ-10.6 μm)

Salmoria et al.

SEM, IR, UV-visible spectroscopy This version of SLS

2012)

(

printers features a

drug delivery

laser

(9 W)

system

(λ-10.6 μm)

Gold Sheen.

RL,

Eudragit L100-55,

Candurin

Paracetamol Kollicoat IR, Eudragit

Progesterone Polycaprolactone Tab le t IR,DSC,SEM,XRD,Texture

Fluorouracil Polycaprolactone Printlet (Tablet) IR and NIR Spectroscopy

Progesterone Polycaprolactone Multi-reservoir

136 T. Karanwad et al.

Salmoria et al.

(2018)

Salmoria et al.

(2017c)

Salmoria et al.

(2016)

laser

This version of SLS

printers features a

(9 W)

(λ-10.6 μm)

IR,DSC,SEM,Dynamic

Mechanical analysis (DMA),

HPLC, Dissolution apparatus

(IUD)

This version of SLS

printers features a

IR,NIR,DSC,SEM,Texture

analyzer (TA), UV-visible

implantable drug

laser

spectroscopy, Dissolution apparatus

delivery

(9 W)

(λ-10.6 μm)

This version of SLS

printers features a

spectroscopy, Dissolution apparatus

laser

(9 W)

(λ-10.6 μm)

Polymers and Excipients Drug delivery system Characterization techniques Printer Reference

Polyethylene Intrauterine device

Active pharmaceutical

ingredients

Tab le 4 .2 Applications of SLS 3D printing in implantable drug delivery

Progesterone,

Fluorouracil

Fluorouracil Polyethylene Wa fﬂ es for

Ibuprofen Polycaprolactone Implant XRD, SEM, TA, DMA, UV-Visible

4 Selective Laser Sintering (SLS) in Pharmaceuticals 137

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4.3 SLS Technologies

The enlisted (Table 4.3) and depicted (Fig. 4.1) SLS technologies from different manufacturing companies have varied laser power, laser wavelength, laser source, build volumes, and software which were explored for pharmaceutical applications.

Among the aforementioned SLS 3D printers, only three laser sources were used for sintering the pharmaceutical SODFs. The results (Fig.

4.2.) depicted the

percentage of exploration of SLS 3D printers based on the laser source used.

4.4 Working Principle of SLS

SLS 3D printer has generally composed of different parts, such as (1) powder reservoir/feed bed, storage tank for the thermoplastic polymer materials (feedstock), which holds the feeded powder material and provides a fresh powder layer to print bed for further sintering process; (2) build plate/print bed, a platform for the sintering of feedstock material to convert it into desired 3D structures layerby-layer; (3) a laser source, responsible for the sintering of powder materials; (4) galvano mirrors, provide directions to the laser beam for proper projection on the print bed; (5) a recoater, a roller that helps to spread fresh powder from the powder reservoir/feed bed to print bed with a constant layer thickness of each powder layer; and (6) an overﬂow bin, collecting chamber or tank for unsintered powder material (Awad et al. summarized in Fig.

The SLS 3D printing technique works in a stepwise process as follows:(1) Preheating/warm-up phase, which includes heating of the powder reservoir/feed bed to activate the feedstock to the processing temperature; (2) build phase, which is further divided into three operational sub-steps: (a) powder recoating, build plate/print bed lowers by the selected layer thickness followed by spreading of the powder layer of a particular thickness from the feed bed to the print bed with the help of a recoater. Excess powder material enters the overﬂow bin; (b) Energy input, laser beam guided by galvano mirrors is applied to the powder material available on the print bed and holds the powder material at the printing temperature; (c) consolidation, powder material present on a print bed is exposed to laser and consolidated to build the part on the print bed. The second step is repeated until the entire structure is fabricated or sintered. (3) The cooldown phase, unsintered powder material on both the feed and print beds was bought at room temperature along with the sintered object (Sivadas et al. isolated, and loosely packed (unsintered) powder material present on the surface of the sintered object was removed manually using a brush or compressed air.

2020a). Various parts of SLS 3D printer and it’s working principle are

4.3.

2021). Finally, the sintered objects were

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