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158 T. Karanwad et al.
6
5
4
3
2
1
Isoniazid plasma concentration (mg/ml)
0
0
Fig. 4.13 Pharmacokinetic profiles of the printlets and compressed tablets in rabbits. Adopted
with permission from (Khuroo et al.
816
2022)
Time (h)
Compressed tablets (F2)
F2 printlets
24
by the addition of an osmotic agent. Using PA12 for the fabrication of high-dose
composite printlets resulted in good mechanical strength of the printlets, along with
a porous internal structure, which can be successfully used for the treatment of H.
pylori infection. Thus, this study highlighted the possible use of materials dedicated
to SLS 3D printing for drug delivery applications, along with the need to search for
other appropriate materials (Kulinowski et al.
2022).
Wei et al. (2022) used a customized 3D printer with a beam homogenizer,
which allowed homogenized spot melting of the powder bed material. It melted the
complete powder layer at a once, helping reducing the surface temperature gradient
of the powder bed. Authors reported the use of crystalline polymer (40% PEG
8000) having a low T
, required flow, and heat conducting properties in molten
g
state as solid binders for formation of sustained-release tablets of indomethacin.
In addition, SLS-mediated printing of berberine hydrochloride was achieved using
various release modifiers, such as: CMS-Na, L-HPC, CCMC-Na, and lactose (Wei
et al.
2022). Shahbazi et al. (2022) performed an interesting study on the molecular
behavior and kinetic evaluation of normal maize starch molecules at the printer
temperature used for the extrusion and powder bed fusion (SLS)-based 3D printing.
SLS offers typical crosslinking or branching behavior to starch, along with increased
molecular size and viscoelastic properties. However, it reduced the digestive extent
of starch. For molecular level characterization, analytical tools such as SEC,
4 Selective Laser Sintering (SLS) in Pharmaceuticals 159
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NMR, DSC, and XRD were employed during the study (Shahbazi et al. 2022).
Santitewagun et al. (2022) reported the applicability of THz-TDS for the evaluation
of solid state of SLS-mediated ASDs of indomethacin. The authors also compared
the traditional methods of solid-state characterization, such as DSC and PXRD, with
THz-TDS. THz-TDS was found to be applicable to the stability prediction of ASD
(Santitewagun et al.
2022).
Vasiljevi’c et al. (2022) employed the SLS technique for the formation of
multiparticulate units using model drugs, caffeine, and ibuprofen as well as different
polymers, including poly(ethylene)oxide, ethyl cellulose, and methacrylic acidethyl acrylate copolymer. The incorporation of polymers was found to notably affect
the properties of multiparticulate units (Vasiljevi´cetal.
2022).
Giri et al. (2023) demonstrated the suitability of SLS technology for the
fabrication of sustained-release tablets, utilizing Kollidon SR as a sustained-release
polymer and acetaminophen as a model drug. Tablets containing 10% drug, 85%
polymer, and 5% laser-absorbing dye showed approximately 90% of the drug
release over 12 h, as opposed to a burst release from the free drug and physical
mixture of drug and polymer before sintering (Fig.
PLM confirmed the amorphization of acetaminophen during sintering (Fig.
4.14). DSC, XRD, WAXD, and
4.15a).
HSM was used to better understand the fusion of particles during the sintering
process at different temperatures; it represents the simulated conditions of the
sintering process at a particular temperature (Fig.
4.15b) (Giri and Maniruzzaman
2023). The era of the SLS 3D printing in pharmaceutical is increasing day by day
Fig. 4.14 Dissolution profiles of the free acetaminophen (ACH), physical mixture (PM), and the
3D-printed tablet (left); schematic illustration of drug release phenomenon from a matrix-based
system containing Kollidon SR as a matrix-forming agent (right). Adapted with permission from
(Giri and Maniruzzaman
2023)
160 T. Karanwad et al.
Fig. 4.15 (a) PLM microscope images of acetaminophen (ACH), Kollidon SR (KSR), Candurin
physical mixture (PM), and the 3D-printed powered tablet. Birefringence is indicated by white
arrows. (b) Hot-state microscopy images of acetaminophen (ACH), Kollidon SR (KSR), and
physical mixture (PM) at 50
Maniruzzaman
2023)
◦
C, 140 ◦C, and 170 ◦C. Adapted with permission from (Giri and
®
,
due to the feasibility and intense applicability of the SLS 3D printing technology.
However, there is a need to understand the setbacks for the scale-up of SLS 3D
printing technology. The implementation of regulatory norms for the acceleration
of SLS 3D printing technology in the pharmaceutical field is required.
4.10 Setbacks for Scale-Up of SLS-Mediated Ra pid Prototyping
SLS is a powder bed fusion technology that has limitations in terms of the
fabrication of SODFs, such as the thermal stability of the drug, post-processing,
recycling, need for system development, and defects (Fig.
4.16) that need to be
discussed in detail for a better understanding in subsequent sections.
4.10.1 Thermal Stability of Drug
In SLS-mediated sintering, a laser is used as a thermal energy source to partially
melt the powder material, forming a melt pool, followed by particle fusion to give
4 Selective Laser Sintering (SLS) in Pharmaceuticals 161
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Fig. 4.16 Setbacks for the scale-up of SLS-mediated rapid prototyping
rise to a 3D object. The utilization of thermal energy in the form of a laser limits the
pharmaceutical applications of SLS for the fabrication of drug delivery systems for
thermally stable drugs. Owing to the higher energy of CO
, the laser can degrade
2
drugs more often than the low-energy beam of a blue diode laser. However, it should
also be considered that the most prevalent SLS printers with a CO
laser beam as
2
the heat source provides a facility to modulate the laser power being traced. Owing
to the limitations of thermal stability, materials, such as proteins, enzymes, and
hormones, cannot be processed using SLS (Charoo et al.
2020; Gueche et al. 2021b).
4.10.2 Post-Processing
The surface of the part fabricated using SLS has a powdery appearance and
rough surface finish because of the presence of a non-sintered powder material
on the surface. Awad et al. (2019) observed particles on the surface of Kollicoat
IR miniprintlets using SEM analysis (Awad et al.
used SLS as a single-step procedure for drug amorphization but still observed the
presence of some crystalline drugs during Raman spectroscopic inspection. This
was owing to the incomplete clearance of the unsintered powder from the surface
of the 3D-printed discs. Thus, to prevent dissolution irregularities and to maintain
a uniform solid state and aesthetic value of the dosage form, post-processing of
the fabricated parts must be performed using compressed air or manual brushing
(Trenfield et al.
2022b).
2019). Trenfield et al. (2022)
162 T. Karanwad et al.
4.10.3 Recycling
Generally, only 5–15% of the total feedstock used undergoes sintering if SLS’s
pharmaceutical applications of SLS are considered. The remaining 85–95% powder material remained unsintered. Economically and ecologically, it is necessary
to reuse the previously processed powdered materials for subsequent sintering.
However, this unsintered powder undergoes specific physical and chemical changes,
including thermal degradation, enhanced viscosity due to increased molecular
weight, changes in the size and shape of particles due to their interaction with the
laser and high-temperature exposure followed by cooling. The reuse of processed
materials can affect the mechanical strength of the finished product. Thus, it is
recommended to add 30% virgin powder material to the unsintered powder material
and reuse it in further batches (Charoo et al.
et al. (2021) studied the potential plasticizing effect of dicarboxylic acids (fumaric,
succinic, malic, maleic, and tartaric acids) on the reduction in the optimal heating
temperature of the polymer powder during SLS, which can reduce the thermal
degradation of the powder and active drug constituents (Gueche et al.
2020; Gueche et al. 2021b). Gueche
2021c).
4.10.4 Need of System Development
(a) In process control/online control. There is no diagnostic system for controlling
the size and shape of melt pools in the present systems. By controlling the
overhangs and thin features online, the final printed part ensures a high accuracy
and repeatability. The incorporation of on-line/in-line control systems in SLS
reduces wastage of time and raw materials.
(b) Multiple laser sources in one system. No single laser source can process a
wide variety of feedstock materials; therefore, it would be beneficial if various
types of laser sources are present in a single system for a wide processing range.
(c) Fabrication time. To make SLS competitive with conventional processes,
production speed must be improved. This can be accomplished through parallel
scanning using multiple beams.
(d) Standardization. Objects printed using different SLS 3D printers exhibit
different appearance and properties. Thus, printers, processes, materials, and
post-processing should be standardized to form proper regulations before
commercialization of the SLS in pharmaceutical applications (Kumar
2014).
4.10.5 Defects
Geometric and dimensional defects, surface quality, microstructure, and mechanical properties are among the most common defects in printlets printed using
the SLS-mediated 3D printing technology. SLS process parameters and material
characteristics generally influence the defect specifications (Charoo et al.
2020).
4 Selective Laser Sintering (SLS) in Pharmaceuticals 163
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The literature extensively discusses shrinkage as one of the fundamental reasons
for dimensional inaccuracy, which results in poor laser sintering performance.
Benedetti et al. (2019) studied the shrinkage behavior of semi-crystalline polymers
(PEKK and PA12) with objects printed using SLS 3D printing technology. They
reported that powder bulk density, crystallization, and thermal retraction are the
main material characteristics that affect shrinkage. The PA12 parts were mostly
distorted by crystallization, accounting for 60% of the overall shrinkage. In PEKK
parts with heights less than 10 mm, an upskin and downskin effect is evident, which
is responsible for the expansion (Benedetti et al.
2019).
4.11 Regulatory Attentions for the SLS
As we have discussed in the above sections, SLS-3D printing technology has
numerous applications in the pharmaceutical field. Owing to the broad applicability
in the pharmaceuticals, researchers successfully had sintered the SODFs with varied
release pattern and shape for different kind of patients, while considering their
requirements. Based on the observations of the studies, there is high percentage of
chances to scale-up the fabrication of sintered dosage forms from the laboratory
to industry. In addition, there is an unconditional requirement is that the wellestablished regulatory consideration from the different regulatory bodies. Imperative
amendment in the FDA guidelines for the 3D printed SODFs will expedite the
tech transfer, in similar way of implementation FDA guidelines for the additive
manufacturing of the medical devices in 2017 (Gueche et al.
Fabrication of SODFs according to the needs of the patient is possible by adjusting the process parameters provided by the SLS-3D printing technology within a
broad window. Utilizing these process parameters researchers had fabricated the
different types of formulations such as ODTS, immediate-release tablets, sustainedrelease tablets, polyprintlets, miniprintlets, and dual miniprintlets, by using various
pharmaceutical grade polymers and other excipients (Fina et al.
2019; Fina et al. 2018c; Giri and Maniruzzaman 2023). Subsequently, the quality
by design method was utilized to optimize the effect of the process parameters on
the quality of the SODFs (Gueche et al.
2021a; Ali et al. 2019; Mohamed et al.
2020). Ultimately, these process parameters affect the characteristics of the sintered
designs. In addition, different SLS 3D printers have different resolution of printing,
reservoir dimensions, types of recoater, slicers, and software’s associated. As
discussed in Sect.
11.4, there is a need to standardize printer and process parameters.
In addition, the laser is the heat source in SLS. To control this additional heat source,
it is necessary to evaluate the drug, excipients, final blend, and formulation using
advanced analytical techniques such as DSC, TGA, and HSM. The feasibility of
SLS as a one-step process for changing crystalline API into amorphous forms has
been investigated. Because of this, PXRD analysis of the aforementioned samples
is required for the inspection of solid-state forms for regulatory consideration.
Trenfield et al. 2022 combined PAT with near-infrared and Raman spectroscopies
2021b).
2017;Awadetal.
164 T. Karanwad et al.
to determine the solid-state (amorphous content) of itraconazole in an SLSmediated solid oral formulation. Consequently, the aforementioned techniques can
be considered for solid-state analysis of SLS-mediated prototypes (Trenfield et al.
2022b).
Using an SLS 3D printer, fabrication is a wholly automated process that takes
place in a contained setting. Printing temperature, laser power, laser-scanning speed,
layer thickness hatch spacing, etc. are all process parameters that affect how quickly
or slowly an object can be fabricated using SLS. Therefore, it is important to create
on-line/in-line quality control tools in order to assess the ongoing printing process
and investigate product quality all at once. A more precise and repeatable end result
can be achieved through the incorporation of these rules into online quality analysis
(Gueche et al.
use of a handheld near-infrared spectrophotometer for the non-destructive dose
analysis of SLS-manufactured polypills containing amlodipine and lisinopril. In
addition, for the first time, they reported a non-destructive quality analysis of the
same polypills using a real-time release (RTR) study (Trenfield et al.
2018, Trenfield et al. (2018) reported the use of PAT as a point-and-shoot method for
non-destructive dose verification of paracetamol in printlets fabricated using SLS.
This approach involves the use of near-infrared spectroscopy and Raman confocal
microscopy for non-destructive quality analysis to facilitate the integration of SLS in
the healthcare sector. Therefore, these techniques can be arranged as online/in-line
quality control tools to save time and waste raw materials (Trenfield et al.
The porosity of the matrix is important to control the release of incorporated
API. Thus, porosity is an essential criterion for evaluating the printed formulations.
Various researchers have reported the use of SEM for qualitative evaluation and
micro-CT for quantitative evaluation of matrix porosity (Giri and Maniruzzaman
2023; Santitewagun et al. 2022). These analytical techniques should be considered
when framing the regulatory considerations for SLS-mediated SODFs. SLS requires
various laser-absorbing agents to improve the sinterability of the unsinterable
pharmaceutical grade excipients/feedstock materials. The laser-absorbing agents
used should be generally recognized as safe (GRAS) certified, which will ultimately
reduce the risk of toxicity. The SLS-mediated fabrication also requires GMP to
prevent reproducibility related issues. Reuse and recycling procedures for used
feedstock should be fixed and well-regulated to achieve uniform manufacturing.
2021b; Kumar 2014). In 2020, Trenfield et al. reported the successful
2020). In
2018).
4.12 Conclusion
SLS 3D printing technology is gaining importance for the preparation of SODFs and
other drug delivery devices. Experimental studies have shown that SLS 3D printing
has numerous applications in drug delivery. SODFs with tunable release behaviors
can be fabricated using different thermoplastic polymers and varying process
parameters. For example, orodispersible, immediate, controlled, and sustained
release as well as ASDs.
4 Selective Laser Sintering (SLS) in Pharmaceuticals 165
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Different SLS 3D printers with unique laser sources of various wavelengths are
commercially available. Each laser source and its characteristics significantly affect
the sinterability of the different thermoplastic polymers. Some of these SLS 3D
printers have been explored in the pharmaceutical field.
Since 2017, the graph of SLS in the pharmaceutical field has been growing
une
xceptionally because of the feasibility of process parameters and materialrelated parameter variations, which ultimately helps to modify dosage forms
according to patient needs. In addition, researchers have discovered drawbacks of
SLS-based AM technology. Overcoming these drawbacks will become a significant
challenge for researchers in coming years. Technology transfer from the lab to
industry will benefit from these regulatory considerations. Furthermore, it may offer
stability for the industrial fabrication of SODFs.
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