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5.7.1.3 Equipment
Although many of the unit activities used to manufacture pharmaceutical tablets are
essentially continuous and have been well researched for years, integrated continu-
ous from-powder-to-tablet systems are still relatively new (Schmidt etal. 2018).
5.7.1.4 Growth inKnowledge
There is a shortage of experienced scientists, process engineers, and operators
(Verstraeten etal. 2017). Accordingly training are required to spread cutting-edge
information (Ye etal. 2019). Additionally, the number of contract research (CRO)
and manufacturing companies with cutting-edge continuous manufacturing (CM)
facilities and knowledge is rather small, which limits the external network’s capac-
ity for production (Kallakunta etal. 2019). Pharmaceutical quality by design (QBD)
seeks to create a reliable medication product that satises the necessary critical
quality attributes (CQAs). The pharmaceutical sector is steadily embracing continu-
ous manufacturing (CM), and more research is being done on completely integrated
powder-to-tablet production lines rather than studies at the unit operation level (Van
Snick et al. 2017). These studies are desperately needed because interactions
between unit activities have an impact on the quality of the end output, and having
this information is crucial for creating and implementing effective control loops (De
Leersnyder etal. 2018).
5.7.1.5 Modern Process Control Techniques
When it came to the earliest commercial continuous manufacturing (CM) imple-
mentations, conservative control measures were used leading to a shortage of regu-
latory and legal standards. But several of them involved switching from batch to
continuous production as a second source for pharmaceutical products, with no
limitations on time and resources (Nasr etal. 2017).
5.7.1.6 Levels ofControl
Three levels may commonly be distinguished among control strategy implementa-
tions. The pharmaceutical sector often uses the lowest degree of control (i.e. level
3), which is based on carefully controlled material properties and process variables.
Here, rigorous nished product testing makes up for the lack of knowledge about
many causes of variability (Schaber etal. 2011).
Through the creation of a multifactorial design space, an intermediate level of
control (i.e. level 2) seeks to run the process with adaptable raw material properties
and process variables (Chopda etal. 2022). A window of opportunity to move con-
trols upstream and decrease the quantity of nished product testing is created here
by the better product and process expertise, which also makes it easier to identify
possible variability sources that might affect quality of the product. The utmost level
of control (i.e. level 1) guarantees that critical quality attributes (CQAs) are moni-
tored and controlled in real time, allowing process variables to be adjusted in reac-
tion to disruptions and guaranteeing that quality characteristics constantly meet the
predened acceptance standards (Baxendale etal. 2015).
P. Saikiran etal.
129
5.8 3D Printing Implementation inOral Solid Dosage Form
3D printing is growing rapidly in the pharmaceutical and healthcare industries. It is
an advancing technology with a great potential for both patients and healthcare
industry; few examples of the fast growing applications of 3D printing in pharma-
ceutical and healthcare industries are rapid prototyping of orthotics, dental retainers
and drug-loaded implants. The 3D printing was rst applied to the development of
pharmaceuticals in 1996 (Okafor-Muo etal. 2020). We can carefully manage dos-
age, release kinetics and a number of attractive aspects of dosage forms, including
colour, shape and texture, using 3D printing (Brenan 2015). Additionally, polypills
can be created with combinations of medications in one solid dosage form at com-
pletely customisable strengths that would be extremely difcult to obtain commer-
cially (Tracy et al. 2022). At the same time that 3D printing technology and
formulations are progressing, the discovery of innovative hybrid materials to make
superior formulations is picking up momentum (Lopez-Vidal etal. 2022). This
technique allows for the accurate creation of dosage forms, and it can help in drug
product production by offering a wide variety of release modes to meet clinical
needs and enable patient compliance, particularly personalised dosing, to treat par-
ticular disease conditions (Fig.5.5) (Dos Santos etal. 2023).
A technique known as ‘4D printing’ facilitates the creation of 3D objects through
the predened modication of intelligent materials in response to outside stimuli
(Zhang etal. 2019). First, a CAD software is used to generate the product design,
geometry and part sizes. The input is then converted to a machine-readable format
and sliced into printable layers (Zhang etal. 2023).
When compared to conventional pharmaceutical techniques, like powder prepa-
ration, milling, blending, granulation and compression, which lack manufacturing
Fig. 5.5 Role of 3D printing in pharmaceutical manufacturing of solid oral dosage form
5 Advances inPharmaceutical Oral Solid Dosage Forms
130
exibility and process capabilities, 3D printing provides novel advantages (Okafor-
Muo etal. 2020). Computer-aided design (CAD) software or imaging techniques
can develop structures from a digital 3D le to generate personalised objects on
demand (Goyanes etal. 2017). There are several 3D printing technologies available
to create oral solid dosage forms.
5.8.1 Selective Laser Sintering (SLS)
Selective laser sintering (SLS) is a 3D printing method that employs the use of laser
beam to fuse powder particles layer by layer. This additive manufacturing approach
has numerous advantages, including excellent resolution, the ability to reuse the
powder and the absence of pre-processing. The principle of selective laser sintering
is consistent with all other powder bed 3D printing techniques, involving the disper-
sion of powder layers, typically ranging from 0.05 to 0.3mm in thickness, followed
by the selective scanning of each layer with a laser beam (Franco etal. 2010). While
the support structure is created by the unsintered excess, which is effectively
removed during post-printing processing, the part or nal structure is generated by
the sintered powder. Every plane that is processed as part of the system’s 3D com-
ponent represents the basic vectors used for laser scanning (Alhnan etal. 2016). The
powder bed surface is decreased by a height equivalent to one layer’s thickness, and
a consecutive layer of powder is deposited and fused by the laser (Qiu etal. 2015).
5.8.1.1 Process Variables
In order to produce a product with the desirable qualities, the SLS process requires
control over the process variables. These selective laser sintering (SLS) process
variables are most widely researched in engineering elds (Akilesh etal. 2019). The
SLS technique is modied to optimise the dosage forms’ dimensional accuracy,
surface/subsurface quality, mechanical properties and other critical quality attri-
butes (CQAs) (Akande etal. 2016). The critical quality attributes are dependent on
several factors, such as precision of the stereolithography (SLA) transcoding of les
from computer-aided design (CAD) software, the division of layers, resolution by
machine, layer thickness, material shrinking, length-to-width ratio and laser beam
spot dimensions. The most signicant processing variables affecting CQAs of dos-
age forms are laser intensity, bed temperature and layer thickness (Ali etal. 2019).
5.8.1.2 Characteristics ofSintered Printlets
Since there are many various processing factors involved, it is critical to determine
key parameters while developing an SLS-printed dosage form in selective laser sin-
tering (SLS) connected to the average powder diameter, size, variation, layer broad-
ness, laser scan speed and consumed power (Kruth etal. 2007). These variables
were utilised to regulate the porosity of circular SLS-printed discs for zero-order
drug release. Ideally, discs featuring two concentric circular regions with varying
porosities are intended to be fabricated, with a porous interior designed for drug
encapsulation (Kumar 2003). The study used powder blends from two
P. Saikiran etal.
131
biodegradable thermoplastic polymers: poly caprolactone (PCL) and poly lactic
acid (PLA), while methylene blue was used as a model drug (Mazzoli 2013).
5.8.2 Applications
Due to its versatility in manufacturing printlets with various geometries and compo-
sitions, 3D printing is anticipated to revolutionise customised medicine. For exam-
ple, it can be used to make medications for orphan or uncommon illnesses, as well
as for paediatric, aged or special-needs patients (Gueche etal. 2021).
5.8.2.1 Stereolithography (SLA)
The rst and oldest of several prospective 3D printing techniques is SLA.It was a
laser-based writing technology, which was rst developed in the year 1986 (Goole
and Amighi 2016). Despite this, due to the high printing resolution, it generates
complex geometries and smooth-surfaced products and is widely employed (Hsiao
et al. 2018). This technique uses consolidation source as UV beam rays. When
focused on a container containing a photosensitive resin, an ultra violet or other
light source induces cross-linking and creates a polymeric matrix. SLA is made up
of two terms: stereo which means solid and photolithography which means ‘writing
with light’. A drug-containing photopolymerisable polymer solution is solidied
using stereolithography (SLA) technology and a laser (Kaale etal. 2002).
5.8.2.2 Printing Dosage Forms
Tablets were manufactured using a commercial form SLA 3D printer from Formlabs
Inc. in the United States (Chia and Wu 2015). The 3D printer software was used to
import stereolithography les (.stl) created by software called Autodesk Meshmixer
2014
®
(Autodesk Inc., USA) as the templates for generating the tablets. The printer
enables the creation of objects with a layer thickness up to 200μm and a resolution
of 300μm (Wang etal. 2016).
5.8.3 Drawbacks andChallenges
There are some drawbacks in this new technology, due to the large and irregular
sizes that must be administered orally, and a few methods that produced highly
porous structures and uneven shapes have been shown to decrease patient accep-
tance (Pravin and Sudhir 2018).
5.8.3.1 Fused Deposition Modelling (FDM)
Fused deposition modelling (FDM) is a form of 3D printing that creates 3D objects
layer by layer by depositing molten polymer on a platform. By feeding a polymer
lament into the heated printhead and nozzle of the 3D printer, construction mate-
rial is deposited. Heating results in the extrusion of a melted semisolid shape onto
the printing surface (Khalid and Billa 2022). The stage is lowered to make space for
5 Advances inPharmaceutical Oral Solid Dosage Forms
132
the subsequent layer when the nozzles extrude the polymer all along x- and y-axis
to form a layer. Thus, material began to accumulate along the z-axis. CAD software
is used to design the printed material’s shape and size (Krueger etal. 2022). There
is no theoretical constraint on composition variations in all three dimensions for
FDM due to the possibility of using several extrusion nozzles, each with a distinct
material. Heat transfer properties and rheological properties are the most essential
material selection parameters for FDM materials (Bandari etal. 2021). Because
they have a low melting point, thermoplastics are often used. Wax for investment
casting, PVC, nylon and ABS have all been utilised effectively. Due to its low cost
and accessible equipment, FDM has become one of the most prominent 3D printing
technologies in the eld of pharmaceutical research (Limongi etal. 2020).
5.8.3.2 Polymer Filaments forFused Deposition Modelling
The primary method to produce laments that serve as the basis for FDM printing
is the hot-melt extrusion technique of thermoplastic polymers. The rst laments
used for FDM printers that were marketed commercially were polylactic acid
(PLA), polyethylene terephthalate glycol-modied (PET-G) and high-impact poly-
styrene (HIPS) (Pereira etal. 2020). These polymers, which are made in the dimen-
sions of 1.75mm and 2.85–3mm to suit print heads presently in use, often have
high melting points and strong mechanical qualities. This guarantees that they can
pass readily through the printer nozzles and resist the pressure and heat generated
by the extruder and printer gears (Kempin etal. 2018).
5.8.3.3 Drawbacks
The necessity for thermoplastic polymers, which are uncommon among pharma-
ceutical grade polymers, is one of the downsides of FDM printing (Treneld etal.
2018). Despite avoiding the use of solvent, FDM demonstrates relatively limited
drug loading capacity, necessitating certain drying steps. The thermal FDM process
limits the inclusion of thermolabile pharmaceuticals and restricts the usage of a
small number of suitable excipients by melting all main medications, excipients and
carriers (Winarso etal. 2022).
5.8.4 Advantages of3D Printing Solid Dosage Forms
5.8.4.1 On-Demand Manufacturing
The use of 3D printing technology can make it simple to create high-quality prod-
ucts in a matter of minutes. On-demand manufacturing by 3D printing can be espe-
cially useful in situations where time and materials are limited, in drug development
for quicker optimisation and in the fabrication of drug products with poor stability
(Norman etal. 2017).
5.8.4.2 Improved Quality Dosage Forms
It is anticipated that using desktop printers in conjunction with computer-aided
designs would improve control over the several variable parameters involved in
P. Saikiran etal.
133
tablet 3D printing (Giannopoulos etal. 2016). Processes such as granulation, mill-
ing, compression, coating and drying are necessary in majority of traditional medic-
inal product formulations, and the more steps involved in these processes, the higher
the chance of batch failure (Montez etal. 2022).
5.9 Summary
In summary, advances in solid oral dosage forms bring countless opportunities in
the pharmaceutical eld, but however some present issues are unmet which should
be resolved before a feasible integration into clinical pharmacy practices can occur.
The conventional techniques widely used in the manufacturing of the solid orals
often face some backlashes. Present advancements in the technology have led to the
fruitful development of various techniques such as continuous manufacturing tech-
nology, articial intelligence and 3D printing which in turn can potentially revolu-
tionise pharmaceutics, providing a high degree of precision and control in the
manufacturing steps of small-scale and/or personalised processes. To elaborate fur-
ther 3D printing in combination with AI, drug design and genetics have fostered the
development of personalised medicine, hence improving treatment efcacy and
patient compliance. Furthermore, the development of techniques such as QbD has
successfully avoided the problems associated with quality and led to the manufac-
turing of dosage forms with built-in quality. The agreement between AI and PAT
helps in the successful management of in-process manufacturing operations in solid
orals, hence avoiding errors.
Acknowledgement The authors are highly thankful to the Department of Pharmaceuticals,
Ministry of Chemicals and Fertilizers, Government of India, New Delhi for providing nancial
assistance.
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5 Advances inPharmaceutical Oral Solid Dosage Forms