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SubhamBanerjeeEditor
Additive
Manufacturing in
Pharmaceuticals
Additive Manufacturing in Pharmaceuticals
Subham Banerjee
Editor
Additive Manufacturing
in Pharmaceuticals
Editor
Subham Banerjee
Department of Pharmaceutics
National
Institute of Pharmaceutical
Education & Research (NIPER)
Guwahati, Assam, India
ISBN 978-981-99-2403-5 ISBN 978-981-99-2404-2 (eBook)
https://doi.org/10.1007/978-981-99-2404-2
© The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore
Pte Ltd. 2023
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Preface
Industrial additive manufacturing (AM)/3D printing has reached a tipping point and
is set to explode into the public. AM technology has evolved far beyond prototyping,
quick tooling, trinkets, and toys, yet a few executives and engineers are unaware of
this development. “AM” is the creation of long-lasting and secure items for sale in
moderate to large volumes to actual customers. 3D printing is “ready to emerge from
its niche position and become a viable alternative to conventional manufacturing
processes in an expanding number of applications.” The applicability of the AM
is increasing day by day in various fields including the pharmaceutical field. AM
has provided a personalization front to the pharmaceutical industry where dosage
development can be patient centric. If needed, 3D printed dosage form can be
formulated with customized shape, size, and release characteristics on the patient
bedside. Hailing from rapid prototyping and into biomedical field, 3D printing has
convincingly revolutionized the pharmaceutical industry and its pace of innovation.
3D printing empowers the formulation design to new directions such as personalized
medicine, controlled-released dosage form, organ-on-a-chip, as well as implants.
Even until a few years ago, it was implausible to foresee the adoption of 3D printing
in the formulation development pipeline such as preformulation to first-in-human
(FIH). And now, 3D printing is being investigated to be used in frontline clinical trial
setting to provide personalized service to the trial patients. Around 30,000 articles
in technological literature have already been published discussing the futuristic
application of 3D printing in the pharmaceutical field. The rapid progression of
3D printing in the pharmaceutical field is a result of an extensive amount of
past research, driven by its vast application potential. In the visible way of the
paradigm shift in AM, the pharmaceutical field also progressed and developed the
levetiracetam-embedded oral dispersible tablets, Spritam, in 2015 using the binder
jet technology. Spritam was the first and only drug-loaded 3D printed formulation
that was approved by the U.S. Food and Drug Administration (FDA). Hence, Chap.
1 encapsulates the past and the present status of 3D printing in pharmaceuticals with
an
open-ended future application possibility.
Known for its flexibility and ease of use, fused deposition modeling (FDM) has
been
one of the first 3D printing processes to be exploited for medical applications.
In FDM 3D printing, feedstock material is fed to a heated nozzle where the
feedstock is softened and deposited on a bed. The resulting 3D object is created in a
layer-by-layer fashion by movement of either the nozzle or the bed along different
v
vi Preface
axes. Chapter 2 discusses the advantages and limitations of the FDM technique, its
numerous applications in the medical field, and its future potential to become an
established pharmaceutical manufacturing technique.
In the pharmaceutical domain, stereolithography (SLA) 3D printing can offer the
ability to rapidly fabricate dimensionally accurate drug-loaded excipients that are
internally solid, cost-effective, and externally smooth. One of the principal benefits
common to 3D printing technology is the ability to personalize medicine. The
pharmaceutical SLA 3D printing domain is relatively new, and there is a huge scope
for further development. Chapter
3 will start by providing a brief history of SLA
3D printing. This will be followed by the coverage of some of the earliest research
in pharmaceutical SLA 3D printing. From there, the chapter will gradually build
up to the latest findings in the domain. Then, the most cutting-edge and promising
developments will be discussed. Finally, t he challenges and future potential of the
technology will be presented.
Rapidly developing and evolving rapid prototyping technologies, as well as the
emergence of 3D printable materials integrated with drug moieties, have enormous
potential in the customization of dosage forms required for patients. Feature-rich
functionalities of solid dosage forms such as desired control over porous internal
architecture, complex geometry, and wide varieties of possible shapes and sizes,
which are very difficult to achieve with mass manufacturing, are now possible
with the use of selective laser sintering (SLS)-mediated rapid prototyping. Thus,
the purpose of Chap.
4 is to discuss the basic fundaments of SLS, its potential
pharmaceutical applications along with diverse processable materials, essential
process parameters and their effect on SLS-mediated fabrication, setbacks for scaleup, regulatory consideration, and future aspects of SLS-mediated 3D printing in
pharmaceuticals.
Semisolid extrusion (SSE) consists of an extrusion-based 3D printing technique
widely employed in food printing and bioprinting. In pharmaceutics, SSE is
becoming the most explored technique to obtain solid dosage forms with specific
characteristics, such as chewable, fast-dissolving, or gastro-floating tablets; polypills; oral and topical films; and rectal suppositories, among others. Due to this
versatility, SSE has become a powerful tool to produce innovative dosage forms with
clinical relevance for specific groups, including pediatric, geriatric, and veterinary
populations, as personalized medicines. This is covered in Chap.
5.
After two decades of foundational work, global interest remains ascendant for
the AM of pharmaceuticals. At the forefront of this interest is binder jetting onto
powder, which holds a unique position due to the early regulatory precedents
established using this technology and also the diversity of materials it can process.
Chapter
6 provides a technical foundation for binder jet printing of pharmaceuticals,
with particular emphasis on its application to novel pharmaceutical dosage forms
and future perspectives in the field.
4D printing is the potential evolution of AM by integrating the time variable. It
can create dynamic structures which transfer a shape to another desired shape due
to the influence of external stimulations. It has attracted the attention in healthcare
with the noticeable advantages of the wide variety of materials used in the printing,
Preface vii
unlimited design, and individual medical use. Chapter 7 represents the significant
role of 4D printing in healthcare, which offers the recent 4D printing technology
to the future directions of 4D printing in healthcare. Frist, a brief overview of
4D printing is introduced. Then, the process of 4D printing methods based on
standardized categories of AM is illustrated. The suitable materials and advantages
in each method are described to introduce a better way in the use of 4D printing.
In addition, the materials used in 4D printing are reviewed with consideration on
stimuli-responsive behaviors and types of initiate materials. Finally, the challenges
and future trend of 4D printing are discussed. 4D printing for the development
of pharmaceutical and drug delivery system is presented and deeply discussed in
Chap.
8.
Commercial launch of a pharmaceutical new chemical entity is an outcome of
extensive financial and time commitments. Failure of drugs at late stage of clinical
trials causes immense loss to the developer. Technological innovations that can
provide reliable prediction of safety and efficacy of the molecules in the early phases
of discovery process are of extreme importance for the pharmaceutical industry.
Due to their ability to better mimic composition and anatomical characteristics of
tissues over conventional two-dimensional monolayer cultures, three-dimensional
(3D) models are increasingly proving beneficial. Successful development of such
3D models is expected to provide better physiological correlation compared to
2D culture, and the former may be used as a replacement for animal models.
Among various other fabrication techniques, bioprinting is an advanced technique to
fulfil the purpose of development of biomimetic constructs. Chapter
9 presents the
fundamental aspects of bioprinting and discusses its application in different stages
of drug discovery, like high-throughput screening and predictive in vitro safety.
3D printed drug product has to meet the standard of identity, strength, quality,
and purity. To encourage the use of novel technology in drug product manufacturing
including 3D printing, the FDA/CDER has established “Emerging Technology
Program” to guide sponsors in identifying and resolving potential technical and
regulatory challenges. Chapter
10 reviews the regulatory aspect of 3D printed drug
products.
In industrial fields, the application of machine learning and deep learning in
AM is expected to be an effective method to optimize the manufacturing process,
to control the quality of 3D printed objects, to detect defects in the objects, and
to predict material properties. Machine learning may hold promise in solving the
complex problems of drug manufacturing using 3D printers. Chapter
11 introduces
the recent advancement of 3D printed medicine and the application of machine
learning. Subsequently, it discusses about 3D printed medicines that use statistical
approaches in the experimental methods. Finally, a possible future is embedded
where “artificial intelligence pharmacists” will regularly use 3D printers in a clinical
setting.
The potential uses of AM are anticipated to have a promising future in the
pharmaceutical industry. Researchers believe that AM is a groundbreaking pharmaceutical technology that may shape the future of many industries, including pharma.
The vision of the studies and diligent work in the field of AM in pharmaceuticals can
viii Preface
be seen day by day in terms of publications and in the pipeline of the pharmaceutical
industry. The current medical research is the primary focus of this book, which
also includes a thorough explanation of the applicability, restrictions, and regulatory
considerations of AM in pharmaceuticals.
Guwahati, India Subham Banerjee, Ph.D.
Contents
1 History and Present Scenario of Additive Manufacturing
in Pharmaceuticals
Koyel Sen, Thomas G. West, and Bodhisattwa Chaudhuri
2 Fused Deposition Modeling (FDM) of Pharmaceuticals ............... 45
Silke Henry, Valérie Vanhoorne, and Chris Vervaet
3 Stereolithography (SLA) in Pharmaceuticals ........................... 97
Prashanth Ravi and Parimal Patel
4 Selective Laser Sintering (SLS) in Pharmaceuticals .................... 125
Tukaram Karanwad, Srushti Lekurwale, and Subham Banerjee
5 Semi-Solid Extrusion (SSE) in Pharmaceuticals ........................ 171
Nadine Lysyk Funk, Júlia Leão, Thayse Viana de Oliveira,
and Ruy Carlos Ruver Beck
6 Inkjet and Binder Jet Printing in Pharmaceuticals ..................... 201
Thomas G. West and Jaedeok Yoo
......................................................... 1
7 4D Printing: The Next Dimension of Healthcare in Cancer
Research
Atchara Chinnakorn, Wiwat Nuansing, Abbas Z. Kouzani,
Mahdi Bodaghi, and Ali Zolfagharian
8 4D Printing in Pharmaceuticals........................................... 271
Irene Chiesa, Amedeo Franco Bonatti, Aurora De Acutis,
Gabriele Maria Fortunato, Giovanni Vozzi, and Carmelo De Maria
9 Bioprinting in Pharmaceuticals ........................................... 293
Mansi Dixit, Nidhi Singh, Priyanka Das, and Pallab Datta
10 Regulatory Perspective of Additive Manufacturing in the Field
of Pharmaceuticals
Ziyaur Rahman, Naseem A. Charoo, Eman M. Mohamed,
Mathew Kuttolamadom, and Mansoor A. Khan
..................................................................... 237
......................................................... 327
ix
x Contents
11 Machine Learning in Additive Manufacturing
of Pharmaceuticals
......................................................... 349
Tatsuaki Tagami, Koki Ogawa, and Tetsuya Ozeki
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