Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5597_Библиотеки_им_академика_М_И_Перельмана
.pdf
https://t.me/med1917
174
Pokala, S., & Samatham, M. (2016). Future of manufacturing technology rapid prototyping
technique. IJMET, 7, 2016.
Praveen, S., & Kim, H. S. (2018). High- entropy alloys: Potential candidates for high-
Handbook of 3D Printing in Pharmaceutics
temperature applications – An overview. Adv Eng Mater, 20(1), 1700645. https:// doi.
org/ https:// doi.org/ 10.1002/ adem.201700 645
Robles- Martinez, P., Xu, X., Treneld, S. J., Awad, A., Goyanes, A., Telford, R., Basit, A.
W., & Gaisford, S. (2019). 3D Printing of a multi- layered polypill containing six drugs
using a novel stereolithographic method. Pharmaceutics, 11(6). https:// doi.org/ 10.3390/
pharma ceut ics1 1060 274
Sadasivuni, K. K., Rattan, S., Deshmukh, K., Makhdoomi, A., Ahamed, B., Pasha, S. K.,
Mazumdar, P., Waseem, S., Grohens, Y., & Kumar, B. (2019). CHAPTER 12: Hybrid
Nano- ller for Value Added Rubber Compounds for Recycling; pp. 310– 329. https:// doi.
org/ 10.1039/ 978178 8013 482- 00310
Sadia, M., Sośnicka, A., Arafat, B., Isreb, A., Ahmed, W., Kelarakis, A., & Alhnan, M. A.
(2016). Adaptation of pharmaceutical excipients to FDM 3D printing for the fabrication
of patient- tailored immediate release tablets. Int J Pharm, 513(1– 2), 659– 668. https://
doi.org/ 10.1016/ j.ijph arm.2016.09.050
Saroia, J., Yanen, W., Wei, Q., Zhang, K., Lu, T., & Zhang, B. (2018). A review on biocom-
patibility nature of hydrogels with 3D printing techniques, tissue engineering applica-
tion and its future prospective. Bio- Design Manufactur, 1. https:// doi.org/ 10.1007/ s42
242- 018- 0029- 7
Schuurman, W., Levett, P. A., Pot, M. W., van Weeren, P. R., Dhert, W. J., Hutmacher, D. W.,
Melchels, F. P., Klein, T. J., & Malda, J. (2013). Gelatin- methacrylamide hydrogels as
potential biomaterials for fabrication of tissue- engineered cartilage constructs. Macromol
Biosci, 13(5), 551– 561. https:// doi.org/ 10.1002/ mabi.201200 471
Sharma, A., Rawal, P., Tripathi, D. M., Alodiya, D., Sarin, S. K., Kaur, S., & Ghosh, S. (2021).
Upgrading hepatic differentiation and functions on 3D printed silk- decellularized liver
hybrid scaffolds. ACS Biomater Sci Eng, 7(8), 3861– 3873. https:// doi.org/ 10.1021/ acsb
ioma teri als.1c00 671
Sharma, R., Smits, I. P. M., De La Vega, L., Lee, C., & Willerth, S. M. (2020). 3D Bioprinting
pluripotent stem cell derived neural tissues using a novel brin bioink containing drug
releasing microspheres [original research]. Front Bioeng Biotechnol, 8. https:// www.fron
tier sin.org/ artic les/ 10.3389/ fbioe.2020.00057
Tagami, T., Fukushige, K., Ogawa, E., Hayashi, N., & Ozeki, T. (2017). 3D printing factors
important for the fabrication of polyvinylalcohol lament- based tablets. Biol Pharm
Bull, 40(3), 357– 364. https:// doi.org/ 10.1248/ bpb.b16- 00878
Turner, P. R., Murray, E., McAdam, C. J., McConnell, M. A., & Cabral, J. D. (2020). Peptide
chitosan/ dextran core/ shell vascularized 3D constructs for wound healing. ACS Appl
Mater Interfaces, 12(29), 32328– 32339. https:// doi.org/ 10.1021/ acs ami.0c07 212
Uddin, M. S., Hall, C., & Murphy, P. (2015). Surface treatments for controlling corrosion
rate of biodegradable Mg and Mg- based alloy implants. Sci Technol Adv Mater, 16(5),
053501. https:// doi.org/ 10.1088/ 1468- 6996/ 16/ 5/ 053 501
Ulery, B. D., Nair, L. S., & Laurencin, C. T. (2011). Biomedical applications of biodegradable
polymers. J Polym Sci B Polym Phys, 49(12), 832– 864 [0887– 6266 (Print)].
Wei, X., Li, D., Jiang, W., Gu, Z., Wang, X., Zhang, Z., & Sun, Z. (2015). 3D Printable graphene
composite. Sci Rep, 5(1), 11181. https:// doi.org/ 10.1038/ srep11 181
Wong, K. (2012). K.V. Wong, A.Hernandez, “A Review of Additive Manufacturing,”
ISRN Mechanical Engineering, Vol 2012 (2012), Article ID 208760, 10 pages. ISRN
Mechanical Engineering, 2012. https:// doi.org/ 10.5402/ 2012/ 208 760
https://t.me/med1917
Next-Generation Computational Automation
Xin, S., Chimene, D., Garza, J. E., Gaharwar, A. K., & Alge, D. L. (2019). Clickable PEG
175
hydrogel microspheres as building blocks for 3D bioprinting [10.1039/ C8BM01286E].
Biomater Sci, 7(3), 1179– 1187. https:// doi.org/ 10.1039/ C8B M012 86E
Yang, X., Lu, Z., Wu, H., Li, W., Zheng, L., & Zhao, J. (2018). Collagen- alginate as bioink for
three- dimensional (3D) cell printing based cartilage tissue engineering. Mater Sci Eng C
Mater Biol Appl, 83, 195– 201. https:// doi.org/ 10.1016/ j.msec.2017.09.002
Zanini, N., Carneiro, E., Menezes, L., Barud, H., & Mulinari, D. (2021). Palm bers residues
from agro- industries as reinforcement in biopolymer laments for 3D- printed scaffolds.
Fiber Polym, 22. https:// doi.org/ 10.1007/ s12 221- 021- 0936- 7
Zhang, F., Li, S., Shen, Z., Cheng, X., Xue, Z., Zhang, H., Song, H., Bai, K., Yan, D., Wang, H.,
Zhang, Y., & Huang, Y. (2021). Rapidly deployable and morphable 3D mesostructures
with applications in multimodal biomedical devices. 118(11), e2026414118. https:// doi.
org/ doi:10.1073/ pnas.202 6414 118
Zhu, J., & Marchant, R. E. (2011). Design properties of hydrogel tissue- engineering scaffolds.
Expert Rev Med Devices, 8(5), 607– 626. https:// doi.org/ 10.1586/ erd.11.27
https://t.me/med1917
https://t.me/med1917
Section VII
Social, Economic,
Environmental, Quality,
and Regulatory Aspects
https://t.me/med1917
https://t.me/med1917
Social, Economic,
10
and Environmental
Justifications
for 3D Printing
of Pharmaceutical
Products
Himanshu Sharma, Siddhant Jai Tyagi,
Neha Pathak, Adarsh Keshari, Prakhar Varshney,
and Rashmi Pathak
10.1 INTRODUCTION
Layers of material are deposited on top of one another during the three-dimensional
(3D) printing process to produce 3D things from digital models. Prototyping, production, art, education, and medicine are a few examples of the uses of 3D printing. In
comparison to conventional fabrication techniques, 3D printing has several benets,
including speed, exibility, customizability, and less waste (Özeren et al., 2023). The
drawbacks of 3D printing include technical restrictions, moral dilemmas, and environmental effects. Future developments in the realm of 3D printing technology might
have a profound impact on a wide range of sectors and businesses (Kapadia et al.,
2020). By building layers of materials on top of one another, 3D printing technology
turns computer models into real objects (Rachmawati et al., 2023). The production of customized medications based on each patient’s dosage, shape, color, avor,
and release prole, as well as the development of innovative drug delivery systems
like implants, patches, inhalers, and microneedles that can improve the efcacy and
safety of currently available medications, are just a few of the many potential uses
for 3D printing in the pharmaceutical industry (Ullah et al., 2023). The pharmaceutical industry stands to benet from 3D printing in several ways, including enhanced
patient- centricity and personalized medicine, improved drug product quality and consistency, decreased risk of errors, contamination, and counterfeiting, increased innovation and creativity in drug design and discovery, and the ability to look into new
directions and solutions (Chakka & Chede, 2023). Assuring the safety, quality, and
179DOI: 10.1201/9781003439509-17
https://t.me/med1917
180
Handbook of 3D Printing in Pharmaceutics
efcacy of 3D- printed drugs requires stringent testing and validation methods and
standards. Addressing the ethical, legal, and social implications of 3D printing, such
as intellectual property rights, data privacy, patient consent, and access to healthcare,
as well as overcoming technical and nancial obstacles, are other challenges and
limitations that 3D printing poses for the pharmaceutical industry (Parry, 2023). The
pharmaceutical sector could change because of the revolutionary technology known
as 3D printing. To ensure its safe and responsible usage, it also needs careful consideration and regulation. 3D printing is a technology that allows actual objects to be
produced from digital models by building complex structures out of multiple layers of
material (Priyadarshini et al., 2023). 3D printing has been used by many businesses,
including the pharmaceutical sector because it offers advantages like customization, personalization, and on- demand medicine production. Quality control, regulatory limitations, and ethical conundrums are just a few of the risks and challenges
associated with 3D printing (Huanbutta et al., 2023). As a result, it is critical to look
at the social, economic, and environmental arguments for implementing 3D printing
in the pharmaceutical industry in order to weigh its advantages and disadvantages
and to determine the best procedures and regulations for its adoption (Eiamin &
Herur Ramesh, 2023). Based on the potential to increase drug availability, cost, and
access for various populations and requirements, 3D printing in the pharmaceutical
industry is socially justied. Drug manufacturing at the point of care is made possible
by 3D printing, which lessens the need for supply chains and distribution systems
and improves the ability to respond quickly to crises and outbreaks (Desselle et al.,
2023). By employing recyclable or biodegradable materials and just manufacturing
the necessary quantity of pharmaceuticals, 3D printing can help reduce the amount
of waste produced by drug production and consumption. By minimizing the use of
animal testing and substances produced from plants, 3D printing can also help conserve biodiversity and natural resources see Figure 10.1 (Kokare et al., 2023).
To ensure that 3D printing is used responsibly and sustainably in the pharmaceutical industry, it is crucial to perform a thorough and impartial review of the grounds
for adoption (Bazli et al., 2023). 3D advantages and disadvantages of the various
methods are shown in Table 10.1.
10.2 PRECISE DOSAGE AND FORMULATIONS
The ability to produce individualized dosages and formulations for specic patients
thanks to 3D printing has the potential to revolutionize personalized medicine. The
ability to develop patient- specic drugs thanks to this ground- breaking technology
offers several advantages and advances in the medical industry (Chambers et al.,
2023). The following are a few of the most signicant effects of 3D printing on
personalized medicine, see Figure 10.2.
10.2.1 tailOreD meDicatiOns FOr sPeciFic cOnDitiOns
Unique formulations that are not frequently found on the market are needed for some
medical disorders. Using sustained- release mechanisms, alternative drug- delivery
methods, or a combination of these to better meet a patient’s individual needs, 3D
https://t.me/med1917
Social, Economic, and Environmental Justifications
181
FIGURE 10.1 The process of 3D printing.
TABLE 10.1
Materials Used in Some 3D Printing Methods, Advantages, and
Disadvantages of the Various Methods
Methods Materials Advantages Disadvantages
Fused deposition
modeling
Stereolithography Resin (Acrylate
Selective laser
sintering
3D inkjet printing Photo- resin or
ABS, PLA, Wax
blend, Nylon
or Epoxy based
with proprietary
photoinitiator)
Metallic powder,
polyamide, PVC
hydrogel
High speed, high
quality, used for
a wide range of
material
Large parts can be
built easily, with
high accuracy and
surface nish
High- resolution,
high strength
Very good accuracy,
very high surface
nishes
The porous structure
of the binder, and
its weak mechanical
properties, often
required support
Expensive, not well-
dened mechanical
properties due
to the usage of
photopolymers
Only metals can
be printed, postprocessing is
required due to its
grainy roughness
Fragile parts, poor
mechanical the
properties
https://t.me/med1917
182
Handbook of 3D Printing in Pharmaceutics
FIGURE 10.2 The role of 3D printing in social justication.
printing enables the development of customized pharmaceuticals. Patients with rare
diseases or complex medical conditions particularly benet from this personalized
approach (Shi & McHugh, 2023).
10.2.2 POtential FOr Patient emPOwerment anD engagement in
healthcare
A revolutionary component of 3D printing technology is its potential to empower
and engage patients in healthcare by allowing them to participate in the design and
fabrication of their prescription drugs. The usual patient– provider relationship is
changed to a more collaborative and patient- centered method by including patients
in the process. The following are the main ways that patients’ empowerment and
involvement might be improved by involving them in the design and manufacture of
pharmaceuticals using 3D printing (Sharma et al., 2023).
10.2.3 PersOnalizatiOn treatments
Based on a person’s specic medical requirements, 3D printing enables the production of customized pharmaceuticals. Patient input on preferences, tolerances and
treatment objectives can be used to actively shape the creation of a patient’s drug.
As a result, treatment outcomes are better, and patients report feeling more satised
with their care. This involvement guarantees that the drug is matched to their unique
requirements (Handa et al., 2023).
10.2.4 inFOrmeD DecisiOn- making
Patients gain a better awareness of their treatment options when they are involved in
the design and development of their medications. Patients can choose their healthcare
https://t.me/med1917
Social, Economic, and Environmental Justifications
183
more intelligently as a result of increased patient knowledge about the ingredients,
potential adverse effects, and benets of the prescription. Between patients and
healthcare providers, this openness develops a relationship of trust and cooperation
(Schroeder et al., 2023).
10.3 ETHICAL CHALLENGES ASSOCIATED WITH THE 3D
PRINTING OF PHARMACEUTICAL PRODUCTS
A cautious response is required to the ethical questions and potential difculties that
the 3D printing of medicinal items raises. Even though this cutting- edge technology
has many advantages, some complications need to be addressed. Here are some of
the main moral issues and difculties posed by the 3D printing of medicinal products
(Manshor et al., 2023).
10.3.1 Quality cOntrOl
It is vitally important to guarantee the quality, safety, and efcacy of 3D- printed
medicines. The 3D printing method presents difculty in maintaining dependable
and uniform manufacturing standards. For the materials utilized, the precision of the
printing process, and the integrity of the nished product to be validated, qualitycontrol methods must be implemented. To ensure that medicines produced by 3D
printing adhere to the same high standards as those applied to pharmaceuticals
produced traditionally, rigorous testing and regulatory control are required (Wang
et al., 2023).
10.3.2 intellectual PrOPerty issues
Concerns concerning intellectual property rights are raised by how simple it is to reproduce designs and make drugs using 3D printing. Patient safety could be jeopardized
and innovation hampered by unauthorized drug reproduction or counterfeiting. It is
critical to strike a balance between safeguarding intellectual property and promoting
developments in 3D printing technology. In the case of 3D- printed drugs, it is crucial
to create proper legal frameworks and enforcement procedures to protect IP rights
(Signé, 2023).
10.3.3 regulatOry FramewOrks
Drugs produced by 3D printing are subject to a changing regulatory environment.
Because of the distinctive features of 3D printing, such as decentralized manufacturing and personalization, regulatory bodies must adjust and create standards that
are particular to this technology. A vital component of the regulatory system is
ensuring patient safety, quality control, and compliance with current laws. To create
thorough and current laws, regulatory agencies must work in conjunction with
pharmaceutical businesses and 3D printing industry professionals (Mladenovska
et al., 2023).
Соседние файлы в папке Библиотека им академика М.И. Перельмана