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Review Article
2025
:20;
10
doi:
10.25259/GJMPBU_19_2025

Revolutionizing Healthcare: Recent Advances of Polyamide 12 in Medical Applications

Postgraduate Unit, School of Dental Sciences, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Malaysia.
Prosthodontics Unit, School of Dental Sciences, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Malaysia.
Biomaterial Unit, School of Dental Sciences, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Malaysia.
Conservative Unit, School of Dental Sciences, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Malaysia.
Author image

*Corresponding author: Nor Aidaniza Abdul Muttlib, Prosthodontics Unit, School of Dental Sciences, Universiti Sains Malaysia, Health Campus, Kubang Kerian, Malaysia. aidaniza@usm.my

Licence
This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

How to cite this article: Thanabalan L, AL-Rawas M, Ghazalli N, Alawi R, Abdul Muttlib N. Revolutionizing Healthcare: Recent Advances of Polyamide 12 in Medical Applications. Glob J Med Pharm Biomed Update. 2025;20:10. doi: 10.25259/GJMPBU_19_2025

Abstract

Objectives:

Polyamide 12 (PA 12), a widely used thermoplastic polymer, exhibits exceptional mechanical, thermal, and chemical properties, making it a crucial material in various industries, particularly the medical sector. With its semi-crystalline structure and low water absorption, PA 12 offers superior flexibility, impact resistance, and processability. This review explores the advancements and applications of PA 12 in medical fields.

Material and Methods:

Only articles published in 2013–2024 and written in English were reviewed in this study. An electronic search was conducted in databases such as Google Scholar, PubMed, PubMed Central, ScienceDirect, and Medline with the terms “polyamide,” “polyamide 12,” and “polyamide 12 in the medical field” used.

Results:

From a pool of 1018 articles initially identified, 211 were deemed relevant to the keywords “polyamide,” “polyamide 12,” and “PA 12 in the medical industry.” Following a screening process focusing on articles published from 2013 to 2024 and reviewing content, only 19 articles met the criteria.

Conclusion:

PA 12 was found to play a vital role in the medical sector, being used in catheters, tissue engineering, biomedical implants, dental prostheses, and many more.

Keywords

Biomaterials
Medical devices
Nylon
Polyamide 12
Polyamide

INTRODUCTION

Huge portions of materials used today are made up of synthetic polymers, which have escalating applications. Polyamide, one of the most widely used thermoplastic polymers, is distinguished by its high electrical and temperature resistance, along with its exceptional mechanical, electrical, and thermal properties.[1] Polyamide has a semi-crystalline structure and comprises a repeating sequence of amide linkages within the polymer backbone, with hydrogen bonds forming between neighboring polymer chains. This amorphous arrangement enhances the material’s rigidity, yield strength, creep resistance, chemical resistance, and elastic properties. Polyamides are available in natural and synthetic forms. Polypeptides and proteins are naturally derived polyamides typically made up of natural aliphatic proteinogenic L-aminoacids. In contrast, synthetic polyamides are homopolymers or diacid-diamine-based polymers, produced from aliphatic and/or aromatic diamines and diacid. Polyamides are manufactured commercially in two different ways. The first method is known as polycondensation of amino acids or the diamines with diacids, while the second method is the ring-opening polymerization of lactams.[2]

Polyamide 12 (PA 12), also known as Nylon-12, was discovered in 1971. It is a nylon polymer with a general formula of [(CH2)11C(O)NH]n. PA 12 is also referred to by alternative names such as poly(imino-1-oxodecamethylene) and polydodecanolactam.[3] PA 12 is widely used in the medical industry. Therefore, this review aims to provide an overview of PA 12, gather and evaluate its recent advancements and pinpoint any existing gaps in its application within the medical field.

MATERIAL AND METHODS

To identify relevant articles, the primary and corresponding authors utilized general search engines and specialized databases, including Google Scholar, Science Direct, PubMed, PubMed Central, and authenticated textbooks, using keywords such as “polyamide,” “polyamide 12,” and “polyamide 12 in the medical industry.” Relevant full-text articles published in English from 2013 to 2024 were appraised, including reviews, meta-analyses, original papers on randomized and non-randomized clinical trials, case reports, and case series on PA 12, and PA 12 in the medical industry. Only publications precisely matching the keywords were considered for inclusion and no manufacturer-supported publications were included in the review process.

A research article was excluded if it was published before 2013, to ensure the inclusion of recent advancements and upto-date research on PA 12 in medical applications. Research articles that do not focus on the medical applications of PA 12 were also excluded, including those related to industrial, automotive, or other non-healthcare-related uses.

RESULTS

From a pool of 1018 articles initially identified, 211 were deemed relevant to the keywords “polyamide,” “polyamide 12,” and “polyamide 12 in the medical industry.” Following a screening process focusing on articles published from 2013 to 2024 and reviewing content, only 19 articles met the criteria and were accessible in full text, aligning with the parameters set in this study. These 19 articles, all published in English and without manufacturer support, form the basis of the research summary presented in Table 1, detailing investigations into PA12 within the medical domain.

Table 1: The summary of research conducted on PA12 in the medical field (n=19).
Focus Field References
Catheter Cardiology Amstutz et al., (2021)[4]
Venoor et al., (2020)[5]
Touris et al., (2020)[6]
Tissue Scaffolds Tissue Engineering Imran et al., (2023)[7]
Dias et al., (2018)[8]
Yao et al., (2023)[9]
Denture Base Dentistry Wieckiewicz et al., (2014)[10]
Vojdani and Giti, (2015)[11]
Biomedical Implants Biomedical Engineering Păcurar et al., (2021)[12]
Subhedar et al., (2016)[13]
3D Printing Medical Imaging and 3D Printing Espera et al., (2019)[14]
Vidakis et al., (2022)[15]
Ma et al., (2022)[16]
Zakręcki et al., (2024)[17]
Kurenov et al.,[18]
Aimar et al., (2019)[19]
Hoy, (2013)[20]
Kumar et al., (2023)[21]
Souza et al., (2022)[22]

DISCUSSION

PA 12 belongs to the synthetic polyamide group [Figure 1]. It has relatively long hydrocarbon chains, significantly contributing to low water absorption. It demonstrated flexibility and remarkably high impact even at low temperatures. In addition, PA 12 exhibits controlled porosity, excellent processability, and outstanding resistance to stress cracking.[22] The performance of PA 12 relies significantly on its morphology and crystal structure. PA 12 exhibits a combination of exceptional mechanical properties, including tensile strength, abrasion resistance, and hardness, surpassing those of other polyamides such as polyamide 6 and polyamide 66. It shares excellent properties with polyolefins, such as low water sensitivity and density. With a melting point ranging from 174°C to 185°C, PA 12 possesses the lowest melting point among essential polyamides yet remains sufficiently high for most practical applications. The density of PA 12 is 1.01, primarily due to its relatively long hydrocarbon chain. This extended structure is also responsible for its low rate of water absorption, which is almost like a paraffin structure.[3]

Classification of polyamides.
Figure 1:
Classification of polyamides.

Conventionally, PA 12 is derived from petroleum-based materials or exotic fatty acids through a complex six-step process. However, in 2012, safety concerns shut down several petroleum-based intermediate production facilities, leading to the identification of alternative plant-based sources. Ricinoleic acid has emerged as a sustainable feedstock for PA 12 synthesis.[23]

PA 12 requires precise thermal management due to a narrow processing window melting temperature of around 180°C and degradation at approximately 320°C. Exceeding the glass transition temperature leads to decreased strength and elasticity.[24,25] Long-term stability can be improved by controlling processing parameters such as melting temperature and cooling time.[26]

PA 12 is reported to be chemically inert, non-toxic, and does not trigger allergic reactions or immune responses in most individuals. It withstands common sterilization techniques such as ethylene oxide (EO), gamma radiation, and autoclaving.[8,27,28]

The primary limitation of PA 12 is its lack of inherent antimicrobial functionality, which restricts its use in applications where microbial resistance is critical.[28,29] PA 12 exhibits no biocidal activity against bacteria, fungi, or viruses in its unmodified form. However, the incorporation of antimicrobial metal oxides such as copper oxide, titanium dioxide, and zinc oxide has been shown to impart significant antimicrobial efficacy. Composites containing these additives demonstrated effective biocidal activity against Candida albicans, Escherichia coli, and Herpes simplex virus type 1 in the same study.[29]

PA 12 plays a significant role in the medical industry in numerous ways. PA 12 has been reported to be utilized in the medical industry as follows:

Catheter

PA 12 is very effective in cardiovascular treatments as a percutaneous transluminal coronary angioplasty (PCTA) balloon catheter.[4] PCTA balloon catheters are needed to restore the blood flow at occluded or stenotic coronary arteries. PA 12 is usually used in the fabrication of distal PCTA balloon catheter shafts as it exhibits a low coefficient of sliding friction, good abrasions, and chemical resistance. The low moisture absorption of PA 12, resulting from its low concentration of amide groups, plays a crucial role in its success as a catheter material. Unlike other polyamides that absorb moisture and may degrade or lose mechanical integrity in humid or aqueous environments, PA 12 maintains its structural stability, flexibility, and performance. This makes it an ideal choice for catheters, which require durability, biocompatibility, and resistance to moisture-related degradation during medical procedures.[5] According to Amstutz et al.,[4] necking, a pre-forming process aimed at reducing the thickness of the outer wall, is highly crucial for boosting material strength. They observed that an increase in temperature leads to further softening of the material, highlighting the possibility of small cross-sectioned catheters with higher mechanical strength in the future. On the other hand, Touris et al.[6] found that PA 12 is susceptible to degradation mechanisms that can cause brittleness and fractures in catheter shafts. Their study focused on the impact of moisture on PA 12, finding that increased hydration makes the polymer more elastic, but this effect is reversible upon drying. They concluded that further research is needed to address and improve the brittleness of PA 12.

Bone tissue engineering (BTE)

BTE is an emerging area of research for treatments of bone defects.[7] BTE provides an innovative approach to regenerating and repairing bone tissue that was damaged by integrating cell growth with 3D porous scaffolds. Innumerable studies are focused on developing biologically inert and cost-effective biomaterials to be used as or substitute adjuvants for treating lesions in various organs and tissues. Dias et al.[8] highlighted the usage of PA 12 in BTE. They observed the growth of highly vascularized connective tissues at the PA 12 rod insertion site, along with differentiation into osteoblasts. There are no signs of acute or chronic inflammatory responses that usually occur when an implant is placed inside an organism. This is due to the biocompatibility of PA 12 with bone tissue, which is evident by no inflammatory reaction recorded in the fragments after 90 days. Furthermore, a strong positive immunostaining for vascular endothelial growth factor, an antibody essential for restoring vascular supply during the angiogenesis phase, was observed in both osteoblasts and endothelial cells, indicating consistent nourishment of the lesion for effective local repair. A study by Yao et al.[9] reported that incorporating hydroxyapatite (HA) in suitable amounts significantly changes the biological activity and mechanical properties of PA 12-based porous scaffolds showing potential for osteochondral regeneration. Furthermore, micro-scale voids within the scaffold, created by incorporating a small amount of HA, promote cell growth and proliferation. Thus, the incorporation of appropriate amounts of HA significantly enhances the biological activity and mechanical properties of porous scaffolds made from PA 12, making them a suitable choice for osteochondral regeneration. The findings from this study highlight the PA 12/HA composite scaffold as a promising candidate for clinical transplantation.[9] Literature also concludes that PA 12 composites can deliver more reliable BTE scaffolds with excellent mechanical properties.[7]

Denture base

Polymethyl methacrylate (PMMA) is the commonly used material in removable denture fabrication, which exhibits adequate material properties and simple application. Yet, the visibility of metal clasps compromises the aesthetic appearance of the acrylic removable partial dentures. The increasing rate of intolerance among medical personnel and patients toward the monomers present in PMMA dentures has raised concern as well. Therefore, it is safe to say PA 12 can be an attainable alternative to PMMA-based removable dentures. The color of the gingiva and teeth can be matched as the flexibility of PA 12 enables retentive elements. However, the biggest drawback observed through this research is that PA 12 is more susceptible to discoloration by staining liquids in opposition to PMMA.[10] Nonetheless, proper oral hygiene practice and professional care should be implemented to substantially minimize the staining problem. In addition, Vojdani and Giti[11] suggested adding glass fiber filler to polyamides to increase stiffness and other mechanical properties. Figure 2 summarizes the other superior and inferior qualities of polyamide-based dentures over conventional PMMA dentures.

Characteristics of polyamide-based denture.
Figure 2:
Characteristics of polyamide-based denture.

Biomedical implants

Over the past two decades, PA 12 has been one of the desirable biomaterials that have gained attention in surgical implants. During total hip replacement surgery, a plastic liner is inserted between the femoral head and the femoral ball. This acetabular liner is generally composed of polymer powder like polyamide. PA 2200 (EOS, GmbH, Germany) which is made from PA 12 is the latest biocompatible powder with great stiffness and strength.[12] Subhedar et al.[13] investigated the applicability of carbon fiber-reinforced PA 12 (CF/PA 12) as a femoral head which forms the body’s largest joint. This study has discovered the application of PA 12 in the management of hip disability and pain, which is mostly caused by rheumatoid arthritis, osteoarthritis, and traumatic arthritis. The fundamental conclusion that derived from the analysis is that PA 12 is the most economical material, and CF/PA 12 material is cytocompatible on which adhesion, spreading, proliferation, and differentiation of immature osteoblastic cells are observed vividly. Specifically, a CF/PA 12 implant exhibits a lower percentage of bone loss (9%) postoperatively. This is due to the implant promoting a more uniform density distribution in the bone and reducing stress shielding compared to metallic implants. Based on these explanations, CF/PA 12 stands out as one of the most suitable implant materials, surpassing metals and ceramics.

3D printing

Three-dimensional (3D) printing is undeniably transitioning rapidly from manufacturing to medical fields and even into the homes of patients and doctors.[18] Since the first report of 3D printed parts by Hideo Kodama in 1982,[30] 3D printing has received a lot of attention and massively helped the medical industry, especially during the unprecedented COVID-19 times.[15] Addictive manufacturing (AM), also called 3D printing, denotes the various processes for printing a physical 3D model using digital information in which incremental layers of the materials are built up under computer control.[18,19] The type of 3D printer used is often determined by the materials to be used and how the layers in the end product are bonded.[20] Various additive manufacturing techniques have been developed through extensive research over time. The different techniques of 3D printing have been summarized in Table 2.

Table 2: Summary of techniques of additive manufacturing.
Techniques Explanation
SLA/Vat Polymerization SLA utilizes a photo-initiated polymerization printing mechanism and is regarded as the most precise and accurate 3D printing method. It features two printing approaches: bottom-up and top-down.
In the bottom-up approach, the printer moves near the bottom, maintaining a gap between the reservoir and platform. This gap is filled with a thin layer of resin, which is cured by exposing it to light from underneath.
Conversely, the top-down approach involves a resin bath surface, over which the building platform is lifted. A laser with a specific wavelength is directed onto the exposed resin surface, initiating the polymerization process.
SLS SLS is a powder bed-based technique that uses a laser as a power source to selectively sinter polymer powders, layer by layer, into a solid object guided by a 3D-CAD model.[31]Powder fusion can be achieved through various binding mechanisms, including SSS, chemical-induced binding, and full or partial melting.
3DP 3DP relies on a powder bed and a liquid binder. First, the powdered material is deposited onto a platform, and a water-based liquid binder is sprayed using inkjet printing. As a two-dimensional pattern forms, a roller spreads an additional layer of powder over the printed layer. A post-heating process is then applied to strengthen the powdered materials used as binding agents.
EP/ME3DP In EP, precise control of the applied force is essential for material deposition. This process is facilitated by stepper motors, pneumatic devices, pistons, and actuators.
FDM FDM uses polymer filaments as raw materials, heating them to a molten state before extruding them through the nozzle of a 3D printer.[32]After depositing the first 2D layer, the build plate moves along the z-axis, enabling a new layer to be added on top.
LOM LOM integrates both additive and subtractive manufacturing techniques. In subtractive manufacturing, mechanical or laser cutting tools are utilized for shaping materials. A 3D structure is formed through adhesion, where an adhesive material is applied before bonding the layers together.
FFF FFF is extensively used for thermoplastic polymeric materials. Engineering thermoplastic polymers, such as PLA and ABS, are commonly used in FFF. However, very limited data is available on the thermal and mechanical properties of semi-crystalline materials such as polyamide 6/66/12 used for FFF mainly due to the difficulty of processing the mentioned materials.[33]

SLA: Stereolithography, SLS: Selective laser sintering, 3DP: Three-dimensional printing, EP: Extrusion printing, M3DP: Material extrusion 3DP, FDM: Fused deposition modeling, LOM: Laminated object manufacturing, FFF: Fused filament fabrication, SSS: Solid-state sintering, PLA: Polylactic acid, ABS: Acrylonitrile butadiene styrene

Over time, extensive research has aimed to enhance the properties of PA 12 for 3D printing use. Research has proved that the incorporation of 1.5 and 3 wt% carbon black (CB) into PA 12 can increase the maximum degradation temperature of the entire sintered CB/PA 12 composite. This improvement is due to the exceptional thermal properties of CB particles, which enhance overall thermal stability. This occurs because a carbon layer forms on the PA 12 surface, which inhibits the combustion process.[14]

Vidakis et al.[15] pointed out that the antibacterial performance of PA 12 can be enhanced with the silver-doped antibacterial nanopowder (AgDANP) for 3D printing applications. Silver nanoparticles possess strong bactericidal characteristics and have proven not accountable for microbial resistance.[22] Hence, they evaluated the potential of the PA 12/AgDANP. The addition of 2.0 wt% of AgDANP showed significantly higher antibacterial properties compared to other nanocomposites.[15] This development presents the potential application of PA 12 membranes, fabricated through selective laser sintering (SLS) and incorporated with AgDANP, for use in wound dressings, which are typically designed to exhibit bactericidal properties.[22]

PA 12 is currently known to replace materials such as acrylonitrile butadiene styrene, polylactic acid, and polyethylene terephthalate glycol in the AM of orthoses because of the high thermal, mechanical, and fatigue strength using Multi Jet Fusion (MJF) and SLS technologies. PA 12 also quickly absorbs moisture from the environment, is biocompatible according to ISO 10993-1, and does not trigger allergic reactions or any immune response in most individuals.[17,28] Another highlighted feature is the ability for polishing, dyeing, powder coating, and many more possibilities for finishing parts as aesthetics is a major concern for orthosis. Zakręcki et al.[17] also revealed the possibility of producing a lightweight and openwork structure for orthosis, which significantly reduces the expenses, production time, and weight. On the other hand, MJF techniques offer a notable benefit over other 3D printing methods, as the geometry components can be created in any orientation without including other materials. However, the absence of resistance to microbial is regarded as a disadvantage and dyeing PA 12 is more challenging due to its chemical composition.[28]

CONCLUSION

The study underscores the significant role of PA 12 in advancing medical applications due to its exceptional mechanical, thermal, and chemical properties. Its flexibility, impact resistance, and biocompatibility make it suitable for diverse medical uses, including catheters, BTE, biomedical implants, and denture bases. PA 12’s integration with additive manufacturing technologies such as Multi Jet Fusion and Selective Laser Sintering further expand its potential in personalized healthcare solutions. Research highlights its antibacterial modification potential, enhanced thermal stability, and improved biocompatibility, though challenges such as microbial resistance and susceptibility to staining remain. Future studies should focus on addressing these limitations to optimize PA 12’s application in medical and industrial settings.

Ethical approval:

The research/study was approved by the Institutional Review Board at Human Research Ethics Committee (HREC) Universiti Sains Malaysia, number USM/JEPeM/KK/24030283, dated 2nd June, 2024.

Declaration of patient consent:

Patient’s consent is not required as there are no patients in this study.

Conflicts of interest:

There are no conflicts of interest.

Use of artificial intelligence (AI)-assisted technology for manuscript preparation:

The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.

Financial support and sponsorship: This work was supported by a Universiti Sains Malaysia, Bridging Grant with Project No: R501-LR-RND003-0000001452-0000.

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