Formulation and Testing of the Recycled Low-Density Polyethylene Montmorillonite Polymer Composite for Drug Eluting Stents

International Journal of Mechanical Engineering

© 2024 by SSRG - IJME Journal

Volume 11 Issue 12

Year of Publication : 2024

Authors : Ogutu John Bosco, Bruno Robert Mose, James Mutuku Mutua, Christiaan Adika Adenya

10.14445/23488360/IJME-V11I12P105

How to Cite?

Ogutu John Bosco, Bruno Robert Mose, James Mutuku Mutua, Christiaan Adika Adenya, "Formulation and Testing of the Recycled Low-Density Polyethylene Montmorillonite Polymer Composite for Drug Eluting Stents," SSRG International Journal of Mechanical Engineering, vol. 11,  no. 12, pp. 47-72, 2024. Crossref, https://doi.org/10.14445/23488360/IJME-V11I12P105

Abstract:

The increasing global prevalence of Coronary Heart Disease (CAD) has driven the demand for innovative solutions in interventional treatments, with Drug-Eluting Stents (DES) becoming a leading choice. However, the existing stent materials are limited by their biocompatibility and mechanical properties, creating the need for new advancements. This study formulates, tests, and characterizes a polymer composite of recycled low-density polyethylene (rLDPE) and montmorillonite (MMT) for potential application in DES. The research involves material characterization, composite simulation, and optimization using Ansys and Minitab tools, followed by 3D printing of tensile and fatigue test samples to evaluate the composite mechanical properties, alongside morphological analysis using a scanning electron microscope (SEM) to assess material interactions. The Mechanical tests reveal an average tensile strength of 2.46±0.01MPa and fatigue strength of 15.03±0.75MPa, much higher than the primary blood pressure goal in patients with established CAD, which is 0.02MPa. The interaction between rLDPE and MMT effectively produces a homogeneous composite with satisfactory mechanical strength, offering a new material for stent construction. Using rLDPE aligns with environmental sustainability by reducing plastic waste and offering a cost-effective alternative to virgin polymers, making DES more accessible while promoting a circular economy. Montmorillonite acts as an excellent reinforcing agent and drug excipient when incorporated into polymer matrices, improving the mechanical strength, flexibility, and drug release control by enhancing the barrier properties of the composite. The study underscores the potential of rLDPE/MMT composites in addressing modern DES technologies' mechanical, environmental, and biocompatibility demands.

Keywords:

Drug-eluting stents, Montmorillonite, Morphological property, Polymer composite, 3D printing.

References:

[1] Fatemeh Ahadi et al., “Evaluation of Coronary Stents: A Review of Types, Materials, Processing Techniques, Design, and Problems,” Heliyon, vol. 9, no. 2, 2023.
[CrossRef] [Google Scholar] [Publisher Link]
[2] Claudiu N. Lungu, Andreea Creteanu, and Mihaela C. Mehedinti, “Endovascular Drug Delivery,” Life, vol. 14, no. 4, pp. 1-39, 2024.
[CrossRef] [Google Scholar] [Publisher Link]
[3] I. Rykowska, I. Nowak, and R. Nowak, “Drug‐Eluting Stents and Balloons-Materials, Structure Designs, and Coating Techniques: A Review,” Molecules, vol. 25, no. 20, pp. 1-52, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[4] Natalia Beshchasna et al., “Recent Advances in Manufacturing Innovative Stents,” Pharmaceutics, vol. 12, no. 4, pp. 1-36, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[5] B. Polanec, J. Kramberger, and S. Glodez, “A Review of Production Technologies and Materials for Manufacturing of Cardiovascular Stents,” Advances in Production Engineering And Management, vol. 15, no. 4, pp. 390-402, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[6] Magesh Sankar et al., “Magnesium-Based Alloys and Nanocomposites for Biomedical Application,” Applications of Nanocomposite Materials in Orthopedics, pp. 83-109, 2019.
[CrossRef] [Google Scholar] [Publisher Link]
[7] K. Milewski et al., “Comparison of Thin-Strut Cobalt-Chromium Stents and Stainless Steel Stents in a Porcine Model of Neointimal Hyperplasia,” Medical Science Monitor, vol. 16, no. 1, 2010.
[CrossRef] [Google Scholar] [Publisher Link]
[8] Ian B. A. Menown et al., “The Platinum Chromium Element Stent Platform: From Alloy, To Design, to Clinical Practice,” Advances in Therapy, vol. 27, pp. 129-141, 2010.
[CrossRef] [Google Scholar] [Publisher Link]
[9] Jiayin Fu et al., “Evolution of Metallic Cardiovascular Stent Materials: A Comparative Study Among Stainless Steel, Magnesium and Zinc,” Biomaterials, vol. 230, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[10] Ahsan Riaz Khan et al., “Recent Advances in Biodegradable Metals for Implant Applications: Exploring in Vivo and in Vitro Responses,” Results in Engineering, vol. 20, pp. 1-16, 2023.
[CrossRef] [Google Scholar] [Publisher Link]
[11] Shukufe Amukarimi, and Masoud Mozafari, “Biodegradable Magnesium‐Based Biomaterials: An Overview of Challenges and Opportunities,” MedComm, vol. 2, no. 2, pp. 123-144, 2021.
[CrossRef] [Google Scholar] [Publisher Link]
[12] Ling Ding et al., “Polymer-Based Drug Delivery Systems for Cancer Therapeutics,” Polymers, vol. 16, no. 6, pp. 1-35, 2024.
[CrossRef] [Google Scholar] [Publisher Link]
[13] Rasit Dinc, and Halit Yerebakan, “Atlas Drug-Eluting Coronary Stents Inhibit Neointimal Hyperplasia in Sheep Modeling,” Acta Cardiol Sin, vol. 40, no. 5, pp. 585-594, 2024.
[CrossRef] [Google Scholar] [Publisher Link]
[14] Arif A. Al Nooryani et al., “The Role of Optical Coherence Tomography Guidance in Scaffold Versus Stent Optimization,” The Egyptian Heart Journal, vol. 72, no. 1, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[15] Ta-Hsin Tsung et al., “Biodegradable Polymer-Based Drug-Delivery Systems for Ocular Diseases,” International Journal of Molecular Sciences, vol. 24, no. 16, pp. 1-32, 2023.
[CrossRef] [Google Scholar] [Publisher Link]
[16] Wei Xu, Makoto Sasaki, and Takuro Niidome, “Sirolimus Release from Biodegradable Polymers for Coronary Stent Application: A Review,” Pharmaceutics, vol. 14, no. 3, pp.1-16, 2022.
[CrossRef] [Google Scholar] [Publisher Link]
[17] Aydin Bordbar-Khiabani, and Michael Gasik, “Smart Hydrogels for Advanced Drug Delivery Systems,” International Journal of Molecular Sciences, vol. 23, no. 7, pp. 1-23, 2022.
[CrossRef] [Google Scholar] [Publisher Link]
[18] Stephanie Fuchs, Kaavian Shariati, and Minglin Ma, “Specialty Tough Hydrogels and Their Biomedical Applications,” Advanced Healthcare Materials, vol. 9, no. 2, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[19] Viritpon Srimaneepong et al., “Graphene for Antimicrobial and Coating Application,” International Journal of Molecular Sciences, vol. 23, no. 1, pp. 1-17, 2022.
[CrossRef] [Google Scholar] [Publisher Link]
[20] Keshav Narayan Alagarsamy et al., “Carbon Nanomaterials for Cardiovascular Theranostics: Promises and Challenges,” Bioactive Materials, vol. 6, no. 8, pp. 2261-2280, 2021.
[CrossRef] [Google Scholar] [Publisher Link]
[21] Lingling Ou et al., “Toxicity of Graphene-Family Nanoparticles: A General Review of the Origins and Mechanisms,” Part Fibre Toxicol, vol. 13, pp. 1-24, 2016.
[CrossRef] [Google Scholar] [Publisher Link]
[22] Jayanta Kumar Patra et al., “Nano Based Drug Delivery Systems: Recent Developments and Future Prospects,” Journal of Nanobiotechnology, vol. 16, no. 1, pp. 1-33, 2018.
[CrossRef] [Google Scholar] [Publisher Link]
[23] Asmaa M. Elsherbini, and Sally A. Sabra, “Nanoparticles-In-Nanofibers Composites: Emphasis on Some Recent Biomedical Applications,” Journal of Controlled Release, vol. 348, pp. 57-83, 2022.
[CrossRef] [Google Scholar] [Publisher Link]
[24] Lara Yildirimer et al., “Toxicology and Clinical Potential of Nanoparticles,” Nano Today, vol. 6, no. 6, pp. 585-607, 2011.
[CrossRef] [Google Scholar] [Publisher Link]
[25] Qing Li, and Yiu-Wing Mai, Biomaterials for Implants and Scaffolds, 1st ed., Springer Berlin, Heidelberg, pp. 1-466, 2017.
[CrossRef] [Google Scholar] [Publisher Link]
[26] Chen Pan, Yafeng Han, and Jiping Lu, “Structural Design of Vascular Stents: A Review,” Micromachines, vol. 12, no. 7, pp. 1-26, 2021.
[CrossRef] [Google Scholar] [Publisher Link]
[27] Melissa Sgarioto et al., “Properties and in Vitro Evaluation of High Modulus Biodegradable Polyurethanes for Applications in Cardiovascular Stents,” Journal of Biomedical Materials Research Part B: Applied Biomaterials, vol. 102, no. 8, pp. 1711-1719, 2014.
[CrossRef] [Google Scholar] [Publisher Link]
[28] Ju-Hwan Park et al., “Application of Montmorillonite in Bentonite as a Pharmaceutical Excipient in Drug Delivery Systems,” Journal of Pharmaceutical Investigation, vol. 46, no. 4, pp. 363-375, 2016.
[CrossRef] [Google Scholar] [Publisher Link]
[29] Saprini Hamdiani et al., “Development of Green Composite Based on Recycled-Low Density Polyethylene (r-LDPE) as an Environmentally Friendly Packaging,” Pijar Mipa Journal, vol. 19, no. 3, pp. 553-557, 2024.
[CrossRef] [Google Scholar] [Publisher Link]
[30] Pamela Rodrigues Passos Severino et al., “Protective Low-Density Polyethylene Residues from Prepreg for the Development of New Nanocomposites with Montmorillonite: Recycling and Characterization,” Recycling, vol. 4, no. 4, pp. 1-12, 2019.
[CrossRef] [Google Scholar] [Publisher Link]
[31] Xiaohong Zhang et al., “Enhanced Breakdown Strength and Electrical Tree Resistance Properties of MMT/SiO2 /LDPE Multielement Composites,” Journal of Applied Polymer Science, vol. 136, no. 17, 2019.
[CrossRef] [Google Scholar] [Publisher Link]
[32] Lijun Yang et al., “Electric Field Inducement of Montmorillonite in Ldpe and Properties of Electrical Tree Growing in this Composite,” IEEE Transactions on Dielectrics and Electrical Insulation, vol. 22, no. 3, pp. 1684-1693, 2015.
[CrossRef] [Google Scholar] [Publisher Link]
[33] Pamela Rodrigues Passos Severino et al., “The Use of Recycled Low-Density Polyethylene Films from Protective Prepreg for the Development of Nanocomposites with Bentonite Clay,” Journal of Applied Polymer Science, vol. 138, no. 24, 2021.
[CrossRef] [Google Scholar] [Publisher Link]
[34] Ruijin Liao et al., “Influence of Montmorillonite on Electrical Treeing and Breakdown Characteristics of Low-Density Polyethylene,” Journal of Reinforced Plastics and Composites, vol. 33, no. 23, pp. 2117-2128, 2014.
[CrossRef] [Google Scholar] [Publisher Link]
[35] M. Safa Bodur, Hasret E. Sonmez, and Mustafa Bakkal, “An Investigation for the Effect of Recycled Matrix on the Properties of Textile Waste Cotton Fiber Reinforced (T‐FRP) Composites,” Polymer Composites, vol. 38, no. 7, pp. 1231-1240, 2017.
[CrossRef] [Google Scholar] [Publisher Link]
[36] ASTM E1252-98 “Standard Practice for General Techniques for Obtaining Infrared Spectra for Qualitative Analysis,” ASTM International West Conshohocken, PA, USA, pp. 1-13, 2021.
[CrossRef] [Google Scholar] [Publisher Link]
[37] ASTM “Standard Test Methods for Chemical Analysis of Hydraulic Cement,” ASTM International, West Conshohocken, PA, USA, pp. 1-30, 2017.
[CrossRef] [Google Scholar] [Publisher Link]
[38] Grace Njeri Wamuti et al., “Optimization of Extrusion Process Parameters of Recycled High-Density Polyethylene-Thermoplastic Starch Composite for Fused Filament Fabrication,” Open Journal of Composite Materials, vol. 13, no. 4, pp. 69-86, 2023.
[CrossRef] [Google Scholar] [Publisher Link]
[39] ASTM E2809-22, “Standard Guide for Using Scanning Electron Microscopy/Energy Dispersive X-Ray Spectroscopy (SEM/EDS) in Forensic Polymer Examinations,” ASTM International, pp. 1-8, 2022.
[CrossRef] [Publisher Link]
[40] Asep Bayu Dan Nandiyanto, Rosi Oktiani, and Risti Ragadhita, “How to Read and Interpret Ftir Spectroscope of Organic Material,” Indonesian Journal of Science and Technology, vol. 4, no. 1, pp. 97-118, 2019.
[Google Scholar] [Publisher Link]
[41] Zhiyu Yang et al., “Strengthening And Weakening Effects of Particles on Strength and Ductility of Sic Particle Reinforced Al-Cu-Mg Alloys Matrix Composites,” Materials, vol. 14, no. 5, pp. 1-11, 2021.
[CrossRef] [Google Scholar] [Publisher Link]
[42] A. Mamoon, and A. Al-Jaafari, “Fatigue Behavior of Aluminum Sic Nano Composites Material with Different Reinforcement Ratio,” IOP Conference Series: Materials Science and Engineering, The International Conference on Engineering and Advanced Technology (ICEAT 2020), Assiut, Egypt, vol .870, no. 1, pp. 1-11, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[43] Mohsin Iqbal Qazi et al., “An Integrated Approach of GRA Coupled with Principal Component Analysis for Multi-Optimization of Shielded Metal Arc Welding (SMAW) Process,” Materials, vol. 13, no. 16, pp. 1-22, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[44] Xianfeng Yue et al., “Loading and Sustained Release of Benzyl Ammonium Chloride (BAC) in Nano-Clays,” Materials, vol. 12, no. 22, pp. 1-12, 2019.
[CrossRef] [Google Scholar] [Publisher Link]
[45] Ahmad Ainurofiq, and Syaiful Choiri, “Application of Montmorillonite, Zeolite and Hydrotalcite Nanocomposite Clays-Drug as Drug Carrier of Sustained Release Tablet Dosage Form,” Indonesian Journal of Pharmacy, vol. 25, no. 3, pp. 125-131, 2014.
[Google Scholar] [Publisher Link]
[46] Baohong Sun et al., “Study On Montmorillonite-Chlorhexidine Acetate-Terbinafine Hydrochloride Intercalation Composites as Drug Release Systems,” RSC Advances, vol. 8, no. 38, pp. 21369-21377, 2018.
[CrossRef] [Google Scholar] [Publisher Link]
[47] Vasudha Vaid Khushbu et al., “A Comparative Evaluation of Sustained Release of Chlorphenamine Based on a Nanocomposite of Chitosan, Pectin and Montmorillonite,” ChemistrySelect, vol. 7, no. 14, 2022.
[CrossRef] [Google Scholar] [Publisher Link]
[48] Valeria Ambrogi, Morena Nocchetti, and Loredana Latterini, “Promethazine-Montmorillonite Inclusion Complex To Enhance Drug Photostability,” Langmuir, vol. 30, no. 48, pp. 14612-14620, 2014.
[CrossRef] [Google Scholar] [Publisher Link]
[49] Nadia Elsayed, Mashari Elsharif, and Wael Sabry Mohamed, “Preparation and Characterization of Melt Spun Polypropylene / Montmorillonite Nanocomposite Fibre for Ibuprofen Drug Delivery Application,” Egyptian Journal of Chemistry, vol. 61, no. 2, pp. 259 268, 2018.
[CrossRef] [Google Scholar] [Publisher Link]
[50] Innocent J. Macha et al., “Marine Structure Derived Calcium Phosphate-Polymer Biocomposites for Local Antibiotic Delivery,” Marine Drugs, vol. 13, no. 1, pp. 666-680, 2015.
[CrossRef] [Google Scholar] [Publisher Link]
[51] Christopher J. Ward, Shang Song, and Edward W. Davis, “Controlled Release of Tetracycline-HCl from Halloysite-Polymer Composite Films,” Journal of Nanoscience and Nanotechnology, vol. 10, no. 10, pp. 6641-6649, 2010.
[CrossRef] [Google Scholar] [Publisher Link]
[52] Murilo L. Bello et al., “Sodium Montmorillonite/Amine-Containing Drugs Complexes: New Insights on Intercalated Drugs Arrangement into Layered Carrier Material,” PLoS One, vol. 10, no. 3, 2015.
[CrossRef] [Google Scholar] [Publisher Link]
[53] Xu Liu et al, “Clay-Polymer Nanocomposites Prepared by Reactive Melt Extrusion for Sustained Drug Release,” Pharmaceutics, vol. 12, no. 1, pp. 1-23, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[54] Angela Faccendini et al., “Norfloxacin-Loaded Electrospun Scaffolds: Montmorillonite Nanocomposite vs. Free Drug,” Pharmaceutics, vol. 12, no. 4, pp. 1-24, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[55] Hirotoshi Watanabe, Takenori Domei, and Takeshi Morimoto, “Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI,” JAMA, vol. 321, no. 24, pp. 2414-2427, 2019.
[CrossRef] [Google Scholar] [Publisher Link]
[56] Santosh K. Misra et al., “3D‐Printed Multidrug‐Eluting Stent from Graphene‐Nanoplatelet‐Doped Biodegradable Polymer Composite,” Advanced Healthcare Materials, vol. 6, no. 11, 2017.
[CrossRef] [Google Scholar] [Publisher Link]
[57] Robert van Lith et al., “3D‐Printing Strong High‐Resolution Antioxidant Bioresorbable Vascular Stents,” Advanced Materials Technologies, vol. 1, no. 9, 2016.
[CrossRef] [Google Scholar] [Publisher Link]
[58] Chya-Yan Liaw, and Murat Guvendiren, “Current and Emerging Applications of 3D Printing in Medicine,” Biofabrication, vol. 9, no. 2, 2017.
[CrossRef] [Google Scholar] [Publisher Link]
[59] Albert Manero et al., “Leveraging 3D Printing Capacity in Times of Crisis: Recommendations for COVID-19 Distributed Manufacturing for Medical Equipment Rapid Response,” International Journal of Environmental Research and Public Health, vol. 17, no. 13, pp. 1-17, 2020.
[CrossRef] [Google Scholar] [Publisher Link]
[60] Brian G. Beitler et al., “Interpretation of Regulatory Factors for 3D Printing At Hospitals and Medical Centers, or at the Point of Care,” 3D Printing in Medicine, vol. 8, no. 1, pp. 1-7, 2022.
[CrossRef] [Google Scholar] [Publisher Link]
[61] Tjaša Kermavnar et al., “Three-Dimensional Printing of Medical Devices Used Directly to Treat Patients: A Systematic Review,” 3D Printing and Additive Manufacturing, vol. 8, no. 6, pp. 366-408, 2021.
[CrossRef] [Google Scholar] [Publisher Link]