Biodegradable AZ91 magnesium alloy/sirolimus/poly D, L-lactic-co-glycolic acid-based substrate for cardiovascular device application.
AZ91 magnesium alloy
coatings
corrosion
spectroscopy
stent
Journal
Journal of biomedical materials research. Part B, Applied biomaterials
ISSN: 1552-4981
Titre abrégé: J Biomed Mater Res B Appl Biomater
Pays: United States
ID NLM: 101234238
Informations de publication
Date de publication:
15 Nov 2023
15 Nov 2023
Historique:
revised:
26
09
2023
received:
06
05
2023
accepted:
30
10
2023
medline:
15
11
2023
pubmed:
15
11
2023
entrez:
15
11
2023
Statut:
aheadofprint
Résumé
Biodegradable drug-eluting stents (DESs) are gaining importance owing to their attractive features, such as complete drug release to the target site. Magnesium (Mg) alloys are promising materials for future biodegradable DESs. However, there are few explorations using biodegradable Mg for cardiovascular stent application. In this present study, sirolimus-loaded poly D, L-lactic-co-glycolic acid (PLGA)-coated/ sirolimus-fixed/AZ91 Mg alloy-based substrate was developed via a layer-by-layer approach for cardiovascular stent application. The AZ91 Mg alloy was prepared through the squeeze casting technique. The casted AZ91 Mg alloy (Mg) was alkali-treated to provide macroporous networks to hold the sirolimus and PLGA layers. The systematic characterization was investigated via electrochemical, optical, physicochemical, and in-vitro biological characteristics. The presence of the Mg
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023 Wiley Periodicals LLC.
Références
Ma X, Oyamada S, Gao F, et al. Paclitaxel/sirolimus combination coated drug-eluting stent: in vitro and in vivo drug release studies. J Pharm Biomed Anal. 2011;54(4):807-811.
Lee DH, de la Torre Hernandez JM. The newest generation of drug-eluting stents and beyond. Eur Cardiol. 2018;13:54-59.
Reddy SRV, Tre R, Welch TR, Nugent AW. Biodegradable stent use for congenital heart disease. Prog Pediatr Cardiol. 2021;61:101349.
Zhu J, Zhang X, Niu J. Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery. Sci Rep. 2021;11:7330.
Dong H, Lin F, Boccaccini AR, Virtanen S. Corrosion behavior of biodegradable metals in two different simulated physiological solutions: comparison of Mg, Zn and Fe. Corros Sci. 2021;182:109278.
Krupa K, Bekiesińska-Figatowska M. Artifacts in magnetic resonance imaging. Pol J Radiol. 2015;80:93-106.
Espiritu J, Meier M, Seitz J-M. The current performance of biodegradable magnesium-based implants in magnetic resonance imaging: a review. Bioact Mater. 2021;6:4360-4367.
Gonzalez J, Hou RQ, Nidadavolu EPS, Willumeit-Römer R, Feyerabend F. Magnesium degradation under physiological conditions-best practice. Bioact Mater. 2018;3(2):174-185.
Johnson I, Liu H. A study on factors affecting the degradation of magnesium and a magnesium-yttrium alloy for biomedical applications. PloS One. 2013;8:e65603.
Bai W, Yu J, Yang Y, Ye Y, Guo J, Zhang Y. Effect of CO2 saturation on the corrosion behaviour of AZ31B magnesium alloy in Na3PO4 solutions. Int J Electrochem Sci. 2013;8(3):3441-3453.
Qu Q, Ma J, Wang L, Li L, Bai W, Ding Z. Corrosion behaviour of AZ31B magnesium alloy in NaCl solutions saturated with CO2. Corros Sci. 2011;53(4):1186-1193.
Esmaily M, Svensson JE, Fajardo S, et al. Fundamentals and advances in magnesium alloy corrosion. Prog Mater Sci. 2017;89:92-193.
Kang M-H, Cheon K-H, Ahn J-H, Kim H-E, Jung H-D, Jang T-S. An asymmetric surface coating strategy for improved corrosion resistance and vascular compatibility of magnesium alloy stents. Mater Des. 2020;196:109182.
Manavitehrani I, Fathi A, Badr H, Daly S, Shirazi AN, Dehghan F. Biomedical applications of biodegradable polyesters. Polymers. 2016;8:20.
Mao L, Shen L, Chen J, et al. A promising biodegradable magnesium alloy suitable for clinical vascular stent application. Sci Rep. 2017;7:46343.
Saberi A, Bakhsheshi-Rad HR, Karamian E, Kasiri-Asgarani M, Ghomi H. A study on the corrosion behavior and biological properties of polycaprolactone/ bredigite composite coating on biodegradable Mg-Zn-Ca-GNP nanocomposite. Prog Org Coat. 2020;147:105822.
Panahi Z, Tamjid E, Rezaei M. Surface modification of biodegradable AZ91 magnesium alloy by electrospun polymer nanocomposite: evaluation of in vitro degradation and cytocompatibility. Surf Coat Technol. 2020;386:125461.
Song G, Atrens A, Wu X, Zhang B. Corrosion behaviour of AZ21, AZ501 and AZ91 in sodium chloride. Corros Sci. 1998;40:1769-1791.
Brown SA, Farnsworth LJ, Merritt K, Crowe TD. In vitro and in vivo metal ion release. J Biomed Mater Res. 1988;22:321-338.
Hanada K, Matsuzaki K, Huang X, Chino Y. Fabrication of Mg alloy tubes for biodegradable stent application. Mater Sci Eng C. 2013;33:4746-4750.
Öcal EB, Esen Z, Dericioğlu AF, Aydınol K. Comparison of the short and long-term degradation behaviors of as-cast pure Mg, AZ91 and WE43 alloys. Mater Chem Phys. 2020;241:122350.
Aljihmani L, Alic L, Boudjemline Y, et al. Magnesium-based bioresorbable stent materials: review of reviews. J Bio- Tribo-Corros. 2019;5:26.
Yue Y, Wang L, Yang N, et al. Effectiveness of biodegradable magnesium alloy stents in coronary artery and femoral artery. J Interv Cardiol. 2015;28:358-364.
Adesoji Adediran A, Babafemi Ogunkola A, Odikpo Edoziuno F, Seun Adesina O, Saravana Kumar M, Christian Okechukwu O. Squeeze casting process: trends and opportunities. IntechOpen; 2022. doi:10.5772/intechopen.103764
Luo AA. Magnesium casting technology for structural applications. J Magnes Alloy. 2013;1:2-22.
Cho DH, Avey T, Nam KH, Dean D, Luo AA. In vitro and in vivo assessment of squeeze-cast Mg-Zn-Ca-Mn alloys for biomedical applications. Acta Biomater. 2022;150:442-455.
Jiang P, Blawert C, Zheludkevich ML. The corrosion performance and mechanical properties of Mg-Zn based alloys-a review. Corros Mater Degrad. 2020;1:92-158.
Alkekhia D, Hammond PT, Shukla A. Layer-by-layer biomaterials for drug delivery. Ann Rev Biomed Eng. 2020;22:1-24.
Kurapati R, Groth TW, Raichur AM. Recent developments in layer-by-layer technique for drug delivery applications. ACS Appl Bio Mater. 2019;2:5512-5527.
Razavi M, Fathi M, Savabi O, Vashaee D, Tayebi L. In vivo assessments of bioabsorbable AZ91 magnesium implants coated with nanostructured fluoridated hydroxyapatite by MAO/EPD technique for biomedical applications. Mater Sci Eng C Mater Biol Appl. 2015;48:21-27.
Yin C, Shen J, Hu S, Zhang Z. Microstructure and mechanical properties of AZ91 magnesium alloy fabricated by multi-layer and multi-pass CMT based WAAM technique. Results Eng. 2023;18:101065.
Li Y, Sun Y, Han Q, Zhang G, Horváth I. Enhanced beads overlapping model for wire and arc additive manufacturing of multi-layer multi-bead metallic parts. J Mater Process Technol. 2018;252:838-848.
Saberi A, Bakhsheshi-Rad HR, Abazari S, et al. A comprehensive review on surface modifications of biodegradable magnesium-based implant alloy: polymer coatings opportunities and challenges. Coatings. 2021;11:747.
Shanaghi A, Mehrjou B, Chu PK. Enhanced corrosion resistance and reduced cytotoxicity of the AZ91 Mg alloy by plasma nitriding and a hierarchical structure composed of ciprofloxacin-loaded polymeric multilayers and calcium phosphate coating. J Biomed Mater Res A. 2021;109:2657-2672.
Majumadar O, Bankoti AKS, Kaur T, Thirugnanam A, Mondal AK. The influence of silane and silane-PMMA coatings on the in-vitro biodegradation behavior of AE42 magnesium alloy for cardiovascular stent applications. RSC Adv. 2016;6:107344-107354.
Kunjukunju S, Roy A, Ramanathan M, Lee B, Candiello JE, Kumta PN. A layer-by-layer approach to natural polymer-derived bioactive coatings on magnesium alloys. Acta Biomater. 2013;9:8690-8703.
Engineer C, Parikh J, Raval A. Effect of copolymer ratio on hydrolytic degradation of poly(lactide-co-glycolide) from drug eluting coronary stents. Chem Eng Res Des. 2011;89:328-334.
Cao Z, Li C, He J, et al. FK506-loaded PLGA nanoparticles improve long-term survival of a vascularized composite allograft in a murine model. Ann Trans Med. 2021;9:1515.
Shi Y, Pei J, Zhang L, et al. Understanding the effect of magnesium degradation on drug release and anti-proliferation on smooth muscle cells for magnesium-based drug eluting stents. Corr Sci. 2017;123:297-309.
Kamde MA, Mahton Y, Ohodnicki J, Roy M, Saha P. Effect of cerium-based conversion coating on corrosion behavior of squeeze cast Mg-4 wt% Y alloy in 0.1 M NaCl solution. Surf Coat Technol. 2021;421:127451.
Bakhsheshi-Rad HR, Hamzah E, Ismail AF, et al. In-vitro degradation behavior, antibacterial activity and cytotoxicity of TiO2-MAO/ZnHA composite coating on Mg alloy for orthopedic implants. Surf Coat Technol. 2018;334:450-460.
A. International. ASTM G31-72: Standard Practice for Laboratory Immersion Corrosion Testing of Metals, United States. 2004.
Li F, Gu Y, Hua R, Ni Z, Zhao G. In-vitro release study of sirolimus from a PDLLA matrix on a bioresorbable drug-eluting stent. J Drug Deliv Sci Technol. 2018;48:88-95.
Mohanta M, Thirugnanam A. Investigation of optical and biocompatible properties of polyethylene glycol-aspirin loaded commercial pure titanium for cardiovascular device applications. J Polym Eng. 2022;42:725-735.
Mohanta M, Thirugnanam A. Evolution of commercially pure titanium/heparin/poly (ethylene glycol) substrate with improved biocompatibility for cardiovascular device applications. Mater Technol. 2022;37(12):3100-3109.
Li W, Zhou J, Xu Y. Study of the in vitro cytotoxicity testing of medical devices. Biomed Rep. 2015;3(5):617-620.
Li J, Chen Z, Jing J, Hou J. Effect of yttrium modification on the corrosion behavior of AZ63 magnesium alloy in sodium chloride solution. J Magnes Alloy. 2021;9(2):613-626.
Li J, Jiang Q, Sun H, Li Y. Effect of heat treatment on corrosion behavior of AZ63 magnesium alloy in 3.5 wt.% sodium chloride solution. Corr Sci. 2016;111:288-301.
Sunil BR, Ganesh KV, Pavan P, et al. Effect of aluminum content on machining characteristics of AZ31 and AZ91 magnesium alloys during drilling. J Magnes Alloy. 2016;4(1):15-21.
Siahsarani A, Samadpour F, Mortazavi MH, Faragi G. Microstructural, mechanical and corrosion properties of AZ91 magnesium alloy processed by a severe plastic deformation method of hydrostatic cyclic expansion extrusion. Met Mater Int. 2021;27:2933-2946.
Mingo B, Arrabal R, Mohedano M, Pardo A, Matykina E, Rivas A. Enhanced corrosion resistance of AZ91 alloy produced by semisolid metal processing. J Electrochem Soc. 2015;162:C180-C188.
Singh IB, Singh M, Das S. A comparative corrosion behavior of Mg, AZ31 and AZ91 alloys in 3.5% NaCl solution. J Magnes Alloys. 2015;3:142-148.
Jiang S, Cai S, Lin Y, et al. Effect of alkali/acid pretreatment on the topography and corrosion resistance of as-deposited CaP coating on magnesium alloys. J Alloys Compd. 2019;793:202-211.
Peng H, Wang W, Jiang H, et al. Effect of galvanic corrosion on the degradability of biomedical magnesium. Front Mater. 2021;8:767179.
Yan W, Lian YJ, Zhang ZY, et al. In-vitro degradation of pure magnesium-the synergetic influences of glucose and albumin. Bioact Mater. 2020;5:318-333.
Brooks EK, Der S, Ehrensberger MT. Corrosion and mechanical performance of AZ91 exposed to simulated inflammatory conditions. Mater Sci Eng C. 2016;60:427-436.
Mena-Morcillo E, Veleva L. Degradation of AZ31 and AZ91 magnesium alloys in different physiological media: effect of surface layer stability on electrochemical behaviour. J Magnes Alloys. 2020;8:667-675.
Li S, Yi L, Liu T, et al. Formation of a protective layer against corrosion on Mg alloy via alkali pretreatment followed by vanillic acid treatment. Werkst Korros. 2020;71:1330-1338.
Echeverry-Rendón M, Berrio LF, Robledo SM, Calderón JA, Castaño JG, Echeverría F. Corrosion resistance and biological properties of pure magnesium modified by PEO in alkaline phosphate solutions. Corros Mater Degrad. 2023;41:96-211.
Yin Z-Z, Qi W-C, Zeng R-C, et al. Advances in coatings on biodegradable magnesium alloys. J Magnes Alloys. 2020;8:42-65.
Jonsson M, Persson D, Thierry D. Corrosion product formation during NaCl induced atmospheric corrosion of magnesium alloy AZ91D. Corros Sci. 2007;49:1540-1558.
Wu D, Wang Y-Q, Wu H-H, Ma L-B, Luo B-J, Zhang Q. Research on preparation and morphology evolution of magnesium carbonate tri-hydrate. J Synth Cryst. 2014;43:606-613.
Wu W, Yu X, Zhao Y, Jiang X, Yang H. Characterization and biocompatibility of insoluble corrosion products of AZ91 Mg alloys. ACS Omega. 2019;4(12):15139-15148.
Srivastava A, Naresh Bhatnagar N. Production and characterisation of new bioresorbable radiopaque Mg-Zn-Y alloy to improve x-ray visibility of polymeric scaffolds. J Magnes Alloys. 2022;10:1694-1703.
General screen film radiography and its limitations. 2007.
Zhang X, Zhang G, Zhang H, Li J, Yao X, Tang B. Surface immobilization of heparin and chitosan on titanium to improve hemocompatibility and antibacterial activities. Colloids Surf B Biointerfaces. 2018;172:338-345.
Camargo WA, Takemoto S, Hoekstra JW, et al. Effect of surface alkali-based treatment of titanium implants on ability to promote in-vitro mineralization and in-vivo bone formation. Acta Biomater. 2017;57:511-523.
Ouyang C, Liu Q, Zhao S, Ma G, Zhang Z, Song C. Synthesis and characterization of star-shaped poly (lactide-co-glycolide) and its drug-loaded microspheres. Polym Bull. 2012;68:27-36.
Gong X, Zheng Y, He G, Chen K, Zeng X, Chen Z. Multifunctional nanoplatform based on star-shaped copolymer for liver cancer targeting therapy. Drug Deliv. 2019;26:595-603.
Gao N, Chen Z, Xiao X, et al. Surface modification of paclitaxel-loaded tri-block copolymer PLGA-b-PEG-b-PLGA nanoparticles with protamine for liver cancer therapy. J Nanopart Res. 2015;17:347.
Ikemoto Y, Harada Y, Tanaka M, et al. Infrared spectra and hydrogen-bond configurations of water molecules at the interface of water-insoluble polymers under humidified conditions. J Phys Chem B. 2022;126(22):4143-4151.
Emami S, Valizadeh H, Islambulchilar Z, Zakeri-Milani P. Development and physicochemical characterization of sirolimus solid dispersions prepared by solvent evaporation method. Adv Pharm Bull. 2014;4(4):369-374.
Bian H, Zhou S, Liang X, Li Q, Han W. In vitro study of poly (ethylene carbonate) as a drug-eluting stent coating. Prog Nat Sci. 2012;22(4):295-302.
Lu B, Lv X, Le Y. Chitosan-modified PLGA nanoparticles for control-released drug delivery. Polymers. 2019;11(2):304.
Zhang Z, Ekanem E, Nakajima M, Bolognesi G, Vladisavljević GT. Monodispersed sirolimus-loaded PLGA microspheres with a controlled degree of drug-polymer phase separation for drug-coated implantable medical devices and subcutaneous injection. ACS Appl Bio Mater. 2022;5:3766-3777.
Zheng R, Lin J, Wang PC, Wu Y. Correlation between surface characteristics and static strength of adhesive-bonded magnesium AZ31B. Int J Adv Manuf Technol. 2016;84:1661-1670.
Woo HN, Chung HK, Ju EJ, et al. Preclinical evaluation of injectable sirolimus formulated with polymeric nanoparticle for cancer therapy. Int J Nanomed. 2012;7:2197-2208.
Makadia HK, Siegel SJ. Poly lactic-co-glycolic acid (PLGA) as biodegradable controlled drug delivery carrier. Polymers (Basel). 2011;3:1377-1397.
Vert M, Mauduit J, Li S. Biodegradation of PLA/GA polymers: increasing complexity. Biomaterials. 1994;15:1209-1213.
Liu H, Slamovich EB, Webster TJ. Less harmful acidic degradation of poly (lacticco-glycolic acid) bone tissue engineering scaffolds through titania nanoparticle addition. Int J Nanomed. 2006;1:541-545.
Lakalayeh GA, Rahvar M, Nazeri N, Ghanbari H. Evaluation of drug-eluting nanoparticle coating on magnesium alloy for development of next generation bioabsorbable cardiovascular stents. Med Eng Phys. 2022;108:1033878.
Yang H, Li J, Patel SK, Palmer KE, Devlin B, Rohan LC. Design of poly (lactic-co-glycolic acid) (PLGA) nanoparticles for vaginal co-delivery of Griffithsin and Dapivirine and their synergistic effect for HIV prophylaxis. Pharmaceutics. 2019;11(4):184.
Snehalatha M, Venugopal K, Saha RN. Etoposide-loaded PLGA and PCL nanoparticles I: preparation and effect of formulation variables. Drug Deliv. 2008;15(5):267-275.
Jahromi LP, Ghazali M, Ashrafi H, Azadi A. A comparison of models for the analysis of the kinetics of drug release from PLGA-based nanoparticles. Heliyon. 2020;6:e03451.
Mohanta M, Thirugnanam A. Development of multifunctional commercial pure titanium-polyethylene glycol drug-eluting substrates with enhanced optical and antithrombotic properties. Cardiovasc Eng Tech. 2022;14(1):37-51.
Mack JM, Richter BGT, Nicholas R, Stewart K, Scrary SE. Effect of sirolimus on coagulopathy of slow-flow vascular malformations. Pediatr Blood Cancer. 2019;66(10):e27896.
Adams DM, Trenor CC, Hammill AM, et al. Efficacy and safety of sirolimus in the treatment of complicated vascular anomalies. Pediatrics. 2016;137(2):e20153257.
Junkar I. Interaction of cells and platelets with biomaterial surfaces treated with gaseous plasma, advances in biomembranes and lipid self-assembly. Acad Press. 2016;23:25-59.
Sledz KM, Moore SF, Durrant TN, Blair TA, Hunter RW, Hers I. Rapamycin restrains platelet procoagulant responses via FKBP-mediated protection of mitochondrial integrity. Biochem Pharmacol. 2020;177:113975.
Thomson AW, Turnquist HR, Raimondi G. Immunoregulatory functions of mTOR inhibition. Nat Rev Immunol. 2009;9:324-337.
Arriola Apelo SI, Lamming DW. Rapamycin: an inhibitor of aging emerges from the soil of Easter Island. J Gerontol A Biol Sci Med Sci. 2016;71(7):841-849.
Saruta J, Sato N, Ishijima M, Okubo T, Hirota M, Ogawa T. Disproportionate effect of sub-micron topography on osteoconductive capability of titanium. Int J Mol Sci. 2019;20(16):4027.
Mohanta M, Thirugnanam A. Sequential immobilization of sirolimus and polyethylene glycol on ultrafine-grained commercial pure titanium for cardiovascular stent application. J Mater Res. 2022;37:3559-3574.
Murad H, Hawat M, Ekhtiar A, et al. Induction of G1-phase cell cycle arrest and apoptosis pathway in MDA-MB-231 human breast cancer cells by sulfated polysaccharide extracted from Laurencia papillosa. Cancer Cell Int. 2016;16:39.
Gentile P, Chiono V, Carmagnola I, Hatton PV. An overview of poly(lactic-co-glycolic) acid (PLGA)-based biomaterials for bone tissue engineering. Int J Mol Sci. 2014;15:3640-3659.