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Original Research

Pharmaceutical Development of 5-Fluorouracil-Eluting Stents for the Potential Treatment of Gastrointestinal Cancers and Related Obstructions

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Pages 1495-1507 | Published online: 09 Apr 2021

References

  • ArafatM, FouladianP, BlencoweA, AlbrechtH, SongY, GargS. Drug-eluting non-vascular stents for localised drug targeting in obstructive gastrointestinal cancers. J Controlled Release. 2019;308:209–231. doi:10.1016/j.jconrel.2019.07.001
  • European Medicines Agency. EMEA/CHMP/EWP/110540/2007. Guideline on the clinical and non clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003275.pdf. Accessed 715, 2017.
  • GuoS-R, ChenW-L, Rong H-JLF. Stents as a platform for drug delivery AU - Lei, Lei. Expert Opin Drug Deliv. 2011;8(6):813–831. doi:10.1517/17425247.2011.57206821548713
  • BaronTH Enteral stents for the management of malignant colorectal obstruction. Available from: https://www.uptodate.com/contents/enteral-stents-for-the-management-of-malignant-colorectal-obstruction?source=search_result&search=enteral%20stent&selectedTitle=2~22. Accessed 630, 2017.
  • BoamAB. Regulatory issues facing the development of drug-eluting stents: a US FDA perspective. Expert Rev Med Devices. 2006;3(3):297–300. doi:10.1586/17434440.3.3.29716681451
  • WuP, GraingerDW. Drug/device combinations for local drug therapies and infection prophylaxis. Biomaterials. 2006;27(11):2450–2467. doi:10.1016/j.biomaterials.2005.11.03116337266
  • SchmidtW, LanzerP. Instrumentation. In: LanzerP, editor. Catheter-Based Cardiovascular Interventions: A Knowledge-Based Approach. Berlin, Heidelberg: Springer Berlin Heidelberg; 2013:445–472.
  • Food and Drug Administration Center for Devices and Radiological Health (CDRH). Guidance for Industry: Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (Draft). Rockville, MD, USA: Food and Drug Administration (FDA); 2008:89.
  • KimS-Y, KimM, KimM-K, et al. Paclitaxel-eluting nanofiber-covered self-expanding nonvascular stent for palliative chemotherapy of gastrointestinal cancer and its related stenosis. Biomed Microdevices. 2014;16(6):897–904. doi:10.1007/s10544-014-9894-925135441
  • KwakTW, LeeHL, SongYH, et al. Vorinostat-eluting poly(DL-lactide-co-glycolide) nanofiber-coated stent for inhibition of cholangiocarcinoma cells. Int J Nanomedicine. 2017;12:7669–7680. doi:10.2147/IJN.S14192029089762
  • LeeDK, KimHS, KimK-S, et al. The effect on porcine bile duct of a metallic stent covered with a paclitaxel-incorporated membrane. Gastrointest Endosc. 2005;61(2):296–301. doi:10.1016/S0016-5107(04)02570-215729251
  • LeeJW, Yang S-GNK. Gemcitabine-releasing polymeric films for covered self-expandable metallic stent in treatment of gastrointestinal cancer. Int J Pharm. 2012;427(2):276–283. doi:10.1016/j.ijpharm.2012.02.01622366483
  • MoonS, Yang S-GNK. An acetylated polysaccharide-PTFE membrane-covered stent for the delivery of gemcitabine for treatment of gastrointestinal cancer and related stenosis. Biomaterials. 2011;32(14):3603–3610. doi:10.1016/j.biomaterials.2011.01.07021334742
  • ClarkJW, GrotheyA Systemic chemotherapy for metastatic colorectal cancer. Available from: https://www.uptodate.com/contents/systemic-chemotherapy-for-metastatic-colorectal-cancer-completed-clinical-trials/print?source=see_link. Accessed 73, 2017.
  • PintoAC, MoreiraJ, SimoesSR. Combination chemotherapy in cancer: principles, evaluation and drug delivery strategies. In: OzdemirO, editor. Current Cancer Treatment - Novel Beyond Conventional Approaches. InTech; 2011:693–714.
  • ThipparaboinaR, KhanW, DombAJ. Eluting combination drugs from stents. Int J Pharm. 2013;454(1):4–10. doi:10.1016/j.ijpharm.2013.07.00523850234
  • National Cancer Institute. Drugs Approved for colon and rectal cancer. https://www.cancer.gov/about-cancer/treatment/drugs/colorectal. Available from: Accessed 73, 2017.
  • GuoQ, GuoS, WangZ. A type of esophageal stent coating composed of one 5-fluorouracil-containing EVA layer and one drug-free protective layer: in vitro release, permeation and mechanical properties. J Controlled Release. 2007;118(3):318–324. doi:10.1016/j.jconrel.2006.12.030
  • GuoS-R, WangZ-M, ZhangY-Q, et al. In Vivo Evaluation of 5-Fluorouracil-Containing Self-Expandable Nitinol Stent in Rabbits: efficiency in Long-Term Local Drug Delivery. J Pharm Sci. 2010;99(7):3009–3018. doi:10.1002/jps.2206620091819
  • LiG, ChenY, HuJ, et al. A 5-fluorouracil-loaded polydioxanone weft-knitted stent for the treatment of colorectal cancer. Biomaterials. 2013;34(37):9451–9461. doi:10.1016/j.biomaterials.2013.08.05524011711
  • OlukmanM, SanliO, SolakEK. Release of Anticancer Drug 5-Fluorouracil from Different Ionically Crosslinked Alginate Beads. J Biomater Nanobiotechnol. 2012;3(4):12. doi:10.4236/jbnb.2012.34048
  • FouladianP, KohlhagenJ, ArafatM, et al. Three-dimensional printed 5-fluorouracil eluting polyurethane stents for the treatment of oesophageal cancers. Biomater Sci. 2020;8(23):6625–6636. doi:10.1039/D0BM01355B33057525
  • LiuJ, WangZ, WuK, et al. Paclitaxel or 5-fluorouracil/esophageal stent combinations as a novel approach for the treatment of esophageal cancer. Biomaterials. 2015;53(SupplementC):592–599. doi:10.1016/j.biomaterials.2015.03.00925890755
  • WangZ, LiuJ, WuK, et al. Nitinol stents loaded with a high dose of antitumor 5-fluorouracil or paclitaxel: esophageal tissue responses in a porcine model. Gastrointest Endosc. 2015;82(1):153–160.e151. doi:10.1016/j.gie.2015.02.03425936448
  • ArmstrongEJ, WaltenbergerJ, RogersJH. Percutaneous coronary intervention in patients with diabetes: current concepts and future directions. J Diabetes Sci Technol. 2014;8(3):581–589. doi:10.1177/193229681351705824876623
  • HtayT, LiuMW. Drug-Eluting Stent: a Review and Update. Vasc Health Risk Manag. 2005;1(4):263–276. doi:10.2147/vhrm.2005.1.4.26317315599
  • KwonH, ParkS. Local delivery of antiproliferative agents via stents. Polymers. 2014;6(3):755. doi:10.3390/polym6030755
  • ManiG, FeldmanMD, PatelD, AgrawalCM. Coronary stents: a materials perspective. Biomaterials. 2007;28(9):1689–1710.17188349
  • Rizas KonstantinosD, MehilliJ. Stent Polymers. Circ Cardiovasc Interv. 2016;9(6):e002943. doi:10.1161/CIRCINTERVENTIONS.115.00294327193905
  • HsuLSF, MarrsTC. Determination of 5-Fluorouracil in human plasma by high-pressure ion-exchange chromatography. Ann Clin Biochem. 1980;17(5):272–276. doi:10.1177/0004563280017005107447361
  • ChappaRA, HergenrotherRW, WadmanSA, WormuthKR Coating systems for the controlled delivery of hydrophilic bioactive agents. Google Patents; 2013.
  • ArafatM, FouladianP, WignallA, et al. Development and in vitro evaluation of 5-fluorouracil-eluting stents for the treatment of colorectal cancer and cancer-related obstruction. Pharmaceutics. 2021;13(1):17. doi:10.3390/pharmaceutics13010017
  • United States Pharmacopeial Convention. Fluorouracil. United States Pharmacopeial Convention; 2019.
  • FreireMCLC, AlexandrinoF, MarcelinoHR, et al. Understanding Drug Release Data through Thermodynamic Analysis. Materials. 2017;10(6):651. doi:10.3390/ma10060651
  • ZhangY, HuoM, ZhouJ, et al. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS J. 2010;12(3):263–271. doi:10.1208/s12248-010-9185-120373062
  • ZuoJ, GaoY, Bou-ChacraN, LöbenbergR. Evaluation of the DDSolver Software Applications. Biomed Res Int. 2014;2014:204925. doi:10.1155/2014/20492524877067
  • ShaikhM, Roy ChoudhuryN, KnottR, KanwarJR, GargS. Effect of polymer microstructure on the docetaxel release and stability of polyurethane formulation. Eur J Pharm Biopharmaceutics. 2016;101:82–89. doi:10.1016/j.ejpb.2016.01.015
  • YukselN, KanıkAE, BaykaraT. Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods. Int J Pharm. 2000;209(1):57–67. doi:10.1016/S0378-5173(00)00554-811084246
  • ChungMJ, KimH, KimKS, ParkS, ChungJB, ParkSW. Safety evaluation of self-expanding metallic biliary stents eluting gemcitabine in a porcine model. J Gastroenterol Hepatol. 2012;27(2):261–267. doi:10.1111/j.1440-1746.2011.06866.x21793905
  • JangSI, KimJH, KimM, et al. Porcine feasibility and safety study of a new paclitaxel-eluting biliary stent with a Pluronic-containing membrane. Endoscopy. 2012;44(09):825–831. doi:10.1055/s-0032-130988122752887
  • LeeSS, ShinJH, HanJM, et al. Histologic influence of paclitaxel-eluting covered metallic stents in a canine biliary model. Gastrointest Endosc. 2009;69(6):1140–1147. doi:10.1016/j.gie.2008.08.00519243763
  • SeoEH, NaK. Polyurethane membrane with porous surface for controlled drug release in drug eluting stent. Biomater Res. 2014;18(1):15.26331066
  • LeiL, LiuX, GuoS, TangM, ChengL, TianL. 5-Fluorouracil-loaded multilayered films for drug controlled releasing stent application: drug release, microstructure, and ex vivo permeation behaviors. J Controlled Release. 2010;146(1):45–53. doi:10.1016/j.jconrel.2010.05.017
  • ThakkarA, RavalA, MandalR, et al. Development and evaluation of drug eluting stent having biphasic release from a single layer of biodegradable polymer. J Med Device. 2013;7(1). doi:10.1115/1.4023414
  • WhitbourneRJ, ChamberlainAM, HullihenDG, RosebroughSF, Calistri-YehM Medicated stent having multi-layer polymer coating. Google Patents; 2012.
  • AmasyaG, GumustasM, BadilliU, OzkanSA, TarimciN. Development of a HILIC method for the determination of 5-fluorouracil from nano drug delivery systems and rat skin extracts. J Pharm Biomed Anal. 2018;154:285–293. doi:10.1016/j.jpba.2018.03.02129567571
  • MattosA, KhalilNM, MainardesRM. Development and validation of an HPLC method for the determination of fluorouracil in polymeric nanoparticles. Br J Pharm Sci. 2013;49:117–126. doi:10.1590/S1984-82502013000100013
  • United States Pharmacopeial Convention. (1225) Validation of Compendial Procedures. United States Pharmacopeial Convention; 2019.
  • ZafarH, MauM, ArshadS, AltafH, MaM, RehmanM. Simultaneous Quantification of 5-Fluorouracil and Leucovorin in Pharmaceutical Dosage Form and Human Spiked Plasma by Using RP- HPLC Method. J Chromatography Separation Tech. 2014;05.
  • SanganalS, KulkarniGB, KaregoudarTB. Development and validation of high performance liquid chromatographic analysis of residual N,N-Dimethylformamide in Spent Medium after Biodegradation by Paracoccus denitrificans SD1. ISRN Chromatography. 2013;2013:401629. doi:10.1155/2013/401629
  • ChanCM, FrimbergerAE, MooreAS. A literature review of reports of the stability and storage of common injectable chemotherapy agents used in veterinary patients. Vet Comp Oncol. 2017;15(4):1124–1135. doi:10.1111/jedm.1204627696684
  • GalantiL, LebitasyMP, HecqJD, CadrobbiJ, VanbeckbergenD, JamartJ. Long-term stability of 5-Fluorouracil in 0.9% sodium chloride after freezing, microwave thawing, and refrigeration. Can J Hosp Pharm. 2009;62(1):34–38. doi:10.4212/cjhp.v62i1.11522478863
  • MilanoG, EtienneM-C, Cassuto-ViguierE, et al. Long-term stability of 5-fluorouracil and folinic acid admixtures. Eur J Cancer. 1993;29(1):129–132. doi:10.1016/0959-8049(93)90590-C
  • WilliamsDA, LokichJ. A review of the stability and compatibility of antineoplastic drugs for multiple-drug infusions. Cancer Chemother Pharmacol. 1992;31(3):171–181. doi:10.1007/BF006855441464154
  • IbrahimRA, SuhailFSA, Al-HakeimHK. Stability of Anticancer Drug 5-Fluorouracil in Aqueous Solution: an Assessment of Kinetic Behavior. Nano Biomed Eng. 2018;10(3):224–234.
  • CharalambidesD, SegalI. Colonic pH: a comparison between patients with colostomies due to trauma and colorectal cancer. Am J Gastroenterol. 1992;87(1):74–78.1728129
  • EvansDF, PyeG, BramleyR, ClarkAG, DysonTJ, HardcastleJD. Measurement of gastrointestinal pH profiles in normal ambulant human subjects. Gut. 1988;29(8):1035–1041.3410329
  • McDougallCJ, WongR, ScuderaP, LesserM, DeCosseJJ. Colonic mucosal pH in humans. Dig Dis Sci. 1993;38(3):542–545. doi:10.1007/BF013165128444087
  • PyeG, EvansDF, LedinghamS, HardcastleJD. Gastrointestinal intraluminal pH in normal subjects and those with colorectal adenoma or carcinoma. Gut. 1990;31(12):1355–1357. doi:10.1136/gut.31.12.13552176170
  • ChinembiriTN, GerberM, Du PlessisL, Du PreezJ, Du PlessisJ. Topical Delivery of 5-Fluorouracil from Pheroid™ formulations and the in vitro efficacy against human melanoma. AAPS PharmSciTech. 2015;16(6):1390–1399. doi:10.1208/s12249-015-0328-725956486
  • VermaasM. Formulation of 5-Fluorouracil for Transdermal Delivery. Potchefstroom, North-West: School of Pharmacy, North-West University; 2010.
  • ShinMS, HongJY, ParkS. Gemcitabine release behavior of polyurethane matrixes designed for local anti-cancer drug delivery via stent. J Drug Deliv Sci Technol. 2012;22(4):301–306. doi:10.1016/S1773-2247(12)50050-X
  • BegeN, SteinmüllerSO, KalinowskiM, et al. Drug eluting stents based on Poly(ethylene carbonate): optimization of the stent coating process. Eur J Pharm Biopharmaceutics. 2012;80(3):562–570. doi:10.1016/j.ejpb.2011.12.006
  • Mc ConvilleC, MajorI, FriendDR, ClarkMR, WoolfsonAD, MalcolmRK. Development of polylactide and polyethylene vinyl acetate blends for the manufacture of vaginal rings. J Biomed Mater Res B Appl Biomater. 2012;100B(4):891–895. doi:10.1002/jbm.b.31919
  • WolinskyJB, ColsonYL, GrinstaffMW. Local drug delivery strategies for cancer treatment: gels, nanoparticles, polymeric films, rods, and wafers. J Control Release. 2012;159(1):14–26. doi:10.1016/j.jconrel.2011.11.03122154931
  • JangSI, LeeDK. Stents with specialized functions: drug-eluting stents and stents with antireflux devices. Gastrointestinal Intervent. 2015;4(1):50–54. doi:10.1016/j.gii.2015.03.004
  • KimDH, JeongY-I, ChungC-W, et al. Preclinical evaluation of sorafenib-eluting stent for suppression of human cholangiocarcinoma cells. Int J Nanomedicine. 2013;8:1697–1711. doi:10.2147/IJN.S4350823658488
  • ZhaoL, GaoY, GuG, et al. Rational design of drug-eluting stents via electrospray and in vivo evaluation of preventing oesophageal stricture. RSC Adv. 2014;4(32):16885–16892. doi:10.1039/C4RA01300J
  • KobryDJ, SowaS, GasztychM, MusiaBW. Influence of hydrophilic polymers on the factor in weibull equation applied to the release kinetics of a biologically active complex of aesculus hippocastanum. Int J Polym Sci. 2017;2017:1–8. doi:10.1155/2017/3486384
  • SmallwoodIM. Methylene chloride. In: SmallwoodIM, editor. Handbook of Organic Solvent Properties. Oxford: Butterworth-Heinemann; 1996:137–139.
  • United States Pharmacopeial Convention. Residual Solvents; 2019. Available from: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/gc-467-residual-solvents-ira-20190927.pdf. Accessed 130, 2020.
  • HarrellCR, DjonovV, FellabaumC, VolarevicV. Risks of using sterilization by gamma radiation: the other side of the coin. Int J Med Sci. 2018;15(3):274–279. doi:10.7150/ijms.2264429483819
  • ICH Harmonised Tripartite Guideline. Stability testing of new drug substances and products Q1A(R2). Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-r2-stability-testing-new-drug-substances-products-step-5_en.pdf. Accessed 223, 2020.
  • KamberiM, RapozaR. Stability testing of drug eluting stents. J Drug Deliv Sci Technol. 2016;35:58–68. doi:10.1016/j.jddst.2016.05.006