Poly(ethylene carbonate): A thermoelastic and biodegradable biomaterial for drug eluting stent coatings?

Journal of Controlled Release

Volumn 117, Issue 3, 2007, Pages 312-321

  Unger, F ^a   Westedt, U ^a   Hanefeld, P ^a   Wombacher, R ^a   Zimmermann, S ^a   Greiner, A ^a   Ausborn, M ^b   Kissel, T ^a  

^a PHILIPPS UNIVERSITY MARBURG   (Germany)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Biocompatibility; Mechanical properties; Poly(ethylene carbonate); Stent; Surface erosion

Indexed keywords

POLY(ETHYLENE CARBONATE); STENT; SURFACE EROSION;

BIOCOMPATIBILITY; COATINGS; DRUG PRODUCTS; POLYETHYLENE GLYCOLS; TENSILE TESTING;

POLYCARBONATES;

BIOMATERIAL; BUFFER; METAL; OXIDE; PACLITAXEL; POLY(4 XYLYLENE); POLY(ETHYLENE CARBONATE); POLYETHYLENE DERIVATIVE; POLYMER; POTASSIUM DERIVATIVE; SUPEROXIDE; UNCLASSIFIED DRUG;

ALKALINITY; ANIMAL CELL; ARTICLE; BIOCOMPATIBILITY; BIODEGRADABILITY; BIODEGRADATION; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; CYTOTOXICITY TEST; DESTRUCTION; DRUG ELUTING STENT; ELASTICITY; FEASIBILITY STUDY; IN VITRO STUDY; ISOTOPE LABELING; MACROPHAGE; MATERIAL COATING; MECHANICAL STRESS; MOLECULAR WEIGHT; MOUSE; NONHUMAN; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; TENSILE STRENGTH;

ANIMALS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BIOCOMPATIBLE MATERIALS; BIOTRANSFORMATION; CALORIMETRY, DIFFERENTIAL SCANNING; CELL SURVIVAL; CHEMISTRY, PHYSICAL; CHROMATOGRAPHY, GEL; ELASTICITY; FIBROBLASTS; MICE; MICROSCOPY, ELECTRON, SCANNING; MOLECULAR WEIGHT; PACLITAXEL; POLYETHYLENES; STENTS; TENSILE STRENGTH; X-RAY DIFFRACTION;

EID: 33846841103     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jconrel.2006.11.003     Document Type: Article

References (47)

1. Greenberg D., Bakhai A., and Cohen D.J. Do the benefits of new technology outweigh the costs? The case of drug-eluting stents. Am. J. Drug Deliv. 1 4 (2003) 255-266
2. Tanabe K., Regar E., Lee C.H., Hoye A., van der Giessen W.J., and Serruys P.W. Local drug delivery using coated stents: new developments and future perspectives. Curr. Pharm. Des. 10 4 (2004) 357-367
3. Virmani R., Kolodgie F.D., Farb A., and Lafont A. Drug eluting stents: are human and animal studies comparable?. Heart 89 2 (2003) 133-138
4. Smith E.J., and Rothman M.T. Antiproliferative coatings for the treatment of coronary heart disease: what are the targets and which are the tools?. J. Interv. Cardiol. 16 6 (2003) 475-483
5. Haase J., Jung T., Stoerger H., Hofmann M., Reinemer H., Schwarz C.-E., Schoepf J., and Schwarz F. Long-term outcome after implantation of bare metal stents for the treatment of coronary artery disease: rationale for the clinical use of antiproliferative stent coatings. J. Interv. Cardiol. 16 6 (2003) 469-473
6. Hofma S.J., van Beusekom H.M.M., Serruys P.W., and van der Giessen W.J. Recent developments in coated stents. Curr. Interv. Cardiol. Rep. 3 1 (2001) 28-36
7. Gunn J., and Cumberland D. Stent coatings and local drug delivery - state of the art. Eur. Heart J. 20 23 (1999) 1693-1700
8. Peng T., Gibula P., Yao K.D., and Goosen M.F.A. Role of polymers in improving the results of stenting in coronary arteries. Biomaterials 117 7 (1996) 685-694
9. Bhatia V., Bhatia R., and Dhindsa M. Drug-eluting stents: new era and new concerns. Postgrad. Med. J. 80 939 (2004) 13-18
10. Perin E.C. Choosing a drug-eluting stent: a comparison between CYPHER and TAXUS. Rev. Cardiovasc. Med. 6 Suppl 1 (2005) 13-21
11. Klugherz B.D., Llanos G., Lieuallen W., Kopia G.A., Papandreou G., Narayan P., Sasseen B., Adelman S.J., Falotico R., and Wilensky R.L. Twenty-eight-day efficacy and phamacokinetics of the sirolimus-eluting stent. Coron. Artery Dis. 13 3 (2002) 183-188
12. Ranade S.V., Miller K.M., Richard R.E., Chan A.K., Allen M.J., and Helmus M.N. Physical characterization of controlled release of paclitaxel from the TAXUS Express2 drug-eluting stent. J. Biomed. Mater. Res. A 71 4 (2004) 625-634
13. Kamath K.R., Barry J.J., and Miller K.M. The Taxus drug-eluting stent: a new paradigm in controlled drug delivery. Adv. Drug Deliv. Rev. 58 3 (2006) 412-436
14. Moses J.W., Leon M.B., Popma J.J., Fitzgerald P.J., Holmes D.R., O'Shaughnessy C., Caputo R.P., Kereiakes D.J., Williams D.O., Teirstein P.S., Jaeger J.L., and Kuntz R.E. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N. Engl. J. Med. 349 14 (2003) 1315-1323
15. Stone G.W., Ellis S.G., Cox D.A., Hermiller J., O'Shaughnessy C., Mann J.T., Turco M., Caputo R., Bergin P., Greenberg J., Popma J.J., Russell M.E., and the TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N. Engl. J. Med. 350 3 (2004) 221-231
16. Lewis A.L., and Stratford P.W. Phosphorylcholine-coated stents. J. Long-Term Eff. Med. Implants 12 4 (2002) 231-250
17. Burke S.E., Kuntz R.E., and Schwartz L.B. Zotarolimus (ABT-578) eluting stents. Adv. Drug Deliv. Rev. 58 3 (2006) 437-446
18. Chen M.C., Liang H.F., Chiu Y.L., Chang Y., Wei H.J., and Sung H.W. A novel drug-eluting stent spray-coated with multi-layers of collagen and sirolimus. J. Control. Release 108 1 (2005) 178-189
19. Acharya G., and Park K. Mechanisms of controlled drug release from drug-eluting stents. Adv. Drug Deliv. Rev. 58 3 (2006) 387-401
20. Westedt U., Wittmar M., Kissel T., Hellwig M., Schaper A.K., Hanefeld P., and Greiner A. Paclitaxel releasing films consisting of poly(vinyl alcohol)-graft-poly(lactide-co-glycolide) and their potential as biodegradable stent coatings. J. Control. Release 111 1-2 (2006) 235-246
21. Greiner A., Mang S., Schaefer O., and Simon P. Poly(p-xylene)s. Synthesis, polymer analogous reactions, and perspectives on structure-property relationships. Acta Polym. 48 1/2 (1997) 1-15
22. Greiner A. Poly(p-xylylene)s (Structure, Properties, and Applications). In: Salamone J.C. (Ed). The Polymeric Materials Encyclopedia vol. 9 (1996), CRC Press, Bocca Raton 7171
23. Dadsetan M., Christenson E.M., Unger F., Ausborn M., Kissel T., Hiltner A., and Anderson J.M. In vivo biocompatibility and biodegradation of poly(ethylene carbonate). J. Control. Release 93 3 (2003) 259-270
24. Stoll G.H., Nimmerfall F., Acemoglu M., Bodmer D., Bantle S., Muller I., Mahl A., Kolopp M., and Tullberg K. Poly(ethylene carbonate)s, part II: degradation mechanisms and parenteral delivery of bioactive agents. J. Control. Release 76 3 (2001) 209-225
25. Acemoglu M. Chemistry of polymer biodegradation and implications on parenteral drug delivery. Int. J. Pharm. 277 1-2 (2004) 133-139
26. Toutouzas K., Colombo A., and Stefanadis C. Inflammation and restenosis after percutaneous coronary interventions. Eur. Heart J. 25 19 (2004) 1679-1687
27. Scott N.A. Restenosis following implantation of bare metal coronary stents: pathophysiology and pathways involved in the vascular response to injury. Adv. Drug Deliv. Rev. 58 3 (2006) 358-376
28. Acemoglu M., Nimmerfall F., Bantle S., and Stoll G.H. Poly(ethylene carbonate)s, part I: syntheses and structural effects on biodegradation. J. Control. Release 49 2-3 (1997) 263-276
29. Schmidt C., Stümpflen V., Wendorff J.H., Hasenhindl A., Gronski W., Ishaque M., and Greiner A. Structural analysis of PPX prepared by vapor phase pyrolysis of [2.2]paracyclophane. Acta Polym. 49 5 (1998) 232-235
30. Zange R. Comparative in vitro biocompatibility testing of polycyanoacrylates and poly(d,l-lactide-co-glycolide) using different mouse fibroblast (L929) biocompatibility test models. Eur. J. Pharm. Biopharm. 44 1 (1997) 149-157
31. Fischer D., Bieber T., Li Y., Elsasser H.P., and Kissel T. A novel non-viral vector for DNA delivery based on low molecular weight, branched polyethylenimine: effect of molecular weight on transfection efficiency and cytotoxicity. Pharm. Res. 16 8 (1999) 1273-1279
32. Fischer D., Li Y., Ahlemeyer B., Krieglstein J., and Kissel T. In vitro cytotoxicity testing of polycations: influence of polymer structure on cell viability and hemolysis. Biomaterials 24 7 (2003) 1121-1131
33. Elbert D.L., and Hubbell J.A. Surface treatments of polymers for biocompatibility. Annu. Rev. Mater. Sci. 26 1 (1996) 365-394
34. Wang Y.X., Robertson J.L., Spillman Jr. W.B., and Claus R.O. Effects of the chemical structure and the surface properties of polymeric biomaterials on their biocompatibility. Pharm. Res. 21 8 (2004) 1362-1373
35. Antony P., Puskas J.E., and Kontopoulou M. Investigation of the rheological and mechanical properties of a polystyrene-polyisobutylene-polystyrene triblock copolymer and its blends with polystyrene. Polym. Eng. Sci. 43 1 (2003) 243-253
36. Elliott Dawn M., Narmoneva Daria A., and Setton Lori A. Direct measurement of the Poisson's ratio of human patella cartilage in tension. J. Biomech. Eng. 124 2 (2002) 223-228
37. Lee M.C., and Haut R.C. Strain rate effects on tensile failure properties of the common carotid artery and jugular veins of ferrets. J. Biomech. 25 8 (1992) 925-927
38. de Jaegere P.P., de Feyter P.J., van der Giessen W.J., and Serruys P.W. Endovascular stents: preliminary clinical results and future developments. Clin. Cardiol. 16 5 (1993) 369-378
39. ISO 10993: Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity. 1999. pp. 393-394.
40. Virmani R., Farb A., Kolodgie F.D., Guagliumi G., Musumeci G., Grieco N., Mihalcsik L., Tespili M., Valsecchi O., and Motta T. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious?. Circulation 109 6 (2004) 701-705
41. Van der Giessen W.J., Van Beusekom H.M.M., Serruys P.W., Lincoff A.M., Ellis S.G., Topol E.J., Schwartz R.S., and Holmes Jr. D.R. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 94 7 (1996) 1690-1697
42. Cha Y., Reardon P., Mah S., and Whitcomb L. In vitro enzymic surface erosion of polyethylene carbonate in the presence of macrophages. Proc. Int. Symp. Control. Release Bioact. Mater. 21 1 (1994) 126-127
43. Edelman E., and Rogers C. Pathobiologic responses to stenting. Am. J. Cardiol. 81 (1998) 4E-6E (Suppl)
44. Kornowski R., Hong M.K., Tio F.O., Bramwell O., Wu H., and Leon M.B. In-stent restenosis: contributions of inflammatory responses and arterial injury to neointimal hyperplasia. J. Am. Coll. Cardiol. 31 1 (1998) 224-230
45. Welt F.G.P., Tso C., Edelman E.R., Seifert P., Rogers C., Paolini J.F., and Kjelsberg M.A. Leukocyte recruitment and expression of chemokines following different forms of vascular injury. Vasc. Med. 8 1 (2003) 1-7
46. W.F. Gorham, p-Xylylene polymers, U.S. Patent 3, 342, 754, (1967).
47. Dani B.A., and DeLuca P.P. Preparation, characterization, and in vivo evaluation of salmon calcitonin microspheres. AAPS PharmSciTech 2 4 (2001) 22