Cytotoxicity of poly(96L/4D-lactide): The influence of degradation and sterilization

Biomaterials

Volumn 21, Issue 23, 2000, Pages 2433-2442

  Cordewener, Fabian W ^a   Van Geffen, Maarten F ^b   Joziasse, Cornelis A P ^c   Schmitz, John P ^d   Bos, Ruud R M ^a   Rozema, Fred R ^a   Pennings, Albert J ^c  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^c UNIVERSITY OF GRONINGEN   (Netherlands)

^d UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

Author keywords

Cytotoxicity; Degradation; Physical properties; Poly(lactide); Poly( hydroxy acid)s; Sterilization

Indexed keywords

ANIMAL CELL CULTURE; BIOASSAY; BIODEGRADATION; ENZYMES; EXTRACTION; FILTRATION; ORGANIC POLYMERS; PH EFFECTS; SOLUBILITY; STERILIZATION (CLEANING); TOXICITY;

CYTOTOXICITY; LACTADE DEHYDROGENASE; POLYLACTIDE;

BIOMATERIALS;

ETHYLENE OXIDE; POLYLACTIDE; POLYMER;

ANIMAL CELL; ARTICLE; BIODEGRADATION; CELL GROWTH; CONTROLLED STUDY; CYTOTOXICITY; FIBROBLAST; GAMMA RADIATION; INSTRUMENT STERILIZATION; MOUSE; NONHUMAN; PRIORITY JOURNAL; WATER VAPOR;

EID: 0034580364     PISSN: 01429612     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0142-9612(00)00111-3     Document Type: Article

References (45)

1. Gogolewski S. Resorbable polymers for internal fixation. Clin Mater. 10:1992;13-20.
2. Bos R.R.M., Boering G., Rozema F.R., Leenslag J.W. Resorbable poly(L-lactide) plates and screws for the fixation of zygomatic fractures. J Oral Maxillofac Surg. 45:1987;751-753.
3. Suuronen R., Laine P., Pohjonen T., Lindqvist C. Sagittal ramus osteotomies fixed with biodegradable screws. a preliminary report J Oral Maxillofac Surg. 52:1994;715-720.
4. Matsusue Y., Yamamuro T., Oka M., Shikinami Y., Hyon S.-H., Ikada Y. In vitro and in vivo studies on bioabsorbable ultra-high-strength poly(L-lactide) rods. J Biomed Mater Res. 26:1992;1553-1567.
5. Vert M., Li S.M., Spenlehauer G., Guerin P. Bioresorbability and biocompatibility of aliphatic polyesters. J Mater Sci. Mater Med 3:1992;432-446.
6. Bergsma E.J., Rozema F.R., Bos R.R.M., deBruijn W.C. Foreign body reactions to resorbable poly(L-lactide) bone plates and screws used for the fixation of unstable zygomatic fractures. J Oral Maxillofac Surg. 51:1993;666-670.
7. Böstman O., Hirvensalo E., Mäkinen J., Rokkanen P. Foreign-body reactions to fracture fixation implants of biodegradable synthetic polymers. J Bone Jt Surg. 72-B:1990;592-596.
8. Fridén T., Rydholm U. Severe aseptic synovitis of the knee after biodegradable internal fixation. Acta Orthop Scand. 63(1):1992;94-97.
9. Cha Y., Pitt C.G. The biodegradability of polyester blends. Biomaterials. 11:1990;108-111.
10. Zhang X., Wyss U.P., Pichora D., Goosen M.F.A. An investigation of poly(lactic acid) degradation. J Bioactive Comp Polym. 9:1994;80-100.
11. Pistner H., Bendix D.R., Muehling J., Reuther J.F. Poly(L-lactide). a long term degradation study in vivo. Part III. Analytical characterization Biomaterials. 14:1993;291-298.
12. Joziasse C.A.P., Grijpma D.W., Bergsma J.E., Cordewener F.W., Bos R.R.M., Pennings A.J. The influence of morphology on the hydrolytic degradation of as-polymerized and hot-drawn poly(L-lactide). Colloid Polym Sci. 276:1998;968-975.
13. Bos R.R.M., Rozema F.R., Boering G., Nijenhuis A.J., Pennings A.J., Verwey A.B., Nieuwenhuis P., Jensen H.W. Degradation of and tissue reaction to biodegradable poly(L-lactide) for use as internal fixation of fractures. Biomaterials. 12:1991;32-36.
14. Cordewener F.W., Rozema F.R., Bos R.R.M., Grijpma D.W., Boering G., Pennings A.J. Material properties and tissue reaction during degradation of poly(96L/4D-lactide). A study in vitro and in rats. J Mater Sci. Mater Med 6:1995;211-217.
15. Matsusue Y., Yamamuro T., Yoshii S., Oka M., Ikada Y., Hyon S.H., Shikinami Y. Biodegradable screw fixation of rabbit tibia proximal osteotomies. J Appl Biomater. 2:1991;1-12.
16. Bergsma J.E., Rozema F.R., Bos R.R.M., Boering G., deBruijn W.C., Pennings A.J. In vivo degradation and biocompatibility study of in vitro pre-degraded as-polymerized polylactide particles. Biomaterials. 16:1995;267-274.
17. Cordewener F.W., Rozema F.R., Joziasse C.A.P., Bos R.R.M., Boering G., Pennings A.J. Poly(96L/4D-lactide) implants for repair of orbital floor defects. an in vitro study of the material properties in a simulation of the human orbit J Mater Sci. Mater Med 6:1995;561-568.
18. Leenslag J.W., Pennings A.J., Bos R.R.M., Rozema F.R., Boering G. Resorbable materials of poly(L-lactide). VI. Plates and screws for internal fracture fixation Biomaterials. 8:1987;70-73.
19. Rozema F.R., Bos R.R.M., Boering G., vanAsten J.A.A.M., Nijenhuis A.J., Pennings A.J. The effects of different steam-sterilization programs on material properties of poly(L-lactide). J Appl Biomater. 2:1991;23-28.
20. The International Organization for Standardization: ISO 10993. Biological testing of medical and dental materials and devices: Part 12. Sample preparation and reference materials. 1991.
21. Olsson N.O., Leclerc A., Jeannin J.F., Martin F. A simple photometric microassay for the quantitative evaluation of macrophage-mediated cytotoxicity on adherent cancer cells. Ann Immunol. 133(D):1982;245-254.
22. Korzeniewski C. Callewaert DM. An enzyme-release assay for natural cytotoxicity. J Immunol Methods. 64:1983;313-320.
23. Bergsma J.E., Rozema F.R., Bos R.R.M., Boering G., Joziasse C.A.P., Pennings A.J. In vitro predegradation at elevated temperatures of poly(lactide). J Mater Sci. Mater Med 6:1995;642-646.
24. Rozema F.R., deBruijn W.C., Bos R.R.M., Boering G., Nijenhuis A.J., Pennings A.J. Late tissue response to bone plates and screws of poly(L-lactide) used for fracture fixation of the zygomatic bone. Doherty P.J., Williams R.L., Williams D.F. Biomaterial-tissue interfaces. Advances in biomaterials. 1992;349-355 Elsevier, Amsterdam.
25. Kirkpatrick C.J., Mittermayer C. Theoretical and practical aspects of testing potential biomaterials in vitro. J Mater Sci. Mater Med 1:1990;9-13.
26. Ciapetti G., Cenni E., Cavedagna D., Pratelli L., Pizzoferrato A. Cell culture methods to evaluate the biocompatibility of implant materials. ATLA/Italian Tissue Culture Meeting. 20:1992;52-60.
27. Rice R.M., Hegyeli A.F., Gourlay S.J. Biocompatibility testing of polymers. in vitro studies with in vivo correlation J Biomed Mater Res. 12:1978;43-54.
28. Spector M., Cease C., Tong-Li X. The local tissue response to biomaterials. Crit Rev Biocompat. 5:1989;269-295.
29. Northup S.J. Perspectives on in vitro toxicity for medical devices. J Amer Coll Toxicol. 7:1988;481-489.
30. Autian J. Toxicological evaluation of biomaterials. primary acute toxicity screening program Artif Org. 1:1977;53-60.
31. vanGeffen MF, Orzechowski TJH, Machielsen JCA, Bisschop A, Teppema JS, vanAsten JAAM. Validation of three cytotoxicity assays in application for medical device biocompatibility assessment, related to the agar-overlay test. Proceedings of the Seventh International Conference on Medical Plastics. Copenhagen, Denmark. 22-23, June 1993. p. 10.5.
32. Sgouras D., Duncan R. Methods for the evaluation of biocompatibility of soluble synthetic poiymers which have the potential for biomedical use. 1. Use of the tetrazolium-based colorimetric assay (MTT) as a preliminary screen for evaluation of in vitro cytotoxicity J Mater Sci. Mater Med 1:1990;61-68.
33. Taylor M.S., Daniels A.U., Andriano K.P., Heller J. Six bioabsorbable polymers. in vitro acute toxicity of accumulated degradation products J Appl Biomat. 5:1994;151-157.
34. Li S.M., Garreau H., Vert M. Structure-property relationships in the case of the degradation of massive poly(. α -hydroxy acids) in aqueous media. Part 3 influence of the morphology of poly(L-lactic acid) J Mater Sci. Mater Med 1:1990;198-206.
35. vanSliedregt A., vanLoon J.A., vanderBrink J., deGroot K., vanBlitterswijk C.A. Evaluation of polylactide monomers in an in vitro biocompatibility assay. Biomaterials. 15:1994;251-256.
36. Spenlehauer G., Vert M., Benoit J.P., Boddaert A. In vitro and in vivo degradation of poly(D, L-lactide/glycolide) type microspheres made by solvent evaporation method. Biomaterials. 10:1989;557-563.
37. Schakenraad J.M., Dijkstra P.J. Biocompatibility of poly(DL-lactic acid/glycine) copolymers. Clin Mater. 7:1991;253-269.
38. Wake M.C., Gerecht P.D., Lu L., Mikos A.G. Effects of biodegradable polymer particles on rat marrow-derived stromal osteoblasts in vitro. Biomaterials. 19:1998;1255-1268.
39. Schmitz J.P., Zardeneta G., Agrawal C.M., Lee T., Athanasiou K., Milam S.B. Protein interactions with polylactide-polyglycolide particles and scaffolds. Tissue Engng. 3:1997;257-266.
40. Grant G., Zardeneta G., Lee T., Milam S.B., Schmitz J.P. The effect of oxidative stress on biodegradable polymer. J Oral Maxillofac Surg. 55(Suppl. 3):1997;93.
41. Böstman O., Päivärinta U., Manninen M., Rokkanen P. Polymeric debris from absorbable polyglycolide screws and pins. intraosseous migration studied in rabbits Acta Orthop Scand. 63:1992;555-559.
42. Sevastjanova N., Mansurova L.A., Dumbrovska L.E., Slutskii L.E. Biochemical characterization of connective tissue reaction in synthetic polymer implants. Biomaterials. 8:1987;242.
43. Taylor S.R., Gibbons D.F. Effect of surface texture on the soft tissue response to polymer implants. J Biomed Mater Res. 17:1983;205-227.
44. Suganuma J., Alexander H. Biological response of intramedullary bone to poly-L-lactic acid. J Appl Biomat. 4:1993;13-27.
45. Northup S.J. Current problems associated with toxicity evaluation of medical device materials and future research needs. Fund Appl Toxicol. 13:1993;196-204.