Biocompatibility issues of implantable drug delivery systems

Pharmaceutical Research

Volumn 13, Issue 12, 1996, Pages 1770-1776

  Park, Haesun ^a   Park, Kinam ^a  

^a PURDUE UNIVERSITY   (United States)

Author keywords

Biocompatibility; Biomaterials; Hydrogels; Implantable drug delivery systems; Implantable glucose sensors

Indexed keywords

BIOMATERIAL; INSULIN; LEVONORGESTREL; SILASTIC;

ARTIFICIAL PANCREAS; BIOCOMPATIBILITY; CELL; DRUG DELIVERY SYSTEM; ENCAPSULATION; HUMAN; HYDROGEL; IMMUNE RESPONSE; IMPLANT; NONHUMAN; PRIORITY JOURNAL; REVIEW; TISSUE REACTION;

BIOCOMPATIBLE MATERIALS; DRUG IMPLANTS; HUMANS; INFUSION PUMPS, IMPLANTABLE; PANCREAS, ARTIFICIAL; SILICONE ELASTOMERS;

EID: 0030444591     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1016012520276     Document Type: Review

References (58)

1. A. Sank, J. Chalabian-Baliozian, D. Ertl, R. Sherman, M. Nimni, and T. L. Tuan. Cellular responses to silicone and polyurethane prosthetic surfaces. J. Surg. Res. 54:12-20 (1993).
2. A. Campbell and N. Brautbar. Norplant: Systemic immunological complications: Case report. Toxicology And Industrial Health 11:41-47 (1995).
3. R. Chuong, M. A. Piper, and T. J. Boland. Recurrent giant cell reaction to residual proplast in the temporomandibular joint. Oral Surg. Oral Med. Oral Path. 76:16-19 (1993).
4. E. Duncan. Biomaterials. What is a biomaterial? Med. Dev. Diag. Ind. 12:138-142 (1990).
5. S. Downes. Growth hormone release from biomaterials. In D. L. Wise, D. J. Trantolo, D. E. Altobelli, M. J. Yaszemski, J. D. Gresser, and E. R. Schwartz (ed.), Encyclopedic Handbook of Biomaterials and Bioengineering. Vol. 2, Part A: Materials, Marcel Dekker, New York, NY, 1995, 1135-1149.
6. D. L. Coleman, R. N. King, and J. D. Andrade. The foreign body reaction: a chronic inflammatory response. J. Biomed. Mater. Res. 8:199-211 (1974).
7. J. Black. Biological Performance of Materials. Fundamentals of Biocompatibility. Marcel Dekker, New York, NY, 1992, 3-9, 125-147.
8. R. E. Marchant. The cage implant system for determining in vivo biocompatibility of medical device materials. Fundamental And Applied Toxicology 13:217-227 (1989).
9. K. Park and S. L. Cooper. Importance of composition of the initial protein layer and platelet spreading in acute surface-induced thrombosis. Trans. Amer. Soc. Artif. Inter. Organs 31:483-488 (1985).
10. M. Amiji and K. Park. Surface modification of polymeric biomaterials with poly(ethylene oxide), albumin, and heparin for reduced thrombogenicity. J. Biomater. Sci. Polymer Edn. 4:217-234 (1993).
11. S. T. Milner. Polymer brushes. Science 251:905-914 (1991).
12. T. Peng, P. Gibula, K. D. Yao, and M. F. A. Goosen. Role of polymers in improving the results of stenting in coronary arteries. Biomaterials 17:685-694 (1996).
13. T. L. Lambert, V. Dev, F. Litvack, J. Forrester, and N. L. Eigler. Localized arterial delivery from a polymer coated removable metallic stent: kinetics and bioactivity of forskolin. Circulation 88:1-310 (1993).
14. J. M. Anderson. Inflammatory response to implants. Trans. Am. Soc. Artif. Intern. Organs 34:101-107 (1988).
15. J. B. Park. Biomaterials Science and Engineering, Plenum Press, New York, NY, 1984, 171-192.
16. A. A. Sharkawy, M. R. Neuman, and W. M. Reichert. Design considerations for biosensor-based drug delivery systems. In K. Park (ed.), Controlled Drug Delivery: Challenges and Strategies, American Chemical Society, Washington, D.C., in press, Chap. 9.
17. F. H. Silver. Breast implants, Chapman & Hall, New York, NY, 1994, 236-249.
18. J. S. Tiffany and D. J. Petraitis. Silicone biomaterials. In D. L. Wise, D. J. Trantolo, D. E. Altobelli, M. J. Yaszemski, J. D. Gresser, and E. R. Schwartz (eds.), Encyclopedic Handbook of Biomaterials and Bioengineering. Vol. 2, Part A: Materials, Marcel Dekker, New York, NY, 1995, 1675-1691.
19. P. D. Darney. Hormonal implants: Contraception for a new century. American Journal Of Obstetrics And Gynecology 170:1536-1543 (1994).
20. D. Granchi, D. Cavedagna, G. Ciapetti, S. Stea, P. Schiavon, R. Giuliani, and A. Pizzoferrato. Silicone breast implants: The role of immune system on capsular contracture formation. J. Biomed.l Mater. Res. 29:197-202 (1995).
21. C. R. Ward, C. M. Peterson, and H. H. Hatasaka. A hook-traction technique for Norplant removal. Obstetrics & Gynecology 86:848-850 (1995).
22. G. S. Letterie and M. Garnaas. Localization of "lost": Norplant capsules using compression film screen mammography. Obstetrics & Gynecology 85:886-887 (1995).
23. G. Velho, P. Froguel, D. R. Thévenot, and G. Reach. In vivo calibration of a subcutaneous glucose sensor for determination of subcutaneous glucose kinetics. Diab. Nutr. Metab. 1:227-233 (1988).
24. J. A. Tamada, N. J. V. Bohannon, and R. O. Potts. Measurement of glucose in diabetic subjects using noninvasive transdermal extraction. Nature Medicine 1:1198-1201 (1995).
25. M. Shichiri, Y. Yamasaki, R. Kawamori, N. Hakui, and H. Abe. Wearable artificial pancreas with needle-type glucose sensor. Lancet 2:1129-1231 (1982).
26. V. Poitout, D. Moatti-Sirat, G. Reach, Y. Zhang, G. S. Wilson, F. Lemonnier, and J. C. Klein. A glucose monitoring system for on line estimation in man of blood glucose concentration using a miniaturized glucose sensor implanted in the subcutaneous tissue and a wearable control unit. Diabetologia 36:658-663 (1993).
27. G. Reach. Towards self-regulation closed-loop treatment for diabetes. Annales D'endocrinologie 56:43-48 (1995).
28. U. Fisher, K. Rebrin, T. V. Woedtke, and P. Abel. Clinical usefulness of the glucose concentration in the subcutaneous tissue - properties and pitfalls of electrochemical biosensors. Hormone & Metabolic Res. 26:515-522 (1994).
29. D. Moatti-Sirat, F. Capron, V. Poitout, G. Reach, D. S. Bindra, Y. Zhang, G. S. Wilson, and D. R. Thévenot. Toward continuous glucose monitoring: in vivo evaluation of a miniaturized glucose sensor implanted for several days in rat subcutaneous tissue. Diabetologia 35:224-230 (1992).
30. W. Kerner, M. Kiwit, B. Linke, F. S. Keck, H. Zier, and F. Pfeiffer. The function of a hydrogen peroxide detecting electroenzymatic glucose electrode is markedly impaired in human subcutaneous tissue and plasma. Biosensors and Bioelectronics 8:473-482 (1993).
31. V. Sluzky, J. A. Tamada, A. M. Klibanov, and R. Langer. Kinetics of insulin aggregation in aqueous solutions upon agitation in the presence of hydrophobic surfaces. Proc. Natl. Aca. Sci. U.S.A. 88:9377-9381 (1991).
32. W. D. Lougheed, H. Woulfe-Flanagan, J. R. Clement, and A. M. Albisser. Insulin aggregation in artificial delivery systems. Diabetologia 19:1-9 (1980).
33. P. Soon-Shiong, E. Feldman, R. Nelson, R. Heintz, Q. Yao, Z. Yao, T. Zheng, N. Merideth, and G. Skjak-Braek. Long-term reversal of diabetes by the injection of immunoprotected islets. Proc. Natl. Acad. Sci. U.S.A. 90:5843-5847 (1993).
34. P. Soon-Shiong, R. E. Heintz, N. Merideth, Q. X. Yao, Z. Yao, T. Zheng, M. Murphy, M. K. Moloney, and M. Schmehl. Insulin independence in a type 1 diabetic patient after encapsulated islet transplantation. Lancet 343:950-951 (1994).
35. B. Thu, P. Bruheim, T. Espevik, O. Smidsrod, P. Soon-Shiong, and G. Skjak-Braek. Alginate polycation microcapsules. II. Some functional properties. Biomaterials 17:1069-1079 (1996).
36. A. S. Sawhney, C. P. Pathak, and J. A. Hubbell. Modification of islet of Langerhans surfaces with immunoprotective poly(ethylene glycol) coatings via interfacial photopolymerization. Biotech. Bioeng. 44:383-386 (1994).
37. H. T. Lau, M. Yu, A. Fontana, and C. J. Stoeckert Jr. prevention of islet allograft rejection with engineered myoblasts expressing FasL in mice. Science 273:109-112 (1996).
38. R. C. Wood, E. L. Lecluyse, and J. A. Fix. Assessment of a model for measuring drug diffusion through implant-generated fibrous capsule membranes. Biomaterials 16:957-959 (1995).
39. L. Christenson, L. Wahlberg, and P. Aebischer. Mast cells and tissue reaction to intraperitoneally implanted polymer capsules. Journal Of Biomedical Materials Research 25:1119-1132 (1991).
40. J. S. Schultz, S. Mansouri, and I. J. Goldstein. Affinity sensor: a new technique for developing implantable sensors for glucose and other metabolites. Diabetes Care 5:245-253 (1982).
41. J. R. Lakowicz. Emerging biomedical applications of time-resolved fluorescence spectroscopy. Volume 4. Probe Design and Chemical Sensing. In J. R. Lakowicz (ed.), Topics in Fluorescence Spectroscopy, Plenum Press, New York, NY, 1994, 1-19.
42. A. A. Obaidat and K. Park. Characterization of the phase transition of glucose sensitive hydrogels. Proc. Intern. Symp. Control. Rel. Bioact. Mater. 23:214-215 (1996).
43. A. A. Obaidat. Characterization of glucose dependent gel-sol phase transition of the polymeric glucose-concanavalin A hydrogel system. Ph.D. thesis, Purdue University, West Lafayette, IN (1996).
44. T. Miyata, A. Jikihara, and K. Nakamae. Preparation of poly(2-glucosyloxyethyl methacrylate)-concanavalin A complex hydrogel and its glucose sensitivity. Macromol. Chem. Phys. 197:1135-1146 (1996).
45. L. Shieh, J. Tamada, I. Chen, J. Pang, A. Domb, and R. Langer. Erosion of a new family of biodegradable polyanhydrides. J. Biomed. Mater. Res. 28:1465-1475 (1994).
46. L. W. Seymour, R. Duncan, J. Duffy, S. Y. Ng, and J. Heller. Poly(ortho ester) matrices for controlled release of the antitumour agent 5-fluorouracil. J. Cont. Rel. 31:201-206 (1994).
47. J. Fiordeliso, S. Bron, and J. Kohn. Design, synthesis and preliminary characterization of tyrosine-containing polyarylates: New biomaterials for medical applications. J. Biomater. Sci. Polymer Edn. 5:497-510 (1994).
48. D. W. Urry. Elastic biomolecular machines. Sci.c Amer. 272:64-69 (1995).
49. J. Cappello. The biological production of protein polymers and their use. Trends In Biotechnology 8:309-311 (1990).
50. M. Richards, B. I. Dahiyat, D. M. Arm, P. R. Brown, and K. W. Leong. Evaluation of polyphosphates and polyphosphonates as degradable biomaterials. J. Biomed. Mater. Res. 25:1151-1168 (1991).
51. S. A. Wainwright. What we can learn from soft biomaterials and structures. In M. Sarikaya and I. A. Aksay (ed.), Biomimetics. Design and Processing of Materials, American Institute of Physics, Woodbury, NY, 1995, 1-12.
52. T. A. Horbett and A. S. Hoffman. Bovine plasma protein adsorption onto radiation-grafted hydrogels based on hydroxyethyl methcarylate and N-vinyl pyrrolidone. Am. Chem. Soc. Adv. Chem. Ser. 145:230-235 (1975).
53. J. A. Braatz, A. H. Heifetz, and C. L. Kehr. A new hydrophilic polymer for biomaterial coatings with low protein adsorption. J. Biomater. Sci. Polymer Edn. 3:451-462 (1992).
54. O. Wichterle and D. Lim. Hydrophilic gels for biological use. Nature 185:117-118 (1960).
55. B. D. Ratner. Biomedical applications of hydrogels: review and critical appraisal. In D. F. Williams (ed.), Biocompatibility of Clinical Implant Materials, Vol. II, CRC Press, Boca Raton, FL, 1981, Chap. 7.
56. G. F. Klomp, H. Hashiguchi, P. C. Ursell, Y. Takeda, T. Taguchi, and W. H. Dobelle. Macroporous hydrogel membranes for a hybrid artificial pancreas. H. Biocompatibility. J. Biomed. Mater. Res. 17:865-871 (1983).
57. J. Honiger, S. Darquy, G. Reach, E. Muscat, M. Thomas, and C. Collier. Preliminary report on cell encapsulation in a hydrogel made of a biocompatible material, AN69, for the development of a bioartificial pancreas. International Journal Of Artificial Organs 17:46-52 (1994).
58. H. Iwata, K. Kobayashi, T. Takagi, T. Oka, H. Yang, H. Amemiya, T. Tsuji, and F. Ito. Feasibility of agarose microbeads with xenogeneic islets as a bioartificial pancreas. J. Biomed. Mater. Res. 28:1003-1011 (1994).