Improving the stability of PLGA-encapsulated proteins

Polymeric Drug Delivery Systems

Volumn , Issue , 2005, Pages 381-416

  Schwendeman, Steven P ^a   Kang, Jichao ^b  

^a UNIVERSITY OF MICHIGAN   (United States)

^b PROTEIN DESIGN LABS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84870534082     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (57)

1. Eppstein DA, Longenecker JP. Alternative delivery systems for peptides and proteins as drugs. Crit Rev Ther Drug Carrier Syst 1988; 5:99-139.
2. Saffran M, Kumar GS, Savariar C, Burnham JC, Williams F, Neckers DC. A new approach to the oral administration of insulin and other peptide drugs. Science 1986; 233:1081-1084.
3. Schwendeman SP, Cardamone M, Brandon MR, Klibanov A, Langer R. Stability of proteins and their delivery from biodegradable polymer microspheres. In: Cohen S, Bernstein H, eds. Microparticulate Systems for the Delivery of Proteins and Vaccines. New York: Marcel Dekker, 1996:1-49.
4. Putney SD, Burke PA. Improving protein therapeutics with sustained-release formulations. Nat Biotechnol 1998; 16: 153-157.
5. Schwendeman SP. Recent advances in the stabilization of protein encapsulated in injectable PLGA delivery systems. Crit Rev Ther Drug Carrier Syst 2002; 19:1-16.
6. Fu K, Klibanov AM, Langer R. Protein stability in controlledrelease systems. Nat Biotechnol 2000; 18:24-25.
7. Crotts G, Park TG. Protein delivery from poly(lactic-co-glycolic acid) biodegradable microspheres: release kinetics and stability issues. J Microencapsul 1998; 15:699-713.
8. Zhu G, Mallery SR, Schwendeman SP. Stabilization of proteins encapsulated in injectable poly(lactide-co-glycolide). Nat Biotechnol 2000; 18:52-57.
9. Jiang W, Schwendeman SP. Stabilization and controlled release of bovine serum albumin encapsulated in poly(D, Llactide) and poly(ethylene glycol) microsphere blends. Pharm Res 2001; 18:878-885.
10. Van de Weert M, Hoechstetter J, Hennink WE, Crommelin DJ. The effect of a water/organic solvent interface on the structural stability of lysozyme. J Contr Rel 2000; 68:351-359.
11. Frangione-Beebe M, Albrecht B, Dakappagari N, Rose RT, Brooks CL, Schwendeman SP, Lairmore MD, Kaumaya PT. Enhanced immunogenicity of a conformational epitope of human T-lymphotropic virus type 1 using a novel chimeric peptide. Vaccine 2000; 19:1068-1081.
12. Johnson OL, Cleland JL, Lee HJ, Charnis M, Duenas E, Jaworowicz W, Shepard D, Shahzamani A, Jones AJS, Putney SD. A month-long effect from a single injection of microencapsulated human growth hormone. Nat Med 1996; 2:795-799.
13. Cleland JL, Mac A, Boyd B, Yang J, Duenas ET, Yeung D, Brooks D, Hsu C, Chu H, Mukku V, Jones AJ. The stability of recombinant human growth hormone in poly(lactic-coglycolic acid) (PLGA) microspheres. Pharm Res 1997; 14:420-425.
14. Kim HK, Park TG. Microencapsulation of human growth hormone within biodegradable polyester microspheres: protein aggregation stability and incomplete release mechanism. Biotechnol Bioeng 1999; 65:659-667.
15. Kersten GF, Donders D, Akkermans A, Beuvery EC. Single shot with tetanus toxoid in biodegradable microspheres protects mice despite acid-induced denaturation of the antigen. Vaccine 1996; 14:1627-1632.
16. Schwendeman SP, Costantino HR, Gupta RK, Tobio M, Chang AC, Alonso MJ, Siber GR, Langer R. Strategies for stabilising tetanus toxoid towards the development of a single-dose tetanus vaccine. Dev Biol Stand 1996; 87:293-306.
17. Chang AC, Gupta RK. Stabilization of tetanus toxoid in poly(DL-lactic-co-glycolic acid) microspheres for the controlled release of antigen. J Pharm Sci 1996; 85:129-132.
18. Johansen P, Men Y, Audran R, Corradin G, Merkle H, Gander B. Improving stability and release kinetics of microencapsulated tetanus toxoid by co-encapsulation of additives. Pharm Res 1998; 15:1103-1110.
19. Tobio M, Schwendeman SP, Guo Y, McIver J, Langer R, Alonso MJ. Improved immunogenicity of a core-coated tetanus toxoid delivery system. Vaccine 1999; 18:618-622.
20. Sanchez A, Villamayor B, Guo Y, McIver J, Alonso MJ. Formulation strategies for the stabilization of tetanus toxoid in poly (lactide-co-glycolide) microspheres. Int J Pharm 1999; 185:255-266.
21. Morlock M, Kissel T, Li YX, Koll H, Winter G. Erythropoietin loaded microspheres prepared from biodegradable LPLG-PEOLPLG triblock copolymers: protein stabilization and in-vitro release properties. J Contr Rel 1998; 56:105-115.
22. Lam XM, Duenas ET, Daugherty AL, Levin N, Cleland JL. Sustained release of recombinant human insulin-like growth factor-I for treatment of diabetes. J Contr Rel 2000; 67:281-292.
23. Cleland JL, Duenas ET, Park A, Daugherty A, Kahn J, Kowalski J, Cuthbertson A. Development of poly-(D, Llactide-coglycolide) microsphere formulations containing recombinant human vascular endothelial growth factor to promote local angiogenesis. J Contr Rel 2001; 72:13-24.
24. Lu W, Park TG. Protein release from poly(lactic-co-glycolic acid) microspheres: protein stability problems. PDA J Pharm Sci Technol 1995; 49:13-19.
25. 3 as additives on the enzymatic activity of carbonic anhydrase encapsulated in poly(lactide-co-glycolide) (PLGA) microspheres. Biochim Biophys Acta 2002; 1570:63-74.
26. Cleland JL, Jones AJ. Stable formulations of recombinant human growth hormone and interferon-gamma for microencapsulation in biodegradable microspheres. Pharm Res 1996; 13:1464-1475.
27. Pean JM, Boury F, Venier-Julienne MC, Menei P, Proust JE, Benoit JP. Why does PEG 400 co-encapsulation improve NGF stability and release from PLGA biodegradable microspheres? Pharm Res 1999; 16:1294-1299
28. Shao PG, Bailey LC. Stabilization of pH-induced degradation of porcine insulin in biodegradable polyester microspheres. Pharm Dev Technol 1999; 4:633-642.
29. Iwata M, Nakamura Y, McGinity JW. In vitro and in vivo release properties of brilliant blue and tumor necrosis factoralpha (TNF-alpha) from poly(D, L-lactic-co-glycolic acid) multiphase microspheres. J Microencapsul 1999; 16:777-792.
30. Cohen S, Yoshioka T, Lucarelli M, Hwang LH, Langer R. Controlled delivery systems for proteins based on poly(lactic/glycolic acid) microspheres. Pharm Res 1991; 8:713-720.
31. Castellanos IJ, Cruz G, Crespo R, Griebenow K. Encapsulation-induced aggregation and loss in activity of gammachymotrypsin and their prevention. J Contr Rel 2002; 81: 307-319.
32. Perez-Rodriguez C, Montano N, Gonzalez K, Griebenow K. Stabilization of alpha-chymotrypsin at the CH2Cl2/water interface and upon water-in-oil-in-water encapsulation in PLGA microspheres. J Contr Rel 2003; 89:71-85.
33. Volkin DB, Klibanov AM. Minimizing protein inactivation. In: Creighton TE, ed. Protein Function: A Practical Approach. Oxford: Oxford University Press, 1989:1-24.
34. Kissel T, Koneberg R. Injectable biodegradable microspheres for vaccine delivery. In: Cohen S, Bernstein H, eds. Microparticulate Systems for the Delivery of Proteins and Vaccines. New York: Marcel Dekker, 1996:51-87.
35. Manning MC, Patella L, Borchardt RT. Stability of protein pharmaceuticals. Pharm Res 1989; 6:903-918.
36. Peters T. Serum albumin. Adv Protein Chem 1985; 37: 161-245.
37. Sommer A, Rifkin D. Interaction of heparin with human basic fibroblast growth factor: protection of the angiogenic protein from proteolytic degradation by a glycosaminoglycan. J Cell Physiol 1989; 138:215-220.
38. Hutchinson FG, Furr BJA. Biodegradable polymers for sustained release of peptides. Biochem Soc Trans 1985; 13:520-523.
39. Heller J. Development of poly(ortho esters): a historical overview. Biomaterials 1990; 11:659-665.
40. Zhu G, Schwendeman SP. Stabilization of proteins encapsulated in cylindrical poly(lactide-co-glycolide) implants: mechanism of stabilization by basic additives. Pharm Res 2000; 17:351-357.
41. Shenderova A, Burke TG, Schwendeman SP. The acidic microclimate in poly(lactide-co-glycolide) microspheres stabilizes camptothecins. Pharm Res 1999; 16:241-248.
42. Kang J, Schwendeman SP. Comparison of the effects of Mg(OH)2 and sucrose on the stability of bovine serum albumin encapsulated in injectable poly(D, L-lactide-co-glycolide) implants. Biomaterials 2002; 23:239-245.
43. Fu K, Pack DW, Klibanov AM, Langer R. Visual evidence of acidic environment within degrading poly(lactic-co-glycolic acid) (PLGA) microspheres. Pharm Res 2000; 17:100-106.
44. Kang J, Schwendeman SP. Dynamics of the reversible transition between open and isolated pores in PLGA and its effect on the controlled release of proteins. Proc Int Symp Contr Rel Bioact Mater 2004; 31:32.
45. Magre EP, Sam AP. Hydrolytic degradation of PLGA, calculation of rate constants from various types of in vitro degradation curves. J Contr Rel 1997; 48:318-319.
46. Schwendeman SP, Costantino HR, Gupta RK, Siber GR, Klibanov AM, Langer R. Stabilization of tetanus and diphtheria toxoids against moisture-induced aggregation. Proc Natl Acad Sci USA 1995; 92:11234-11238.
47. Jiang W, Schwendeman SP. Formaldehyde-mediated aggregation of protein antigens: comparison of untreated and formalinized model antigens. Biotechnol Bioeng 2000; 70:507-517.
48. Jiang W, Schwendeman SP. Stabilization of a model formalinized protein antigen encapsulated in PLGA-based microspheres. J Pharm Sci 2001; 90:1558-1569.
49. Aguado MT. Future approaches to vaccine development: single-dose vaccines using controlled-release delivery systems. Vaccine 1993; 11:596-597.
50. Tobio M, Nolley J, Guo Y, McIver J, Alonso MJ. A novel system based on a poloxamer/PLGA blend as a tetanus toxoid delivery vehicle. Pharm Res 1999; 16:682-688.
51. Nugyen TH, Carole W. Stability characterization and formulation development of Alteplase, a recombined tissue plasminogen activator. In: Wang YJ, Pearlman R, eds. Stability and Characterization of Protein and Peptide Drugs: Case Histories. New York: Plenum Press, 1993:91-133.
52. Modi NB, Fox NL, Clow FW, Tanswell P, Cannon CP, Van de Werf F, Braunwald E. Pharmacokinetics and pharmacodynamics of tenecteplase: results from a phase II study in patients with acute myocardial infarction. J Clin Pharmacol 2000; 40:508-515.
53. Maksimenko AV, Tischenko EG. New thrombolytic strategy: bolus administration of tPA and urokinase-fibrinogen conjugate. J Thromb Thrombolysis 1999; 7:307-312.
54. Hubbell JA. Hydrogel systems for barriers and local drug delivery in the control of wound healing. J Contr Rel 1996; 39:305-313.
55. Zhou T, Lewis H, Foster RE, Schwendeman SP. Development of a multiple-drug delivery implant for intraocular management of proliferative vitreoretinopathy. J Contr Rel 1998; 55:281-295.
56. Wang YJ, Shahrokh Z, Vemuri S, Eberlein G, Beylin I, Busch M. Characterization, stability, and formulations of basic fibroblast growth factor. In: Pearlman R, Wang YJ, eds. Formulation, Characterization, and Stability of Protein Drugs. New York: Plenum Press, 1996:141-180.
57. Edelman ER, Nugent MA, Karnovsky MJ. Perivascular and intravenous administration of basic fibroblast growth factor: vascular and solid organ deposition. Proc Natl Acad Sci USA 1993; 90:1513-1517.