Stabilization of recombinant interferon-α by pegylation for encapsulation in PLGA microspheres

International Journal of Pharmaceutics

Volumn 252, Issue 1-2, 2003, Pages 111-122

  Diwan, Manish ^a,b   Park, Tae Gwan ^a  

^a Korea Advanced Institute of Science and Technology (KAIST)   (South Korea)

^b UNIVERSITY OF ALBERTA   (Canada)

Author keywords

Interferon; Microspheres; PEG; Pegylation; Protein stability

Indexed keywords

DICHLOROMETHANE; GLYCOL; METHOXYPOLYETHYLENE GLYCOL; MICROSPHERE; POLYGLACTIN; RECOMBINANT ALPHA INTERFERON; UNCLASSIFIED DRUG;

AQUEOUS SOLUTION; ARTICLE; BIODEGRADABILITY; CHEMICAL MODIFICATION; CONTROLLED DRUG RELEASE; DRUG CONJUGATION; DRUG FORMULATION; DRUG SOLUBILITY; DRUG STABILITY; GEL PERMEATION CHROMATOGRAPHY; MATRIX ASSISTED LASER DESORPTION IONIZATION TIME OF FLIGHT MASS SPECTROMETRY; MICROENCAPSULATION; PEGYLATION; PH; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; PROTEIN STABILITY; SIMULATION;

DRUG COMPOUNDING; DRUG STABILITY; INTERFERON TYPE I, RECOMBINANT; LACTIC ACID; MICROSPHERES; POLYGLYCOLIC ACID; POLYMERS;

EID: 0037452405     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-5173(02)00636-1     Document Type: Article

References (32)

1. Bailon P., Palleroni A., Schaffer C.A., Spence C.L., Fung W.J., Porter J.E., Ehrlich G.K., Pan W., Xu Z.X., Modi M.W., Farid A., Berthold W., Graves M. Rational design of a potent, long-lasting form of interferon: a 40 kDa branched polyethylene glycol-conjugated interferon alpha-2a for the treatment of hepatitis C. Bioconjug. Chem. 12:2001;195-202.
2. Baron S., Trying S.K., Fleischmann W.R., Coppenhaver D.H., Niesel D.W., Klimpel G.R., Stanton G.J., Hughes T.K. The interferons. Mechanisms of action and clinical applications. JAMA. 266:1991;1375-1383.
3. Chapman A.P., Antoniw P., Spitali M., West S., Stephens S., King D. Therapeutic antibody fragments with prolonged in vivo half-lives. Nat. Biotech. 17:1999;780-783.
4. Cleland J.L., Builder S.E., Swartz J.R., Winkler M., Chang J.Y., Wang D.I. Polyethylene glycol enhanced protein refolding. Biotechnology. 10:1992;1013-1019.
5. Crotts G., Sah H., Park T.G. Adsorption determines in-vitro protein release rate from biodegradable microspheres: quantitative analysis of surface area during degradation. J. Control. Rel. 47:1997;101-111.
6. Diwan M., Dawar H., Talwar G.P. Induction of early and bioeffective antibody response in rodents with the luteinizing hormone-releasing hormone vaccine given as a single dose in biodegradable microspheres along with alum. Prostate. 35:1998;279-284.
7. Diwan M., Park T.G. Pegylation enhances protein stability during encapsulation in PLGA microspheres. J. Control. Rel. 73:2001;233-244.
8. Edwards C.K. PEGylated recombinant human soluble tumour necrosis factor receptor type I (r-Hu-sTNF-RI): novel high affinity TNF receptor designed for chronic inflammatory diseases. Ann. Rheum. Dis. 58:1999;I73-I81.
9. Glue P., Rouzier-Panis R., Raffanel C., Sabo R., Gupta S.K., Salfi M., Jacobs S., Clement R.P. A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C. The Hepatitis C Intervention Therapy Group. Hepatology. 32:2000;647-653.
10. Hershfield M.S., Buckley R.H., Greenberg M.L., Melton A.L., Schiff R., Hatem C., Kurtzberg J., Markert M.L., Kobayashi R.H., Kobayashi A.L. Treatment of adenosine deaminase deficiency with polyethylene glycol-modified adenosine deaminase. New Engl. J. Med. 316:1987;589-596.
11. Hu Z.X., Hoffman J., Patel I., Joubert P. Single-dose, safety-tolerability and pharmacokinetic-pharmacodynamics following administration of ascending subcutaneous doses of pegylated-interferon and interferon alpha-2a to healthy subjects. Hepatology. 28:1998;A708.
12. Itri L.M. The interferons. Cancer. 70:1992;940-945.
13. Johansen P., Men Y., Audran R., Corradin G., Merkle H.P., Gander B. Improving stability and release kinetics of microencapsulated tetanus toxoid by co-encapsulation of additives. Pharm. Res. 15:1998;1103-1110.
14. Jurgens H., Schwamborn D., Korholz D., Wahn V., Gobel U. Clinical experiences with polyethylene glycol-bound E. coli L-asparaginase in patients with multiple recurrences of acute lymphoblastic leukemia. Klin. Pediatr. 200:1988;184-189.
15. Kim H., Park T.G. Microencapsulation of human growth hormone within biodegradable polyester microspheres: protein aggregation, stability and incomplete release mechanism. Biotechnol. Bioeng. 65:1999;659-667.
16. Kishnamurthy R., Lumpkin J.A., Sridhar R. Inactivation of lysozyme by sonication under conditions relevant to microencapsulation. Int. J. Pharm. 205:2000;23-34.
17. Kozlowski A., Harris J.M. Improvements in protein pegylation: pegylated interferons for treatment of hepatits C. J. Control. Rel. 72:2001;217-224.
18. Kuboi R., Morita S., Ota H., Umakoshi H. Protein refolding using stimuli-responsive polymer-modified aqueous two-phase systems. J. Chromatogr. B: Biomed. Sci. Appl. 743:2000;213-223.
19. Leong S.R., DeForge L., Presta L., Gonzalez T., Fan A., Reichert M., Chuntharapai A., Jin Kim K., Tumas D.B., Lee W.P., Gribling P., Snedecor B., Chen H., Hsei V., Schoenhoff M., Hale V., Deveney J., Koumenis I., Shahrokh Z., McKay P., Galan W., Wagner B., Narindray D., Hebert C., Zapata G. Adapting pharmacokinetic properties of a humanized anti-interleukin-8 antibody for therapeutic applications using site-specific pegylation. Cytokine. 16:2001;106-119.
20. Li X., Zhang Y., Yan R., Jia W., Yuan M., Deng X., Huang Z. Influence of process parameters on the protein stability encapsulated in poly-DL-lactide-poly(ethylene glycol) microspheres. J. Control. Rel. 68:2000;41-52.
21. Liang T.J., Rehermann B., Seeft L.B., Hoofnagle J.H. Pathogenesis, natural history, treatment and prevention of hepatitis C. Ann. Int. Med. 132:2000;296-305.
22. Lu W., Park T.G. Protein release from poly(lactic-c-glycolic acid) microspheres: protein stability problems. PDA J. Pharm. Sci. Technol. 49:1995;13-19.
23. Marinina J., Shenerova A., Mallery S.R., Schwendeman S.P. Stabilization of vinca alkaloids encapsulated in poly(lactide-co-glycolide) microspheres. Pharm. Res. 17:2000;677-683.
24. McPherson, T.B., Lee, S.J., Park, K., 1995. Analysis of the prevention of protein adsorption by steric repulsion theory. In: Horbett, T.A., Brash, J.C. (Eds.), Proteins at Interface II: Fundamentals and Applications. ACS Symposium Series Vol. 602. ACS, Washington, DC, pp. 395-404.
25. Morlock M., Kissel T., Li Y.X., Koll H., Winter G. Erythropoietin loaded microspheres prepared from biodegradable LPLG-PEO-LPLG triblock copolymers: protein stabilization and in-vitro release properties. J. Control. Rel. 56:1998;105-115.
26. Olson, K., Gehant, R., Mukku, V., et al., 1997. Preparation and characterization of poly(ethylene glycol)ylated human growth hormone antagonist. In: Harris, J.M., Zalipsky, S. (Eds.), Poly(ethylene glycol): Chemistry and Biological Applications. ACS Book, Washington, DC, pp. 170-181.
27. Péan J.M., Boury F., Venier-Julienne M.C., Menei P., Proust J.E., Benoit J.P. Why does PEG 400 co-encapsulation improve NGF stability and release from PLGA biodegradable microspheres. Pharm. Res. 16:1999;1294-1299.
28. Spiegel R.J. Alpha interferons: a clinical overview. Urology. 34:1989;75-79.
29. Stuart-Harris R.C., Lauchlan R., Day R. The clinical applications of the interferons: a review. Med. J. Aust. 156:1992;869-872.
30. Weert M.V., Hof R.V., Weed J.V., Heeren R.M.A., Posthuma G., Hennink W.E., Crommelin D.J.A. Lysozyme distribution and conformation of in a biodegradable polymer matrix as determined by FTIR techniques. J. Control. Rel. 68:2000;31-40.
31. Xing D.K., McLellan K., Corbel M.J., Sesardic D. Estimation of antigenic tetanus toxoid extracted from biodegradable microspheres. Biologicals. 24:1996;57-65.
32. Zu G., Mallery S.R., Schwendeman S.P. Stabilization of proteins encapsulated in injectable poly(lactide-co-glycolide). Nat. Biotech. 18:2000;52-57.