Development of interferon alpha-2b microspheres with constant release

International Journal of Pharmaceutics

Volumn 410, Issue 1-2, 2011, Pages 48-53

  Li, Zhiping ^a   Li, Lin ^b   Liu, Yan ^a   Zhang, Hui ^a   Li, Xueru ^a   Luo, Fang ^a   Mei, Xingguo ^a  

^a BEIJING INSTITUTE OF PHARMACOLOGY AND TOXICOLOGY   (China)

^b BEIJING INSTITUTE OF MICROBIOLOGY AND EPIDEMIOLOGY   (China)

Author keywords

Complete release; Interferon alpha 2b; Microspheres; Zero order

Indexed keywords

ALPHA2B INTERFERON; GELATIN; MICROSPHERE; OIL; POLYETHYLENE TEREPHTHALATE; POLYGLACTIN; WATER; ZINC SULFATE;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG RELEASE; FREEZE DRYING; IN VITRO STUDY; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; MICROENCAPSULATION; MOUSE; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; SUSTAINED DRUG RELEASE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANIMALS; DELAYED-ACTION PREPARATIONS; DRUG DELIVERY SYSTEMS; EXCIPIENTS; FREEZE DRYING; GELATIN; IMMUNOLOGIC FACTORS; INTERFERON ALFA-2B; MICROSPHERES; PARTICLE SIZE; RATS; RATS, SPRAGUE-DAWLEY; ZINC SULFATE;

EID: 79955581199     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2011.03.016     Document Type: Article

References (52)

1. Al-Azzam, W., Pastrana, E.A., Griebenow, K., 2002. Co-lyophilization of bovine serum albumin (BSA) with poly(ethylene glycol) improves efficiency of BSA encapsulation and stability in polyester microspheres by a solid-in-oil-in-oil technique. Biotechnol. Lett. 24, 1367-1374.
2. Bayraktar, Y., Koseoglu, T., Somner, C., Kayhan, B., Temizer, A., Uzunalimoglu, B., De Maria, N., Van Thiel, D.H., 1996. The use of deferoxamine infusions to enhance the response rate to interferon-alpha treatment of chronic viral hepatitis B. J. Viral Hepat. 3, 129-135. (Pubitemid 126734179)
3. Bezemer, J.M., Radersma, R., Grijpma, D.W., Dijkstra, P.J., Feijen, J., Van Blitterswijk, C.A., 2000. Zero-order release of lysozyme from poly(ethylene glycol)/poly(buthylene terephthalate) matrices. J. Control. Release 64, 179-192. (Pubitemid 30035318)
4. Blanco-Príeto, M.J., Campanero, M.A., Besseghir, K., Heimgatner, F., Gander, B., 2004. Importance of single or blended polymer types for controlled in vitro release and plasma levels of a somatostatin analogue entrapped in PLA/PLGA microspheres. J. Control. Release 96, 437-448. (Pubitemid 38553922)
5. Bordens, R., Grossberg, S.E., Trotta, P.P., Nagabhushan, T.L., 1997. Molecular and biologic characterization of recombinant interferon-alpha 2b. Semin. Oncol. 24, S9-41-S9-51.
6. Carrasquillo, K.G., Staneley, A.M., Aponte Carro, J.C., De Jésus, P., Costantino, H.R., Bosques, C.J., Griebenow, K., 2001. Non-aqueous encapsulation of excipient-stabilized spray-dried BSA into poly(lactide-co- glycolide) microspheres results in release of native protein. J. Control. Release 76, 199-208. (Pubitemid 32913430)
7. Castellanos, I.J., Cuadrado, W.L., Griebenow, K., 2001. Prevention of structural perturbations and aggregation upon encapsulation of bovine serum albumin into poly(lactide-co-glycolide) microspheres using the solid-in-oil-in-water technique. J. Pharm. Pharmacol. 53, 1099-1107.
8. Comets, E., Mentre, F., Kawai, R., Nimmerfall, F., Marbach, P., Vonderscher, J., 2000. Modeling the kinetics of release of octreotide from long-acting formulations injected intramuscularly in rabbits. J. Pharm. Sci. 89, 1123-1133.
9. Coombes, A.G.A., Yeh, M.-K., Lavelle, E.C., Davis, S.S., 1998. The control of protein release from poly(dl-lactide co-glycolide) microparticles by variation of the external aqueous phase surfactant in the water-in oil-in water method. J. Control. Release 52, 311-320. (Pubitemid 28135259)
10. Crotts, G., Park, T.G., 1997. Stability and release of bovine serum albumin encapsulated within poly(lactide-co-glycolide) microparticles. J. Control. Release 44, 123-134. (Pubitemid 27039109)
11. Degling, L., Stjärnkvist, P., Sjöholm, I., 1993. Interferon-gamma in starch microparticles: nitric oxide-generating activity in vitro and antileishmanial effect in mice. Pharm. Res. 6, 783-790.
12. Diwan, M., Park, T.G., 2003. Stabilization of recombinant interferon-α by pegylation for encapsulation in PLGA microspheres. Int. J. Pharm. 252, 111-122.
13. Freiberg, S., Zhu, X.X., 2004. Polymer microspheres for controlled drug release Int. J. Pharm. 282, 1-18. (Pubitemid 39178480)
14. Freitas, S., Merkle, H.P., Gander, B., 2005. Microencapsulation by solvent extraction/ evaporation: reviewing the state of the art of microsphere preparation process technology. J. Control. Release 102, 313-332. (Pubitemid 40093756)
15. Jiang, G., Qiu, W., DeLuca, P.P., 2003. Preparation and in vitro/in vivo evaluation of insulin-loaded poly(acryloyl-hydroxyethyl starch)-PLGA composite microspheres. Pharm. Res. 20, 452-459.
16. Johnson, O.L., Jaworowicz, W., Cleland, J.L., Bailey, L., Charnis, M., Duenas, E., Wu, C., Shepard, D., Magil, S., Last, T., Jones, A.J., Putney, S.D., 1997. The stabilization and encapsulation of human growth hormone into biodegradable microspheres. Pharm. Res. 14, 730-735.
17. Jones, A.J., Putney, S., Johnson, O.L., Cleland, J.L., 1997. Recombinant human growth hormone poly(lactic-co-glycolic acid) microsphere formulation development. Adv. Drug Deliv. Rev. 28, 71-84.
18. Jorgensen, L., Moeller, E.H., van de Weert, M., Nielsen, H.M., Frokjaer, S., 2006. Preparing and evaluating delivery systems for proteins. Eur. J. Pharm. Sci. 29, 174-182.
19. Kim, H.K., Chung, H.J., Park, T.G., 2006. Biodegradable polymeric microspheres with "open/closed" pores for sustained release of human growth hormone. J. Control. Release 112, 167-174.
20. Kim, H.K., Park, T.G., 1999. Microencapsulation of human growth hormone within biodegradable polyester microspheres: protein aggregation stability and incomplete release mechanism. Biotechnol. Bioeng. 65, 659-667.
21. Kirkwood, J.M., Ibrahim, J.G., Sondak, V.K., Ernstoff, M.S., Ross, M., 2002. Interferon alfa-2a for melanoma metastases. Lancet 359, 978-979.
22. Kwon, Y.M., Baudys, M., Knutson, K., Kim, S.W., 2001. In situ study of insulin aggregation induced by water-organic solvent interface. Pharm. Res. 18, 1754-1759.
23. Lam, X.M., Duenas, E.T., Daugherty, A.L., Levin, N., Cleland, J.L., 2000. Sustained release of recombinant human insulin-like growth factor-I for treatment of diabetes. J. Control. Release 67, 281-292. (Pubitemid 30303842)
24. Lee, E.S., Kwon, M.J., Lee, H., Kim, J.J., 2007. Stabilization of protein encapsulated in poly(lactide-co-glycolide) microspheres by novel viscous S/W/O/W method. Int. J. Pharm. 331, 27-37.
25. Lu, W., Park, T.G., 1995a. In vitro release profiles of eristostatin from biodegradable polymeric microspheres: protein aggregation problems. Biotechnol. Prog. 11, 224-227.
26. Lu, W., Park, T.G., 1995b. Protein release from poly (lactic-co-glycolic acid) microspheres: protein stability problems. PDA J. Pharm. Sci. Tech. 49, 13-19.
27. Machida, Y., Onishi, H., Kurita, A., Hata, H., Morikawa, A., Machida, Y., 2000. Pharmacokinetics of prolonged-release CPT-11-loaded microspheres in rats. J. Control. Release 66, 159-175. (Pubitemid 30160854)
28. Manish, D., Tae, G.P., 2003. Stabilization of recombinant interferon-α by pegylation for encapsulation in PLGA microspheres. Int. J. Pharm. 252, 111-122.
29. Morita, T., Sakamura, Y., Horikiri, Y., Suzuki, T., Yoshino, H., 2000. Protein encapsulation into biodegradable microspheres by a novel S/O/W emulsion method using poly(ethylene glycol) as a protein micronization adjuvant. J. Control. Release 69, 435-444.
30. Park, T.G., Yong Lee, H., Sung Nam, Y., 1998. A new preparation method for protein loaded poly(dl-lactic-co-glycolic acid) microspheres and protein release mechanism study. J. Control. Release 55, 181-191.
31. Periti, P., Mazzei, T., Mini, E., 2002. Clinical pharmacokinetics of depot leuprorelin. Clin. Pharmacokinet. 41, 485-504.
32. Ruiz, L., Reyes, N., Duany, L., Franco, A., Aroche, K., Hardy Rando, E., 2003. Long-term stabilization of recombinant human interferon alpha 2b in aqueous solution without serum albumin. Int. J. Pharm. 264, 57-72.
33. Sánchez, A., Tobío, M., González, L., Fabra, A., Alonso, M.J., 2003. Biodegradable microand nanoparticles as long-term delivery vehicles for interferon-alpha. Eur. J. Pharm. Sci. 18, 221-229.
34. Santana, H., Espino, Y., Franco, A., Furrazola, G., Hardy, E., 1999. A sandwich-type enzyme-linked immunosorbent assay for the analysis of recombinant human interferon α-2b. Biotech. Tech. 5, 341-346.
35. Sebeka, H.K., Starkuviene, B., Trepsiene, O.V., Pauliukonis, A.A., Bumelis, V.A., 2001. Comparative effects of stabilizing additives on the rates of heat inactivation of recombinant human interferon α-2b in solution. Antiviral Res. 50, 117-127. (Pubitemid 32441826)
36. Sinha, V.R., Trehan, A., 2003. Biodegradable microspheres for protein delivery. J. Control. Release 90, 261-280. (Pubitemid 36859959)
37. Sohier, J., Haan, R.E., de Groot, K., Bezemer, J.M., 2003. A novel method to obtain protein release from porous polymer scaffolds: emulsion coating. J. Control. Release 87, 57-68. (Pubitemid 36258387)
38. Sohier, J., Vlugt, T.J.H., Cabrol, N.,VanBlitterswijk, C., de Groot, K., Bezemer, J.M., 2006. Dual release of proteins from porous polymeric scaffolds. J. Control. Release 111, 95-106. (Pubitemid 43292485)
39. Spenlehauer, G., Vert, M., Benoit, J.P., Boddaert, A., 1989. In vitro and In vivo degradation of poly(dl lactide/glycolide) type microspheres made by solvent evaporation method. Biomaterials 10, 557-563.
40. Tabata, Y., Ikada, Y., 1989. Synthesis of gelatin microspheres containing interferon. Pharm. Res. 6, 422-427.
41. Takada, S., Yamagata, Y., Misaki, M., Taira, K., Kurokawa, T., 2003. Sustained release of human growth hormone from microcapsules prepared by a solvent evaporation technique. J. Control. Release 88, 229-242. (Pubitemid 36287340)
42. Tracy, M.A., Ward, K.L., Firouzabadian, L., Wang, Y., Dong, N., Qian, R., Zhang, Y., 1999. Factors affecting the degradation rate of poly(lactide-co- glycolide) microspheres in vivo and in vitro. Biomaterials 20, 1057-1062. (Pubitemid 29229474)
43. Tuncay, M., Calis, S., Kas, H.S., Ercan, M.T., Peksoy, I., Hincal, A.A., 2000. Diclofenac sodium incorporated PLGA (50:50) microspheres: formulation considerations and in vitro/in vivo evaluation. Int. J. Pharm. 195, 179-188.
44. Uchida, T., Yagi, A., Oda, Y., Nakada, Y., Goto, S., 1996. Instability of bovine insulin in poly(lactide-co-glycolide) (PLGA) microspheres. Chem. Pharm. Bull. 44, 235-236.
45. van de Weert, M., Hennink, W.E., Jiskoot, W., 2000. Protein instability in poly(lacticcoglycolic acid) microparticles. Pharm. Res. 17, 1159-1167.
46. van Dijkhuizen-Radersma, R., Hesseling, S.C., Kaim, P.E., de Groot, K., Bezemer, J.M., 2002. Biocompatibility and degradation of poly(ether-ester) microspheres: invitro and in-vivo evaluation. Biomaterials 23, 4719-4729. (Pubitemid 35286693)
47. Yoshikawa, Y., Komuta, Y., Nishihara, T., Itoh, Y., Yoshikawa, H., Takada, K., 1999. Preparation and evaluation of once-a-day injectable microspheres of interferon alpha in rats. J. Drug Target 6, 449-461. (Pubitemid 29452688)
48. Yuan, W., Wu, F., Guo, M., Jin, T., 2009. Development of protein delivery microsphere system by a novel S/O/O/W multi-emulsion. Eur. J. Pharm. Sci. 36, 212-218.
49. Zoon, K.C., Zur Nedden, D., Hu, R., Arnheiter, H., 1986. Analysis of the steady state binding, internalization, and degradation of human interferon-alpha2. J. Biol. Chem. 261 (11), 4993-4996.
50. Bernstein, H., Zhang,Y., Khan, M.A., Tracy, M.A., 2002. Modulated release from biocompatible polymers. Patent No.:US6,368,630 B1.
51. Tracy, M.A., Bernstein, H., Khan, M.A., 2000. Controlled release of metal cationstabilized interferon. United States Patent 6(379), 701.
52. Peg-Intron. Clinical Pharmacology http://www.rxlist.com/peg-intron-drug. htm. Last reviewed on RxList: 7/10/2009.