Cationic and thermosensitive protamine conjugated gels for enhancing sustained human growth hormone delivery

Biomaterials

Volumn 31, Issue 6, 2010, Pages 1349-1359

  Park, Mi Ran ^a,c   Chun, ChangJu ^a   Ahn, Sung Won ^b   Ki, Min Hyo ^b   Cho, Chong Su ^c,d   Song, Soo Chang ^a  

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

^b Chong Kun Dang Research Institute   (South Korea)

^c Seoul National University   (South Korea)

^d Seoul National University   (South Korea)

Author keywords

Complexation; Human growth hormone (hGH); Ionic interaction; Protamine; Sustained protein delivery; Thermosensitive hydrogel

Indexed keywords

HUMAN GROWTH HORMONE; IONIC INTERACTION; PROTEIN DELIVERY; SUSTAINED PROTEIN DELIVERY; THERMO-SENSITIVE HYDROGEL;

AMIDES; CARBOXYLIC ACIDS; GELS; INORGANIC POLYMERS; ORGANIC ACIDS; PROTEINS;

HYDROGELS;

AMIDE; CARBOXYLIC ACID; DRUG CARRIER; HUMAN GROWTH HORMONE; POLY(ORGANOPHOSPHAZENE); POLYMER; PROTAMINE; SOMATOMEDIN C; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; AQUEOUS SOLUTION; AREA UNDER THE CURVE; ARTICLE; COMPLEX FORMATION; CONJUGATION; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG HALF LIFE; GEL; HEAT SENSITIVITY; IN VITRO STUDY; IN VIVO STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MONKEY; NONHUMAN; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; RAT; SUSTAINED RELEASE FORMULATION; SYNTHESIS; TEMPERATURE; TIME TO MAXIMUM PLASMA CONCENTRATION; ZETA POTENTIAL;

ANIMALS; CATIONS; DRUG CARRIERS; GELS; HUMAN GROWTH HORMONE; HUMANS; MACACA FASCICULARIS; MALE; MATERIALS TESTING; METABOLIC CLEARANCE RATE; PROTAMINES; RATS; RATS, SPRAGUE-DAWLEY; TEMPERATURE;

MACACA FASCICULARIS;

EID: 72149088227     PISSN: 01429612     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biomaterials.2009.10.022     Document Type: Article

References (45)

1. Lee H.J., Riley G., Johnson O., Cleland J.L., Kim N., Charnis M., et al. In vivo characterization of sustained-release formulations of human growth hormone. J Pharmacol Exp Ther 281 (1997) 1431-1439
2. IMS Health, MIDAS, MAT Dec, 2007.
3. Dumlao J.S., Brooks M.H., Krauss M.T., Bronsky D., and Waldstein S.S. Suppression of thyroidal iodine uptake after indocyanine green. J Clin Endocrinol Metab 30 (1970) 531-532
4. Laursen T., Jorgensen J., Jakobsen G., Hansen B., and Christiansen J. Continuous infusion versus daily injections of growth hormone (GH) for 4 weeks in GH-deficient patients. J Clin Endocrinol Metab 80 (1995) 2410-2418
5. Lee E., Kim Y., Lee H., Park S., Jung H., Lee J., et al. Stabilizing peptide fusion for solving the stability and solubility problems of therapeutic proteins. Pharm Res 22 (2005) 1735-1746
6. Govardhan C., Khalaf N., Jung C.W., Simeone B., Higbie A., Qu S., et al. Novel long-acting crystal formulation of human growth hormone. Pharm Res 22 (2005) 1461-1470
7. Johnson O.F.L., Jaworowicz W., Cleland J.L., Bailey L., Charnis M., Duenas E., et al. The stabilization and encapsulation of human growth hormone into biodegradable microspheres. Pharm Res 14 (1997) 730-735
8. Johnson O.F.L., Cleland J.L., Lee H.J., Charnis M., Duenas E., Jaworowicz W., et al. A month-long effect from a single injection of microencapsulated human growth hormone. Nat Med 2 (1996) 795-798
9. Chung H.J., Lee Y., and Park T.G. Thermo-sensitive and biodegradable hydrogels based on stereocomplexed pluronic multi-block copolymers for controlled protein delivery. J Control Release 127 (2008) 22-30
10. Tae G., Kornfield J.A., and Hubbell J.A. Sustained release of human growth hormone from in situ forming hydrogels using self-assembly of fluoroalkyl-ended poly(ethylene glycol). Biomaterials 26 (2005) 5259-5266
11. Hutchinson F.G., and Furr B.J.A. Biodegradable polymers for sustained release of peptides. Biochem Soc Trans (1985) 520-523
12. Sanders L.M., Kell B.A., Mcrae G.I., and Whitehead G.W. Prolonged controlled release of nafarelin, a luteinizing hormone-releasing hormone analogue from biodegradable polymeric implants: influence of composition and molecular weight of polymer. J Pharm Sci 75 (1986) 356-360
13. Kim H.K., and 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
14. Elbert D.L., Pratt A.B., Lutolf M.P., Halstenberg S., and Hubbell J.A. Protein delivery from materials formed by self-selective conjugate addition reactions. J Control Release 76 (2001) 11-25
15. Fu K., Pack D.W., Klibanov A.M., and Langer R. Visual evidence of acidic environment within degrading poly(lactic-co-glycolic acid) (PLGA) microspheres. Pharm Res 17 (2000) 100-106
16. Peppas N.A., Bures P., Leobandung W., and Ichikawa H. Hydrogels in pharmaceutical formulations. Eur J Pharm Biopharm 50 (2000) 27-46
17. Packhaeuser C.B., Schnieders J., Oster C.G., and Kissel T. In situ forming parenteral drug delivery systems: an overview. Eur J Pharm Biopharm 58 (2004) 445-455
18. Guan J., Hong Y., Ma Z., and Wagner W.R. Protein-reactive, thermoresponsive copolymers with high flexibility and biodegradability. Biomacromolecules 9 (2008) 1283-1292
19. Lee K.Y., and Yuk S.H. Polymeric protein delivery systems. Prog Polym Sci 32 (2007) 669-697
20. Lee B.H., Lee Y.M., Sohn Y.S., and Song S.-C. A thermosensitive poly(organophosphazene) gel. Macromolecules 35 (2002) 3876-3879
21. Lee B.H., and Song S.-C. Synthesis and characterization of biodegradable thermosensitive poly(organophosphazene) gels. Macromolecules 37 (2004) 4533-4537
22. Lee B.H., Park J.S., and Song S.-C. Synthesis and biocompatibility of thermosensitive poly(organophosphazene) gels. Biomater Res 7 (2003) 182-187
23. Lakshmi S., Katti D.S., and Laurencin C.T. Biodegradable polyphosphazenes for drug delivery applications. Adv Drug Deliv Rev 55 (2003) 467-482
24. Gómez J.M.M., Csaba N., Fischer S., Sichelstiel A., Kudig T.M., Gander B., et al. Surface coating of PLGA microparticles with protamine enhances their immunological performance through facilitated phagocytosis. J Control Release 130 (2008) 161-167
25. Bromberg L., and Temchenko M. Self-assembly in aqueous solutions of poly(ethylene oxide)-b-poly(propylene oxide)-b-poly(ethylene oxide)-b-poly(vinyl alcohol). Langmuir 15 (1999) 8633-8639
26. Greenstein J.D., and Winitz M. Chemistry of the amino acids (1961), John Wiley and Sons, New York
27. Chun C., Lee S.M., Kim S.Y., Yang H.K., and Song S.-C. Thermosensitive poly(organophosphazene)-paclitaxel conjugate gels for antitumor applications. Biomaterials 30 (2009) 2349-2360
28. Crommen J., Vandorpe J., and Schacht E. Degradable polyphosphazenes for biomedical applications. J Control Release 24 (1993) 167-180
29. Kang G.D., Cheon S.H., Khang G., and Song S.-C. Thermosensitive poly(organophosphazene) hydrogels for a controlled drug delivery. Eur J Pharm Biopharm 63 (2006) 340-346
30. Lee S.B., Song S.-C., Jin J.-I., and Sohn Y.S. A new class of biodegradable thermosensitive polymers. 2. hydrolytic properties and salt effect on the lower critical solution temperature of poly(organophosphazenes) with methoxypoly(ethylene glycol) and amino acid esters as side groups. Macromolecules 32 (1999) 7820-7827
31. Ando T., Yamasaki M., and Suzuki K. In: Kleinzeller A. (Ed). Molecular biology, biochemistry, and biophysics (1973), Springer-Verlag 1-109
32. In: Mahato R.I. (Ed). Biomaterials for delivery and targeting of proteins and nucleic acids (2005), CRS Press
33. Chang L.-C., Lee H.-F., Chung M.-J., and Yang V.C. PEG-modified protamine with improved pharmacological/pharmaceutical properties as a potential protamine substitute: synthesis and in vitro evaluation. Bioconjug Chem 16 (2005) 147-155
34. Koo H., Kand H., and Lee Y. Analysis of the relationship between the molecular weight and transfection efficiency/cytotoxicity of poly-l-arginine on a mammalian cell line. Bull Korean Chem Soc 30 (2009) 927-930
35. Na C., and Olson T.M. Relative reactivity of amino acids with chlorine in mixtures. Environ Sci Technol 41 (2007) 3220-3225
36. Cozzone P., Toniolo C., and Jardetzky O. NMR study of the main components of clupeine and their possible interaction with nucleic acids. FEBS Lett 110 (1980) 21-24
37. Pretsch E., Bühlmann P., and Affolter C. Structure determination of organic compounds (2000), Springer-Verlag, Berlin Heidelberg p. 296
38. Cunningham B., Mulkerrin M., and Wells J. Dimerization of human growth hormone by zinc. Science 253 (1991) 545-548
39. Coleman J.E. Zinc proteins: enzymes, storage proteins, transcription factors, and replication proteins. Annu Rev Biochem 61 (1992) 897-946
40. Brodbeck K.J., Pushpala S., and McHugh A.J. Sustained release of human growth hormone from PLGA solution depots. Pharm Res 16 (1999) 1825-1829
41. Park T.G., Lu W., and Crotts G. Importance of in vitro experimental conditions on protein release kinetics, stability and polymer degradation in protein encapsulated poly (-lactic acid-co-glycolic acid) microspheres. J Control Release 33 (1995) 211-222
42. Daughaday W.F. Growth hormone, insulin-like growth factors and acromegaly (1995), W. B Saunders and Co., Philadelphia
43. Osborn B.L., Sekut L., Corcoran M., Poortman C., Sturm B., Chen G., et al. Albutropin: a growth hormone-albumin fusion with improved pharmacokinetics and pharmacodynamics in rats and monkeys. Eur J Pharmacol 456 (2002) 149-158
44. Kim S.J., Hahn S.K., Kim M.J., Kim D.H., and Lee Y.P. Development of a novel sustained release formulation of recombinant human growth hormone using sodium hyaluronate microparticles. J Control Release 104 (2005) 323-335
45. Hahn S.K., Kim S.J., Kim M.J., and Kim D.H. Characterization and in vivo study of sustained-release formulation of human growth hormone using sodium hyaluronate. Pharm Res 21 (2004) 1374-1381