A month-long effect from a single injection of microencapsulated human growth hormone

Nature Medicine

Volumn 2, Issue 7, 1996, Pages 795-799

  Johnson, Olufunmi L ^a   Cleland, Jeffrey L ^b   Lee, Hye Jung ^a   Charnis, Margarita ^a   Duenas, Eileen ^b   Jaworowicz, Warren ^a   Shepard, Douglas ^a   Shahzamani, Azin ^b   Jones, Andrew J S ^b   Putney, Scott D ^a  

^a ALKERMES INC   (United States)

^b GENENTECH INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN GROWTH HORMONE; MICROSPHERE; SOMATOMEDIN; SOMATOMEDIN BINDING PROTEIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BIODEGRADATION; DRUG DELIVERY SYSTEM; DRUG DEVELOPMENT; DRUG RELEASE; MONKEY; NONHUMAN; PRIORITY JOURNAL; SUSTAINED RELEASE PREPARATION;

ANIMALS; DELAYED-ACTION PREPARATIONS; DRUG CARRIERS; GROWTH HORMONE; HUMANS; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3; INSULIN-LIKE GROWTH FACTOR I; MACACA MULATTA; MALE; MICROSPHERES; RECOMBINANT PROTEINS;

ANIMALIA;

EID: 15844364250     PISSN: 10788956     EISSN: None     Source Type: Journal    
DOI: 10.1038/nm0796-795     Document Type: Article

References (40)

1. Langer, R. New methods of drug delivery. Science 249, 1527-1533 (1990).
2. Mulligan, R.C. The basic science of gene therapy. Science 260, 926-932 (1993).
3. Wise, D.L., Jackanics, T.M., Nash, H.A. & Gregory, J.B. Polylactic acid as a biodegradable carrier for contraceptive steroids. Contraception 8, 227-234 (1973).
4. Beck, L.R., Pope, V.Z., Cowsar, D.R., Lewis, D.H. & Tice, T.R. Evaluation of a new three-month contraceptive microsphere system in primates. J. Contracept. Deliv. Sys. 1, 79-82 (1980).
5. Pitt, G.C., Marks, A. & Schindler, A. Biodegradable drug delivery systems based on aliphatic polymers: Application to contraceptives and narcotic antagonists. in Controlled Release of Bioactive Agents. (ed. Baker, R.W.) 19-43 (Academic Press, New York, 1980).
6. Hutchinson, F.G. & Furr, B.J.A. Biodegradable polymers for sustained release of peptides. Biochem. Soc. Trans. 13, 520-523 (1985).
7. Ogawa, Y., Okada, H., Yamamota, M. & Shimamoto, T. In vivo release profiles of leuprolide acetate from microcapsules prepared with polylactic acids or copoly(lactic/glycolic) acids and in vivo degradation of these polymers. Chem. Pharm. Bull. 36, 2576-2581 (1988).
8. Sanders, L.M., Kell, B.A., McRae, G.I. & 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, 356-360 (1986).
9. Austin, P.E. et al. Subcuticular sutures and the rate of inflammation in noncontaminated wounds. Ann. Emerg. Med. 25, 328-330 (1995).
10. Pihlajamaki, H., Bostman, O., Hirvensalo, E., Tormala, P. & Rokkanen, P. Absorbable pins of self-reinforced poly-L-lactic acid for fixation of fractures and osteotomies. J. Bone Joint Surg. 74, 853-857 (1992).
11. Winde, G. et al. Clinical and functional results of abdominal rectopexy with absorbable mesh-graft for treatment of complete rectal prolapse. Eur. J. Surg. 159, 301-305 (1993).
12. Cohen, S. et al. Ionically cross-linkable polyphosphazene: A novel polymer for microencapsulation. J. Am. Chem. Soc. 112, 7832-7833 (1990).
13. Ogawa, Y., Yamamoto, M., Okada, H., Yashiki, T. & Shimamoto, T. A new technique to efficiently entrap leuprolide acetate into microcapsules of polylactic acid or copoly(lactic/glycolic) acid. Chem. Pharm. Bull. 5, 1095-1103 (1988).
14. Cohen, S., Yoshioka, T., Lucarelii, M., Hwang, L.H. & Langer, R. Controlled delivery systems for proteins based on poly(lactic/glycolic acid) microspheres. Pharm. Research 8, 713-720 (1991).
15. Mathiowitz, E., Saltzman, W.M., Domb, A., Dor, P. & Langer, R. Polyanhydride microspheres as drug carriers. II. Microencapsulation by solvent removal. J. Appl. Polymer Sci. 35, 755-774 (1988).
16. Daughaday, W.F. Growth hormone, insulin-like growth factors and acromegaly. in Endocrinology. (ed. DeGroot, L.J.) 303-329 (Saunders, Philadelphia, 1995).
17. Pearlman, R. & Bewley, T.A. Stability and characterization of human growth hormone. in Stability and Characterization of Protein and Peptide Drugs: Case Histories. (eds. Wang, Y.J. & Pearlman, R.) 1-58 (Plenum, New York, 1993).
18. Laursen, T., Jorgensen, O.L., Jakobsen, G., Hansen, B.L. & Christiansen, J.S. Continuous infusion versus daily injections of growth hormone (GH) for 4 weeks in GH-deficient patients. J. Clin. Endocrinol. Metab. 80, 2410-2418 (1995).
19. Tauber, H., De Bouet du Portal, H., Sallerin-Caute, B., Rochiccioli, P. & Bastide, R. Differential regulation of serum growth hormone (GH)-binding protein during continuous infusion vs. daily injection of recombinant human GH in GH-deficient children. J. Clin. Endocrinol. Metab. 76, 1135-1139 (1993).
20. Thorlacius-Ussing, O. Zinc in the anterior pituitary of the rat: A histochemical and analytical work. Neuroendocrinology 45, 233-242 (1987).
21. Cunningham, B.C., Mulkerrin, M.G. & Wells, J.A. Dimerization of human growth hormone by zinc. Science 253, 545-548 (1991).
22. Coleman, J.E. Zinc proteins: Enzymes, storage proteins, transcription factors, and replication proteins. Annu. Rev. Biochem. 61, 897-946 (1992).
23. Steiner, D.F., Bell, G.I., Tager, H.S. & Rubenstein, A.H. Chemistry and biosynthesis of the islet hormones: Insulin, islet amyloid polypeptide (amylin), glucagon, somatostatin, and pancreatic polypeptide. in Endocrinology. (ed. DeGroot, L.J.) 1296-1328 (Saunders, Philadelphia, 1995).
24. Mathews, L.S., Norstedt, G. & Palmiter, R.D. Regulation of insulin-like growth factor I gene expression by growth hormone. Proc. Natl. Acad. Sci. USA 83, 9343-9347 (1986).
25. Hardouin, S. et al. Molecular forms of serum insulin-like growth factor (IGF)-binding proteins in man: Relationships with growth hormone and IGFs and physiological significance. J. Clin. Endocrinol. Metab. 69, 1291-1301 (1989).
26. Wilson, M.E. & Tanner, J.M. Long-term effects of recombinant human growth hormone treatment on skeletal maturation and growth in female rhesus monkeys with normal pituitary function. J. Endocrinol. 130, 435-441. (1991).
27. Li, C.H., Lahm, H.W. & Stein, S. The primary structure of monkey pituitary growth hormone. Arch. Biochem. Biophys. 245, 287-291 (1986).
28. Schwendeman, S.P., Cardamone, M., Brandon, M.R., Klibanov, A. & Langer, R. Stability of proteins and their delivery from biodegradable polymer microspheres. in Microspheres/Microparticles: Characterization and Pharmaceutical Application. (eds. Cohen, S. & Bernstein, H.) 1-49 (Marcel Dekker Inc., New York, 1996).
29. Cleland, J.L. & Yang, J. In vitro release of bioactive recombinant human interferon from PLGA microspheres. Proc. Int. Symp. Control. Rel. Bioact. Mater. 22, 518-519 (1995).
30. Pitt, C.G. The controlled parenteral delivery of polypeptides and proteins. Int. J. Pharm. 59, 173-196 (1990).
31. Shah, S.S., Cha, Y. & Pitt, C.G. Poly(glycolic acid-CO-DL-lactic acid): Diffusion or degradation controlled delivery? J. Control. Rel. 18, 261-270 (1992).
32. Cleland, J.L. et al. Characterization of recombinant human growth hormone-PLGA formulations in animals. Proc. Int. Symp. Control. Rel. Bioact. Mater. 22, 143-144 (1995).
33. Physician's Desk Reference. 2502-2506 (Medical Economics Data, Montvale, New Jersey, 1995).
34. Eckhardt, B.M., Oeswein, J.Q. & Bewley, T.A. Effect of freezing on aggregation of human growth hormone. Pharm. Res. 8, 1360-1364 (1991).
35. Battersby, J.E., Hancock, W.S., Canova-Davis, E., Oeswein, J. & O'Connor, B. Diketopiperazine formation and N-terminal degradation in recombinant human growth hormone. Int. J. Peptide Protein Res. 44, 215-222 (1994).
36. Battersby, J.E., Mukku, V.R., Clark, R.G. & Hancock, W.S. Affinity purification and microcharacterization of recombinant DNA-derived human growth hormone isolated from an in vivo model. Anal. Chem. 67, 447-455 (1995).
37. Canova-Davis, E. et al. Properties of a cleaved two-chain form of recombinant human growth hormone. Int. J. Peptide Protein Res. 35, 17-24 (1990).
38. Teshima, G., Stults, J.T., Ling, V. & Canova-Davis, E. Isolation and characterization of a succinimide variant of methionyl human growth hormone. J. Biol. Chem. 266, 13544-13547 (1991).
39. Teshima, G. & Canova-Davis, E. Separation of oxidized human growth hormone variants by reversed-phase high-performance liquid chromatography. J. Chromatogr. 625, 207-215 (1992).
40. Laemmli, U.K. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 227, 680-685 (1970).