Stable formulations of recombinant human growth hormone and interferon-γ for microencapsulation in biodegradable microspheres

Pharmaceutical Research

Volumn 13, Issue 10, 1996, Pages 1464-1475

  Cleland, Jeffrey L ^a   Jones, Andrew J S ^a  

^a GENENTECH INC   (United States)

Author keywords

Drug delivery; Growth hormone; Interferon; Microspheres; Proteins; Stability

Indexed keywords

GAMMA INTERFERON; HUMAN GROWTH HORMONE; MICROSPHERE; ORGANIC SOLVENT;

ARTICLE; CIRCULAR DICHROISM; CONFORMATION; DRUG FORMULATION; DRUG STABILITY; FREEZE DRYING; GEL PERMEATION CHROMATOGRAPHY; MICROENCAPSULATION; PRIORITY JOURNAL; SUSTAINED RELEASE PREPARATION;

CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; DRUG STABILITY; GROWTH HORMONE; HUMANS; INTERFERON-GAMMA, RECOMBINANT; ISOELECTRIC FOCUSING; LACTIC ACID; MICROSPHERES; PARTICLE SIZE; POLYGLYCOLIC ACID; POLYMERS; PRECIPITATION; PROTEIN CONFORMATION; SOLUTIONS;

EID: 0029859532     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1016063109373     Document Type: Article

References (31)

1. J. L. Cleland. In: Vaccine Design: The Subunit Approach, M. F. Powell, and M. Newman, Plenum Publishing, New York, NY, pp. 439-472 (1995).
2. W. R. Gombotz, M. S. Healy, L. R. Brown, and H. E. Auer. Process for producing small particles of biologically active molecules. U.S. Patent 5,019,400 (1991).
3. T. W. Randolph, A. D. Randolph, M. Mehes, and S. Yeung. Biotech. Prog. 9:429-435 (1993).
4. K. P. Johnston, K. L. Harrison, M. J. Clarke, S. M. Howdle, M. P. Heitz, F. V. Bright, C. Arlier, and T. W. Randolph. Science 271:624-626 (1996).
5. L. Bromberg and A. M. Klibanov. PNAS 91:143-147 (1994).
6. J. Matsuura, M. E. Powers, M. C. Manning, and E. Shefter. J. Am. Chem. Soc. 115:1261-1264 (1993).
7. J. L. Cleland. In: Protein Delivery: Physical Systems, L. Sanders and W. Hendren, Eds., Plenum Publishing, New York, NY, in press (1996).
8. S. Cohen, T. Yoshioka, M. Lucarelli, L. H. Hwang, and R. Langer. Pharm. Res. 8:713-720 (1991).
9. M. S. Hora, R. K. Rana, J. H. Nunberg, T. R. Tice, R. M. Gilley, and M. E. Hudson. Pharm. Res. 7:1190-1194 (1990).
10. C. Yan, J. H. Resau, J. Hewetson, M. West, W. L. Rill, and M. Kende. J. Contr. Rel. 32:231-241 (1994).
11. D. T. O'Hagen, J. P. McGee, M. Lindblad, and J. Holmgren. Int. J. Pharm. 119:251-255 (1995).
12. W. Lu and T. G. Park, PDA J. Pharm. Sci. Tech. 49:13-19 (1995).
13. E. C. Roswell, V. R. Mukku, A. B. Chen, E. H. Hoff, H. Chu, P. A. McKay, K. C. Olson, J. E. battersby, R. L. Gehant, A. Meunier and R. L. Garnick. Biologicals, in press (1996).
14. R. Pearlman and T. A. Bewley. In: Stability and Characterization of Protein and Peptide Drugs: Case Histories, Y. J. Wang and R. Pearlman, Eds., Plenum Press, New York, NY, pp. 1-58 (1993).
15. N. B. Bam. T. W. Randolph and J. L. Cleland. Pharm. Res. 12:1-12 (1995).
16. H. Okada and H. Toguchi. Critical Rev. Therapeutic Drug Carrier Systems 12:1-99 (1995).
17. A.-C. Chang and R. K. Gupta. J. Pharm. Sci. 85:129-132 (1996).
18. T. A. Bewley. Recent Prog. Hormone Res. 35:155-213 (1979).
19. S. Wicar, M. G. Mulkerrin, G. Bathory, L. H. Khundkar, and B. L. Karger. Anal. Chem. 66:3908-3915 (1994).
20. N. Bam, J. L. Cleland, and T. W. Randolph. Biotech. Progress, in press (1996).
21. M. DeFillipis, L. A. Alter, A. H. Pekar, H. A. Havel, and D. N. Brems. Biochemistry 32:1555-1562 (1993).
22. Y.-R. Hsu and T. Arakawa. Biochemistry 24:7959-7963 (1985).
23. J. H. Senior, K. R. Trimble, and R. Maskiewicz. Biochim. Biophys. Acta 1070:173-179 (1991).
24. M. Mummenthaler, C. C. Hsu, and R. Pearlman. Pharm. Res. 11:12-17 (1994).
25. R. Pearlman and T. H. Nguyen. In: Therapeutic Peptides and Proteins: Formulation. Delivery and Targeting., D. Marshak; and D. Liu, Eds., New York, pp. 23- (1989).
26. A. Herman, R. Wong, and J. Hwang-Felgner. Personal communication, Genentech, Inc., S. San Francisco, CA (1986).
27. T. Arakawa and S. N. Timasheff. Biochemistry 21:6536 (1982).
28. J. F. Carpenter, S. J. Prestrelski, and T. Arakawa. Arch. Biochem. Biophys. 303:456-464 (1993).
29. S. J. Prestrelski, T. Arakawa, and J. F. Carpenter. Arch. Biochem. Biophys. 303:465-473 (1993).
30. S. J. Prestrelski, K. A. Pikal, and T. Arakawa. Pharm Res. 12:1250-1259 (1995).
31. J. L. Cleland, M. F. Powell, and S. J. Shire. CRC Critical Reviews in Therapeutic Drug Carrier Systems 10:307-377 (1993).