Effects of bovine somatotropin (rbSt) concentration at different moisture levels on the physical stability of sucrose in freeze-dried rbSt/sucrose mixtures

Journal of Pharmaceutical Sciences

Volumn 86, Issue 3, 1997, Pages 365-371

  Sarciaux, Jeanne Marie E ^a,b,c   Hageman, Michael J ^a  

^a PFIZER INC   (United States)

^b PURDUE UNIVERSITY   (United States)

^c UNIVERSITÉ DE RENNES 1   (France)

Author keywords

[No Author keywords available]

Indexed keywords

GROWTH HORMONE; SUCROSE;

ARTICLE; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG MIXTURE; DRUG STABILITY; DRUG STORAGE; FREEZE DRYING; GRAVIMETRY; HUMIDITY; LYOPHILISATE; MOISTURE; WATER CONTENT;

EID: 0031048684     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js960217k     Document Type: Article

References (29)

1. Pikal, M. J. Biopharm. 1990, 3, 26-30.
2. Skrabanja, A. T. P.; De Meere, A. L. J.; De Ruiter, R. A.; Van Den Oetelaar, P. J. M. J. Pharm. Sci. Technol. 1994, 48, 311-17.
3. Izutsu, K. I.; Yoshioka, S.; Kojima, S. Pharm. Res. 1994, 11, 995-999.
4. Saleki-Gerhardt, A.; Zografi, G. Pharm. Res. 1994, 11, 1166-1173.
5. Roos, Y.; Karel, M. J. Food. Sci. 1991, 56(1), 38-43.
6. Carstensen, J. T.; Van Scoik, K. Pharm. Res. 1990, 7, 1278-1281.
7. Schott, H. In Physical Pharmacy Fourth Edition; Martin, A., Swarbrick, J., Cammarata, A., Ed.; Lea & Febiger: Philadelphia, 1993; p 586.
8. Levine, H.; Slade, L. In Physical Chemistry of Foods; Schwartzberg, H. G., Hartel, R. W., Ed.; Marcel Dekker: New York, 1992; pp 83-221.
9. Hageman, M. J. Water sorption and solid state stability of proteins. In Stability of Protein Pharmaceuticals Part A; Ahern, T. J., Manning, M. C., Eds; Plenum: New York, 1992; pp 273-310.
10. Green, J. L.; Fan, J.; Angell, C. A. J. Phys. Chem. 1994, 98, 13780-13790.
11. Te Booy, M. P. W. M.; De Ruiter, R. A.; De Meere, A. L. J. Pharm. Res. 1992, 9, 109-114.
12. Davio, S. R.; Hageman, M. J. In Stability and Characterization of Protein and Peptide Drugs: Case Histories; Wang, Y. J., Pearlman, R., Eds; Plenum: New York, 1993; pp 59-89.
13. Speicher, J. A.; Tucker, H. A.; Ashley, R. W.; Stanisienski, E. P.; Boucher, J. F.; Sniffen, C. J. J. Dairy. Sci. 1994, 77, 2509-2517.
14. Reading, M.; Elliot, D.; Hill, V. L. J. Therm. Anal. 1993, 40, 949-955.
15. Coleman, N. J.; Craig, D. Q. M. Int. J. Pharm. 1996, 135, 13-29.
16. Bergren, M. S. Int. J. Pharm. 1994, 103, 103-114.
17. Nyqvist, H. Int. J. Pharm. Tech. Prod. Mfr. 1983, 4, 47-48.
18. Hageman, M. J.; Possert, P. L.; Bauer, J. M. J. Agric. Food. Chem. 1992, 40, 342-347.
19. Struik, L. C. E. In Physical Aging in Amorphous Polymers and Other Materials; Struik, L. C. E., Ed.; Elsevier: Amsterdam, 1978; p 64.
20. Jolley, E. I. Photographic Sci. Eng. 1970, 14, 169-177.
21. French, D. L.; McAuley, A. J.; Chang, B.; Niven, R. W. Pharm. Res. 1995, 12, S-3.
22. Van Scoik, K. G.; Carstensen, J. T. Int. J. Pharm. 1990, 58,185-196.
23. Sochava, I. V.; Smirnova, O. I. Food Hydrocolloids 1993, 6, 513-524.
24. Fan, J.; Cooper, E. I.; Angell, C. A. J. Phys. Chem. 1994, 98, 9345-9349.
25. Makower, B.; Dye, W. B. Agric. Food Chem. 1956, 4, 72-77.
26. Van Hook, A.; Frulla, F. Ind. Eng. Chem. 1952, 44, 1305-1308.
27. Carpenter, J. F.; Crowe, J. H. Biochemistry 1989, 28, 3916-3922.
28. Prestrelski, S. J.; Tedeschi, N.; Arakawa, T.; Carpenter, J. F. Biophysical. J. 1993, 65, 661-671.
29. Sarciaux, J. M.; Hageman, M. J.; Bauer, J. M.; Chao, R. S.; Sado, P. A.; Nail, S. L. Proceed. Intern. Symp. Control. Rel. Bioact. Mater., Controlled Release Society, Kyoto, Japan, 1996, #5207, p 823.