Effect of lyophilization on the structure and phase changes of PEGylated-bovine serum albumin

International Journal of Pharmaceutics

Volumn 304, Issue 1-2, 2005, Pages 124-134

  Tattini Jr , Virgilio ^a   Parra, Duclerc F ^b   Polakiewicz, Bronislaw ^a   Pitombo, Ronaldo N M ^a  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

^b INSTITUTO DE PESQUISAS ENERGÉTICAS E NUCLEARES   (Brazil)

Author keywords

Bovine serum albumin; Freeze drying; Glass transition; Lyophilization; PEGylation; Raman spectroscopy

Indexed keywords

ANTIBODY; ANTIGEN; BOVINE SERUM ALBUMIN; MACROGOL DERIVATIVE; METHOXYPOLYETHYLENE GLYCOL 5000; POLYPEPTIDE; PROTEINASE; UNCLASSIFIED DRUG; WATER;

ANTIGEN PRESENTATION; ARTICLE; CHEMICAL REACTION; COMPARATIVE STUDY; DEAMINATION; DESICCATION; DIFFERENTIAL SCANNING CALORIMETRY; ENVIRONMENTAL TEMPERATURE; ENZYME DEGRADATION; FREEZE DRYING; GLASS TRANSITION TEMPERATURE; HEATING; HYDROLYSIS; MOLECULAR SIZE; PH MEASUREMENT; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; PROTEIN DENATURATION; PROTEIN STABILITY; RAMAN SPECTROMETRY; STORAGE; STRESS; THEORETICAL MODEL; TITRIMETRY; WATER CONTENT;

ANIMALS; CALORIMETRY, DIFFERENTIAL SCANNING; CATTLE; DRUG CARRIERS; DRUG STABILITY; FREEZE DRYING; MOLECULAR STRUCTURE; POLYETHYLENE GLYCOLS; SERUM ALBUMIN, BOVINE; SOLUTIONS; SPECTRUM ANALYSIS, RAMAN; TEMPERATURE; TIME FACTORS;

EID: 26444542866     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2005.08.006     Document Type: Article

References (14)

1. W. Al-Azzam, E.A. Pastrana, Y. Ferrer, Q. Huang, R. Schweitzer-Stenner, and K. Griebenow Structure of poly(ethylene glycol)-modified horseradish peroxidase in organic solvents: infrared amide I spectral changes upon protein dehydration are largely caused by protein structural changes and not by water removal per se Biophys. J. 83 2002 3637 3651
2. K. Amin, R.M. Dannenfelser, J. Zielinski, and B. Wang Lyophilization of polyethylene glycol mixtures J. Pharm. Sci. 93 2004 2244 2249
3. J.F. Carpenter, S.J. Prestrelski, and A. Dong Application of infrared spectroscopy to development of stable lyophilized protein formulations Eur. J. Pharm. Biopharm. 45 1998 231 238
4. I.J. Castellanos, W. Al-Azzam, and K. Griebenow Effect of the covalent modification with poly (ethylene glycol) on alpha-chymotrypsin stability upon encapsulation in poly (lactic-co-glycolic) microspheres J. Pharm. Sci. 94 2005 327 340
5. T. Chen, and D.M. Oakley Thermal analysis of proteins of pharmaceutical interest Thermochim. Acta 248 1995 229 244
6. R. Clark, K. Olson, G. Fuh, M. Marian, D. Mortensen, G. Teshima, S. Chang, H. Chu, V. Mukku, E. Canova-Davis, T. Somers, M. Cronin, M. Winkler, and J.A. Wells Long-acting growth hormones produced by conjugation with polyethylene glycol J. Biol. Chem. 271 1996 21969 21977
7. A. Dong, S.J. Prestrelski, S.D. Allison, and J.F. Carpenter Infrared spectroscopic studies of lyophilization- and temperature-induced protein aggregation J. Pharm. Sci. 84 1995 415 424
8. FDA (Food and Drug Administration), 1990. Guideline for the Determination of Residual Moisture in Dried Biological Products. Center for Biologics Evaluation and Research (CBER).
9. S. Herman, G. Hooftman, and E. Schacht Poly(ethylene glycol) with reactive endgroups: I. Modification of proteins J. Bioact. Compat. Polym. 10 1995 145 187
10. J.M. Harris, N.E. Martin, and M. Modi Pegylation a novel process for modifying pharmacokinetics Clin. Pharmcokinet. 40 2001 539 551
11. N.V. Katre The conjugation of proteins with polyethylene glycol and other polymers: altering properties of proteins to enhance their therapeutic potential Adv. Drug Del. Rev. 10 1993 91 114
12. S.J. Prestrelski, N. Tedeschi, T. Arakawa, and J.F. Carpenter Dehydration-induced conformational changes in proteins and their inhibition by stabilizers Biophys. J. 65 1993 661 671
13. I. Roy, and M.N. Gupta Freeze-drying of proteins: some emerging concerns Biotechnol. Appl. Biochem. 39 2004 165 177
14. S. Radaev, and P.D. Sun Crystallization of protein-protein complexes J. Appl. Cryst. 35 2002 674 676