Stability of proteins in aqueous solution and solid state

Indian Journal of Pharmaceutical Sciences

Volumn 68, Issue 2, 2006, Pages 154-163

  Jacob, S ^a   Shirwaikar, A ^a   Srinivasan, K ^a   Joseph, Alex ^a   Prabu, S ^a   Mahalaxmi, R ^a   Kumar, Ravi ^a  

^a MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES   (India)

Author keywords

[No Author keywords available]

Indexed keywords

MICROSPHERE; PROTEIN; RECOMBINANT PROTEIN;

ADSORPTION; AQUEOUS SOLUTION; DEAMINATION; DRUG FORMULATION; FREEZE DRYING; GLYCATION; MOLECULAR INTERACTION; MOLECULAR WEIGHT; OXIDATION KINETICS; PH MEASUREMENT; PHOTODEGRADATION; PHYSICAL CHEMISTRY; PRECIPITATION; PROTEIN AGGREGATION; PROTEIN DEGRADATION; PROTEIN DENATURATION; PROTEIN STABILITY; PROTEIN STRUCTURE; REVIEW; SHELF LIFE; SOLID STATE; STORAGE; STRUCTURE ANALYSIS;

EID: 33745162542     PISSN: 0250474X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0250-474x.25708     Document Type: Review

References (114)

1. Sislbart, L.K. and Karen, D.F., Science., 1989, 243, 1462.
2. Pan, Y., Li, Y., Zhao, H., Zheng, J., Xu., wei, G., Hao, J. and Cui, F., Int. J. Pharm ., 2002, 249 ,139.
3. Fattal, E., Pecquet, S., Couvreur, P. and Andremont, A., Int. J. Pharm., 2002, 242,15.
4. Reddy, T. and Tammishetti, S., J. Microencapsul., 2002,19, 311.
5. Eiamtrakarn, S., Itoh, Y., Kishimoto, J., Yoshikawa, Y., Shibata, N., Murakami. M. and Takada, K., Biomaterials, 2002, 23, 145.
6. Zheng, J.Y., Fulu, M.Y., Lee, D.Y., Barber, T.E. and Adjei, A.L., Pharm.Dev. Technol., 2001, 6, 521.
7. Gautam, S., Barna, B., Chiang, T., Pettay, J. and Deodhar, S., J. Biol. Response Mod., 1987, 6, 346,.
8. Reddy, R.K. and Banga, A.K., Pharm. Times., 1993, 59, 92.
9. Manning, M.C., Patel, K. and Borchardt, R. T., Pharm. Res., 1989, 6,903-918.
10. Goolcharran, C., Khossravi, M. and Borchardt, R.T., In; Frokjaer, S. and Hovgaards, L. Eds., Pharmaceutical Formulation and Development of Peptides and Proteins, Taylor and Francis, London, 2000, 70.
11. Brange, J., In; Frokjaer, S. and Hovgaards, L Eds., Pharmaceutical Formulation and Development of Proteins and Peptides, Taylor and Francis, London, 2000, 89.
12. Volkin, D.B. and Middaugh, C.R., In; Ahern, T.J. and Mannings, M.C Eds., Stability of Protein Pharmaceuticals Part A: Chemical and Physical Pathways of Protein Degradation, Plenum Press, New York, 1992,215.
13. Manning, M.C., Patel. and Borchardt, R.T., Pharm. Res., 1989, 6,903.
14. Brange, J., In; Frokjaer, S. and Hovgaards, L Eds., Pharmaceutical Formulation and Development of Proteins and Peptides, Taylor and Francis, London, 2000, 89.
15. Volkin, D.B. and Middaugh, C.R. In; Ahern, T.J. and Manning, M.C Eds., Stability of Protein Pharmaceuticals Part A: Chemical and Physical Pathways of Protein Degradation, Plenum Press, New York, 1992,216
16. Randolph, T.W. and Sjones, L. In; Carpenter,J.F. and Mannings,M.C. Eds., Rational design of Stable Protein Formulations, Theory and Practice, Kluwert Academic /Plenum Publishers, New York 2002, 198.
17. Israelachvili, J.In; Intermolecular and surface forces, Academic Press, SanDiego, California, 1992.
18. Labuza, T.P. and Saltmarch, M., In; water activity: Influence on food quality, Rockland, L.B.and Stewart, G.F.Eds., Academic Press, NewYork, 1981,605.
19. Li, S., Patapoff, T.W., Overcashier, D., Hsu, C., Nguyen, T.H. and Borchardt, R.T., J. Pharm. Sci., 1996, 85,873.
20. Schwendeman, S.P., Castantino, H.R., Gupta, R.K., Siber, G.R., Klibanov, A.M. and R, Langer., Proc. Natl. Acad. Sci.,U.S.A,1995,92,11234.
21. Connors, K.A., Amidon, G.L. and Stella, V.J., In; Chemical stability of pharmaceuticals, 2nd edition., John Wiley and sons, NewYork, 1986, 115.
22. Ahlneck, C.and Zografi, G., Int. J. Pharm., 1990, 62, 87.
23. Azuaga, A.I., Dobson, C.M., Mateo, P.L. and F.Conejero-Lara., Eur. J. Biochem., 2002, 269, 4121.
24. Hageman, M.J., In; Stability of Protein Pharmaceuticals, Part A Chemical and Physical Pathways of Protein degradation; Ahern, T. J.and.Manning, M.C., Eds., Plenum Press, NewYork, 1992, 273.
25. Carpenter, J.F., Pikal, M., Chang, B.S. and Randolph, T.W., Pharm. Res., 1997, 14,969.
26. Pikal, M.J., Dellerman, K.M., Ray, M.L., Riggin, R.M., Pharm. Res.,1991, 8, 427.
27. Jordan, G.M., Yashioka, S. and Terao, T., Biotechnol. Bioeng., 1991, 37, 177.
28. Eichner, K.and Ciner-Daruk, M., In; water activity: Influence on food quality, Rockland, L.B. and Stewart, G.F., Eds, Academic Press, Oxford, 1996, 4,567.
29. Lea, C.H. and Hanman, R.S., Biochem. Biophys. Acta. 1949, 3, 313.
30. Schwartz, H.M. and Lea, C.H., Biochem. J., 1952, 50,713.
31. Oliyai, C., Patel, J., Carr, L and Borchardt, R.T., J. Parenteral Sci. Technol., 1994, 48, 67.
32. Chen, B.L., Arakawa, T., Murris, C.F., Kenney, W.C., Wells, C.M. and Pitt, C.G., Pharm. Res., 1994, 11, 1581.
33. Strickley, R.G. and Anderson, B.D., J. Pharm. Sci., 1997, 86, 645.
34. Johnson, R.E. Lanaski, L.A., Gupta, V., Griffin, M.J. Needham, T.E.and Zien, H. J. Control. Release, 1991,17,61.
35. Parki, T.G., Lu, W.and Crotts, G., J. Control. Release, 1995, 33,211.
36. Cleland, J.L., Mac, A., B. Boyd, Yang, J., Duenas, E. T., Yeung, D., Brooks ,D., Hsu, C., Chu, H., Mukku, V.and Jones, A. J. S., Pharm. Res., 1997, 14,420.
37. Johnson, O.L., Joworowicz, W., Cleland, J.L., Bailey, L., Charnis, M., Duenas, E.,
38. Wu, C., Shepard, D., Magil, S., Last, T.Jones, A.J.S. and Putney, S.D., Pharm. Res., 1997, 14,730.
39. Putney, S.D.and Burke, P.A., Nature Biotechnol., 1998, 16,153.
40. Dill, K.A., Biochemistry, 1990, 29, 7133.
41. Chi, E.Y., Krishnan, S. and Kendrick, B.S., Protein Sci., 2003,12, 903.
42. Striolo, A., Bratko, D., Blanch, H.W. and Prausnitz, J.M., J. Chem. Phys., 2002, 116, 7733.
43. Pickel, M.J.and Rigsbee, D.R., Pharm. Res., 1997, 14,1379-1387.
44. Davis-Searles, P.R., Saundes, A.J.and Pielak, G. J., Annu. Rev. Biophys. Biomol. Str., 2001,30,271.
45. Cacace, M.G., Landau, E. M. and Ramsden, J. J., Q. Rev. Biophys., 1997, 30,241.
46. Arakawa, T. and Timasheff, S.N., Biochemistry., 1982, 21,6536.
47. Lee, J.C and Timasheff, S.N., J. Biol. Chem., 1981,256,7193.
48. Sousa, R., Acta. Cryst., 1995,D51,271.
49. Arakawa, T. and Timasheff,S. N., Biochemistry., 1984, 23,5912.
50. MacLean, D.S., Qian, O.S.and Middaugh, C.R., J. Pharm. Sci., 2002, 91,2220.
51. Nishimura, C., Uversky, V. N. and Fink, A. L., Biochem., 2001, 40, 2113.
52. Curtis, R. A., Ulrich, J., Montaser,A. and Blanch,H.W., Biotechnol. Bioeng.,2002, 79,367.
53. Maa, Y.F. and Hsu C. C., Int. J. Pharm., 1996, 140,155.
54. Bam, N. M., Cleland, J. L., Yang, J.and Carpenter, J. F., J. Pharm. Sci., 1998, 87, 1554.
55. Oliyai, C., Patel, J.P., Carr,L. and Borchardt, R.T., Pharm. Res.,1994,11,901.
56. Cartensen, J. T. and Morris, T., J. Pharm. Sci., 1993, 82, 657.
57. Pikal, M.J., Dellerman, K.L., Roy, M.L. and Riggin, R.M., Pharm. Res., 1991, 8, 427.
58. Geiger, T. and Clarke, S., J. Biol. chem.,1987, 262, 785.
59. Clarke, S., Int. J. Pept. Protein. Res., 1987, 30, 808.
60. Liu, D.T., Trends Biotechnology., 1992, 10, 364.
61. Strickley, R.G. and Anderson. B.D., Pharm. Res., 1996, 13, 1142.
62. Becker, G.W., Tackitt, P.M., Bromer, W.W., Lefeber, D.S. and Riggin, R.M., Biotechnol. Appl. Biochem., 1988, 10, 326.
63. Przysiecki, C.T., Joyce, J.G., Keller, P.M., Markus, H.Z., Carty, C.E., Hagopian, A., Sardana, M.K., Dunwiddie, C.T., Ellis, R.W., Miller, W.J. and Lehman, E.D., Protein. Exp. Purif., 1992, 3, 185.
64. Fransson, J., Florin-Robertson, E., Axelsson, K. and Nyhlen, C., Phar. Res., 1996, 13, 1252.
65. Liu, J.L., Lu, K.V., Eris, T., Katta, V., Westcott, K.R., Narhi, L.O., Lu, H.S., Pharm. Res., 1998, 15, 632.
66. Savige, W.E., Int. J. Pep. Protein. Res., 1980, 15, 285.
67. Canova-Davis, E. and Ramachandran, J., Biochemistry., 1976, 5, 921.
68. Przysiecki, C.T., Joyce, J.G., Keller, P.M., Markus, H.Z., Carty, C.A., Hagopian, A., Sardana, M.K., Dunwiddie, C.T., Ellis, R.W., Miller, W.J. and Lehman, E.D., Protein. Expr. Purif.,1992, 3, 185.
69. Kornfelt, T., Persson, E. and Palm, J., Arch. Biochem. Biophys., 1999, 363, 43.
70. Van Pattern, S.M., Hanson, E., Bernasconi, R., Zhang, K., Manavalan, P., Cole, E.S., McPherson, M. and Edmunds., J. Biol. Chem.,1999, 274, 10268.
71. George-Nascimento, C., Gynes, A., Halloran, S.M., Merryweather, J., Valenzuela, P., Steimer, K.S., Masiarz, F.R. and A Randolph., Biochemistry., 1988, 27,797.
72. Antonini, G. and Spoto, G., Biochem. Int., 1988, 16, 1009.
73. Creighton, T.E., In; Protein Structure: A Practical Approach, IRL Oxford, 1989, 155.
74. Fransson, J.R., J. Pharm. Sci., 1997, 86, 1046.
75. Gergel, D. and Cederbaum, A.I., Biochemistry.,1996,35,186.
76. Betaseron, L.L., Dev. Biol. Stand. 1998, 96, 97.
77. Hanson, M.A., J. Parent. Sci. Tech., 1998, 42, S3.
78. Bohidar, H.B., Biopolymers, 1998, 45,1.
79. Brange, J. and Langkjoer, L., Pharm. Biotechnol., 1993, 5, 315.
80. Li, S., Nguyen, T.H., Schoneich, C. and Borchardt, R.T., Biochemistry. 1995, 34, 5762.
81. Runkel, L., Meirer, W., Pepinsky, R.B., Karpuss, M., Whitty, A., Kimball, K., Breickelmaier, M., Muldowney, C., Jones, and Goelz, S. E., Pharm. Res.,1998, 15, 641.
82. Burgon, P.G., Stanton, P.G., Pettersson, K. and Robertson, D.M., Reprod. Fertil. Dev.,1997, 9, 501.
83. Baudys, M., Uchio, T., Mix, D., Wilson, D. and Kim, S.W., J. Pharm. Sci., 1995, 84, 28.
84. Lougheed, W.D., Woulfe-Flanagen, H., Clement, J.R and Albisser, A.M., Diabetologica., 1980, 19, 1.
85. Shah, V.P., J. Control. Release, 1999, 58, 143.
86. Chan, H.K., Au-Yeung, K.L. and Gonda, I., Pharm. Res., 1996, 13, 756.
87. Remmele, R.L., Bhatt, S.D., Phan, D.H. and Gombotz, W.R., Biochemistry., 1999, 38, 52, 41.
88. Andya, J.D., Maa,Y.F., Constantino, H.R., Nguyen,P.A., Dasovich, N., Sweeny, T.D., Hsu, C.C. and Shire, S.J., Pharm. Res., 1999, 16, 350.
89. Tzannis, S.T. and Prestrelski, S.J., J. Pharm. Sci.,1999, 88, 351.
90. Ip, A.Y., Arakawa, T., Silvers, H., Ransone, C.M. and Niven, R.W., J. Pharm. Sci., 1995, 84, 1210.
91. Maa, Y.F., Nguyen, A.P. and Hsu, S.W., J. Pharm. Sci., 1998, 87, 152.
92. Katakam, M. and Banga, A.K., Phar. Dev. Technol., 2, 143.
93. Katakam, M. and Banga, A.K., J. Pharm. Sci. Technol., 1995, 49, 160.
94. Katakam, M. and Banga, A.K., J. Pharm. Pharmacol., 1995, 47, 103.
95. Shahrokh, Z., Stratton, P.R., Eberlein, G.A. and Wang, Y.G., J. Pharm. Sci., 1994, 83, 1645.
96. Chen, B.L., Arakawa, T., Morris, C.F., Kenney, W.C., Wells, C.M. and Pitts, C.G., Pharm. Res., 1994, 11, 1581.
97. Gu, L.C., Erdos, E.A., Chiang, H.S., Calderwodd, T., Tsaie, K., Visor, G.C., Duffy, J., Hsu ,W.C.and Foster, I., Pharm. Res., 1991, 8, 485.
98. Schrier, J., Kenley, R.A., Williams, R.A., Corcoran, R.J., Kim, Y., Nothey, R.P., Augusta, D. and Huberty, M., Pharm. Res., 1993, 10, 944.
99. Wang, W., Int. J. Pharm., 2005, 289, 1.
100. Pompa, P.P., Bramanti, P.P., Maraccio, A., Del Mercato, A., Cingolani, L.L., L. and Rinaldi, R., Chemical Physics Letters. 2005, 404, 59.
101. Kim J. H., Tapuja, A., Knutson, K. and Han Bae Y., J. Control. Release, 2005, 105, 32.
102. Wang, S. L., Liu , S, Y., Wei , Y.S., Hsieh, T. F., Biophys Chem., 2005, 114, 205.
103. Amal, A., Elkordy, Robert, T., Forbes. and Brian , W. B., Int. J. of Pharm., 2004, 278, 209.
104. Feigner, P.L. and Wilson, J.E., Anal. Biochem., 1976, 74, 631.
105. Andrade, J. D., In; Principle of Protein Adsorption Surface and Interfacial Aspects of Biomedical Polymers, Plenum Press, NewYork, 1985, 1.
106. Stella, V. J., J. Parent. Sci. Technol., 1986, 40, 142.
107. Vando-Oetelaar, P. J. M., Mentink, I. M. and Brinks, G. J., Drug. Devel. Ind. Pharm., 1989, 15, 97.
108. Wu, G. S. C. and Chen, G.C., Anal. Biochem.,1989, 177, 178.
109. Saelter, C. H. and M. Deluca., Anal. Biochem., 1983, 135, 112.
110. Wang, Y. C. J. and Hanson, M. A., J. Parent. Sci. Technol., 1988, 42, S3.
111. Law, S. L. and Shih, C. L., Drug. Dev. Ind. Pharm., 1999, 25, 253.
112. Gidalevitz, D., Huang, Z. and Rice, S. A., Biophys. J., 1999, 76, 2792.
113. Lu, J. R., Su, T. J. and Thomas, R.K., J. Colloid. Interface. Sci., .1999, 213, .426.
114. Puff, N., Cagna, A., Aguie-Beghin, V., and Douillard, R., J. Colloid. Interface. Sci., 1998, 208, 405.