Effects of additives on the stability of Humicola lanuginosa lipase during freeze-drying and storage in the dried solid

Journal of Pharmaceutical Sciences

Volumn 88, Issue 3, 1999, Pages 281-290

  Kreilgaard, Lotte ^b,c   Frokjaer, Sven ^b   Flink, James M ^d   Randolph, Theodore W ^e   Carpenter, John F ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c AMGEN INC   (United States)

^d NOVO NORDISK A S   (Denmark)

^e UCB 450   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEXTRAN; DRUG ADDITIVE; MANNITOL; POLYSORBATE 20; SUCROSE; TREHALOSE; TRIACYLGLYCEROL LIPASE;

ARTICLE; CRYSTALLIZATION; DESICCATION; DRUG FORMULATION; DRUG STORAGE; ENZYME STABILITY; FREEZE DRYING; HYDROGEN BOND; HYDROPHOBICITY; INFRARED SPECTROSCOPY; MOISTURE;

EID: 0032969861     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js980399d     Document Type: Article

References (45)

1. Carpenter, J. F.; Crowe, J. H. An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemistry 1989, 28, 3916-3922.
2. Kreilgaard, L.; Frokjaer, S.; Flink, J. M.; Randolph, T. W.; Carpenter, J. F. Effect of additives on the storage stability of recombinant human factor XIII during freeze-drying and storage in the dried solid. Arch. Biochem. Biophys. 1998, 360, 121-134.
3. Chang, B. S.; Beauvais, R. M.; Dong, A.; Carpenter, J. F. Physical factors affecting the storage stability of freeze-dried interleukin-1 receptor antagonist: glass transition and protein conformation. Arch. Biochem. Biophys. 1996, 331, 249-258.
4. Prestrelski, S. J.; Pikal, K. A.; Arakawa, T. Optimization of lyophilization conditions for recombinant human interleukin-2 by dried-state conformational analysis using Fourier-transform infrared spectroscopy. Pharm. Res. 1995, 12, 1250-1259.
5. Boel, E.; Huge-Jensen, I. B. Recombinant Humicola lipase and process for the production of recombinant humicola lipases. European Patent Office Publication No: 0 305 216.
6. Holmquist, M.; Martinelle, M.; Clausen, I. G.; Patkar, S.; Svendsen, A.; Hult, K. Trp89 in the lid of Humicola lanuginosa lipase is important for efficient hydrolysis of tributyrin. Lipids 1994, 29, 599-603.
7. Naver, H.; Løvborg, U. The importance of noncharged amino acids in antibody binding to Humicola lanuginosa lipase. Scand. J. Immunol. 1995, 41, 443-448.
8. Huge-Jensen, I. B.; Gormsen, E. Enzymatic detergent additive. European Patent Office Publication No: 0 285 068.
9. Huge-Jensen, B. Recombinantly produced lipases for therapeutical treatment. Patent Cooperation Treaty, International Publication No: WO 91/18623.
10. Izutsu, K.; Yoshioka, S.; Terao, T. Effect of mannitol crystallinity on the stabilization of enzymes during freeze-drying. Chem. Pharm. Bull. (Tokyo) 1994, 42, 5-8.
11. Izutsu, K.; Yoshioka, S.; Kojima, S. Physical stability and protein stability of freeze-dried cakes during storage at elevated temperatures. Pharm. Res. 1994, 11, 995-999.
12. Cardona, S.; Schebor, C.; Buera, M. P.; Karel, M.; Chirife, J. Thermal stability of invertase in reduced-moisture amorphous matrixes in relation to glassy state and trehalose crystallization. J. Food Sci. 1997, 61, 105-112.
13. Roos, Y.; Karel, M. Plasticizing effects on water on thermal behavior and crystallization of amorphous food models. J. Food Sci. 1991, 56, 38-43.
14. Makower, B.; Dye, W. B. Equilibrium moisture content and crystallization of amorphous sucrose and glucose. J. Agric. Food Chem. 1956, 4, 72-77.
15. Hancock, B. C.; Zografi, G. The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids. Pharm. Res. 1994, 11, 471-477.
16. To, E. C.; Flink, J. M. "Collapse", a structural transition in freeze-dried carbohydrates. I. Evaluation of analytical methods. J. Food Technol. 1978, 13, 551-565.
17. Sarciaux, J. M.; Hageman, M. J. Effects of bovine somatotropin (rbSt) concentration at different moisture levels on the physical stability of sucrose in freeze-dried rbSt/sucrose mixtures. J. Pharm. Sci. 1997, 86, 365-371.
18. French, D. L.; McAuley, A. J.; Chang, B.; Niven, R. W. Moisture-induced state changes in spray-dried trehalose/ protein formulations. Pharm. Res. 1995, 12, S-83.
19. Green, J. L.; Angell, C. A. Phase relations and vitrification in saccharide-water solutions and the trehalose anomaly. J. Phys. Chem. 1989, 93, 2880-2882.
20. Crowe, L. M.; Reid, D. S.; Crowe, J. H. Is trehalose special for preserving dry biomaterials? Biophys. J. 1996, 71, 2087-2093.
21. Miller, D. P.; de Pablo, J. J.; Corti, H. Thermophysical properties of trehalose and its concentrated aqueous solutions. Pharm. Res. 1997, 14, 578-590.
22. Duddu, S. P.; Dal Monte, P. R. Effect of glass transition temperature on the stability of lyophilized formulations containing a chimeric therapeutic monoclonal antibody. Pharm. Res. 1997, 14, 591-595.
23. Dong, A.; Huang, P.; Caughey, W. S. Protein secondary structures in water from second-derivative amide I infrared spectra. Biochemistry 1990, 29, 3303-3308.
24. Dong, A.; Caughey, W. S. Infrared methods for study of hemoglobin reactions and structures. Methods Enzymol. 1994, 232, 139-175.
25. Kendrick, B. S.; Cleland, J. L.; Lam, X.; Nguyen, T.; Randolph, T. W.; Manning, M. C.; Carpenter, J. F. Aggregation of recombinant human interferon gamma: kinetics and structural transitions. J. Pharm. Sci. 1998, 87, 1069-1076.
26. Stratton, L. P.; Dong, A.; Manning, M. C.; Carpenter, J. F. Drug delivery matrix containing native protein precipitates suspended in a poloxamer gel. J. Pharm. Sci. 1997, 86, 1006-1010.
27. Lee, J. C.; Timasheff, S. N. The stabilization of proteins by sucrose. J Biol. Chem. 1981, 256, 7193-7201.
28. Xie, G.; Timasheff, S. N. The thermodynamic mechanism of protein stabilization by trehalose. Biophys. Chem. 1997, 64, 25-43.
29. Izutsu, K.; Yoshioka, S.; Kojima, S.; Randolph, T. W.; Carpenter, J. F. Effects of sugars and polymers on crystallization of poly(ethylene glycol) in frozen solutions: phase separation between incompatible polymers. Pharm. Res. 1996, 13, 1393-1400.
30. Sjöberg, Å.; Karlström, G.; Tjerneld, F. Effects on the cloud point of aqueous poly(ethylene glycol) solutions upon addition of low molecular weight saccharides. Macromolecules 1989, 22, 4512-4516.
31. Galema, S. A.; Høiland, H. Stereochemical aspects of hydration of carbohydrates in aqueous solutions. 3. Density and ultrasound measurements. J. Phys. Chem. 1991, 95, 5321-5326.
32. Dong, A.; Kendrick, B. S.; Kreilgard, L.; Matsuura, J.; Manning, M. C.; Carpenter, J. F. Spectroscopic study of secondary structure and thermal denaturation of recombinant human factor XIII in aqueous solution. Arch. Biochem. Biophys. 1997, 347, 213-220.
33. Allison, S. D.; Dong, A.; Carpenter, J. F. Counteracting effects of thiocyanate and sucrose on chymotrypsinogen secondary structure and aggregation during freezing, drying, and rehydration. Biophys. J. 1996, 71, 2022-2032.
34. Kendrick, B. S.; Meyer, J. D.; Matsuura, J. E.; Carpenter, J. F.; Manning, M. C. Hydrophobic ion-pairing as a method for enhancing structure and activity of lyophilized subtilisin BNF suspended in isooctane. Arch. Biochem. Biophys. 1997, 347, 113-118.
35. Prestrelski, S. J.; Tedeschi, N.; Arakawa, T.; Carpenter, J. F. Dehydration-induced conformational transitions in proteins and their inhibition by stabilizers. Biophys. J. 1993, 65, 661-671.
36. Allison, S. D.; Randolph, T. W.; Chang, B. S.; Carpenter, J. F. Unpublished results.
37. Randolph, T. W. Phase separation of excipients during lyophilization: Effects on protein stability. J. Pharm. Sci. 1997, 86, 1198-1203.
38. Franks, F.; Hatley, R. H. M.; Mathias, S. F. Materials science and the production of shelf-stable biologicals. BioPharm 1991, 4, 38-55.
39. Angell, C. A. Formation of glasses from liquids and biopolymers. Science 1995, 267, 1924-1939.
40. Pikal, M. J.; Dellerman, K. M.; Roy, M. L.; Riggin, R. M. The effects of formulation variables on the stability of freeze-dried human growth hormone. Pharm. Res. 1991, 8, 427-436.
41. Tanaka, T.; Takeda, R.; Miyajama, R. Cryoprotective effect of saccharides on denaturation of catalase during freeze-drying. Chem. Pharm. Bull. 1991, 39, 1091-1094.
42. To, E. C.; Flink, J. M. "Collapse", a structural transition in freeze-dried carbohydrates: II. Effect of solute composition. J. Food. Technol. 1978, 13, 567-581.
43. te Booy, M. P.; de Ruiter, R. A.; de Meere, A. L. Evaluation of the physical stability of freeze-dried sucrose-containing formulations by differential scanning calorimetry. Pharm. Res. 1992, 9, 109-114.
44. Pikal, M. J.; Shah, S. Moisture transfer from stopper to product and resulting stability implications. Dev. Biol. Stand. 1992, 74, 165-177.
45. Flink, J. M. Structure and structure transitions in dried carbohydrate materials. In Physical Properties of Foods; Peleg, M., Bagley, E. B., Eds.; AVI Publishing Co.: Westport, CT, 1983; pp 473-521.