Effects of various cyclodextrins on the stability of freeze-dried lactate dehydrogenase

Journal of Pharmaceutical Sciences

Volumn 96, Issue 11, 2007, Pages 3140-3143

  Iwai, Junya ^a   Ogawa, Noriko ^a   Nagase, Hiromasa ^a   Endo, Tomohiro ^a   Loftsson, Thorsteinn ^b   Ueda, Haruhisa ^a  

^a HOSHI UNIVERSITY   (Japan)

^b UNIVERSITY OF ICELAND   (Iceland)

Author keywords

2 hydroxypropyl cyclodextrin; Cyclodextrins; Freeze drying; LDH; Low molecular weight saccharides; Proteins; Stability

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; CARBOHYDRATE; CYCLODEXTRIN; LACTATE DEHYDROGENASE; TREHALOSE;

ARTICLE; CONTROLLED STUDY; ENZYME ACTIVITY; ENZYME STABILITY; FREEZE DRYING; NONHUMAN; SUBSTITUTION REACTION;

EID: 36849026069     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.20847     Document Type: Article

References (18)

1. Griebenow K, Klibanov AM. 1995. Lyophilization-induced reversible changes in the secondary structure of proteins. Proc Natl Acad Sci 92:10969-10976.
2. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. 1997. Rational design of stable lyophilized protein formulations: Some practical advice. Pharm Res 14:969-975.
3. Tamiya T, Okahashi N, Sakuma R, Aoyama T, Akahane T, Matsumoto JJ. 1985. Freeze denaturation of enzymes and its prevention with additives. Cryobiology 22:446-456.
4. Izutsu K, Yoshioka S, Terao T. 1994. Stabilizing effect of amphiphilic excipients on the freeze-thawing and freeze-drying of lactate dehydrogenase. Biotechnol Bioeng 43:1102-1107.
5. Hatley RHM, Franks F. 1989. The cold-induced denaturation of lactate dehydrogenase at sub-zero temperatures in the absence of perturbants. FEBS Lett 257:171-173.
6. Greiff D, Kelley RT. 1966. Cryotolerance of enzymes. I. Freezing of lactic dehydrogenase. Cryobiology 2:335-341.
7. Carpenter JF, Crowe JH. 1989. An infrared spectroscopic study of the interactions of carbohydrates with dried proteins. Biochemistry 28:3916-3922.
8. Franks F, Hatley RHM, Mathias SF. 1991. Materials science and the production of shelf-stable biologicals. BioPharm 4:38-42.
9. Allison SD, Chang CB, Randolph TW, Carpenter JF. 1999. Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding. Arch Biochem Biophys 365:289-298.
10. CaBreen ED, Curley JG, Overcashier DE, Hsu CC, Shire SJ. 2001. Effect of moisture on the stability of a lyophilized humanized monoclonal antibody formulation. Pharm Res 18:1345-1353.
11. Uekama K, Hirayama F, Irie T. 1998. Cyclodextrin drug carrier systems. Chem Rev 98:2045-2076.
12. Szente L, Szejtli J. 1999. Highly soluble cyclodextrin derivatives: Chemistry, properties, and trends in development. Adv Drug Deliv Rev 36:17-28.
13. Tavornvipas S, Tajiri S, Hirayama F, Arima H, Uekama K. 2004. Effects of hydrophilic cyclodextrins on aggregation of recombinant human growth hormone. Pharm Res 21:2369-2376.
14. Fredholt K, Østergaard J, Savolainen J, Friis GJ. 1999. α-Chymotrypsin-catalyzed degradation of desmopressin (dDAVP): Influence of pH, concentration and various cyclodextrins. Int J Pharm 137:223-229.
15. Brewster ME, Hora MS, Simpkins JW, Bodor N. 1991. Use of 2-hydroxypropyl-β- cyclodextrin as a solubilizing and stabilizing excipient for protein drugs. Pharm Res 8:792-795.
16. Hora MS, Rana RK, Smith FW. 1992. Lyophilized formulations of recombinant tumor necrosis factor. Pharm Res 9:33-36.
17. Trinadha RC, Pitha J, Lindberg B, Lindberg J. 1992. Distribution of substituents in O-(2-hydroxypropyl) derivatives of cyclomalto-oligosaccharides (cyclodextrins): Influence of increasing substitution, of the base used in the preparation, and of macrocyclic size. Carbohydr Res 223:99-107.
18. Irie T, Uekama K. 1997. Pharmaceutical applications of cyclodextrins. III. Toxicological issues and safety evaluation. J Pharm Sci 86:147-162.