Effect of polyols on the conformational stability and biological activity of a model protein lysozyme

AAPS PharmSciTech

Volumn 4, Issue 3, 2003, Pages

  Singh, Somnath ^a,b   Singh, Jagdish ^a  

^a NORTH DAKOTA STATE UNIVERSITY   (United States)

^b CREIGHTON UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Differential scanning calorimeter; Enzyme activity assay; Lysozyme; Polyols; Protein conformational stability

Indexed keywords

GLYCEROL; LACTOSE; LYSOZYME; MANNITOL; POLYOL; PROPYLENE GLYCOL; SUCROSE; ALCOHOL DERIVATIVE; EGG WHITE; POLYMER;

ACIDITY; ARTICLE; BIOASSAY; CONTROLLED STUDY; DEAMINATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG ACTIVITY; DRUG CONFORMATION; DRUG FORMULATION; DRUG OXIDATION; DRUG STABILITY; ENTHALPY; ENZYME ACTIVITY; ENZYME SPECIFICITY; MATHEMATICAL COMPUTING; PH; PROTEIN AGGREGATION; PROTEIN DEGRADATION; SCREENING TEST; THERMODYNAMICS; TRANSITION TEMPERATURE; ANIMAL; CHEMICAL MODEL; CHEMISTRY; CHICKEN; DRUG EFFECT; ENZYME STABILITY; METABOLISM; METHODOLOGY; PROTEIN CONFORMATION;

ALCOHOLS; ANIMALS; CALORIMETRY, DIFFERENTIAL SCANNING; CHEMISTRY, PHARMACEUTICAL; CHICKENS; EGG WHITE; ENZYME STABILITY; MODELS, CHEMICAL; MURAMIDASE; POLYMERS; PROTEIN CONFORMATION; THERMODYNAMICS;

EID: 23144432254     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt040342     Document Type: Article

References (35)

1. Lee HJ. Protein drug oral delivery: the recent progress. Arch Pharm Res. 2002;25:572-584.
2. Jen A, Merkle HP. Diamonds in the rough protein crystals from a formulation perspective. Pharm Res. 2001;18:1483-1488.
3. DiBiase MD, Kottke MK. Stability of polypeptides and proteins. In: Carstensen JT, Rhodes CT, eds. Drugs and the Pharmaceutical Sciences, Drug Stability. New York, NY: Marcel Dekker; 2000;107:853-874.
4. Cleland JL, Daugherty A, Mrsny R. Emerging protein delivery methods. Curr Opin Biotechnol. 2001;12:212-219.
5. Cleland JL, Powell MF, Shire JS. The development of stable protein formulations: a close look at protein aggregation, deamidation, and oxidation. Crit Rev Ther Drug Carrier Syst. 1993;10:307-377.
6. Wang W. Instability, stabilization, and formulation of liquid protein pharmaceuticals. Int J Pharm. 1999;185:129-188.
7. Xie M, Schowen R. Secondary structure and protein deamidation. J Pharm Sci. 1999;88:8-13.
8. Daniel RM, Dines M, Petach HH. The denaturation and degradation of stable enzymes at higher temperature. Biochem J. 1996;317:1-11.
9. Li S, Schoneich C, Borchardt RT. Chemical instability of protein pharmaceuticals: Mechanism of oxidation and strategies for stabilization. Biotechnol Bioeng. 1995;48:490-500.
10. Bummer PM, Koppenol S. Chemical and physical considerations in protein and peptide stability. In: McNally EJ, ed. Drugs and the Pharmaceutical Sciences, Protein Formulation and Delivery. New York, NY: Marcel Dekker; 2000:15-18.
11. Stoll VS, Blanchard JS. Buffers: principles and practice. In: Deutscher M, Abelson J, eds. Guide to Protein Purification: Methods in Enzymology (Methods in Enzymology Series). Vol 182. London, UK: Academic Press; 1990:24-37.
12. Shugar D. The measurement of lysozyme activity and the ultra-violet inactivation of lysozyme. Biochim Biophys Acta. 1952;8:302-309.
13. Smith PK, Krohn RI, Hermanson GT, et al. Measurement of protein using bicinchoninic acid. Anal Biochem. 1985;150:76-85.
14. Richard L, Remmele RL Jr, Nancy SN, Subhashini S, Wayne RG. Interleukin-1 receptor (IL-1R) liquid formulation development using differential scanning calorimetry. Pharm Res. 1998;15:200-208.
15. Azuaga AI, Dobson CM, Mateo PL, Conejero LF. Unfolding and aggregation during the thermal denaturation of streptokinase. Eur J Biochem. 2002;269:4121-4133.
16. Barone G, Catanzano F, Del Vecchio P, Giancola C, Graziano G. Thermodynamics of protein stability: a family of ribonucleases. Pure Appl Chem. 1997;69:2307-2313.
17. Komsa PR, Koynova R, Kostov G, Tenchov B. Discrete reduction of type 1 collagen thermal stability upon oxidation. Biophys Chem. 2000;83:185-195.
18. Sebastien B, Forbes RT, York P, Nyqvist H. A central composite design to investigate the thermal stabilization of lysozyme. Pharm Res. 1999;16:702-708.
19. Chang BS, Randall CS, Lee YS. Stabilization of lyophilized porcine pancreatic elastase. Pharm Res. 1993;10:1478-1483.
20. Johnson CM, Cooper A, Stockley PG. Differential scanning calorimetry of thermal unfolding of the methionine repressor protein (MetJ) from Escherichia coli. Biochemistry. 1992;31:9717-9724.
21. Kenar KT, Garcia-Moreno B, Freire EA. Calorimetric characterization of the salt dependence of the stability of the GCN4 leucine zipper. Protein Sci. 1995;4(9):1934-1938.
22. Son K, Kwon C. Stabilization of human epidermal growth factor (hEGF) in aqueous formulation. Pharm Res. 1995;12:451-454.
23. Shire SJ. Stability characterization and formulation development of recombinant human deoxyribonuclease I (Pulmozyme, [dornase alpha]). In: Pearlman R, Wang YJ, eds. Formulation, Characterization, and Stability of Protein Drugs. New York, NY: Plenum Press; 1996:393-426.
24. Cross RT, Schirch V. Effect of amino acid sequence, buffers, and ionic strength on the rate and mechanism of deamidation of asparagine residues in small peptide. J Biol Chem. 1991;266:22549-22556.
25. Voet D, Voet, JG. Biochemistry. New York, NY: John Wiley & Sons, Inc: 1995:381-383.
26. Powell MF. A compendium and hydropathy/flexibility analysis of common reactive sites in proteins: reactivity at Asn, Asp, Gln, and Met motifs in neutral pH solution. In: Pearlman R, Wang YJ, eds. Formulation, Characterization, and Stability of Protein Drugs. New York, NY: Plenum Press; 1996:1-140.
27. Patel K, Borchardt RT. Chemical pathways of peptide degradation. II. Kinetics of deamidation of an asparaginyl residue in a model hexapeptide. Pharm Res. 1990;7:703-711.
28. Oliyai C, Borchardt RT. Chemical pathways of peptide degradation. IV. Pathways, kinetics, and mechanism of degradation of an asparyl residue in a model hexapeptide. Pharm Res. 1993;10:95-102.
29. Richards FM. Protein stability: still an unsolved problem. Cell Mol Life Sci. 1997;53:790-802.
30. Kang F, Jiang G, Hinderliter A, DeLuca PP, Singh J. Lysozyme stability in primar emulsion for PLGA microsphere preparation: effect of recovery methods and stabilizing excipients. Pharm Res. 2002;19:629-633.
31. Capan Y, Jiang G, Giovagnoli S, Na K-H, DeLuca PP. Preparation and characterization of poly(D,L-lactide-co-glycolide) microspheres for controlled release of human growth hormone. AAPS PharmSciTech. 2003;4(2):article 28.
32. Prestrelski SJ, Tedeschi N, Arakawa T, Carpenter JF. Dehydration-induced conformational changes in proteins and their inhibition by stabilizers. Biophys J. 1993;65:661-671.
33. Allison SD, Chang B, Randolph TW, Carpenter JF. Hydrogen bonding between sugar and protein is responsible for inhibition of dehydration-induced protein unfolding. Arch Biochem Biophys. 1999;365:289-298.
34. Kendrick BS, Chang BS, Arakawa T, Peterson B, Randolph TW, Manning MC, Carpenter JF. Preferential exclusion of sucrose from recombinant interleukin-1 receptor antagonist: role in restricted conformational mobility and compaction of native state. Proc Natl Acad Sci U S A. 1997;94:11917-11922.
35. Lee JC, Timasheff SN. The stabilization of proteins by sucrose. J Biol Chem. 1981;256:7193-7201.