Effect of excipients on product characteristics and structure of lyophilized lasota vaccine

Indian Journal of Biotechnology

Volumn 4, Issue 1, 2005, Pages 106-114

  Kadam, S S ^a   Pisal, S S ^a   Mane, J J ^a   Shah, M H ^a  

^a BHARATI VIDYAPEETH DEEMED UNIVERSITY   (India)

Author keywords

Additives; Antibody titer; DSC; FTIR; Lasota; Lyophilization; XRPD

Indexed keywords

EXCIPIENT; LASOTA VACCINE; MACROGOL 6000; NEWCASTLE DISEASE VACCINE; PF 127; POVIDONE; SUCROSE; TREHALOSE; UNCLASSIFIED DRUG;

ALPHA HELIX; ANTIBODY TITER; ARTICLE; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG STABILITY; FREEZE DRYING; INFRARED SPECTROSCOPY; NONHUMAN; X RAY DIFFRACTION;

EID: 13544267608     PISSN: 09725849     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. Kathy & Rouan E, Modern pharmaceutics (Marcel Dekker, Inc., New York) 1996, 843-874.
2. Bohm B & Bollscheiler C, Pharmaproteins, Angew Chem Int, 27 (1988) 207-225.
3. Manning M & Patel K, Stability of protein pharmaceuticals, Pharm Res, 6 (1989) 903-918.
4. Chang B S & Kendrick B S, Surface-induced denaturation of proteins during freezing and its inhibition by surfactants, J Pharm Sci, 85 (1996) 1325-1330.
5. Skrabanja A T P & De Meere A L J, Lyophilization of. biotechnology products, PDA J Pharm Sci Technol, 48 (1994) 311-317.
6. Alexander D J, Newcastle disease (Kluwer Academic Publisher, London) 1988, 23-40.
7. Murphy F A & Gibbs E P J, Veterinary virology (Academic Press, San Diego) 1999, 17-35.
8. rd Indian Pharm Congr, New Delhi, 2001 (A57).
9. Moreng R E & Avens J S, Poultry science and production (Reston Publishing Company, Inc., Virginia) 1985, 143.
10. Sarciaux J M & Mansour S, Effects of buffer composition and processing conditions on aggregation of bovine IgG during freeze-drying, J Pharm Sci, 88(1999) 1354-1361.
11. Pikal M J & Shah S, The collapse temperature in freeze-drying: Dependence on measurement methodology and rate of water removal from the glassy phase, Int J Pharm, 62 (1990) 165-186.
12. Allan W H & Lancaster J E, Newcastle disease vaccines (FAO, Rome) 1978, 52-54.
13. Tyle P, Drug delivery, devices: Fundamentals and applications (Marcel Dekker Inc., New York) 1988, 404.
14. Pikal M J, Freeze-drying/lyophilization of pharmaceutical and biological products (Marcel Dekker, Inc., New York) 1999, 161-198.
15. Lalla J K & Sharma A H, Freeze-drying and its applications, Indian Drugs, 31 (1993) 503-518.
16. Tarelli E SL Wheeler S F, Drying from phosphate buffered solutions can result in the phosphorylation of primary and secondary alcohol groups of saccharides, hydroxylated amino acids, proteins, and glycoproteins, Anal Biochem, 222 (1994) 196-201.
17. Allison S D & Manning M C, Optimization of storage stability of lyophilized actin-using combination of disaccharides and dextran, J Pharm Sci, 89 (2000) 199-214.
18. Prasad K N & Luong T T, Surface activity and association of ABA polyoxyethylene-polyoxypropylene block copolymer in aqueous solution, J Colloid Interface Sci, 69 (2001) 225-233.
19. Nagaraj R H & Monnier V M, Protein modification by the degradation products of ascorbate: Formation of a novel pyrrole from the Maillard reaction of L-trhalose with protein, Biochim Biophys Acta, 1253 (1995) 75-84.
20. Her L M & Nail S L, Measurement of glass transition temperatures of freeze concentrated solutes by differential scanning calorimetry, Pharm Res, 11 (1994) 54-59.
21. Kibbe A H, Handbook of pharmaceutical excipients (American Pharmaceutical Association & Pharmaceutical Press, London) 2000, 386-433.
22. Shamblin S L & Taylor L S, Mixing behaviour of colyoptilized binary systems, J Pharm Sci, 87 (1998) 694-701.
23. Taylor L S & Zograti G, Sugar-polymer hydrogen bond interactions in lyophilized amorphous mixtures, J Pharm Sci, 87 (1998) 1615-1621.
24. Johnson R E & Kirchoff C F, Mannitol-sucrose mixtures-Versatile formulations for protein lyophilization, J Pharm Sci, 91 (2002) 914-922.
25. Carpenter J F & Izutsu K I, Freeze drying/Lyophilization of pharmaceutical and biological products (Marcel Dekker Inc., New York) 1999, 123-160.
26. Kendrick B S & Dong A, Quantitation of the area of overlap between second derivative amide I infrared spectra to determine the structural similarity of a protein in different states, J Pharm Sci, 85 (1996) 155-158.
27. Dong A & Huang P, Protein secondary structure in water from second-derivative amide I infrared spectra, Biochemistry, 29 (1990) 3303-3308.
28. Pikal-Cleland K A & Carpenter J F, Lyophilization induced protein denaturation in phosphate buffer systems: Monomeric and tetrameric β-galactosidase, J Pharm Sci, 90 (2001) 1255-1268.
29. Byler M D & Susi H, Examination of the secondary structure of proteins by deconvolved FTIR spectra, Biopolymers, 25 (1986) 469-487.
30. Dong A & Prestrelski S J, Infrared spectroscopic studies of lyophilization and temperature induced protein aggregation, J Pharm Sci, 84 (1995) 415-424.
31. Jones L S & Carpenter J F, The effects of tween 20 and sucrose on the stability of anti-L-selectin during lyophilization and reconstitution, J Pharm Sci, 90 (2001) 1466-1477.
32. Chen B L & Arawaka T, Strategies to suppress aggregation of recombinant keratinocyte growth factor during liquid formulation development, J Pharm Sci, 83 (1994) 1657-1661.
33. Hellman K & Miller D S, The effect of freeze-drying on the quaternary structure of L-asparginase from Enwinia carotovora, Biochim Biophys Acta, 749 (1983) 133-142.