Molecular Mobility of freeze-dried formulations as determined by NMR relaxation, and its effect on storage stability

Freeze-Drying/Lyophilization of Bharmaceutical and Biological Products

Volumn , Issue , 2004, Pages 187-212

  Yoshioka, Sumie ^a  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

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[No Author keywords available]

Indexed keywords

EID: 85042129038     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (34)

1. SP Duddu, K Weller. Importance of glass transition temperature in accelerated stability testing of amorphous solids: case study using a lyophilized aspirin formulation. J Pharm Sci 85:345-347, 1996.
2. BD Herman, BD Sinclair, N Milton, SL Nail. The effect of bulking agent on the solid-state stability of freeze-dried methylprednisolone sodium succinate. Pharm Res 11:1467-1473, 1994.
3. L Streefland, AD Auffret, F Franks. Bond cleavage reactions in solid aqueous carbohydrate solutions. Pharm Res 15:843-849, 1998.
4. MC Lai, MJ Hageman, RL Schowen, RT Borchardt, EM Topp. Chemical stability of peptides in polymers. 1. Effect of water on peptide deamidation in poly(vinly alcohol) and poly(vinyl pyrrolidone) matrixes. J Pharm Sci 88:1073-1080, 1999.
5. MC Lai, MJ Hageman, RL Schowen, RT Borchardt, EM Topp. Chemical stability of peptides in polymers. 2. Discriminating between solvent and plasticizing effects of water on peptide deamidatin in poly(vinylpyrrolidone). J Pharm Sci 88:1081-1089, 1999.
6. SP Duddu, G Zhang, PR Dal Monte. The relationship between protein aggregation and molecular mobility below the glass transition temperature of lyophilized formulations containing a monoclonal antibody. Pharm Res 14:596-600, 1997.
7. MJ Pikal, K Dellerman, ML Roy. Formulation and stability of freeze-dried proteins: effects of moisture and oxygen on the stability of freeze-dried formulations of human growth hormone. Dev Biol Stand 74:21-38, 1991.
8. ML Roy, MJ Pikal, EC Rickard, AM Maloney. The effects of formulation and moisture on the stability of a freeze-dried monoclonal antibody-vinca conjugate: a test of the WLF glass transition theory. Dev Biol Stand 74:323-340, 1991.
9. M Hageman. Water sorption and solid-state stability of proteins. In: Stability of Protein Pharmaceuticals, Part A: Chemical and Physical Pathways of Protein Degradation. New York: Plenum Press, 1992.
10. LN Bell, MJ Hageman, LM Muraoka. Thermally induced denaturation of lyophilized bovine somatotropin and lysozyme as impacted by moisture and excipients. J Pharm Sci 84:707-712, 1995.
11. F Franks. Freeze drying: A combination of physics, chemistry, engineering and economics. Jpn J Freezing Drying 38:5-16, 1992.
12. M Pikal. Freeze-drying of proteins. Biopharm 3:26-30, 1990.
13. SJ Prestrelski, KA Pikal, T Arakawa. Pharm Res 12:1250-1259, 1995.
14. SP Duddu, PR Dal Monte. Effect of glass transition temperature on the stability of lyophilized formulations containing a chimeric therapeutic monoclonal antibody. Pharm Res 14:591-595, 1997.
15. HR Costantino, R Langer, AM Klivanov. Aggregation of a lyophilized pharmaceutical protein, recombinant human albumin: Effect of moisture and stabilization by excipients. Bio/Technology 13:493-496, 1995.
16. SL Shamblin, X Tang, L Chang, BC Hancock, MJ Pikal. Characterization of the time scales of molecular motion in pharmaceutically important glasses. J Phys Chem 103:4113-4121, 1999.
17. V Andronis, G Zografi. The molecular mobility of supercooled amorphous indomethacin as a funciton of temperature and relative humidity. Pharm Res 15:835-842, 1998.
18. MT Kalichevsky, EM Jaroszkiewicz, S Ablett, JMV Blanshard, PJ Lillford. The glass transition of amylopectin measured by DSC, DMTA and NMR. Carbohyd Polym 18:77-88, 1992.
19. MT Kalichevsky, EM Jaroszkiewicz, JMV Blanshard. A study of the glass transition of amylopectin-sugar mixtures. Polymer 34:346-358, 1993.
20. CA Oksanen, G Zografi. Molecular mobility in mixtrures of absorbed water and solid poly(vinylpyrrolidone). Pharm Res 10:791-799, 1993.
21. S Yoshioka, Y Aso, T Otsuka, S Kojima, J Pharm Sci 84:1072-1077, 1995.
22. CA Rubin, JM Wasylyk, JG Baust.Investigation of vitrificaiton by nuclcar magnetic resonance and differential scanning calorimetry in honey: a model carbohydrate system. J Agric Food Chem 38:1824-1827, 1990.
23. S Yoshioka, Y Aso, S Kojima. Dependence of the molecular mobility and protein stability of freeze-dried y-globulin formulations on the molecular weight of dextran. Pharm Res 14:736-741, 1997.
24. S Yoshioka, Y Aso, Y Nakai, S Kojima. Effect of high molecular mobility of poly(vmyl alcohol) on protein stability of lyophilized y-globulin formulations. J Pharm Sci 87:147-151, 1998.
25. S Yoshioka, Y Aso, S Kojima. The effect of excipients on the molecular mobility of lyophilized formulations, as measured by glass transition temperature and NMR relaxation-based critical mobility temperature, Pharm Res 16:135-140, 1999.
26. S Yoshioka, Y Aso, S Kojima. Different molecular motions in lyophilized protein formulations as determined by laboratory and rotating frame spin- lattice relaxation times. J Pharm Sci 91:2203-2210, 2002.
27. 13C CP/MAS NMR spectroscopy. J Polym Sci Part B 30:591-601, 1992.
28. 3C solid-state NMR. Pharm Res 16:1621-1625, 1999.
29. BC Hancock, G Zografi. Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 86:1 12, 1997.
30. IM Hodge. Physical aging in polymer glasses. Science 267:1945-1947, 1995.
31. BC Hancock, SL Shamblin, G Zografi. Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures, Pharm Res 12:799-806, 1995.
32. V Andronis, G Zografi. Molecular mobility of supercooled amorphous indomethacin, determined by dynamic mechanical analysis. Pharm Res 14:410 414, 1997.
33. S Yoshioka, Y Aso, S Kojima. Temperature dependence of biomolecular reactions associated with molecular mobility in lyophilized formulations. Pharm Res 17:923-927, 2000.
34. S Yoshioka, Y Aso,.S Kojima. Usefulness of the Kohlrausch-Williams-Watts stretched exponential function to describe protein aggregation in lyophilized formulations and the temperature dependence near the glass transition temperature. Pharm Res 18:256 260, 2001.