Use of dynamic mechanical analysis (DMA) to determine critical transition temperatures in frozen biomaterials intended for lyophilization

Cryobiology

Volumn 61, Issue 1, 2010, Pages 27-32

  Gearing, John ^a   Malik, Kiran P ^b   Matejtschuk, Paul ^b  

^a Gearing Scientific Ltd   (United Kingdom)

^b NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

Dynamic mechanical analysis; Freeze drying; Frozen state; Glass transition; Lyophilization; Trehalose

Indexed keywords

BIOMATERIAL; DEXTRAN; LACTOSE; TREHALOSE;

ANALYTIC METHOD; ARTICLE; CARBOHYDRATE ANALYSIS; CHEMICAL ANALYSIS; COMPLEX FORMATION; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DYNAMIC MECHANICAL ANALYSIS; FREEZE DRYING; GLASS TRANSITION TEMPERATURE; MATERIAL STATE; MOLECULAR MECHANICS; PHYSICAL PHASE; PRIORITY JOURNAL; TEMPERATURE SENSITIVITY;

ANIMALS; ANTIGENS, VIRAL; EXCIPIENTS; FREEZE DRYING; HEPARIN; HUMANS; PLASMA; SERUM ALBUMIN; SWINE; TRANSITION TEMPERATURE;

EID: 77955414493     PISSN: 00112240     EISSN: 10902392     Source Type: Journal    
DOI: 10.1016/j.cryobiol.2010.04.002     Document Type: Article

References (21)

1. Blanshard J., Lillford P. The Glassy State in Foods 1993, Nottingham University Press, Nottingham, UK.
2. Lyophilization of biopharmaceuticals 2004, AAPS Press, Arlington, VA, USA. H.R. Constantino, M.J. Pikal (Eds.).
3. Cruz I.B., Oliveira J.C., MacInnes W.M. Dynamic mechanical thermal analysis of aqueous sugar solutions containing fructose, glucose, sucrose, maltose and lactose. Int. J. Food Sci. Technol. 2001, 36:539-550.
4. 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.
5. Duncan J. Principles and applications of mechanical thermal analysis. Principles and Application to Thermal Analysis 2008, 119-163. Blackwell, Oxford, UK.
6. Ferry J. Viscoelastic Properties of Polymers 1961, John Wiley, New York.
7. Fleck R., Green E., Matejtschuk P. Freeze drying microscopy, process optimization in the preparation of biological standards. G.I.T. Imag. Microscopy 2003, 5(1):11-13.
8. Gearing J. Handbook of Polymer Testing, Physical Methods 1999, 501-531. Marcel Dekker, New York. R. Brown (Ed.).
9. Jones D.S. Dynamic mechanical analysis of polymeric systems of pharmaceutical and biomedical significance. Int. J. Pharm. 1999, 179:167-178.
10. Kett V., McMahon D., Ward K. Thermoanalytical techniques for the investigation of the freeze drying process and freeze-dried products. Curr. Pharm. Biotechnol. 2005, 6(3):239-250.
11. P. Matejtschuk, M. Andersen, P. Phillips, Freeze drying of biological standards, in: L. Rey, J.C. May (Eds.), Freeze drying/lyophilization of pharmaceutical and biological products, second ed., Marcel Dekker, New York. Drugs in the Pharmaceutical Sciences 137 (2004) 385-424.
12. Meister E., Giesler H. A significant comparison between collapse and glass transition temperatures. Eur. Pharm. Rev. 2008, 13(5):73-79.
13. Nail S.L., Jiang S., Chongprasert S., Knopp SA. Fundamentals of freeze-drying. Pharm. Biotechnol. 2002, 14:281-360.
14. Nielsen L. Mechanical Properties of Polymers 1962, Reinhold, New York.
15. Price D.M. Thermomechanical, dynamic mechanical and dielectric methods. Principles of Thermal Analysis and Calorimetry 2002, 94-128. Royal Society of Chemistry.
16. L. Rey, in L. Rey, J.C. May (Eds.), Freeze drying/lyophilization of pharmaceutical and biological products, second ed., Marcel Dekker, New York. Drugs in the Pharmaceutical Sciences 137 (2004) 1-32.
17. Royall P.G., Huang C.-Y., Tang S.-W.J., Duncan J., Van de Velde G., Brown M.B. The development of DMA for the detection of amorphous content in pharmaceutical powdered materials. Int. J. Pharm. 2005, 301:181-191.
18. Sacha G.A., Nail S.L. Thermal analysis of frozen solutions: multiple glass transitions in amorphous systems. J. Pharm. Sci. 2009, 98(9):3397-3405.
19. Tang X., Pikal M.J. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm. Res. 2004, 21(2):191-200.
20. Wang W. Lyophilization and development of solid protein pharmaceuticals. Int. J. Pharm. 2000, 203:1-60.
21. Wu J., Reading M., Craig D.Q.M. Application of calorimetry, sub-ambient atomic force microscopy and dynamic mechanical analysis to the study of frozen aqueous trehalose solutions. Pharm. Res. 2008, 25:1396-1404.