Mechanistic studies of glass vial breakage for frozen formulations. I. Vial breakage caused by crystallizable excipient mannitol

PDA Journal of Pharmaceutical Science and Technology

Volumn 61, Issue 6, 2007, Pages 441-451

  Jiang, Ge ^a   Akers, Mike ^a   Jain, Manish ^a   Guo, Jeremy ^a   Distler, Adrian ^a   Swift, Rob ^a   Wadhwa, Manpreet Vick S ^a   Jameel, Feroz ^a   Patro, Sugu ^a   Freund, Erwin ^a  

^a AMGEN INC   (United States)

Author keywords

Amorphous; Crystalizable excipient; Freeze thaw; Frozen protein formulation; Glass vial breakage; Mannitol

Indexed keywords

ALUMINUM; EXCIPIENT; MANNITOL; POLYURETHAN FOAM; STAINLESS STEEL;

ARTICLE; CORRELATION ANALYSIS; CRYSTALLIZATION; DRUG FORMULATION; FREEZE THAWING; GEL ELECTROPHORESIS; GLASS BOTTLE; MECHANICS; STATISTICAL ANALYSIS; TEMPERATURE; THERMAL ANALYSIS;

CHEMISTRY, PHARMACEUTICAL; CRYSTALLIZATION; DRUG PACKAGING; DRUG STORAGE; EXCIPIENTS; FREEZING; GLASS; MANNITOL; THERMODYNAMICS;

EID: 38549154516     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (21)

1. Carpenter, J. F.; Chang, B. S.; Garzon-Rodriguez, W.; Randolph, T. W. Rational design of stable lyophilized protein formulations: theory and practice. Pharm. Biotechnol. 2002, 13, 109-133.
2. Chatterjee, K.; Shalaev, E. Y.; Suryanarayanan, R. Partially crystalline systems in lyophilization: I. Use of ternary state diagrams to determine extent of crystallization of bulking agent. J. Pharm. Sci. 2005, 94, 798-808.
3. Chatterjee, K.; Shalaev, E. Y.; Suryanarayanan, R. Partially crystalline systems in lyophilization: II. Withstanding collapse at high primary drying temperatures and impact on protein activity recovery. J. Pharm. Sci. 2005, 94, 809-820.
4. Chen, B. L.; Arakawa, T.; Hsu, E.; Narhi, L. O.; Tressel, T. J.; Chien, S. L. Strategies to suppress aggregation of recombinant keratinocyte growth factor during liquid formulation development. J. Pharm. Sci. 1994, 83, 1657-1661.
5. Chi, E. Y.; Krishnan, S.; Randolph, T. W.; Carpenter, J. F. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm. Res. 2003, 20, 1325-1336.
6. Izutsu, K.; Kojima, S. Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying. J. Pharm. Pharmacol. 2002, 54, 1033-1039.
7. Jiang, G.; Joshi, S. B.; Peek, L. J.; Brandau, D. T.; Huang, J.; Ferriter, M. S.; Woodley, W. D.; Ford, B. M.; Mar, K. D.; Mikszta, J. A.; Hwang, C. R.; Ulrich, R.; Harvey, N. G.; Middaugh, C. R.; Sullivan, V. J. Anthrax vaccine powder formulations for nasal mucosal delivery. J. Pharm. Sci. 2006, 95, 80-96.
8. Jiang, G.; Akers, M.; Jain, M.; Guo, J.; Distler, A.; Swift, R.; Wadhwa, M. S.; Jameel, F.; Patro, S.; Freund, E. Mechanistic studies of glass vial breakage for frozen formulations: II. Vial breakage caused by amorphous protein formulations. PDA J. Pharm. Sci. Tech. 2007, 452-460.
9. Toninato, T.; Salvagno, L.; Rigoli, A.; Moretti, C. Observations on the mechanical resistance of neutral glass vials in the lyophilization process. Il Farmaco; edizione pratica 1981, 36, 78-88.
10. Williams, N. A.; Lee, Y.; Polli, G. P.; Jennings, T. A. The effects of cooling rate on solid phase transitions and associated vial breakage occurring in frozen mannitol solutions. J. Parenter. Sci. Technol. 1986, 40, 135-141.
11. Williams, N. A.; Dean, T. Vial breakage by frozen mannitol solutions: correlation with thermal characteristics and effect of stereoisomerism, additives, and vial configuration. J. Parenter. Sci. Technol. 1991, 45, 94-100.
12. Hirakura, Y.; Kojima, S.; Okada, A.; Yokohama, S.; Yokota, S. The improved dissolution and prevention of ampoule breakage attained by the introduction of pretreatment into the production process of the lyophilized formulation of recombinant human Interleukin-11 (rhIL-11). Int. J. Pharm. 2004, 286, 53-67.
13. Khandare, P. M.; Zondlo, J. W.; Panvlovic, A. S. The measurement of the glass transition temperature of mesophase pitches using a thermomechanical device. Carbon 1996, 34, 663-669.
14. Foreman, J. Thermal and Mechanical Analysis of Plastics in Industry and Research. Proceedings of the Joint Regional Technical Conference, Newark, DE, Nov. 2, 1999; pp 60-67.
15. Williams N. A.; Guglielmo, J. Thermal mechanical analysis of frozen solutions of mannitol and some related stereoisomers: evidence of expansion during warming and correlation with vial breakage during lyophilization. J. Parenter. Sci. Technol. 1993, 47, 119-123.
16. Craig, G. D.; Moreno, M.; Mishra, D.; Milton, N.; Roy, M.; Yu, L. Use of the Strain Gage to Study the Dynamics of Stress Generation in Vials during Freeze-Drying. Breckenridge Protein Stability Conference, Breckenridge, CO, July 28-31, 2004.
17. Kachigan, S. K. Statistical Analysis: An Interdisciplinary Introduction to Univariate & Multivariate Methods. Radium Press: New York, 1986.
18. Arendt, V. D. Compositions and Method for Reducing Vial Breakage during Lyophilization. U.S. Patent 5,169,834, December 8, 1992.
19. Cavatur, R. K.; Vemuri, N. M.; Pyne, A.; Chrzan, Z.; Toledo-Velasquez, D.; Suryanarayanan, R. Crystallization behavior of mannitol in frozen aqueous solutions. Pharm. Res. 2002, 19, 894-900.
20. Liao, X.; Krishnamurthy, R.; Suryanarayanan, R. Influence of processing conditions on the physical state of mannitol - implications in freeze-drying. Pharm. Res. 2007, 24, 370-376.
21. Tang, X.; Pikal, M. J. Design of freeze-drying processes for pharmaceuticals: practical advice. Pharm. Res. 2004, 21, 191-200.