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Journal of Materials Science

, Volume 42, Issue 3, pp 801–811 | Cite as

Corrosive attack of glass by a pharmaceutical compound

  • Ronald G. IacoccaEmail author
  • Matthew Allgeier
Article

Abstract

Glass delamination, or the generation of glass flakes, continues to be an unwanted occurrence in the manufacture of parenteral (injectable) solutions and suspensions. In this root cause analysis study, advanced analytical tools including atomic force microscopy, environmental scanning electron microscopy, quantitative image analysis, and dynamic secondary ion mass spectroscopy (D-SIMS) showed significant differences in glass characteristics and performance. By observing the size and spatial arrangement of defects found on the interior surface of vials used as primary packaging for these products, in conjunction with the chemical changes that can occur to the glass because of product contact, a considerable amount of insight can be obtained into this phenomenon. Elemental depth profiling obtained by D-SIMS revealed that the interior vial surface was significantly altered by the presence of the parenteral solution, while another vial (manufactured by another vendor) was not. Although significant chemical changes can occur to the glass, the surface defect structure appears to be the dominant factor controlling the generation of glass flakes.

Keywords

Ammonium Sulfate Interior Surface Incongruent Dissolution Diamine Tetraacetate Glass Antiquity 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

The authors would like to acknowledge the many participants in this study including: Dr. Dinesh Mishra, Dr. Heather Weimer, Mr. Eric Olsen, Ms. Sheryl Peoples, and Mr. David Crozier.

References

  1. 1.
    Ennis RD et al (2001) Pharm Dev Technol 6(3):393CrossRefGoogle Scholar
  2. 2.
    Roseman TJ, Brown JA, Scothorn WW (1976) J Pharm Sci 65(1):22CrossRefGoogle Scholar
  3. 3.
    Borchert SJ, Ryan MM (1989) J Parent Sci Technol 43(2):67–79Google Scholar
  4. 4.
    White WB (1992) In: Clark DE, Zoitos BK (eds) Corrosion of glass, ceramics and ceramic superconductors: principles, testing, characterization, and applications. Noyes Publications, Park Ridge, NJ, pp 2–28Google Scholar
  5. 5.
    Doremus RH (1967) In: Mitchell JW, DeVries RC (eds) Reactivity of solids. Wiley, New York, p 667Google Scholar
  6. 6.
    McIntyre NS, Strathdee GG, Phillips BF (1980) Surf Sci 100:71CrossRefGoogle Scholar
  7. 7.
    Dimbley B (1953) J Pharm Pharmacol 5:969CrossRefGoogle Scholar
  8. 8.
    Bacon FR, Raggon FC (1959) J Am Ceram Soc 42(4):199CrossRefGoogle Scholar
  9. 9.
    Stevens HJ (1991) In: Schneider SJ (ed) Ceramics and glasses. ASM International, Materials Park, pp 394–401Google Scholar
  10. 10.
    Leadley SR et al (1998) Macromolecules 31(25):8957CrossRefGoogle Scholar
  11. 11.
    Rossi A et al (2000) Surf Interface Anal 29(7):460CrossRefGoogle Scholar
  12. 12.
    Swift AJ (1995) Mikrochim Acta 120(1–4):149CrossRefGoogle Scholar
  13. 13.
    Vickerman JC, Briggs D (eds) (2001) ToF-SIMS: surface analysis by mass spectrometry. IMS Publications and Surface Spectra Limited, ChichesterGoogle Scholar
  14. 14.
    Doremus RH (1995) J Mater Res 10(9):2379CrossRefGoogle Scholar
  15. 15.
    Tomozawa H, Tomozawa M (1989) J Non-Crystal Solids 109:311CrossRefGoogle Scholar
  16. 16.
    Doremus RH (1994) Glass science, 2nd edn. John Wiley & Sons Inc, New York, p 339Google Scholar
  17. 17.
    Adams PB (1977) Bull Parent Drug Assoc 31(5):213Google Scholar
  18. 18.
    Hair ML, Chapman ID (1966) J Am Ceram Soc 49(12):651CrossRefGoogle Scholar
  19. 19.
    Davison RM, DeBold R, Johnson MJ (1987) In: Korb LJ, Olson BA (eds) ASM handbook. ASM International, Materials Park, OH, pp 547–566Google Scholar
  20. 20.
    Uhlig HH, Revie RW (1985) Corrosion and corrosion control, 3rd edn. John Wiley & Sons, New York, p 441Google Scholar
  21. 21.
    Fontana MG (1986) Corrosion engineering, 3rd edn. McGraw-Hill, New York, p 556Google Scholar
  22. 22.
    Fern S, McPhail DS, Oakley V (2004) Appl Surf Sci 231–232:510CrossRefGoogle Scholar
  23. 23.
    Branda F et al (1999) Glass Technol 40(3):89Google Scholar
  24. 24.
    Gillies KJS, Cox A (1988) Glastech Ber 61(4):101Google Scholar
  25. 25.
    Schreiner M (1988) Glastech Ber 61(7):197Google Scholar
  26. 26.
    Rogers P, McPhail D, Ryan J (1993) Glass Technol 34(2):67Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  1. 1.Materials Science and Physical CharacterizationEli Lilly and CompanyIndianapolisUSA

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