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Research ArticleTechnology/Application

Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations

Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair and Deirdre Murphy Piedmonte
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 96-107; DOI: https://doi.org/10.5731/pdajpst.2015.01007
Renuka Thirumangalathu
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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  • For correspondence: renukat@amgen.com
Kwun Ngok Wong
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
§Current address: University of Southern California, Los Angeles, CA 90089
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James Coultas
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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Alison Hair
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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Deirdre Murphy Piedmonte
‡Drug Product Development, Process and Product Development, Amgen Inc., Thousand Oaks, CA; and
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References

  1. 1.↵
    1. Ennis R. D.,
    2. Pritchard R.,
    3. Nakamura C.,
    4. Coulon M.,
    5. Yang T.,
    6. Visor G. C.,
    7. Lee W. A.
    Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination. Pharm. Dev. Technol. 2001, 6 (3), 393–405.
    OpenUrlPubMed
  2. 2.↵
    1. Wirth G. S.,
    2. Gieskes J. M.
    The initial kinetics of the dissolution of vitreous silica in aqueous media. J. Colloid Interface Sci. 1978, 68 (3), 492–500.
    OpenUrl
  3. 3.↵
    1. Bohrer D.,
    2. Do Nascimento P. C.,
    3. Becker E.,
    4. Bortoluzzi F. D.,
    5. De Carvalho L. M.
    Critical evaluation of the standard hydrolytic resistance test for glasses used for containers for blood and parenteral formulations. PDA J. Pharm. Sci. Technol. 2004, 58 (2), 96–105.
    OpenUrlAbstract/FREE Full Text
  4. 4.↵
    1. Conradt R.
    Chemical durability of oxide glasses in aqueous solutions: a review. J. Am. Ceram. Soc. 2008, 91 (3), 728–735.
    OpenUrl
  5. 5.↵
    1. Bunker B. C.
    Molecular mechanisms for corrosion of silica and silicate glasses. J. Non-Cryst. Solids 1994, 179, 300–308.
    OpenUrl
  6. 6.↵
    1. Baillif P.,
    2. Chouikhi B.,
    3. Touray J. C.
    Dissolution mechanisms of boro-silicate glass fibres in saline solution with added dissolved silica J. Mater. Sci. 2000, 35 (4), 967–973.
    OpenUrl
  7. 7.↵
    1. Chan S. H.
    A review on solubility and polymerization of silica. Geothermics 1989, 18 (1), 49–56.
    OpenUrlCrossRef
  8. 8.↵
    1. Iler R. K.
    The Chemistry of Silica; John Wiley & Sons: New York, 1979.
  9. 9.↵
    1. Dietzel M.
    Impact of cyclic freezing on precipitation of silica in SiO2–H2O systems and geochemical implications for cryosoils and sediments. Chemical Geology 2005, 216, 79–88.
    OpenUrlCrossRefGeoRefWeb of Science
  10. 10.↵
    1. Dove P. M.,
    2. Han N.,
    3. Wallace A. F.,
    4. De Yoreo J. J.
    Kinetics of amorphous silica dissolution and the paradox of the silica polymorphs. Proc. Natl. Acad. Sci. USA 2008, 105 (29), 9903–9908.
    OpenUrlAbstract/FREE Full Text
  11. 11.↵
    1. Iacocca R. G.,
    2. Allgeier M.
    Corrosive attack of glass by a pharmaceutical compound. J. Mater. Science 2007, 42 (3), 801–811.
    OpenUrl
  12. 12.↵
    1. Ledieu A.,
    2. Devreux F.,
    3. Barboux P.,
    4. Sicard L.,
    5. Spalla O.
    Leaching of borosilicate glasses. I. Experiments. J. Non-Cryst. Solids 2004, 343 (1), 3–12.
    OpenUrl
  13. 13.↵
    1. Borchert S. J.,
    2. Ryan M. M.,
    3. Davison R. L.,
    4. Speed W.
    Accelerated extractable studies of borosilicate glass containers. PDA J. Pharm. Sci. Technol. 1989, 43 (2), 67–79.
    OpenUrlAbstract/FREE Full Text
  14. 14.↵
    1. Abernethy S.,
    2. Dowd N.,
    3. Bochert S.,
    4. Butler D. A.,
    5. Clayton R.,
    6. Eckhart C.,
    7. et al
    . Glass: Isolation and Identification of extractables from USP grade glass. J. Parenter. Sci. Technol. 1986, 40 (supplement), S3–S11.
    OpenUrl
  15. 15.↵
    USP. Evaluation of the Inner Surface Durability of Glass Containers Posted for Comment, 2012. http://www.usp.org/usp-nf/notices/evaluation-inner-surface-durability-glass-containers-posted-comment.
  16. 16.↵
    1. Iacocca R. G.,
    2. Toltl N.,
    3. Allgeier M.,
    4. Bustard B.,
    5. Dong X.,
    6. Foubert M.,
    7. Hofer J.,
    8. Peoples S.,
    9. Shelbourn T.
    Factors affecting the chemical durability of glass used in the pharmaceutical industry. AAPS PharmSciTech 2010, 11 (3), 1340–1349.
    OpenUrlPubMed
  17. 17.↵
    1. Ratnaswamy G.,
    2. Hair A.,
    3. Li G.,
    4. Thirumangalathu R.,
    5. Nashed-Samuel Y.,
    6. Brych L.,
    7. Dharmavaram V.,
    8. Wen Z.,
    9. Fujimori K.,
    10. Jing W.,
    11. Sethuraman A.,
    12. Swift R.,
    13. Ricci M. S.,
    14. Piedmonte D. M.
    A case study of non-delamination glass dissolution resulting in visible particles: implications for neutral pH formulations J. Pharm. Sci. 2013, 103 (4), 1104–1114.
    OpenUrl
  18. 18.↵
    1. Perera G.,
    2. Doremus R.
    Dissolution rates of silicate glasses in water at pH 7. J. Am. Ceram. Soc. 1991, 74 (6), 1269–1274.
    OpenUrl
  19. 19.↵
    1. Cox B.
    Glass quality crisis prompts multi-faceted array of risk-based improvements. The Gold Sheet 2011, 45.
  20. 20.↵
    Two ways to minimize the delamination risk of glass containers. Schott Pharmaceutical Packaging Newsflash 2012, 17.
  21. 21.↵
    1. Bohrer D.,
    2. Bortoluzzi F.,
    3. Nascimento P. C.,
    4. Carvalho L. M.,
    5. Ramirez A. G.
    Silicate release from glass for pharmaceutical preparations. Int. J. Pharm. 2008, 355 (1), 174–183.
    OpenUrlCrossRefPubMedWeb of Science
  22. 22.↵
    1. Guadagnino E.,
    2. Zuccato D.
    Delamination propensity of pharmaceutical glass containers by accelerated testing with different extraction media. PDA J. Pharm. Sci. Technol. 2012, 66 (2), 116–125.
    OpenUrlAbstract/FREE Full Text
  23. 23.↵
    1. Schwartz M.
    Photometric determination of silica in presence of phosphates. Industrial and Engineering Chemistry 1942, 14 (11), 893–895.
    OpenUrl
  24. 24.↵
    Determination of Silicate in High Purity Water Using Ion Chromatography and AutoPrep. Dionex Application Note 170. Dionex Corporation/ThermoScientific (Sunnyvale CA), 2014. [Online]. http://www.dionex.com/en-us/webdocs/62945-AN170-IC-Silicate-UHPW-AN70946_E.pdf. (accessed 12/1/2014).
  25. 25.↵
    Determination of Dissolved Silica and Common Anions Using Dual Detection. Dionex Application Update 113. Dionex Corporation/ThermoScientific (Sunnyvale, CA), 2009. [Online]. www.dionex.com/en-us/webdocs/4072-AN113_LPN0736.pdf. (accessed 12/1/2014).
  26. 26.↵
    1. Wen Z. Q.,
    2. Torraca G.,
    3. Masatani P.,
    4. Sloey C.,
    5. Phillips J.
    Nondestructive detection of glass vial inner surface morphology with differential interference contrast microscopy. J. Pharm. Sci. 2012, 101 (4), 1378–1384.
    OpenUrlPubMed
  27. 27.↵
    1. Tarutani T.
    Polymerization of silicic acid: a review. Anal. Sci. 1989, 5 (3), 245–252.
    OpenUrl
  28. 28.↵
    1. Govett G. J. S.
    Critical factors in the colorimetric determination of silica. Anal. Chim. Acta, 1961, 25 (1), 69–80.
    OpenUrlCrossRefGeoRefWeb of Science
  29. 29.↵
    1. Vial J.,
    2. Jardy A.
    Taking into account both preparation and injection in high-performance liquid chromatography linearity studies. J. Chromatogr. Sci. 2000, 38 (5), 189–194.
    OpenUrlAbstract/FREE Full Text
  30. 30.↵
    1. Apostol I.,
    2. Miller K. J.,
    3. Ratto J.,
    4. Kelner D. N.
    Comparison of different approaches for evaluation of the detection and quantitation limits of a purity method: a case study using a capillary isoelectrofocusing method for a monoclonal antibody. Anal. Biochem. 2009, 385 (1), 101–106.
    OpenUrlPubMed
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PDA Journal of Pharmaceutical Science and Technology: 69 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 2015
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Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair, Deirdre Murphy Piedmonte
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 96-107; DOI: 10.5731/pdajpst.2015.01007

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Implementation of a High-Throughput Ion Chromatographic Assay To Assess Glass Degradation in Drug Product Formulations
Renuka Thirumangalathu, Kwun Ngok Wong, James Coultas, Alison Hair, Deirdre Murphy Piedmonte
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 96-107; DOI: 10.5731/pdajpst.2015.01007
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Keywords

  • Silicic acid
  • Soluble silica
  • Glass delamination
  • Glass degradation
  • Ion chromatography
  • Formulation container incompatibility
  • Molybdate
  • Silico-molybdate complex
  • Glass lamellae
  • glass dissolution

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