Factors affecting the chemical durability of glass used in the pharmaceutical industry

AAPS PharmSciTech

Volumn 11, Issue 3, 2010, Pages 1340-1349

  Iacocca, Ronald G ^a   Toltl, Nick ^a   Allgeier, M ^a   Bustard, B ^a   Dong, Xia ^a   Foubert, M ^a   Hofer, J ^b   Peoples, S ^a   Shelbourn, T ^a  

^a ELI LILLY AND COMPANY   (United States)

^b Pharmaceutical Product Development Statistics   (United States)

Author keywords

delamination; glass corrosion; ICP OES; particle formation; pH

Indexed keywords

GLASS; GLUTARIC ACID; HIPPURIC ACID;

ARTICLE; ATOMIC EMISSION SPECTROMETRY; CHEMICAL COMPOSITION; CHEMICAL DURABILITY; CHEMICAL PHENOMENA; CHEMICAL STRUCTURE; CORROSION; DRUG INDUSTRY; DYNAMIC SECONDARY ION MASS SPECTROSCOPY; EXPERIMENTAL DESIGN; GLASS TRANSITION TEMPERATURE; PARTICULATE MATTER; PH MEASUREMENT; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; SPECTROSCOPY; THERMAL EXPOSURE;

DRUG PACKAGING; DRUG STORAGE; EQUIPMENT DESIGN; EQUIPMENT FAILURE ANALYSIS; GLASS; HOT TEMPERATURE;

EID: 78649907811     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-010-9506-9     Document Type: Article

References (39)

1. TJ Roseman JA Brown WW Scothorn 1976 Glass for parenteral products: a surface view using the scanning electron microscope J Pharm Sci 65 1 22 29 1:CAS:528:DyaE28XnvFKqsA%3D%3D 10.1002/jps.2600650103 1255429
2. RD Ennis R Pritchard C Nakamura M Coulon Y Taiyin GC Visor, et al. 2001 Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination Pharm Dev Technol 6 3 393 405 1:CAS:528:DC%2BD3MXls1WmsL0%3D 10.1081/PDT-100002248 11485181 (Pubitemid 32678245)
3. B Dimbley 1953 Glass for pharmaceutical purposes J Pharm Pharmacol 5 969 989
4. PB Adams 1977 Surface properties of glass containers for parenteral solutions Bull Parenter Drug Assoc 31 5 213 225 1:CAS:528:DyaE1cXislKqtg%3D%3D 922239
5. S Abernethy N Dowd S Bochert DA Butler R Clayton C Eckhart, et al. 1986 Glass: isolation and identificaiton of extractables from usp grade glass J Parenter Sci Technol 40 supplement S3 S11
6. AL Hinson 1971 Flouride washing of glass containers Bull Parenter Drug Assoc 25 6 266 269 1:CAS:528:DyaE38XmtlWntQ%3D%3D 5132980
7. Y Yamanaka J Akagi M Hattori 1985 Reaction of pyrex type borosilicate glass with water in autoclave J Non-Cryst Solids 70 279 290 1:CAS:528: DyaL2MXitVyitL8%3D 10.1016/0022-3093(85)90327-8 (Pubitemid 15569211)
8. JB Brown AS Watts 1937 Some studies on reactions between glasses and phosphate solution J Am Ceram Soc 20 245 250 1:CAS:528:DyaA2sXks1ajtQ%3D%3D 10.1111/j.1151-2916.1937.tb19897.x
9. FR Bacon FC Raggon 1959 Promotion of attack on glass and silica by citrate and other anions in neutral solution J Am Ceram Soc 42 4 199 205 1:CAS:528:DyaG1MXmvFClsw%3D%3D 10.1111/j.1151-2916.1959.tb12947.x
10. L Tian R Dieckmann C-Y Hui Y-Y Lin 2001 Effect of water incorporation on the diffusion of sodium in type I silica glass J Non-Cryst Solids 286 146 161 1:CAS:528:DC%2BD3MXkvVGitrs%3D 10.1016/S0022-3093(01)00520-8 (Pubitemid 32599982)
11. RH Doremus 2000 Diffusion of water in rhyolite glass: diffusion-reaction model J Non-Cryst Solids 261 101 107 1:CAS:528:DC%2BD3cXnvFKh 10.1016/S0022-3093(99)00604-3 (Pubitemid 30527066)
12. M Tomozawa 1985 Water in glass J Non-Cryst Solids 73 197 204 1:CAS:528:DyaL2MXlt1Ors7s%3D 10.1016/0022-3093(85)90346-1
13. Doremus RH. Chemical durability of glass. Treatise on materials science and technology. New York: Academic; 1979. p. 41-69.
14. RH Doremus 1995 Diffusion of water in glass J Mater Res 10 9 2379 2389 1:CAS:528:DyaK2MXns12jtr0%3D 10.1557/JMR.1995.2379
15. A Agarwal M Tomozawa WA Lanford 1994 Effect of stress on water diffusion in silica glass at various temperatures J Non-Cryst Solids 167 139 148 1:CAS:528:DyaK2cXhsVWksL0%3D 10.1016/0022-3093(94)90378-6
16. M Nogami M Tomozawa 1984 Effect of stress on water diffusion in silica glass J Am Ceram Soc 67 2 151 154 1:CAS:528:DyaL2cXht1Gltbg%3D 10.1111/j.1151-2916.1984.tb09634.x (Pubitemid 14545558)
17. H Wakabayashi M Tomozawa 1989 Diffusion of water into silica at low temperature J Am Ceram Soc 72 10 1850 1855 1:CAS:528:DyaL1MXmtlyitbs%3D 10.1111/j.1151-2916.1989.tb05990.x
18. M Tomozawa 1998 Stress corrosion reaction of silica glass and water Phys Chem Glasses 39 2 65 69 1:CAS:528:DyaK1cXjslegtL0%3D
19. H Tomozawa M Tomozawa 1989 Diffusion of water into a borosilicate glass J Non-Cryst Solids 109 311 317 1:CAS:528:DyaL1MXltF2mu7Y%3D 10.1016/0022-3093(89) 90044-6
20. BMJ Smets MG Lommen 1982 The role of molecular water in the leaching of glass Phys Chem Glasses 24 1 35 36
21. White WB. Theory of corrosion of glass and ceramics. In: Clark DE, Zoitos BK, editors. Corrosion of glass, ceramics and ceramic superconductors: principles, testing, characterization, and applications. Park Ridge: Noyes Publications; 1992. p. 2-28.
22. DR Baer LR Pederson GL McVay 1984 Glass reactivity in aqueous solutions J Vac Sci Technol A2 738 743
23. R Gy 2003 Stress corrosion of silicate glass: a review J Non-Cryst Solids 316 1 11 1:CAS:528:DC%2BD3sXjtlCjsw%3D%3D 10.1016/S0022-3093(02)01931-2
24. J Chene P Trocellier 2004 Investigation of alkali borosilicate glass durability using tritium tracing, beta-autoradiography, scanning electron microscopy, and ion beam analysis J Non-Cryst Solids 337 86 96 1:CAS:528:DC%2BD2cXktVCms7s%3D 10.1016/j.jnoncrysol.2004.02.094
25. ML Hair ID Chapman 1966 Surface composition of porous glass J Am Ceram Soc 49 12 651 654 1:CAS:528:DyaF2sXktVegtQ%3D%3D 10.1111/j.1151-2916.1966. tb13193.x
26. RG Iacocca MA Allgeier 2007 Corrosive attack of glass by a pharmaceutical compound J Mater Sci 42 3 801 811 1:CAS:528:DC%2BD2sXhs1Wiurg%3D 10.1007/s10853-006-0156-y
27. SJ Borchert MM Ryan 1989 Accelerated extractable studies of borosilicate containers J Parenter Sci Technol 43 2 67 79 1:CAS:528:DyaL1MXitlOis70%3D 2709238
28. F Branda G Laudisio A Constantini C Piccioli 1999 Weathering of a roman glass: a new hypothesis for pit formation on glass surfaces Glass Technol 40 3 89 91 1:CAS:528:DyaK1MXltleltbk%3D
29. KJS Gillies A Cox 1988 Decay of medieval stained glass at york, canterbury, and carlisle: Part 2. Relationship between the composition of the glass, its durability and the weathering products Glastech Ber 61 4 101 107 1:CAS:528:DyaL1cXkslals7w%3D
30. P Rogers D McPhail J Ryan 1993 A quantitative study of decay processes of venetian glass in a museum environment Glass Technol 34 2 67 68 1:CAS:528:DyaK3sXlsVCktrw%3D
31. M Schreiner 1988 Deterioration of stained medieval glass by atmospheric attack Glastech Ber 61 7 197 204 1:CAS:528:DyaL1cXmtlGmu7c%3D
32. AT Hsu WA Jemian RC Wilcox 1976 Solvent effect of water on S-glass J Mater Sci. 11 2099 2104 1:CAS:528:DyaE2sXitVynsg%3D%3D 10.1007/BF02403360
33. Iler RK. The chemistry of silica. New York: Wiley-Interscience; 1979.
34. H Baumann 1955 Solubility of silica in water Beitr Silikose-Forsch 37 47
35. Cherkinskii YS, Knyaz ' kova IS. Dokl Akad Nauk SSSR. 1971;198:358.
36. BC Bunker 1994 Molecular mechanisms for corrosion of silica and silicate glasses J Non-Cryst Solids 179 pt 3 300 308 1:CAS:528:DyaK2MXitlanurY%3D 10.1016/0022-3093(94)90708-0
37. Batyrev IG, Tuttle B, Fleetwood DM, Schrimpf RD, Tsetseris L, Pantelides ST. Reactions of water molecules in silica-based network glasses. Phys Rev Lett. 2008.100(10):105503:1-8.
38. S Gin N Gordon JP Mestre EY Vernaz D Beaufort 1994 Espericamental investigation of aqueous corrosion of R7T7 nuclear glass at 90°C in the presence of organic species Appl Geochem 9 3 255 269 1:CAS:528: DyaK2cXltF2qtr8%3D 10.1016/0883-2927(94)90036-1 (Pubitemid 24427271)
39. BE Ramachandran N Balasubramanian GV Rao G Aravamudan 1981 Effect of organic acids on e-glass fabric J Am Ceram Soc 64 9 C122 C124 1:CAS:528:DyaL38XhtVKjtQ%3D%3D 10.1111/j.1151-2916.1981.tb10332.x