Profiling of metal ions leached from pharmaceutical packaging materials

PDA Journal of Pharmaceutical Science and Technology

Volumn 60, Issue 6, 2006, Pages 337-342

  Fliszar, Kyle A ^a   Walker, David ^a   Allain, Leonardo ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

HDPE; Inorganic leachable; LDPE; Metal ions; PET; SiO 2 coated glass; Type I glass

Indexed keywords

EXCIPIENT; GLASS; ION; METAL; PLASTIC; SOLVENT;

ARTICLE; ATOMIC ABSORPTION SPECTROMETRY; CHEMISTRY; DRUG PACKAGING; SOLUTION AND SOLUBILITY; STANDARD;

CHEMISTRY, PHARMACEUTICAL; DRUG PACKAGING; EXCIPIENTS; GLASS; IONS; METALS; PHARMACEUTICAL SOLUTIONS; PLASTICS; REFERENCE STANDARDS; SOLVENTS; SPECTROPHOTOMETRY, ATOMIC;

EID: 33847287881     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (23)

1. Jenke, D. R. Evaluation of model solvent systems for assessing the accumulation of container extractables in drug formulations. Int. J. Pharm. 2001, 224, 51-60.
2. Buiarelli, F.; Cartoni, G.; Coccioli, F. HPLC and GC-MS determination of compounds released to mineral waters stored in plastic bottles of PET and PVC. Anal. Chem. 1993, 83, 93-104.
3. Ulsaker, G. A.; Teinen, G. Identification of caprolactam as a potential contaminant in parenteral solutions stored in overwrapped PVC bags. J. Pharm. Biomed. Anal. 1992, 10, 77-80.
4. Arbin, A.; Jacobsson, S.; Hanninen, K.; Hagman, A.; Ostelius, J. Studies on contamination of intravenous solutions from PVC-bags with dynamic headspace GC-MS and LC-diode array techniques," Int. J. Pharm. 1986, 28, 211-221.
5. Snell, R. P. Capillary GC analysis of compounds leached into parenteral solutions packaged in plastic bags. J. Chromatogr. Sci. 1989, 27, 524-528.
6. Berg, B. E.; Hegna, D. R.; Orlien, N.; Greibrokk, T. Determination of low levels of polymer additives migrating from polypropylene to food simulated liquids by capillary SFC and solvent venting injection. Chromatographia 1993, 37, 271-276. (Pubitemid 23287910)
7. Nerin, C.; Rubio, C.; Salafranca, J.; Batlle, R. The simplest sample treatment techniques to assess the quality and safety of food packaging materials. Anal. Chem. 2000, 19, 435-465.
8. Reif, O. W.; Solkner, P.; Rupp, J. Analysis and evaluation of filter cartridge extractables for validation in pharmaceutical downstream processing. PDA J. Pharm. Sci. Technol. 1996, 50 (6), 399-410.
9. Alam, M. S.; Srivastava, S. P.; Seth, P. K. Factors influencing the leaching of heavy metals from plastic materials used in the packaging of food and biomedical devices. Indian Journal of. Environmental Health 1998, 30, 131.
10. Kassem, M. A.; Kassem, A. A.; Ammar, H. O. On heavy metal ions contamination from ampoule glass. Pharm. Acta Helv. 1969, 44, 535-540.
11. Klein, G. L.; Leichtner, A. M.; Heyman, M. B. Aluminum in large and small volume parenterals used in total parenteral nutrition: Response to the Food and Drug Administration notice of proposed rule by the North American Society for Pediatric Gastroenterology and Nutrition. Journal of Pediatric Gastrointestinal Nutrition 1998, 27, 257.
12. Baydar, T.; Aydin, A.; Duru, S.; Isimer, A.; Sahin, G. Aluminum in enteral nutrition formulas and parenteral solutions. J. Toxicol. Clin. Toxicol. 1997, 35 (3), 277-281.
13. Johnson, D. M.; Gu, L. C. Autoxidation and Antioxidants. In Encyclopedia of Pharmaceutical Technology; Swarbrick, J., Boylan, L. C., Eds.; Marcel Dekker, Inc.: New York, 1988; pp 415-449.
14. Lachman, L. Antioxidants and chelating agents as stabilizers in liquid dosage forms. Drug Cosmet. Ind. 1968, 146, 36-40.
15. Kumar, V.; Sunder, N.; Potdar, A. Critical factors in developing pharmaceutical formulations - An overview, Part II. Pharm. Technol. 1992, 16 (4), 86-92.
16. Kasraian, K.; Kuzniar, A.; Wilson, G.; Wood, J. Developing an injectable formula containing an oxygen-sensitive drug: A case study of danofloxacin injectable. Pharm. Dev. Technol. 1999, 4 (4), 475-480.
17. Jenke, D. Extractable/leachable substances from plastic materials used as pharmaceutical product containers/devices. PDA J. Pharm. Sci. Technol. 2002, 56 (6), 332-371.
18. Borchert, S.; Ryan, M.; Davison, R.; Speed, W. Accelerated extractable studies of borosilicate glass. J. Parenteral Sci. Technol. 1989, 43, 67-79. (Pubitemid 19103048)
19. Hasegawa, K.; Hashi, K.; Okada, R. Physiochemical stability of pharmaceutical phosphate buffer solutions. II. Complexation behavior of Al(III) with additives in phosphate buffer solutions. J. Parenteral Sci. Technol. 1982, 36, 128.
20. Hasegawa, K.; Hashi, K.; Okada, R. Physiochemical stability of pharmaceutical phosphate buffer solutions. IV. Prevention of precipitation in phosphate buffer solutions. J. Parenteral Sci. Technol. 1982, 36, 210.
21. McHalsky, M. L.; Rainbow, B. E.; Ericson, S. P.; Weltzer, J. A.; Ayd, S. W. Reduction of aluminum levels in dialysis fluids through the development and use of accurate and sensitive analytical methodology. J. Parenteral Sci. Technol. 1987, 41, 67.
22. Reinke, C.; Breitkreutz, J.; Leuenberger, H. Aluminum in over-the-counter drugs: risks outweigh benefits? Drug Safety 2003, 26, 1011-1025.
23. Lione, A. Aluminum toxicology and the aluminum containing medications. Pharmacol. Ther. 1985, 29, 255-285.