RT Journal Article
SR Electronic
T1 Aluminum in Albumin for Injection
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 187
OP 190
VO 42
IS 6
A1 Quagliaro, D. A.
A1 Geraci, V. A.
A1 Dwan , R. E.
A1 Kent, R. S.
A1 OLSON, W. P.
YR 1988
UL http://journal.pda.org/content/42/6/187.abstract
AB Aluminum, presented intravenously to patients with impaired kidney function, is toxic. Solutions of human albumin, used for the replacement of plasma colloids, initially acquire aluminum from the following sources: the diatomaceous earth used during processing " the glass final containers > clayfilled elastomeric closures > depth filters containing diatomaceous earth. The final containers and closures provide an ongoing source of aluminum until the lime of use and, over time in the final container, glass becomes the predominant source of Al. A reduction in the exposure time of the plasma fraction to diatomaceous earth, and attention to the pH of that exposure, appeared to reduce the Al burden of the albumin product. Coating the glass vial with a layer of heat-fused silicone appeared to retard the migration of Al from glass into the product; a plastic container contributed no Al. We speculate that elastomeric closures containingfillers other than clay, e.g., carbon, also would contribute to reducing the Al burden of the product.