Patent ID: 6730286
Filing Date: 2004-05-04
Classification: A61K

Abstract:
A process for preparing a sterile, non-pyrogenic injectable suspension of radiolabeled macroaggregate particles of albumin for scanning a mammalian patient comprising the steps of:a) mixing serum albumin with 0.9% w/v saline solution and ultrafiltering the mixture through a membrane having a molecular weight cut-off of 10,000; b) mixing a buffer having a pH of from 4.95 to about 5.25 with the ultrafiltered mixture to obtain a buffered, ultrafiltered mixture; c) passing the buffered, ultrafiltered mixture through a sterilizing filter to obtain a sterile mixture; d) adding a sterile filtered stannous halide in HCl solution to the buffered sterile mixture to obtain a sterile reaction mixture; e) heating the reaction mixture gradually while stirring continuously so that it attains about 75Â° C. to 95Â° C. in about 90 to about 110 minutes; f) cooling the reaction mixture gradually while stirring continuously so that the macroaggregates containing the stannous halide are formed; g) separating the macroaggregates from the reaction mixture, resuspending them in sterile water for injection, and filtering them through a sizing screen; h) adjusting the concentration of the macroaggregates with sterile water for injection and adding sterile, filtered, purified albumin; i) transferring the suspension into vials for storage and lyophilization; j) flooding the lyophilized vial with inert gas before sealing the lyophilized vial under an inert gas atmosphere; and k) reconstituting the lyophilized serum albumin with aqueous 99mTc pertechnate solution.