Formulación de -Macroagregados de albúmina para estudios de perfusión pulmonar

abstract the present paper shows the design, optimization, quality control for testing radiochemical purity, biological quality and realtime stability studies of a preparation of macroaggregated albumin from the controlled denaturation of hsa. an experimental design with a factorial plan was carried out in order to determine the ideal conditions for the preparation. the results showed that variations of albumin concentrations within the range of 515 mg/ml were irrelevant, however, the final ph of the mixture and the stirring speed were significant variables, as well as their interaction. formulations with particles of diameter between 11 and 80 μ were obtained with the conditions selected in the experimental design which met the internationally established criteria for radiochemical purity, sterility and apyrogenicity. the biodistribution in experimental animals showed good quality lung images. the produced lots maintained physical, radiochemical, biological and microbiological stability during 90 days of storage at 4°c.