Desenvolvimento de um método de obtenção do radiofármaco macro-agregado de albumina para marcação com 99mTC e aplicação em medicina nuclear

Abstract

This work proposes a methodology to obtain the radiopharmaceutical Human Macro-Aggregate Albumin (MAA) for further labeling with the radioisotope technetium-99-metastable (99mTc) and use in diagnostic imaging. The method proposes a process improvement during the manufacturing process for the production of this radiopharmaceutical regarding the established procedures described in international bibliography. 99mTc-MAA is a indispensable radiopharmaceutical, especially for the diagnosis of lung diseases, allowing the evaluation of patient perfusion capacity. This work presents the studies designed to obtain a lyophilized, non-toxic, sterile and pyrogen-free pharmaceutical preparation for intravenous administration. The injectable product reconstituted was characterized by the uniformity of the particles in suspension in relation to the number and size of protein aggregates. The analysis of optical microscopy and scanning electron microscopy (SEM) to check the number and size of particles have showed that none of the aggregates had size larger than 150 microns, therefore, within the clinical application limit. The radiochemical assays demonstrated the production of a product with high radiochemical purity (RQP). The radiochemical characteristics presented by the marked product according to the international pharmacopoeial requirements (QRP > 90%) allowing its use for diagnostic imaging through the technique that uses scintigraphic evaluation of pulmonary perfusion in nuclear medicine by single-photon emission computed tomography (SPECT).