Banca de DEFESA: GABRIELA LEMOS RIBEIRO DE SOUZA

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : GABRIELA LEMOS RIBEIRO DE SOUZA
DATE: 01/03/2024
TIME: 09:00
LOCAL: Auditório Campus Nova Gameleira
TITLE:

"OTIMIZATION AND VALIDATION OF ANALYTICAL METHODOLOGY APPLIED TO HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY FOR THE CHARACTERIZATION OF THE RADIODRUG PSMA-1007 (18F)."

KEY WORDS:

Quality Control, prostate, radiopharmaceutical, PSMA, HPLC.

PAGES: 52
BIG AREA: Ciências Exatas e da Terra
AREA: Química
SUBÁREA: Química Analítica
SPECIALTY: Separação
SUMMARY:

In Brazil, prostate cancer is the second most common type of malignant tumor in males. When this type of cancer is detected early, the chance of a cure increases significantly. In nuclear medicine, radiopharmaceuticals have been widely used for diagnostic and/or therapeutic purposes of the disease, such as in Positron Emission Tomography and Computed Tomography (PET/CT) examinations, respectively. When administered to the patient, the radiopharmaceutical is directed to an organ of interest due to the physiological or pathophysiological function of the disease. Prostate Specific Membrane Antigen marked with 18F, Prostate Specific Membrane Antigen (PSMA-1007(18F)) is a new radiopharmaceutical that has a positron-emitting radionuclide and is used for diagnostic purposes. In prostate cancer cells, PSMA is overexpressed, so PSMA molecules labeled with ¹⁸F will bind to them with high affinity. PSMA-1007(¹⁸F) accumulation in these cells allows PET images to be obtained revealing the presence of the tumor, as well as its extent and aggressiveness. The synthesis of this radiopharmaceutical is carried out via nucleophilic substitution, where the radiolabeled fluoride (¹⁸F-) attacks the precursor of the C₅₄H₆₄F₃N₉O₁₈ reaction, and for its use to be safe, ANVISA recommends quality control tests that meet the Good Manufacturing Practices established by regulatory body.

Aiming to optimize quality control, an analytical method implemented in High Efficiency Liquid Chromatography (HPLC) was developed to determine purity and radiochemical identification. The method elaborated in the present work, in relation to the methodology developed at CDTN based on the methodology described in the European Pharmacopoeia, presents some advantages such as replacing the organic solvent with a cheaper one, easier to acquire and with lower toxicity, changing the solvent aqueous by one that does not use buffer, avoiding column clogging and reducing the running time from 21 minutes to 10 minutes. As a result, there was less solvent consumption, less generation of chemical waste, a reduction in experiment costs and health risks, resulting in a more sustainable process. The analytical validation of the process was satisfactory as it met all the criteria required in RDC nº 166/2017 of ANVISA.

COMMITTEE MEMBERS:
Presidente - ILDEFONSO BINATTI
Interno - PATTERSON PATRICIO DE SOUZA
Externa ao Programa - JUNIA DE OLIVEIRA ALVES BINATTI
Externo ao Programa - CLEVERSON FERNANDO GARCIA