Avaliação da estabilidade de formulação oral líquida hospitalar de benzoato de sódio

Abstract

Urea Cycle Disorders are types of metabolic conditions related with the erroneous metabolism of plasmatic ammonium. Sodium Benzoate is a substance used on the treatment of these genetic diseases. It is capable of forcing the metabolism of toxic ammonium through the synthesis of hippuric acid by activating an alternative pathway. Because children are the ones usually affected by this syndrome, it is extremely important to hold information on the stability of the formulations used on such cases. A sodium benzoate 333 mg/mL water solution, used in the Hospital de Clínicas of Porto Alegre, had its chemical stability evaluated. For the study, the analytical method was validated. The samples were divided in two types of flasks: amber glass flaks and polyethylene terephthalate (PET) flasks. During six weeks three samples were stored in the refrigerator (2-5 ºC), at room temperature (25 ºC) and in a lab oven (40 ºC) and analyzed every two weeks. The studied showed that the formulation was stable during the whole period, not showing an important difference on its concentration or its pH value.