RESUMO
Accelerated stability tests are indicated to assess, within a short time, the degree of chemical degradation that may affect an active substance, either alone or in a formula, under normal storage conditions. This method is based on increased stress conditions to accelerate the rate of chemical degradation. Based on the equation of the straight line obtained as a function of the reaction order (at 50 and 70 degrees C) and using Arrhenius equation, the speed of the reaction was calculated for the temperature of 20 degrees C (normal storage conditions). This model of accelerated stability test makes it possible to predict the chemical stability of any active substance at any given moment, as long as the method to quantify the chemical substance is available. As an example of the applicability of Arrhenius equation in accelerated stability tests, a 2.5% sodium hypochlorite solution was analyzed due to its chemical instability. Iodometric titration was used to quantify free residual chlorine in the solutions. Based on data obtained keeping this solution at 50 and 70 degrees C, using Arrhenius equation and considering 2.0% of free residual chlorine as the minimum acceptable threshold, the shelf-life was equal to 166 days at 20 degrees C. This model, however, makes it possible to calculate shelf-life at any other given temperature.
Assuntos
Irrigantes do Canal Radicular/química , Hipoclorito de Sódio/química , Algoritmos , Cloro/análise , Estabilidade de Medicamentos , Armazenamento de Medicamentos , CinéticaRESUMO
Introduction: Sodium hypochlorite has been used as an endodontic irrigant since 1936, when Walker used it as Sodium Chlorine. Since then it has became the most well acceptable endodontic irrigant. During the last few years many studies have reported the importance of pH control. Objective: This study evaluates the inflammatory response of some endodontic irrigations solutions in the subcutaneous connective tissue of mice. Material and methods: Thirty-six mice were obtained from the Biomedical Sciences Institute at the University of São Paulo. Their backs were divided into four quadrants and each quadrant was injured with an 8 mm punch. Three of these wounds were submitted to differents solutions, while the fourth was used as a control. This experiment was done in triplicate. After the irrigation of the wounds, the mice were sacrificed at 3, 7 and 14 days. The samples were fixed on 10% formalin and histologically analyzed after hematoxylin and eosin staining. Results: At 14 days all wounds were covered with epithelium with a mild inflammatory infiltrate in the subjacent connective tissue, except for the group that employed 5% sodium hypochlorite at pH 11. Conclusion: The greatest the pH and concentration of sodium hypochlorite solutions, the most toxic they are.
RESUMO
Accelerated stability tests are indicated to assess, within a short time, the degree of chemical degradation that may affect an active substance, either alone or in a formula, under normal storage conditions. This method is based on increased stress conditions to accelerate the rate of chemical degradation. Based on the equation of the straight line obtained as a function of the reaction order (at 50 and 70 ºC) and using Arrhenius equation, the speed of the reaction was calculated for the temperature of 20 ºC (normal storage conditions). This model of accelerated stability test makes it possible to predict the chemical stability of any active substance at any given moment, as long as the method to quantify the chemical substance is available. As an example of the applicability of Arrhenius equation in accelerated stability tests, a 2.5 percent sodium hypochlorite solution was analyzed due to its chemical instability. Iodometric titration was used to quantify free residual chlorine in the solutions. Based on data obtained keeping this solution at 50 and 70 ºC, using Arrhenius equation and considering 2.0 percent of free residual chlorine as the minimum acceptable threshold, the shelf-life was equal to 166 days at 20 ºC. This model, however, makes it possible to calculate shelf-life at any other given temperature.
Testes acelerados de estabilidade são indicados para avaliar, em um curto período de tempo, o grau de degradação química que poderá afetar uma substância química, isoladamente ou quando inserida em uma fórmula, sob condições normais de armazenamento. Este método está fundamentado na intensificação das condições de estresse para acelerar a velocidade de degradação química. Baseando-se na equação da reta obtida e na ordem de reação determinada (a 50 e 70 ºC) e usando a equação de Arrhenius, a velocidade de reação foi calculada para a condição de temperatura de 20ºC (condições normais de armazenamento). Este modelo de teste acelerado de estabilidade torna possível a predição da estabilidade química de qualquer substância, em qualquer tempo, desde que o método de quantificação da substância química esteja disponível. Como exemplo da aplicabilidade da equação de Arrhenius em teste acelerado de estabilidade, uma solução de hipoclorito de sódio a 2,5 por cento foi analisada por ser quimicamente instável. A quantificação do cloro residual livre foi determinada através de titulação iodométrica. A partir dos dados obtidos decorrentes das amostras submetidas às temperaturas de 50 e 70 ºC e com o emprego da equação de Arrhenius, o tempo de prateleira obtido foi de 166 dias em temperatura de 20 ºC, considerando como limite inferior a concentração de 20 mg/mL de cloro residual livre. Este modelo, entretanto, possibilita o cálculo de tempo de prateleira em qualquer outra temperatura de interesse.