Background Defects in the urea cycle are genetic diseases in which nitrogen accumulates as ammonia, resulting as highly toxic, especially in paediatric patients. Sodium benzoate (SB) is conjugated with glycine, giving rise to hippurate, which is excreted in the urine. Currently there are only intravenous SB commercial presentations, but no oral preparation is commercialised. Due to this, its manufacture in hospital pharmacy services is necessary.
Purpose The main objective is to evaluate the stability of an oral solution of 10% SB at different storage conditions for the treatment of urea cycle disorders in paediatric patients.
Material and methods Initially, six 10% SB samples were prepared from the commercial SB powder (Acofarma) and sterile water. Three were kept at room temperature and three were stored at 2°C–8°C during 30 days, protected from light. On the other hand, SB was characterised spectrophotometrically in water, to obtain a calibration curve. We studied several physical and chemical parameters after preparation (day 0) and after 7 and 30 days. These parameters were colour, opacity and the presence of precipitation, absorbance and pH. Each preparation was visually inspected in front of a black and white background. pH measurements were carried out by pH indicator strips. All absorbance measurements were obtained after dilution of solutions, with a Shimadzu spectrophotometer model UVmini-1240 UV-Vis.
Results All 10% SB solutions were initially homogenous and transparent. A calibration curve was obtained at 223 nm (y=56 495x+0.0177; R2=0.9995), with an average recovery percentage of 99.92% (SD=1.21; CV=1.21). On day 7 post-elaboration, an average degradation of 1.49% of active ingredient was observed in room-temperature stored samples and 2.82% in refrigerated samples. On day 30, the percentage of loss increased to 2.55% and 3.48% respectively. After 30 days, no colour change, no opacity and no precipitation were observed. In all test solutions the pH-values remained unchanged.
Conclusion The results allow us to conclude that our 10% SB oral solution, used in urea cycle defects in paediatric patients, are physically and chemically stable for at least 30 days when stored at room temperature or at 5°C±3°C with protection from light.
References and/or acknowledgements N/A.
No conflict of interest.
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