Stability study of an extemporaneous furosemide oral suspension prepared using commercially available tablets with X-Temp® Oral Suspension System

Introduction:Furosemide is a widely used loop diuretic for managing conditions such as oedema and hypertension.In paediatric patients, especially in the absence of commercially available liquid formulations, extemporaneous oral suspensions are often prepared.This study aimed to evaluate the stability of furosemide oral suspensions formulated at two different concentrations, made from commercial tablets using the X-Temp Oral Suspension System.Methods: Furosemide suspensions were prepared at concentrations of 2 mg/mL and 10 mg/mL using the X-Temp system, then packaged in amber HDPE bottles.The suspensions were stored under refrigeration (5 3C) or at room temperature (30 2C) for a duration of up to 90 days.A comprehensive evaluation protocol, including visual inspections, pH measurements, and HPLC assays, provided a multifaceted assessment of the samples' stability over the 90-day period.The inclusion of microbiological testing at each interval further reinforced the safety profile of the product.A validated HPLC method was used to determine furosemide content in the oral suspension, ensuring the accuracy, precision, and reliability of the analytical data provided by the system.Results: The results showed no statistically significant changes in the assay of furosemide suspension at concentrations of 2 mg/mL and 10 mg/mL over 90 days (n = 3, p > 0.05).In addition, the stability studies revealed that furosemide in X-Temp suspension was physically and microbiologically stable throughout the study period.HPLC analysis results shows that all the samples maintained drug concentrations within the specified range.Therefore, it can be concluded that furosemide tablets can be compounded extemporaneously using the X-Temp Oral Suspension System at concentrations between 2 mg/mL and 10 mg/mL.The resulting suspensions remain stable for up to 90 days when stored in amber HDPE bottles at either 5 3C or 30 2C.Conclusion: This study provides important insights into the stability of extemporaneous furosemide oral suspensions compounded using the X-Temp Oral Suspension System.The findings offer valuable guidelines for the preparation, storage, and use of furosemide in X-Temp suspensions in paediatric care, highlighting the need for careful consideration of storage conditions to ensure therapeutic efficacy.