Dose Uniformity of Two Formulations Compounded Furosemide 2 mg/ml Syrup
摘要
Furosemide is sulfonamide diuretic, potent loop of Henle diuretic drug that is most common diuretic used in newborn period. In pediatric patients, furosemide is used in medical conditions of acute and chronic edema associated with cardiovascular, hepatic, pulmonary and renal disease. Licensed furosemide is in form of tablets and injectables with no licensed product for children at all. Hospital pharmacist are trained to bypass this problem by formulating compounded medicines that are customized to ensure flexible and precise dosing. These preparation are essential in cases when drug is not commercially available or suitable in terms of strength or route of administration. During formulating and compounding process it is necessary to consider physical stability of suspensions as well as and chemical stability of furosemide as active pharmaceutical ingredient. Aim of this work is to examine dose uniformity between two different extempore formulations of compounded furosemide syrup made from injections and the other made from tablets, using syrup simplex as vehiculum. Considering physical and chemical characteristics of furosemide most convenient formulation was evaluated. Two different ethanol/preservative free formulations were examined in order to evaluate homogeneity and consequently dose uniformity of every single dose. Visually evaluated parameters of different furosemide oral syrups were appearance, color, and taste. Redispersion after shaking and forming precipitate is estimated. Method for assay determination was based on ultraviolet (UV) spectrophotometry. Absorbance was measured at 272 nm. Calibration curve was constructed in concentrations 0,009–0,012 mg/ml. Both extempore formulation have good visual characteristic with good homogeneity, redispersion and pourability. Uniformity of dosage units is within declared limits in both formulation. For formulation 1 it was in range between 92.67% and 99.17% and for formulation 2 in range between 92.89% and 102.15%. However formulation 1 has better characteristics as pouring from the bottle due to less viscosity.