Formulation Development of Aqueous Injection of Poorly Soluble Drug Using Mixed Hydrotropic Solubilization Concept and Its Evaluation
Keywords:
Topics covered include synergistic augmentation, mixed hydrotropy, solubilization, furosemide, urea, sodium acetate, and sodium benzoate in an aqueous injection setting.Abstract
Edema caused by congestive heart failure, liver cirrhosis, renal illness (including nephrotic syndrome), and other conditions may be treated
with furosemide, a high ceiling diuretic that also has antihypertensive action. It dissolves very little, if any, in water. An examination was
conducted into how several hydrotropes, including urea, sodium citrate, sodium benzoate, sodium acetate, and mixtures thereof, impacted the
solubility of furosemide. When compared to its solubility in distilled water, furosemide's solubility in 40% sodium benzoate, 14.81 urea, 11.85
sodium citrate, and 9.35 sodium acetate solutions was up to 200.46 times, 11.5 fold, and 9.35 fold, respectively. Compared to blend BU, which
had sodium benzoate and urea in a ratio of 20:20, the drug's solubility was increased by 357.87 times in blend BUC, which contained sodium
citrate, urea, and sodium benzoate in a ratio of 13.3:13.3:13.3. Mixed hydrotropy resulted in a synergistic increase in the solubility of a
medication that was previously poorly soluble in water. Reducing the potential for separate toxicities, a synergistic solvent effect may be
achieved by combining hydrotropic compounds. This allows for a less quantity of hydrotropic agents to be used. Using the combined
hydrotropic solubilization approach, furosemide was created for aqueous injection. Researchers looked at the physical and chemical stability
of the new composition. There was no change to the color stability of the produced formulation. The developed formulation did not exhibit
any color change or precipitate. By the conclusion of the freeze-thaw test, the parenteral formulation that had been designed had neither
precipitation nor turbidity. After 30 days of storage at varying temperatures, the chemical stability test revealed that the formulation retained
an equivalent amount of furosemide. It follows that the formulation should be chemically stable enough to be stored at room temperature.
