Hospital preparations of ethanol-free furosemide oral solutions: Formulation and stability study

Area of Science:

• Pharmaceutical Sciences
• Pediatric Pharmacology

Background:

• Furosemide is a vital diuretic for managing edema and hypertension.
• Existing furosemide dosage forms are inadequate for children under six, highlighting a critical unmet need.
• Development of pediatric-specific hospital preparations is essential.

Purpose of the Study:

• To formulate and evaluate oral pediatric furosemide solutions (2 mg/mL).
• To assess the physicochemical and microbiological stability of these formulations under storage conditions.
• To identify a suitable furosemide preparation for pediatric hospital use.

Main Methods:

• Four oral furosemide solutions were formulated, with two being ethanol-free.
• Batches were prepared and packaged in brown glass bottles.
• Physicochemical properties (pH, osmolarity, drug content) and microbiological quality were assessed initially and after 90 days of storage at 30°C/65% RH.

Main Results:

• All freshly prepared solutions met specifications.
• After 90 days of storage, solutions with sucrose and ethanol-free formulations showed a slight decrease in pH and furosemide content (2.5%-4.5%).
• Despite minor changes, all formulations remained within acceptable specifications.

Conclusions:

• Ethanol-free furosemide oral solutions, particularly one containing sorbitol, exhibit adequate stability for pediatric use.
• This formulation is a promising candidate for implementation in hospitals for pediatric patient care.
• Addressing the lack of suitable pediatric furosemide formulations is critical for effective treatment.