Metronidazole Suspension for Paediatric Use in Developing Countries: Formulation, Quality, and Stability

Area of Science:

• Pharmaceutical Sciences
• Pediatric Drug Development

Background:

• Paediatric populations remain a therapeutic orphan group, with significant drug formulation shortfalls, especially in low and middle-income countries.
• Existing challenges necessitate the development of accessible and effective pediatric medications.

Purpose of the Study:

• To develop a simple, low-cost metronidazole liquid formulation for pediatric use.
• To ensure the quality and stability of the pediatric metronidazole suspension under various storage conditions.

Main Methods:

• Preparation of various excipient mixtures to achieve a 250 mg/5 mL metronidazole concentration.
• Quality control testing including content uniformity, pH, and dispersion.
• Stability evaluation over 180 days at room temperature, 40°C, and 4°C.

Main Results:

• The developed metronidazole formulation demonstrated excellent quality and stability.
• No significant variation (>10%) in metronidazole concentration or pH was observed after 180 days across all tested temperatures.
• Microscopic analysis confirmed formulation integrity over the study period.

Conclusions:

• The metronidazole suspension is stable under diverse environmental conditions, suitable for use in tropical regions with variable storage capabilities.
• Its simple composition and preparation method allow for quality-assured production in any setting, improving pediatric medicine accessibility.