Target product profiles for paediatric formulations of azithromycin and nitrofurantoin

Area of Science:

• Pharmaceutical Sciences
• Pediatric Infectious Diseases
• Drug Formulation

Background:

• Bacterial infections remain a leading cause of mortality in children under five.
• A significant gap exists in age-appropriate antibiotic formulations, limiting effective treatment.
• Existing pediatric antibiotic options often have palatability issues or safety concerns regarding excipients.

Purpose of the Study:

• To develop Target Product Profiles (TPPs) for age-appropriate antibiotic formulations for azithromycin and nitrofurantoin.
• To guide pharmaceutical development and regulatory processes for pediatric antibiotic needs.
• To address the World Health Organization's (WHO) priority list for pediatric antibiotic formulations.

Main Methods:

• Utilized WHO's established methodologies to create TPPs for azithromycin and nitrofurantoin.
• Defined optimal and minimum requirements for dispersible and orodispersible formulations.
• Considered WHO-recommended pediatric dosage guidelines for nitrofurantoin.

Main Results:

• For azithromycin, optimal formulations include 100 mg dispersible tablets or 50 mg orodispersible multiparticulate systems; 50 mg dispersible tablets are the minimum.
• For nitrofurantoin, optimal formulations are orodispersible multiparticulate or scored dispersible tablets; dispersible tablets are the minimum.
• Recommended optimal nitrofurantoin unit doses of 5 mg and 10 mg for pediatric use, based on a 4 mg/kg/day dosage.

Conclusions:

• The developed TPPs provide clear targets for creating safer and more effective pediatric antibiotic formulations.
• These profiles will aid stakeholders in advancing the availability of child-appropriate azithromycin and nitrofurantoin.
• Improving formulation accessibility is key to enhancing pediatric healthcare and reducing mortality from bacterial infections.