Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North...

Area of Science:

• Pharmaceutical Sciences
• Pediatric Pharmacology
• Drug Development

Background:

• Limited availability of US Food and Drug Administration (US-FDA)-approved oral liquid medications for pediatric populations in North America.
• Challenges in accessing standardized and high-quality compounded nonsterile preparations (CNSPs) for children.

Purpose of the Study:

• Evaluate current US-FDA-approved oral liquid, powder, or granule products for pediatric suitability.
• Identify promising Active Pharmaceutical Ingredients (APIs) for future FDA-approved liquid dosage forms.
• Propose a framework for developing commercially available liquid formulations and guide extemporaneous compounding practices.

Main Methods:

• Review of recent US-FDA-approved marketed oral pediatric products.
• Analysis of APIs with high potential for liquid dosage form development.
• Categorization of compounded nonsterile preparations (CNSPs) for commercialization versus continued extemporaneous compounding.

Main Results:

• Identification of suitable existing US-FDA-approved products for pediatric use.
• A prioritized list of APIs for development into FDA-approved liquid formulations.
• Recommendations for specific CNSPs to transition to commercial manufacturing.

Conclusions:

• Collaboration between industry, government, and professionals is crucial for improving pediatric medication options.
• Standardization of compounded preparations and development of new FDA-approved liquid products will enhance patient safety and access.
• This work provides a roadmap for optimizing the availability of liquid medications for pediatric patients.