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 Pediatric Formulations Initiative (PFI)

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Best Pharmaceuticals for Children Act (BPCA)

​​​​​​The PFI is designed to look at all the factors that affect the development of pediatric drugs. The goals are to create a roadmap for removing/mitigating barriers to pediatric drug development, and to connect researchers and experts in pediatric formulation to discuss issues and challenges that may stimulate further research in the field.

The PFI has four groups:

  • ​Scientific, technical, and regulatory barriers for the development of pediatric formulations
  • Taste, smell, and flavor research in infants and children
  • Economic issues and partnerships
  • Use and application in pediatrics of new drug delivery systems

Following are links to the minutes from past PFI meetings:

Pediatric Formulations Platform

The lack of a pediatric formulation was one consideration for prioritization, because the lack of commercially available oral pediatric formulations is a continuing problem for children, parents, and pediatricians. Also, there is no coherent approach to the development of pediatric formulations.

​The ideal pediatric dosage form would:

  • Be orally dissolvable
  • Be tasteless
  • Have an appropriate dosage increment for the smallest infants
  • Contain minimal amounts of excipients
  • Be stable in light, humidity, and heat
  • Have the necessary release characteristics, as applicable
​The Pediatric Formulations Platform uses NIH BPCA funds to: (1) fund FDA chemists' assessment of pediatric product formulations, and to: (2) produce an open-source, publicly available approach to pediatric oral formulations manufacturing.

The work of the Platform includes five tasks:
  1. Perform an assessment of all commercially available products to determine which have pediatric formulations.
  2. Determine what technologies are publicly available, how these technologies have been used, and for what types of products.
  3. Use prototypical drug products and employ computational methods to distinguish their molecular structure through characteristics such as solubility, permeability, light sensitivity, pH instability, heat instability, hygroscopic properties, and bitterness.
  4. Determine the best formulations technology for specific drug categories, based on information from tasks 1–3.
  5. Produce prototype batches of selected drug products.

The goal is to make these data publicly available as soon as possible.

As a first step, the Biopharmaceutics Classification System assessment of all commercially available products is archived as "Oral Formulations Platform—Reports 1 and 2." When further stages are completed, they will be posted.

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