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U.S. Department of Health and Human Services

About FDA

Pediatric Platform Technologies

Description: This project, as part of an Inter-Agency agreement with the National Institutes of Health (NIH), seeks to identify formulation challenges in pediatric platform development, and to promote development of safe and effective medications for children by formulating prototype batches of selected drug products.

Accomplishment: Agency and the public have a better appreciation of the technical challenges of developing pediatric friendly dosage forms. Depending upon the solubility and permeability classification, drug substances can be formulated as syrups, suspensions, pediatric friendly orally disintegrating tablets, or other dosage forms. Several molecules with very bitter functional groups can be complex or coated with excipients to mask their taste. Some of the findings have been communicated by publications and in public workshops conducted by NIH/NICHD, American Association of Pharmaceutical Scientists (AAPS), European Pediatric Formulations Initiative (EuPFI), FDA Pediatric Advisory Committee, and CDE Science Rounds.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Assess commercially available products to determine and classify formulation challenges

3/31/2011

Completed 3/31/2011

2. Determine publicly available technologies in current use for producing pediatric formulations for various drug product classes

6/30/2011

Completed 6/30/2011

3. Employ computational methods to categorize the molecular structures of prototypical drug products

10/31/2011

Completed 10/31/2011

4. Determine the optimal platform technologies for specific drug categories using the information from 1-3

2/28/2012

Completed 2/28/2012

5. Formulate and evaluate prototype batches of selected pediatric formulations

6/30/2012

Completed 10/2012

6. Document results through publically accessible publications, presentations and a joint workshop with NIH collaborators

11/30/2012

Completed 11/30/12

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.