Formulation
The development of an age-appropriate formulation and commitment to
commercialization if use of the product is extended to the pediatric
population based on study results is a requirement of the WR.
Bioavailability of any formulation used in the studies must be
characterized, and as needed, a relative bioavailability study comparing
the approved drug to the age appropriate formulation may be conducted in
adults. Special formulations have been developed for 5 drugs in response
to the WRs initiated since 2001. For example, the adult formulation of
capecitabine is tablets. Pediatric film-coated tablets were designed to
quickly disperse in water so that can be administered to pediatric
patients who are unable to swallow tablets.
(https://www.fda.gov/media/87706/download).