Pediatric Pharmaceutical Reformulation Program

While there has been much progress in providing pediatricians information on the safe and effective use of medicines in children, many medicines are still not available in a dosage or delivery form that is optimal for use by children and their families. Extemporaneous preparations of medicines may not be available, and where they are, they are often not validated for quality. The gap in availability of safe, stable, validated, and palatable formulations defines the need for a robust portfolio of new, differentiated, value-added formulations of existing medicines.

IPI’s Pediatric Pharmaceutical Reformulation Program focuses on existing medicines that already have FDA approval, and that require reformulation to enhance their safe, effective, and compliant use in children. In consultation with the Federal Drug Administration (FDA), National Institute of Child Health and Human Development (NICHD), United States Pharmacopeia ( USP) , World Health Organization (WHO) and other public and private organizations, we are defining needs and working toward the development of new medicinal products for children.

Members of our Pediatric Hospital Consortium are providing detailed data on the compounds they reformulate. Our advisors and other collaborators participate at critical stages in defining product needs and specifications, and in evaluating products as they are developed. IPI will work with partnering organization to help develop initial formulations, and with commercial entities that can convert concepts into products for pedicatric use that are manufactured and marketed according to Good Manufacturing Practice (GMP) standards.

Children’s Mercy Hospital and Clinics in Kansas City, one of our hospital partners, has provided initial funding for the program. Stephen P. Spielberg, MD, PhD, is the principal investigator for the Pediatric Pharmaceutical Reformulation Program.