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The AAPS Journal

, Volume 15, Issue 4, pp 1072–1081 | Cite as

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

  • Anne Zajicek
  • Michael J. Fossler
  • Jeffrey S. Barrett
  • Jeffrey H. Worthington
  • Robert Ternik
  • Georgia Charkoftaki
  • Susan Lum
  • Jörg Breitkreutz
  • Mike Baltezor
  • Panos Macheras
  • Mansoor Khan
  • Shreeram Agharkar
  • David Douglas MacLaren
Commentary Theme: Challenges and Opportunities in Pediatric Drug Development

Abstract

Despite the fact that a significant percentage of the population is unable to swallow tablets and capsules, these dosage forms continue to be the default standard. These oral formulations fail many patients, especially children, because of large tablet or capsule size, poor palatability, and lack of correct dosage strength. The clinical result is often lack of adherence and therapeutic failure. The American Association of Pharmaceutical Scientists formed a Pediatric Formulations Task Force, consisting of members with various areas of expertise including pediatrics, formulation development, clinical pharmacology, and regulatory science, in order to identify pediatric, manufacturing, and regulatory issues and areas of needed research and regulatory guidance. Dosage form and palatability standards for all pediatric ages, relative bioavailability requirements, and small batch manufacturing capabilities and creation of a viable economic model were identified as particular needs. This assessment is considered an important first step for a task force seeking creative approaches to providing more appropriate oral formulations for children.

KEY WORDS

children drugs formulations manufacturing palatability pediatrics regulatory 

Notes

ACKNOWLEDGMENTS

The authors would like to thank Drs. Philip Mayer and David Mitchell and AAPS for facilitating this effort and to Sharon Pichon of AAPS for facilitating the calls and meetings with the co-authors

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Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  • Anne Zajicek
    • 1
  • Michael J. Fossler
    • 2
  • Jeffrey S. Barrett
    • 3
  • Jeffrey H. Worthington
    • 4
  • Robert Ternik
    • 5
  • Georgia Charkoftaki
    • 6
  • Susan Lum
    • 7
  • Jörg Breitkreutz
    • 8
  • Mike Baltezor
    • 9
  • Panos Macheras
    • 6
  • Mansoor Khan
    • 10
  • Shreeram Agharkar
    • 11
  • David Douglas MacLaren
    • 12
  1. 1.Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentNational Institutes of HealthBethesdaUSA
  2. 2.Clinical Pharmacology Modeling and SimulationGlaxoSmithKlineKing of PrussiaUSA
  3. 3.Clinical Pharmacology & Therapeutics DivisionThe Children’s Hospital of PhiladelphiaPhiladelphiaUSA
  4. 4.Senopsys LLCWoburnUSA
  5. 5.Small Molecule Design and DevelopmentEli Lilly and CompanyIndianapolisUSA
  6. 6.Laboratory of Biopharmaceutics & Pharmacokinetics, Faculty of PharmacyNational & Kapodistrian University of AthensAthensGreece
  7. 7.Bureau of Pharmaceutical Sciences, Therapeutics Products DirectorateHealth CanadaOttawaCanada
  8. 8.Institute of Pharmaceutics and BiopharmaceuticsHeinrich Heine UniversityDüsseldorfGermany
  9. 9.Biotechnology Innovation and Optimization Center, Institute for Advancing Medical InnovationUniversity of KansasLawrenceUSA
  10. 10.FDA Center for Drug Evaluation and ResearchSilver SpringUSA
  11. 11.Global CMC—Strategy & Scientific Affairs; Lead Generation & Candidate Realization, Sanofi R&DBridgewaterUSA
  12. 12.Drug Product Development and CT ManufacturingEli Lilly and CompanyIndianapolisUSA

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