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

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  • Theme: Challenges and Opportunities in Pediatric Drug Development
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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.

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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

Author information

Authors and Affiliations

  1. Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA

    Anne Zajicek

  2. Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, King of Prussia, Philadelphia, USA

    Michael J. Fossler

  3. Clinical Pharmacology & Therapeutics Division, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA

    Jeffrey S. Barrett

  4. Senopsys LLC, Woburn, Massachusetts, USA

    Jeffrey H. Worthington

  5. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    Robert Ternik

  6. Laboratory of Biopharmaceutics & Pharmacokinetics, Faculty of Pharmacy, National & Kapodistrian University of Athens, Athens, Greece

    Georgia Charkoftaki & Panos Macheras

  7. Bureau of Pharmaceutical Sciences, Therapeutics Products Directorate, Health Canada, Ottawa, Ontario, Canada

    Susan Lum

  8. Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Düsseldorf, Germany

    Jörg Breitkreutz

  9. Biotechnology Innovation and Optimization Center, Institute for Advancing Medical Innovation, University of Kansas, Lawrence, Kansas, USA

    Mike Baltezor

  10. FDA Center for Drug Evaluation and Research, Silver Spring, Maryland, USA

    Mansoor Khan

  11. Global CMC—Strategy & Scientific Affairs; Lead Generation & Candidate Realization, Sanofi R&D, Bridgewater, New Jersey, USA

    Shreeram Agharkar

  12. Drug Product Development and CT Manufacturing, Eli Lilly and Company, Indianapolis, Indiana, USA

    David Douglas MacLaren

Authors
  1. Anne Zajicek
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  2. Michael J. Fossler
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  3. Jeffrey S. Barrett
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  4. Jeffrey H. Worthington
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  5. Robert Ternik
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  6. Georgia Charkoftaki
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  7. Susan Lum
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  8. Jörg Breitkreutz
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  9. Mike Baltezor
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  10. Panos Macheras
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  11. Mansoor Khan
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  12. Shreeram Agharkar
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  13. David Douglas MacLaren
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Corresponding author

Correspondence to Anne Zajicek.

Additional information

Guest Editors: Bernd Meibohm, Jeffrey S. Barrett, and Gregory Knipp

During the 2010 Pharmaceutical Sciences World Congress in New Orleans, 19 of the 47 partnering scientific organizations met to discuss further collaborations among all pharmaceutical scientific organizations. During that meeting, several topics were selected for further collaborations. This paper is the result of one of those topics.

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Comments and views of the authors do not necessarily represent the views of the governmental agencies or the other organizations with whom they are affiliated.

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Zajicek, A., Fossler, M.J., Barrett, J.S. et al. A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms. AAPS J 15, 1072–1081 (2013). https://doi.org/10.1208/s12248-013-9511-5

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