title: A report from the pediatric formulations task force: perspectives on the state of child-friendly oral dosage forms.
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.
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA, zajiceka@mail.nih.gov.
authors.forename: Anne
authors.initials: A
authors.lastname: Zajicek
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Fossler
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Barrett
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Worthington
authors.forename: Robert
authors.initials: R
authors.lastname: Ternik
authors.forename: Georgia
authors.initials: G
authors.lastname: Charkoftaki
authors.forename: Susan
authors.initials: S
authors.lastname: Lum
authors.forename: Jörg
authors.initials: J
authors.lastname: Breitkreutz
authors.forename: Mike
authors.initials: M
authors.lastname: Baltezor
authors.forename: Panos
authors.initials: P
authors.lastname: Macheras
authors.forename: Mansoor
authors.initials: M
authors.lastname: Khan
authors.forename: Shreeram
authors.initials: S
authors.lastname: Agharkar
authors.forename: David Douglas
authors.initials: DD
authors.lastname: MacLaren
mesh_terms: D000284:Administration, Oral; D026683:Advisory Committees / Q000639:trends; D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000639:trends; D002648:Child; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry*; D058028:Research Report / Q000639:trends; D013649:Taste / Q000187:drug effects / Q000502:physiology
chemical_list: D004364:Pharmaceutical Preparations
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