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

Abstract

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.

Farmacocinética comparada de metformina, en forma sólida y en formulación extemporánea líquida para pediatría, en voluntarios adultos sanos

“…20 Tanto la Agencia Europea de Medicamentos (EMA) como la Agencia de Alimentos y Medicamentos (FDA) de Estados Unidos establecen evaluar la biodisponibilidad de formulaciones extemporá-neas en voluntarios adultos sanos y extrapolar los resultados a la población pediátrica, dado que no es ético ejecutar este tipo de estudios en niños sanos. 12 En nuestro estudio ha quedado demostrado que no existen diferencias significativas entre los parámetros farmacocinéticos de la formulación comparados con los de la tableta comercial fraccionada. No se presentaron reacciones adversas a la formulación extemporánea de metformina.…”

“…11,12 Estos factores hacen poco costeable la producción de metformina pediá-trica por la industria farmacéutica, ya que su uso en niños y adolescentes es menos frecuente que en adultos. Actualmente, el personal médico y los familiares deben fraccionar las tabletas para ajustar la dosis.…”

Pharmacokinetics of a Taste-Masked Prednisone Oral Microsphere Powder

“…An API commonly cited as extremely bitter and difficult to mask is prednisone [10,11]. This corticosteroid is used in paediatrics and adults for a plethora of indications including respiratory conditions, dermatologic diseases and allergic response.…”

Quality Assessment in the Extemporaneous Pediatric Preparation of Powder Papers Containing Crushed Tablets of Spironolactone or Amiodarone

“…[1] Therefore, a pediatric formulation design requires an interdisciplinary work that comprehensively covers aspects of efficacy, safety and quality according to the proposed therapeutic goal. [2,3] Many traditional formulations have been produced under the premise that the efficacy in adults is equal in pediatrics, [4] but it is not known how safe the drugs are for this population, [5] particularly in neonates [6] where the physiological conditions are significantly different. [7] Most drug doses have been calculated using allometric scales that relate children's body weight or body surface area to the recommended adult dosage.…”