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The Clinical Relevance of Pediatric Formulations

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Pediatric Formulations

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 11))

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Abstract

Extensive variability in dose and dosing regimens used to treat pediatric patients, based on maturational and non-maturational differences between individuals, is part of the essence of pediatric clinical pharmacology today. Consequently, the pediatric community is in need of drug formulations tailored to the specific needs of neonates, infants, children, and adolescents. This must include valid data on product stability, palatability, and compatibility. Most of the time, children are still treated with medicines that were neither designed, developed nor evaluated specifically for use by children. As a consequence, there is a risk of suboptimal (too low, too high, or too variable) dosing and side effects from potentially toxic ingredients, including excipients.

The topic of excipients will be used to illustrate the clinical relevance and the feasibility of collecting information about formulations for children. This will be followed by a road map reflecting a clinician’s view of how the current situation related to child-size formulations can be improved, based on collaborative efforts between manufacturers, agencies, regulatory bodies, caregivers, and academia.

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Abbreviations

ADME:

Absorption, distribution, metabolism, and excretion

BW:

Birth weight

CL:

Clearance

EMA:

European medicines agency

ESNEE:

European Study for Neonatal Excipient Exposure

EUPFI:

European Paediatric Formulation Initiative

FDA:

Food and Drug Administration

GRAS:

Generally regarded as safe

HIV:

Human immunodeficiency virus

IV:

Intravenous

PD:

Pharmacodynamics

PedCo:

Pediatric Committee

PG:

Propylene glycol

PIP:

Paediatric Investigation Plan

PK:

Pharmacokinetics

PNA:

Postnatal age (days)

SPC:

Summary of product characteristics

STEP:

Safety and Toxicity of Excipients for Paediatrics database

WHO:

World Health Organization

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Author information

Authors and Affiliations

  1. Neonatal Intensive Care Unit, University Hospitals, Herestraat 49, 3000, Leuven, Belgium

    Karel Allegaert

  2. Pharmacy Department, Ghent University Hospital, Ghent, Belgium

    Pieter De Cock

  3. Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium

    Pieter De Cock

  4. Division of Pediatric Clinical Pharmacology, Children’s National Medical Center, Washington, DC, USA

    Johannes N. van den Anker

  5. Departments of Pediatrics, Pharmacology, Physiology and Integrative Systems Biology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA

    Johannes N. van den Anker

  6. Intensive Care, Erasmus MC-Sophia Children’s Hospital, Rotterdam, The Netherlands

    Johannes N. van den Anker

Authors
  1. Karel Allegaert
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  2. Pieter De Cock
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  3. Johannes N. van den Anker
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Corresponding author

Correspondence to Karel Allegaert .

Editor information

Editors and Affiliations

  1. Department of Pharmaceutics Department of Analytical Chemistry, University of Copenhagen, Denmark

    Daniel Bar-Shalom

  2. Pediatric Drug Development & More, klausrose Consulting, Riehen, Switzerland

    Klaus Rose

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Allegaert, K., De Cock, P., van den Anker, J.N. (2014). The Clinical Relevance of Pediatric Formulations. In: Bar-Shalom, D., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 11. Springer, New York, NY. https://doi.org/10.1007/978-1-4899-8011-3_6

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