Copyright ©2013 Baishideng. All rights reserved.
World J Clin Pediatr. Feb 8, 2013; 2(1): 1-5
Published online Feb 8, 2013. doi: 10.5409/wjcp.v2.i1.1
Neonates need tailored drug formulations
Karel Allegaert
Karel Allegaert, Department of Development and Regeneration, University Hospitals, 3000 Leuven, Belgium
Karel Allegaert, Neonatal Intensive Care Unit, University Hospitals, Leuven, 3000 Leuven, Belgium
Author contributions: Allegaert K wrote this paper.
Supported by The Fund for Scientific Research, Flanders (Fundamental Clinical Investigatorship 1800209N)
Correspondence to: Karel Allegaert, MD, PhD, Neonatal Intensive Care Unit, University Hospital, Herestraat 49, 3000 Leuven, Belgium. karel.allegaert@uzleuven.be
Telephone: +32-16-343850 Fax: +32-16-343209
Received: December 10, 2012
Revised: December 15, 2012
Accepted: January 18, 2013
Published online: February 8, 2013

Drugs are very strong tools used to improve outcome in neonates. Despite this fact and in contrast to tailored perfusion equipment, incubators or ventilators for neonates, we still commonly use drug formulations initially developed for adults. We would like to make the point that drug formulations given to neonates need to be tailored for this age group. Besides the obvious need to search for active compounds that take the pathophysiology of the newborn into account, this includes the dosage and formulation. The dosage or concentration should facilitate the administration of low amounts and be flexible since clearance is lower in neonates with additional extensive between-individual variability. Formulations need to be tailored for dosage variability in the low ranges and also to the clinical characteristics of neonates. A specific focus of interest during neonatal drug development therefore is a need to quantify and limit excipient exposure based on the available knowledge of their safety or toxicity. Until such tailored vials and formulations become available, compounding practices for drug formulations in neonates should be evaluated to guarantee the correct dosing, product stability and safety.

Keywords: Drug formulation, Newborn, Excipient, Safety, Quality control