Pediatric Drugs

, Volume 18, Issue 3, pp 231–233 | Cite as

Substitution as a Strategy to Improve Excipient Exposure in Neonates: One Piece of the Puzzle

Commentary
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Keywords

Propylene Glycol Poloxamer Systematic Strategy Flexible Dose Saccharin Sodium 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

The clinical research of K Allegaert was supported by the Fund for Scientific Research, Flanders (fundamental clinical investigatorship 1800214N) and the research activities are further facilitated by the agency for innovation by Science and Technology in Flanders (IWT) through the SAFEPEDRUG project (IWT/SBO 130033).

Compliance with Ethical Standards

Conflict of interest

K. Allegaert and I. Spriet declare that they have no relevant conflicts of interest.

Source of funding

No sources of funding were used to support the writing of this manuscript.

References

  1. 1.
    Allegaert K, van den Anker J. Neonatal drug therapy: the first frontier of therapeutics for children. Clin Pharmacol Ther. 2015;98:288–97.CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Turner MA, Duncan JC, Shah U, Mestvaht T, Varendi H, Nellis G, et al. Risk assessment of neonatal excipient exposure: lessons from food safety and other areas. Adv Drug Deliv Rev. 2014;73:89–101.CrossRefPubMedGoogle Scholar
  3. 3.
    Nellis G, Metsvaht T, Varendi H, Lass J, Duncan J, Nunn AJ, et al. Product substitution as a way forward in avoiding potentially harmful excipients in neonates. Pediatr Drugs. 2016. doi: 10.1007/s40272-016-0173-5.Google Scholar
  4. 4.
    Institute for Safe Medication Practices. Medication Safety Alert, February 13, 2014. Survey links PN component shortages to adverse outcomes. http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=70. Accessed 11 Apr 2016.
  5. 5.
    Klingmann V, Seitz A, Meissner T, Breitkreutz J, Moeltner A, Bosse HM. Acceptability of uncoated mini-tablets in neonates-a randomized controlled trial. J Pediatr. 2015;167:893–96e2.Google Scholar
  6. 6.
    Salunke S, Brandys B, Giacoia G, Tuleu C. The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2—the pilot version. Int J Pharm. 2013;457:310–22.CrossRefPubMedGoogle Scholar
  7. 7.
    Salunke S, Tuleu C, European Paediatric Formulation Initiative (EuPFI). The STEP database through the end-users eyes-USABILITY STUDY. Int J Pharm. 2015;492:316–31.CrossRefPubMedGoogle Scholar
  8. 8.
    Kulo A, de Hoon JN, Allegaert K. The propylene glycol research project to illustrate the feasibility and difficulties to study toxicokinetics in neonates. Int J Pharm. 2012;435:112–4.CrossRefPubMedGoogle Scholar
  9. 9.
    Turner MA, Duncan J, Shah U, Metsvaht T, Varendi H, Nellis G, et al. European study of neonatal exposure to excipients: an update. Int J Pharm. 2013;457:357–8.CrossRefPubMedGoogle Scholar
  10. 10.
    De Cock RF, Allegaert K, Vanhaesebrouck S, de Hoon J, Verbesselt R, Danhof M, et al. Low but inducible contribution of renal elimination to clearance of propylene glycol in preterm and term neonates. Ther Drug Monit. 2014;36:278–87.CrossRefPubMedGoogle Scholar
  11. 11.
    Pandya HC, Mulla H, Hubbard M, Cordell RL, Monks PS, Yakkundi S, et al. Essential medicines containing ethanol elevate blood acetaldehyde concentrations in neonates. Eur J Pediatr. 2016. doi: 10.1007/s00431-016-2714-x.PubMedGoogle Scholar
  12. 12.
    Schmitt G. Safety of excipients in pediatric formulations—a call for toxicity studies in juvenile animals ? Children. 2015;2:191–7.CrossRefGoogle Scholar
  13. 13.
    Lau K, Swiney BS, Reeves N, Noguchi KK, Farber NB. Propylene glycol produces excessive apoptosis in the developing mouse brain, alone and in combination with phenobarbital. Pediatr Res. 2012;71:54–62.CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.Intensive Care and Department of SurgeryErasmus MC-Sophia Children’s HospitalRotterdamThe Netherlands
  2. 2.Department of Development and RegenerationKU LeuvenLeuvenBelgium
  3. 3.Pharmacy DepartmentUniversity Hospitals LeuvenLeuvenBelgium
  4. 4.Department of Pharmacological and Pharmaceutical SciencesClinical Pharmacology and Pharmacotherapy, KU LeuvenLeuvenBelgium
  5. 5.Neonatal Intensive Care UnitUniversity HospitalLeuvenBelgium

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