Skip to main content
Log in

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

  • Commentary
  • Published:
Pediatric Drugs Aims and scope Submit manuscript

The Original Article was published on 21 April 2016

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Allegaert K, van den Anker J. Neonatal drug therapy: the first frontier of therapeutics for children. Clin Pharmacol Ther. 2015;98:288–97.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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. 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. 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.

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    PubMed  Google Scholar 

  12. Schmitt G. Safety of excipients in pediatric formulations—a call for toxicity studies in juvenile animals ? Children. 2015;2:191–7.

    Article  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

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).

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Karel Allegaert.

Ethics declarations

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.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Allegaert, K., Spriet, I. Substitution as a Strategy to Improve Excipient Exposure in Neonates: One Piece of the Puzzle. Pediatr Drugs 18, 231–233 (2016). https://doi.org/10.1007/s40272-016-0178-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40272-016-0178-0

Keywords

Navigation