A Pediatrics Utilization Study in The Netherlands to Identify Active Pharmaceutical Ingredients Suitable for Inkjet

J Carolina Visser1, Lisa Wibier1,2, Olga Kiefer3

  • 1Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.

Pharmaceutics
|February 22, 2020
PubMed

Insights

This study explored active pharmaceutical ingredients (APIs) for inkjet-printed orodispersible films (ODFs) in children aged 0-5 years. Pharmaceutical inkjet printing shows promise for pediatric ODFs, though achieving higher drug doses requires further development.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Drug Delivery
  • Formulation Development

Background:

  • Medication use in pediatrics (0-5 years) was investigated to identify suitable active pharmaceutical ingredients (APIs).
  • The focus was on APIs amenable to inkjet printing onto orodispersible films (ODFs) for pharmacy-based manufacturing.
  • This research addresses the need for tailored pediatric dosage forms.

Purpose of the Study:

  • To identify active pharmaceutical ingredients (APIs) suitable for inkjet printing on orodispersible films (ODFs) for pediatric use.
  • To explore medication dispensing data in children aged 0-5 years in the Netherlands.
  • To assess the feasibility of pharmaceutical inkjet printing for pediatric ODF formulations.

Main Methods:

  • Utilized the IADB.nl database for pharmacy dispensing data in children aged 0-5 years.
  • Employed a stepwise exclusion approach to identify potential drug candidates for ODF development.
  • Evaluated 34 selected APIs for their suitability for inkjet printing, considering water solubility.

Main Results:

  • 612 APIs were dispensed to the pediatric group, predominantly antibiotics; 221 were used off-label.
  • Most identified APIs exhibited low water solubility, posing challenges for formulation.
  • 34 APIs were shortlisted for inkjet printing suitability assessment.

Conclusions:

  • Pharmaceutical inkjet printing is a viable technique for pediatric ODF manufacturing.
  • Montelukast is a promising candidate due to its high water solubility for aqueous solutions.
  • Achieving higher drug loads may involve multi-layer printing or using highly soluble APIs/suspensions.
Abstract

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