A Pediatrics Utilization Study in The Netherlands to Identify Active Pharmaceutical Ingredients Suitable for Inkjet Printing on Orodispersible Films.

J. Carolina Visser,Olga Kiefer,Lisa Wibier,Mine Orlu,Herman J. Woerdenbag,Jörg Breitkreutz,Katja Taxis

doi:10.3390/pharmaceutics12020164

Abstract

Background: The use of medication in pediatrics, children aged 0–5 years, was explored so as to identify active pharmaceutical ingredients (APIs) suitable for inkjet printing on a plain orodispersible film (ODF) formulation in a pharmacy. Methods: The database IADB.nl, containing pharmacy dispensing data from community pharmacies in the Netherlands, was used to explore medication use in the age group of 0–5 years old, based on the Anatomical Therapeutic Chemical classification code (ATC code). Subsequently, a stepwise approach with four exclusion steps was used to identify the drug candidates for ODF formulation development. Results: there were 612 Active Pharmaceutical Ingredients (APIs) that were dispensed to the target group, mostly antibiotics. Of the APIs, 221 were not registered for pediatrics, but were used off-label. After the exclusion steps, 34 APIs were examined regarding their suitability for inkjet printing. Almost all of the APIs were sparingly water soluble to practically insoluble. Conclusion: Pharmaceutical inkjet printing is a suitable new technique for ODF manufacturing for pediatric application, however the maximal printed dose as found in the literature remained low. From the selected candidates, only montelukast shows a sufficiently high water-solubility to prepare a water-based solution. To achieve higher drug loads per ODF is ambitious, but is theoretically possible by printing multiple layers, using highly water-soluble APIs or highly loaded suspensions.

Highlights

Drug utilization research is an effective tool to identify the most used medications in patient groups, to assess the quality of prescribing and to facilitate rational drug use [1,2]
This results in manipulations of commercially available dosage forms, which may lead to medication errors [4]
The dose of antibiotics is usually too high to fit in an orodispersible film (ODF)

Summary

Introduction

Drug utilization research is an effective tool to identify the most used medications in patient groups, to assess the quality of prescribing and to facilitate rational drug use [1,2]. It is useful in pediatrics, a heterogeneous group of patients who frequently use off-label medications [2]. There is an apparent lack of age-appropriate dosage forms [2] This results in manipulations of commercially available dosage forms, which may lead to medication errors [4]. The use of medication in pediatrics, children aged 0–5 years, was explored so as to identify active pharmaceutical ingredients (APIs) suitable for inkjet printing on a plain orodispersible film (ODF) formulation in a pharmacy. To achieve higher drug loads per ODF is ambitious, but is theoretically possible by printing multiple layers, using highly water-soluble APIs or highly loaded suspensions

Methods

Discussion

Conclusion