3PC-029 Compatibility of age-appropriate compounded oral suspensions

<h3>Background and Importance</h3> Oral administration is the primary route for drug delivery; however, standard licensed medications often fail to meet the specific needs of neonates, infants, young children, and older adults. Challenges such as dose adjustments and swallowing difficulties can compromise treatment efficacy and adherence, as common practices like splitting or crushing pills may lead to inaccurate dosing and reduced drug stability. Compounded medications offer a valuable alternative by allowing (hospital)pharmacists to create tailored formulations that address individual patient requirements. In addition, compounded medications may help overcome shortages of oral-liquid medications. <h3>Aim and Objectives</h3> This study evaluated the compatibility of various oral suspensions compounded with the ready-to-use suspending agent SyrSpend SF and assessed their suitability for age-appropriate formulations across ten different pharmacological classes. <h3>Material and Methods</h3> Nineteen APIs were compounded with SyrSpend SF PH4 liquid and stored at refrigerated (2–8°C) and room temperatures (20–25°C). Physical-chemical compatibility was assessed over 90 days by measuring percent recovery using a stability-indicating high-performance liquid chromatography (HPLC-UV) method. At the end of the shelf life, the antimicrobial effectiveness (AET) was performed according to the current EP guideline. <h3>Results</h3> Most compounded suspensions remained compatible for 90 days under both refrigerated and room temperature conditions, with the following exceptions: Cefadroxil was stable for 60 days when refrigerated and for 7 days at room temperature; Cimetidine was stable for 30 days at room temperature. Losartan Potassium, Nystatin, and Theophylline were not stable at room temperature, while Pyridostigmine Bromide was not stable when refrigerated. All other APIs and conditions were stable for at least 90 days. Additionally, all compounds met AET specifications. Notably, the pH of cimetidine was adjusted to approximately four during compounding. <h3>Conclusion and Relevance</h3> Compounded oral suspensions demonstrated potential as personalised, age-appropriate formulations, ensuring dose consistency and stability across a diverse group of APIs. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> Corporate sponsored research or other substantive relationships: ECF Dijkers, M Kousteliou, and HC Polonini are employees of Fagron BV. The National and Kapodistrian University of Athens has received financial compensation for the performance of the stability studies.

Authors

Institutions

Publication Details

Published
2025-03-01
DOI
https://doi.org/10.1136/ejhpharm-2025-eahp.61
Primary Topic
Safe Handling of Antineoplastic Drugs
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

3PC-029 Compatibility of age-appropriate compounded oral suspensions

Eli Dijkers, Hudson Polonini, M Kostakis, M Kousteliou et al.
Safe Handling of Antineoplastic Drugs
article

3PC-029 Compatibility of age-appropriate compounded oral suspensions

Eli Dijkers, Hudson Polonini, M Kostakis, M Kousteliou, P Dallas
article en

Abstract

<h3>Background and Importance</h3> Oral administration is the primary route for drug delivery; however, standard licensed medications often fail to meet the specific needs of neonates, infants, young children, and older adults. Challenges such as dose adjustments and swallowing difficulties can compromise treatment efficacy and adherence, as common practices like splitting or crushing pills may lead to inaccurate dosing and reduced drug stability. Compounded medications offer a valuable alternative by allowing (hospital)pharmacists to create tailored formulations that address individual patient requirements. In addition, compounded medications may help overcome shortages of oral-liquid medications. <h3>Aim and Objectives</h3> This study evaluated the compatibility of various oral suspensions compounded with the ready-to-use suspending agent SyrSpend SF and assessed their suitability for age-appropriate formulations across ten different pharmacological classes. <h3>Material and Methods</h3> Nineteen APIs were compounded with SyrSpend SF PH4 liquid and stored at refrigerated (2–8°C) and room temperatures (20–25°C). Physical-chemical compatibility was assessed over 90 days by measuring percent recovery using a stability-indicating high-performance liquid chromatography (HPLC-UV) method. At the end of the shelf life, the antimicrobial effectiveness (AET) was performed according to the current EP guideline. <h3>Results</h3> Most compounded suspensions remained compatible for 90 days under both refrigerated and room temperature conditions, with the following exceptions: Cefadroxil was stable for 60 days when refrigerated and for 7 days at room temperature; Cimetidine was stable for 30 days at room temperature. Losartan Potassium, Nystatin, and Theophylline were not stable at room temperature, while Pyridostigmine Bromide was not stable when refrigerated. All other APIs and conditions were stable for at least 90 days. Additionally, all compounds met AET specifications. Notably, the pH of cimetidine was adjusted to approximately four during compounding. <h3>Conclusion and Relevance</h3> Compounded oral suspensions demonstrated potential as personalised, age-appropriate formulations, ensuring dose consistency and stability across a diverse group of APIs. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> Corporate sponsored research or other substantive relationships: ECF Dijkers, M Kousteliou, and HC Polonini are employees of Fagron BV. The National and Kapodistrian University of Athens has received financial compensation for the performance of the stability studies.

National and Kapodistrian University of Athens (GR), International Council for Research and Innovation in Building and Construction (NL)
Openalex Percentile: Top 93%
Safe Handling of Antineoplastic Drugs
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.