Year: 2025
Type: conference-paper
Abstract: Background and Importance 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. Aim and Objectives 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. Material and Methods 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. Results 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. Conclusion and Relevance Compounded oral suspensions demonstrated potential as personalised, age-appropriate formulations, ensuring dose consistency and stability across a diverse group of APIs. References and/or Acknowledgements Conflict of Interest 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.
Institution: National and Kapodistrian University of Athens
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408376040