BetaEntity Annotation Prototype
← Back to drugs

Annotated abstract

3PC-041 Getting the dose right: evaluating consistency in oral compounding

ejhpharm · 2026-03-18 · canonical JSON source

6 visible annotations · policy: published · automated confidence ≥ 75.00%

Document resource

Background and Importance In daily (hospital) pharmacy practice, extemporaneous compounding remains a vital solution for patients with limited commercial options - especially in paediatric and geriatric care. Yet, ensuring consistent dosing across preparations is a known challenge. To support pharmacists in delivering safe and reliable care, we consolidated previously generated and new stability data and calculated content uniformity across multiple compounded suspensions using a single, standardised vehicle. This approach offers practical insights into dose consistency and helps address long-standing concerns around variability in extemporaneous formulations.Aim and Objectives To assess dose uniformity and stability in extemporaneously compounded oral suspensions prepared with SyrSpend SF PH4. By combining results from previously conducted studies, we aim to provide (hospital) pharmacists with a clearer understanding of the accuracy and reliability of these suspensions.Material and Methods The analysis included 180 formulations containing 127 active pharmaceutical ingredients (APIs), with 5,700 samples stored at room temperature and under refrigeration. Formulations were prepared under controlled laboratory conditions using validated compounding procedures and analysed with stability indicating HPLC-UV methods. Method specificity was confirmed through forced degradation. To mimic routine patient use, samples were manually agitated before six aliquots were drawn from the centre of each container at day 0, 7, 14, 30, 60, and 90. Content uniformity was assessed using USP <905> acceptance criteria, adjusted to account for the available sample size. Chemical stability was determined by comparing recovery values to initial concentrations.Results All formulations tested met the acceptance limits of both the United States Pharmacopeia (USP) and the British Pharmacopoeia (BP). Average recovery values were 99.81% at room temperature and 100.21% under refrigeration, with no samples exceeding USP maximum limits. Mean concentrations remained within 90.86% and 109.91% of label claim, indicating accurate and consistent dosing. These findings confirm that SyrSpend SF PH4 maintains content uniformity and chemical stability across a wide range of APIs under different storage conditions.Conclusion and Relevance This study provides (hospital) pharmacists with a practical, evidence-based framework for dose accuracy in extemporaneous compounding. Demonstrating reliable content uniformity and stability across multiple APIs and storage conditions, it supports safer, more standardised preparation of oral suspensions. These results can strengthen internal quality assurance processes and reinforce confidence in everyday compounding decisions.Conflict of Interest Corporate sponsored research or other substantive relationships:Carolina Schettino Kegele, Hudson Polonini and Eli Dijkers are employees of Fagron Group. The University of Athens has been provided a financial compensation to cover the costs of executing part of the stability studies presented in this abstract.