Vol. 2, Issue 2, Part A (2025)

The stabilization and beyond-use dating (BUD) of extemporaneously compounded pediatric oral suspensions remain a critical challenge in clinical pharmacy practice. This multicenter study aimed to evaluate the stability of seven commonly compounded pediatric APIs (amlodipine, tacrolimus, omeprazole, quetiapine, spironolactone, lansoprazole, and furosemide) in three widely used vehicles (SyrSpend® SF pH 4, Ora-Plus/Sweet, and Oral Mix/Blend) under refrigerated and room-temperature storage conditions. A total of 378 compounded batches were analyzed across six compounding sites for chemical potency, physical attributes, and microbiological quality over 90 days. The results demonstrated that refrigerated storage significantly enhanced stability compared to room temperature, and the vehicle composition played a key role in determining the stability of each API. Non-PPI APIs exhibited extended stability up to 60 days under refrigeration, whereas acid-labile PPIs (omeprazole and lansoprazole) failed to meet extended BUDs in acidic vehicles, supporting the need for alkaline vehicles for such drugs. All formulations passed microbiological testing, with preservative systems meeting USP <51> antimicrobial effectiveness standards. Based on these findings, we propose extended BUDs for several APIs beyond the standard 14-day limit in specific vehicles, particularly under refrigeration. The study emphasizes the need for evidence-based BUDs, standardized compounding procedures, and a careful balance of excipient safety when determining BUDs for pediatric formulations. This research provides actionable data for improving the safety and efficacy of pediatric compounding, reducing unnecessary refills, and ensuring the availability of stable medications.