Impact of extemporaneous compounding on palatability, and in vitro bioaccessibility of azithromycin dry suspension assessed by electronic tongue and a dynamic gastrointestinal system (DHSI-IV).

The shortage of pediatric formulations remains a critical issue, often necessitating the extemporaneous compounding of adult medications to meet pediatric dosing requirements. However, this approach introduces potential challenges in dosing accuracy, stability, and bioavailability. In this study, an oral pharmaceutical vehicle, a commonly used medium for pediatric dose division, was employed to reconstitute azithromycin dry suspensions from three different manufacturers. Compared to the water-based reconstitution, all the vehicle-based preparations ensured homogeneous dispersion for up to 90 days shown RSD <5 % among ten sampling points of the drug, and maintained chemical stability for 14 days stored at 5 °C and 25 °C with the lowest retention concentration of 90.63 % relative to the 0-day samples. The liquid vehicle not only enabled precise volumetric delivery, but also significantly improved the palatability of azithromycin suspension, enhancing their acceptability in pediatric applications. Although the alkaline nature of the vehicle reduced acid-induced degradation of azithromycin in the stomach, its high viscosity and colloidal form impeded gastrointestinal transit and limited drug dissolution, ultimately reducing bioaccessibility by about 50 %. These findings suggest that oral vehicle can enhance dose precision and taste acceptance in pediatric compounding, but their impact on drug release and absorption highlights the necessity for further clinical validation.