Abstract

This dataset reports the results of the development and characterization of orodispersible wafers (ODWs) for the administration of omeprazole (OMZ) in pediatric patients, particularly toddlers. Addressing the limitations of conventional compounded oral suspensions — namely poor stability and lack of gastroprotection — this work presents a child-appropriate, stable, ready-to-use dosage form suitable for hospital pharmacy preparation. ODWs were formulated using natural polymers, including pectin, κ-carrageenan, and maltodextrins, and produced by lyophilization. Gastroprotection of OMZ was achieved through encapsulation approaches involving calcium alginate–zein beads and lipid microparticles (LMPs) based on Geleol® and Dynasan® 114 (trimyristin). The dataset includes comprehensive physicochemical characterization of beads, LMPs and ODWs, covering drug loading, encapsulation efficiency, thermogravimetric analysis (TGA), and solid-state evaluation by X-ray diffraction (XRD), and demonstrates final formulation stability for up to six months. In addition, the results of dissolution studies conducted in both physiological buffers and biorelevant media are reported.