Розробка та характеристика наночастинок езетимібу для лікування гіперліпідемії

The aim of the work. Ezetimibe (EZ) is categorized as a Biopharmaceutics Classification System class II (BCS II) agent that possesses poor solubility and is highly permeable. This work aimed to incorporate EZ into nanoparticles (NPs) to accelerate release and to enhance its bioavailability. Materials and Methods. A stability-indicating method for the computation of EZ was developed to compute EZ in NPs in fresh and stored samples. Nine formulations of EZ-NPs were developed by solvent evaporation using HPMC 6 cps, sodium alginate, and Tween 80 in various proportions. A HPLC method was designed to estimate EZ in NPs. EZ-NPs were tested chemically and characterized. Results. The developed method was fully validated, and EZ NPs comprising HPMC and tween 80 had zeta potential (ZP) ranging from -21.6 mV to -30.1 mV, higher than other formulae, and their release was enhanced. The formulation (HP4) had an elevated ZP (-30.1 mV) and released about 91% of EZ within 20 min. HP4 was chosen for stability assessment and proved to be stable. Conclusion. The formulation (HP4), including 0.1:0.5:0.4 ratios of the EZ: HPMC: sodium alginate, was the optimized EZ-NPs formulation. Microencapsulation of EZ with HPMC: sodium alginate in a 0.1:0.5:0.4 ratio could enhance the release and achieve stability