Development and Evaluation of Solvent-Evaporated Solid Dispersions of Ziprasidone Hydrochloride Monohydrate for Improved Biopharmaceutical Performance
Keywords:
Ziprasidone Hydrochloride Monohydrate, solid dispersion, solubility, bioavailability, BCS Class II drugs, oral drug deliveryAbstract
This study aimed to enhance the solubility and oral bioavailability of Ziprasidone Hydrochloride Monohydrate (ZHM), a poorly water-soluble BCS Class II drug, by developing solid dispersions using hydrophilic carriers—PEG 6000, PVP K30, and urea—via solvent evaporation. Solid dispersions were prepared in drug-to-carrier ratios of 1:1, 1:2, and 1:3 and characterized for physicochemical properties, drug content, melting point, FTIR compatibility, and in vitro dissolution. Results demonstrated that the 1:3 ratio with urea (SDUR3) exhibited the highest solubility and dissolution rate, achieving up to 86.32% drug release within 90 minutes. Melting point reduction indicated conversion to an amorphous form, and FTIR studies confirmed no chemical interactions, ensuring formulation stability. The enhanced dissolution is attributed to reduced crystallinity and improved wettability by the carriers. This research validates solid dispersion technology as an effective strategy to improve the oral delivery and bioavailability of poorly soluble drugs like ZHM, with potential applicability in broader pharmaceutical formulations. Further studies are recommended to explore solubility mechanisms for optimization.
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