Prasugrel hydrochloride (Prasugrel HCl), a potent thienopyridine-class antiplatelet agent, is classified as a Biopharmaceutics Classification System (BCS) Class II drug, characterized by low aqueous solubility and high permeability, which limits its oral bioavailability. To address these challenges, nanosponges—three-dimensional, porous nanostructures—were developed using β-cyclodextrin (β-CD) and ethyl cellulose (EC) cross-linked with dichloromethane (DCM) via the emulsion solvent evaporation method. Four formulations (F1–F4) were prepared by varying polymer ratios and processing parameters. Preformulation studies confirmed Prasugrel HCl's physicochemical properties, including a melting point of 120.5–121.9°C, log P of 3.54, and poor water solubility (<0.1 mg/mL). Characterization revealed F3 (300 mg β-CD:200 mg EC, 1000 rpm stirring) as optimal, exhibiting 26.4% drug loading, 89.7% encapsulation efficiency, particle size of 268.4 nm, PDI of 0.278, and negative zeta potential (-27.2 mV) for stability. SEM analysis showed uniform spherical morphology with 60–120 nm pores in F3, while FTIR confirmed drug-excipient compatibility without chemical interactions. These nanosponges enhance solubility and enable sustained release, positioning F3 as a promising carrier for improved Prasugrel HCl delivery in cardiovascular therapy
Keywords: Prasugrel HCl; Nanosponges; β-Cyclodextrin; Ethyl cellulose; Solubility enhancement; Antiplatelet therapy
How to cite this article: Suryawanshi AN,Ratnparkhi MP, Formulation and Characterization of β-Cyclodextrin and Ethyl Cellulose-Based Nanosponges for Enhanced Solubility and Sustained Delivery of Prasugrel Hydrochloride...Int J Drug Deliv Technol. 2025;15(4): 1632-1640, DOI: 10.25258/ijddt.15.4.15