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Formulation and Evaluation of Dexlansoprazole-Loaded Solid Lipid Nanoparticles for Solubility Enhancement

Aashwini Ghuge*, Dr. Pravin Wakte, Dr. Sachin Bhusari, Renuka Dhakne, Dr. Preeti Sable

Zenodo (CERN European Organization for Nuclear Research), 2025

Abstract

Dexlansoprazole, a proton pump inhibitor widely used in the management of gastroesophageal reflux disease (GERD), belongs to the Biopharmaceutical Classification System (BCS) Class II, characterized by low aqueous solubility and high permeability. Its poor solubility and acid-labile nature significantly limit oral bioavailability and therapeutic effectiveness. The present study was aimed at the formulation and evaluation of Dexlansoprazole-loaded solid lipid nanoparticles (SLNs) to enhance solubility, stability, and dissolution performance. SLNs were prepared using a modified single-emulsion solvent evaporation method assisted by probe sonication. Glyceryl monostearate (GMS) was used as the lipid matrix, Tween 80 as the surfactant, and dimethylformamide as the organic solvent. Optimization of formulation variables was carried out using a factorial design approach to achieve minimal particle size and maximum entrapment efficiency. The optimized formulation exhibited a mean particle size of approximately 156 nm with a narrow polydispersity index, indicating uniform nanoparticle distribution. Fourier Transform Infrared (FTIR) analysis confirmed the absence of chemical interactions between Dexlansoprazole and formulation excipients, indicating physical entrapment of the drug. Scanning Electron Microscopy (SEM) revealed spherical nanoparticles with smooth surface morphology. Entrapment efficiency was found to be significantly high, demonstrating effective drug incorporation…

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