Formulation and Evaluation of Self-Nanoemulsifying Drug Delivery System (SNEDDS) of Pravastatin

Abstract

The present study was undertaken to develop and evaluate a Self-Nanoemulsifying Drug Delivery System (SNEDDS) of Pravastatin to enhance its intestinal permeability, dissolution rate, and oral bioavailability. Pravastatin, a BCS Class III drug, exhibits high aqueous solubility but poor permeability, leading to variable and limited oral absorption. To overcome this limitation, lipid-based SNEDDS formulations were designed using different combinations of oils, surfactants, and co-surfactants. Preformulation studies, including solubility analysis, melting point determination, UV spectroscopy, and FTIR, confirmed the physicochemical characteristics and compatibility of the drug with selected excipients. Nine SNEDDS formulations (F1–F9) were prepared and evaluated for droplet size, polydispersity index (PDI), zeta potential, self-emulsification efficiency, drug content, and in vitro dissolution behavior. The results indicated that all formulations formed stable nanoemulsions upon dilution. Among them, formulation F5 exhibited optimal characteristics with the smallest droplet size, low PDI, satisfactory zeta potential, and superior drug release profile. The in vitro dissolution study demonstrated significantly enhanced drug release compared to conventional systems, indicating improved solubilization and potential for enhanced absorption. Overall, the developed SNEDDS formulations successfully improved the biopharmaceutical performance of Pravastatin, suggesting that this approach can be an effective strategy for enhancing oral delivery of poorly permeable drugs.

Keywords: SNEDDS, Pravastatin, Nanoemulsion, Bioavailability enhancement, BCS Class III drug, Lipid-based drug delivery system, Oral drug delivery, Dissolution improvement.