Formulation and Evaluation of Solid-Self Nano Emulysifying Drug Delivery System of poorly soluble drug Rosuvastatin for increased its bioavailability

Pharmaceutics

Rosuvastatin is a potent antihyperlipidemic agent whose oral bioavailability is limited by poor aqueous solubility and slow dissolution. The present study aimed to develop and evaluate a solid self-nanoemulsifying drug delivery system (S-SNEDDS) to improve the dissolution behavior and oral performance of rosuvastatin. Liquid SNEDDS composed of Capmul MCM, Tween 80, and egg lecithin were transformed into solid systems by adsorption onto suitable carriers and subsequently compressed into tablets by direct compression. The prepared formulations were characterized for physicochemical properties, drug–excipient compatibility, thermal behavior, and in vitro drug release. The tablet formulations exhibited acceptable weight uniformity, hardness, friability, and flow characteristics, indicating good compressibility and mechanical strength. Fourier-transform infrared spectroscopy confirmed the absence of significant interactions between rosuvastatin and the excipients, while differential scanning calorimetry demonstrated the disappearance of the characteristic melting peak of the drug, suggesting its conversion into an amorphous or molecularly dispersed state within the lipid matrix. In vitro dissolution studies revealed a marked enhancement in drug release from all S-SNEDDS formulations compared with pure rosuvastatin. More than 90% of the drug was released within 30 min, whereas the pure drug showed only 29.54% release. Among the investigated formulations, F4 exhibited the highest dissolution performance, which was attributed to rapid emulsification and the formation of fine nano-sized droplets. These findings demonstrate that S-SNEDDS represent an efficient and promising strategy for improving the dissolution characteristics and potential oral bioavailability of poorly water-soluble rosuvastatin.

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