Formulation And Evaluation Of Simvastatin Self-Nanoemulsifying Drug Delivery Systems
Main Article Content
Abstract
The objective of this study is to improve dissolution rate, and oral bioavailability of the poorly water-soluble rosuvastatin calcium, this study set out to develop a one-of-a-kind self-nanoemulsifying drug delivery system to demonstrate the effects of oil, surfactant, and cosurfactant on drug solubility, pseudoternary phase diagrams were designed. The liquid SNEDDS formulation with Capmul PG8 (oil), Tween 20 (surfactant), and Transcutol P (cosurfactant) among the liquid SNEDDS formulations tested, it produced the smallest emulsion droplet size. Solubility studies served as the foundation for the selection of the lipids, surfactants, and co- surfactants used in SNEDDS. The effect of the concentration of the oil (X1), surfactant (X2), and cosurfactant (X3) as independent variables was investigated on the droplet size (Y1), and the as dependent variables, the percentage of cumulative drug release (Y2) was used by D-Optimal mixture design. To study in vivo Pharmacodynamic potential of SNEDDS formulation on Wistar rats. An optimized SNEDDS formulations with droplet sizes in the nano range of less than 200 nm (58.82 nm), the D-optimal combination design yielded in vitro drug release >90% within 30 minutes. When compared to pure drug and commercially available tablets, the developed formulation had a greater antihyperlipidemic capability, according to an in vivo pharmacodynamic study performed on rats. Rosuvastatin calcium initial drug release profile from improved formulation F5 was shown 99.98 release of drug which is significantly faster than that of marketed rosuvastatin calcium, according to in vitro drug release experiments. The mixture design showed significant systemic and successful developments of SNEDDS with better in vitro and in vivo performance as compared to market formulation. The study showed promising approach for standard doses.
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References
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