ABSTRACT
The objectives of this study were to optimize the formula of the self-nanoemulsifying drug delivery system (SNEDDS)containing rosuvastatin and to evaluate its physicochemical characteristics. The solubility and compatibility ofrosuvastatin in surfactants, cosurfactants, and oil excipients were evaluated. The D-optimal experimental design,created by JMP 15 software, was used for analyzing the effects of excipients on the physicochemical characteristicsof SNEDDS to optimize the rosuvastatin SNEDDS formula. The generated nanoemulsions from Ros SNEDDS werecharacterized for droplet size, polydispersity index, and entrapment efficiency. As a result, Cremophor RH40, Capryol90, and PEG 400 were selected to develop the pseudoternary phase diagram to identify the area capable of selfforming nanoemulsion. As the percentage of rosuvastatin calcium increased from 8% to 12%, the area for optimizingthe formula of Ros SNEDDS decreased. The Ros SNEDDS prepared according to predicted formulas possessed selfemulsification to form nanoemulsion with average droplet size less than 100 nm, polydispersity index less than 0.3,and rosuvastatin entrapment higher than 90%.
ABSTRACT
Nitrofurantoin is effective against many urinary tract pathogens. It acts as bacteriostatic and/or bactericidal by inhibiting DNA-RNA protein& cell wall synthesis. Nanostructured Lipid Carriers (NLCs) of NFT was prepared by Hot Homogenization Process. Glyceryl Monostearate and Miglyol 812 were heated at 80ºC temperature on hot plate. In the melted lipid, drug was added with continuous stirring at high speed homogenization. Formulation NLC12B has % Entrapment efficiency 89.1 ± 0.5, PDI 0.11 ± 0.01 and mean particle size 237 ± 7nm represents narrow particle size distribution. Spherical feature of NLCs with better uniformity without aggregation of Nitrofurantoin loaded NLC was confirmed by TEM. Moreover, efficient miscibility of drug in lipids was confirmed by the absence of intense and characteristic peak of NFT in XRPD. After 6 month storage at 2-8°C there was no significant changes in the PDI as well as mean particle size.