Bosentan Solid Lipid Nanoparticle Development and Statistical Optimization Using 3² Full Factorial Design

Bosentan is a BCS class II drug having a problem of oral bioavailability. This research work gives an idea of solid lipid nanoparticles (SLN) as a drug carrier system for enhancing solubility of the poorly water soluble drug. According to the results, bosentan solubility is greatly increased by SLN; the optimized batch showed a solubility of roughly 64.37±0.33 µg/mL. An optimized SLN batch was analyzed using DSC, FTIR, XRD, SEM, and TEM. The XRD analysis indicated a transition of the drug's crystalline characteristics to an amorphous state, resulting in a smoother and larger particle surface area compared to its crystalline form, which subsequently enhances solubility. SEM images indicate that the optimized batch contains spherical globules within the nanometric range. The detected particle size in TEM was determined to be precisely 100 nm, which is comparable to the particle size recorded in DLS. TEM pictures showed a smooth-surfaced, spherical shape. After 12 h, the in vitro investigation reveals 94.59% drug release. In accordance with ICH recommendations, the optimized batch was also examined for an accelerated stability assessment in a stability chamber at 25 ºC ±2 ºC and 60±5% relative humidity (RH). The optimized batch (SLN 6) did not exhibit any signs of color or particle size changes.