Formulation and Evaluation of Self Nano Emulsifying Drug Delivery System Containing Mesalamine

The Self-Nano Emulsifying Drug Delivery System (SNEDDS) represents a modern strategy to improving the oral availability of poorly water-soluble medication. The two main goals of the study were to design and evaluate mesalamine containing S-SNEDDS that would deliver the medicine particularly to the colon, increasing its oral bioavailability, and to investigate the characteristics of biosurfactants as pharmaceutical emulsifiers for L-SNEDDS. The optimal formulations were determined using a pseudo-ternary phase diagram comprising olive oil as the oil phase, biosurfactant as the surfactant, and PEG-400 as the co-surfactant. The solid adsorption process was employed to transform L-SNEDDS into free-flowing S-SNEDDS, using Syloid 244FP as the solid carrier. Out of 63 patients, 36 patients with small varices (F1/F2) and 27 with larger (F3) varices were detected on endoscope. Significant increase in mean splenic index from low (86.7 +/- 27.4) to high (94.7 +/- 27.7) grade varices was documented. Opposite trend was found with platelets (120.2 +/- 63.5 to 69.8 +/- 36.1) and platelets/ splenic diameter ratio (1676.7 to 824.6) declining significantly. Logistic regression showed splenic collaterals and platelets are significantly but negatively associated with esophageal varices grades. The evaluation of mesalamine-loaded L-SNEDDS revealed the following results: a transmittance of 85.57%, clear dispersibility, rapid self-emulsification within one minute, globule size of up to 100 nm, zeta potential of -31 mV, transmission electron microscopy (TEM) analysis, and an entrapment efficiency of 94.40%. Additionally, in vitro cell viability assays, micrometric characteristics, Fourier-transform infrared (FTIR) spectroscopy, drug content of 97%, and in vitro study of S-SNEDDS were also conducted. The findings indicate that biosurfactants serve as effective emulsifiers for L-SNEDDS, enhancing emulsifying property and stabilizing dispersions over time. Batch MF6 was optimized based on globule size, entrapment efficiency, and release profiles, demonstrating an improved dissolution rate compared to the marketed formulation.