Development and Evaluation of a (SEDDS) Self-Emulsifying Drug Delivery System for Darifenacin Hydrobromide

Background: The formulation and development of new chemical entities has the major challenge of low solubility. A fraction of newly manufactured drugs (40%) have poor hydrophilicity. As a result, the delivery of these drugs bioavailability, thus limiting the rate of absorption of hydrophobic drugs. Method: Self-Emulsifying Drug Delivery (SEDDS) system with the poorly hydrophilic drug, darifenacin was developed. We conducted solubility studies to obtain the materials that allowed for the maximum solubility of darifenacin. Results: The highest solubility was found to be labrafil 1944 CS (Surfactant) polyethylene glycol 400 (Co-surfactant) and peanut oil. Emulsion regions were evaluated in constructed ternary phase diagrams. Thermodynamic stability and phase separation studies were conducted to investigate the degree of phase separation of the various formulations. The average globule size of SEDDS was witnessed to be less than 200 nm for in our optimized formulations and exhibiting negative zeta potential. When we compared the dissolution of emulsion formulations to pure darifenacin and the results showed that the rate of dissolution in the developed formulations with darifenacin was increased as compared to pure drug. Conclusion: Thus, SEDDS may provide a viable alternative for existing formulations of darifenacin on the market.