Quality by Design Optimization of Telmisartan-loaded Self-nanoemulsifying Drug Delivery Systems

Aim: This study aimed to develop a QbD-based SNEDDS for Telmisartan to enhance its biopharmaceutical performance. Background: Quality by Design (QbD) was incorporated by selecting the Critical Process Pa-rameters (CPPs) as influential variables upon the desired responses. Using Design of Experiments (DoE) software, oil, and S/CoS were tested for pre-isotropic compatibility and formulation im-provement. A heating-cooling cycle and phase separation were used to determine the formula-tions' dispersibility, self-emulsifying time, mean globule size, and stability. Objective: Using Design of Experiments (DoE) software, oil (Capmul MCM C-10) and surfactant (Labrasol)/co-surfactant (Tween-20, and PEG-600) (S/CoS) ratios were optimized for pre-isotropic compatibility and formulation improvement. Methods: Aerosil-200, Sylysia-350, 550, and 730 were used as porous carriers, and Neusilin US2 as an adsorbing agent resulted in free-flowing granules of self-nano emulsifying drug delivery systems. The SNEDDS was further formulated into tablets using a direct compression technique with enhanced disintegration properties. Results: The prepared SNEDDS tablets exhibited a 71% increase in drug dissolution as compared to the pure drug and marketed formulation after the in vitro dissolution studies. Conclusion: This QbD approach offers a promising strategy for developing SNEDDS formula-tions for poorly soluble drugs like Telmisartan.