Design and evaluation of deep eutectic solvent system for dabigatran etixilate.

Dabigatran Etexilate (DAB), a potent oral anticoagulant, suffers from poor solubility and low bioavailability. This study designed, characterized, and evaluated Deep Eutectic Solvents (DES) to overcome these constraints. Various DES were synthesized using Choline Chloride as a Hydrogen Bond Acceptor paired with Hydrogen Bond Donors including glycerol, oxalic acid, citric acid, PEG 400, and propylene glycol in different molar ratios. Systems were evaluated for stability, pH, and kinematic viscosity. Characterization used FTIR for compatibility, while solubility and Franz cell in vitro diffusion quantified performance. Accelerated stability studies per ICH Q1A (R2) guidelines were performed. Among screened formulations, a ternary Choline Chloride:Glycerol:PEG 400 (1:2:1) system demonstrated significant DAB solubility (168.2 mg/mL) over aqueous media. FTIR confirmed DAB integrity within the DES matrix. In-vitro diffusion revealed a three-fold release increase; the DES-DAB system reached 93.4±0.5% cumulative release at 7 hours versus 31.04±0.5% for pure drug. Accelerated stability confirmed the formulation meets regulatory shelf limits, maintaining over 95% chemical recovery for six months. The developed DES systems effectively resolved Dabigatran Etexilate solubility challenges, highlighting their potential for enhancing BCS Class II and IV drug delivery.