Abstract

Dr. Ghanshyam Patel*, Abidhusain Sunasara, Dr. Yogesh Patel, Dr. Disha Suthar, Ms. Jaini Patel, Dr. Divyakant Patel

ABSTRACT

The present study focuses on the development and characterization of a pH-responsive mucoadhesive microemulsion of Vonoprazan Fumarate for targeted esophageal drug delivery in the management of gastroesophageal reflux disease (GERD). Capryol 90 was selected as the oil phase due to its high solubilization capacity for the drug. Tween 20 and propylene glycol, in a 1:2 ratio, were used as surfactant and co-surfactant to form a stable microemulsion. Chitosan lactate was incorporated as a mucoadhesive polymer to enhance retention at the esophageal mucosa, while Eudragit E 12.5 was employed as a pH-responsive polymer for site-specific release under mildly acidic conditions. The formulations were prepared using the phase titration method and optimized through D-optimal design. The optimized formulation was characterized for droplet size, zeta potential, viscosity, pH, drug content, in vitro release, and mucoadhesion. Results confirmed the optimized microemulsion exhibited ~150 nm droplets, positive zeta potential (+32 mV), good viscosity, pH-responsive release, and strong mucoadhesion. These findings suggest the potential of this delivery system to improve solubility, retention, and therapeutic effectiveness of Vonoprazan Fumarate in GERD.